Toxic substances: Perfluorooctyl sulfonates,

[Federal Register: October 18, 2000 (Volume 65, Number 202)]

[Proposed Rules]

[Page 62319-62333]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr18oc00-23]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

OPPTS-50639; FRL-6745-5 RIN 2070-AD43

Perfluorooctyl Sulfonates; Proposed Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the following chemical substances: Perfluorooctanesulfonic acid (PFOSA) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (PFOSF), certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. All of these chemical substances are referred to collectively in this proposed rule as perfluorooctyl sulfonates, or PFOS. This proposed rule would require manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document. EPA believes that this action is necessary because the chemical substances included in this proposed rule may be hazardous to human health and the environment. The required notice would provide EPA with the opportunity to evaluate an intended new use and associated activities and, if necessary, to prohibit or limit that activity before it occurs.

DATES: Comments, identified by the docket number OPPTS-50639, are due November 17, 2000.

[[Page 62320]]

ADDRESSES: 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-50639 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Office of Program Management and Evaluation, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

For technical information contact: Mary Dominiak, Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-7768; fax number: (202) 260-1096; e-mail address: dominiak.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

  1. General Information

    1. Does this Notice Apply to Me?

      You may be affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in Table 2 or Table 3 of this unit. Persons who intend to import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements, and to the regulations codified at 19 CFR 12.118 through 12.127 and 12.728. Those persons must certify that they are in compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export any of the chemical substances listed in Table 2 or Table 3 of this unit are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR 721.20 and 40 CFR part 707, subpart D. Entities potentially affected by the SNUR requirements in this proposed rule may include, but are not limited to:

      Table 1.--Entities Potentially Affected by the SNUR Requirements

      Examples of Categories

      NAICS codes potentially affected entities

      Chemical manufacturers or 325

      Persons who importers

      manufacture (defined by statute to include import) one or more of the subject chemical substances Chemical exporters

      325

      Persons who export, or intend to export, one or more of the subject chemical substances

      This listing is not intended to be exhaustive. Instead, it provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in Table 1 of this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist in determinations of whether this action might apply to certain entities. To determine if you or your business is affected by this action, you should carefully examine the applicability provisions at 40 CFR 721.5 for SNUR-related obligations. Also, consult Unit III. Note that because this proposed rule would designate certain manufacturing and importing activities as significant new uses, persons that solely process the chemical substances that would be covered by this action would not be subject to the rule. 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.

      Table 2.--Chemicals Requiring a Significant New Use Notice On or After January 1, 2001

      CAS No./PMN

      Ninth Collective Index chemical name

      383-07-3....................................... 2-Propenoic acid, 2- [butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 423-82-5....................................... 2-Propenoic acid, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 2250-98-8...................................... 1-Octanesulfonamide, N,N',N''-[phosphinylidynetris(oxy-2,1- ethanediyl)]tris[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-. 14650-24-9..................................... 2-Propenoic acid, 2-methyl-, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester. 30381-98-7..................................... 1-Octanesulfonamide, N,N'-[phosphinicobis(oxy-2,1- ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, ammonium salt. 55120-77-9..................................... 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluoro-, lithium salt. 57589-85-2..................................... Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3- [[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]- , monopotassium salt. 61660-12-6..................................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3- (trimethoxysilyl)propyl]-. 67969-69-1..................................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2- (phosphonooxy)ethyl]-, diammonium salt. 68156-01-4..................................... Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt. 68329-56-6..................................... 2-Propenoic acid, eicosyl ester, polymer with 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2- propenoate, hexadecyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2- propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2- propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2- propenoate and octadecyl 2-propenoate. 68555-91-9..................................... 2-Propenoic acid, 2-methyl-, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl- 2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate and octadecyl 2-methyl-2-propenoate. 68555-92-0..................................... 2-Propenoic acid, 2-methyl-, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl- 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate and octadecyl 2-methyl-2-propenoate.

      [[Page 62321]]

      68608-14-0..................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N- (hydroxyethyl), reaction products with 1,1'-methylenebis[4- isocyanatobenzene]. 68909-15-9..................................... 2-Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl acrylate, 2-[methyl[(nonafluorobutyl) sulfonyl]amino]ethyl acrylate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(undecafluoropentyl) sulfonyl]amino]ethyl acrylate, polyethylene glycol acrylate Me ether and stearyl acrylate. 70776-36-2..................................... 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2- propenoate, N-(hydroxymethyl)-2-propenamide, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2- propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2- propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2- propenoate. 73772-32-4..................................... 1-Propanesulfonic acid, 3-[[3- (dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2- hydroxy-, monosodium salt. 81190-38-7..................................... 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3- sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N- dimethyl-, hydroxide, monosodium salt. 94133-90-1..................................... 1-Propanesulfonic acid, 3-[[3- (dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]- 2-hydroxy-, monosodium salt. 117806-54-9.................................... 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-, lithium salt. 127133-66-8.................................... 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl methacrylate. 129813-71-4.................................... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N- (oxiranylmethyl). 148240-78-2.................................... Fatty acids, C18-unsatd., trimers, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. 148240-79-3.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters. 148240-80-6.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters. 148240-81-7.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters. 148240-82-8.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters. 148684-79-1.................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N- methyl, reaction products with 1,6-diisocyanatohexane homopolymer and ethylene glycol. 178535-22-3.................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N- (hydroxyethyl)-, polymers with 1,1'-methylenebis[4- isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked. P-83-1102...................................... Fatty acids, linseed-oil, dimers, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. P-84-1163...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and N,N',2-tris(6-isocyanatohexyl)imidodicarbonic diamide, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2- hydroxyethyl)-1-octanesulfonamide and N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2- hydroxyethyl)-1-heptanesulfonamide, compds. with triethylamine. P-84-1171...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,1'-methylenebis[4-isocyanatobenzene] and 1,2,3-propanetriol, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2- hydroxyethyl)-1-octanesulfonamide and N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2- hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine. P-86-0301...................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N- methyl, reaction products with 12-hydroxystearic acid and 2,4-TDI, ammonium salts. P-89-0799...................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N- (hydroxyethyl), reaction products with 2-ethyl-1-hexanol and polymethylenepolyphenylene isocyanate. P-94-0545...................................... 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2- propenyl)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl acrylate. P-94-0927...................................... 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2- (hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N- ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amides- blocked. P-94-2205...................................... Polymethylenepolyphenylene isocyanate and bis(4-NCO- phenyl)methane reaction products with 2-ethyl-1-hexanol, 2- butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide. P-94-2206...................................... Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2- propenyl)oxy]propylgroup]-terminated, polymers with 2- [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate. P-96-1645...................................... Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl esters. P-97-0790...................................... 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1- octanesulfonic acid (1:1). P-98-0251...................................... 2-Propenoic acid, butyl ester, polymers with acrylamide, 2- [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride. P-98-1272...................................... 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, polymers with acrylic acid, 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2'- (methylimino)bis[ethanol]. P-99-0188...................................... Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N- methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.- blocked. P-99-0319...................................... Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]- .omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro- C4-8-alkyl)sulfonyl] derivs..

