Source: https://www.federalregister.gov/documents/2000/12/26/00-32766/significant-new-uses-of-certain-chemical-substances
Timestamp: 2018-02-22 15:55:11
Document Index: 43621181

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The effective date of this rule is February 26, 2001 without further notice, unless EPA receives adverse comment or notice of intent to submit adverse comment before January 25, 2001. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on January 9, 2001.
81386-81404 (19 pages)
OPPTS-50638
FRL-6592-8
https://www.federalregister.gov/d/00-32766 https://www.federalregister.gov/d/00-32766
EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 40 chemical substances which were the subject of premanufacture notices (PMNs) and subject to TSCA section 5(e) consent orders issued by EPA. Today's action requires persons who intend to manufacture, import, or process these substances for a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing of the substance for a use designated by this rule as a significant new use. The required notice will provide EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risk of injury to human health or the environment. EPA is promulgating this SNUR using direct final procedures.
If EPA receives adverse comment or notice before January 25, 2001 that someone wishes to submit adverse or critical comments on EPA's action in establishing a significant new use rule (SNUR) for one or more of the chemical substances subject to this rule, EPA will withdraw the SNUR before the effective date for the substance for which the comment or notice of intent to comment is received and will issue a proposed SNUR providing a 30-day period for public comment.
Comments or notice of intent to submit adverse or critical comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50638 in the subject line on the first page of your response.
For technical information contact: James Alwood , Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-1857; e-mail address: alwood.jim@epa.gov.
1. Electronically. You may obtain copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. You may also obtain copies of the notice of availability documents for the 850 (62 FR 16486, April 15, l996) (FRL-5363-1) and 870 (63 FR 41845, August 5, l998) (FRL-5740-1) series OPPTS harmonized test guidelines at this same site. To access these documents, on the Home Page, select “Laws and Regulations,” “Regulations and Proposed Rules,” and Start Printed Page 81387then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​. The OPPTS harmonized test guidelines referenced in this document are available on EPA's Internet Home Page at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm.
2. In person. The Agency has established an official record for this action under docket control number OPPTS-50638. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50638 in the subject line on the first page of your response.
3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50638. Electronic comments may also be filed online at many Federal Depository Libraries.
6. Offer alternative ways to improve the rule.
This SNUR will require persons to notify EPA at least 90 days before commencing manufacturing, importing, or processing a substance for any activity designated by this SNUR as a significant new use. The supporting rationale and background to this rule are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for the rules and on the basis for significant new use designations including provisions for developing test data.
General provisions for SNURs appear under subpart A of 40 CFR part 721. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section Start Printed Page 813885 (h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUR notice, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUR notice. 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.
EPA is establishing significant new use and recordkeeping requirements for the following chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides a brief description for each substance, including its 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 action taken by EPA in the TSCA section 5(e) consent order or as a non-section 5(e) SNUR for the substance (including the statutory citation and specific finding), toxicity concern, and the CFR citation assigned in the regulatory text section of this rule. The specific uses which are designated as significant new uses are cited in the regulatory text section of this document by reference to 40 CFR part 721, subpart E where the significant new uses are described in detail. Certain new uses, including production limits and other uses designated in the rule are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VII.
Where the underlying TSCA section 5(e) consent order prohibits the PMN submitter from exceeding a specified production limit without performing specific tests to determine the health or environmental effects of a substance, the tests are described in this unit. As explained further in Unit VI., the SNUR for such substances contains the same production limit, and exceeding the production limit is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a significant new use notice (SNUN) at least 90 days in advance. In addition, this unit describes tests that are recommended by EPA to provide sufficient information to evaluate the substance, but for which no production limit has been established in the TSCA section 5(e) consent order. Descriptions of recommended tests are provided for informational purposes.
Data on potential exposures or releases of the substances, testing other than that specified in the TSCA section 5(e) consent order for the substances, or studies on analogous substances, which may demonstrate that the significant new uses being reported do not present an unreasonable risk, may be included with significant new use notification. Persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs, as stated in 40 CFR 721.1(c), including submission of test data on health and environmental effects as described in 40 CFR 720.50.
