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Bulletin
Office of Toxic Substances
(OTS)
Vol.5, No. 1 March 1984
This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (TSCA) about recent
developments and near-term plans. For further information or to request copies of documents mentioned, write the TSCA
Assistance Office (TAO), (TS-799) EPA, Washington, D.C. 20460, or call toll-free 800-424-9065 or, in Washington, D.C., or from
outside the continental United States, (202) 554-1404.
REGULATORY & REQUIRED ACTIONS
TESTING OF CHEMICAL SUBSTANCES
AND MIXTURES . . . SECTION 4
Section 4 of TSCA gives EPA authority to require manufac-
turers or processors of chemicals to test the toxic effects
of a designated substance. To require testing EPA must
find that the chemical may present an unreasonable risk;
that there are insufficient data available with which to per-
form a reasoned risk assessment; and that testing is neces-
sary to generate such data. A test rule may also be based on
an EPA finding of substantial production and exposure to
humans or the environment, in addition to findings of
insufficient data and need for testing.
Under section 4(e) an Interagency Testing Committee (ITC)
was established to recommend chemicals to EPA for prior-
ity consideration for the promulgation of section 4 test
rules. The ITC can designate up to 50 chemicals or cate-
gories of chemicals for testing and must make revisions to
this section 4 priority list as needed. In turn, EPA must re-
spond within one year after the ITC adds a substance to the
priority list by starting rulemaking under section 4 or giving
reasons for not doing so.
The ITC is made up of appointed members from eight Fed-
eral agencies, as specified in TSCA. Representatives from
six additional Federal agencies serve in a liaison capacity.
Section 4(f) requires EPA within 180 days after receipt of
test data (or other information that indicates a chemical
substance or mixture may pose a significant risk of serious
or widespread harm to human beings from cancer, gene
mutations or birth defects) to: (a) initiate appropriate action
under sections 5, 6, or 7 of TSCA or (b) publish a notice say-
ing why the risk is not unreasonable. The 180-day review
may be extended for up to 90 additional days for good
cause.
EPA Initiates Priority Review of 1,3-Butadiene
EPA issued notice of a 180-day section 4(f) review of
1,3-butadiene on January 5, 1984 (49 FR 845). Informa-
tion reviewed during the period will help EPA decide
whether it should take action to prevent or reduce risk
from the chemical or help the Agency decide the risk is
not unreasonable. Information for review had to be sub-
mitted to EPA by March 5, 1984.
Studies reported that 1,3-butadiene caused cancer in
laboratory tests of mice and rats. The studies have been
reviewed and found valid by EPA, the National Toxicol-
ogy Program and industry scientists. The chemical is a
short-chain unsaturated hydrocarbon that is primarily
used as a compound in the manufacture of various types
of synthetic rubber, plastics and latexes.
EPA Responds to ITC Designations
At the end of December 1983 and in early January 1984 EPA
issued various types of notices on 16 chemicals that the
ITC had designated tor test consideration. A summary of
EPA's actions follows:
Aryl phosphates
EPA is seeking comments on its conclusion that there is
need for further testing of aryl phosphates, a category of
chemicals that the ITC designated for health and environ-
mental testing in 1978. Manufacturers of aryl phosphates
are conducting tests that EPA believes will provide ade-
quate data in some areas. However, EPA, in a December 29,
1
-------
1983 notice (48 FR 57452) asked the public for additional
data on the chemical category, and to respond by February
27,1984 to a series of issues the Agency listed in the notice.
The December 29 notice was an Advance Notice of Pro-
posed Rulemaking due to some of the complexities in-
volved in assessing this large category of chemical
substances.
Formamide
EPA reaffirmed an earlier decision not to propose at this
time a section 4(a) rule requiring health effects testing of
formamide. In a December 29, 1983 notice (48 FR 57366)
EPA said it reviewed its preliminary decision and public
comment on that judgment and found no reason to alter its
earlier conclusion. That decision [May 23, 1983 (48 FR
23098)3 was based on EPA's evaluation of existing
formamide data, the expected exposure profile for the
chemical, and EPA's tentative acceptance of a testing pro-
gram submitted by BASF Wyandotte Corp. In 1982, the ITC
designated formamide for health effects testing considera-
tion.
Glycidol and its derivatives
EPA has responded to the ITC's designation of glycidol and
its derivatives for priority consideration for testing. In an
Advance Notice of Proposed Rulemaking [December 30,
1978 (48 FR 57562)] EPA explained the rationale it proposes
to use in selecting chemicals in the glycidol category for
testing and defined the testing it is considering. The Agen-
cy set a February 28,1984 deadline for written comments on
its plan.
Halogenated alkyl epoxides
At this time EPA will not initiate section 4{a) rulemaking to
require health effects testing of the entire category of
halogenated alkyl epoxides [December 30, 1983 (48 FR
57695)]. This is due to the existence of data on some mem
bers of the category and the lack of exposure to other cate
gory members. The category was recommended to EPA foi
health effects testing by the ITC in 1978. In another Decern
ber 30,1983 notice EPA did propose testing for one member
of the alkyl epoxides category hexafluoropropylene oxide
(HFPO). The Agency's action on HFPO follows.
Hexafluoropropylene oxide
EPA is proposing that manufacturers and processors of
hexafluoropropylene oxide (HFPO) test the substance for
mutagenicity, oncogenicity and reproductive effects
[December 30,1983 (48 FR 57686)]. H FPO is a member of the
category of halogenated alkyl epoxides. The entire category
was designated for priority consideration by the ITC in
1978. EPA's decision on the rest of the halogenated alkyl
epoxide category is reported immediately above.
EPA is not proposing that HFPO be tested for teratogenic-
ity or that an epidemiology study be conducted as recom-
mended by the ITC because EPA has found neither evi-
dence that HFPO may produce teratogenic effects nor a
suitable cohort for an epidemiology test. The public Is
asked to submit written comments to the proposed rule on
HFPO by February 28,1984. If persons request time for oral
comments. EPA will hold a public meeting on HFPO in
Washington, D.C. on March 14,1984.
