WTOHSSMiFTO*: fciiJHfc HO
Office of Toxic Substances
(OTS)
Vol. 6, No. 5 December 1985
INSIDE
What's Happening in OTS by Don R. Clay, OTS Director
Processing New Chemicals Under TSCA
Page 2
OTS Spotlight - Wendy Cleland-Hamnett
Page 2
ITC
Adds Three Chemicals in 17th Report
Page 3
ITC Priority List
Page 3
EPA RESPONDS TO ITC DESIGNATIONS
Anthraquinone
Page 4
Cumene
Page 4
Fluoroalkenes
Page 5
2-Mercaptobenzothiazole
Page 5
Octamethylcyclotetrasiloxane
Page 5
Pentabromoethylbenzene
Page 5
Sodium N-methyl-N-oleoyltaurine
Page 6
Chloroprene
Page 6
4-Chlorobenzotrifluoride
Page 6
Biphenyl
Page 6
EPA REPORTS ON REGULATORY INVESTIGATION OF FORMALDEHYDE
Page 7
EPA BEGINS INVESTIGATION OF METHYLENE CHLORIDE RISK
Page 8
EPA ASKS OSHA TO CONSIDER REGULATING 1,3-BUTADIENE
Page 7
EPA FINES 12 FIRMS FOR TSCA IMPORT RULE VIOLATIONS
Page 8
FIRST FINES FOR TSCA TESTING VIOLATIONS
Page 8
OTS PROPOSES 33 SUBSTANCES FOR 8(d) LIST TO SUPPORT OSW
Page 9
FOR YOUR INFORMATION
Latest Substantial Risk Notices
Page 10
OTS Receives 31 Initial FYI Submissions
Page 10
OTS Seeks CHIP Data on Brominated Biphenyl Esters
Page 8
TSCA Videotape Available
Page 2
EPA Publishes TSCA Test Guidelines
Page 8
National Conference on Risk Communication
Page 7
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What's Happening in OTS - Don R. Clay
Fiscal 85, which ended on September 30, was our busiest year for reviewing new chemicals.
We received nearly 1,500 new chemical notices, an increase of about 22 percent over fiscal
84 It's hard to believe, but on the average, OTS decides the fate of a new chemical every one
and one-half working hours.
As most of you know, our new chemical program is designed to prevent potential problems
before they occur without unduly impeding innovation.
Most new chemicals aren't a problem either because they aren't likely to be toxic or because
they are handled carefully. However, some of these chemicals do need either testing or
controls to minimize human exposure or environmental release. In FY 85, OTS took
regulatory action on 47 chemicals, in addition to 56 informal actions. In all, we acted on
about 7 percent of the new chemicals reviewed.
We also developed new exemption categories for certain polymers and for very low volume
chemicals. This allows OTS to focus our resources on riskier chemicals, while minimizing
use of resources on lower risk categories. Industry benefits because these exempted
chemicals maybe manufactured after 21 days, rather than the usual 90 days. We handled 84 eligible low volume exemptions and 130
eligible polymer exemptions.
We're proud of our new chemical program, and we expect to do even better this fiscal year.
Wendy Cleland-Hamnett is Chief of the Premanufacture
Notice (PMN) Management Branch in the Chemical Control
Division. The branch is responsible for overseeing and man-
aging the evaluation and disposition of section 5 PMNs and
exemptions. Based on preliminary risk screening, the branch
identifies chemicals which require further assessment of
exposure and health and environmental concerns. The
assessment is based on data on
OTS SPOTLIGHT structurally similar chemicals
(structure/activity relationship),
as well as on information submitted with the PMN. Although
toxicological data need not be developed solely for new
chemical review, it must be submitted if available. EPA has
broad authority under section 5, formally and informally, to
obtain such data when needed for evaluation of potential risk.
Under Wendy's direction, the staff of program managers
coordinate these risk assessments, economic and policy ana-
lyses, and recommend regulatory actions. These actions can
include testing requirements, controls on use or exposure,
and Significant New Use Rules (SNURs) which track changes
in use and exposure.
The branch of 27 persons, including two attorneys, is respon-
sible for preparing TSCA section 5(e) SNURs and for present-
ing the Agency's findings to the company which submitted
the PMN. The branch also provides guidance to companies in
OTS is giving a seminar for small manufacturers,
importers and processors on "What Small Chemical
Companies Must Know About TSCA." While the
seminar is directed to small companies, large firms may
attend. The meeting will be held Tuesday, February 4,
1986 at Rutgers University, New Brunswick, N.J. The
seminar is free but preregistration is required. For reg-
istration and details call the TAO information special-
ists (800) 424-9065 (or in the Washington, D C. area
554-1404), or write: Edward A. Klein, Director, TAO,
TS-799, EPA, Washington, D C. 20460.
response to questions including whether a PMN is required
for certain substances, or what type of information should be
included in a notice.
A recent development is the use of a production volume
"trigger'' in certain section 5 orders. This provision requires
submission of test data when a chemical of concern reaches a
pre-determined production volume. The net effect of this
approach is to get needed information to support the review of
new chemical substances without unduly impeding innova-
tion. Until the test results are reviewed and a final decision on
the chemical is made, the order requires that human health
and the environment be protected through limitations on use
and exposure.
The PMN branch just published a second summary of
actions taken under the TSCA new chemicals program.
The report, Chemical Control in the United States:
Accomplishments Under the New Chemical Program,
is a compilation of major formal and informal actions
taken by EPA in response to PMN submissions during
the year ending on June 30, 1985. The report is availa-
ble through the TAO.
TSCA Videotape Available
EPA is releasing a 15-minute videotape, TSCA; Balancing
Risks and Benefits." The tape presents general information on
TSCA in clear, concise language and is aimed for audiences
that have little or no knowledge of the law. The tape is approp-
riate for a broad audience including State governments, Con-
gressional staffers, labor and public interest groups.
The tape is sold at cost through Color Film Corp., Video
Division, 98 Commerce Road, Stamford, Connecticut 06904;
(800) 551-6891. Beta I or II costs $21.75, VHS, $22.65, and 3A
inch, $29.85. Connecticut residents and corporations should
include an additional 7Vi percent for State sales tax. A few
copies of the tape are available for short loan periods. Call or
write the TAO and your name can be added to the loan waitina
list.
This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (T .
developments and near-term plans. For further information or to request conies nf rinnim»mc . about recent
Ass,stance Office (TAO), (TS-799, EPA, Washington, D C. 20460. The TAO alphas a^lo^ee telell' k'
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ITC Adds Three Chemicals to Priority List
17th ITC Report
On November 1, 1985 three chemicals were added to the
TSCA section 4 priority list by the Interagency Testing Com-
mittee (ITC) in its 17th report to the EPA Administrator. None
of the three chemicals is designated for EPA response within
12 months. With the 17th report the ITC began using a new
category called "recommended with intent-to-designate."
The ITC, by placing two of the three chemicals on the 17th
report in this new category, is taking advantage of recent EPA
amendments to TSCA section 8(a) and 8(d) rules on auto-
matic reporting requirements for non-designated ITC recom-
mendations [August 28, 1985 (50 FR 34805; 34809)]. The
section 8(a) and 8(d) rules require the submission to EPA of
information on production, use, exposure and unpublished
health and safety studies that may not be publicly available.
The information received on chemicals in the "recommended
with intent-to-designate" grouping will assist the ITC in
deciding whether to designate the chemicals for EPA
response within 12 months in later reports to the
Administrator.
The two chemicals in the recommended with intent-to-
designate group are:
Cyclohexane
2,6-Di-ferf-butyl-phenol
110-82-7
128-39-2
The chemical recommended without being designated for
response within 12 months is:
Diisodecyl phenyl phosphate
25550-98-5
The TSCA Section 4(e) Priority List
November 1985
Chemicals and groups of chemicals designated for response within
12 months
Chemical/Group
Do + Oltto
Month of ITC
Designation
1
Methyicyciopentane
5/85
2
Tetrabromobisphenol A
Do
3
Triethylene glycol monomethyl ether
Do
4
Triethylene glycol monoethyl ether
Do
5
Triethylene glycol monobutyl ether
Do
Other Recommended Chemical* and Group* of Chemicals
Recommended with Intent-to-deslgnate
1 Cyclohexane
2 2,6-Di-fert-butyi-phenol
11/85
Do
Recommended but not designated lor response within 12 months
1 3,4-Dichlorobenzotrifluoride
2 Diisodecyl phenyl phosphite
5/84
11/85
Cumulative R emovals from the TSCA Section 4(e) Priority List
November 1985
EPA Responses to ITC Recommendations
Chemical/Group Do + Ditto
Federal Register Notice
Latest EPA Action
1 Acetonitrile
2 Acrylamide (health effects)
(environmental effects)
3 Alkyl epoxides
(see 1,2-Butylene oxide)
(see Ethylene oxide)
(see Propylene oxide)
4 Alkyl phthalates
5 Alkyltin compounds'
49 FR 44142
50 FR 5421
48 FR 724
50 FR 36476
50 FR 46699
46 FR 5456
11/2/84
2/8/85
1/6/83
9/6/85
11/12/85
2/5/85
Chemical/Group
Recommended Studies
Cyclohexane
110-82-7
2,6-Di-terf-butyl-
phenol
128-39-2
Diisodecyl phenyl
phosphate
25550-98-5
Health Effects:
Chronic toxicity including
oncogenicity and neurotox-
icity; teratogenicity; reproduc-
tive toxicity.
Health Effects:
Toxicokinetics; chronic toxicity.
Chemical Fate:
Persistence in aerobic and
anaerobic sediments.
Ecological Effects:
Acute toxicity to benthic orga-
nisms; bioconcentration in
benthic organisms.
Health Effects:
Toxicokinetics; subchronic tox-
icity including neurotoxicity.
6
Aniline and bromo-,
49 FR 108
1/3/84
chloro-, and/or
nitroanilines
7
Anthraquinone
50 FR 46090
11/6/85
8
Antimony metal
48 FR 716
1/6/83
9
Antimony sulfide
Do
Do
10
Antimony trioxide
Do
Do
11
Aryl phosphates
48 FR 46699
11/12/85
12
Benzidine-based dyes
46 FR 55004
11/5/81
13
Benzyl butyl phthaiate
50 FR 36446
9/6/85
14
Biphenyl
50 FR 37182
9/12/85
15
Bisphenol A
50 FR 46699
11/12/85
16
Bis(2-ethylhexyl)
Do
Do
terephthalate
17
2-(2-Butoxyethoxy)ethyl
49 FR 45606
11/19/84
acetate
18
1,2-Butylene oxide
49 FR 18779
5/2/84
(aee Alkyl epoxides)
19
Butyl glycolyl butyl
46 FR 54487
11/2/81
phthaiate
20
Calcium naphthenate
49 FR 30114
7/26/84
21
Carbofuran intermediates
50 FR 29761
7/22/85
22
Chlorendic acid
47 FR 44878
10/12/82
23
Chlorinated benzenes
(mono-, di, tri, tetra, and
penta)
(health effects)
49 FR 18779
5/2/84
(environmental effects)
49 FR 1760
1/13/84
24
Chlorinated naphthalenes
49 FR 32113
8/24/84
25
Chlorinated paraffins
49 FR 44142
11/2/84
26
4-Chlorobenzotrifluoride
50 FR 42216
10/18/85
27
2-Chloro-1,3-butadiene
50 FR 34546
8/26/85
(chloroprene)
28
Chloromethane
50 FR 19213
5/7/85
29
2-Chlorotoluene
50 FR 40445
10/3/85
30
Cobalt naphthenate
49 FR 21411
5/21/84
31
Cresols
48 FR 31812
7/11/83
32
Cumene (isopropyl
50 FR 46104
11/6/85
benzene)
33
Cyclohexanone
49 FR 44142
11/2/84
34
o-Dianisidine-based dyes
46 FR 55004
11/5/81
35
1,2-Dlbromo-4-(1,2-
50 FR 19460
5/8/85
dibromethyl) cyclohexane
3
-------
36 Dibutyltin bis(isooctyl
maleate)!
37 Dibutyltin bis(isooctyl
mercaptoacetate)2
38 Dibutylti bis(lauryl
mercaptide)2
39 Dibutyltin dilaurate?
40 Dichloromethane
41 1,2-Dichloropropane
42 Diethylenetriamine
43 Dimethyltin bis(isooctyl
mercaptoacetate)2
44 1,3-Dioxolane
45 Ethylene bis(oxyethylene)
diacatate
46 Ethylene oxide
(see Alkyl epoxides)
47 2-Ethylhexanoic acid
48 Ethyltoluene
49 Fluoroalkenes
50 Formamide
51 Glycidol and its derivatives
52 Halogenated alkyl epoxides
(see Hexafluoropro-
pylene oxide)
53 Hexachloro-1,3-butadiene
54 Hexachlorocyclo-
pentadiene
55 Hexachloroethane
56 1,2,3,4,7,7-Hexachloro-
norbornadiene
57 Hexafluoropropylene oxide
(see Halogenated alkyl
epoxides)
58 Hydroquinone
59 Isophorone
60 Isopropyl biphenyl/
diisopropyl biphenyl
61 Lead naphthenate
62 2-Mercaptobenzothiazole
63 Mesityl oxide
64 4,4-Methylenedianiline
65 Methyl ethyl ketone
66 Methyl isobutyl ketone
48
FR 51361
11/8/83
67
Methylolurea
49 FR 21371
5/21/84
68
Monobutyltin tris(isoocytyI
48 FR 51361
11/8/83
Do
Do
mercaptoacetate)8
69
Monomethyltin tris(isooctyl
Do
Do
Do
Do
mercaptoacetate)2
70
Nitrobenzene
49 FR 25013
6/19/84
Do
Do
71
Octamethylcyclotetra-
50 FR 45123
10/30/85
49
FR
25009
6/19/84
siloxane
49
FR
899
1/6/84
72
Oleylamine
50 FR 31919
8/7/85
50
FR
21413
5/23/82
73
Pentabromoethybenzene
50 FR 46699
11/13/85
50
FR
21398
Do
74
2-Phenoxyethanol
50 FR 31919
6/19/84
48
FR
51361
11/8/83
75
Phenylenediamines
50 FR 4267
1/30/85
76
Polychlorinated terphenyls
46 FR 54482
11/2/81
50
FR
31919
8/7/84
77
Propylene oxide
50 FR 46700
11/12/85
49
FR 45651
11/19/84
(see Alkyl epoxides)
78
Pyridine
47 FR 58031
12/29/82
49
FR
200
1/3/84
79
Quinone
49 FR 456
1/4/84
80
Sodium N-methyl-N-
50 FR 46178
11/6/85
50
FR 20678
5/17/85
oleoyltaurine
50
FR
20662
Do
81
4-(l ,1,3,3-Tetramethy-
50 FR 5421
2/8/85
50
FR 46133
11/6/85
butyl) phenol
50
FR
31919
8/7/85
82
o-Tolidine-based dyes
46 FR SSOOrt
n/s/a-i
48
FR
57562
12/30/83
83
Toluene
47 FR 56391
12/16/82
48
FR
57695
Do
84
1,2,4-Trimethylbenzene
50 FR 20662
5/17/85
47
FR
58029
12/29/82
47
FR
58023
Do
47
FR
18175
4/28/82
49
FR 45654
11/19/84
48
FR
57686
12/30/83
49
FR
438
1/4/84
50
FR
5421
2/8/85
50
FR
18920
5/3/85
49
FR
21411
5/21/84
50
FR
46121
11/6/85
49
FR
1536
1/12/84
49
FR
31806
7/11/83
50
FR
5421
2/8/85
Do
Do
85 Trimethylbenzenes
86 1,1,1-Trichloroethane
87 Tris(2-chloroethyl)
phosphite
88 Tris(2-ethylhexyl)
trimellitate
89 Xylenes
Do
50 FR 31895
47 FR 49466
Do
8/7/85
11/1/82
50 FR 46699 11/12/85
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
(17th) report submitted to EPA. Copies of the 17th 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 desig-
nated in the 11th ITC report for priority consideration, see
chemical number 5 in this list.
2One of seven alkyltin compounds. See note 1 above. See
chemicals number 36-39, 43, 68 and 69 in this list.
EPA Responds to ITC Designations
In early November 19SS EPA took regulatory action on chemi-
cals that the ITC designated for priority consideration In Its
15th report which was published on November 29,1984 (49 FR
46939). EPA also responded to one class of chemicals desig-
nated for priority consideration In the ITC's 7th report, which
was published on November 25,1980 (45 FR 78432). A sum-
mary of EPA's actions on these chemicals follows:
Anthraquinone
EPA is proposing that manufacturers and importers of 9,10-
anthraquinone (anthraquinone) be required to test the chemi-
cal for water solubility, bioconcentration and acute toxicity to
aquatic organisms. The Agency also proposed in the same
November 6, 1985 action (50 FR 46090) that each manufac-
turer and importer be required to submit an annual report to
EPA stating the volume of anthraquinone handled during the
firm's latest corporate fiscal year. EPA plans to require testing
the chemical for biodegradation and chronic toxicity to aqua-
tic organisms, if the acute toxicity or bioconcentration level
meets certain criteria. EPA's proposed rule is in response to
the ITC's designation of anthraquinone for priority considera-
tion for chemical fate and environmental effects testing.
Anthraquinone (84-61-1) is a pale crystalline solid which has
not been produced in the United States in five years, but EPA
knows of three importers who import a total of about 700,000
pounds a year. The chemical is used in the production of
some dyes and in the paper-pulp industry. Anthraquinone
catalyzes the removal of lignin from wood, thereby increasing
pulp yield and quality. EPA reported, because of the eco-
nomic benefits of using anthraquinoe in the pulping industry,
the use of the chemical should increase, with future need as
high as seven million pounds a year.
Anthraquinone has been reported in waste effluents of dye-
manufacturing and paper-pulping plants. Finished drinking
water samples from 12 Great Lakes municipalities were found
to contain anthraquinone. EPA said available monitoring data
suggest that anthraquinone is the atmosphere, which is inad-
vertent, is widespread but generally at very low concentra-
tions. The most significant release of the chemical is in treated
industrial waste water.
Cumene
EPA is proposing that manufacturers and processors of
cumene (isopropyl benzene) test the chemical for pharmaco-
kinetics, subchronic toxicity, oncogenicity, mutagenicity,
neurotoxicity, developmental toxicity and reproductive toxic-
ity. The Agency also suggests that testing for acute and
chronic aquatic toxicity in saltwater fish and invertebrates;
and for biodegradation and volatilization in fresh water may
-------
be necessary, [November 6, 1985 (50 FR 46104)]. The ITC
designated cumene (98-82-8) for priority consideration in its
15th report.
Cumene is a colorless liquid with a sharp, penetrating odor,
and is used to manufacture phenol, alpha-methylstryene and
as a chain inhibitor in the polymer industry. It has been used
to produce cumene sulfonate and used in the manufacture of
liquid detergents and surfactants. The combined cumene
annual production capacity by 10 U.S. producers is four to
five billion pounds with additional capacity in reserve.
Approximately 339 million pounds of cumene were imported
during 1984. Demand for the chemical in 1988 is expected to
be almost five billion pounds.
Fluoroalkenes
EPA is proposing a rule that would require health effects
testing for four out of six substances in the chemical category
of fluoroalkenes. The substances are:
vinyl fluoride (VF) 75-02-5
hexafluoropropene (HFP) 116-15-4
vinylidene fluoride (VDF) 75-38-7
tetrafluoroethane (TFE) 116-14-3
The proposed testing consists of reproductive effects testing
for VDF; subchronic toxicity testing for HFP; chronic oncoge-
nicity bioassays for VF and VDF; tiered mutagencity testing
for VF, VDF, HFP, and TFE; and, depending on the outcome of
the mutagenicity testing, chronic oncogenicity, bioassays for
HFP and TFE (November 6, 1985 (50 FR 46133)].
The ITC designated fluoroalkenes for priority consideration
in its 7th report and recommended testing for the health
effects of oncogenicity, mutagenicity, teratogenicity, repro-
ductive and other toxic effects [November 25, 1980 (45 FR
78432)]. On October 30, 1981, EPA responded to the ITC
designation by issuing an Advance Notice of Proposed Rule-
making (ANPR) (46 FR 53704) in which the Agency stated its
intention to develop a test rule for VF, VDF, HFP, TFE, and its
decision not to require further testing of trifluoroethane and
3,3,3-trifluoro-1-propene. Responding to the ANPR, an indus-
try group submitted a proposed testing program. On June 4,
1984 (49 FR 23112) EPA published a notice on a proposed
negotiated testing agreement for the chemicals and asked for
public comment. A subsequent Federal Court decision found
that negotiated testing agreements, such as proposed for the
fluoroalkenes, legally are not adequate alternatives to test
rules in obtaining needed test data for ITC-designated chemi-
cals. On October 30, 1984, the Court ordered EPA to reevalu-
ate the testing needs for the fluoroalkenes either by proposing
a test rule for the chemicals in the category or to publish the
Agency's reasons for not doing so. In line with this ruling EPA
is proposing a test rule for VDF, VF, HFP and TFE.
2-Mercaptobenzothfazole
EPA is proposing that manufacturers and processors of 2-
mercaptobenzothiazole (MBT) be required to test the chemi-
cal for persistence and mobility, chronic aquatic toxicity,
pharmacokinetics, developmental toxicity, reproductive tox-
icity, neurotoxicity and chromosomal aberrations. The pro-
posed rule is in response to the ITC's designation of MBT for
priority consideration for chemical fate and environmental
effects testing in its 15th report.
MBT (149-30-4) isayellow solid with a disagreeable odor. It is
manufactured by the reaction of aniline with equimolar quan-
tities of sulfur and carbon disulfide at 250° centigrade and
450 psi in a continuous process at high pressure. Purification
can be accomplished by dissolving an aqueous base followed
by representation in acid.
MBT is used mainly as a vulcanization accelerator in rubber
manufacture and as an intermediate in the production of other
accelerators.
The 1984 MBT production volumes, submitted to EPA as
confidential business information, cannot be given. However,
the MBT volume for 1981 was more than two million pounds.
The major manufacturers are B.F. Goodrich Co., Goodyear
Tire and Rubber Co., Monsanto Co. and Uniroyal Chemical
Co. More than 550,000 people in the industry and an unknown
number of consumers using products containing MBT may be
exposed to MBT, EPA reported in its November 6, 1985
response (50 FR 46121).
The EPA response reported the greatest potential for environ-
mental exposure of nonhuman populations to MBT is the
aquatic environment receiving waste water from plants manu-
facturing, processing and using the substance.
Octamethylcyclotetrasiloxane
EPA is proposing that manufacturers and processors of
octamethylcyclotetrasiloxane (OMCTS) conduct chemical
fate and environmental effects tests. The proposed testing
includes biodegradation and environmental effects studies.
The ITC designated OMCTS for chemical fate and environ-
mental effects tests in its 15th report.
OMCTS (556-67-2) is a silicone compound, and is often called
D4, because of its tetrameric structure. It is a colorless oily
liquid with little solubility in water. About 110 to 130 million
pounds of OMCTS was imported into or manufactured in the
United States in 1984. About 80 percent of OMCTS was used
on-site as an intermediate in the production of polydimethyl-
siloxane. OMCTS is chosen by industry in formulations
because it is volatile and will evaporate readily.
In the October 30,1985 proposal EPA stated the persistence
of OMETS, or its polymers, trapped in soils, sediments and
sludges is not well-defined, and environmental effects studies
already conducted cannot be used to assess risk to the envir-
onment (50 FR 45123). EPA has found that the use and dispo-
sal of OMCTS may present an unreasonable risk of toxicity to
the environment. The Agency found that data are insufficient
to reasonably determine or predict environmental toxicity
effects or acute toxicity of OMCTS.
Pantabromoethylbanzene
Testing by manufacturers and processors of pentabromo-
ethylbenzene (PEB) for chemical fate and environmental
effects will be required if an EPA proposed rule becomes final
[November 13, 1985 (50 FR46785)]. The proposal is EPA's
response to the ITC's designation that PEB be considered for
health effects testing (including chronic effects and teratoge-
nicity) and ecological effects testing (including acute and
chronic toxicity to fish, aquatic invertebrates and plants).
PEB (85-22-3) is an additive type flame retardant used in
textiles, adhesives, and polyurethane foam. There is only one
U.S. manufacturer of PEB, and it reports that when PEB crys-
tals are washed with water during separation from the mother
liquor it is possible that through this washing process PEBs
may be released to the aquatic environment. Therefore, EPA
is proposing chemical fate testing to determine whether PEB
is released to aquatic environments and is persistent in soil
environments.
5
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Sodium N-methyl-N-oleoyltaurine
A November 6, 1985 notice issued by EPA stated that the
Agency will not initiate rulemaking at this time to require
health or environmental effects testing of sodium-N-methyl-
N-oleoyltaurine (SMOT). The ITC designated SMOT for
priority consideration in its 15th report. EPA said its notice (50
FR 46178) constitutes its reply to the ITC designation.
EPA's analysis of available data indicates that few people are
exposed to SMOT, exposure levels are low, and only small
amounts of the chemical are released to the atmosphere. The
Agency also reported health effects data do not suggest the
potential for an unreasonable risk at expected exposure lev-
els. The ITC had recommended that SMOT be considered for
a staged health effects testing program.
SMOT (137-20-2), an anionic surfactant produced in the form
of a fine white powder with a sweet odor, is produced by six
firms at seven locations in the United States. The major users
of the substance are the textile and pesticide-formulating
industries. In textile mills SMOT and other surfactants are
used for washing fabrics before, during and after dyeing. An
estimated 585 textile workers potentially are exposed to
SMOT, according to the EPA notice.
Chloroprene
EPA is not initiating rulemaking at this time to require chemi-
cal fate or environmental effects testing of 2-chloro-1,3-
butadiene (chloroprene). The chemical was designated by
the ITC for priority consideration in its 15th report [November
29, 1984 (49 FR 46931)]. The ITC did not designate chloro-
prene (CAS 126-99-8) for health effects testing.
In its August 26, 1985 response (50 FR 34546) EPA said the
proposed testing of chloroprene under section 4 of TSCA was
not necessary. EPA decided that testing was not necessary at
this time because water solubility data are available; adequate
fate and monitoring data and modeling results are available to
predict reasonably limited persistence in the environment;
available data provide no evidence of potential unreasonable
risk to aquatic organisms; and although there is substantia!
production and release of choloroprene to the air, available
data are sufficient to predict reasonably that the chemical will
not enter or partition to the aquatic environment in sufficient
quantities to warrant further aquatic toxicity testing. The
Agency also said chloroprene is degraded rapidly in the
atmosphere and is not expected to enter the aquatic environ-
ment in substantial quantities. For an explanation of section 4
of TSCA and the ITC see page 11 and 12 of this Bulletin.
Blphenyl
Manufacturers and processors of biphenyl must test the
chemical for environmental effects and chemical fate accord-
ing to protocols to be submitted to and approved by EPA. This
rule, which became effective on October 28,1985, is in com-
pliance with the ITC designation of biphenyl for priority con-
sideration. The rule was published on September 12,1985 (50
FR 37182).
Biphenyl (92-54-4), a solid organic compound at ambient
temperature and pressure, was designated by the ITC in its
Tenth report [May 25,1982 (47 FR 22585)]. Biphenyl is used to
produce dye carriers, heat transfer fluids and alkylated
biphenyls. It also has the potential to be released into the
environment at significant concentrations from dye carrier
applications and through waste water discharge or from leak-
age of heat transfer fluids. EPA found that environmental
release of biphenyl may present an unreasonable risk of
adverse effects to aquatic organisms and may produce
chronic effects. Testing for environmental effects and chemi-
cal fate test will be for chronic fish toxicity, chronic dephnid
toxicity, acute oyster toxicity, oyster bioconcentration and
chronic oyster toxicity and aerobic and anaerobic biodegra-
dation. The testing will be done under section 4 of TSCA. For a
further explanation of section 4 and the ITC, see page 11 and
12 of this Bulletin.
4-Chlorobenzotrifluoride
EPA will not require further testing of 4-clorobenzotrifluoride
(4-CBTF) for health effects, environmental effects and chemi-
cal fate. The Agency determined that data now available,
including data received pursuant to a negotiated testing
agreement, are adequate to characterize the chemical for
these effects. No further testing need be required at this time.
The chemical was designated for priority testing considera-
tion by the ITC in its 9th report, published on February 5,1982
(47 FR 5456). The ITC recommended 4-CBTF be tested for
chronic health effects, for bioconcentration in fish and for
chemical fate. On July 18, 1983 (48 FR 32730) EPA published a
notice of a negotiated testing agreement between the Agency
and the one corporation that manufactured 4-CBTF. Thecor-
poration proposed a multi-tiered series of health and environ-
mental effects tests. I n addition atmospheric fate studies were
conducted. The screening, the base set ana the atmospheric
tests were completed and sent to EPA.
On August 24, 1984 the U.S. District Court, Southern District
of New York, ruled that negotiated testing agreements were
not an adequate legal substitute for rulemaking under section
4 of TSCA as EPA's response to ITC priority testing designa-
tions. The court ruled that EPA must issue a test rule for
4-CBTF or state reasons for not issuing one. For an explana-
tion of section 4 and the ITC, see page 11 and 12 of this
Bulletin.
In the July 1985 issue of the Chemicals-in-Progress
Bulletin, it was reported that the ITC was seeking spe-
cific information on three chemicals to determine if the
substances should be designated in future TSCA sec-
tion 4 priority lists. In its 17th report (November 1985)
the ITC stated new information received on 1H-
benzotriazole (95-14-7), one of the three chemicals,
shows the chemical is unlikely to be present in the
environment at concentrations that will cause signifi-
cant environmental effects. Based on this information
the ITC decided to defer indefinitely further considera-
tion of 1H-benzotriazole.
New information received on the second of the three
chemicals, Pigment Green 7 (1328-53-8), shows the
water solubility of this pigment is extremely low. The
ITC decided to defer indefinitely further consideration
of Pigment Green 7.
On the third chemical, N-ethyl-N-benzylaniline (92-59-
1), the ITC sought information on chemical fate and
ecological effects but received none. However, new
information was received which shows the substance is
produced at only one plant in the United States. The
chemical is used as an intermediate in the production
of dyes and, when released to the wastewater treatment
facilities at this plant in low to moderate amounts, it is
sorbed to sludge solids, according to the ITC report.
Because of the potential for low release to surface
waters at just one location the ITC decided to defer
indefinitely further consideration of N-ethyl-N-
benzylaniline.
6
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EPA Reports on Regulatory Investigation of Formaldehyde
On May 23, 1984 EPA found under section 4(f) of TSCA that
there may be a reasonable basis to conclude that two expo-
sure patterns may present a significant risk of widespread
harm from cancer. These formaldehyde exposures were to
residents of mobile and conventionally-built homes made
with urea-formaldehyde wood products and to employees
manufacturing durable-press apparel. In the Federal Register
notice announcing this decision and "initiating appropriate
action" (49 FR 21898) EPA stated it would report semiannually
on the progress of its formaldehyde investigation. This is the
third such report.
Since the last report, the Office of Pesticides and Toxic Sub-
stances (OPTS) has incorporated an assessment of non-
carcinogenic health effects into the risk assessment and has
had the revised risk assessment reviewed by EPA's Science
Advisory Board (SAB). EPA has responded to the SAB's com-
ments and has reviewed data on formaldehyde metabolism
and pharmacokinetics as requested by the SAB. Final revi-
sions to the risk assessment are expected to be completed by
February 1986. Since the last report, EPA also completed
assessments that will facilitate regulatory decision-making.
These assessments include an exposure assessment, an
assessment of methods for reducing exposure, and an
assessment of costs and benefits of alternative options.
EPA Deputy Administrator James Barnes chaired an option
selection meeting on August 5, 1985 on the OPTS regulatory
investigation of formaldehyde risks. He decided at that time to
discontinue EPA's investigation of risks to apparel workers
and refer the matter to the Occupational Safety and Health
Administration because OSHA had strongly represented an
intention to commence rulemaking on all occupational risks
to formaldehyde. OSHA issued a proposed rule and notice of
hearing on December 10, 1985 (50 FR 50412).
Another option selection meeting will be held early in 1986 to
consider options for addressing risks from wood products.
Progress will be reported in the next Bulletin.
EPA to Co-sponsor Conference on Risk Communication
A national conference on risk communication will be held in
Washington, D.C. on January 29-31,1986. EPA Administrator,
Lee Thomas, invites the public to attend. EPA is a conference
co-sponsor. Those attending the three-day meeting will
include government, Industry, environmental and consumer
leaders. They will try to find new and practical ways to com-
municate about health, safety and environmental risks to a
national audience other than through debate. Hazardous
wastes, nuclear energy and pesticides will be some of the
concerns discussed. The public attendees will be encouraged
to participate in the discussions of actual cases. Other co-
sponsors include the Conservation Foundation, the National
Science Foundation, the American Industrial Health Council
and the University of Southern California. The registration fee
is $95. For additional information call or write, the conference
coordinator, The Conservation Foundation, 1255 23rd St.
N.W., Washington, D.C. 20037 (202) 293-4800.
EPA Asks OSHA to Consider Regulating 1,3-Butadiene
EPA recently transmitted a report on 1,3-butadiene to the
Occupational Safety and Health Administration (OSHA) ref-
erring the chemical for possible regulation. The report des-
cribes the occupational risks of 1,3-butadiene and asks OSHA
to respond within 180 days of October 10, 1985, the day the
notice appeared in the Federal Register.
On the same day EPA issued another notice in the Federal
Register on 1,3-butadine under the Clean Air Act, a law EPA
administers (see box).
In the referral notice to OSHA (50 FR 41393) EPA said it
classifies 1,3-butadiene as a probable human carcinogen
based upon the weight of available evidence. Because of
workplace exposure, EPA, exercising its referral authority
under section 9 of TSCA, gave OSHA a first opportunity to
regulate workplace exposures to the chemical. Section 9 pro-
vides a mechanism for coordinating the regulation of risks
where there are overlapping Federal laws.
About three billion pounds of 1,3-butadiene are produced in
the United States or imported each year. The chemical is used
mostly as a monomer in the production of various types of
synthetic rubbers, plastics and resins. End products include
tires, molded and extruded plastics, belts, hoses, wire and
cable coating, footwear, foam rubber, carpet backing, auto-
motive goods, appliances, recreational equipment, adhe-
sives, textiles, pipe, building materials, and toys. At ambient
temperatures 1,3-butadiene is a gas, and in that state, a signif-
icant route for human exposures at the workplace via inhala-
tion. Worker exposure could occur during manufacture of the
mononmer, during processing into polymers or during pro-
duct fabrication. Although there is concern for a large number
of workers that may be exposed to 1,3-butadiene, the report
sent to OSHA describes the estimated risk for 5,300 to 8,250
workers exposed to the chemical in the monomer and poly-
mer production plants.
OSHA may respond to the EPA report in several ways. If
OSHA does not act or decides that it does not have the author-
ity to sufficiently reduce the risk, EPA then may take whatever
action it can under its regulatory authorities. If OSHA con-
cludes it does have the authority to reduce risk sufficiently,
OSHA has three alternatives:
• Declare that the risk is not unreasonable. Under the law,
this precludes EPA from taking regulatory action.
• Decide that the risk Is unreasonable and begin regulatory
action within 180 days. This precludes EPA from taking
regulatory action.
• Decide that the risk is unreasonable but choose not to
begin action within 180 days. In this situation, EPA may
take regulatory action.
On October 10, 1985 EPA issued another Federal Reg-
ister notice on 1,3-butadiene (50 FR 41460). In that
notice published under the authority of the Clean Air
Act (CAA). EPA said It intends to list 1,3-butadiene as a
hazardous air pollutant under section 112 of CAA. This
action trigger further evaluation that could lead to the
proposal of standards limiting emission of 1,3-
butadiene. Regulations that could be promulgated for
the chemical under CAA would reduce those risks to
the general public, while the TSCA action deals with
workers. Under CAA, the Agency will assess further the
public health risks from ambient exposures and possi-
ble techniques to control 1,3-butadiene emissions
before making a final decision.
7
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EPA Fines 12 Companies for TSCA Import Rule Violations
EPA Begins Investigation ot Methylene Chloride Risk
In September, EPA fined 12 companies a total of $90,000 for
violating import certification requirements of section 13 of
TSCA. Each of the 12 companies was cited for failure to sign a
written certification that certain imported chemicals were
subject to TSCA. Each had been warned previously by EPA
about the import requirements of the law.
"The certification requirements are our primary means of
detecting the importation of chemicals regulated underTSCA
and of preventing the entry of illegal substances in the United
States," said Dr. John A Moore, Assistant Administrator for
Pesticides and Toxic Substances. The fines were the first
enforcement actions taken by EPA for violation of section 13
of TSCA.
Atlantic Chemical Corp., Nutley, N.J., and TopTex, Inc., Sum-
mit, N.J., were fined $18,000 and $12,000 respectively. The
other companies were fined $6,000 each. They are Kaneka
America Corp., New York, N.Y.,; Joseph H. Lowenstein &
Sons, Inc., Brooklyn, N.Y.; Tartaric Chemical Corp., New
York, N.Y.; Minolta Corp., Ramsey, N.J.; Sanyo Business Sys-
tems, Moonachie, N.J.,; Gallard-Schlesinger Corp., Carle
Place, N.Y.; Pfister Chemical Inc., Ridgefield, N.J.; Perry
Chemical Corp., Elmhurst, N.Y.; Pylam Products Inc., Garden
City, N.Y.; and Andrews Paper and Chemical Co., Port
Washington, N.Y.
All the section 13 violations took place in late 1984 or 1985 at
the Port of New York. All the chemicals were imported from
countries in the Far East or Europe. Section 13 of TSCA
authorizes the U.S. Treasury Department and its Customs
Service to refuse entry of any chemical into the United States
that is in violation of TSCA. When violations occur, EPA rather
than the Treasury takes enforcement action. See page 12 of
this Bulletin for an explanation of section 13.
First Fines for TSCA Testing Violations
In September, EPA fined three corporations $25,000 each for
violating the chemical testing requirements of TSCA. The
actions were the first taken by EPA for test rule violations and
involved the chemical 1,1,1-trichloroethane, also known as
methyl chloroform, which is used by the metal cleaning indus-
try as a solvent for metal degreasing.
In October 1984 EPA issued a TSCA section 4 test rule requir-
ing all manufacturers and processors of methyl chloroform to
conduct health effects testing of the substance, A company
may apply for an exemption from a test rule requirement on
the grounds that the substance is being tested elsewhere. The
fined companies neither applied for exemptions nor tested
the chemical by the date required in the application.
"TSCA's testing requirements are used to gather needed tox-
icity and exposure information about suspected high-risk
chemicals," said Dr. John A. Moore, Assistant Administrator
for Pesticides and Toxic Substances. "Without testing, EPA
cannot adequately protect the public from potentially danger-
ous substances," he said.
The fined corporations are Thorson Chemical Corp., New
York, N.Y.; Atochem U.S.A., Inc., Paramus, N.J.; and Tech-
tronics Ecological Corp., Brooklyn, N.Y.
Section 4 of TSCA authorizes EPA to require companies to
test any chemical substance or mixture whose manufacture,
distribution, processing, use or disposal is suspected ol pres-
enting an unreasonable risk of injury to health or the environ-
ment and about which there is insufficient data. For a further
explanation of section 4 of TSCA see page 11 of this Bulletin.
On October 17, 1985 EPA published an Advance Notice of
Proposed Rulemaking (ANPR) which announced the Agen-
cy's initiation of a comprehensive regulatory investigation of
methylene chloride (also known as dichloromethane, DCM).
This action is the Agency's response to a finding underTSCA
section 4 (f) in May 1985 that methylene chloride may present
a risk of human cancer from certain exposures.
EPA intends to conduct an Agency-wide investigation of
methylene chloride under all the relevant statutes it adminis-
ters. Other Federal agencies, including the Occupational
Safety and Health Administration, the Consumer Product
Safety Commission and the Food and Drug Administration,
also are participating in this integrated investigation.
"This action signifies EPA's intention to move aggressively
toward gathering and analyzing the information needed to
make a sound decision on protecting public health from any
risks posed by methylene chloride," said John A. Moore, EPA
Assistant Administrator for Pesticides and Toxic Substances.
Methylene chloride is a nonflammable, colorless, volatile liq-
uid. Domestic production of the chemical In 1984 was an
estimated 584 million pounds. Imports were about 44 million
pounds. A large number of people are exposed to methylene
chloride in the workplace. The chemical is used as a
degreaser, aerosol propellant and solvent in paint removers.
Aerosol uses include aerosol automobile products, insect
sprays, paints and coatings, and hair sprays.
Methylene chloride is the fourth chemical EPA has given a
4 (f) priority designation. The others are 4,4'-MDA and 1,3-
butadiene in 1983, and formaldehyde in 1984. For further
explanation of section 4 (f) see page 12 of this Bulletin.
Persons with data on methylene chloride are asked to submit
this information to EPA.
EPA Publishes TSCA Test Guidelines
EPA has codified and published TSCA test guidelines for
health effects, chemical fate and environmental effects. On
the same day the TSCA guidelines appeared in the Federal
Register, September 27,1985, EPA also published the Organi-
zation for Economic Development guidelines for testing of
chemicals. The latter also are codified as additional TSCA test
guidelines. A copy of the 264-page TSCA test guidelines is
available through the TAO.
The TSCA test guidelines comply with section 4 of the Act,
which specifies that test rules are to include procedures for
laboratory testing required for the development of test data.
Specific guidelines will not become mandatory test standards
until they are issued in chemical-specific section 4 test rules.
OTS Seeks CHIP Data
OTS is asking the public for unpublished information about
the following chemicals:
Brominated biphenyl ethers
(CAS Nos. in order of increasing number of bromines
include the following:
1-Br
2-Br
3-Br
4-Br
5-Br
6-Br
7-Br
8-Br
9-Br
10-Br
101-55-3
2050-47-7
49690-94-0
40088-47-9
32534-81-9
36483-60-0
68928-80-3
32536-52-0
63936-56-1
68928-79-0
1163-19-5)
(continued)
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Icontinued from previous page)
Organosilanes
(CAS Nos. for the selected compounds within this class are as
follows: 75-76-3; 78-10-4; 107-46-0; 556-67-2; 597-67-1; en-
SB-?; 681-84-5; 947-42-2; 1185-55-3; 1825-62-3; 2157-45-1;
2487-90-3; 2530-85-0; 2627-95-4; 3027-21-2; 3388-04-3; 4130-
08-9; 5356-83-2; 15112-89-7; 21297-72-3; 67762-92-9; 69155-
42-6)
These chemicals have been selected for preliminary assess-
ment review. OTS has preliminary information about potential
effects of these chemicals to health and the environment and
is doing reviews to find what other information is available
about these chemicals. Information should be sent to:
TSCA Document Control Office (TS-793)
ATTN: Mr. Terry O'Bryan
U.S. Environmental Protection Agency
Washington, D.C. 20460
Persons who have unpublished data about the chemicals, 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.
All information 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 confiden-
tiality, in accordance with the provisions of section 14 of
TSCA. EPA will handle all confidentiality claims in accor-
dance with its procedures governing the confidentiality of
business information.
OTS Proposes 33 Substances for 8(d) List to Support OSW
On October 7, 1985 (50 FR 40874) the Office of Toxic Sub-
stances (OTS) proposed to add 33 chemical substances to the
list of chemical substances and mixtures for which chemical
manufacturers, importers, and processors are required to
submit to EPA lists and copies of unpublished health and
safety studies. The information obtained by the final rule will
be used by the Office of Solid Waste (OSW) in the assessment
of the health and environmental risks of these substances,
and determine treatment standards prior to land disposal of
the substances. The health-based standards will then be used
by OSW to develop land disposal restrictions regulations.
This Is the first time section 8 of TSCA has been used primarily
to support the activities of a program other than OTS.
Because seven of the 33 substances are not on the TSCA
Inventory, EPA is also proposing to revise the exemption to
the 8(d) reporting requirements for chemicals not on the
Inventory. For additional information on the TSCA section
8(d) model health and safety rule. See page 12 of this Bulletin.
The 33 substances and their CAS Numbers are:
591-08-2
Acetamide, N-(aminothioxomethyl)-
696-28-6
Arsine, dichlorophenyl-
692-42-2
Arsine, diethyl-
95-53-4
Benzenamine, 2-methyl-
106-49-0
Benzenamine, 4-methyl-
122-09-8
Benzeneethanamine, alpha, alpha-
dimethyl-
98-09-9
Benzenesulfonyl chloride
The OTS review of the chemicals, when completed, will be in
reports called Chemical Hazard Information Profiles (CHIPs).
A CHIP is a brief summary of readily available information
concerning the health and environmental effects and poten-
tial exposure to a chemical. CHIP candidates are chosen on
the basis of information indicating a potential for adverse
health or environmental effects along with evidence of a sig-
nificant 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 ref-
erence 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 production
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 is distributing copies of the
following recently
completed CHIPs:
Dimethoxyethyl Phthalate
117-82-8
Phenylethanol
60-12-8
& Acetate
703-45-7
Phthalimide
85-41-6
Triethyl phosphate
78-40-0
OTS encourages comments on the accuracy and thor-
oughness of information presented
in the CHIPs.
108-98-5
Benzenethiol
4170-30-3
2-Butenal
86-74-8
9H-Carbazole
357-57-3
2,3-Dimethoxystrychnidin-10-one
111-91-1
Ethane, 1,1'-[methylenebis(oxy)]
bis(2-chloro-
110-75-8
Ethene, (2-chloroethoxy)-
62-74-8
Fluoroacetic acid, sodium salt
80-15-9
Hydroperoxide, 1-methyl-1-
phenylethyl-
2763-96-4
3(2H)lsoxazolone, 5-(aminomethyl)-
3288-58-2
Phosphorodithioic acid, 0,0-diethyl
S-methyl ester
107-10-8
1-Propanamlne
142-84-7
1-Propanamine, N-propyl-
78-99-9
Propane, 1,1-dichloro-
142-28-9
Propane, 1,3-dichloro-
594-20-7
Propane, 2,2-dichloro-
109-77-3
Propanedinitrile
75-86-5
Propanenitrile, 2-hydroxy-2-methyl-
616-23-9
1-Propanol, 2,3-dichloro-
78-83-1
1-Propanol, 2-methyl-
598-31-2
2-Propanone, 1-bromo-
563-58-6
1-Propene, 1,1-dichloro-
563-54-2
1-Propene, 1,2-dichloro-
1888-71-7
1-Propene, 1,1,2,3,3,3-hexachloro-
107-19-7
2-Propyn-1-o1
757-58-4
Tetraphosphoric acid, hexaethyl ester
5344-82-1
Thiourea, (2-chlorophenyl)-
9
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Section 8(e)... Substantial Risk
Below is a list of recent initial section 8(e) notices placed in
EPA's public file. For an explanation of section 8(e) and how
copies of notices can be acquired see page 12 of this Bulletin.
Log No. 8EHQ-
[CAS No.]
0785-0562 S
Dichlorophenyl-alkoxylalkyl-oxoheteromonocycle
Preliminary and final results from chronic toxicity
and reproductive toxicity studies
0785-0563
Tetramethoxysilane 681-84-5
Results of a 5-day inhalation study
0885-0564 S
N-Nitrosodiethanolamine
N-Nitrosodimethylamine
N-Nitrosomorpholine
Data submitted on detection of nitrosamines in
automotive coolants
0885-0565 S
The reaction product of 1 mole of succinic anhydride (CAS
No. 108-30-50) and 1 mole of Jeffamine D-2000 (an amine
terminated polypropylene glycol; CAS No. 9046-10-0) in
combination with other undetermined chemicals
Results of,acute dermal application
0985-0566
UCON Lubricant LB-250 9003-13-8
Sulfuric acid 7664-93-9
Isopropyl alcohol 67-63-0
A followup report of an emergency incident of
environmental contamination
0985-0567
1,4-Dichloro-2-butene
Summary report on the results of a chronic inhalation study
Latest FYI Submissions
EPA received in recent weeks initial FYI (For Your Informa-
tion) submissions listed below. For additional information on
FYls see page 12 of this Bulletin,
Document Control No. FYI-
Chemical Name(s) CAS No.
AX-0785-0427
Carbon disulfide 75-15-0
Epidemiology report on mortality in the U.S.
