f
TS#V
b
tj-
ii'i
II ,wvr« 4 ; I V
Chemicals-in-Progress i
U\ ^Bulletin
;C3P
1 *!•#
Jlf nar^sm
Office of Toxic Substances
(OTS)
VOL. 7 No. 2
June 1986
INSIDE
What's Happening in OTS
Don Clay is leaving
ITC
Adds Tributyl Phosphate to Priority List
May Designate Isopropanol for Testing
LATEST EPA ACTIONS ON ITC DESIGNATIONS
Chlorinated Benzenes
Cresols
Diethylenetriamine
Formamide
Methylcyclopentane
C9 Aromatic Hydrocarbon Fraction
Tetrabromobisphenol A
Triethylene Glycol Ethers
AGREEMENTS ENHANCE FEDERAL TOXIC SUBSTANCES CONTROL
EPA DENIES PETITIONS CONCERNING PLANNED PCB FACILITY
PMN REVISIONS COVER R&D PROCEDURES
PMN VIOLATIONS
Seek $2.7 Million For Violation
EPA Assesses $476,250 Penalty
Company Fined $172,000 for Illegal Manufacture
Corporation Agrees to Pay $500,000 Fine
NEW STUDY ON ASBESTOS ABATEMENT
REPORT ON REGULATORY INVESTIGATION OF FORMALDEHYDE
PMN PROVISIONS COVER R&D PROCEDURES
EPA ISSUES FINAL AND PROPOSED SNURs
Page 2
Page 2
Page 2
Page 4
Page 4
Page 5
Page 5
Page 5
Page 5
Page 5
Page 5
Page 6
Page 5
Page 7
Page 7
Page 7
Page 7
Page 7
Page 6
Page 6
Page 7
Page 6
-------
What's Happening in OTS—Don R. Clay
When I took over as the Director for the Oftice of Toxic Substances nearly five years ago, I
planned to stay in the position for three to five years. Well, two months shy of completing my
fifth year here, I've accepted a position as the Deputy Assistant Administrator in EPA's Office
of Air and Radiation. I'm really looking forward to the challenges in my new job, but I am also
going to miss OTS ... especially the people.
Five years ago when I came to OTS, I found a young and very talented staff struggling to get
the organization and the programs in place. Together, we worked to build the OTS programs.
For example, when I came to OTS, the new chemical program had only reviewed a few hun-
dred chemicals. This year, we anticipate reviewing approximately 2,000 new chemicals. Back
then, we did not have a procedural rule or a form on which new chemical notices had to be
submitted. Today we have a streamlined, efficient system capable of handling a huge
workload. We have always tried to meet our goals: to protect the public health and the environ-
ment from unreasonable risks while at the same time minimizing impacts on industry.
In the testing area, we've had our ups and downs. When I arrived, we were not meeting the
statutory deadlines in responding to Interagency Testing Committee recommendations. Now,
we are meeting all of the statutory deadlines. We've also streamlined the process so that we're
able to get more rules out in a shorter length of time. For a pe-
riod of time, we were doing negotiated test agreements, but a
court ruled that this was inappropriate for chemicals recom-
mended by the Interagency Testing Committee. Hopefully, OTS
will soon be able to use a negotiating process which will allow
us to reach legally enforceable consent agreements for testing.
The intent is to get needed data in the quickest, cheapest, and
fairest way possible.
lished a routine screening process for reviewing existing
chemicals.
In the existing chemicals area, we have also made progress.
We have issued a series of rules on PCBs, a final statement of
policy dealing with biotechnology, and a proposed rule on as-
bestos that would essentially eliminate the use of asbestos in
the United States over a ten-year period. We have also estab-
So, as I said before, on the one hand, I'm right on target in ac-
cepting the new challenge in the Office of Air and Radiation. I'll
be taking with me the experience that I have gained in the TSCA
program over the past five years, and I believe that I can make a
valuable contribution to the Office of Air and Radiation.
On the other hand, I'm a little sad about leaving. I must say that
I have never worked with a finer group of people than the OTS
staff. The people in OTS are highly competent, dedicated and
hardworking. They are as professional a group as I have worked
with in my career, and I'm really going to miss them.
New Rule Requires Partial Updating of TSCA Inventory Production and Site Data
see page 10
FOR YOUR INFORMATION
OTS Gets 13 Substantial Risk Notices
New Data on 10 Chemicals
18 New FYls Available
OTS Seeks CHIP Data
Page 8
Page 8
Page 9
Page 8
ITC Adds Tributyl Phosphate to Priority List
On May 1, 1986, one chemical, tributyl phosphate, was recom-
mended with intent-to-designate for testing under section 4 of
TSCA by the Interagency Testing Committee (ITC). By placing
tributyl phosphate in this category, the chemical is subject to
TSCA section 8(a) and 8(d) rules on automatic reporting re-
quirements. The section 8(a) and 8(d) rules require the submis-
sion to EPA of information on production, use, exposure and un-
published health and safety studies that may not be publicly
available. The information received on tributyl phosphate will as-
sist the ITC in deciding whether to designate the chemical for
EPA response within 12 months in a subsequent report to the
Administrator.
The ITC also designated for response within 12 months two
chemicals that were recommended with intent-to-designate in its
17th report to the EPA Administrator. (November 19, 1985 (50
FR 47603)]. The designated chemicals are cyclohexane and
2,6-di-fert-butylphenol. After reviewing information received in
response to the 17th report the ITC concluded that needed data
are still lacking on cyclohexane and 2,6-di-fert-butylphenol.
ITC May Designate Isopropanol For Testing
The ITC may designate isopropanol (CAS No. 67-63-0) for cer-
tain health effects testing in a future report to the EPA Adminis-
trator, according to a February 12, 1986 notice (51 FR 5250).
More than a billion pounds of isopropanol are produced each
year in the United States and there appears to be significant
workplace exposure to the chemical, the ITC reported. But the
Committee found only fragmentary and inconclusive information
on the toxicological endpoints of concern for isopropano
uncontaminated with isopropyl sulfate. The ITC notice reported
that the health effects of concern are genotoxicity, carcinogenic
ity, and reproductive and developmental effects.
2
-------
Chemical/Group
ITC Recommended Studies
Cyclohexane
(CAS No. 110-82-7)
2,6-Di-fert-
butylphenol (CAS No.
128-39-2)
Tributyl phosphate
(CAS No. 126-73-8)
Health Effects'"Chronic toxicity in-
cluding oncogenicity and neuro-
toxicity; teratogenicity; reproduc-
tive toxicity.
