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Daily Rules, Proposed Rules, and Notices of the Federal Government

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0277; FRL-9364-5]

RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
SUMMARY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 78 chemical substances which were the subject of premanufacture notices (PMNs). Seven of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 78 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
DATES: Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before November 5, 2012 (see Unit VI. of theSUPPLEMENTARY INFORMATION).

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

ADDRESSES: *Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments.

*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:OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: Docket ID Number EPA-HQ-OPPT-2012-0277. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions:Direct your comments to docket ID number EPA-HQ-OPPT-2012-0277. EPA's policy is that all comments received will be included in the docket without change and may be made available online athttp://www.regulations.gov,including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an "anonymous access" system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket:All documents in the docket are listed in the docket index available athttp://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically athttp://www.regulations.gov,or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

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

• Manufacturers, importers, 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 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply withthe export notification requirements in 40 CFR part 707, subpart D.

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

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

2.Tips for preparing your comments.When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading,Federal Registerdate and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background A. What action is the Agency taking?

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in theFederal Registerissue of April 24, 1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

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

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in theFederal Registerits reasons for not taking action.

III. Significant New Use Determination

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

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

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

To determine what would constitute a significant new use for the 78 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 84 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders).

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).

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

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

This rule includes 7 PMN substances (P-04-80, P-06-149, P-06-153, P-07-327, P-09-48, P-09-636, and P-10-367) that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.

This rule also includes SNURs on 71 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

PMN Number P-00-535

Chemical name:1-Octadecanol, manuf. of, distn. lights, fractionation heavies, distn. lights.

CAS number:243640-46-2.

Basis for action:The PMN states that the substance will be used as a feedstock for esterification. Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 part per billion (ppb) of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a feedstock for esterification may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish early-life stage toxicity test (Office of Pollution Prevention and Toxics (OPPTS) Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (Office for Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10426.

PMN Number P-01-579

Chemical name:Acrylate ester (generic).

CAS number:Not available.

Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on EcoSAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 50 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 50 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 50 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation:40 CFR 721.10537

PMN Number P-02-161

Chemical name:Phosphonium, tetrakis (hydroxymethyl)-, chloride (1:1), reaction products with 1-tetradecanamine and urea.

CAS number:359406-89-6.

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

Recommended testing:EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); and an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) would help characterize the environmental and fate effects of the PMN substance.

CFR citation:40 CFR 721.10538.

PMN Number P-02-653

Chemical name:Bis[phenyl-2H-1,3-benzoxazine]derivative (generic).

CAS number:Not available.

Basis for action:The PMN states that the substance will be used as a resin for electronic laminates, adhesives, encapsulants, and composites. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10539.

PMN Number P-02-984

Chemical name:1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.

CAS number:404362-22-7.

Basis for action:The PMN states that the substance will be used as an epoxy curing agent. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 5 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation:40 CFR 721.10540.

PMN Number P-03-481

Chemical name:5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine, octahydro-1,3,4,7,8,10-hexanitro-.

CAS number:135285-90-4.

Basis for action:The PMN substance will be used as an explosive and propellant. Based on structure activity relationship (SAR) analysis of test data on analogous octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine (also called HMX or octogen); CAS No. 2691-41-0, as well as test data for hexahydro-1,3,5-trinitro-1,3,5-triazine (also called RDX, cyclonite, hexogen, or cyclotrimethylenetrinitramine); CAS No. 121-82-4, EPA identified concerns for neurotoxicity, including severe convulsions or seizures, systemic effects, reproductive and developmental effects, immunotoxicity and oncogenicity from exposure to the PMN substance. In addition, based on EcoSAR analysis of test data on analogous polynitro organic analogues, EPA predicts toxicity to aquatic organisms from the degradation product of the PMN substance at surface water concentrations that exceed 50 ppb of the degradation product. For the use described in the PMN, dermal and inhalation exposures are not expected, and releases to surface waters are not expected to result in surface water concentrations exceeding 50 ppb for the PMN degradation product. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without respiratory protection, impervious gloves, or release to surface waters without chemical destruction or conversion may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).

