2016-11121. 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 55 chemical substances which were the subject of premanufacture notices (PMNs). Ten 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 55 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

DATES:

This rule is effective on July 15, 2016. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 31, 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 June 15, 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 before June 15, 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-2015-0810, 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: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture (defined by statute to include import), 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 a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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) (FRL-3658-5). 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. Persons who must report are described in § 721.5.

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 § 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 section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

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 55 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 55 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 (assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) consent order or the basis for the TSCA non-section 5(e) SNURs (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 10 PMN substances (P-11-150, P-11-484, P-11-543, P-14-67, P-15-59, P-15-60, P-15-104, P-15-154, P-15-328, and P-15-502) that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “TSCA section 5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The TSCA section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

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 § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 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.

This rule also includes SNURs on 45 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “TSCA non-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all TSCA non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities 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 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-11-150

Chemical name: Alkali transition metal oxide (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: April 14, 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 battery material. Based on test data on the PMN substance and structural activity relationship (SAR) analysis of test data on analogous respirable, poorly soluble particulates, subcategory titanium dioxide, EPA identified concerns for lung, blood, kidney, and adrenal toxicity, neurotoxicity, developmental toxicity, developmental neurotoxicity, cardiovascular and gastrointestinal effects, and immunosuppression. 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. Hazard communication. Establishment and use of a hazard communication program, including human health precautionary statements on each label and the Material Safety Data Sheet (MSDS).

2. Use of personal protective equipment including a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10 or compliance with a New Chemicals Exposure Limit (NCEL) of 2.4 milligrams/cubic meter (mg/m³) as an 8-hour time-weighted average, when there is potential inhalation exposure.

3. 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 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. It is not necessary to look at internal organs. EPA recommends that a recovery period of 60 days be included to assess the progression or regression of any lesions would help characterize possible health effects of the substance. The submitter has agreed to complete this testing by the confidential aggregate production volume identified in the consent order. In addition, EPA has determined that the results of a carcinogenicity test (OPPTS 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 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 721.10875.

PMN Numbers P-11-484 and P-11-543

Chemical names: Perfluoroalkyl substituted alkyl sulfonate (generic) (P-11-484); and Polyfluorinated alkyl quaternary ammonium chloride (generic) (P-11-543).

CAS numbers: Claimed confidential.

Effective date of TSCA section 5(e) consent order: October 30, 2014.

Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as surfactants. Based on physical chemical properties data, as well as test data on analogous perfluorinated chemicals and potential perfluorinated degradation products including perfluorooctanoic acid (PFOA), perfluorooctanesulfonate (PFOS), perfluorohexane sulfonate (PFHS), and 1H,1H,2H,2H-perfluorooctanesulfonic acid (6-2 FTSA), 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. Further, based on test data on P-11-484, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2,800 and 1 part per billion (ppb) respectively for PMN substances P-11-484 and P-11-543 respectively in surface waters. 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 these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these exposures and risks, the consent order requires:

1. 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.

2. Submission of certain physical/chemical property, human health and environmental toxicity, and environmental fate testing prior to exceeding the confidential production volume limits specified in the consent order.

3. Recording and reporting of certain fluorinated impurities in the starting raw material; and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities.

4. Use of the PMN substances only for the confidential uses specified in the consent order, where use in consumer products that could be spray applied are prohibited.

5. Disposal of the PMN substance according to the incineration conditions specified in the consent order.

6. 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 certain environmental fate and human health and environmental toxicity testing would help characterize human health and environmental effects of the PMN substances. The submitter has agreed to conduct the testing identified in the consent agreement by the confidential triggers identified in the consent order. Further, EPA has determined that the results of an acute inhalation toxicity test (OPPTS Test Guideline 870.1300) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to 3 months and BALF analysis would help characterize the human health effects from spray application 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 citations: 40 CFR 721.10876 (P-11-484) and 40 CFR 721.10877 (P-11-543).

PMN Number P-14-67

Chemical name: Polyfluorinatedalkylsulfonyl substituted alkane derivative (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: November 4, 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 polymer additive. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These fluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers which suggest that under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including PFOA and other perfluorinated alkyls, including the presumed environmental degradant. EPA also has concerns that under some conditions of use, particularly non-industrial, commercial, or consumer use, the PMN substance could cause lung effects, based on limited data on some perfluorinated compounds. Concerns for the PMN substance are for lung toxicity from waterproofing of lung membrane, based on PMN properties. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that these substances and their potential degradation products may present an unreasonable risk of injury to the environment and human health.

1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substance 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.

2. Submission of certain environmental fate testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance.

3. No use of the PMN substance in consumer spray products.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of the modified aerobic activated sludge biodegradation test submitted by the company for EPA review would help characterize the possible degradation of the PMN substance. The submitter has agreed to submit the results of this test by the confidential production volume identified in the consent order. EPA had determined that the results of a phototransformation of chemicals on soil surfaces (Organisation for Economic Co-operation and Development (OECD) Draft Document January 2002) would help characterize the degradation potential 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 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 721.10878.

PMN Number P-14-125

Chemical name: 1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)-N,N-dimethyl-, chloride (1:1).

CAS number: 3001-63-6.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate for surfactant production. Based on test data on the PMN substance, as well as SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 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 2 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use resulting in surface water concentrations exceeding 2 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10879.

PMN Numbers P-14-153, P-14-154, P-15-79, and P-15-80

Chemical names: Fatty acid rxn products with aminoalkylamines (generic).

CAS numbers: Claimed confidential.

Basis for action: The PMN states that these substances will be used as chemical intermediates, additives for flotation products, and as adhesion promoters 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 the PMN substances in surface waters. For the uses described in the PMN, releases of the substances are not expected to result in surface water concentrations exceeding 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, excluding the uses described in the PMNs, result in in releases to surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (Office of Chemical Safety and Pollution Prevention (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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be consulted to facilitate solubility in the test media. Testing should be tiered, starting with water solubility and log Kow measurements before proceeding with higher tier toxicity tests.

CFR citation: 40 CFR 721.10880.

PMN Numbers P-14-155 and P-14-156

Chemical names: Fatty acid amides (generic).

CAS numbers: Claimed confidential.

Basis for action: The PMNs state that the 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 predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 and 3 ppb respectively of the PMN substances P-14-155 and P-14-156 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 2 ppb and 3 ppb of the PMN substances respectively. 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 uses described in the PMNs, resulting in surface water concentrations exceeding 2 ppb (P-14-155) or 3 ppb (P-14-156) of the PMN substances may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(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); 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. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be consulted to facilitate solubility in the test media, because of the PMN's low water solubility. Testing should be tiered, starting with water solubility and log Kow measurements before proceeding with higher tier toxicity tests.

CFR citation: 40 CFR 721.10881.

