Preliminary List of
Chemical Substances
t
For
Further Evaluation
Toxic Substances Control Act
Interagency Testing Committee
-------
PRELIMINARY LIST OF CHEMICAL SUBSTANCES
FOR FURTHER EVALUATION BY THE TOXIC SUBSTANCES CONTROL ACT
INTERAGENCY TESTING COMMITTEE
JULY 1977
-------
CONTENTS
SUMMARY 1
PART I. PRELIMINARY LIST OF CHEMICAL SUBSTANCES I
PART II. BACKGROUND DOCUMENT: PREPARATION OF THE
PRELIMINARY LIST 19
1.0 INTRODUCTION
1.1 Committee Establishment and Responsibilities 19
1.2 Basic Approach Adopted by the Committee 21
1.3 Request for Comments on Preliminary List 22
2.0 THE PRELIMINARY LIST 22
3.0 METHODOLOGY USED TO DEVELOP THE PRELIMINARY LIST
3.1 Overview 23
3.2 The Initial Listing 23
3.3 The Master File 24
3.4 The Preliminary List 24
4.0 TYPES OF COMMENTS SOUGHT AND RECOMMENDED FORMATS
4.1 General Information 25
4.2 Comments on Methodology Used in Developing the
Preliminary List 26
4.3 Comments on the Content of the Preliminary List 27
4.4 Comments on Test Data Needs 27
5.0 PROCEDURES FOR SUBMISSION OF COMMENTS 32
APPENDIXES
A. Membership of TSCA Interagency Testing Committee 33
B. Data Sources Used for Preparation of Initial List 35
C. Chemical Scores 39
D. Rank Ordering the Chemicals ^5
-------
SUMMARY
The Toxic Substances Control Act established the TSCA Interagency
Testing Committee under Section 4(e). The Committee is charged with
responsibility for making recommendations to the Administrator of the
Environmental Protection Agency regarding chemical substances or
mixtures which should be given priority by EPA for testing to
determine adverse effects on human health and the environment. The
Committee's recommendations are to be transmitted to the EPA
Administrator by October 1, 1977. At least every six months
thereafter, the Committee is required to review its recommendations
and make such revisions as it deems necessary.
The Committee has encountered certain limitations in trying to
evaluate all chemicals on the specific factors set forth in Section
4(e). There is no data system of corfsolidated chemical information
which permitted retrieval of all of the required data. In addition,
the many existing data systems are not uniformly formatted in such a
manner to easily permit merging of data files. Certain information
such as uses and exposure data is often unavailable.
In the light of these limitations, as well as the time constraints,
the Committee chose as an initial step to summarize and select from
existing lists of prioritized potentially hazardous substances
developed by Federal Agencies and other organizations. These lists
included some chemicals not subject to the authority of the Toxic
Substances Control Act. These were deleted unless they were judged
likely to have another use subject to TSCA regulation. In addition,
those substances judged not to be in commercial production were
removed from the list on the assumption they had low potential for
human exposure or environmental contamination. After these deletions,
the remaining list consisted of approximately 2100 chemicals or
categories which are being further screened in a multi-step process.
The first stage involved screening primarily on the basis of potential
for human or environmental exposure. In addition, the Committee
exercised professional judgment in eliminating from current
consideration many chemicals which are: a) currently under regulation
or are being considered for regulation, e.g., vinyl chloride and
benzene; b) reasonably well-characterized as hazardous e.g., mercury;
c) considered essentially inert materials, such as certain polymers;
and d) natural products which would be difficult to characterize for
testing purposes, e.g., wood or gasoline.
The first stage has resulted in the identification of approximately
300 substances, mixtures or categories, which are designated as the
Preliminary List. These chemicals will be further evaluated in the
second stage for their potential for adverse effects to humans and the
environment.
-------
In several cases the Committee has grouped chemicals, fully cognizant
of the difficulties in identifying appropriate groupings for testing
purposes. Among the methods of grouping under consideration are:
primary use, structural similarities, predicted toxic effect, etc.
While some categories are presented on the Preliminary List, such
groupings will be further considered in the review process.
The Preliminary List is in alphabetical order. The presence of a
substance on the Preliminary List does not indicate that the Committee
is making any statement at this time on whether the substance should
be regulated or even tested. Only after the Committee has evaluated
the substance's potential for adversely affecting human health or the
environment and the adequacy of existing test data bearing on such
effects, will the Committee make recommendations. These will be in
the form of a list of not more than 50 chemical substances or
categories set forth, either individually or in groups, in the
priority in which the Committee determines the EPA Administrator
should consider taking action.
The Committee seeks comments on the procedures used in developing the
preliminary list and on the specific substances or categories that
should be further considered by the Committee. Such comments will, to
the extent possible, be considered in the development of the list of
testing priorities to be sent to the EPA Administrator in October.
Because of the statutory deadline, it may be necessary to defer some
suggestions, especially as regards procedures, for subsequent
revisions. Comments should be submitted by August 22 according to
instructions provided in the Background Document.
ii
-------
PART I. PRELIMINARY LIST OF CHEMICAL SUBSTANCES FOR FURTHER EVALUATION
BY THE TSCA INTERAGENCY TESTING COMMITTEE (JULY 1977)
CHEMICAL OR CATEGORY NAME
Acetaldehyde, Chloro-
Acet amide
Acetamide, Thio-
Acetic acid, Benzyl ester
Acetic acid, Chloro-
Acetic acid, Diazo-, ethyl ester
*
Acetic acid, (Ethylenedinitrilo)tetra-,
tetrasodium salt
Acetic acid, Iminodi-
Acetic acid, Nitrilotri-
Acetic acid, Trichloro-
Acetonitrile
Acetophenone, Chloro-
Acetylene
Acetyl peroxide
Acrolein
Acrylamide
Acrylic acid
Acrylic acid, 2-Cyano-, methyl ester
NIOSH No.l
AB24500
AB40250
AC89250
AF50750
AF85750
AG57750
AH50750
AI29750
AJ01750
AJ78750
AL77000
AM61250
A096000
AP85000
AS10500
AS33250
AS43750
AS70000
CAS No.2
000107200
000060355
000062555
000140114
000079118
000064028
000142734
000139139
000076039
000075058
001341248
000074862
000110225
000107028
000079061
000079107
000137053
(1) Identification number as given in the Registry of Toxic Effects of
Chemical Substances, 1976 edition, National Institute for Occupational
Safety and Health. In cases where the substance or mixture of substances
was not included in the NIOSH Registry, an identification number was
created for the substance in the same format as the NIOSH number. Such
numbers are indicated by an asterisk (*).
(2) Chemical Abstracts Service (CAS) number as given in the NIOSH Registry.