ALKYL EPOXIDES
The ITC designated the alkyl epoxides category for health
and environmental fate testing. EPA decided to address
the designation in four separate notices, ethylene oxide,
propylene oxide, 1,3-butylene oxide, and the rest of the
category under the term "alkyl epoxides."
Ethylene oxide
EPA has decided not to initiate rulemaking to require health
or environmental fate testing of ethylene oxide. In a January
3, 1984 notice (49 FR 200) EPA said it would begin health
effects testing of ethylene oxide only If other Federal units
request test data under TSCA. The existing testing data-
base on ethylene oxide is quite extensive, and both the U.S.
Occupational Safety and Health Administration and EPA's
Office of Pesticide Programs have significant regulatory
activities underway on ethylene oxide. EPA said existing
data are adequate to reasonably predict the environmental
fate of ethylene oxide.
Propylene oxide
EPA is proposing a rule that would require manufacturers
and processors of propylene oxide to test the chemical for
teratogenicity. [January 4,1984 (FR 49 430)]. EPA is not pro-
posing epidemiological studies or testing for carcinogenic-
ity, mutagenicity, other chronic effects, or environmental
fate at this time, all of which were included in the ITC desig-
nation, in the light of ongoing or already completed testing.
EPA set a deadline of March 5, 1984 for comments.
1,2-Butytene oxide
EPA is not initiating section 4(a) rulemaking at this time to
require health or environmental fate testing of 1,2-butylene
oxide [January 4,1984 (49 FR 503)]. EPA cited a combination
of available data and ongoing testing for Its decision. These
data and the testing will be sufficient to either evaluate or
reasonably predict the carcinogenicity, teratogenicity and
other chronic effects of the substance which were of con-
cern to the ITC.
Alkyl epoxides
An Advance Notice of Proposed Rulemaking (ANPR) to re-
quire testing of the alkyl epoxides category has been pro-
posed by EPA [January 4,1984 (49 FR 449)). Due to certain
complexities relating to resolving the issues concerning
these chemicals, EPA chose to first publish an ANPR rather
than a proposed ruie to inform the public of the rationale to
be used in selecting the chemicals for testing, to define the
regulatory approaches that are being considered and to
seek public comment on its approach in proposing a test
rule. EPA set a deadline of March 5,1984 for comments.
2
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Aniline and bromo-, chloro- and/or nltroanlllnes
The EPA process of requiring the health arid environmental
effects testing of chemicals in the anilines category began
with the publishing of an Advance Notice of Proposed Rule-
making [January 3, 1984 (49 FR 108)]. "Aniline and chloro-,
bromo- and/or nitroanillnes" as a category was designated
by the ITC for testing consideration in 1978. EPA's prelimi-
nary analysis of the category indicated that a broad range of
health and environmental effects testing was necessary.
EPA sought comments by March 5,1984 on the need for fur-
ther testing of the category.
Cyclohexanone
Cyclohexanone will not be subject to a section 4(a) testing
rule at this time, EPA said in a January 3,1984 notice (49 FR
136). In 1979 the ITC designated the chemical for priority
consideration for health and environmental effects testing.
EPA now has tentatively concluded that an industry test-
ing proposal is adequate to address testing concerns for
health effects and that environmental effects testing for
cyclohexanone is not necessary.
Hydroquinone
Manufacturers and processors of hydroquinone will be re-
quired to perform tests to evaluate the chemical's toxico-
kinetics, if a proposed EPA rule becomes final. Tests to
evaluate the chemical's potential nervous system, repro-
ductive, teratogenic and mutagenic effects and epidemio-
logic studies are also included in the proposed rule as are
chemical fate and environmental effects testing [January 4,
1984 (49 FR 4380]. The proposed rule on hydroquinone is
EPA's response to the ITC's designation of the chemical as
a priority candidate for testing. Written comments on the
proposed rule had to be submitted to EPA by March 5,1984.
EPA will hold a public meeting on hydroquinone on March
18,1984 in Washington, D.C. if requested to do so.
Qulnone
EPA Is proposing that qulnone be tested for Its carcino-
genic potential, chemical fate and environmental effects by
manufacturers and processors of the substance [January 4,
1984 (49 FR 456)]. The ITC recommended that EPA consider
carcinogenicity, teratogenicity and environmental fate
testing of quinone. EPA is not proposing teratogenicity
testing because in reviewing the existing data, It found no
reason to believe that the chemical may produce an unrea-
sonable risk of teratogenic effects. The public was asked to
submit written comments on this proposed rule by March 5,
1984.
Isophorone
EPA is not proposing a section 4(a) rule at this time to re-
quire isophorone be tested for health effects [January 17,
1984 (49 FR 2012)]. The chemical had been designated by
the ITC for health effects testing. EPA has found no reason
to alter an earlier Agency decision that a Chemical Manu-
facturers Association testing program, together with a
National Toxicology Program long-term bioassay for
isophorone, will provide sufficient data to reasonably deter-
mine the health effects of isophorone.
Chlorinated benzenes
EPA is proposing a rule to require mono-, di-, and
trichlorinated benzenes be tested under section 4 for cer-
tain chemical fate and environmental effects by the manu-
facturers and processors of the substances. In the proposal
[January 13,1984 (49 FR 1760)] EPA said it is issuing an Ad-
vance Notice of Proposed Rulemaking for tetrachlorinated
benzenes to obtain comment on the possible need to issue
a proposed test rule for one or more of the substance's
isomers. EPA is not proposing chemical fate or environ-
mental fate testing of the tetrachlorobenzenes or penta-
chlorobenzenes at this time. In 1977 the ITC designated
chlorinated benzenes for priority health and environmental
effects testing. EPA responded to the health effects desig-
nation on July 18, 1980 (45 FR 48524).
