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Chemicals-in-Progress
Bulletin . ^
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Office of Toxic Substances
(OTS)
Vol. 5, No. 3
July 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. The TAO also has a toll-free telephone number (800) 424-9065.
In the Washington D.C. area, or from outside the continental United States call (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 insuf-
ficient 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.
EPA Wants Data on Urea-Formaldehyde Resins
EPA has tentatively concluded that health effects testing
for urea-formaldehyde (UF) resins is warranted under sec-
tion 4(a). This judgment was followed with the issuance of a
May 21, 1984 Advance Notice of Proposed Rulemaking
(ANPR), which is the Agency's response to the ITC's desig-
nation of methylolurea for health effects testing. The
designation was made in May 1983 as part of the ITC's 12th
Report.
In the May 21, 1984 ANPR (49 FR 21371) EPA said testing
only methylolurea would not be appropriate because the
substance is a non-isolated intermediate and only one of
the many related components of UF resins. EPA chose an
ANPR because the Agency could not propose a test sub-
stance at this time due to the complexity of the UF resin
mixture. Comments should be submitted by July 20, 1984 in
triplicate and bear the document control number OPTS-
42056. The address is: TSCA Public Information Office,
TS-793, Room E-108, 401 M St. SW, Washington, DC 20460.
EPA Receives Data on Chemicals
EPA recently received test data on five chemicals that are
subjects of section 4 negotiated testing agreements (May 2,
1984 [49 FR 18779]). Each of the five chemicals originally
was recommended to EPA for priority consideration for
testing by the ITC. The chemicals and the approximate num-
ber of pages of each report are:
alkyl phthalates 368 pages
4-chlorobenzotrifluoride 757 pages
2-chlorotoluene 31 pages
1,2-butylene oxide 6 pages
chlorinated benzenes 38 pages
Persons interested in an outline of the studies received
should request the May 2, 1984 Federal Register notice
from the TAO. Persons who want copies of the data submis-
sions should write: EPA, Freedom of Information, Ms. Jerri
Green, (A-101), Washington, D.C. 20460. There is no charge
for duplicating the first 49 pages of a study, but at page 50
of a request for duplication there is a $10.00 fee and a 20
1
-------
cent charge for each additional page (e.g. 51 pages cost
$10.20). See related item on page 7.
EPA Proposes to Accept Fluoroalkene Test Program
EPA tentatively accepted an industry proposed negotiated
testing program for fluoroalkenes [June 4, 1984 (49 FR
23112)]. In 1980, a group of six fluoroalkenes, as a category,
were designated by the ITC for priority health effects
testing consideration. On October 30,1981, EPA, respond-
ing to the ITC, published an Advance Notice of Proposed
Rulemaking (ANPR), which indicated the Agency was initi-
ating rulemaking to require testing of certain fluoroalkenes.
In responding to the ANPR, a fluoroalkenes industry con-
sortium submitted to EPA unpublished test reports, ex-
posure studies and a proposed testing program. EPA has
evaluated the data and the industry plans for testing and
has tentatively accepted the proposals, thus discontinuing
the rulemaking initiated-in the ANPR. Comments on the
latest decision must be submitted by August 3, 1984 in
triplicate and bear the document control number OPTS-
42002A. The address is: TSCA Public information Office,
TS-793, Room E-108,401 M St., SW, Washington, DC 20460.
OOTP Test Plan Accepted
EPA believes that a negotiated testing program proposed
by the Eastman Kodak Company for dioctyl terephthalate
(DOTP) will provide sufficient data to predict the health and
environmental effects of bis(2-ethylhexyl) terephthalate,
also known as DOTP. In a June 4,1984 notice (49 FR 23110)
the Agency said it received no public comments on its
November 14, 1983 preliminary decision on DOTP. The
earlier decision was based on the evaluation of the existing
DOTP data, the expected exposure pattern for the sub-
stance and EPA's tentative acceptance of a comprehensive
testing proposal by Kodak. Originally the substance was
designated by the ITC, in Its 11th report, for health and envi-
ronmental effects testing consideration.
Section 4(f) of TSCA requires EPA within 180 days
after receipt of test data (or other information) that in-
dicates 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 sec-
tions 5, 6, or 7 of TSCA or (b) publish a notice saying
why the risk is not unreasonable. The 180-day review
may be extended for up to 90 additional days for good
cause.
EPA Takes Action on Formaldehyde
EPA decided that there may be a reasonable basis to
conclude that certain exposures to formaldehyde pre-
sent or will present a significant risk of widespread
harm to humans from cancer (May 23, 1984 [49 FR
21870]). Two formaldehyde exposure categories trig-
gered the EPA decision~exposures associated with
the manufacture of apparel from fabrics treated with
formaldehyde-based resins, and residences (both
conventional and manufactured homes) containing
construction materials In which certain formalde-
hyde-based resins are used.
The EPA decision came after reviewing scientific
data and public comments on formaldehyde. The
decision was accompanied by an Advance Notice of
Proposed Rulemaking (ANPR), which initiated a full
investigation of regulatory options. Persons have un-
til July 23,1984 to comment. By publishing the ANPR
the Agency did not conclude that the designated for-
maldehyde exposures present an unreasonable risk.
To reach such a determination EPA must further
weigh the toxicity of formaldehyde and take into con-
sideration the economic impact of regulation against
the benefits of reducing such risks by regulation.
All comments should be sent In triplicate to:
EPA-OTS
Document Control Office (TS-793)
Rm. E-409
401 M Street, S.W.
Washington, D.C. 20460
Comments should Include docket control number
OPTS 62033. Comments received on this ANPR, ex-
cept those containing Confidential Business Infor-
mation will be available for review at Rm. E-107 at the
above address.
See page 7 for additional Information on formalde-
hyde.
ITC Adds Six Chemicals to Priority List
The ITC transmitted its 14th report to EPA Administrator
William D. Ruckelshaus on May 8, 1984. The report added
six chemicals to the section 4(e) priority list. The chemicals
are:
Blsphenol A 80-05-7
2-Ethylhexanolc acid 149-57-5
1,2-Dibromo-4-(1,2-dibromoethyl) cyclohexane 3322-93-8
Isopropyl biphenyl 25640-78-2
Diisopropyl biphenyl 69009-90-1
3,4-Dichlorobenzotrifluoride 328-84-7
Five of the six chemicals have been designated by the ITC
to be given priority consideration for the issuance of testing
rules. EPA must respond to the ITC within 12 months. The
sixth chemical, 3,4-dichiorobenzotrifluoride, also was given
priority consideration, but it was not designated for a
response within 12 months. EPA's notice on the ITC report
was published on May 29,1984 (49 FR 22389).
14th ITC Report
Chemical/Group
with CAS no.
Recommended Studies
Bisphenol A
80-05-7
1,2-Dibromo-4-
(1,2-dlbromoethyl)
cyclohexane
3322-93-8
2-Ethylhexanoic acid
149-57-5
Chemical Fate:
Octanol/water partition coeffi-
cient; persistence.
Health Effects:
Chronic effects including onco-
genicity; reproductive effects.
Ecological Effects:
Acute and chronic toxicity to
fish, aquatic Invertebrates, and
algae; bioconcentration.
Chemical Fate:
Water solubility, octanol/water
partition coefficient; soil mobil-
ity; persistence.
Health Effects:
Toxlcokinetlc studies; subchronic
studies Including sperm morphol-
ogy and vaginal cytology evalua-
tion; chronic toxicity studies
Including oncogenicity.
Ecological Effects:
Acute and chronic toxicity to
fish, aquatic invertebrates, and
algae; bioconcentration.
Health Effects:
Chronic effects Including
oncogenicity.
-------
Isopropyl biphenyl
25640-78-2
and
Diisopropyl biphenyl
69009-90-1
3,4-Dichlorobenzo-
trif luoride
328-84-7
Chemical Fate:
Water solubility; octanol/water
partition coefficient; persistence;
soil mobility.
Health Effects:
Chronic toxicity, with emphasis
on neurotoxic and kidney effects.
Ecological Effects:
Acute and chronic toxicity to
fish, aquatic invertebrates, and
algae; bioconcentration.
Chemical Fate:
Water solubility; octanol/water
partition coefficient; soil mobil-
ity; persistence.
Health Effects:
Toxicokinetics; genotoxicity; sub-
chronic effects; chronic effects
including oncogenicity.
Ecological Effects:
Acute and chronic toxicity to
fish, aquatic invertebrates, and
algae; bioconcentration.
The TSCA Section 4(e) Priority List*
July 1984
Chemical/Group Date of Designation
Chemicals and groups of chemicals designated for response within
12 Months
Do = Ditto
1 Bisphenol A 5/84
2 2-(2-Butoxyethoxy)ethyl acetate 11/83
3 Calcium naphthenate 5/83
4 Cobalt naphthenate Do
5 1,2-Dibromo-4-(1,2-dlbromoethyl)cyclohexane. 5/84
6 Diisopropyl biphenyl Do
7 Ethyene bls(oxyethylene) diacetate 11/83
8 2-Ethylhexanoicacid 5/84
9 1,2,3,4,7,7-Hexachloronorbornadiene 11/83
10 Isopropyl biphenyl 5/84
11 Lead naphthenate 5/83
12 Oleylamine 11/83
13 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 Intermediates 11/82
2 3,4-Dlchlorobenzotrifluorlde 5/84
Cumulative Removal* from the TSCA Section 4(e)
Priority List*
July 1984
EPA Responses to ITC Recommendations
Chemical/Group
Do i
Federal Register Notice
= Ditto Latest EPA Action
Acetonitrile
Acrylamlde (health effects)
(environmental effects)
Alkyl epoxides
|m» 1,2-Butylene oxide)
(see Ethylene oxide)
(see Propylene oxide)
Alkyl phthalates
Alkyltin compounds'
Aniline and ctrloro-, bromo*,
and/or nitroanllines
Antimony metal
Antimony sulfide
Antimony trloxide
48 FR 50942
45 FR 48510
48 FR 724
49 FR 449
49 FR 18779
46 FR 5456
49 FR 108
48 FR 716
DO
Do
11/4/83
7/18/80
1/6/83
1/4/84
5/2/84
2/5/82
1/3/84
mm
DO
Do
10
Aryl phosphates
48
FR 57452
12/29/83
11
Benzidine-based dyes
46
FR 55004
11/5/81
12
Benzyl butyl phthalate
46
FR 53775
10/30/81
13
Biphenyl
48
FR 23080
5/23/83
14
Bis(2-ethylhexyl
48
FR 51845
11/14/83
terephthalate
15
1,2-Butylene oxide
49
FR 18779
5/2/84
(see Alkyl epoxides)
16
Butyl glycolyl butyl
46
FR 54487
11/2/81
phthalate
17
Chlorendic acid
47
FR 44878
10/12/82
18
Chlorinated benzenes
(mono-, di, tri, tetra, and
penta)
(health effects)
49
FR 18779
5/2/84
(environmental effects)
49
FR 1760
1/13/84
19
Chlorinated naphthalenes
46
FR 54491
11/2/81
20
Chlorinated paraffin
47
FR 1017
1/8/82
21
4-Chlorobenzotrif luoride
49
FR 18779
5/2/84
22
Chloromethane
45
FR 48524
7/18/80
23
2-Chlorotoluene
49
FR 18779
5/2/84
24
Cresols
48
FR 31812
7/11/83
25
Cyclohexanone
49
FR 136
1/3/84
26
o-Dianisidlne-based dyes
46
FR 55004
11/5/81
27
Dibutyltin bis(isooctyl
48
FR 51361
11/8/83
maleate)2
28
Dibutyltin bis(isooctyl
Do
Do
mercaptoacetate)'
29
Dibutyltin bis(lauryl
Do
Do
mercaptide)2
30
Dibutyltin dilaurate2
Do
Do
31
Dichloromethane
46
FR 30300
6/5/81
32
1,2-Dichloropropane
49
FR 899
1/9/84
33
Dlethylenetriamine
47
FR 18386
4/29/82
34
Dimethyltin bls(isooctyl
48
FR 51361
11/8/83
mercaptoacetate)2
35
1,3-Dioxolane
48
FR 51839
11/14/83
36
Ethylene oxide
49
FR 200
1/3/84
(see Alkyl epoxides)
37
Ethyltoluene
49
FR 1696
1/13/84
38
Fluoroalkenes
49
FR 23112
6/4/84
39
Formamide
48
FR 57366
12/29/83
40
Glycidol and its
48
FR 57562
12/30/83
derivatives
41
Halogenated alkyl epoxides
48
FR 57695
Do
(see Hexafluoropropylene
42
oxide)
Hexachloro-1,3-butadiene
47
FR 58029
12/29/82
43