-------
Acrylic acid esters
e.g. Acrylic acid, ethyl ester
Acrylic acid, 2-ethylhexyl ester
Acrylic acid, methyl ester
Alkoxy alkanols
e.g. Ethanol, 2-Butoxy-
Ethanol, 2-(2-Butoxyethoxy)-
Ethanol, 2-Ethoxy-
Ethanol, 2-(2-Ethoxyethoxy)-
Ethanol, 2-Methoxy-
Ethanol, 2-(2-Methoxyethoxy)-
Ethanol, 2-(2-(2-Methoxyethoxy)ethoxy )•
2-Propanol, 1,1'-Oxydi-
Alkyl adipates
e.g. Adipic acid, Bis(2-ethylhexyl) ester
Adipic acid, n-octyl n-decyl ester
Alkyl amines
e.g. Cyclohexylamine
Diethylamine
Dimethylamine
Dodecylamine
Ethanaraine
1,2-Ethanediamine
Isopropylamine
Methanamine, N,N-Dimethyl-
Methylamine
Triethylamine
Alkyl epoxides
e.g. Butane, l,2:3,4-Diepoxy-
Butane, (-+-)-1,2:3,4-Diepoxy-
Butane, l,2:3,4-Diepoxy-, meso-
Ethylene oxide
Butylene oxide
AT07000
AT08550
AT28000
KJ85750
KJ91000
KK80500
KK87500
KL57750
KL61250
KL63900
UB87850
AU97000
*ZZ02084
GX07000
HZ87500
IP87500
JR64750
KH21000
KH85750
NT84000
PA03500
PF63000
YE01750
EJ82250
EJ84000
EJ87500
KX24500
EK36750
000140885
000103117
000096333
000111762
000112345
000111900
000109864
000111773
000112356
000110985
000103231
000108918
000109897
000124403
000124221
000075047
000107153
000075310
000075503
000074895
000121448
001464535
000298180
000564001
000075218
000106887
-------
Alkyl phthalates (short chain)
e.g. Dibutyl phthalate
Diethyl phthalate
Dimethyl phthalate
Dimethyl terephthalate
Alkyl phthalates (long chain)
e.g. Bis(2-ethylhexyl) phthalate
Dicyclohexyl phthalate
Diisodecyl phthalate
Diisooctyl phthalate
Dioctyl phthalate
Ditridecyl phthalate
n-Octyl n-decyl phthalate
Alkyl sulfates and sulfonates, linear
t
e.g. Dodecyl sulfate, triethanolamine salt
Monododecyl sulfate, sodium salt
Octyl sulfate, sodium salt
Tridecyl sulfate, sodium salt
Allylamine
Aluminum distearate
Ammonium, Alkyl(C8-C18)dimethyl 3,4-
dichlorobenzyl-, chloride
Aniline
Aniline, o-Chloro-
Aniline, 3,4-Dichloro-
Aniline, N,N-Diethyl-
Aniline, N,N-Dimethyl
Aniline, N,N-Dimethyl-p-nitroso-
Aniline,4,4'-Methylenebis(N,N'-dimethyl)-
Aniline, 4,4'-Methylenedi-
Aniline, N-Methyl-N,2,4,6-tetranitro-
Aniline, p-Nitro-
Aniline, p-(Phenylazo)-
Aniline, 2,4,5-Trimethyl-
TI08750
TI10500
TI15750
WZ12250
TI03500
*ZZ02069
*ZZ02104
*ZZ02051
TI19250
*ZZ02051
*ZZ02110
*ZZ02105
WT10500
*ZZ02056
*ZZ02057
BA54250
*ZZ02128
000084742
000084662
000131113
000120616
000117817
000117840
000151213
000107119
B032000 MX8023538
BW66500 000062533
BX05250 000095512
BX26250 000095761
*ZZ02065
BX47250 000121697
BX71750 000138896
BY52500 000101611
BY54250 000101779
BY63000 000479458
BY70000 000100016
BY82250 000060093
*BZ08750500
-------
p-Anisidine
Anthranilic acid
Antimony and Antimony compounds
e.g. Antimony
Antimony (III) chloride
Antimony trioxide
Antimony trisulfide
Arsine
Aryl phosphates
e.g. Cresyl diphenyl phosphate
Triphenyl phosphate
Tris(2-ethylhexyl) phosphate
Tris(isopropylphenyl) phosphate
Tritolyl phosphate
Aryl sulfonic acids and salts
e.g. Benzenesulfonic acid, Dodecyl-
Xylenesulfonic acid, sodium salt
Azelate, Di(2-ethylhexyl)-
1-Aziridineethanol
Az ir id ine, 2-Me thy1-
Azoxybenzene
Benzaldehyde
Benzene, Chloro-
Benzene, l-Chloro-2-nitro-
Benzene, l-Chloro-3-nitro-
Benzene, l-Chloro-4-nitro-
Benzene, Dichloro-
e.g. Benzene, p-Dichloro-
Benzene, o-Dichloro-
Benzene, Dinitroso-
Benzene, Divinyl-
Benzene, (Epoxyethyl)-
Benzene, Ethyl-
BZ54500 000104949
CB24500 000118923
CC40250
CC49000
CC94500
CG64750
007440360
001345046
007784421
TC84000 000115866
TD01750 001330785
DB64750
ZE51000
CM20000
CM70000
CM80500
C040250
CU43750
CZ01750
CZ08750
CZ09400
CZ10500
027176870
000103242
001072522
000075558
000495487
000100527
000108907
000088733
000121733
000100005
CZ45500 000106467
CZ45000 000095501
*ZZ02060
CZ96250 000096093
DA07000 000100414
-------
Benzene, Hexachloro-
Benzene, 1,2-(Methylenedioxy)-4-propeny1-
Benzene, Nitro-
Benzene, Pentachloro-
Benzidine, 3,3'-Dimethoxy-
Benzimidazole, 6-Nitro-
Benzoic acid, 2-((4-Dimethylamino)phenylazo)-
Benzophenone, 4,4'-Bis(dimethylamino)-
p-Benzoquinone dioxime
Benzothiazole, 2,2'-Dithiobis-
Benzothiazole, 2-(Morpholino-thio)-
2-Benzothiazolesulfenamide, N-Cyclohexyl-
Benzoyl chloride
Benzoyl peroxide
Benzyl alcohol
Beryl
Beryllium oxide
Biphenyl
Biphenylamines
e.g. 2-Biphenylamine
4-Biphenylamine
2,4'-Biphenyldiamine
Bismuth and Bismuth compounds
e.g. Bismuth
Bismuth, Tris(
-------
1-Butene
2-Butene (cis and trans)
2-Butene, 1,4-Dichloro-, (e)-
t-Butyl peroxide
Carbon black
Carbon disulfide
Carbon tetrabromide
Carbon tetrafluoride
Cellulose tetranitrate
Chloral hydrate
Chloramine
Chlorinated paraffins, 35-64% chlorine
Chromium compounds
e.g. Chromic acid, calcium salt (1:1), dihydrate
Chromic acid, dipotassium salt
Chromium (III) oxide (2:3)
Chromium (VI) oxide (1:3)
Cobalt
Cobalt (II) nitrate (1:2)
Cobalt (II) sulfide
Copper and Copper compounds
e.g. Copper (metal)
Cresol
e.g. Cresol
o-Cresol
m-Cresol, 4,4 '-Butylideneb.is(-6-tert-butyl>-
p-Cresol, 2,6,-Dinitro-
m-Cresol, 4,4'-Thiobis(6-tert-butyl)-
Crotonaldehyde, (e)-
Cumene
*EM28900250
*EM28900500
EM49030 000110576
ER24500 000110054
FF66500
FG47250
FG49200
FJ60000
FM87500
000075150
000558134
000075730
PM9004700
000302170
*RV03500500
*GB42000500
GB28000 010060089
GB29400 007789006
GB64750 001308389
GB66500 001333820
GF87500 007440484
GG11090 010141056
GG33250 001317426
*GL53250500
GL53250 007440508
G059500
G063000
G070500
G098000
GP31500
GP96250
GR85750
001319773
000095487
000085609
000096695
000123739
000098828
-------
Cyanamide, calcium salt
Cyclohexanol
Cyclohexanol, Methyl-
Cyclohexanone
Cyclohexene
1-Cyclohexene, 4-Vinyl-
1,3-Cyclopentadiene
Cyclopentadiene, Hexachloro-
Cyclopentane
Cyclopentane, Methyl-
Decaborane(14)
Dibenzofuran
Diethylamlne, 2,2'-Dichloro-N-methyl-
Dimethyl sulfoxide
p-Dioxane
Diphenylamine
Diphenylamine, 2,2', 4,4', 6,6'-Hexanitro-
Diphenylamine, 4-Isopropoxy-
Diphenylamine, N-Nitroso-
Diphenylamine, 4-Nitroso-
Ethane, Bromo-
Ethane, Chloro-
Ethane, 1,2-Dichloro-
Ethane, 1,1,2,2-Tetrabromo-
Ethane, 1,1,1-Trichloro-
Ethane, 1,1,2-Trichloro-
Ethanol, 2-Amino-
Ethanol, 2-Chloro-
GS60000 000156627
GV78750 000108930
GW01750
GW10500 000108941
GW25000 000110838
GW66500 000100403
GY10000 000542927
GY12250
GY23900 000287923
GY46400 000096377
HD14000 017702419
*HP45500500
IA17500 000051752
PV62100 000067685
JG82250 000123911
JJ78000 000122394
JJ92750 000131737
JJ95000 000101735
JJ98000 000086306
JK01750 000156105
KH64750 000074964
KH75250 000075003
KI05250 000107062
KI82250 000079276
KJ29750 000071556
KJ31500 000079005
KJ57750 000141435
KK08750 000107073
-------
KV93600
KV94000
Ethanol, 2-Dimethylamino- KK61250
Ethanol, 2,2'-Iminodi- KL29750
Ethanol, 2,2',2"-Nitrilotri- KL92750
Ether, 2-Chloroethyl vinyl KN63000
Ethylene KU53400
Ethylene, Bromo- KU84000
Ethylenediamine, N-(l-Naphthyl)-, dihydrochloride KV53300
Ethylene, 1,1-Dichloro- KV92750
Ethylene, 1,2-Dichloro
e.g. Ethylene, 1,2-Dichloro-
Ethylene, 1,2-Dichloro-,(e)-
Ethylene, Tetrachloro- KX38500
Ethylene, Trichloro- KX45500
Ferrocene LK07000
Flame retardants (brominated alcohols)
e.g. Dibromobutenediol
Dibromoneopentyl glycol
2,3-Dibromopropanol
Tribromoneopentyl alcohol
Flame retardants (brominated aromatic compounds)
e.g. Decabromobiphenyl
Decabromobiphenyl ether
Hexabromobenzene
Hexabromobiphenyl
Hexabromocyclododecane
Flame retardants (halogenated phosphates and phosphonates)
e.g. Bis(2-chloroethyl)vinyl phosphonate
Chlorinated polyphosphates
Diethyl 2-bromoethylphosphonate
Tris(4-bromophenyl) phosphate
Tris(2-chloroethyl) phosphate
Tris(2,3-dibromopropyl) phosphate
Tris(2,3-dichloropropyl) phosphate
Tris(2,4,6-tribromophenyl) phosphate
000108010
000111422
000102716
000110758
000074851
000593602
001465254
000075354
000540590
000127184
000079016
000010254
UB01750 000096139
-------
Flame retardants (hexachlorocyclopentadiene derivatives)
e.g. Bis(chlorendo) bicyclopentadiene