The TSCA Section 4(e) Priority List*
February 1984
Chemical/Group Date of Designation
Chemicals and groups of chemicals designated for response within
12 Months
Do = Ditto
1
2-(2-Butoxyethoxy) ethyl acetate
... 11/83
2
Calcium naphthenate
5/83
3
Cobalt naphthenate
... Do
4
Ethylene bis(oxyethylene) diacetate
... 11/83
5
1,2,3,4,7,7-Hexachloronorbornadlene
... Do
6
Lead naphthenate
5/83
7
Methyloiurea
... Do
8
Oleylamlne
.... 11/83
9
2-Phenoxyethanol
5/83
Other Recommended Chemicals and Groups of Chemicals
Entry Date of Recommendation
Recommended but not designated for response within 12 months
1 Carbofuran Intermediate 11/82
1,2-Dlchloropropane
A rule has been proposed by EPA to require manufacturers
and processors of 1,2-dichloropropane to conduct health
and environmental effects testing [January 6, 1984 (49 FR
899)]. The proposed health effects tests include neurotox-
icity, mutagenicity, teratogenicity and reproductive effects
tests. The proposed environmental effects tests include
acute and chronic toxicity tests for aquatic invertebrates
and an aquatic plant test. Written comments on the pro-
posed rule had to be submitted to EPA by March 6,1984.
EPA will hold a public meeting on 1,2-dichloropropane in
Washington, D.C. if requested to do so.
Cumulative Removals from the TSCA Section 4(e)
Priority List*
February 1984
EPA Responses to ITC Recommendations
Federal Register Notice
Chemical/Group Do * Ditto Latest EPA Action
1 Acetonltrlle 47 FR 58019 12/29/82
2 Acrylamlde (health effects) 45 FR 48510 7/18/80
(environmental effects) 48 FR 724 1/6/83
3 Alkyl epoxides 49 FR 449 1/4/84
(see 1,2-Butylene oxide)
(see Ethylene oxide)
(see Propylene oxide)
3
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4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
Alkyl phthaiates
Alkyltin compounds'
Aniline and chloro-, bromo-,
and/or nitroanilines
Antimony metal
Antimony sulfide
Antimony trioxide
Aryl phosphates
Benzidine-based dyes
Benzyl butyl phthalate
Biphenyl
Bis(2-ethylhexyl)
terephthalate
1,2-Butylene oxide
(see Alkyl epoxides)
Butyl glycolyl butyl
phthalate
Chlorendlc acid
Chlorinated benzenes
(mono-, di, trl, tetra, and
penta)
(health effects)
(environmental effects)
Chlorinated naphthalenes
Chlorinated paraffins
Chlorobenzotrifluoride
Chloromethane
Cyclohexanone
2-Chlorotoluene
Cresols
o-Dianisldine-based dyes
Oibutyltin bls(isooctyl
maieate)2
Dlbutyltin b!s(isooctyl
mercaptoacetate)2
Oibutyltin bis(lauryl
mercaptide)2
Dlbutyltin dilaurate2
Dichloromethane
1.2-Dichloropropane
Diethylenetriamine
Dlmethyltin bis(!sooctyl
mercaptoacetate)*
1.3-Dloxotane
Ethylene oxide
(see Alkyl epoxides)
Ethyltoluene
Fluoroalkenes
46
FR
53775
10/30/81
39
Formamide
48
FR
57366
12/29/83
46
FR
5456
2/5/82
40
Glycidol and its derivatives
48
FR
57562
12/30/83
49
FR
108
1/3/84
41
Halogenated alkyl epoxides
48
FR
57695
Do
(see Hexafluoropropylene
48
FR
716
1/6/83
oxide)
Do
Do
42
Hexachloro-1,3-butadiene
47
FR
58029
12/29/82
Do
Do
43
Hexachlorocyclopentadiene
47
FR
58023
Do
48
FR
57452
12/29/83
44
Hexachloroethane
47
FR
18175
4/28/82
46
FR
55004
11/5/81
45
Hexafluoropropylene oxide
48
FR
57686
12/30/83
46
FR
53775
10/30/81
(see Halogenated alkyl
48
FR
23080
5/23/83
epoxides)
48
FR
51845
11/14/83
46
Hydroquinone
49
FR
438
1/4/84
47
Isophorone
49
FR
2012
1/17/84
49
FR
503
1/3/84
48
Mesityi oxide
49
FR
1536
1/12/84
49
4,4-Methylenedianiline
48
FR
31806
7/11/83
46
FR
54487
11/2/81
50
Methyl ethyl ketone
47
FR
58025
12/29/82
51
Methyl isobutyl ketone
Do
Do
47
FR
44878
10/12/82
52
Monobutyltin tris(isooctyl
48
FR
51361
11/8/83
mercaptoacetate)2
53
Monomethyltin tris(isooctyl
Do
Do
mercaptoacetate)2
45
FR
48524
7/18/80
54
Nitrobenzene
46
FR
30300
6/5/81
49 FR
1760
1/13/84
55
Phenyienediamines
47
FR
973
1/8/82
46
FR
54491
11/2/81
56
Polychlorinated terphenyls
46
FR
54482
11/2/81
47
FR
1017
1/8/82
57
Propylene oxide
49
FR
430
1/4/84
47
FR
50555
11/8/82
(see Alkyl epoxides)
45
FR 48524
7/18/80
58
Pyridine
47
FR
58031
12/29/82
49
FR
136
1/3/84
59
Quinone
49
FR
456
1/4/84
47
FR
18172
4/28/82
60
4-(1,1,3,3-Tetramethylbutyl)
48
FR
51971
11/15/83
48
FR
31812
7/11/83
phenol
46
FR 55004
11/5/81
61
o-Tolidine-based dyes
46
FR
55004
11/5/81
48 FR 51361
11/8/83
62
Toluene
47
FR
56391
12/16/82
63
1,2,4-T rimethylbenzene
49
FR
1696
1/13/84
Do
Do
64
Trlmethylbenzenes
Do
Do
65
1,1,1-Trichloroethane
46
FR
30300
6/5/81
Do
Do
66
T ris(2-chloroethyl)phosphite
47
FR
49466
11/1/82
67
Tris(2-ethyihexyl)trimellitate
48
FR
51841
11/14/83
Do
Do
68
Xylenes
47
FR
56392
12/16/82
46 FR 30300
49 FR 899
47 FR 18386
48 FR 51361
48 FR 51839
49 FR 200
49 FR 1696
46 FR 53704
6/5/81
1/9/84
4/29/82
11/8/83
11/14/83
1/3/84
1/13/84
10/30/81
•This priority list Is updated to reflect very recent EPA actions and
therefore differs with the list provided In the latest ITC (13th) Report
submitted to EPA. Copies of the 13th ITC Report are available
through the TAO.