Hexach lorocyc lopentad len e
47
FR 58023
Do
44
Hexachloroethane
47
FR 18175
4/28/82
45
Hexafluoropropylene oxide
48
FR 57686
12/30/83
(see Halogenated alkyl
epoxides)
46 Hydroqulnone
47 Isophorone
48 Mesityl oxide
49 4,4 '-Methylenedianlline
50 Methyl ethyl ketone
51 Methyl isobutyl ketone
52 Methylolurea
53 Monobutyltin trls(isoocytyl
mercaptoacetate'
54 Monomethyitln tris(isooctyl
mercaptoacetate)'
55 Nitrobenzene
56 Phenylenediamines
57 Potychlorinated terphenyls
58 Propylene oxide
(tee Alkyl epoxides)
59 Pyridine
60 Qulnone
61 4-{1.1.3,3-Tetramethylbuty I)
phenol
62 o-Toildlne-based dyes
63 Toiuene
64 1,2,4-Trimethylbenzene
49 FR 438
1/4/84
49 FR 2012
1/17/84
49 FR 1536
1/12/84
48 FR 31806
7/11/83
47 FR 58025
12/29/82
Do
Do
49 FR 21371
5/21/84
48 FR 51361
11/8/83
Do
Do
46 FR 30300
6/5/81
47 FR 973
1/8/82
46 FR 54482
11/2/81
48 FR 430
1/4/84
47 FR 58031
12/29/82
49 FR 456
1/4/84
48 FR 51971
11/15/83
46 FR 55004
11/15/81
47 FR 66391
12/16/82
49 FR 1696
1/13/84
3
-------
65
Trimethylbenzenes
Do
Do
66
1,1,1-Trichloroethane
46
FR
30300
6/5/81
67
Tris(2-chloroethyl)
phosphite
47
FR
49466
11/1/82
68
Tris(2-ethylhexyl)
trimellitate
49
FR
23116
6/4/84
69
Xylenes
47
FR
56392
12/16/82
•This priority list Is updated to reflect very recent EPA actions and
therefore differs with the list provided In the latest ITC (14th) report
submitted to EPA. Copies of the 14th ITC report, as reported In the
Federal Register, are available through the TAO.
' Removed by the ITC for reconsideration. Seven Individual alkyltin
compound group members were subsequently designated In the
11th ITC report for priority consideration.
' One of seven alkyltin compounds. See Note 1 above.
MANUFACTURING AND PROCESSING NOTICES ... SECTION 5
Section 5 of TSCA gives EPA authority to quickly review and control, It 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 May 1984 Chemlcals-ln-Praflras* Bulletin)
PMN no. Submitter
CBI = Confidential Business Information
Chemical Identification
G = Generic Name*
FR
Citation
Do = Ditto
80-51
CBI
G
Polymer formed from phenol formaldehyde resin and
diazo oxonaphthalene sulfonyl chloride
81-3
Do
Methyl, bis (hydroxy propyl) tallowaikyl ammonium
methyl sulfate
81-391
E.I. du Pont de Nemours &
G •
Acrylic polymer
Co., Inc.
81-548
CBI
G
A polymer of acrylic and methacryllc acid derivatives, a
vinyl aromatic compound and a substituted propene
compound
82-526
Do
G
Polyester modified epoxy resin
82-535
Coastal States Chemical Co.
G
Modified phenol formaldehyde substituted alkyiamine
82-590
CBI
G
Fatty acid esters of monohydrlc alcohol
83-65
Do
G
Polymer of disubstltuted propenoates
83-100
Do
G
Copolymer of styrene with substituted alkanole
derivatives
83-371
Do
Polymer of neopentyl glycol, 1,6 hexanediol,
trimethylol propane, dimethyl 1,4 cyclohexane
dicarboxylate, azelalc acid, isophthalic acid
83-417
Do
G
Alky! diamine
83-479
Sandoz Colors & Chemicals
G
Monoazo substituted aromatic
83-487
CBI
G
Alkyl sulfide
83-571
Do
G
Fatty acids, carbomonocyclic ester
83-593
Do
G
Dlalkytamtno xylenol
83-611
Do
G
Disubstltuted glycine
83-616
Carus Chemical Co.