Bis(chlorendo) cyclooctadiene
Bis(chlorendo) furan
Bishexachlorocyclopentadiene
Chlorendic acid
Chlorendic anhydride
Chlorendic salts
Chlorendocyclooctadiene
Bromochlorendocyclooctadiene
2,3,4,5-Tetrabromophenyl-2,2a,2a,3,4,5-hexachloro-bicycloheptadiene
Flame retardants (miscellaneous halogenated compounds)
e.g. Ammonium bromide
Tetrabromobisphenol A, Bis(2,3-dibromopropyl ether)
Tetrabromophthalic anhydride
2,2',6,6'-Tetrabromo-3,3',5,5'-tetramethyl-4,4'-dihydroxybiphenyl
Tetrachlorobisphenol A
Tetrachlorophthalic anhydride
Flame retardants (phosphonium compounds)
e.g. Tetrakis(hydroxymethyl) phosphonium bromide
Tetrakis(hydroxymethyl) phosphonium chloride
Tetrakis(hydroxymethyl) phosphonium hydroxide
Tetrakis(hydroxymethyl) phosphonium sulfate
Fluorescent brightening agents
e.g. 4,4'-Diamino-2,2'-stilbenedisulfonic acid
Fluoroacetamide
*LM59500500
*ZZ02081
AC12250 000640197
Fluorocarbons (excluding fully halogenated chlorofluoro-
alkanes)
e.g. Ethane, l-Chloro-l,l-difluoro-
Methane, Chlorodifluoro-
Methane, Dichlorofluoro-
Formaldehyde
Formamide
Formamide, N,N-Dimethyl-
Formic acid
Fumaric acid
2-Furaldehyde
Furan, Tetrahydro-
KH76500
PA63900
PA84000
000075683
000075456
000075434
LP89250 000050000
LQ05250 000075127
LQ21000 000068122
LQ49000 000064186
LS96250 000110178
LT70000 000098011
LU59500 000109999
-------
Glycols (low molecular weight)
e.g. Diethylene glycol
Ethylene glycol
1,2-Propanediol
Tetraethylene glycol
Triethylene glycol
Heptane
Heptene (mixed isomers)
Hexamethylenetetramine
1,6-Hexanediamine
Hexanes and other C6 hydrocarbons
e.g. Cyclohexane
Hexane
Pentane, 2-Methyl-
1-Hexanol, 2-Ethyl-
Hydrazine, methyl hydrazines, and their derivatives
e.g. Hydrazine
Hydrazine, 1,1-Dimethyl-
Hydrazine, Methyl-
Hydrazine, monohydrate
Hydrazine, 1,1-Diphenyl-
Hydrazobenzene
Hydrocyanic acid
Hydrogen selenide
Hydrogen sulfide
Hydroperoxide, alpha, alpha-Dimethylbenzyl-
Hydroquinone
Hydroxylamine
Hydroxylamine, 0-Methyl-
Hydroxylamine, N-Phenyl-
Isocyanic acid, p-chlorophenyl ester
Isophthalic acid
Isoprene
ID59500 000111466
KW29750 000107211
TY20000 000057556
XC21000 000112607
YE45500 000112276
MI77000 000142825
MJ88500
MN47250 000100970
M011800 000124094
*MN92750500
GU63000 000110827
MN92750 000110543
SA29950 000107835
MP03500 000104767
MU71750 000302012
MV24500 000057147
MV56000 000060344
MV80500 007803578
*MW26250500
MW26250 000122667
MW68250 000074908
MX10500 007783075
MX12250 007783064
MX24500 000080159
MX35000 000123319
NC29750 007803498
NC38500 000067629
NC49000 000100652
NQ85750 000104121
NT20000 000121915
NT40370 000078795
10
-------
Ketones, asymmetric
e.g. 2H-Azepin-2-one, Hexahydro-
2-Butanone
Cyclohexanone, 2-Methyl-
2-Heptanone
3-Heptanone, 5-Methyl-
2-Hexanone
2-Hexanone, 5-Methyl-
2-Pentanone, 4-Methyl-
Lauroyl peroxide
Lead, Bis(dimethyldithiocarbamato)-
Ligninsulfonic acid, calcium salt
Ligninsulfonic acid, ferrochrome salt
t
Lithium hydride
Maleic acid, dibutyl ester
Maleic anhydride
Manganese
Manganese, Tricarbonyl 2-methylcyclopentadienyl
Melamine
p-Menthane-8-hydroperoxide
Mercaptans
e.g. Dodecyl mercaptan
Methacrylic acid esters
e.g. Methacrylic acid, butyl ester
Methacrylic acid, ethyl ester
Methacrylic acid, methyl ester
Methane, Bis(2-chloroethoxy)-
Methane, Bromo-
Methane, Bromochloro-
Methane, Bromotrifluoro-
Methane, Chloro-
Methane, Dibromo-
CM36750 000105602
EL64750 000078933
GW17500
MJ50750 000110430
MJ73500 000541855
MP14000 000591786
MP38500 000110123
SA92750
OF26250 000105748
OF88500 019010663
*ZZ02119
*OI31500500
OJ63000 007580678
ON08750 000105760
ON36750 000108316
0092750 007439965
OP14700
OS07000 000108781
OS94500
*OU22750500
*JR80500500
OZ36750
OZ45500
OZ50750
PA36750
PA49000
PA52500
PA54250
PA63000
PA73500
000097881
000097632
000080626
000111911
000074839
000074975
000075638
000074873
000074953
11
-------
Methane, Dihromodifluoro-
Methane, Dichloro-
Methane, Dimethoxy-
Methane, lodo-
Methane, Tribromo-
Morpholine
Naphthalene
Naphthalene, Decahydro-
Naphthalene, 1-Nitro
Naphthalenes, chlorinated
e.g. Naphthalene, Pentachloro-
Naphthalene, Tetrachloro-
Naphthalene, Trichloro-
"Chlorinated naphthalenes"
Naphthenic acid, copper salt
Naphthenic acid, lead salt
2-Naphthylamine, N,N-Bis(2-chlorethyl)-
2-Naphthylamine, N-Phenyl-
Nickel and Nickel compounds
e.g. Nickel (metal)
Nickel (II) acetate(1:2)
Nickel, compd with pi-cyclopentadienyl (1:2)
Nickel (II) oxide (1:1)
Nitrophenols
e.g. Phenol, m-Nitro-
Phenol, o-Nitro-
Phenol, p-Nitro-
Nonene (mixed isomers)
Octadecanoic acid, 9,10-Epoxy-, butyl ester
Octane
Oxalic acid
2H-1,3,2-oxyazaphosphorine, 2-(Bis(2-chloroethyl)amino)
tetrahydro-, 2-oxide
PA75250 000075616
PA80500 000075092
PA87500 000109875
PA94500 000074884
PB56000 000075252
QD64750 000110918
QJ05250 000091203
QJ31500 000091178
QJ97200 000086577
QK03000
QK37000
QK40250 001321659
*QJ21000500
QK91000 001338029
OG20250
QM24500 000494031
QM45500 000135886
QR59500 007440020
QR61250 000373024
QR65000 001271289
QR84000 001313991
SM19250
SM21000
SM22750
RA85500
RG15750
RG84000
R024500
RP59500
000554847
000088755
000100027
000106832
000144627
000050180
12
-------
Pentane
1,3-Pentanediol, 2,2,4-Trimethyl-
1-Pentanol, 2-Methyl-
2-Pentanol, 4-Methyl-
Peroxide, Bis(alpha,alpha-dimethyIbenzyl)
Peroxide, Bis(dimethylethyl)
Peroxyacetic acid
Peroxybenzoic acid, t-butyl ester
Petroleum distillates (boiling point 35-130°C)
e.g. Petroleum spirits (ligroin, solyent naphtha)
Benzin
RZ94500 000109660
SA14000 000144194
SA71750 000105306
SA73500 000108112
SD81500 000080433
*SD78850500
SD87500 000079210
SD94500 000614459
SE75550
DE30300 008030306
Phenol, 2,4-Dichloro-
Phenol, Dodecyl-
Phenol, 4,4'-Isopropylidenedi-
Phenol, Nonyl-
Phenol, Tetrachloro-
Phenol, 3,4,5-Trichloro-
o-Phenylenediamine
p-Phenylenediamine
p-Phenylenediamine, dihydrochloride
p-Phenylenediamine, N,N'-Diphenyl-
o-Phenylenediamine, 4-Nitro-
Phosphine oxide, Tris(l-aziridinyl)-
Phosphine
Phosphines (PR3)
i.e. R = alkyl, aryl and alkoxy (mixed)
Phosphonic acid, bis(2-chloroethyl)(1-hydroxyethyl) ester
Phosphorane, Pentachloro-
SK85750 000120832
SL36750 001331573
000080057
025154523
025167833
SL63000
SM56000
SM91000
SN16500 000609198
SS78750 000095545
SS80500 000106503
ST03500 000624180
ST22750 000074317
ST29750 000099569
SZ17500 000545551
SY75250 007803512
TB61250 010026138
13
-------
Phosphoric triamide, Hexamethyl-
Phosphorotrithioic acid, S,S,S,-tributyl ester
Phthalic acid
Phthalic anhydride
Picric acid
e.g. Picric acid (dry)
Picric acid (wet)
Pigment blue 15, alpha and beta forms
Pigment green 7
Pigment yellow 12
Pine oil
Polyacrylonitrile (fibers)
Polychlorinated diphenyl ethers
Polychlorinated triphenyls
Potassium pyrophosphates
Propane, l-Chloro-2,3,-epoxy-
Propane, 1,2-Dichloro-
Propane, 1,2-Epoxy-
Propane, 1-Nitro-
Propane, 2-Nitro-
Propane, 2,2'-Oxybis-
Propane, 1,2,3-Trichloro-
2-Propanol, 1-Chloro-
1-Propanol, 2,3-Epoxy-
2-Propanone, 1-Chloro-
2-Propanone, 1,1,1,3,3,3-Hexafluoro-
Propene
Propene, 3-Chloro-
Propene, l-Chloro-2-methyl-
14
TD08750
TG54250
TH96250
TI31500
TJ78780
TJ88500
*ZZ02123
*ZZ02062
*ZZ02076
TK51000
*TQ03500500
*KN89700500
TQ13800
TT49000
TX49000
TX96250
TZ29750
TZ50750
TZ52500
TZ54250
TZ92750
UA87500
UB43750
UC07000
UC24500
UC67400
UC73500
UC80450
000680319
000078488
000088993
000085449
MK8006880
000106898
000078875
000075569
000108032
000079469
000108203
000096184
000127004
000556525
000078955
000684162
000115071
000107051
-------
Propene, 3-Chloro-2-methyl-
Propene, 2-Methyl-
2-Propenoic acid, butyl ester
Propionitrile, 3-Amino-
Propyne, mixed with propadiene
Pyridine
Quinoline, l,2-Dihydro-2,2,4-trimethyl-
8-Quinolinol
Sebacic acid, Bis(2-ethylhexyl) ester
i
Selenium dimethyldithiocarbamate
Selenium, Tetrakis(diethyldithiocarbamato)-
Silver iodide
Soaps (fatty acid salts)
Sodium dibutyldithiocarbamate