PMN Number P-14-198

Chemical name: Trialkylammonium borodibenzoate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a color developer for general printing applications. Based on test data on the PMN substance and SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 47 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 domestic manufacture or 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 47 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing (defined by statute to include import), processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture or 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 § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10882.

PMN Number P-14-324

Chemical name: Fatty ester derivatives, reaction products with alkanolamine, hydroxylated, borated (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as a lubricating oil additive. Based on SAR analysis of test data on analogous boron compounds, 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 (defined by statute to include import), processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a lubricating oil additive may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a chronic fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10883.

PMN Number P-14-397

Chemical name: Benzenepropanol, 1-benzoate.

CAS number: 60045-26-3.

Basis for action: The PMN states that the substance will be used as a plasticizer in adhesives for food-product packaging, a diluents-type plasticizer in plastisols, a coalescent in architectural paints and coatings, and a fragrance carrier in fragrances. Based on SAR analysis of test data on analogous esters, 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 uses described in the PMN. For the uses 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 § 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 substance.

CFR citation: 40 CFR 721.10884.

PMN Number P-14-448

Chemical name: Alcohols, C_12-22, distn. residues.

CAS number: 1476777-83-9.

Basis for action: The PMN states that the use of the substance will be used in formulation of defoamers used in the production of paper. Based on structure-activity relationship SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 waters exceed releases from the use described in the PMN. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 7 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, any use where the cumulative molecular weights of the C₁₂ and C₁₄ components exceed 2 percent by weight of the overall molecular weight of the PMN substance may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 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. Before conducting these aquatic toxicity testing, EPA recommends chemical characterization of the alkyl range for the alcohol moiety and a water solubility test (OECD Test Guideline 105) should be conducted.

CFR citation: 40 CFR 721.10885.

PMN Number P-14-501 and P-14-502

Chemical names: Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters (P-14-501), and Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts (P-14-502).

CAS numbers: 1502809-48-4 (P-14-501) and 1502809-56-4 (P-14-502).

Basis for action: The PMN states that substances will be used as gellants for use in oil fracturing. Based on structure-activity relationship (SAR) analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 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 4 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 substances resulting in releases to surface water concentrations exceeding 4 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10886 (P-14-501) and 40 CFR 721.10887 (P-14-502).

PMN Numbers P-15-59, P-15-60, and P-15-104

Chemical names: Siloxanes and Silicones, 3-[(2-aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric acid and oleylamine (P-15-59); Dodecanoic acid, reaction products with cadmium zinc selenide sulfide and oleylamine (P-15-60); and Phosphonic acid, P-tetradecyl-, reaction products with cadmium selenide (CdSe) (P-15-104).

CAS numbers: 1623456-05-2 (P-15-59); 1773514-92-3 (P-15-60); and 1773514-66-1 (P-15-104).

Effective date of TSCA section 5(e) consent order: May 5, 2015.

Basis for TSCA section 5(e) consent order: The PMNs state that the substances will be used as a down converter for an optical filter for light emitting diodes used in displays (P-15-59) and as chemical intermediates (P-15-60 and P-15-104). Based on SAR analysis of test data on analogous respirable, poorly soluble particulates and the presence of cadmium, EPA identified concerns for lung effects, kidney effects, and oncogenicity. In addition, EPA predicts chronic toxicity to aquatic organisms from exposure to cadmium. 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 impervious gloves to prevent dermal exposures, where there is a potential for dermal exposures.

2. Submission of certain material characterization data on P-15-59 by the time triggers specified in the consent order.

3. Manufacture, process, or use the PMN substances only in a liquid formulation.

4. Manufacture, process, and use P-15-59 only as a down converter for an optical filter for light emitting diodes used in displays.

5. Manufacture, process, and use of P-15-60 and P-15-104 only as chemical intermediates.

6. Disposal of the PMN substances only by incineration in a permitted hazardous waste incinerator.

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 material characterization data specified in the consent order on PMN substance P-15-59 would help characterize the possible effects of the PMN substance. The submitter has agreed to submit the results of these studies prior to 3 and 18 month time triggers identified in the consent order. In addition, EPA determined that the results of a metabolism and pharmacokinetics test (OPPTS Test Guideline 870.7485) would help characterize the human health and environmental effect 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 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 721.10888 (P-15-59), 40 CFR 721.10889 (P-15-60), and 40 CFR 721.10890 (P-15-104).

PMN Number P-15-81

Chemical name: Alkyl silicate, polymer with 2-(chloromethyl)oxirane and 4,4′0-(1-methylethylidene)bis[phenol], alkoxylated (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 SAR analysis of test data on analogous epoxides, there were health concerns regarding skin and lung sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive, liver, and kidney toxicity based on the epoxide oxidation product as well as irritation and lung toxicity expected from the ethoxy silane hydrolysis product from exposure to the PMN substance via dermal exposure. Further, based on SAR analysis of test data on analogous epoxides, 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, occupational exposures are expected to be minimal due to use of adequate dermal personal protection equipment and 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 without the use of impervious gloves, where there is a potential for dermal exposure, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); a Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200); 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 human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10891.

PMN Number P-15-109

Chemical name: Reaction product of a mixture of aromatic dianhydrides and aliphatic esters with an aromatic diamine (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an intermediate. Based on SAR analysis of test data on analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 11 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 11 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 11 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301) 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 721.10892.

PMN Number P-15-111

Chemical name: Fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a hardener for coating systems. 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 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 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing (defined by statute to include import), processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance, or any use of the PMN substance other than as described in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301) 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 721.10893.

PMN Number P-15-120

Chemical name: Substituted benzyl acrylate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a resin for industrial coating. Based on SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301) 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 721.10894.

PMN Number P-15-154

Chemical name: Fluoroalkyl acrylate copolymer (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: May 14, 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 textile treatment. 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 the environment. To protect against these risks, the consent order requires:

1. 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.

2. 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.

3. 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.

The SNUR designates as a “significant new use” the absence of these protective measures.

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) with a 60-day holding period, and certain physical chemical property and environmental fate testing identified in the consent order would help characterize the human health and fate 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 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 721.10895.

PMN Number P-15-176

Chemical name: 1-Hexanol, 6-mercapto-.

CAS number: 1633-78-9.

Basis for action: The PMN states that the substance will be used as a chemical intermediate to curable monomers. Based on SAR analysis of test data on analogous thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 8 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in surface water concentrations exceeding 8 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability test (OECD Test Guideline 301B) 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 721.10896.

PMN Number P-15-177

Chemical name: Phenol, 2,2′-[1,2-disubstituted-1,2-ethanediyl]bis(iminomethylene)bis[substituted- (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst in the process to manufacture a crop protection chemical. Based on test data on the PMN substance, EPA identified concerns for blood toxicity to workers from dermal exposures to the PMN substance. As described in the PMN, occupational exposures are expected to be minimal due to use of adequate dermal personal protection 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 any use of the substance without the use of chemical impervious gloves, where there is a potential for dermal exposure, or any use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing: EPA has determined that the results of a skin absorption, In vitro method (OECD Test Guideline 428) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10897.

