Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62319

PART 801—LABELING

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) * * *

Ranges of absorbency in grams1 Corresponding term of absorbency

6 and under Light absorbency.

6 to 9 Regular absorbency.

9 to 12 Super absorbency.

12 to 15 Super plus absorbency.

15 to 18 Ultra absorbency.

Above 18 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. 00–26249 Filed 10–17–00; 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 the

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. 00–26502 Filed 10–17–00; 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.

62320 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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., NW.,

Washington, DC 20460; telephone

number: (202) 554–1404; e-mail address:

TSCA-Hotline@epa.gov.

For technical information contact:

Mary Dominiak, Chemical Control

Division (7405), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (202) 260–7768; fax

number: (202) 260–1096; e-mail address:

dominiak.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

You may be affected by this action if

you manufacture (defined by statute to

include import) any of the chemical

substances that are listed in Table 2 or

Table 3 of this unit. Persons who intend

to import any chemical substance

governed by a final SNUR are subject to

the TSCA section 13 (15 U.S.C. 2612)

import certification requirements, and

to the regulations codified at 19 CFR

12.118 through 12.127 and 12.728.

Those persons must certify that they are

in compliance with the SNUR

requirements. The EPA policy in

support of import certification appears

at 40 CFR part 707, subpart B. In

addition, any persons who export or

intend to export any of the chemical

substances listed in Table 2 or Table 3

of this unit are subject to the export

notification provisions of TSCA section

12(b) (15 U.S.C. 2611(b)), and must

comply with the export notification

requirements in 40 CFR 721.20 and 40

CFR part 707, subpart D. Entities

potentially affected by the SNUR

requirements in this proposed rule may

include, but are not limited to:

TABLE 1.—ENTITIES POTENTIALLY AFFECTED BY THE SNUR REQUIREMENTS

Categories NAICS codes Examples of potentially affected entities

Chemical manufacturers or importers 325 Persons who manufacture (defined by statute to include import) one or more of

the subject chemical substances

Chemical exporters 325 Persons who export, or intend to export, one or more of the subject chemical

substances

This listing is not intended to be

exhaustive. Instead, it provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in Table 1 of this unit

could also be affected. The North

American Industrial Classification

System (NAICS) codes have been

provided to assist in determinations of

whether this action might apply to

certain entities. To determine if you or

your business is affected by this action,

you should carefully examine the

applicability provisions at 40 CFR 721.5

for SNUR-related obligations. Also,

consult Unit III. Note that because this

proposed rule would designate certain

manufacturing and importing activities

as significant new uses, persons that

solely process the chemical substances

that would be covered by this action

would not be subject to the rule. If you

have any questions regarding the

applicability of this action to a

particular entity, consult the technical

person listed under FOR FURTHER

INFORMATION CONTACT.

TABLE 2.—CHEMICALS REQUIRING A SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2001

CAS No./PMN Ninth Collective Index chemical name

383–07–3 ........... 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.

423–82–5 ........... 2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.

2250–98–8 ......... 1-Octanesulfonamide, N,N’,N’’-[phosphinylidynetris(oxy-2,1-ethanediyl)]tris[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-

heptadecafluoro-.

14650–24–9 ....... 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester.

30381–98–7 ....... 1-Octanesulfonamide, N,N’-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

, ammonium salt.

55120–77–9 ....... 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt.

57589–85–2 ....... Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, monopotassium salt.

61660–12–6 ....... 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3-(trimethoxysilyl)propyl]-.

67969–69–1 ....... 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2-(phosphonooxy)ethyl]-, diammonium

salt.

68156–01–4 ....... Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt.

68329–56–6 ....... 2-Propenoic acid, eicosyl ester, polymer with 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, hexadecyl

2-propenoate, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-

[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and octadecyl 2-propenoate.

68555–91–9 ....... 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-

[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate.

68555–92–0 ....... 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl

2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate.

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62321

TABLE 2.—CHEMICALS REQUIRING A SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2001—Continued

CAS No./PMN Ninth Collective Index chemical name

68608–14–0 ....... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1’-methylenebis[4-

isocyanatobenzene].

68909–15–9 ....... 2-Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl

acrylate, 2-[methyl[(nonafluorobutyl) sulfonyl]amino]ethyl acrylate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl

acrylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(undecafluoropentyl) sulfonyl]amino]ethyl

acrylate, polyethylene glycol acrylate Me ether and stearyl acrylate.

