TSCA
Chemicals-in-Progress ! ¦!
SfesE *t
(OTS) ^
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1?
Vol. 4, No. 6 December 1983
This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (TSCA) about
recent developments and near-term plans. For further information or to request copies of documents mentioned,
write the TSCA Assistance Office (TAO), (TS-799) EPA, Washington, D.C. 20460, or call toll-free 800-424-9065 or, in
Washington, D.C., or from outside the continental United States, (202) 554-1404.
REGULATORY & REQUIRED ACTIONS
TESTING OF CHEMICAL SUBSTANCES
AND MIXTURES... SECTION 4
Section 4 of TSCA gives EPA authority to require manu-
facturers or processors of chemicals to test the toxic ef-
fects of a designated substance. To require testing EPA
must find that the chemical may present an unreasona-
ble risk; that there are insufficient data available with
which to perform a reasoned risk assessment; and that
testing is necessary to generate such data. A test rule
may also be based on an EPA finding of substantial pro-
duction and exposure to humans or the environment, in
addition to findings of insufficient data and need for
testing.
Under section 4(e) an Interagency Testing Committee
(ITC) was established to recommend chemicals to EPA
for priority consideration for the promulgation of sec-
tion 4 test rules. The ITC can designate up to 50 chemi-
cals or categories of chemicals for testing and must
make revisions to this section 4 priority list as needed.
In turn, EPA must respond within one year after the ITC
adds a substance to the priority list, by starting
rulemaking under section 4 or giving reasons for not
doing so.
The ITC is made up of appointed members from eight
Federal agencies, as specified in TSCA. Representatives
from six additional Federal agencies serve in a liaison
capacity.
Section 4(f) requires EPA within 180 days after receipt
of test data (or other information that indicates a chem-
ical substance or mixture may pose a significant risk of
serious or widespread harm to human beings from can-
cer, gene mutations or birth defects) to: (a) initiate ap-
propriate action under sections 5, 6, or 7 of TSCA or (b)
publish a notice saying why the risk is not unreasona-
ble. The 180-day review may be extended for up to 90
additional days for good cause.
EPA Voids Its 4(f) Formaldehyde Judgment
EPA has rescinded its February 1982 decision that sec-
tion 4(f) does not apply to formaldehyde. In a Novem-
ber 18, 1983 notice (48 FR 52507) EPA announced this
decision and asked the public to provide their com-
ments to help the Agency determine whether formalde-
hyde will present a significant risk to humans.
In February 1982, EPA decided that formaldehyde did
not meet statutory criteria for priority consideration un-
der section 4(f). The 1982 decision prompted a July
1983 lawsuit by the Natural Resources Defense Council"
and the American Public Health Association. Because of
controversy surrounding the decision, the Agency de-
cided to reexamine the issue.
Persons sending EPA comments on whether formalde-
hyde will present a significant risk to humans must in-
clude the code "OPTS 44004." The comments must be
received by EPA by January 17, 1984. They should be
sent in triplicate to:
EPA—TS 793
TSCA Public Information Office
Washington, D.C. 20460
Section 8(c) Videotape Available
The TAO now has available an 18-minute videotape that
outlines the recording and reporting requirements of
section 8(c) of TSCA. The tape will aid in understanding
the rationale for the rule, what a significant adverse re-
action is, the relationship of 8(c) to other parts of the
Act, and who is subject to 8(c). The tape also suggests
ways of developing an 8(c) recordkeeping system. The
tape is available on a lending basis in 3/4", VHS and
Beta 2. A transcript is also available. To order, write or
call the TAO.
1
-------
EPA Negotiates Testing on TOTM
EPA at this time will not initiate rulemaking for health
and environmental effects testing for tris (2-ethylhexyl)
trimellitate, which is also known as trioctyltrimellitate
(TOTM). In its 11th report, the ITC designated TOTM for
health and environmental effects testing consideration.
Since then, the Chemical Manufacturers Association
(CMA) has presented EPA with a program for testing.