PMN Number P-15-188

Chemical name: Carbomonocycles, polymer with substituted heteromonocycle, succinate, methyl acrylate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as a pigment-wetting resin for Ultra Violet (UV)-curable coatings. Based on SAR analysis of test data on analogous methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 7 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 § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a water solubility test (OECD Test Guideline 105); 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 water solubility testing should be conducted prior to conducting the ecotoxicity testing as the results of the water solubility may change the recommended ecotoxicity testing.

CFR citation: 40 CFR 721.10898.

PMN Number P-15-190

Chemical name: Halogenated alkyl trimethylaminium halide (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be for cationization of starch. Based on test data on analogous alkylating agents, there were health concerns regarding mutagenicity, oncogenicity, developmental toxicity and respiratory sensitization based from exposure to the PMN substance via inhalation exposure. In addition, based on SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 88 ppb of the PMN substance in surface waters. As described in the PMN, exposure is expected to be minimal due to use of adequate respiratory personal protection equipment and releases of the substance are not expected to result in surface water concentrations that exceed 88 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 without the use of NIOSH-certified respirator with an APF of at least 10, where there is a potential for respiratory exposure, or any use of the substance resulting in surface water concentrations exceeding 88 ppb may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a bacterial reverse mutation test, (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395); an acute oral toxicity test (OPPTS Test Guideline 870.1100); a repeated dose 28-day oral toxicity study in rodents (OPPTS Test Guideline 870.3050); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10899.

PMN Number P-15-252

Chemical name: Titanium salt, reaction products with silica (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 insoluble metal oxides, EPA identified concerns for lung toxicity if inhaled based on lung overload for respirable, poorly soluble particulates. For the use described in the PMN, inhalation exposures are expected to be minimal as the PMN is handled in an enclosed process. 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 in a non-enclosed process, or any use of the substance other than listed in the PMN may result in significant adverse human health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60-day holding period and a particle size distribution/fiber length and diameter distributions (OECD Test Guideline 110) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10900.

PMN Number P-15-272

Chemical name: Formaldehyde, reaction products with aniline and aromatic mono- and di-phenol mixture (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a resin. Based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability (OECD Test Guideline 301) 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 721.10901.

PMN Number P-15-276

Chemical name: Functionalized carbon nanotubes (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as a thin film for electronic device applications. Based on SAR analysis of test data on analogous carbon nanotubes and other respirable poorly soluble particulates, EPA identified potential lung effects and skin penetration and toxicity induction from inhalation and dermal exposure to the PMN substance. Further, EPA predicts toxicity to aquatic organisms via releases of the PMN substance to surface water. Although there is potential for dermal exposure, EPA does not expect significant occupational exposures due to the use of impervious gloves, and because the PMN is used in a liquid and is not spray applied except in a closed system. Further, EPA does not expect environmental releases during the use identified in the PMN submission. Therefore, EPA has not determined that the proposed manufacturing, processing, and or use of the substance may present an unreasonable risk to human health or the environment. EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol except in a closed system; or any release of the PMN substance into surface waters or disposal other than by landfill or incineration may cause serious health effects or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); a 90-day inhalation toxicity test (OPPTS 870.3465) with additional testing parameters beyond those noted at CFR 870.3465, for using the 90-day subchronic protocol for nanomaterial assessment; a two-year inhalation bioassay (OPPTS Test Guideline 870.4200); and a surface charge by electrophoresis (for example, using ASTM E2865-12 or NCL Method PCC-2—Measuring the Zeta Potential of Nanoparticles) would help characterize the health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10902.

PMN Number P-15-295

Chemical name: Acrylated mixed metal oxides (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on SAR analysis of test data on respirable poorly soluble particulates, EPA identified potential lung effects and dermal toxicity from inhalation and dermal exposure to the PMN substance. Further, EPA predicts toxicity to aquatic organisms via releases of the PMN substance to surface water. Although there is potential for dermal exposure, EPA does not expect significant occupational exposures due to the use of impervious gloves, and because the PMN is used in a liquid and is not spray applied. Further, EPA does not expect environmental releases during the use identified in the PMN submission. Therefore, EPA has not determined that the proposed manufacturing, processing, and or use of the substance may present an unreasonable risk to human health or the environment. EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is potential for dermal exposure; manufacturing, processing, or using the PMN substance in a form other than as a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; any release of the PMN substance into surface waters; or disposal other than by landfill or incineration may cause serious health effects or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b))(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day holding period; 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 and health effects of the PMN substance.

CFR citation: 40 CFR 721.10903.

PMN Number P-15-306

Chemical name: Phenol, 1,1-dimethylalkyl derivatives (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a process intermediate. Based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 13 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 13 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 13 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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); an algal toxicity test (OCSPP Test Guideline 850.4500); and a Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200) 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 721.10904.

PMN Number P-15-319

Chemical name: Butanedioic acid, 2-methylene-, dialkyl ester (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate for production of a lubricant additive. Based on SAR analysis of test data on analogous acrylates and esters, 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 resulting in 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 § 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); an algal toxicity test (OCSPP Test Guideline 850.4500); and a ready biodegradability (OECD Test Guideline 301) 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 721.10905.

PMN Number P-15-324

Chemical name: Magnesium alkaryl sulfonate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the use of the substance will be as a detergent additive in crankcase lubricant applications. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 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 1 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 § 721.170(b)(4)(i).

Recommended testing: EPA has determined that the results of a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10906.

PMN Number P-15-326

Chemical name: Polyfluorohydrocarbon (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a specialty gas and transfer fluid. Based on test data on the PMN substance, EPA identified concerns for neurotoxicity and uncertain concern for cardiac sensitization. Further, based on SAR analysis of test data on analogous substances, EPA identified concerns for developmental toxicity. As described in the PMN, EPA does not expect significant occupational exposures due to use of adequate personal protective equipment, and consumer exposures are not expected as the PMN substance is not used in consumer products. 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 or any use in a consumer product may result in significant adverse human health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of 90-day inhalation toxicity (OPPTS Test Guideline 870.3465) would help characterize the health effects of the PMN substance.

CFR citation: 40 CFR 721.10907.

PMN Number P-15-328

Chemical name: Aluminum calcium oxide salt (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: June 2, 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 cement additive. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity based on lung overload. 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. Hazard communication. Establishment and use of a hazard communication program, including human health precautionary statements on each label and the MSDS.

2. Use of personal protective equipment including a NIOSH-certified respirator with an APF of at least 10 or compliance with a NCEL of 5 mg/m³ as an 8-hour time-weighted average (when there is potential inhalation exposure), when there is potential inhalation exposure.

3. Manufacture, processing or use of the PMN substance only for the use 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 a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats would help characterize possible health effects of the 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 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 721.10908.