      Table 3.--Chemicals Subject to Volume Cap Restrictions On or After January 1, 2001 and Requiring a Significant New Use Notice On or After January 1, 2003

      CAS No./PMN

      Ninth Collective Index chemical name

      307-35-7.................... 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 307-51-7.................... 1-Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10 ,10-heneicosafluoro- 376-14-7.................... 2-Propenoic acid, 2-methyl-, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl ester

      [[Page 62322]]

      423-50-7.................... 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro- 754-91-6.................... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 1652-63-7................... 1-Propanaminium, 3- [[(heptadecafluorooctyl)sulfonyl]amino]- N,N,N-trimethyl-, iodide 1691-99-2................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)- 1763-23-1................... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 2795-39-3................... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, potassium salt 2991-51-7................... Glycine, N-ethyl-N- [(heptadecafluorooctyl)sulfonyl]-, potassium salt 4151-50-2................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 17202-41-4.................. 1-Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9- nonadecafluoro-, ammonium salt 24448-09-7.................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)-N- methyl- 25268-77-3.................. 2-Propenoic acid, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl ester 29081-56-9.................. 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, ammonium salt 29117-08-6.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl]-.omega.-hydroxy- 29457-72-5.................. 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, lithium salt 31506-32-8.................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-methyl- 38006-74-5.................. 1-Propanaminium, 3- [[(heptadecafluorooctyl)sulfonyl]amino]- N,N,N-trimethyl-, chloride 38850-58-7.................. 1-Propanaminium, N-(2-hydroxyethyl)-N,N- dimethyl-3-[(3- sulfopropyl)[(tridecafluorohexyl)sulfonyl ]amino]-, inner salt 67584-42-3.................. Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt 67906-42-7.................. 1-Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10 ,10-heneicosafluoro-, ammonium salt 68298-62-4.................. 2-Propenoic acid, 2- [butyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl ester, telomer with 2- [butyl[(pentadecafluoroheptyl)sulfonyl]am ino]ethyl 2-propenoate, methyloxirane polymer with oxirane di-2-propenoate, methyloxirane polymer with oxirane mono-2- propenoate and 1-octanethiol 68541-80-0.................. 2-Propenoic acid, polymer with 2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl 2-methyl-2-propenoate and octadecyl 2-propenoate 68555-90-8.................. 2-Propenoic acid, butyl ester, polymer with 2-[[(heptadecafluorooctyl)sulfonyl] methylamino]ethyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate 68586-14-1.................. 2-Propenoic acid, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl ester, telomer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, .alpha.-(2-methyl-1- oxo-2-propenyl)-.omega.-hydroxypoly(oxy- 1,2-ethanediyl), .alpha.-(2-methyl-1-oxo- 2-propenyl)-.omega.-[(2-methyl-1-oxo-2- propenyl)oxy]poly(oxy-1,2-ethanediyl), 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate and 1-octanethiol 68649-26-3.................. 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)-, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2- hydroxyethyl)-1-butanesulfonamide, N- ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-N-(2-hydroxyethyl)-1- heptanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N- (2-hydroxyethyl)-1-hexanesulfonamide, N- ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro- N-(2-hydroxyethyl)-1-pentanesulfonamide, polymethylenepolyphenylene isocyanate and stearyl alc. 68867-60-7.................. 2-Propenoic acid, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate and .alpha.-(1-oxo-2- propenyl)-.omega.-methoxypoly(oxy-1,2- ethanediyl) 68867-62-9.................. 2-Propenoic acid, 2-methyl-, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl ester, telomer with 2- [ethyl[(nonafluorobutyl)sulfonyl]amino]et hyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]am ino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino ]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino ]ethyl 2-methyl-2-propenoate, 1- octanethiol and .alpha.-(1-oxo-2- propenyl)-.omega.-methoxypoly(oxy-1,2- ethanediyl) 68891-96-3.................. Chromium, diaquatetrachloro[.mu.-[N-ethyl- N- [(heptadecafluorooctyl)sulfonyl]glycinato- .kappa.O:.kappa.O']]-.mu.-hydroxybis(2- methylpropanol)di- 68958-61-2.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl]-.omega.-methoxy- 70225-14-8.................. 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, compd. with 2,2'- iminobis[ethanol] (1:1) 71487-20-2.................. 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate and 2-propenoic acid 91081-99-1.................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)-N- methyl-, polymer with(chloromethyl)oxirane, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2- hydroxyethyl)-N-methyl-1- butanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-N-(2-hydroxyethyl)-N- methyl-1-heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N- (2-hydroxyethyl)-N-methyl-1- hexanesulfonamide and 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2- hydroxyethyl)-N-methyl-1- pentanesulfonamide, hexanedioate (ester) 98999-57-6.................. Sulfonamides, C7-8-alkane, perfluoro, N- methyl-N-[2-[(1-oxo-2-propenyl) oxy]ethyl], polymers with 2-ethoxyethyl acrylate, glycidyl methacrylate and N,N,N- trimethyl-2-[(2-methyl-1-oxo-2- propenyl)oxy]ethanaminiumchloride 182700-90-9................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-methyl-, reaction products with benzene-chlorine-sulfur chloride (S2Cl2) reaction products chlorides L-92-0151................... 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-methyl-, 2-[ethyl [(heptadecafluorooctyl)sulfonyl]amino]eth yl 2-methyl-2-propenoate, 2- [ethyl[(nonafluorobutyl)sulfonyl]amino]et hyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]am ino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino ]ethyl 2-methyl-2-propenoate, and 2- propenoic acid P-80-0183................... Sulfonamides, C4-8-alkane, perfluoro, N-[3- (dimethylamino)propyl], reaction products with acrylic acid

      [[Page 62323]]

      P-86-0958................... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro- C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride P-90-0111................... Sulfonamides, C4-8-alkane, perfluoro, N- methyl-N-[(3-octadecyl-2-oxo-5- oxazolidinyl)methyl] P-91-1419................... Poly(oxy-1,2-ethanediyl), .alpha.-hydro- .omega.-hydroxy-, polymer with 1,6- diisocyanatohexane, N-(2-hydroxyethyl)-N- methyl perfluoro C4-8-alkane sulfonamide- blocked P-93-1444................... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyl)-2- propenamide, 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chloride P-95-0120................... Sulfonamides, C4-8-alkane, perfluoro, N,N'- [1,6-hexanediylbis[[2-oxo-3,5- oxazolidinediyl)methylene]]bis[N-methyl- P-96-1262................... Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether P-96-1424................... 2-Propenoic acid, 2-methyl-, 2- (dimethylamino)ethyl ester, telomers with 2-[ethyl[(perfluoro-C4-8- alkylsulfonyl]amino]ethyl methacrylate and 1-octanethiol, N-oxides P-96-1433................... Sulfonamides, C4-8-alkane, perfluoro, N-[3- (dimethyloxidoamino)propyl], potassium salts

    2. How Can I get Additional Information, Including Copies of this Document or Other Related Documents?

      1. Electronically. You may obtain electronic 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/. To access this document, on the Home Page select ``Law and Regulations,'' ``Regulations and Proposed Rules,'' then look up the entry for this document under ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. In addition, you may access other information about the Office of Prevention, Pesticides and Toxic Substances (OPPTS) and related programs at http://www.epa.gov/ internet/oppts/.

      2. In person. The Agency has established an official record for this action under docket control number OPPTS-50639. The official record consists of the documents referenced in this action, any public comments received during the comment period, and other information related to this rulemaking, including information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as all 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 that may be submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, Room NE B-607, 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 of the Center is (202) 260-7099.

    3. How and to Whom Do I Submit Comments?

      You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, your comments must identify docket control number OPPTS-50639 in the subject line on the first page of your response.

      1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

      2. In person or by courier. Deliver your comments to: OPPT's Document Control Office (DCO), East Tower Room G-099, Waterside Mall, 401 M St., SW., Washington, DC. 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) 260-7093.

      3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail or deliver your computer disk to the addresses identified in Unit I.C.1. or I.C.2. Do not submit any information electronically that you consider to be CBI. E-mailed comments must be submitted as an ASCII file, avoiding the use of special characters or any form of encryption. Comments will also be accepted on standard computer disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50639. Electronic comments may also be filedonline at many Federal Depository Libraries.

