E7-18502. 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 section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 38 chemical substances which were the subject of premanufacture notices (PMNs). One of these chemical substances is also subject to a TSCA section 5(e) consent order issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 38 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:

The effective date of this rule is November 19, 2007 without further notice, unless EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments before October 19, 2007. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on October 3, 2007.

If EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before October 19, 2007 EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2006-0898, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 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. Attention: Docket ID number EPA-HQ-OPPT-2006-0898. 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 [phone]. 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-2006-0898. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at http://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 e-mail. The regulations.gov website 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 e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. 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 at http://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 Federal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. 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 general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Karen Chu, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. Potentially affected entities may include, but are not limited to:

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any 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 19, 2007 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 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 e-mail. 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 Register date 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. Additional rationale and background to this rule are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register of April 24, 1990 (55 FR 17376). 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 those listed in TSCA section 5(a)(2). 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. The mechanism for reporting under this requirement is established under 40 CFR 721.5.

C. Applicability of General Provisions

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

Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of the import certification appears at 40 CFR part 707, subpart B.

III. Substances Subject to this Rule

EPA is establishing significant new use and recordkeeping requirements for 38 chemical substances under 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).
• CAS number (if assigned for non-confidential chemical identities).
• Basis for the section 5(e) consent order, or, for non-5(e) SNURs, the basis for the SNUR.
• Toxicity concerns.
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VI. for more information).
• CFR citation assigned in the regulatory text section of this rule.

The specific activities designated as significant new uses are listed in the regulatory text section of 40 CFR part 721, subpart E. Certain new uses, including production limits and other uses designated in the rule are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VII.

This rule includes a SNUR on one PMN substance that is subject to a “risk-based” consent order under TSCA section 5(e)(1)(A)(ii)(I) wherein EPA determined that activities associated with the PMN substance may present unreasonable risk to health or the environment. The consent order requires protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNUR” on this substance is promulgated pursuant to 40 CFR 721.160, and is based on and consistent with the provisions in the underlying consent order. The SNUR designates as a “significant new use” the absence of the protective measures required in the consent order.

This rule also includes SNURs on 37 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under section 5(e) of TSCA. EPA, however, 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-5(e) SNURs” are promulgated pursuant to 40 CFR 721.170. EPA has determined that every activity designated as a “significant new use” in all the non-5(e) SNURs issued under 40 CFR 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 Numbers P-01-759 and P-05-555

Chemical name: Dodecandioic acid, 1, 12-dihydrazide.

CAS number: 4080-98-2.

Basis for action: The PMNs state that the generic (non-confidential) uses of the substance will be as a raw material for coating and sealants and as a curing agent. Based on molecular structure and test data on analogous substances, EPA has identified health concerns for carcinogenicity, developmental toxicity, and irritation to mucous membranes. Also, based on test data on the PMN substance, EPA has identified concerns for dermal sensitization. As described in the PMNs and accompanying Material Safety Data Sheets, workers will be warned that the substance may cause dermal sensitization and will wear gloves and National Institute for Occupational Safety and Health (NIOSH) approved respirators with an assigned protection factor (APF) of 50 or greater. Based on adequate personal protective equipment and hazard communication, significant worker exposure is unlikely. Further, consumer use 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 use of the substance without workers wearing gloves and a respirator, and without an appropriate hazard communication program, may cause serious human health effects. Respirators must provide a NIOSH APF of at least 50. The following NIOSH-approved respirators meet the minimum requirement for § 721.63(a)(4): Air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; powered air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters; supplied air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting full facepiece. Because the substance is a dermal sensitizer and irritates mucous membranes, half-face respirators do not provide adequate protection. 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 oral toxicity test in rats (OPPTS 870.3100 test guideline) and a mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10057.

PMN Numbers P-03-546, P-03-550, and P-03-551

Chemical names: (P-03-546) Reaction product of alkylphenol, aromatic cyclicamine, alkyl diglycidyl dibenzene, and formaldehyde (generic); (P-03-550) Reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine, and alkyl diglycidyl dibenzene (generic); and (P-03-551) Reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine, alkyl diglycidyl dibenzene, and polyalkylcyclicdiamine (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the substances will be used as epoxy curing agents. Based on test data on structurally analogous polycationic polymers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 20 parts per billion (ppb) of the PMN substances in surface waters. As described in the PMNs, the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that uses of the substances resulting in release to surface waters 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 the following tests would help characterize the environmental effects of the PMN substances: A fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)).

CFR citations: 40 CFR 721.10058 (P-03-546); 40 CFR 721.10059 (P-03-550); and 40 CFR 721.10060 (P-03-551).

PMN Number P-04-341

Chemical name: Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)-.

CAS number: 132182-92-4.

Basis for action: The PMN states that the substance will be used as a solvent coating and heat transfer fluid. EPA has identified health and environmental concerns because the substance is potentially a persistent, bio-accumulative, and toxic (PBT) chemical, consistent with the New Chemical Program's PBT Category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000, based on test data indicating a fish bioaccumulation factor of 3.2 and a log K_ow of 4.70. As described in the PMN, the substance is not released to surface water. 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 release of the PMN substance to surface waters may cause significant adverse environmental effects, since the PMN substance has been characterized by EPA as a PBT. 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 the tiered testing as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the substance. EPA has determined that the results of an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)), a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would further characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10061.

PMN Number P-04-627

Chemical name: 2,5-Furandione, polymer with oxybis[propanol], benzoate.

CAS number: 103458-14-6.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a spray-applied filled backing resin. Based on test data on structurally similar acrylates and esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 9 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 substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters 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 850.1075 test guideline (public draft)), an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10062.

PMN Number P-04-792

Chemical name: Halo substituted hydroxy nitrophenyl amide (generic).

CAS number: Not available.

Basis for action: The PMN states that generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on structurally analogous phenols, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 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 unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters 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 the following tests would help characterize the environmental effects of the PMN substance: An algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)); a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)); a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)); and either a porous pot test (OPPTS 835.3220 test guideline) or an aerobic sewage treatment test (Organization for Economic Cooperation and Development (OECD) 303A test guideline). The algal toxicity study should be performed using the static method with measured concentrations and the fish and daphnid tests should be performed using the flow-through method with measured concentrations.

CFR citation: 40 CFR 721.10063.

PMN Number P-04-909

Chemical name: 2-Propenoic acid, 2-[2-(ethenyloxy)ethoxy]ethyl ester.

CAS number: 86273-46-3.

Effective date of section 5(e) consent order: 6-26-2006.

Basis for section 5(e) consent order: The PMN states the substance will be used as an ultraviolet-curable monomer for polymerization. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA, based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires use of gloves demonstrated by testing to be impervious (North Butyl Black gloves and T-1 Dailove Ethylene Vinylalcohol Copolymer Laminated Blue gloves have satisfied this requirement) and a hazard communication program. The SNUR designates as a ‘significant new use’ the absence of these protective measures.

Toxicity concern: Based on test data on chemicals analogous to the PMN substance, EPA has concerns that the PMN substance may cause developmental toxicity, mutagenicity, reproductive toxicity, and oncogenicity. Also, EPA has health concerns for sensitization based on submitted test data on the PMN substance and via analogy to TSCA section 8(e) submission number 8EHQ-1092-11387, skin irritation and kidney toxicity concerns based on data for a bismethacrylate analog TSCA section 8(e) submission number 8EHQ-0695-13474, and skin cancer concerns (if exposed individuals are not protected from skin damage from the irritant properties of the chemical) based on male mouse chronic dermal toxicity test data for an analog, For Your Information (FYI) submission number FYI-0691-01262.

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity test with reproduction/developmental screening (OPPTS 870.3650 test guideline) would help characterize the human health effects of the PMN substance. The test should be done in rats, through the oral route of exposure, and be modified to dose for 70 days, an entire sperm cycle, before mating occurs. The PMN submitter has agreed not to exceed the production volume limit without performing this test.

CFR citation: 40 CFR 721.10064.

PMN Numbers P-04-961 and P-04-962

Chemical names: (P-04-961) 1-Tetradecanesulfonic acid, (dimethylphenyl)- and (P-04-962) 1-Hexanesulfonic acid, (dimethylphenyl)-.

CAS numbers: (P-04-961) 671756-61-9 and (P-04-962) 676143-36-5.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be to help recover additional quantities of oil from subterranean reservoirs and also to impart improved properties to products derived from such recovered oil. Based on test data on chemicals with molecular structures similar to the PMN substances, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 20 ppb of the PMN substances in surface waters. As described in the consolidated PMNs, the substances will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters 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 the following tests would help characterize the environmental effects of the PMN substances: A porous pot test (OPPTS 835.3220 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test freshwater in daphnids (OPPTS 850.1010 test guideline (public draft)); and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)).

CFR citations: 40 CFR 721.10065 (P-04-961) and 40 CFR 721.10066 (P-04-962).

PMN Numbers P-05-57, P-05-58, P-05-59, P-05-60, P-05-61, P-05-62, P-05-63, P-05-64, and P-05-65

Chemical names: (P-05-57, P-05-58, P-05-59, P-05-61, P-05-62, P-05-63, P-05-64, and P-05-65) Ether amine phosphonate salt (generic) and (P-05-60) Ether amine phosphonate (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as a contained use in energy production. Based on test data on chemicals with molecular structures similar to the PMN substances, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 30 ppb of the PMN substances in surface waters. As described in the consolidated PMNs, the substances will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters 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 an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)) on P-05-57, P-05-58, and P-05-64 and a ready biodegradation test (OPPTS 835.3110 test guideline) on P-05-57, P-05-59, and P-05-61 or P-05-64 would help characterize the environmental effects of the PMN substances.

