65 FR 202 pgs. 62319-62333 - Perfluorooctyl Sulfonates; Proposed Significant New Use Rule
Type: PRORULEVolume: 65Number: 202Pages: 62319 - 62333
Docket number: OPPTS-50639; FRL-6745-5
FR document: [FR Doc. 00-26751 Filed 10-17-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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.
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:
I. General Information
A. 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:
| Categories | NAICS codes | Examples of potentially affected entities |
|---|---|---|
| Chemical manufacturers or importers | 325 | Persons who 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 readersregarding entities likely to be affected by this action. Other types of entities not listed in Table 1of 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 mightapply to certain entities. To determine if you or your business is affected by this action, youshould carefully examine the applicability provisions at 40 CFR 721.5 for SNUR-relatedobligations. Also, consult Unit III. Note that because this proposed rule would designate certainmanufacturing and importing activities as significant new uses, persons that solely process thechemical substances that would be covered by this action would not be subject to the rule. Ifyou have any questions regarding the applicability of this action to a particular entity, consult thetechnical person listed under FOR FURTHER INFORMATION CONTACT .
| 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]ethylester | |
| 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-propenoateand octadecyl 2-methyl-2-propenoate | |
| 68555-92-0 | 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethylester, 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 with1,1'-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-propenoateand 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 and2-[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]ethylesters | |
| 148240-79-3 | Fatty acids, C18-unsatd., trimers, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethylesters | |
| 148240-80-6 | Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethylesters | |
| 148240-81-7 | Fatty acids, C18-unsatd., trimers, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethylesters | |
| 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 productswith 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-ethylhexylesters, Me Et ketone oxime-blocked | |
| P-83-1102 | Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethylesters | |
| 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 withN-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide andN-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 productswith12-hydroxystearic acid and 2,4-TDI, ammonium salts | |
| P-89-0799 | Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with2-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 reactionproducts with2-ethyl-1-hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8perfluoroalkanesulfonamide | |
| 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 stearylmethacrylate | |
| P-96-1645 | Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethylesters | |
| 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. |
| 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]amino]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]methylamino]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]amino]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)-, potassiumsalt |
| 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]amino]ethyl ester, telomer with2-[butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, methyloxiranepolymer 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]amino]ethyl2-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]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate,2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate |
| 68586-14-1 | 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, telomer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 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]amino]ethyl 2-propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl2-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]methylamino]ethyl ester, polymer with 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.alpha.-(1-oxo-2-propenyl)-.omega.-methoxypoly(oxy-1,2-ethanediyl) |
| 68867-62-9 | 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester,telomer 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,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]amino]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]methylamino]ethyl 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 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 methacrylateand 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]ethyl 2-methyl-2-propenoate,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, 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 with1,6-diisocyanatohexane, N-(2-hydroxyethyl)-N-methyl perfluoro C4-8-alkanesulfonamide-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 |
B. How Can I get Additional Information, Including Copies of this Document or OtherRelated Documents?
1. Electronically . You may obtain electronic copies of thisdocument and certain other related documents that might be available electronically, from the EPA Internet Home Page athttp://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." Youcan also go directly to the Federal Register listings athttp://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 thisaction under docket control number OPPTS-50639. The official record consists of thedocuments referenced in this action, any public comments received during the comment period,and other information related to this rulemaking, including information claimed as ConfidentialBusiness Information (CBI). This official record includes the documents that are physicallylocated in the docket, as well as all documents that are referenced in those documents. Thepublic version of the official record does not include any information claimed as CBI. Thepublic version of the official record, which includes printed paper versions of any electroniccomments that may be submitted during an applicable comment period, is available forinspection in the TSCA Nonconfidential Information Center, Room NE B-607, 401 MSt., 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.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensureproper receipt by EPA, your comments must identify docket control numberOPPTS-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'sDocument 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 electronicallyby e-mail to: oppt.ncic@epa.gov, or mail or deliver your computer disk to the addressesidentified in Unit I.C.1. or I.C.2. Do not submit any information electronically that youconsider to be CBI. E-mailed comments must be submitted as an ASCII file, avoiding the use ofspecial characters or any form of encryption. Comments will also be accepted on standardcomputer disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic formmust be identified by docket control number OPPTS-50639. Electronic comments mayalso be filed online at many Federal Depository Libraries.
