81 FR 81250 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 222 (November 17, 2016)
Federal Register Volume 81, Issue 222 (November 17, 2016)
| Page Range | 81250-81274 | |
| FR Document | 2016-27326 |
[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)] [Rules and Regulations] [Pages 81250-81274] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27326] [[Page 81249]] Vol. 81 Thursday, No. 222 November 17, 2016 Part II Environmental Protection Agency ----------------------------------------------------------------------- 40 CFR Parts 9 and 721 Significant New Use Rules on Certain Chemical Substances; Final Rule Federal Register / Vol. 81 , No. 222 / Thursday, November 17, 2016 / Rules and Regulations [[Page 81250]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2016-0207; FRL-9953-41] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. ----------------------------------------------------------------------- SUMMARY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 57 chemical substances which were the subject of premanufacture notices (PMNs). The applicable review periods for the PMNs submitted for these 57 chemical substances all ended prior to June 22, 2016 (i.e., the date on which President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which amends TSCA). Thirty-four of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 57 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 initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and take such actions as are required with that determination. DATES: This rule is effective on January 17, 2017. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on December 1, 2016. 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 December 19, 2016 (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 December 19, 2016, EPA will withdraw the relevant sections of this direct final rule before its effective date. For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0207, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after December 19, 2016 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. [emsp14]721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. What action is the Agency taking? EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. 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. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). [[Page 81251]] Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data. B. What is the Agency's authority for taking this action? 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. 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 (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. C. Applicability of General Provisions 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 Sec. [emsp14]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 section 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 must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings. III. Significant New Use Determination Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: The projected volume of manufacturing and processing of a chemical substance. The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance. The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance. The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors. To determine what would constitute a significant new use for the 57 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. IV. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for 57 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: PMN number. Chemical name (generic name, if the specific name is claimed as CBI). Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities). Basis for the TSCA section 5(e) consent order or, for non- section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders). Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information). CFR citation assigned in the regulatory text section of this rule. 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 34 PMN substances that are subject to ``risk- based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called ``TSCA section 5(e) SNURs'' on these PMN substances are promulgated pursuant to Sec. [emsp14]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. Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the Sec. 721.63 respirator requirements may request to do so under Sec. [emsp14]721.30. EPA expects that persons whose Sec. 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance. [[Page 81252]] This rule also includes SNURs on 23 PMN substances that are not subject to consent orders under TSCA section 5(e). These cases completed Agency review prior to June 22, 2016. Under TSCA, prior to the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a ``significant new use.'' These so-called ``non- TSCA section 5(e) SNURs'' are consistent with the determination made at the time and are promulgated pursuant to Sec. [emsp14]721.170. EPA has determined that every activity designated as a ``significant new use'' in all non-TSCA section 5(e) SNURs issued under Sec. [emsp14]721.170 satisfies the two requirements stipulated in Sec. 721.170(c)(2), i.e., these significant new use activities, ``(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified'' for the PMN substance. PMN Number P-11-482 Chemical name: Bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: September 30, 2015. The PMN states that the generic use of the PMN substance will be as a specialty additive. Based on test data on analogous respirable, poorly soluble particulates and nanocarbon materials, EPA identified concerns for pulmonary toxicity and oncogenicity. Based on test data for other nanocarbon materials EPA identified concerns for environmental toxicity. 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 these risks, the consent order requires: 1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposures) and a National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 (where there is a potential for inhalation exposures). 2. Submission of a dustiness test within six months of notice of commencement of manufacture (NOC). 3. Submission of certain physical-chemical properties data within the time limits specified in the consent order. 4. Processing and use of the PMN substance only for the use specified in the consent order, including no application method that generates a vapor, mist or aerosol unless the application method occurs in an enclosed process. 5. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration. The SNUR would designate as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the development of data on certain physical-chemical properties, as well as certain human health and environmental toxicity testing would help characterize possible effects of the substance. The submitter has agreed to provide a dustiness test (European Standard EU 15051) by six months from commencement of manufacture. In addition, the submitter has agreed to provide certain physical-chemical property testing as required in the consent order after the commencement of manufacture. Although the order does not require a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 413) in rats with a post-exposure observation period of up to 9 months (including BALF analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart), a two-year inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), or an algal toxicity test (OCSPP Test Guideline 850.4500), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10927. PMN Number P-12-292 Chemical name: Coke (coal), secondary pitch. Definition: A carbon-containing residue from the coking of air blown pitch coke oil and/or pitch distillate. Composed primarily of isotropic carbon, it contains small amounts of sulfur and ash constituents. CAS number: 94113-91-4. Effective date of TSCA section 5(e) consent order: July 1. 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be in the carbon graphite industry. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, subcategory carbon black, EPA identified concerns for lung effects and cancer to workers exposed to the PMN substance by the inhalation route. 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. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 50 or compliance with a NCEL of 0.0025 mg/m\3\ as an 8-hour time-weighted average, when there is a potential for inhalation exposures. 2. Hazard communication. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Material Safety Data Sheet (MSDS). 3. No domestic manufacture of the PMN substance. 4. Use of the PMN substances only for the confidential uses specified in the consent order. 5. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the development of data on certain physical-chemical properties, as well as certain human health toxicity testing would help characterize possible effects of the substance. The submitter has agreed to provide the physical/chemical properties data and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a post-exposure observation period of 60 days (including BALF analysis) before exceeding the [[Page 81253]] production volume limits in the consent order. Although the order does not require a two-year inhalation bioassay (OPPTS Test Guideline 870.4200), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information CFR citation: 40 CFR 721.10928. PMN Numbers P-13-718, P-13-719, P-13-720, P-13-721, P-14-655, P-14-656, P-14-657, and P-14-658 Chemical name: Single-walled carbon nanotubes (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: July 1. 2015. Basis for TSCA section 5(e) consent order: The PMNs state that the use of the PMN substances will be as: a semi-conductor, conductive, or resistive element in electronic circuitry and devices; an electro- mechanical switch in electronic circuitry and devices; a film laminate to improve structural, electrical or electro-chemical properties of composite materials; a film laminate to improve conductivity in batteries, capacitors and fuels cells; with composite materials to improve their mechanical properties and electrical conductivities; catalyst support for use in fuel cells; in a nanoporous network in gas diffusion layers; for separation of chemicals; an additive to improve corrosion resistance of metals; an additive in lubricants and greases to improve wear resistance; an additive for transparency and conductivity in electronic devices; an additive for fibers in structural and electrical applications; an additive for fibers in fabrics and as a chemical intermediate. Based on test data on analogous respirable, poorly soluble particulates and other carbon nanotubes, EPA identified concerns for pulmonary toxicity and oncogenicity. Based on test data for other carbon nanotubes, EPA identified concerns for environmental toxicity. 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 substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposures) and a National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 (where there is a potential for inhalation exposures). 2. Submission of certain physical-chemical data for the PMN substances within the time triggers specified in the consent order. 3. Submission of certain human health testing prior to exceeding the confidential production volume limit specified in the consent order. 4. Establishment of a medical surveillance program as specified in the consent order. 5. Processing and use of the PMN substances only for the uses specified in the consent order, including no application method that generates a vapor, mist or aerosol unless the application method occurs in an enclosed process. 6. No use of the PMN substances resulting in releases to surface waters and disposal of the PMN substances only by landfill or incineration. The SNUR would designate as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the development of data on certain physical-chemical properties, as well as certain human health and environmental toxicity testing would help characterize possible effects of the substance. The submitter has agreed to provide the physical/chemical properties data within the specified time limits. In addition, the submitter has agreed not to exceed the confidential production limit without performing a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) in rats with a post-exposure observation period of up to 9 months (including BALF analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart). Although the order does not require a two-year inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), or an algal toxicity test (OCSPP Test Guideline 850.4500), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10929. PMN Numbers P-14-150, P-14-151, P-14-152, P-14-165, and P-14-166 Chemical name: Fatty acid amides (generic). CAS number: Claimed confidential. Basis for Action: The PMNs states that these substances will be used as chemical intermediates, additives for flotation products, and adhesion promoters for use in asphalt applications. Based on SAR analysis of test data on analogous amides and aliphatic amines, EPA expects toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of PMNs P-14-150 and P-14-165, 2 ppb of PMN P-16-166, and 4 ppb of PMNs P-14-151 and P-14-152 in surface waters. For the uses described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed their respective concern concentration levels. 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, excluding the uses described in the PMNs, resulting in releases to surface waters exceeding 1 ppb (P-15-150 and P-14-165), 2 ppb (P-16-166), or 4 ppb (P-15-151 and P-15-152) may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 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 (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances P-14-150, P-14-151, and P-14-152. Further, EPA has determined results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); log Kow and water solubility measurements, as well as either the fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the whole sediment acute toxicity invertebrates, freshwater test (OPPTS Test Guideline 850.1735) would help characterize the environmental effects of the PMN substances P-14-165 and P-14-166. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD Test Guideline 23) be followed to [[Page 81254]] facilitate solubility in the test media, because of the low water solubility of the PMNs. EPA recommends conducting the water solubility and log Kow measurements testing first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10930. PMN Number P-14-413 Chemical name: Kaolin, reaction products with polysiloxane (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: October 22, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an insulator. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects to workers exposed to the PMN substance by the inhalation route. 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. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 1,000 or compliance with a NCEL of 0.1 mg/m\3\ as an 8-hour time-weighted average, when there is a potential for inhalation exposures. 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the MSDS. 3. Submission of a 90-day inhalation study on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: The submitter has agreed to provide a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a post-exposure observation period of 60 days (including BALF analysis) before exceeding the production volume limit in the consent order. Although the order does not require a two-year inhalation bioassay (OPPTS Test Guideline 870.4200), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10931. PMN Numbers P-14-428, P-14-429, P-14-430, and P-14-431 Chemical name: Fatty acid amides (generic). CAS number: Claimed confidential. Basis for Action: The consolidated PMN states that the substances will be used as adhesion promoters and emulsifier intermediates for use in asphalt applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of P-14-428 and P-14-430, and 2 ppb of P-14-429 and P-14-431 in surface waters. For the uses described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed their respective concentration values. 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, excluding the uses described in the PMNs, resulting in releases to surface waters exceeding 1 ppb of P-14-428 and P-14-430, and 2 ppb of P-14-429 and P-14-431, may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.10932. PMN Numbers P-14-523, P-14-524, P-14-525, P-14-526, and P-14-527 Chemical name: Copolymers of perfluorinated and alkyl methacrylates (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: August 24, 2015. Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as additives for textile finishing. Based on physical-chemical properties data, as well as test data on analogous perfluorinated chemicals and potential perfluorinated degradation products, EPA identified concerns for irritation to skin, eyes, lungs, mucous membranes, lung toxicity, liver toxicity, blood toxicity, male reproductive toxicity, immunosupression, and oncogenicity. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. The Order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that the 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 exposures and risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator when there is a potential for inhalation exposures. 2. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into an MSDS, within 90 days. 3. Manufacture of the PMN substances: (a) According to the chemical composition section of the consent order, including analyzing and reporting certain starting raw material impurities to EPA; and (b) within the maximum established limits of certain fluorinated impurities of the PMN substance as stated in the consent order. 4. Submission of certain toxicity, physical-chemical property, and environmental fate testing on the PMN substance prior to exceeding the confidential production volume limits as specified in the consent order. 5. Use of the PMN substances only for water and oil repellent use on military protective clothing. 6. No distribution of the PMN substances for consumer use. 7. No manufacture of the PMN substances in the United States. 8. No water releases of the PMN substances exceeding 17 ppb. Recommended testing: EPA has determined that the results of certain toxicity and environmental fate testing would help characterize the PMN substance. The submitter has agreed to complete the testing identified in the testing section of the consent order by the confidential limits specified. In addition, EPA has determined that the results of a 90-day inhalation toxicity test in rats (OPPTS Test Guideline 870.3465/OECD Test Guideline 413) [[Page 81255]] with a 60-day holding period, and an avian reproduction test (OECD Test Guideline 206) in mallard ducks would help characterize potential human health and environmental effects of the PMN substances. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10933. PMN Number P-14-580 Chemical name: Alkenoic acid, polymer with alkyl alkenoate, alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate, compds. with alkylaminoalcanol (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: October 21, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a coating additive. Based on physical chemical properties data, as well as test data on analogous perfluorinated chemicals and potential perfluorinated degradation products, EPA identified concerns for irritation to skin, eyes, lungs, mucous membranes, lung toxicity, liver toxicity, blood toxicity, male reproductive toxicity, immunosupression, and oncogenicity. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. The Order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that the substance may present an unreasonable risk of injury to the environment and human health, the substance 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 substance and its potential degradation products. To protect against these exposures and risks, the consent order requires: 1. Use of a NIOSH-certified respirator when there is a potential for inhalation exposures. 2. Use of impervious gloves where there is a potential for dermal exposures. 3. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into an MSDS, within 90 days. 4. Manufacture of the PMN substance: (a) According to the chemical composition section of the consent order, including analyzing and reporting certain starting raw material impurities to EPA; and (b) within the maximum established limits of certain fluorinated impurities of the PMN substance as stated in the consent order. 5. Submission of certain toxicity, physical-chemical property, and environmental fate testing on the PMN substance prior to exceeding the confidential production volume limits as specified in the consent order. 6. Use of the PMN substance only for the confidential uses specified in the consent order. Recommended testing: EPA has determined that the results of certain toxicity and environmental fate testing would help characterize the PMN substance. The submitter has agreed to complete the testing identified in the testing section of the consent order by the confidential limits specified. In addition, EPA has determined that the results of a hydrolysis as a function of pH and temperature (OPPTS Test Guideline 835.2130); an indirect photolysis screening test (OPPTS Test Guideline 835.5270); a modified semi-continuous activated sludge (SCAS) test (OPPTS Test Guideline 835.5045 or OECD Test Guideline 302A) with analysis of degradation products; a simulation test-aerobic sewage treatment (activated sludge units) OECD Test Guideline OECD 303A); a phototransformation of chemicals in soils surfaces (Draft OECD Test Guideline Jan. 2002); an acute inhalation toxicity test (OPPTS Test Guideline 870.1300); and a fish short-term reproduction test (OPPTS Test Guideline 890.1350) would help characterize potential human health and environmental effects of the PMN substances. The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10934. PMN Number P-14-643 Chemical name: Titanium oxide compound (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: July 15, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a physical characteristics modifier for composite articles. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects to workers exposed to the PMN substance by the inhalation route. 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. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 10 or compliance with a NCEL of 2.4 mg/m\3\ as an 8-hour time-weighted average, when there is a potential for inhalation exposures. 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the MSDS. 3. Submission of a 90-day inhalation study on the PMN substance prior to exceeding the production volume limit specified in the consent order of the PMN substance. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: The submitter has agreed to provide a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a post-exposure observation period of 60 days (including BALF analysis) before exceeding the production volume limit in the consent order. Although the order does not require a two-year inhalation bioassay (OPPTS Test Guideline 870.4200), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10935. PMN Numbers P-14-688, P-14-689, P-14-690, and P-14-691 Chemical name: Fatty acid amide hydrochlorides (generic). CAS number: Claimed confidential. Basis for Action: The PMNs state that the substances will be used as surfactants for use in asphalt emulsions. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed [[Page 81256]] 1 ppb for P-14-688, P-14-689, P-14-690, and 2 ppb for P-14-691 in surface waters. For the uses described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed their respective concern concentration levels. 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, excluding the uses described in the PMNs, resulting in releases to surface waters exceeding 1 ppb for P-14-688, P-14-689, P-14-690, and 2 ppb for P-14- 691, may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. EPA recommends that testing be conducted on P-14-688. CFR citation: 40 CFR 721.10936. PMN Numbers P-14-712, P-14-713, P-14-714, and P-14-715 Chemical names: Plastics, wastes, pyrolyzed, bulk pyrolysate (generic) (P-14-712); Plastics, wastes, pyrolyzed, light distillate (generic) (P-14-713); Plastics, wastes, pyrolyzed, middle distillate (generic) (P-14-714); and Plastics, wastes, pyrolyzed, heavy distillate (generic) (P-14-715). CAS numbers: Claimed confidential. Effective date of TSCA section 5(e) consent order: July 27, 2015. Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of P-14-712 is a petroleum blend stock, of P-14-713 and P-14-714 is a fuel blend stock, and of P-14-715 is a component of grease or wax products. Based on the presence of benzene and naphthalene, EPA identified concerns for oncogenicity, immunotoxicity, liver toxicity, and blood toxicity. There is also a concern that polychlorinated dibenzo-p-dioxins and dibenzofurans could be present in the PMN substances. 