PMN Number P-15-332

Chemical name: Polyalkyltrisiloxane (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a site-limited intermediate. Based on SAR analysis of test data on an analogous substance, there were health concerns regarding liver and kidney toxicity, thyroid effects, and reproductive and developmental toxicity from dermal and inhalation exposures to the PMN substance. Further, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters. EPA also 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. Further, as described in the PMN, exposure is expected to be minimal due to use of adequate respiratory and dermal personal protection equipment and releases of the substance are not expected to result in surface water concentrations exceeding 4 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 waters exceeding 4 ppb, any use other than that as a site-limited intermediate, or any use without the use of a NIOSH-certified respirator with gas/vapor cartridges and an APF of at least 10 and impervious gloves, may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a sediment-water lumbriculus toxicity test (OECD Test Guideline 225); a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. All ecotoxicity tests should analyze the PMN substance as well as the hydrolysis products.

CFR citation: 40 CFR 721.10909.

PMN Number P-15-356

Chemical names: Oxirane, 2,2′-[[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-phenyleneoxymethylene)]bis- (P-15-356, Chemical A); and 2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B).

CAS numbers: 115254-47-2 (P-15-356, Chemical A) and 180063-56-3 (P-15-356, Chemical B).

Basis for action: The PMN states that the substances will be used as additives in polymer formulation for electronics. Based on test data on the PMN substances and on SAR analysis of test data on analogous epoxides, EPA identified concerns for respiratory sensitization and irritation, mutagenicity, developmental toxicity, male reproduction toxicity, liver and kidney toxicity, and oncogenicity. Additionally, based on SAR analysis of test data on analogous polyepoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. Further, EPA has concerns that the PMN substances are potentially PBT chemicals as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. For the use described in the PMN, EPA expects occupational exposures to be minimal and does not expect releases to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as additives in polymer formulation for electronics or any use of the substances resulting in releases to surface waters may cause serious human health or significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); a sediment-water chironomid life-cycle toxicity test (OECD Test Guideline 233), using spiked water or spiked sediment; 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 human health and environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10910 (P-15-356, chemical A) and 40 CFR 721.10911 (P-15-356, chemical B).

PMN Number P-15-363

Chemical name: Aliphatic acrylate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 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 721.10912.

PMN Number P-15-378

Chemical name: Diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as a dual cure/UV cure adhesion/barrier coating for wood substrates. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory sensitization. As described in the PMN, EPA does not expect significant occupational dermal or inhalation exposure due to use of adequate personal protective equipment and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10 where there is a potential for inhalation exposure, or any use in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and 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 721.10913.

PMN Number P-15-382

Chemical name: Polyitaconic acid, sodium zinc salt (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as an odor neutralization for pet litter and cleaning hard surface surfaces, fabrics, skin and hair; an odor neutralization for air car; and an odor neutralization for waste processing and solid waste management in paper, oil, gas, mining, agriculture, food and municipal industries. Based on SAR analysis of test data on analogous zinc salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 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 4 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 § 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 substance.

CFR citation: 40 CFR 721.10914.

PMN Number P-15-411

Chemical name: Fatty acid esters with polyols polyalkyl ethers (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an anti-rust coating solution additive. Based on SAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 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 30 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 30 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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 721.10915.

PMN Number P-15-435

Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-3-[substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3) (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a direct anionic dyestuff for the printing industry. Based on the results of a 28-day oral study for the PMN substance, EPA predicts anemia, effects on the adrenals, spleen, kidney, lymph nodes and immunotoxicity. In addition, based on the lithium salt of the PMN, EPA identified concerns for developmental toxicity and neurotoxicity. Further, based on SAR analysis of test data on analogous azo reduction products, EPA identified concerns for blood effects, developmental toxicity, oncogenicity, and mutagenicity. As described in the PMN, EPA does not expect significant risk to workers due to 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 any use of the substance other than in a liquid formulation could result in exposures which may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of an ames assay (OPPTS Test Guideline 870.5100) with the rival modification; a mouse micronucleus assay conducted by the oral route (OPPTS Test Guideline 870.5395); and a combined repeated dose and developmental toxicity and reproductive toxicity screening test (OPPTS Test Guideline 870.3650) would help to characterize the health effects of the PMN substance.

CFR citation: 40 CFR 721.10916.

PMN Number P-15-492

Chemical name: Polymethylsiloxane, distillation residues (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a site-limited intermediate. Based on SAR analysis test data on analogous silanes, EPA identified concerns for mutagenicity, liver and kidney toxicity, thyroid effects, and reproductive and developmental toxicity from dermal and inhalation exposures to the PMN substance. Further, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the intermediate use described in the PMN, occupational exposures are expected to be minimal due to the use of adequate respiratory and dermal personal protection equipment, and 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 without the use of a NIOSH-certified respirator with gas/vapor cartridges and an APF of at least 10, where there is a potential for inhalation exposures, any use of the substance without the use of impervious gloves, where there is a potential for dermal exposures; any use of the substance other than an intermediate; or any use of the substance resulting in surface water concentrations exceeding 1 ppb may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a sediment-water lumbriculus toxicity test (OECD Test Guideline 225) using spiked sediment; a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); 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 human health and environmental effects of the PMN substance. All ecotoxicity tests should analyze for the PMN substance as well as the hydrolysis products.

CFR citation: 40 CFR 721.10917.

PMN Number P-15-502

Chemical name: Perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: November 4, 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 protective treatment. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These fluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers which suggest that under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including PFOA and other perfluorinated alkyls, including the presumed environmental degradant. EPA also has concerns that under some conditions of use, particularly non-industrial, commercial, or consumer use, the PMN substance could cause lung effects, based on limited data on some perfluorinated compounds. Concerns for the PMN substance are for lung toxicity from waterproofing of lung membrane, based on PMN properties. 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 and its potential intermediate and/or ultimate degradation products may present an unreasonable risk of injury to the environment and human health.

1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substance 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.

2. Submission of certain environmental fate testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the consent order of the PMN substance.

3. No use of the PMN substance in consumer spray products.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of an aerobic and anaerobic transformation in soil test (OECD Test Guideline 307) would help characterize the possible degradation of the PMN substance. The submitter has agreed to submit the results of this test by the confidential production volume identified in the consent order. EPA had determined that the results of a phototransformation of chemicals on soil surfaces (OECD Draft Document January 2002) would help characterize the degradation potential 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 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 721.10918.

PMN Number P-15-542

Chemical name: Quaternary ammonium compounds, (3-chloro-2-hydroxypropyl)coco alkyldimethyl, chlorides.

CAS number: 690995-44-9.

Basis for action: The PMN states that the substance will be used as an intermediate for surfactant production, and as a chemical intermediate for sale into commerce. Based on SAR analysis of test data on analogous cationic (quaternary ammonium) surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 24 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 24 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 24 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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 substance.