D. 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 mayclaim information that you submit in response to this document as CBI by marking any part orall of that information as CBI. Information so marked will not be disclosed except in accordancewith procedures set forth in 40 CFR part 2. In addition to one complete version of the commentsthat include any information claimed as CBI, a sanitized copy of the comments which does notcontain the information claimed as CBI must be submitted for inclusion in the public version ofthe official record. Information not marked confidential will be included in the public version ofthe official record by EPA without prior notice. If you have any questions about CBI or theprocedures for claiming CBI, consult the technical person listed under FOR FURTHERINFORMATION CONTACT .
E. What Should I Consider as I Prepare My Comments for EPA?
We invite you to provide your views on the various options we propose, newapproaches we have not considered, the potential impacts of the various options (includingpossible unintended consequences), and any data or information that you would like the Agencyto consider during the development of the final SNUR. You may find the following suggestionshelpful 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 yourviews.
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 youare commenting on. To ensure proper receipt by EPA, your comments must identify the docketcontrol number assigned to this action in the subject line on the first page of your response. Youmay also provide the title, date, and Federal Register citation.
II. Background
A. What Action is the Agency Taking?
This proposal would require persons to notify EPA at least 90 days beforecommencing 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 substancesidentified in Table 2 and Table 3 of Unit I.A. include PFOSA, PFOSS, PFOSF, certain higher and lowerhomologues of PFOSA and PFOSF, and certain other chemical substances, including polymers,that contain PFOSA and its homologues as substructures. These chemical substances arecollectively 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 listedin Table 3 of Unit I.A. in excess of an aggregate volume of 1,100,000 pounds per person per calendar yearon 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.
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that ause of a chemical substance is a "significant new use." The Agency makes thisdetermination by rule after considering all relevant factors, including those listed in TSCAsection 5(a)(2). These factors include the volume of a chemical substance's production; theextent to which a use changes the type, form, magnitude, or duration of exposure to thesubstance; and the reasonably anticipated manner of producing or otherwise managing thesubstance. Once EPA makes this determination and promulgates a SNUR, TSCA section5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90days before they manufacture, import, or process the chemical substance for that significant newuse (15 U.S.C. 2604 (a)(1)(B)).
C. 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 toreporting requirements, and applicability of the rule to uses occurring before the effective date ofthe final rule. Note that because this proposed rule would designate certain manufacturing andimporting activities as significant new uses, persons that solely process the chemical substancesthat would be covered by this action would not be subject to the rule. Provisions relating to userfees appear at 40 CFR part 700. Persons subject to this proposed SNUR would be required tocomply 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: theinformation 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 ofTSCA 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 nottake action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
III. 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 higherand lower homologues of PFOSA and PFOSF, and certain other chemical substances, includingpolymers, that contain PFOSA and its homologues as substructures. All of these chemicalsubstances are referred to collectively in this proposed rule as perfluorooctyl sulfonates, orPFOS. All of these chemical substances have the potential to degrade back to PFOSA in theenvironment, and PFOSA does not degrade further. PFOSA is highly persistent in theenvironment and has a strong tendency to bioaccumulate. Studies have found PFOS in verysmall quantities in the blood of the general human population as well as in wildlife, indicatingthat exposure to the chemicals is widespread, and recent tests have raised concerns about theirpotential 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 overtime 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 manufacturedand 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 bydiscontinuing the manufacture of certain of these chemical substances on a global basis for theirmost widespread uses by the end of December 2000, by steadily reducing their productionvolume on the remaining chemicals through 2001 and 2002, and by entirely discontinuing themanufacture of all of these PFOS chemicals by December 31, 2002 (Ref. 6). The chemicalslisted 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, andthen to cease manufacturing by December 31, 2002. EPA believes that any manufacture orimport of these PFOS chemicals occurring after 3M's global phase-out dates would increase themagnitude and duration of exposure to these chemicals. Therefore, EPA is proposing todesignate 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. inexcess of an aggregate annual manufacture and import volume cap for all of these chemicals of1,100,000 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 Table 3 of Unit I.A. on or after January 1, 2003.
Given that no companies other than 3M are currently producing the chemicals listedon Table 3 of Unit I.A., and given the negative commercial and regulatory environment associated with thesechemicals, EPA believes it is unlikely that companies would incur the costs associated withestablishing new manufacturing capacity for these chemicals in order to enter this market.