Cesium permanganate
83-617
Do
Cesium aluminum sulfate
83-643
CBI
G
Disubstltuted benzoxazole
83-857
Do
G
Pentasubatltuted benzimldazollum
83-071
Do
G
Tetrasubstituted benzothiazole
45 FR 21023
3/31/80
46 FR 11349
2/6/81
46- -FR 440-t#
8/2/81
46 FR 55001
11/5/81
47 FR 34187
8/6/82
Do
47 FR 39241
9/7/82
47 FR 50338
11/5/82
47 FR 52220
11/19/82
48 FR 3045
1/24/83
48 FR 5304
2/4/83
48 FR 7299
2/18/83
48 FR 8343
2/28/83
48 FR 14035
4/1/83
48 FR 15180
4/7/83
48 FR 16331
4/15/83
Do
Do
48 FR 20487
5/6/83
Do
48 FR 20490
5/6/83
4
-------
83-672
Do
G
Trlsubstltuted benzothiazole salt
Do
83-691
Do
G
Do
48 FR 21371
5/12/83
83-692
Do
G
Do
Do
83-711
Do
G
Metal oxide, reaction products with fatty alcohol and
48 FR 22792
mineral acid
5/20/83
83-835
Do
G
Substituted benzoate salt
48 FR 29054
6/24/83
83-866
Do
G
Modified rosin zinc salt
48 FR 31460
7/8/83
83-879
Do
G
Epoxy modified acrylic copolymer
Do
83-883
Do
G
Modified rosin calcium salt
48 FR 32381
7/15/83
83-919
E.I. du Pont de Nemours &
G
Trlsubstituted pyrimidlne
Do
Co., Inc.
83-933
Exxon Chemical Americas
Polymer of styrene and sodium styrene sulfonate
48 FR 33532
7/22/83
83-944
CBI
G
Catlonic polymer
Do
83-951
Do
G
Polypropylene glycol/bisphenol copolymer
Do
83-957
Do
G
Spiro-[isobenzofuran xanthene]
Do
83-1008
Do
G
Dlhydro-(substltuted)-(substituted)-(substltuted)-
48 FR 36647
1H-indole
8/12/83
83-1023
Do
G
Alkyl aryl phosphine
DO
83-1047
Do
Polymer of benzophenone tetracarboxylic dianhydride,
48 FR 38889
methylene dianillne, bicyclo (2,2,1)-5-hepten-2,3-
8/26/83
dlcaboxyllc anhydride
83-1052
Calgon Corp.
Polymer of tannin, formaldehyde, monoethanolamlne,
Do
83-1078
hydrochloric acid
CBI
G
Unsaturated polyester
48 FR 39689
83-1100
9/1/83
Do
G
Heteromonocycllc substituted dlester
48 FR 41638
9/16/83
83-1101
Do
G
Do
Do
83-1164
E.I. du Pont de Nemours &
G
Trisubstltuted pyrimidlne
Do
Co., Inc.
83-1165
Do
G
Monosubstituted benzenesulfonyllsocyanate
Do
83-1239
CBI
G
Modified acrylic polymer
48 FR 43397
83-1247
9/23/83
Do
G
Dlaikyl maleate ester
Do
83-1252
Do
G
Potassium salt of a substituted propyl sulfonic acid
Do
84-35
Do
G
(Substitutedphenyl)(heterocyclesubstituted
alkyl)ketone
48 FR 48863
84-41
10/21/83
Do
G
Metal complex with amine fatty acid salt
DO
84-47
E.I. du Pont de Nemours &
G
Ester urethane copolymer
48 FR 50951
84-59
Co., Inc.
11/4/83
CBI
G
Copolyester polymer
Do
84-95
B F Goodrich Co.