    4. How Should I Handle CBI Information that I Want to Submit to the Agency?

      Do not submit any information electronically that you consider to be CBI. You may claim information that you submit in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comments that include any information claimed as CBI, a sanitized copy of the comments which does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

    5. What Should I Consider as I Prepare My Comments for EPA?

      We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final SNUR. You may find the following suggestions helpful for preparing your comments:

      1. Explain your views as clearly as possible.

      2. Describe any assumptions that you used.

      3. Provide copies of any technical information and/or data you used that support your views.

        [[Page 62324]]

      4. If you estimate potential burden or costs, explain how you arrived at the estimate.

      5. Provide specific examples to illustrate your concerns.

      6. Offer alternative ways to improve the proposed rule or data collection activity.

      7. Make sure to submit your comments by the deadline specified in this document.

      8. At the beginning of your comments, be sure to properly identify the document you are commenting on. To ensure proper receipt by EPA, your comments must identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the title, date, and Federal Register citation.

  2. Background

    1. What Action is the Agency Taking?

      This proposal would require persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 2 or Table 3 of Unit I.A., for the significant new uses described in this document. The chemical substances identified in Table 2 and Table 3 of Unit I.A. include PFOSA, PFOSS, PFOSF, certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. These chemical substances are collectively referred to throughout this proposed rule as PFOS.

      The significant new uses described by this notice are:

      1. The manufacture or import for any use of any of the chemicals listed in Table 2 of Unit I.A. on or after January 1, 2001.

      2. The manufacture or import for any use of any one or more of the chemicals listed in Table 3 of Unit I.A. in excess of an aggregate volume of 1,100,000 pounds per person per calendar year on or after January 1, 2001 and before January 1, 2003.

      3. The manufacture or import for any use of any of the chemicals listed in Table 3 of Unit I.A. on or after January 1, 2003.

    2. 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.'' The Agency makes this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). These factors include the volume of a chemical substance's production; the extent to which a use changes the type, form, magnitude, or duration of exposure to the substance; and the reasonably anticipated manner of producing or otherwise managing the substance. Once EPA makes this determination and promulgates a SNUR, 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 significant new use (15 U.S.C. 2604 (a)(1)(B)).

    3. Which General Provisions Apply?

      General provisions for SNURs are published under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Note that because this proposed rule would designate certain manufacturing and importing activities as significant new uses, persons that solely process the chemical substances that would be covered by this action would not be subject to the rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this proposed SNUR would be required to comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (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), (2), (3), and (5); the export notification provisions of TSCA section 12(b); and the export notification requirements in 40 CFR part 707, subpart D. Once EPA receives a SNUN, EPA may take regulatory action under TSCA sections 5(e), 5(f), 6, or 7, if appropriate, to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

  3. Summary of this Proposed Rule

    The chemical substances subject to this proposed SNUR are listed in Table 2 and Table 3 of Unit I.A. These chemical substances include PFOSA, PFOSS, PFOSF, certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. All of these chemical substances are referred to collectively in this proposed rule as perfluorooctyl sulfonates, or PFOS. All of these chemical substances have the potential to degrade back to PFOSA in the environment, and PFOSA does not degrade further. PFOSA is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3). These factors, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment.

    EPA believes that the chemical substances listed in Tables 2 and 3 of Unit I.A. are manufactured and imported in the United States only by the Minnesota Mining and Manufacturing Company (3M) (Refs. 4 and 5). 3M has committed to phase out these chemicals voluntarily by discontinuing the manufacture of certain of these chemical substances on a global basis for their most widespread uses by the end of December 2000, by steadily reducing their production volume on the remaining chemicals through 2001 and 2002, and by entirely discontinuing the manufacture of all of these PFOS chemicals by December 31, 2002 (Ref. 6). The chemicals listed in Table 2 of Unit I.A. are those which 3M has committed to cease manufacturing by December 31, 2000. The chemicals listed in Table 3 of Unit I.A. are those which 3M has committed first to reduce, and then to cease manufacturing by December 31, 2002. EPA believes that any manufacture or import of these PFOS chemicals occurring after 3M's global phase-out dates would increase the magnitude and duration of exposure to these chemicals. Therefore, EPA is proposing to designate the following as significant new uses:

    1. Any manufacture or import for any use of the chemicals listed in Table 2 of Unit I.A. on or after January 1, 2001.

    2. Any manufacture or import for any use of the chemicals listed in Table 3 of Unit I.A. in excess of an aggregate annual manufacture and import volume cap for all of these chemicals of 1,100,000 pounds per person per calendar year on or after January 1, 2001 and before January 1, 2003.

    3. Any manufacture or import for any use of any of the chemicals listed in

    [[Page 62325]]

    Table 3 of Unit I.A. on or after January 1, 2003.

    Given that no companies other than 3M are currently producing the chemicals listed on Table 3 of Unit I.A., and given the negative commercial and regulatory environment associated with these chemicals, EPA believes it is unlikely that companies would incur the costs associated with establishing new manufacturing capacity for these chemicals in order to enter this market.

    This proposed rule, when finalized, would require persons who intend to manufacture or import the PFOS chemicals listed in this proposed rule to notify EPA, through the submission of a SNUN, at least 90 days before commencing the manufacture or importation of any of these chemicals for any use designated by this proposed SNUR as a significant new use. The required notice would provide EPA with the opportunity to evaluate the intended use, and, if necessary, to prohibit or limit that use before it occurs. These proposed requirements are summarized in the following Table 4:

    Table 4.--Summary of Proposed SNUR Requirements

    You must file a significant new use notice (SNUN) if you:

    Manufacture or import:

    When?

    How much?

    Chemical substances listed in After December 31, Any amount Table 2 of Unit I.A.

    2000 Chemical substances listed in January 1, 2001 Aggregate amount Table 3 of Unit I.A.

    through December exceeding 1,100,000 31, 2002

    lbs per person per calendar year Chemical substances listed in After December 31, Any amount Table 3 of Unit I.A.

    2002

  4. Chemical Compound History

    1. Defining PFOS

      This proposed rule applies to a large group of fully fluorinated alkyl sulfonate-containing substances, none of which occur naturally. The Ninth Collective Index chemical names and CAS Registry Numbers (CAS No.) (when available) provided in Table 2 and Table 3 of Unit I.A. are for the specific chemical substances that are subject to the provisions contained in this proposed SNUR (for example, entry #8 on Table 3 of Unit I.A. lists CAS No.1763-23-1 for the compound named 1- octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, commonly referred to as PFOSA). All of the chemical substances listed in Table 2 and Table 3 of Unit I.A. have a common chemical structure consisting of a PFOS moiety, as illustrated here, somewhere in the molecule.

      [GRAPHIC] [TIFF OMITTED] TP18OC00.044

      BILLING CODE 6560-50-C

      The number of carbon atoms present in the moiety varies from 4 to 10 (x = 3-9) among the listed chemicals. In addition, there are many examples of different chemical functionality (free acids (Y = OH), metal salts (Y = O-M\+\), sulfonyl halides (Y = X), sulfonamides (Y= NH\2\), and other derivatives). The listed chemical substances also include polymers.

      The class of chemical substances including the perfluoroalkyl sulfonyl moiety described by the structure shown in this unit contains more chemical substances than are specified in the lists in Table 2 and Table 3 of Unit I.A. Only the listed chemical substances, which are manufactured or imported exclusively by 3M and which 3M has voluntarily committed to cease producing, are subject to this SNUR. EPA is evaluating further this overall structural class of chemical substances and may take additional regulatory action as appropriate.

    2. Environmental Fate

      The basic building block of all of the PFOS chemicals is PFOSF, which is used as an intermediate in the production of the PFOS chemicals. PFOSA results from the chemical or enzymatic hydrolysis of PFOSF. Current information strongly supports that PFOSA is an extremely stable substance which resists breakdown by chemical or biological processes. Therefore PFOSA is the ultimate degradation product from PFOS chemicals and will persist in that form (Refs. 1 and 2).