70776–36–2 ....... 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, 2-

[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, N-(hydroxymethyl)-2-propenamide, 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2-

[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate.

73772–32–4 ....... 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, monosodium salt.

81190–38–7 ....... 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3-sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N-dimethyl-, hydroxide, monosodium salt.

94133–90–1 ....... 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]-2-hydroxy-, monosodium salt.

117806–54–9 ..... 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt.

127133–66–8 ..... 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoro-C4-8-

alkyl)sulfonyl]amino]ethyl methacrylate.

129813–71–4 ..... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranylmethyl).

148240–78–2 ..... Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.

148240–79–3 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters.

148240–80–6 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters.

148240–81–7 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters.

148240–82–8 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters.

148684–79–1 ..... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6-diisocyanatohexane

homopolymer and ethylene glycol.

178535–22–3 ..... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1’-methylenebis[4-isocyanatobenzene]

and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked.

P-83–1102 ......... Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.

P-84–1163 ......... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and N,N’,2-

tris(6-isocyanatohexyl)imidodicarbonic diamide, reaction products with N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-

heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-

hydroxyethyl)-1-heptanesulfonamide, compds. with triethylamine.

P-84–1171 ......... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,1’-methylenebis[4-isocyanatobenzene] and 1,2,3-

propanetriol, reaction products with N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-

octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide,

compds. with morpholine.

P-86–0301 ......... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12-hydroxystearic acid and 2,4-

TDI, ammonium salts.

P-89–0799 ......... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and

polymethylenepolyphenylene isocyanate.

P-94–0545 ......... 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu

methacrylate and 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate.

P-94–0927 ......... 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2-

(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amidesblocked.

P-94–2205 ......... Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide.

P-94–2206 ......... Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propylgroup]-terminated, polymers with 2-

[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate.

P-96–1645 ......... Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters.

P-97–0790 ......... 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid

(1:1).

P-98–0251 ......... 2-Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and

vinylidene chloride.

P-98–1272 ......... 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, polymers with acrylic acid, 2-[methyl[(perfluoro-C4-8-

alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2’-

(methylimino)bis[ethanol].

P-99–0188 ......... Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.-

blocked.

P-99–0319 ......... Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro-C4-8-

alkyl)sulfonyl] derivs..

TABLE 3.—CHEMICALS SUBJECT TO VOLUME CAP RESTRICTIONS ON OR AFTER JANUARY 1, 2001 AND REQUIRING A

SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2003

CAS No./PMN Ninth Collective Index chemical name

307–35–7 ............. 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro307–51–7 ............. 1-Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro376–14–7 ............. 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester

62322 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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

423–50–7 ............. 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro754–91–6 ............. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro1652–63–7 ........... 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-heptadecafluoro2795–39–3 ........... 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-heptadecafluoro17202–41–4 ......... 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-methyl25268–77–3 ......... 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester

29081–56–9 ......... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, ammonium salt

29117–08–6 ......... Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-hydroxy29457–72–5 ......... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt

31506–32–8 ......... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl38006–74–5 ......... 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride

38850–58–7 ......... 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3-sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-, inner salt

67584–42–3 ......... Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt

67906–42–7 ......... 1-Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro-, ammonium salt

68298–62–4 ......... 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]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

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 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

68586–14–1 ......... 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, telomer with 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, .alpha.-(2-methyl-1-oxo-2-propenyl)-.omega.-hydroxypoly(oxy1,2-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

68649–26–3 ......... 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-, reaction products with

N-ethyl-1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-1-butanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-

pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(2-hydroxyethyl)-1-hexanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-1-pentanesulfonamide,

polymethylenepolyphenylene isocyanate and stearyl alc.