Health Effects: Toxicokinetics;
chronic toxicity.
Chemical Fate: Persistence in aero-
bic and anaerobic sediments.
Ecological Effects: Acute toxicity to
benthic organisms; bioconcen-
tration in benthic organisms.
Health Effects: Chronic toxicity in-
cluding oncogenic, neurotoxic, re-
nal, reproductive and developmen-
tal effects.
Chemical Fate: Persistence in anae-
robic soils and sediments.
Ecological Effects: Chronic effects
on aquatic and terrestrial plants;
chronic effects on daphnids and/or
other aquatic invertebrates; acute
and chronic effects on benthic or-
ganisms and soil invertebrates, if
found persistent under anaerobic
conditions.
CA Index Name (9 CI)
1. Cyclohexane
2. Phenol, 2,6-bis(1,1 -dimethyl ethyl)-
3. Phosphoric acid, tributyl ester
The T8CA Section 4(e) Priority List
May 1980
Chemical
Do=Ditto
Month of ITC
Designation
Chemicals designated for response within 12 months
1 Cyclohexane 5/86
2 2,6-Di-tert-butylphenot Do
Chemical recommended with intent-to-designate
Tributyl phosphate 5/86
Recommended chemicals but not designated for
response within 12 months
1 3,4-Dichlorobenzotrifluoride 5/84
2 Dlisodecyl phenyl phosphite 11/85
This news bulletin is intended to inform ail persons concerned
with the Toxic Substances Control Act (TSCA) about recent de-
velopments and near-term plans. For further information or to re-
quest 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) 484-9085. »n the
Washington D.C. area, or from outside the continental United
States call (202) 564-1404.
Cumulative Removals from the TSCA
Section 4(e) Priority List
May 1986*
EPA Responses to ITC Recommendation
Chemical/Group Do = Ditto
Federal Register Notice
Latest EPA Action
1 Acetonitrile
49 FR 44142
11/02/84
2 Acrylamide (health effects)
50 FR 5421
2/08/85
(environmental effects)
48 FR 724
1/06/83
3 Alkyl epoxides
50 FR 36476
9/06/85
(see 1,2-Butylene oxide)
(see Ethylene oxide)
(see Propylene oxide)
4 Alkyl phthalates
51 FR 6168
2/24/86
5 Alkyltin compounds1
46 FR 5456
2/05/85
6 Aniline and bromo-chloro-, and/or 49 FR 108
1/03/84
nltroanilines
7 Anthraqulnone
50 FR 46090
11/06/85
8 Antimony metal
48 FR 716
1/06/83
9 Antimony sulfide
Do
Do
10 Antimony trioxide
51 FR 6168
2/24/86
11 Aryl phosphates
Do
Do
12 Benzidine-based dyes
46 FR 55004
11/05/81
13 Benzyl butyl phthalate
50 FR 36446
9/06/85
14 Biphenyl
50 FR 37182
9/12/85
15 Bisphenol A
50 FR 46699
11/12/85
16 Bis (2-ethylhexyl)
51 FR 6168
2/24/86
terephthalate
11/19/84
17 2-(2-Butoxyethoxy)ethyl
49 FR 45606
acetate
18 1,2-Butylene oxide
49 FR 18779
5/02/84
(see Alkyl epoxides)
19 Butyl glycolyi butyl
46 FR 54487
11/02/81
phthalate
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)
(environmental effects)
24 Chlorinated naphthalenes
25 Chlorinated paraffins
26 4-Chlorobenzotrifluorlde
27 2-Chloro-1,3-butadiene
(chloroprene)
28 Chloromethane
29 2-Chlorotoluene
30 Cobalt naphthenate
31 Cresols
32 Cumene (Isopropyl benzene)
33 Cyclohexanone
34 o-Dianisidine-baaed dyes
35 1,2-Dlbromo-4-(1 ,2-dlbro-
moetbyl) cyclohexane
36 Dibutyttin bis(i*ooctyl maleate)*
37 Dibutyttin bt#(lsooctyl
mercaptoacetate)®
% Dibutyttin b!s(lauryf msrcaptlde)*
39 DibirtyNin dilaurate*
40 Dtohloiomethane
41 1,2-Djchloropropane
42 Diethylirvatilamine
43 Dlmethyttln bls(lsoootyl
mercaptoacetate)*
44 i>Dloxoiane
45 Ethylene bis(oxyethylene)
dlacatate
49 FR
18779
5/02/84
51 FR
11728
4/7/86
49 FR
32113
8/24/84
49 FR
44142
11/02/84
50 FR
42216
10/18/85
50 FR
34546
8/26/85
50 FR
19213
5/07/85
51 FR
6168
2/24/86
49 FR
21411
5/21/84
51 FR
15803
4/28/86
50 FR
46104
11/06/85
49 FR
44142
11/02/84
46 FR
55004
11/05/81
50 FR
19460
5/08/85
48 FR
51361
11/08/83
Do
DO
Do
Do
Do
Do
49 FR
25009
6/19/84
49 FR
899
1/06/84
61 FR
12344
4/10/86
48 FR
5138
11/08/83
51 FR
6168
2/24/86
49 FR
45651
11/19/84
i
-------
46 Ethylene oxide
(see Alky! epoxides)
47 2-Ethylhexanoic acid
48 Ethyltoluene
49 Fluoroalkenes
50 Formamide
51 Glycidol and its derivatives
52 Halogenated alkyl epoxides (see
Hexafluoropropylene oxide)
53 Hexachloro-1, 3-butadiene
54 Hexachlorocyclopentadiene
55 Hexachloroethane
56 1,2,3,4,7,7-Hexachloro-
riorbornadiene
57 Hexafluoropropylene oxide (see
Halogenated alkyl epoxides)
58 Hydroquinone
59 Isophorone
60 Isopropyl bipheny/diisopropyl
biphenyl
61 Lead naphthenate
62 2-Mercaptobenzothiazole
63 Mesityl oxide
64 Methylcyclopentane
65 4,4'-Methylenedianiline
66 Methyl ethyl ketone
67 Methyl isobutyl ketone
68 Methylolurea
69 Monobutyltin tris(isooctyl
mercaptoacetate)3
70 Monomethyltin tris(isooctyl
mercaptoacetate)2
71 Nitrobenzene
49 FR 200
50 FR 20678
51 FR 10577
50 FR 46133
51 FR 6829
48 FR 57562
48 FR 57695
47 FR 58029
47 FR 58023
47 FR 18175
49 FR 45654
1/03/84
5/17/85
3/27/86
11/06/85
2/27/86
12/30/83
Do
12/29/82
Do
4/28/82
11/19/84
48 FR 57686 12/30/83
51 FR 6168
50 FR 5421
50 FR 18920
49 FR 21411
50 FR 46121
49 FR 1536
51 FR 17854
49 FR 31806
50 FR 5421
Do
49 FR 21371
48 FR 51361
Do
2/24/86
2/08/85
5/03/85
5/21/84
11/06/85
1/12/84
5/15/86
7/11/83
2/08/85
Do
5/21/84
11/08/83
Do
50 FR 45123
50 FR 31919
50 FR 46699
50 FR 31919
51 FR 6168
46 FR 54482
51 Fr 6168
47 FR 58031
49 FR 456
50 FR 46178
51 FR 17872
50 FR 5421
49 FR 25013 6/19/84
72 Octamethyl-cyclotetra-siloxane
73 Oleylamine
74 Pentabromoethylbenzene
75 2-Phenoxyethanol
76 Phenylenediamines
77 Polychlorinated terphenyls
78 Propylene oxide (see Alkyl
epoxides)
79 Pyridine
80 Quinone
81 Sodium N-methyl-N- oleoyltaurine
82 Tetrabromobisphenol A
83 4-( 1,1,3,3-Tetramethybuty!)