      EPA cannot currently conduct a definitive assessment of the environmental transport and partitioning of PFOS. The available data are limited and their accuracy uncertain. Also, the accuracy of the estimation models is limited by the quality of data input into them. Depending on what data are consulted and utilized, the environmental fate and transport of PFOS vary. Biological sampling recently discovered the presence of certain perfluoroalkyl compounds in fish and in fish-eating birds across the United States and in locations in Canada, Sweden, and the South Pacific (Ref. 1). The wide distribution of the chemicals in high trophic levels is strongly suggestive of the potential for bioaccumulation/bioconcentration. The widespread presence of PFOS suggests the possibility of transport in air as well as water, but the multimedia equilibrium criterion model (EQC) suggests otherwise (Ref. 7). Using data provided by 3M as inputs, the model indicates that PFOS would fall out of air and partition almost equally in water and soil. The Henry's Law values calculated utilizing the vapor pressure of 3.31 E-4 Pa@20 C and water solubility values of 370, 570, 5, and 25 milligram/Liter (mg/L) in fresh water, pure water, unfiltered seawater, and filtered seawater, respectively yielded Henry's Law values of 4.7 E-9 , 7.2 E-9, 6.4 E-11, and 3.2 E-10 atm.m3/mole (atmospheres per meter cubed per mole), respectively. The vapor pressure and water solubility values were obtained from Table 4, p.16 of the March 1, 2000, white paper by 3M, Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate and Effects (Ref. 1). These Henry's Law values suggest that volatilization from water to air is not very likely. According to 3M, testing is planned and/or underway for the environmental properties, fate, and transport of PFOS (Ref. 1). With more complete data, EPA would be able to make more definitive assessments. With the present data, the Agency can only speculate on environmental transport and partitioning of PFOS, although current information suggests strongly that it is persistent and may bioaccumulate.

    3. Health Effects

      The Agency's hazard analysis for PFOS is a review of health hazard and biomonitoring data (Ref. 8). Toxicology studies show that PFOS is well absorbed

      [[Page 62326]]

      orally and distributes primarily in the serum and liver. PFOS can also be formed as a metabolite of other perfluorinated sulfonates. It does not appear to be further metabolized. Elimination from the body is slow and occurs via both urine and feces. Serum PFOS levels in three retired male 3M chemical workers have been followed for 51/2 years and suggest a mean elimination half-life (t 1/2) of 1,428 days (approximately 4 years). Based on the pharmacokinetic data obtained from a 28-day oral study in male and female monkeys, a volume of distribution (Vd) of 0.19 L/kilogram (kg) was reported; no sex differences in the pharmacokinetic parameters were noted.

      PFOS has shown moderate acute toxicity by the oral route with a rat LD50of 251 mg/kg. A 1-hour LC50of 5.2 mg/L in rats has been reported. PFOS was found to be mildly irritating to the eyes and non-irritating to the skin of rabbits. PFOS was negative in mutagenicity studies in five strains of salmonella and did not induce micronuclei in an in vivo mouse bone marrow micronucleus assay.

      Numerous repeat-dose oral toxicity studies on PFOS have been conducted in rats and primates. Adverse signs of toxicity observed in rat studies included increases in liver enzymes, hepatic vacuolization and hepatocellular hypertrophy, gastrointestinal effects, hematological abnormalities, weight loss, convulsions, and death. These effects were reported at doses of 2 mg/kg/day and above. Adverse signs of toxicity observed in Rhesus monkey studies included anorexia, emesis, diarrhea, hypoactivity, prostration, convulsions, atrophy of the salivary glands and the pancreas, marked decreases in serum cholesterol, and lipid depletion in the adrenals. The dose range for these effects was reported between 1.5-300 mg/kg/day. No monkeys survived beyond 3 weeks into treatment at 10 mg/kg/day, or beyond 7 weeks into treatment at doses as low as 4.5 mg/kg/day. At doses as low as 0.75 mg/kg/day, Cynomolgus monkeys exhibited low food consumption, excessive salivation, labored breathing, hypoactivity, ataxia, hepatic vacuolization and hepatocellular hypertrophy, significant reductions in serum cholesterol levels, and death.

      Postnatal deaths and other developmental effects were reported at low doses in offspring in a 2-generation reproductive toxicity study in rats. At the two highest doses of 1.6 and 3.2 mg/kg/day, pup survival in the first generation was significantly decreased. All first generation offspring (F1 pups) at the highest dose died within a day after birth while close to 30% of the F1 pups in the 1.6 mg/kg/day dose group died within 4 days after birth. As a result of the pup mortality in the two top dose groups, only the two lowest dose groups, 0.1 and 0.4 mg/kg/day, were continued into the second generation. The no observed adverse effect level (NOAEL) and lowest observed adverse effect level (LOAEL) for the second generation offspring (F2 pups) were 0.1 mg/kg/day and 0.4 mg/kg/day, respectively, based on reductions in pup body weight. Reversible delays in reflex and physical development were also observed in this study, raising concerns about the potential for developmental neurotoxicity following exposure to PFOS.

      Developmental effects were also reported in prenatal developmental toxicity studies in the rat and rabbit, although at slightly higher dose levels. Signs of developmental toxicity were evident at doses of 5 mg/kg/day and above in rats administered PFOS during gestation. Significant decreases in fetal body weight and significant increases in external and visceral anomalies, delayed ossification, and skeletal variations were observed. Abnormalities of the lens of the eye were also reported at doses as low as 1 mg/kg/day in one rat prenatal developmental study, but could not be repeated in a second study of similar design. At doses of 2.5 mg/kg/day and above, significant reductions in fetal-body weight and significant increases in delayed ossification were observed in rabbits administered PFOS during gestation.

      In human blood samples, PFOS has been detected in the serum of occupational and general populations in the parts per million (ppm) to parts per billion (ppb) range. In the United States, recent blood serum levels of PFOS in manufacturing employees have been as high as 12.83 ppm, while in the general population, serum collected from blood banks and commercial sources have indicated mean PFOS levels of 30-44 ppb. Levels in a very small sample of children yielded even higher results, with a mean level of 54 ppb.

      Sampling of several wildlife species from a variety of sites across the United States has shown widespread distribution of PFOS. In recent analyses, PFOS was detected in the ppb range in the plasma of several species of eagles, wild birds, and fish. Endogenous levels of PFOS have also been detected in the ppb range in the livers of unexposed rats used in toxicity studies, presumably through a dietary source (fishmeal).

      Although the PFOS levels detected in the blood of the general population are low, this widespread presence, combined with the persistence, the bioaccumulative potential, and the reproductive and subchronic toxicity of the chemical, raises concerns for potential adverse effects on people and wildlife over time should the chemical substances continue to be produced, released, and accumulated in the environment.

    4. Exposure Data

      As indicated in Unit IV.C., PFOS has been detected at low levels in the blood of humans and wildlife throughout the United States, providing clear evidence of widespread exposure to the chemical. PFOS has been in commercial use since the 1950's, predominantly in soil and stain-resistant coating products on fabrics, carpets, and leather, and in grease and oil resistant coatings on paper products, including food contact papers. Other uses leading to environmental releases include fire fighting foams. The various surface treatment uses constitute the largest volume of PFOS production and are believed to present the greatest potential for widespread human and environmental exposure to PFOS. Studies are underway to determine the routes of exposure which have led to the detection of PFOS in human and animal blood. There are several potential pathways that may account for the widespread exposure to PFOS including: Dietary intake from the consumption of food wrapped in paper containing PFOS derivatives; inhalation from aerosol applications of PFOS-containing consumer products; and inhalation, dietary, or dermal exposures resulting from manufacturing, as well as industrial, commercial, and consumer use and disposal of PFOS-derived chemicals and products.