G
Thermoplastic polyurethane
48 FR 50944
84-122
11/4/83
CBI
G
SuDstituted-benzenesulfonlc acid sodium salt
DP
84-123
Sage Technology Inc. and
G
Naphthoqulnone-(1,2)-dlazide-(1)-8ulfonlc-(5)-acld ester
DO
Molecular Rearrangement Inc.
84-171
CBI
G
Functional polyurethane
Do
84-185
Do
G
Perhaiooiefln
Do
84-187
GTE Products
Yttrium aluminum gallium oxide
48 FR 54503
11/18/83
84-197
Emery Industries
Carboxyllc acids, C«-C>i mono and C«-Cn di-, polymers
48 FR 5250$
with neopentyl glycol and propylene glycol
11/18/83
84-202
Mllllken & Co.
G
Chromophore substituted polyoxyalkylene
Do
84-203
Do
G
Trlsubstltuted amino thlophene
Do
84-205
B F Goodrich Co.
G
Thermoplastic polyurethane
48 FR 53182
11/25/83
84-208
CBI
G
Vegetable oil polyamld« resin
Do
84-217
Do
©
Phosphonlum catalyst
Do
84-220
Do
G
Benzenesulfonic acid, 4-n4-substltuted]-3-methyl-5-oxo-
DO
2*pyrazolliv1-yl)><, salt
84-239
Do
G
Amine derivative of a fatty acid condensation polymer
48 FR 5S332
12/12/83
84-240
Do
G
Trlsubstltuted benzoxazoilum salt
Do
84-241
Do
G
Do
Do
84-245
FerroCorp.
8
Zinc amino aold complex
48 FR 55916
12/16/83
84-246
Do
ft
Do
DO
84-247
Do
&
Do
Oq
84-248
Do
Q
Do
Do
-------
84-254
CBI
Polymer of 1,3-benzenedicarboxylic acid,
1,4-benzenedicarboxylic acid, hexanedioic acid,
2,2'-oxybis(ethanol), 1,3-dihydro-1,3-dioxo-5-iso
benzofuran carboxylic acid, 2,2-dimethyl-1,3-
propanediol, 2,2,4-trimethyl-l,3-pentanediol
48
FR 56846
12/23/83
84-263
Do
G
Alkyl phosphate ester amine salt
Do
84-264
Chevron Chemical Co.
G
Alkyl sulfonate
48
FR 57618
12/30/83
84-268
CBI
G
Isocyanate-terminated polyurethane
Do
84-273
Do
G
Polyurethane dispersion
Do
84-278
Do
11-Bromoundecanoyl chloride
Do
84-279
Do
Cholest-5-en-3-ol(3/3)-, 11-bromoundecanoate
Do
84-280
Do
Cholest-5-en-3-ol(3/3)-, 11-[(1-oxo-2-
propenyl)oxy]undecanoate
Do
84-281
Do
Cholest-5-en-3-ol(3/3)-4-[c(1-oxo-2-propenyl)oxy]
butanoate
Do
84-282
Do
Cholest-5-en-3-ol(3(3)-,4-chlorobutanoate
Do
84-286
Do
G
3-Methyl substituted aliphatic nitrite
49
FR 930
1/6/84
84-287
Do
Do
Do
84-288
Do
Do
Do
84-292
King Industries Inc.
Naphthalene sulfonic acid, diisononyl-, compound with
Do
morpholine
84-293
CBI
G
Di-alkyl methyl amine
Do
84-311
Do
G
Cyclic alkene-yne
49
FR 1787
1/13/84
84-317
Roure Bertrand Dupont
5-Oxa-2-methyl-7-phenyl-2-heptene
49
FR 2526
1/20/84
•The generic name Is the name that was provided by the submitter when the corresponding PMN was filed. A different generic
name may be assigned to the compound by EPA when published in the TSCA Inventory of Chemical Substances.
Significant New Use
Under section 5(a)(2) of TSCA the Administrator may deter-
mine when certain uses of chemical substances are signifi-
cant new uses. A determination is made by a significant
new use rule (SNUR) promulgated after considering all rele-
vant factors. These factors include the projected manufac-
turing (import) and processing volume of the substance, the
extent to which the substance's ubo changes the type and
form of exposure to humans or the environment, and the an-
ticipated manner and methods of manufacture, processing,
distribution 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. 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 followed 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 4) 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.