This proposed rule, when finalized, would require persons who intend tomanufacture or import the PFOS chemicals listed in this proposed rule to notify EPA, throughthe submission of a SNUN, at least 90 days before commencing the manufacture or importationof any of these chemicals for any use designated by this proposed SNUR as a significant newuse. 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 aresummarized in the following Table 4:
| You must file a significant new use notice (SNUN) if you: | Manufacture or import: | When? | How much? |
|---|---|---|---|
| Chemical substances listed in Table 2 of Unit I.A. | After December 31, 2000 | Any amount | |
| Chemical substances listed in Table 3 of Unit I.A. | January 1, 2001 through December 31, 2002 | Aggregate amount exceeding 1,100,000 lbs per person per calendar year | |
| Chemical substances listed in Table 3 of Unit I.A. | After December 31, 2002 | Any amount |
IV. Chemical Compound History
A. 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 chemicalnames 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 thisproposed SNUR (for example, entry #8 on Table 3 of Unit I.A. lists CAS No.1763-23-1for 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 inTable 2 and Table 3 of Unit I.A. have a common chemical structure consisting of a PFOS moiety, asillustrated here, somewhere in the molecule.
[Federal Register graphic "EP18oc00.044" is not available. Please view the graphic in the PDF version of this document.]
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 differentchemical functionality (free acids (Y = OH), metal salts (Y = O - M+ ), sulfonyl halides (Y = X), sulfonamides (Y= NH2 ), and other derivatives). The listed chemical substances also include polymers.
The class of chemical substances including the perfluoroalkyl sulfonyl moietydescribed by the structure shown in this unit contains more chemical substances than are specified inthe lists in Table 2 and Table 3 of Unit I.A. Only the listed chemical substances, which are manufactured orimported exclusively by 3M and which 3M has voluntarily committed to cease producing, aresubject to this SNUR. EPA is evaluating further this overall structural class of chemicalsubstances and may take additional regulatory action as appropriate.
B. Environmental Fate
The basic building block of all of the PFOS chemicals is PFOSF, which is used as anintermediate in the production of the PFOS chemicals. PFOSA results from the chemical orenzymatic hydrolysis of PFOSF. Current information strongly supports that PFOSA is anextremely stable substance which resists breakdown by chemical or biological processes.Therefore PFOSA is the ultimate degradation product from PFOS chemicals and will persist inthat form (Refs. 1 and 2).
EPA cannot currently conduct a definitive assessment of the environmental transportand partitioning of PFOS. The available data are limited and their accuracy uncertain. Also, theaccuracy of the estimation models is limited by the quality of data input into them. Dependingon what data are consulted and utilized, the environmental fate and transport of PFOS vary.Biological sampling recently discovered the presence of certain perfluoroalkyl compounds infish and in fish-eating birds across the United States and in locations in Canada, Sweden, and theSouth Pacific (Ref. 1). The wide distribution of the chemicals in high trophic levels is stronglysuggestive of the potential for bioaccumulation/bioconcentration. The widespread presence ofPFOS suggests the possibility of transport in air as well as water, but the multimedia equilibriumcriterion model (EQC) suggests otherwise (Ref. 7). Using data provided by 3M as inputs, themodel 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 andwater 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 watersolubility 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 andEffects (Ref. 1). These Henry's Law values suggest that volatilization from water to air isnot very likely. According to 3M, testing is planned and/or underway for the environmentalproperties, fate, and transport of PFOS (Ref. 1). With more complete data, EPA would be able tomake more definitive assessments. With the present data, the Agency can only speculate onenvironmental transport and partitioning of PFOS, although current information suggestsstrongly that it is persistent and may bioaccumulate.
C. Health Effects
The Agency's hazard analysis for PFOS is a review of health hazard andbiomonitoring data (Ref. 8). Toxicology studies show that PFOS is well absorbed orally anddistributes primarily in the serum and liver. PFOS can also be formed as a metabolite of otherperfluorinated sulfonates. It does not appear to be further metabolized. Elimination from thebody is slow and occurs via both urine and feces. Serum PFOS levels in three retired male 3Mchemical workers have been followed for 5½ years and suggest a mean elimination half-life (t ½) of 1,428 days (approximately 4 years). Based on thepharmacokinetic data obtained from a 28-day oral study in male and female monkeys, a volumeof distribution (Vd) of 0.19 L/kilogram (kg) was reported; no sex differences in thepharmacokinetic parameters were noted.
