Document 44YZe5rpkZvpowLeg1zKq0rEx

-Pt({ Jl SlQ _ /// -teosc,^ UNITED STATES EN VIRO NM EN TAL PROTECTION AGENCY WASHINGTON D.C., 20460 September 5, 2002 OFFICE 0F PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Mr. Richard Sigman Organisation for Economie Cooperation and Development Environment Directorate Re: Response to Questions about Risk Management Activities on PFOS Dear Mr. Sigman: ersos CO m~o o ro "U O r o --im 55* t ^ fr\ 55 o O jr* This letter contains the responses of the United States to the questions presented in Rob Visser's letter of June 12, 2002, concerning risk management activities in the United States on perfluorooctane sulfonate and its salts (PFOS). 1. Have you identified the exposure situation in your country? If so, please provide details as appropriate (note that the assessment report on PFOS includes some exposure information gathered for OECD countries and non-Member countries; please verify or amend this information as appropriate). If you haven't yet identified the exposure situation, do you plan to do so? A. To the extent that exposures in the United States have been identified, they are described in the OECD assessment report on PFOS. Actual exposure levels and routes for the general population and for wildlife are not known, but study data documenting internal dose as described by blood serum levels of PFOS in humans and PFOS concentrations in various tissues in wildlife form part of the background materials used in the OECD assessment report, and are publicly available from the Toxic Substances Control Act (TSCA) Non-Confidential Information Center (NCIC). Persons wishing to access this information can request a copy of the Index to Administrative Record AR-226 by sending email to the NCIC at oppt.ncic@epa.gov. Individual documents in AR-226 can be obtained from the NCIC in Portable Document Format (PDF) files either by email or on CD-ROM, and information on those options is available from the NCIC. Some of this information is also located in docket OPPTS-50639, which is also available from the NCIC. OOOOOl 2. Does your country currently regulate (or plan to regulate) the production, importation, or use of PFOS compounds? A. Yes. 3. If your country regulates, or plans to regulate PFOS substances: 3.a.l please summarise the control action, date of implementation (or date the regulation will be proposed), and chemicals covered by the action. A. The U.S. Environmental Protection Agency published a proposed Significant New Use Rule (SNUR) on 90 PFOS chemicals on October 18, 2000 (65 FR 62319). This proposed rule identified new manufacture or importation of these chemicals into the United States as a significant new use which would require prior notification to the Agency, which would then have the opportunity to review the proposed use and determine whether or not, or under what conditions, to allow the use, based on the impact the use would have on the type, form, magnitude, and duration of exposure to the chemicals. That rule was made final with respect to 13 chemicals on March 11, 2002, and two chemicals that had been included in the original proposal in error were removed from the list (67 FR 11008). This final rule became effective on April 11, 2002. On the same day, the Agency published a supplemental proposed rule on the 75 remaining chemicals, which proposed to amend the definition of a significant new use to exclude certain specifically identified low volume, low release, and controlled exposure uses in semiconductor manufacturing, aviation hydraulics, and analog and digital imaging (67 FR 11014). This proposal would allow the chemicals to be manufactured or imported for use only in these specific applications without requiring prior notice to the Agency. This proposal, and the final rule published the same day, both adopted the designation of "perfluoroalkyl sulfonates," or PFAS, as the collective name for the chemicals rather than PFOS, since many of the chemicals included a range of carbon chain lengths in addition to the 8-carbon characteristic of PFOS. A final rule concerning these chemicals is expected to be published in Fall 2002. A Portable Document Format (PDF) file copy of the final and supplemental proposed rules is attached. These publications include tables fisting the specific chemicals which are subject to the rules, which are not reproduced here because of their length. 3.a.2 what PFOS substances (or uses) are not covered (or will not be covered) in the regulation and why? A. The final and supplemental proposed SNURs apply only to substances that were publicly discontinued by 3M. To issue a SNUR on an existing chemical, the Agency must have information that the chemical is not currently being employed in the use which is being defined as significant and new. There are more PFOS substances on the Toxic Substances Control Act (TSCA) Inventory of chemicals which were not included in these particular regulatory actions, because they had not been publicly withdrawn from commerce and 000002 thus did not immediately lend themselves to control through this type of action. The Agency is continuing to evaluate these chemicals and its regulatory options. The supplemental proposed SNUR proposes to exclude from the regulated use definition certain specifically defined uses of the listed chemicals in semiconductor manufacturing, aviation hydraulics, and analog and digital imaging. The rationale behind this proposal is that these uses are very low volume, and take place under conditions of controlled exposure and limited release. In addition, no viable alternatives to PFOS have yet been identified to meet the technical requirements of these uses. 4. Are you aware of (or involved with) any voluntary agreement with industry (or initiative by industry) to phase out the production and/or use of PFOS substances? If so, please describe the agreement, and deadline(s) for the phase-out. A. Yes. 3M submitted to the Agency a plan for the phaseout of its PFOS products which terminated most production by the end of 2000, and which phased out the remainder of these products by the end of 2002. The final and supplemental proposed SNURs effectively extend that phaseout from a voluntary unilateral action by 3M to the entire U.S. market. Copies of the 3M phaseout plan can be obtained as described in the response to question 1 of this survey, by requesting document AR226-0600. In addition, comments on the supplemental proposed SNUR submitted by the Eastman Kodak Company on behalf of the imaging industry document efforts on the part of that industry to reduce the use of PFOS substances. The imaging industry comments can be obtained by requesting document C2-007 (or C2-007a, for an electronic version) in Docket OPPTS-50639, as described in the response to question 1. 5. Has your country taken action (or does it plan to take action) on PFAS (perfluoroalkyl sulfonates)? If so, please answer questions 1 - 4 for PFAS. (PFAS is a generic term that includes PFOS chemicals. One OECD country has initiated regulatory action on the entire category of PFAS.) A. As explained in the response to question 3 .a. 1., the United States regulation uses PFAS as the collective descriptor for the chemicals subject to the final and proposed rules. These rules apply to a number of chemicals that include a range of high and lower homologues, although all of the chemicals subject to the rules include as part of that range the 8-carbon chain length characteristic of PFOS. We hope that this information is helpful to you. Sincerely, Attachment Charles M. Auer, Director Chemical Control Division 000003 Federal R egister/Voi. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62319 P A R T 801-- LA B E LIN G 1. The authority citation for 21 CFR part 801 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374. 2. Section 801.430 is amended by revising the table in paragraph (e)(1) to read as follows: 801.430 User labeling for menstrual tampons. ***** (e) * * * (1) * * * 212SEP 12 AM11*1*1 Ranges of absorbency in grams1 Corresponding term of absorbency 6 and under 6 to 9 9 to 12 12 to 15 15 to 18 Above 18 Light absorbency. Regular absorbency. Super absorbency. Super plus absorbency. Ultra absorbency. No term. 1These ranges are defined, respectively, as follows: Less than or equal to 6 grams (g); greater than 6 g up to and Including 9 g; greater than 9 g up to and including 12 g; greater than 12 g up to and including 15 g; greater than 15 g up to and including 18 g; and greater than 18 g. ***** Dated: October 2, 2000. Margaret M. Dotzel, Associate Commissioner for Policy. [FR Doc. 0 0 - 2 6 2 4 9 Filed 1 0 -1 7 -0 0 ; 8:45 am] BILLING CODE 4160-01-F ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [MO 114-1114; FRL-6885-7] Approval and Promulgation of Implementation Plans; State of Missouri; Designation of Areas for Air Quality Planning Purposes; Dent Township AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA proposes to approve a State Implementation Plan (SIP) revision submitted by the state of Missouri and Missouri's request to redesignate the lead nonattainment area in western Iron County, Missouri, to attainment of the National Ambient Air Quality Standards (NAAQS). EPA proposes to approve the maintenance plan for this area including a consent order which was submitted with the redesignation request, and also proposes to approve the revision to Missouri's Restriction of Emissions of Lead From Specific Lead Smelter-Refinery Installations rule which ensures the permanent and enforceable emission reductions by clarifying the emissions limits for the Doe Run Resource Recycling Facility, and removes the text which could have allowed this facility to resume operation as a primary smelter. In the final rules section of today's Federal Register, EPA is approving the state's SIP revision and redesignation request as a direct final rule without prior proposal because the Agency views this as a noncontroversial action and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. DATES: Comments on this proposed action must be received in writing by November 17, 2000. ADDRESSES: Comments may be mailed to Kim Johnson, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. FOR FURTHER INFORMATION CONTACT: Kim Johnson at (913) 551-7975. SUPPLEMENTARY INFORMATION: See th e information provided in the direct final rule which is located in the rules section of today's Federal Register. Dated: September 27, 2000. Dennis Grams, Regional Administrator, Region 7. [FR Doc. 0 0 -2 6 5 0 2 Filed 1 0 -1 7 -0 0 ; 8:45 am] BILLING CODE 6560-50-P 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. 000004 62320 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 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., N W ., 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: T a b l e 1.-- E n t it ie s P o t e n t ia l l y A f f e c t e d b y t h e SNUR R e q u ir e m e n t s Categories NAICS codes Examples of potentially affected entities Chemical manufacturers or importers Chemical exporters 325 325 Persons who manufacture (defined by statute to include import) one or more of the subject chemical substances Persons who export, or intend to export, one or more of the subject chemical substances This listing is not intended to be exhaustive. Instead, it provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in Table 1 of this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist in determinations of whether this action might apply to certain entities. To determine if you or your business is affected by this action, you should carefully examine the applicability provisions at 40 CFR 721.5 for SNUR-related obligations. Also, consult Unit III. Note that because this proposed rule would designate certain manufacturing and importing activities as significant new uses, persons that solely process the chemical substances that would be covered by this action would not be subject to the rule. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. 2.-- 1, 2001T a b l e C h e m ic a ls R e q u ir in g a S ig n if ic a n t N e w U se N o t ic e O n o r A f t e r Ja n u a r y CAS No./PMN 3 8 3 -0 7 -3 ... 4 2 3 -8 2 -5 ... 2250-98-8 . 14650-24-9 30381-98-7 55120-77-9 57589-85-2 61660-12-6 67969-69-1 68156--01--4 68329-56-6 68555-91-9 68555-92-0 Ninth Collective Index chemical name 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 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-. 2- Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamlno]ethyl ester. 1-Octanesulfonamide, N,N'-[phosphinlcobis(oxy-2,1-ethanediyl)]bls[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- , ammonium salt. 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt. Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, monopotassium salt. 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)propyi]-. 1- Octanesulfonamlde, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2-(phosphonooxy)ethyl]-, dlammonium salt. Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt. 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. 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2- [ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2- methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate. 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate. 000005 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62321 2 1 2001T a b l e .-- C h e m ic a l s R e q u ir in g a S ig n if ic a n t N e w U s e N o t ic e O n o r A f t e r Ja n u a r y , -- C ontinued CAS No./PMN Ninth Collective Index chemical name 68608-14-0 68909-15-9 70776-36-2 73772-32--4 . 81190-38-7 . 94133-90-1 . 117806-54-9 127133-66-8 129813-71-4 148240-78-2 148240-79-3 148240-80-6 148240-81-7 148240-82-8 148684-79-1 178535-22-3 P-83-1102 ... P-84-1163 ... P-84-1171 P-86-0301 P-89-0799 P-94-0545 P-94-0927 P-94-2205 P-94-2206 P-96-1645 P-97-0790 P-98-0251 P-98-1272 P-99-0188 P-99-0319 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1'-methylenebis[4- isocyanatobenzene], 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. 2-Propenolc 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]amlno]ethyl 2- propenoate, 2-[methyl[(trldecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate. 1-Propanesulfonic acid, 3-[[3-(dimethyIarnino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, monosodium salt. 1-Propanaminlum, N-(2-hydroxyethyl)-3-[(2-hydroxy-3-sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N-dimethyl-, hy droxide, monosodium salt. 1-Propanesulfonic acid, 3-[[3-(dimethylamlno)propyI][(heptadecafluorooctyl)sulfonyl]amino]-2-hydroxy-, monosodium salt. 1- Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt. 2- Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl methacrylate. Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranylmethyl). Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters. Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6-diisocyanatohexane homopolymer and ethylene glycol. Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1'-methylenebis[4-isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked. Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. 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. Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,V-methylenebis[4-isocyanatobenzene] and 1,2,3- propanetriol, reaction products with N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1- octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine. Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12-hydroxystearic acid and 2,4- TDI, ammonium salts. Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and polymethylenepolyphenylene isocyanate. 1- Hexadecanaminium, N,N-dimethyl-N-t2-[(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. 2- Propenoic acid, 2-methyl-, 2-methylpropyi ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2- (hydroxymethyl)-l ,3-propanediol and 2-propenoic acid, N-ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amides- blocked. Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-buta- none, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide. Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propylgroup]-terminated, polymers with 2- [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate. Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters. 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). 2- Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride. 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]. Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.- blocked. Poly(oxy-1,2-ethanediyl), ,alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro-C4-8- alkyl)sulfonyl] derivs.. Table 3.-- Chemicals Subject to Volume Cap Restrictions On or A fter January 1, 2001 and Requiring a Significant New Use Notice On or After January 1,2003 CAS No./PMN Ninth Collective Index chemical name 3 0 7 -3 5 -7 ............. 3 0 7 -5 1 -7 ............. 3 7 6 -1 4 -7 ............. 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro1- Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro2- Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester 000006 62322 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules Table 3.-- Chemicals Subject to Volume Cap Restrictions On or After January 1, 2001 and Requiring a Significant New Use Notice On or After January 1, 2003-- Continued CAS No./PMN Ninth Collective Index chemical name 4 2 3 -5 0 -7 ... 7 5 4 -9 1 -6 ... 1652-63-7 . 1691-99-2 . 1763-23-1 . 2795-39-3 . 2991-51-7 . 4151-50-2 . 17202-41-4 24448-09-7 25268-77-3 29081-56-9 29117-08-6 29457-72-5 31506-32-8 38006-74-5 38850-58-7 67584-42-3 67906-42-7 68298-62-4 68541-80-0 68555-90-8 68586-14-1 68649-26-3 68867-60-7 68867-62-9 68891-96-3 68958-61-2 70225-14-8 71487-20-2 91081-99-1 98999-57-6 . 182700-90-9 L-92-0151 .... P-80-0183 ... 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro- 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, iodide 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)- 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, potassium salt Glycine, N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]-, potassium salt 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- l-Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-nonadecafluoro-, ammonium salt 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- 2- Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, ammonium salt Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyi[(heptadecafluorooctyl)sulfonyl]amino]ethy!]-.omega.-hydroxy- 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt 1-Octanesulfonamlde, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl- 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3-sulfopropyl)[(trldecafluorohexyl)sulfonyl]amino]-, inner salt Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt 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 2 - Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2- [butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, methyloxirane polymer with oxirane di-2-propenoate, methyloxirane polymer with oxirane mono-2-propenoate and 1-octanethiol 2-Propenoic acid, polymer with 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2- propenoate 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 and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate 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]ethyl 2-propenoate and 1-octanethiol 1- Octanesulfonamide, N-ethyi-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-heptanesuIfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(2-hydroxy- ethyl)-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 ale. 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) 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) Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glycinato-. kappa.O:. kappa. 0 ']]-.mu.