EPA is not publishing SNURs for PMNs P-98-487, P-98-496, P-98-1033/1034/1035, P-99-31/32/33/34, P-99-531, P-99-519/522/593/594, P-99-544/545/546/547/548/583/584/585/ 586/587/588, P-99-703, and P-99-1131/1132/1133/1134/1135/1138, which are subject to a final TSCA section 5(e) consent order. The TSCA section 5(e) consent orders for these substances are derived from an exposure finding based solely on substantial production volume and significant or substantial human exposure and/or release to the environment of substantial quantities. For these cases there were limited or no toxicity data available for the PMN substances. In such cases, EPA regulates the new chemical substances under TSCA section 5(e) by requiring certain toxicity tests. For instance, chemical substances with potentially substantial releases to surface waters would be subject to toxicity testing of aquatic organisms and chemicals with potentially substantial human exposures would be subject to health effects testing for mutagenicity, acute effects, and subchronic effects. However, for these substances, the short-term toxicity testing required by the TSCA section 5(e) consent order is usually completed within 1 to 2 years of notice of commencement (NOC). EPA's experience with exposure-based SNURs requiring short-term testing is that the SNUR is often revoked within 1 to 2 years when the test results are received. Rather than issue and revoke SNURs in such a short span of time, EPA will defer publication of exposure-based SNURs until either a NOC or data demonstrating risk are received unless the toxicity testing required is long-term. EPA is issuing this explanation and notification as required in 40 CFR 721.160(a)(2) as it has determined that SNURs are not needed at this time for these substances which are subject to a final section 5(e) consent order under TSCA.
PMN Number P-97-0766
Chemical name: (generic) Tetrahydrohetero polycycle.
Effective date of section 5(e) consent order: January 29, 1999.
Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health.
Toxicity concern: Based on data on structural analogues, the substance may cause mutagenicity and carcinogenicity to workers who are exposed by either inhalation or dermal route.
Recommended testing: EPA has determined that a Mitogenicity Assay for rats via gavage based on the consent order guidelines and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the production volume limit without performing the Mitogenicity Assay.
CFR citation: 40 CFR 721.6479.
PMN Number P-97-0916
Chemical name: (generic) 4,4'-(1-methylethylidene)bisphenol, polymer with (chloromethyl)oxirane and a diamine.
CAS number: Not available. Effective date of section 5(e) consent order: March 30, 1999.
Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment.
Toxicity concern: Based on test data submitted on the PMN substance, the concentration of concern for the PMN substance is 2 parts per billion (ppb) for daphnids and 8 ppb for fish.
Recommended testing: EPA has determined that the following testing would help characterize the environmental effects of the PMN substance:
Tier I: A daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1330 test guideline (public draft)). If test chemical shows no effects at saturation, Start Printed Page 81389then no further testing is required. If the test chemical shows chronic toxicity toward daphnids, then proceed to next tier.
Tier II: A chronic fish early life stage toxicity test in rainbow trout (40 CFR CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)).
CFR citation: 40 CFR 721.5585.
PMN Number P-98-0002
Chemical name: (generic) Mixed metal oxides.
Effective date of section 5(e) consent order: April 29, l999.
Basis for action: The order was issued under section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health.
Toxicity concern: Based on test data on structural analogues, the PMN substance may pose a risk of lung toxicity or fibrosis, developmental toxicity, or carcinogenicity through inhalation or ingestion of the PMN substance.
Recommended testing: EPA has determined that a 90-day subchronic inhalation study in rats (40 CFR 798.2450 or OPPTS 870.3465 test guideline) and a 2-year, two-species oral carcinogenicity test (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health concerns. The consent order contains a production volume limit. The PMN submitter has agreed not to exceed the production volume limit without performing the 90-day oral subchronic toxicity test.
CFR citation: 40 CFR 721.4610.
PMN Number P-98-0903
Chemical name: (generic) Polyalkylene glycol polyamide ester phosphate.
Basis for action: The PMN substance will be used as a coating additive. Based on structural analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 60 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)); a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6180.
PMN Number P-98-1016
Chemical name: (generic) Polymer of polyalkylenepolyol and trisubstituted phenol.
Basis for action: The PMN substance will be used as an emulsifying component for adhesive resin. Based on structural analogy to alkyl ethoxylated nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 10 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters above 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.6515.
PMN Numbers P-98-1274 and P-98-1275
Chemical names: (generic) (P-98-1274) Silicoaluminophosphates compd. with organic amine; (P-98-1275) Aluminosilicates, phospho-.
CAS numbers: Not available for (P-98-1274); for (P-98-1275) it is 201167-69-3.
Effective date of section 5(e) consent order: May 4, 1999.
Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that these substances may present an unreasonable risk of injury to human health.
Toxicity concern: Structurally similar chemicals have been shown to cause lung effects and cancer in humans and test animals.
Recommended testing: EPA has determined that a 90-day subchronic inhalation toxicity study in rats (40 CFR 798.2450 or OPPTS 870.3465 test guideline) with special attention to lung tissues and histopathology of the lung tissues and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects of the substances. The PMN submitter has agreed not to exceed the production volume limit without performing the 90 day inhalation toxicity test on P-98-1275.