Recommended testing:EPA has determined that the results of a combined repeated dose toxicity study with reproductive/developmental toxicity screening test, including neurotoxicity assessment and functional observations (OPPTS Test Guideline 870.3650); a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a hydroysis as a function of pH and temperature test (OPPTS Test Guideline 835.2130); and a ready biodegradability test (OPPTS Test Guideline 835.3110) would help to characterize the human health and environmental fate of the PMN substance.

CFR citation:40 CFR 721.10541.

PMN Number P-03-624

Chemical name:Dodecanedioic acid, 1,12-dimethyl ester.

CAS number:1731-79-9.

Basis for action:The PMN states that the substance will be used as a chemical intermediate. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 30 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 30 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation:40 CFR 721.10542.

PMN Number P-04-79

Chemical name:Oxetane, 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]-.

CAS number:449177-94-0.

Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a monomer in the production of reactive polymers for surface coatings and other polymer intermediates. Based on SAR analysis of test data on analogous oxetanes, EPA identified concerns for male reproductive toxicity, liver toxicity, and thyroid effects from exposure to the PMN substance. As described in the PMN, significant inhalation exposures are not expected and dermal exposures are not expected due to the use of protective gloves. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance without dermal protection where there is a potential for dermal exposures may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing:EPA has determined that the results of a combined repeated dose test with a reproductive/developmental toxicity screening (Organisation for Economic Co-operation and Development (OECD) Test Guideline 422) via gavage in rats would help characterize the human health effects of the PMN substance.

CFR citation:40 CFR 721.10543.

PMN Number P-04-80

Chemical name:Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-nonafluorohexyl)oxy]methyl]-.

CAS number:475678-78-5.

Effective date of TSCA section 5(e) consent order:December 28, 2004.

Basis for TSCA section 5(e) consent order:The PMN states that the substance will be used as a monomer in the production of reactive polymers for surface coating materials and other polymer intermediates. EPA has identified health and environmental concerns because the substance may be a persistent, bio-accumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). Also, based on SAR analysis of test data on analogous oxetanes, EPA identified concerns for male reproductive toxicity and systemic effects from exposures to the PMN substance. Further, based on EcoSAR analysis of analogous oxetanes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to human health and the environment, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against these risks, the consent order requires:

1. Use of personal protective equipment including dermal protection (where there is a potential for dermal exposure).

2. Establishment and use of a hazard communication program.

3. 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.

Recommended testing:EPA has determined that the results of a combined repeated dose toxicity test with a reproductive/developmental toxicity screening test (OPPTS Test Guideline 870.3650 or OECD Test Guideline 422) in rats by gavage would help characterize possible human health effects of the PMN substance. The PMN submitter has agreed not to exceed the confidential production limit specified in the consent order without performing this test. In addition, EPA has determined the results of a log Kow test (OECD Test Guideline 117), and (depending upon the results of the log Kow test) a fish BCF test (OPPTS Test Guideline 850.1730); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500), would help characterize the persistence, bioaccumulation, and environmental effects of the PMN substance. The consent order does not require submission of this additional recommended testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10544.

PMN Number P-04-313

Chemical name:Aminotriazine modified cresol novolec resin (generic).

CAS number:Not available.

Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a glass epoxy laminate. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 10 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish BCF test (OPPTS Test Guideline 850.1730), and either an aerobic and anaerobic transformation in aquatic sediment systems test (OECD Test Guideline 308) or a shake flask die-away test (OPPTS Test Guideline 835.3170) would help to characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10545.

PMN Number P-04-340

Chemical name:Pentenylated polyethylene glycol sulfate salt (generic).

CAS number:Not available.

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

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

CFR citation:40 CFR 721.10546.

PMN Number P-04-587

Chemical name:Dialkyl dimethyl ammonium methylcarbonate (generic).

CAS number:Not available.

Basis for action:The PMN states that the substance will be used as a chemical intermediate. Based on EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from the use described in the PMN. For the chemical intermediate use described in the PMN, environmental releases did not exceed 5 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance other than as a chemical intermediate may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation:40 CFR 721.10547.