- hydroxybis(2-methylpropanol)di- Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-methoxy- 1- Octanesulfonlc acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, compd. with 2,2'-lminobis[ethanol] (1:1) 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 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-heptanesulfonamlde, 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) Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-I(1-oxo-2-propenyl) oxy]ethyl], polymers with 2-ethoxyethyl acrylate, glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethanamlnlumchloride 1- Octanesulfonamlde, 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 (S2CI2) reaction products chlorides 2- Propenoic acid, 2-methyl-, butyl ester, polymer with 2-methyl-, 2-[ethyl [(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-meth- yl-2-propenoate, 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyi)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, and 2-propenoic acid Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethylamino)propyl], reaction products with acrylic acid 000007 Federal Register/ Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62323 T a b l e 3.-- C h e m ic a l s S u b j e c t t o V o l u m e C a p R e s t r ic t io n s O n o r a f t e r J a n u a r y 1, 2001 a n d R e q u ir in g a S ig n if ic a n t N e w U s e N o t ic e O n o r A f t e r Ja n u a r y 1, 2003-- Continued CAS No./PMN Ninth Collective Index chemical name P-86-0958 P-90-0111 P-91-1419 P-93-1444 P-95-0120 P-96-1262 P-96-1424 P-96-1433 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl] Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane, N-(2-hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamide-blocked 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 Sulfonamides, C4-8-alkane, perfluoro, N,N'-[1,6-hexanediylbis[[2-oxo-3,5-oxazolidinediyl)methylene]]bis[N-methylSulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether 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 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts B, How Can I get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www.epa.gov/. To access this document, on the Home Page select "Law and Regulations," "Regulations and Proposed Rules," then look up the entry for this document under "Federal Register--Environmental Documents. '' You can also go directly to the Federal Register listings at http://www.epa.gov/ fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/ opptsfrs/home/guidelin.htm. In addition, you may access other information about the Office of Prevention, Pesticides and Toxic Substances (OPPTS) and related programs at http://www.epa.gov/ internet/ oppts /. 2. In person. The Agency has established an official record for this action under docket control number OPPTS-50639. The official record consists of the documents referenced in this action, any public comments received during the comment period, and other information related to this rulemaking, including information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as all documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed paper versions of any electronic comments that may be submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, Room NE B-607, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 260-7099. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, your comments must identify docket control number OPPTS-50639 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: OPPT's Document Control Office (DCO), East Tower Room G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093. 3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail or deliver your computer disk to the addresses identified in Unit I.C.l. or I.C.2. Do not submit any information electronically that you consider to be CBI. E-mailed comments must be submitted as an ASCII file, avoiding the use of special characters or any form of encryption. Comments will also be accepted on standard computer disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50639. Electronic comments may also be 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 may claim information that you submit in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comments that include any information claimed as CBI, a sanitized copy of the comments which does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. 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, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final SNUR. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 000008 62324 Federal Register/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 4. If you estimate potential burden or costs, explain how you arrived at the estimate. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the proposed rule or data collection activity. 7. Make sure to submit your comments by the deadline specified in this document. 8. At the beginning of your comments, be sure to properly identify the document you are commenting on. To ensure proper receipt by EPA, your comments must identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the title, date, and Federal Register citation. II. Background A. What Action is the Agency Taking? This proposal would require persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 2 or Table 3 of Unit I.A., for the significant new uses described in this document. The chemical substances identified in Table 2 and Table 3 of Unit I.A. include PFOSA, PFOSS, PFOSF, certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. These chemical substances are collectively referred to throughout this proposed rule as PFOS. The significant new uses described by this notice are: 1. The manufacture or import for any use of any of the chemicals listed in Table 2 of Unit I.A. on or after January 1, 2001. 2. The manufacture or import for any use of any one or more of the chemicals listed in Table 3 of Unit I.A. in excess of an aggregate volume of 1,100,000 pounds per person per calendar year on or after January 1, 2001 and before January 1, 2003. 3. The manufacture or import for any use of any of the chemicals listed in Table 3 of Unit I.A. on or after January 1, 2003. B. What is the Agency's Authority for Taking this Action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use." The Agency makes this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). These factors include the volume of a chemical substance's production; the extent to which a use changes the type, form, magnitude, or duration of exposure to the substance; and the reasonably anticipated manner of producing or otherwise managing the substance. Once EPA makes this determination and promulgates a SNUR, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that significant new use (15 U.S.C. 2604 (a)(1)(B)). 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 to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Note that because this proposed rule would designate certain manufacturing and importing activities as significant new uses, persons that solely process the chemical substances that would be covered by this action would not be subject to the rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this proposed SNUR would be required to comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include: the information submission requirements of TSCA section 5(b) and 5(d)(1); the exemptions authorized by TSCA section 5 (h)(1), (2), (3), and (5); the export notification provisions of TSCA section 12(b); and the export notification requirements in 40 CFR part 707, subpart D. Once EPA receives a SNUN, EPA may take regulatory action under TSCA sections 5(e), 5(f), 6, or 7, if appropriate, to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. 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 higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. All of these chemical substances are referred to collectively in this proposed rule as perfluorooctyl sulfonates, or PFOS. All of these chemical substances have the potential to degrade back to PFOSA in the environment, and PFOSA does not degrade further. PFOSA is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3). These factors, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment. EPA believes that the chemical substances listed in Tables 2 and 3 of Unit I.A. are manufactured and imported in the United States only by the Minnesota Mining and Manufacturing Company (3M) (Refs. 4 and 5). 3M has committed to phase out these chemicals voluntarily by discontinuing the manufacture of certain of these chemical substances on a global basis for their most widespread uses by the end of December 2000, by steadily reducing their production volume on the remaining chemicals through 2001 and 2002, and by entirely discontinuing the manufacture of all of these PFOS chemicals by December 31, 2002 (Ref. 6). The chemicals listed in Table 2 of Unit I.A. are those which 3M has committed to cease manufacturing by December 31, 2000. The chemicals listed in Table 3 of Unit I.A. are those which 3M has committed first to reduce, and then to cease manufacturing by December 31, 2002. EPA believes that any manufacture or import of these PFOS chemicals occurring after 3M's global phase-out dates would increase the magnitude and duration of exposure to these chemicals. Therefore, EPA is proposing to designate the following as significant new uses: 1. Any manufacture or import for any use of the chemicals listed in Table 2 of Unit I.A. on or after January 1, 2001. 2. Any manufacture or import for any use of the chemicals listed in Table 3 of Unit I.A. in excess of an aggregate annual manufacture and import volume cap for all of these chemicals of 1,100,000 pounds per person per calendar year on or after January 1, 2001 and before January 1, 2003. 3. Any manufacture or import for any use of any of the chemicals listed in 000009 Federal Register/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/Proposed Rules 62325 Table 3 of Unit I.A. on or after January 1, 2003. Given that no companies other than 3M are currently producing the chemicals listed on Table 3 of Unit I.A., and given the negative commercial and regulatory environment associated with these chemicals, EPA believes it is unlikely that companies would incur the costs associated with establishing new manufacturing capacity for these chemicals in order to enter this market. This proposed rule, when finalized, would require persons who intend to manufacture or import the PFOS chemicals listed in this proposed rule to notify EPA, through the submission of a SNUN, at least 90 days before commencing the manufacture or importation of any of these chemicals for any use designated by this proposed SNUR as a significant new use, The required notice would provide EPA with the opportunity to evaluate the intended use, and, if necessary, to prohibit or limit that use before it occurs. These proposed requirements are summarized in the following Table 4: Table 4.-- S ummary of Proposed SNUR Requirements Manufacture or import: You must file a significant new use notice (SNUN) if you: When? How much? Chemical substances listed in Table 2 of Unit I.A. Chemical substances listed in Table 3 of Unit I.A. Chemical substances listed In Table 3 of Unit I.A. After December 31, 2000 January 1, 2001 through December 31, 2002 After December 31, 2002 Any amount Aggregate amount exceeding 1,100,000 lbs per person per calendar year 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 chemical names and CAS Registry Numbers (CAS No.] (when available) provided in Table 2 and Table 3 of Unit I.A. are for the specific chemical substances that are subject to the provisions contained in this proposed SNUR (for example, entry #8 on Table 3 of Unit I.A. lists CAS No.1763-23-1 for the compound named 1-octanesulfonic acid, 1,1 ,2,2,3 ,3 ,4 ,4,5,5,6,6 ,7,7,8 ,8,8- heptadecafluoro-, commonly referred to as PFOSA). All of the chemical substances listed in Table 2 and Table 3 of Unit I.A. have a common chemical structure consisting of a PFOS moiety, as illustrated here, somewhere in the molecule. F FO I I1 F - C - Cx -- S -- Y I 1 11 F FO BILLING CODE 6560-50-C The number of carbon atoms present in the moiety varies from 4 to 10 (x = 3--9) among the listed chemicals. In addition, there are many examples of different chemical functionality (free acids (Y = OH), metal salts (Y = O- M+), sulfonyl halides (Y = X), sulfonamides (Y= NH2), and other derivatives). The listed chemical substances also include polymers. The class of chemical substances including the perfluoroalkyl sulfonyl moiety described by the structure shown in this unit contains more chemical substances than are specified in the lists in Table 2 and Table 3 of Unit I.A. Only the listed chemical substances, which are manufactured or imported exclusively by 3M and which 3M has voluntarily committed to cease producing, are subject to this SNUR. EPA is evaluating further this overall structural class of chemical substances and may take additional regulatory action as appropriate. B. Environmental Fate The basic building block of all of the PFOS chemicals is PFOSF, which is used as an intermediate in the production of the PFOS chemicals. PFOSA results from the chemical or enzymatic hydrolysis of PFOSF. Current information strongly supports that PFOSA is an extremely stable substance which resists breakdown by chemical or biological processes. Therefore PFOSA is the ultimate degradation product from PFOS chemicals and will persist in that form (Refs. 1 and 2). EPA cannot currently conduct a definitive assessment of the environmental transport and partitioning of PFOS. The available data are limited and their accuracy uncertain. Also, the accuracy of the estimation models is limited by the quality of data input into them. Depending on what data are consulted and utilized, the environmental fate and transport of PFOS vary. Biological sampling recently discovered the presence of certain perfluoroalkyl compounds in fish and in fish-eating birds across the United States and in locations in Canada, Sweden, and the South Pacific (Ref. 1). The wide distribution of the chemicals in high trophic levels is strongly suggestive of the potential for bioaccumulation/ bioconcentration. The widespread presence of PFOS suggests the possibility of transport in air as well as water, but the multimedia equilibrium criterion model (EQC) suggests otherwise (Ref. 7). Using data provided by 3M as inputs, the model indicates that PFOS would fall out of air and partition almost equally in water and soil. The Henry's Law values calculated utilizing the vapor pressure of 3.31 E-4 Pa@20 C and water solubility values of 370, 570, 5, and 25 milligram/Liter (mg/ L) in fresh water, pure water, unfiltered seawater, and filtered seawater, respectively yielded Henry's Law values of 4.7 E -9,7.2 E-9, 6.4 E -ll, and 3.2 E10 atm.m3/mole (atmospheres per meter cubed per mole), respectively. The vapor pressure and water solubility values were obtained from Table 4, p.16 of the March 1, 2000, white paper by 3M, Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate and Effects (Ref. 1). These Henry's Law values suggest that volatilization from water to air is not very likely. According to 3M, testing is planned and/or underway for the environmental properties, fate, and transport of PFOS (Ref. 1). With more complete data, EPA would be able to make more definitive assessments. With the present data, the Agency can only speculate on environmental transport and partitioning of PFOS, although current information suggests strongly that it is persistent and may bioaccumulate. C. Fiealth Effects The Agency's hazard analysis for PFOS is a review of health hazard and biomonitoring data (Ref. 8). Toxicology studies show that PFOS is well absorbed OOOOl 62326 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules orally and distributes primarily in the serum and liver. PFOS can also be formed as a metabolite of other perfluorinated sulfonates. It does not appear to be further metabolized. Elimination from the body is slow and occurs via both urine and feces. Serum PFOS levels in three retired male 3M chemical workers have been followed for 54 years and suggest a mean elimination half-life (t 4) of 1,428 days (approximately 4 years). Based on the pharmacokinetic data obtained from a 28-day oral study in male and female monkeys, a volume of distribution (Vd) of 0.19 L/kilogram (kg) was reported; no sex differences in the pharmacokinetic parameters were noted. PFOS has shown moderate acute toxicity by the oral route with a rat LDso of 251 mg/kg. A 1-hour LC50 of 5.2 mg/ L in rats has been reported. PFOS was found to be mildly irritating to the eyes and non-irritating to the skin of rabbits. PFOS was negative in mutagenicity studies in five strains of salmonella and did not induce micronuclei in an in vivo mouse bone marrow micronucleus assay. Numerous repeat-dose oral toxicity studies on PFOS have been conducted in rats and primates. Adverse signs of toxicity observed in rat studies included increases in liver enzymes, hepatic vacuolization and hepatocellular hypertrophy, gastrointestinal effects, hematological abnormalities, weight loss, convulsions, and death. These effects were reported at doses of 2 mg/ kg/day and above. Adverse signs of toxicity observed in Rhesus monkey studies included anorexia, emesis, diarrhea, hypoactivity, prostration, convulsions, atrophy of the salivary glands and the pancreas, marked decreases in serum cholesterol, and lipid depletion in the adrenals. The dose range for these effects was reported between 1.5-300 mg/kg/day. No monkeys survived beyond 3 weeks into treatment at 10 mg/kg/day, or beyond 7 weeks into treatment at doses as low as 4.5 mg/kg/day. At doses as low as 0.75 mg/kg/day, Cynomolgus monkeys exhibited low food consumption, excessive salivation, labored breathing, hypoactivity, ataxia, hepatic vacuolization and hepatocellular hypertrophy, significant reductions in serum cholesterol levels, and death. Postnatal deaths and other developmental effects were reported at low doses in offspring in a 2-generation reproductive toxicity study in rats. At the two highest doses of 1.6 and 3.2 mg/ kg/day, pup survival in the first generation was significantly decreased. All first generation offspring (Fl pups) at the highest dose died within a day after birth while close to 30% of the Fl pups in the 1.6 mg/kg/day dose group died within 4 days after birth. As a result of the pup mortality in the two top dose groups, only the two lowest dose groups, 0.1 and 0.4 mg/kg/day, were continued into the second generation. The no observed adverse effect level (NOAEL) and lowest observed adverse effect level (LOAEL) for the second generation offspring (F2 pups) were 0.1 mg/kg/day and 0.4 mg/ kg/day, respectively, based on reductions in pup body weight. Reversible delays in reflex and physical development were also observed in this study, raising concerns about the potential for developmental neurotoxicity following exposure to PFOS. Developmental effects were also reported in prenatal developmental toxicity studies in the rat and rabbit, although at slightly higher dose levels. Signs of developmental toxicity were evident at doses of 5 mg/kg/day and above in rats administered PFOS during gestation. Significant decreases in fetal body weight and significant increases in external and visceral anomalies, delayed ossification, and skeletal variations were observed. Abnormalities of the lens of the eye were also reported at doses as low as 1 mg/kg/day in one rat prenatal developmental study, but could not be repeated in a second study of similar design. At doses of 2.5 mg/kg/day and above, significant reductions in fetalbody weight and significant increases in delayed ossification were observed in rabbits administered PFOS during gestation. In human blood samples, PFOS has been detected in the serum of occupational and general populations in the parts per million (ppm) to parts per billion (ppb) range. In the United States, recent blood serum levels of PFOS in manufacturing employees have been as high as 12.83 ppm, while in the general population, serum collected from blood banks and commercial sources have indicated mean PFOS levels of 30-44 ppb. Levels in a very small sample of children yielded even higher results, with a mean level of 54 ppb. Sampling of several wildlife species from a variety of sites across the United States has shown widespread distribution of PFOS. In recent analyses, PFOS was detected in the ppb range in the plasma of several species of eagles, wild birds, and fish. Endogenous levels of PFOS have also been detected in the ppb range in the livers of unexposed rats used in toxicity studies, presumably through a dietary source (fishmeal). Although the PFOS levels detected in the blood of the general population are low, this widespread presence, combined with the persistence, the bioaccumulative potential, and the reproductive and subchronic toxicity of the chemical, raises concerns for potential adverse effects on people and wildlife over time should the chemical substances continue to be produced, released, and accumulated in the environment. D. Exposure Data As indicated in Unit IV.C., PFOS has been detected at low levels in the blood of humans and wildlife throughout the United States, providing clear evidence of widespread exposure to the chemical. PFOS has been in commercial use since the 1950's, predominantly in soil and stain-resistant coating products on fabrics, carpets, and leather, and in grease and oil resistant coatings on paper products, including food contact papers. Other uses leading to environmental releases include fire fighting foams. The various surface treatment uses constitute the largest volume of PFOS production and are believed to present the greatest potential for widespread human and environmental exposure to PFOS. Studies are underway to determine the routes of exposure which have led to the detection of PFOS in human and animal blood. There are several potential pathways that may account for the widespread exposure to PFOS including: Dietary intake from the consumption of food wrapped in paper containing PFOS derivatives; inhalation from aerosol applications of PFOScontaining consumer products; and inhalation, dietary, or dermal exposures resulting from manufacturing, as well as industrial, commercial, and consumer use and disposal of PFOS-derived chemicals and products. 