CFR citations: 40 CFR 721.632 (P-98-1274) and 40 CFR 721.633 (P-98-1275).
PMN Number P-99-0026
Chemical name: Cerium, hydroxy oleate propionate complexes.
Basis for action: The PMN substance will be used as a fuel oil/diesel additive. Based on structural analogy to lanthanides or rare earth metals, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 7 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the substance is not released to surface waters above 7 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters above 7 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.8657.
PMN Number P-99-0052
Chemical name: (generic) Hydrofluoric acid, reaction products with octane.
Basis for action: The PMN substance will be used as a chemical intermediate. Based on structural analogy to neutral Start Printed Page 81390organics, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 400 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.4461.
PMN Number P-99-0093
Chemical name: 1,4-Dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione, 8,8- dioctyl-.
CAS number: 56875-68-4.
Basis for action: The PMN substance will be used as an additive for plastic. EPA has identified health concerns for neurotoxicity and immunotoxicity based on organotin compounds. Since significant worker exposure is unlikely when used, as described in the PMN, EPA has not determined that proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance could result in exposures that may cause serious health effects. Also, based on organotin data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 6 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance. EPA has determined that a 90-day oral subchronic study in rodents (40 CFR 798.2650 or OPPTS 870.3100 test guideline) would help to characterize the human health effects.
CFR citation: 40 CFR 721.9535.
PMN Number P-99-0114
Chemical name: Chromate (5-), bis[4-hydroxy-7-[(2-hydroxy-1- naphthalenyl)azo]-3-[(2-hydroxy-3-nitro-5-sulfophenyl)azo]-2- naphthalenesulfonato(4-)]-, pentasodium.
CAS number: 159574-72-8.
Basis for action: The PMN substance will be used as an acid dye for dyeing leather. EPA has identified health concerns for skin sensitization and blood toxicity based on submitted test data; and concerns for developmental toxicity, reproductive toxicity and carcinogenicity based on data for structurally similar substances. Since significant worker exposure is unlikely because it would not be manufactured, processed, or used as a powder, EPA has not determined that manufacturing, processing, or use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that manufacturing, processing, or use of the substance as a powder may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(B), (b)(3)(i), and (b)(3)(ii) .
Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two-species (40 CFR 799.9370) and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300) or 870.4200 test guideline)) would help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.5284.
PMN Number P-99-0115
Chemical name: (generic) Aminoester of polyalkenylated alkyldicarboxylic acid.
Basis for action: The PMN substance will be used as an emulsifier. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.480.
PMN Numbers P-99-0143/0144/0145/0146
Chemical names: (generic) (P-99-0143) Dimer acid/rosin amidoamine reaction product; (generic) (P-99-0144) Dimer acid/polymerized rosin amidoamine reaction product; (generic) (P-99-0145) Rosin amidoamine, and (generic) (P-99-0146) Polymerized rosin amidoamine.
Basis for action: The PMN substances will be used as described in the PMN. Based on structural analogy to aliphatic amines, EPA is concerned that effects to the aquatic environment may occur at a concentration as low as 40 ppb of the PMN substances in surface waters. Since significant environmental exposure is unlikely, as the substances are not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public Start Printed Page 81391draft)) would help to characterize the environmental effects of the PMN substances.
CFR citations: 40 CFR 721.9484 (P-99-0143), 40 CFR 721.9485 (P-99-0144), 40 CFR 721.9486 (P-99-0145), and 40 CFR 721.9487 (P-99-0146).
PMN Number P-99-0157
Chemical name: (generic) Ethyl silicate, reaction products with modified alkoxysilane salt.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to aliphatic amines and inorganic phosphoric acid, EPA is concerned that toxicity to aquatic organisms may occur at a concentration of 30 ppb in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.9514.
PMN Number P-99-0198
Chemical name: (generic) Tetraaryltin.
Basis for action: The PMN substance will be used as a coating system intermediate. EPA has identified health concerns for reproductive toxicity in males, immunotoxicity, and allergic reaction based on analogy to organotin compounds; and concern for mutagenicity based on data for triphenyltin hydroxide. Since significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing and use of the substance may present an unreasonable health risk. EPA has determined, however, that other uses of the substance other than as an intermediate may result in serious health effects. Also, based on data on organotins, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since environmental releases are not expected above 1 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that any release of the PMN substance to surface waters above 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a prenatal development toxicity study by the oral route in two-species (40 CFR 799.9370) would help to characterize the human health effects of the PMN substance. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects: A fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public)).
CFR citation: 40 CFR 721.9670.
PMN Number P-99-0199
Chemical name: (generic) Triaryltin.
