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 23 chemical substances which were the subject of premanufacture notices (PMNs). Four of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 23 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 August 24, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 24, 2009. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on July 8, 2009.
If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before July 24, 2009, 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.
Additionally, significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule June 24, 2009. See the discussion in Unit VII. for more specific details.
Further, for persons intending to import or export any of the chemical substances in this rule, they are subject to the TSCA section 13 import certification requirements and the export notification provisions of TSCA section 12(b) as of July 24, 2009. See the discussion in Unit I.A. and Unit II.C. for more specific details.
ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2008-0252, 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-2008-0252. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions : Direct your comments to docket ID number EPA-HQ-OPPT-2008-0252. 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 at http://www.regulations.gov . Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically 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 (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT:
For 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: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov .
For technical information contact : Tracey Klosterman, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2209; e-mail address: klosterman.tracey@epa.gov .
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. 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 § 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. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after July 24, 2009 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI . Do not submit this information to EPA through regulations.gov or 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. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register 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 § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same 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 for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
Chemical importers are subject to the TSCA section 13 (15 U.S.C. 1612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemical substances subject to a proposed or final SNUR must certify their compliance with the SNUR requirements. In addition, any 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) (15 U.S.C. 2612 (b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 23 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the above four factors listed in TSCA section 5(a)(2).
IV. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping requirements for 23 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• CAS number (if assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders).
• Toxicity concerns.
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).
• CFR citation assigned in the regulatory text section of this rule.
The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e. limits on manufacture and importation) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.
This rule includes 4 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.
Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.
This rule also includes SNURs on 19 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). 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 § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.
PMN Number P-05-1
Chemical name: Formaldehyde, polymer with dialkylphenylamine, dialkylphenol and trimethylhexanediamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a curing agent for epoxy coating systems. Based on test data on analogous phenols, aliphatic amines, and benzyl amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in 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 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, fresh water 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. All aquatic toxicity testing should be performed using the static method with nominal concentrations at a pH of 7. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10134.
PMN Number P-05-11
Chemical name: Phosphinic acid, P,P-diethyl-, zinc salt (2:1).
CAS number: 284685-45-6.
Basis for action: The PMN states that the substance will be used as a flame retardant for polyamide thermoplastic epoxy resins. Based on test data on the PMN substance and analogous zinc salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 12 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 12 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 12 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) with rainbow trout and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10135.
PMN Number P-05-177
Chemical name: 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with hexakis(alkoxyalkyl)melamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a base resin in UV/EB curable and peroxide curable formulations. Based on test data on analogous methacrylates and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 100 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in 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 Zahn-Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute toxicity test, freshwater and marine (OPPT 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. Fish and daphnia testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10136.
PMN Number P-05-329
Chemical name: Halogenated phenoxy aromatic (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a fungicide intermediate. EPA identified health and environmental concerns because the substance may be a persistent, bioaccumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on test data on analogous neutral organic substances, EPA predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant 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)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of a subset of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. EPA has determined that a ready biodegradability test (OPPTS 835.3110 test guideline); a fish bioconcentration factor test (OPPTS 850.1730 test guideline (public draft)); and a combined repeated dose study with the reproductive/developmental toxicity screening test (OPPTS 870.3650 or Organisation for Economic Co-operation and Development (OECD) 422 test guidelines) would help characterize the human health and environmental effects of the PMN substance. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10137.
PMN Number P-05-336
Chemical name: 3-Isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester.
CAS number: 163520-33-0.
Basis for action: The PMN states that the substance will be used as an herbicide safener in formulated pesticide products. Based on test data on the PMN substance submitted under TSCA section 8(e), the substance may cause liver, kidney, heart and spleen toxicity. Also, based on information submitted in the PMN Material Safety Data Sheet (MSDS), EPA has concerns for dermal sensitization. In addition, based on test data on the PMN substance and analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is not expected. Further, general population exposure is not expected as the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) with rainbow trout and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. Further, a certificate of analysis should be provided for the test substance. No human health testing is recommended at this time.
CFR citation: 40 CFR 721.10138.
PMN Number P-05-776
Chemical name: Ethanone, 1-(1-chlorocyclopropyl)-.
CAS number: 63141-09-3.
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 the PMN substance, EPA has concerns for acute toxicity, strong solvent (defatting) irritation, and dermal sensitization. Also, based on test data on analogous chloroalkanes, EPA has concerns for potential mutagenicity. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 500 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely due to the use of adequate personal protective equipment. Significant general population exposure is not expected to result from the identified environmental releases from the proposed manufacturing, processing, or use of the substance. Further, significant environmental exposure is unlikely as the substance is not released to surface waters resulting in stream concentrations that exceed 500 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 other than as an intermediate or any use of the substance resulting in surface water concentrations exceeding 500 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of 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)); a mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline) by the intraperitoneal route; and a repeated dose 28-day oral toxicity study in rodents (OPPTS 870.3050 test guideline) would help characterize the human health and environmental effects of the PMN substance. Fish and daphnia testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10139.
PMN Number P-06-33
Chemical name: Phosphoric acid, tin (2+) salt (2:3).
CAS number: 15578-32-2.
Basis for action: The PMN states that the substance will be used as a pigment in plastic compounds for laser marking and laser welding. Based on test data on the PMN substance and on analogous respirable, poorly soluble particulates, EPA has identified concerns that the PMN substance may cause lung overload, immunotoxicity, and reproductive toxicity. Also, based on test data on the PMN substance and analogous inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely due to the use of adequate personal protective equipment. Further, environmental exposure is unlikely, as the substance is not released to surface waters. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or any use of the substance resulting in release to surface waters may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (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)); an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public draft)); and a reproduction/developmental toxicity screening test (OPPTS 870.3550 test guideline) would help characterize the human health and environmental effects of the PMN substance. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10140.
PMN Number P-06-163
Chemical name: Oils, ginger, zingiber purpureum.
CAS number: 864662-46-4.
Basis for action: The PMN states that the substance will be used in fragrance compositions in cosmetic products, air fresheners, household cleaners, dishwashing detergents, and laundry detergents. Based on test data on analogous methyl eugenol, EPA identified concerns that the PMN substance may cause cancer. As described in the PMN, significant worker dermal exposure is unlikely due to the use of adequate dermal protection. Although there is potential for consumer exposure, significant dermal and inhalation exposures are not expected. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or use of the substance without the use of impervious gloves, where there is a potential for potential worker dermal exposure, 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 an in vitro mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline); a salmonella typhimurium reverse mutation assay (OPPTS.870.5265 test guideline); and a carcinogenicity test (OPPTS 870.4200 test guideline) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10141.
PMN Number P-06-199
Chemical name: Oxabicycloalkane carboxylic acid alkanediyl ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 any use 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 early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) with freshwater fish and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10142.
PMN Number P-06-733
Chemical name: Amines, bis (C11-14-branched and linear alkyl).
CAS number: 900169-60-0.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. EPA identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release of the PMN substance into the waters of the United States may cause serious health effects and significant 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)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. The neutralized substance should be used for all human health testing. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10143.
PMN Number P-06-805
Chemical name: Modified thiocarbamate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a mining chemical reagent. Based on test data on a structurally similar substance, EPA identified human health concerns for toxicity to liver, thymus, spleen, kidney, and red blood cells from exposure via drinking water and fish ingestion resulting from releases to surface and ground water. Further, based on test data on the PMN substance and analogous imides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 70 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be released to surface and ground waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in 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)(3)(ii), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a bacterial reverse mutation test (OPPTS 870.5100 test guideline); a mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline) by the intraperitoneal route; a repeated dose 28-day oral toxicity in rodents (OPPTS 870.3050 test guideline); an acute oral toxicity (OPPTS 870.1100 test guideline); 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 ready biodegradability test (OPPTS 835.3110 test guideline) or a sealed vessel carbon dioxide production test (OPPTS 835.3120 test guideline) would help characterize the human health and environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10144.
PMN Number P-06-816
Chemical name: Modified reaction products of alkyl alcohol, halogenated alkane, substituted epoxide, and amino compound (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: May 25, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a hydrophobic surface active agent for cellulosic substrates and similar materials. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment and human health, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against this exposure and risk, the consent order requires that the PMN substance be tested, before a certain production volume is reached, in various fate and physical/chemical tests to determine its fate and composition in various media and conditions in the environment. In addition, for the fluorinated portion of the polymer, the submitter has agreed to analyze, report, and limit specific fluorinated impurities of the PMN substance where the carbon chain meets or exceeds a specified length, if these values exceed those reported in the PMN. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: EPA has concerns for potential incineration or other decomposition products of the PMN substance. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist (P) in the environment, could bioaccumulate (B) or biomagnify, and could be toxic (T) to people, wild mammals, and birds, based on data on analog chemicals, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, including the presumed environmental degradation product. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species. Cancer may also be of concern. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife. There is also limited pharmacokinetic data and toxicological data in animals on other perfluoroalkyls, including the presumed degradation product and precursors. These data indicate a different and less toxic profile for the presumed degradation product and precursors. EPA expects that additional animal data will be developed under various consent orders that have the expected common degradation product or analog information.
Recommended testing: EPA has determined that the results of certain fate and physical/chemical property tests would help characterize possible effects of the substance. The PMN submitter has agreed not to exceed the production volume limit without performing these tests. The consent order contains one production volume limit. The PMN submitter has agreed not to exceed the production volume limit without performing the following studies: A modified semi-continuous activated sludge (SCAS) test for insoluble and volatile chemicals (OPPTS 835.5045 or OECD 302A test guidelines), with analysis for degradation products; a UV visible light absorption test (OPPTS 830.7050 or OECD 101 test guidelines); a direct photolysis rate in water by sunlight test (OPPTS 835.2210 test guideline), if wavelengths greater than 290 nanometers (nm) are absorbed in the previous test; an indirect photolysis screening test (OPPTS 835.5270 test guideline); a phototransformation of chemicals on soil surfaces test (Draft OECD guideline January 2002) using two soils; an anaerobic biodegradability of organic compounds in digested sludge test (OECD 311 test guideline); an aerobic and anaerobic transformation in aquatic sediment systems test (OECD 308 test guideline); and an aerobic sewage treatment simulation test (OECD 303A test guideline).
CFR citation: 40 CFR 721.10145.
PMN Number P-07-87
Chemical name: Partially fluorinated condensation polymer (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 10, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an open, non-dispersive carpet treatment. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment and human health, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against this exposure and risk, the consent order requires that the PMN substance be tested, before certain production volumes are reached, in various fate and physical/chemical tests to determine its fate and composition in various media and conditions in the environment. The order also limits the concentration of the PMN substance in products sold to non-industrial users or distributors to non-industrial users that could spray apply the substance (after further dilution). Also, the consent order forbids the sale of the PMN substance to consumers in a spray application formulation. In addition, for the fluorinated portion of the polymer, the submitter has agreed to analyze, report, and limit specific fluorinated impurities of the PMN substance where the carbon chain meets or exceeds a specified length. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: EPA has concerns for potential incineration or other decomposition products of the PMN substance. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist (P) in the environment, could bioaccumulate (B) or biomagnify, and could be toxic (T) to people, wild mammals, and birds, based on data on analog chemicals, including PFOA and other perfluorinated alkyls, including the presumed environmental degradant. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species. Cancer may also be of concern. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife. There is also limited pharmacokinetic data and toxicological data in animals on other perfluoroalkyls, including the presumed degradant and precursors. These data indicate a different and less toxic profile for the presumed degradant and precursors. EPA expects that additional animal data will be developed under various consent orders that have the expected common degradant or analog information. EPA also has concerns that the PMN substance, under some conditions of use—particularly non-industrial, commercial, or consumer use—could cause lung effects, based on limited data on some perfluorinated compounds and an acute inhalation study on a related polymer.
Recommended testing: EPA has determined that the results of certain fate and physical/chemical property tests would help characterize possible effects of the substance. The PMN submitter has agreed not to exceed the production volume limits without performing these tests. The consent order contains three production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing the following studies: A modified SCAS test for insoluble and volatile chemicals (OPPTS 835.5045 or OECD 302A test guidelines), with analysis for degradation products; a UV visible light absorption test (OPPTS 830.7050 or OECD 101 test guidelines); a direct photolysis rate in water by sunlight test (OPPTS 835.2210 test guideline), if wavelengths greater than 290 nm are absorbed in the previous test; an indirect photolysis screening test (OPPTS 835.5270 test guideline); a hydrolysis as a function of pH and temperature test (OPPTS 835.2130 test guideline); an aerobic and anaerobic transformation in soil test (OECD 307 test guideline); and an anaerobic biodegradability of organic compounds in digested sludge test (OECD 311 test guideline). The PMN submitter has also agreed not to exceed the second higher production volume limit without performing the following tests: A phototransformation of chemicals on soil surfaces test (Draft OECD guideline January 2002) using two soils; an aerobic sewage treatment simulation test (OECD 303A test guideline); and an aerobic and anaerobic transformation in aquatic sediment systems test (OECD 308 test guideline). Finally, the PMN submitter has also agreed not to exceed the highest production volume limit without performing an aerobic and anaerobic transformation in soil test (OECD 307 test guideline).
CFR citation: 40 CFR 721.10146.
PMN Number P-07-198
Chemical name: Acrylate derivative of alkoxysilylalkane ester and mixed metal oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a film coating additive. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substance. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substance. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, 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 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 721.10147.
PMN Number P-07-330
Chemical name: Acryloxy alkanoic alkane derivative with mixed metal oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a film coating additive. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substance. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substance. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, 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 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 721.10148.
PMN Numbers P-07-0522 and P-07-523
Chemical names: (P-07-522) Carbon black, (3-methylphenyl)-modified, substituted (generic) and (P-07-523) Carbon black, (4-methylphenyl)-modified, substituted (generic).
CAS numbers: Not available.
Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as colorant process intermediates. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substances. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substances. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 use of the substances without the use of impervious gloves where there is a potential for dermal exposure; use of the substances other than as described in the PMN; or manufacture, processing, or use of the substances in a powder form, may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) with a post-observation period of up to 3 months would help characterize the human health effects of the PMN substances. Evaluations should include markers of damage, oxidant stress, cell proliferation, the degree/intensity and duration of pulmonary inflammation, and a cytotoxic effects and histopathology of pulmonary tissues in addition to the standard requirements in the test guideline.
CFR citations: 40 CFR 721.10149 (P-07-522) and 40 CFR 721.10150 (P-07-523).
PMN Number P-07-642
Chemical name: Modified styrene, divinylbenzene polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a cleaning and polishing chemical for semiconductor manufacturing. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substance. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substance. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, 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 a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) with a post-observation period of up to 3 months would help characterize the human health effects of the PMN substance. Evaluations should include markers of damage, oxidant stress, cell proliferation, the degree/intensity and duration of pulmonary inflammation, and a cytotoxic effects and histopathology of pulmonary tissues, in addition to the standard requirements in the test guideline.
CFR citation: 40 CFR 721.10151.
PMN Number P-07-674
Chemical name: Oxirane, substituted silylmethyl-, hydrolysis products with alkanol zirconium(4+) salt and silica, acetates (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a protective coating. Based on test data on analogous respirable, poorly soluble particulates, EPA believes that the PMN substance may cause lung effects. Based on physical properties, EPA believes that the PMN substance may cause systemic effects via dermal exposure. As described in the PMN, significant worker exposure is unlikely due to use in an enclosed process with 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 without the use of impervious gloves where there is a potential for dermal exposure; use of the substance in non-enclosed processes during spray application; use other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, 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 a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) with the addition of a post-exposure observation period of up to 3 months, and a glove permeation test (American Society for Testing and Materials (ASTM) F739 and F1194-99 test guidelines) would help characterize the human health effects of the PMN substance. Evaluations for the inhalation study should include markers of damage, oxidant stress, cell proliferation, the degree/intensity and duration of pulmonary inflammation, and a cytotoxic effects and histopathology of pulmonary tissues, in addition to the standard requirements in the test guideline.
CFR citation: 40 CFR 721.10152.
PMN Number P-08-6
Chemical name: Modified methyl methacrylate, 2-hydroxyethyl methacrylate polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a resin for coatings. Based on test data on analogous respirable, poorly soluble particulates, EPA believes that the PMN substance might cause lung effects. Based on physical properties, EPA believes that the PMN substance may cause systemic effects via dermal exposure. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, 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 a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) with the addition of a post-exposure observation period of up to 3 months, and a glove permeation test (ASTM F739 and F1194-99 test guidelines) would help characterize the human health effects of the PMN substance. Evaluations for the inhalation study should include markers of damage, oxidant stress, cell proliferation, the degree/intensity and duration of pulmonary inflammation, and a cytotoxic effects and histopathology of pulmonary tissues, in addition to the standard requirements in the test guideline.
CFR citation: 40 CFR 721.10153.
PMN Number P-08-157
Chemical name: Quaternary ammonium compounds, dicoco alkyldimethyl, chlorides, reaction products with silica.
CAS number: 956147-76-5.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as raw material for the manufacture of release coatings. Based on test data on analogous respirable, poorly soluble particulates, EPA believes that the PMN substance may cause lung effects. Based on physical properties of the PMN substance, EPA believes that it may cause systemic effects via dermal exposure. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, 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 a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) with the addition of a post-exposure observation period of up to 3 months, and a glove permeation test (ASTM F739 and F1194-99 test guidelines) would help characterize the human health effects of the PMN substance. Evaluations for the inhalation toxicity study should include markers of damage, oxidant stress, cell proliferation, the degree/intensity and duration of pulmonary inflammation, and a cytotoxic effects and histopathology of pulmonary tissues, in addition to the standard requirements in the test guideline. For the glove permeation testing, gloves should be exposed to the expected conditions of exposure, including the likely combinations of chemical substances to which the gloves may be exposed to in the work area. Results should be recorded as a cumulative permeation rate as a function of time, and shall be documented in accordance with ASTM F739 using the format specified in ASTM F1194-99 “Guide for Documenting Results of Chemical Permeation Testing on Protective Clothing Materials” or its equivalent.
CFR citation: 40 CFR 721.10154.
PMN Number P-08-177
Chemical name: Multi-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 11, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a property modifier in electronic applications and as a property modifier in polymer composites. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA believes that the PMN substance might cause lung effects. To protect against this risk, the consent order requires use of a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator with N-100 cartridges. Based on physical properties of the PMN substance, EPA believes it may cause health effects via dermal exposure. To protect against this risk, the consent order requires that workers wear gloves and protective clothing impervious to the chemical substance. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: There is a concern for lung health effects based on data for poorly soluble particulates and for other CNTs, and for lung irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including bronchoalveolar lavage fluid (BALF) analysis (OPPTS 870.3465 or OECD 413 test guidelines) and certain material characterization data, would help characterize possible effects of the PMN substance. In the consent order, the PMN submitter has agreed not to exceed a specified production volume or production time limit (whichever comes first) without performing these tests.
CFR citation: 40 CFR 721.10155.
PMN Number P-08-328
Chemical name: Single-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: September 15, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a property modifier in electronic applications and as a property modifier in polymer composites. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA believes that the PMN substance might cause health effects. To protect against this risk, the consent order requires use of a NIOSH-approved full-face respirator with N-100 cartridges. Based on physical properties of the PMN substance, EPA believes it may cause health effects via dermal exposure. To protect against this risk, the consent order requires that workers wear gloves and protective clothing impervious to the chemical substance. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: There is a concern for health effects based on data for poorly soluble particulates and for other CNTs and for lung irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including bronchoalveolar lavage fluid (BALF) analysis (OPPTS 870.3465 or OECD 413 test guidelines) and certain material characterization data, would help characterize possible effects of the PMN substance. In the consent order, the PMN submitter has agreed not to exceed a specified production volume or production time limit (whichever comes first) without performing these tests.
CFR citation: 40 CFR 721.10156.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 4 of the 23 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160.
In the other 19 cases, where 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 § 721.170 were met, as discussed in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:
• EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.
• 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.
• 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. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/newchems/pubs/invntory.htm .
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), this rule is effective August 24, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 24, 2009.
If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before July 24, 2009, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.
This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. EPA solicits comments on whether any of the uses described as significant new uses are ongoing.
VII. Applicability of Rule to Uses Occurring Before Effective Date of the Rule
To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 4 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders 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 concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 16 of the 23 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 § 720.25 and § 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.
As discussed in the Federal Register of April 24, 1990, EPA has decided that the intent of TSCA section 5(a)(1)(B) 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 effective, and then argue that the use was ongoing before the effective date of the 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 (see Unit III.).
EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN, except where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)). Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Many test guidelines are now available on the Internet at http://www.epa.gov/opptsfrs/home/guidelin.htm . The OECD test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org . The ASTM test guidelines are available at http://www.astm.org/Standard/index.shtml .
In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture/import or processing.
The recommended tests may not be the only means of addressing the potential risks of the chemical substance. 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 PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Potential benefits of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This rule cross-references § 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 SNUR that includes specific significant new uses that are CBI.
Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.
If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.
X. SNUN Submissions
As stated in Unit II.C., according to § 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 § 721.25 and § 720.40). Forms and information are also available electronically at http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm .
XI. 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.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This final rule establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
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 these SNURs will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. The requirement to submit a SNUN 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.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use 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 5 notices per year. Of those SNUNs submitted from 2006-2008, only one appears to be from a small entity. In addition, the estimated reporting cost for submission of a SNUN (see Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with these SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its 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 rule. As such, EPA has determined that this rule 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
This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This 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 9, 2000), do not apply to this rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
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
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
XIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This 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: June 11, 2009.
Barbara A. Cunningham,
Acting 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 § 721.10134 to subpart E to read as follows:
§ 721.10134
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as formaldehyde, polymer with dialkylphenylamine, dialkylphenol and trimethylhexanediamine (PMN P-05-1) 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) 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.
3. By adding new § 721.10135 to subpart E to read as follows:
§ 721.10135
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as phosphinic acid, P,P-diethyl-, zinc salt (2:1) (PMN P-05-11; CAS No. 284685-45-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water . Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=12).
(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 § 721.10136 to subpart E to read as follows:
§ 721.10136
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as 2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with hexakis(alkoxyalkyl)melamine (PMN P-05-177) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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 § 721.10137 to subpart E to read as follows:
§ 721.10137
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as halogenated phenoxy aromatic (PMN P-05-329) 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 § 721.10138 to subpart E to read as follows:
§ 721.10138
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as 3-isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester (PMN P-05-336; CAS No. 163520-33-0) 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) 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 § 721.10139 to subpart E to read as follows:
§ 721.10139
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as ethanone, 1-(1-chlorocyclopropyl)- (PMN P-05-776; CAS No. 63141-09-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80(g).
(ii) Release to water . Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=500).
(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.
8. By adding new § 721.10140 to subpart E to read as follows:
§ 721.10140
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as phosphoric acid, tin (2+) salt (2:3) (PMN P-06-33, CAS No. 15578-32-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80(f).
(ii) Release to water . Requirements as specified in § 721.90 (b)(1) and (c)(1).
(b) Specific requirements . The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, 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 § 721.10141 to subpart E to read as follows:
§ 721.10141
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as oils, ginger, zingiber purpureum (PMN P-06-163; CAS No. 864662-46-4) 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) 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(f).
(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.
10. By adding new § 721.10142 to subpart E to read as follows:
§ 721.10142
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as oxabicycloalkane carboxylic acid alkanediyl ester (PMN P-06-199) 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 § 721.10143 to subpart E to read as follows:
§ 721.10143
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as amines, bis (C11-14-branched and linear alkyl) (PMN P-06-733; CAS No. 900169-60-0) 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) 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 § 721.10144 to subpart E to read as follows:
§ 721.10144
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as modified thiocarbamate (PMN P-06-805) 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.
13. By adding new § 721.10145 to subpart E to read as follows:
§ 721.10145
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as modified reaction products of alkyl alcohol, halogenated alkane, substituted epoxide, and amino compound (PMN P-06-816) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities) and (q).
(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.
14. By adding new § 721.10146 to subpart E to read as follows:
§ 721.10146
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as partially fluorinated condensation polymer (PMN P-07-87) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), (l) (maximum percentage of the PMN substance in a non-industrial product or distributed for use as a non-industrial product), (o) (use in a consumer product that could be spray applied), and (q).
(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.
15. By adding new § 721.10147 to subpart E to read as follows:
§ 721.10147
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as acrylate derivative of alkoxysilylalkane ester and mixed metal oxides (PMN P-07-198) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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.
16. By adding new § 721.10148 to subpart E to read as follows:
§ 721.10148
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as acryloxy alkanoic alkane derivative with mixed metal oxides (PMN P-07-330) 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.
17. By adding new § 721.10149 to subpart E to read as follows:
§ 721.10149
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as carbon black, (3-methylphenyl)-modified, substituted (PMN P-07-522) 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 these substances.
(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 § 721.10150 to subpart E to read as follows:
§ 721.10150
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as carbon black, (4-methylphenyl)-modified, substituted (PMN P-07-523) 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 these substances.
(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.
19. By adding new § 721.10151 to subpart E to read as follows:
§ 721.10151
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as modified styrene, divinylbenzene polymer (PMN P-07-642) 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 these substances.
(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 § 721.10152 to subpart E to read as follows:
§ 721.10152
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as oxirane, substituted silylmethyl-, hydrolysis products with alkanol zirconium(4+) salt and silica, acetates (PMN P-07-674) 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 (a), (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 these substances.
(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.
21. By adding new § 721.10153 to subpart E to read as follows:
§ 721.10153
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as modified methyl methacrylate, 2-hydroxyethyl methacrylate polymer (PMN P-08-6) 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)(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 these substances.
(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.
22. By adding new § 721.10154 to subpart E to read as follows:
§ 721.10154
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified as quaternary ammonium compounds, dicoco alkyldimethyl, chlorides, reaction products with silica (PMN P-08-157; CAS No. 956147-76-5) 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) 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 these substances.
(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.
23. By adding new § 721.10155 to subpart E to read as follows:
§ 721.10155
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as multi-walled carbon nanotubes (PMN P-08-177) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace . Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National Institute for Occupational Safety and Health (NIOSH)-approved air-purifying, tight-fitting full-face respirator equipped with N100 filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80 (j) and (q).
(b) Specific requirements . The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (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.
24. By adding new § 721.10156 to subpart E to read as follows:
§ 721.10156
(a) Chemical substance and significant new uses subject to reporting . (1) The chemical substance identified generically as single-walled carbon nanotubes (PMN P-08-328) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace . Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National Institute for Occupational Safety and Health (NIOSH)-approved air-purifying, tight-fitting full-face respirator equipped with N100 filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities . Requirements as specified in § 721.80 (j) and (q).
(b) Specific requirements . The provisions of subpart A of this part apply to this section except as modified by this paragraph.
(1) Recordkeeping . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (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.
[FR Doc. E9-14780 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S