    5. Use Data

      PFOS and related sulfonyl-based fluorochemicals are used in a variety of products, which can be divided into three main categories of use: Surface treatments, paper protectors, and performance chemicals (Ref. 4). The various surface treatment and paper protection uses constitute the largest volume of PFOS production and are believed to present the greatest potential for widespread human and environmental exposure to PFOS.

      PFOS chemicals produced for surface treatment applications provide soil, oil, and water resistance to personal apparel and home furnishings. Specific applications in this use category include protection of apparel and leather, fabric/upholstery, and carpet. These applications are undertaken in

      [[Page 62327]]

      industrial settings by customers such as textile mills, leather tanneries, finishers, fiber producers, and carpet manufacturers. PFOS chemicals are also used in aftermarket treatment of apparel and leather, upholstery, carpet, and automobile interiors by the general public or professional applicators (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this use category is estimated to be approximately 2.4 million pounds (Ref. 6).

      PFOS chemicals produced for paper protection applications provide grease, oil, and water resistance to paper and paperboard as part of a sizing agent formulation. Specific applications in this use category include food contact applications (plates, food containers, bags, and wraps) regulated by the Food and Drug Administration (FDA) under 21 CFR 176.170, as well as non-food contact applications (folding cartons, containers, carbonless forms, and masking papers). The application of sizing agents is undertaken mainly by paper mills and, to some extent, converters who manufacture bags, wraps, and other products from paper and paperboard (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this use category is estimated to be approximately 2.7 million pounds (Ref. 6).

      PFOS chemicals in the performance chemicals category are used in a wide variety of specialized industrial, commercial, and consumer applications. Specific applications include fire fighting foams, mining and oil well surfactants, acid mist suppressants for metal plating and electronic etching baths, alkaline cleaners, floor polishes, photographic film, denture cleaners, shampoos, chemical intermediates, coating additives, carpet spot cleaners, and as an insecticide in bait stations for ants (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this use category is estimated to be approximately 1.5 million pounds (Ref. 6).

      On May 16, 2000, following discussions with the Agency, 3M issued a press release announcing that it would discontinue the production of perfluorooctanyl chemicals used to produce some of its repellent and surfactant products. In its statement, 3M committed to ``substantially phase out production'' by the end of calendar year 2000 (Ref. 9). In subsequent correspondence with the Agency, 3M provided a schedule documenting its complete plan for discontinuing all manufacture of specific PFOS and related chemicals for most surface treatment and paper protection uses (including food contact uses regulated by the FDA) by the end of 2000, and discontinuing all manufacture for any uses by the end of 2002 (Ref. 6). This schedule, and 3M's anticipated production volumes, are summarized in Table 5.

      Table 5.--Anticipated Annual U.S. Production Volume (Pounds) for PFOS Use Categories

      Use category

      2000

      2001

      2002

      2003

      Surface treatment

      2,356,700

      0

      0

      0 Paper protection

      2,670,700

      0

      0

      0 Performance chemicals

      1,462,500

      1,011,900

      443,700

      0 Total

      6,489,900

      1,011,900

      443,700

      0

      According to the information currently available to EPA, 3M is the sole manufacturer of PFOS chemicals affected by this proposed SNUR (Ref. 5). 3M plans to discontinue the manufacture of the chemicals identified in Table 2 of Unit I.A. (in general, those associated with surface treatment and paper protection uses) by the end of 2000 and to discontinue the chemicals identified in Table 3 of Unit I.A. (in general, those associated with performance chemical applications) by the end of 2002.

  5. Objectives and Rationale for this Proposed Rule

    In determining what would constitute a significant new use for the chemical substances that are the subjects of this proposed SNUR, EPA considered relevant information on the toxicity of the substances, likely exposures associated with potential uses, information provided by industry sources, and the four factors listed in TSCA section 5(a)(2) and Unit II.B.

    Based on these considerations, EPA wants to achieve the following objectives with regard to the significant new uses that are designated in this proposed rule. EPA wants to ensure that:

    1. EPA would receive notice of any person's intent to manufacture or import PFOS chemicals for a designated significant new use before that activity begins.

    2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or importing the subject chemical substances for a significant new use.

    3. EPA would be able to regulate prospective manufacturers and importers of the subject chemical substances before a significant new use occurs, provided such regulation is warranted pursuant to TSCA section 5(e) or (f).

    EPA has concerns regarding the toxicity, persistence, and bioaccumulative potential of the chemical substances that are included in this proposed SNUR. 3M, the sole manufacturer of these chemicals in the United States, has chosen voluntarily to discontinue their manufacture and sale for all uses by December 31, 2002, and to substantially reduce their manufacture for their most widespread uses by December 31, 2000. With 3M's exit from the market, EPA believes that all manufacture of these chemicals likely will cease. However, EPA is concerned that manufacture could be reinitiated in the future, and wants the opportunity to evaluate and control, if appropriate, exposures associated with that activity. The notice that would be required by the SNUR would provide EPA with the opportunity to evaluate activities associated with a significant new use as proposed herein and an opportunity to protect against unreasonable risks, if any, from exposure to the substances which could result.

    Given that no companies other than 3M are currently producing the chemicals listed on Table 3 of Unit I.A., and given the negative commercial and regulatory environment associated with these chemicals, EPA believes it is unlikely that companies would incur the costs associated with establishing new manufacturing capacity for these chemicals in order to enter this market. EPA will use information submitted pursuant to the Inventory Update Rule (40 CFR part 710) to track the production volumes of these chemicals. In the event that the phase-out of these chemicals does not progress as

    [[Page 62328]]

    described in this proposed rule, EPA may pursue additional regulatory action as appropriate under TSCA sections 4, 6, and 8.

  6. Alternatives

    Before proposing this SNUR, EPA considered the following alternative regulatory actions for the chemical substances listed in Tables 2 and 3 of Unit I.A. In addition, EPA determined that these chemical substances are currently not subject to Federal notification requirements.

    1. Promulgate a chemical-specific TSCA section 8(a) reporting rule for the chemical substances listed in Tables 2 and 3 of Unit I.A. Under a TSCA section 8(a) rule, EPA could require any person to report information to the Agency when they intend to manufacture or import the substances listed in Tables 2 and 3 of Unit I.A. for the significant new uses listed in this proposed rule (15 U.S.C. 2607). However, the use of TSCA section 8(a) rather than SNUR authority would not provide the opportunity for EPA to review human and environmental hazards and exposures associated with the new uses of these substances and, if necessary, to take immediate regulatory action under TSCA section 5(e) or section 5(f) to prohibit or limit the activity before it begins. In addition, EPA may not receive important information from small businesses, because those firms generally are exempt from TSCA section 8(a) reporting requirements. In view of EPA's concerns about these chemical substances and its interest in having the opportunity to regulate these substances further as needed, pending the development of exposure and/or hazard information should a significant new use be initiated, the Agency believes that a TSCA section 8(a) rule for those chemical substances would not meet all of EPA's regulatory objectives.

    2. Regulate the chemical substances listed in Tables 2 and 3 of Unit I.A. under TSCA section 6. EPA must regulate under TSCA section 6 if there is a reasonable basis to conclude that the manufacture, import, processing, distribution in commerce, use, or disposal of a chemical substance or mixture ``presents or will present'' an unreasonable risk of injury to human health or the environment. Given the decision by the sole manufacturer 3M to discontinue manufacturing these chemicals, and thus to remove the bulk of the existing potential risk which they present, EPA concluded that risk management action under TSCA section 6 is probably not necessary at this time. This proposed SNUR will allow the Agency to address the potential risks associated with any intended significant new use of these substances. If the phase-out of these chemicals does not occur as anticipated, EPA may reconsider this decision and pursue additional regulatory action as appropriate.

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

    EPA believes 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 proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing.