Basis for action: The PMN substance will be used as a coating system intermediate. EPA has identified health concerns for reproductive toxicity in males, carcinogenicity, immunotoxicity, and allergic reaction based on analogy to organotin compounds; and concern for mutagenicity based on data for triphenyltin hydroxide. Since significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable health risk. EPA has determined, however, that other uses of the substance other than as an intermediate may result in serious health effects. Also, based on data on organotins, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since environmental releases are not expected above 1 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that any release of the PMN substance to surface waters above 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a prenatal development toxicity study by the oral route in two-species (40 CFR 799.9370) would help to characterize the human health effects of the PMN substance. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects: A fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)).
CFR citation: 40 CFR 721.9671.
PMN Numbers P-99-0207 and P-99-0208
Chemical names: (P-99-0207) L-Glutamic acid, N-(1-oxododecyl)-, disodium salt; and (P-99-0208) L-Glutamic acid, N-(1-oxododecyl)-.
CAS numbers: 50622-20-3 and 3397-65-7.
Basis for action: The PMN substances will be used as isolated intermediates. Based on structural analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 200 ppb of the PMN substances in surface waters as a soluble salt at pH7. Since significant environmental exposure is unlikely, as the substances are not released to surface waters in significant amounts, as described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substances. The sodium salt at pH7 should be tested for P-99-0208. Start Printed Page 81392
CFR citations: 40 CFR 721.3820 (P-99-0207) and 40 CFR 721.3821 (P-99-0208).
PMN Number P-99-0313
Chemical name: (generic) Substituted ethoxylated hydrocarbon.
Basis for action: The PMN substance will be used as an intermediate. Based on structural analogy to ethoxylated nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters above 100 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.4365.
PMN Number P-99-0365
Chemical name: (generic) Substituted acetate.
CAS number: Not available. donna
Basis for action: The PMN substance will be used as a chemical intermediate. EPA has identified health concerns for developmental toxicity, reproductive toxicity, and immunotoxicity based on data from the carboxylic acid based ester hydrolysis product, and concern for neurotoxicity based on solvent properties. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which 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 28-day oral toxicity study in rats (Organization for Economic Cooperation and Development (OECD) guideline no. 407) that includes a neurotoxicity functional observational battery (National Technical Information Service (NTIS) (NTIS: PB 91-154617)) for all test doses with the highest dose set at 1,000 milligram/kilogram (mg/kg), and for the highest test dose group only, histopathologic examination shall be extended to include testes/ovaries and lungs, and an oral developmental toxicity study in two-species (40 CFR 798.4900 or OPPTS 870.3700 test guideline) would help to characterize the health effects of the substance.
CFR citation: 40 CFR 721.303.
PMN Numbers P-99-0368 and P-99-0369
Chemical name: (generic) Dimethyl alkylamine salt.
Basis for action: The PMN substances will be used as water clarifiers. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb in surface waters for P-99-0368 and 6 ppb in surface waters for P-99-0369. Since significant environmental exposure is unlikely, as the substances are not released to surface waters in significant amounts, when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that use of the substances other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a freshwater fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an freshwater algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.333.
PMN Number P-99-0385
Chemical name: (generic) Fatty alkyl phosphate, alkali metal salt.
Basis for action: The PMN substance will be used as a lubricant. Based on structural analogy to phosphate-based anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 8 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.5985.
PMN Number P-99-0423
Chemical name: (generic) Polyalkylene oxide dialkylamine.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 100 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.2265.
PMN Number P-99-0435 Start Printed Page 81393
Chemical name: (generic) Polyether modified fatty acids.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 4 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substances other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.3710.
PMN Number P-99-0467
Chemical name: (generic) Acrylated (long-chainalkyl) glycidyl ether.
Basis for action: The PMN substance will be used as an intermediate. Based on structural analogy to acrylates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance in surface waters. Since environmental exposure is unlikely, as the substance is not released to surface water above 2 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases 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).
CFR citation: 40 CFR 721.3850.
PMN Number P-99-0472
Chemical name: (generic) Polyalkenylalkylphenol.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.545.
PMN Number P-99-0479
Chemical name: (generic) Polysubstituted bis phenylazonapthalene disulfonic acid.
Basis for action: The PMN substance will be used in leather dyeing as described in the PMN. Based on structural analogy to aminoaniline anionic dyes, EPA has identified health concerns for carcinogenicity, developmental toxicity, kidney toxicity, liver toxicity and neurotoxicity based on the potential azo reduction products. Since significant worker exposure is unlikely, when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacturing could result in exposures which may cause serious chronic and developmental 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 oral subchronic in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) with neurotoxicity adjuncts (NTIS PB 91-154517), a prenatal development toxicity study by the oral route in two-species (40 CFR 799.9370), and a 2-year, two-species oral carcinogenicity study (40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.5914.