Sodium thiosulfate, pentahydrate
Stearic acid, methyl ester
Stibene
Styrene
Styrene, alpha-Methyl-
S tyrenes, chlor inat ed
e.g. Chlorostyrene
Sulfide, Bis(dimethylthiocarbamoy1)
Terephthalic acid
Thiophene, 2,5-Dihydro-, 1,1-dioxide
Thiophene, Tetrahydro-, 1,1-dioxide
Titanium dioxide
Toluene
Toluene, alpha-Chloro-
UC80500
UD08900
UD31500
UG03500
UK49200
UR84000
VB49000
VC42000
VS10000
VT07000
EZ38800
WE66600
WI44600
WJ07000
WL36750
WL52500
WL41500
WQ17500
WZ08750
XM91000
XN07000
XR22750
XS52500
XS89250
000563473
000115117
000141322
000151188
000110861
000147477
000148243
000122623
017156831
000136301
010102177
000112618
007803523
000100425
000098839
001331288
000097745
000100210
000077792
000126330
013463677
000108883
000100447
15
-------
Toluene, p-Chloro-
Toluene-2,4-diamine
Toluene-2,4-and-2,6-diisocyanate (80/20 mixture)
Toluene, 2,4, (and 2,6)-Dinitro-
Toluene, alpha,alpha,alpha-Trichloro-
Toluene, Vinyl (mixed isomers)
Toluidines
e.g. m-Toluidine
o-Toluidine
p-Toluidine
Triallylamine
s-Triazine, Hexahydro-1,3,5-trinitro-
s-Triazine, 2,4,6-Trichloro-
s-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5,-Trichloro-
Trichlorobenzenes, mixed
Triethylenetetramine
Tungsten
Tungsten carbide
Turpentine
Vanadium compounds
e.g. Vanadium pentoxide (dust and fume)
Vat blue 6
Xylenes
e.g.
Xylene (mixed isomers)
"Mixed Xylene"
m-Xylene
o-Xylene
p-Xylene
Xylenols
e.g.
2,5-Xylenol
3,4-Xylenol
3,5-Xylenol
XS90100 000106434
XS96250 000095807
*CZ63000500
*XT15750500
XT92750 000098077
XU03500
XU28000
XU29750
XU31500
XX59500
XY94500
XZ14000
XZ19250
000108441
000095534
000106490
000102705
000121824
000108770
000087901
YE66500 000112243
Y071750 007440337
Y084000 MX8006642
*YW15750500
YW24500 001314621
YW24600
*ZZ02058
ZE21000
ZE21900
ZE22750
ZE24500
ZE26250
ZE57750
ZE63000
ZE64750
001330207
000108383
000095476
000106423
000095874
000095658
000108689
16
-------
Xylidine
Zinc (metal)
Zinc, Bis(dibutyldithiocarbamato)-
Zinc, Bis(diethyldithiocarbamato)-
ZE85750
ZG86000
ZH01750
ZH03500
001300738
007440666
000136232
000136947
17
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PART II. BACKGROUND DOCUMENT: PREPARATION OF PRELIMINARY LIST OF
CHEMICAL SUBSTANCES FOR FURTHER EVALUATION BY THE TSCA
INTERAGENCY TESTING COMMITTEE
July 1977
1. INTRODUCTION
1.1 COMMITTEE ESTABLISHMENT AND RESPONSIBILITIES
Section 4(e) of the Toxic Substances Control Act (P.L. 94-469)
established an Interagency Committee charged with making
recommendations to the Administrator of the Environmental Protection
Agency regarding chemical substances or -mixtures to which EPA should
give priority attention in the development and promulgation of
regulations under Section 4(a) of the Act which authorizes the testing
of substances or mixtures to determine what adverse effects they may
have on human health and the environment.
t
The Committee has eight members, appointed by the eight Federal
agencies identified for membership in Section 4(e) (2)(A) of the Act.
In addition, a number of alternates have been designated as permitted
by Section 4(e)(2)(B)(i). The Committee has adopted the name "TSCA
Interagency Testing Committee", referred to in this report as the
"Committee". As provided by Section 4(e)(2)(B)(iii), it has selected
a chairman from among its members. The Committee has also invited
several other Federal agencies with programs related to the control of
toxic substances but which were not included in the statutory
membership of the Committee to designate observers to attend Committee
meetings. Current Committee members, alternates, and observers are
listed in Appendix A.
The Committee's testing priority recommendations are required by
Section 4(e) to be published in the Federal Register and transmitted
to the EPA Administrator by no later than October 1, 1977. At least
every six months thereafter, the Committee is required to review its
recommendations and make such revisions as are necessary.
The Committee's recommendations will be in the form of a list of
chemical substances or mixtures set forth, either individually or in
groups, in the order in which the Committee determines the EPA
Administrator should consider taking action under Section 4(a)
rulemaking in developing and promulgating testing regulations. The
Committee is authorized to designate up to 50 substances or groups for
which the EPA Administrator must within 12 months either initiate
rulemaking requiring their testing or publish reasons for not taking
such action.
In developing its recommendations, the Committee is directed by the
statute (Section 4Ce)) to consider, along with all other relevant
factors: the production volume, environmental release, occupational
exposure, and non-occupational human exposure to the substance or
19
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mixture; the similarity of the substance or mixture in question to
others known to present unreasonable risk of injury to health or the
environment; the extent of data on the effects of the substance or
mixture in question on health or the environment and the extent to
which additional testing of the substance or mixture may produce data
from which effects can reasonably be determined or predicted; and the
reasonably foreseeable availability of facilities and personnel for
performing the testing being recommended. The Committee is also
directed by the statute (Section (4e)) to give priority attention in
establishing its list of recommendations to substances or mixtures
which are known or suspected to cause or contribute to cancer, gene
mutations, or birth defects.
While the Committee will review existing data on toxic effects it
should be emphasized that the purpose of the Committee is to recommend
substances for testing. Lack of data indicating possible hazard will
not prejudice against its being recommended for testing in those cases
where significant exposure can occur. Indeed many such chemicals may
be prime candidates for testing. The Committee will also exercise
judgment as to adequacy of existing test results.
The Committee's specific reasons for including each substance or
mixture in its recommendations are required to be published in the
Federal Register and transmitted to the EPA Administrator along with
the priority list.
While Section 4(e) refers to the Committee's recommendations as a list
of "chemical substances and mixtures", Section 26(c)(l) authorizes the
EPA Administrator to take actions (including the promulgation of
Section 4(a) testing regulations) with respect to categories of
chemical substances or mixtures as well. A category is defined by the
Act as a group whose members are similar in molecular structure; in
physical, chemical, or biological properties; in use; in mode of
entrance into the human body or into the environment; or in any other
way, so long as the grouping is not based solely on its members being
"new chemical substances" as defined in the Act. Since the EPA
Administrator is authorized to promulgate testing regulations for
categories of chemical substances or mixtures, the Committee has
interpreted that its recommendations to the EPA Administrator may also
include categories (or groups) of chemical substances or mixtures as
well as individual substances and mixtures. This conclusion is
consistent with Section 4(e) which states that the Committee's
recommendations for testing "shall be in the form of a list of
chemical substances or mixtures which shall be set forth either by
individual substance or mixture or by groups of substances or
mixtures."
In order to maintain consistency in this report and in keeping with
the meaning in the Act, the term "category" will be used to reflect
groupings of substances. Likewise "substance" will refer to both
individual chemicals as well as mixtures.