PMN Number P-04-624

Chemical name:Mixed alkyl phosphate esters alkoxylated (generic).

CAS number:Not available.

Basis for action:The PMN substance will be used as a component in a lubricant blend. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 40 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 40 ppb. Therefore, EPA has not determined that manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 40 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

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

CFR citation:40 CFR 721.10548.

PMN Number P-04-635

Chemical name:Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy)-.

CAS number:406-78-0.

Basis for action:The PMN states that the substance will be used for cleaning electronic components, precision cleaning, dewatering of electronic components and other parts following aqueous cleaning, and as a carrier/lubricant coating for hard disk drives and other precision parts. Based on test data on the PMN substance, EPA identified concerns for neurotoxicity. For the industrial use described in the PMN, the substance is imported and no significant worker exposures are expected. Therefore, EPA has not determined that the proposed processing or use of the substance presents an unreasonable risk. EPA has determined, however, that domestic manufacture, use in non-industrial products, or use other than as described in the PMN may cause serious chronic health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing:EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2012-0277) would help characterize the human health effects of the PMN substance.

CFR citation:40 CFR 721.10549.

PMN Number P-05-324

Chemical name:Rare earth salt of a carboxylic acid (generic).

CAS number:Not available.

Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a paint component. Based on SAR analysis of test data on analogous lanthanides, EPA identified concerns for developmental toxicity, kidney toxicity, and blood toxicity (specifically, anticoagulant activity). In addition, based on EcoSAR analysis of test data on analogous organic and inorganic salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substance in surface waters. For the use described in the PMN, significant worker and general population exposures are not expected, and releases of the substance are not expected to result in surface water concentrations that exceed 5 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN, or any use resulting in surface water concentrations exceeding 5 ppb may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).

Recommended testing:EPA has determined that the results of an acute oral toxicity test (OPPTS Test Guideline 870.1100); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; a repeated dose 28-day oral toxicity test in rodents (OPPTS Test Guideline 870.3050), including a neurotoxicity functional observational battery, as described in the neurotoxicity screening battery (OPPTS Test Guideline 870.6200); a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700) in one species, via the oral route; either a porous pot test (OPPTS Test Guideline 835.3220) or an aerobic sewage treatment simulation test (OECD Test Guideline 303A); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation:40 CFR 721.10550.

PMN Number P-05-613

Chemical name:Bisphenol S mono ether (generic).

CAS number:Not available.

Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a color developer. Based on SAR analysis of test data on analogous epoxides, EPA identified concerns for respiratory sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive toxicity, liver toxicity, and kidney toxicity. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface water. For the use described in the PMN, occupational exposures during manufacture are not expected as the PMN substance is imported. Occupational exposures during processing and use are not expected to be significant due to expected use of appropriate personal protective equipment, and the substance is not released to surface waters during processing or use. Therefore, EPA has not determined that the proposed processing or use of the substance presents an unreasonable risk. EPA has determined, however, that domestic manufacture, any use of the substance other than as described in the PMN, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).

Recommended testing:EPA has determined that the results of a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650); a carcinogenicity test (OPPTS Test Guideline 870.4200); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance.

CFR citation:40 CFR 721.10551.

PMN Number P-05-774

Chemical name:Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-chlorophenyl)methyl]-.

CAS number:134818-68-1.

Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization. In addition, based on SAR analysis of test data on analogous epoxides and chlorobenzenes, EPA identified concerns for carcinogenicity, mutagenicity, systemic toxicity, neurotoxicity, and reproductive toxicity from worker exposures. Further, based on test data on the PMN substance and EcoSAR analysis of test data on analogous monoepoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. For the site-limited intermediate use described in the PMN, significant worker dermal exposure is unlikely due to the use of impervious personal protective equipment and releases of the substance are not expected to result in surface water concentrations that exceed 2 ppb. Therefore, EPA has not determined that manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without workers wearing impervious gloves, where there is a potential for dermal exposures; use of the substance other than as a site-limited chemical intermediate, or any use of the substance resulting in surface water concentrations exceeding 2 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).