    Persons who begin commercial manufacture or import of PFOS for the significant new uses listed in this proposed SNUR after the proposal has been published must stop that activity before the effective date of the final rule. Persons who ceased those activities will have to meet all SNUR notice requirements and wait until the end of the notice review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who begin commercial manufacture or import of these chemical substances between the proposal and the effective date of the SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45(h), those persons will be considered to have met the final SNUR requirements for those activities.

  8. Test Data and Other Information

    EPA recognizes that under TSCA section 5, persons are not required to develop any particular test data before submitting a SNUN. Rather, 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 (15 U.S.C. 2604(d); 40 CFR 721.25).

    However, in view of the potential health and environmental risks posed by the significant new uses of the chemical substances listed in Table 2 and Table 3 of Unit I.A., EPA requests that potential SNUN submitters include data that would permit a reasoned evaluation of risks posed by these chemical substances when used for an intended significant new use. EPA currently believes that the known or reasonable ascertainable results of the following tests could help adequately characterize possible health effects of these chemical substances: Reproductive and developmental toxicity studies, mutagenicity, gene mutation, immunotoxicity, neurotoxicity, carcinogenicity, and acute, subchronic, and chronic toxicity studies, as well as pharmacokinetics and mechanistic studies. Because of the specific concerns that EPA has for the persistence and bioaccumulation potential of these chemicals, EPA also encourages SNUN submitters to provide information on environmental fate and transport, specifically including measured values for the octanol/water partition coefficient (log P), log of the soil/sediment adsorption coefficient (log Koc), bioconcentration factor (BCF), melting and/or boiling point, vapor pressure, Henry's Law constant, biodegradation, atmospheric oxidation and the fugacity-based multimedia equilibrium criterion level lll (EQC lll) model (Ref. 10). However, completion of those studies may not be the only means of identifying potential risks. For example, analyses of potential exposure may demonstrate that associated risks would be of low concern. A SNUN submitted without accompanying test data may increase the likelihood that EPA will take action under TSCA section 5(e).

    EPA encourages persons to consult with the Agency before submitting a SNUN for any of the PFOS substances listed in Table 2 or Table 3 of Unit I.A. As part of this optional pre-notice consultation, EPA will discuss specific test data it believes are necessary to evaluate a significant new use of the chemical substances and advise the submitter on the selection of test protocols. The Agency requests that all test data be developed according to the TSCA Good Laboratory Practice Standards in 40 CFR part 792. Failure to do so may result in EPA's finding that submitted data are insufficient to reasonably evaluate the health effects and public health implications of these chemical substances.

    EPA urges SNUN submitters to provide detailed information on human and environmental exposures that would result or could reasonably be anticipated to result from the significant new uses of the chemical substances listed in Table 2 and Table 3 of Unit I.A. and at Sec. 721.9582 of the proposed regulation. In addition, EPA encourages persons to submit information on potential benefits of these chemical substances and information on risks posed by these chemical substances compared to risks posed by possible substitutes.

    [[Page 62329]]

  9. Economic Considerations

    EPA has evaluated the potential costs of establishing a SNUR for PFOS listed in Table 2 and Table 3 of Unit I.A. These potential costs are related to the submission of SNUNs, the export notification requirements of TSCA section 12(b), and the development of test data. EPA notes that, with the possible exception of the export notification requirements, these costs will not be incurred by any company unless that company decides to pursue a significant new use as defined in this SNUR.

    1. SNUNs

      Because of uncertainties related to predicting the number of SNUNs that will be submitted as a result of this SNUR, EPA is unable to calculate the total annual cost of compliance with the final rule. However, EPA estimates that the cost for preparation and submission of a SNUN ranges from approximately $8,500 to $9,800, which includes a $2,500 user fee (Ref. 11). EPA notes that small businesses with annual sales of less than $40 million are subject to a reduced user fee of $100.

      Based on past experience with SNURs and the low number of SNUNs which are submitted on an annual basis, EPA believes that there would be few, if any, SNUNs submitted as a result of this SNUR. Furthermore, no company is required to submit a SNUN for the chemicals listed in this SNUR unless that company decides to begin manufacture or importation those chemicals. As a result, EPA expects that companies would be able to determine if the burden of submitting a SNUN would be likely to create significant adverse economics impacts for the company prior to incurring SNUN-related costs.

    2. Export Notification

      As noted in Unit II.A., persons who 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. 2611 (b)). These provisions require that a company notify EPA of the first shipment to a particular country of an affected chemical. EPA believes that most companies comply with these provisions by compiling a list of products that are subject to TSCA section 12(b) reporting. Outgoing orders are checked to see if the chemical or product is on the list, and whether it is the first shipment to the importing country or the first shipment of the calendar year to that country. If so, a form letter is sent to EPA. In most cases, the entire process is computerized. The estimated cost of the TSCA section 12(b)(1) export notification, which would be required for the first export to a particular country of a chemical subject to the rule, is estimated to be $83.38 for the first time that an exporter must comply with TSCA section 12(b)(1) export notification requirements, and $19.08 for each subsequent export notification submitted by that exporter (Ref. 12).

      EPA is unable to estimate the total number of TSCA section 12(b) notifications that will be received as a result of this SNUR, or the total number of companies that will file these notices. However, EPA expects that the total cost of complying with the export notification provisions of TSCA section 12(b) will be limited based on historical experience with TSCA section 12(b) notifications, the relatively few companies with fluorocarbon production capabilities, and the limited number of chemicals listed in this SNUR. If companies were to manufacture any of the chemicals covered by this SNUR for export only, these companies would incur costs associated with export notification even if these companies decided to forgo any domestic significant new use. EPA is not aware of any companies in this situation, and expects that any potential impact would be limited to the small burden of export notification.

    3. Testing

      In Unit VIII., EPA has identified certain tests that SNUN submitters may choose to conduct to assist EPA in evaluating the risks posed by these chemical substances when used for an intended significant new use. The estimated cost of these tests ranges from $1,450 for the acute oral toxicity test using the up-or-down method to $2.24 million for the 2-species carcinogenicity test by the inhalation route (Ref. 13).

      As noted in Unit VIII., development of any particular test data would be at the discretion of the submitter of the SNUN. EPA is not able to predict which specific tests will be conducted for chemicals that are the subject of SNUNs. However, EPA notes that companies would be able to determine if the burden of developing test data would be likely to create significant adverse economic impacts for the company prior to incurring these testing costs.

  10. References

    These references have been placed in the official record that was established under docket control number OPPTS-50639 for this rulemaking as indicated in Unit I.B.2. Reference documents identified with an administrative record number (AR) are cross-indexed to non-regulatory, publicly accessible information files maintained in the TSCA Nonconfidential Information Center. Copies of these documents can be obtained as described in Unit I.B.2.

    1. (AR226-0620) Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 2000.

    2. (AR226-0547) The Science of Organic Fluorochemistry. 3M. St. Paul, MN. February 5, 1999.

    3. (AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999.

    4. (AR226-0550) Fluorochemical Use, Distribution, and Release Overview. 3M. St. Paul, MN. May 26, 1999.

    5. Rice, Cody. Domestic Manufacturers or Importers of PFOS Chemicals Other Than 3M. USEPA/OPPT/EETD. Washington, DC. August 31, 2000.

    6. (AR226-0600) Weppner, William A. Phase-out Plan for POSF-Based Products. 3M. St. Paul, MN. July 7, 2000.

    7. MacKay, D., DiGuardo, A., Paterson, S., and Cowan, C.E. Evaluating the Environmental Fate of a Variety of Types of Chemicals Using the EQC Model. Environmental Toxicology and Chemistry. SETAC Press. Houston, TX. 1996. Vol. 15, No. 9, pp.1627-1637.

    8. Seed, Jennifer. Hazard Assessment and Biomonitoring Data on Perfluorooctane Sulfonate--PFOS. USEPA/EPA/RAD. Washington, DC. August 31, 2000.