1 Removed by the ITC for reconsideration. Seven individual
alkyltin compound group members were subsequently des-
ignated in the 11th ITC Report for priority consideration.
* One of seven alkyltin compounds. See Note 1 above.
4
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MANUFACTURING AND PROCESSING NOTICES ... SECTION 5
Section 5 of TSCA gives EPA authority to quickly review and control, if necessary, new chemicals to prevent large scale
distribution before a new substance's effects on health or the environment are fully determined. Below and on the next few
pages are subsections of section 5 highlighted because of recent EPA actions.
Commencement Of Manufacture Notices
Under section 5(a)(1) a person who intends to introduce into commerce a chemical substance not on the TSCA Inventory must
notify EPA at least 90 days before beginning manufacture or import. Listed below on the next few pages are the latest com-
mencement of manufacture notices EPA has received.
NEW CHEMICAL SUBSTANCES FOR WHICH EPA HAS RECEIVED COMMENCEMENT
OF MANUFACTURE NOTICES
(since publication of the December 1983 Chemlcals-ln-Progress Bulletin)
FR
PMN no. Submitter Chemical Identification Citation
CBI = Confidential Business Information G = Generic Name Do = Ditto
80-1
Far Best Corp.
G
3-alkoxy(C«>-Ci4)-2-hydroxypropyl ester of dimer/trimer
45
FR 3467
acids (fatty ester)
1/21/80
80-44
CBI
G
Alpha aikene copolymer with alpha aikene
45
FR 23507
4/7/80
80-158
E.I. du Pont de Nemours &
Polymer of epoxy resin, maleic anhydride, butanol,
45
FR 51264
80-177
Co., Inc.
styrene and methacrylic acid
8/1/80
CBI
Oxirane, polymer with methyl oxirane, 3-
45
FR 54422
diisocyanatomethyi-benzene and (2-hydroxyethyl)-
8/15/80
80-355
2-propenoate
Do
G
(p-Dlalkylamino phenyl)-diaryl heterocycle
46
FR 11026
2/5/81
81-165
Spencer Kellogg Div. of
G
Siliconized alkyd resin
46
FR 24990
Textron, Inc.
5/4/81
81-187
CBI
G
Cycloaliphatic polyester modified with a polyether
46
FR 28004
81-222
glycol
5/22/81
Do
G
Oligomer of alkanedlolc acid, dlmer fatty acids,
46
FR 31345
substituted and unsubstituted alkanediols and
6/15/81
81-250
benzene dicarboxylic acids
Do
G
Disu bstitutedbenzeneamlne
46
FR 32494
81-535
6/23/81
Do
G
Heteromonocycle modified fumarated rosin ester
46
FR 53522
81-606
10/29/81
Do
G
Substituted-(2-hydroxy-benzophenone oxy)propane
46
FR 60055
81-645
12/8/81
Air Products and Chemicals
G
Organic salts of tertiary aliphatic amines
47
FR 336
Inc.
1/5/82
81-646
Do
G
Do
Do
81-647
Do
G
Do
Do
82-162
Montedison USA, Inc.
2-[2,2-dlfluorohydroxyethyl-poly-(oxydlfluoro-methylene)-
47
FR 39241
poly-(oxytrlfluoroethylene)oxyj-2,2-difluoroethanol
9/7/82
82-165
Do
2[isocyanato-2,2-difluoroethyl-poly-(oxydifluoro-
Do
methylene)-poly-(oxytetrafluroethylene)oxy]-2,2-
82-241
difluoroethyl isocyanate
Sandoz Colors and Chemicals
Penta(oxy-1,2-ethanediyI), alpha-(carboxymethyl)-omega-
47
FR 15406
82-249
hydroxy-, Cu-<» linear primary-alkyl ethers
4/9/82
CBI
G
Modified hydroxy functional acrylic copolymer
47
FR 16403
82-258
4/16/82
Do
G
Heterocyclic-methoxyphenylazo substance
Do
82-305
Hercules Inc.
G
Modified hydroxyethylcellulose
47
FR 19781
82-374
5/7/82
CBI
G
Alkyl thladiazole
47
FR 23552
82-656
Do
5/28/82
G
Polymer of disubstituted benzenes and disubstltuted
47
FR 41167
82-658
Do
alkane
9/17/82
G
Substituted pyrazlne salt
47
FR 42151
9/24/82
5
-------
83-239 Do G
83-240 Do G
83-243 Do G
83-296 Do G
83-325 Do G
83-335 Do G
83-349 Do G
83-370 Do
83-399 Do
Polyester polyurethane from a diisocyanate and an
alkanediol with alkanolc acid and anhydride
Reaction product of an inorganic acid with the reaction
product of carboxylic acid and alkanolamine
Methyl-oxyethyl-methyleneimidazolium derivative of
copper phthalocyanine methoxyacetate
Rosin metallic salt
Polyester polyurethane from carbomonocyclic
anhydride, alkanediols and dilsocyanates
((Substituted phenyl)azo) naphthalenesulfonic acid,
sodium salt
8-Acetyl-3-dodecyl-7,7,9,9-tetramethyl-1,3,8-
triazaspiro[4,5]decane-2,3-dione
Polymer of dimethyl ester of 4,4'-(hydroxymethylene)
bis-1,2-benzenedicarboxylic acid with 4,4'-
oxydianiline
Polyol polymethacrylate
83-400
Do
G
Copolymer of acrylic and methacrylic monomers
83-435
Do
G
Acrylate of polybutadiene
83-462
Do
G
Succinate ester amide
83-475
Do
G
Chlorendic anhydride base alkyd polymer
83-483
Do
G
Mixed fatty acids; alkanepolyol; benzenecarboxylic
acids polymer
83-506
Do
G
Modified acrylic polymer
83-527
Do
G
Sulfonaphtholazonaphthol, chromium complex
83-546
Do
G
Substituted phenolazo, substituted pyrazolone
83-547
Do
G
Do
83-572
Do
G
Polyester polycarboxylate salt
83-583
Petrarch Systems, Inc.