20
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1.2 BASIC APPROACH ADOPTED BY THE COMMITTEE
Section 4(e), as previously noted, requires the Committee to evaluate
a number of factors for each chemical substance or mixture included in
its list of priority recommendations to the EPA Administrator. In
considering possible approaches to meeting these responsibilities,
certain limitations became evident. There was no data system of
consolidated chemical information which permitted retrieval of all of
the required data. In addition, the many existing data systems were
not formatted in such a manner to easily permit merging of data files,
e.g., CAS numbers were not always available and chemical names were
not always designated in a uniform manner. Certain information
required by the Committee was often unavailable. This was
particularly critical for chemical uses and occurrences thus limiting
the Committee's knowledge of overall exposure to many chemicals.
In the light of these limitations as well as the time constraints of
its charge, the Committee chose to use existing lists of prioritized
potentially hazardous substances developed by other agencies and
organizations as a primary starting point in its review process.
Since the criteria used in the development of these lists were similar
to those of the Committee, the lists were used in their original form.
The sources of these starting lists are discussed in Section 3.
When these lists were combined, an initial listing emerged containing
approximately 3500 substances and categories. Included in this was a
number of drugs, food additives or pesticides not subject to the
authority of the Toxic Substances Control Act. These substances were
dropped from the list unless they were judged likely to have another
use subject to TSCA regulation. In addition, those substances judged
not to be in commercial production were removed from the list on the
assumption that they had low potential for human exposure or
environmental contamination. After these deletions, the remaining
list consisted of approximately 2100 substances which is hereafter
referred to as the "Master File1'.
The Master File will be screened in a 3-stage process. The first
stage has been completed and involved screening the substances on the
basis of potential for human or environmental exposure. From this
stage, approximately 300 substances and categories have been designated
as the "Preliminary List" which is presented here for information and
comment. In the second stage, the substances and categories on the
Preliminary List will be further evaluated on the basis of their
potential for adverse effects to humans and the environment. It is
anticipated that perhaps 100 substances or categories, will emerge
from the second phase of screening for a most intensive and detailed
third stage review by the Committee.
Subsequent to the development of the Master File, additional
information has been made available by the Consumer Product Safety
Commission consisting of 1288 chemicals occurring most often in over
15,000 consumer products surveyed in 1976. From this new data source
as well as comments received from the public regarding the Preliminary
List, it is possible that additional chemicals will be considered in
detail by the Committee.
21
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1.3
REQUEST FOR COMMENTS ON PRELIMINARY LIST
The Preliminary List and this Background Document are being made
available at this time to allow public comment on the procedures used
by the Committee in developing the Preliminary List and on the
specific chemical substances, mixtures and categories which should be
further evaluated by the Committee for possible inclusion in its
testing priority recommendations to be made to the EPA Administrator
by October 1, 1977.
Sections 2 and 3 of this Background Document discuss in more detail
the rationale behind the Preliminary List and the methods and data
sources which were used to develop it. Section 4 outlines specific
areas in which the Committee seeks comments and discusses the types of
data and formats for submission of such data which would be most
helpful to the Committee in evaluating proposed changes to the list of
substances. Finally, Section 5 provides details on the procedures for
submitting comments on the Preliminary List.
Only the Preliminary List will be distributed to the public. The
Master File and the list of other chemicals or categories considered
by the Committee will also be available for inspection at the Council
on Environmental Quality and Headquarters and Regional Offices of the
Environmental Protection Agency.
2. THE PRELIMINARY LIST
The Preliminary List which accompanies this Background Document
contains in alphabetical order the names of chemical substances,
mixtures and categories which are candidates for inclusion in the
priority list under development by the Committee. The presence of a
substance on the list indicates that the substance:
(a) Was on one of a number of previously developed
lists of substances which may pose adverse
health and/or environmental effects; and
(b) Was judged by the Committee to warrant further
evaluation because significant human exposures
and/or environmental release can be expected.
On the other hand, the presence of a substance on the Preliminary List
does not, by itself, indicate that the Committee is making any
statement on whether the substance should be regulated or on the need
or priority for further testing of that substance. The Committee has
not yet completely evaluated the substance's potential for adversely
affecting human health or the environment. Nor has the Committee yet
evaluated the adequacy of existing test data bearing on such effects.
Only after the Committee has evaluated these factors will
recommendations be developed. Moreover, the Committee does not
exclude the possibility of recommending the testing of additional
substances or categories, even though they do not appear on the
Preliminary List. In general, categories of substances appearing on
the Preliminary List reflect category or group entries on one or more
of the source lists used by the Committee. The Committee will
consider the rationale for those categories as well as the
desirability of forming other categories in developing its
recommendations.
22
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3. METHODOLOGY USED TO DEVELOP THE PRELIMINARY LIST
3.1 OVERVIEW
The statute imposes a deadline of October 1, 1977 for the Committee to
make its initial recommendations to the EPA Administrator. As
discussed earlier in Section 1.2, a method was chosen to maximize the
retrieval and consolidation of available data in view of this imposed
time constraint. The methodology possesses three main features: 1)
it relies heavily on previous efforts to identify chemicals which may
pose a hazard to man or the environment; 2) it makes maximum use of
readily available chemical data; and 3) it incorporates subjective
judgment in those areas where data are absent or not easily accessible.
Accordingly, the Committee adopted a methodolgy whereby an initial
listing of chemicals was successively reduced to smaller lists through
the application of screening criteria. The initial compilation of the
various lists resulted in a compendium consisting of approximately
3500 different substances and categories that were previously
identified either as potentially hazardous to man or the environment
or in annual production in quantities of over one million pounds per
year. The sources of the initial listing are given in Appendix B.
3.2 THE INITIAL LISTING
The initial listing included a number of substances that had
pesticide, food additive, or drug uses, all of which are regulated
under other Federal statutes and exempted from regulation by TSCA.
Therefore, the initial listing was purged of substances with such uses
by screening it against lists of pesticides prepared by the EPA and
lists of food additives and drugs prepared by the Food and Drug
Administration. The basis for comparing chemicals on the three
listings was the Chemical Abstracts Service (CAS) Registry Number.
The attempted purge of these regulated substances was incomplete,
since some entries on source lists did not include CAS numbers. To
compensate for this, a further manual purging was required.
Consideration was also given to the fact that a chemical with <*
pesticide, food additive or drug use may have other uses that are
subject to the authority of TSCA. Thus chemicals with over 10 million
pounds of annual production were retained in the truncated list for
further review of possible uses, as were chemicals which had known
uses that were within the TSCA regulation.
The resulting file was further reduced by the elimination of chemicals
which were judged not likely to be in commercial production. This was
accomplished by comparing the file against EPA's Candidate List of
Chemical Substances, prepared by the Office of Toxic Substances (dated
April 1977) . Again, the basis of comparison for this purge was an
assigned CAS number. Consequently, this purge did not affect those
chemicals on source lists for which no CAS number was given. In an
attempt to eliminate substances which are not in commerical
production, the following rule was adopted: any substance not
23
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identified by a CAS number which appeared on the NIOSH Registry
(Source List 13 of Appendix B) and on none of the other source files,
was judged not likely to be in commercial production. This decision
was based on the fact that the NIOSH Registry lists any chemical for
which toxic effects have been reported, including research chemicals.
A study of the chemicals eliminated by the application of this rule
upholds its validity: few of the purged chemicals were recognized to
be in commercial production.
3.3 THE MASTER FILE
As a result of the purges described above, a Master File of
approximately 2100 substances emerged. The Committee reduced this
list by the further application of a set of screening criteria. This
screen was designed to truncate the Master File on the basis of each
chemical's relative potential for entering the environment in
appreciable quantities with consequent exposure to humans and other
sensitive species. The screening factors selected for this purpose
correspond to the first four factors set forth in TSCA Sec. 4(e) as
ones which the Committee should consider when making its
recommendations to the EPA Administrator. They are:
(i) quantity produced annually
(ii) amount released into the environment
(iii) number of individuals who are occupationally exposed
(iv) extent to which the general population will be exposed.
Using a combination of published data and judgment, an attempt was
made to score each substance on the Master File on each of these four
factors. Appendix C describes in more detail how scores were assigned
to substances. A score was assigned to a substance only if
information was available giving the use or uses of the substance.
For approximately 1400 substances, inadequate data on uses prevented
their scoring and further evaluation. The Committee will attempt to
obtain the needed information on these substances to permit their
consideration for subsequent Committee revisions.
3.4 THE PRELIMINARY LIST
In the first stage (exposure) screen, approximately 700 chemicals were
assigned scores for the four exposure factors. Chemicals were ranked
by summing the individual scores, assigning equal weighting to each
factor. This ranking was the principal basis for selection of
substances for the Preliminary List. In addition, the Committee
exercised professional judgment in eliminating from current
consideration many chemicals which are: a) currently under regulation
or being considered for regulation, e.g., vinyl chloride and benzene;
b) reasonably well-characterized as hazardous, e.g., mercury; c)
considered essentially inert materials, such as certain polymers; and
d) natural products which would be difficult to characterize for
testing purposes, e.g., wood or gasoline.
The first stage of screening resulted in the identification of
approximately 300 substances, mixtures or categories, which are
designated as the Preliminary List. These chemicals will be further
evaluated in the second stage for their potential for adverse effects
to humans and the environment.
24
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In several cases the Committee has grouped chemicals, fully cognizant
of the difficulties in identifiying appropriate groupings for testing
purposes. Among the method of grouping under consideration are:
primary use, structural similarities, predicted toxic effect, etc.