CFR citation: 40 CFR 721.10919.

PMN Number P-15-559

Chemical name: Modified diphenylmethane diisocyanate prepolymer with polyol (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material for flexible foam. Based on SAR analysis of analogous diisocyanates, EPA identified concerns for potential dermal and respiratory sensitization from dermal and inhalation exposures, and for pulmonary toxicity from inhalation exposure, to the PMN substance where the average molecular weight is below 7,500 daltons and any molecular weight species is below 1,000 daltons. For the molecular weight distribution described in the PMN, significant occupational exposures are not expected. Therefore, EPA has not determined that the proposed manufacture of the substance may present an unreasonable risk. EPA has determined, however, that any manufacture of the PMN substance with an average molecular weight below 7,500 daltons, and where any molecular weight species is below 1,000 daltons may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and 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 721.10920.

PMN Number P-15-573

Chemical name: 2-Furancarboxyaldehyde, 5-(chloromethyl)-.

CAS number: 1623-88-7.

Basis for action: The PMN states that the use of the substance will be as a chemical intermediate. Based on SAR analysis of test data on analogous aldehydes, the EPA identified human health concerns for liver toxicity, neurotoxicity, sensitization, and cancer to workers exposed through dermal and inhalation routes. For the chemical intermediate use described in the PMN, occupational exposures are expected to be minimal due to the use of adequate personal protective equipment and a continuous reaction process such that no greater than 50 kilograms of the PMN substance is present in the workplace at a given time for this use. 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 without the use of a NIOSH-certified respirator with an APF of at least 50, where there is a potential for inhalation exposures; any use without the use of impervious gloves, where there is a potential for dermal exposures, any use of the substance other than as a chemical intermediate; or any use beyond the annual production volume limit of 15,000 kilograms may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a skin sensitization (OECD Test Guideline 406) would help characterize the human health effects of the PMN substance; a combined repeated dose toxicity test with the reproduction/developmental toxicity screening test (OECD Test Guideline 422) with functional observational battery (FOB); a standard test method for permeation of liquids and gases through protective clothing materials under conditions of continuous contact (ASTM Test Guideline F739) using the format specified in the standard guide for documenting the results of chemical permeation testing of materials used in protective clothing materials (ASTM Test Guideline F1194-99(2010)); and a carcinogenicity test (OECD Test Guideline 451) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10921.

PMN Number P-15-607

Chemical name: 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an initiator for polymerization. Based on data on the PMN substance, as well as SAR analysis of test data on analogous peroxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 56 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 56 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 § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) using a solvent where the effects of the solvent are already known or measured, would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10922.

PMN Number P-15-671

Chemical name: 9-Octadecen-1-amine, hydrochloride (1:1), (9 Z)-.

CAS number: 41130-29-4.

Basis for action: The PMN states that the substance will be used as an emulsifying agent used in the production of asphalt emulsions for chipsealing and other road maintenance techniques. Based on test data for 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 resulting in 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 § 721.170 (b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10923.

PMN Numbers P-15-689 and P-15-690

Chemical names: Vegetable fatty acid alkyl esters (generic).

CAS numbers: Claimed confidential.

Basis for action: The PMNs state that the substances will be used as chemical intermediates. Based on SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substances to surface water exceeds releases from the use described in the PMN. For the chemical intermediate use described in the PMN, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as an intermediate may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish 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 to characterize the environmental effects of the PMN substances. Depending on the results of these tests, EPA has determined that the results of an aerobic and anaerobic metabolism test (OECD Test Guideline 308) in aquatic sediment systems test; and a sediment water chironomid life-cycle toxicity test (OECD Test Guideline 233) using spiked water or spiked sediment would help to further characterize the environmental effects of the PMN substances.

CFR citation: 40 CFR 721.10924.

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 10 of the 55 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit VI.).

In the other 45 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

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 regulate prospective manufacturers or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
• 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 § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is July 15, 2016 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before June 15, 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 June 15, 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 the Significant New Use Designation

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for 10 of the 55 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 41 of the 55 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Therefore, EPA designates May 16, 2016 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses.

VIII. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-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 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 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 § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture 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 § 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 § 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-2015-0810.

XII. 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.

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).

XIII. 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: May 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]

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.

2. In § 9.1, add the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

§ 9.1

OMB approvals under the Paperwork Reduction Act.

* * * * *

40 CFR citation	OMB control No.
	*    *    *    *    *
Significant New Uses of Chemical Substances
	*    *    *    *    *
721.10875	2070-0012
721.10876	2070-0012
721.10877	2070-0012
721.10878	2070-0012
721.10879	2070-0012
721.10880	2070-0012
721.10881	2070-0012
721.10882	2070-0012
721.10883	2070-0012
721.10884	2070-0012
721.10885	2070-0012
721.10886	2070-0012
721.10887	2070-0012
721.10888	2070-0012
721.10889	2070-0012
721.10890	2070-0012
721.10891	2070-0012
721.10892	2070-0012
721.10893	2070-0012
721.10894	2070-0012
721.10895	2070-0012
721.10896	2070-0012
721.10897	2070-0012
721.10898	2070-0012
721.10899	2070-0012
721.10900	2070-0012
721.10901	2070-0012
721.10902	2070-0012
721.10903	2070-0012
721.10904	2070-0012
721.10905	2070-0012
721.10906	2070-0012
721.10907	2070-0012
721.10908	2070-0012
721.10909	2070-0012
721.10910	2070-0012
721.10911	2070-0012
721.10912	2070-0012
721.10913	2070-0012
721.10914	2070-0012
721.10915	2070-0012
721.10916	2070-0012
721.10917	2070-0012
721.10918	2070-0012
721.10919	2070-0012
721.10920	2070-0012
721.10921	2070-0012
721.10922	2070-0012
721.10923	2070-0012
721.10924	2070-0012
721.10925	2070-0012
	*    *    *    *    *

* * * * *

PART 721—[AMENDED]

3. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

4. Add § 721.10875 to subpart E to read as follows:

§ 721.10875

Alkali transition metal oxide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkali transition metal oxide (PMN P-11-150) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. (A) Requirements as specified in § 721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b)(concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an Assigned Protection Factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(1) Any NIOSH-certified air-purifying elastomeric half-mask respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(2) Any appropriate NIOSH-certified N100 (if oil aerosols absent), R100, or P100 filtering facepiece respirator.

(3) Any NIOSH-certified air-purifying full facepiece respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(4) Any NIOSH-certified negative pressure (demand) supplied air respirator equipped with a half-mask.

(5) Any NIOSH-certified negative pressure (demand) self-contained breathing apparatus (SCBA) equipped with a half-mask.

(B) As an alternative to the respiratory requirements listed here, a manufacturer or processor may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 2.4 mg/m³ as an 8-hour time weighted average (TWA) verified by actual monitoring data.