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 substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of a NIOSH-certified respirator with an APF of at least 10 (where there is a potential for inhalation exposures) or, as an alternative, maintaining workplace airborne concentrations of the chemical substances identified in the consent order at a level below the specified Exposure Limit (EL) of 0.1 ppm and 10 ppm respectively for an 8-hour time weighted average. 2. Use of the PMN substances only for the uses specified in the consent order. 3. Manufacture P-14-712 only as described in the PMN. 4. Provide personal protective equipment to workers to prevent dermal exposure, where there is a potential for dermal exposures. 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the MSDS. 6. Record and report on a quarterly basis polychlorinated dibenzo- p-dioxin and dibenzofuran levels for P-14-712. Recommended testing: EPA has determined that quarterly testing of polychlorinated dibenzo-p-dioxin and dibenzofuran levels for P-14-712 will characterize potential health effects of the PMN substances. CFR citations: 40 CFR 721.10937 (P-14-712); 40 CFR 721.10938 (P-14- 713); 40 CFR 721.10939 (P-14-714); and 40 CFR 721.10940 (P-14-715). PMN Number P-15-28 Chemical name: Carbon silicon oxide. CAS number: 39345-87-4. Effective date of TSCA section 5(e) consent order: September 22, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of P-15-28 is a colorant for industrial, architecture, plastics, inks and automotive applications. Based on the presence on data on structurally analogous poorly soluble particulates, EPA identified concerns for lung overload. The Order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to human health, and that the substance will 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 substance. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 10 or compliance with a NCEL of 6 mg/m\3\ as an 8-hour time-weighted average, when there is a potential for inhalation exposures. 2. Hazard communication. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the MSDS. 3. Manufacture of the PMN substance only as described in the Consent Order. 4. Submission of certain toxicity testing on the PMN substance within two years of submission of the NOC, as specified in the consent order of the PMN substance. Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity study, with a 60-day holding period (OPPTS Test Guideline 870.3465), would help characterize human health and environmental effects of the PMN substance. The submitter has agreed to conduct this test within two years of submission of the Notice of Commencement of Manufacture (NOC). EPA has also determined that the results of a Chronic Toxicity test (OPPTS Test Guideline 870.4100) via the inhalation route would further help characterize human health effects of the PMN substance, The Order does not require this testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10941. PMN Number P-15-54 Chemical name: Carbon nanotubes (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: August 31, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a chemical intermediate. Based on test data on analogous respirable, poorly soluble particulates and carbon nanotubes, EPA identified concerns for pulmonary toxicity and oncogenicity. Based on test data for other nanocarbon materials EPA identified concerns for environmental toxicity. 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 these risks, the consent order requires: 1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is [[Page 81257]] a potential for dermal exposures) and a National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight- fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 (where there is a potential for inhalation exposures). 2. Submission of certain physical chemical properties according to the time limits described in the order. 3. Submission of a 90-day inhalation study within one year of notice of commencement. 4. Use of the PMN substance only as a chemical intermediate. 5. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration. The SNUR would designate as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the development of data on certain physical-chemical properties, as well as certain human health and environmental toxicity testing would help characterize possible effects of the substance. The submitter has agreed to provide the results of certain physical-chemical property testing annually for at least three years after the commencement of manufacture. The submitter has also agreed to provide the results of a 90-day inhalation toxicity study already being conducted. Although the order does not require a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), or an algal toxicity test (OCSPP Test Guideline 850.4500), the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10942. PMN Number P-15-149 Chemical name: Sulfonated alkylbenzene salts (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: September 15, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be for enhanced oil recovery. Based on test data on analogous surfactants, EPA identified concerns for surfactant effects on the lung and irritation to eyes and mucous membranes. Further, based on structural activity relationship (SAR) analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. 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 these risks, the consent order requires: 1. Hazard communication. Establishment and use of a hazard communication program, including environmental and human health precautionary statements on each label and in the MSDS. 2. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance. 3. Use of the PMN substance only for the confidential use specified in the consent order. 4. Comply with the release to water provisions specified in the consent order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate 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 submitter has agreed to complete this testing by the confidential production volume identified in the consent order. In addition, EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); acute inhalation toxicity test (OPPTS Test Guideline 870.1300); acute eye irritation test (OPPTS Test Guideline 870.2400); and acute dermal irritation test (OPPTS Test Guideline OPPTS 870.2500) would help characterize the potential environmental and human health effects of the PMN substance. The Order does not require these tests at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10943. PMN Number P-15-267 Chemical name: Substituted quinoline derivative (generic). CAS number: Claimed confidential. Basis for Action: The PMN states that the generic (non- confidential) use of the substance will be as a pesticide additive. Based on test data on the PMN substance, EPA identified concerns for chronic toxicity including blood, kidney, and spleen toxicity. As described in the PMN, occupational exposures are expected to be minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without use of impervious dermal protection where there is potential for dermal exposures, use of a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures, and use other than as a pesticide additive may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i). Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10944. PMN Number P-15-470 Chemical name: Algal oil amide (generic). CAS number: Claimed confidential. Basis for Action: The PMN states that the generic (non- confidential) use of the substance will be as a chemical intermediate. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 2 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that [[Page 81258]] any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 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 acute invertebrate 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 721.10945. PMN Number P-15-485 Chemical name: Bismuth compound (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: December 21, 2015. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for industrial coatings. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity. 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. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 10 or compliance with a NCEL of 2.4 mg/m\3\ as an 8-hour time-weighted average, when there is a potential for inhalation exposures. 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the MSDS. 3. Submission of certain toxicity testing on the PMN substance prior to exceeding the production volume limit as specified in the consent order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465) with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and various parameters of the bronchoalveolar lavage fluid (BALF) (e.g., maker enzyme activities, total protein content, total cell count, cell differential, and cell viability) would help to characterize the health effects of the PMN substance. The submitter has agreed to complete this testing by the aggregate production volume identified in the consent order. In addition, EPA has determined that the results of a 2-year inhalation bioassay (OCSPP Test Guideline 870.4200) would help characterize the potential human health effects of the PMN substance. The Order does not require this test at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citation: 40 CFR 721.10946. PMN Numbers P-15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, and P-15-618 Chemical names: Sulfur thulium ytterbium yttrium oxide (P-15-612); Gadolinium sulfur ytterbium yttrium oxide, erbium- and thulium-doped (P-15-613); Neodymium sulfur yttrium oxide (P-15-614); Erbium gadolinium neodymium sulfur ytterbium yttrium oxide (P-15-615); Erbium gadolinium sulfur ytterbium yttrium oxide (P-15-616); Erbium gadolinium ytterbium oxide (P-15-617); and Erbium gadolinium sulfur ytterbium oxide (P-15-618). CAS numbers: 180189-40-6 (P-15-612); 1651187-84-6 (P-15-613); 1651158-45-5 (P-15-614); 1651152-96-3 (P-15-615); 1622295-07-1 (P-15- 616); 1651152-05-4 (P-15-617); and 934388-91-7 (P-15-618). Effective date of TSCA section 5(e) consent order: December 21, 2015. Basis for TSCA section 5(e) consent order: The PMNs state that the use of the substances will be as additives for brand protection and anti-counterfeiting inks and polymers. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity. 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. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 10 or compliance with a NCEL of 0.07 mg/m\3\ as an 8-hour time-weighted average, when there is a potential for inhalation exposures. 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the MSDS. 3. Submission of certain toxicity testing on the PMN substances prior to exceeding the production volume limit as specified in the consent order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465) with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and various parameters of the bronchoalveolar lavage fluid (BALF) (e.g., maker enzyme activities, total protein content, total cell count, cell differential, and cell viability) would help to characterize the health effects of the PMN substance. The submitter has agreed to complete this testing by the aggregate production volume identified in the consent order. In addition, EPA has determined that the results of a 2-year inhalation bioassay (OCSPP Test Guideline 870.4200) would help characterize the potential human health effects of the PMN substances. The Order does not require this test at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CFR citations: 40 CFR 721.10947 (P-15-612); 40 CFR 721.10948 (P-15- 613); 40 CFR 721.10949 (P-15-614); 40 CFR 721.10950 (P-15-615); 40 CFR 721.10951 (P-15-616); 40 CFR 721.10952 (P-15-617); and 40 CFR 721.10953 (P-15-618). PMN Number P-15-655 Chemical names: 2-Ethylhexanoic acid, compound with alkyamino cyclohexane (generic) (P-15-0655, chemical A); and 2-Ethylhexanoic acid, compound with cyclohexylamine (generic) (P-15-0655, chemical B). CAS numbers: Claimed confidential. Basis for Action: The PMN states that the generic (non- confidential) use of the substances will be as an epoxy curing agent. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 34 ppb of the PMN substances in surface waters. As described in the PMN, releases of the substances are not expected to result in surface water concentrations that exceed 34 ppb. Therefore, EPA has not [[Page 81259]] 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 that results in releases to surface water concentrations exceeding 34 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 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 acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.10954. PMN Number P-15-680 Chemical name: Propenoic acid, alkyl ester, polymer with 1,3- cyclohexanedialkylamine, reaction products with oxirane(alkoxyalkyl) (generic). CAS number: Claimed confidential. Basis for Action: The PMN states that the generic (non- confidential) use of the substance will be as an ingredient in liquid paint coating. Based on data on the PMN substance as well as SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of an activated sludge sorption isotherm test (OPPTS Test Guideline 835.1110); 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 substance. CFR citation: 40 CFR 721.10955. PMN Number P-15-691 Chemical name: Acrylic acid, polymer with polyalkylene polyamine (generic). CAS number: Claimed confidential. Basis for Action: The PMN states that the use of the substance will be as a chemical intermediate. Based on data on the PMN substance and SAR analysis of test data on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 5 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a Zahn- Wellens/EMPA Test (OPPTS Test Guideline 835.3200); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a fish acute- toxicity test (OPPTS Test Guideline 850.1085) mitigated by humic acid test; and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); would help characterize the environmental effects of the PMN substance. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. CFR citation: 40 CFR 721.10956. PMN Number P-16-30 Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-(2- phenylhydrazide). CAS number: 1807977-72-5. Basis for Action: The PMN states that the substance will be used as a curing agent in anaerobic adhesive and sealant formulations. Based on test data on analogous hydrazines, EPA identified concerns for blood toxicity, neurotoxicity, oncogenicity, and mutagenicity. Hydrazides are expected to be positive in the chromosome aberration test and positive for lung sensitization. Based on the presence of a free acid, irritation to moist tissue (eyes, lungs, and mucous membranes) is expected. As described in the PMN, occupational exposures are expected to be minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without use of impervious gloves and impervious clothing where there is a potential for dermal exposures, may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii). Recommended testing: EPA has determined that the results of a 90- day dermal toxicity test (OPPTS Test Guideline 870.3250) and a carcinogenicity test (OPPTS Test Guideline 870.4200) by the expected route of exposure in two species of rodents, would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10957. PMN Number P-16-52 Chemical name: 2,5-Furandione, dihydro-, polymer with 1,1'- iminobis[2-propanol], benzoate (ester), N-benzoyl derivs. CAS number: 592479-38-4. Basis for Action: The PMN states that the generic (non- confidential) use of the substance will be as printing ink. Based on SAR analysis of test data on analogous esters and amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 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 5 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 5 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 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 [[Page 81260]] 850.1075); an acute invertebrate 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 721.10958. PMN Numbers P-16-56 and P-16-57 Chemical name: Dialkyl fattyalkylamino propanamide alkylamine acetates (generic). CAS number: Claimed confidential. Basis for Action: The PMNs state that the generic (non- confidential) use of the substances is in oil production. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances 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 substances may present an unreasonable risk. EPA has determined, however, that any use of the substances that results in releases to surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a mysid chronic toxicity test (OPPTS Test Guideline 850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.10959. PMN Number P-16-58 Chemical name: Dialkylaminopropylaminopropanoate ester (generic). CAS number: Claimed confidential. Basis for Action: The PMN states that the substance will be used as a chemical intermediate. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 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 14 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 14 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at Sec. 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 acute invertebrate 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 721.10960. V. Rationale and Objectives of the Rule A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 34 of the 57 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 Sec. [emsp14]721.160 (see Unit VI.). In the other 23 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 Sec. [emsp14]721.170 were met, as discussed in Unit IV. B. Objectives 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: EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs. EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements. Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in Sec. [emsp14]721.160(c)(3) and Sec. [emsp14]721.170(d)(4). In accordance with Sec. [emsp14]721.160(c)(3)(ii) and Sec. [emsp14]721.170(d)(4)(i)(B), the effective date of this rule is January 17, 2017 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before December 19, 2016. 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 December 19, 2016, 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. This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. VII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule 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 [[Page 81261]] 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 34 of the 57 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 46 of the 57 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per Sec. Sec. 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 November 9, 2016 (the date of public release/web posting of this rule) as the cutoff date for determining whether the new use is ongoing. This designation varies slightly from EPA's past practice of designating the date of Federal Register publication as the date for making this determination. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule. In developing this rule, EPA has recognized that, given EPA's practice of now posting rules on its Web site a week or more in advance of Federal Register publication, this objective could be thwarted even before that publication. Thus, EPA has slightly modified its approach in this rulemaking and plans to follow this modified approach in future significant new use rulemakings. 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 Sec. 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. VIII. Development and Submission of Information EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)). In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information 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-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. ASTM International standards are available at http://www.astm.org/Standard/index.shtml. 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 at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) 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. The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN 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. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: Human exposure and environmental release that may result from the significant new use of the chemical substances. Potential benefits of the chemical substances. Information on risks posed by the chemical substances compared to risks posed by potential substitutes. IX. Procedural Determinations By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1). Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to [[Page 81262]] manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in Sec. 721.1725(b)(1) with that under Sec. 721.11 into a single step. If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. X. SNUN Submissions According to Sec. [emsp14]721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and Sec. 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. XI. Economic Analysis 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-2016-0207. XII. Scientific Standards, Evidence, and Available Information EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2). The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule. XIII. Statutory and Executive Order Reviews A. Executive Order 12866 This action establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act (PRA) 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 action. 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. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. C. Regulatory Flexibility Act (RFA) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this action. This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. [[Page 81263]] Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) 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 action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E. Executive Order 13132 This action will 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). F. Executive Order 13175 This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does 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 action. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). XIV. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: November 3, 2016. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: PART 9--[AMENDED] 0 1. The authority citation for part 9 continues to read as follows: Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j- 2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 0 2. In Sec. 9.1, add the following sections in numerical order under the undesignated center heading ``Significant New Uses of Chemical Substances'' to read as follows: Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act. * * * * * ------------------------------------------------------------------------ OMB Control 40 CFR citation No. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Significant New Uses of Chemical Substances ------------------------------------------------------------------------ * * * * * 721.10927............................................... 2070-0012 721.10928............................................... 2070-0012 721.10929............................................... 2070-0012 721.10930............................................... 2070-0012 721.10931............................................... 2070-0012 721.10932............................................... 2070-0012 721.10933............................................... 2070-0012 721.10934............................................... 2070-0012 721.10935............................................... 2070-0012 721.10936............................................... 2070-0012 721.10937............................................... 2070-0012 721.10938............................................... 2070-0012 721.10939............................................... 2070-0012 721.10940............................................... 2070-0012 721.10941............................................... 2070-0012 721.10942............................................... 2070-0012 721.10943............................................... 2070-0012 721.10944............................................... 2070-0012 721.10945............................................... 2070-0012 721.10946............................................... 2070-0012 721.10947............................................... 2070-0012 721.10948............................................... 2070-0012 721.10949............................................... 2070-0012 721.10950............................................... 2070-0012 721.10951............................................... 2070-0012 721.10952............................................... 2070-0012 721.10953............................................... 2070-0012 721.10954............................................... 2070-0012 721.10955............................................... 2070-0012 721.10956............................................... 