CFR citations: 40 CFR 721.10067 (P-05-57, P-05-58, P-05-59, P-05-61, P-05-62, P-05-63, P-05-64, and P-05-65) and 40 CFR 721.10069 (P-05-60).

PMN Number P-05-309

Chemical name: 1,3-Butanediol, 3-methyl-.

CAS number: 2568-33-4.

Basis for action: The PMN states that the substance will be used as inkjet ink. Based on test data on the PMN substance and on analogous chemicals, the PMN substance may cause developmental toxicity, liver toxicity, blood/immune system effects and possibly digestive tract and kidney effects. As described in the PMN, the substance is imported in an inkjet cartridge so domestic worker exposure is not expected. Although there is potential for short-term, infrequent consumer dermal exposure, based on test data on the closest analog, the margin of exposure is greater than 1,000. Therefore, EPA has not determined that the proposed use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacturing or use other than as described in the PMN could result in serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day oral toxicity test in rodents (OPPTS 870.3100 test guideline) and a prenatal developmental toxicity study (OPPTS 870.3700 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10070.

PMN Number P-05-364

Chemical name: 9H-Thioxanthenium, 10-[1,1′-biphenyl]-4-yl-2-(1-methylethyl)-9-oxo-, hexafluorophosphate (1-) (1:1).

CAS number: 591773-92-1.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a benzene-free cationic photoinitiator. Based on submitted test data on the PMN substance, the substance may cause mutagenicity, lung toxicity, thyroid toxicity, irritation to eyes, mucous membranes and lung, dermal sensitization, and developmental toxicity resulting from thyroid effects. In addition, based on submitted test data on the PMN substance, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 6 ppb of the PMN substance in surface waters. As described in the PMN, significant inhalation exposure is unlikely, and the substance is not released to water. 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 domestic manufacture or any import, processing, or use of the PMN substance in a solid form may cause serious health and environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i) and (b)(4)(i).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and a 90-day oral toxicity test in rodents (OPPTS 870.3100 test guideline) would help characterize the environmental and human health effects of the PMN substance. The fish and daphnid tests should be performed using the flow-through method with measured concentrations.

CFR citation: 40 CFR 721.10071.

PMN Number P-05-380

Chemical name: Benzene, 1,1′-methylenebis[4-isocyanato-, polymer with benzenedicarboxylic acid, butyl dialkyl ester, poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-hydroxy-, oxirane, alkyl-, polymer with oxirane, ether with propanepolyol and Sartomer's HLBH P-3000 and Lexorez 1180 (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a roofing adhesive for bonding roof membranes. Based on test data on analogous substances, the PMN substance may cause lung toxicity. As described in the PMN, significant worker inhalation exposure is unlikely. 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 involving an application method that generates a vapor, mist, or aerosol 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 90-day inhalation toxicity test in rats (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10072.

PMN Number P-05-536

Chemical name: Modified alkyl acrylamide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on analogy to acrylamide, the PMN substance may cause neurotoxicity, mutagenicity, carcinogenicity, reproductive toxicity, developmental toxicity, and immunotoxicity. As described in the PMN, worker dermal exposure is not expected and inhalation exposure is expected to be negligible. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day oral toxicity test with neuropathology in rodents (OPPTS 870.3100 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10073.

PMN Number P-05-568

Chemical name: Acetic acid, 2-chloro-, 1-(3,3-dimethylcyclohexyl)ethyl ester.

CAS number: 477218-59-0.

Basis for action: The PMN states that the substance will be used as an isolated intermediate. Based on test data on analogous esters, the PMN substance may cause toxicity to aquatic organisms at concentrations at or above 6 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released in significant amounts 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 use of the PMN substance other than as a site-limited 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 acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)), an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10074.

PMN Number P-05-722

Chemical name: Carbon black, 4-[[2-(Sulfooxy)ethyl] substituted] phenyl-modified, sodium salts (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of this substance will be as a step 1 black pigment intermediate. Based on test data on analogous respirable, poorly soluble, particulates, the PMN substance may cause lung effects. Based on its physical properties, dermal exposure to the PMN substance may cause systemic effects. As described in the PMN, dermal and inhalation exposure are 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 use of the substance other than as described in the PMN, or any manufacturing, processing, or use of the substance as a powder 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 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10075.

PMN Number P-05-792

Chemical name: Substituted benzenediamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate that will be destroyed during use. Based on test data on analogous chemicals, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 2 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 above 2 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in surface water concentrations above 2 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 the following tests would help characterize the environmental effects of the PMN substance: A ready biodegradability test (OPPTS 835.3110 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)).

CFR citation: 40 CFR 721.10076.

PMN Numbers P-06-1 and P-06-166

Chemical name: 3H-1,2,4-Triazol-3-one, 1,2-dihydro-.

CAS number: 930-33-6.

