Source: https://www.federalregister.gov/documents/2018/09/17/2018-19950/significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2020-01-26 21:08:59
Document Index: 558506005

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A Rule by the Environmental Protection Agency on 09/17/2018
This document was corrected by a document published on 10/01/2018. View Correction
This rule is effective on November 16, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 1, 2018.
83 FR 47004
47004-47025 (22 pages)
FRL-9983-14
EPA Response to Comments on Proposed Rule 17-5
Premanufacture Notice (PMN) for P16-0590
P-17-0345 SAT report sanitized
P-17-0345 exposure report sanitized
P-17-0345 eng sanitized
P-17-0345 post focus health risk sanitized
P-17-0326 human health risk sanitized
P-17-0326 SAT report sanitized
P-17-0326 Exposure report sanitized
P-17-0326 eng sanitized
PMN Number: P-14-758
PMN Number: P-16-493
PMN Number: P-16-514
PMN Numbers: P-16-576 and P-16-577
PMN Number: P-16-590
PMN Number: P-16-593
PMN Number: P-17-5
PMN Numbers: P-17-149, P-17-150, P-17-151, and P-17-165
PMN Number: P-17-175
PMN number: P-17-199
PMN Number: P-17-206
PMN Number: P-17-223
PMN Number: P-17-230
PMN Number: P-17-236
PMN numbers: P-17-241, P-17-242, P-17-243, P-17-244
PMN number: P-17-265
PMN number: P-17-301
PMN number: P-17-318
PMN number: P-17-323
PMN number: P-17-326
PMN number: P-17-345
https://www.federalregister.gov/d/2018-19950 https://www.federalregister.gov/d/2018-19950
EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 28 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to the TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 28 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
Written adverse comments on one or more of these SNURs must be received on or before October 17, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments, on one or more of these SNURs before October 17, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date.
Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001.
For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: moss.kenneth@epa.gov.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after October 17, 2018 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.
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark 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. Proposed Rule. In addition to this Direct Final Rule, elsewhere in this issue of the Federal Register, EPA is issuing a Notice of Proposed Rulemaking for this rule. If EPA receives no adverse comment, the Agency will not take further action on the proposed rule and the direct final rule will become effective as provided in this action. If EPA receives adverse comment on one or more of SNURs in this action by October 2, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the Agency will publish in the Federal Start Printed Page 47005Register a timely withdrawal of the specific SNURs that the adverse comments pertain to, informing the public that the actions will not take effect. EPA would then address all adverse public comments in a response to comments document in a subsequent final rule, based on the proposed rule.
To determine what would constitute a significant new use for the 28 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is establishing significant new use and recordkeeping requirements for 28 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
These rules include 28 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A). Each Order is based on one or more of the findings in TSCA section 5(a)(3)(B): There is insufficient information to permit a reasoned evaluation; in the absence of sufficient information to permit a reasoned evaluation, the activities associated with the PMN substances may present unreasonable risk to human health or the environment; the substance is or will be produced in substantial quantities, and enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant (substantial) human exposure to the substance. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). Where EPA determined that the PMN substance may present an unreasonable Start Printed Page 47006risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order required, 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) 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 that 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) Order for the same chemical substance.
Chemical name: 2-Propenenitrile, polymer with methanamine, hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated.
CAS number: 2055838-16-7.
Effective date of TSCA section 5(e) Order: September 15, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as urethane foam. Based on physical/chemical properties, EPA has identified concern for lung toxicity. Based on SAR analysis of polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 416 parts per billion (ppb). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
1. Refraining from manufacturing the PMN substance in the United States (i.e. import only);
3. Use of a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
5. No application method of the PMN substance that results in greater worker inhalation exposures to vapor, mist, or aerosol than those encountered in roller coating application;
6. Use of the PMN substance only for the confidential uses specified in the Order; and
Potentially useful information: EPA has determined that certain information about the physical-chemical properties, fate, ecotoxicity and pulmonary effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of physical-chemical property testing, fate, acute and chronic aquatic toxicity testing, and pulmonary toxicity testing would help characterize the potential environmental and health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.
CFR citation: 40 CFR 721.11124.
Chemical Name: Dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2- ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, alkanedioic acid, alkyl 2-rnethylprop-2-enoate, alkyl prop-2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic).
Effective date of TSCA section 5(e) Order: September 18, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as paint. Based on physical/chemical properties of the PMN substance and test data on analogous diisocyanates, EPA identified concerns for dermal sensitization, respiratory sensitization, lung effects, neurotoxicity, and developmental toxicity, as well as skin irritation, and a potential for cancer to workers due to the possibility of isocyanate residuals. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
1. Refraining from manufacturing or processing the PMN substance in the United States (i.e., import only);
2. Import of the PMN substance to contain no more than 0.1% residual isocyanate by weight; and
3. Import of the PMN substance to contain no more than 1% of a confidential component by weight.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of sensitization and pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.