68867–60–7 ......... 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-

[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and .alpha.-(1-oxo-2-propenyl)-.omega.-methoxypoly(oxy1,2-ethanediyl)

68867–62–9 ......... 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2-

[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 1-octanethiol and .alpha.-(1-oxo-2-propenyl)-

.omega.-methoxypoly(oxy-1,2-ethanediyl)

68891–96–3 ......... Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glycinato-.kappa.O:.kappa.O’]]-.mu.-

hydroxybis(2-methylpropanol)di68958–61–2 ......... Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-methoxy70225–14–8 ......... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, compd. with 2,2’-iminobis[ethanol] (1:1)

71487–20–2 ......... 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2-

[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-

[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-

propenoate and 2-propenoic acid

91081–99–1 ......... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N-methyl-, polymer

with(chloromethyl)oxirane, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methyl-1-butanesulfonamide,

1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-N-methyl-1-heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-

tridecafluoro-N-(2-hydroxyethyl)-N-methyl-1-hexanesulfonamide and 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-

N-methyl-1-pentanesulfonamide, hexanedioate (ester)

98999–57–6 ......... Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-[(1-oxo-2-propenyl) oxy]ethyl], polymers with 2-ethoxyethyl acrylate,

glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethanaminiumchloride

182700–90–9 ....... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl-, reaction products with benzene-chlorinesulfur chloride (S2Cl2) reaction products chlorides

L-92–0151 ............ 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-methyl-, 2-[ethyl [(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl

2-methyl-2-propenoate, and 2-propenoic acid

P-80–0183 ........... Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethylamino)propyl], reaction products with acrylic acid

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62323

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

P-86–0958 ........... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and

vinylidene chloride

P-90–0111 ........... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl]

P-91–1419 ........... Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane, N-(2-hydroxyethyl)-N-methyl

perfluoro C4-8-alkane sulfonamide-blocked

P-93–1444 ........... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyl)-2-propenamide, 2-[methyl[(perfluoro-C4-8-

alkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chloride

P-95–0120 ........... Sulfonamides, C4-8-alkane, perfluoro, N,N’-[1,6-hexanediylbis[[2-oxo-3,5-oxazolidinediyl)methylene]]bis[N-methylP-96–1262 ........... Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether

P-96–1424 ........... 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, telomers with 2-[ethyl[(perfluoro-C4-8-alkylsulfonyl]amino]ethyl

methacrylate and 1-octanethiol, N-oxides

P-96–1433 ........... Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts

B. How Can I get Additional

Information, Including Copies of this

Document or 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.1. or I.C.2. Do not

submit any information electronically

that you consider to be CBI. E-mailed

comments must be submitted as an

ASCII file, avoiding the use of special

characters or any form of encryption.

Comments will also be accepted on

standard computer disks in WordPerfect

6.1/8.0 or ASCII file format. All

comments in electronic form must be

identified by docket control number

OPPTS–50639. Electronic comments

may also be 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.

62324 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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

Federal Register / Vol. 65, No. 202 / Wednesday, 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.—SUMMARY OF PROPOSED SNUR REQUIREMENTS

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

Manufacture or import: When? How much?

Chemical substances listed in Table 2 of Unit I.A. After December 31, 2000 Any amount

Chemical substances listed in Table 3 of Unit I.A. January 1, 2001 through December 31,

2002

Aggregate amount exceeding 1,100,000 lbs per

person per calendar year

Chemical substances listed in Table 3 of Unit I.A. After December 31, 2002 Any amount

IV. Chemical Compound History

A. Defining PFOS

This proposed rule applies to a large

group of fully fluorinated alkyl

sulfonate-containing substances, none of

which occur naturally. The Ninth

Collective Index 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.

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-11, 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. Health Effects

The Agency’s hazard analysis for

PFOS is a review of health hazard and

biomonitoring data (Ref. 8). Toxicology

studies show that PFOS is well absorbed

62326 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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 5c years and suggest a mean

elimination half-life (t c) 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 LD50

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 (F1 pups)

at the highest dose died within a day

after birth while close to 30% of the F1

pups in the 1.6 mg/kg/day dose group

died within 4 days after birth. As a

result of the pup mortality in the two

top dose groups, only the two lowest

dose groups, 0.1 and 0.4 mg/kg/day,

were continued into the second

generation. The no observed adverse

effect level (NOAEL) and lowest

observed adverse effect level (LOAEL)

for the second generation offspring (F2

pups) were 0.1 mg/kg/day and 0.4 mg/

kg/day, respectively, based on

reductions in pup body weight.

Reversible delays in reflex and physical

development were also observed in this

study, raising concerns about the

potential for developmental

neurotoxicity following exposure to

PFOS.

Developmental effects were also

reported in prenatal developmental

toxicity studies in the rat and rabbit,

although at slightly higher dose levels.