Recommended testing:EPA has determined that the results of a porous pot test (OPPTS Test Guideline 835.3220); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) by the intraperitoneal route; a combined repeated dose toxicity test (OPPTS Test Guideline 870.3650) with the reproduction/development toxicity screening test and neurotoxicity endpoints; a carcinogenicity test (OPPTS Test Guideline 870.4200); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation:40 CFR 721.10552.

PMN Number P-06-149

Chemical name:Potassium titanium oxide.

CAS number:12673-69-7.

Effective date of TSCA section 5(e) consent order:March 18, 2008.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance is as a physical characteristics modifier for industrial use in certain solid composite articles. Based on test data on the PMN substance and SAR analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route. The Order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires:

1. Use of personal protective equipment including a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10, or compliance with a NCEL of 1.5 mg/m3as a time weighted average (when there is a potential for inhalation exposures).

2. Establishment and use of a hazard communication program.

3. No manufacture of the PMN substance with a particle size less than 100 nanometers.

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

Recommended testing:EPA determined that the results of the following study would help characterize the human health effects of the PMN substance: A 90-day inhalation toxicity test with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the broncoalveolar lavage fluid (BALF), e.g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability (OPPTS Test Guideline 870.3465).

CFR citation:40 CFR 721.10553.

PMN Number P-06-153

Chemical name:Iso-tridecanol (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:October 13, 2006.

Basis for TSCA section 5(e) consent order:The PMN states that the substance will be used as a reactant. Based on test data on the PMNsubstance, and EcoSAR analysis of test data on analogous neutral organic compounds, EPA predicts toxicity to aquatic organisms at concentrations that exceed 8 ppb of the PMN substance in surface waters. Further, aquatic toxicity, persistence, and bioaccumulation potential vary depending on the isoindex (i.e., the average number of branches per alkyl unit) of the PMN substance. EPA has determined that as the isoindex increases, persistence and bioaccumulation values increase. At the isoindex value of 2.32 for the intended PMN substance, the substance is not considered a PBT chemical and aquatic toxicity risk is mitigated by the decrease in persistence. However, as the isoindex increases above 3, EPA estimates that the PMN substance will persist in the environment more than two months and EPA estimates a bioaccumulation factor of greater than or equal to 1000. If the isoindex is less than three, the PMN is not expected to persist. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to the environment. To protect against these risks, the consent order requires manufacture of the PMN substance according to the chemical composition section of the consent order, with no greater than an average of three branches per alkyl unit and routine analysis of the PMN substance to verify compliance with the average number of alkyl units restriction. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing:EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. The consent order does not require the submission of this testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10554.

PMN Number P-06-370

Chemical name:Benzoic acid nonyl ester, branched and linear.

CAS number:670241-72-2.

Basis for action:The PMN states that the substance will be used as a softener for polyvinyl chloride. Based on test data on the PMN substance, EPA identified concerns for developmental toxicity from exposure to the PMN substance. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. As described in the PMN, dermal exposures are not expected due to the use of impervious gloves and no domestic manufacture, and releases of the PMN substance are not expected to result in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed processing or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance without impervious gloves, where there is a potential for dermal exposures; any domestic manufacture; or any use of the substance resulting in surface water concentrations exceeding 6 ppb may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(4)(i), and (b)(4)(ii).

Recommended testing:EPA has determined that the results of a 90-day subchronic dermal toxicity test in rats (OPPTS Test Guideline 870.3250) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation:40 CFR 721.10555.

PMN Numbers P-06-450, P-06-451, and P-06-452

Chemical names:(P-06-450) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C12-15-alkyl ethers; (P-06-451) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C10-16-alkyl ethers; and (P-06-452) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-hydroxy-,C12-16-alkyl ethers.

CAS numbers:(P-06-450) 675869-02-0; (P-06-451) 620610-66-4; and (P-06-452) 675869-05-3.