CFR citation: 40 CFR 721.11125.
Chemical Name: Mixed metal oxide (generic).
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-Start Printed Page 47007confidential) use of the substance will be as a catalyst. Based on SAR analysis of test data on analogous mixed metal oxides, EPA identified concerns for lung effects, systemic effects, eye irritation and allergic skin reaction. EPA also identified risk to workers for lung toxicity based on lung overload for respirable, poorly soluble particulates. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:
1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order;
3. Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure or compliance with a NCEL of 0.04 mg/m3 as an 8-hour time-weighted average to prevent inhalation exposure;
5. Refraining from manufacturing or processing the PMN substance in the United States (i.e., import only);
6. Use of the PMN substance only for the confidential use stated in the Order; and
7. Disposal of the PMN substance only by recycling as described in the PMN.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific pulmonary and internal organ toxicity testing.
CFR citation: 40 CFR 721.11126.
Chemical names: Modified alkyl polyamine (generic) (P-16-576) and alkyl polyamine (generic) (P-16-577).
Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as an intermediate (P-16-576) and an oil lubricant additive (P-16-577). Based on the physical/chemical properties of the PMN substances, analogue toxicity data, and data on the PMN substances, EPA has identified concerns for irritation to the skin, eyes, mucous membranes, and lungs; effects to the GI tract, adrenal glands, and blood; immunotoxicity; and reproductive toxicity. Based on Structure Activity Relationship (SAR) predictions for polycationic polymers and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 parts per billion. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
1. Use of the PMN substances only for the confidential uses stated in the Order;
3. Submission to EPA of certain toxicity testing for P-16-577 no later than 9 months and 12 months from the date of the Notice of Commencement (NOC) of either substance;
4. Refraining from manufacture, processing or use for consumer use or in commercial use where there is use in a consumer setting; and
5. No release of P-16-577 resulting in surface water concentrations that exceed 2 ppb.
Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed certain time limits without performing specific pharmacokinetic and developmental toxicity testing. Additionally, EPA has determined that the results of chronic aquatic toxicity testing on P-16-577 would help characterize the potential environmental effects caused by the PMN substances. Although the Order does not require this test, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.
CFR citations: 40 CFR 721.11127 (P-16-576) and 40 CFR 721.11128 (P-16-577).
Chemical Name: Silica gel, reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum.
CAS Number: 932384-12-8.
Effective date of TSCA section 5(e) Order: September 13, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a catalyst for polyethylene polymerization. Based on the reactivity of the PMN substance and the presence of chromium VI, EPA identified concerns for oncogenicity, reproductive toxicity, respiratory sensitization, and severe irritation to skin, eyes, lung and mucous membranes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health. To protect against these risks, the Order requires:
1. Handling the PMN substance under an inert atmosphere using containers and systems designed not to be exposed to the air;
3. Use of a NIOSH-certified respirator with an APF of 10 to 1,000 depending on monitoring results from the methods required in the Order; and
4. Disposal of all waste streams containing the PMN substance and the constituent breakdown products of the PMN substance in a Resource Conservation and Recovery Act (RCRA) hazardous waste landfill.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a Start Printed Page 47008significant new use that would be designated by this SNUR. EPA has determined that the results of a pulmonary toxicity study and a carcinogenicity study would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11129.
Chemical Name: Carboxylic acids, C6-18 and C5-15-di-, polymers with diethyleneglycol, glycerol, sorbitol and terephthalic acid.
CAS Number: 1967778-37-5.
Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an aromatic polyester polyol for rigid foam. EPA identified concerns for lung effects and irritation to the eyes and mucous membranes based on the physical/chemical properties of the PMN substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
2. Use of the PMN substance only as an aromatic polyester polyol for rigid foam;
3. No manufacture, processing, or use of the PMN substance to result in inhalation exposures to a vapor, mist or aerosol; and
Potentially useful information: EPA has determined that certain information about the physical-chemical properties and health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of physical-chemical property testing and pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11130.
Chemical name: 1-tetradecene homopolymer hydrogenated.
CAS number: 1857296-89-9.