G
Organotrimethoxysilane
83-623
Do
G
[Bis(alkylphenamlno)-fluoran] [(phenimidazolyl)bis
methylene] derivative of phosphate
83-625
The Warfleid Co., Inc.
Polyamlne adduct
83-627
Allied Corp.
G
Substituted dlyne urethane
83-652
CBI
G
Modified poly (amido-amine)
83-680
Do
G
Hydroxyethylaminoethylated tannin
83-685
Rohm and Haas Co.
G
[(Substituted phenylhydrazonoljsubstituted
oxoheteromonocycle
83-691
CBI
G
TriBubstltuted benzothiazole salt
83-697
Do
G
Fatty acid alkyd based polymer
83-708
Mllliken & Co.
G
Chromophore substituted poly(oxyalkylene)
83-712
Andrews Paper & Chemical
G
Polyhydroxyaromatic amine sulfonate salt
Co., Inc.
83-730
CBI
Oxo-hexyl acetate
83-752
Do
G
Benzothiazole, N-substltuted-2-substltuted
83-779
Chem-Fleur, Inc.
G
Cyclomethylene cltronellol
83-798
Essex Specialty Products
G
Blocked polyurethane prepolymer
83-805
Lilly Industrial Coatings, Inc.
G
Saturated polyester resin
83-817
CBI
G
Disperse blue azo dye
83-824
Do
G
Organofunctional polydlmethylsiloxane
83-828
Andrews Paper & Chemical
G
Aliphatic sulfonate salt
Co., Inc.
47 FR 53782
11/29/82
Do
Do
47 FR 57332
12/23/82
48 FR 72
1/3/83
Do
48 FR 862
1/7/83
48 FR 3045
1/24/83
48 FR 5304
2/4/83
Do
48 FR 6396
2/11/83
48 FR 7299
2/18/83
Do
Do
48 FR 9365
3/4/83
48 FR 10468
3/11/83
48 FR 11499
3/18/83
Do
48 FR 14035
4/1/83
Do
48 FR 16331
4/15/83
Do
48 FR 17385
4/22/83
48 FR 20487
5/6/83
48 FR 21370
5/12/83
Do
Do •
Do
48 FR 22792
5/20/83
Do
48 FR 23903
5/27/83
Do
48 FR 24967
6/3/83
48 FR 26884
6/10/83
DO
48 FR 29048
6/24/83
Do
48 FR 29054
6/24/83
6
-------
83-832
CBI
G
Prepolymerlzed halogenated magnesium, zirconium,
Do
aluminum oxo-titanate
83-871
Do
G
[Alkoxyalkyloxadiazol-nltrophenazo]-
48 FR 31460
[bisalkylamlnomethpyridinenltrll]
7/8/83
83-917
Do
G
Substituted (cyanophenyl-thlazyl)tetraazo
48 FR 32381
dimethoxybenzene
7/15/83
83-930
Do
G
Modified phenol/formaldehyde resin
49 FR 33532
7/22/83
83-950
Do
G
Carboxylated arylalkene alkadiene
Do
83-959
Do
G
Cresol-formaldehyde resin
Do
83-962
Do
G
Acrylic unsaturated acid terpolymer
Do
83-978
Do
G
Aromatic copolyester
48 FR 34506
7/29/83
83-980
Do
G
Cyanoacetate ester
Do
83-981
Do
G
Quaternized alkyl amine
Do
83-982
Do
G
Cyanoacryiate ester
Do
83-994
Do
G
Saturated natural fatty acid choline chloride
48 FR 35713
8/5/83
83-999
Do
G
Substituted oxazoline
Do
83-1010
Essex Specialty Products
G
Aromatic, tertiary amine containing polyether
48 FR 36647
polyurethane prepolymer
8/12/83
83-1014
CBI
G
Hydroxy functional acrylic copolymer
Do
83-1034
Milllken & Co.
G
Polyoxyalkylene acetate ester
48 FR 37699
8/19/83
83-1035
Do
G
Substituted polyoxyalkylene aniline
Do
83-1036
Do
G
Chromophore substituted polyoxyalkylene
Do
83-1037
Do
G
Chromophore substituted polyoxyalkylene
Do
83-1060
Do
G
Polyamlde of tall oil, diethylenetriamine and polybasic
48 FR 38889
acid
8/26/83
83-1083
Do
G
Modified polyether polyurethane from substituted
48 FR 39690
83-1085
alkanepolyols and an aromatic dilsocyanate
9/1/83
Do
G
Substituted phenylacetamide
Do
83-1086
Do
G
Aliphatic unsaturated copolyester
48 FR 40782
9/9/83
83-1107
Do
G
Amine salt of a carboxyl terminated polyester urethane
48 FR 41638
polymer
9/16/83
83-1253
Do
G
Rare earth silicate
48 FR 43397
9/23/83
83-1260
Do
G
Substituted heterocycle
Do
83-1261
Do
G
Disub8tituted aniline
Do
83-1262
Do
G
Polysubstltuted heterocycle
DO
83-1263
Do
G
Substituted heterocyclic azo disubstltuted aniline
Do
83-1265
Sun Chemical Corp.
G
Polyesteramide CR1236
Do
83-1282
CBI
G
Reaction product of metal complex, diazotized
48 FR 44900
aromatic compounds and fustic extract
9/30/83
83-1285
Do
G
Reaction product of diazotized aromatic compounds
Do
with fustic extract
7
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Significant New Use
Under section 5(a)(2) EPA determines when certain uses of
chemical substances are significant new uses. A determi-
nation is made by a significant new use rule (SNUR) promul-
gated after considering all relevant factors. These factors
include the projected manufacturing (import) and process-
ing volume of the substance, the extent to which the sub-
stance's new use changes the type and form of exposure to
humans or the environment, the extent to which the sub-
stance's use increases the magnitude and duration of expo-
sure to humans or the environment, and the anticipated
manner and methods of manufacture, processing, distribu-
tion in commerce, use, or disposal of the substance. Under
section 5(a)(1)(B), persons must notify EPA at least 90 days
before manufacturing or processing a chemical substance
for a significant new use as determined by EPA. If the
substance is imported, the importer must comply with cer-
tification requirements of TSCA section 13. In addition, per-
sons who intend to export, for any purpose, a substance
that is subject to a proposed or promulgated SNUR must
notify EPA under section 12(b).