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, and performance chemicals (Ref. 4). The various surface treatment and paper protection uses constitute the largest volume of PFOS production and are believed to present the greatest potential for widespread human and environmental exposure to PFOS. PFOS chemicals produced for surface treatment applications provide soil, oil, and water resistance to personal apparel and home furnishings. Specific applications in this use category include protection of apparel and leather, fabric/ upholstery, and carpet. These applications are undertaken in O O O O ll Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62327 industrial settings by customers such as textile mills, leather tanneries, finishers, fiber producers, and carpet manufacturers. PFOS chemicals are also used in aftermarket treatment of apparel and leather, upholstery, carpet, and automobile interiors by the general public or professional applicators (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this use category is estimated to be approximately 2.4 million pounds (Ref. 6). PFOS chemicals produced for paper protection applications provide grease, oil, and water resistance to paper and paperboard as part of a sizing agent formulation. Specific applications in this use category include food contact applications (plates, food containers, bags, and wraps) regulated by the Food and Drug Administration (FDA) under 21 CFR 176.170, as well as non-food contact applications (folding cartons, containers, carbonless forms, and masking papers). The application of sizing agents is undertaken mainly by paper mills and, to some extent, converters who manufacture bags, wraps, and other products from paper and paperboard (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this use category is estimated to be approximately 2.7 million pounds (Ref. 6). PFOS chemicals in the performance chemicals category are used in a wide variety of specialized industrial, commercial, and consumer applications. Specific applications include fire fighting foams, mining and oil well surfactants, acid mist suppressants for metal plating and electronic etching baths, alkaline cleaners, floor polishes, photographic film, denture cleaners, shampoos, chemical intermediates, coating additives, carpet spot cleaners, and as an insecticide in bait stations for ants (Ref. 4). In 2000, the domestic production volume of PFOS chemicals for this use category is estimated to be approximately 1.5 million pounds (Ref. 6). On May 16, 2000, following discussions with the Agency, 3M issued a press release announcing that it would discontinue the production of perfluorooctanyl chemicals used to produce some of its repellent and surfactant products. In its statement, 3M committed to "substantially phase out production" by the end of calendar year 2000 (Ref. 9). In subsequent correspondence with the Agency, 3M provided a schedule documenting its complete plan for discontinuing all manufacture of specific PFOS and related chemicals for most surface treatment and paper protection uses (including food contact uses regulated lay the FDA) by the end of 2000, and discontinuing all manufacture for any uses by the end of 2002 (Ref. 6). This schedule, and 3M's anticipated production volumes, are summarized in Table 5. Table 5.--Anticipated Annual U.S. Production Volume (Pounds) for PFOS Use Categories Use category 2000 2001 2002 2003 Surface treatment Paper protection Performance chemicals Total 2,356,700 2,670,700 1,462,500 6,489,900 0 0 1,011,900 1,011,900 0 0 443,700 443,700 0 0 0 0 According to the information currently available to EPA, 3M is the sole manufacturer of PFOS chemicals affected by this proposed SNUR (Ref. 5). 3M plans to discontinue the manufacture of the chemicals identified in Table 2 of Unit I.A. (in general, those associated with surface treatment and paper protection uses) by the end of 2000 and to discontinue the chemicals identified in Table 3 of Unit I.A. (in general, those associated with performance chemical applications) by the end of 2002. V. Objectives and Rationale for this Proposed Rule In determining what would constitute a significant new use for the chemical substances that are the subjects of this proposed SNUR, EPA considered relevant information on the toxicity of the substances, likely exposures associated with potential uses, information provided by industry sources, and the four factors listed in TSCA section 5(a)(2) and Unit II.B. Based on these considerations, EPA wants to achieve the following objectives with regard to the significant new uses that are designated in this proposed rule. EPA wants to ensure that: 1. EPA would receive notice of any person's intent to manufacture or import PFOS chemicals for a designated significant new use before that activity begins. 2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or importing the subject chemical substances for a significant new use. 3. EPA would be able to regulate prospective manufacturers and importers of the subject chemical substances before a significant new use occurs, provided such regulation is warranted pursuant to TSCA section 5(e) or (f). EPA has concerns regarding the toxicity, persistence, and bioaccumulative potential of the chemical substances that are included in this proposed SNUR. 3M, the sole manufacturer of these chemicals in the United States, has chosen voluntarily to discontinue their manufacture and sale for all uses by December 31, 2002, and to substantially reduce their manufacture for their most widespread uses by December 31, 2000. With 3M's exit from the market, EPA believes that all manufacture of these chemicals likely will cease. However, EPA is concerned that manufacture could be reinitiated in the future, and wants the opportunity to evaluate and control, if appropriate, exposures associated with that activity. The notice that would be required by the SNUR would provide EPA with the opportunity to evaluate activities associated with a significant new use as proposed herein and an opportunity to protect against unreasonable risks, if any, from exposure to the substances which could result. Given that no companies other than 3M are currently producing the chemicals listed on Table 3 of Unit I.A., and given the negative commercial and regulatory environment associated with these chemicals, EPA believes it is unlikely that companies would incur the costs associated with establishing new manufacturing capacity for these chemicals in order to enter this market. EPA will use information submitted pursuant to the Inventory Update Rule (40 CFR part 710) to track the production volumes of these chemicals. In the event that the phase-out of these chemicals does not progress as 000012 62328 Federal R egister/Vol. 65, No. 202 /W ednesday, October 18, 2000/P roposed Rules described in this proposed rule, EPA may pursue additional regulatory action 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 that these chemical substances are currently not subject to Federal notification requirements. 1. Promulgate a chemical-specific TSCA section 8(a) reporting rule for the chemical substances listed in Tables 2 and 3 of Unit I.A. Under a TSCA section 8(a) rule, EPA could require any person to report information to the Agency when they intend to manufacture or import the substances listed in Tables 2 and 3 of Unit I.A. for the significant new uses listed in this proposed rule (15 U.S.C. 2607). However, the use of TSCA section 8(a) rather than SNUR authority would not provide the opportunity for EPA to review human and environmental hazards and exposures associated with the new uses of these substances and, if necessary, to take immediate regulatory action under TSCA section 5(e) or section 5(f) to prohibit or limit the activity before it begins. In addition, EPA may not receive important information from small businesses, because those firms generally are exempt from TSCA section 8(a) reporting requirements. In view of EPA's concerns about these chemical substances and its interest in having the opportunity to regulate these substances further as needed, pending the development of exposure and/or hazard information should a significant new use be initiated, the Agency believes that a TSCA section 8(a) rule for those chemical substances would not meet all of EPA's regulatory objectives. 2. Regulate the chemical substances listed in Tables 2 and 3 of Unit I.A. under TSCA section 6. EPA must regulate under TSCA section 6 if there is a reasonable basis to conclude that the manufacture, import, processing, distribution in commerce, use, or disposal of a chemical substance or mixture "presents or will present" an unreasonable risk of injury to human health or the environment. Given the decision by the sole manufacturer 3M to discontinue manufacturing these chemicals, and thus to remove the bulk of the existing potential risk which they present, EPA concluded that risk management action under TSCA section 6 is probably not necessary at this time. This proposed SNUR will allow the Agency to address the potential risks associated with any intended significant new use of these substances. If the phase-out of these chemicals does not occur as anticipated, EPA may reconsider this decision and pursue additional regulatory action as appropriate. VII. Applicability of Proposed Rule to Uses Occurring Before the Effective Date of the Final Rule EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing. Persons who begin commercial manufacture or import of PFOS for the significant new uses listed in this proposed SNUR after the proposal has been published must stop that activity before the effective date of the final rale. Persons who ceased those activities will have to meet all SNUR notice requirements and wait until the end of the notice review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who begin commercial manufacture or import of these chemical substances between the proposal and the effective date of the SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45(h), those persons will be considered to have met the final SNUR requirements for those activities. VIII. Test Data and Other Information EPA recognizes that under TSCA section 5, persons are not required to develop any particular test data before submitting a SNUN. Rather, persons are required only to submit test data in their possession or control and to describe any other data known to, or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25). However, in view of the potential health and environmental risks posed by the significant new uses of the chemical substances listed in Table 2 and Table 3 of Unit I.A., EPA requests that potential SNUN submitters include data that would permit a reasoned evaluation of risks posed by these chemical substances when used for an intended significant new use. EPA currently believes that the known or reasonable ascertainable results of the following tests could help adequately characterize possible health effects of these chemical substances: Reproductive and developmental toxicity studies, mutagenicity, gene mutation, immunotoxicity, neurotoxicity, carcinogenicity, and acute, subchronic, and chronic toxicity studies, as well as pharmacokinetics and mechanistic studies. Because of the specific concerns that EPA has for the persistence and bioaccumulation potential of these chemicals, EPA also encourages SNUN submitters to provide information on environmental fate and transport, specifically including measured values for the octanol/water partition coefficient (log P), log of the soil/sediment adsorption coefficient (log Koc), bioconcentration factor (BCF), melting and/or boiling point, vapor pressure, Henry's Law constant, biodegradation, atmospheric oxidation and the fugacity-based multimedia equilibrium criterion level 111(EQC 111) model (Ref. 10). However, completion of those studies may not be the only means of identifying potential risks. For example, analyses of potential exposure may demonstrate that associated risks would be of low concern. A SNUN submitted without accompanying test data may increase the likelihood that EPA will take action under TSCA section 5(e). EPA encourages persons to consult with the Agency before submitting a SNUN for any of the PFOS substances listed in Table 2 or Table 3 of Unit I.A. As part of this optional pre-notice consultation, EPA will discuss specific test data it believes are necessary to evaluate a significant new use of the chemical substances and advise the submitter on the selection of test protocols. The Agency requests that all test data be developed according to the TSCA Good Laboratory Practice Standards in 40 CFR part 792. Failure to do so may result in EPA's finding that submitted data are insufficient to reasonably evaluate the health effects and public health implications of these chemical substances. EPA urges SNUN submitters to provide detailed information on human and environmental exposures that would result or could reasonably be anticipated to result from the significant new uses of the chemical substances listed in Table 2 and Table 3 of Unit I.A. and at 721.9582 of the proposed regulation. In addition, EPA encourages persons to submit information on potential benefits of these chemical substances and information on risks posed by these chemical substances compared to risks posed by possible substitutes. 000013 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62329 IX. Economic Considerations EPA has evaluated the potential costs of establishing a SNUR for PFOS listed in Table 2 and Table 3 of Unit I.A. These potential costs are related to the submission of SNUNs, the export notification requirements of TSCA section 12(b), and the development of test data. EPA notes that, with the possible exception of the export notification requirements, these costs will not be incurred by any company unless that company decides to pursue a significant new use as defined in this SNUR. A. SNUNs Because of uncertainties related to predicting the number of SNUNs that will be submitted as a result of this SNUR, EPA is unable to calculate the total annual cost of compliance with the final rule. However, EPA estimates that the cost for preparation and submission of a SNUN ranges from approximately $8,500 to $9,800, which includes a $2,500 user fee (Ref. 11). EPA notes that small businesses with annual sales of less than $40 million are subject to a reduced user fee of $100. Based on past experience with SNURs and the low number of SNUNs which are submitted on an annual basis, EPA believes that there would be few, if any, SNUNs submitted as a result of this SNUR. Furthermore, no company is required to submit a SNUN for the chemicals listed in this SNUR unless that company decides to begin manufacture or importation those chemicals. As a result, EPA expects that companies would be able to determine if the burden of submitting a SNUN would be likely to create significant adverse economics impacts for the company prior to incurring SNUNrelated costs. B. Export Notification As noted in Unit II.A., persons who intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611 (b)). These provisions require that a company notify EPA of the first shipment to a particular country of an affected chemical. EPA believes that most companies comply with these provisions by compiling a list of products that are subject to TSCA section 12(b) reporting. Outgoing orders are checked to see if the chemical or product is on the list, and whether it is the first shipment to the importing country or the first shipment of the calendar year to that country. If so, a form letter is sent to EPA. In most cases, the entire process is computerized. The estimated cost of the TSCA section 12(b)(1) export notification, which would be required for the first export to a particular country of a chemical subject to the rule, is estimated to be $83.38 for the first time that an exporter must comply with TSCA section 12(b)(1) export notification requirements, and $19.08 for each subsequent export notification submitted by that exporter (Ref. 12). EPA is unable to estimate the total number of TSCA section 12(b) notifications that will be received as a result of this SNUR, or the total number of companies that will file these notices. However, EPA expects that the total cost of complying with the export notification provisions of TSCA section 12(b) will be limited based on historical experience with TSCA section 12(b) notifications, the relatively few companies with fluorocarbon production capabilities, and the limited number of chemicals listed in this SNUR. If companies were to manufacture any of the chemicals covered by this SNUR for export only, these companies would incur costs associated with export notification even if these companies decided to forgo any domestic significant new use. EPA is not aware of any companies in this situation, and expects that any potential impact would be limited to the small burden of export notification. C. Testing In Unit VIII., EPA has identified certain tests that SNUN submitters may choose to conduct to assist EPA in evaluating the risks posed by these chemical substances when used for an intended significant new use. The estimated cost of these tests ranges from $1,450 for the acute oral toxicity test using the up-or-down method to $2.24 million for the 2-species carcinogenicity test by the inhalation route (Ref. 13). As noted in Unit VIII., development of any particular test data would be at the discretion of the submitter of the SNUN. EPA is not able to predict which specific tests will be conducted for chemicals that are the subject of SNUNs. However, EPA notes that companies would be able to determine if the burden of developing test data would be likely to create significant adverse economic impacts for the company prior to incurring these testing costs. X. References These references have been placed in the official record that was established under docket control number OPPTS50639 for this rulemaking as indicated in Unit I.B.2. Reference documents identified with an administrative record number (AR) are cross-indexed to nonregulatory, publicly accessible information files maintained in the TSCA Nonconfidential Information Center. Copies of these documents can be obtained as described in Unit I.B.2. 1. (AR226--0620) Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 2000. 2. (AR226--0547) The Science of Organic Fluorochemistry. 3M. St. Paul, MN. February 5, 1999. 3. (AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999. 4. (AR226-0550) Fluorochemical Use, Distribution, and Release Overview. 3M. St. Paul, MN. May 26, 1999. 5. Rice, Cody. Domestic Manufacturers or Importers of PFOS Chemicals Other Than 3M. USEPA/ OPPT/EETD. Washington, DC. August 31, 2000. 6. (AR226-0600) Weppner, William A. Phase-out Plan for POSF-Based Products. 