2070-0012 721.10957............................................... 2070-0012 721.10958............................................... 2070-0012 721.10959............................................... 2070-0012 721.10960............................................... 2070-0012 * * * * * ------------------------------------------------------------------------ * * * * * PART 721--[AMENDED] 0 3. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 4. Add Sec. [emsp14]721.10927 to subpart E to read as follows: Sec. [emsp14]721.10927 Bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a bimodal mixture [[Page 81264]] consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) (particulate), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P- 100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of Sec. 721.63(a)(4). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) and (q). A significant new use is any use involving an application method that generates a vapor, mist or aerosol. (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 5. Add Sec. [emsp14]721.10928 to subpart E to read as follows: Sec. [emsp14]721.10928 Coke (coal), secondary pitch; a carbon- containing residue from the coking of air blown pitch coke oil and/or pitch distillate; composed primarily of isotropic carbon, it contains small amounts of sulfur and ash constituents. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as coke (coal), secondary pitch. Definition: A carbon-containing residue from the coking of air blown pitch coke oil and/or pitch distillate. Composed primarily of isotropic carbon, it contains small amounts of sulfur and ash constituents (PMN P-12-292; CAS No. 94113-91-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4), (a)(6)(particulate), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P- 100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of Sec. 721.63(a)(4). (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0025 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 0.1 percent), (f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iv), (g)(1)(This substance may cause lung effects), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k), and (q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d), and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 6. Add Sec. [emsp14]721.10929 to subpart E to read as follows: Sec. [emsp14]721.10929 Single-walled carbon nanotubes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as single walled carbon nanotubes (PMNs P-13-718, P-13-719, P-13-720, P-13-721, P-14-655, P-14-656, P-14-657, and P-14-658) are 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 the PMN substance when it is embedded or incorporated into a polymer matrix that itself has been reacted (cured), embedded in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing, or incorporated into an article as defined at 40 CFR 720.3(c). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)(particulate), (b), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P- 100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of Sec. 721.63(a)(4). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k)(A significant new use is use other than as: A semi-conductor, conductive, or resistive element in electronic circuitry and devices; an electro-mechanical switch in electronic circuitry and devices; a film laminate to improve structural, [[Page 81265]] electrical or electro-chemical properties of composite materials; a film laminate to improve conductivity in batteries, capacitors and fuels cells; with composite materials to improve their mechanical properties and electrical conductivities; catalyst support for use in fuel cells; in a nanoporous network in gas diffusion layers; for separation of chemicals; an additive to improve corrosion resistance of metals; an additive in lubricants and greases to improve wear resistance; an additive for transparency and conductivity in electronic devices; an additive for fibers in structural and electrical applications; an additive for fibers in fabrics and as a chemical intermediate) and (q). A significant new use is any use involving an application method that generates a vapor, mist or aerosol unless such application method occurs in an enclosed process. An enclosed process is defined as an operation that is designed and operated so that there is no release associated with normal or routine production processes into the environment of any substance present in the operation. An operation with inadvertent or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to and environmental contamination from the releases. (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 7. Add Sec. 721.10930 to subpart E to read as follows: Sec. 721.10930 Fatty acid amides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amides (PMNs P-14-150, P-14-151, P-14-152, P-14-165, and P-14-166) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. A significant new use of the substances is any use other than as chemical intermediates, additives for flotation products, or adhesion promoters for use in asphalt applications where the surface water concentrations described under paragraph (a)(3)(i) of this section are exceeded. (ii) [Reserved] (3) The significant new uses for any use other than as chemical intermediates, additives for flotation products, or adhesion promoters for use in asphalt applications are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where (N=1 for PMNs P-15-150 and P-14- 165), (N=2 for PMN P-14-166), and (N=4 for PMNs P-14-151 and P-14-152). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 8. Add Sec. 721.10931 to subpart E to read as follows: Sec. 721.10931 Kaolin, reaction products with polysiloxane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as kaolin, reaction products with polysiloxane (PMN P-14-413) 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 Sec. 721.63(a)(1), (a)(4), (a)(6) (particulate), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. A NIOSH-certified powered air purifying full facepiece respirator with an Assigned Protection Factor (APF) of at least 1,000 equipped with an appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridge in combination with HEPA filters or a NIOSH-certified continuous flow supplied air respirator equipped with a full facepiece meet the requirements of Sec. 721.63(a)(4). (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.1 mg/ m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a), through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d), and (f), through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 9. Add Sec. 721.10932 to subpart E to read as follows: Sec. 721.10932 Fatty acid amides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amides (PMNs P-14-428, P-14-429, P-14-430, and P-14-431) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as [[Page 81266]] specified in Sec. 721.80. A significant new use of the substances is any use other than as emulsifier intermediates or adhesion promoters for use in asphalt applications where the surface water concentrations described under paragraph (a)(3)(i) of this section are exceeded. (ii) [Reserved] (3) The significant new uses for any use other than as emulsifier intermediates or adhesion promoters for use in asphalt applications are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where (N=1 for PMNs P-14-428 and P-14- 429) and (N=2 for PMNs P-14-429 and P-14-431). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 10. Add Sec. 721.10933 to subpart E to read as follows: Sec. 721.10933 Copolymers of perfluorinated and alkyl methacrylates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as copolymers of perfluorinated and alkyl methacrylates (PMNs P-14-523, P- 14-524, P-14-525, P-14-526, and P-14-527) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4), (a)(6) (particulate, gas/vapor or a combination gas/vapor and particulate)), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k) (analysis and reporting and limitations of maximum impurity levels of certain impurities), (o) and (q). It is a significant new use to use the PMN substance other than for water and oil repellent use on military protective clothing. (iii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N=17. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 11. Add Sec. 721.10934 to subpart E to read as follows: Sec. 721.10934 Alkenoic acid, polymer with alkyl alkenoate, alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate, compds. with alkylaminoalcanol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, polymer with alkyl alkenoate, alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate, compds. with alkylaminoalcanol (PMN P-14-580) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4), (a)(6) (particulate, gas/vapor or a combination gas/vapor and particulate), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain impurities; and use other described in the consent order) and (q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraphs (a)(2)(ii) of this section. 0 12. Add Sec. 721.10935 to subpart E to read as follows: Sec. 721.10935 Titanium oxide compound (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as titanium oxide compound (PMN P-14-643) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6) (particulate), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 2.4 mg/ m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a), through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). [[Page 81267]] (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (4,300,000 kilograms). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d), and (f), through (i) are applicable to manufacturers and processors of this. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 13. Add Sec. 721.10936 to subpart E to read as follows: Sec. 721.10936 Fatty acid amide hydrochlorides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amide hydrochlorides (PMNs P-14-688, P-14-689, P-14-690, and P-14- 691) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. A significant new use of the substances is any use other than as surfactants for use in asphalt applications where the surface water concentrations described under paragraph (a)(3)(i) of this section are exceeded. (ii) [Reserved] (3) The significant new uses for any use other than as surfactants for use in asphalt applications are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1 for PMNs P-14-688, P-14-689, and P-14-690) and (N=2 for PMN P-14-691). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 14. Add Sec. 721.10937 to subpart E to read as follows: Sec. 721.10937 Plastics, wastes, pyrolyzed, bulk pyrolysate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as plastics, wastes, pyrolyzed, bulk pyrolysate (PMN P-14-712) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6)(particulate or a combination gas/vapor and particulate), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the exposure limit (EL) provision listed in the TSCA section 5(e) consent order for this substance. The EL is both 0.1 ppm for benzene and 10 ppm for naphthalene as an 8-hour time weighted average. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). It is a significant new use to manufacture this substance other than as described in the PMN. It is a significant new use to manufacture this substance without testing the substance for polychlorinated dibenzo-p-dioxin and dibenzofuran impurities using EPA Method 8290A at each facility of manufacture, conducting the testing every quarter that the PMN substance is manufactured, submitting the results of any testing conducted, or providing test results more than 45 days after receiving them. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 15. Add Sec. 721.10938 to subpart E to read as follows: Sec. 721.10938 Plastics, wastes, pyrolyzed, light distillate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as plastics, wastes, pyrolyzed, light distillate (PMN P-14-713) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6)(particulate or a combination gas/vapor and particulate), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the exposure limit (EL) provision listed in the TSCA section 5(e) consent order for this substance. The EL is both 0.1 ppm for benzene and 10 ppm for naphthalene as an 8-hour time weighted average. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and (g)(5). [[Page 81268]] (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (k). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 16. Add Sec. 721.10939 to subpart E to read as follows: Sec. 721.10939 Plastics, wastes, pyrolyzed, middle distillate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as plastics, wastes, pyrolyzed, middle distillate (PMN P-14-714) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6)(particulate or a combination gas/vapor and particulate), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the exposure limit (EL) provision listed in the TSCA section 5(e) consent order for this substance. The EL is both 0.1 ppm for benzene and 10 ppm for naphthalene as an 8-hour time weighted average. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 17. Add Sec. 721.10940 to subpart E to read as follows: Sec. 721.10940 Plastics, wastes, pyrolyzed, heavy distillate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as plastics, wastes, pyrolyzed, heavy distillate (PMN P-14-715) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6) (particulate or a combination gas/vapor and particulate), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the exposure limit (EL) provision listed in the TSCA section 5(e) consent order for this substance. The EL is both 0.1 ppm for benzene and 10 ppm for naphthalene as an 8-hour time weighted average. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i), through (g)(1)(ix), (g)(2)(i), through (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(ii), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 18. Add Sec. 721.10941 to subpart E to read as follows: Sec. 721.10941 Carbon silicon oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carbon silicon oxide (PMN P-15-28; CAS No. 39345-87-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6) (particulate or a combination gas/vapor and particulate), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 6 mg/ m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 [[Page 81269]] respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). (iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture the PMN substance other than specified in the TSCA section 5(e) consent order. Requirements as specified in Sec. 721.80(p) (within 24 months of submission of a Notice of Commencement of Manufacture). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 19. Add Sec. 721.10942 to subpart E to read as follows: Sec. 721.10942 Carbon nanotubes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon nanotubes (PMN P-15-54) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) (particulate), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. A National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 50 with an N-100, P-100, or R-100 cartridge meets the requirements of Sec. 721.63(a)(4). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k)(chemical intermediate) and (p)(one year). (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 20. Add Sec. 721.10943 to subpart E to read as follows: Sec. 721.10943 Sulfonated alkylbenzene salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonated alkylbenzene salts (PMN P-15-149) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1) (serious eye damage), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i) and (g)(5). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) and (q). (iii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=2). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (f), (g), (h), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 21. Add Sec. 721.10944 to subpart E to read as follows: Sec. 721.10944 Substituted quinoline derivative (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted quinoline derivative (PMN P-15-267) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(3), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6) (particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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 Sec. 721.80(j). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), through (e), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 22. Add Sec. 721.10945 to subpart E to read as follows: Sec. 721.10945 Algal oil amide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as algal oil amide (PMN P-15-470) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(j). (ii) [Reserved] [[Page 81270]] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 23. Add Sec. 721.10946 to subpart E to read as follows: Sec. 721.10946 Bismuth compound (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bismuth compound (PMN P-15-485) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this order do not apply when the chemical substance has been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6) (particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 2.4 mg/ m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (360,000 kilograms). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d), and (f), through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 24. Add Sec. 721.10947 to subpart E to read as follows: Sec. 721.10947 Sulfur thulium ytterbium yttrium oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as sulfur thulium ytterbium yttrium oxide (PMN P-15-612; CAS No. 180189-40-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6) (particulate), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 25. Add Sec. 721.10948 to subpart E to read as follows: Sec. 721.10948 Gadolinium sulfur ytterbium yttrium oxide, erbium- and thulium-doped. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as (PMN P-15-613; CAS No, 1651187- 84-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6) (particulate), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted [[Page 81271]] average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a), through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 26. Add Sec. [emsp14]721.10949 to subpart E to read as follows: Sec. [emsp14]721.10949 Neodymium sulfur yttrium oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as neodymium sulfur yttrium oxide (PMN P-15-614; CAS No. 1651158-45-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 27. Add Sec. [emsp14]721.10950 to subpart E to read as follows: Sec. [emsp14]721.10950 Erbium gadolinium neodymium sulfur ytterbium yttrium oxide (P-15-615). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as erbium gadolinium neodymium sulfur ytterbium yttrium oxide (PMN P-15-615; CAS No. 1651152-96-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a) through (d), and (f), through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 28. Add Sec. [emsp14]721.10951 to subpart E to read as follows: Sec. [emsp14]721.10951 Erbium gadolinium sulfur ytterbium yttrium oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as erbium gadolinium sulfur ytterbium yttrium oxide (P-15-616; CAS No. 1622295-07-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(particulate), [[Page 81272]] (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a) through (d), and (f),through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 29. Add Sec. [emsp14]721.10952 to subpart E to read as follows: Sec. 721.10952 Erbium gadolinium ytterbium oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as erbium gadolinium ytterbium oxide (PMN P-15-617; CAS No. 1651152-05-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a) through (d), and (f), through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 30. Add Sec. [emsp14]721.10953 to subpart E to read as follows: Sec. 721.10953 Erbium gadolinium sulfur ytterbium oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as erbium gadolinium sulfur ytterbium oxide (PMN P-15-618; CAS No. 934388-91-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(4)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10), (a)(6)(particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.07 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order. (B) [Reserved] (ii) Hazard communication program. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(6,000 kilograms, aggregate of PMNs P- 15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, combined). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (d), (f), through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 31. Add Sec. [emsp14]721.10954 to subpart E to read as follows: [[Page 81273]] Sec. [emsp14]721.10954 2-Ethylhexanoic acid, compound with alkyamino cyclohexane (generic); and 2-Ethylhexanoic acid, compound with cyclohexylamine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as 2- ethylhexanoic acid, compound with alkyamino cyclohexane (PMN P-15-0655, chemical A); and 2-ethylhexanoic acid, compound with cyclohexylamine (PMN P-15-0655, chemical B) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 34. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 32. Add Sec. 721.10955 to subpart E to read as follows: Sec. 721.10955 Propenoic acid, alkyl ester, polymer with 1,3- cyclohexanedialkylamine, reaction products with oxirane(alkoxyalkyl) (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as propenoic acid, alkyl ester, polymer with 1,3-cyclohexanedialkylamine, reaction products with oxirane(alkoxyalkyl) (PMN P-15-680) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) where N = 1. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 33. Add Sec. 721.10956 to subpart E to read as follows: Sec. 721.10956 Acrylic acid, polymer with polyalkylene polyamine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylic acid, polymer with polyalkylene polyamine (PMN P-15-691) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(g). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 34. Add Sec. [emsp14]721.10957 to subpart E to read as follows: Sec. [emsp14]721.10957 1,2-Cyclohexanedicarboxylic acid, 1-(2- phenylhydrazide). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as (1,2- cyclohexanedicarboxylic acid, 1-(2-phenylhydrazide) (PMN P-16-30; CAS No. 1807977-72-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(6)(particulate), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 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. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 35. Add Sec. [emsp14]721.10958 to subpart E to read as follows: Sec. [emsp14]721.10958 2,5-Furandione, dihydro-, polymer with 1,1'- iminobis[2-propanol], benzoate (ester), N-benzoyl derivs. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2,5-furandione, dihydro-, polymer with 1,1'-iminobis[2-propanol], benzoate (ester), N- benzoyl derivs. (PMN P-16-52; CAS No. 592479-38-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 5. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 36. Add Sec. [emsp14]721.10959 to subpart E to read as follows: Sec. [emsp14]721.10959 Dialkyl fattyalkylamino propanamide alkylamine acetates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as dialkyl fattyalkylamino propanamide alkylamine acetates (PMNs P-16-56 and P-16-57) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 1. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. [[Page 81274]] (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 37. Add Sec. [emsp14]721.10960 to subpart E to read as follows: Sec. [emsp14]721.10960 Dialkylaminopropylaminopropanoate ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkylaminopropylaminopropanoate ester (PMN P-16-58) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 14. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [FR Doc. 2016-27326 Filed 11-16-16; 8:45 am] BILLING CODE 6560-50-P
![81250 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
ENVIRONMENTAL PROTECTION ADDRESSES: Submit your comments, requirements promulgated at 19 CFR
AGENCY identified by docket identification (ID) 12.118 through 12.127 and 19 CFR
number EPA–HQ–OPPT–2016–0207, by 127.28. Chemical importers must certify
40 CFR Parts 9 and 721 one of the following methods: that the shipment of the chemical
[EPA–HQ–OPPT–2016–0207; FRL–9953–41]
• Federal eRulemaking Portal: http:// substance complies with all applicable
www.regulations.gov. Follow the online rules and orders under TSCA. Importers
RIN 2070–AB27 instructions for submitting comments. of chemicals subject to these SNURs
Do not submit electronically any must certify their compliance with the
Significant New Use Rules on Certain information you consider to be SNUR requirements. The EPA policy in
Chemical Substances Confidential Business Information (CBI) support of import certification appears
AGENCY: Environmental Protection or other information whose disclosure is at 40 CFR part 707, subpart B. In
Agency (EPA). restricted by statute. addition, any persons who export or
• Mail: Document Control Office intend to export a chemical substance
ACTION: Direct final rule.