EPA proposes SNURs for chemical substances which are
on the TSCA chemical inventory. A SNUR may be proposed
in conjunction with a 5(e) order Issued during the PMN
review period or may be proposed at any time following ad-
dition of a chemical to the chemical inventory. Section 5(e)
orders that allow use of a PMN substance under controlled
conditions are usually accompanied by a proposed SNUR
because the order applies only to the original submitter.
When the PMN submitter sends EPA a notice of commence-
ment of manufacture (see page 5) the Agency adds the PMN
substance to the chemical inventory. A SNUR is necessary
in order to assure that controls imposed by the 5(e) order
will also apply to anyone else who may decide to manufac-
ture or process the new chemical in question.
Section 5(e) Action Pending Development of Information
The Administrator may issue a section 5(e) order to take
effect at the end of the PMN review period. The order may
limit or prohibit manufacture (import), processing, distribu-
tion in commerce, use, or disposal of the PMN substance.
The action can be taken if information available to EPA is in-
sufficient to permit a reasoned evaluation of the risks, and
if the substance may present an unreasonable risk to either
health or the environment. A 5(e) order may also be Issued if
there is insufficient information and the substance may be
produced in large quantities and may result in significant or
substantial human exposure, or substantial release to the
environment.
A 5(e) order can be a consent order or a unilateral order. In a
consent order EPA negotiates the terms of the order with
the company that submitted the PMN. The company agrees
to be bound by the order and waives its rights to file objec-
tions to the order. This waiver does not affect any other
rights that the company may have under TSCA. In a unilat-
eral order, EPA takes action to restrict or prohibit the
manufacture or use in commerce of the PMN substance.
PMN
Chemical Identification
Do = Ditto
5(e)
Consent Order or
Unilateral Order
5(a)(2)
(SNUR)
80-289
80-290
Isopropylamine, distillation residues
Ethyiamine, distillation residues
—
50503
48 FR 38502
8/24/83
82-326
G
Substituted methylpyridine
—
50506
49 FR 4390
2/6/84
82-400
82-409
Potassium N,N-bis (hydroxyethyl) cocoamine oxide phosphate
Potassium N,N-bls (hydroxyethyl) tallowamine oxide phosphate
Consent Order
9/10/83
50501
48 FR 7142
2/17/83
82-684
G
Derivative of tetrachloro-ethylene
Consent Order
1/17/83
50507
48 FR 91
1/3/84
82-678
82-679
G
G
Chlorinated aromatic azo anthraquinone pigment
Chlorinated aromatic azo pigment
Unilateral Order
7/20/83
—
83-23,75
83-24,49
& 272
G
G
Substituted 2-phenoxypyridine
Substituted methylpyridine
Consent
Order
3/7/83
50505
49 FR 99
1/3/84
83-105
1,2 Benzenediamlne, 4-ethoxy, sulfate (1:1)
—
50504
49 FR 39245
8/30/83
83-129
83-130 thru 235
Full range, dewaxed, dearsenited shale oil ("Syncrude")
Shale derived refining streams
Consent Order
5/23/83
—
83-237 Q Substituted methylpyridine Consent Order 50506
3/30/83 49 FR 4390
2/6/84
8
-------
83-330
G Substituted 2-phenoxypyridlne
Do
83-255
G
Dicarboxylic acid monoester
Consent Order
4/8/83
50508
49 FR 82
1/3/84
83-370
8-Acetyl-3-dodecyl-7,7,9,9-tetramethyl-1,3,8-triaza-spiro [4,5]
decane-2,4-dione
Consent Order
12/13/83
50509
49 FR 1753
1/13/84
83-394
G
Substituted polyglycidyl benzeneamine
Consent Order
8/16/83
50510
48 FR 57740
12/29/83
83-401
G
Naphthalenetrisulfonic acid, chlorotriazinylamino-
methoxymethyiphenylazo
Unilateral Order
7/25/83
—
83-418
G
Benzenedisulfonic acid, chlorotriazinylamino-dimethylphenylazo
sulfonaphthaleneazo
Do
—
83-434
G
Unsaturated aliphatic diester
Consent Order
1/13/84
—
83-663
G
Alkyl-substituted aromatic amine
Unilateral Order
11/16/83
—
83-769
G
Disubstituted heterocycle
Consent Order
11/2/83
—
83-906
83-908
83-909
83-910
G
G
G
G
Brominated aryl alkyl ether
Ethylated amino phenol
Amino phenol
Aniiino ether
Consent
Order
11/10/83
—
83-1023
G
Alkyl aryl phosphine
Consent Order
1/16/84
—
83-1085
G
Substituted phenylacetamide
Consent Order
12/6/83
—
Chlorinated naphthalenes
*Not subject to PMN
—
50502
48 FR 20688
5/16/83
REGULATION OF HAZARDOUS SUBSTANCES ...
SECTION 6
Under section 6 of TSCA, EPA is authorized to control a
chemical as a hazardous substance If the Agency finds that
there Is a reasonable basis to conclude that the chemical
presents or will present an unreasonable risk of injury to
human health or the environment. Under section 6(a), EPA
may apply one or more of several different regulating meas-
ures to the extent necessary to protect adequately against
the risk.
Under section 5(f)(2) EPA can issue an Immediately effective
proposed rule under section 6(a) to apply to a chemical that
is the subject of a section 5 premanufacturlng notice (PMN)
if the Agency finds there is a reasonable basis to conclude
that the manufacture, processing, distribution In com-
merce, use, or disposal of the chemical presents or will pre-
sent an unreasonable risk of injury to human health or the
environment before a final rule promulgated under section 6
can protect against such risk.
EPA Issues Immediately Effective Rule
Using authority under section 5(f)(2) for the first time, EPA
Issued an Immediately effective section 8(a) proposed rule
on January 24,1984 (49 FR 2762) to prevent a possible oar*
clnogenlc risk to metalworKers. The proposed rule prohibits
the addition of nitrosatlng agents, such as nitrites, to water-
based cutting fluids containing a PMN chemical, which
serves as a ferrous metal corrosion inhibitor. The proposed
rule also covers a new Intermediate used to produce the
new corrosion Inhibitor. An Importer filed PMNs for both
substances (83-1005 and 83-1062). The PMN review ended
January 23, 1984 for 83-1062 and January 24, 1984 for
83-1005. The Importer of 83-1005 claimed confidentiality
for Its identity, the production, volume, and the specific
chemical name. The assigned generic name for PMN 83-
1005 Is trlethanolamine salt of tricarboxylic acid. The Inter-
mediate substance (PMN 83-1062) is generlcally called
tricarboxylic acid.
EPA believes nitrosatlng agents may be added to water-
based cutting fluids containing the new corrosion inhibitor.
The EPA action Is prompted by a concern over the forma-
tion of nltrosamlnes In water-based metalworklng fluids
which contain the PMN 83-1005 should nitrosatlng agents
be added to such fluids. The rule requires distributors of
both the Inhibitor and the intermediate to notify customers
of the rule's restriction by letter prior to shipping the
substance. Distributors of the inhibitor must also notify
machine shop workers of the health hazard through labels
on metalworklng fluids containing the substance.
9
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EPA Denies PCB Petition
EPA denied a section 21 citizen's petition which asked that
polychlorinated biphenyl (PCB) regulations be amended so
that PCB-contaminated soil now in a mine shaft be left in
place. The January 13, 1984 EPA ruling (49 FR 1697) said
transferring the PCB-contaminated soil to an EPA-approved
landfill did not pose an unreasonable risk. EPA rejected the
assertion by Cannelton Industries, Inc. that the sealed mine
shaft containing the accidentally spilled PCB was an ac-
ceptable disposal site. The spill occurred in a West Virginia
mine when a PCB transformer ruptured.
REPORTING RULES
More Substances Subject to Section 8 Actions
EPA has added several chemicals and one designated mix-
ture to its section 8(d) list since mid-December 1983. During
the same period the Agency also issued a section 8(a) rule
and proposed a section 8(a) rule.
Chemical Name
CAS No.
TSCA Action
2-(2-Butoxyethoxy)ethyl
124-17-4
8(a)* & 8(d)*
acetate
Ethylene bis(oxyethylene)
111-21-7
8(a)* & 8(d)*
diacetate
1,2,3,4,7,7-
3389-71-7
8(a)* & 8(d)*
Hexachloronorbornadlene
Oleylamlne
112-90-3
8(a)* & 8(d)*
Mesityl oxide
141-79-7
8(a)**
Trlmethylbenzene (mixed
25551-13-7
8(d)***
Isomers)
1,2,3-T rimethylbenzene
526-73-8
8(d)***
1,3,5-T rimethylbenzene
108-67-8
8(d)***
Methallyl 2-nitrophenyl ether
13414-54-5
8(d)***
7-Amlno-2,2-dlmethyl-2,3-
68298-46-4
8(d)***
dlhydrobenzofuran
7-Nitro-2,2-dimethyl-2,3-
13414-55-6
8(d)*"*
dihydrobenzofuran
'section 8(a) and 8(d) final rules, 12/14/83 [49 FR 5568S and 55686]
~•proposed rule section 8(a), 1/12/84 (49 FR 1536)
•••final rule section 8(d), 1/13/84 (49 FR 1696)
The designated mixture included in the final section 8(d)
rule (January 13,1984) is "aromatic C» fraction from petro-
leum refining." The mixture is composed of the following
substances In varying proportions:
1.2.3-Trlmethylbenzene
1.2.4-Trlmethylbenzene
1.3.5-Trimethylbenzene
Mixed trimethylbenzenes
ortho-Ethyltoluene
meta-Ethyltoluene
para-Ethyitoluene
Mixed ethyltoluenes
526-73-8
95-63-6
108-67-8
25551-13-7
611-14-3
620-14-4
622-96-8
25550-14-5
Substantial Risk ... Section 8(e)
Under section 8(e) persons who obtain new Information
which reasonably supports the conclusion that a substance
presents substantial risk of Injury to human health or the
environment must notify EPA within 15 days. These notices
are then reviewed by the Office of Toxic Substances (OTS)
and an Initial evaluation Is prepared containing, If appropri-
ate, followup questions to the submitter, referrals to other
agencies, and recommended OTS/EPA followup actions.
The 8(e) notices represent a company's first review of a
situation and a judgment in compliance with the statute to
submit a notice within 15 days of obtaining the information.
EPA publishes its evaluations of these notices to make this
section 8(e) information widely available and understand-
able to a broad public. The submissions and the initial
evaluations are located in the OTS Public Reading Room,
first floor, East Tower, Waterside Mall, 401 M Street, SW,
Washington, D.C.
Persons wishing to obtain a copy of section 8(e) notices
may write: EPA, Freedom of Information, Ms. Jerri Green,
(A-101), Washington, D.C. 20460. There is no charge for
duplicating the first 49 pages, but at page 50 of a request for
duplication there is a $10.00 fee and a 20c charge for each
additional page (e.g., 51 pages cost $10.20).
Single copies of the 8(e) initial evaluation (not the full sub-
mission) are available from the TSCA Assistance Office.
Recent Section 8(e) Notices of Substantial Risk
Log No. 8EHQ—
1083-0494
Sodium Azide 26628-22-8
Summarized results of subchronlc toxicity studies
1083-0495
2-Amlno-4-phenylphenol 1134-36-7
Final results from a mammalian cell transformation assay
and three Ames assays
1083-0496
4-Methyi-2-nitroaniline 89-62-3
Final results from several mammalian cell transformation
and mutagenicity assays and two Ames assays
1083-0497
Titanium dioxide 13463-67-7
Summarized preliminary findings from a two-year inhalation
study
1083-0498
Gulf aromatic pyrolysis oil 64742-90-1
Final results from subacute dermal toxicity and inhalation
toxicity studies
1083-0499
Methyl chloride 74-87-3
Summarized results of two reproduction studies
1283-0500 S
Substituted polyglycidyl benzenamine
Summarized final results from a battery of genotoxicity
tests
1283-0501 S
2-(2-Oxobutyl)-5-(2-ethylthio)-propyi-3- 79419-43-5
hydroxy-2-cyclohexen-1-one
Summarized results of two acute toxicity studies
S at the end of Log Number means a sanitized version Is
available.
N.B.: All toxicity, oncogenicity, teratogenicity and mutagenicity
studies Involve animals unless otherwise stated. Additional tests
(e.g., bacterial cell) are noted or are Included In the term "battery."
10
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SUPPORT ACTIVITY
OTS Seeks CHIP Data
OTS is asking the public for unpublished information about
the following chemicals:
Hydroxylamine and its 7803-49-8,
hydrochloride and sulfate 5470-11-1,
salts 10039-54-0
Butylated hydroxytoluene (BHT) 128-37-0
Dihydrosafrole 94-58-6
These chemicals have been selected for preliminary assess
ment review, information should be sent as soon as pos i
ble to:
TSCA Document Control Office (TS-793)
ATTN: T. O'Bryan
Washington, D.C. 20460
Persons who have unpublished data about any of the chem
icals, but who also want answers to questions Pr°r
responding should contact Justine Welch Schaeffer, o
OTS Chemical Screening Branch, (202) 382-3470, as soon
possible.
The OTS review of the chemicals when published will be in-
cluded in reports called Chemical Hazard Information ro
files (CHIPs). A CHIP is a brief summary of readily avaiiaDie
Information concerning the health and environmen a e -
fects and potential exposure to a chemical. CHIP can -
dates are chosen on the basis of Information indicating
potential for adverse health or environmental effects along
with the evidence of significant production or some type ot
exposure.
When OTS searches the literature in preparing a CHIP it
generally limits the search to automated data bases a a
reference works. But OTS encourages individuals and firm
to submit unpublished or recently published reports and
other hard-to-obtain studies on the chemical selected fo a
CHIP. Relevant studies from the public could Include data
on health effects, environmental effects, commercial pro-
duction and uses, exposed populations, environmen
levels, or any other material that can aid In the assessmen
of the chemical's Impact on health or the environmen •
is also interested in knowing of current testing of a
candidate or assessment activities by other organiza
The TAO will notify individuals and organizations by letter
every time OTS starts a new CHIP. Persons who think tney
can aid the CHIP Information-gathering process wjil nave
their names added to the list If they contact the TAO. a in-
formation submitted in response to the solicitations w
Placed In a public file and made available for public inspec-
tion, unless the submitter is able to assert a claim of con
fidentiallty, in accordance with the provisions of section
of TSCA. EPA will handle all confidentiality claims in ac-
cordance with Its procedures governing the confidential! y
of business Information.
Report Outlines Fate of PCBs
The TAO is distributing an EPA report that summarizes the
environmental fate of PCBs. "Environmental Transport and
Transformation of Polychlorinated Biphenyls" describes
the physical and chemical processes/properties of PCBs in-
cluding the abiotic transformation processes and the
biological degradation of the compounds.
Quarterly Existing Chemicals Report Available
The quarterly activities report (October-December 1983) on
existing chemicals evaluation is now available through the
TAO. The report shows, in table form, the status of more
than 50 chemicals and chemical categories that are being
reviewed by the Office of Toxic Substances.
EPA Considers Leaking Underground Storage Tanks
Leaking underground storage tanks have the potential to be
a serious problem of national scope, and EPA is consider-
ing which Federal legislation should be used to study and
possibly regulate the matter. A TSCA review is now focus-
ing on underground gasoline storage tanks and pipelines.
Tanks storing hazardous wastes are excluded from the sur-
vey because waste storage is regulated under the Resource
Conservation and Recovery Act, a law also administered by
EPA. A preliminary fact sheet on leaking underground stor-
age tanks is being distributed by the TAO.
To Hold Conference on Structure-Activity Relationships
A conference on "Structure-Activity Relationships (SAR)
and Toxicity Assessment" will be held June 8-8,1984, at the
National Bureau of Standards in Gaithersburg, Maryland.
This conference will cover both the technical and policy
aspects of SAR. Presentations will review state-of-the art
SAR relative to various areas of toxicology. They also will
address the issues regarding SAR's current and future
applications. Emphasis will be placed on building a critical
perspective in order to explore the capabilities and limits,
benefits and problems associated with SAR.
The Conference Is being sponsored by the American
Chemical Society's (ACS) Task Force in TSCA (Committee
on Chemistry and Public Affairs), in cooperation with ACS'
Committee on Environmental Improvement, ACS' Divisions
of Analytical Chemistry, Environmental Chemistry, Medic-
inal Chemistry, Pesticide Chemistry, Chemical Manufac-
turers Association, The Conservation Foundation, National
Bureau of Standards, National Institute of Environmental
Health Sciences, Society of Toxicology, and the U.S. Envi-
ronmental Protection Agency.
The registration fee for the Conference is $180. Attendance
at the Conference's reception and dinner will cost an addi-
tional $25. For more information contact T. L. Nally, Federal
Regulatory Programs, ACS Department of Public Affairs,
1155 16th Street, N.W„ Washington, D.C. 20036, or call at
202/872-8724, or call the TAO.
The TAO Is now distributing copies of the following
recently completed CHIPs: 8
Methyinitropropyl-4-nitrosoanlllne 24458-4o-o
Quinoline It'rZ
OTS encourages comments on the accuracy a
thoroughness of information presented in the cm
11
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TSCA Assistance Office (TS-799)
Office of Pesticides & Toxic Substances
U.S.E.P.A.
Washington, D.C. 20460
Official Bu«in«w
Penalty for Privet* U*a
$300
First Clan Mall
Poataga and Faaa Paid
EPA
Parmit No. G-3S
THE TSCA CHEMICALS-IN-PROGESS BULLETIN
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