EPA Issues Consent Order for PMN
On April 9, 1984 the Assistant Administrator for the Office
of Pesticides and Toxic Substances signed a consent order
stating that EPA determined the information available to it
In PMN 84-27 was insufficient to permit a reasoned evalua-
tion of the potential health effects of the substance. The
company that submitted the PMN signed the consent order
on April 3. The company claimed Its identity, the specific
chemical Identity, the estimated production volume, pro-
cess date and the use to be confidential business Informa-
tion. EPA assigned the generic name of polyol carboxylate
ester to PMN 84-27. The consent order only applies to the
manufacture of PMN 84-27. The order does not prohibit
manufacture, and the substance will be added to the TSCA
Chemical Substance Inventory when the company begins
production. In the order, EPA said It may issue a SNUR,
which will require any other person who intends to
manufacture, import or process the same substance under
certain to also submit a PMN before beginning the action
Section 6(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 to evaluate risk 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
6
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REPORTING RULES
PRELIMINARY ASSESSMENT INFORMATION ...
SECTION 8(a)
Under an amendment to the section 8(a) rule [May 11, 1983
<48 FR 21294)] companies that manufacture or import
chemicals designated by the ITC may be subject to the
reporting requirements of the rule if an amendment is
publishment in the Federal Register.
HEALTH AND SAFETY RULES ... SECTION 8(d)
Section 8(d) authorizes EPA to promulgate rules on specific
chemicals and categories of chemicals that require
manufacturers and processors to submit lists and copies of
health and safety studies that they have conducted or were
initiated by them.
EPA Requires Manufacturer Reporting
EPA, on May 29,1984 issued amendments to two final rules
adding five chemicals to the section 8(a) Preliminary
Assessment Information rule and to the section 8(d) Health
and Safety rule for which lists and copies of unpublished
health and safety studies must be submitted. The five
substances are:
Blsphenol A 80-05-7
2-Ethylhexanoic acid 149-57-5
1,2-Dlbromo-4-(1,2-dibromoethyl)
cyclohexane 3322-93-8
Isopropyl biphenyl 25640-78-2
Dllsopropyl biphenyl 69009-90-1
The five chemicals were designated for priority considera-
tion by the ITC in its 14th Report. (See page 1 for back-
ground on the ITC and for additional information on the
above five chemicals.)
A section 8(a) preliminary assessment report for each
chemical must be submitted for each Importing or manufac-
turing site by August 27, 1984. The same date Is the dead-
line for submitting to EPA lists and copies of unpublished
health and safety studies on the five chemicals as required
by section 8(d). Both the section 8(a) and 8(d) notices were
in the May 29,1984 issue of the Federal Register.
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 1$ 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.
SUPPORT
Formaldahyda Background
November 1979 Interim results of a 24-month rat
bioassay conducted by the Chemical
Industry Institute of Technology (CUT)
shows that a number of rats developed
nasal cancer after inhalation of
formaldehyde.
November 1980 The CUT presents preliminary results of
its full study, which found statistically
aignfflcant increases in the Incidence of
malignant tumors in rats exposed to
formaldehyde vapors at the highest of
three levels tested. The Federal Panel on
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 Qreen,
(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 20- 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— [CAS NO]
0384-0508
Hydrochloric acid, hydrofluoric acid,
refrigerants and antimony pentachloride
Report of accidental workplace exposure
1083-0509
0184-0509 (followup)
Diethyl sulfate 64-67-5
Final results from a battery of genotoxicity
assays and a chronic skin-painting study
0484-0510
2,3,4-Trihydroxybenzophenone 1143-72-2
Summary results from several genotoxicity and
acute toxicity studies
0484-0511
Butadiene feedstock
Summary results from a battery of genotoxicity studies
0484-0512
Qulfcrown Grease E.P. No. 2
Summary findings from a battery of genotoxicity studies
0484-0513
Phenylhydroxylamine 100-62-2
Final report of an acute dermal toxicity study
0584-0515 S
Epoxy resin finish
Summary results from a battery of genotoxicity tests
S at the end of a Log Number means a sanitized version is
available.
N.B. All toxicity, oncogenicity, teratogenicity and mutagenicity
studies Involve animals unless otherwise staled. Additional tests
(e.g., bacterial tell) are noted or are included in the term "battery."