Basis for action: The PMNs state that the substance will be used as a chemical intermediate. Based on test data on 1,2,4-Triazole, EPA has concern for developmental toxicity. Also, based on test data on structural analogues, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 20 ppb of the PMN substance in surface waters. As described in the PMNs, the substance will not be released to surface water and worker exposure will be minimal due to adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance resulting in release to surface waters or use of the substance without appropriate hazard communication and worker respiratory protection may cause significant adverse environmental and human health 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 the following tests would help characterize the environmental and health effects of the PMN substance: A ready biodegradability test using any of the six methods (OPPTS 835.3110 test guideline); a porous pot test (OPPTS 835.3220 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)); and a prenatal developmental toxicity study (OPPTS 870.3700 test guideline). The porous pot test is suggested only if the substance does not pass the ready biodegradation test.

CFR citation: 40 CFR 721.10077.

PMN Number P-06-4

Chemical name: Butanamide, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxo-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)substituted]phenyl derivs., hydrochlorides (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a step 2 yellow pigment intermediate. Based on test data on other aliphatic polyamines and cationic dyes, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 10 ppb of this substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations above 10 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 uses of the substance resulting in surface water concentrations above 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 the following tests would help characterize the environmental effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)).

CFR citation: 40 CFR 721.10078.

PMN Number P-06-7

Chemical name: Quino[2,3-b]acridine-7, 14-dione, 5,12-dihydro-2,9-dimethyl-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)substituted]phenyl derivs., hydrochlorides (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a step 2 magenta pigment intermediate. Based on test data on analogous respirable, poorly soluble, particulates, the PMN substance may cause lung toxicity. Based on its physical properties, EPA has concerns for dermal exposure to the PMN substance. Based on test data on analogous aliphatic polyamines and cationic dyes, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 10 ppb of the PMN substance in surface waters. As described in the PMN, dermal and inhalation exposures to the PMN substance are not expected and environmental releases of the substance are not expected to result in surface water concentrations above 10 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 use of the substance without appropriate worker protection, use other than as described in the PMN, and manufacturing, processing, or use as a solid may cause serious health effects. Additionally, use of the substance resulting in surface water concentrations above 10 ppb may cause 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 the following tests would help characterize the environmental and health effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)); and a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline).

CFR citation: 40 CFR 721.10079.

PMN Number P-06-8

Chemical name: Carbon black, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl) substituted] phenyl-modified, hydrochlorides (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a step 2 black pigment intermediate. Based on test data on analogous respirable, poorly soluble, particulates, the PMN substance may cause lung toxicity. Based on its physical properties, EPA has concerns for dermal exposure to the PMN substance. Based on test data on analogous aliphatic polyamines and cationic dyes, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 10 ppb of the PMN substance in surface waters. As described in the PMN, dermal and inhalation exposures to the PMN substance are not expected and environmental releases of the substance are not expected to result in surface water concentrations above 10 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 use of the substance without appropriate worker protection, use other than as described in the PMN, and manufacturing, processing, or use as a solid may cause serious health effects. Additionally, use of the substance resulting in surface water concentrations above 10 ppb may cause 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 the following tests would help characterize the environmental and health effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)); and a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline).

CFR citation: 40 CFR 721.10080.

PMN Number P-06-26

Chemical name: Aromatic urethane acrylate oligomer (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an aromatic urethane acrylate oligomer in ultraviolet-curable inks and coatings. Based on test data on structurally analogous polyanionic polymers and monomers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 90 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be 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 other uses of the substance resulting in release to surface waters 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 850.1075 test guideline (public draft)), an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. The fish and daphnid tests should use flow-through conditions and measured concentrations. The algal test should use the static method and measured concentrations.

CFR citation: 40 CFR 721.10081.

PMN Number P-06-29

Chemical name: Amine modified monomer acrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an amine-modified monomer acrylate in ultraviolet-curable inks and coatings. Based on structural analogy to polyanionic polymers/monomers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 10 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be 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 other uses of the substance resulting in release to surface waters 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 the following tests would help characterize the environmental effects of the PMN substance: A ready biodegradability test (OPPTS 835.3110 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); and an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)). EPA recommends that the biodegradability testing be performed first. The fish and daphnid tests should use flow-through conditions and measured concentrations. The algal test should use the static method and measured concentrations.

CFR citation: 40 CFR 721.10082.

PMN Number P-06-70

Chemical name: Copper, [29H, 31H-phthalocyaninato (2-)-κN 29, κN 30, κN 31, κN 32]-, 4-[(17-substituted-3,6,9,12,15- pentaazaheptadec-1-yl) substituted] phenyl derivs., hydrochlorides (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a step 2 cyan pigment intermediate. Based on test data on analogous respirable, poorly soluble, particulates, the PMN substance may cause lung toxicity. Based on its physical properties, EPA has concerns for dermal exposure to the PMN substance. Based on test data on analogous aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 10 ppb of the PMN substance in surface waters. As described in the PMN, dermal and inhalation exposures to the PMN substance are not expected and environmental releases of the substance are not expected to result in surface water concentrations above 10 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 use of the substance without appropriate worker protection, use other than as described in the PMN, and manufacturing, processing, or use as a solid may cause serious health effects. Additionally, use of the substance resulting in surface water concentrations above 10 ppb may cause 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 the following tests would help characterize the environmental and health effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)); and a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline).