While some categories are presented on the Preliminary List, such
groupings will be further considered in the review process.
The chemicals on the Preliminary List will be further screened on the
basis of potential for carcinogenic, mutagenic and teratogenic
activity, other human effects, ecological potential hazards and the
need for further testing. This screening process will result in the
Committee recommending to the EPA Administrator up to 50 substances or
categories that require priority consideration for testing.
4- TYPES OF COMMENTS SOUGHT AND RECOMMENDED RESPONSE FORMATS
A.I GENERAL INFORMATION
Comments are specifically sought by the'Committee on the methodology
used in developing the Preliminary List, on the content of the
Preliminary List, and on the specific types of test data which are
needed on substances appearing on the Preliminary List.
Because of the October 1, 1977 statutory deadline for the Committee's
initial recommendations to the EPA Administrator, it is necessary that
comments on the Preliminary List be timely and concise, but that they
provide adequate information to allow the Committee to evaluate the
recommendations made by commentors. This is particularly important in
the case of comments on the content of the Preliminary List (i.e.,
recommendations that the Committee consider a substance not appearing
on the Preliminary List or drop from consideration a substance which
does appear on the Preliminary List).
As an aid to commentors, this section of the Background Document
discusses the specific types of information which the Committee
considers desirable to permit adequate evaluation of comments and
provides recommended formats for the submission of information by
commentors on the content of the Preliminary List. While it is not
mandatory that commentors follow the recommended formats, failure to
provide the types of information requested in the formats and marked
deviations from the suggested formats may make it difficult for the
Committee to take such comments into account in establishing its
initial list of recommendations to the EPA Administrator.
While submission of adequate supporting data is important to the
effective and timely consideration by the Committee of commentors1
recommendations, submission of voluminous studies and large volumes of
raw data may impede, rather than assist, the Committee's consideration
of the commentor's views. Therefore, it is requested that commentors
summarize information where possible in their submissions providing
references to primary data sources on which the summarized comments
are based, and where applicable identify an individual as a contact
point.
25
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It is also requested that commentors not submit with their comments
data or copies of studies for which the commentor wishes to claim
confidential treatment. Copies of all comments on the Preliminary
List submitted to the Committee will be subject to public inspection.
Where information which the commentor considers confidential is
critical to adequately support the recommendations made in the
comments, it is requested that the existence and general nature of the
information be noted in the comments in a way which would not reveal
any trade-secret data and that an individual be identified for the
Committee to contact should it wish to subsequently request submission
of the information.
4.2 COMMENTS ON METHODOLOGY USED IN DEVELOPING THE PRELIMINARY LIST
Comments are sought by the Committee on the methodology it has used in
developing the Preliminary List. That methodology is described in
Section 3 of this Background Document. Comments are specifically
sought in the following areas:
a. The general approach used by the Committee in screening substances
appearing on a number of existing lists of chemicals of potential
hazard to health or the environment to identify those with the
greatest potential for human exposure and/or environmental release.
Suggestions of alternative approaches which might be considered by the
Committee in preparing subsequent revisions of its recommendations are
sought.
b. The various lists used by the Committee in constructing its
initial listing. Commentors are requested to suggest additional
sources for identification of potentially hazardous chemicals for
review by the Committee.
c. Data sources for identifying drugs, food additives, pesticides,
and non-commercial chemicals appearing on the initial listing.
d. Additional sources of data on production volumes, uses,
environmental releases of, and exposure to chemicals.
e. The scoring and weighting factors used by the Committee to
evaluate the relative levels of human exposure to and environmental
release of chemicals for purposes of selecting items to be included on
the Preliminary List.
Comments on the methodology used in developing the Preliminary List
will, to the extent possible, be considered by the Committee in its
further development of its initial recommendations of testing
priorities. However, because of the statutory deadline for
transmitting those recommendations, extensive modifications in
approach will be considered principally by the Committee in developing
procedures to be used for subsequent revisions of its recommendations.
26
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4.3 COMMENTS ON THE CONTENT OF THE PRELIMINARY LIST
Commentors may recommend specific modifications to the list, including
additions or deletions of specific substances or exceptions of
substances from inclusion in a category. In order to evaluate
recommended additions, the Committee desires pertinent information
about the substance, its production, use, environmental release, human
exposure, and its health and environmental effects. A rationale for
deletions or category modification should also be presented.
In view of the Committee's statutory deadline for developing its
initial testing priority recommendations, it is important that the
needed information be submitted by the commentor in a form which will
simplify the Committee's consideration. With this in mind, it is
requested that the formats as presented in Tables 4.1 - 4.2 be
followed. While commentors are encouraged to provide all the
requested items, failure to do so will not jeopardize consideration of
the comments. Commentors may supply additional data to support their
recommendations.
4.4 COMMENTS ON TEST DATA NEEDS
The Committee also seeks comments on the needs for further testing of
substances appearing on the Preliminary List. Commentors are
requested to identify the substance on which they are commenting using
the name as it appears on the Preliminary List and to specify the type
of testing recommended by the commentor and the reasons for that
recommendation. If a commentor wishes to recommend that further
testing of a substance appearing on the Preliminary List is not
needed, the substance should again be identified using the name as it
appears on the Preliminary List and the reasons provided for the
recommendation together with appropriate supporting data (such as a
summary of existing test data with literature references).
Those wishing to submit comments on the relative priority for further
testing of substances appearing on the Preliminary List (and other
substances proposed for consideration by the commentor) are requested
to provide a discussion of the reasons for their priority
recommendations.
27
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Tattle 4.1
Recommended Format for Proposing for Committee Consideration a Chemical
Substance, Mixture, or Category Not on the Preliminary List:
(Please use separate sheet for each nomination)
RECOMMENDATION FOR ADDITION TO THE PRELIMINARY LIST FOR CONSIDERATION
BY THE TSCA INTERAGENCY TEST COMMITTEE
A. Identification and Chemical/Physical Properties
1. Name and CAS Number: (Use Chemical Abstracts Service
preferred name and its number if known or available)
2. Type of Substance: (Specify whether substance is a pure
substance, mixture, commercial or trade-name product, or category.)
3. Additional Identifying Information:
a. For a mixture, identify the component substances (using
CAS preferred names and giving CAS Registry Numbers, if known)
and their proportions in the mixture.
b. For a commercial or trade-name product, identify the
ingredient(s) of concern and/or impurities or
contaminants of concern, using CAS preferred names and giving
CAS Registry Numbers, if known.
c. For a category, provide a proposed definition of the
category and identify any members of that category already
appearing on the Preliminary List.
4. Chemical and Physical Properties: (Relevant data on chemical
structure, molecular weight, isomers, chemical reactivity, boiling
and melting points, solubility and partition coefficients, etc,
may be attached).
B. Production, Use, Environmental Release, and Human Exposure
1. Production Volume: (Summarize available data on U.S. annual
production volume, imports, and exports. Specify year to which
data apply and indicate any anticipated trends.)
2. Uses:
a. Indicate if substance is used as a cosmetic ingredient,
drug, food or food additive or pesticide.
b. Summarize other known types of uses and indicate fraction
of production going to each use, if known.
28
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3. Environmental Release
a. Summarize known data on release of substance to the
environment, indicating type of operation (manufacture, use,
disposal, etc.) causing release, medium (air, water, etc.) to
which release occurs, total quantity released, and
concentration of release.
b. Summarize known data on environmental persistence and
transformations, including information on half-life and
products of degradation.
c. Summarize known data on ambient environmental
concentrations of substance.
A. Human Exposure:
(Summarize known data on human exposure to substance, indicating
population group exposed, number of, individuals exposed, route of
exposure (oral, inhalation, etc.), and level and duration of
exposure.)
C. Health and Environmental Effects
1. Toxicology: (Summarize known data on toxicology of substance
and its metabolites for humans and experimental animals,
indicating test species, route of exposure, level and duration of
exposure, and types and frequencies of effects observed. Also
summarize data from in vitro testing, indicating test system used
and results.)
2. Epidemiology: (Summarize known data on human epidemiology of
substance, indicating population exposed, route of exposure, level
and duration of exposure, and types and frequencies of effects
observed.)
3. Environmental Effects: (Summarize known data on adverse
environmental effects of substance and its decay products or
metabolites, indicating species or material affected, exposure
medium, level and duration of exposure, and type and frequency of
effects.)
D. Reasons for Proposing Committee Consideration of Substance
1. Basis of Concern: (Indicate whether the substance is
recommended for consideration by the Committee because of evidence
of substantial human exposure or substantial environmental release
alone, or because of suspicion of some particular type of adverse
effect on human health or the environment. In the latter case,
identify the type of adverse effect suspected and explain the
basis for the suspicion.)
29
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2. Data Needed; (Identify the specific types of data which are
considered to be needed to evaluate the effects of the
manufacture, distribution in commerce, processing, use, and
disposal of the substance on health and the environment but which
are presently unavailable.)
3. Testing Recommended: (Identify any specific types of testing
which are recommended to provide the needed data.)
4. Additional Information:
a. In the case of a mixture, commercial or trade-name product,
indicate the reasons why it is recommended that the mixture or
product be tested rather than the chemical substance(s) or
contaminant(s) of concern in the mixture or product.
b. In the case of a category, indicate the reasons for
recommending testing of all substances or mixtures contained
within the definition of the category, rather than a limited
number of specific substances or mixtures.