phenol
84 o-Tolidine-based dyes
85 Toluene
86 Triethylene glycol ethers
87 Trimethylbenzenes
88 1,1,1 -T richloroethane
89 Tris(2-chloroethyl) phosphite
90 Tris(2-ethylhexyl) trimellitate
91 Xylenes
This priority list is updated to reflect very recent EPA actions,
and therefore differs with the list provided in the latest ITC (18th)
report submitted to EPA. Copies of the 18th ITC report, as re-
ported in the Federal Register, are available through the TAO.
Remove by the ITC for reconsideration. Seven individual
alkyltin compound group members were subsequently desig*
nated in the 11th ITC report for priority consideration; see chem-
ical number 5 in this list.
aOne of seven alkyltin compounds. See note 1 above. See
chemicals number 36-39, 43, 68 and 69 in this list.
46 FR
47 FR
51 FR
51 FR
50 FR
47 FR
51 FR
47 FR
55004
56391
17883
10577
31895
49466
6168
56392
10/30/85
8/07/85
11/13/85
6/19/84
2/24/86
11/02/81
2/24/86
12/29/82
1/04/84
11/06/85
5/15/06
2/08/85
11/05/81
12/16/82
5/15/86
3/27/86
8/07/85
11/01/82
2/24/86
2/16/82
EPA Responds to ITC Designations
In April and May 1986, EPA took regulatory action on chem-
icals that the ITC designated for priority consideration. A
summary of EPA actions on these chemicals follows.
Chlorinated benzenes
Manufacturers and processors of certain chlorinated benzenes
are now required to conduct tests on the chemicals. This rule
was published on April 7, 1986 (51 FR 11728). The ITC had
designated these substances lor priority testing consideration.
The substances covered by the rule, their CA8 Numbers, the
tests required of manufacturers and processors are:
(87-61-6)
(95-50-1
& chemical fate
108-46-7)
(120-62-1) chemical fate and envi-
ronmental effects
Also on April 7, 1986, EPA proposed that certain TSCA test
guidelines be used as test standards for the development of
data under this final rule (51 FR 11756).
1,2,3-trlchlorobenzene
1.4-dlchlorobenzene
1 •2,4-trichlonobenzene
environmental effects
Cresola
EPA issued a final rule setting test requirements for
ers and processors of cresols and also proposed that ce ^
TSCA test guidelines be used as the test standards
quired studies. EPA also proposed on the same day. *P ^
1986, specified time frames for the test submissions t ^ ^
15803. The testing requirements proposal is a final Phase
rule of a proposed two-phase development process.
. __ _ _ amiSOi ISO"
Cresols is a chemical category consisting of three ^rTg
mere: oitho-cresoi (CAS No. 106-44-5), meta-creW' V* . re.
108-39-4) and para-cresol (CAS No. 106-44-5)- Th® _os0.
quires mutagenic effects studies including tests for Qn
mal aberrations, gene mutations and cellular transformations
specified cresot Isomers. Also required Is a developmental to*
ity study and two-generation reproductive effects study
each cresol isomer. When these proposed study plans 8"°
schedules are submitted, EPA wlli review them and then issue a
Phase il test rule oroDoaal.
EPA decided not to require environmental effects testing of cre-
sols at this time because the extensive data now avaitabie are
sufficient to reasonably predict the environmental effects of re-
leases of cresols.
4
-------
Dlethylenetriamine
On April 10, 1986 (51 FR 12344) EPA proposed the adoption of
study plans and schedules for testing diethylenetriamine
(DETA). Industry's submission of study plans for approval was
one of the first requirements of a May 23,1985 final Phase I rule
that requires manufacturers and processors of DETA (CAS No.
111 -40-0) to test the substance for oral subchronic toxicity,
dermal absorption, chemical fate and mutagenicity (both gene
mutation and chromosomal aberration).
Formamide
EPA has decided not to require further health effects testing of
formamide, an 1TC designated chemical. A Federal court in
1984 ruled that EPA must issue a proposed test rule for the
chemical by March 1986 or state reasons for not issuing one.
On February 27,1986 (51 FR 6929) EPA said it had determined
that data now available, including data received pursuant to a
negotiated testing agreement, are adequate to characterize
formamide (CAS No. 75-12-7) for health effects and no further
testing is required at this time. However, EPA said it may pro-
pose rulemaking to monitor any significant change in exposure
to the chemical.
Methylcyclopentane
EPA is proposing that manufacturers and processors of
methylcyclopentane (MCP) be required to test the chemical for
neurotoxic effects, and inhalation and dermal pharmacokinetics.
The Agency issued the proposed rule in response to the ITC's
designation of the chemical for priority consideration in 1985.
All current exposure to MCP results from Its presence in Ce hy-
drocarbon products such as commercial hexane. EPA finds
there is widespread exposure to commercial hexane, and is
proposing testing for that chemical within the same proposal
[May 15, 1986 (51 FR 17854)]. Manufacturers of hexane will be
required to test for acute and subchronic toxicity, oncogenicity,
reproductive toxicity, developmental toxicity, mutagenicity,
neurotoxicity, and inhalation and dermal pharmacokinetics, if the
final rule on MCP is unchanged.