(7407M), Office of Pollution Prevention that is the subject of this rule on or after
SUMMARY: EPA is promulgating and Toxics (OPPT), Environmental December 19, 2016 are subject to the
significant new use rules (SNURs) under Protection Agency, 1200 Pennsylvania export notification provisions of TSCA
the Toxic Substances Control Act Ave. NW., Washington, DC 20460–0001. section 12(b) (15 U.S.C. 2611(b)) (see
(TSCA) for 57 chemical substances • Hand Delivery: To make special § 721.20), and must comply with the
which were the subject of arrangements for hand delivery or export notification requirements in 40
premanufacture notices (PMNs). The delivery of boxed information, please CFR part 707, subpart D.
applicable review periods for the PMNs follow the instructions at http://
www.epa.gov/dockets/contacts.html. B. What should I consider as I prepare
submitted for these 57 chemical my comments for EPA?
substances all ended prior to June 22, Additional instructions on
2016 (i.e., the date on which President commenting or visiting the docket, 1. Submitting CBI. Do not submit this
Obama signed into law the Frank R. along with more information about information to EPA through
Lautenberg Chemical Safety for the 21st dockets generally, is available at http:// regulations.gov or email. Clearly mark
Century Act which amends TSCA). www.epa.gov/dockets. the part or all of the information that
Thirty-four of these chemical substances FOR FURTHER INFORMATION CONTACT: you claim to be CBI. For CBI
are subject to TSCA section 5(e) consent For technical information contact: information in a disk or CD–ROM that
orders issued by EPA. This action Kenneth Moss, Chemical Control you mail to EPA, mark the outside of the
requires persons who intend to Division (7405M), Office of Pollution disk or CD–ROM as CBI and then
manufacture (defined by statute to Prevention and Toxics, Environmental identify electronically within the disk or
include import) or process any of these Protection Agency, 1200 Pennsylvania CD–ROM the specific information that
57 chemical substances for an activity Ave. NW., Washington, DC 20460–0001; is claimed as CBI. In addition to one
that is designated as a significant new telephone number: (202) 564–9232; complete version of the comment that
use by this rule to notify EPA at least email address: moss.kenneth@epa.gov. includes information claimed as CBI, a
90 days before commencing that For general information contact: The copy of the comment that does not
activity. The required notification TSCA-Hotline, ABVI-Goodwill, 422 contain the information claimed as CBI
initiates EPA’s evaluation of the South Clinton Ave., Rochester, NY must be submitted for inclusion in the
intended use within the applicable 14620; telephone number: (202) 554– public docket. Information so marked
review period. Manufacture and 1404; email address: TSCA-Hotline@ will not be disclosed except in
processing for the significant new use is epa.gov. accordance with procedures set forth in
unable to commence until EPA has SUPPLEMENTARY INFORMATION: 40 CFR part 2.
conducted a review of the notice, made 2. Tips for preparing your comments.
I. General Information When preparing and submitting your
an appropriate determination on the
notice, and take such actions as are A. Does this action apply to me? comments, see the commenting tips at
required with that determination. http://www.epa.gov/dockets/
You may be potentially affected by
DATES: This rule is effective on January
comments.html.
this action if you manufacture, process,
17, 2017. For purposes of judicial or use the chemical substances II. Background
review, this rule shall be promulgated at contained in this rule. The following list
1 p.m. (e.s.t.) on December 1, 2016. A. What action is the Agency taking?
of North American Industrial
Written adverse or critical comments, Classification System (NAICS) codes is EPA is promulgating these SNURs
or notice of intent to submit adverse or not intended to be exhaustive, but rather using direct final procedures. These
critical comments, on one or more of provides a guide to help readers SNURs will require persons to notify
these SNURs must be received on or determine whether this document EPA at least 90 days before commencing
before December 19, 2016 (see Unit VI. applies to them. Potentially affected the manufacture or processing of a
of the SUPPLEMENTARY INFORMATION). If entities may include: chemical substance for any activity
EPA receives written adverse or critical • Manufacturers or processors of one designated by these SNURs as a
comments, or notice of intent to submit or more subject chemical substances significant new use. Receipt of such
adverse or critical comments, on one or (NAICS codes 325 and 324110), e.g., notices allows EPA to assess risks that
more of these SNURs December 19, chemical manufacturing and petroleum may be presented by the intended uses
mstockstill on DSK3G9T082PROD with RULES2
2016, EPA will withdraw the relevant refineries. and, if appropriate, to regulate the
sections of this direct final rule before This action may also affect certain proposed use before it occurs.
its effective date. entities through pre-existing import Additional rationale and background to
For additional information on related certification and export notification these rules are more fully set out in the
reporting requirement dates, see Units rules under TSCA. Chemical importers preamble to EPA’s first direct final
I.A., VI., and VII. of the SUPPLEMENTARY are subject to the TSCA section 13 (15 SNUR published in the Federal Register
INFORMATION. U.S.C. 2612) import certification issue of April 24, 1990 (55 FR 17376).
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/1.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81259
determined that the proposed PMN Number P–15–691 neurotoxicity, oncogenicity, and
manufacturing, processing, or use of the Chemical name: Acrylic acid, mutagenicity. Hydrazides are expected
substance may present an unreasonable polymer with polyalkylene polyamine to be positive in the chromosome
risk. EPA has determined, however, that (generic). aberration test and positive for lung
any use of the substances that results in CAS number: Claimed confidential. sensitization. Based on the presence of
releases to surface water concentrations Basis for Action: The PMN states that a free acid, irritation to moist tissue
exceeding 34 ppb may cause significant the use of the substance will be as a (eyes, lungs, and mucous membranes) is
adverse environmental effects. Based on chemical intermediate. Based on data on expected. As described in the PMN,
this information, the PMN substances the PMN substance and SAR analysis of occupational exposures are expected to
meet the concern criteria at test data on analogous polycationic be minimal due to the use of adequate
§ 721.170(b)(4)(ii). personal protective equipment.
polymers, EPA predicts toxicity to
Recommended testing: EPA has Therefore, EPA has not determined that
aquatic organisms may occur at
determined that the results of a fish the proposed manufacturing,
concentrations that exceed 5 ppb of the
acute toxicity test, freshwater and processing, or use of the substance may
PMN substance in surface waters for
marine (OPPTS Test Guideline present an unreasonable risk. EPA has
greater than 20 days per year. This 20-
850.1075); an acute invertebrate toxicity determined, however, that use of the
day criterion is derived from partial life
test, freshwater daphnids (OPPTS Test substance without use of impervious
cycle tests (daphnid chronic and fish
Guideline 850.1010); and an algal gloves and impervious clothing where
early life stage tests) that typically range
toxicity test (OCSPP Test Guideline there is a potential for dermal
from 21 to 28 days in duration. EPA
850.4500) would help characterize the exposures, may result in serious health
predicts toxicity to aquatic organisms effects. Based on this information, the
environmental effects of the PMN may occur if releases of the substance to
substances. PMN substance meets the concern
surface water, from uses other than as criteria at § 721.170(b)(1)(i)(C) and
CFR citation: 40 CFR 721.10954. described in the PMN, exceed releases (b)(3)(ii).
PMN Number P–15–680 from the use described in the PMN. For Recommended testing: EPA has
the use described in the PMN, determined that the results of a 90-day
Chemical name: Propenoic acid, alkyl environmental releases did not exceed 5
ester, polymer with 1,3- dermal toxicity test (OPPTS Test
ppb for more than 20 days per year. Guideline 870.3250) and a
cyclohexanedialkylamine, reaction Therefore, EPA has not determined that
products with oxirane(alkoxyalkyl) carcinogenicity test (OPPTS Test
the proposed manufacturing, Guideline 870.4200) by the expected
(generic). processing, or use of the substance may
CAS number: Claimed confidential. route of exposure in two species of
present an unreasonable risk. EPA has rodents, would help characterize the
Basis for Action: The PMN states that determined, however, that any use of
the generic (non-confidential) use of the human health effects of the PMN
the substance other than as listed in the substance.
substance will be as an ingredient in PMN may result in significant adverse CFR citation: 40 CFR 721.10957.
liquid paint coating. Based on data on environmental effects. Based on this
the PMN substance as well as SAR information, the PMN substance meets PMN Number P–16–52
analysis of test data on analogous the concern criteria at § 721.170(b)(4)(i) Chemical name: 2,5-Furandione,
aliphatic amines, EPA predicts toxicity and (b)(4)(ii). dihydro-, polymer with 1,1’-iminobis[2-
to aquatic organisms may occur at Recommended testing: EPA has propanol], benzoate (ester), N-benzoyl
concentrations that exceed 1 ppb of the determined that the results of a Zahn- derivs.
PMN substance in surface waters. As Wellens/EMPA Test (OPPTS Test CAS number: 592479–38–4.
described in the PMN, releases of the Guideline 835.3200); a fish early-life Basis for Action: The PMN states that
substance are not expected to result in stage toxicity test (OPPTS Test the generic (non-confidential) use of the
surface water concentrations that exceed Guideline 850.1400); a fish acute- substance will be as printing ink. Based
1 ppb. Therefore, EPA has not toxicity test (OPPTS Test Guideline on SAR analysis of test data on
determined that the proposed 850.1085) mitigated by humic acid test; analogous esters and amides, EPA
manufacturing, processing, or use of the and a daphnid chronic toxicity test predicts toxicity to aquatic organisms
substance may present an unreasonable (OPPTS Test Guideline 850.1300); may occur at concentrations that exceed
risk. EPA has determined, however, that would help characterize the 5 ppb of the PMN substance in surface
any use of the substance that results in environmental effects of the PMN waters. As described in the PMN,
releases to surface water concentrations substance. EPA recommends that the releases of the substance are not
exceeding 1 ppb may result in fate testing be performed first as the expected to result in surface water
significant adverse environmental results may mitigate the need for further concentrations that exceed 5 ppb.
effects. Based on this information, the toxicity testing or change the testing Therefore, EPA has not determined that
PMN substance meets the concern recommendations. the proposed manufacturing,
criteria at § 721.170(b)(4)(i) and CFR citation: 40 CFR 721.10956. processing, or use of the substance may
(b)(4)(ii). present an unreasonable risk. EPA has
Recommended testing: EPA has PMN Number P–16–30 determined, however, that any use of
determined that the results of an Chemical name: 1,2- the substance resulting in surface water
activated sludge sorption isotherm test Cyclohexanedicarboxylic acid, 1-(2- concentrations exceeding 5 ppb may
(OPPTS Test Guideline 835.1110); a fish phenylhydrazide). cause significant adverse environmental
mstockstill on DSK3G9T082PROD with RULES2
early-life stage toxicity test (OPPTS Test CAS number: 1807977–72–5. effects. Based on this information, the
Guideline 850.1400); and a daphnid Basis for Action: The PMN states that PMN substance meets the concern
chronic toxicity test (OPPTS Test the substance will be used as a curing criteria at § 721.170(b)(4)(ii).
Guideline 850.1300) would help agent in anaerobic adhesive and sealant Recommended testing: EPA has
characterize the environmental effects of formulations. Based on test data on determined that the results of a fish
the PMN substance. analogous hydrazines, EPA identified acute toxicity test, freshwater and
CFR citation: 40 CFR 721.10955. concerns for blood toxicity, marine (OPPTS Test Guideline
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/10.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81263
Therefore, the promulgation of the expected to affect energy supply, undesignated center heading
SNUR would not have a significant distribution, or use and because this ‘‘Significant New Uses of Chemical
economic impact on a substantial action is not a significant regulatory Substances’’ to read as follows:
number of small entities. action under Executive Order 12866.
§ 9.1 OMB approvals under the Paperwork
D. Unfunded Mandates Reform Act I. National Technology Transfer and Reduction Act.
(UMRA) Advancement Act (NTTAA) * * * * *
Based on EPA’s experience with In addition, since this action does not
proposing and finalizing SNURs, State, involve any technical standards, OMB
40 CFR citation Control No.
local, and Tribal governments have not NTTAA section 12(d) (15 U.S.C. 272
been impacted by these rulemakings, note), does not apply to this action.
and EPA does not have any reasons to * * * * *
J. Executive Order 12898
believe that any State, local, or Tribal
government will be impacted by this This action does not entail special
action. As such, EPA has determined considerations of environmental justice Significant New Uses of Chemical Substances
that this action does not impose any related issues as delineated by
enforceable duty, contain any unfunded Executive Order 12898, entitled
* * * * *
mandate, or otherwise have any effect ‘‘Federal Actions to Address 721.10927 ............................. 2070–0012
on small governments subject to the Environmental Justice in Minority 721.10928 ............................. 2070–0012
requirements of UMRA sections 202, Populations and Low-Income 721.10929 ............................. 2070–0012
203, 204, or 205 (2 U.S.C. 1501 et seq.). Populations’’ (59 FR 7629, February 16, 721.10930 ............................. 2070–0012
1994). 721.10931 ............................. 2070–0012
E. Executive Order 13132 721.10932 ............................. 2070–0012
XIV. Congressional Review Act 721.10933 ............................. 2070–0012
This action will not have a substantial
direct effect on States, on the Pursuant to the Congressional Review 721.10934 ............................. 2070–0012
relationship between the national Act (5 U.S.C. 801 et seq.), EPA will 721.10935 ............................. 2070–0012
submit a report containing this rule and 721.10936 ............................. 2070–0012
government and the States, or on the 721.10937 ............................. 2070–0012
distribution of power and other required information to the U.S. 721.10938 ............................. 2070–0012
responsibilities among the various Senate, the U.S. House of 721.10939 ............................. 2070–0012
levels of government, as specified in Representatives, and the Comptroller 721.10940 ............................. 2070–0012
Executive Order 13132, entitled General of the United States prior to 721.10941 ............................. 2070–0012
‘‘Federalism’’ (64 FR 43255, August 10, publication of the rule in the Federal 721.10942 ............................. 2070–0012
1999). Register. This action is not a ‘‘major 721.10943 ............................. 2070–0012
rule’’ as defined by 5 U.S.C. 804(2). 721.10944 ............................. 2070–0012
F. Executive Order 13175 721.10945 ............................. 2070–0012
This action does not have Tribal List of Subjects 721.10946 ............................. 2070–0012
implications because it is not expected 721.10947 ............................. 2070–0012
40 CFR Part 9 721.10948 ............................. 2070–0012
to have substantial direct effects on Environmental protection, Reporting 721.10949 ............................. 2070–0012
Indian Tribes. This action does not and recordkeeping requirements. 721.10950 ............................. 2070–0012
significantly nor uniquely affect the 721.10951 ............................. 2070–0012
communities of Indian Tribal 40 CFR Part 721 721.10952 ............................. 2070–0012
governments, nor does it involve or Environmental protection, Chemicals, 721.10953 ............................. 2070–0012
impose any requirements that affect Hazardous substances, Reporting and 721.10954 ............................. 2070–0012
Indian Tribes. Accordingly, the 721.10955 ............................. 2070–0012
recordkeeping requirements. 721.10956 ............................. 2070–0012
requirements of Executive Order 13175,
Dated: November 3, 2016. 721.10957 ............................. 2070–0012
entitled ‘‘Consultation and Coordination
Maria J. Doa, 721.10958 ............................. 2070–0012
with Indian Tribal Governments’’ (65 FR 721.10959 ............................. 2070–0012
67249, November 9, 2000), do not apply Director, Chemical Control Division, Office
of Pollution Prevention and Toxics. 721.10960 ............................. 2070–0012
to this action.
Therefore, 40 CFR parts 9 and 721 are * * * * *
G. Executive Order 13045 amended as follows:
This action is not subject to Executive * * * * *
Order 13045, entitled ‘‘Protection of PART 9—[AMENDED]
Children from Environmental Health PART 721—[AMENDED]
■ 1. The authority citation for part 9
Risks and Safety Risks’’ (62 FR 19885,
continues to read as follows: ■ 3. The authority citation for part 721
April 23, 1997), because this is not an
economically significant regulatory Authority: 7 U.S.C. 135 et seq., 136–136y; continues to read as follows:
action as defined by Executive Order 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; Authority: 15 U.S.C. 2604, 2607, and
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
12866, and this action does not address 2625(c).
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
environmental health or safety risks 1321, 1326, 1330, 1342, 1344, 1345(d) and ■ 4. Add § 721.10927 to subpart E to
disproportionately affecting children. (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, read as follows:
mstockstill on DSK3G9T082PROD with RULES2
H. Executive Order 13211 1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2, § 721.10927 Bimodal mixture consisting
This action is not subject to Executive 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, of multi-walled carbon nanotubes and other
Order 13211, entitled ‘‘Actions 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., classes of carbon nanotubes (generic).
Concerning Regulations That 6901–6992k, 7401–7671q, 7542, 9601–9657, (a) Chemical substance and
Significantly Affect Energy Supply, 11023, 11048. significant new uses subject to reporting.