Effective date of TSCA section 5(e) Order: August 9, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a base fluid/carrier fluid for additives in motor oil, automatic transmission fluid, and industrial lubricants. Based on analysis of test data on an analogous chemical substance, EPA has identified concerns for irritation to mucous membranes and hydrocarbon pneumonia. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. The Order was also issued under TSCA section 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the Order requires:
1. Submission to EPA of certain toxicity testing no later than 9 months after the NOC;
3. No manufacture, processing, or use of the PMN substance to result in inhalation exposure to a vapor, mist, or aerosol; and
4. Not process the PMN substance for use other than as a base fluid/carrier fluid for additives in motor oil, automatic transmission fluid, and industrial lubricants.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific pulmonary toxicity testing.
CFR citation: 40 CFR 721.11131.
Chemical Name: Fluorocyanophenyl alkylbenzoate (generic)
Effective date of TSCA section 5(e) Order: August 10, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substances will be for electronic device use. Based on analysis of test data on analogous chemicals, EPA identified concerns for reproductive toxicity, developmental toxicity, neurotoxicity, and lung and skin effects. Based on SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb for P-17-165 and 4 ppb for the other PMN substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
4. Use of the PMN substances only for the confidential use specified in the Order;
5. No modification of the manufacture, processing or use of the PMN substances to result in inhalation exposure to vapor, dust, mist, or aerosol; and
6. No release of the PMN substances resulting in surface water concentrations that exceed 2 ppb for P-17-165 and 4 ppb for the other PMN substances.
The SNUR designates as a “significant new use” the absence of these protective measures.Start Printed Page 47009
Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific reproductive/developmental toxicity testing and acute and chronic aquatic toxicity testing.
CFR citation: 40 CFR 721.11132.
Chemical Name: Fluorinated propenoic poly alkyl ether ester (generic).
Effective date of TSCA section 5(e) Order: September 1, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a leveling agent for coatings applied to aluminum printing plates. Based on analysis of test data on the analogue perfluorohexanoic acid, EPA identified concerns for liver toxicity, blood toxicity, and male reproductive toxicity for the potential incomplete incineration product. Based on SAR predictions for polyanionic polymers for the potential degradation product, EPA also identified concern for effects of the potential degradation products to terrestrial wild animals and birds based on test data for analogous perfluoro chemicals in mammals. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e., import only);
2. No manufacture (including import) beyond a maximum annual production volume of 60 kg; and
3. Use of the PMN substance only as a leveling agent for coatings applied to aluminum printing plates.
Potentially useful information: EPA has determined that certain information about the physical-chemical properties and fate of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific physical-chemical properties, environmental fate, and bioaccumulation testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11133.
Chemical name: Oxyalkylene urethane polyolefin (generic).
Effective date of TSCA section 5(e) Order: September 14, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a binder in sealant. Based on the physical/chemical properties of the PMN substance, EPA identified concerns for oncogenicity, male reproductive effects, developmental toxicity and sensitization if the PMN substance were manufactured differently. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:
1. Manufacture of the PMN substance at no less than the average molecular weight specified in the Order; and
2. Manufacture of the PMN substance with no more than 1% of the molecular weight content below 1,000 Daltons.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific developmental toxicity, internal organ toxicity, and sensitization testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11134.
Chemical Name: Imino alkane amine phosphate (generic).
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a flame retardant for textiles. EPA identified concerns for irritation to eyes, mucous membranes, and lungs based on the pH of the PMN substance being 5. Also based on SAR analysis of test data on the nearest analogue inorganic phosphates EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
3. No modification of the processing or use of the PMN substance to result in inhalation exposures to vapor, dust, mist, or aerosol;
4. Use of the PMN substance only for the confidential use specified in the Order;
5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
6. No release of the PMN substance into the waters of the United States; and
7. Disposal of the PMN substance and waste streams containing the PMN substance by incineration.
Potentially useful information: EPA has determined that certain information about the environmental effects of the PMN substance may be potentially useful in support of a request by the Start Printed Page 47010PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific acute aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citations: 40 CFR 721.11135 (P-17-206).
Chemical Name: Fatty acids, tall-oil, reaction products with 2-[(2-aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogenphosphate alkyl ether (generic).
Effective date of TSCA section 5(e) Order: September 12, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for open, non-dispersive use. EPA identified concerns for developmental toxicity based on N-heterocyclic compounds and concerns for possible irritation to mucous membranes and lung toxicity based on potential surfactancy properties. Also based on SAR analysis of test data on nearest analogue of soluble forms of inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 15 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
2. Refraining from manufacture, processing, or use for consumer use or in commercial use where there is use in a consumer setting;
3. Refrain from domestic manufacture in the United States (i.e., import only);
5. Use of the PMN substance in the confidential formulation at a concentration not greater than 1 percent by weight or volume;
6. Use of personal protective equipment where there is a potential for dermal exposure;
7. Refraining from modifying the processing if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol at a concentration of greater than 1 percent by weight or volume;
8. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and
9. No release of the PMN substance resulting in surface water concentrations that exceed 15 ppb.
Potentially useful information: EPA has determined that certain information about the physical-chemical properties, environmental effects, and health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific reproductive/developmental toxicity testing and acute aquatic toxicity testing. EPA has also determined that the results of specific physical-chemical property and pulmonary toxicity testing would help characterize the potential human and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11136.
Chemical Name: Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with 2,2′,2″-nitrilotris-[alkanol] (generic).
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for open, non-dispersive use. Based on the potential surfactant properties, cationic binding to lung tissues, EPA identified concerns for lung toxicity and skin irritation. Based SAR analysis of test data on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 65 parts per billion. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
3. Refraining from domestic manufacture in the United States (i.e., import only);
7. Refraining from modifying the processing method if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol, at a concentration of greater than 1 percent by weight or volume;
9. No release of the PMN substance resulting in surface water concentrations that exceed 65 ppb.
Potentially useful information: EPA has determined that certain information about the physical-chemical properties, environmental effects, and health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific acute aquatic and sediment toxicity testing. EPA has also determined that the results of specific physical-chemical property and pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Start Printed Page 47011Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11137.
Chemical Name: Formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (generic).
Effective date of TSCA section 5(e) Order: September 11, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as matrix resin for composite materials and binder resin for electronic materials. Based on analysis of test data on the PMN substance, analysis of data on analogous chemicals, and on the epoxide chemical category of concern, EPA identified concerns for skin and lung sensitization, oncogenicity, developmental toxicity, and male reproductive toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health. To protect against these risks, the Order requires:
4. Refraining from domestic manufacture in the United States (i.e., import only);
5. Use of the PMN substance only as described in the PMN; and
6. No manufacture, processing, or use that results in inhalation exposure to vapor, dust, mist, or aerosol.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing sensitization testing. EPA has also determined that the results of specific internal organ toxicity and carcinogenicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11138.
Chemical names: Acid, reaction products with cadmium selenide (CdSe), trioctylphosphine and trioctylphosphine oxide (generic) (P-17-241), Acid, reaction products with cadmium selenide sulfide, acid, trioctylphosphine and trioctylphosphine oxide (generic) (P-17-242), Acid, reaction products with cadmium metal selenide sulfide, trioctylphosphine and trioctylphosphine oxide (generic) (P-17-243), Metal oxide reaction products with cadmium metal selenide sulfide, and amine (generic) (P-17-244).
Effective date of TSCA section 5(e) Order: September 20, 2017.
Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of P-17-241, P-17-242, and P-17-243 will be as chemical intermediates, and the specific use of P-17-244 will be as a down converting phosphor particle for use in conjunction with optoelectronic components. Based on analogy to respirable poor soluble particulates and the presence of cadmium, EPA identified concerns for lung effects, kidney effects, and oncogenicity for the PMN substances. EPA also identified concerns for neurotoxicity, developmental toxicity, and kidney toxicity for PMN P-17-244 based on the presence of other chemicals. Based on analysis of test data for cadmium and selenium core components, there is high hazard for acute and chronic environmental toxicity for PMNs P-17-241, P-17-242, and P-17-243. There is potential chronic environmental toxicity for PMN P-17-244 based on the presence of cadmium. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substances may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:
1. Submission to EPA of certain testing for P-17-244 before exceeding the confidential production volume limit specified in the Order;
2. Use of personal protective equipment where there is potential for dermal exposure;
3. Manufacture, processing, and use P-17-241, P-17-242, and P-17-243 only as chemical intermediates as required in the Order;
4. Manufacture, processing, and use P-17-241, P-17-242, and P-17-243 only in liquid formulations;
5. No use of P-17-241, P-17-242, and P-17-243 in applications that generate a dust, mist, or aerosol;
6. Manufacture, processing and use of P-17-244, only as a down-converter for use in conjunction with optoelectronic components;
7. For workers potentially exposed to the solid form of P-17-244, use of a laminar-flow fume hood or glove box to reduce or eliminate inhalation exposure, and workers who may still be exposed by inhalation will use a NIOSH-certified full-faced respirator with an APF of at least 50; and
8. Disposal of the PMN substances only by incineration in a permitted hazardous waste incinerator.
Potentially useful information: EPA has determined that certain information about the fate and health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing certain fate and internal organ toxicity testing on P-17-244. EPA has also determined that the results of specific fate testing would help characterize the potential health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citations: 40 CFR.11139 (P-17-241), 40 CFR.11140 (P-17-242), 40 CFR.11141 (P-17-243), and 40 CFR.11142 (P-17-244).
Chemical name: Alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl Start Printed Page 47012alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-initiated (generic).
Effective date of TSCA section 5(e) Order: August 16, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a coating resin intermediate. Based on physical/chemical properties EPA identified concerns for lung toxicity, systemic toxicity, reproductive toxicity, corrosion, and irritation for the PMN substance when it has an acid concentration greater than 20% or an amine concentration greater than 5%. Based on SAR analysis for anionic polymers and physical/chemical properties, EPA has identified concern for environmental effects when it has an acid concentration greater than 20%. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:
1. Refraining from manufacturing the PMN substance with an acid concentration greater than 20%; and
2. Refraining from manufacturing the PMN substance with an amine concentration greater than 5%.
Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific physical-chemical property testing, pulmonary toxicity testing, irritation testing, and acute and chronic aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11143.
Chemical name: Manganese heterocyclic-amine carboxylate complexes (generic).
Effective date of TSCA section 5(e) Order: September 22, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic use of the PMN substance will be as a surface drier in clear and pigmented coatings systems. Based on the physical/chemical properties of the PMN substance and analysis of analogue test data, EPA identified concerns for neurotoxicity, developmental toxicity, and eye and skin irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the Order requires:
1. Submission to EPA of certain testing before exceeding an aggregate total production of 430,000 kilograms of the PMN substance;
3. Use of a NIOSH-certified respirator with an APF of at least 10 where there is potential for inhalation exposure;
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and
5. No use of the PMN substance other than as a surface drier in clear and pigmented coatings systems.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific reproductive/developmental toxicity testing.
CFR citation: 40 CFR 721.11144.
Chemical name: Sulfuric acid mixed salt (generic).
Effective date of TSCA section 5(e) Order: September 25, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a component in nutrient solutions. Based on analogue data and information provided in the SDS, EPA has identified concerns for skin, eye, respiratory, and GI tract irritation, corrosion and acute toxicity. Also, based on SAR predictions for analogue inorganic salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 760 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit specified in the Order.
2. Use of personal protective equipment where there is a potential for dermal exposure.
3. Use of the PMN substance only for the confidential use specified in the Order.
5. Manufacture of the PMN substance to contain no more than 1% free ammonia.
Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific acute aquatic toxicity testing. EPA has also determined that the results of specific reproductive/developmental toxicity testing would help characterize the potential health and environmental Start Printed Page 47013effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11145.
Chemical name: 2-Propenoic acid, branched alkyl ester (generic).
Effective date of TSCA section 5(e) Order: September 26, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a reactive monomer for use in producing polymers. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on SAR analysis of test data on analogous acrylates and from the branched acid that may be formed after ester hydrolysis, EPA has identified concerns for eye and skin irritation, oncogenicity, developmental toxicity, liver toxicity, kidney toxicity, and sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order;
3. No use of the PMN substance other than as a reactive monomer for use in producing polymers;
5. Refraining from domestic manufacture in the United States (i.e., import only); and
6. No release of the PMN substance to the waters of the United States.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific developmental/reproductive toxicity and sensitization testing. EPA has also determined that the results of specific fate testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11146.
Chemical name: Allyloxymethylacrylate (generic).
Effective date of TSCA section 5(e) Order: September 5, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an ultraviolet curable monomer. Based on analysis of test data on the PMN substance and the physical/chemical properties of the PMN substance, EPA identified concerns for oncogenicity, developmental and reproductive effects, liver and kidney toxicity, sensitization, and irritation. Additionally, the SDS indicates concerns for severe skin and eye damage and allergic skin reaction. Based on analysis of acute aquatic toxicity data, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 26 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the PMN substance may present an unreasonable risk of injury to health and the environment. To protect against these risk, the Order requires:
3. Use of NIOSH certified respirators with an APF of 10 to prevent inhalation exposure where there is potential for inhalation exposure;
5. Refraining from domestic manufacture in the United States (i.e., import only);
6. Use of the PMN substance only as specified in the Order; and
Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific developmental/reproductive toxicity and sensitization testing. EPA has also determined that the results of specific chronic aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 721.11147.
Chemical name: Polyurethane, methacrylate blocked (generic).
Effective date of TSCA section 5(e) Order: September 6, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a resin intermediate. Based on physical/chemical properties of the PMN substance, EPA identified concerns for irritation to skin, eye, lung, mucous membranes, and potential neurotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing within six months from the date of the NOC;
2. Use of personal protective equipment where there is potential for dermal exposure;Start Printed Page 47014
3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and SDS;
4. No manufacturing, processing, or use of the PMN substance in a manner that would result in inhalation exposure to vapor, mist, aerosol, or dust; and
5. Use the PMN substance only as specified in the Order.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific eye irritation testing.
CFR citation: 40 CFR 721.11148.
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 28 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) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters.
EPA will identify as significant new uses any manufacturing, processing, use, distribution in commerce, use, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
EPA is issuing these SNURs as a direct final rule. The effective date of this rule is November 16, 2018 without further notice, unless EPA receives written adverse comments before October 17, 2018.
If EPA receives written adverse comments on one or more of these SNURs before October 17, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date.
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 an 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) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of 24 of the 28 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) for a chemical substance covered by this action. 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 September 17, 2018 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule.
In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists required or recommended Start Printed Page 47015testing for all of the listed 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. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
In certain of the TSCA section 5(e) Orders for 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. Listings of the tests specified in the TSCA section 5(e) Orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) 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.
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-2018-0567.
This action establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) 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).
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 Start Printed Page 47016of 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.
Start Part Start Printed Page 47017
2. In § 14;9.1, add the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
721.11124 2070-0012
721.11125 2070-0012
721.11126 2070-0012
721.11127 2070-0012
721.11128 2070-0012
721.11129 2070-0012
721.11130 2070-0012
721.11131 2070-0012
721.11132 2070-0012
721.11133 2070-0012
721.11134 2070-0012
721.11135 2070-0012
721.11136 2070-0012
721.11137 2070-0012
721.11138 2070-0012
721.11139 2070-0012
721.11140 2070-0012
721.11141 2070-0012
721.11142 2070-0012
721.11143 2070-0012
721.11144 2070-0012
721.11145 2070-0012
721.11146 2070-0012
721.11147 2070-0012
721.11148 2070-0012
4. Add § 14;721.11124 to subpart E to read as follows:
§ 721.11124
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-Propenenitrile, polymer with methanamine, hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated (PMN P-14-758; CAS No. 2055838-16-7) 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 they have been completely reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 50), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g. enclosure or confinement of 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). A significant new use is any spray application method that results in greater worker inhalation exposures to vapor, mist, or aerosol than the roller coating application.
(iv) Release to water. Requirements as specified in § 721.90(b)(1), and (c)(1).
5. Add § 14;721.11125 to subpart E to read as follows:
§ 721.11125
Dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, alkanedioic acid, alkyl 2-rnethylprop-2-enoate, alkyl prop-2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, alkanedioic acid, alkyl 2-methylprop-2-enoate, alkyl prop-2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-blocked, compds with 2-(alkylamino)alkanol (P-16-493) 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 substance after they have been reacted (cured).
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f). It is a significant new use to import the PMN substance to contain more than 0.1% residual isocyanate by weight. It is a significant new use to import the PMN substance to contain more than 1% of a confidential component by weight.
6. Add § 721.11126 to subpart E to read as follows:
§ 721.11126
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as a mixed metal oxide (P-16-514) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 1,000), and (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 0.04 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), (lung toxicity if inhaled), (eye irritation), (allergic skin reaction), (g)(2)(i) through (iii) and (v) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.04 mg/m3), (g)(4)(i), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(e), (f), (k), and (q).
(iv) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the PMN substance other than by recycling as described in the Order.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (j) are applicable to manufacturers, importers, and processors of this substance.
7. Add § 721.11127 to subpart E to read as follows:
§ 721.11127
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as modified alkyl polyamine (PMN P-16-576) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6) (particulate), (vapor), (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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture the chemical substance more than 9 months.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), are applicable to manufacturers and processors of this substance.
8. Add § 721.11128 to subpart E to read as follows:
§ 721.11128
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkyl polyamine (PMN P-16-577) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i)(iii), (a)(3), (a)(6)(v), (a)(6) (particulate), (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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are Start Printed Page 47019applicable to manufacturers and processors of this substance.
9. Add § 721.11129 to subpart E to read as follows:
§ 721.11129
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silica gel, reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum is (P-16-590, CAS No. 932384-12-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of 10 to 1,000 depending on the results of the exposure monitoring as described in the Order for P16-590 and required by this section (a)(2)(i), (a)(6) (particulate), and (a)(6) (vapor), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4) engineering control measures (e.g. enclosure or confinement of 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), § 721.63(b) (concentration set at 0.1%), and § 721.63(c). It is a significant new use to not conduct the exposure monitoring required in the Order for P16-590 when workers are reasonably likely to be exposed by inhalation.
(ii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80. It is a significant new use to manufacture, process, or use the PMN substance other than in a system where the PMN substance is handled in an inert atmosphere and is not designed to be exposed to air.
(iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of all waste streams containing the PMN substance and the constituent breakdown products of the PMN substance other than in a Resource Conservation and Recovery Act hazardous waste landfill.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) are applicable to manufacturers, importers, and processors of this substance.
10. Add § 14;721.11130 to subpart E to read as follows:
§ 721.11130
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carboxylic acids, C6-18 and C5-15-di-, polymers with diethylene glycol, glycerol, sorbitol and terephthalic acid (P-16-593, CAS No. 1967778-37-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), 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 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), (irritation), (g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(k)(aromatic polyester polyol for rigid foam). It is a significant new use to manufacture, process, or use the PMN substance to result in inhalation exposure to a vapor, mist or aerosol.
11. Add § 14;721.11131 to subpart E to read as follows:
§ 721.11131
1-tetradecene homopolymer hydrogenated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-tetradecene homopolymer hydrogenated (PMN P-17-5, CAS No. 1857296-89-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k)(base fluid/carrier fluid for additives in motor oil, automatic transmission fluid, and industrial lubricants). It is a significant new use to manufacture the chemical substance more than 9 months. It is a significant new use to manufacture, process, or use the PMN substance to resuls in inhalation exposure to a vapor, mist or aerosol.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance.
12. Add § 14;721.11132 to subpart E to read as follows:
§ 721.11132
Fluorocyanophenyl alkylbenzoate (generic)
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances generically identified as fluorocyanophenyl alkylbenzoate (P-17-149), (P-17-150), (P-17-151), and (P-17-165) are subject Start Printed Page 47020to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v), (particulate), (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 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), § 721.63(b) (concentration set at 1.0%) and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) through (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture, process, or use the PMN substance to result in inhalation exposures to vapor, dust, mist, or aerosols to the substance.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 2 for P-17-165 and N = 4 for P-17-149, P-17-150, and P-17-151.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers, importers, and processors of these substances.
13. Add § 14;721.11133 to subpart E to read as follows:
§ 721.11133
Fluorinated propenoic poly alkyl ether ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as fluorinated propenoic poly alkyl ether ester (P-17-175) 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 substance after they have been reacted (cured).
(i) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f) and (t)(60 kilograms). It is a significant new use to use the substance other than as a leveling agent for coatings applied to aluminum printing plates.
14. Add § 14;721.11134 to subpart E to read as follows:
§ 721.11134
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as oxyalkylene urethane polyolefin (PMN P-17-199) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. It is a new use the manufacture (including import) the PMN substance with an average molecular weight greater than specified in the Order or with more than 1% of the molecular weight content below 1,000 Daltons.
15. Add § 14;721.11135 to subpart E to read as follows:
§ 721.11135
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as imino alkane amine phosphate (P-17-206) 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 substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6)(v), (particulate), (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 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), § 721.63(b) (concentration set at 1.0%) and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (g)(2)(i) and (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5), Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). It is a significant new use to modify processing or use if it results in inhalation exposure to vapor, dust, mist, or aerosols to the substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.Start Printed Page 47021
16. Add § 14;721.11136 to subpart E to read as follows:
§ 721.11136
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as fatty acids, tall-oil, reaction products with 2-[(2-aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogen phosphate alkyl ether (P-17-223) 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 substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and, engineering control measures (e.g. enclosure or confinement of 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), § 721.63(b) (concentration set at 1.0%) and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), and (g)(5), Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). It is a significant new use to modify any processing if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol, at a concentration of greater than 1 percent by weight or volume. It is a significant new use to use the PMN substance in the confidential formulation identified in the Order at concentration greater than 1 percent by weight or volume. It is a significant new use to manufacture, process, or use the substance for consumer use or for commercial uses that could introduce the substance into a consumer setting.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 15.
17. Add § 14;721.11137 to subpart E to read as follows:
§ 721.11137
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with 2,2′,2″-nitrilotris-[alkanol] (P-17-230) 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 substance after they have been reacted (cured).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and (ii), (eye irritation), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). It is a significant new use to modify processing methods if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol, at a concentration of greater than 1 percent by weight or volume. It is a significant new use to use the PMN substance in the confidential formulation at a concentration greater than 1 percent by weight or volume. It is a significant new use to manufacture, process, or use the substance for consumer use or for commercial uses that could introduce the substance into a consumer setting.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 65.
18. Add § 14;721.11138 to subpart E to read as follows:
§ 721.11138
Formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (P-17-236) 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 the PMN substance after it has been incorporated into the confidential forms identified in the Order.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering Start Printed Page 47022control measures (e.g. enclosure or confinement of 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), (vi), (vii), and (ix), (skin sensitization), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). It is a significant new use to modify manufacture, processing, or use if it results in inhalation exposure to vapor, dust, mist, or aerosols to the substance.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(1) and (a)(2)(iii) of this section.
19. Add § 14;721.11139 to subpart E to read as follows:
§ 721.11139
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as acid, reaction products with cadmium selenide (CdSe), trioctylphosphine and trioctylphosphine oxide (PMN P-17-241) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (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), and § 721.63(c).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g) and (y)(1). It is a significant new use to manufacture, process, or use the substance other than in a liquid formulation.
(iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the substance and any waste stream containing the substance other than in a permitted hazardous waste incinerator.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance.
20. Add § 14;721.11140 to subpart E to read as follows:
§ 721.11140
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as acid, reaction products with cadmium selenide sulfide, acid, trioctylphosphine and trioctylphosphine oxide (PMN P-17-242), is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
21. Add § 721.11141 to subpart E to read as follows:
§ 721.11141
Acid, reaction products with cadmium metal selenide sulfide, trioctylphosphine and trioctylphosphine oxide (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as acid, reaction products with cadmium metal selenide sulfide, trioctylphosphine and trioctylphosphine oxide (PMN P-17-243), is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(b) Specific requirements. The provisions of subpart A of this part Start Printed Page 47023apply to this section except as modified by this paragraph (b).
22. Add § 721.11142 to subpart E to read as follows:
§ 721.11142
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as metal oxide reaction products with cadmium metal selenide sulfide, and amine (PMN P-17-244) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor (APF) of at least 50), and (a)(6)(particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (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), and § 721.63(c). It is a significant new use to handle the solid form of the substance without use of a fume hood or glove box.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q), (k) (down converting phosphor particle for use in conjunction with optoelectronic components), and (y)(1) and (2).
(3) Determining whether a specific use us subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
23. Add § 721.11143 to subpart E to read as follows:
§ 721.11143
Alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-initiated (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-initiated (PMN P-17-265) 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 substance after they have been completely reacted or cured.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. It is a significant new use to manufacture the PMN substance with an acid concentration greater than 20%. It is a significant new use to manufacture the PMN substance with an amine concentration greater than 5%.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i).
24. Add § 721.11144 to subpart E to read as follows:
§ 721.11144
Manganese heterocyclic-amine carboxylate complexes (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as manganese heterocyclic-amine carboxylate complexes (PMN P-17-301) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this Order do not apply to quantities of the PMN substance after they have been entrained in cured coating or ink.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10), and (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g. enclosure or confinement of 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) through (iii) and (ix), (eye irritation), (g)(2)(ii) through (iv), (avoid skin and eye contact), (use skin and eye protection), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (surface drier in clear and pigmented coatings systems) and (p) (430,000 kilograms).
25. Add § 721.11145 to subpart E to read as follows:
§ 721.11145
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfuric acid mixed salt (PMN P-17-318) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), and (a)(6)(v), (particulate), (when Start Printed Page 47024determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or confinement of 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (irritation to eye, respiratory, and GI tract), (corrosion), (acute toxicity), (g)(2)(i) and (iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture of the PMN substance with more than 1% free ammonia content.
26. Add § 721.11146 to subpart E to read as follows:
§ 721.11146
2-Propenoic acid, branched alkyl ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, branched alkyl ester (PMN P-17-323) 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 substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v), (particulate), (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 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), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), and (g)(1)(iv) and (ix), (skin and eye irritation), (oncogenicity), (sensitization), (g)(2)(i), (iii), and (v), (use eye protection), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k) (reactive monomer for use in producing polymers), and (q).
(iv) Release to water. Release to water requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k).
27. Add § 721.11147 to subpart E to read as follows:
§ 721.11147
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as allyloxymethylacrylate (PMN P-17-326) is subject to reporting under this section for the significant new uses as described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 10), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measure (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (iv), (vi), and (ix), (sensitization), (g)(2)(i) through (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(1) Recordkeeping. Requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers and processors of this substance.
28. Add § 721.11148 to subpart E to read as follows:
§ 721.11148
(a) Chemical substance and significant new sues subject to reporting. (1) The chemical substance generically identified as polyurethane, methacrylate blocked (PMN P-17-345) 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 substance after they have been completely reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i)(iii), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering Start Printed Page 47025control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measure (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(irritation to skin, eyes, lungs, and mucous membranes), (g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture the chemical substance more than 6 months. It is a significant new use to modify manufacture, processing, or use if it results in inhalation exposure to vapor, dust, mist, or aerosols to the substance.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except ss modified by this paragraph (b).
[FR Doc. 2018-19950 Filed 9-14-18; 8:45 am]