Signs of developmental toxicity were

evident at doses of 5 mg/kg/day and

above in rats administered PFOS during

gestation. Significant decreases in fetal

body weight and significant increases in

external and visceral anomalies, delayed

ossification, and skeletal variations were

observed. Abnormalities of the lens of

the eye were also reported at doses as

low as 1 mg/kg/day in one rat prenatal

developmental study, but could not be

repeated in a second study of similar

design. At doses of 2.5 mg/kg/day and

above, significant reductions in 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

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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

by the FDA) by the end of 2000, and

discontinuing all manufacture for any

uses by the end of 2002 (Ref. 6). This

schedule, and 3M’s anticipated

production volumes, are summarized in

Table 5.

TABLE 5.—ANTICIPATED ANNUAL U.S. PRODUCTION VOLUME (POUNDS) FOR PFOS USE CATEGORIES

Use category 2000 2001 2002 2003

Surface treatment 2,356,700 0 0 0

Paper protection 2,670,700 0 0 0

Performance chemicals 1,462,500 1,011,900 443,700 0

Total 6,489,900 1,011,900 443,700 0

According to the information

currently available to EPA, 3M is the

sole manufacturer of PFOS chemicals

affected by this proposed SNUR (Ref. 5).

3M plans to discontinue the

manufacture of the chemicals identified

in Table 2 of Unit I.A. (in general, those

associated with surface treatment and

paper protection uses) by the end of

2000 and to discontinue the chemicals

identified in Table 3 of Unit I.A. (in

general, those associated with

performance chemical applications) by

the end of 2002.

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

62328 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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 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.

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 lll (EQC lll)

model (Ref. 10). However, completion of

those studies may not be the only means

of identifying potential risks. For

example, analyses of potential exposure

may demonstrate that associated risks

would be of low concern. A SNUN

submitted without accompanying test

data may increase the likelihood that

EPA will take action under TSCA

section 5(e).

EPA encourages persons to consult

with the Agency before submitting a

SNUN for any of the PFOS substances

listed in Table 2 or Table 3 of Unit I.A.

As part of this optional pre-notice

consultation, EPA will discuss specific

test data it believes are necessary to

evaluate a significant new use of the

chemical substances and advise the

submitter on the selection of test

protocols. The Agency requests that all

test data be developed according to the

TSCA Good Laboratory Practice

Standards in 40 CFR part 792. Failure to

do so may result in EPA’s finding that

submitted data are insufficient to

reasonably evaluate the health effects

and public health implications of these

chemical substances.

EPA urges SNUN submitters to

provide detailed information on human

and environmental exposures that

would result or could reasonably be

anticipated to result from the significant

new uses of the chemical substances

listed in Table 2 and Table 3 of Unit I.A.

and at § 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.

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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 OPPTS–

50639 for this rulemaking as indicated

in Unit I.B.2. Reference documents

identified with an administrative record

number (AR) are cross-indexed to 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.1., or in paper by contacting the OPP

Public Docket at (703) 305–5805 or by

e-mail at: opp-docket@epa.gov. Final

guidelines, only, are available from the

U.S. Government Printing Office

Bookstore, 810 North Capitol St., NW.,

Washington, DC or by calling (202) 512–

1800 and ordering ASCII disks or paper

copies. The EQC model is available for

download from the Trent University

web site at http://www.trentu.ca/

envmodel.

11. (AR 204–001) TSCA Section

5(a)(2) Significant New Use Rules for

62330 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed 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 SNUR.

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.

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62331

Dated: October 12, 2000.

William H. Sanders, III

Director, Office of Pollution Prevention and

Toxics.

Therefore, it is proposed that 40 CFR

chapter I be amended as follows:

PART 721—[AMENDED]

1. The authority citation for part 721

would continue to read as follows:

Authority: 15 U.S.C. 2604, 2607 and

2625(e).

2. By adding new § 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 SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2001

CAS No./PMN Ninth Collective Index chemical name

383–07–3 ........... 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.

423–82–5 ........... 2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.

2250–98–8 ......... 1-Octanesulfonamide, N,N’,N’’-[phosphinylidynetris(oxy-2,1-ethanediyl)]tris[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-

heptadecafluoro-.

14650–24–9 ....... 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester.

30381–98–7 ....... 1-Octanesulfonamide, N,N’-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

, ammonium salt.