PFOS has shown moderate acute toxicity by the oral route with a rat LD 50 of 251 mg/kg. A 1-hour LC 50 of 5.2 mg/L in rats has been reported. PFOS was foundto be mildly irritating to the eyes and non-irritating to the skin of rabbits. PFOS was negative inmutagenicity 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 andprimates. Adverse signs of toxicity observed in rat studies included increases in liver enzymes,hepatic vacuolization and hepatocellular hypertrophy, gastrointestinal effects, hematologicalabnormalities, weight loss, convulsions, and death. These effects were reported at doses of 2mg/kg/day and above. Adverse signs of toxicity observed in Rhesus monkey studies includedanorexia, emesis, diarrhea, hypoactivity, prostration, convulsions, atrophy of the salivary glandsand 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 monkeyssurvived beyond 3 weeks into treatment at 10 mg/kg/day, or beyond 7 weeks into treatment atdoses as low as 4.5 mg/kg/day. At doses as low as 0.75 mg/kg/day, Cynomolgus monkeysexhibited low food consumption, excessive salivation, labored breathing, hypoactivity, ataxia,hepatic vacuolization and hepatocellular hypertrophy, significant reductions in serum cholesterollevels, and death.
Postnatal deaths and other developmental effects were reported at low doses inoffspring in a 2-generation reproductive toxicity study in rats. At the two highest doses of 1.6and 3.2 mg/kg/day, pup survival in the first generation was significantly decreased. All firstgeneration offspring (F1 pups) at the highest dose died within a day after birth while close to30% of the F1 pups in the 1.6 mg/kg/day dose group died within 4 days after birth. As a resultof the pup mortality in the two top dose groups, only the two lowest dose groups, 0.1 and 0.4mg/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 generationoffspring (F2 pups) were 0.1 mg/kg/day and 0.4 mg/kg/day, respectively, based on reductions inpup body weight. Reversible delays in reflex and physical development were also observed inthis study, raising concerns about the potential for developmental neurotoxicity followingexposure to PFOS.
Developmental effects were also reported in prenatal developmental toxicity studiesin the rat and rabbit, although at slightly higher dose levels. Signs of developmental toxicitywere 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 visceralanomalies, delayed ossification, and skeletal variations were observed. Abnormalities of the lensof the eye were also reported at doses as low as 1 mg/kg/day in one rat prenatal developmentalstudy, but could not be repeated in a second study of similar design. At doses of 2.5 mg/kg/dayand above, significant reductions in fetal-body weight and significant increases in delayedossification were observed in rabbits administered PFOS during gestation.
In human blood samples, PFOS has been detected in the serum of occupational andgeneral populations in the parts per million (ppm) to parts per billion (ppb) range. In the UnitedStates, recent blood serum levels of PFOS in manufacturing employees have been as high as12.83 ppm, while in the general population, serum collected from blood banks and commercialsources have indicated mean PFOS levels of 30-44 ppb. Levels in a very small sampleof 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 Stateshas shown widespread distribution of PFOS. In recent analyses, PFOS was detected in the ppbrange in the plasma of several species of eagles, wild birds, and fish. Endogenous levels ofPFOS have also been detected in the ppb range in the livers of unexposed rats used in toxicitystudies, 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 thereproductive and subchronic toxicity of the chemical, raises concerns for potential adverseeffects on people and wildlife over time should the chemical substances continue to beproduced, released, and accumulated in the environment.
D. Exposure Data
As indicated in Unit IV.C., PFOS has been detected at low levels in the blood ofhumans and wildlife throughout the United States, providing clear evidence of widespreadexposure to the chemical. PFOS has been in commercial use since the 1950's, predominantly insoil and stain-resistant coating products on fabrics, carpets, and leather, and in grease and oilresistant coatings on paper products, including food contact papers. Other uses leading toenvironmental releases include fire fighting foams. The various surface treatment uses constitutethe largest volume of PFOS production and are believed to present the greatest potential forwidespread human and environmental exposure to PFOS. Studies are underway to determine theroutes of exposure which have led to the detection of PFOS in human and animal blood. Thereare 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, andconsumer use and disposal of PFOS-derived chemicals and products.
E. 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, andperformance chemicals (Ref. 4). The various surface treatment and paper protection usesconstitute the largest volume of PFOS production and are believed to present the greatestpotential for widespread human and environmental exposure to PFOS.