(ii) Hazard communication program. Requirements as specified in § 721.72(a) through (e)(concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv)(use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 2.4 mg/m³), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 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 § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

5. Add § 721.10876 to subpart E to read as follows:

§ 721.10876

Perfluoroalkyl substituted alkyl sulfonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl substituted alkyl sulfonate (PMN P-11-484) 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 § 721.80 (k)(analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities; and use other described in the consent order), (o)(use in a consumer product that could be spray applied), and (q).

(ii) Disposal. Requirements as specified in § 721.85. Incineration of wastes in an incinerator operating at the temperature of at least 1,000 degrees Celsius and a residence time of minimum of 2 seconds. Any tank or vessel washings, residues from transport vessels or tanks, and similar materials that are captured and retained in the normal course of manufacturing and processing for re-use in manufacturing of the PMN substance or products made from the PMN substance are exempt from this method of disposal.

(iii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1) apply to the PMN substance except under the terms specified in the consent order.

(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 § 721.125(a), (b), (c), (i), (j), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(i) and (iii) of this section.

6. Add § 721.10877 to subpart E to read as follows:

§ 721.10877

Polyfluorinated alkyl quaternary ammonium chloride (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinated alkyl quaternary ammonium chloride (PMN P-11-543) 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 § 721.80(k)(analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities; and use other described in the consent order), (o)(use in a consumer product that could be spray applied), and (q).

(ii) Disposal. Requirements as specified in § 721.85. Incineration of wastes in an incinerator operating at the temperature of at least 1,000 degrees Celsius and a residence time of minimum of 2 seconds. Any tank or vessel washings, residues from transport vessels or tanks, and similar materials that are captured and retained in the normal course of manufacturing and processing for re-use in manufacturing of the PMN substance or products made from the PMN substance are exempt from this method of disposal.

(iii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1) apply to the PMN substance except under the terms specified in the consent order.

(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 § 721.125(a), (b), (c), (i), (j), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(i) and (iii) of this section.

7. Add § 721.10878 to subpart E to read as follows:

§ 721.10878

Polyfluorinatedalkylsulfonyl substituted alkane derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorinatedalkylsulfonyl substituted alkane derivative (PMN P-14-67) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Hazard communication program. Requirements as specified in § 721.72. A significant new use of the substance is any manner or method of manufacture or processing associated with any use of the substance without providing risk notification as follows:

(A) If as a result of the test data required under TSCA section 5(e) consent order for the substance, the employer becomes aware that the substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If the substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.

(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) and (o)(use in a consumer product that could be spray applied), 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 § 721.125(a), (b), (c), (f), (h), and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

8. Add § 721.10879 to subpart E to read as follows:

§ 721.10879

1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)-N,N-dimethyl-, chloride (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-octadecanaminium, N-(3-chloro-2-hydroxypropyl)-N,N-dimethyl-, chloride (1:1) (PMN P-14-125; CAS No. 3001-63-6) 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) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=2).

(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 § 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 § 721.185 apply to this section.

9. Add § 721.10880 to subpart E to read as follows:

§ 721.10880

Fatty acid rxn products with aminoalkylamines (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid rxn products with aminoalkylamines (PMNs P-14-153, P-14-154, P-15-79, and P-15-80) 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 § 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 intermediated, additives for flotation products, or adhesion promoters for use in asphalt applications are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (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 § 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 § 721.185 apply to this section.

10. Add § 721.10881 to subpart E to read as follows:

§ 721.10881

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-14-155 and P-14-156) 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 § 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 intermediated, additives for flotation products, or adhesion promoters for use in asphalt applications are:

(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=2 for P-14-155 and N=3 for P-14-156).

(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 § 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 § 721.185 apply to this section.

11. Add § 721.10882 to subpart E to read as follows:

§ 721.10882

Trialkylammonium borodibenzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trialkylammonium borodibenzoate (PMN P-14-198) 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 § 721.80(f) and (j).

(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 § 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 § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

12. Add § 721.10883 to subpart E to read as follows:

§ 721.10883

Fatty ester derivatives, reaction products with alkanolamine, hydroxylated, borated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty ester derivatives, reaction products with alkanolamine, hydroxylated, borated (PMN P-14-324) 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 § 721.80. A significant new use of the substance is a use other than as a lubricating oil additive.

(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 § 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 § 721.185 apply to this section.

13. Add § 721.10884 to subpart E to read as follows:

§ 721.10884

Benzenepropanol, 1-benzoate.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenepropanol, 1-benzoate (PMN P-14-397; CAS No. 60045-26-3) 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) Industrial commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use of the substance is use other than as a plasticizer in adhesives for food-product packaging; a diluents-type plasticizer in plastisol; a coalescent in architectural paints and coating; and a fragrance carrier in fragrances.

(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 § 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 § 721.185 apply to this section.

14. Add § 721.10885 to subpart E to read as follows:

§ 721.10885

Alcohols, C_12-22, distn. residues.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alcohols, C_12-22, distn. residues (PMN P-14-448; CAS No. 1476777-83-9) 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 § 721.80. A significant new use of the substance is any use where the cumulative molecular weights of the C₁₂ and C₁₄ components exceed 2 percent by weight of the overall molecular weight of the PMN substance.

(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 § 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 § 721.185 apply to this section.

15. Add § 721.10886 to subpart E to read as follows:

§ 721.10886

Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters (PMN P-14-501; CAS No. 1502809-48-4) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=4).

(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 § 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 § 721.185 apply to this section.

16. Add § 721.10887 to subpart E to read as follows:

§ 721.10887

Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphoric acid, mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts (PMN P-14-502; CAS No. 1502809-56-4) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=4).

(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 § 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 § 721.185 apply to this section.

17. Add § 721.10888 to subpart E to read as follows:

§ 721.10888

Siloxanes and Silicones, 3-[(2-aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric acid and oleylamine.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as siloxanes and silicones, 3-[(2-aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric acid and oleylamine (PMN P-15-59; CAS No. 1623456-05-2) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63 (a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(p) (three months and eighteen months). A significant new use of the substance is manufacture, process, or use the chemical substance other than as a down converter for an optical filter for light emitting diodes used in displays, or other than in a liquid formulation.

(iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the chemical substance other than by incineration in a permitted hazardous waste incinerator.

(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 § 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

18. Add § 721.10889 to subpart E to read as follows:

§ 721.10889

Dodecanoic acid, reaction products with cadmium zinc selenide sulfide and oleylamine.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as dodecanoic acid, reaction products with cadmium zinc selenide sulfide and oleylamine (PMN P-15-60; CAS No. 1773514-92-3) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. It is a significant new use to manufacture, process, or use the chemical substance other than as a chemical intermediate or other than in a liquid formulation.

(iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the chemical substance other than by incineration in a permitted hazardous waste incinerator.