CFR citation: 40 CFR 721.10083.

PMN Number P-06-124

Chemical name: Modified thionocarbamate (generic).

CAS number: Not available.

Basis for action: The PMN states that generic (non-confidential) use of the substance will be as a sulfide mineral processing reagent. Based on test data on structurally similar analogs, EPA is concerned that toxicity to aquatic organisms may occur at concentrations at or above 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be 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 other uses of the substance resulting in release to surface waters 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 an activated sludge sorption isotherm test (OPPTS 835.1100 test guideline), a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10084.

PMN Number P-06-232

Chemical name: Substituted polyaryl sulfonium polyhalide phosphate salt (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a photo initiator used in photo-curable compositions. Based on test data on the PMN substance, EPA has concerns for widespread systemic toxicity in most organ systems, persistent eye irritation, male reproductive toxicity, and developmental-neurotoxicity in off-spring (caused by maternal thyroid toxicity) for the PMN material. As described in the PMN, worker inhalation and eye exposure are 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 domestic manufacture or the use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity study with the reproduction/developmental screening test (OPPTS 870.3650 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10085.

PMN Number P-06-295

Chemical name: Ethane, 2-(difluoromethoxy)-1,1,1-trifluoro-.

CAS number: 1885-48-9.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on test data on structural analogues, EPA has concerns for solvent neurotoxicity, solvent irritation, and developmental toxicity for the PMN substance. As described in the PMN, only limited worker dermal and inhalation exposures are 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 use of the substance other than as an intermediate with workers wearing impervious gloves may cause serious 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 study (OPPTS 870.3465 test guideline) with a neurotoxicity functional observational battery (National Technical Information Service (NTIS) PB 91-154617) and neuropathology would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10086.

PMN Number P-06-332

Chemical name: Substituted alkyl phosphine oxide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a bonded flame retardant. Based on test data on analogous alkyl and aryl phosphates, EPA believes the PMN substance may cause delayed neurotoxicity in humans. At the production volume stated in the PMN, significant human exposure is unlikely. 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 increased importation or production volumes 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 an acute and 28-day delayed neurotoxicity of organophosphorus substances study (OPPTS 870.6100 test guideline) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10087.

PMN Number P-07-283

Chemical name: Thiophene, 2,5-dibromo-3-hexyl-.

CAS number: 116971-11-0.

Basis for action: The PMN states that the substance will be used as a reactive intermediate monomer for use in manufacturing a p-type organic semiconductor polymer. The polymer will be used in printed organic electronics applications. Based on structure activity relationship analyses for thiophenes, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 1 ppb of the PMN substance in surface waters. At the production volume stated in the PMN, releases of the PMN substance are not expected to result in surface water concentrations above 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 increased production or importation volumes or other uses of the substance resulting in surface water concentrations above 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 an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)), a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. The fish and daphnid tests should use flow-through conditions and measured concentrations.

CFR citation: 40 CFR 721.10088.

IV. Objectives and Rationale 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 one of the 38 chemical substances, regulation was warranted under section 5(e) of TSCA, pending the development of information sufficient to make a reasoned evaluation of the health effects of the chemical substance. The basis for such findings is outlined in Unit III. Based on these findings, a TSCA section 5(e) consent order requiring the use of appropriate exposure controls was negotiated with the PMN submitter; the SNUR provisions for this chemical substance listed in this document are consistent with the provisions of the TSCA section 5(e) consent order.

In the other 37 cases for which the proposed uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at 40 CFR 721.170 were met, as discussed in Unit III.

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:

1. EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.

2. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.

3. EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.

4. EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Manufacturers, importers, and processors are responsible for ensuring that a new chemical substance subject to a final SNUR is listed on the TSCA Inventory.

V. Direct Final Procedures

EPA is issuing these SNURs as a direct final rule, as described in 40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR 721.160(c)(3)(ii) and 721.170(d)(4)(i), this rule will be effective November 19, 2007, unless EPA receives a written notice by October 19, 2007 of adverse or critical comments, or notice of intent to submit adverse or critical comments, on EPA's action. If EPA receives such a notice, EPA will publish a document to withdraw the direct final SNUR for the specific chemical substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific chemical substance providing a 30-day comment period.

This action establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in a notice.

VI. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them. However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit III. lists those tests. Unit III. also lists recommended testing for the chemical substances that would be covered by the non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Many test guidelines are now available on the Internet at http://www.epa.gov/​opptsfrs/​home/​guidelin/​htm. OECD test guidelines are available from the OECD Bookshop (http://www.oecdbookshop.org) or Source OECD (http://www.sourceoecd.org).