PFOS chemicals produced for surface treatment applications provide soil, oil, andwater resistance to personal apparel and home furnishings. Specific applications in this usecategory include protection of apparel and leather, fabric/upholstery, and carpet. Theseapplications are undertaken in industrial settings by customers such as textile mills, leathertanneries, finishers, fiber producers, and carpet manufacturers. PFOS chemicals are also used inaftermarket treatment of apparel and leather, upholstery, carpet, and automobile interiors by thegeneral public or professional applicators (Ref. 4). In 2000, the domestic production volume ofPFOS 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, andwater resistance to paper and paperboard as part of a sizing agent formulation. Specificapplications 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, aswell as non-food contact applications (folding cartons, containers, carbonless forms, andmasking papers). The application of sizing agents is undertaken mainly by paper mills and, tosome extent, converters who manufacture bags, wraps, and other products from paper andpaperboard (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this usecategory is estimated to be approximately 2.7 million pounds (Ref. 6).
PFOS chemicals in the performance chemicals category are used in a wide variety ofspecialized industrial, commercial, and consumer applications. Specific applications include firefighting foams, mining and oil well surfactants, acid mist suppressants for metal plating andelectronic etching baths, alkaline cleaners, floor polishes, photographic film, denture cleaners,shampoos, chemical intermediates, coating additives, carpet spot cleaners, and as an insecticidein bait stations for ants (Ref. 4). In 2000, the domestic production volume of PFOS chemicalsfor 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 releaseannouncing that it would discontinue the production of perfluorooctanyl chemicals used toproduce 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). Insubsequent correspondence with the Agency, 3M provided a schedule documenting its completeplan for discontinuing all manufacture of specific PFOS and related chemicals for most surfacetreatment and paper protection uses (including food contact uses regulated by the FDA) by theend of 2000, and discontinuing all manufacture for any uses by the end of 2002 (Ref. 6). Thisschedule, and 3M's anticipated production volumes, are summarized in Table 5.
| 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 solemanufacturer of PFOS chemicals affected by this proposed SNUR (Ref. 5). 3M plans todiscontinue the manufacture of the chemicals identified in Table 2 of Unit I.A. (in general, those associatedwith surface treatment and paper protection uses) by the end of 2000 and to discontinue thechemicals identified in Table 3 of Unit I.A. (in general, those associated with performance chemicalapplications) by the end of 2002.
V. Objectives and Rationale for this Proposed Rule
In determining what would constitute a significant new use for the chemicalsubstances that are the subjects of this proposed SNUR, EPA considered relevant information onthe toxicity of the substances, likely exposures associated with potential uses, informationprovided 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 withregard to the significant new uses that are designated in this proposed rule. EPA wants to ensurethat:
1. EPA would receive notice of any person's intent to manufacture or import PFOSchemicals for a designated significant new use before that activity begins.
2. EPA would have an opportunity to review and evaluate data submitted in aSNUN before the notice submitter begins manufacturing or importing the subject chemicalsubstances 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 listedon Table 3 of Unit I.A., and given the negative commercial and regulatory environment associated with thesechemicals, EPA believes it is unlikely that companies would incur the costs associated withestablishing new manufacturing capacity for these chemicals in order to enter this market. EPAwill use information submitted pursuant to the Inventory Update Rule (40 CFR part 710) to trackthe production volumes of these chemicals. In the event that the phase-out of these chemicalsdoes not progress as described in this proposed rule, EPA may pursue additional regulatoryaction as appropriate under TSCA sections 4, 6, and 8.
VI. 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 thatthese chemical substances are currently not subject to Federal notification requirements.
1. Promulgate a chemical-specific TSCA section 8(a) reporting rule for the chemicalsubstances listed in Tables 2 and 3 of Unit I.A. Under a TSCA section 8(a) rule, EPA could require anyperson to report information to the Agency when they intend to manufacture or import thesubstances listed in Tables 2 and 3 of Unit I.A. for the significant new uses listed in this proposed rule (15U.S.C. 2607). However, the use of TSCA section 8(a) rather than SNUR authority would notprovide the opportunity for EPA to review human and environmental hazards and exposuresassociated with the new uses of these substances and, if necessary, to take immediate regulatoryaction 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 thosefirms generally are exempt from TSCA section 8(a) reporting requirements. In view of EPA'sconcerns about these chemical substances and its interest in having the opportunity to regulatethese substances further as needed, pending the development of exposure and/or hazardinformation should a significant new use be initiated, the Agency believes that a TSCA section8(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 themanufacture, import, processing, distribution in commerce, use, or disposal of a chemicalsubstance or mixture "presents or will present" an unreasonable risk of injury to humanhealth or the environment. Given the decision by the sole manufacturer 3M to discontinuemanufacturing these chemicals, and thus to remove the bulk of the existing potential risk whichthey present, EPA concluded that risk management action under TSCA section 6 is probably notnecessary at this time. This proposed SNUR will allow the Agency to address the potential risksassociated with any intended significant new use of these substances. If the phase-out of thesechemicals does not occur as anticipated, EPA may reconsider this decision and pursue additionalregulatory action as appropriate.
