FLUORIDE ACTION NETWORK PESTICIDE PROJECT
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Perfluorooctyl Sulfonates. October
18, 2000. Federal Register.
Proposed Significant New Use Rule (SNUR).
http://www.epa.gov/EPA-TOX/2000/October/Day-18/t26751.htm
[Federal Register: October 18, 2000 (Volume 65, Number 202)]
[Proposed Rules]
[Page 62319-62333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc00-23]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
OPPTS-50639; FRL-6745-5
RIN 2070-AD43
Perfluorooctyl Sulfonates; Proposed Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
following chemical substances: Perfluorooctanesulfonic acid (PFOSA) and
certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (PFOSF),
certain higher and lower homologues of PFOSA and PFOSF, and certain
other chemical substances, including polymers, that contain PFOSA and
its homologues as substructures. All of these chemical substances are
referred to collectively in this proposed rule as perfluorooctyl
sulfonates, or PFOS. This proposed rule would require manufacturers and
importers to notify EPA at least 90 days before commencing the
manufacture or import of these chemical substances for the significant
new uses described in this document. EPA believes that this action is
necessary because the chemical substances included in this proposed
rule may be hazardous to human health and the environment. The required
notice would provide EPA with the opportunity to evaluate an intended
new use and associated activities and, if necessary, to prohibit or
limit that activity before it occurs.
DATES: Comments, identified by the docket number OPPTS-50639, are due
November 17, 2000.
[[Page 62320]]
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket control
number OPPTS-50639 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Director, Office of Program Management and
Evaluation, Office of Pollution Prevention and Toxics (7401),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 554-1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: Mary Dominiak, Chemical Control
Division (7405), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 260-7768; fax number:
(202) 260-1096; e-mail address: dominiak.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
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
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially affected
entities
------------------------------------------------------------------------
Chemical manufacturers or 325 Persons who
importers manufacture (defined
by statute to
include import) one
or more of the
subject chemical
substances
Chemical exporters 325 Persons who export,
or intend to export,
one or more of the
subject chemical
substances
------------------------------------------------------------------------
This listing is not intended to be exhaustive. Instead, it provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in Table 1 of this unit
could also be affected. The North American Industrial Classification
System (NAICS) codes have been provided to assist in determinations of
whether this action might apply to certain entities. To determine if
you or your business is affected by this action, you should carefully
examine the applicability provisions at 40 CFR 721.5 for SNUR-related
obligations. Also, consult Unit III. Note that because this proposed
rule would designate certain manufacturing and importing activities as
significant new uses, persons that solely process the chemical
substances that would be covered by this action would not be subject to
the rule. If you have any questions regarding the applicability of this
action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.
Table 2.--Chemicals Requiring a Significant New Use Notice On or After January 1, 2001
----------------------------------------------------------------------------------------------------------------
CAS No./PMN Ninth Collective Index chemical name
---------------------------------------------------------------------------------------------------------------
383-07-3....................................... 2-Propenoic acid, 2-
[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.
423-82-5....................................... 2-Propenoic acid, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.
2250-98-8...................................... 1-Octanesulfonamide, N,N',N''-[phosphinylidynetris(oxy-2,1-
ethanediyl)]tris[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-.
14650-24-9..................................... 2-Propenoic acid, 2-methyl-, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester.
30381-98-7..................................... 1-Octanesulfonamide, N,N'-[phosphinicobis(oxy-2,1-
ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, ammonium salt.
55120-77-9..................................... 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, lithium salt.
57589-85-2..................................... Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-
[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-
, monopotassium salt.
61660-12-6..................................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3-
(trimethoxysilyl)propyl]-.
67969-69-1..................................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2-
(phosphonooxy)ethyl]-, diammonium salt.
68156-01-4..................................... Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-,
potassium salt.
68329-56-6..................................... 2-Propenoic acid, eicosyl ester, polymer with 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-
propenoate, hexadecyl 2-propenoate, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate,
2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-
propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-
propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-
propenoate and octadecyl 2-propenoate.
68555-91-9..................................... 2-Propenoic acid, 2-methyl-, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester,
polymer with 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl
2-methyl-2-propenoate, 2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-
2-propenoate, 2-
[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate, 2-
[ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate and octadecyl 2-methyl-2-propenoate.
68555-92-0..................................... 2-Propenoic acid, 2-methyl-, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester,
polymer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl
2-methyl-2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-
2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate and octadecyl 2-methyl-2-propenoate.
[[Page 62321]]
68608-14-0..................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-
(hydroxyethyl), reaction products with 1,1'-methylenebis[4-
isocyanatobenzene].
68909-15-9..................................... 2-Propenoic acid, eicosyl ester, polymers with branched octyl
acrylate, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl acrylate,
2-[methyl[(nonafluorobutyl) sulfonyl]amino]ethyl acrylate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl
acrylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl
acrylate, 2-[methyl[(undecafluoropentyl)
sulfonyl]amino]ethyl acrylate, polyethylene glycol acrylate
Me ether and stearyl acrylate.
70776-36-2..................................... 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with
1,1-dichloroethene, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-
propenoate, N-(hydroxymethyl)-2-propenamide, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate,
2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-
propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-
propenoate and 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-
propenoate.
73772-32-4..................................... 1-Propanesulfonic acid, 3-[[3-
(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-
hydroxy-, monosodium salt.
81190-38-7..................................... 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3-
sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N-
dimethyl-, hydroxide, monosodium salt.
94133-90-1..................................... 1-Propanesulfonic acid, 3-[[3-
(dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]-
2-hydroxy-, monosodium salt.
117806-54-9.................................... 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-, lithium salt.