In the TSCA section 5(e) consent order for the chemical notified under P-04-909, EPA has established a production volume limit which 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 this chemical substance. Under recent consent orders, the PMN submitter is required to submit the results of the required studies at least 14 weeks (earlier consent orders required submissions at least 12 weeks) before reaching the specified production limit. The tests specified in the TSCA section 5(e) consent order are included in Unit III. The SNUR contains the same production volume limit as the consent order. Exceeding this production limit 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.

The recommended tests may not be the only means of addressing the potential risks of the chemical substances regulated under this rule. However, SNUNs submitted for significant new uses 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 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:

1. Human exposure and environmental release that may result from the significant new use of the chemical substances.

2. Potential benefits of the chemical substances.

3. Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

VII. Procedural Determinations

EPA is establishing through this rule certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2. EPA is required to keep this information confidential to protect the CBI of the original PMN submitter. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This procedure appears in 40 CFR 721.1725(b)(1) and is similar to that in § 721.11 for situations where the chemical identity of the chemical substance subject to a SNUR is CBI. This procedure is cross-referenced in each of these SNURs that include specific significant new uses that are CBI.

A manufacturer or importer may request EPA to determine whether a proposed use would be a significant new use under this rule. Under the procedure in § 721.1725(b)(1), a manufacturer or importer must show that it has a bona fide intent to manufacture or import the chemical substance and must identify the specific use for which it intends to manufacture or import the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or import 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 a manufacturer or importer is told that the production volume identified in the bona fide submission would not be a significant new use, i.e., it is below the level that would be a significant new use, that person can manufacture or import the chemical substance as long as the aggregate amount does not exceed that identified in the bona fide submission to EPA. 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. EPA is considering whether to adopt a special procedure for use when CBI production volume is designated as a significant new use. Under such a procedure, a person showing a bona fide intent to manufacture or import the chemical substance, under the procedure described in § 721.11, would automatically be informed of the production volume that would be a significant new use. Thus, the person would not have to make multiple bona fide submissions to EPA for the same chemical substance to remain in compliance with the SNUR, as could be the case under the procedures in § 721.1725(b)(1).

VIII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have recently undergone premanufacture review. A TSCA section 5(e) consent order has been issued for one chemical substance and the notice submitter is prohibited by the TSCA section 5(e) consent order from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA has concluded that the uses are not ongoing. However, EPA recognizes in cases when chemical substances identified in this SNUR are added to the TSCA Inventory prior to the effective date of the rule, the chemical substances may be manufactured, imported, or processed by other persons for a significant new use as defined in this rule before the effective date of the rule. However, 26 of the 38 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per 40 CFR 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the following regulatory text are ongoing. EPA solicits comments on whether any of the uses described as significant new uses are ongoing.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.

EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.

IX. SNUN Submissions

EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 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 mailed to the Environmental Protection Agency, OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 (see 40 CFR 721.25 and 720.40). Forms and information are also available electronically at http://www.epa.gov/​opptintr/​newchems/​pubs/​pmnforms.htm.

X. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the public docket.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that proposed or final SNURs are not a “significant regulatory action” subject to review by OMB, because they do not meet the criteria in section 3(f) of the Executive order.

B. Paperwork Reduction Act

According to the Paperwork Reduction Act (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 the 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.

The information collection requirements related to this action have already been approved by OMB pursuant to the 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

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN, no economic impact will even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 10 notices per year. Of those SNUNs submitted, none appear to be from small entities in response to any SNUR. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.), are minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented it's general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act

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 rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

E. Executive Order 13132: Federalism

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: Consultation and Coordination with Indian Tribal Governments

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or 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 6, 2000), do not apply to this rule.

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

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: Actions that Significantly Affect Energy Supply, Distribution, or Use

This rule 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.

I. National Technology Transfer Advancement Act

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

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).

K. Executive Order 12630: Governmental Actions and Interference with Constitutionally Protected Property Rights (Takings)

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive order.

L. Executive Order 12988: Civil Justice Reform

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

XII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a final rule may take effect, the Agency promulgating it must submit a final rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this final 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 final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

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

Dated: September 6, 2007.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR part 721 is amended as follows:

PART 721—[AMENDED]

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

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

2. By adding new § 721.10057 to subpart E to read as follows:

§ 721.10057

Dodecanedioic acid, 1, 12-dihydrazide.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as dodecanedioic acid, 1, 12-dihydrazide (PMNs P-01-759 and P-05-555; CAS No. 4080-98-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6), (b), and (c). Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. The following NIOSH-approved respirators meet the minimum requirement for § 721.63(a)(4): Air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; powered air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters; supplied air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting full facepiece. Because the substance is a dermal sensitizer and irritates mucous membranes, half-face respirators do not provide adequate protection.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(vii), (g)(1)(ix), and (g)(2)(i).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (f), (g), and (h) are applicable to manufacturers, importers, and processors of this substance.