MCP occurs naturally in crude oil and natural gas liquids and is
an unintentional constituent of some refinery hydrocarbon proc-
essing streams, such as straight-run gasoline, and in finished
petroleum products such as jet fuel and hexane solvent. MCP
also is present as a nonisolated in-stream component of a feed
stream used in the production of hexane isomers. Only one
company manufactures MCP in the United States.
The ITC designated MCP (CAS No. 86-37-7) for priority consid-
eration for health effects testing in Its 18th report (May 21,1985
(50 FR 20930)]. The ITC's rationale for conducting the tests was
based on the potentially high exposure of the general population
to MCP through the substance's presence in commercial hex-
ane solvents and gasoline, the fact that more than one million
workers may have been potentially exposed to MCP, and the
lack of animal inhalation testing—the route by which people are
more likely to be exposed to MCP.
C, Aromatic hydrocarbon fraction
Secona-phase regulation of the C» aromatic hydrocarbon frao-
«on began on March 27,1986 when EPA proposed test stand-
ards (61 PR 10557). The proposed standards closely fellow pro-
tocols submitted by the American Petroleum Institute, with minor
additions proposed by the Agency In the proposed rule, EPA
also proposed a schedule for testing the fraction.
Tetrabromobisphenol A
EPA is proposing that manufacturers and processors of
tetrabromobisphenol A (TBBPA) be required to test for chemical
fate and environmental effects. The compound is used primarily
as a reactive flame retardant in epoxy resins, polycarbonates
and unsaturated polyesters. To a lesser extent, it is used as a
reactive flame retardant. A small portion may be used as an ad-
ditive flame retardant in thermoplastics, polystyrene and phe-
nolic resins.
The May 15,1986 EPA proposed rule (51 FR 17872) responds
to the ITC designation of TBBPA (CAS No. 79-94-7) for priority
consideration for chemical fate and environmental effects
testing. No health effects tests were recommended by the ITC.
Triethylene glycol ethers
EPA proposed on May 15,1986 (51 FR 17883) that manufactur-
ers and processors of three triethylene glycol
ethers—monomethyl (CAS No. 112-35-6) monoethyl (CAS No.
112-50-5) and monobutyl (CAS No. 143-22-6)—test these sub-
stances for subchronic toxicity, developmental toxicity,
neurotoxicity, mutagenicity, reproductive toxicity and onco-
genicity. The ITC designated the three chemicals for health ef-
fects testing in its 16th report [May 12, 1985 (50 FR 20930)].
They are used primarily as diluents for brake fluid; the major ex-
posure is to people who work with brake fluid. Because these
chemicals have very low vapor pressure, the major human route
of exposure is dermal.
EPA Denies Two Petitions Concerning Planned PCB Facility
On February 24, 1986, EPA denied two citizens' petitions on
polycholorinated biphenyl (PCB) matters because the Agency
has neither the authority to amend TSCA, nor to issue a pro-
posed order to prevent construction of a planned PCB facility
(51 FR C423) as requested.
In November 1985, Citizens for Healthy Progress (CHP) peti-
tioned EPA under section 21 of TSCA to take action under sec-
tion 5(e) of the Act to halt construction of a planned PCB dis-
posal facility in Henderson, Kentucky. The petition claimed that
EPA lacked sufficient information at that time to make a decision
on the safety of the facility, and that construction of the facility
should not be allowed to occur until the Information is available.
CHP specifically asked EPA to "amend an order" under TSCA
section 5(e), by adding language which would permit the Admin-
istrator to issue a "proposed order" to prohibit the construction or
completion of a facility such as the one planned for Henderson,
pending the development of information.
In December 1985, a second group, Valley Watch (VW) also pe-
titioned EPA under section 21 of TSCA to issue either a "pro-
posed order" under section 5(e) of the Act, or an Injunction
prohibiting the construction of the Henderson facility, in addi-
tion, VW petitioned for the Issuance of a regulation under the
Resource Conservation and Recovery Act (RCRA), a law also
administered by EPA. The Agency treated that part of the re-
quest as a petition seeking rulemaking under subtitle C of
RCRA, EPA tentatively decided that VW's petition for rule-
making under RCRA should be denied, but said it intends to list
wastes containing PCSs as hazardous wastes under RCRA,
thereby subjecting PCB waste management facilities to RCRA
regulations.
In its roply to the TSCA portions of the petitions, EPA stated that
only Congress can amend the Act and that the Agency does not
have the authority under section 6(e) of TSCA to prevent con-
struction of the Henderson facility. Section 5(e) proposed orders
are invoked only when a proposed process involves a new
chemical substance not include in the TSCA inventory or a "sig-
ntficantnew use" of anexisting chemical.
-------
EPA Issues Final and Proposed SNUBs
EPA is proposing a TSCA significant new use rule (SNUR) for
four acrylate substances that the Agency believes to be hazard-
ous to health because certain uses of these substances may re-
sult in significant human or environmental exposure. The sub-
stances listed in the April 4,1986 proposed rule (51 FR 11591)
are:
2-oxepanone, homopolymer, ester with 3-hydroxy-2,
2-dimethylpropanoic acid (2:1), di-2-propenoate;
2-oxepanone, homopolymer, 2-propenoate, (tetrahydro-2-
furany) methyl ester;
2-oxepanone, homopolymer, 2-propenoate, ester with
2,2'-[oxybia (methylene)] bis (2-hydroxymethyl)-1,
3-propanediol);
2-propenoic acid, [2-(1,1-dimethyl-2-[(1-oxo-2-propenyl)
oxylethyl]-5-ethyl-1,3-dioxan-5-yl) methyl ester.
* * *
EPA issued a final TSCA significant new use rule (SNUR) for
two substances because it believes that they may be hazardous
to health and their use may result in significant human and envi-
ronmental exposures. The substances are hexamethylphos-
phoramide (HMPA; CAS No. 680-31-9) and urethane (CAS No.
51-79-6), which is also known as ethyl carbamate. Both sub-
stances are known animal carcinogens and suspected human
carcinogens. Neither chemical has been imported into the
United States or manufactured or processed here, for some
time. The March 19, 1986 SNUR requires that any person who
intends to manufacture, import or process either chemical for
any use must submit a significant new use notice to EPA (51 FR
9460).