127133-66-8.................................... 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate,
lauryl methacrylate and 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl methacrylate.
129813-71-4.................................... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-
(oxiranylmethyl).
148240-78-2.................................... Fatty acids, C18-unsatd., trimers, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.
148240-79-3.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters.
148240-80-6.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters.
148240-81-7.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters.
148240-82-8.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters.
148684-79-1.................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-
methyl, reaction products with 1,6-diisocyanatohexane
homopolymer and ethylene glycol.
178535-22-3.................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-
(hydroxyethyl)-, polymers with 1,1'-methylenebis[4-
isocyanatobenzene] and polymethylenepolyphenylene
isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked.
P-83-1102...................................... Fatty acids, linseed-oil, dimers, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.
P-84-1163...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and
N,N',2-tris(6-isocyanatohexyl)imidodicarbonic diamide,
reaction products with N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-
hydroxyethyl)-1-octanesulfonamide and N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-
hydroxyethyl)-1-heptanesulfonamide, compds. with
triethylamine.
P-84-1171...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with 1,1'-methylenebis[4-isocyanatobenzene] and
1,2,3-propanetriol, reaction products with N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-
hydroxyethyl)-1-octanesulfonamide and N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-
hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine.
P-86-0301...................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-
methyl, reaction products with 12-hydroxystearic acid and
2,4-TDI, ammonium salts.
P-89-0799...................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-
(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and
polymethylenepolyphenylene isocyanate.
P-94-0545...................................... 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-
propenyl)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu
methacrylate and 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl acrylate.
P-94-0927...................................... 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer
with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-
ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amides-
blocked.
P-94-2205...................................... Polymethylenepolyphenylene isocyanate and bis(4-NCO-
phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-
butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8
perfluoroalkanesulfonamide.
P-94-2206...................................... Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-
propenyl)oxy]propylgroup]-terminated, polymers with 2-
[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate
and stearyl methacrylate.
P-96-1645...................................... Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl esters.
P-97-0790...................................... 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-
octanesulfonic acid (1:1).
P-98-0251...................................... -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-98-1272...................................... 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester,
polymers with acrylic acid, 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol
monoacrylate, hydrolyzed, compds. with 2,2'-
(methylimino)bis[ethanol].
P-99-0188...................................... Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-
methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.-
blocked.
P-99-0319...................................... Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-
.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro-
C4-8-alkyl)sulfonyl] derivs..
----------------------------------------------------------------------------------------------------------------
Table 3.--Chemicals Subject to Volume Cap Restrictions On or After
January 1, 2001 and Requiring a Significant New Use Notice On or After
January 1, 2003
------------------------------------------------------------------------
CAS No./PMN Ninth Collective Index chemical name
------------------------------------------------------------------------
307-35-7.................... 1-Octanesulfonyl fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
307-51-7.................... 1-Decanesulfonyl fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10
,10-heneicosafluoro-
376-14-7.................... 2-Propenoic acid, 2-methyl-, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl ester
[[Page 62322]]
423-50-7.................... 1-Hexanesulfonyl fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-
754-91-6.................... 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
1652-63-7................... 1-Propanaminium, 3-
[[(heptadecafluorooctyl)sulfonyl]amino]-
N,N,N-trimethyl-, iodide
1691-99-2................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-
1763-23-1................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-
2795-39-3................... 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, potassium salt
2991-51-7................... Glycine, N-ethyl-N-
[(heptadecafluorooctyl)sulfonyl]-,
potassium salt
4151-50-2................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
17202-41-4.................. 1-Nonanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-
nonadecafluoro-, ammonium salt
24448-09-7.................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-N-
methyl-
25268-77-3.................. 2-Propenoic acid, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl ester
29081-56-9.................. 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, ammonium salt
29117-08-6.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl]-.omega.-hydroxy-
29457-72-5.................. 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, lithium salt
31506-32-8.................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-methyl-
38006-74-5.................. 1-Propanaminium, 3-
[[(heptadecafluorooctyl)sulfonyl]amino]-
N,N,N-trimethyl-, chloride
38850-58-7.................. 1-Propanaminium, N-(2-hydroxyethyl)-N,N-
dimethyl-3-[(3-
sulfopropyl)[(tridecafluorohexyl)sulfonyl
]amino]-, inner salt
67584-42-3.................. Cyclohexanesulfonic acid,
decafluoro(pentafluoroethyl)-, potassium
salt
67906-42-7.................. 1-Decanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10
,10-heneicosafluoro-, ammonium salt
68298-62-4.................. 2-Propenoic acid, 2-
[butyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl ester, telomer with 2-
[butyl[(pentadecafluoroheptyl)sulfonyl]am
ino]ethyl 2-propenoate, methyloxirane
polymer with oxirane di-2-propenoate,
methyloxirane polymer with oxirane mono-2-
propenoate and 1-octanethiol
68541-80-0.................. 2-Propenoic acid, polymer with 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl 2-methyl-2-propenoate and
octadecyl 2-propenoate
68555-90-8.................. 2-Propenoic acid, butyl ester, polymer
with 2-[[(heptadecafluorooctyl)sulfonyl]
methylamino]ethyl 2-propenoate, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate and 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate
68586-14-1.................. 2-Propenoic acid, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl ester, telomer with 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, .alpha.-(2-methyl-1-
oxo-2-propenyl)-.omega.-hydroxypoly(oxy-
1,2-ethanediyl), .alpha.-(2-methyl-1-oxo-
2-propenyl)-.omega.-[(2-methyl-1-oxo-2-
propenyl)oxy]poly(oxy-1,2-ethanediyl), 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate and 1-octanethiol
68649-26-3.................. 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-,
reaction products with N-ethyl-
1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-1-butanesulfonamide, N-
ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-N-(2-hydroxyethyl)-1-
heptanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-
(2-hydroxyethyl)-1-hexanesulfonamide, N-
ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-
N-(2-hydroxyethyl)-1-pentanesulfonamide,
polymethylenepolyphenylene isocyanate and
stearyl alc.
68867-60-7.................. 2-Propenoic acid, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl ester, polymer with 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate and .alpha.-(1-oxo-2-
propenyl)-.omega.-methoxypoly(oxy-1,2-
ethanediyl)
68867-62-9.................. 2-Propenoic acid, 2-methyl-, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl ester, telomer with 2-
[ethyl[(nonafluorobutyl)sulfonyl]amino]et
hyl 2-methyl-2-propenoate, 2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]am
ino]ethyl 2-methyl-2-propenoate, 2-
[ethyl[(tridecafluorohexyl)sulfonyl]amino
]ethyl 2-methyl-2-propenoate, 2-
[ethyl[(undecafluoropentyl)sulfonyl]amino
]ethyl 2-methyl-2-propenoate, 1-
octanethiol and .alpha.-(1-oxo-2-
propenyl)-.omega.-methoxypoly(oxy-1,2-
ethanediyl)
68891-96-3.................. Chromium, diaquatetrachloro[.mu.-[N-ethyl-
N-
[(heptadecafluorooctyl)sulfonyl]glycinato-
.kappa.O:.kappa.O']]-.mu.-hydroxybis(2-
methylpropanol)di-
68958-61-2.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl]-.omega.-methoxy-
70225-14-8.................. 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, compd. with 2,2'-
iminobis[ethanol] (1:1)
71487-20-2.................. 2-Propenoic acid, 2-methyl-, methyl ester,
polymer with ethenylbenzene, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl 2-propenoate, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate and 2-propenoic acid
91081-99-1.................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-N-
methyl-, polymer
with(chloromethyl)oxirane,
1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-N-methyl-1-
butanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-N-(2-hydroxyethyl)-N-
methyl-1-heptanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-
(2-hydroxyethyl)-N-methyl-1-
hexanesulfonamide and
1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-
hydroxyethyl)-N-methyl-1-
pentanesulfonamide, hexanedioate (ester)
98999-57-6.................. Sulfonamides, C7-8-alkane, perfluoro, N-
methyl-N-[2-[(1-oxo-2-propenyl)
oxy]ethyl], polymers with 2-ethoxyethyl
acrylate, glycidyl methacrylate and N,N,N-
trimethyl-2-[(2-methyl-1-oxo-2-
propenyl)oxy]ethanaminiumchloride
182700-90-9................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-methyl-, reaction
products with benzene-chlorine-sulfur
chloride (S2Cl2) reaction products
chlorides
L-92-0151................... 2-Propenoic acid, 2-methyl-, butyl ester,
polymer with 2-methyl-, 2-[ethyl
[(heptadecafluorooctyl)sulfonyl]amino]eth
yl 2-methyl-2-propenoate, 2-
[ethyl[(nonafluorobutyl)sulfonyl]amino]et
hyl 2-methyl-2-propenoate, 2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]am
ino]ethyl 2-methyl-2-propenoate, 2-
[ethyl[(tridecafluorohexyl)sulfonyl]amino
]ethyl 2-methyl-2-propenoate, and 2-
propenoic acid
P-80-0183................... Sulfonamides, C4-8-alkane, perfluoro, N-[3-
(dimethylamino)propyl], reaction products
with acrylic acid
[[Page 62323]]
P-86-0958................... 2-Propenoic acid, 2-methyl-, dodecyl
ester, polymers with 2-[methyl[(perfluoro-
C4-8-alkyl)sulfonyl]amino]ethyl acrylate
and vinylidene chloride
P-90-0111................... Sulfonamides, C4-8-alkane, perfluoro, N-
methyl-N-[(3-octadecyl-2-oxo-5-
oxazolidinyl)methyl]
P-91-1419................... Poly(oxy-1,2-ethanediyl), .alpha.-hydro-
.omega.-hydroxy-, polymer with 1,6-
diisocyanatohexane, N-(2-hydroxyethyl)-N-
methyl perfluoro C4-8-alkane sulfonamide-
blocked
P-93-1444................... 2-Propenoic acid, 2-methyl-, dodecyl
ester, polymers with N-(hydroxymethyl)-2-
propenamide, 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl methacrylate,
stearyl methacrylate and vinylidene
chloride
P-95-0120................... Sulfonamides, C4-8-alkane, perfluoro, N,N'-
[1,6-hexanediylbis[[2-oxo-3,5-
oxazolidinediyl)methylene]]bis[N-methyl-
P-96-1262................... Sulfonic acids, C6-8-alkane, perfluoro,
compds. with polyethylene-polypropylene
glycol bis(2-aminopropyl) ether
P-96-1424................... 2-Propenoic acid, 2-methyl-, 2-
(dimethylamino)ethyl ester, telomers with
2-[ethyl[(perfluoro-C4-8-
alkylsulfonyl]amino]ethyl methacrylate
and 1-octanethiol, N-oxides
P-96-1433................... Sulfonamides, C4-8-alkane, perfluoro, N-[3-
(dimethyloxidoamino)propyl], potassium
salts
------------------------------------------------------------------------
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.
[[Page 62324]]
4. If you estimate potential burden or costs, explain how you
arrived at the estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the proposed rule or data
collection activity.
7. Make sure to submit your comments by the deadline specified in
this document.