E. Identification of Submitter
(Provide name, organizational affiliation if any, address, and
telephone number of person submitting recommendation.)
30
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Table 4.2
Recommended Format for Proposing Chat the Committee Drop From Further
Consideration a Chemical Substance, Mixture, or Category Appearing on
the Preliminary List:
CPlease use separate sheet for each subject)
RECOMMENDATION TO DELETE FROM COMMITTEE CONSIDERATION
A. Name of Substance, Mixture, or Category
(Provide the name of the chemical substance, mixture, or category
proposed to be dropped from further consideration as that name
appears on the Preliminary List.)
B. Reasons for Recommending Dropping from Further Consideration
(Summarize reasons for recommending that the specific chemical
substance, mixture, or category not be further considered by the
Committee for possible inclusion in its recommendations to the EPA
Administrator. Examples of such reasons might be:
1. Substance is used exclusively as a drug and is not subject to
the Toxic Substances Control Act;
2. There is no human exposure to or environmental release of the
substance; or
3. The effects of the substance on human health and the
environment have been adequately tested.
C. Supporting Data
(Provide data and/or references to support the reasons given
above. NOTE: Data which the submitter considers to be
confidential should not be submitted with comments on the
Preliminary List, since all such comments will be made available
for public inspection. If the submitter possesses information
critical to the support of his comments on the Preliminary List
for which confidentiality is claimed, the availability of such
information may be identified in the submitter's public comments
for possible later request by the Committee.)
D. Identification of Submitter
(Provide the name, organizational affiliation if any, address, and
telephone number of the person submitting the recommendation.)
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5. PROCEDURES FOR SUBMISSION 07 COMMENTS
Comments on the Preliminary List should be submitted in triplicate
to:
Ms. Phyllis Tucker
Council on Environmental Quality
722 Jackson Place, N.W.
Washington, B.C. 20006
It is requested that comments on the Preliminary List be submitted
no later than August 22. 1977. Comments received after that date
may not be considered by the Committee in developing its initial
recommendations due on or before October 1, 1977, but will be
considered at a later time when the Committee reviews those
recommendations for possible revision.
Copies of all comments received will be available for public
inspection from 9 a.m. to 5 p.m., Monday through Friday, in Room
5020, New Executive Office Building, 726 Jackson Place, N.W.,
Washington, D.C.
32
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APPENDIX A
MEMBERSHIP OF TSCA INTERAGENCY
TESTING COMMITTEE
Statutory Member Agencies
Council on Environmental Quality
Dr. Warren R. Muir, Member
and Chairman
Department of Commerce
Dr. Sidney R. Caller, Member
Dr. Bernard Greifer, Alternate
Environmental Protection Agency
Dr. William M. Ilpholt, Member
National Science Foundation
Dr. Marvin E. Stephenson,
Member and Vice Chairman
National Institute of Environmental
Health Sciences
Dr. Hans L. Falk, Member
Dr. Warren T. Piver, Alternate
National Institute of Occupational
Safety and Health
t
Dr. Norbert P. Page, Member
Dr. Jean G. French, Alternate
National Cancer Institute
Dr. James M. Sontag, Member
Occupational Safety and Health
Administration
Mr. Grover C. Wrenn, Member
Ms. Carter Schuth, Alternate
Department of Defense
Dr. Seymour L. Friess
Food and Drug Administration
Dr. Allen H. Heim
EPA Administrative Support Staff
Executive Secretary: (To Be Named)
Secretary: Ms. Phyllis D. Tucker
Dr. James M. Vail, Alternate
Observer Agencies
Department of Interior
Mr. Charles R. Walker
U.S. Consumer Product Safety Commission
Dr. Robert M. Hehir
33
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APPENDIX B
DATA SOURCES USED FOR PREPARATION OF INITIAL LIST
01 Toxic Pollutants in Point Source Water Effluent Discharge
This list of 120 chemicals and groups consists of Appendices
A and C of the settlement agreement dated 7 June 1976 between
the Environmental Defense Fund and EPA. It is a priority list
of toxic pollutants subject to regulations through point source
effluent limitation (Section 307(a)) under the Federal Water
Pollution Control Act.
02 Scoring of Organic Air Compounds, June 1976, MITRE, MTR-6248
This list of 337 chemicals and groups was compiled and docu-
mented by MITRE (September 1976) under contract to EPA. The
relevant factors in selecting chemicals for the list were:
(1) Quantity produced, (2) potential for atmospheric release,
and (3) toxicological effects.
03 Final Report of NSF Workshop Panel to Select Organic Compounds
Hazardous to the Environment, April 1975
This list of 80 chemicals and groups was compiled and docu-
mented by Stanford Research Institute under contract to the
National Science Foundation. The list consists of those chemicals
having the greatest potential for environmental release,
selected from the universe of manufactured organic chemicals with
the highest calculated release rates.
04 Potential Industrial Carcinogens and Mutagens
This list of 88 chemicals has been compiled by the National
Center for Toxicological Research. The list is made up of industrial
compounds which are potential carcinogens and/or mutagens,_and
which have been selected based upon available data concerning
activity, use, production, and population at risk.
05 Occupational Carcinogens for Potential Regulatory Action
This list of 116 chemicals and groups was compiled by OSHA from
suspected carcinogens. Selection was primarily based upon data
available through the NIOSH Registry.
07 Chemicals Tested or Scheduled for Testing at the Fish-Pesticide
Research Laboratory, Department of Interior
This list consists of 174 toxic chemicals which are suspected
of being hazardous to fish and wildlife.
35
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08 Substances with Chronic Effects other than Mutagenicity, Carcin-
ogenicity or Teratogenicity: A subfile of the NIOSH Registry
(Source List 13).
09 Criteria Documents Prepared or Planned by NIOSH, February 24, 1977
This list of 126 chemicals and groups consists of substances
for which criteria documents have been or will be prepared and
delivered to the Department of Labor. In selecting these chemicals
NIOSH considered a) the number of workers exposed, b) known or
suspected toxic effects, and c) physical and chemical properties.
10 Suspected Carcinogens; A Subfile of the NIOSH Registry
This is a list of 1,900 chemicals and groups which have been
reported to have produced cancer in test animals. The list is
included in List Source 13.
11 Suspected Mutagens; A Subfile of the NIOSH Registry
This is a list of approximately 100 chemicals and groups which
have been reported to have produced mutagenic effects in test
animals. This list is included in List Source 13.
12 Suspected Teratogens; A Subfile of the NIOSH Registy
This is a list of approximately 200 chemicals and groups which
have been reported to have produced teratogenic effects in test
animals. The list is included in List Source 13.
13 NIOSH Registry of Toxic Effects of Chemical Substances, 1976
This list of 21,543 chemicals and groups was compiled and
documented in the NIOSH Registry. Only those substances which
were on lists 8, 10, 11, and 12 were considered to be priority.
17 The Ecological Impact of Synthetic Organic Compounds on Estuarine
Ecosystems, September, 1976, EPA-1600/3-76-075
This list of 9 chemicals was compiled as part of a study of
the impact of synthetic organic compounds on estuarine ecosystems.
The effect of the 9 chemicals and a number of pesticides was
analyzed and documented in the study.
18 Threshold Limit Values for Chemical Substances and Physical .Agents
in the Workroom Environment with Intended Changes for 1976,
American Conference of Government Industrial Hygienists
This list of approximately 570 chemicals and groups was compiled
by NIOSH to give Threshold Limit Values for chemical substances and
physical agents in the workroom environment.
36
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19 National Occupational Hazard Survey (1972-1974)
This list of over 7,000 chemicals and other hazards has been
compiled by NIOSH. T.hese hazards are ranked according to expected
amount of occupational exposure. Only the chemicals ranked among
the top 500 hazards were considered to be priority chemicals.
20 Chemicals Being Tested for Carcinogenicity by the Bioassay Program,
DCCP, National Cancer Institute, 1977
This list of 372 chemicals includes those which have been
selected for bioassay by the National Cancer Institute.
21 EPA, Office of Toxic Substances List of Priority Toxic Chemicals,
1977
This list of 162 chemicals was compiled by EPA/OTS from the
NIOSH list of carcinogens (List Source 10).
22 A Study of Industrial Data on Candidate Chemicals for Testing,
EPA Contract # 68-01-4109, November, 1976
This list of 650 chemicals and groups was compiled by Stanford
Research Institute as part of the contracted effort to produce List
Source 03. Production and calculated release data are included.
24 General List of Problem Substances, Environmental Contaminants
Committee, Ottawa, Ontario, Canada, 1977
This list of 160 chemicals and groups of environmental concern
was compiled by the Canadian government.
OTHER LISTS WHICH WERE REFERENCED:
06 Survey of Compounds which have been tested for Carcinogenic
Activity (Index, 1970-1971), NIH/HEW
This list of 3,634 chemicals and groups is a cumulative index
by CAS number of PHS 149 volumes through 1970-1971.
14 Research Project to Gather and Analyze Data and Information on
Chemicals that Impact Man and the Environment
This list of 3,200 chemicals and groups was compiled and docu-
mented by Stanford Research Institute under contract to the National
Cancer Institute. The documentation included total production and
calculated release data for each of the chemicals for nine hazard
categories: (1) over-the-counter drugs, (2) prescription drugs,
(3) cosmetics, (4) trade-sales paint, (5) water pollutants, (6) air
pollutants, (7) soap and detergents, (8) pesticide residues in food,
and (9) intentional food additives.