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

3. By adding new § 721.10058 to subpart E to read as follows:

§ 721.10058

Reaction product of alkylphenol, aromatic cyclicamine, alkyl diglycidyl dibenzene, and formaldehyde (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction product of alkylphenol, aromatic cyclicamine, alkyl diglycidyl dibenzene, and formaldehyde (PMN P-03-546) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

4. By adding new § 721.10059 to subpart E to read as follows:

§ 721.10059

Reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine, and alkyl diglycidyl dibenzene (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine, and alkyl diglycidyl dibenzene (PMN P-03-550) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

5. By adding new § 721.10060 to subpart E to read as follows:

§ 721.10060

Reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine, alkyl diglycidyl dibenzene, and polyalkylcyclicdiamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine, alkyl diglycidyl dibenzene, and polyalkylcyclicdiamine (PMN P-03-551) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

6. By adding new § 721.10061 to subpart E to read as follows:

§ 721.10061

Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)- (PMN P-04-341; CAS No. 132182-92-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

7. By adding new § 721.10062 to subpart E to read as follows:

§ 721.10062

2,5-Furandione, polymer with oxybis[propanol], benzoate.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2,5-furandione, polymer with oxybis[propanol], benzoate (PMN P-04-627; CAS No. 103458-14-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

8. By adding new § 721.10063 to subpart E to read as follows:

§ 721.10063

Halo substituted hydroxy nitrophenyl amide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halo substituted hydroxy nitrophenyl amide (PMN P-04-792) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

9. By adding new § 721.10064 to subpart E to read as follows:

§ 721.10064

2-Propenoic acid, 2-[2-(ethenyloxy)ethoxy]ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-[2-(ethenyloxy)ethoxy]ethyl ester (PMN P-04-909; CAS No. 86273-46-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3)(i), (b), and (c). North Butyl Black gloves and T-1 Dailove Ethylene Vinylalcohol Copolymer Laminated Blue gloves have been demonstrated to satisfy (a)(3)(i). Other demonstrated impervious gloves that satisfy (a)(3)(i) are also permissible.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

10. By adding new § 721.10065 to subpart E to read as follows:

§ 721.10065

1-Tetradecanesulfonic acid, (dimethylphenyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-tetradecanesulfonic acid, (dimethylphenyl)- (PMN P-04-961; CAS No. 671756-61-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

11. By adding new § 721.10066 to subpart E to read as follows:

§ 721.10066

1-Hexanesulfonic acid, (dimethylphenyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-hexanesulfonic acid, (dimethylphenyl)- (PMN P-04-962; CAS No. 676143-36-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

12. By adding new § 721.10067 to subpart E to read as follows:

§ 721.10067

Ether amine phosphonate salt (generic).

(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as ether amine phosphonate salt (PMNs P-05-57, P-05-58, P-05-59, P-05-61, P-05-62, P-05-63, P-05-64, and P-05-65) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

13. By adding new § 721.10069 to subpart E to read as follows:

§ 721.10069

Ether amine phosphonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ether amine phosphonate (PMN P-05-60) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

14. By adding new § 721.10070 to subpart E to read as follows:

§ 721.10070

1,3-Butanediol, 3-methyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-butanediol, 3-methyl- (PMN P-05-309; CAS No. 2568-33-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f) and (j)(use as inkjet ink).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

15. By adding new § 721.10071 to subpart E to read as follows:

§ 721.10071

9H-Thioxanthenium, 10-[1,1′-biphenyl]-4-yl-2-(1-methylethyl)-9-oxo-, hexafluorophosphate (1-) (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9H-thioxanthenium, 10-[1,1′-biphenyl]-4-yl-2-(1-methylethyl)-9-oxo-, hexafluorophosphate (1-) (1:1) (PMN P-05-364; CAS No. 591773-92-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f), (v)(2), (w)(2), and (x)(2).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

16. By adding new § 721.10072 to subpart E to read as follows:

§ 721.10072

Benzene, 1,1′-methylenebis[4-isocyanato-, polymer with benzenedicarboxylic acid, butyl dialkyl ester, poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-hydroxy-, oxirane, alkyl-, polymer with oxirane, ether with propanepolyol and Sartomer's HLBH P-3000 and Lexorez 1180 (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzene, 1,1′-methylenebis[4-isocyanato-, polymer with benzenedicarboxylic acid, butyl dialkyl ester, poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-hydroxy-, oxirane, alkyl-, polymer with oxirane, ether with propanepolyol and Sartomer's HLBH P-3000 and Lexorez 1180 (PMN P-05-380) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

17. By adding new § 721.10073 to subpart E to read as follows:

§ 721.10073

Modified alkyl acrylamide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified alkyl acrylamide (PMN P-05-536) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

18. By adding new § 721.10074 to subpart E to read as follows:

§ 721.10074

Acetic acid, 2-chloro-, 1-(3,3-dimethylcyclohexyl)ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as acetic acid, 2-chloro-, 1-(3,3-dimethylcyclohexyl)ethyl ester (PMN P-05-568; CAS No. 477218-59-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

19. By adding new § 721.10075 to subpart E to read as follows:

§ 721.10075

Carbon black, 4-[[2-(Sulfooxy) ethyl]substituted] phenyl- modified, sodium salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon black, 4-[[2-(Sulfooxy) ethyl]substituted] phenyl-modified, sodium salts (PMN P-05-722) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent), and (c).