8. At the beginning of your comments, be sure to properly identify
the document you are commenting on. To ensure proper receipt by EPA,
your comments must identify the docket control number assigned to this
action in the subject line on the first page of your response. You may
also provide the title, date, and Federal Register citation.
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
[[Page 62325]]
Table 3 of Unit I.A. on or after January 1, 2003.
Given that no companies other than 3M are currently producing the
chemicals listed on Table 3 of Unit I.A., and given the negative
commercial and regulatory environment associated with these chemicals,
EPA believes it is unlikely that companies would incur the costs
associated with establishing new manufacturing capacity for these
chemicals in order to enter this market.
This proposed rule, when finalized, would require persons who
intend to manufacture or import the PFOS chemicals listed in this
proposed rule to notify EPA, through the submission of a SNUN, at least
90 days before commencing the manufacture or importation of any of
these chemicals for any use designated by this proposed SNUR as a
significant new use. The required notice would provide EPA with the
opportunity to evaluate the intended use, and, if necessary, to
prohibit or limit that use before it occurs. These proposed
requirements are summarized in the following Table 4:
Table 4.--Summary of Proposed SNUR Requirements
------------------------------------------------------------------------
You must file a significant new use notice (SNUN) if you:
-------------------------------------------------------------------------
Manufacture or import: When? How much?
------------------------------------------------------------------------
Chemical substances listed in After December 31, Any amount
Table 2 of Unit I.A. 2000
Chemical substances listed in January 1, 2001 Aggregate amount
Table 3 of Unit I.A. through December exceeding 1,100,000
31, 2002 lbs per person per
calendar year
Chemical substances listed in After December 31, Any amount
Table 3 of Unit I.A. 2002
------------------------------------------------------------------------
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.
[GRAPHIC] [TIFF OMITTED] TP18OC00.044
BILLING CODE 6560-50-C
The number of carbon atoms present in the moiety varies from 4 to
10 (x = 3-9) among the listed chemicals. In addition, there are many
examples of different chemical functionality (free acids (Y = OH),
metal salts (Y = O- M\+\), sulfonyl halides (Y = X),
sulfonamides (Y= NH\2\), and other derivatives). The listed chemical
substances also include polymers.
The class of chemical substances including the perfluoroalkyl
sulfonyl moiety described by the structure shown in this unit contains
more chemical substances than are specified in the lists in Table 2 and
Table 3 of Unit I.A. Only the listed chemical substances, which are
manufactured or imported exclusively by 3M and which 3M has voluntarily
committed to cease producing, are subject to this SNUR. EPA is
evaluating further this overall structural class of chemical substances
and may take additional regulatory action as appropriate.
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 E-10 atm.m3/mole (atmospheres per
meter cubed per mole), respectively. The vapor pressure and water
solubility values were obtained from Table 4, p.16 of the March 1,
2000, white paper by 3M, Sulfonated Perfluorochemicals in the
Environment: Sources, Dispersion, Fate and Effects (Ref. 1). These
Henry's Law values suggest that volatilization from water to air is not
very likely. According to 3M, testing is planned and/or underway for
the environmental properties, fate, and transport of PFOS (Ref. 1).
With more complete data, EPA would be able to make more definitive
assessments. With the present data, the Agency can only speculate on
environmental transport and partitioning of PFOS, although current
information suggests strongly that it is persistent and may
bioaccumulate.
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
[[Page 62326]]
orally and distributes primarily in the serum and liver. PFOS can also
be formed as a metabolite of other perfluorinated sulfonates. It does
not appear to be further metabolized. Elimination from the body is slow
and occurs via both urine and feces. Serum PFOS levels in three retired
male 3M chemical workers have been followed for 51/2 years and suggest
a mean elimination half-life (t 1/2) of 1,428 days (approximately 4
years). Based on the pharmacokinetic data obtained from a 28-day oral
study in male and female monkeys, a volume of distribution (Vd) of 0.19
L/kilogram (kg) was reported; no sex differences in the pharmacokinetic
parameters were noted.
PFOS has shown moderate acute toxicity by the oral route with a rat
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 fetal-body weight and significant increases in delayed
ossification were observed in rabbits administered PFOS during
gestation.
In human blood samples, PFOS has been detected in the serum of
occupational and general populations in the parts per million (ppm) to
parts per billion (ppb) range. In the United States, recent blood serum
levels of PFOS in manufacturing employees have been as high as 12.83
ppm, while in the general population, serum collected from blood banks
and commercial sources have indicated mean PFOS levels of 30-44 ppb.
Levels in a very small sample of children yielded even higher results,
with a mean level of 54 ppb.
Sampling of several wildlife species from a variety of sites across
the United States has shown widespread distribution of PFOS. In recent
analyses, PFOS was detected in the ppb range in the plasma of several
species of eagles, wild birds, and fish. Endogenous levels of PFOS have
also been detected in the ppb range in the livers of unexposed rats
used in toxicity studies, presumably through a dietary source
(fishmeal).
Although the PFOS levels detected in the blood of the general
population are low, this widespread presence, combined with the
persistence, the bioaccumulative potential, and the reproductive and
subchronic toxicity of the chemical, raises concerns for potential
adverse effects on people and wildlife over time should the chemical
substances continue to be produced, released, and accumulated in the
environment.
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 PFOS-containing consumer products; and inhalation,
dietary, or dermal exposures resulting from manufacturing, as well as
industrial, commercial, and consumer use and disposal of PFOS-derived
chemicals and products.
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
[[Page 62327]]
industrial settings by customers such as textile mills, leather
tanneries, finishers, fiber producers, and carpet manufacturers. PFOS
chemicals are also used in aftermarket treatment of apparel and
leather, upholstery, carpet, and automobile interiors by the general
public or professional applicators (Ref. 4). In 2000, the domestic
production volume of PFOS chemicals for this use category is estimated
to be approximately 2.4 million pounds (Ref. 6).