EPA is proposing a SNUR to require persons to notify the
Agency at least 90 days before beginning the manufacture,
import, or processing of pentachloroethane (CAS No. 76-01-7)
for any use. At one time pentachloroethane was used as an in-
termediate in the production of tetrachtoroethyiene. The Agency
believes that initiation of a significant new use of penta-
chloroethane could result in significant human exposure. Should
the March 24, 1986 proposal become final, EPA will be able to
evaluate new uses, and take steps to protect against potentially
adverse exposures to the chemical substance before such ex-
posures can occur (51 FR 10024).
f PA Reports on New Asbestos Abatement Study
It is possible to remove asbestos-containing material from a
school and achieve low airborne asbestos levels after the re-
moval through post-removal cleanup. That was the major con-
clusion of a newly released EPA study of asbestos removal from
four schools In a suburban school district. The schools were se«
lected by EPA for the study because the district was committed
to an asbestos removal program, EPA was able to carry out the
study without setting the removal techniques used or the timing.
The study also concluded that transmission electron microscopy
(TEM) provides the clearest documentation of changes in
airborne asbestos levels, TEM and two other analytical meth-
ods, scanning electron microscopy and phase contrast micros-
copy, were studied. A 4-page asbestos-in-buildings technical
bulletin on the study ("Evaluation of Asbestos Abatement Tech-
niques; Phase t: Removal") is available through the TAO,
Agreements Enhance Federal Toxic Substances Control
The EPA Administrator recently signed separate agreements
with the heads of two other Federal agencies to enhance intera-
gency control of toxic substances. The^agreements coordinate
and streamline the way TSCA section 9(a) actions are handled
by EPA, the Occupational Safety and Health Administration
(OSHA) and the Consumer Product Safety Commission
(CPSC). Copies of the two memoranda of agreement are avail-
able through the TAO.
The intent of the two memoranda of understanding is to promote
more efficient EPA administration of TSCA section 9(a) actions
in order to conform with the responsibilities of OSHA and CPSC.
Section 9(a) requires that when EPA concludes that a sub-
stance poses an unreasonable risk to health or the environment,
and finds that the risk may be prevented or reduced to a suffi-
cient extent by action taken under another Federal agency's ju-
risdiction, the Agency then refers the substance to that other
agency.
EPA, OSHA and CPSC have different, though related, responsi-
bilities and objectives in carrying out their respective statutory
powers with regard to toxic substance control. In order to regu-
late a toxic substance under TSCA, EPA must make a finding of
unreasonable risk of injury to health or the environment. The
Occupational Safety and Health Act, enacted in 1970, requires
OSHA to demonstrate that there is a significant risk to employ-
ees from a substance in the workplace, in order for OSHA to
regulate that toxic substance.
CPSC administers three laws that could be used in certain cir-
cumstances to address those risks that EPA would otherwise
process under TSCA. These acts are the Consumer Product
Safety Act, the Federal Hazardous Substances Act and the
Poison Prevention Packaging Act.
EPA ReporU on Regulatory Investigation o(JEoiraaldeiuide,
On May 23,1984, EPA determined under section 4(f) of TSCA
that exposure to formaldehyde may pose significant risk of wide-
spread harm to the large number of persons who live in mobile
and conventional homes made with urea-formaldehyde wood
products and who manufacture apparel from fabric treated with
formaldehyde-based, durable-press resins. In announcing this
decison in the Federal Register (49 FR 21898), EPA stated that
it would report semiannually on the progress of its formaldehyde
investigation. This is the Agency's fourth report.
On March 19, 1986, EPA published a notice (51 FR 9409)
announcing that EPA was ending its investigation of the risk
posed by formaldehyde exposure in the workplace Including the
risk to manufacture apparel workers and was sending the infor-
mation it had developed to the Occupational Safety and Health
Administration pursuant to section 9(d) of TSCA.
With respect to the risks posed by exposures in mobile and con-
ventional homes, the Assistant Administrator of the Office of
Pesticides and Toxic Substances (OPTS) decided In October
1985 that EPA would await receipt of the results of two nearly-
complete epidemiology studies dealing with formaldehyde be-
fore further considering alternative actions It could take. These
studies should help to clarify the magnitude of human risk posed
by chronic formaldehyde exposure. One study performed by the
National Cancer Institute has since been completed; the other,
an EPA-sponsored study of exposures in the State of Washing-
ton, is presently in the final stages of preparation and review.
OPTS will analyze the information contained in these studies
and, based on this Information, revise the regulatory options pa-
per to be submitted to the Deputy Administrator of EPA. The
regulatory options paper will be the focal point for discussion at
an upcoming EPA options selection meeting, and will present
several alternative courses for future Agency action.
6
-------
EPA Seeks $2.7 Million for PMN Violation
EPA is seeking a $2.7 million civil penalty from Werner G,
Smith, inc., of Cleveland, Ohio, for violating the premanufactur-
ing notice requirements of TSCA. The proposed penalty is one
of the largest EPA has ever sought under the Act.
The civil administrative complaint, filed by EPA's regional office
in Chicago, charged the company with illegally manufacturing
several millon pounds of two new chemicals during 111 days of
production at a Cleveland plant between 1980 and 1982, and
subsequently, distributing these products. A fine of $25,000 per
day for each day of production is permitted under TSCA. The
names of both substances are classified as confidential busi-
ness information and will not be released by EPA.
Corporation Agrees to Pay $500,000 Fine
The BASF Wyandotte Corp. recently signed a consent agree-
ment with EPA and will pay $500,000 for violating the
premanufacturing notice provisions of TSCA. In 1985, the com-
pany was cited by EPA's regional office in Chicago for manufac-
turing a chemical that was not on the TSCA Chemical Sub-
stance Inventory. The chemical was used to formulate a variety
of products that were distributed in commerce. BASF Wyandotte
also was cited for importing a second chemical not on the TSCA
Inventory.
Under the terms of the agreement the corporation also is re-
quired to certify to EPA by June 15, 1986, that all chemicals
manufactured, imported and used at 13 of its facilities are on the
TSCA Inventory.
Company Fined for Illegal Manufacture of Chemicals
EPA assessed a $476,250 penalty against E.I. du Pont de
Nemours and Company for violating the premanufacturing no-
tice provisions of TSCA. The violations were voluntarily dis-
closed by du Pont. In the administrative civil complaint, EPA
cited du Pont with failing to notify the Agency prior to manufac-
turing two new chemicals. TSCA requires manufacturers and
importers to notify EPA 90 days prior to manufacturing or
importing a new chemical which is not the TSCA Inventory. The
complaint also cited du Pont for using chemical substances for
commercial purposes. The chemicals were not named in the
complaint because du Pont declared them to be confidential
business information.