3M. St. Paul, MN. July 7, 2000. 7. MacKay, D., DiGuardo, A., Paterson, S., and Cowan, C.E. Evaluating the Environmental Fate of a Variety of Types of Chemicals Using the EQC Model. Environmental Toxicology and Chemistry. SETAC Press. Houston, TX. 1996. Vol. 15, No. 9, pp.1627-1637. 8. Seed, Jennifer. Hazard Assessment and Biomonitoring Data on Perfluorooctane Sulfonate--PFOS. USEPA/EPA/RAD. Washington, DC. August 31, 2000. 9. 3M Phasing Out Some of its Specialty Materials. 3M News. 3M. St. Paul, MN. May 16, 2000. 10. Guidelines for the requested fate and transport data can be found in OPPTS Harmonized Test Guidelines, Series 835, Fate, Transport And Transformation Test Guidelines. These guidelines, both Public Drafts and Finals, are available electronically in PDF (portable document format) on the EPA World Wide Web site, see Unit I.B.I., or in paper by contacting the OPP Public Docket at (703) 305-5805 or by e-mail at: opp-docket@epa.gov. Final guidelines, only, are available from the U.S. Government Printing Office Bookstore, 810 North Capitol St., NW., Washington, DC or by calling (202) 5121800 and ordering ASCII disks or paper copies. The EQC model is available for download from the Trent University web site at http://www.teentu.ca/ envmodel. 11. (AR 204-001) TSCA Section 5(a)(2) Significant New Use Rules for 000014 62330 Federal Register/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules Existing Chemicals. ICR #1188.06, OMB No. 2070-0038 (Undated). 12. (AR 205-001) TSCA Section 12(b) Notification of Chemical Exports. ICR #0795.10, OMB No. 2070-0030 (Undated). 13. Rice, Cody. Estimated Costs of Testing Recommended for PFOS SNIJR. USEPA/OPPT/EETD. Washington, DC. July 25, 2000. XI. Regulatory Assessment Requirements Under Executive Order 12866, entitled Regulatory Planning and Review {58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that SNURs are not a "significant regulatory action" subject to review by OMB, because SNURs do not meet the criteria in section 3(f) of the Executive Order. Based on EPA's experience with past SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Similarly, this action is not subject to the requirement for prior consultation with Indian tribal governments as specified in Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998). Nor will this action have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). In issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this proposed rule in accordance with the "Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings" issued under the Executive Order. This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action. Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a "significant new use." By definition of the word "new," and based on all information currently available to EPA, it appears that no small or large entities currently engage in such activity. Since a SNUR requires merely that any person who intends to engage in such activity in the future must first notify EPA (by submitting a SNUN), no economic impact will even occur until someone decides to engage in those activities. As a voluntary action, it is reasonable to presume that this decision would be based on a determination by the person submitting the SNUN that the potential benefits would outweigh the costs. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. EPA's experience to date is that, in response to the promulgation of over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that, the economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration. According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost of between $5,957 and $7,192 per SNUN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required significant new use notice, and maintain the required records. This burden estimate does not include 1 hour of technical time at $64.30 per hour estimated to be required for customer notification of SNUR requirements, or the $2,500 user fee for submission of a SNUN ($100 for businesses with less than $40 million in annual sales). Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, as instructed in Unit I.C. or to the Director, Collection Strategies Division, Office of Environmental Information,. Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW,, Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. List of Subjects in 40 CFR Part 721 Environmental Protection, Chemicals, Hazardous materials, Recordkeeping and reporting requirements. 000015 Federal Register/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62331 Dated: October 12, 2000. William H. Sanders, III Director, Office o fPollution 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 as follows: 721.9582 Certain perfluorooctyl sulfonates. (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances listed in Tables 1 and 2 of this paragraph are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. Table 1 --Chemicals Requiring a S ignificant New Use Notice On or After J anuary 1, 2001 CAS No./PMN 3 8 3 -0 7 -3 ... 4 2 3 -8 2 -5 ... 2250-98-8 . 14650-24-9 30381-98-7 55120-77-9 57589-85-2 61660-12-6 67969-69-1 68156-01-4 68329-56-6 68555-91-9 68555-92-0 68608-14-0 68909-15-9 70776-36-2 73772-32-4 . 81190-38-7 . 94133-90-1 . 117806-54-9 127133-66-8 129813-71-4 148240-78-2 148240-79-3 148240-80-6 148240-81-7 148240-82-8 148684-79-1 178535-22-3 P-83-1102 ... P-84-1163 ... Ninth Collective Index chemical name 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester. 2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amlno]ethyl ester. 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-. 2- Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester. 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. 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt. Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, monopotassium salt. 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]-. 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. Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt. 2- Propenoic acid, eicosyi 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[(trldecafluorohexyl)sulfonyl]amino]ethyl 2- propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and octadecyl 2-propenoate. 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2- [ethyl[(nonafluorobutyl)sulfonyi]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amlno]ethyl 2- methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate. 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amlno]ethyl 2-methyl-2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amlno]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate. Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1'-methylenebis[4- isocyanatobenzene], 2-Propenoic acid, eicosyi ester, polymers with branched octyl acrylate, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl acrylate, 2-[methyl[(nonafluorobutyl) sulfonyl]amino)ethyl acrylate, 2-[methyl[(pentadecafluoroheptyI)sulfonyl]amlno]ethyI acrylate, 2-[methyl[(tridecafIuorohexyl)sulfonyI]amino]ethyl acrylate, 2-[methyl[(undecafluoropentyl) sulfonyljaminojethyl acrylate, polyethylene glycol acrylate Me ether and stearyi acrylate. 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, N-(hydroxymethyl)-2-propenamide, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2- propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate. 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, monosodium salt. 1-Propanaminium, N-(2-hydroxyethy()-3-[(2-hydroxy-3-sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N-dimethyl-, hy droxide, monosodium salt. 1-Propanesulfonic acid, 3-[[3-(dimethylamlno)propyl][(heptadecafluorooctyl)sulfonyl]amino]-2-hydroxy-, monosodium salt. 1- Heptanesulfonlc acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt. 2- Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl methacrylate. Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranylmethyl). Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(nonafluorobutyl)sulfonyl]amino)ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters. Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters. Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6-diisocyanatohexane homopolymer and ethylene glycol. Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1'-methylenebis[4-isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked. Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters. 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 dlamide, 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 Methylamine. 000016 62332 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules Table 1.-- Chemicals Requiring a Significant New Use Notice On or After January 1, 2001-- Continued CAS No./PMN P-84-1171 P-86-0301 P-89-0799 P-94-0545 P-94-0927 P-94-2205 P-94-2206 P-96-1645 P-97-0790 P-98-0251 P-98-1272 P-99-0188 P-99--0319 Ninth Collective Index chemical name Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,T-methylenebis[4-isocyanatobenzene] and 1,2,3propanetriol, 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)-1octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1 -heptanesulfonamide, compds. with morpholine. Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12-hydroxystearic acid and 2,4TDI, ammonium salts. Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and polymethylenepolyphenylene isocyanate. 1- Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-propenyi)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu methacrylate and 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate. 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-a!kanesulfon amidesblocked. Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide. Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propylgroup]-terminated, polymers with 2[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate. Fatty acids, C 18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters. 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). 2- Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8-alkyi)sulfonyl]amino)ethyl acrylate and vinylidene chloride. 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[ethanoi]. Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.blocked. Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro-C4-8alkyl)sulfonyl] derivs.. T a b l e 2.-- C h e m ic a l s S u b j e c t t o V o l u m e C a p R e s t r ic t io n s O n o r A f t e r J a n u a r y 1, 2001 a n d R e q u ir in g a S ig n if ic a n t N e w U s e N o t ic e O n o r A f t e r J a n u a r y 1, 2003 CAS No./PMN 3 0 7 -3 5 -7 ... 3 0 7 -5 1 -7 ... 3 7 6 -1 4 -7 ... 4 2 3 -5 0 -7 ... 7 5 4 -9 1 -6 ... 1652-63-7 . 1691-99-2 . 1763-23-1 . 2795-39-3 . 2991-51-7 . 4151-50-2 . 17202-41-^f 24448-09-7 25268-77-3 29081-56-9 29117-08-6 29457-72-5 31506-32-8 38006-74-5 38850-58-7 67584-42-3 67906-42-7 68298--62^1 68541-80-0 68555-90-8 68586-14-1 Ninth Collective Index chemical name 1- Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 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- 2- Propenoic acid, 2-methyl-, 2-[ethy![(heptadecafluorooctyl)sulfonyl]amino]ethyl ester 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro- 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, iodide 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafIuoro-N-(2-hydroxyethyl)- 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-hepiadecafluoro-, potassium salt Glycine, N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]-, potassium salt 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 1-Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-nonadecafiuoro-, ammonium salt 1- Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafiuoro-N-(2-hydroxyethyl)-N-methyl- 2- Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-hepfadecafluoro-, ammonium salt Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-hydroxy- 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl- 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3-sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-, inner salt Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt 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 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2- [butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, methyloxirane polymer with oxirane di-2-propenoate, methyloxirane polymer with oxirane mono-2-propenoate and 1-octanethiol 2-Propenoic acid, polymer with 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2- propenoate 2-Propenoic acid, butyl ester, polymer with 2-[[(heptadecafiuorooctyl)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 and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate 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[(pentadecafiuoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2- propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and 1-octanethiol 000017 Federal R egister/Vol. 65, No. 2 0 2 /W ednesday, October 18, 2000/P roposed Rules 62333 Table 2.--Chemicals S ubject to Volume Cap Restrictions On or After January 1,2001 and Requiring a S ignificant New Use Notice On or After January 1, 2003--Continued CAS No./PMN Ninth Collective Index chemical name 68649-26-3 68867-60-7 68867-62-9 68891-96-3 68958-61-2 70225-14-8 71487-20-2 91081-99-1 98999-57-6 . 182700-90-9 L-92-0151 .... P-80-0183 P-86-0958 P-90-0111 P-91-1419 P-93-1444 P-95-0120 P-96-1262 P-96-1424 P-96-1433 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-trldecafluoro-N-(2-hydroxy- ethyl)-1-hexanesulfonamlde, N-ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-1-pentanesulfonamide, polymethylenepolyphenylene isocyanate and stearyl aie. 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) 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)sulfonyi]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) Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glyclnato-.kappa.O:.kappa.O'])-.mu.- hydroxybis(2-methylpropanol)di- Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amlno]ethyl]-.omega.-methoxy- 1- Ocfanesulfonic 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) 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[(trldecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2- propenoate and 2-propenoic acid 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) Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-[(1-oxo-2-propenyl) oxy]ethyl], polymers with 2-ethoxyethyl acrylate, glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethanaminiumchloride 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 (S2CI2) reaction products chlorides 2- Propenoic acid, 2-methyl-, butyl ester, polymer with 2-methyl-, 2-[ethyl [(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-meth- yl-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 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethylamino)propyl], reaction products with acrylic acid 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl] Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6-dlisocyanatohexane, N-(2-hydroxyethyi)-N-methyl perfluoro C4-8-alkane sulfonamide-blocked 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 Sulfonamides, C4-8-alkane, perfluoro, N,N'-[1,6-hexanediylbis[[2-oxo-3,5-oxazolidinediyl)methylene]]bis[N-methyl- Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether 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 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts (2) The significant new uses are: (i) Any manufacture or import for any use of any chemical listed in Table 1 of paragraph (a)(1) of this section on or after January 1, 2001. (ii) Any manufacture or import for any use of any one or more of the chemicals listed in Table 2 of paragraph (a)(1) of this section in excess of an aggregate volume for all of these chemicals of 1,100,000 pounds per person per calendar year on or after January 1, 2001 and before January 1, 2003. (iii) Any manufacture or import for any use of any of the chemicals listed in Table 2 of paragraph (a)(1) of this section on or after January 1, 2003. (b) [Reserved]. [FR Doc. 0 0 -2 6 7 5 1 Filed 1 0 -1 7 -0 0 ; 8:45 am] BILLING CODE 6560-50-S 000018 * -------------------- Part in Environmental Protection Agency 40 CFR Part 721 Perfluoroalkyl Sulfonates; Significant New Use Rule; Final Rule and Supplemental Proposed Rule 000019 11008 Federal Register / Vol. 67, No. 47/M onday, March 11, 2002/R ules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [OPPTS-50639D; FRL-6823-6] RIN 2070-AD43 Perfluoroalkyl Sulfonates; Significant New Use Rule AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 13 chemicals, including polymers, that are derived from perfluorooctanesulfonic acid (PFOSH) and its higher and lower homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. This rule requires 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 PFAS component of these chemical substances may be hazardous to human health and the environment. The required notice will 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. This action promulgates a portion of the proposed SNUR originally published in the Federal Register of October 18, 2000. This action also removes from the SNUR two chemicals that were listed erroneously in that original proposal. Published elsewhere in today's issue of the Federal Register is a supplemental proposed rule which addresses the remainder of the chemicals listed in the original proposed SNUR. DATES: This final rale is effective on April 10, 2002. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, 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 F. Dominiak, Chemical Control Division, (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-8104; email address: dominiak.mary@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in Table 2 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 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. Potentially affected categories and entities may include, but are not limited to: Table 1.-- Potentially Affected Entities Categories Chemical Manufacturers or Importers Chemical Exporters NAICS codes 325 325 Examples of potentially affected entities Persons who manufacture (defined by statute to include import) one or more of the subject-chemical substances Persons who export, or intend to export, one or more of the subject chemical substances This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action applies to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5 for SNUR-related obligations. Also, consult Unit II. Note that because this rule designates certain manufacturing and importing activities as significant new uses, persons that solely process existing stocks of the chemical substances that are covered by this action would not be subject to the rule. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. One chemical in Table 2 of this unit is identified by both premanufacture notice (PMN) and Chemical Abstract Service number (CAS No.). In the proposed SNUR, only the PMN appeared with the chemical. Table 2.-- Chemical Substances Covered by this Final Rule CAS No./PMN 2250-98-8 30381-98-7 CAS Ninth Collective Index Name 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- 1-Octanesulfonamide, N,N'-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8heptadecafluoro-, ammonium salt OOOOEO Federal Register / Vol. 67, No. 47/M onday, March 11, 2002/R ules and Regulations 11009 Table 2 -- Chemical Substances Covered by this Final Rule-- Continued CAS No./PMN CAS Ninth Collective Index Name 57589-85-2 Benzoic add, 2,3,4,5-tetrachloro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amlno]carbonyl]-, monopotassium salt 61660-12-6 1-Octanesulfonamlde, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3-(trimethoxysllyl)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-heptadecaf!uoro-N-[2-(phosphonooxy)ethyl]-, diammonium salt 68608-14-0 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1'-methylenebis[4isocyanatobenzene] 70776-36-2 2-Propenoic acid, 2-methyl-, octadecyi ester, polymer with 1,1-dichloroethene, [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl '2-propenoate, N'(hydroxymethyl)-2-propenamide, [methyl((nonafluorobutyl)sulfonyllamino]ethyl 2-propenoate, [methyl[(pentadecafluoroheptyl)sulfonyljamino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate 22222- 127133-66-8 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoroC4-8-alkyl)sulfonyl]amino]ethyl methacrylate 148240-78-2 Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methytamino]ethyl esters 148684-79-1 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6diisocyanatohexane homopolymer and ethylene glycol 178535-22-3 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1'-methylenebis[4isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked P-94-2205 P-96-1645 306974-63-0 Polymethylenepolyphenylene Isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www.epa.gov/. To access this document, on the Home Page select "Laws and Regulations,'' "Regulations and Proposed Rules," and then look up the entry for this document under the "Federal Register--Environmental Documents." You can also go directly to the Federal Register listings at http:// www.epa .gov/fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPPTS-50639D. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099. II. Background A. What Action is the Agency Taking? This rule requires persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 2, Unit I.A., for the significant new use described in this document. The chemical substances identified in Table 2, Unit I.A., are 13 chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemical substances are collectively referred to throughout this rule as PFAS. In the original proposed SNUR, these chemicals had been referred to collectively as perfluorooctyl sulfonates, or PFOS, but commenters noted that this generic usage of the term PFOS was inconsistent with the use by the manufacturer, the Minnesota Mining and Manufacturing Company (3M), of PFOS to refer only to chemicals with an eight-carbon, or C8, chain length. Many of the chemicals in the SNUR include a range of carbon chain lengths, although they all include C8 within the range. Accordingly, EPA will use the generic term PFAS to refer to any carbon chain length, including higher and lower homologues as well as C8, and the term PFOS to represent only those chemical substances which are predominantly C8. The significant new use described by this document is: The manufacture or import for any use of any of the chemicals listed in Table 2, Unit I.A., on or after January 1, 2001. The chemical substances subject to this SNUR are listed in Table 2, Unit I.A. All of these chemical substances have the potential to degrade to PFOSH in the environment. Information also suggests that these chemical substances may be converted to PFOSH via incomplete oxidation during the J00021 11010 Federal Register/Vol. 67, No. 4 7 /M onday, March 11, 2 0 0 2 /Rules and Regulations incineration of PFOS-containing materials. Once PFOSH has been released to the environment, it does not undergo further chemical (hydrolysis), microbial, or photolytic degradation. PFOS is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3). These facts, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment. Based on all information available to EPA, including the comments filed on the proposed SNUR published in the Federal Register of October 18, 2000 (65 FR 62319) (FRL-6745-5), EPA believes that the chemical substances listed in Table 2, Unit I.A., were manufactured and imported in the United States only by 3M (Refs. 4 and 5). 3M committed to phase out these chemicals voluntarily by discontinuing their manufacture on a global basis by the end of December 2000, and 3M has confirmed that these chemicals were discontinued on schedule (Refs. 6 and 7). EPA believes that any manufacture or import for any use of these specific PFAS chemicals occurring after 3M's phase-out would thus be new. All manufactured PFAS has the potential to contribute to the globally available reservoir of PFAS that has resulted in the detectable levels of PFOS in the general population and wildlife. Any new manufacture or import of the PFAS chemicals listed in this rule, particularly for their historical, high volume uses, would significantly increase the magnitude and duration of exposure to these chemicals by adding to the existing burden of PFOS in the environment. The chemical substances listed in Table 2, Unit I.A., were principally associated with uses in carpet, fabric, leather, textile, and paper coatings. None of the comments received on the proposed SNUR addressed any of these uses or focused on these particular substances. Although certain initial comments filed on the proposed SNUR sought blanket exemptions for specific uses of any chemical substances listed in the proposed SNUR, including the ones covered by this final rule, subsequent clarifications and additional correspondence submitted to the docket by the commenters indicated that none of the chemical substances listed in Table 2, Unit I.A., were or are being manufactured for, imported, or used in any of the specific uses for which they sought an exemption. This action also removes from the original proposed SNUR two chemicals which were not included in the 3M phaseout plan. These two chemicals (CAS No. 148240-79-3 and CAS No. 148240-81-7) were listed in the originally proposed SNUR due to an error by EPA in correlating information provided by 3M with chemical identity data furnished by the Chemical Abstract Service. Comments submitted by 3M pointed out this error. EPA acknowledges that, because these two chemicals were not included in the 3M phaseout plan, they should not have been included in the original proposed SNUR. Accordingly, these two chemicals are not subject to any current proposed or final SNUR, and thus would not be subject to any corresponding SNUR-related reporting obligations. Other chemicals originally included in the two tables in the proposed SNUR are addressed separately in a supplemental proposed SNUR published elsewhere in today's issue of the Federal Register. This final rule applies only to the specific chemical substances listed in Table 2, Unit I.A., on which no comments were received. B. What is the Agency's Authority for Taking this Action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use." The Agency makes this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). These factors include the volume of a chemical substance's production; the extent to which a use changes the type, form, magnitude, or duration of exposure to the substance; and the reasonably anticipated manner of producing or otherwise managing the substance. Once EPA makes this determination and promulgates a SNUR, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that significant new use (15 U.S.C. 2604 (a)(1)(B)). With respect to the chemical substances listed in Table 2, Unit I.A., all production had ceased on or before December 31, 2000, as discussed in Unit II.A. Any new manufacture or import for any use following that date would thus significantly change the volume of production, which was zero. By adding to the base amount of PFOS already detected in the environment around the world, any new manufacture or import for any use of these substances would also change the magnitude and duration of exposure to PFOS, because PFOS has been found to be both persistent and bioaccumulative. No comments submitted on the proposed SNUR suggested that these specific substances might be produced or managed any differently than they were in the past if they were to be produced again, particularly for their former uses, leading to the reasonable inference that any new manufacture or importation of these substances for any use would present hazard, exposure, and release concerns similar to those which prompted the promulgation of this SNUR. Accordingly, pursuant to TSCA section 5(a)(1)(B), EPA requires persons to submit a SNUN to EPA at least 90 days before they manufacture or import the chemical substances listed in Table 2 for any use (15 U.S.C. 2604 (a)(1)(B)). As noted in the proposed SNUR, EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing. Accordingly, persons who may have begun commercial manufacture or import of.the PFAS chemicals listed in Table 2, Unit I.A., for the significant new uses listed in this final SNUR after the proposal was published on October 18, 2000, must stop that activity before the effective date of this final rule. Persons who ceased those activities will have to meet all SNUR notice requirements and wait until the end of the notice review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who may have begun commercial manufacture or import of these chemical substances between the proposal and the effective date of the SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45(h), those persons will be considered to have met the final SNUR requirements for those activities. III. References These references have been placed in the official record that was established under docket control number OPPTS- 000022 Federal R egister/Yol. 67, No. 4 7 /M onday, March 11, 2002/R ules and Regulations 11011 50639 for this rulemaking as indicated in Unit I.B.2. Reference documents identified with an Administrative Record number (AR) are cross-indexed to non-regulatory, publicly accessible information files maintained in the TSCA Nonconfidential Information Center. Copies of these documents can be obtained as described in Unit I.B.2. 1. (AR226--0620) Sulfonated Perfluorochemicals in the Environment: Sources. Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 2000. 2. (AR226--0547) The Science of Organic Fluorochemistry. 3M. St. Paul, MN. February 5, 1999. 3. [AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999. 4. (AR226-0550) Fluorochemical Use, Distribution, and Release Overview. 3M. St. Paul, MN. May 26, 1999. 5. Rice, Cody. Domestic Manufacturers or Importers of PFOS Chemicals Other Than 3M. USEPA/ OPPT/EETD. Washington, DC. August 31, 2000. 6. (AR226-0600) Weppner, William A. Phase-out Plan for POSF-Based Products. 3M. St. Paul, MN. July 7, 2000. 7. (AR226--0997) Santoro, Mike. Email to Charles Auer, Production of PFOS Derivatives. 3M. St. Paul, MN. March 2, 2001. IV. Regulatory Assessment Requirements Under Executive Order 12866, entitled Regulatory Planning and Review {58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that SNURs are not a "significant regulatory action'' subject to review by OMB, because SNURs do not meet the criteria in section 3(f) of the Executive order. Based on EPA's experience with past SNURs, State, local, and tribal governments have not been impacted by these rules, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rule. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203. 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to this'mle. Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), which took effect on January 6, 2001, revokes Executive Order 13084 as of that date. EPA developed this rulemaking, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. For the same reasons stated for Executive Order 13084, the requirements of Executive Order 13175 do not apply to this rule either. Nor will this action have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use. In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the "Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings" issued under the Executive Order. This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action. Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a "significant new use." By definition of the word "new," and based on all information currently available to EPA, it appears that no small or large entities currently engage in such activity. Since a SNUR requires merely that any person who intends to engage in such activity in the future must first notify EPA (by submitting a SNUN), no economic impact will even occur until someone decides to engage in those activities. As a voluntary action, it is reasonable to presume that this decision would be based on a determination by the person submitting the SNUN that the potential benefits would outweigh the costs. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. EPA's experience to date is that, in response to the promulgation of over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that the economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration. According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the '>00023 11012 Federal R egister/Vol. 67, No. 4 7 /M onday, March 11, 2 0 0 2 /Rules and Regulations PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost of between $5,957 and $7,192 per SNUN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required SNUN, and maintain the required records. This burden estimate does not include 1 hour of technical time at $64.30 per hour estimated to be required for customer notification of SNUR requirements, or the $2,500 user fee for submission of a SNUN [$100 for businesses with less than $40 million in annual sales). Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, Office of Environmental Information, Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. V, Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a "major rule" as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous materials, Reporting and recordkeeping requirements, Significant new uses. Dated: March 4, 2002. William H. Sanders, III, Director, Office o f Pollution Prevention and Toxics. Therefore, 40 CFR chapter I is amended as follows: PART 721-- [AMENDED] 1. The authority citation for part 721 continues to read as follows: A uthority: 15 U.S.C. 2604, 2607, and 2625(c). 2. By adding new 721.9582 to subpart E to read as follows: 721.9582 Certain perfluoroalkyl sulfonates. (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances listed in Table 1 of this paragraph are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. T a b l e 1 -- P F A S C h e m ic a l s S u b j e c t t o R e p o r t in g o n o r A f t e r J a n u a r y 1, 2 0 0 1 CAS No./PMN CAS Ninth Collective Index Name 2250-98-8 1-Octanesulfonamide, N,N',N"-[phosphinylidynetris(oxy-2,1- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- ethanediyl)]tris(N-ethyl- 30381-98-7 1-Octanesulfonamide, N,N'-[phosphlnlcobis(oxy-2,1-ethanediyl)]bls[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8heptadecafluoro-, ammonium salt 57589-85-2 Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyi]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-heptadecafIuoro-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 68608-14-0 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1'-methylenebis[4isocyanatobenzene] 70776-36-2 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, [[(heptadecaf!uorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, N-(hydroxymethyl)-2-propenamide, [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate 22222- 127133-66-8 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfiuoroC4-8-alkyl)sulfonyl]amino]ethyl methacrylate 148240-78-2 148684-79-1 Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)su!fonyl]methylamino]ethyl esters Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6diisocyanatohexane homopoiymer and ethylene glycol 000024 Federal R egister/ Vol. 67, No. 47/M onday, March 11, 2002/R uIes and Regulations 11013 Table 1.--PFAS Chemicals S ubject to Reporting on or After January 1, 2001--Continued CAS No./PMN CAS Ninth Collective Index Name 178535-22-3 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1'-methylenebis[4- isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked P-94-2205 P-96-1645 306974-63-0 Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyi)sulfonyl]amino]ethyl esters (2] The significant new uses are: paragraph (a)(1) of this section on or (i) Any manufacture or import for any after January 1, 2001. use of any chemical listed in Table 1 of (ii) [Reserved] (b) [Reserved] [FR Doc. 0 2 -5 7 4 6 Filed 3-8-02; 8:45 am] BILLING CODE 6560-50-S 000025 11014 Federal Register/ Vol. 67, No. 4 7 / Monday, March 11, 2 0 0 2 /Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [OPPTS-50639C; FRL-6823-7] RIN 2070-AD43 Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule AGENCY: Environmental Protection Agency (EPA). a c t io n : Supplemental proposed rule. SUMMARY: EPA is proposing a supplemental significant new use rule (SNUR) under section 5(a)[2) of the Toxic Substances Control Act (TSCA) for the following 75 substances: Perfluorooctanesulfonic acid (PFOSH) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (POSF), certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. 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. This supplemental action takes into account comments received on an earlier proposed SNUR published in the Federal Register of October 18, 2000, amends the description and the list of chemicals to which this proposed SNUR For technical information contact: would apply, and clarifies the Mary F. Dominiak, Chemical Control definitions of significant new uses. EPA believes that this action is necessary because the PFAS component of these chemical substances may be hazardous to human health and the environment. The required notice will provide EPA Division (7405M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-8104; email address: dominiak.mary@epa.gov. with the opportunity to evaluate an SUPPLEMENTARY INFORMATION: intended new use and associated activities and, if necessary, to prohibit I. General Information or limit that activity before it occurs. A. Does this Action Apply to Me? Published elsewhere in today's issue of the Federal Register is a final rule which addresses the remainder of the chemicals listed in the original You may be potentially affected by this action if you manufacture (defined by statute to include import) any of the proposed SNUR. chemical substances that are listed in DATES: Comments, identified by docket control number OPPTS-50639C, must be received on or before April 10, 2002. Table 2 of this unit. Persons who intend to import any chemical substance governed by a final SNUR are subject to 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 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 SUPPLEMENTARY INFORMATION. To ensure in compliance with the SNUR proper receipt by EPA, it is imperative requirements. The EPA policy in that you identify docket control number support of import certification appears OPPTS-50639C in the subject line on at 40 CFR part 707, subpart B. In the first page of your response. addition, any persons who export or FOR FURTHER INFORMATION CONTACT: For intend to export any of the chemical general information contact: Barbara substances listed in Table 2 of this unit Cunningham, Acting Director, are subject to the export notification Environmental Assistance Division provisions of TSCA section 12(b) (15 (74080), Office of Pollution Prevention U.S.C. 2611(b)), and must comply with and Toxics, Environmental Protection the export notification requirements in Agency, 1200 Pennsylvania Ave., NW,, 40 CFR 721.20 and 40 CFR part 707, Washington, DC 20460; telephone subpart D. Potentially affected number: (202) 554-1404; e-mail address: categories and entities may include, but TSCA-Hotline@epa.gov. are not limited to: Table 1.-- Potentially Affected Entities 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, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in Table 1 of this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action applies to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5 for SNUR-related obligations. Also, consult Unit III. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. Some chemicals in Table 2 of this unit are identified by both premanufacture notice (PMN) and Chemical Abstract Service numbers (CAS No.). In the original proposed SNUR, only the PMN appeared with those chemicals. Table 2.