55120–77–9 ....... 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt.

57589–85–2 ....... Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, monopotassium salt.

61660–12–6 ....... 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3-(trimethoxysilyl)propyl]-.

67969–69–1 ....... 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2-(phosphonooxy)ethyl]-, diammonium

salt.

68156–01–4 ....... Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt.

68329–56–6 ....... 2-Propenoic acid, eicosyl ester, polymer with 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, hexadecyl

2-propenoate, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-

[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and octadecyl 2-propenoate.

68555–91–9 ....... 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-

[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate.

68555–92–0 ....... 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl

2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate.

68608–14–0 ....... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1’-methylenebis[4-

isocyanatobenzene].

68909–15–9 ....... 2-Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl

acrylate, 2-[methyl[(nonafluorobutyl) sulfonyl]amino]ethyl acrylate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl

acrylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl acrylate, 2-[methyl[(undecafluoropentyl) sulfonyl]amino]ethyl

acrylate, polyethylene glycol acrylate Me ether and stearyl acrylate.

70776–36–2 ....... 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, 2-

[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, N-(hydroxymethyl)-2-propenamide, 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2-

[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate.

73772–32–4 ....... 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, monosodium salt.

81190–38–7 ....... 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3-sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N-dimethyl-, hydroxide, monosodium salt.

94133–90–1 ....... 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]-2-hydroxy-, monosodium salt.

117806–54–9 ..... 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt.

127133–66–8 ..... 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2-[methyl[(perfluoro-C4-8-

alkyl)sulfonyl]amino]ethyl methacrylate.

129813–71–4 ..... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranylmethyl).

148240–78–2 ..... Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.

148240–79–3 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters.

148240–80–6 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters.

148240–81–7 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters.

148240–82–8 ..... Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters.

148684–79–1 ..... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6-diisocyanatohexane

homopolymer and ethylene glycol.

178535–22–3 ..... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl)-, polymers with 1,1’-methylenebis[4-isocyanatobenzene]

and polymethylenepolyphenylene isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked.

P-83–1102 ......... Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.

P-84–1163 ......... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and N,N’,2-

tris(6-isocyanatohexyl)imidodicarbonic diamide, reaction products with N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-

heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-

hydroxyethyl)-1-heptanesulfonamide, compds. with triethylamine.

62332 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules

TABLE 1.—CHEMICALS REQUIRING A SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2001—Continued

CAS No./PMN Ninth Collective Index chemical name

P-84–1171 ......... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,1’-methylenebis[4-isocyanatobenzene] and 1,2,3-

propanetriol, reaction products with N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-

octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide,

compds. with morpholine.

P-86–0301 ......... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12-hydroxystearic acid and 2,4-

TDI, ammonium salts.

P-89–0799 ......... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and

polymethylenepolyphenylene isocyanate.

P-94–0545 ......... 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu

methacrylate and 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate.

P-94–0927 ......... 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2-

(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amidesblocked.

P-94–2205 ......... Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide.

P-94–2206 ......... Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propylgroup]-terminated, polymers with 2-

[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate.

P-96–1645 ......... Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters.

P-97–0790 ......... 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid

(1:1).

P-98–0251 ......... 2-Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and

vinylidene chloride.

P-98–1272 ......... 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, polymers with acrylic acid, 2-[methyl[(perfluoro-C4-8-

alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2’-

(methylimino)bis[ethanol].

P-99–0188 ......... Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.-

blocked.

P-99–0319 ......... Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro-C4-8-

alkyl)sulfonyl] derivs..

TABLE 2.—CHEMICALS SUBJECT TO VOLUME CAP RESTRICTIONS ON OR AFTER JANUARY 1, 2001 AND REQUIRING A

SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2003

CAS No./PMN Ninth Collective Index chemical name

307–35–7 ............. 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro307–51–7 ............. 1-Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro376–14–7 ............. 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester

423–50–7 ............. 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro754–91–6 ............. 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro1652–63–7 ........... 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-heptadecafluoro2795–39–3 ........... 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-heptadecafluoro17202–41–4 ......... 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-methyl25268–77–3 ......... 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester

29081–56–9 ......... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, ammonium salt

29117–08–6 ......... Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-hydroxy29457–72–5 ......... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt

31506–32–8 ......... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl38006–74–5 ......... 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride

38850–58–7 ......... 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3-sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-, inner salt

67584–42–3 ......... Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt

67906–42–7 ......... 1-Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro-, ammonium salt

68298–62–4 ......... 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]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

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 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

68586–14–1 ......... 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, telomer with 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, .alpha.-(2-methyl-1-oxo-2-propenyl)-.omega.-hydroxypoly(oxy1,2-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

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62333

TABLE 2.—CHEMICALS SUBJECT TO VOLUME CAP RESTRICTIONS ON OR AFTER JANUARY 1, 2001 AND REQUIRING A

SIGNIFICANT NEW USE NOTICE ON OR AFTER JANUARY 1, 2003—Continued

CAS No./PMN Ninth Collective Index chemical name

68649–26–3 ......... 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-, reaction products with

N-ethyl-1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-1-butanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-

pentadecafluoro-N-(2-hydroxyethyl)-1-heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(2-hydroxyethyl)-1-hexanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-1-pentanesulfonamide,

polymethylenepolyphenylene isocyanate and stearyl alc.

68867–60–7 ......... 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-

[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-

[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and .alpha.-(1-oxo-2-propenyl)-.omega.-methoxypoly(oxy1,2-ethanediyl)

68867–62–9 ......... 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2-

[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-

methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 1-octanethiol and .alpha.-(1-oxo-2-propenyl)-

.omega.-methoxypoly(oxy-1,2-ethanediyl)

68891–96–3 ......... Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glycinato-.kappa.O:.kappa.O’]]-.mu.-

hydroxybis(2-methylpropanol)di68958–61–2 ......... Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-methoxy70225–14–8 ......... 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, compd. with 2,2’-iminobis[ethanol] (1:1)

71487–20–2 ......... 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2-

[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-

propenoate, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-

[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-

propenoate and 2-propenoic acid

91081–99–1 ......... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N-methyl-, polymer

with(chloromethyl)oxirane, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methyl-1-butanesulfonamide,

1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-N-methyl-1-heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-

tridecafluoro-N-(2-hydroxyethyl)-N-methyl-1-hexanesulfonamide and 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-

N-methyl-1-pentanesulfonamide, hexanedioate (ester)

98999–57–6 ......... Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-[(1-oxo-2-propenyl) oxy]ethyl], polymers with 2-ethoxyethyl acrylate,

glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethanaminiumchloride

182700–90–9 ....... 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl-, reaction products with benzene-chlorinesulfur chloride (S2Cl2) reaction products chlorides

L-92–0151 ............ 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-methyl-, 2-[ethyl [(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-

[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl

2-methyl-2-propenoate, and 2-propenoic acid

P-80–0183 ........... Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethylamino)propyl], reaction products with acrylic acid

P-86–0958 ........... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and

vinylidene chloride

P-90–0111 ........... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl]

P-91–1419 ........... Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane, N-(2-hydroxyethyl)-N-methyl

perfluoro C4-8-alkane sulfonamide-blocked

P-93–1444 ........... 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyl)-2-propenamide, 2-[methyl[(perfluoro-C4-8-

alkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chloride

P-95–0120 ........... Sulfonamides, C4-8-alkane, perfluoro, N,N’-[1,6-hexanediylbis[[2-oxo-3,5-oxazolidinediyl)methylene]]bis[N-methylP-96–1262 ........... Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2-aminopropyl) ether

P-96–1424 ........... 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, telomers with 2-[ethyl[(perfluoro-C4-8-alkylsulfonyl]amino]ethyl

methacrylate and 1-octanethiol, N-oxides

P-96–1433 ........... Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts

(2) The significant new uses are:

(i) Any manufacture or import for any

use of any chemical listed in Table 1 of

paragraph (a)(1) of this section on or

after January 1, 2001.

(ii) Any manufacture or import for

any use of any one or more of the

chemicals listed in Table 2 of paragraph

(a)(1) of this section in excess of an

aggregate volume for all of these

chemicals of 1,100,000 pounds per

person per calendar year on or after

January 1, 2001 and before January 1,

2003.

(iii) Any manufacture or import for

any use of any of the chemicals listed

in Table 2 of paragraph (a)(1) of this

section on or after January 1, 2003.

(b) [Reserved].

[FR Doc. 00–26751 Filed 10–17–00; 8:45 am]

BILLING CODE 6560–50–S