PMN Number P-99-0531
Chemical name: (generic) Formaldehyde, reaction products with an alkylated phenol and an aliphatic amine.
Basis for action: The PMN substance will be used as a detergent additive for gasoline and diesel fuel. Based on structural analogy to aliphatic amines and phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substances other than as described in the PMN 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 a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance. The PMN substance should be tested as 100 percent active ingredients.
CFR citation: 40 CFR 721.3830.
PMN Number P-99-0557
Chemical name: Benzenamine,4,4'-methylenebis[N-ethyl-N-methyl-.
CAS number: 76176-94-8.
Basis for action: The PMN substance will be used as an intermediate. EPA has identified health concerns for mutagenicity, developmental toxicity, and sensitization based on analogy to Start Printed Page 81394methylenedianiline (MDA). EPA also has concerns for carcinogenicity and male reproductive toxicity based on analogy to N,N,N',N'-tetramethyl methylenedianiline (tetramethyl MDA). Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN could result in exposures which 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 28-day oral toxicity study in rats (OECD guideline no. 407) where histopathologic examination shall be extended to include testes/ovaries and lungs, and an oral developmental toxicity study by oral route in two-species (40 CFR 798.4900 or OPPTS 870.3700 test guideline) would help to characterize the health effects of the substance.
CFR citation: 40 CFR 721.1085.
PMN Number P-99-0558
Chemical name: (generic) Formaldehyde, polymers with substituted phenols.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to polynonionic polymers and phenols, EPA has concern for toxicity to aquatic organisms, which may occur at a concentration as low as 5 ppb of the PMN substance with a number average-molecular weight below 600. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters of lower molecular weight species may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.3810.
PMN Number P-99-0610
Chemical name: (generic) Modified hydroxystyrene homopolymer.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to polynonionic polymers and phenols, EPA has concern for toxicity to aquatic organisms, which may occur at a concentration as low as 5 ppb of the PMN substance with a number average-molecular weight below 600. Since significant exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters of lower molecular weight species may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.4565.
PMN Number P-99-0618
Chemical name: (generic) Hydrochloride salt of a fatty polyalkylene polyamine.
Basis for action: The PMN substance will be used as a processing aid. Based on structural analogy to aliphatic amines, EPA is concerned that effects to the aquatic environment may occur at a concentration as low as 50 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases 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).
CFR citation: 40 CFR 721.6196.
PMN Number P-99-0645
Chemical name: (generic) Amidoamine modified polyethylene glycol.
Basis for action: The PMN substance will be used as a surfactant. Based on structural analogy to aliphatic amines, EPA is concerned that effects to the aquatic environment may occur at a concentration as low as 20 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases 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 a fish chronic toxicity study (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6493.
PMN Number P-99-0654
Chemical name: (generic) Thiosubstituted carbonate ester.
Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to thiocarbamates esters, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental Start Printed Page 81395exposure is unlikely, as the substance is not released to surface waters, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases 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).
CFR citation: 40 CFR 721.2121.
PMN Number P-99-0723
Chemical name: (generic) Phenoxazin-5-ium, 3-dialkylamino-7-arylamino-, salt.
Basis for action: The PMN substance will be used as a basic dye for cationic dyeable polyester fibers. Based on structural analogy to cationic dyes with delocalized cationic charge, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters in significant amounts, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the substance may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.5912.
PMN Number P-99-0754
Chemical name: 9-Phosphabicyclo[3.3.1]nonane, 9,9'-(1,2-ethanediyl)bis- (9C1).
CAS number: 153280-11-6.
Basis for action: The PMN substance will be used as a catalyst. EPA has identified health concerns for neurotoxicity and internal organ effects based on analogy to structurally similar compounds. Since significant worker exposure is unlikely when the substance is used as a liquid. EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable health risk. EPA has determined, however, that manufacture, process, or use of the substance as a solid may result in serious health effects. Also, based on analogy to cationic dyes with delocalized charge, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely as the substance is not released to surface waters as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that other uses of the substance resulting in releases 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) and (b)(4)(ii).
Recommended testing: EPA has determined that a 28-day oral toxicity study in rats (OECD guideline no. 407) that includes a neurotoxicity functional observational battery (NTIS: PB 91-154617) for all test doses with the highest dose set at 1,000 mg/kg, and for the highest test dose group only, histopathologic examination shall be extended to include testes/ovaries and lungs, would help to characterize the human health effects of the PMN substance. In addition, the following chronic aquatic toxicity tests would help to characterize the environmental effects: A fish chronic toxicity study (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft)), and an algal toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft)).
CFR citation: 40 CFR 721.5378.
During review of the PMNs submitted for the chemical substances that are subject to this SNUR, EPA concluded that for 5 of the 40 substances, regulation was warranted under section 5(e) of TSCA, pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the substances. The basis for such findings is outlined in Unit III. 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 substances designated herein are consistent with the provisions of the TSCA section 5(e) consent orders.
In the other 35 cases for which the proposed uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at 40 CFR 721.170 were met.
4. All manufacturers, importers, and processors of the same chemical substance which 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 substance is listed on the TSCA Inventory. Manufacturers, importers, and processors are responsible for ensuring that a new chemical substance subject to a final SNUR is listed on the TSCA Inventory.
EPA is issuing these SNURs as a direct final rule, as described in 40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR 721.160(c)(3)(ii), this rule will be effective February 26, 2001, unless EPA receives a written notice by January 25, 2001 that someone wishes to make adverse or critical comments on EPA's action. If EPA receives such a notice, EPA will publish a document to Start Printed Page 81396withdraw the direct final SNUR for the specific substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific substance providing a 30-day comment period.
This action establishes SNURs for a number of chemical substances. Any person who submits a notice of intent to submit adverse or critical comments must identify the substance and the new use to which it applies. EPA will not withdraw a SNUR for a substance not identified in a notice.
However, EPA has established production limits in the TSCA section 5(e) consent orders for several of the substances regulated under this rule, 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 substances. These production 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 substances. Under recent consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier 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 III. The SNURs contain the same production volume limits as the consent orders. Exceeding these production limits is defined as a significant new use.
EPA is establishing through this rule some significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2. EPA is required to keep this information confidential to protect the CBI of the original PMN submitter. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This procedure appears in 40 CFR 721.1725(b)(1) and is similar to that in § 721.11 for situations where the chemical identity of the substance subject to a SNUR is CBI. This procedure is cross-referenced in each of these SNURs.
To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have recently undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 5 substances and notice 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 an NOC and the substance has not been added to the Inventory, no other person may commence such activities without first submitting a PMN. For substances for which an NOC has not been submitted at this time, EPA has concluded that the uses are not ongoing. However, EPA recognizes in cases when chemical substances identified in this SNUR are added to the Inventory prior to the effective date of the rule, the substances may be manufactured, imported, or processed by other persons for a significant new use as defined in this rule before the effective date of the rule. However, 31 of the 40 substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions, the Agency believes that it is highly unlikely that any of the significant new uses described in the following regulatory text are ongoing.
As discussed in the Federal Register of April 24, 1990, EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication rather than as of the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the 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 Start Printed Page 81397until the notice review period, including all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities. If persons who begin commercial manufacture, import, or processing of the substance between publication and the effective date of the SNUR do not meet the conditions of advance compliance, they must cease that activity before the effective date of the rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.
EPA has evaluated the potential costs of establishing significant new use notice requirements for potential manufacturers, importers, and processors of the chemical substance subject to this rule. EPA's complete economic analysis is available in the official record for this rule (OPPTS-50638).
Based on EPA's experience with proposing and finalizing SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect 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).
Similarly, this action is not subject to the requirement for prior consultation with Indian tribal governments as specified in Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998). Nor will this action 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).
EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this final rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN, no economic impact will even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities in response to any SNUR. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.), are minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impact of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented 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.
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 significant new use notice 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 significant new use notice.
Send any comments about the accuracy of the burden estimate, and Start Printed Page 81398any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, OP Regulatory Information Division (2137), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a final rule may take effect, the Agency promulgating it must submit a final rule report, which includes a copy of the final rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).
Acting Office Director, Office of Pollution Prevention and Toxics.
2. By adding new § 721.303 to subpart E to read as follows:
§ 721.303
Substituted acetate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted acetate (PMN P-99-0365) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
3. By adding new § 721.333 to subpart E to read as follows:
§ 721.333
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as a Dimethyl alkylamine salt (PMNs P-99-0368 and P-99-0369) are subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
4. By adding new § 721.480 to subpart E to read as follows:
§ 721.480
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Aminoester of polyalkenylated alkyldicarboxylic acid (PMN P-99-0115) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
5. By adding new § 721.545 to subpart E to read as follows:
§ 721.545
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Polyalkenylalkylphenol (PMN P-99-0472) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
6. By adding new § 721.632 to subpart E to read as follows:
§ 721.632
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as Silicoaluminophosphates, compd. with organic amine (PMN P-98-1274) is subject to reporting under this section for the significant new uses described in paragraph (a)(2)of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(5)(i), (b) and (c). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor Start Printed Page 81399may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the section TSCA 5(e) consent order for these substances. The NCEL is 0.1 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (g)(1)(ii), (g)(1)(iv), (g)(1) (vii), (g)(2)(i), (g)(2)(iv), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).
7. By adding new § 721.633 to subpart E to read as follows:
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Aluminosilicates, phospho- (PMN P-98-1275; CAS No. 201167-69-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(5)(i), (b), and (c). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the NCEL provisions listed in the TSCA section 5(e) consent order for these substances. The NCEL is 0.1 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.
8. By adding new § 721.1085 to subpart E to read as follows:
§ 721.1085
Benzenamine,4,4'-methylenebis[N-ethyl-N-methyl-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a Benzenamine,4,4'-methylenebis[N-ethyl-N-methyl- (PMN P-99-0557; CAS No. 76176-94-8) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
9. By adding new § 721.2121 to subpart E to read as follows:
§ 721.2121
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Thiosubstituted carbonate ester (PMN P-99-0654) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
10. By adding new § 721.2265 to subpart E to read as follows:
§ 721.2265
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Polyalkylene oxide dialkylamine (PMN P-99-0423) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
11. By adding new § 721.3710 to subpart E to read as follows:
§ 721.3710
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Polyether modified fatty acids (PMN P-99-0435) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
Start Printed Page 81400 Start Amendment Part
12. By adding new § 721.3810 to subpart E to read as follows:
§ 721.3810
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Formaldehyde, polymers with substituted phenols (PMN P-99-0558) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
13. By adding new § 721.3820 to subpart E to read as follows:
§ 721.3820
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as L-Glutamic acid, N-(1-oxododecyl)-, disodium salt (PMN P-99-0207; CAS No. 50622-20-3) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
14. By adding new § 721.3821 to subpart E to read as follows:
§ 721.3821
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as L-Glutamic acid, N-(1-oxododecyl)- (PMN P-99-0208; CAS No. 3397-65-7) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
15. By adding new § 721.3830 to subpart E to read as follows:
§ 721.3830
Formaldehyde, reaction products with an alkylated phenol and an aliphatic amine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Formaldehyde, reaction products with an alkylated phenol and an aliphatic amine (PMN P-99-0531) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
16. By adding new § 721.3850 to subpart E to read as follows:
§ 721.3850
Acrylated (long-chainalkyl) glycidyl ether (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Acrylated (long-chainalkyl) glycidyl ether (PMN P-99-0467) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified § 721.90 (a)(4), (b)(4), and (c)(4) (N=2 ppb).
17. By adding new § 721.4365 to subpart E to read as follows:
§ 721.4365
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Substituted ethoxylated hydrocarbon (PMN P-99-0313) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified § 721.90 (a)(4), (b)(4), and (c)(4) (N=1 ppb).
18. By adding new § 721.4461 to subpart E to read as follows:
§ 721.4461
(a) Chemical substance and significant new uses subject to reporting. Start Printed Page 81401(1) The chemical substance identified generically as a hydrofluoric acid, reaction products with octane (PMN P-99-0052) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
19. By adding new § 721.4565 to subpart E to read as follows:
§ 721.4565
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Modified hydroxystyrene homopolymer (PMN P-99-0610) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
20. By adding new § 721.4610 to subpart E to read as follows:
§ 721.4610
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the NCEL provisions listed in the TSCA 5(e) consent order for this substance. The NCEL is 0.05 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f) (g)(1)(ii), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv).
(1) Recordkeeping. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance, as specified in § 721.125 (a), (b), (c), (d), (f), (g), (h), and (i).
21. By adding new § 721.5284 to subpart E to read as follows:
§ 721.5284
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a Chromate (5-), bis[4-hydroxy-7-[(2-hydroxy-1- naphthalenyl)azo]- 3-[(2-hydroxy-3-nitro-5-sulfophenyl)azo]-2- naphthalenesulfonato(4-)]-, pentasodium (PMN P-99-0114; CAS No. 159574-72-8) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (v)(1), (w)(1), and (x)(1).
22. By adding new § 721.5378 to subpart E to read as follows:
§ 721.5378
9-Phosphabicyclo[3.3.1]nonane,9,9'-(1,2-ethanediyl)bis- (9C1).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 9-Phosphabicyclo[3.3.1]nonane,9,9'-(1,2-ethanediyl)bis- (9C1) (PMN P-99-0754; CAS No.153280-11-6) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f), (v)(2), (w)(2), and (y)(2).
(ii) Release to water. Requirements as specified § 721.90 (a)(1), (b)(1), and (c)(1).
23. By adding new § 721.5585 to subpart E to read as follows:
§ 721.5585
4,4'-(1-methylethylidene)bisphenol, polymer with (chloromethyl)oxirane and a diamine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 4,4'-(1-methylethylidene)bisphenol, polymer with (chloromethyl) oxirane and a diamine (PMN P-97-0916) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=2 ppb). Start Printed Page 81402
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
24. By adding new § 721.5912 to subpart E to read as follows:
§ 721.5912
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Phenoxazin-5-ium, 3-dialkylamino-7-arylamino-, salt (PMN P-99-0723) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
25. By adding new § 721.5914 to subpart E to read as follows:
§ 721.5914
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Polysubstituted bis phenylazonapthalene disulfonic acid. (PMN P-99-0479) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
26. By adding new § 721.5985 to subpart E to read as follows:
§ 721.5985
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a fatty alkyl phosphate, alkali metal salt (PMN P-99-0385) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
27. By adding new § 721.6180 to subpart E to read as follows:
§ 721.6180
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyalkylene glycol polyamide ester phosphate (PMN P-98-0903) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
28. By adding new § 721.6196 to subpart E to read as follows:
§ 721.6196
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Hydrochloride salt of a fatty polyalkkylene polyamine (PMN P-99-0618) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
29. By adding new § 721.6479 to subpart E to read as follows:
§ 721.6479
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Tetrahydroheteropolycycle (PMN P-97-0766) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xiii), (a)(5)(xiv), (a)(6)(i), (a)(6)(ii) (a)(6)(iii), (a)(6)(iv), (a)(6)(v), and (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c). The imperviousness of each item pursuant to paragraph (a)(2)(i) must be demonstrated by actual testing under paragraph (a)(3) and not by manufacturer specifications. Permeation Start Printed Page 81403testing shall be conducted according to the American Society for Testing Materials (ASTM) F739 “Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases.” Results shall 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 1194-89 “Guide for Documenting the Results of Chemical Permeation Testing on Protective Clothing Materials.” Gloves may not be used for a time period longer than they are actually tested and must be replaced at the end of each work shift. The manufacturer, importer, or processor must submit all test data to the Agency and must receive written Agency approval for each type of glove tested prior to use of such gloves. The following gloves have been tested in accordance with the ASTM F739 method and found to satisfy the requirements for use by EPA: Latex (at least 14 mils thick), Nitrile (at least 16 mils thick), and Silvershield (at least 3 mils thick). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the NCEL provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time weighted average verified by actual monitoring data.
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(p) (12,300 kilograms).
30. By adding new § 721.6493 to subpart E to read as follows:
§ 721.6493
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a amidoamine modified polyethylene glycol (PMN P-99-0645) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
31. By adding new § 721.6515 to subpart E to read as follows:
§ 721.6515
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of polyalkylenepolyol and trisubstituted phenol (PMN P-98-1016) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10 ppb).
32. By adding new § 721.8657 to subpart E to read as follows:
§ 721.8657
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Cerium, hydroxy oleate propionate complexes (PMN P-99-0026) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=7 ppb).
33. By adding new § 721.9484 to subpart E to read as follows:
§ 721.9484
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Dimer acid/rosin amidoamine reaction product (PMN P-99-0143) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
34. By adding new § 721.9485 to subpart E to read as follows:
§ 721.9485
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Dimer acid/polymerized rosin amidoamine reaction product (PMN P-99-0144) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(b) Specific requirements. The provisions of subpart A of this part Start Printed Page 81404apply to this section except as modified by this paragraph.
35. By adding new § 721.9486 to subpart E to read as follows:
§ 721.9486
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Rosin amidoamine (PMN P-99-0145) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
36. By adding new § 721.9487 to subpart E to read as follows:
§ 721.9487
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Polymerized rosin amidoamine (PMN P-99-0146) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
37. By adding new § 721.9514 to subpart E to read as follows:
§ 721.9514
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Ethyl silicate, reaction products with modified alkoxysilane salt (PMN P-99-0157) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
38. By adding new § 721.9535 to subpart E to read as follows:
§ 721.9535
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a 1,4-Dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione, 8,8-dioctyl- (PMN P-99-0093; CAS No. 56875-68-4) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) and (f).
39. By adding new § 721.9670 to subpart E to read as follows:
§ 721.9670
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Tetraaryltin (PMN P-99-0198) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(ii) Release to water. Requirements as specified § 721.90 (a)(4), (b)(4), and (c)(4) (N=1 ppb).
40. By adding new § 721.9671 to subpart E to read as follows:
§ 721.9671
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a Triaryltin (PMN P-99-0199) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
[FR Doc. 00-32766 Filed 12-22-00; 8:45 am]