    9. 3M Phasing Out Some of its Specialty Materials. 3M News. 3M. St. Paul, MN. May 16, 2000.

    10. Guidelines for the requested fate and transport data can be found in OPPTS Harmonized Test Guidelines, Series 835, Fate, Transport And Transformation Test Guidelines. These guidelines, both Public Drafts and Finals, are available electronically in PDF (portable document format) on the EPA World Wide Web site, see Unit I.B.1., or in paper by contacting the OPP Public Docket at (703) 305-5805 or by e- mail at: opp-docket@epa.gov. Final guidelines, only, are available from the U.S. Government Printing Office Bookstore, 810 North Capitol St., NW., Washington, DC or by calling (202) 512-1800 and ordering ASCII disks or paper copies. The EQC model is available for download from the Trent University web site at http://www.trentu.ca/envmodel.

    11. (AR 204-001) TSCA Section 5(a)(2) Significant New Use Rules for

      [[Page 62330]]

      Existing Chemicals. ICR #1188.06, OMB No. 2070-0038 (Undated).

    12. (AR 205-001) TSCA Section 12(b) Notification of Chemical Exports. ICR #0795.10, OMB No. 2070-0030 (Undated).

    13. Rice, Cody. Estimated Costs of Testing Recommended for PFOS SNUR. USEPA/OPPT/EETD. Washington, DC. July 25, 2000.

  11. Regulatory Assessment Requirements

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

    Based on EPA's experience with past SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

    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).

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

    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 proposed 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.

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

    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.

    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.

    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. 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 currently engage in such activity. Since a SNUR requires merely 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. As a voluntary action, it is reasonable to presume that this decision would be based on a determination by the person submitting the SNUN that the potential benefits would outweigh the costs. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. 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 fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that, the economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration.

    According to the Paperwork Reduction Act (PRA), 44 USC 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, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9.

    The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188.06). 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 98.96 and 118.92 hours per response at an estimated reporting cost of between $5,957 and $7,192 per SNUN. 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, and maintain the required records. This burden estimate does not include 1 hour of technical time at $64.30 per hour estimated to be required for customer notification of SNUR requirements, or the $2,500 user fee for submission of a SNUN ($100 for businesses with less than $40 million in annual sales).

    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, as instructed in Unit I.C. or to the Director, Collection Strategies Division, Office of Environmental Information,. Environmental Protection Agency (2822), 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.

    List of Subjects in 40 CFR Part 721

    Environmental Protection, Chemicals, Hazardous materials, Recordkeeping and reporting requirements.

    [[Page 62331]]

    Dated: October 12, 2000.

    William H. Sanders, III

    Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as follows:

    PART 721--[AMENDED]

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

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

    2. By adding new Sec. 721.9582 to subpart E to read as follows:

      Sec. 721.9582 Certain perfluorooctyl sulfonates.

      (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances listed in Tables 1 and 2 of this paragraph are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

      Table 1.--Chemicals Requiring a Significant New Use Notice On or After January 1, 2001

      CAS No./PMN

      Ninth Collective Index chemical name

      383-07-3....................................... 2-Propenoic acid, 2- [butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 423-82-5....................................... 2-Propenoic acid, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 2250-98-8...................................... 1-Octanesulfonamide, N,N',N''-[phosphinylidynetris(oxy-2,1- ethanediyl)]tris[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-. 14650-24-9..................................... 2-Propenoic acid, 2-methyl-, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester. 30381-98-7..................................... 1-Octanesulfonamide, N,N'-[phosphinicobis(oxy-2,1- ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, ammonium salt. 55120-77-9..................................... 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluoro-, lithium salt. 57589-85-2..................................... Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3- [[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]- , monopotassium salt. 61660-12-6..................................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3- (trimethoxysilyl)propyl]-. 67969-69-1..................................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2- (phosphonooxy)ethyl]-, diammonium salt. 68156-01-4..................................... Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt. 68329-56-6..................................... 2-Propenoic acid, eicosyl ester, polymer with 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2- propenoate, hexadecyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2- propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2- propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2- propenoate and octadecyl 2-propenoate. 68555-91-9..................................... 2-Propenoic acid, 2-methyl-, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl- 2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate and octadecyl 2-methyl-2-propenoate. 68555-92-0..................................... 2-Propenoic acid, 2-methyl-, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl- 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate and octadecyl 2-methyl-2-propenoate. 68608-14-0..................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N- (hydroxyethyl), reaction products with 1,1'-methylenebis[4- isocyanatobenzene]. 68909-15-9..................................... 2-Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl acrylate, 2-[methyl[(nonafluorobutyl) sulfonyl]amino]ethyl acrylate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(undecafluoropentyl) sulfonyl]amino]ethyl acrylate, polyethylene glycol acrylate Me ether and stearyl acrylate. 70776-36-2..................................... 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2- propenoate, N-(hydroxymethyl)-2-propenamide, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2- propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2- propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2- propenoate. 73772-32-4..................................... 1-Propanesulfonic acid, 3-[[3- (dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2- hydroxy-, monosodium salt. 81190-38-7..................................... 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3- sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N- dimethyl-, hydroxide, monosodium salt. 94133-90-1..................................... 1-Propanesulfonic acid, 3-[[3- (dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]- 2-hydroxy-, monosodium salt. 117806-54-9.................................... 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-, lithium salt. 127133-66-8.................................... 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl methacrylate. 129813-71-4.................................... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N- (oxiranylmethyl). 148240-78-2.................................... Fatty acids, C18-unsatd., trimers, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. 148240-79-3.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters. 148240-80-6.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters. 148240-81-7.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters. 148240-82-8.................................... Fatty acids, C18-unsatd., trimers, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters. 148684-79-1.................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N- methyl, reaction products with 1,6-diisocyanatohexane homopolymer and ethylene glycol. 178535-22-3.................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N- (hydroxyethyl)-, polymers with 1,1'-methylenebis[4- isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked. P-83-1102...................................... Fatty acids, linseed-oil, dimers, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. P-84-1163...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and N,N',2-tris(6-isocyanatohexyl)imidodicarbonic diamide, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2- hydroxyethyl)-1-octanesulfonamide and N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2- hydroxyethyl)-1-heptanesulfonamide, compds. with triethylamine.

      [[Page 62332]]

      P-84-1171...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,1'-methylenebis[4-isocyanatobenzene] and 1,2,3-propanetriol, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2- hydroxyethyl)-1-octanesulfonamide and N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2- hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine. P-86-0301...................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N- methyl, reaction products with 12-hydroxystearic acid and 2,4-TDI, ammonium salts. P-89-0799...................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N- (hydroxyethyl), reaction products with 2-ethyl-1-hexanol and polymethylenepolyphenylene isocyanate. P-94-0545...................................... 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2- propenyl)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl acrylate. P-94-0927...................................... 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2- (hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N- ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amides- blocked. P-94-2205...................................... Polymethylenepolyphenylene isocyanate and bis(4-NCO- phenyl)methane reaction products with 2-ethyl-1-hexanol, 2- butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide. P-94-2206...................................... Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2- propenyl)oxy]propylgroup]-terminated, polymers with 2- [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate. P-96-1645...................................... Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl esters. P-97-0790...................................... 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1- octanesulfonic acid (1:1). P-98-0251...................................... 2-Propenoic acid, butyl ester, polymers with acrylamide, 2- [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride. P-98-1272...................................... 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, polymers with acrylic acid, 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2'- (methylimino)bis[ethanol]. P-99-0188...................................... Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N- methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.- blocked. P-99-0319...................................... Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]- .omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro- C4-8-alkyl)sulfonyl] derivs..