EPA has tentatively concluded INovember 14, 1983 (48
FR 51842)J that the CMA program when combined with
related data from the CMA phthalate esters program
and the National Toxicology Program information will
supply enough data so that the toxicity of TOTM can be
predicted. Comments on the Agency's decision should
be received by EPA by December 29, 1983.
No Rulemaking Plans for TMBP
EPA is not initiating rulemaking on 4-(1,1,3,3-tetra-
methybutyl)phenol (TMBP) at this time, because the
Agency received new health effects information and is
now negotiating with industry to perform additional
testing. While the data do not provide adequate infor-
mation, the negotiated testing will provide sufficient
informtion to reasonably predict the effects of TMBP.
TMBP was recommended for testing by the ITC in No-
vember 1982 in its 11th report. The ITC had recom-
mended the substance be tested for short-term health
effects including mutagenicity and environmental ef-
fects, including acute and chronic toxicity to fish and
aquatic invertebrates, toxicity to plants, bioconcentra-
tion and chemical fate. EPA's decision not to initiate
rulemaking on TMBP was published on November 15,
1983 (48 FR 51971).
EPA Approves Industry Test Plan for 1,3 Dioxolane
EPA has tentatively decided that a testing program pre-
sented by two corporations is sufficient to evaluate the
potential health effects of 1,3 dioxolane. Consequently,
EPA is not initiating rulemaking under section 4. The
ITC, in its 11th report, had designated 1,3 dioxolane for
health effects testing consideration. Since then the
Ferro Corp. and PPG Industries submitted to EPA a joint
proposed testing plan. In tentatively concluding that the
joint program will provide sufficient informtion to eval-
uate the substance's health effects ((November 14, 1983
(48 FR 51839)1, EPA is asking for comments on the ade-
quacy of the plan and the Agency's conclusion. Com-
ments should be received at EPA by December 29,1983.
EPA Proposes Negotiated Testing Program for OOTP
EPA will not begin section 4 rulemaking for dioctyl ter-
ephthalate (DOTP) because it has tentatively accepted a
negotiated testing program for the substance. In its
11th report, the ITC designated bis(2-ethylhexyl) tere-
phthalate, also known as DOTP, for health and environ-
mental effects testing consideration. After negotiating
with the Agency, Eastman Kodak Co. presented EPA
with a health and environmental effects testing pro-
gram for DOTP. In addition, the National Toxicology
Program nominated a variety of chemicals containing
the 2-ethylhexyl moiety and 2-ethylhexanol for toxicity
testing. EPA has decided [November 14, 1983 (48 FR
51845)] that these two programs will provide sufficient
data to evaluate the health and environmental effects of
DOTP. All comments on EPA's action should be re-
ceived at the Agency by December 29, 1983.
Find Insufficient Basis for Alkyltin Rulemaking
EPA is not initiating rulemaking under section 4 for sev-
en alkyltin substances at this time. In November 1982,
the ITC designated the seven alkyltin substances for pri-
ority consideration. The ITC recommended the sub-
stances be considered by EPA for chemical fate and en-
vironmental effects testing. But, in a November 8, 1983
notice (48 FR 51361), EPA indicated there is insufficient
basis to find that the substances present an unreasona-
ble risk to the environment, or that there is or may be
substantial environmental release of the substances. In
coming to its decision, EPA considered the information
in the ITC report, other published and unpublished data,
production volume, use and exposure information re-
ported by manufacturers of the alkyltins.
The notice stated that the environmental release of the
seven designated mono or dialkyltins is not substantial,
and that the Agency found no evidence that the current
manufacture, distribution in commerce, processing, use
or disposal of the substances present an unreasonable
risk of injury to the environment.
The seven alkyltin substances are-.