Ciba-Geigy Pays $172,000 For PMN Violation
On March 24, 1986 EPA officials in Chicago signed a consent
agreement with Ciba-Geigy Corp. concerning violations of TSCA
premanufacturing notice (PMN) requirements. Ciba-Geigy
agreed to pay a penalty of $172,000 for the PMN violations.
In June 1985, EPA charged Ciba-Gelgy's Ren Plastics unit in
East Lansing, Michigan, for Importing two chemical substances
not on the TSCA Inventory. The corporation was also cited for Il-
legally using two of the chemicals on several occasions to for-
mulate products that were distributed in commerce.
TSCA requires a company to notify EPA 90 days before manu-
facturing or importing a new chemical not on the TSCA Chemi-
cal Substance Inventory. This gives the Agency time to evaluate
the chemical's Impact on health and the environment. If a chem-
ical presents an unreasonable risk, EPA can regulate or ban it?
manufacture, distribution, use and disposal.
PMN Revisions Cover R&D Procedures
On April 22,1986, EPA published final regulations tor the stayed
provisions of TSCA's premanufacturing notice (PMN) rule, aa
well as several other provisions of the rule. These revisions Be-
come effective on June 5, 1986.
The major provisions of this action address the:
• terms of the export-only exemptions tor PMN requirements
• definition of data In a person's possession or control
• Information requirements concerning data on chemicals re-
nted to the PMN substance
• procedural and recordkeeping requirements associated with
the Act's seotlon 5(h)(3) exemption
• requirements related to the notice of commencement of
manufacture
Of particular interest to PMN filers are thee&anoas in
reouirements reiated to research ami devetopn^1^^"'
efhpnon. Recordkeeptafl for R&D acttvttiea are
white at tne same time manufacturers are provided suDKarroftny
more flexibility in usino or disposing of. R&D materials alter com-
pletion of R&D activities.
For mere irrformattsm about (51 FR 16096) contact th# TAQ.
Inventory Videotape
To aid persons who must report during the partial
updating of the TCSA foventory:(see page 10 of this le-
#ue), the TAG has produced an 16»mir»ute instructional
videotape;
TSCA Inventory Update:
An Overview for Chemical Manufacturers and
importers
The tape can be bought in Beta I, Beta ll, VHS, or 3/4"
formate from:
Color Film Corp;, Video Division
770 ConnecticutAve.
NorwaJk, Of <#854
(800)882-1120
(203) 888-2711
The coftla; $23.10 for Beta l and ii. mSG for VHSand
$31.28 for W, eomwwcut residents and corporations
add 7.5%.
ooplec of the acrlpj and
videotape on «aen tonrwct avaBafcle for loan periods of
«GWf»4tyf» jw seflptwwjape may be reproduced.
I
-------
OTS Seeks CHIP Data
OTS is asking the puaiic for unpublished information about the
following chemical:
Chlorendic acid/anhydride (CAS No. 115-26-6 & 115-27-5}
This chemical has been selected for a preliminary assessment
review. Information should be sent to:
TSCA Document Control Office (TS-790)
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 LeiUke of Hie OTS Chemical Screening Branch,
(202) 362-3507, as soon as possible.
All information submitted in response to the solicitation will be
placed in a public file and made available for public inspection,
unless the submitter is alJle to assert a claim of confidentiality.
EPA will handle all confidentiality claims In accordance with its
procedures governing the confidentiality of business information.
The CTS 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 o' exposure.
chemical than can be acquired using automated data bases and
standard reference works. Thus, OTS encourages individuals
and firms to submit unpublished or recently published reports
and all other hard-to-oblaln 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 me 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 to preparing an annotated bibliography an 2-nl-
tropropane (CAS No. 79-46-9) for the World Health Or-
ganization. Those wishing to submit unpublished informa-
tion on this chemical should follow the same procedures
as for CHIPS.
Thtt TAO la distributing copies of the tallowing recently
completed CHIP:
Basic Red 8 Mono HCl [CAS No 569-St-9i
New Data Available on 10 Substances
OTS received new test data submissions on 10 chemicals and
category of chemicals that are subject to negotiated testing
agreement programs under TSCA section 4 (February 24,1986
(51 FR 6168)]. The data are available for inspection at the OTS
Public Reading Room, first floor fr. 107), East Tower, Waterside
Mall, 401 M St., S.W., Washington, D.C.
Persons interested in obtaining copies of the dsta may wirle:
EPA, Freedom of Information, Ms. Jeralene Green (A-101)
Washington, D.C. 20460. There is a 20 cent charge for
duplicating each page.
The chemical categories or specific chemicals with their Chemi-
cal Abstract Service Registry numbers are:
Alkyl phthatate category
Antimony troxide 1309-64-4
Aryl phosphate category
Bis(2-ethyihexyl) terephthalale 6422-06-2
2-ChSorotoluene 9549-6
1,3-Dioxolane 646-06-0
Hydroquinone 125-31-9
Phenylenediarnine category
Propylene oxide 76-56-9
Tris (2-ethylhexyl) trimellitate 3319-31-1
Section 6(e)... Substantial Risk
Below is a list of initial section 8(e) notices recently 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.
uogMo.seHQ- tets/'Wrr
1285-0561
C.». Basic Red 12 6320-14-5
Summarized results of en acute oral toxicity study in rats
0166-0582 S
Chlorophenoxy chloropheny! alkyl substituted heteromono-
cyclic heteromonocycle
Pr&liminaty results of a 13-week dietary feeding study in dogs
0565-0563 S
1085-0583 S Followup
HAD Chemical
Interim results of a 2-year dietary oncogenicity and ctironc tox-
icity study in mice
0186-0584
5-i(2-Ethylthio)propyl]-2-( 1 -oxopropyt)- 99422-01-2
1 3-cyclohexanedione
Summarized results of an scuta ens/ toxicity study in rats
0186-0585 S
Tiniwln® 144 63843-89-0
Final results of a 28-day oral gevaga study M rats
018WK86S
2-Chloro-N-methyi-N-subsHtuted-acetairtde (PMN 84-393)
Summarized results of a 90-day dietary feeding study in rats
0186-0567
Phenyletftyt alcohol 60-12-8
Preliminary rssufts of oral and dermal ferafotogfc studies in rats
8
-------
0286-0588
Mercury vapor and manganese dust
Published study on fertility of male workers exposed to mercury
vapor or manganese dust
0386-0589 S
C.I. Reactive Orange 12 12225-84-2
Observation of respiratory sensitization in workers
0386-0590 S
Alkyl aryl phosphine (PMN 83-1023)
Summarized results of a 28-day neurotoxicity study in rats
0386-0591
Dioctyl dimethyl ammonium chloride 5538-94-3
Summarized results of a sub-acute skin application study in
rabbits
0386-0592
Acrylic acid 79-10-7
Summarized results of 1) chronic dermal application in mice
and 2) in vitro DNA binding study
0386-0593
Ethoxyethyl acetate 111-15-19
Emergency incident of environmental contamination
"S" at the end of a Log Number means a santized 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".