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16 Other Potential Modifiers of the Stratosphere, 1975
This list of 41 chemicals was compiled by the National
Institute of Environmental Health Sciences from the universe
of 275 manufactured chemicals ranked by release rate used by
by Stanford Research Institute in preparing Source List 03. This
list included potential modifiers of the stratosphere and related
information.
23 EPA/Office of Research and Development, Chemical Production
Set of production data compiled on approximately 140 chemicals
38
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APPENDIX C
CHEMICAL SCORES
A. The four factors described in the text were scored in the
following manner.
Factor 1; Production.
Annual production data was collected from a number of
sources:
a. Scoring of Organic Air Compounds (Source List 02 of
Appendix B)
b. A Study of Industrial Data on Candidate Chemicals for
Testing (Source List 22 of Appendix B)
c. EPA/OR&D Chemical Production (Source List 23 of Appendix
B)
d. Synthetic Organic Chemicals, United States Production
and Sale, 1975, United States International Trade
Commission
e. Chemical Economics Handbook, 1975 Stanford Research
Institute
f. Chemical and Engineering News: Vol. 52, No. 51, 12/23/74;
Vol. 55, No. 18, 5/2/77; Vol. 55, No. 24, 6/13/77.
The Factor 1 score assigned to a chemical was the common logarithm of
the highest annual production value (in millions Ibs/yr) found io any
of the above sources. If an annual production value was not available
for a chemical in any of these sources, a Factor 1 score of -0.5229
(corresponding to an assumed annual production of 300,000 pounds) was
assigned.
Factor 2; Quantity Released into the Environment
The quantity of chemical released into the environment
was scored on a scale from 0 to 3 as follows:
39
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Score Release Rate Estimate Based on Uses
3 ^ 30% Mostly dispersive uses
2 3 to 30% Some dispersive uses
1 .3 to 3% Few dispersive uses; or
primarily industrial chemical
with propensity for leaks
0 ^.3% Well contained industrial
chemical
Estimates of release rates for a number of chemicals are given
in Source List 22 of Appendix B. For those chemicals for which
no release rates were given, an estimate was made on the basis of
the dispersive nature of the chemical's uses as indicated in the
above table.
An estimate was also made of the chemical's persistence ac-
cording to the following table:
Score Lifetime Example
3 Infinite (years Compounds of metals, freons,
or greater) CC14, N20, SFg, many poly-
mers
2 Order of 1 year Tetrachloroethylene, flame
retardants, phthalate esters,
silicones
1 Order of a few SO2
days
0 Hours or less Reactive compounds
The sum of the scores of the two sub-factors, release quantity
and persistence, was taken as an indication of the environmental
burden posed by the chemical.
Factor 3; Occupational Exposure
The source of data on occupational exposure to chemicals was the National
Occupational Hazard Survey (NOHS) conducted by the National Institute for
Occupational Safety and Health. In this survey, the approximately 7000 most
common hazards occurring in the working place were rank ordered. To achieve
40
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an occupational exposure score with a range and direction similar to those
of the other factors, the Factor 3 score assigned to a chemical was 3.3^51
minus the common logarithm of its rank on the NOHS list. (3.8U51 is the
logarithm of 7000.) Chemicals which did not appear on the NOHS list were
given a score of zero, equivalent to having been ranked number 7000 on the
survey.
Factor 4; Extent to Which the General Population is Exposed
Pour individual sub-factors were scored and then summed
to measure the general population exposure. The four sub-factors
were scored as follows:
SUB-FACTOR 1 Number of people exposed to the chemical (exclusive of
a workplace environment)
Score No. of People Example
3 >20 X 10 Widely used household products
(e.g. wearing apparel, shoe
polish, certain surface coatings,
common paints and their solvents,
common plastics and their addi-
tives, detergents, furnishings
and carpets, wood cleaning pro-
ducts, refrigerants, natural gas,
nonfood packaging materials,
flame proofers)
General air, food and water con-
taminants
Automotive products (e.g. gasoline
and additives, rubber, surface
coatings, plasticizers, flame
proofers)
Products used widely in commercial
buildings (mostly same as household,
including commercial cleaners, dis-
infectants)
2 2-20 X 106 Less widely used household products
(e.g. uncommon paints, specialty
apparel such as baby wear, hobby
uses, arts and crafts, tools)
Regional air and water pollutants,
farm chemicals (exclusive of pesti-
cides)
41
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0.2-2 X
<2 X 105
Specialty hobbies(e.g. photography),
specialty products
Neighborhood air and water pollu-
tants from local industries
Chemical intermediates rarely
found outside the workplace
SUB-FACTOR 2
Frequency of exposure (to the typical person considered
in ranking number of people exposed under Sub-factor 1)
Score
Frequency
Daily or more
often
Weekly
Monthly
Yearly or less
frequently
Examples
General air, food and water
contaminants, household products
in regular use, material used
inside automobiles, clothing
Hobby crafts, household products
used intermittently (e.g. certain
cleaners), bleaches, gardening
products
Dry cleaning, certain solvents,
house maintenance (e.g. polishes,
certain cleaning agents), auto-
mobile maintenance
Application of household paints,
specialty products
SUB-FACTOR 3
Exposure Intensity. This is intended to reflect the
total amount of material that comes into contact with
the average or typical person whose exposure has been
scored under sub-factors 1 and 2. In scoring this
factor, one should consider the number of grams of the
material that makes contact with the average person in
the course of one exposure (daily, weekly, monthly or
yearly as scored in sub-factor 2). Thus, for example,
a trace pollutant may lead to exposure of a typical
person of the order of micrograms per day every day;
use of a specialty solvent might lead to exposure of a typical
person of the order of grams per day once a. year; these would
be scored 350 and 0,3 respectively on sub-factors 2 and 3.
42
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Intensity
High (10~1 or more
grams per exposure)
Examples
Plastics, fabrics, surface
coatings, volatile solvents
in closed spaces, liquids
contacting skin, high con-
centration gases
Medium (10 to
10 g per exposure)
Fabric additives, solvents in
open spaces or outdoors, dusts,
solutes, transitory exposures
to vapors or aerosols
Low (10~3 to 10~4
per exposure)
Low level indoor exposure,
volatile substances from home'
furnishings and building
materials (e.g. plasticizers,
flame proofers), low volatility
solvents, pigments
Very low (less than
10 9 Per exposure)
Environmental contaminants
(low level air, food and
water contaminants), monomers
in polymers
SUB-FACTOR 4
Penetrability. This is a measure of the material that
comes into contact with a person (whether by dermal, in-
halation, or ingestion exposure) and that is expected to
be absorbed into the body (even transitorily) with
potential for interaction with cells.
High (10-100%
absorption)
Medium (1-10%
absorption)
Organic solvents in liquid,
mist or aerosol form, vapors
and gases if likely to be
soluble in body fluids,
respirable-sized particles,
surface active agents, materials
known to have high dermal
systemic toxicity.
Solvents with low volatitily
and/or larger molecules,
organic materials in water
solution, waxes and polishes,
coarse dusts
43
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Low (0.01 - 1% Certain solids, dermal ex-
absorption) posure to most inorganic
materials in water solution
0 Negligible Polymers, metals
«0.01% absorption)
B. In making the judgments called for in scoring Factors
2 and 4 above, some knowledge of the chemical's uses was
necessary. Use information was collected from the following
sources:
a. The Condensed Chemical Dictionary. Ninth
Edition, Hawley, Van Nostrand Reinhold
Company, New York, 1977.
b. The Merck Index, Ninth Edition, Merck and
Company, Inc., Rahway N.J., 1976.
c. Faith, Keyes, and Clark's Industrial Chemicals,
Lowenheim and Moran, Fourth Edition, J. Wiley
and Sons, Inc., New York, 1975.
d. Chemical Marketing Reporter, Schnell Publishing
Co., Inc., New York.
e. Encyclopedia of Chemical Technology, Kirk-Othmer,
Inter~Science Publishing Company, New York, 1972.
44
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APPENDIX D
Rank Ordering the Chemicals
A linear weighting scheme was used to rank order the
chemicals.. The rank of the jth chemical, r • , was computed
by the formula:
-a
.
I- 1 S,
where Wj_ is the weight assigned to the ith factor,
fi- is the ith factor score of the jth chemical,
and 3^ is a scaling factor chosen to normalize the assigned
scores.
The four scaling factors employed were:
si = log 20,850 = ^.3191; 20,850 million Ib/yr being the
maxim-urn of all Factor 1 chemical production quantities.
B£ - 6; 6 being the maximum of all Factor 2 environmental
release scores.
s3 = 3.8U51 - log 3 = 3.3680; third being the highest NOHS
rank among^the scored chemicals. (Ranked first and second o'n the NOHS
list were continuous noise and mineral oil, the former not being a
chemical hazard and the latter not being among the scored chemicals.)
SL = 12; 12 being the maximum of all Factor k general
population exposure scores.
This choice of s^, 82, 83,34, guaranteed that 1 _jM <
I S \
fill -
M
for all i and j, and furthermore, that for each i,
= 1 for at least one chemical j,
45
GPO 917-942
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