VII. Applicability of Proposed Rule to Uses Occurring Before the Effective Dateof the Final Rule
EPA believes that the intent of TSCA section 5(a)(1)(B) is best served bydesignating a use as a significant new use as of the proposal date of the SNUR, rather than as ofthe effective date of the final rule. If uses begun after publication of the proposed SNUR wereconsidered to be ongoing, rather than new, it would be difficult for EPA to establish SNURnotice requirements, because any person could defeat the SNUR by initiating the proposedsignificant 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 significantnew uses listed in this proposed SNUR after the proposal has been published must stop thatactivity before the effective date of the final rule. Persons who ceased those activities will haveto 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 substancesbetween the proposal and the effective date of the SNUR meet the conditions of advancecompliance as codified at 40 CFR 721.45(h), those persons will be considered to have met thefinal SNUR requirements for those activities.
VIII. Test Data and Other Information
EPA recognizes that under TSCA section 5, persons are not required to develop anyparticular test data before submitting a SNUN. Rather, persons are required only to submit testdata in their possession or control and to describe any other data known to, or reasonablyascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25).
However, in view of the potential health and environmental risks posed by thesignificant new uses of the chemical substances listed in Table 2 and Table 3 of Unit I.A., EPA requests thatpotential SNUN submitters include data that would permit a reasoned evaluation of risks posedby these chemical substances when used for an intended significant new use. EPA currentlybelieves that the known or reasonable ascertainable results of the following tests could helpadequately characterize possible health effects of these chemical substances: Reproductive anddevelopmental toxicity studies, mutagenicity, gene mutation, immunotoxicity, neurotoxicity,carcinogenicity, and acute, subchronic, and chronic toxicity studies, as well as pharmacokineticsand mechanistic studies. Because of the specific concerns that EPA has for the persistence andbioaccumulation potential of these chemicals, EPA also encourages SNUN submitters to provideinformation 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'sLaw constant, biodegradation, atmospheric oxidation and the fugacity-based multimediaequilibrium criterion level lll (EQC lll) model (Ref. 10). However, completion of those studiesmay not be the only means of identifying potential risks. For example, analyses of potentialexposure may demonstrate that associated risks would be of low concern. A SNUN submittedwithout accompanying test data may increase the likelihood that EPA will take action underTSCA section 5(e).
EPA encourages persons to consult with the Agency before submitting a SNUN forany of the PFOS substances listed in Table 2 or Table 3 of Unit I.A. As part of this optional pre-noticeconsultation, EPA will discuss specific test data it believes are necessary to evaluate a significantnew 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 LaboratoryPractice Standards in 40 CFR part 792. Failure to do so may result in EPA's finding thatsubmitted data are insufficient to reasonably evaluate the health effects and public healthimplications of these chemical substances.
EPA urges SNUN submitters to provide detailed information on human andenvironmental exposures that would result or could reasonably be anticipated to result from thesignificant new uses of the chemical substances listed in Table 2 and Table 3 of Unit I.A. and at§ 721.9582 of the proposed regulation. In addition, EPA encourages persons tosubmit information on potential benefits of these chemical substances and information on risksposed by these chemical substances compared to risks posed by possible substitutes.
IX. Economic Considerations
EPA has evaluated the potential costs of establishing a SNUR for PFOS listed inTable 2 and Table 3 of Unit I.A. These potential costs are related to the submission of SNUNs, the exportnotification requirements of TSCA section 12(b), and the development of test data. EPA notesthat, with the possible exception of the export notification requirements, these costs will not beincurred by any company unless that company decides to pursue a significant new use as definedin this SNUR.
A. SNUNs
Because of uncertainties related to predicting the number of SNUNs that will besubmitted as a result of this SNUR, EPA is unable to calculate the total annual cost ofcompliance with the final rule. However, EPA estimates that the cost for preparation andsubmission of a SNUN ranges from approximately $8,500 to $9,800, whichincludes a $2,500 user fee (Ref. 11). EPA notes that small businesses with annual salesof 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 aresubmitted on an annual basis, EPA believes that there would be few, if any, SNUNs submitted asa result of this SNUR. Furthermore, no company is required to submit a SNUN for thechemicals listed in this SNUR unless that company decides to begin manufacture or importationthose chemicals. As a result, EPA expects that companies would be able to determine if theburden of submitting a SNUN would be likely to create significant adverse economics impactsfor the company prior to incurring SNUN-related costs.