Distribution, or Use’’ (66 FR 28355, May ■ 2. In § 9.1, add the following sections (1) The chemical substance identified
22, 2001), because this action is not in numerical order under the generically as a bimodal mixture
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/14.svg)
![81264 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
consisting of multi-walled carbon (1) The chemical substance identified as § 721.125(a) through (d), and (f) through
nanotubes and other classes of carbon coke (coal), secondary pitch. Definition: (i) are applicable to manufacturers and
nanotubes (PMN P–11–482) is subject to A carbon-containing residue from the processors of this substance.
reporting under this section for the coking of air blown pitch coke oil and/ (2) Limitations or revocation of
significant new uses described in or pitch distillate. Composed primarily certain notification requirements. The
paragraph (a)(2) of this section. of isotropic carbon, it contains small provisions of § 721.185 apply to this
(2) The significant new uses are: amounts of sulfur and ash constituents section.
(i) Protection in the workplace. (PMN P–12–292; CAS No. 94113–91–4) (3) Determining whether a specific use
Requirements as specified in is subject to reporting under this section is subject to this section. The provisions
§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), for the significant new uses described in of § 721.1725(b)(1) apply to paragraph
(a)(4), (a)(6) (particulate), and (c). When paragraph (a)(2) of this section. (a)(2)(iii) of this section.
determining which persons are (2) The significant new uses are: ■ 6. Add § 721.10929 to subpart E to
reasonably likely to be exposed as (i) Protection in the workplace. read as follows:
required for § 721.63(a)(1) and (a)(4), Requirements as specified in
engineering control measures (e.g., § 721.63(a)(1), (a)(4), (a)(6)(particulate), § 721.10929 Single-walled carbon
enclosure or confinement of the (b)(concentration set at 0.1 percent), and nanotubes (generic).
operation, general and local ventilation) (c). When determining which persons (a) Chemical substance and
or administrative control measures (e.g., are reasonably likely to be exposed as significant new uses subject to reporting.
workplace policies and procedures) required for § 721.63(a)(1) and (a)(4), (1) The chemical substances identified
shall be considered and implemented to engineering control measures (e.g., generically as single walled carbon
prevent exposure, where feasible. A enclosure or confinement of the nanotubes (PMNs P–13–718, P–13–719,
National Institute for Occupational operation, general and local ventilation) P–13–720, P–13–721, P–14–655, P–14–
Safety and Health (NIOSH)-certified air or administrative control measures (e.g., 656, P–14–657, and P–14–658) are
purifying, tight-fitting full-face workplace policies and procedures) subject to reporting under this section
respirator equipped with N–100, P–100, shall be considered and implemented to for the significant new uses described in
or R–100 cartridges, or power air prevent exposure, where feasible. A paragraph (a)(2) of this section. The
purifying particulate respirator with an National Institute for Occupational requirements of this rule do not apply
Assigned Protection Factor (APF) of at Safety and Health (NIOSH)-certified air to the PMN substance when it is
least 50 meets the requirements of purifying, tight-fitting full-face embedded or incorporated into a
§ 721.63(a)(4). respirator equipped with N–100, P–100, polymer matrix that itself has been
(ii) Industrial, commercial, and or R–100 cartridges, or power air reacted (cured), embedded in a
consumer activities. Requirements as purifying particulate respirator with an permanent solid polymer form that is
specified in § 721.80(k) and (q). A Assigned Protection Factor (APF) of at not intended to undergo further
significant new use is any use involving least 50 meets the requirements of processing, except mechanical
an application method that generates a § 721.63(a)(4). processing, or incorporated into an
vapor, mist or aerosol. (A) As an alternative to the respirator article as defined at 40 CFR 720.3(c).
(iii) Disposal. Requirements as requirements in paragraph (a)(2)(i) of (2) The significant new uses are:
specified in § 721.85(a)(1), (a)(2), (b)(1), this section, a manufacturer or processor (i) Protection in the workplace.
(b)(2), (c)(1), and (c)(2). may choose to follow the new chemical Requirements as specified in
(iv) Release to water. Requirements as exposure limit (NCEL) provision listed § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3),
specified in § 721.90(a)(1), (b)(1), and in the TSCA section 5(e) consent order (a)(4), (a)(6)(particulate), (b), and (c).
(c)(1). for this substance. The NCEL is 0.0025 When determining which persons are
(b) Specific requirements. The mg/m3 as an 8-hour time weighted reasonably likely to be exposed as
provisions of subpart A of this part required for § 721.63(a)(1) and (a)(4),
average. Persons who wish to pursue
apply to this section except as modified engineering control measures (e.g.,
NCELs as an alternative to § 721.63
by this paragraph. enclosure or confinement of the
(1) Recordkeeping. Recordkeeping respirator requirements may request to
so under § 721.30. Persons whose operation, general and local ventilation)
requirements as specified in or administrative control measures (e.g.,
§ 721.125(a) through (e), (i), (j), and (k) § 721.30 requests to use the NCELs
approach are approved by EPA will be workplace policies and procedures)
are applicable to manufacturers and shall be considered and implemented to
processors of this substance. required to follow NCELs provisions
comparable to those contained in the prevent exposure, where feasible. A
(2) Limitations or revocation of National Institute for Occupational
certain notification requirements. The corresponding TSCA section 5(e)
consent order. Safety and Health (NIOSH)-certified air
provisions of § 721.185 apply to this purifying, tight-fitting full-face
section. (B) [Reserved]
(ii) Hazard communication program. respirator equipped with N–100, P–100,
(3) Determining whether a specific use or R–100 cartridges, or power air
is subject to this section. The provisions Requirements as specified in § 721.72(a)
through (e)(concentration set at 0.1 purifying particulate respirator with an
of § 721.1725(b)(1) apply to paragraph Assigned Protection Factor (APF) of at
(a)(2)(ii) of this section. percent), (f), (g)(1)(vii), (g)(2)(ii),
(g)(2)(iv), (g)(1)(This substance may least 50 meets the requirements of
■ 5. Add § 721.10928 to subpart E to § 721.63(a)(4).
cause lung effects), and (g)(5).
read as follows: (iii) Industrial, commercial, and (ii) Industrial, commercial, and
consumer activities. Requirements as consumer activities. Requirements as
mstockstill on DSK3G9T082PROD with RULES2
§ 721.10928 Coke (coal), secondary pitch;
a carbon-containing residue from the specified in § 721.80(f), (k), and (q). specified in § 721.80(k)(A significant
coking of air blown pitch coke oil and/or (b) Specific requirements. The new use is use other than as: A semi-
pitch distillate; composed primarily of provisions of subpart A of this part conductor, conductive, or resistive
isotropic carbon, it contains small amounts apply to this section except as modified element in electronic circuitry and
of sulfur and ash constituents. by this paragraph. devices; an electro-mechanical switch in
(a) Chemical substance and (1) Recordkeeping. Recordkeeping electronic circuitry and devices; a film
significant new uses subject to reporting. requirements as specified in laminate to improve structural,
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/15.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81265
electrical or electro-chemical properties significant new uses described in Assigned Protection Factor (APF) of at
of composite materials; a film laminate paragraph (a)(2) of this section. least 1,000 equipped with an
to improve conductivity in batteries, (2) The significant new uses are: appropriate gas/vapor (acid gas, organic
capacitors and fuels cells; with (i) Industrial, commercial, and vapor, or substance specific) cartridge in
composite materials to improve their consumer activities. Requirements as combination with HEPA filters or a
mechanical properties and electrical specified in § 721.80. A significant new NIOSH-certified continuous flow
conductivities; catalyst support for use use of the substances is any use other supplied air respirator equipped with a
in fuel cells; in a nanoporous network than as chemical intermediates, full facepiece meet the requirements of
in gas diffusion layers; for separation of additives for flotation products, or § 721.63(a)(4).
chemicals; an additive to improve adhesion promoters for use in asphalt (A) As an alternative to the respirator
corrosion resistance of metals; an applications where the surface water requirements in paragraph (a)(2)(i) of
additive in lubricants and greases to concentrations described under this section, a manufacturer or processor
improve wear resistance; an additive for paragraph (a)(3)(i) of this section are may choose to follow the new chemical
transparency and conductivity in exceeded. exposure limit (NCEL) provision listed
electronic devices; an additive for fibers (ii) [Reserved] in the TSCA section 5(e) consent order
in structural and electrical applications; (3) The significant new uses for any for this substance. The NCEL is 0.1
an additive for fibers in fabrics and as use other than as chemical mg/m3 as an 8-hour time weighted
a chemical intermediate) and (q). A intermediates, additives for flotation average. Persons who wish to pursue
significant new use is any use involving products, or adhesion promoters for use NCELs as an alternative to § 721.63
an application method that generates a in asphalt applications are: respirator requirements may request to
vapor, mist or aerosol unless such (i) Release to water. Requirements as do so under § 721.30. Persons whose
application method occurs in an specified in § 721.90(a)(4), (b)(4), and § 721.30 requests to use the NCELs
enclosed process. An enclosed process (c)(4) where (N=1 for PMNs P–15–150 approach are approved by EPA will be
is defined as an operation that is and P–14–165), (N=2 for PMN P–14– required to follow NCELs provisions
designed and operated so that there is 166), and (N=4 for PMNs P–14–151 and comparable to those contained in the
no release associated with normal or P–14–152). corresponding TSCA section 5(e)
routine production processes into the (ii) [Reserved] consent order.
environment of any substance present in (b) Specific requirements. The (B) [Reserved]
the operation. An operation with provisions of subpart A of this part (ii) Hazard communication program.
inadvertent or emergency pressure relief apply to this section except as modified Requirements as specified in
releases remains an enclosed process so by this paragraph. § 721.72(a), through (e) (concentration
(1) Recordkeeping. Recordkeeping set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii),
long as measures are taken to prevent
requirements as specified in (g)(2)(iii), (g)(2)(iv), and (g)(5).
worker exposure to and environmental
§ 721.125(a), (b), (c), (i), and (k) are (iii) Industrial, commercial, and
contamination from the releases.
applicable to manufacturers and consumer activities. Requirements as
(iii) Disposal. Requirements as
processors of these substances. specified in § 721.80(q).
specified in § 721.85(a)(1), (a)(2), (b)(1), (2) Limitations or revocation of
(b)(2), (c)(1), and (c)(2). (b) Specific requirements. The
certain notification requirements. The provisions of subpart A of this part
(iv) Release to water. Requirements as provisions of § 721.185 apply to this
specified in § 721.90(a)(1), (b)(1), and apply to this section except as modified
section. by this paragraph.
(c)(1).
■ 8. Add § 721.10931 to subpart E to (1) Recordkeeping. Recordkeeping
(b) Specific requirements. The
read as follows: requirements as specified in
provisions of subpart A of this part
§ 721.125(a) through (d), and (f), through
apply to this section except as modified § 721.10931 Kaolin, reaction products with (i) are applicable to manufacturers and
by this paragraph. polysiloxane (generic).
processors of this substance.
(1) Recordkeeping. Recordkeeping (a) Chemical substance and (2) Limitations or revocation of
requirements as specified in significant new uses subject to reporting. certain notification requirements. The
§ 721.125(a) through (e), (i), (j), and (k) (1) The chemical substance identified provisions of § 721.185 apply to this
are applicable to manufacturers and generically as kaolin, reaction products section.
processors of this substance. with polysiloxane (PMN P–14–413) is (3) Determining whether a specific use
(2) Limitations or revocation of subject to reporting under this section is subject to this section. The provisions
certain notification requirements. The for the significant new uses described in of § 721.1725(b)(1) apply to paragraph
provisions of § 721.185 apply to this paragraph (a)(2) of this section. (a)(2)(iii) of this section.
section. (i) Protection in the workplace. ■ 9. Add § 721.10932 to subpart E to
(3) Determining whether a specific use Requirements as specified in read as follows:
is subject to this section. The provisions § 721.63(a)(1), (a)(4), (a)(6) (particulate),
of § 721.1725(b)(1) apply to paragraph (b) (concentration set at 1.0 percent), § 721.10932 Fatty acid amides (generic).
(a)(2)(ii) of this section. and (c). When determining which (a) Chemical substance and
■ 7. Add § 721.10930 to subpart E to persons are reasonably likely to be significant new uses subject to reporting.
read as follows: exposed as required for § 721.63(a)(1) (1) The chemical substances identified
and (a)(4), engineering control measures generically as fatty acid amides (PMNs
§ 721.10930 Fatty acid amides (generic). (e.g., enclosure or confinement of the P–14–428, P–14–429, P–14–430, and P–
mstockstill on DSK3G9T082PROD with RULES2
(a) Chemical substance and operation, general and local ventilation) 14–431) are subject to reporting under
significant new uses subject to reporting. or administrative control measures (e.g., this section for the significant new uses
(1) The chemical substances identified workplace policies and procedures) described in paragraph (a)(2) of this
generically as fatty acid amides (PMNs shall be considered and implemented to section.
P–14–150, P–14–151, P–14–152, P–14– prevent exposure, where feasible. A (2) The significant new uses are:
165, and P–14–166) are subject to NIOSH-certified powered air purifying (i) Industrial, commercial, and
reporting under this section for the full facepiece respirator with an consumer activities. Requirements as
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/16.svg)
![81266 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
specified in § 721.80. A significant new use the PMN substance other than for (1) Recordkeeping. Recordkeeping
use of the substances is any use other water and oil repellent use on military requirements as specified in
than as emulsifier intermediates or protective clothing. § 721.125(a) through (e), and (i) are
adhesion promoters for use in asphalt (iii) Release to water. Requirements as applicable to manufacturers and
applications where the surface water specified in § 721.90(a)(4), (b)(4), and processors of this substance.
concentrations described under (c)(4) where N=17. (2) Limitations or revocation of
paragraph (a)(3)(i) of this section are (b) Specific requirements. The certain notification requirements. The
exceeded. provisions of subpart A of this part provisions of § 721.185 apply to this
(ii) [Reserved] apply to this section except as modified section.
(3) The significant new uses for any by this paragraph. (3) Determining whether a specific use
use other than as emulsifier (1) Recordkeeping. Recordkeeping is subject to this section. The provisions
intermediates or adhesion promoters for requirements as specified in of § 721.1725(b)(1) apply to paragraphs
use in asphalt applications are: § 721.125(a) through (e), and (i) are (a)(2)(ii) of this section.
(i) Release to water. Requirements as applicable to manufacturers and ■ 12. Add § 721.10935 to subpart E to
specified in § 721.90(a)(4), (b)(4), and processors of this substance. read as follows:
(c)(4) where (N=1 for PMNs P–14–428 (2) Limitations or revocation of
and P–14–429) and (N=2 for PMNs certain notification requirements. The § 721.10935 Titanium oxide compound
P–14–429 and P–14–431). provisions of § 721.185 apply to this (generic).
(ii) [Reserved] section. (a) Chemical substance and
(b) Specific requirements. The (3) Determining whether a specific use significant new uses subject to reporting.
provisions of subpart A of this part is subject to this section. The provisions (1) The chemical substance identified
apply to this section except as modified of § 721.1725(b)(1) apply to paragraph generically as titanium oxide compound
by this paragraph. (a)(2)(ii) of this section. (PMN P–14–643) is subject to reporting
(1) Recordkeeping. Recordkeeping ■ 11. Add § 721.10934 to subpart E to under this section for the significant
requirements as specified in read as follows: new uses described in paragraph (a)(2)
§ 721.125(a), (b), (c), (i), and (k) are of this section.
§ 721.10934 Alkenoic acid, polymer with (2) The significant new uses are:
applicable to manufacturers and alkyl alkenoate, alkylalkylalkenoate,
processors of these substances. (i) Protection in the workplace.
alkenoic acid and tridecafluoro
(2) Limitations or revocation of alkylalkenoate, compds. with Requirements as specified in
certain notification requirements. The alkylaminoalcanol (generic). § 721.63(a)(1), (a)(4) (respirators must
provisions of § 721.185 apply to this (a) Chemical substance and provide a National Institute for
section. significant new uses subject to reporting. Occupational Safety and Health
■ 10. Add § 721.10933 to subpart E to (1) The chemical substance identified (NIOSH) assigned protection factor of at
read as follows: generically as alkenoic acid, polymer least 10), (a)(6) (particulate), (b)
with alkyl alkenoate, (concentration set at 1.0 percent), and
§ 721.10933 Copolymers of perfluorinated (c). When determining which persons
alkylalkylalkenoate, alkenoic acid and
and alkyl methacrylates (generic). are reasonably likely to be exposed as
tridecafluoro alkylalkenoate, compds.