Latest ffll^tnhfrstohs
In recent weeks EPA received the following FYI (For Your
Information) submissions listed below. "For additional In-
formation on FYls see page 12 of this Bulletin.
Document Control No. FYI-
Chemical Name(«)
CAS No.
OTS-0186-0473
Substituted Methylpyridlne Confidential
Summarized final results from a 2-week Inhalation study In rats
and mice
AX-0186-0474
Hydrodesulfurized Kerosine 64742-81-0
Hydrodesulfurized Middle Distillate 84742-80-9
Final report from a 4-week Inhalation study In rats
AX-0186-0475
Low Boiling Petroleum Fractions Unknown
Final report from a mosua skin-painting carcinogenesis
bioassay
OTS-0186-0476
Sodium Dlmethyldlthiocarbamate 128-04-1
Final reports from a battery of genotoxldty assays:
AX-0286-0477
Tri-2-Ethylhexyl Trimellitate 3319-31-1
Final reports from a 28-day rat feeding study and a 21-day life
cycle test in Drosophila magna
OTS-0286-0478
Diundecyl Phthalate 368-20-2
Phthalate Esters None
final report from a 21-day feeding study in rats; metabolismI
pharmacokinetics data for several phthalate esaters
OTS-0286-0479
Diisopropyl Sulfate 2973-10-6
EPA request for information for a CHIP in preparation
OTS-0286-0480
Sodium Dimethyldithiocarbamate 128-04-1
Report of nltrosamine contamination in samples of a chemical
used in rubber production and pesticide manufacture
AX-0286-0481
Polynuclear Aromatic Hydrocarbons (PAHs) None
Preliminary report from a study to determine PAH levels in fish
tissue following various methods of cooking
OTS-0286-0482
Benzene 81-43-2
Letter describing the occurrence of leukemia and other
hematopoitic tumors among workers exposed to ambient air
pollutants, Including benzene
OTS-0286-0483 S
Substltued Dlphenyl Ether Confidential
Summarized final results from an oral teratology probe study In
rats
OTS-0286-0484 S
Polychlorlnated Biphenyls (PCBs) 1336-36-3
Letter reporting PCB contamination of electrical cables
OTS-0286-0485
Formaldehyde 50-00-0
Latter discussing the results of an epidemiologic mortality study
0TS*Q38&0496 23209-59-8
Pheephrt* Fiber ¦
Summarized final reeutte irom a rat plural Implant study
AX-0386-0487
Petroleum Hydrocarbons None
Final report from a pathology study comparing normal renal tis-
sue In hydrocarbon exposed arid non-exposed humans who
developed renal cell carcinoma ¦¦¦¦<¦¦•
AX-0386-0488
Gasoline Vapors None
Preliminary report on toe absorption of inhaled gaaolkm vapors
inrats
AX-0386-0489 P
Borax 1303-96-4
Letter describing acute toxic reactions in human* fallowing ex-
posure*) borated soaps
OTS-03W-0490 -
74NM^»43ihydio-2> 38420-60-9
Plmetftylfeerutofuran Bteulfate
Smm0ied1lftatieaua* turn an Ames mutagenicity assay.
-------
TSCA CHEMICAL SUBSTANCE INVENTORY: 1985 Edition
The Toxic Substances Control Act (TSCA) Inventory lists over
63,000 chemical substances (as defined by TSCA) whose man-
ufacture, importation, or processing for commercial purpdg&SIn
the United States has taken place since January 1, 1975.
The printed Inventory is a 5-volume set containing TSCA Inven-
tory substances listed by Chemical Abstract Service (CAS) Reg-
istry Numbers or Accession Numbers (Volume I). Indexes are
provided for Substance Names (Volumes II & III), Molecular For-
mulae (Volume IV) and substances of Unknown or Variable
Composition, Complex Reaction Products and Biologicals, and
Substances Subject to Regulatory Action (Volume V).
Those who wish to purchase 5-volume sets should fill out the at-
tached order form and mail it to: Superintendent of Documents,
Washington, DC 20402.
ORDER FORM
Mail to: Superintendent of Documents
Washington, DC 20402
(202) 783-3238
~ Yes, please send me sets of the 5-volume TSCA In-
ventory: 1985 Edition at $181.00 per set for the U.S. and Can-
ada; and $201.25 for anyone outside of the U.S. or Canada.
(S/N 055-000-00254-1)
The total cost of my order is $
(Please type or print.)
(Nam#'
(Address)
(Additional address)
(Additional address)
(City, State and Zip Code)
Please check method of payment:
~ Check made out to the Superintendent of Documents.
~ GPO Deposit AcoountODDtlODCHZ]
~ VISA, MasterCard or Choice.
¦ (Signature)
(Credit Card Expiration Date) ~
New Rule Requires Partial Updating of TSCA Inven-
tory Production and Site Data
EPA is issuing a rule requiring manufacturers and import-
ers of certain chemical substances included on the TSCA
Chemical Substance Inventory to report current data on
production volume, plant site and site-limited status of
these substances.
Companies who are uncertain as to whether substances
they manufacture or import are included on the inventory
should consult the TSCA Chemical Substance Inven-
tory 1985 Edition (see form on this page).
During the initial reporting period every manufacturer of a
substance covered by this rule who produces over
10,000 pounds (4,540 kilograms) per year of a reportable
substance must report separately on every substance at
each plant site. After the initial reporting period, the same
type of reporting will be required every four years, so long
as the rule is in effect.
Four categories of substances on the TSCA Inventory are
generally excluded from reporting: polymers, inorganic
substances, microorganisms and naturally occurring sub-
stances. However, no substance, except one which is
naturally occurring, is excluded from reporting if the sub-
stance is subject to an order issued under section 5(e) of
TSCA or subject to a rule proposed or issued under sec-
tion 4, 5(a)(2), 5(b)(4), or a rule issued under section 6
nwBila lmiiwtJfwty wmmwr wmui ¦initial*
substance is subject of relief granted under a civil action
under section 5 or 7.