PFOS chemicals produced for paper protection applications provide
grease, oil, and water resistance to paper and paperboard as part of a
sizing agent formulation. Specific applications in this use category
include food contact applications (plates, food containers, bags, and
wraps) regulated by the Food and Drug Administration (FDA) under 21 CFR
176.170, as well as non-food contact applications (folding cartons,
containers, carbonless forms, and masking papers). The application of
sizing agents is undertaken mainly by paper mills and, to some extent,
converters who manufacture bags, wraps, and other products from paper
and paperboard (Ref. 4). In 2000, the domestic production volume of
PFOS chemicals for this use category is estimated to be approximately
2.7 million pounds (Ref. 6).
PFOS chemicals in the performance chemicals category are used in a
wide variety of specialized industrial, commercial, and consumer
applications. Specific applications include fire fighting foams, mining
and oil well surfactants, acid mist suppressants for metal plating and
electronic etching baths, alkaline cleaners, floor polishes,
photographic film, denture cleaners, shampoos, chemical intermediates,
coating additives, carpet spot cleaners, and as an insecticide in bait
stations for ants (Ref. 4). In 2000, the domestic production volume of
PFOS chemicals for this use category is estimated to be approximately
1.5 million pounds (Ref. 6).
On May 16, 2000, following discussions with the Agency, 3M issued a
press release announcing that it would discontinue the production of
perfluorooctanyl chemicals used to produce some of its repellent and
surfactant products. In its statement, 3M committed to ``substantially
phase out production'' by the end of calendar year 2000 (Ref. 9). In
subsequent correspondence with the Agency, 3M provided a schedule
documenting its complete plan for discontinuing all manufacture of
specific PFOS and related chemicals for most surface treatment and
paper protection uses (including food contact uses regulated by the
FDA) by the end of 2000, and discontinuing all manufacture for any uses
by the end of 2002 (Ref. 6). This schedule, and 3M's anticipated
production volumes, are summarized in Table 5.
Table 5.--Anticipated Annual U.S. Production Volume (Pounds) for PFOS Use Categories
----------------------------------------------------------------------------------------------------------------
Use category 2000 2001 2002 2003
----------------------------------------------------------------------------------------------------------------
Surface treatment 2,356,700 0 0 0
Paper protection 2,670,700 0 0 0
Performance chemicals 1,462,500 1,011,900 443,700 0
Total 6,489,900 1,011,900 443,700 0
----------------------------------------------------------------------------------------------------------------
According to the information currently available to EPA, 3M is the
sole manufacturer of PFOS chemicals affected by this proposed SNUR
(Ref. 5). 3M plans to discontinue the manufacture of the chemicals
identified in Table 2 of Unit I.A. (in general, those associated with
surface treatment and paper protection uses) by the end of 2000 and to
discontinue the chemicals identified in Table 3 of Unit I.A. (in
general, those associated with performance chemical applications) by
the end of 2002.
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
[[Page 62328]]
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
Sec. 721.9582 of the proposed regulation. In addition, EPA encourages
persons to submit information on potential benefits of these chemical
substances and information on risks posed by these chemical substances
compared to risks posed by possible substitutes.
[[Page 62329]]
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 SNUN-related 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 non-regulatory,
publicly accessible information files maintained in the TSCA
Nonconfidential Information Center. Copies of these documents can be
obtained as described in Unit I.B.2.
1. (AR226-0620) Sulfonated Perfluorochemicals in the Environment:
Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1,
2000.
2. (AR226-0547) The Science of Organic Fluorochemistry. 3M. St.
Paul, MN. February 5, 1999.
3. (AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human
Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999.
4. (AR226-0550) Fluorochemical Use, Distribution, and Release
Overview. 3M. St. Paul, MN. May 26, 1999.
5. Rice, Cody. Domestic Manufacturers or Importers of PFOS
Chemicals Other Than 3M. USEPA/OPPT/EETD. Washington, DC. August 31,
2000.
6. (AR226-0600) Weppner, William A. Phase-out Plan for POSF-Based
Products. 3M. St. Paul, MN. July 7, 2000.
7. MacKay, D., DiGuardo, A., Paterson, S., and Cowan, C.E.
Evaluating the Environmental Fate of a Variety of Types of Chemicals
Using the EQC Model. Environmental Toxicology and Chemistry. SETAC
Press. Houston, TX. 1996. Vol. 15, No. 9, pp.1627-1637.
8. Seed, Jennifer. Hazard Assessment and Biomonitoring Data on
Perfluorooctane Sulfonate--PFOS. USEPA/EPA/RAD. Washington, DC. August
31, 2000.
9. 3M Phasing Out Some of its Specialty Materials. 3M News. 3M. St.
Paul, MN. May 16, 2000.
10. Guidelines for the requested fate and transport data can be
found in OPPTS Harmonized Test Guidelines, Series 835, Fate, Transport
And Transformation Test Guidelines. These guidelines, both Public
Drafts and Finals, are available electronically in PDF (portable
document format) on the EPA World Wide Web site, see Unit I.B.1., or in
paper by contacting the OPP Public Docket at (703) 305-5805 or by e-
mail at: opp-docket@epa.gov. Final guidelines, only, are available from
the U.S. Government Printing Office Bookstore, 810 North Capitol St.,
NW., Washington, DC or by calling (202) 512-1800 and ordering ASCII
disks or paper copies. The EQC model is available for download from the
Trent University web site at http://www.trentu.ca/envmodel.