ACTIVITY
Formaldehyde says the CUT bioassay
methodology is consistent with accept-
able testing standards. Using the data
available through the 18-month point of
the study the Panel concludes that
"formaldehyde should be presumed to
pose a risk of cancer to humans."
February 1982 EPA decides the Information available to
It as to formaldehyde's cancer risk to
humans does not meet the statutory
criteria for priority designation under
section 4(f) of TSCA.
7
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July 1983 A suit is filed in a Federal court challeng-
ing the EPA February 1982 decision by
the Natural Resources Defense Council
and the American Public Health
Association.
October 1983 The Consensus Workshop on Formalde-
hyde, with over 60 scientists attending,
is held in Little Rock, Arkansas. It is
charged with reviewing scientific studies
and other data relevant to formaldehyde.
The scientists write a report on formalde-
hyde in relation to health, exposure and
risk estimation.
November 1983 EPA rescinds its February 1982 section
4(f) formaldehyde decision and asks the
public to provide comments and data to
help the Agency determine whether the
substance will present a significant risk
to humans and should be given priority
consideration under section 4(f). EPA
says it expects to reach a new decision
by May 18,1984.
May 1984 EPA, in accordance with the November
1983 section 4(f) policy decision, desig-
nates formaldehyde for priority consider-
ation under section 4(f). The designation
came after analyzing formaldehyde data
as to cancer, mutagenicity, metabolism,
epidemiology and exposure. In addition,
numerous public comments were re-
ceived. A quantitative risk analysis was
prepared.
(Saa page 2 for a racant EPA formaldahyde declalon.)
OTS Seeks CHIP Data
OTS is asking the public for unpublished information about
the following chemicals:
Methyl bromide
Trlethyl phosphate
Dlmethoxyethyl phthalate
Tetrachloropropene (1,1,2,3)
74-83-9
78-40-0
117-82-8
10436-39-2
These chemicals have been selected for preliminary assess-
ment review. Information should be sent as soon as possi-
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 prior to
responding should contact John Leitzke of the OTS
Chemical Screening Branch, (202) 382-3507, as soon as
possible.
The OTS review of the chemicals when published will be in-
cluded in reports called Chemical Hazard Information Pro-
files (CHIPs). A CHIP is a brief summary of readily available
information concerning the health and environmental ef-
fects and potential exposure to a chemical. CHIP candi-
dates are chosen on the basis of information Indicating a
potential for adverse health or environmental effects along
with the evidence of significant production or some type of
exposure.
When OTS searches the literature in preparing a CHIP it
generally limits the search to automated data bases and
reference works. But OTS encourages individuals and firms
to submit unpublished or recently published reports and all
other hard-to-obtain studies on the chemical selected for a
CHIP. Relevant studies from the public could include data
on health effects, environmental effects, commercial pro-
duction and uses, exposed populations, environmental
levels, or any other material that can aid in the assessment
of the chemical's impact on health or the environment. OTS
is also interested in knowing of current testing of a CHIP
candidate or assessment activities by other organizations.
The TAO wilt notify individuals and organizations by letter
every time OTS starts a new CHIP. Persons who think they
can aid the CHIP information-gathering process will have
their names added to the list if they contact the TAO. All In-
formation submitted in response to the solicitations will be
placed in a public file and made available for public Inspec-
tion, unless the submitter is able to assert a claim of con-
fidentiality, in accordance with the provisions of section 14
of TSCA. EPA will handle all confidentiality claims in ac-
cordance with its procedures governing the confidentiality
of business information.
The TAO ts distributing copies of the following
recently completed CHIPs:
Dihydrosafrole
Vinyl Acetate
OTS encourages comments on the
94-58-6
108-05-4
accuracy and
thoroughness of Information presented In the CHIPs.
TSCA Assistance Office (TS-799) Official Businass
Office of Pesticide & Toxic Substances tor Pr,vat® Um
U.S.E.P.A.
Washington, D.C. 20460
First Class Mall
Postaga and Faaa Paid
EPA
Parmlt No. 0-38
THE TSCA CHEMICAL8-IN-PR0QRES3 BULLETIN
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