Dibutyltin bis(isooctyl maleate)
25168-21-2
Dibutyltin bis(isooctyl
mercaptoacetate)
25168-24-5
Dibutyltin bis(lauryl mercaptide)
1185-81-5
Dibutyltin dilaurate
77-58-7
Dimethyltin bis(isooctyl
mercaptoacetate)
26636-01-1
Monobutyltin tris(isooctyl
mercaptoacetate)
25852-70-4
Monomethyltin tris(isooctyl
mercaptoacetate)
54849-38-6
EPA Approves Plans for Testing MIBK and MEK
EPA has given final approval to an industry sponsored
program for health effects testing of methyl isobutyl ke-
tone (MIBK) or methyl ethyl ketone (MEK). In a Septem-
ber 30, 1983 notice (48 FR 44905) EPA found no reason
to alter a December 29, 1982 preliminary decision not to
propose a section 4(a) rule.
In 1979, the ITC designated the two chemicals for priori-
ty consideration for health effects testing, but after the
designation additional testing data were made available
to EPA. In addition, since the designation, major U. S.
manufacturers of both chemicals have given EPA plans
for testing. Because of the newer data, and recent nego-
tiations between EPA and the manufacturers, EPA said
in a December 29, 1982 notice that rulemaking to re-
quire the testing recommended by ITC was not war-
ranted. However, in the December 1982 notice EPA
asked for comments on the Agency decision.
EPA received comments on the proposed negotiated
testing agreements from the Natural Resources Defense
Council (NRDC) and from the Ketones Program Panel, of
the Chemical Manufacturers Association. No other com-
ments were received. The Ketones Panel advocated ac-
ceptance of the program submitted to EPA. NRDC
raised various legal issues about EPA's acceptance of a
negotiated testing agreement in lieu of rulemaking un-
der section 4(a). NRDC was also concerned about the
setting of schedules for testing.
2
-------
ITC Adds 4 Chemicals to Priority List
The ITC transmitted its 13th report to EPA Administrator
William D. Ruckelshaus, on November 8, 1983. The re-
port added four chemicals to the section 4(e) priority
list. The chemicals are:
2-(2-Butoxyethoxyl)ethyl acetate
Ethylene bis(oxyethylene) diacetate
1,2,3,4,7,7-Hexachloronorbornadiene
Oleylamine
Each of the four chemicals has been designated by the
ITC to be given priority consideration for the promulga-
tion of testing rules. EPA must respond to the ITC with-
in 12 months. In a December 14, 1983 notice, EPA
scheduled focus meetings on the four substances for
January 16 and 17, 1984. Call the TAO for the hours
scheduled for each chemical. The focus meetings will
be held at:
EPA—Waterside Mall
401 M Street, S.W.
Washington, D.C.
On the subject chemicals EPA invites detailed written
comment or additional information about ongoing
health and safety studies or human and environmental
exposure. Written comments should be received on or
before January 13, 1984, and bear docket number OPTS
41013, and be sent to:
TSCA TS -793
Public Information Office
Room E -108
Washington, D.C. 20460
Chemicals
2-(2-
Butoxyethoxy)
ethyl acetate
124-17-4
Ethylene
bis(oxyethylene)
diacetate
111-21-7
13th ITC Report
Recommended Studies
Health Effects:
subchronic toxicity; toxicokinetic
studies; reproductive effects.
Health Effects:
subchronic toxicity; toxicokinetic
studies; reproductive effects.
1,2,3,4,7,7-
Hexachloro-
norbornadiene
3389-71-7
Health Effects:
subchronic tests, including
neurotoxicity; biochemical ef-
fects, including enzyme- inducing
capabilities.
Oleylamine Health Effects:
112-90-3 toxicokinetic studies;
genotoxicity and teratogenicity
studies if percutaneous absorp-
tion is demonstrated.
See ralated ITC story on paga 10.