-- Chemical Substances Covered by this Proposed Rule CAS No./PMN CAS Ninth Collective Index 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- 000026 Federal R egister/Vol. 67, No. 47/M onday, March 11, 2 0 0 2 /Proposed Rules 11015 Table 2 -- Chemical Substances Covered by this Proposed Rule-- Continued CAS No./PIVIN 307-51-7 CAS Ninth Collective Index Name 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- 376-14-7 383-07-3 423-50-7 423-82-5 754-91-6 1652-63-7 1691-99-2 1763-23-1 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, iodide 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)1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- 2795-39-3 2991-51-7 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, potassium salt Glycine, N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]-, potassium salt 4151-50-2 14650-24-9 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro2-Propenoic acid', 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester 17202-41-4 24448-09-7 25268-77-3 29081-56-9 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 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N-methyl2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester 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 29457-72-5 31506-32-8 38006-74-5 38850-58-7 55120-77-9 67584-42-3 67906-- 42--7 68156-01-4 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-hydroxy1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3-sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-, inner salt 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt 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 Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt 68298-62-4 68329-56-6 68541-80-0 68555-90-8 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2[butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyi 2-propenoate, methyloxirane polymer with oxirane di-2propenoate, methyloxirane polymer with oxirane mono-2-propenoate and 1-octanethioi 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 2-Propenoic acid, polymer with 2-[ethy![(heptadecafIuorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-propenoate 2-Propenoic acid, butyl ester, polymer with 2-[[(heptadecafluorooctyl)su!fonyl]methylamino]ethyl propenoate, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate 2222- 000027 11016 Federal R egister/Vol. 67, No. 4 7 / Monday, March 11, 2 0 0 2 /Proposed Rules Table 2.-- Chemical Substances Covered by this Proposed Rule-- Continued CAS No./PMN 68555-91-9 68555-92-0 68586-14-1 68649-26-3 68891-96-3 68867-60-7 68867-62-9 68909-15-9 68958-61-2 70225-14-8 71487-20-2 73772-32-4 81190-38-7 CAS Ninth Collective Index Name 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[(pentadecafluQroheptyl)sulfanyl]amina]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2- propenoate 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyljmethylamino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]aminoJethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2- propenoate 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-pro- penyl)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]ethyl 2-propenoate and 1-octanethiol 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)-, reac tion 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 ale. Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glycinato-.kappa.O:.kappa.O']],mu.-hydroxybis(2-methyl-1-propanol)di- 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[(tridecafIuorohexyl)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) 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyi)sulfonyl]amino]ethyl ester, telomer with 2- [ethyl[(nonafluorobutyl)sulfonyl]aminojethyl 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) 2-Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2- [[(heptadecafIuorooctyl)sulfonyl]methylamino]ethyl acrylate, 2-[methyl [(nonafluorobutyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl ac rylate, 2-[methyi[(tridecafluorohexyl)sulfonyl]amino]ethyl acrylate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl acrylate, polyethylene glycol acrylate Me ether and ste aryl acrylate Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafiuorooctyl)sulfonyl]amino]ethyl]-.omega.-methoxy- 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) 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and 2-propenoic acid 22- 222- 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, mono sodium salt 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3-sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-N,Ndimethyl-, hydroxide, monosodium salt 000028 Federal R egister/Vol. 67, No. 4 7 /M onday, March 11, 2002 / Proposed Rules 11017 Table 2 -- Chemical Substances Covered b y this Proposed Rule-- Continued CAS No./PMN CAS Ninth Collective Index Name 91081-99-1 Sulfonamides, C4-8-aikane, perfluoro, N-(hydroxyethy!)-N-methyl, reaction products with epichlorohydrin, adipates (esters) 94133-90-1 1-Propanesulfonic add, 3-[[3-(dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]-2-hydroxy-, monosodium salt 98999-57-6 Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-[(1-oxo-2-propenyl)oxy]ethyl], polymers with 2- ethoxyethy! acrylate, glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethanaminium chloride 117806-54-9 129813-71-4 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranylmethyl) 148240-80-6 Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters 148240-82-8 Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters 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 (S2CI2) reaction products chlorides L-92-0151 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-[ethyl[(heptadecafiuorooctyl)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 192662-29-6 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethylamino)propyl], reaction products with acrylic acid P-83-1102 306973-46-6 Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters P-84-1163 306975-56-4 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3propanediol 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-ethyi1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide, compds. with triethylamine P-84-1171 306975-57-5 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1, T-methylenebis[4isocyanatobenzene] and 1,2,3-propanetriol, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide and N-ethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine P-86-0301 306973-47-7 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12-hydroxystearic acid and 2,4-TDI, ammonium salts P-86-0958 306975-62-2 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride P-89-0799 160901-25-7 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and polymethylenepolyphenylene isocyanate P-90-0111 306974-19-6 Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl] P-91-1419 306975-84-8 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6-dilsocyanatohexane, N-(2-hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamides-blocked P-93-- 1444 306975-85-9 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyi)-2-propenamide, 2[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chlo ride P-94-0545 306976-25-0 P-94-0927 306976-55-6 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 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl2-(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-ethyl-N-(hydroxyethyl)perfluoro-C4-8alkanesulfonamides-blocked P-94-2206 306974-28-7 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]ethyi acrylate and stearyl methacrylate 000029 11018 Federal Register /Vol. 67, No. 4 7 /M onday, March 11, 2 0 0 2 /Proposed Rules Table 2 -- Chemical Substances Covered by this Proposed Rule-- Continued CAS No./PMN CAS Ninth Collective Index Name P-95-0120 306980-27-8 Sulfonamides, C4-8-alkane, perfluoro, N,N'-[1,6-hexanediylbis[(2-oxo-3,5-oxazolidinediyl)methylene]]bis[Nmethyl- P-96-1262 306974-45-8 P-96-1424 306977-10-6 P-96-1433 179005-06-2 P-97-0790 251099-16-8 Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester,- telomer with 2-[ethyl[(perfluoro-C4-8alkyl)sulfonyl]amino]ethyl methacrylate and 1-octanethiol, N-oxldes Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts 1-Decanaminium, N-decyl-N,N-dlmethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1octanesulfonic acid (1:1) P-98-0251 306978-04-1 2-Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride P-98-1272 306977-58-2 2-Propenolc acid, 2-methyl-, 3-(trlmethoxysilyl)propyl ester, polymers with acrylic acid, 2-[methyl[(perfluoroC4-8-alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2'-(methylimino)bis[ethanol] P-99-0188 306978-65-4 Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro-C4-8-alkane sulfonamidesand stearyl ale.-blocked P-99-0319 306979-40-8 Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N[(perfluoro-C4-8-alkyl)sulfonyl) derivs. B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www.epa.gov/. To access this document, on the Home Page select "Laws and Regulations," "Regulations and Proposed Rules," and then look up the entry for this document under the "Federal Register--Environmental Documents." You can also go directly to the Federal Register listings at http:// www.epa.gov/fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPPTS-50639C. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of tire official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS--50639C in the subject line on the first page of your response. 1. By mail. Submit your comments to: Document Control Office (7407M), 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 Document Control Office (DCO) in Rm. 6428, EPA East, 1201 Constitution Ave., NW., 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) 564-8930. 3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50639C. Electronic comments may also 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 may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person 000030 Federal R egister/Vol. 67, No. 4 7 /M onday, March 11, 2002 / Proposed Rules 11019 listed under FOR FURTHER INFORMATION CONTACT. E. What Should l Consider as l Prepare My Comments for EPA? We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the proposed rule or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background A. What Action is the Agency Taking? The Agency is supplementing the proposed SNUR published in the Federal Register of October 18, 2000 (65 FR 62319) (FRL-6745-5), to take into account comments submitted on that proposed rule, to amend the list of chemical substances to which the proposed SNUR would apply, and to more clearly define significant new uses of these chemical substances. This supplemental proposed rule would require persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 2, Unit LA., for the significant new uses described in this document. The chemical substances identified in. Table 2, Unit I.A., are 75 chemical substances, including PFOSH, PFOSS, POSF, certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to throughout this proposed rule as PFAS. In the original proposed SNUR, these chemicals were referred to collectively as perfluorooctylsulfonates, or PFOS, but commenters noted that this generic usage of the term PFOS was inconsistent with the use by the manufacturer, the Minnesota Mining and Manufacturing Company (3M), of PFOS to refer only to chemicals with an eight-carbon, or C8, chain length. Many of the chemicals in the proposed SNUR include a range of carbon chain lengths, although they all include C8 within the range. Accordingly, EPA will use the generic term PFAS to refer to any carbon chain length, including higher and lower homologues as well as C8, and the term PFOS to represent only those chemical substances which are predominantly C8. The significant new uses described by this document are: 1. Any manufacture or import for any use of any chemical listed in Table 2, Unit I.A., on or after January 1, 2003, except as noted in Unit II.A.2. 2. Manufacture or import of any chemical listed in Table 2, Unit I.A., solely for one or more of the following specific uses shall not be considered as a significant new use subject to reporting under this section: i. Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids. ii. Use as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. iii. Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in Unit II.A.2.i. or ii. iv. Use in a surface tension and static discharge control coating on films, papers, and printing plates, or as a surfactant or defoamer in solutions used to process films and papers, in traditional and laser medical imaging and in industrial and consumer film products. B. What is the Agency's Authority for Taking this Action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use." The Agency makes this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). These factors include the volume of a chemical substance's production; the extent to which a use changes the type, form, magnitude, or duration of exposure to the substance; and the reasonably anticipated manner of producing or otherwise managing the substance. Once EPA makes this determination and promulgates a SNUR, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that significant new use (15 U.S.C. 2604 (a)(1)(B)). 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 to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Note that because this proposed rule would designate certain manufacturing and importing activities as significant new uses, persons that solely process or use the chemical substances that would be covered by this action would not be subject to the rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this proposed SNUR would be required to comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include: The information submission requirements of TSCA section 5(b) and 5(d)(1); the exemptions authorized by TSCA section 5 (h)(1), (2), (3), and (5); the export notification provisions of TSCA section 12(b); and the export notification requirements in 40 CFR part 707, subpart D. Once EPA receives a SNUN, EPA may take regulatory action under TSCA sections 5(e), 5(f), 6, or 7, if appropriate, to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. III. Summary of this Supplemental Proposed Rule The chemical substances subject to this supplemental proposed SNUR are listed in Table 2, Unit I.A. These chemical substances include PFOSH, PFOSS, POSF, certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. All of these chemical substances are referred to collectively in this proposed rule as perfluoroalkyl sulfonates, or PFAS. In the original proposed SNUR (65 FR 000031 11020 Federal Register /Vol. 67, No. 47 / Monday, March 11, 2 0 0 2 /Proposed Rules 62319, October 18, 2000), these chemicals as described in the original EPA determined that the remaining 75 chemicals had been referred to proposed SNUR. chemicals, which appear in Table 2, collectively as perfluorooctylsulfonates, The original proposed SNUR included Unit I.A., presented issues that or PFOS. but commenters noted that these and 15 other chemicals, and warranted the proposal of this this generic usage of PFOS was would have identified as a significant supplemental SNUR. Commenters inconsistent with 3M's use of PFOS to new use: Any manufacture or import of provided information confirming that, refer only to chemicals with an eight- any of these chemicals for any use on contrary to the information available to carbon, or C8, chain length. Many of the or after January 1, 2003; and any the EPA when the original proposed chemicals in the proposed SNUR manufacture or import in excess of SNUR was published, 3M was not the included a range of carbon chain specified volume limits between sole manufacturer of certain of the lengths, although they all did include January 1, 2001, and December 31, 2002. chemical substances on Table 2, Unit C8 within the range. Accordingly, EPA At the request of prospective I.A., which commenters were importing will use the generic term PFAS to refer commenters, EPA extended the date for in small quantities below mandatory to any chain length, including higher submitting comments from November. reporting thresholds for their specific and lower homologues as well as C8, 17, 2000, to January 1, 2001 (65 FR uses from non-3M sources outside the and the term PFOS to represent only those chemicals which are 69889, November 21, 2000) (FRL-6756- United States prior to the publication of 9). Twenty-six timely comments were the proposed SNUR. The identities, predominantly C8. submitted on the proposed SNUR. amounts, and suppliers of those specific All of the chemical substances listed in this supplemental proposed SNUR have the potential to degrade to PFOSH in the environment. Information also suggests that these chemical substances may be converted to PFOSH via incomplete oxidation during the incineration of PFAS-containing materials. Once PFOSH has been released to the environment, it does not undergo further chemical (hydrolysis), microbial, or photolytic degradation. PFOSH is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS chemicals in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3). These facts, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment. A detailed discussion of these concerns appeared in the original proposed SNUR (65 FR 62319, October 18, 2000) and in the EPA Hazard Assessment document in the docket for Because of the complexity of the issues and the interest expressed by the commenters, EPA announced a public meeting on the proposed SNUR (66 FR 11243, February 23, 2001) (FRL-67714), which was conducted on March 27, 2001, to provide commenters with the opportunity to expand upon their comments, offer clarifications, and further explain their issues and concerns. At that meeting, several participants expressed a willingness to gather and submit additional information concerning their need for and specific use of certain of these chemicals, and EPA indicated that it would consider those post-meeting submissions as a formal part of the rulemaking record. EPA requested that these submissions include specific information on PFAS exposures and releases associated with various uses, as well as documentation about the extent to which PFAS chemical substances on the proposed SNUR lists were being obtained for specific uses from sources other than 3M, and thus would not be affected by 3M's unilateral decision to discontinue production. (Ref. 5) The final such submission was received by the EPA on October 3, 2001. All of these submissions are in the docket for this proceeding. chemicals were claimed as confidential business information (CBI), and thus cannot be specifically identified in this proposed rule. To the extent that specific PFAS chemical substances on the proposed SNUR lists were being obtained from sources other than 3M for specific uses prior to the publication of the proposed SNUR, and thus would not be affected by 3M's unilateral decision to discontinue production, those particular uses of those specific chemicals would be considered ongoing and would not be subject to a significant new use determination. These specific uses are: As a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. Accordingly, this supplemental proposed SNUR identifies these specific uses of those particular chemicals as not being significant new uses of the chemicals listed in Table 2, Unit I.A., and thus as not being subject to this proposed SNUR. Some commenters in this industry who were not importing from non-3M sources indicated that they were using the proposed SNUR (Ref. 4). In its Following review and consideration certain chemicals listed in the proposed comments on the proposed SNUR, 3M of all the comments, correspondence, SNUR, as well as other PFAS chemicals emphasized that no data indicated that and additional submissions, EPA that were not included in the proposed adverse effects were currently being determined that the proposed SNUR SNUR. Both individually and through observed in humans and wildlife. 3M should be promulgated as final for the an industry-wide submission of mass also noted that additional data under 13 chemicals, employed principally in balance data tracking the use and final development might change some of the coatings for textiles, carpet, apparel, disposition of these PFAS chemicals, all EPA's preliminary conclusions. 