(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 § 721.125(a) through (e), (i) and (j) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

19. Add § 721.10890 to subpart E to read as follows:

§ 721.10890

Phosphonic acid, P-tetradecyl-, reaction products with cadmium selenide (CdSe).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonic acid, P-tetradecyl-, reaction products with cadmium selenide (CdSe) (PMN P-15-104; CAS No. 1773514-66-1) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. It is a significant new use to manufacture, process, or use the chemical substance other than as a chemical intermediate or other than in a liquid formulation.

(iii) Disposal. Requirements as specified in § 721.85 It is a significant new use to dispose of the chemical substance other than by incineration in a permitted hazardous waste incinerator.

(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 § 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

20. Add § 721.10891 to subpart E to read as follows:

§ 721.10891

Alkyl silicate, polymer with 2-(chloromethyl)oxirane and 4,4′-(1-methylethylidene)bis[phenol], alkoxylated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl silicate, polymer with 2-(chloromethyl)oxirane and 4,4′-(1-methylethylidene)bis[phenol], alkoxylated (PMN P-15-81) 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 40 CFR 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=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 § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

21. Add § 721.108992 to subpart E to read as follows:

§ 721.10892

Reaction product of a mixture of aromatic dianhydrides and aliphatic esters with an aromatic diamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction product of a mixture of aromatic dianhydrides and aliphatic esters with an aromatic diamine (PMN P-15-109) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=11).

(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 § 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 § 721.185 apply to this section.

22. Add § 721.10893 to subpart E to read as follows:

§ 721.10893

Fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil, reaction products with an ether and triethylenetetramine (PMN P-15-111) 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 § 721.80(f) and (j).

(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 § 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 § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

23. Add § 721.10894 to subpart E to read as follows:

§ 721.10894

Substituted benzyl acrylate (generic)

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzyl acrylate (PMN P-15-120) 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 § 721.90(a)(4), (b)(4), and (c)(4) (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 § 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 § 721.185 apply to this section.

24. Add § 721.10895 to subpart E to read as follows:

§ 721.10895

Fluoroalkyl acrylate copolymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fluoroalkyl acrylate copolymer (PMN P-15-154) 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 § 721.72. A significant new use of the substance is any manner or method of manufacture or processing associated with any use of the substance without providing risk notification as follows:

(A) If as a result of the test data required under TSCA section 5(e) consent order for the substance, the employer becomes aware that the substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If the substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.

(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), 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 § 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 § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

25. Add § 721.10896 to subpart E to read as follows:

§ 721.10896

1-Hexanol, 6-mercapto-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-hexanol, 6-mercapto-. (PMN P-15-176; CAS No.1633-78-9) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=8).

(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 § 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 § 721.185 apply to this section.

26. Add § 721.10897 to subpart E to read as follows:

§ 721.10897

Phenol, 2,2′-[1,2-disubstituted-1,2-ethanediyl]bis(iminomethylene)bis[substituted- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified generically as phenol, 2,2′-[1,2-disubstituted-1,2-ethanediyl]bis(iminomethylene)bis[substituted- (PMN P-15-177) 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 § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), and (a)(3).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 721.125(a), (b), (c), (d), (e), and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

27. Add § 721.10898 to subpart E to read as follows:

§ 721.10898

Carbomonocycles, polymer with substituted heteromonocycle, succinate, methyl acrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbomonocycles, polymer with substituted heteromonocycle, succinate, methyl acrylate (PMN P-15-188) 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 § 721.80. A significant new use of the substance is any use other than as a pigment-wetting resin for UV-curable coatings.

(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 § 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 § 721.185 apply to this section.

28. Add § 721.10899 to subpart E to read as follows:

§ 721.10899

Halogenated alkyl trimethylaminium halide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated alkyl trimethylaminium halide (PMN P-15-190) 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 § 721.63(a)(4), (a)(6)(i), (b)(concentration set at 0.1 percent) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified power air- purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.

(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet.

(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=88).

(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 § 721.125(a), (b), (c), (d), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

29. Add § 721.10900 to subpart E to read as follows:

§ 721.10900

Titanium salt, reaction products with silica (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as titanium salt, reaction products with silica (PMN P-15-252) 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 § 721.63(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified air-purifying elastomeric half-mask respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

(B) NIOSH-certified N100 (if oil aerosols absent), R100, or P100 filtering facepiece respirator.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 721.125(a) through (d) and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

30. Add § 721.10901 to subpart E to read as follows:

§ 721.10901

Formaldehyde, reaction products with aniline and aromatic mono- and di-phenol mixture (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde, reaction products with aniline and aromatic mono- and di-phenol mixture (PMN P-15-272) 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 § 721.90(a)(4), (b)(4), and (c)(4) (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 § 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 § 721.185 apply to this section.

31. Add § 721.10902 to subpart E to read as follows:

§ 721.10902

Functionalized carbon nanotubes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as functionalized carbon nanotubes (PMN P-15-276) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use is manufacture, process, or use of the PMN substance other than in a liquid formulation. A significant new use is use other than as a thin film for electronic device applications or 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 § 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).

(iv) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section.

32. Add § 721.10903 to subpart E to read as follows:

§ 721.10903

Acrylated mixed metal oxides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acrylated mixed metal oxides (PMN P-15-295) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1).

(iii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).

(iv) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section.

33. Add § 721.10904 to subpart E to read as follows:

§ 721.10904

Phenol, 1,1-dimethylalkyl derivatives (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically phenol, 1,1-dimethylalkyl derivatives (PMN P-15-306) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=13).

(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 § 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 § 721.185 apply to this section.

34. Add § 721.10905 to subpart E to read as follows:

§ 721.10905

Butanedioic acid, 2-methylene-, dialkyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanedioic acid, 2-methylene-, dialkyl ester (PMN P-15-319) 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 § 721.90(a)(4), (b)(4), and (c)(4) (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 § 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 § 721.185 apply to this section.

35. Add § 721.10906 to subpart E to read as follows:

§ 721.10906

Magnesium alkaryl sulfonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as magnesium alkaryl sulfonate (PMN P-15-324) 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 § 721.80. A significant new use of the substance is any use other than as a detergent additive in crankcase lubricant applications.

(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 § 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 § 721.185 apply to this section.

36. Add § 721.10907 to subpart E to read as follows:

§ 721.10907

Polyfluorohydrocarbon (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyfluorohydrocarbon (PMN P-15-326) 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 § 721.80(j) and (o).

(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 § 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 § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

37. Add § 721.10908 to subpart E to read as follows:

§ 721.10908

Aluminum calcium oxide salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aluminum calcium oxide salt (PMN P-15-328) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63 (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an Assigned Protection Factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.

(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting face piece, hood, or helmet.

(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full face piece.

As an alternative to the respiratory requirements listed here, a manufacturer or processor may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 5 mg/m³ as an 8-hour time weighted average verified by actual monitoring data.