The TSCA Section 4(e) Priority List*
November 1983
Entry Date of Designation
Chemicals and groups of chemicals designated for response within
12 months
8
9
10
11
12
13
14
15
16
17
18
19
20
Alkyl epoxides 10/77
Aniline and bromo-, chloro-, and/or
nitroanilines 4/79
Aryl phosphates 4178
2-(2-Butoxyethoxy)ethyl acetate 11 /83
Calcium naphthenate 5/83
Chlorinated benzenes, mono- and di (envi-
ronmental affects) 10/77
Chlorinated benzenes, tri-, tetra-and
penta-(environmental effects) 10/78
Cobalt naphthenate 5/83
Cyclohexanone 4/79
1,2-Dichloropropane 10/78
Ethylene bis(oxyethylene) diacetate 11 /83
Glycidol and its derivatives 10/78
Halogenated alkyl epoxides 4/78
1,2,3,4,7,7-Hexachloronorbornadiene 11 /83
Hydroquinone 11/79
Lead naphthenate 5/83
Methylolurea Do
Oleylamine 11/83
2-Phenoxyethanol 5/83
Quinone 11/79
Other Recommended Chemicals and Groups of Chemicals
Entry Date of Recommendation
Recommended but not designated for response within 12 months
1 Carbofuran intermediate
11/82
*This list is updated to reflect very recent EPA actions
and therefore differs with the ITC 13th Report submitted
to EPA.
Cumulative Removals from the TSCA Section 4(a)
Priority List*
November 1983
EPA Responses to ITC Recommendations
Federal Register Notice
Chemical/Group Do=Ditto
1
Acetonitrile
47 FR 58019
12/29/82
2
Acrylamide I health enacts)
45 FR 48510
7/18/80
(environmental effects)
48 FR 724
1/6/83
3
Alkyl phthalates
46 FR 53775
10/30/81
4
Alkyltin compounds'
46 FR 5456
2/5/82
5
Antimony metal
48 FR 716
1/6/83
6
Antimony sulfide
Do
Do
7
Antimony trioxide
Do
Do
8
Benzidine-based dyes
46 FR 55004
1W5/81
9
Benzyl butyl phthalate
46 FR 53775
10/30/81
10
Biphenyl
48 FR 23080
5/23/83
3
-------
11 Bis(2-ethylhexyl)terephthalate 48 FR 51845
12 Butyl glycolyl butyl phthalate 46 FR 54487
13 Chlorendic acid 47 FR 44878
14 Chlornates benzenes 45 FR 48524
(health effects)
15 Chlorinated naphthalenes 46 FR 54491
16 Chlorinated paraffins 47 FR 1017
17 Chlorobenzotrifluoride 47 FR 50555
18 Chloromethane 45 FR 48524
19 2-Chlorotoluene 47 FR 18172
20 Cresols 48 FR 31812
21 o-Dianisidine-based dyes 46 FR 55004
22 Dibutyltin bis(isooctyl 48 FR 51361
maleate)2
23 Dibutyltin bis(isooctyl Do
mercaptoacetate2
24 Dibutyltin bisdauryl Do
mercaptide)2
25 Dibutyltin dilaurate2 Do
26 Dichloromethane 46 FR 30300
27 Diethylenetriamine 47 FR 18386
28 Dimethyltin bis(isooctyl 48 FR 51361
mercaptoacetate)2
29 1,3-Dioxolane 48 FR 51839
30 Ethyltoluene 48 FR 23088
31 Fluoroalkenes 46 FR 53704
32 Formamide 48 FR 23098
33 Hexachloro-1,3-butadiene 47 FR 58029
34 Hexachlorocyclopentadiene 47 FR 58023
35 Hexachloroethane 47 FR 18175
36 Isophorone 48 FR 727
11/14/83
1112 /81
10/12/82
7/18/80
1112 /81
1 18182
11/8/82
7/18/80
4128182
7 n 1 J83
11/5/81
1118183
Do
Do
Do
6/5/81
4 /29182
11/8/83
11/14/83
5123183
10/30 /81
5 /23 /83
12/29182
Do
4/28/82
1 /6/83
37
Mesityl oxide
48 FR
30699
715183
38
4,4-Methylenedianiline
48 FR
31806
1111183
39
Methyl ethyl ketone
47 FR
58025
12/29 /82
40
Methyl isobutyl ketone
Do
Do
41
Monobutyltin tris(isooctyl
48 FR
51361
1118183
mercaptoacetate)2
42
Monomethyltin tris(isooctyl
Do
Do
mercaptoacetate)2
43
Nitrobenzene
46 FR
30300
6/5 /81
44
Phenylenediamines
47 FR
973
1 18182
45
Polychlorinated terphenyls
46 FR
54482
11 12 /81
46
Pyridine
47 FR
58031
12/29/82
47
4-(1,1,3,3-Tetramethylbutyl)
48 FR
51971
11 /15/83
phenol
48
o-Tolidine-based dyes
46 FR
55004
11/5/81
49
Toluene
47 FR
56391
12/16/82
50
1,2,4-T rimethylbenzene
48 FR
23088
5123183
51
Trimethylbenzenes
Do
Do
52
1,1,1-Trichloroethane
46 FR
30300
615 /81
53
Tris(2-chloroethyl)phosphite
47 FR
49466
11 /1 182
54
Tris(2-ethylhexyl)trimellitate
48 FR
51842
11/14/83
55
Xylenes
47 FR
56392
12/16/82
*This list is updated to reflect very recent EPA actions and
therefore differs with the ITC 13th Report submitted to EPA.