3M leather, and paper, on which no commenters in this industry indicated challenged the simplification in the comments were received and which 3M, that these chemicals were used in very preamble of EPA's characterization of the sole manufacturer, confirmed were small quantities under 2,000 kilograms certain of the hazard studies analyzed in discontinued from manufacture before (kg) (4,400 lbs) per year total in the the EPA Hazard Assessment, which 3M December 31, 2000. EPA also removed United States, under controlled felt overstated some of tlie EPA's hazard from the rule two chemicals that had conditions that virtually eliminated conclusions. None of the other appeared by error in the original occupational exposures to the chemicals comments submitted on the proposal proposed SNUR. That final rule is and presented very low releases to the addressed the hazards, environmental published elsewhere in today's issue of environment. They also presented fate, or exposures associated with these the Federal Register. information on the lack of viable 000032 Federal R egister/Vol. 67, No. 47/M onday, March 11, 2 0 0 2 /Proposed Rules 11021 alternatives for these chemicals because of their unique performance characteristics, and described their efforts to further reduce the use of PFAS chemicals and to continually improve their handling and disposal practices to reduce or eliminate PFAS exposures and releases. (Ref. 6) Given the extremely low volume of use and the stringent controls on exposure and releases. EPA is proposing not to include in the definition of significant new use the manufacture or import of chemicals listed in Table 2, Unit I.A., including chemicals which had not been imported from non-3M sources prior to the publication of the proposed SNUR, for use as a component of a photoresist substance, including a photo acid generator or surfactant, or a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. EPA is proposing this exclusion in recognition of the industry's commitment to continue to pursue better controls to ensure that this use will not increase the type, magnitude, or duration of exposure to PFAS chemicals. Three commenters also provided information indicating that their specific use of the 3M formulations FC93 and FC98, which contain three of the PFAS chemicals (CAS Nos. 279539-3, 67584-42-3,and 68156-01-4) listed in Table 2, Unit I.A, as an anti erosion additive in fire-resistant phosphate ester aviation hydraulic fluids, was critical to the safe performance of large cargo and passenger aircraft, and that there are at present no viable alternatives to PFAS for this use. These commenters also indicated that, although 3M has been their source, the PFAS chemicals used in this application have also been produced by other foreign sources prior to the publication of the SNUR, although they have not been imported. They reported that the total aggregate use of PFAS in this application by all aviation consumers is' less than 5,000 lbs per year (2.273 kg), and that because these systems are sealed at the time of manufacture, worker exposures and releases to the environment are minimal. They noted that ongoing research for possible replacement chemicals could not produce viable alternatives for se v e ra l years, because of requirements that these products meet military specifications or gain approval from the Federal Aviation Administration (FAA). (Refs. 7, 8, 9, and 10) Based on the information presented, including the very low volume of use and the low potential for exposure, as well as the critical safety nature of the use, EPA proposes to exclude the manufacture or import of these PFAS chemicals for use in this application from the definition of significant new use. Commenters in the semiconductor and aviation hydraulics industries also indicated that, in order to produce the specific PFAS chemicals used in their applications, certain additional chemicals on the list in Table 2, Unit I.A., would be required for use as intermediate chemicals in the manufacturing process. Accordingly, EPA proposes to exclude from the significant new use definition the use of these PFAS chemicals as intermediates only to produce other chemicals used solely for the excluded semiconductor and aviation hydraulics uses. Commenters in the photography industry, in addition to raising the semiconductor applications addressed earlier in this section, also identified as critical the use of certain PFAS chemicals in surface tension and static discharge control coatings on films, papers, and printing plates, and as surfactants and defoamers in solutions used to process films and papers, particularly in both traditional and laser medical imaging and in some industrial and consumer film products. The industry estimated the total annual use of these PFAS chemicals in medical imaging for disease diagnosis at 30,600 kg (67,320 lbs), with another 5,400 kg (11,880 lbs) used per year in industrial (i.e., oil pipeline x-ray; aerial reconnaissance photography) and some consumer applications. Some information on specific chemicals used in these applications, as well as on the sources of those chemicals, was claimed as confidential. Specific information on exposures and releases from all these uses was not provided. These commenters indicated that they were conducting research to find alternatives to these PFAS chemicals in these uses, but that they believed they would not be able to find and technically qualify viable alternatives for use before the end of the phase-out period. (Refs. 11 and 12) EPA is proposing to exclude these photographic uses from the definition of significant new use in the SNUR, based on its understanding that the industry is actively working to move away from these PFAS chemicals and to reduce the use and release of PFAS. EPA is concerned, however, that these uses, while much lower in volume than the discontinued coating uses on textiles, apparel, carpet, furniture, and paper, are substantially greater in volume than the semiconductor and aviation uses for which exclusions are being proposed, and much less is known about the extent of exposures and releases related to these uses. EPA is concerned that new manufacture or importation for these photographic uses may significantly affect the type, magnitude, and duration of exposure to these chemicals because of their known persistence. EPA therefore specifically requests comment on this proposed exclusion of these photographic uses from the significant new use definition, particularly addressing the anticipated exposures and releases that may result from these uses, and including information on handling and disposal controls that would control, reduce, or eliminate such exposures and releases. In the absence of such information to confirm the Agency's understanding and support the proposed exclusion, EPA may include these photographic uses in the definition of significant new uses that would be subject to this SNUR at such time as a final rule is promulgated, perhaps defining the new use based on a volume cap on new manufacture or importation intended for this use. Accordingly, EPA proposes to require persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 2, Unit I.A., for the significant new uses described in this document. The significant new uses described by this notice are: 1. Any manufacture or import for any use of any chemical listed in Table 2 of Unit I.A., on or after January 1, 2003, except as noted Unit III.2. 2. Manufacture or import of any chemical listed in Table 2, Unit I.A., solely for one or more of the following specific uses shall not be considered as a significant new use subject to reporting under this section: i. Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids. ii. Use as a com ponent of a photoresist substance, including a photo acid generator or surfactant, or as a com ponent of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other m iniaturized devices. iii. Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in Unit III.2.i. or ii. iv. Use in a surface tension and static discharge control coating on films, papers, and printing plates, or as a surfactant or defoamer in solutions used to process films and papers, in traditional and laser medical imaging 000033 11022 Federal Register/Vol. 67, No. 47/M onday, March 11, 2 0 0 2 /Proposed Rules and in industrial and consumer film products. IV. Applicability of Proposed Rule to Uses Occurring Before the Effective Date of the Final Rule EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing. Persons who begin commercial manufacture or import of the PFAS chemicals listed in Table 2, Unit I.A., for the significant new uses listed in this proposed SNUR after the proposal has been published must stop that activity before the effective date of the final rule. Persons who ceased those activities will have to meet all SNUR notice requirements and wait until the end of the notice review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who begin commercial manufacture or import of these chemical substances between the proposal and the effective date of the SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45(h), those persons will be considered to have met the final SNUR requirements for those activities. V. Summary and Response to Comments on Original Proposed Rule EPA received 26 timely comments on the original proposed SNUR, and numerous additional presentations and correspondence at and following the public meeting. As described in this unit and in Unit III, all of these materials were taken into consideration in the preparation of this supplemental proposed SNUR. All of these materials have been placed in docket OPPTS-- 50639. One comment addressed the use of PFOS in aqueous film-forming foam (AFFF) fire fighting products, and commended the Agency for terminating this application. 3M voluntarily exited this market, and was the only producer of PFOS-based AFFF, although nonPFOS-based AFFF products using other fluorinated surfactants remain in use and are unaffected by this proposed regulation, EPA is continuing to investigate these related fluorinated surfactants to determine whether they may present issues and concerns similar to those associated with PFOS. One comment indicated that certain of the chemicals on the list were in use and registered as active ingredients in pesticide formulations, and that chemicals in such use, being regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), would be excluded from the TSCA definition of a "chemical substance" and would thus not be subject to the proposed SNUR or other reporting requirements under TSCA. Pesticides are excluded from regulation under TSCA, although pesticide intermediates (chemicals manufactured for the purpose of producing regulated pesticide ingredients) are subject to TSCA regulation. Following the publication of the proposed SNUR, however, the pesticide registrants voluntarily negotiated product stewardship agreements with the EPA Office of Pesticide Programs to cancel some registered products and to phase out others. Three commenters noted that three PFAS chemicals included in the proposed SNUR (CAS Nos. 2795-39--3, 67584-42-3, and 68156-01-4) were components of 3M products FC93 and FC 98, currently being used in very small concentrations (generally less than 500 parts per million (ppm), or 0,05% PFOS) as anti-erosion additives in fire-resistant phosphate ester aviation hydraulic fluids, and that these uses were critical to the safe functioning of control surfaces, brakes, steering, and landing gear on virtually all large cargo, military, and passenger transport aircraft. The commenters indicated that untreated phosphate ester fluids, used for their high fire resistance, support electrochemical erosion of control valves within sealed hydraulic systems, and that these PFAS chemicals were the only additives discovered in twenty years of research that could eliminate this problem. They indicated that the total aggregate use of PFAS in this application by all aviation consumers is less than 5,000 lbs (2,273 kg) per year, and that because these systems are sealed at the time of manufacture, worker exposures and releases to the environment are minimal. They noted that ongoing research for possible replacement chemicals could not produce any viable alternatives for several years, because of requirements that these products meet military specifications or gain approval from FAA. Given the low volumes involved, the minimal exposure and release potential, the aviation safety requirements, and the demonstrated lack of viable alternatives, EPA is proposing to exclude the manufacture or importation of PFAS chemicals specifically for use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids from the definition of significant new use to which this proposed SNUR would apply. No SNUN w ould thus be required from a com pany or individual manufacturing or importing any of the PFAS chem icals on Table 2, Unit I.A., for this specific use. Several companies in the semiconductor industry submitted comments and participated in meetings both individually and through their respective trade associations, indicating that 3M was not the only supplier of the specific PFAS chemicals used in their particular applications; some companies supplied confidential data indicating that they had been importing very small quantities of certain of these chemicals from non-3M sources. At the time the original SNUR was proposed, EPA was unaware that this importation was taking place, because the quantities involved were below the threshold for reporting such importation to the EPA. Both individually and through an industry-wide mass balance submission, the commenters indicated that these chemicals were used in very small quantities, under 2,000 kg (4,400 lbs) per year total in the United States, under controlled conditions that virtually eliminated occupational exposures to the chemicals. They also presented information concerning their search for and conversion to non-PFOS chemicals in certain applications, as well as ongoing modifications to their wastewater handling and treatment operations that would dramatically reduce their PFAS releases to the environment. They expressed an interest in continuing to work with the EPA to further reduce the use of PFAS, but indicated that, at present, viable alternatives for PFAS have not been qualified for two uses critical to both the commercial success of the industry and to its technological contributions to national security; as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. Because companies had been importing certain of the chemical substances on Table 2, Unit I.A., in very small quantities from non-3M sources for use as a component of a photoresist substance or an anti-reflective coating used in a photomicrolithography process prior to the publication of the Federal Register/Vol. 67, No.' 47 / Monday, March 11, 2002 / Proposed Rules 11023 original proposed SNUR, EPA considers those uses of those particular substances to be ongoing, and the continuing manufacture or import of those specific PFAS chemicals for those uses, particularly in the small amounts and under the types of exposure and release controls described by the commenters, would thus not be subject to the SNUR, as reflected in this supplemental proposal. EPA further proposes to exclude from the significant new use definition these specific uses of the additional PFAS chemicals on Table 2, Unit I.A, which had not previously been imported into the United States from non-3M sources. In proposing this exclusion, EPA recognizes that the amounts involved are small, and that the industry has committed to continue to pursue better controls to ensure that this use will not increase the type, magnitude, or duration of exposure to PFAS chemicals. No SNUN would thus be required from a company or individual manufacturing or importing any of the PFAS chemicals on Table 2, Unit I.A. for this specific use. Commenters in both the aviation and semiconductor industries also indicated that certain chemical substances listed in the SNUR are essential chemical intermediates required to make the PFAS products that are actually used in electronics manufacture and hydraulic fluids. EPA proposes to exclude from the significant new use definition the use of listed PFAS chemicals as intermediates only to produce other chemical substances to be used solely for the semiconductor and aviation uses already described. EPA commends the aviation and semiconductor industries in particular for their diligence in providing useful tools and information and in working with the Agency to achieve a full understanding of the issues presented by PFAS in these industries. EPA further acknowledges their pledge to continue to work toward further reductions in the use and release of PFAS chemicals notwithstanding the proposed identification of these low volume, low release, and controlled exposure uses as not included within the definition of significant new uses subject to this SNUR. Four companies and a trade association presented comments and supplementarv correspondence concerning the use of PFAS chemicals in the photography industry. To the extent that those comments concerned photomicrolithography in the semiconductor context, they are addressed above in the EPA's response to the semiconductor industry in this unit. Separately from the semiconductor issues, the photography industry also identified as critical the use of certain PFAS chemicals in surface tension and static discharge control coatings on films, papers, and printing plates, and as surfactants and defoamers in solutions used to process films and papers, particularly in both traditional and laser medical imaging and in some industrial and consumer film products. The industry estimated the total annual use of these PFAS chemicals in medical imaging for disease diagnosis at 30,600 kg (67,320 lbs), with another 5,400 kg (11,880 lbs) used per year in industrial (i.e., oil pipeline x-ray; aerial reconnaissance photography) and some consumer applications. Specific information on exposures and releases from all these uses was not provided. Some of the specific chemicals used, the sources from which those chemicals were obtained, and the amounts used by individual companies were claimed as confidential business information. The photographic industry commenters expressed willingness to work toward reducing the amount of PFAS being used in their applications, but indicated concern that viable alternatives might not be available or qualified by the phase-out date announced by 3M and reflected in the original proposed SNUR. They requested an extension of the phase-out period for their claimed critical use applications. The phase-out dates in the original proposed SNUR were determined by 3M's voluntary commitment to discontinue production of these PFAS chemicals. The basis for EPA's original SNUR proposal was that any production of these chemicals following the 3M phaseout would by definition be new, since at the time the proposal issued, 3M had been the sole producer; and any new production would necessarily affect the type, magnitude, and duration of exposure, because these chemicals are persistent. New production would add to the base amount of these chemicals already present in the environment, and widespread exposure to these chemicals has been demonstrated through the detection of PFOS in the blood of the general population and of wildlife. The commenters did not propose a time frame for an extended phase-out of these chemicals for their specific use. Because the amount of time that might be required is uncertain, instead of proposing a specific extension of the phase-out period, EPA is proposing to exclude these photographic uses from the definition of a significant new use under the SNUR, on the understanding that the industry is actively working to move away from these PFAS chemicals and to reduce the use and release of PFAS. EPA is concerned, however, that these uses, while much lower in volume than the discontinued coating uses on textiles, apparel, carpet, furniture, and paper, are substantially greater than the semiconductor and aviation uses for which exclusions are also being proposed, and much less is known about the extent of exposures and releases related to these uses. EPA is concerned that these photographic uses may significantly affect the type, magnitude, and duration of exposure to these chemicals because of their known persistence. EPA therefore specifically requests comment on this proposed exclusion of these photographic uses, particularly addressing the anticipated exposures and releases that may result from these uses, and including information on handling and disposal controls that would control, reduce, or eliminate such exposures and releases. In the absence of such information to confirm the Agency's understanding and support the proposed exclusion, EPA may include these photographic uses in the definition of significant new uses that would be subject to this SNUR at such time as a final rule is promulgated, perhaps defining the new use based on a volume cap on new manufacture or importation intended for this use. One commenter indicated that it imported small quantities of some of the chemicals listed in the original proposed SNUR for various applications, but gave no further information to identify which chemicals it imported, or whether 3M--which has production facilities abroad--was the source of the imported chemicals. Some of the uses mentioned in this comment have been addressed in this unit in the contexts of the industries which provided more details on use. Without more specific substantiation of the asserted importation, this comment cannot be further addressed. One private citizen commended the EPA for taking action on PFOS, but noted that there must be more PFAS chemicals on the Inventory than were listed in the original SNUR, and that similar action should be taken to address those other chemicals. EPA is evaluating other PFAS and PFASrelated chemicals, but used the mechanism of the proposed SNUR to address the specific chemicals that it had sufficient reason to believe were either not currently in use or were being phased out by their sole producer. If regulatory action on other PFAS or PFAS-related chemicals is warranted, EPA will propose appropriate action when its evaluation is complete. 