Basis for action:The consolidated PMN states that the substances will be used as wetting agents for low foam spray metal cleaning. Based on EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substances in surface waters. At the combined production volume stated in the notice, releases of the PMN substances are not expected to result in surface water concentrations that exceed 10 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any increase in the combined annual manufacture and import volume of 45,000 kilograms (kgs) of the substances could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) on any of the three PMN substances would help characterize the environmental effects of the PMN substances.

CFR citations:40 CFR 721.10556 (P-06-450); 40 CFR 721.10557 (P-06-451); and 40 CFR 721.10558 (P-06-452).

PMN Number P-06-793

Chemical name:Morpholine, 4-C6-12acyl derivs.

CAS number:887947-29-7.

Basis for action:The PMN states that the substance will be used as a pesticide dispersant/solvent. Based on test data on the PMN substance, EPA identified concerns for systemic effects from dermal exposures. As described in the PMN, worker dermal exposures are not expected due to the use of impervious skin protection and hazard communication warnings for systemic effects. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without impervious dermal protection, where there is a potential for dermal exposures, or any use of the substance without hazard communication warnings for systemic effects may cause serious health effects. Based on this information, the PMN meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing:EPA has determined that the results of 90-day subchronic dermal toxicity test (OPPTS Test Guideline 870.3250) would help characterize the human health effects of the PMN substance.

CFR citation:40 CFR 721.10559.

PMN Numbers P-07-143 and P-07-144

Chemical names:Alkanoldioic dialkyl esters (generic).

CAS numbers:Not available.

Basis for action:The PMNs state that the generic (non-confidential) use of the substances will be as lubricant additives. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 3 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances presents an unreasonable risk. EPA has determined, however, that any use of the substances other than as described in the PMNs may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) would help characterize the environmental effects of the PMN substances. EPA also recommends that the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.

CFR citation:40 CFR 721.10560.

PMN Number P-07-327

Chemical name:Substituted phenol (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:September 17, 2008.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance will be as an antioxidant. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to the environment, may be produced in substantial quantities, and may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the consent order requires:

1. Establishment and use of a hazard communication program.

2. 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.

Recommended testing:EPA has determined that the results of certain human health toxicity testing specified in the consent order would help characterize the human health effects of the substance. The PMN submitter has agreed not to exceed the confidential production volume limit without performing anin vitromouse lymphoma assay (mammalian cell mutation test) (OPPTS Test Guideline 870.5300) and a repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050) to include a neurotoxicity battery (OPPTS Test Guideline 870.6200).

In addition, EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. The consent order does not require submission of this aquatic toxicity testing by any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10561.

PMN Number P-07-375

Chemical name:Aluminum trihydrate and silane homopolymer (generic).

CAS number:Not available.

Basis for action:The PMN states that the use of the substance will be as a flame retardant. Based on test data on an analogous insoluble high molecular weight polymer, EPA identified concerns for lung toxicity if the PMN substance is inhaled. At an annual production volume of 100,000 kgs, worker exposure is limited and consumer exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any increase of the annual 100,000 kg production volume may result in increased exposure to the PMN substance which may cause significant adverse human health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

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

CFR citation:40 CFR 721.10562.

PMN Number P-07-496

Chemical name:2-Oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-.

CAS number:71604-74-5.

Basis for action:The PMN substance will be used as a preparation of pre-impregnated cloth/fiber tapes for aerospace composite articles. Based on SAR analysis of test data on analogous epoxides, EPA identified concerns for oncogenicity, mutagenicity, developmental toxicity, reproductive toxicity, and liver toxicity from exposure to the PMN substance. As described in the PMN, worker dermal exposure to the PMN substance will be minimal due to the use of impervious gloves, and no significant inhalation exposure is expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without the use of impervious gloves, where there is potential for dermal exposure, or any use of the substance other than as a preparation of pre-impregnated cloth/fiber tapes for aerospace composite articles may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing:EPA has determined that the results of a 90-day subchronic dermal toxicity test in rats (OPPTS Test Guideline 870.3250) and a dermal carcinogenicit