11. (AR 204-001) TSCA Section 5(a)(2) Significant New Use Rules for
[[Page 62330]]
Existing Chemicals. ICR #1188.06, OMB No. 2070-0038 (Undated).
12. (AR 205-001) TSCA Section 12(b) Notification of Chemical
Exports. ICR #0795.10, OMB No. 2070-0030 (Undated).
13. Rice, Cody. Estimated Costs of Testing Recommended for PFOS
SNUR. USEPA/OPPT/EETD. Washington, DC. July 25, 2000.
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.
[[Page 62331]]
Dated: October 12, 2000.
William H. Sanders, III
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607 and 2625(e).
2. By adding new Sec. 721.9582 to subpart E to read as follows:
Sec. 721.9582 Certain perfluorooctyl sulfonates.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances listed in Tables 1 and 2 of this
paragraph are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
Table 1.--Chemicals Requiring a Significant New Use Notice On or After January 1, 2001
----------------------------------------------------------------------------------------------------------------
CAS No./PMN Ninth Collective Index chemical name
---------------------------------------------------------------------------------------------------------------
383-07-3....................................... 2-Propenoic acid, 2-
[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.
423-82-5....................................... 2-Propenoic acid, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester.
2250-98-8...................................... 1-Octanesulfonamide, N,N',N''-[phosphinylidynetris(oxy-2,1-
ethanediyl)]tris[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-.
14650-24-9..................................... 2-Propenoic acid, 2-methyl-, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester.
30381-98-7..................................... 1-Octanesulfonamide, N,N'-[phosphinicobis(oxy-2,1-
ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, ammonium salt.
55120-77-9..................................... 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, lithium salt.
57589-85-2..................................... Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-
[[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-
, monopotassium salt.
61660-12-6..................................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3-
(trimethoxysilyl)propyl]-.
67969-69-1..................................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2-
(phosphonooxy)ethyl]-, diammonium salt.
68156-01-4..................................... Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-,
potassium salt.
68329-56-6..................................... 2-Propenoic acid, eicosyl ester, polymer with 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-
propenoate, hexadecyl 2-propenoate, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate,
2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-
propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-
propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-
propenoate and octadecyl 2-propenoate.
68555-91-9..................................... 2-Propenoic acid, 2-methyl-, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester,
polymer with 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl
2-methyl-2-propenoate, 2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-
2-propenoate, 2-
[ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate, 2-
[ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate and octadecyl 2-methyl-2-propenoate.
68555-92-0..................................... 2-Propenoic acid, 2-methyl-, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester,
polymer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl
2-methyl-2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-
2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-
propenoate and octadecyl 2-methyl-2-propenoate.
68608-14-0..................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-
(hydroxyethyl), reaction products with 1,1'-methylenebis[4-
isocyanatobenzene].
68909-15-9..................................... 2-Propenoic acid, eicosyl ester, polymers with branched octyl
acrylate, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl acrylate,
2-[methyl[(nonafluorobutyl) sulfonyl]amino]ethyl acrylate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl
acrylate, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl
acrylate, 2-[methyl[(undecafluoropentyl)
sulfonyl]amino]ethyl acrylate, polyethylene glycol acrylate
Me ether and stearyl acrylate.
70776-36-2..................................... 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with
1,1-dichloroethene, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-
propenoate, N-(hydroxymethyl)-2-propenamide, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate,
2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-
propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-
propenoate and 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-
propenoate.
73772-32-4..................................... 1-Propanesulfonic acid, 3-[[3-
(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-
hydroxy-, monosodium salt.
81190-38-7..................................... 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3-
sulfopropyl) [(tridecafluorohexyl)sulfonyl]amino]-N,N-
dimethyl-, hydroxide, monosodium salt.
94133-90-1..................................... 1-Propanesulfonic acid, 3-[[3-
(dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]-
2-hydroxy-, monosodium salt.
117806-54-9.................................... 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-, lithium salt.
127133-66-8.................................... 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate,
lauryl methacrylate and 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl methacrylate.
129813-71-4.................................... Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-
(oxiranylmethyl).
148240-78-2.................................... Fatty acids, C18-unsatd., trimers, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.
148240-79-3.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl esters.
148240-80-6.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters.
148240-81-7.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl esters.
148240-82-8.................................... Fatty acids, C18-unsatd., trimers, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters.
148684-79-1.................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-
methyl, reaction products with 1,6-diisocyanatohexane
homopolymer and ethylene glycol.
178535-22-3.................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-
(hydroxyethyl)-, polymers with 1,1'-methylenebis[4-
isocyanatobenzene] and polymethylenepolyphenylene
isocyanate, 2-ethylhexyl esters, Me Et ketone oxime-blocked.
P-83-1102...................................... Fatty acids, linseed-oil, dimers, 2-
[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters.
P-84-1163...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and
N,N',2-tris(6-isocyanatohexyl)imidodicarbonic diamide,
reaction products with N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-
hydroxyethyl)-1-octanesulfonamide and N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-
hydroxyethyl)-1-heptanesulfonamide, compds. with
triethylamine.
[[Page 62332]]
P-84-1171...................................... Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with 1,1'-methylenebis[4-isocyanatobenzene] and
1,2,3-propanetriol, reaction products with N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-
hydroxyethyl)-1-octanesulfonamide and N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-
hydroxyethyl)-1-heptanesulfonamide, compds. with morpholine.
P-86-0301...................................... Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-
methyl, reaction products with 12-hydroxystearic acid and
2,4-TDI, ammonium salts.
P-89-0799...................................... Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-
(hydroxyethyl), reaction products with 2-ethyl-1-hexanol and
polymethylenepolyphenylene isocyanate.
P-94-0545...................................... 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-
propenyl)oxy]ethyl]-, bromide, polymers with Bu acrylate, Bu
methacrylate and 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl acrylate.
P-94-0927...................................... 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer
with 2,4-diisocyanato-1-methylbenzene, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-
ethyl-N-(hydroxyethyl)perfluoro-C4-8-alkanesulfon amides-
blocked.
P-94-2205...................................... Polymethylenepolyphenylene isocyanate and bis(4-NCO-
phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-
butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8
perfluoroalkanesulfonamide.
P-94-2206...................................... Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-
propenyl)oxy]propylgroup]-terminated, polymers with 2-
[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate
and stearyl methacrylate.
P-96-1645...................................... Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl esters.
P-97-0790...................................... 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-
octanesulfonic acid (1:1).
P-98-0251...................................... 2-Propenoic acid, butyl ester, polymers with acrylamide, 2-
[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate
and vinylidene chloride.
P-98-1272...................................... 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester,
polymers with acrylic acid, 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol
monoacrylate, hydrolyzed, compds. with 2,2'-
(methylimino)bis[ethanol].
P-99-0188...................................... Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-
methyl perfluoro C4-8-alkane sulfonamide- and stearyl alc.-
blocked.
P-99-0319...................................... Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-
.omega.-[(1,1,3,3-tetramethylbutyl)phenoxy]-, N-[(perfluoro-
C4-8-alkyl)sulfonyl] derivs..
----------------------------------------------------------------------------------------------------------------
Table 2.--Chemicals Subject to Volume Cap Restrictions On or After
January 1, 2001 and Requiring a Significant New Use Notice On or After
January 1, 2003
------------------------------------------------------------------------
CAS No./PMN Ninth Collective Index chemical name
------------------------------------------------------------------------
307-35-7.................... 1-Octanesulfonyl fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
307-51-7.................... 1-Decanesulfonyl fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10
,10-heneicosafluoro-
376-14-7.................... 2-Propenoic acid, 2-methyl-, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl ester
423-50-7.................... 1-Hexanesulfonyl fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-
754-91-6.................... 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
1652-63-7................... 1-Propanaminium, 3-
[[(heptadecafluorooctyl)sulfonyl]amino]-
N,N,N-trimethyl-, iodide
1691-99-2................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-
1763-23-1................... 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
2795-39-3................... 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, potassium salt
2991-51-7................... Glycine, N-ethyl-N-
[(heptadecafluorooctyl)sulfonyl]-,
potassium salt
4151-50-2................... 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-
17202-41-4.................. 1-Nonanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-
nonadecafluoro-, ammonium salt
24448-09-7.................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-N-
methyl-
25268-77-3.................. 2-Propenoic acid, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl ester
29081-56-9.................. 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, ammonium salt
29117-08-6.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl]-.omega.-hydroxy-
29457-72-5.................. 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, lithium salt
31506-32-8.................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-methyl-
38006-74-5.................. 1-Propanaminium, 3-
[[(heptadecafluorooctyl)sulfonyl]amino]-
N,N,N-trimethyl-, chloride
38850-58-7.................. 1-Propanaminium, N-(2-hydroxyethyl)-N,N-
dimethyl-3-[(3-
sulfopropyl)[(tridecafluorohexyl)sulfonyl
]amino]-, inner salt
67584-42-3.................. Cyclohexanesulfonic acid,
decafluoro(pentafluoroethyl)-, potassium
salt
67906-42-7.................. 1-Decanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10
,10-heneicosafluoro-, ammonium salt
68298-62-4.................. 2-Propenoic acid, 2-
[butyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl ester, telomer with 2-
[butyl[(pentadecafluoroheptyl)sulfonyl]am
ino]ethyl 2-propenoate, methyloxirane
polymer with oxirane di-2-propenoate,
methyloxirane polymer with oxirane mono-2-
propenoate and 1-octanethiol
68541-80-0.................. 2-Propenoic acid, polymer with 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl 2-methyl-2-propenoate and
octadecyl 2-propenoate
68555-90-8.................. 2-Propenoic acid, butyl ester, polymer
with 2-[[(heptadecafluorooctyl)sulfonyl]
methylamino]ethyl 2-propenoate, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate and 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate
68586-14-1.................. 2-Propenoic acid, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl ester, telomer with 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, .alpha.-(2-methyl-1-
oxo-2-propenyl)-.omega.-hydroxypoly(oxy-
1,2-ethanediyl), .alpha.-(2-methyl-1-oxo-
2-propenyl)-.omega.-[(2-methyl-1-oxo-2-
propenyl)oxy]poly(oxy-1,2-ethanediyl), 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate and 1-octanethiol
[[Page 62333]]
68649-26-3.................. 1-Octanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-,
reaction products with N-ethyl-
1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-1-butanesulfonamide, N-
ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-N-(2-hydroxyethyl)-1-
heptanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-
(2-hydroxyethyl)-1-hexanesulfonamide, N-
ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-
N-(2-hydroxyethyl)-1-pentanesulfonamide,
polymethylenepolyphenylene isocyanate and
stearyl alc.