(a) Chemical substance and with alkylaminoalcanol (PMN P–14– required for § 721.63(a)(1) and (a)(4),
significant new uses subject to reporting. 580) is subject to reporting under this engineering control measures (e.g.,
(1) The chemical substances identified section for the significant new uses enclosure or confinement of the
generically as copolymers of described in paragraph (a)(2) of this operation, general and local ventilation)
perfluorinated and alkyl methacrylates section. or administrative control measures (e.g.,
(PMNs P–14–523, P–14–524, P–14–525, (2) The significant new uses are: workplace policies and procedures)
P–14–526, and P–14–527) are subject to (i) Protection in the workplace. shall be considered and implemented to
reporting under this section for the Requirements as specified in prevent exposure, where feasible.
significant new uses described in § 721.63(a)(1), (a)(4), (a)(6) (particulate, (A) As an alternative to the respirator
paragraph (a)(2) of this section. gas/vapor or a combination gas/vapor requirements in paragraph (a)(2)(i) of
(2) The significant new uses are: and particulate), and (c). When this section, a manufacturer or processor
(i) Protection in the workplace. determining which persons are may choose to follow the new chemical
Requirements as specified in reasonably likely to be exposed as exposure limit (NCEL) provision listed
§ 721.63(a)(1), (a)(4), (a)(6) (particulate, required for § 721.63(a)(1) engineering in the TSCA section 5(e) consent order
gas/vapor or a combination gas/vapor control measures (e.g., enclosure or for this substance. The NCEL is 2.4
and particulate)), and (c). When confinement of the operation, general mg/m3 as an 8-hour time weighted
determining which persons are and local ventilation) or administrative average. Persons who wish to pursue
reasonably likely to be exposed as control measures (e.g., workplace NCELs as an alternative to § 721.63
required for § 721.63(a)(1) engineering policies and procedures) shall be respirator requirements may request to
control measures (e.g., enclosure or considered and implemented to prevent do so under § 721.30. Persons whose
confinement of the operation, general exposure, where feasible. § 721.30 requests to use the NCELs
and local ventilation) or administrative (ii) Industrial, commercial, and approach are approved by EPA will be
control measures (e.g., workplace consumer activities. Requirements as required to follow NCELs provisions
policies and procedures) shall be specified in § 721.80(k) (analysis and comparable to those contained in the
considered and implemented to prevent reporting and limitations of maximum corresponding TSCA section 5(e)
mstockstill on DSK3G9T082PROD with RULES2
exposure, where feasible. impurity levels of certain impurities; consent order.
(ii) Industrial, commercial, and and use other described in the consent (B) [Reserved]
consumer activities. Requirements as order) and (q). (ii) Hazard communication program.
specified in § 721.80(f), (k) (analysis and (b) Specific requirements. The Requirements as specified in
reporting and limitations of maximum provisions of subpart A of this part § 721.72(a), through (e) (concentration
impurity levels of certain impurities), apply to this section except as modified set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii),
(o) and (q). It is a significant new use to by this paragraph. (g)(2)(iii), and (g)(2)(iv), and (g)(5).
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/17.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81267
(iii) Industrial, commercial, and § 721.10937 Plastics, wastes, pyrolyzed, apply to this section except as modified
consumer activities. Requirements as bulk pyrolysate (generic). by this paragraph.
specified in § 721.80(p) (4,300,000 (a) Chemical substance and (1) Recordkeeping. Recordkeeping
kilograms). significant new uses subject to reporting. requirements as specified in
(b) Specific requirements. The (1) The chemical substance identified § 721.125(a) through (i) are applicable to
provisions of subpart A of this part generically as plastics, wastes, manufacturers and processors of this
apply to this section except as modified pyrolyzed, bulk pyrolysate (PMN P–14– substance.
by this paragraph. 712) is subject to reporting under this (2) Limitations or revocation of
(1) Recordkeeping. Recordkeeping section for the significant new uses certain notification requirements. The
requirements as specified in described in paragraph (a)(2) of this provisions of § 721.185 apply to this
§ 721.125(a) through (d), and (f), through section. section.
(2) The significant new uses are: (3) Determining whether a specific use
(i) are applicable to manufacturers and (i) Protection in the workplace.
processors of this. is subject to this section. The provisions
Requirements as specified in of § 721.1725(b)(1) apply to paragraph
(2) Limitations or revocation of § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)
certain notification requirements. The (a)(2)(iii) of this section.
(respirators must provide a National
provisions of § 721.185 apply to this Institute for Occupational Safety and ■ 15. Add § 721.10938 to subpart E to
section. Health (NIOSH) assigned protection read as follows:
■ 13. Add § 721.10936 to subpart E to factor of at least 10), (a)(6)(v), (a)(6)(vi), § 721.10938 Plastics, wastes, pyrolyzed,
read as follows: (a)(6)(particulate or a combination gas/ light distillate (generic).
vapor and particulate), (b)(concentration
§ 721.10936 Fatty acid amide (a) Chemical substance and
set at 0.1 percent), and (c). When
hydrochlorides (generic). significant new uses subject to reporting.
determining which persons are
(1) The chemical substance identified
(a) Chemical substance and reasonably likely to be exposed as
generically as plastics, wastes,
significant new uses subject to reporting. required for § 721.63(a)(1) and (a)(4),
pyrolyzed, light distillate (PMN P–14–
(1) The chemical substances identified engineering control measures (e.g.,
713) is subject to reporting under this
generically as fatty acid amide enclosure or confinement of the
section for the significant new uses
hydrochlorides (PMNs P–14–688, P–14– operation, general and local ventilation)
described in paragraph (a)(2) of this
689, P–14–690, and P–14–691) are or administrative control measures (e.g.,
section.
subject to reporting under this section workplace policies and procedures)
(2) The significant new uses are:
for the significant new uses described in shall be considered and implemented to
(i) Protection in the workplace.
paragraph (a)(2) of this section. prevent exposure, where feasible.
(A) As an alternative to the respirator Requirements as specified in
(2) The significant new uses are: § 721.63(a)(1), (a)(2)(i), (a)(3),
(i) Industrial, commercial, and requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor (a)(4)(respirators must provide a
consumer activities. Requirements as National Institute for Occupational
specified in § 721.80. A significant new may choose to follow the exposure limit
(EL) provision listed in the TSCA Safety and Health (NIOSH) assigned
use of the substances is any use other protection factor of at least 10), (a)(6)(v),
than as surfactants for use in asphalt section 5(e) consent order for this
substance. The EL is both 0.1 ppm for (a)(6)(vi), (a)(6)(particulate or a
applications where the surface water combination gas/vapor and particulate),
concentrations described under benzene and 10 ppm for naphthalene as
an 8-hour time weighted average. (b)(concentration set at 0.1 percent), and
paragraph (a)(3)(i) of this section are (c). When determining which persons
exceeded. (B) [Reserved]
(ii) Hazard communication program. are reasonably likely to be exposed as
(ii) [Reserved] Requirements as specified in § 721.72(a) required for § 721.63(a)(1) and (a)(4),
(3) The significant new uses for any through (e)(concentration set at 1.0 engineering control measures (e.g.,
use other than as surfactants for use in percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), enclosure or confinement of the
asphalt applications are: (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), operation, general and local ventilation)
(i) Release to water. Requirements as (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), or administrative control measures (e.g.,
specified in § 721.90(a)(4), (b)(4), and (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and workplace policies and procedures)
(c)(4) (N=1 for PMNs P–14–688, P–14– (g)(5). shall be considered and implemented to
689, and P–14–690) and (N=2 for PMN (iii) Industrial, commercial, and prevent exposure, where feasible.
P–14–691). consumer activities. Requirements as (A) As an alternative to the respirator
(ii) [Reserved] specified in § 721.80(k). It is a requirements in paragraph (a)(2)(i) of
(b) Specific requirements. The significant new use to manufacture this this section, a manufacturer or processor
provisions of subpart A of this part substance other than as described in the may choose to follow the exposure limit
apply to this section except as modified PMN. It is a significant new use to (EL) provision listed in the TSCA
by this paragraph. manufacture this substance without section 5(e) consent order for this
testing the substance for substance. The EL is both 0.1 ppm for
(1) Recordkeeping. Recordkeeping benzene and 10 ppm for naphthalene as
requirements as specified in polychlorinated dibenzo-p-dioxin and
dibenzofuran impurities using EPA an 8-hour time weighted average.
§ 721.125(a), (b), (c), (i), and (k) are (B) [Reserved]
applicable to manufacturers and Method 8290A at each facility of
manufacture, conducting the testing (ii) Hazard communication program.
mstockstill on DSK3G9T082PROD with RULES2
processors of these substances.
every quarter that the PMN substance is Requirements as specified in § 721.72(a)
(2) Limitations or revocation of manufactured, submitting the results of through (e) (concentration set at 1.0
certain notification requirements. The any testing conducted, or providing test percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii),
provisions of § 721.185 apply to this results more than 45 days after receiving (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii),
section. them. (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii),
■ 14. Add § 721.10937 to subpart E to (b) Specific requirements. The (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and
read as follows: provisions of subpart A of this part (g)(5).
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/18.svg)
![81268 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
(iii) Industrial, commercial, and (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (ii) Hazard communication program.
consumer activities. Requirements as (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), Requirements as specified in § 721.72(a)
specified in § 721.80 (k). (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and through (e) (concentration set at 1.0
(b) Specific requirements. The (g)(5). percent), (f), (g)(1)(i), through (g)(1)(ix),
provisions of subpart A of this part (iii) Industrial, commercial, and (g)(2)(i), through (g)(2)(iii), (g)(2)(v),
apply to this section except as modified consumer activities. Requirements as (g)(3)(i), (g)(3)(ii), and (g)(5).
by this paragraph. specified in § 721.80(k). (iii) Industrial, commercial, and
(1) Recordkeeping. Recordkeeping (b) Specific requirements. The consumer activities. Requirements as
requirements as specified in provisions of subpart A of this part specified in § 721.80(k).
§ 721.125(a) through (i) are applicable to apply to this section except as modified (b) Specific requirements. The
manufacturers and processors of this by this paragraph. provisions of subpart A of this part
substance. (1) Recordkeeping. Recordkeeping apply to this section except as modified
(2) Limitations or revocation of requirements as specified in by this paragraph.
certain notification requirements. The § 721.125(a) through (i) are applicable to (1) Recordkeeping. Recordkeeping
provisions of § 721.185 apply to this manufacturers and processors of this requirements as specified in
section. substance. § 721.125(a) through (i) are applicable to
(3) Determining whether a specific use (2) Limitations or revocation of manufacturers and processors of this
is subject to this section. The provisions certain notification requirements. The substance.
of § 721.1725(b)(1) apply to paragraph provisions of § 721.185 apply to this (2) Limitations or revocation of
(a)(2)(iii) of this section. section. certain notification requirements. The
■ 16. Add § 721.10939 to subpart E to (3) Determining whether a specific use provisions of § 721.185 apply to this
read as follows: is subject to this section. The provisions section.
of § 721.1725(b)(1) apply to paragraph (3) Determining whether a specific use
§ 721.10939 Plastics, wastes, pyrolyzed, (a)(2)(iii) of this section. is subject to this section. The provisions
middle distillate (generic). of § 721.1725(b)(1) apply to paragraph
■ 17. Add § 721.10940 to subpart E to
(a) Chemical substance and read as follows: (a)(2)(iii) of this section.
significant new uses subject to reporting. ■ 18. Add § 721.10941 to subpart E to
(1) The chemical substance identified § 721.10940 Plastics, wastes, pyrolyzed, read as follows:
generically as plastics, wastes, heavy distillate (generic).
pyrolyzed, middle distillate (PMN P– (a) Chemical substance and § 721.10941 Carbon silicon oxide.
14–714) is subject to reporting under significant new uses subject to reporting. (a) Chemical substance and
this section for the significant new uses (1) The chemical substance identified significant new uses subject to reporting.
described in paragraph (a)(2) of this generically as plastics, wastes, (1) The chemical substance identified as
section. pyrolyzed, heavy distillate (PMN P–14– carbon silicon oxide (PMN P–15–28;
(2) The significant new uses are: 715) is subject to reporting under this CAS No. 39345–87–4) is subject to
(i) Protection in the workplace. section for the significant new uses reporting under this section for the
Requirements as specified in described in paragraph (a)(2) of this significant new uses described in
§ 721.63(a)(1), (a)(2)(i), (a)(3), section. paragraph (a)(2) of this section.
(a)(4)(respirators must provide a (2) The significant new uses are: (2) The significant new uses are:
National Institute for Occupational (i) Protection in the workplace. (i) Protection in the workplace.
Safety and Health (NIOSH) assigned Requirements as specified in Requirements as specified in
protection factor of at least 10), (a)(6)(v), § 721.63(a)(1), (a)(2)(i), (a)(3), § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)
(a)(6)(vi), (a)(6)(particulate or a (a)(4)(respirators must provide a (respirators must provide a National
combination gas/vapor and particulate), National Institute for Occupational Institute for Occupational Safety and
(b)(concentration set at 0.1 percent), and Safety and Health (NIOSH) assigned Health (NIOSH) assigned protection
(c). When determining which persons protection factor of at least 10), (a)(6)(v), factor of at least 10), (a)(6)(v), (a)(6)(vi),
are reasonably likely to be exposed as (a)(6)(vi), (a)(6) (particulate or a (a)(6) (particulate or a combination gas/
required for § 721.63(a)(1) and (a)(4), combination gas/vapor and particulate), vapor and particulate), (b)
engineering control measures (e.g., (b)(concentration set at 0.1 percent), and (concentration set at 1.0 percent), and
enclosure or confinement of the (c). When determining which persons (c). When determining which persons
operation, general and local ventilation) are reasonably likely to be exposed as are reasonably likely to be exposed as
or administrative control measures (e.g., required for § 721.63(a)(1) and (a)(4), required for § 721.63(a)(1) and (a)(4),
workplace policies and procedures) engineering control measures (e.g., engineering control measures (e.g.,
shall be considered and implemented to enclosure or confinement of the enclosure or confinement of the
prevent exposure, where feasible. operation, general and local ventilation) operation, general and local ventilation)
(A) As an alternative to the respirator or administrative control measures (e.g., or administrative control measures (e.g.,
requirements in paragraph (a)(2)(i) of workplace policies and procedures) workplace policies and procedures)
this section, a manufacturer or processor shall be considered and implemented to shall be considered and implemented to
may choose to follow the exposure limit prevent exposure, where feasible. prevent exposure, where feasible.
(EL) provision listed in the TSCA (A) As an alternative to the respirator (A) As an alternative to the respirator
section 5(e) consent order for this requirements in paragraph (a)(2)(i) of requirements in paragraph (a)(2)(i) of
substance. The EL is both 0.1 ppm for this section, a manufacturer or processor this section, a manufacturer or processor
mstockstill on DSK3G9T082PROD with RULES2
benzene and 10 ppm for naphthalene as may choose to follow the exposure limit may choose to follow the new chemical
an 8-hour time weighted average. (EL) provision listed in the TSCA exposure limit (NCEL) provision listed
(B) [Reserved] section 5(e) consent order for this in the TSCA section 5(e) consent order
(ii) Hazard communication program. substance. The EL is both 0.1 ppm for for this substance. The NCEL is 6
Requirements as specified in § 721.72(a) benzene and 10 ppm for naphthalene as mg/m3 as an 8-hour time weighted
through (e) (concentration set at 1.0 an 8-hour time weighted average. average. Persons who wish to pursue
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (B) [Reserved] NCELs as an alternative to § 721.63
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/19.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81269
respirator requirements may request to Factor (APF) of at least 50 with an N– ■ 21. Add § 721.10944 to subpart E to
do so under § 721.30. Persons whose 100, P–100, or R–100 cartridge meets read as follows:
§ 721.30 requests to use the NCELs the requirements of § 721.63(a)(4).
approach are approved by EPA will be (ii) Industrial, commercial, and § 721.10944 Substituted quinoline
consumer activities. Requirements as derivative (generic).
required to follow NCELs provisions
comparable to those contained in the specified in § 721.80(k)(chemical (a) Chemical substance and
corresponding TSCA section 5(e) intermediate) and (p)(one year). significant new uses subject to reporting.
consent order. (iii) Disposal. Requirements as (1) The chemical substance identified
(B) [Reserved] specified in § 721.85(a)(1), (a)(2), (b)(1), generically as substituted quinoline
(ii) Hazard communication program. (b)(2), (c)(1), and (c)(2). derivative (PMN P–15–267) is subject to
Requirements as specified in § 721.72(a) (iv) Release to water. Requirements as reporting under this section for the
through (e) (concentration set at 1.0 specified in § 721.90(a)(1), (b)(1), and significant new uses described in
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (c)(1). paragraph (a)(2) of this section.