Small businesses (as defined by the rule) are exempted
from reporting except for substances which are subject to
an order, rule, or action listed above (with exception of
section 5(c)(2) SNURs).
Manufacturers and importers may obtain reporting mate-
rials, including copies of the rule, reporting instructions
and reporting forms by contacting:
EPA Document Control Office
ATTN: Inventory Update Rule
OTS TS-790
401 M St. SW
Washington, D.C. 20460
(202) 382-3598 and 755-4880
The specialists at this office will answer questions about:
Filing of forms
Current actions on TSCA chemicals
Filing by computer tape
Status of filed forms
Availability of instructionai videotape
(See page 7 of this issue for information on a inventory
videotape)
10
-------
®®tew and on the next page are explanation# of sections of
TSCA that are cited In this Issue of the Bulletin. For addi-
tional Information about TSCA's provisions, call (800)
424-8065; In the Washington, D.C. area, (202) 554-1404, or
write the TAO.
Tasting 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 starting 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.
SionffloantNew Uee RuleeftNUftoK.^
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.
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.
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-
atarwe. Tne action can be taken if information available to EPA
Is irtmJfflcteht to permit a reasoned evaluation of the health and
environmental effeots of the substance; and it the substance
A section 5(e) order may be issued also if there is insufficient in-
formation 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 db a consent order or a unilateral order,
lit a consent order, &pa negotiates the terms of the order with
the company that submitted the notice. Ths comuany 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 T8CA. 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 of
use in commerce of the substance without negotiating the terms
of the order with the company that submitted the notice.
Health and Safety Data
... 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
processors 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,
11
-------
Part ial
Corrections to Information Concerning
Updating of TSCA Inventory Production and
(Inventory Update Rule)
Site Data
Several errors have appeared in the FEDERAL REGISTER notice
of June 12, 1986 announcing the Inventory Update Rulefot^in the
article on the Inventory Update Rule appearing i n the June
1986 edition of the "TSCA ChemicaLs-in-Progress Bulletin."
The correct information is as follows:
NEW RULE REQUIRES PARTIAL UPDATING OF TSCA INVENTORY
PRODUCTION AND SITE DATA
On June 12, 1986, EPA published a rule in the FEDERAL REGISTER
(51 FR 21438) requiring manufacturers and importers of certain
chemical substances included on the TSCA Chemical Substance
Inventory to report current data on production volume, plant
site and site-limited status of these substances.
Four categories of substances on the TSCA Inventory are
generally excluded from reporting: polymers, inorganic
substances, microorganisms, and naturally occurring substances.
However, no substance, except one which is naturally occurring,
is excluded from reporting if the substance is subject to a
rule proposed or issued under section 4, 5(a)(2), 5(b)(4) or
6 of TSCA, is tho subject of an order issued under section
5(e) or 5(f), or is the subject of relief granted under a
civil action under section 5 or 7.
Small businesses, as defined by 40 CFR §704.3(r), are exempted
from reporting except for substances which are subject to an
order, rule, or action listed above (with the exception of
section 5(a)(2) SNURs). Other exemptions are discussed in
the rule.
Companies report by individual plant site. For each reportable
substance a company manufactures or imports, it is required
to report data only for those plant sites with an annual
production volume of at least 10,000 pounds.
Reporting is to take place between August 25, 1986 and December
23 , 1986 (the FEDERAL REGISTER notice incorrectly listed
October 10, 1986 as the end of the reporting period).
Reporting will also be required between August 25, 199U and
December 23, 1990, and every four years thereafter.
Companies who are uncertain as to whether substances they
manufacture or ii^(^y:t are included on the TSCA Inventory may
consult the "TSCA^^mical Substance Inventory: 1985 Edition"
(available from the Government Printing Office). A computer
tape version of the Inventory will also be made available
this summer from the National Technical Information Service.
See the reporting instructions tor information on ordering
the Inventory.
Manufacturers and importers may obtain reporting materials,
including copies of the rule, reporting instructions and
reporting forms, by contacting:
OTS Document Control Officer (Room E-220)
U.S. Environmental Protection Agency
Office of Toxic Substances (TS-790)
401 M Street, S.W.
Washington, DC 20460
Attn: Inventory Update Rule
Telephone: (202) 382-3698 or (202) 755-4880
The specialists at this otfice will answer questions about:
Reporting requirements
Filing instructions
Status of filings
Current actions on TSCA chemicals
-------
se-o ON tiUiJBd
„ Vd3
piBj saaj pue sSeisod
|ic^ sseio isjy
HOLLOW NOIIOHHHOO INVMOdWI
Niianna tS3aooadj|HsivDiiAi3Ho vosi 3Hi
091702 0 a 'uoj6uiqse/\ft
ones WTSTI
Bsn sibauj joj Ajieuaj S80UBjsqns Ojxoj^ 43 sapuiisaj jo aoj^O
ssauisng isiaiyo (66Z."Si.) 0O!WO aoueisissy Ajjsnpui
IMPORTANT fDRRECTICW NOTICE
ON THE
inventory UPDATE
-------
Substantial Risk ... Section 8(e)
Under section 8(e), persons who obtain new information that
reasonably supports the conclusion that a substance or mixture
which they manufacture, import, process or distribute presents
substantial risk or injury to human health or the environment,
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 judgment
in compliance with the statute to submit a notice within 15 work-
ing days of obtaining the information.
EPA publishes its status reports to make 8(e) information widely
available and understandable to a broad public. The submis-
sions 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
duplicating the first 49 pages, but at page 50 of a request for du-
plication there is a $10.00 fee and a 20 cent charge for each ad-
ditional page (e.g., 51 pages will cost $10.20).
Single copies of the section 8(e) status report? (not the full sub-
missions) are available from the TAO.
Cltzens' 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. If 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 FY1, follow the
Bravura.jouUinfid..urw1nr. lartinn UA nn ,»hi>
page.
TSCA Assistance Office (TS-799) otneM •mtMu
Office of Pesticide & Toxic Substances *"¦"* »«* *•
U.S.E.P.A.
Washington, D.C. 20460.
nrttCMMMlM
and Hm NW
fPA
Ptrmtt Mo. O-M
THE TSCA CHEMICALS-IN-PROQRESS BULLETIN
------- |