(ii) Hazard communication program. Requirements as specified in § 721.72(a) trhough (f)(concentration set at 1.0 percent), (g)(1)(ii), (g)(2)(When using this substance avoid breathing the substance, and use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 5 mg/m³.) and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 721.125(a) through (d) and (f) through and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

38. Add § 721.10909 to subpart E to read as follows:

§ 721.10909

Polyalkyltrisiloxane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkyltrisiloxane (PMN P-15-332) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(i), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified power air- purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.

(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet.

(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece.

(ii) Industrial commercial, and consumer activities. Requirements as specified in § 721.80(h).

(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=4).

(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 § 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

39. Add § 721.10910 to subpart E to read as follows:

§ 721.10910

Oxirane, 2,2′-[[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-phenyleneoxymethylene)]bis- (P-15-356, Chemical A).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2,2′-[[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-phenyleneoxymethylene)]bis- (PMN P-15-356, Chemical A; CAS No. 115254-47-2) 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 § 721.80. A significant new use of the substance is any use other than as an additive in polymer formulation for electronics.

(ii) Release to water. Requirements as specified in § 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 § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

40. Add § 721.10911 to subpart E to read as follows:

§ 721.10911

2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]- (PMN P-15-356, Chemical B; CAS No. 180063-56-3) 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) Industrial, commercial and consumer activities. Requirements as specified in § 721.80. A significant new use of the substance is any use other than as an additive in polymer formulation for electronics.

(ii) Release to water. Requirements as specified in § 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 § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

41. Add § 721.10912 to subpart E to read as follows:

§ 721.10912

Aliphatic acrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic acrylate (PMN P-15-363) 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 § 721.90(a)(4), (b)(4), and (c)(4) (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 § 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 § 721.185 apply to this section.

42. Add § 721.10913 to subpart E to read as follows:

§ 721.10913

Diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (PMN P-15-378) 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 § 721.63(a)(4), (a)(6)(ii), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters.

(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet.

(C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o).

(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 § 721.125(a) through (d) and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

43. Add § 721.10914 to subpart E to read as follows:

§ 721.10914

Polyitaconic acid, sodium zinc salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyitaconic acid, sodium zinc salt (PMN P-15-382) 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 § 721.80. A significant new use of the substance is any use other than as an odor neutralization for pet litter and cleaning hard surface surfaces, fabrics, skin and hair; an odor neutralization for air car; and an odor neutralization for waste processing and solid waste management in paper, oil, gas, mining, agriculture, food and municipal industries.

(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 § 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 § 721.185 apply to this section.

44. Add § 721.10915 to subpart E to read as follows:

§ 721.10915

Fatty acid esters with polyols polyalkyl ethers (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid esters with polyols polyalkyl ethers (PMN P-15-411) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=30).

(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 § 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 § 721.185 apply to this section.

45. Add § 721.10916 to subpart E to read as follows:

§ 721.10916

2,7-Naphthalenedisulfonic acid, 4-amino-3-[substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2,7-naphthalenedisulfonic acid, 4-amino-3-[substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3) (PMN P-15-435) 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 § 721.80. A significant new use of the substance is any use other that in a liquid formulation.

(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 § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

46. Add § 721.10917 to subpart E to read as follows:

§ 721.10917

Polymethylsiloxane, distillation residues (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymethylsiloxane, distillation residues (PMN P-15-492) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operations, general and local ventilation) or administrative control measure (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10 meets the minimum requirements for § 721.63(a)(4): NIOSH-certified powered air-purifying respirator with a hood or helmet and with appropriate gas-vapor (acid gas, organic vapor, or substance specific) cartridges.

(ii) Industrial commercial, and consumer activities. Requirements as specified in § 721.80(g).

(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=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 § 721.125(a) through (e), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

47. Add § 721.10918 to subpart E to read as follows:

§ 721.10918

Perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane (PMN P-15-502) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Hazard communication program. A significant new use of the substance is any manner or method of manufacture or processing associated with any use of the substance without providing risk notification as follows:

(A) If as a result of the test data required under TSCA section 5(e) consent order for the substance, the employer becomes aware that the substances may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in § 721.72(c) within 90 days from the time the employer becomes aware of the new information. If the substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace.

(B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 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 § 721.125(a), (b), (c), (f), (h), and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

48. Add § 721.10919 to subpart E to read as follows:

§ 721.10919

Quaternary ammonium compounds, (3-chloro-2-hydroxypropyl)coco alkyldimethyl, chlorides.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as quaternary ammonium compounds, (3-chloro-2-hydroxypropyl)coco alkyldimethyl, chlorides (PMN P-15-542; CAS No. 690995-44-9) 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 § 721.90(a)(4), (b)(4), and (c)(4) (N=24).

(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 § 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 § 721.185 apply to this section.

49. Add § 721.10920 to subpart E to read as follows:

§ 721.10920

Modified diphenylmethane diisocyanate prepolymer with polyol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified diphenylmethane diisocyanate prepolymer with polyol (PMN P-15-559) 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 § 721.80. A significant new use of the substance is manufacture of the substance where the average molecular weight is below 7,500 daltons, and where any molecular weight species is below 1,000 daltons.

(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 § 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 § 721.185 apply to this section.

50. Add § 721.10921 to subpart E to read as follows:

§ 721.10921

2-Furancarboxyaldehyde, 5-(chloromethyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-furancarboxyaldehyde, 5-(chloromethyl)- (PMN P-15-573; CAS No. 1623-88-7) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of § 721.63(a)(4):

(A) NIOSH-certified powered air-purifying respirator with a tight-fitting half mask and HEPA filters.

(B) NIOSH-certified continuous flow supplied-air respirator equipped with a tight-fitting half mask.

(C) NIOSH-certified negative pressure (demand) supplied-air respirator equipped with a full facepiece.

(ii) Industrial commercial, and consumer activities. Requirements as specified in § 721.80(g) (chemical intermediate use in a continuous reaction process such that no greater than 50 kilograms is present in the workplace at a given time) and (s)(15,000 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 § 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 § 721.185 apply to this section.

51. Add § 721.10922 to subpart E to read as follows:

§ 721.10922

1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 11,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. (PMN P-15-607) 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 § 721.80(j).

(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 § 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 § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

52. Add § 721.10923 to subpart E to read as follows:

§ 721.10923

9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9-octadecen-1-amine, hydrochloride (1:1), (9Z)- (PMN P-15-671; CAS No. 41130-29-4) 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 § 721.90(a)(4), (b)(4), and (c)(4) (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 § 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 § 721.185 apply to this section.

53. Add § 721.10924 to subpart E to read as follows:

§ 721.10924

Vegetable fatty acid alkyl esters (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as vegetable fatty acid alkyl esters (PMNs P-15-689 and P-15-690) 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 § 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 § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.