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). (b) Specific requirements. The (2) The significant new uses are:
(iii) Industrial, commercial, and provisions of subpart A of this part (i) Protection in the workplace.
consumer activities. It is a significant apply to this section except as modified Requirements as specified in
new use to manufacture the PMN by this paragraph. § 721.63(a)(1), (a)(3), (a)(4) (respirators
substance other than specified in the (1) Recordkeeping. Recordkeeping must provide a National Institute for
TSCA section 5(e) consent order. requirements as specified in Occupational Safety and Health
Requirements as specified in § 721.80(p) § 721.125(a) through (e), (i), (j), and (k) (NIOSH) assigned protection factor of at
(within 24 months of submission of a are applicable to manufacturers and least 10), (a)(6) (particulate),
Notice of Commencement of processors of this substance. (b)(concentration set at 1.0 percent), and
Manufacture). (2) Limitations or revocation of (c). When determining which persons
(b) Specific requirements. The certain notification requirements. The are reasonably likely to be exposed as
provisions of subpart A of this part provisions of § 721.185 apply to this required for § 721.63(a)(1) and (a)(4),
apply to this section except as modified section. engineering control measures (e.g.,
by this paragraph. ■ 20. Add § 721.10943 to subpart E to enclosure or confinement of the
(1) Recordkeeping. Recordkeeping read as follows: operation, general and local ventilation)
requirements as specified in § 721.10943 Sulfonated alkylbenzene salts
or administrative control measures (e.g.,
§ 721.125(a) through (i) are applicable to (generic). workplace policies and procedures)
manufacturers and processors of this. shall be considered and implemented to
(a) Chemical substance and
(2) Limitations or revocation of prevent exposure, where feasible.
significant new uses subject to reporting.
certain notification requirements. The (ii) Industrial, commercial, and
(1) The chemical substance identified
provisions of § 721.185 apply to this consumer activities. Requirements as
generically as sulfonated alkylbenzene
section. specified in § 721.80(j).
salts (PMN P–15–149) is subject to
(3) Determining whether a specific use (b) Specific requirements. The
reporting under this section for the
is subject to this section. The provisions provisions of subpart A of this part
significant new uses described in
of § 721.1725(b)(1) apply to paragraph apply to this section except as modified
paragraph (a)(2) of this section.
(a)(2)(iii) of this section. (2) The significant new uses are: by this paragraph.
■ 19. Add § 721.10942 to subpart E to (i) Hazard communication program. (1) Recordkeeping. Recordkeeping
read as follows: Requirements as specified in § 721.72(a) requirements as specified in
through (e)(concentration set at 1.0 § 721.125(a), through (e), and (i) are
§ 721.10942 Carbon nanotubes (generic). applicable to manufacturers and
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)
(a) Chemical substance and (serious eye damage), (g)(2)(i), (g)(2)(ii), processors of this substance.
significant new uses subject to reporting. (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (2) Limitations or revocation of
(1) The chemical substance identified (g)(4)(i) and (g)(5). certain notification requirements. The
generically as carbon nanotubes (PMN (ii) Industrial, commercial, and provisions of § 721.185 apply to this
P–15–54) is subject to reporting under consumer activities. Requirements as section.
this section for the significant new uses specified in § 721.80(k) and (q). (3) Determining whether a specific use
described in paragraph (a)(2) of this (iii) Release to water. Requirements as is subject to this section. The provisions
section. specified in § 721.90(a)(4), (b)(4), and of § 721.1725(b)(1) apply to paragraph
(2) The significant new uses are: (c)(4) (N=2). (a)(2)(ii) of this section.
(i) Protection in the workplace. (b) Specific requirements. The ■ 22. Add § 721.10945 to subpart E to
Requirements as specified in provisions of subpart A of this part read as follows:
§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), apply to this section except as modified
(a)(4), (a)(6) (particulate), and (c). When by this paragraph. § 721.10945 Algal oil amide (generic).
determining which persons are (1) Recordkeeping. Recordkeeping (a) Chemical substance and
reasonably likely to be exposed as requirements as specified in significant new uses subject to reporting.
required for § 721.63(a)(1) and (a)(4), § 721.125(a), (b), (c), (f), (g), (h), (i), and (1) The chemical substance identified
engineering control measures (e.g., (k) are applicable to manufacturers and generically as algal oil amide (PMN P–
enclosure or confinement of the processors of this substance. 15–470) is subject to reporting under
operation, general and local ventilation) (2) Limitations or revocation of this section for the significant new uses
mstockstill on DSK3G9T082PROD with RULES2
or administrative control measures (e.g., certain notification requirements. The described in paragraph (a)(2) of this
workplace policies and procedures) provisions of § 721.185 apply to this section.
shall be considered and implemented to section. (2) The significant new uses are:
prevent exposure, where feasible. A (3) Determining whether a specific use (i) Industrial, commercial, and
National Institute for Occupational is subject to this section. The provisions consumer activities. Requirements as
Safety and Health (NIOSH)-certified of § 721.1725(b)(1) apply to paragraph specified in § 721.80(j).
respirator with an Assigned Protection (a)(2)(ii) of this section. (ii) [Reserved]
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/20.svg)
![81270 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
(b) Specific requirements. The (ii) Hazard communication program. comparable to those contained in the
provisions of subpart A of this part Requirements as specified in § 721.72(a) corresponding TSCA section 5(e)
apply to this section except as modified through (e) (concentration set at 1.0 consent order.
by this paragraph. percent), (f), (g)(1)(ii), (g)(2)(ii), (B) [Reserved]
(1) Recordkeeping. Recordkeeping (g)(2)(iii), and (g)(2)(iv), and (g)(5). (ii) Hazard communication program.
requirements as specified in (iii) Industrial, commercial, and Requirements as specified in
§ 721.125(a), (b), (c), and (i) are consumer activities. Requirements as § 721.72(a), (b), (c), (d), (e)
applicable to manufacturers and specified in § 721.80(p) (360,000 (concentration set at 1.0 percent), (f),
processors of this substance. kilograms). (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and
(2) Limitations or revocation of (b) Specific requirements. The (g)(2)(iv), and (g)(5).
certain notification requirements. The provisions of subpart A of this part (iii) Industrial, commercial, and
provisions of § 721.185 apply to this apply to this section except as modified consumer activities. Requirements as
section. by this paragraph. specified in § 721.80(p) (6,000
(3) Determining whether a specific use (1) Recordkeeping. Recordkeeping kilograms, aggregate of PMNs P–15–612,
is subject to this section. The provisions requirements as specified in P–15–613, P–15–614, P–15–615, P–15–
of § 721.1725(b)(1) apply to paragraph § 721.125(a) through (d), and (f), through 616, P–15–617, P–15–618, combined).
(a)(2)(i) of this section. (i) are applicable to manufacturers and (b) Specific requirements. The
■ 23. Add § 721.10946 to subpart E to processors of this substance. provisions of subpart A of this part
read as follows: (2) Limitations or revocation of apply to this section except as modified
certain notification requirements. The by this paragraph.
§ 721.10946 Bismuth compound (generic). provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping
(a) Chemical substance and section. requirements as specified in
significant new uses subject to reporting. ■ 24. Add § 721.10947 to subpart E to § 721.125(a), (b), (c), (d), (f), (g), (h), and
(1) The chemical substance identified read as follows: (i) are applicable to manufacturers and
generically as bismuth compound (PMN processors of this substance.
P–15–485) is subject to reporting under § 721.10947 Sulfur thulium ytterbium (2) Limitations or revocation of
this section for the significant new uses yttrium oxide. certain notification requirements. The
described in paragraph (a)(2) of this (a) Chemical substance and provisions of § 721.185 apply to this
section. The requirements of this order significant new uses subject to reporting. section.
do not apply when the chemical (1) The chemical substance identified as ■ 25. Add § 721.10948 to subpart E to
substance has been completely reacted sulfur thulium ytterbium yttrium oxide read as follows:
(cured). (PMN P–15–612; CAS No. 180189–40–6)
(2) The significant new uses are: is subject to reporting under this section § 721.10948 Gadolinium sulfur ytterbium
(i) Protection in the workplace. for the significant new uses described in yttrium oxide, erbium- and thulium-doped.
Requirements as specified in paragraph (a)(2) of this section. (a) Chemical substance and
§ 721.63(a)(1), (a)(4) (respirators must (2) The significant new uses are: significant new uses subject to reporting.
provide a National Institute for (i) Protection in the workplace. (1) The chemical substance identified as
Occupational Safety and Health Requirements as specified in (PMN P–15–613; CAS No, 1651187–
(NIOSH) assigned protection factor of at § 721.63(a)(1), (a)(4) (respirators must 84–6) is subject to reporting under this
least 10), (a)(6) (particulate), provide a National Institute for section for the significant new uses
(b)(concentration set at 1.0 percent), and Occupational Safety and Health described in paragraph (a)(2) of this
(c). When determining which persons (NIOSH) assigned protection factor of at section.
are reasonably likely to be exposed as least 10), (a)(6) (particulate), (b) (2) The significant new uses are:
required for § 721.63(a)(1) and (a)(4), (concentration set at 1.0 percent), and (i) Protection in the workplace.
engineering control measures (e.g., (c). When determining which persons Requirements as specified in
enclosure or confinement of the are reasonably likely to be exposed as § 721.63(a)(1), (a)(4) (respirators must
operation, general and local ventilation) required for § 721.63(a)(1) and (a)(4), provide a National Institute for
or administrative control measures (e.g., engineering control measures (e.g., Occupational Safety and Health
workplace policies and procedures) enclosure or confinement of the (NIOSH) assigned protection factor of at
shall be considered and implemented to operation, general and local ventilation) least 10), (a)(6) (particulate), (b)
prevent exposure, where feasible. or administrative control measures (e.g., (concentration set at 1.0 percent), and
(A) As an alternative to the respirator workplace policies and procedures) (c). When determining which persons
requirements in paragraph (a)(2)(i) of shall be considered and implemented to are reasonably likely to be exposed as
this section, a manufacturer or processor prevent exposure, where feasible. required for § 721.63(a)(1) and (a)(4),
may choose to follow the new chemical (A) As an alternative to the respirator engineering control measures (e.g.,
exposure limit (NCEL) provision listed requirements in paragraph (a)(2)(i) of enclosure or confinement of the
in the TSCA section 5(e) consent order this section, a manufacturer or processor operation, general and local ventilation)
for this substance. The NCEL is 2.4 mg/ may choose to follow the new chemical or administrative control measures (e.g.,
m3 as an 8-hour time weighted average. exposure limit (NCEL) provision listed workplace policies and procedures)
Persons who wish to pursue NCELs as in the TSCA section 5(e) consent order shall be considered and implemented to
an alternative to § 721.63 respirator for this substance. The NCEL is 0.07 prevent exposure, where feasible.
requirements may request to do so mg/m3 as an 8-hour time weighted (A) As an alternative to the respirator
mstockstill on DSK3G9T082PROD with RULES2
under § 721.30. Persons whose § 721.30 average. Persons who wish to pursue requirements in paragraph (a)(2)(i) of
requests to use the NCELs approach are NCELs as an alternative to § 721.63 this section, a manufacturer or processor
approved by EPA will be required to respirator requirements may request to may choose to follow the new chemical
follow NCELs provisions comparable to do so under § 721.30. Persons whose exposure limit (NCEL) provision listed
those contained in the corresponding § 721.30 requests to use the NCELs in the TSCA section 5(e) consent order
TSCA section 5(e) consent order. approach are approved by EPA will be for this substance. The NCEL is 0.07
(B) [Reserved] required to follow NCELs provisions mg/m3 as an 8-hour time weighted
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/21.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81271
average. Persons who wish to pursue this section, a manufacturer or processor operation, general and local ventilation)
NCELs as an alternative to § 721.63 may choose to follow the new chemical or administrative control measures (e.g.,
respirator requirements may request to exposure limit (NCEL) provision listed workplace policies and procedures)
do so under § 721.30. Persons whose in the TSCA section 5(e) consent order shall be considered and implemented to
§ 721.30 requests to use the NCELs for this substance. The NCEL is 0.07 mg/ prevent exposure, where feasible.
approach are approved by EPA will be m3 as an 8-hour time weighted average. (A) As an alternative to the respirator
required to follow NCELs provisions Persons who wish to pursue NCELs as requirements in paragraph (a)(2)(i) of
comparable to those contained in the an alternative to § 721.63 respirator this section, a manufacturer or processor
corresponding TSCA section 5(e) requirements may request to do so may choose to follow the new chemical
consent order. under § 721.30. Persons whose § 721.30 exposure limit (NCEL) provision listed
(B) [Reserved] requests to use the NCELs approach are in the TSCA section 5(e) consent order
(ii) Hazard communication program. approved by EPA will be required to for this substance. The NCEL is 0.07 mg/
Requirements as specified in follow NCELs provisions comparable to m3 as an 8-hour time weighted average.
§ 721.72(a), through (e) (concentration those contained in the corresponding Persons who wish to pursue NCELs as
set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), TSCA section 5(e) consent order. an alternative to § 721.63 respirator
(g)(2)(iii), and (g)(2)(iv), and (g)(5). (B) [Reserved] requirements may request to do so
(iii) Industrial, commercial, and (ii) Hazard communication program. under § 721.30. Persons whose § 721.30
consumer activities. Requirements as Requirements as specified in § 721.72(a) requests to use the NCELs approach are
specified in § 721.80(p)(6,000 kilograms, through (e) (concentration set at 1.0 approved by EPA will be required to
aggregate of PMNs P–15–612, P–15–613, percent), (f), (g)(1)(ii), (g)(2)(ii), follow NCELs provisions comparable to
P–15–614, P–15–615, P–15–616, P–15– (g)(2)(iii), and (g)(2)(iv), and (g)(5). those contained in the corresponding
617, P–15–618, combined). (iii) Industrial, commercial, and TSCA section 5(e) consent order.
(b) Specific requirements. The consumer activities. Requirements as (B) [Reserved]
provisions of subpart A of this part specified in § 721.80(p)(6,000 kilograms, (ii) Hazard communication program.
apply to this section except as modified aggregate of PMNs P–15–612, P–15–613, Requirements as specified in § 721.72(a)
by this paragraph. P–15–614, P–15–615, P–15–616, P–15– through (e) (concentration set at 1.0
(1) Recordkeeping. Recordkeeping 617, P–15–618, combined). percent), (f), (g)(1)(ii), (g)(2)(ii),
requirements as specified in (b) Specific requirements. The (g)(2)(iii), and (g)(2)(iv), and (g)(5).
§ 721.125(a), (b), (c), (d), (f), (g), (h), and provisions of subpart A of this part (iii) Industrial, commercial, and
(i) are applicable to manufacturers and apply to this section except as modified consumer activities. Requirements as
processors of this substance. by this paragraph. specified in § 721.80(p)(6,000 kilograms,
(2) Limitations or revocation of (1) Recordkeeping. Recordkeeping aggregate of PMNs P–15–612, P–15–613,
certain notification requirements. The requirements as specified in P–15–614, P–15–615, P–15–616, P–15–
provisions of § 721.185 apply to this § 721.125(a), (b), (c), (d), (f), (g), (h), and 617, P–15–618, combined).
section. (i) are applicable to manufacturers and (b) Specific requirements. The
■ 26. Add § 721.10949 to subpart E to processors of this substance. provisions of subpart A of this part
read as follows: (2) Limitations or revocation of apply to this section except as modified
certain notification requirements. The by this paragraph.
§ 721.10949 Neodymium sulfur yttrium provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping
oxide. section. requirements as specified in § 721.125
(a) Chemical substance and ■ 27. Add § 721.10950 to subpart E to (a) through (d), and (f), through (i) are
significant new uses subject to reporting. read as follows: applicable to manufacturers and
(1) The chemical substance identified as processors of this substance.
neodymium sulfur yttrium oxide (PMN § 721.10950 Erbium gadolinium (2) Limitations or revocation of
P–15–614; CAS No. 1651158–45–5) is neodymium sulfur ytterbium yttrium oxide certain notification requirements. The
subject to reporting under this section (P–15–615). provisions of § 721.185 apply to this
for the significant new uses described in (a) Chemical substance and section.
paragraph (a)(2) of this section. significant new uses subject to reporting. ■ 28. Add § 721.10951 to subpart E to
(2) The significant new uses are: (1) The chemical substance identified as read as follows:
(i) Protection in the workplace. erbium gadolinium neodymium sulfur
Requirements as specified in ytterbium yttrium oxide (PMN P–15– § 721.10951 Erbium gadolinium sulfur
§ 721.63(a)(1), (a)(4)(respirators must 615; CAS No. 1651152–96–3) is subject ytterbium yttrium oxide.
provide a National Institute for to reporting under this section for the (a) Chemical substance and
Occupational Safety and Health significant new uses described in significant new uses subject to reporting.