000035 11024 Federal Register/ Vol. 67, No. 4 7 /Monday, March 11, 2 0 0 2 /Proposed Rules The National Aeronautics and Space Administration (NASA) noted that it used many chemicals in,its Space Shuttle program and was not certain at the time of its initial comment submission whether those would include any of the PFAS chemicals in the proposed SNUR. EPA has not received any subsequent communications from NASA that would indicate that NASA concluded that the proposed SNUR would present issues. 3M provided comments suggesting some changes in the acronyms used in the proposed SNUR to make them consistent with the nomenclature customarily used by 3M and the industry, 3M also requested minor changes to the two tables of chemicals listed in the SNUR to correct the assignment of four chemicals to the wrong table, and to remove two chemicals that had not been included in 3M's phaseout plan. EPA adopted the 3M nomenclature and made the table adjustments. 3M emphasized that no data indicated that adverse effects were currently being observed in humans and wildlife. 3M also noted that additional data under development might change some of the EPA's preliminary conclusions. 3M challenged the simplification in the preamble of EPA's characterization of certain of the hazard studies analyzed in the EPA Hazard Assessment, which 3M felt overstated some of the hazard conclusions that were drawn in the assessment. 3M requested that these statements be rephrased more accurately in any discussion of hazard in the final rule. VI. References These references have been placed in the official record that was established under docket control number OPPTS50639 for this rulemaking as indicated in Unit I.B.2. Reference documents identified with an Administrative Record number (AR) are cross-indexed to non-regulatory, publicly accessible information files maintained in the TSCA Nonconfidential Information Center. Copies of these documents can be obtained as described in Unit I.B.2. 1. (AR226--0620) Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate, and Effects. 3M. St. Paul. MN. March 1, 2000. 2. (AR226--0547) The Science of Organic Fluorochemistry. 3M. St. Paul, MN. February 5. 1999. 3. (AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999. 4. Seed, Jennifer. Hazard Assessment and Biomonitoring Data on Perfluorooctane Sulfonate--PFOS, USEPA/OPPT/RAD. Washington, DC. August 31, 2000. 5. Dominiak, Mary. PFOS Public Meeting Summary and Attendee List. USEPA/OPPT/CCD. Washington, DC. April 27, 2001. 6. Harper, Stephen and Dripps, Greg. Letter (with appendices) to Charles M. Auer. Semicondustor Industry Association and Semiconductor Equipment and Materials International. Washington, DC. October 3, 2001. 7. Jamot, Bruce. Comments of ExxonMobil Lubricants and Petroleum Specialties. Fairfax, VA. November 16, 2000. 8. Frank, Matthew. Comments of Boeing. Arlington, VA. November 17, 2000. 9. Downes, Jim. Comments of Solutia. St. Louis, MO. November 13, 2000. 10. Downes, Jim. Supplementary Comments of Solutia at EPA Public Meeting. Washington, DC. March 27, 2001. 11. O'Donoghue, John. PFOS and Imaging. Presentation of Photographic and Imaging Manufacturers Association at EPA Public Meeting. Washington, DC. March 27, 2001. 12. O'Donoghue, John. Letter to Charles M. Auer, Followup to the March 27, 2001 Public Meeting. Rochester, NY. April 24, 2001. VII. Regulatory Assessment Requirements Under Executive Order 12866, entitled Regulatory Planning and Review {58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that SNURs are not a "significant regulatory action" subject to review by OMB, because SNURs do not meet the criteria in section 3(f) of the Executive order. Based on EPA's experience with past SNURs, State, local, and tribal governments have not been impacted by these rules, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this proposed rule. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This proposed rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to this proposed rule. Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), which took effect on January 6, 2001, revokes Executive Order 13084 as of that date. EPA developed this proposed rule, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. For the same reasons stated for Executive Order 13084, the requirements of Executive Order 13175 do not apply to this proposed rule either. Nor will this action have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999}. This proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use. In issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this proposed rule in accordance with the "Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings" issued under the Executive order. This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action is not subject to Executive Order 13045, entitled Protection of 000036 Federal Register/ Vol. 67, No. 47/M onday, March 11, 2002 / Proposed Rules 11025 Children from Environmental Health Risks and Safety Risks [62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action. Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a "significant new use." Based on all information currently available to EPA, it appears that no small or large entities currently engage in such activity. Since a SNUR requires merely that any person who intends to engage in such activity in the future must first notify EPA (by submitting a SNUN), no economic impact will even occur until someone decides to engage in those activities. As a voluntary action, it is reasonable to presume that this decision would be based on a determination by the person submitting the SNUN that the potential benefits would outweigh the costs. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. EPA's experience to date is that, in response to the promulgation of over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that, the economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration. According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost of between $5,957 and $7,192 per SNUN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required SNUN, and maintain the required records. This burden estimate does not include 1 hour of technical time at $64.30 per hour estimated to be required for customer notification of SNUR requirements, or the $2,500 user fee for submission of a SNUN ($100 for businesses with less than $40 million in annual sales). Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, as instructed in Unit I.D. or to the Director, Collection Strategies Division, Office of Environmental Information, Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW,, Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous materials, Reporting and recordkeeping requirements, Significant new uses. Dated: M arch 4, 2002. William H. Sanders, HI, Director, Office ofPollution 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(c). 2. By revising 721.9582 in subpart E to read as follows: 721.9582 Certain perfluoraikyl sulfonates. (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances listed in Table 1 and Table 2 of this paragraph are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. T a b l e 1.-- P F A S C h e m ic a l s S u b je c t t o R e p o r t in g o n o r A f t e r J a n u a r y 1, 2001 C AS N o./PM N C A S Ninth C ollective Index N am e 22 50-98-8 1-O ctanesulfonam ide, N ,N ',N" -[phosphinylldynetris(oxy-2,1-ethanedlyl)]tris[N -ethyl- 1 ,1 ,2 ,2 ,3 ,3 ,4 ,4 ,5 ,5 ,6 ,6 ,7 ,7 ,8 ,8 ,8 -h e p ta d e c a flu o ro - 3 0 3 8 1 -9 8 -7 1 -O c ta n e su lfo n a m id e , N .N '-tp h o s p h in ic o b ls to x y ^ .l-e th a n e d iy O jb is tN -e th y l-I.I^ ^ .S .S A ^ .S .S .e .e T T .S .S .S heptadecafluoro-, am m onium salt 5 7 5 8 9 -8 5 -2 B enzoic a c id , 2,3,4,5-tetrachioro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]am inojcarbonyi]-, m onopotassium salt 6 1 6 6 0 -1 2 -6 1-O ctanesulfonam ide, N -ethyl-1,1 ,2,2,3 ,3,4 ,4,5,5,6,6 ,7,7 ,8,8,8-he ptad ecafluo roN -[3-(trim eth oxysilyl)propyl]- 67969-69-1 1-O ctanesulfonam ide, N -ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N -[2-(phosphonooxy)ethyl]-, dlam m onium salt " ^-Jr 5' 000037 11026 Federal R egister/Vol. 67, No. 4 7 / Monday, March 11, 2 0 0 2 /Proposed Rules T a b l e 1.-- PFAS C h e m ic a l s S u b j e c t t o R e p o r t in g o n o r A f t e r J a n u a r y 1, 2001-- Continued CAS No./PMN CAS Ninth Collective Index Name 68608-14-0 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1'-methylenebis[4isocyanatobenzene] 70776-36-2 2-Propenoic add, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, N-(hydroxymethyl)-2-propenamide, [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate 22222- 127133-66-8 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perf!uoroC4-8-alkyl)sulfonyl]amino]ethyl methacrylate 148240-78-2 148684-79-1 Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters Sulfonamides, C4-8-a(kane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6diisocyanatohexane homopolymer and ethylene glycol 178535-22-3 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1'-methylenebis[4isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked P-94-2205 Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide P-96-1645 306974-63-0 Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters Table 2.-- PFAS Chemicals Subject to Reporting on or A fter January 1, 2003 CAS No./PMN CAS Ninth Collective Index 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 383-07-3 2-Propenoic acid, 2-[butyl[(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- 423-82-5 2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester 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-heptadecaf!uoro- 14650-24-9 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester 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)sulfonyi]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 000038 Federal R egister/Vol. 67, No. 4 7 /Monday, March 11, 2 0 0 2 /Proposed Rules 11027 T a b l e 2.-- PFAS C h e m ic a l s S u b j e c t t o R e p o r t in g o n o r a f t e r J a n u a r y 1, 2003-- Continued CAS No./PMN 31506-32-8 38006-74-5 38850-58-7 CAS Ninth Collective Index Name 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3-sulfopropyl)[(tridecafluorohexyi)sulfonyl]amino]-, inner salt 55120-77-9 67584-42-3 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt 67906-42-7 68156-01-4 68298-62-4 68329-56-6 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 Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2[butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, methyloxirane polymer with oxirane di-2propenoate, methyloxirane polymer with oxirane mono-2-propenoate and 1-octanethiol 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 68541-80-0 2-Propenoic acid, polymer with 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-propenoate 68555-90-8 2-Propenoic acid, butyl ester, polymer with 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl propenoate, 2-[methyi[(nonafluorobutyl)sulfonyl]amino]ethyi 2-propenoate, [methyl[(pentadecaf!uoroheptyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and [methyl[(undecafluoropentyl)Sulfonyl]amino]ethyl 2-propenoate 2222- 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-methyi-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2- propenoate 68555-92-0 68586-14-1 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyi]methylamino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(tridecafluorohexyi)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2- propenoate 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyi]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-pro- penyl)oxy]poly(oxy-1,2-ethanediyl), 2-[methyl[(pentadecafluoroheptyi)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[ (tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and 1-octanethiol 68649-26-3 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-, reac tion 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, polymethyienepolyphenylene isocyanate and stearyl ale. 68891-96-3 68867-60-7 Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glycinato-.kappa.O:.kappa.O']],mu.-hydroxybis(2-methyl-1 -propanol)di- 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) OOOOS 11028 Federal R egister/Vol. 67, No. 4 7 /Monday, March 11, 2002 / Proposed Rules T a b l e 2.-- PFAS C h e m ic a l s S u b j e c t t o R e p o r t in g o n o r A f t e r J a n u a r y 1, 2003-- Continued CAS No./PMN 68867-62-9 CAS Ninth Collective Index Name 2-Propenoic acid, 2-methyi-, 2-[ethyl[(heptadecaf!uorooctyl)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) 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]amlno]ethyl ac rylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amlno]ethyl acrylate, 2- [methyl((undecafluoropentyl)sulfonyi]aminolethyl acrylate, polyethylene glycol acrylate Me ether and ste- aryl acrylate 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, [[(heptadecaf!uorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, [methyl[(nonafluorobutyl)sulfonyl]amlno]ethyl 2-propenoate, [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-prope'noate and 2-propenoic acid 22222- 73772-32-4 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, mono sodium salt 81190-38-7 1-Propanaminlum, N-(2-hydroxyethyi)-3-[(2-hydroxy-3-sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-N,Ndimethyl-, hydroxide, monosodium salt 91081-99-1 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with epichlorohydrin, adipates (esters) 94133-90-1 1-Propanesulfonic acid, 3-[[3-(dimethylamlno)propyl][(heptadecafluorooctyl)sulfonyl]amino]-2-hydroxy-, monosodium salt 98999-57-6 Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-[(1-oxo-2-propenyl)oxy]ethyl], polymers with 2ethoxyethyl acrylate, glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethanaminium chloride 117806-54-9 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt 129813-71-4 Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranyimethyl) 148240-80-6 Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters 148240-82-8 Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters 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-chiorine-suifur chloride (S2CI2) reaction products chlorides L-- 92-- 0151 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-[ethyl[(heptadecafluorooctyl)sulfonyl)amlno]ethyl 2- methyl-2-propenoate, 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafiuoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and 2-propenoic acid P-80-0183 192662-29-6 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dlmethylamino)propyl], reaction products with acrylic add P-- 83-- 1102 306973-46-6 Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters P-84-1163 306975-56-4 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3propanediol and N,N',2-tris(6-isocyanatohexyl)imidodicarbonlc dlamide, reaction products with N-ethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-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 000040 Federal R egister/Vol. 67, No. 4 7 / Monday, March 11, 2 0 0 2 /Proposed Rules 11029 Table 2 -- PFAS Chemicals S ubject to Reporting on or After January 1, 2003-- Continued CAS No./PMN CAS Ninth Collective Index Name P-84-1171 306975-57-5 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,1'-methylenebis[4isocyanatobenzene] and 1,2,3-propanetriol, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecaf!uoro-N-(2-hydroxyethyl)-1-octanesulfonamide and N-ethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine P-86-0301 306973-47-7 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12-hydroxystearic acid and 2,4-TDI, ammonium salts P-86-0958 306975-62-2 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride P-89-0799 160901-25-7 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and polymethylenepolyphenylene isocyanate P-90-0111 306974-19-6 Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl] P-91-1419 306975-84-8 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane, N-(2-hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamides-blocked P-93-1444 306975-85-9 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyl)-2-propenamide, 2[methyl[(perfluoro-C4-8-atkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chlo ride P-94-0545 306976-25-0 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 306976-55-6 2-Propenoic acid, 2-methyl-, 2-methyipropyl ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl2-(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-ethyl-N-(hydroxyethyl)perfluoro-C4-8alkanesulfonamides-blocked P-94-2206 306974-28-7 Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propylgroup]-terminated, polymers with 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate P-95-0120 306980-27-8 Sulfonamides, C4-8-alkane, perfluoro, N,N'-[1,6-hexanediylbis[(2-oxo-3,5-oxazolidinediyl)methylene]]bis[Nmethyl- P-96-1262 306974-45-8 Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether P-96-1424 306977-10-6 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, telomer with 2-[ethyl[(perfluoro-C4-8alkyl)sulfonyl]amino]ethyl methacrylate and 1-octanethiol, N-oxides P-96-1433 179005-06-2 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts P-97-0790 251099-16-8 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-heptadecafIuoro-1octanesulfonic acid (1:1) P-98-0251 306978-04-1 2-Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride P-98-1272 306977-58-2 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyi ester, polymers with acrylic acid, 2-[methyl[(perfluoroC4-8-alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2'-(methylimino)bis[ethanol] P-99-0188 306978-65-4 Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro-C4-8-alkane sulfonamidesand stearyl alc.-blocked P-99-0319 306979-40-8 Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N[(perfluoro-C4-8-alkyl)sulfonyl] derivs. (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 chemical listed in Table 2 of paragraph (a)(1) of this section on or after January 1, 2003, except as noted in paragraph (a)(3) of this section. (3) Manufacture or import of any chemical listed in Table 2 of paragraph (a)(1) of this section for the following specific uses shall not be considered as a significant new use subject to reporting under this section: (i) Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids. (ii) Use as a component of a photoresist substance, including a photo 000041 11030 Federal Register/Vol. 67, No. 4 7 /Monday, March 11, 2 0 0 2 /Proposed Rules acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicro lithography process to produce semiconductors or similar components of electronic or other miniaturized devices. (iii) Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in and in industrial and consumer film paragraph (a)(3)(i) or (ii) of this section. products. (iv) Use in a surface tension and static discharge control coating on films, (b) [Reserved] papers, and printing plates, or as a [FR Doc. 0 2 - 5 7 4 7 Filed 3 -8 -0 2 ; 8:45 am] surfactant or defoamer in solutions used BILLING CODE 6560-50-S to process films and papers, in traditional and laser medical imaging 000042