'Removed by the ITC for reconsideration. Seven individual
alkyltin compound group members were subsequently
designated in the 11th ITC Report for priority
consideration.
2One of seven alkyltin compounds. See Note 1.
COMMENCEMENT OF MANUFACTURE NOTICES...
SECTION 5
Under section 5(a)( 1) a person who intends to introduce into
commerce a chemical substance not on the TSCA Inventory
must notify EPA at feast 90 days before beginning manufac-
ture or import. Listed below and on the next few pages are
the latest commencement of manufacture notices EPA has
received.
NEW CHEMICAL SUBSTANCES FOR WHICH EPA HAS RECEIVED COMMENCEMENT
OF MANUFACTURE NOTICES
{tine* publication of th« October 1983 Chomicals-in-Progr«s$ Bullatic)
PMN no. Submitter
CBi-Confidential Business
Information
Chemical Identification
G=Ganric Name
FR
Citation
Do - Ditto
80-177 CBI
81 -107 Do
81 -158 E.I. du Pont de Nemours 8t
Co., Inc.
81 -159 Do
81 -1&0 Do
81 -254 CBI
81 -406 Duolite International Inc.
81 -669 Do
Oxiran, polymer with methyl oxirane,
1,3-diisocyanatomethylbenzene and
(2-hydroxyethyl)-2-propenoate
Modified water-borne linseed fatty acid based alkyd
G Ethylene interpolymer
G
G
Do
Do
Polymer product of a methacrylate ester and a
polyhydroxy compound
Benzenemethanamine, benzene-ethenyl-N-methano-
phosphoric acid /disodium salt, polymer with diethyl-
benzene
Benzene, ar-bromoethenyl-, polymer with
diethenylbenzene
45 FR 54423
8/15/80
46 FR 20767
4/7/81
46 FR 24990
5/4/81
Do
46 FR 25693
5/8/81
46 FR 35342
718 /81
46 FR 44495
9/4/81
47 FR 1411
1/13/82
4
-------
82 -227 Do
82 -228 Do
82 -338 Do
82 -339 Do
82-516 American Cyanamid Co.
82 -569 Lilly Industrial Coatings, Inc.
82 -630 CBI
82 -632 Do
82 -690 Do
83 -35 Do
83 -38 Do
83-45 Magnesium Elektron, Inc.
83 -61 CBI
83 -62 Do
83 -95 Do
83 -324 Do
83 -364 The Upjohn Co.
83 -395 CBI
83 -416 Sandoz Colors & Chemicals
83 -432 Do
83 -463 CBI
83 -464 Do
83 -467 Do
83 -493 Do
83 -494 Do
83 -508 Do
83-514 Do
83 -518 Dow Chemical Co.
83-519 CBI
83 -522 Dow Chemical Co.
83 -524 CBI
83 -549 Do
83 -568 Do
83 -569 Do
83 -573 Do
83 -585 E.I. du Pont de Nemours &
Co., Inc.
83 -590 CBI
2-propenamide, N-l3-(dimethylamino) propyl]-,
polymer with diethenylbenzene and 2,2-bis
f(2-propenyloxy)methyl]-1-butanol
1-Propanaminium, N,N,N-trimethyl-3-[(1-oxo-2-
propenyl)amino]-, chloride, polymer with
diethenylbenzene and 2,2-bis[(2-propenyloxy)
methyl]-1-butanol
G Disubstituted triazolidine
G Disubstituted triazolidine salt
G Aromatic amine derivative
G Epoxidized hydroxystearic acid
G Unsaturated alkyl fatty amine
G Fatty secondary amide
[(Hydroxy(methylsulfonyl)phenyll azo substituted
heteromonocycle, metal complex (2:1), compound
with alkanamine (1:1)
G Sulfophenylazonaphthyl dye
G Do
Propionic acid, zirconium salt
G Disubstituted benzothiazole
G Disubstituted benzothiazole salt
G Trisubstituted benzothiazole salt
G Modified bisphenol A. epichlorohydrin polymer
Polymer of 1,1'-methylene-bis (4-isocyanatobenzene);
1,9-nonanedtoic acid (azelaic) and 1,4-butanediol
Modified alkyd polymer from a vegetable oil,
carbomonocyclic anhydride, carbomonocyclic acid, a
substituted alkane triol and a substituted alkanoic
ester
Disazo substituted aromatic compound
Disazo aromatic compound
G
G
G
G
G
G
G
G
Amino aliphatic propoxylate
Sodium sulfosuccinate of ethoxylated substituted
phenol
Alkyl cyclohexane carboxaldehyde
Alkoxylated alcohol compounds
Propylene glycol compounds
Substituted benzenesulfonic acid
Substituted indolium, salt
1,1 '[lsopropylidenebis(6-hydroxy-m-phenylene)]bis
(tetrahydrothiophenium hydroxide) bis (inner salt)
tetrahydrate
Functionalized acrylic polymer
Reacton product of succinic anhydride and
1,2-ethanediamine, N-l3-(trimethoxy-silyl)propyll
Polymer of trisubstituted methane, alkyl phenol and
substituted bis benzene derivative
Substitute acetamide
G Substituted styrene
G Phenyl substituted
G Unsaturated polyester
G Polymer of styrene, mixed acrylates and acrylic amide
G Arylsulfonic acid [[(arylamino)phenyl]azo] compound
with alkanolamine
47 FR 14218
412182
Do
47 FR 20852
5/14/82
Do
47 FR 33234
7130182
47 FR 36469
8120182
47 FR 39884
9/10/82
Do
47 FR 44606
10/8182
47 FR 47066
10/22/82
Do
47 FR 49072
10/29182
Do
Do
47 FR 52220
11/19/82
48 FR 72
113183
48 FR 1820
1 /14/83
48 FR 5304
2/4/83
Do
48 FR 6396
2 n 1 /83
48 FR 7299
2/18/83
Do
Do
48 FR 8343
2/28/83
Do
48 FR 10468
3 /11 183
Do
Do
Do
Do
Do
48 FR 11499
3/18/83
48 FR 12590
3/25/83
Do
48 FR 14035
4/1/83
Do
48 FR 15180
4/7/83
5
-------
83 -653
Do
83-659
Do
G
83-689
Do
G
83-698
Do
G
83-699
Do
G
83 -706
Polymer Applications, Inc.
G
83-717
CBI
G
83-726
Do
G
83 -727
Do
G
83 -741
Do
G
83 -742
Do
G
83 -752
Do
G
83 -761
Do
G
83 -762
Do
G
83 -772
Do
G
83 -774
Do
G
83 -776
Do
G
83 -779
Chem-Fleur Inc.
G
83 -788
CBI
G
83 -789
Do
G
83 -791
Do
G
83 -802
Do
G
83-807
Do
G
83 -810
Do
G
83-811
Do
G
83-813
Enwright Research Corp.
G
83-814
E.I. du Pont de Nemours &
G
Co., Inc.