      Table 2.--Chemicals Subject to Volume Cap Restrictions On or After January 1, 2001 and Requiring a Significant New Use Notice On or After January 1, 2003

      CAS No./PMN

      Ninth Collective Index chemical name

      307-35-7.................... 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 307-51-7.................... 1-Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10 ,10-heneicosafluoro- 376-14-7.................... 2-Propenoic acid, 2-methyl-, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl ester 423-50-7.................... 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro- 754-91-6.................... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 1652-63-7................... 1-Propanaminium, 3- [[(heptadecafluorooctyl)sulfonyl]amino]- N,N,N-trimethyl-, iodide 1691-99-2................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)- 1763-23-1................... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 2795-39-3................... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, potassium salt 2991-51-7................... Glycine, N-ethyl-N- [(heptadecafluorooctyl)sulfonyl]-, potassium salt 4151-50-2................... 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro- 17202-41-4.................. 1-Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9- nonadecafluoro-, ammonium salt 24448-09-7.................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)-N- methyl- 25268-77-3.................. 2-Propenoic acid, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl ester 29081-56-9.................. 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, ammonium salt 29117-08-6.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl]-.omega.-hydroxy- 29457-72-5.................. 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, lithium salt 31506-32-8.................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-methyl- 38006-74-5.................. 1-Propanaminium, 3- [[(heptadecafluorooctyl)sulfonyl]amino]- N,N,N-trimethyl-, chloride 38850-58-7.................. 1-Propanaminium, N-(2-hydroxyethyl)-N,N- dimethyl-3-[(3- sulfopropyl)[(tridecafluorohexyl)sulfonyl ]amino]-, inner salt 67584-42-3.................. Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt 67906-42-7.................. 1-Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10 ,10-heneicosafluoro-, ammonium salt 68298-62-4.................. 2-Propenoic acid, 2- [butyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl ester, telomer with 2- [butyl[(pentadecafluoroheptyl)sulfonyl]am ino]ethyl 2-propenoate, methyloxirane polymer with oxirane di-2-propenoate, methyloxirane polymer with oxirane mono-2- propenoate and 1-octanethiol 68541-80-0.................. 2-Propenoic acid, polymer with 2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl 2-methyl-2-propenoate and octadecyl 2-propenoate 68555-90-8.................. 2-Propenoic acid, butyl ester, polymer with 2-[[(heptadecafluorooctyl)sulfonyl] methylamino]ethyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate 68586-14-1.................. 2-Propenoic acid, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl ester, telomer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, .alpha.-(2-methyl-1- oxo-2-propenyl)-.omega.-hydroxypoly(oxy- 1,2-ethanediyl), .alpha.-(2-methyl-1-oxo- 2-propenyl)-.omega.-[(2-methyl-1-oxo-2- propenyl)oxy]poly(oxy-1,2-ethanediyl), 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate and 1-octanethiol

      [[Page 62333]]

      68649-26-3.................. 1-Octanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)-, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2- hydroxyethyl)-1-butanesulfonamide, N- ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-N-(2-hydroxyethyl)-1- heptanesulfonamide, N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N- (2-hydroxyethyl)-1-hexanesulfonamide, N- ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro- N-(2-hydroxyethyl)-1-pentanesulfonamide, polymethylenepolyphenylene isocyanate and stearyl alc. 68867-60-7.................. 2-Propenoic acid, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate and .alpha.-(1-oxo-2- propenyl)-.omega.-methoxypoly(oxy-1,2- ethanediyl) 68867-62-9.................. 2-Propenoic acid, 2-methyl-, 2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl ester, telomer with 2- [ethyl[(nonafluorobutyl)sulfonyl]amino]et hyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]am ino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino ]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino ]ethyl 2-methyl-2-propenoate, 1- octanethiol and .alpha.-(1-oxo-2- propenyl)-.omega.-methoxypoly(oxy-1,2- ethanediyl) 68891-96-3.................. Chromium, diaquatetrachloro[.mu.-[N-ethyl- N- [(heptadecafluorooctyl)sulfonyl]glycinato- .kappa.O:.kappa.O']]-.mu.-hydroxybis(2- methylpropanol)di- 68958-61-2.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2- [ethyl[(heptadecafluorooctyl)sulfonyl]ami no]ethyl]-.omega.-methoxy- 70225-14-8.................. 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-, compd. with 2,2'- iminobis[ethanol] (1:1) 71487-20-2.................. 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2- [[(heptadecafluorooctyl)sulfonyl]methylam ino]ethyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]e thyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]a mino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amin o]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amin o]ethyl 2-propenoate and 2-propenoic acid 91081-99-1.................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-hydroxyethyl)-N- methyl-, polymer with(chloromethyl)oxirane, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2- hydroxyethyl)-N-methyl-1- butanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-N-(2-hydroxyethyl)-N- methyl-1-heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N- (2-hydroxyethyl)-N-methyl-1- hexanesulfonamide and 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2- hydroxyethyl)-N-methyl-1- pentanesulfonamide, hexanedioate (ester) 98999-57-6.................. Sulfonamides, C7-8-alkane, perfluoro, N- methyl-N-[2-[(1-oxo-2-propenyl) oxy]ethyl], polymers with 2-ethoxyethyl acrylate, glycidyl methacrylate and N,N,N- trimethyl-2-[(2-methyl-1-oxo-2- propenyl)oxy]ethanaminiumchloride 182700-90-9................. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-methyl-, reaction products with benzene-chlorine-sulfur chloride (S2Cl2) reaction products chlorides L-92-0151................... 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-methyl-, 2-[ethyl [(heptadecafluorooctyl)sulfonyl]amino]eth yl 2-methyl-2-propenoate, 2- [ethyl[(nonafluorobutyl)sulfonyl]amino]et hyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]am ino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino ]ethyl 2-methyl-2-propenoate, and 2- propenoic acid P-80-0183................... Sulfonamides, C4-8-alkane, perfluoro, N-[3- (dimethylamino)propyl], reaction products with acrylic acid P-86-0958................... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro- C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride P-90-0111................... Sulfonamides, C4-8-alkane, perfluoro, N- methyl-N-[(3-octadecyl-2-oxo-5- oxazolidinyl)methyl] P-91-1419................... Poly(oxy-1,2-ethanediyl), .alpha.-hydro- .omega.-hydroxy-, polymer with 1,6- diisocyanatohexane, N-(2-hydroxyethyl)-N- methyl perfluoro C4-8-alkane sulfonamide- blocked P-93-1444................... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyl)-2- propenamide, 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chloride P-95-0120................... Sulfonamides, C4-8-alkane, perfluoro, N,N'- [1,6-hexanediylbis[[2-oxo-3,5- oxazolidinediyl)methylene]]bis[N-methyl- P-96-1262................... Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether P-96-1424................... 2-Propenoic acid, 2-methyl-, 2- (dimethylamino)ethyl ester, telomers with 2-[ethyl[(perfluoro-C4-8- alkylsulfonyl]amino]ethyl methacrylate and 1-octanethiol, N-oxides P-96-1433................... Sulfonamides, C4-8-alkane, perfluoro, N-[3- (dimethyloxidoamino)propyl], potassium salts

      (2) The significant new uses are:

      (i) Any manufacture or import for any use of any chemical listed in Table 1 of paragraph (a)(1) of this section on or after January 1, 2001.

      (ii) Any manufacture or import for any use of any one or more of the chemicals listed in Table 2 of paragraph (a)(1) of this section in excess of an aggregate volume for all of these chemicals of 1,100,000 pounds per person per calendar year on or after January 1, 2001 and before January 1, 2003.

      (iii) Any manufacture or import for any use of any of the chemicals listed in Table 2 of paragraph (a)(1) of this section on or after January 1, 2003.

      (b) [Reserved].

      [FR Doc. 00-26751Filed10-17-00; 8:45 am]

      BILLING CODE 6560-50-S

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