68867-60-7.................. 2-Propenoic acid, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl ester, polymer with 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate and .alpha.-(1-oxo-2-
propenyl)-.omega.-methoxypoly(oxy-1,2-
ethanediyl)
68867-62-9.................. 2-Propenoic acid, 2-methyl-, 2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl ester, telomer with 2-
[ethyl[(nonafluorobutyl)sulfonyl]amino]et
hyl 2-methyl-2-propenoate, 2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]am
ino]ethyl 2-methyl-2-propenoate, 2-
[ethyl[(tridecafluorohexyl)sulfonyl]amino
]ethyl 2-methyl-2-propenoate, 2-
[ethyl[(undecafluoropentyl)sulfonyl]amino
]ethyl 2-methyl-2-propenoate, 1-
octanethiol and .alpha.-(1-oxo-2-
propenyl)-.omega.-methoxypoly(oxy-1,2-
ethanediyl)
68891-96-3.................. Chromium, diaquatetrachloro[.mu.-[N-ethyl-
N-
[(heptadecafluorooctyl)sulfonyl]glycinato-
.kappa.O:.kappa.O']]-.mu.-hydroxybis(2-
methylpropanol)di-
68958-61-2.................. Poly(oxy-1,2-ethanediyl), .alpha.-[2-
[ethyl[(heptadecafluorooctyl)sulfonyl]ami
no]ethyl]-.omega.-methoxy-
70225-14-8.................. 1-Octanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, compd. with 2,2'-
iminobis[ethanol] (1:1)
71487-20-2.................. 2-Propenoic acid, 2-methyl-, methyl ester,
polymer with ethenylbenzene, 2-
[[(heptadecafluorooctyl)sulfonyl]methylam
ino]ethyl 2-propenoate, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]e
thyl 2-propenoate, 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]a
mino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amin
o]ethyl 2-propenoate, 2-
[methyl[(undecafluoropentyl)sulfonyl]amin
o]ethyl 2-propenoate and 2-propenoic acid
91081-99-1.................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-(2-hydroxyethyl)-N-
methyl-, polymer
with(chloromethyl)oxirane,
1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-N-methyl-1-
butanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-N-(2-hydroxyethyl)-N-
methyl-1-heptanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-
(2-hydroxyethyl)-N-methyl-1-
hexanesulfonamide and
1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-
hydroxyethyl)-N-methyl-1-
pentanesulfonamide, hexanedioate (ester)
98999-57-6.................. Sulfonamides, C7-8-alkane, perfluoro, N-
methyl-N-[2-[(1-oxo-2-propenyl)
oxy]ethyl], polymers with 2-ethoxyethyl
acrylate, glycidyl methacrylate and N,N,N-
trimethyl-2-[(2-methyl-1-oxo-2-
propenyl)oxy]ethanaminiumchloride
182700-90-9................. 1-Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-N-methyl-, reaction
products with benzene-chlorine-sulfur
chloride (S2Cl2) reaction products
chlorides
L-92-0151................... 2-Propenoic acid, 2-methyl-, butyl ester,
polymer with 2-methyl-, 2-[ethyl
[(heptadecafluorooctyl)sulfonyl]amino]eth
yl 2-methyl-2-propenoate, 2-
[ethyl[(nonafluorobutyl)sulfonyl]amino]et
hyl 2-methyl-2-propenoate, 2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]am
ino]ethyl 2-methyl-2-propenoate, 2-
[ethyl[(tridecafluorohexyl)sulfonyl]amino
]ethyl 2-methyl-2-propenoate, and 2-
propenoic acid
P-80-0183................... Sulfonamides, C4-8-alkane, perfluoro, N-[3-
(dimethylamino)propyl], reaction products
with acrylic acid
P-86-0958................... 2-Propenoic acid, 2-methyl-, dodecyl
ester, polymers with 2-[methyl[(perfluoro-
C4-8-alkyl)sulfonyl]amino]ethyl acrylate
and vinylidene chloride
P-90-0111................... Sulfonamides, C4-8-alkane, perfluoro, N-
methyl-N-[(3-octadecyl-2-oxo-5-
oxazolidinyl)methyl]
P-91-1419................... Poly(oxy-1,2-ethanediyl), .alpha.-hydro-
.omega.-hydroxy-, polymer with 1,6-
diisocyanatohexane, N-(2-hydroxyethyl)-N-
methyl perfluoro C4-8-alkane sulfonamide-
blocked
P-93-1444................... 2-Propenoic acid, 2-methyl-, dodecyl
ester, polymers with N-(hydroxymethyl)-2-
propenamide, 2-[methyl[(perfluoro-C4-8-
alkyl)sulfonyl]amino]ethyl methacrylate,
stearyl methacrylate and vinylidene
chloride
P-95-0120................... Sulfonamides, C4-8-alkane, perfluoro, N,N'-
[1,6-hexanediylbis[[2-oxo-3,5-
oxazolidinediyl)methylene]]bis[N-methyl-
P-96-1262................... Sulfonic acids, C6-8-alkane, perfluoro,
compds. with polyethylene-polypropylene
glycol bis(2-aminopropyl) ether
P-96-1424................... 2-Propenoic acid, 2-methyl-, 2-
(dimethylamino)ethyl ester, telomers with
2-[ethyl[(perfluoro-C4-8-
alkylsulfonyl]amino]ethyl methacrylate
and 1-octanethiol, N-oxides
P-96-1433................... Sulfonamides, C4-8-alkane, perfluoro, N-[3-
(dimethyloxidoamino)propyl], potassium
salts
------------------------------------------------------------------------
(2) The significant new uses are:
(i) Any manufacture or import for any use of any chemical listed in
Table 1 of paragraph (a)(1) of this section on or after January 1,
2001.
(ii) Any manufacture or import for any use of any one or more of
the chemicals listed in Table 2 of paragraph (a)(1) of this section in
excess of an aggregate volume for all of these chemicals of 1,100,000
pounds per person per calendar year on or after January 1, 2001 and
before January 1, 2003.
(iii) Any manufacture or import for any use of any of the chemicals
listed in Table 2 of paragraph (a)(1) of this section on or after
January 1, 2003.
(b) [Reserved].
[FR Doc. 00-26751 Filed 10-17-00; 8:45 am]
BILLING CODE 6560-50-S