(NIOSH) assigned protection factor of at paragraph (a)(2) of this section. (1) The chemical substance identified as
least 10), (a)(6)(particulate), (2) The significant new uses are: erbium gadolinium sulfur ytterbium
(b)(concentration set at 1.0 percent), and (i) Protection in the workplace. yttrium oxide (P–15–616; CAS No.
(c). When determining which persons Requirements as specified in 1622295–07–1) is subject to reporting
are reasonably likely to be exposed as § 721.63(a)(1), (a)(4)(respirators must under this section for the significant
required for § 721.63(a)(1) and (a)(4), provide a National Institute for new uses described in paragraph (a)(2)
engineering control measures (e.g., Occupational Safety and Health of this section.
enclosure or confinement of the (NIOSH) assigned protection factor of at (2) The significant new uses are:
mstockstill on DSK3G9T082PROD with RULES2
operation, general and local ventilation) least 10), (a)(6)(particulate), (i) Protection in the workplace.
or administrative control measures (e.g., (b)(concentration set at 1.0 percent), and Requirements as specified in
workplace policies and procedures) (c). When determining which persons § 721.63(a)(1), (a)(4)(respirators must
shall be considered and implemented to are reasonably likely to be exposed as provide a National Institute for
prevent exposure, where feasible. required for § 721.63(a)(1) and (a)(4), Occupational Safety and Health
(A) As an alternative to the respirator engineering control measures (e.g., (NIOSH) assigned protection factor of at
requirements in paragraph (a)(2)(i) of enclosure or confinement of the least 10), (a)(6)(particulate),
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/22.svg)
![81272 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
(b)(concentration set at 1.0 percent), and (i) Protection in the workplace. oxide (PMN P–15–618; CAS No.
(c). When determining which persons Requirements as specified in 934388–91–7) is subject to reporting
are reasonably likely to be exposed as § 721.63(a)(1), (a)(4)(respirators must under this section for the significant
required for § 721.63(a)(1) and (a)(4), provide a National Institute for new uses described in paragraph (a)(2)
engineering control measures (e.g., Occupational Safety and Health of this section.
enclosure or confinement of the (NIOSH) assigned protection factor of at (2) The significant new uses are:
operation, general and local ventilation) least 10), (a)(6)(particulate), (i) Protection in the workplace.
or administrative control measures (e.g., (b)(concentration set at 1.0 percent), and Requirements as specified in
workplace policies and procedures) (c). When determining which persons § 721.63(a)(1), (a)(4)(respirators must
shall be considered and implemented to are reasonably likely to be exposed as provide a National Institute for
prevent exposure, where feasible. required for § 721.63(a)(1) and (a)(4), Occupational Safety and Health
(A) As an alternative to the respirator engineering control measures (e.g., (NIOSH) assigned protection factor of at
requirements in paragraph (a)(2)(i) of enclosure or confinement of the least 10), (a)(6)(particulate),
this section, a manufacturer or processor operation, general and local ventilation) (b)(concentration set at 1.0 percent), and
may choose to follow the new chemical or administrative control measures (e.g., (c). When determining which persons
exposure limit (NCEL) provision listed workplace policies and procedures) are reasonably likely to be exposed as
in the TSCA section 5(e) consent order shall be considered and implemented to required for § 721.63(a)(1) and (a)(4),
for this substance. The NCEL is 0.07 mg/ prevent exposure, where feasible. engineering control measures (e.g.,
m3 as an 8-hour time weighted average. (A) As an alternative to the respirator enclosure or confinement of the
Persons who wish to pursue NCELs as requirements in paragraph (a)(2)(i) of operation, general and local ventilation)
an alternative to § 721.63 respirator this section, a manufacturer or processor or administrative control measures (e.g.,
requirements may request to do so may choose to follow the new chemical workplace policies and procedures)
under § 721.30. Persons whose § 721.30 exposure limit (NCEL) provision listed shall be considered and implemented to
requests to use the NCELs approach are in the TSCA section 5(e) consent order prevent exposure, where feasible.
for this substance. The NCEL is 0.07 mg/ (A) As an alternative to the respirator
approved by EPA will be required to
m3 as an 8-hour time weighted average. requirements in paragraph (a)(2)(i) of
follow NCELs provisions comparable to
Persons who wish to pursue NCELs as this section, a manufacturer or processor
those contained in the corresponding
an alternative to § 721.63 respirator may choose to follow the new chemical
TSCA section 5(e) consent order.
requirements may request to do so exposure limit (NCEL) provision listed
(B) [Reserved]
under § 721.30. Persons whose § 721.30 in the TSCA section 5(e) consent order
(ii) Hazard communication program.
requests to use the NCELs approach are for this substance. The NCEL is 0.07
Requirements as specified in § 721.72(a)
approved by EPA will be required to mg/m3 as an 8-hour time weighted
through (e) (concentration set at 1.0
follow NCELs provisions comparable to average. Persons who wish to pursue
percent), (f), (g)(1)(ii), (g)(2)(ii),
those contained in the corresponding NCELs as an alternative to § 721.63
(g)(2)(iii), and (g)(2)(iv), and (g)(5).
TSCA section 5(e) consent order. respirator requirements may request to
(iii) Industrial, commercial, and do so under § 721.30. Persons whose
consumer activities. Requirements as (B) [Reserved]
(ii) Hazard communication program. § 721.30 requests to use the NCELs
specified in § 721.80(p)(6,000 kilograms, approach are approved by EPA will be
aggregate of PMNs P–15–612, P–15–613, Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0 required to follow NCELs provisions
P–15–614, P–15–615, P–15–616, P–15– comparable to those contained in the
617, P–15–618, combined). percent), (f), (g)(1)(ii), (g)(2)(ii),
(g)(2)(iii), and (g)(2)(iv), and (g)(5). corresponding TSCA section 5(e)
(b) Specific requirements. The consent order.
(iii) Industrial, commercial, and
provisions of subpart A of this part (B) [Reserved]
consumer activities. Requirements as
apply to this section except as modified (ii) Hazard communication program.
specified in § 721.80(p)(6,000 kilograms,
by this paragraph. Requirements as specified in § 721.72(a)
aggregate of PMNs P–15–612, P–15–613,
(1) Recordkeeping. Recordkeeping through (e) (concentration set at 1.0
P–15–614, P–15–615, P–15–616, P–15–
requirements as specified in § 721.125 percent), (f), (g)(1)(ii), (g)(2)(ii),
617, P–15–618, combined).
(a) through (d), and (f),through (i) are (b) Specific requirements. The (g)(2)(iii), and (g)(2)(iv), and (g)(5).
applicable to manufacturers and provisions of subpart A of this part (iii) Industrial, commercial, and
processors of this substance. apply to this section except as modified consumer activities. Requirements as
(2) Limitations or revocation of by this paragraph. specified in § 721.80(p)(6,000 kilograms,
certain notification requirements. The (1) Recordkeeping. Recordkeeping aggregate of PMNs P–15–612, P–15–613,
provisions of § 721.185 apply to this requirements as specified in § 721.125 P–15–614, P–15–615, P–15–616, P–15–
section. (a) through (d), and (f), through (i) are 617, P–15–618, combined).
■ 29. Add § 721.10952 to subpart E to applicable to manufacturers and (b) Specific requirements. The
read as follows: processors of this substance. provisions of subpart A of this part
(2) Limitations or revocation of apply to this section except as modified
§ 721.10952 Erbium gadolinium ytterbium certain notification requirements. The by this paragraph.
oxide. (1) Recordkeeping. Recordkeeping
provisions of § 721.185 apply to this
(a) Chemical substance and section. requirements as specified in
significant new uses subject to reporting. ■ 30. Add § 721.10953 to subpart E to
§ 721.125(a) through (d), (f), through (i)
(1) The chemical substance identified as are applicable to manufacturers and
mstockstill on DSK3G9T082PROD with RULES2
read as follows:
erbium gadolinium ytterbium oxide processors of this substance.
(PMN P–15–617; CAS No. 1651152–05– § 721.10953 Erbium gadolinium sulfur (2) Limitations or revocation of
4) is subject to reporting under this ytterbium oxide. certain notification requirements. The
section for the significant new uses (a) Chemical substance and provisions of § 721.185 apply to this
described in paragraph (a)(2) of this significant new uses subject to reporting. section.
section. (1) The chemical substance identified as ■ 31. Add § 721.10954 to subpart E to
(2) The significant new uses are: erbium gadolinium sulfur ytterbium read as follows:
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/23.svg)
![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations 81273
§ 721.10954 2-Ethylhexanoic acid, ■ 33. Add § 721.10956 to subpart E to § 721.125(a) through (e) are applicable
compound with alkyamino cyclohexane read as follows: to manufacturers and processors of this
(generic); and 2-Ethylhexanoic acid, substance.
compound with cyclohexylamine (generic). § 721.10956 Acrylic acid, polymer with (2) Limitations or revocation of
(a) Chemical substance and polyalkylene polyamine (generic).
certain notification requirements. The
significant new uses subject to reporting. (a) Chemical substance and provisions of § 721.185 apply to this
(1) The chemical substances identified significant new uses subject to reporting. section.
generically as 2-ethylhexanoic acid, (1) The chemical substance identified
■ 35. Add § 721.10958 to subpart E to
compound with alkyamino cyclohexane generically as acrylic acid, polymer with
read as follows:
(PMN P–15–0655, chemical A); and 2- polyalkylene polyamine (PMN P–15–
ethylhexanoic acid, compound with 691) is subject to reporting under this § 721.10958 2,5-Furandione, dihydro-,
cyclohexylamine (PMN P–15–0655, section for the significant new uses polymer with 1,1′-iminobis[2-propanol],
chemical B) are subject to reporting described in paragraph (a)(2) of this benzoate (ester), N-benzoyl derivs.
under this section for the significant section. (a) Chemical substance and
new uses described in paragraph (a)(2) (2) The significant new uses are: significant new uses subject to reporting.
of this section. (i) Industrial, commercial, and (1) The chemical substance identified as
(2) The significant new uses are: consumer activities. Requirements as 2,5-furandione, dihydro-, polymer with
(i) Release to water. Requirements as specified in § 721.80(g). 1,1′-iminobis[2-propanol], benzoate
specified in § 721.90(a)(4), (b)(4), and (ii) [Reserved] (ester), N-benzoyl derivs. (PMN P–16–
(c)(4) where N = 34. (b) Specific requirements. The 52; CAS No. 592479–38–4) is subject to
(ii) [Reserved] provisions of subpart A of this part reporting under this section for the
(b) Specific requirements. The apply to this section except as modified significant new uses described in
provisions of subpart A of this part by this paragraph. paragraph (a)(2) of this section.
apply to this section except as modified (1) Recordkeeping. Recordkeeping (2) The significant new uses are:
by this paragraph. requirements as specified in (i) Release to water. Requirements as
(1) Recordkeeping. Recordkeeping § 721.125(a), (b), (c), and (k) are specified in § 721.90(a)(4), (b)(4), and
requirements as specified in applicable to manufacturers and (c)(4) where N = 5.
§ 721.125(a), (b), (c), and (k) are processors of this substance. (ii) [Reserved]
applicable to manufacturers and (2) Limitations or revocation of (b) Specific requirements. The
processors of this substance. certain notification requirements. The provisions of subpart A of this part
(2) Limitations or revocation of provisions of § 721.185 apply to this apply to this section except as modified
certain notification requirements. The section. by this paragraph.
provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping
■ 34. Add § 721.10957 to subpart E to
section. requirements as specified in
read as follows:
■ 32. Add § 721.10955 to subpart E to § 721.125(a), (b), (c), and (k) are
read as follows: § 721.10957 1,2-Cyclohexanedicarboxylic applicable to manufacturers and
acid, 1-(2-phenylhydrazide). processors of this substance.
§ 721.10955 Propenoic acid, alkyl ester,
polymer with 1,3-cyclohexanedialkylamine,
(a) Chemical substance and (2) Limitations or revocation of
reaction products with oxirane(alkoxyalkyl) significant new uses subject to reporting. certain notification requirements. The
(generic). (1) The chemical substance identified as provisions of § 721.185 apply to this
(a) Chemical substance and (1,2-cyclohexanedicarboxylic acid, 1-(2- section.
significant new uses subject to reporting. phenylhydrazide) (PMN P–16–30; CAS ■ 36. Add § 721.10959 to subpart E to
(1) The chemical substance identified No. 1807977–72–5) is subject to read as follows:
generically as propenoic acid, alkyl reporting under this section for the
ester, polymer with 1,3- significant new uses described in § 721.10959 Dialkyl fattyalkylamino
paragraph (a)(2) of this section. propanamide alkylamine acetates (generic).
cyclohexanedialkylamine, reaction
products with oxirane(alkoxyalkyl) (2) The significant new uses are: (a) Chemical substance and
(PMN P–15–680) is subject to reporting (i) Protection in the workplace. significant new uses subject to reporting.
under this section for the significant Requirements as specified in (1) The chemical substances identified
new uses described in paragraph (a)(2) § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), generically as dialkyl fattyalkylamino
of this section. (a)(6)(particulate), (b)(concentration set propanamide alkylamine acetates
(2) The significant new uses are: at 1.0 percent), and (c). When (PMNs P–16–56 and P–16–57) are
(i) Release to water. Requirements as determining which persons are subject to reporting under this section
specified in § 721.90 (a)(4), (b)(4), and reasonably likely to be exposed as for the significant new uses described in
(c)(4) where N = 1. required for § 721.63(a)(1) engineering paragraph (a)(2) of this section.
(ii) [Reserved] control measures (e.g., enclosure or (2) The significant new uses are:
(b) Specific requirements. The confinement of the operation, general (i) Release to water. Requirements as
provisions of subpart A of this part and local ventilation) or administrative specified in § 721.90(a)(4), (b)(4), and
apply to this section except as modified control measures (e.g., workplace (c)(4) where N = 1.
by this paragraph. policies and procedures) shall be (ii) [Reserved]
(1) Recordkeeping. Recordkeeping considered and implemented to prevent (b) Specific requirements. The
requirements as specified in exposure, where feasible. provisions of subpart A of this part
mstockstill on DSK3G9T082PROD with RULES2
§ 721.125(a), (b), (c), and (k) are (ii) [Reserved] apply to this section except as modified
applicable to manufacturers and (b) Specific requirements. The by this paragraph.
processors of this substance. provisions of subpart A of this part (1) Recordkeeping. Recordkeeping
(2) Limitations or revocation of apply to this section except as modified requirements as specified in
certain notification requirements. The by this paragraph. § 721.125(a), (b), (c), and (k) are
provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping applicable to manufacturers and
section. requirements as specified in processors of this substance.
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/24.svg)
![81274 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
(2) Limitations or revocation of generically as apply to this section except as modified
certain notification requirements. The dialkylaminopropylaminopropanoate by this paragraph.
provisions of § 721.185 apply to this ester (PMN P–16–58) is subject to (1) Recordkeeping. Recordkeeping
section. reporting under this section for the requirements as specified in
■ 37. Add § 721.10960 to subpart E to significant new uses described in § 721.125(a), (b), (c), and (k) are
read as follows: paragraph (a)(2) of this section. applicable to manufacturers and
(2) The significant new uses are: processors of this substance.
§ 721.10960 (i) Release to water. Requirements as (2) Limitations or revocation of
Dialkylaminopropylaminopropanoate ester specified in § 721.90(a)(4), (b)(4), and certain notification requirements. The
(generic). (c)(4) where N = 14. provisions of § 721.185 apply to this
(a) Chemical substance and (ii) [Reserved] section.
significant new uses subject to reporting. (b) Specific requirements. The [FR Doc. 2016–27326 Filed 11–16–16; 8:45 am]
(1) The chemical substance identified provisions of subpart A of this part BILLING CODE 6560–50–P
mstockstill on DSK3G9T082PROD with RULES2
VerDate Sep<11>2014 22:04 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00026 Fmt 4701 Sfmt 9990 E:\FR\FM\17NOR2.SGM 17NOR2](https://thefederalregister.org/doc/81_FR_81472/page/25.svg)
Document Created: 2016-11-17 03:00:21
Document Modified: 2016-11-17 03:00:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This rule is effective on January 17, 2017. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on December 1, 2016. | |
| Contact | For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email | |
| FR Citation | 81 FR 81250 | |
| RIN Number | 2070-AB27 | |
| CFR Citation | 40
CFR
721 40 CFR 9 | |
| CFR Associated | Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR