Significant New Use Rules on Certain Chemical Substances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 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.

DATES:

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.

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.

For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0567, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: moss.kenneth@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after 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.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

1. Direct Final Rule. EPA is promulgating these SNURs using direct final rule procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices obligates EPA to assess risks that may be associated with the significant new uses under the conditions of use and, if appropriate, to regulate the proposed uses before they occur.

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 Register 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.

B. What is the Agency's authority for taking this action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

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.

IV. Substances Subject to This Rule

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:

• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) Order.
• Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical 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 designated by the SNUR.

This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VIII. for more information.

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

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 risk 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.

PMN Number: P-14-758

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);

2. Use of personal protective equipment where there is a potential for dermal exposure;

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

7. No release of the PMN substance into the waters of the United States.

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

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.

PMN Number: P-16-493

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).

CAS Number: Not available.

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.

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

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.

PMN Number: P-16-514

Chemical Name: Mixed metal oxide (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: August 7, 2017.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) 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;

2. Use of personal protective equipment where there is a potential for dermal exposure;

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;

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS);

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.

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

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.

PMN Numbers: P-16-576 and P-16-577

Chemical names: Modified alkyl polyamine (generic) (P-16-576) and alkyl polyamine (generic) (P-16-577).

CAS numbers: Not available.

Effective date of TSCA section 5(e) Order: September 18, 2017.

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;

2. Use of personal protective equipment where there is a potential for dermal exposure;

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.

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

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).

PMN Number: P-16-590

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;

2. Use of personal protective equipment where there is a potential for dermal exposure;

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.

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

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 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.

PMN Number: P-16-593

Chemical Name: Carboxylic acids, C6-18 and C5-15-di-, polymers with diethyleneglycol, glycerol, sorbitol and terephthalic acid.

CAS Number: 1967778-37-5.

Effective date of TSCA section 5(e) Order: August 7, 2017.

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:

1. Use of personal protective equipment where there is a potential for dermal exposure;

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

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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.

PMN Number: P-17-5

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;

2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

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.

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

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.

PMN Numbers: P-17-149, P-17-150, P-17-151, and P-17-165

Chemical Name: Fluorocyanophenyl alkylbenzoate (generic)

CAS Numbers: Not available.

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:

1. Submission to EPA of certain toxicity testing before 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. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

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.

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.

PMN Number: P-17-175

Chemical Name: Fluorinated propenoic poly alkyl ether ester (generic).

CAS Number: Not available.

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.

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

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.

PMN number: P-17-199

Chemical name: Oxyalkylene urethane polyolefin (generic).

CAS number: Not available.

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.

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

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.

PMN Number: P-17-206

Chemical Name: Imino alkane amine phosphate (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: August 9, 2017.

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:

1. Refraining from domestic manufacture in the United States (i.e., import only);

2. Use of personal protective equipment where there is a potential for dermal exposure;

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.

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

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 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 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).

PMN Number: P-17-223

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).

CAS Number: Not available.

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:

1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order;

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);

4. Use of the PMN substance only for the confidential use specified in the Order;

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.

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

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.

PMN Number: P-17-230

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).

CAS Number: Not available.

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. 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:

1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order;

2. Refraining from manufacture, processing, or use for consumer use or in commercial use where there is use in a consumer setting;

3. Refraining from domestic manufacture in the United States (i.e., import only);

4. Use of the PMN substance only for the confidential use specified in the Order;

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 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;

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 65 ppb.

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

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 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 721.11137.

PMN Number: P-17-236

Chemical Name: Formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (generic).

CAS Number: Not available.

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:

1. Submission to EPA of certain toxicity testing before 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. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

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.

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

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.

PMN numbers: P-17-241, P-17-242, P-17-243, P-17-244

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).

CAS numbers: Not available.

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.

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

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).

PMN number: P-17-265

Chemical name: Alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-initiated (generic).

CAS number: Not available.

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%.

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

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.

PMN number: P-17-301

Chemical name: Manganese heterocyclic-amine carboxylate complexes (generic).

CAS number: Not available.

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;

2. Use of personal protective equipment where there is a potential for dermal exposure;

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.

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

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.

PMN number: P-17-318

Chemical name: Sulfuric acid mixed salt (generic).

CAS number: Not available.

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.

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

5. Manufacture of the PMN substance to contain no more than 1% free ammonia.

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

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 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 721.11145.

PMN number: P-17-323

Chemical name: 2-Propenoic acid, branched alkyl ester (generic).

CAS number: Not available.

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;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. No use of the PMN substance other than as a reactive monomer for use in producing polymers;

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

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.

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

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.

PMN number: P-17-326

Chemical name: Allyloxymethylacrylate (generic).

CAS number: Not available.

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:

1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order;

2. Use of personal protective equipment where there is potential for dermal exposure;

3. Use of NIOSH certified respirators with an APF of 10 to prevent inhalation exposure 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;

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

7. No release of the PMN substance into the waters of the United States.

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

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.

PMN number: P-17-345

Chemical name: Polyurethane, methacrylate blocked (generic).

CAS number: Not available.

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;

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.

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

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.

V. Rationale and Objectives of the Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 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.

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).

B. Objectives

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
• EPA will 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).

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

EPA is issuing these SNURs as a direct final rule. 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.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse comments must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received 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.

Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait 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.

VIII. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists required or recommended testing 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.

Any request by EPA for the triggered and pended testing described in the Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

Potentially useful information identified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

IX. Procedural Determinations

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at § 721.1725(b)(1).

Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

X. SNUN Submissions

According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2018-0567.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

This action establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “ Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

A copy of that certification is available in the docket for this action.

This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
• Submission of the SNUN would not cost any small entity significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

F. Executive Order 13175

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211

This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

• Environmental protection
• Reporting and recordkeeping requirements

40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9—[AMENDED]

1. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2. In § 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:

PART 721—[AMENDED]

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

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

4. Add § 14;721.11124 to subpart E to read as follows:

5. Add § 14;721.11125 to subpart E to read as follows:

6. Add § 721.11126 to subpart E to read as follows:

7. Add § 721.11127 to subpart E to read as follows:

8. Add § 721.11128 to subpart E to read as follows:

9. Add § 721.11129 to subpart E to read as follows:

10. Add § 14;721.11130 to subpart E to read as follows:

11. Add § 14;721.11131 to subpart E to read as follows:

12. Add § 14;721.11132 to subpart E to read as follows:

13. Add § 14;721.11133 to subpart E to read as follows:

14. Add § 14;721.11134 to subpart E to read as follows:

15. Add § 14;721.11135 to subpart E to read as follows:

16. Add § 14;721.11136 to subpart E to read as follows:

17. Add § 14;721.11137 to subpart E to read as follows:

18. Add § 14;721.11138 to subpart E to read as follows:

19. Add § 14;721.11139 to subpart E to read as follows:

20. Add § 14;721.11140 to subpart E to read as follows:

21. Add § 721.11141 to subpart E to read as follows:

22. Add § 721.11142 to subpart E to read as follows:

23. Add § 721.11143 to subpart E to read as follows:

24. Add § 721.11144 to subpart E to read as follows:

25. Add § 721.11145 to subpart E to read as follows:

26. Add § 721.11146 to subpart E to read as follows:

27. Add § 721.11147 to subpart E to read as follows:

28. Add § 721.11148 to subpart E to read as follows: