Office of Toxic Substances
(OTS)
VOL. 7 No. 1 March 1986
INSIDE
What's Happening in OTS by Don R. Clay, OTS Director
The Chemical Emergency Preparedness Program Page 2
OTS Spotlight-Michael Shapiro Page 2
ASBESTOS
EPA Proposes Asbestos Ban Page 3
EPA Sues 28 for Asbestos Violations Page 3
TSCA RULE TO ASSIST OSW Page 4
EPA PROPOSES TESTING, REPORTING OF DIOXINS AND FURANS Page 7
LATEST EPA ACTIONS ON ITC DESIGNATIONS
Chlorinated benzenes Page 9
Hexachloronorbornadiene Page 8
Hydroquinone Page 5
Mesityl oxide Page 6
Propylene oxide Page 4
1,1,1 -T richloroethane Page 4
17th ITC Chemicals Page 8
EPA ISSUES RULE AND ADVISORY ON BURNING USED MOTOR OIL Page 5
REPORTING REQUIREMENTS
Vinyl acetate Page 8
FOR YOUR INFORMATION
EPA Issues Guidance to Aid Section 21 Petitioners Page 8
OTS Seeks CHIP Data Page 5
OTS Receives 14 Initial FYI Submissions Page 6
EPA Amends Section 8(c) Rule Page 7
OTS Receives 13 Substantial Risk Notices Page 7
EPA Issues SNUR for Resin Page 8
This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (TSCA) about recent develop-
ments 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.
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I
What's Happening in OTS—Don R. Clay
How do you identity those chemicals that could cause serious harm to human health, even
death, in an accidental, airborne release? That was the problem OTS faced in identifying the
very acutely toxic chemicals for the Chemical Emergency Preparedness Program (CEPP).
Initiated in June, 1985, as part of a larger air toxics program, the CEPP is a voluntary program
that provides to states and communities guidance for community organization, identification of
potential chemical accident hazards, and emergency preparedness and response plans. A list
of acutely toxic chemicals for focusing those activities is also provided.
While the Office of Solid Waste and Emergency Response worked on community organization
and planning, we in OTS began with a review of existing toxic chemical lists and potential acci-
dent hazard identification techniques. We soon determined that none of the lists were specifi-
cally targeted to the needs of this program. Early in the project we recognized that the identifi-
cation of potential chemical accident hazards involved not just recognition of acutely toxic
chemicals but site specific activities that could present some threat to the community. OTS de-
veloped site specific guidance to assist states and communities in identifying the potential for
exposure at the local level.
For development of the list we selected, in consultation with the
Agency's Science Advisory Board, criteria nearly equal to that
developed by the World Bank and European Economic
Community—acute lethality, median lethal dose or median lethal
concentration values in any mammalian species. We then se-
lected chemicals meeting these criteria that appear on the Reg-
istry of Toxic Effects of Chemical Substances (RTECS) and ei-
ther the TSCA Inventory or the list of active pesticide
ingredients. In addition, we selected chemicals with somewhat
lower toxicity but high production capacity.
We identified 402 chemicals—220 from the TSCA Inventory, 97
from the list of active pesticide ingredients, and 85 on both lists.
But the number of chemicals listed doesn't tell the whole story.
There may be other chemicals that meet the criteria for which
data are not available. The list will be revised trom time to time
to reflect new information. In order to give the public an opportu-
nity to respond, the program was released as "interim guidance"
in December with comments to be submitted by March 17. (See
box below.)
Perhaps most important, identifying a chemical that meets the
criteria does not in itself indicate that the community is in dan-
ger. It tells a community, working with local companies, that it
should look further—at production, storage or handling of the
chemical—to determine the degree of risk associated with that
chemical for that community. The site specific guidance devel-
oped by OTS and incorporated into the interim guidance docu-
ment is designed to assist the site risk evaluation by providing a
list of information to gather. Site guidance also provides a proce-
dure to determine minimum quantities of concern for listed
chemicals. OTS has also prepared information profiles on each
of the 402 chemicals.
We hope that responsible community and industry leaders will
view our list as a tool they can use in organizing and directing
their ettorts toward protecting public health and oatety
Michael Shapiro is Director of the Economics and Technology
Division (ETD) of OTS. Shapiro's division managed OTS' contri-
butions to the Chemical Emergency Preparedness Program for
dealing with the accidental release of toxic chemicals.
Involvement in the emergency preparedness program has been
an unusual program management responsibility for Shapiro and
his division. The everyday respon-
OTS SPOTLIGHT sibilities of the division's 45 chem-
ists, chemical engineers, and econ-
omists include giving industrial chemistry, chemical engineering
and economic analysis support to OTS projects involving new or
existing chemicals.
Shapiro has three branches in his division. The Industrial Chem-
istry Branch provides basic information on chemical identity,
physical-chemical properties, and the chemistry of manufactur-
ing processes and use. The Chemical Engineering Branch eval-
uates manufacturing and processing operations to determine
occupational exposures to chemicals, releases of chemicals to
the air or water, and the effectiveness of controls to reduce ex-
posure and release. The Regulatory Impacts Branch provides
decision makers with analyses of the costs, benefits and eco-
nomic impacts of actions being considered under OTS' various
programs, and supports other technical staff by providing basic
information on chemical markets and uses.
Information on organizing the community to develop
emergency response plans, along with the criteria and
list, are available by calling, toll free, the Chemical Emer-
gency Preparedness Program hotline: 800-535-0202. In
Washington, D C. the number is (202) 479-2449. Written
comments should be sent to:
TSCA Public Information Office (TS-793),
Office of Toxic Substances,
Environmental Protection Agency,
Room E-108
401 M Street, SW
Washington, D.C. 20460
An original and two copies should be submitted, bearing
the docket control number OPTS-00066.
2
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EPA Proposes Asbestos Ban
EPA has proposed a rule, under section 6 of TSCA, to ban the
manufacture, import and processing of certain asbestos prod-
ucts. The Agency also proposes to phase out asbestos use in
other products and require labeling for any product containing
asbestos that is not banned.
The proposed rule "is a major new step toward eliminating any
public exposure to asbestos," said EPA Administrator Lee
Thomas. "It is another in a long series of actions by EPA to re-
duce the risks from this well-documented cause of cancer in our
society."
Asbestos is a known human carcinogen that causes lung can-
cer, and mesothelioma (a cancer of the chest and abdominal lin-
ing), other cancers and lung disorders, such as asbestosis. EPA
estimates that previous exposures to asbestos are now causing
from 3,300 to 12,000 cancer cases a year in the United States,
almost all of which are fatal. About 65,000 people in the United
States are currently suffering from asbestosis.
Under section 6, EPA plans to prohibit five asbestos products:
roofing felts, flooring felts (and felt-backed sheet flooring), vinyl-
asbestos floor tile, asbestos cement pipe and fittings, and cloth-
ing. In addition, all remaining domestic mining and importation of
asbestos would be phased out over a 10-year period. The
10-year phaseout affecting other products would be accom-
plished via a transferable permit system, under which EPA
would allocate permission to mine or import a specific volume of
asbestos per year. About 240,000 metric tons of asbestos were
used domestically in 1984.
In addition to an immediate ban of certain products and the
phaseout of all others, EPA is considering other alternatives to
address the risks associated with asbestos products. These ap-
proaches include banning categories of asbestos products such
as asbestos construction products and asbestos friction prod-
ucts at staged intervals.
Under the section 6 proposed rule, all products that are not im-
mediately banned would be labeled as containing asbestos. La-
beling would ensure that persons working with the products
would know they contain asbestos, and it would enable these
people to reduce the likelihood of exposure.
"In encouraging the development of substitutes, EPA will be
promoting a significant reduction in risk," said Thomas. Cur-
rently, products that are replacing asbestos appear to present
lower risk. However, EPA will monitor the development of sub-
stitutes, and will use TSCA to require testing of substitutes if
necessary to ensure their safety."
The total cost of this rule will be about $2 billion, but when
spread over the total population over the next 15 years the im-
pact on most persons will be small.
"EPA has weighed the health risks from continued use of asbes-
tos against the cost of the proposed rule, and concluded that the
avoidance of about 1,900 cancer cases and many other inci-
dents of asbestos-related disease substantially outweigh the
economic effect," said Thomas.
Persons who want to comment on this proposal have until April
29, 1986 to do so. Comments should be sent to: Document
Control Officer, OTS/EPA TS-793, Room E-209, 401 M St.,
SW, Washington, D.C. 20460. Hearings will begin around May
14, 1986. For further information and the time and place time
place of the hearings contact the TAO.
EPA Sues 28 for Asbestos Violations
In a nationwide crackdown, EPA and the Justice Department
filed eleven lawsuits against 28 building owners and contractors,
charging them with asbestos violations. The defendants were
charged on January 16, 1986 with violating the Clean Air Act
(CAA) rules protecting people from asbestos exposure during
renovation and demolition of buildings. The asbestos exposures
took place in the District of Columbia, Massachusetts, New Jer-
sey, Pennsylvania, Florida, Iowa, Colorado, Idaho, California,
and Washington State.
"I hope these lawsuits heighten the awareness of building own-
ers and renovation and demolition contractors of their responsi-
bility and potential legal liability under the Federal Clean Air
Act," said Courtney M. Price, the EPA Assistant Administrator
for Enforcement and Compliance Monitoring. EPA has strong in-
dications that many small business owners and others "don't
know or don't want to know, that they're covered by the rules
protecting people from asbestos exposure," Price said. In each
of the 11 suits, the Justice Department will ask for civil penalties
of $25,000 for each day of violation and an injunction against
further violations of the CAA.
The regulations require owners or operators of renovation or
demolition firms to notify EPA, or a State agency if EPA has del-
egated the authority, in advance of beginning renovation or
demolition involving friable asbestos. Asbestos is friable when it
is easily crumbled. As a result, during demolition or renovation,
fibers are released into the surrounding air where they can be
breathed by humans. Inhaled asbestos can cause lung cancer,
mesothelioma (cancer of the chest and abdominal lining) and
asbestosis, a scarring of the lungs.
EPA has specific renovation and demolition work standards
when asbestos is involved. The rules apply to owners and les-
sees of buildings being renovated or demolished and to
companies doing renovation or demolition and any subcon-
tractor hired specifically to do asbestos work. If the renovation or
demolition involves an amount of asbestos equal to or greater
than 260 linear or 160 square feet, the asbestos must be re-
moved before any wrecking or dismantling that would break up
the asbestos materials. The asbestos must be wetted before it is
stripped or removed and must be kept wet until collected for dis-
posal. The owner or operator must collect and transport the
wastes in certain types of containers and handle the asbestos in
a way that prevents release of fibers into the atmosphere. Then
the asbestos waste must be deposited at a disposal site that
meets certain EPA criteria.
For more information on the enforcement of these rules, call
Elliott Gilbert (202) 382-2864. For copies of the asbestos reno-
vation and demolition rules or for technical information, call or
write the TAO.
3
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TSCA Rule to Assist Office of Solid Waste
The Office of Toxic Substances (OTS) has promulgated a final
rule under section 8(d) of TSCA which will collect valuable
health and safety data for the Office of Solid Waste (OSW). The
rule, published in the Federal Register on January 22, 1986 (51
FR 2890) requires past, current, and prospective manufacturers,
importers, and processors of the 33 listed chemical substances
to submit to EPA lists and copies of unpublished health and
safety studies on those substances. The rule also contains an
exclusion from the exemption from reporting on chemical sub-
stances not listed on the TSCA Inventory. Seven of the 33 sub-
stances are not on the Inventory.
OSW requested that OTS collect these data because of the
mandates of the Hazardous and Solid Waste Amendments of
1984 (HSWA), which prescribe statutory deadlines for EPA to
develop land disposal restriction regulations for certain sub-
stances subject to the Resource Conservation and Recovery
Act (RCRA). These deadlines must be met, or the HSWA
imposes an automatic ban on the land disposal of the subject
substances. OSW is devising treatment standards for which
health and safety data on these 33 substances are needed.
The substances added to the section 8(d) rule are:
CAS
Number Chemical Name
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
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) Isoxazolone, 5-(aminomethyl)-
3288-58-2 Phosphorodithioic acid, O.O-diethyl S-methyl ester
107-10-8 1-Propanamine
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 -ol
757-58-4 Tetraphosphoric acid, hexaethyl ester
5344-82-1 Thiourea, (2-chlorophenyl)-
Propylene oxide
Manufacturers and processors of propylene oxide now are re-
quired to test the chemical for developmental toxicity, according
to a new EPA final rule [November 27, 1985 (50 FR 48762)]. On
the same day, EPA proposed (50 FR 48803) TSCA test
guideline for developmental toxicity be used as a standard for
the required study and that test data be submitted within a
specified time.
Propylene oxide is a member of the alkyl epoxide category. In
1977, the ITC designated the entire category tor priority consid-
eration for epidemiological studies and testing for
carcinogenicity, mutagenicity, teratogenicity, other chronic ef-
fects and environmental fate. In 1984, EPA decided to address
some chemicals within the alkyl epoxide category individually.
EPA concluded that existing data were sufficient to reasonably
predict the environmental fate of propylene oxide and that data
from completed and ongoing testing should be sufficient to rea-
sonably determine the reproductive and neurotoxic effects and
carcinogenicity of the chemical. EPA postponed its decision on
additional mutagenicity testing of propylene oxide until the re-
sults of a number of mutagenicity tests in progress on a closely-
related chemical, ethylene oxide, were analyzed by the Agency.
Propylene oxide (CAS. No. 75-56-9) is a volatile, colorless liquid
that has an ether-like odor and is extremely flammable. In 1980,
domestic production of the chemical totaled 1.77 billion pounds.
It is produced by two firms at four sites within the United States.
Propylene oxide's major use is as a chemical intermediate, but it
is used also as a stabilizer in dichloromethane. Estimates indi-
cate that in excess of 40,000 people may be exposed to the
chemical during its manufacturing, processing and use.
1,1,1-Trichloroethane
Final test standards and reporting requirements for 1,1,1 -tri-
chloroethane (TCEA) were issued by EPA on December
1985 (50 FR 51683). The required protocols and schedules
were identical with those submitted by a TCEA industry consor
tium earlier in the year. The ITC designated TCEA (CAS o.
71-55-6) for priority testing consideration in 1978. In response
EPA issued a final phase 1 rule on October 10, 198 {
39810), requiring testing of TCEA after it found that the c e
is produced in substantial quantities, and there is substantia
cupational and consumer exposure to it.
TCEA is a colorless nonflammable volatile liquid at standard
temperature and pressure. In 1983 approximately 586 million
pounds of TCEA were produced in the United States, of which
57 million pounds were exported.
4
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Hydroquinone
On December 30, 1985 EPA issued a rule establishing test re-
quirements for manufacturers and processors of hydroquinone
(50 FR 53146). The Agency is requiring that hydroquinone be
tested for reproductive, teratogenic and nervous system effects
and that the chemical's toxicokinetics be evaluated. On the
same day EPA proposed a rule that the TSCA test guidelines
and industry-submitted guidelines be used as the test standards
for the required studies for hydroquinone (50 FR 53160). In
1979, the ITC designated hydroquinone for priority consideration
by EPA for carcinogenicity and teratogencity and that epidemiol-
ogy, human metabolism and environmental fate studies of the
chemical also be considered.
Hydroquinone (CAS No. 123-31-9) is a white crystalline solid at
room temperature. It is very soluble in water, ethanol and ace-
tone. It acts chemically as a reducing agent, being oxidized to
quinone. Hydroquinone is produced in both photographic and
technical grades. Hydroquinone annual production in the United
States is estimated to be as high as 27 million pounds.
EPA Issues Rule and Advisory on
Burning of Used Motor Oil
Persons burning used oil in space heaters should make certain
the units are vented so that the exhaust gases escape to the
outside air, in order to minimize exposure to lead and other toxic
substances. The heaters should be vented so as not to cause
unnecessary exposure to people outside th heated workplace.
The above advice is included in a chemical advisory issued by
EPA's Office of Pesticides and Toxic Substances.
In addition to the warning, EPA issued a rule on November 29,
1985, prohibiting the burning in un-vented space heaters of
used oil or hazardous waste fuel that does not meet specifica-
tion levels for certain hazardous contaminants and flash points.
The rule (50 FR 49164) was issued under the Resource Conser-
vation and Recovery Act (RCRA), a law that is administered by
EPA.
For more information about the rule, call the RCRA hotline:
(800) 424-9346 or (202) 382-3000. For copies of the chemical
advisory, Burning Used Oil in Space Heaters, call or write the
TAO. See the TAO telephone number and address listed in the
front of this Bulletin.
Garages, service stations and other workplaces often heat by
burning used oil drained from gasoline-powered engines. Ac-
cording to the chemical advisory, this oil contains lead that has
been deposited as a by-product of fuel combustion in the
engine.
When the used oil is burned in un-vented heaters, lead in the
exhaust gases enters the workplace air. Excessive lead levels in
inhaled air can cause toxic effects in humans, including nerve
and irreversible brain damage, kidney failure, anemia, high
blood pressure, various blood and metabolic disorders and gas-
trointestinal disturbances. Lead particles may also be deposited
on workplace surfaces, if exhaust gases are not vented. These
particles can be ingested inadvertently, increasing the total
exposure.
In addition, waste oil usually contains other toxic materials or
chemicals that are not destroyed completely or removed during
combustion. In some waste oil samples, EPA found high levels
of arsenic, cadmium, chromium, barium, polynuclear aromatic
hydrocarbons, and various solvents. Emissions of some of these
chemicals, such as arsenic and chromium from a space heater,
are associated with significant cancer risk. Oxides of nitrogen
and sulfur, which can cause respiratory impairments in humans,
are also present in exhaust gases from waste oil burning.
The Agency conducted test burns on vaporizing and atomizing
the two types of space heaters. Based on their measurements,
EPA estimates that un-vented oil-burning heaters may produce
levels of lead in workplace air that could be from six to 1,400
times greater than the levels known to cause toxic effects in
adults.
OTS Seeks CHIP Data
OTS is asking the public for unpublished information about the
following chemical:
Diisopropyl sulfate (CAS No. 2973-10-6)
This chemical has been selected for preliminary assessment re-
view. OTS has preliminary information about potential effects of
this chemical to health and the environment and is doing a re-
view to find what other information is available about this chemi-
cal. 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 chemical, 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 inspection,
unless the submitter is able to assert a claim of confidentiality, in
accordance with the provisions of section 14 of TSCA. EPA will
handle all confidentiality claims in accordance with its proce-
dures governing the confidentiality of business information.
The OTS review of the chemical when completed, will be in a re-
port called Chemical Hazard Information Profile (CHIP). A CHIP
is a brief summary of readily available information concerning
the health and environmental effects and potential exposure to a
chemical. CHIP candidates are chosen on the basis of informa-
tion indicating a potential for adverse health or environmental ef-
fects along with evidence of a significant production or some
type of exposure.
When OTS searches the literature in preparing a CHIP it gener-
ally, limits the search to automated data bases and reference
works. But OTS encourages individuals and firms to submit un-
published 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, en-
vironmental 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.
5
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The TAO is distributing copies of tha
following recently
completed CHlPs
{CAS No. J
3-Chlort>-2-metby!propene
563-47-3
Dieyandiamide-Dietbylerielriamine-
Epichlorohydrin (DDE) Resin
67953—54-2
Nonylphenoi
25154-52-3
(including 4- S 2-Nonylphenalj
104—40—5
136-8-3-4
T^aikyl/atkaxy) Phosphates
(Trifetbyihexyi} Phosphate
78--42-2
(Tnlbutr/xyetnyi) Pnosphale
78-51-3
(Tributyl Phosphate
186-73-8
(Trimefiy* Phosphate
512-56-1
Tripheny! Phosphate
101-02-0
4- Vin ylcyciohexene
101-40-3
Latest FYI Submissions
In recerrt weeks EPA received the inifiai FYI (For Your Informa-
tion) submissions listed below. For additional information on
fvts see page 11 of this Bulletin.
Document Control No. FYI-
Chernlcat Name(s|
AX-1085-0459
n-Hexane
Commercial Hexanes
Preliminary results trom a single-generation m-
hatation reproductictn/fertiliiy s1udy of corr-
marciai hexanes in rats
AX-10B5-0460
Cs-C16 Petroleum Hydrocarbons
UnleatSeti Gasolitvs
Final report from a 4-week oral nephrotoxicity
screening study with 12 petroleum hydrocar-
bons and ubeaded gasoline in mate rata
OTS-1185-0461
Benzene
Summarized final results of an epidemiology
study emitted "An Update ot Mortality Among
Chemical Workers Exposed lo Benzene '
OTS-1185-0462 Sanitized
N-CMoro-2-Propylamine
N-Chtara-S-Bjtyiamiie
t ,a-Dichtoro-5-ethyl-5-methythyctantoin
1,3-Oichloro-5,5-dimeihy1tydsmtoin
Summarized final resets ot a battery ot acute
toxicity tests (species not specified)
CAS No.
110-54-3
unknown
Several
(5006-51 —9
71—43-2
34508-68—4
34508-69-^5
unknown
unknown
AX-118&-0463
Shale Oil Derived Steams
PreliminaTy results (ram a lifetims dermal
careincgsness tioassay in mice of 30 shale
oil derived streams
AX-1285-Q464
2,2,4-T rimethylperrtane
Preliminary results from a 4-week oral feeding
study in rats to investigate alteration of renal
functions duvitig introduction ot light hydro-
carbon rieohropathy
OTS—1285-0465
0,0- Qiethlphosphorcdilbioale
Final report tram an Ames mutagenicity assay
C'TS-128^-0465
Diisopcapyl Sulfate
Summarized final results of a long-term mouse
skin parting and subcutaneous injection
carcinogenesis bioassay
OTS-1185-0467
Brommatad Biptienyl Ethers
EPA requesl for information on a chemical,
preceding CHIP preparation
AX-1285-0468
Hydtouu inane
Final report from a developmental toxicity study
in rats
OTS-1265-0469
Qrganosilanes
EPA request for information on a chemical pre-
ceding CHIP preparation
OTS-1285-0470
Polymer ot Acrylic Acid, Atkane—
Poty (Alkenoate; and Sodium Acryiale
Summarized pretiminary and final results of
chronic ana sutrclirartic tests in rats
OTS-1285-0471
Household Cleaning Product Mixture
Butyl Diglycol
Sodium Citrate
Sodium Curriers Sulfonate
Sodium Alkyl Benzene Sulfonate
Summarized report of a fatal ingestion by a
human
AX-0186-0472
Petroleum Refinery Chemicals
Fir,Eil report cm a cohort mortality study of pe-
troleum refinery workers (Torrance, CA'j
Unknown
540-84-t
298-06-6
2973-10-6
Several
123-31-9
Several
Confidential
Norte
112-34-5
53-04-2
26348-53-0
none
Unknown
Me»ityl Oxide
EPA issued a rule requiring the testing of mesityi oxide {MO) by
manufacturers and processors of the substance {Oeo&mber 20,
1985 (50 FR 51857)]. To assess oofeolial chronic effects,
mutagenicity and inhalation subchromc toxicity are required in at
least one animal species, If certain mutagenicity tesl resu>rs are
positive, than oncogenicity testing is required. In t979, tha ITC
designated MO for priority consideration and recommended cer-
tain health effects testing.
MO is a colorless, oily liquid which vaporizes at room tempera-
ture, producing a marked odor of pepperwit (V at is detectable
down to Q.C17 ppm. Six facilities in the United States produce
approximately t20 mite^on pounds of MO, which is used as s/i in-
termediate in tha manufacture ot methyl isobutyl ketone. Merhyi
isobutyl carfcirtot can aiso b6 produced sis a co-product of the
same system.
6
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EPA Proposes Testing and Reporting
of Dioxins and Furans
EPA has proposed a rule that would require manufacturers and
importers of 14 commercial organic chemicals to test the sub-
stances for the presence of chlorinated and brominated dioxins
and furans. Under the proposal, the manufacturers and import-
ers also would be required to submit existing test data on con-
tamination of the 14 chemicals with dioxins or furans. If the test
results are positive, the manufacturer or importer would also be
required under TSCA to submit production, use, exposure and
disposal data for the chemical.
The December 19, 1985 proposal (50 FR 51974) also called for
such testing and reporting of 20 other organic chemicals not
now commercially manufactured in the United States or cur-
rently being imported, if manufacture of importation resumes.
The EPA proposed rule is in response to an October 22, 1984
citizens' petition, filed under section 21 of TSCA, requesting,
among other things, that EPA initiate a number of specific regu-
latory and information-gathering steps to control the generation
of specific 2,3,7,8-substituted chlorinated and brominated iso-
mers of dioxins and furans. EPA responded to the section 21
petition on January 30, 1985 (50 FR 4426). See pages 9 and 10
of this Bulletin for an explanation of TSCA sections 4, 8 and 21.
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 11 of this Bulletin.
Log No. 8EHQ—
09835-0568 S
1,1 -Diethoxy-2-trimethylsilyl-1 -sila-2-
azacyclo-pentane
1, t -Diethoxy-2-trimethylsilyl-1 -sila-2-
azacyclo-pentane dimer
T rimethylethoxysilane
Summarized results of acute inhalation toxicity
tests
1085-0569
n-Octylamine
Summarized results of acute oral, dermal and
eye toxicity tests
1085-0570
Chlordene
Results of an oral teratology study
1085-0571 S
Aromatic diamine
Summarized results of acute dermal, eye, and
inhalation toxicity and in vitro mutagenicity
studies
[CAS No.]
21297-72-3
1825-62-3
11-86-4
3734-48-3
0585-0572
0985-0572 Followup
2-Methoxy-1-propyl acetate
Preliminary results from inhalation and dermal
teratologic studies
1185-0573
Butyraldoxime
Summarized results of an acute dermal toxicity
study
1185-0574
Silicon carbide
Interim results of a subchronic inhalation study
1185-0575
2-((4-Amino-3-methylphenyl)ethylamino)
ethanol sulfate
Summarized results of an acute oral toxicity
study
1285-0576
Clarified slurry oil
Summarized results from a subchronic dermal
toxicity study
1285-0578
Acetyl ferrocene
Summarized results from acute oral, dermal
and eye toxicity studies
1285-0579 S
p-Vinyl phenol
Summarized results from acute oral, dermal,
and eye toxicity studies and an in vitro
mutagenicity study
1285-0580
1 -Methylamino-4-(p-tolylamino)
anthraquinone
Summarized results from a battery of in vitro
genotoxicity assays and an acute dermal
toxicity/sensitization study
0685-0583 S
1085-0583 S Followup
R&D Chemical
Interim results of a 2-year dietary oncogenicity
and chronic toxicity study.
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 stated. Additional
tests (e.g., bacterial cell) are noted or are included in the term
"battery."
70657-70-4
110-69-0
409-21-2
25646-77-9
64741-62-4
1274-55-2
2628-17-3
128-85-8
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EPA Proposes SNUR for Resin
EPA has proposed a significant new use rule (SNUR) for an
epoxy resin. The resin was added to the Inventory as N,N,N',N'-
Tetrakis (oxiranylmethyl) 1,3-cyclohexanedimethanamine (CAS
65962-66-7). The substance was the subject of a premanu-
facture notice received by EPA in October 1983. Before being
added to the Inventory the chemical was the subject of a TSCA
section 5(e) consent order because EPA concluded that the
uncontrolled manufacture, import, processing, distribution in
commerce and use of the substance might present an unrea-
sonable risk of injury to human health or the environment. The
consent order permitted the PMN submitter to produce the sub-
stance, but only if: (1) appropriate worker protection controls are
used, including protective clothing, gloves and face shields; (2)
respirators are required for workers during spray application; (3)
workers are informed of the hazards of the substance; and (4)
containers to be used in distribution of the product are labeled.
The January 13,1986 SNUR (51 FR 1396) would ensure that all
manufacturers, importers and processors of the chemical are
subject to similar requirements. For a further explanation of sec-
tion 5(e) consent orders and SNURS see page 10.
Vinyl acetate
Past, current and prospective manufacturers, importers and
processors of vinyl acetate now are required to provide EPA
with lists and copies of unpublished health and safety studies on
this substance. The information received will be used to support
a detailed assessment of the health and environmental risks of
this major industrial chemical. The December 27,1985 EPA ac-
tion was taken under the section 8(d) TSCA Model Health and
Safety Data Reporting rule, (50 FR 52923).
EPA Amends TSCA's Section 8(c) Rule
The TSCA section 8(c) rule requires manufacturers and
processors to keep records of "significant adverse reactions" al-
leged to have been caused by substances and mixtures. EPA
amended the rule on November 13, 1985 (50 FR 46766). The
amendments exempt coincidental manufacturers of substances,
and revise the description of processors subject to the section
8(c) rule.
Hexachloronorbornadlene
EPA is monitoring the manufacture, importation and processing
of 1,2,3,4,7,7-hexachloronorbornadiene (HEX-BCH) to deter-
mine production and processing volumes, the number of people
exposed to it, the manner of its environmental release and the
method of its disposal. To monitor the chemical, EPA is using
two provisions of TSCA—section 8(a) and section 5(a). On No-
vember 19, 1985 EPA said in a final rule (50 FR 47534) it will
use the information to help it determine if further HEX-BCH reg-
ulatory action is needed.
Manufacturers, importers and processors of HEX-BCH who use
it, or propose to use it, as an intermediate in the production of
isodrin or endrin will have to report under the section 8(a) provi-
sions. Endrin is a restricted use pesticide and is regulated by
EPA under the Federal Insecticide, Fungicide and Rodenticide
Act, when used as such.
Persons who intend to manufacture, import or process the
chemical for any other use will be required to submit a signifi-
cant new use notice, as required under section 5(a).
HEX-BCH is moderately toxic, affects neuromuscular functions,
and may be a carcinogen. Environmentally, it is a persistent
substance that is highly toxic to fish, has a high bioconcentration
factor and will tend to partition to soil and sediment.
17th ITC Chemicals
named in the Intera*61^ 3nd Processors of the three chemicals
must report volum!96"^ Tes,in9 Committee's 17th Report
health and safetv 6nd Use' e*Posure, and unpublished
safety data on the chemicals to EPA.
The three chemicals are:
Cyclohexane
2,6-Di-fert-butyl phenol
D»oSodecylphenylphosphjte
110-82*7
128-39-2
22550-96-5
On November 19,1985, EPA added the chemicals to two model
information gathering rules, TSCA's 8(a) Preliminary ^
ment Information rule and the 8(d) Health and Safety ua
porting rule (50 FR 47538).
EPA Issues Guidance to Aid Section 21 Petitioners
EPA made guidance available to help people who want to file
more effective TSCA section 21 petitions. The guidance, pub-
lished on November 13, 1985 (50 FR 46825), should help peti-
tioners present their cases with pertinent and available sup-
porting information. Effectively filed petitions also will assist EPA
to evaluate the petition properly within the 90-day review man-
dated by TSCA. For an explanation of section 21, see page 11.
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Chlorinated benzenes
EPA is revising its proposed rule for the chlorinated benzenes
by updating certain health effects testing requirements. The pro-
posed revisions [November 27, 1985 (50 FR 48805)] reflect cur-
rent TSCA test guidelines. The guidelines are to be used as test
standards for the proposed oncogenicity testing of 1,2,4-tri-
chlorobenzene; oncogenicity, reproductive effects and
teratogenicity testing of 1,2,4,5-tetrachlorobenzene and the re-
productive effects testing of monochlorobenzene, ortho- and
paradichlorobenzenes. The original proposed rule was pub-
lished on July 18, 1980 (45 FR 48524).
A revised edition of the TSCA Chemical Substance In-
ventory is being published. It contains all chemicals from
the 1977 Inventory (except for a few chemicals that were
delisted by EPA because they were erroneously included
in the Inventory) as well as new chemicals whose manu-
facture or importation began prior to September 30,1985.
The printed version of the Inventory is expected to be
available from the Government Printing Office in April, for
approximately $120 for shipment within the United
States. It will be somewhat higher for orders shipped out-
side the United States. Computer-readable tapes of the
Inventory will be offered for sale by the National Techni-
cal Information Service.
Below and on the next pages are explanations of sections
of TSCA that are cited in this issue of the Bulletin. For addi-
tional 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 substance
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 reasonably deter-
mine 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 hu-
mans or the environment, in addition to findings of insufficient
data and need for testing.
Priority List... Section 4(e) (ITC)
Under section 4(e) an Interagency Testing Committee (ITC) was
established to recommend chemicals to EPA for priority testing
consideration. In addition to recommending, the ITC can "desig-
nate" chemicals. EPA must respond to the designation within 12
months by starling rulemaking under section 4 or giving reasons
for not so doing. The ITC can designate up to 50 chemicals or
categories of chemicals for testing and must make revisions to
this section 4 priority list semiannually.
The ITC is comprised of appointed members from eight Federal
agencies, as specified in TSCA. Representatives from six addi-
tional Federal agencies serve in a liaison capacity.
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, or prospective manufacturers, importers, and proces-
sors of certain named substances to submit unpublished health
and safety data to EPA. EPA adds substances to the model rule
as the Agency identifies a need for health and safety
information.
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Significant New Use Rules (SNURs) ... Section 5(a)(2)
Under section 5(a)(2) EPA may determine by rule that certain
uses of chemical substances are significant new uses. These
rules are referred to as Significant New Use Rules (SNURs). In
making the determination, the Agency considers the potential
exposure associated with the use, the toxicity associated with
the chemical, and whether the use is ongoing at the time the
rule is proposed. Persons subject to a SNUR must notify EPA at
least 90 days before manufacturing, importing, or processing the
chemical substance identified in the SNUR for the defined signif-
icant new use or uses.
A SNUR may be issued for any TSCA chemical substance.
SNURs may be written for individual chemicals, for chemical
categories, and for new or existing chemicals. SNURs may be
written in conjunction with a section 5(e) order.
A section 5(e) order can limit or prohibit the use of a chemical
substance that has been the subject of a premanufacture notice
(PMN) or Significant New Use Notice. With regard to new (PMN)
chemicals, once commercial manufacture begins, the chemical
is placed on the Inventory. If no SNUR is issued, the chemical
may be used by other manufacturers without any restrictions. To
establish equity of treatment, EPA issues SNURs to followup
section 5(e) orders, requiring manufacturers to notify EPA be-
fore manufacturing, importing, or processing the substance for
any activities other than those permitted in the section 5(e)
order.
Section 5(e) Action Pending Development of Information
The Administrator may issue a section 5(e) order to take effect
at the end of the Agency review period following receipt of a
premanufacture notice (PMN) or a significant new use notice.