B. Export Notification
As noted in Unit II.A., persons who intend to export a chemical substance identifiedin a proposed or final SNUR are subject to the export notification provisions of TSCA section12(b) (15 U.S.C. 2611 (b)). These provisions require that a company notify EPA of the firstshipment to a particular country of an affected chemical. EPA believes that most companiescomply with these provisions by compiling a list of products that are subject to TSCA section12(b) reporting. Outgoing orders are checked to see if the chemical or product is on the list, andwhether it is the first shipment to the importing country or the first shipment of the calendar yearto that country. If so, a form letter is sent to EPA. In most cases, the entire process iscomputerized. The estimated cost of the TSCA section 12(b)(1) export notification, which wouldbe required for the first export to a particular country of a chemical subject to the rule, isestimated to be $83.38 for the first time that an exporter must comply with TSCA section12(b)(1) export notification requirements, and $19.08 for each subsequent exportnotification submitted by that exporter (Ref. 12).
EPA is unable to estimate the total number of TSCA section 12(b) notifications thatwill be received as a result of this SNUR, or the total number of companies that will file thesenotices. However, EPA expects that the total cost of complying with the export notificationprovisions of TSCA section 12(b) will be limited based on historical experience with TSCAsection 12(b) notifications, the relatively few companies with fluorocarbon productioncapabilities, and the limited number of chemicals listed in this SNUR. If companies were tomanufacture any of the chemicals covered by this SNUR for export only, these companies wouldincur costs associated with export notification even if these companies decided to forgo anydomestic significant new use. EPA is not aware of any companies in this situation, and expectsthat any potential impact would be limited to the small burden of export notification.
C. Testing
In Unit VIII., EPA has identified certain tests that SNUN submitters maychoose to conduct to assist EPA in evaluating the risks posed by these chemical substances whenused 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 $2.24million 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 ofthe submitter of the SNUN. EPA is not able to predict which specific tests will be conducted forchemicals that are the subject of SNUNs. However, EPA notes that companies would be able todetermine if the burden of developing test data would be likely to create significant adverseeconomic impacts for the company prior to incurring these testing costs.
X. References
These references have been placed in the official record that was established underdocket 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 theTSCA Nonconfidential Information Center. Copies of these documents can be obtained asdescribed 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 HumanSera, 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 ofPFOS Chemicals Other Than 3M. USEPA/OPPT/EETD. Washington, DC. August 31, 2000.
6. (AR226-0600) Weppner, William A. Phase-out Plan for POSF-BasedProducts. 3M. St. Paul, MN. July 7, 2000.
7. MacKay, D., DiGuardo, A., Paterson, S., and Cowan, C.E. Evaluating theEnvironmental Fate of a Variety of Types of Chemicals Using the EQC Model. EnvironmentalToxicology and Chemistry. SETAC Press. Houston, TX. 1996. Vol. 15, No. 9,pp.1627-1637.
8. Seed, Jennifer. Hazard Assessment and Biomonitoring Dataon 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 OPPTSHarmonized 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 OPPPublic 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 papercopies. The EQC model is available for download from the Trent University web site athttp://www.trentu.ca/envmodel.
11. (AR 204-001) TSCA Section 5(a)(2) Significant New Use Rules for 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 forPFOS SNUR. USEPA/OPPT/EETD. Washington, DC. July 25, 2000.
XI. Regulatory Assessment Requirements
Under Executive Order 12866, entitled Regulatory Planning andReview (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB)has determined that SNURs are not a "significant regulatory action" subject toreview 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 governmentshave not been impacted by these rulemakings, and EPA does not have any reasons to believe thatany State, local, or tribal government will be impacted by this rulemaking. As such, EPA hasdetermined that this regulatory action does not impose any enforceable duty, contain anyunfunded mandate, or otherwise have any affect on small governments subject to therequirements 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 withIndian 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 relationshipbetween the national government and the States, or on the distribution of power andresponsibilities 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 errorsand ambiguity, minimize potential litigation, and provide a clear legal standard for affectedconduct, as required by section 3 of Executive Order 12988, entitled Civil JusticeReform (61 FR 4729, February 7, 1996).
EPA has complied with Executive Order 12630, entitled GovernmentalActions 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 Avoidanceof Unanticipated Takings" issued under the Executive Order.