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

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e) and (i) are applicable to manufacturers, importers, and processors of this substance.

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

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

20. By adding new § 721.10076 to subpart E to read as follows:

§ 721.10076

Substituted benzenediamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzenediamine (PMN P-05-792) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=2).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

21. By adding new § 721.10077 to subpart E to read as follows:

§ 721.10077

3H-1,2,4-Triazol-3-one, 1,2-dihydro-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 3H-1,2,4-triazol-3-one, 1,2-dihydro- (PMNs P-06-1 and P-06-166; CAS No. 930-33-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(5), (a)(6), (b), and (c). Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10. The following NIOSH-approved respirators with an assigned protection factor (APF) of 10-25 meet the minimum requirements for § 721.63(a)(4): Air-purifying, tight-fitting respirator equipped with N100 (if aerosols absent), R100, or P100 filters (either half- or full-face); powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters; powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters; and supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face).

(ii) Hazard communication program. Requirements as specified in § 721.72 (g)(1)(ix), (g)(2)(iv), (g)(3)(ii), and (g)(4)(iii).

(iii) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (f), (g), (h), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

22. By adding new § 721.10078 to subpart E to read as follows:

§ 721.10078

Butanamide, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxo-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)substituted]phenyl derivs., hydrochlorides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanamide, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxo-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)substituted]phenyl derivs., hydrochlorides (PMN P-06-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

23. By adding new § 721.10079 to subpart E to read as follows:

§ 721.10079

Quino[2,3-b]acridine-7, 14-dione, 5,12-dihydro-2,9-dimethyl-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)substituted]phenyl derivs., hydrochlorides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as quino[2,3-b]acridine-7, 14-dione, 5,12-dihydro-2,9-dimethyl-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)substituted]phenyl derivs., hydrochlorides (PMN P-06-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent), and (c).

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

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

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

24. By adding new § 721.10080 to subpart E to read as follows:

§ 721.10080

Carbon black, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl) substituted] phenyl-modified, hydrochlorides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon black, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl) substituted] phenyl-modified, hydrochlorides (PMN P-06-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent), and (c).

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

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

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

25. By adding new § 721.10081 to subpart E to read as follows:

§ 721.10081

Aromatic urethane acrylate oligomer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic urethane acrylate oligomer (PMN P-06-26) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

26. By adding new § 721.10082 to subpart E to read as follows:

§ 721.10082

Amine modified monomer acrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amine modified monomer acrylate (PMN P-06-29) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

27. By adding new § 721.10083 to subpart E to read as follows:

§ 721.10083

Copper, [29H, 31H-phthalocyaninato (2-)-κN 29, κN 30, κN 31, κN 32]-, 4-[(17-substituted-3,6,9,12,15- pentaazaheptadec-1-yl) substituted] phenyl derivs., hydrochlorides (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as copper, [29H, 31H-phthalocyaninato (2-)-κN 29, κN 30, κN 31, κN 32]-, 4-[(17-substituted-3,6,9,12,15- pentaazaheptadec-1-yl) substituted] phenyl derivs., hydrochlorides (PMN P-06-70) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent), and (c).

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

(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

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

28. By adding new § 721.10084 to subpart E to read as follows:

§ 721.10084

Modified thionocarbamate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified thionocarbamate (PMN P-06-124 is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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

29. By adding new § 721.10085 to subpart E to read as follows:

§ 721.10085

Substituted polyaryl sulfonium polyhalide phosphate salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted polyaryl sulfonium polyhalide phosphate salt (PMN P-06-232) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f) and (j) (photo initiator used in photo-curable compositions).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

30. By adding new § 721.10086 to subpart E to read as follows:

§ 721.10086

Ethane, 2-(difluoromethoxy)-1,1,1-trifluoro-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as ethane, 2-(difluoromethoxy)-1,1,1-trifluoro- (PMN P-06-295; CAS No. 1885-48-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b), and (c).

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

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e) and (i) are applicable to manufacturers, importers, and processors of this substance.

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

31. By adding new § 721.10087 to subpart E to read as follows:

§ 721.10087

Substituted alkyl phosphine oxide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted alkyl phosphine oxide (PMN P-06-332) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (100,000 kilograms/year).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

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

32. By adding new § 721.10088 to subpart E to read as follows:

§ 721.10088

Thiophene, 2,5-dibromo-3-hexyl-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as thiophene, 2,5-dibromo-3-hexyl- (PMN P-07-283; CAS No. 116971-11-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (500 kilograms).

(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

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