The order may limit or prohibit manufacture (import), processing,
distribution in commerce, use, or disposal of a chemical sub-
stance. The action can be taken if information available to EPA
is insufficient to permit a reasoned evaluation of the health and
environmental effects of the substance, and if the substance
may present an unreasonable risk to health or the environment.
A section 5(e) order may be also be issued if there is insufficient
information and the substance is or will be produced in large
quantities and may result in significant or substantial human ex-
posure, or substantial release to the environment.
A section 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 notice. The company agrees to
be bound by the order and waives its right to file objections to
the order. This waiver does not affect any other rights that the
company may have under TSCA. The company at a later date
can request a modification of the consent order. In a unilateral
order EPA takes action to restrict or prohibit the manufacture or
use in commerce of the substance without negotiating the terms
of the order with the company that submitted the notice.
The Agency also writes followup SNURs for certain new chemi-
cals which were not subject to section 5(e) orders. These
SNURs address concerns which did not trigger a section 5(e)
order either because the concerns arose after the completion of
the PMN review or because the uses described in the PMN did
not involve enough exposure to warrant action. Followup
SNURs allow the Agency to permit safe uses of potentially haz-
ardous new substances while ensuring that it has the opportu-
nity to review uses which may lead to significant changes in hu-
man or environmental exposure.
Finally, EPA develops SNURs to support the Existing Chemical
Program s risk assessment and risk management activities.
SNURs for existing chemicals are used to monitor significant
new uses of substances on the TSCA Chemical Substance In-
ventory. As with SNURs for new chemicals, existing chemical
SNURs ensure that the Agency will receive information on sig-
nificant new uses of potentially hazardous substances before
such uses occur. These SNURs also enable EPA to take imme-
diate followup control action (under TSCA section 5(e) or 5(f)) to
limit potential exposure resulting from significant new uses of
existing chemical substances, provided that such followup ac-
tion is necessary.
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Substantial Risk ... Section 8(e)
Under section 8(e), persons who obtain new information that
reasonably supports the conclusion that a substance or mix ure
which they manufacture, import, process or distribute presens
substantial risk or injury to human health or the environmen ,
must notify EPA with 15 working days. These notices are
reviewed by the Office of Toxic Substances (OTS) and an inina
evaluation (status report) is prepared containing, if appropria e,
followup questions to the submitter, referrals to other agenci ,
and recommended OTS/EPA followup actions. The 8(e) not'^®
represent a company's first review of a situation and a |U g
ment in compliance with the statute to submit a notice wi in
working days of obtaining the information.
EPA publishes its status reports to make 8(e) information widely
available and understandable to a broad public. The su mi
sions and status reports are located in the OTS Public eai i g
Room, first floor, East Tower, Waterside Mall, 401 M btre ,
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 Gree
(A-101), Washington, D.C., 20460. There is no charge tor
duplicating the first 49 pages, but at page 50 of a request for u-
plication there is a $10.00 fee and a 20 cent charge for eac a
ditional page (e.g., 51 pages will cost $10.20).
Single copies of the section 8(e) status reports (not the full sub-
mission) are available from the TAO.
Citizens' Petition ... Section 21
Under section 21 of the TSCA any person may petition the EPA
Administrator to begin a proceeding for the issuance, amend-
ment or repeal of a rule under section 4, 6 or 8 of TSCA, or an
order under section 5(e) or 6(b) of the Act. Within 90 days after
the petition is filed the Administrator must either grant or deny
the petition. The Administrator may hold a public hearing or con-
duct an investigation or proceeding as deemed appropriate in
order to determine whether the petition should be granted, tf the
petition is denied the Administrator must publish the reasons for
the denial in the Federal Register. If the petition is granted the
Administrator must promptly initiate an appropriate proceeding
in accordance with section 4, 5, 6 or 8 of TSCA.
For Your Information (FYI)
For Your Information (FYI) submissions are submitted voluntar-
ily to the Agency or to the Office of Toxic Substances (OTS) on
chemical toxicity and/or exposure. FYls are submitted by chemi-
cal manufacturers, processors and distributors, trade associa-
tions, labor organizations, Federal, State or local agencies, for-
eign governments, academia, public interest and environmental
groups, as well as by the general 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 under section 8(e) Substantial Risk on this
page.
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PCB Videotape Available
EPA is releasing a 12-minute videotape "Reducing the
Risks of PCBs." The tape presents general information
on PCBs in clear, concise language and is appropriate for
broad audiences including the utility industry, fire depart-
ments, building owners, scrap and salvage dealers, labor
and public interest groups.
The tape is sold at cost through Color Film Corp., Video
Division, 770 Connecticut Ave., Norwalk, CN 06854,
(800) 882-1120. Beta I or II costs $21.75, VHS $22.65
and 3/4 inch, $29.85. Connecticut residents and corpora-
tions should include an additional 7'/2 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 waiting list.
TSCA Assistance Office (TS-799)
Office of Pesticide & Toxic Substances
U.S.E.P.A.
Washington, D.C. 20460.
Official Butlnna
Panalty (or Prl»at« U»a
$300
First Claaa Mall
Poalaga and Faaa Paid
EPA
Parmlt No. S-3S
THE TSCA CHEMICALS-IN-PROGRESS BULLETIN
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