rayon industry
OTS-0785-0428
An R & D pesticide Confidential
Summarized final results of oral terato-
genicity studies in rats and rabbits
OTS-0785-0429
Perchloroethylene 127-18-4
Epidemiology report on a retrospective
mortality study in dry cleaner workers
OTS-0785-0430
Hexafluoroisobutylene 382-10-5
Information for CHIP in preparation
AX-0885-0431
Hydrotreated light naphthlenic distillate
Light alkylate naphtha
Final reports of 28-day dermal toxicity
studies in rabbits
AX-0885-0432
Oil production discharge waters
Progress report from a study to examine
environmental fate and effects on the
marine environment
OTS-0885-0433
DBE dibasic ester solvent
Summarized final results from inhalation
reproductive effects, developmental
toxicity and 90-day subchronic toxicity
studies in rats
OTS-0885-0434
2,4-Pentanedione
Final report of a 14-week vapor inhalation
study in rats
OTS-0885-0435
2-Ethylhexanol
Report of an accidental environmental
discharge
OTS-0885-0436
Confidential
Final reports from a battery of acute toxicity
studies in rats, rabbits and environmental
species; the guinea pig maximization
(contact allergenicity) test; Ames Salmo-
nella test; and biodegradation and
chemical oxygen demand studies
OTS-0885-0437 S
3 Epoxy resins
Final reports of Ames Salmonella and in
vitro sister chemical exchange tests in
Chinese hamster ovary cells
OTS-0885-0438
Alkyl phenols
Summarized final result of acute toxicity
studies in fish with phenolic-containing
effluents
OTS-0885-0439
Unleaded gasoline
Leaded gasoline
Final report of an evaluation of a 3-month
inhalation toxicity study in rats
OTS-0885-0440
Acrylamide
Final report from a battery of genotoxicity
tests
OTS-0885-0441
Benzene
Epidemiology risk assessment of benzene
and leukemia
OTS-0885-0442
Cyclohexanone
Summarized final results of a 2-generation
inhalation reproductive effects study in
rats
64742-53-6
64741-66-8
Mixture
Mixture
123-54-6
104-76-7
Confidential
Confidential
Several
8006-01-9
Unknown
79-06-1
71-43-2
108-94-1
10
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OTS-0885-0443
Aldicarb oxime 1646-75-9
Summarized final results of rabbit acute
dermal and rat acute inhalation toxicity
studies; final report of a 13-week oral
toxicity study in rats; and final report of
an Ames Salmonella test
AX-0885-0444
Ethylbenzene 100-41-4
Chemical literature review
AX-0885-0445
Petroleum crude (Prudhoe Bay) 8002-05-9
Final report of a study on the effects of oil
on homing ability in salmon
OTS-0985-0446 S
WT B-2352 R15 (5 substances) Confidential
Final reports and summarized results from
Ames Salmonella, mouse lymphema and
in vitro sister chromatid exchange tests
AX-0985-0447
Ozone 10028-15-6
Final report of a study on short-term
responses of healthy and asthamatic men
to ozone
AX-0985-0448
Petroleum crude 8002-05-9
Petroleum fractions Several
Final report on human health impact of
petroleum in the marine environment
AX-0985-0449
Petroleum crude 8002-05-9
Dispersants Unknown
Final report on the effects and effectiveness
of dispersants to control oil spills
AX-0985-0450
Petroleum crude 8002-05-9
Dispersants Unknown
Final report on the effects of dispersed and
undispersed crude oil in the marine
environment
OTS-0985-0451
Petroleum crude 8002-05-9
Dispersants Unknown
Final report on the effects and effectiveness
of dispersants to control oil spills
OTS-0985-0452
Bontron S31 32517-36-7
Summarized final results of an Ames
Salmonella test
OTS-0985-0453 S
Solid particulates of polypropenoates
Summarized final results of a 2-week rat
inhalation test
OTS-1085-0454
Chlorendic anhydride
Final report of a pharmakokinetics study in
rats
OTS-1085-0455
p-Chloronitrobenzene
Summarized final results of a subchronic
inhalation toxicity study
AX-1085-0456
Ozone
Sulfur dioxide
Final report characterizing ozone and sulfur
dioxide exposures near U.S. national
forests
OTS-1085-0457
1,3-Butadiene
Preliminary report of an ongoing study to
investigate the relative effect of murine
virus on mouse oncogenicity
Confidential
115-27-5
100-00-5
10028-15-6
7446-09-5
106-99-0
Below and on the next page are explanations of sections of
TSCA that are cited In this Issue of the Bulletin. For additional
information about TSCA's provisions, call (800) 424-9065; in
the Washington, D.C. area, (202) 554-1404, or write the TAO.
Testing of Chemical Substances and Mixtures—Section 4
Section 4 gives EPA authority to require manufacturers or
processors of chemicals to test the toxic effects of a sub-
stance they manufacture or process. To require testing EPA
must find that the chemical may present an unreasonable risk;
that there are insufficient data available with which to reason-
ably determine or predict the effects of the chemical and that
testing is necessary to generate such data. A test rule may
also be based on an EPA finding of substantial production and
exposure to humans or the environmemt, in addition to find-
ings of insufficient data and need for testing.
11
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Priority List...Section 4(e)
Under section 4 (e) an Interagency Testing Committee (ITC)
was established to recommend chemicals to EPA for priority
testing consideration. Besides recommending, the ITC can
additionally "designate" the chemicals, in which case EPA
must respond to the designation within 12 months by starting
rulemaking under section 4 or giving reasons for not doing so.
The ITC can designate up to 50 chemicals or categories of
chemicals for testomg and must make revisions to this section
4 priority list semiannually.
The ITC is made up of appointed membersfrom eight Federal
agencies, as specified in TSCA. Representatives from six
additional Federal agencies serve in a liaison capacity.
Priority Review...Section 4(f)
Under section 4 (f), if EPA receives information indicating that
there may be a reasonable basis to conclude that a chemical
will present a signficant risk of serious or widespread harm to
humans from cancer, gene mutations, or birth defects, the
Administrator must either initiate appropriate action under
TSCA sections 5, 6, or 7 to prevent or reduce sufficiently such
risk or publish a finding in the Federal Register that such risk
is not unreasonable.
Substantial Risk-Section 8(e)
Under Section 8(e), persons who obtain new information that
reasonably supports the conclusion that a substance which
they manufacture, import, process or distribute presents sub-
stantial risk of injury to human health ortheenvironment must
notify EPA with 15 working days. These notices are then
reviewed by the Office of Toxic Substances (OTS) and an
initial evaluation (status report) is prepared containing, if
appropriate, 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 judgement in compliance with the statute to
submit a notice within 15 working days of obtaining the infor-
mation. See page 10 of this issue for the latest section 8(e)
notices.
EPA publishes its status reports to make 8(e) information
widely available and understandable to a broad public. The
submissions and status reports are located in the OTS Public
Reading Room, first floor, East Tower, Waterside Mall, 401 M
Street, S.W., Washington, D.C.
Persons wishing to obtain a copy of a section 8(e) notice may
write: EPA, Freedom of Information, Ms. Jeralene Green (A-
101), Washington, D.C., 20460. There is no charge for dupli-
cating the first 49 pages, but at page 50 of a request for
duplication there is a $10.00 fee and a 20 cent charge for each
additional page (e.g., 51 pages cost $10.20).
Single copies of the section 8(e) status reports (not the full
submission) are available from the TAO.
Health and Safety Data Reporting...Section 8(d)
Under section 8(d) of TSCA, EPA has issued a model health
and safety data reporting rule. This model rule requires past,
current, and prospective manufacturers, importers, and pro-
cessors of certain named substances to submit health and
safety data to EPA. EPA adds substances to the model rule as
the Agency identifies a health and safety need.
Chemical Imports and Exports—Section 13
Under section 13, the U.S. Treasury Department is required to
refuse entry into the United States customs territory to chem-
cial substances, mixtures or articles containing chemical sub-
stances or mixtures that do not comply with TSCA rules, or
that are offered for entry in violation of any TSCA rule or order
under sections 5, 6, or 7 that are in effect. In addition, section
13 requires the Treasury Department to consult with EPA and
issue rules to administer this program.
For Your Information
For Your Information (FVI) submissions are notices submit-
ted voluntarily to the Agency or to the Office of Toxic Sub-
stances (OTS) on chemical toxicity and/or exposure. FYlsare
submitted by chemical manufacturers, processors and dis-
tributors, trade associations, labor organizations, Federal,
State or local agencies, foreign governments, academia, pub-
lic interest and environmental groups, as well as by the gen-
eral public. Microfiche copies of these submissions are
located in the OTS Public Reading Room, first floor, East
Tower, Waterside Mall, 401 M Street, S.W., Washington, D.C.
To obtain a copy of an FYI, follow the procedure outlined on
this page for TSCA section 8 (e) Substantial Risk.
TSCA Assistance Office (TS-799) Official Business
Office of Pesticide & Toxic Substances « <0' p"vate u"
U.S.E.P.A.
Washington, D.C. 20460.
First Class Mail
Postage and Fees Paid
EPA
Permit No. G-35
THE TSCA CHEMICALS-IN-PROGRESS BULLETIN
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