This action does not involve special considerations of environmental justice relatedissues as required by Executive Order 12898, entitled Federal Actions to AddressEnvironmental Justice in Minority Populations and Low-Income Populations (59 FR 7629,February 16, 1994).
This action is not subject to Executive Order 13045, entitled Protectionof 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 ExecutiveOrder 12866, and this action does not address environmental health or safety risksdisproportionately 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 Law104-113, 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 havea significant adverse economic impact on a substantial number of small entities. A SNURapplies to any person (including small or large entities) who intends to engage in any activitydescribed 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 nosmall or large entities currently engage in such activity. Since a SNUR requires merely that anyperson who intends to engage in such activity in the future must first notify EPA (by submittinga SNUN), no economic impact will even occur until someone decides to engage in thoseactivities. As a voluntary action, it is reasonable to presume that this decision would be based ona determination by the person submitting the SNUN that the potential benefits would outweighthe costs. Although some small entities may decide to conduct such activities in the future, EPAcannot presently determine how many, if any, there may be. EPA's experience to date is that, inresponse to the promulgation of over 530 SNURs, the Agency has received fewer than 15SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expectsto 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 expectedto be significant or adversely impact a substantial number of small entities. This rationale hasbeen 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 acollection of information that requires OMB approval under the PRA, unless it has beenapproved by OMB and displays a currently valid OMB control number. The OMB controlnumbers for EPA's regulations, after initial display in the Federal Register andin 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 beenapproved 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 anentity were to submit a SNUN to the Agency, the annual burden is estimated to average between98.96 and 118.92 hours per response at an estimated reporting cost of between $5,957and $7,192 per SNUN. This burden estimate includes the time needed to reviewinstructions, 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 hourestimated to be required for customer notification of SNUR requirements, or the $2,500user fee for submission of a SNUN ($100 for businesses with less than $40million in annual sales).
Send any comments about the accuracy of the burden estimate, and any suggestedmethods for minimizing respondent burden, including through the use of automated collectiontechniques, as instructed in Unit I.C. or to the Director, Collection Strategies Division, Office ofEnvironmental Information,. Environmental Protection Agency (2822), 1200 Pennsylvania Ave.,NW., Washington, DC 20460. Please remember to include the OMB control number in anycorrespondence, 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.
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 § 721.9582 to subpart E to read asfollows:
§ 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.
| 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]ethylester | |
| 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-propenoateand octadecyl 2-methyl-2-propenoate | |
| 68555-92-0 | 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethylester, 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 with1,1'-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-propenoateand 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 and2-[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]ethylesters | |
| 148240-79-3 | Fatty acids, C18-unsatd., trimers, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethylesters | |
| 148240-80-6 | Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethylesters | |
| 148240-81-7 | Fatty acids, C18-unsatd., trimers, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethylesters | |
| 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 productswith 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-ethylhexylesters, Me Et ketone oxime-blocked | |
| P-83-1102 | Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethylesters | |
| 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 withN-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide andN-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 productswith12-hydroxystearic acid and 2,4-TDI, ammonium salts | |
| P-89-0799 | Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with2-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 reactionproducts with2-ethyl-1-hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8perfluoroalkanesulfonamide | |
| 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 stearylmethacrylate | |
| P-96-1645 | Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethylesters | |
| 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. |
| 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]amino]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]methylamino]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]amino]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)-, potassiumsalt |
| 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]amino]ethyl ester, telomer with2-[butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, methyloxiranepolymer 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]amino]ethyl2-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]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate,2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate |
| 68586-14-1 | 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, telomer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 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]amino]ethyl 2-propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl2-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]methylamino]ethyl ester, polymer with 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.alpha.-(1-oxo-2-propenyl)-.omega.-methoxypoly(oxy-1,2-ethanediyl) |
| 68867-62-9 | 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester,telomer 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,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]amino]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]methylamino]ethyl 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 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 methacrylateand 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]ethyl 2-methyl-2-propenoate,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, 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 with1,6-diisocyanatohexane, N-(2-hydroxyethyl)-N-methyl perfluoro C4-8-alkanesulfonamide-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 chemicalslisted in Table 2 of paragraph (a)(1) of this section in excess of an aggregate volume for all ofthese chemicals of 1,100,000 pounds per person per calendar year on or after January 1, 2001and 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. 00-26751 Filed 10-17-00; 8:45 am]
BILLING CODE 6560-50-S