83-818
CBI
G
83-819
Do
G
83-823
83-824
83-827
83-829
83 —830
83-841
83 -842
Do
Do
Do
Do
Do
Do
Do
83-644
Do
83 -847
Do
83 -848
Do
83 -849
Do
83-650
Do
83 -852
Do
Disubstituted isobenzofurandione, disubstituted bis
phenylerieoxy bis copolymer with tetracarboxy
carbocycle and disubstituted benzenediamine
Tetrasubstituted benzene
Water reducible alkyd resin
Copolymer of unsaturated organic compounds with
polyols and isocyanates
Do
Resorcinol-fatty acid polymer
Oxopentadecanolide
Reaction product of an aliphatic diisocyanate, aliphatic
diol, aliphatic triol and aliphatic dicarboxylic acid
Do
Substituted polyalkylene polyamine
Polyalkyleneoxy alkanoate
Benzothiazole, N-substituted-2-substituted
Substituted cyclopentadione
Octenal
[(Haloheterocyclicoxy)aryl oxy] alkanoate
Substituted phenolic derivative alkyl ester
Hydrogenated diene copolymer
Cyclomethylene citronellal
Reaction product of fatty alkene amine and isocyanate
Reaction product of fatty alkene amine, aromatic amine
and isocyanate
Vegetable oil polyamide resin
Polymer of mixed fatty acids, unsubstituted aromatic
and aliphatic dicarboxylic acids, an alkyl-substituted
triol and substituted alkyl diols
Substituted azo substituted benzenesulfonic acid
Cyclo alkyl acrylate
Aliphatic alkyl acrylate
Cationic polymer
G Styrene, mixed acrylate copolymer
Disperse blue azo dye
Polymer of a long chain fatty acid, hydroxy functional
alkane, phthalic acid, substituted arid unsubstituted
anhydrides and a hydroxy functional resin
G Organofunctional polydimethylsiloxane
G Do
G Disubstituted pyridinium bromide
Bis(azo) substituted naphthalenedisulfonic acid, alkali
metal salt
Arylazo disubstituted naphthalenedisulfonic acid, alkali
metal salt
2,2-Dimethyl-1,3-propanediol polymer with
1,4-cyclohexane-dimethanol, 1,6-hexanedioic acid,
1.3-benzenedicarboxylic acid and
1.4-benzenedicarboxylic acid
2,2-Dimethyl-1,3-propanediol polymer with
1,6-hexanediol, 1,6-hexanedioic acid,
1.3-benzenedicarboxylic acid and
1.4-benzenedicarboxylic acid
Disubstituted heteropolycyclic dye
Spiro-xanthene
Modified polyester polyurethane containing substi-
tuted alkanediol and diphenylmethane diisocyanate
Metal complex with substituted 4-phenylazo pyrazol-
one and substituted benzenesulfonic acid
Substituted phenylazo naphthalenesulfonic acid
Addition polymerization product of isoborynl
methacrylate, isobutyl methacrylate and
isocyanatoethyl methacrylate
48 FR 20487
516 /83
Do
48 FR 21370
5/12/83
48 FR 22792
5120183
Do
Do
Do
Do
Do
48 FR 23903
5121183
Do
Do
48 FR 24967
613183
Do
Do
Do
Do
Do
48 FR 26884
6/10/83
Do
Do
Do
Do
Do
Do
48 FR 29048
6/24/83
Do
Do
Do
Do
Do
48 FR 29054
6/24/83
Do
Do
48 FR 30434
7 /1183
Do
Do
Do
Do
Do
Do
Do
6
-------
83 -862
Do
G
Anhydro polyol monoalkanoate
Do
83 -863
American Hoechst Corp.
G
Thiazolium salt, N-substituted, 3-substituted
Do
83 -869
CBI
G
Reaction product of a diamine, cycloaliphatic diepoxide
48 FR 31460
and a hydroxyl functional acid
7/8/83
83 -870
Do
G
Modified polyurethane from aliphatic polyester alkane-
Do
polyols and aliphatic diisocyanate
83 -893
Do
G
Substituted sulfobenzoic acid
48 FR 32381
7/15/83
83 -894
Do
G
Trisubstituted benzenesulfonic acid
Do
83 -895
Do
G
Disubstituted benzenesulfonic acid
Do
83 -896
Do
G
Trisubstituted benzenesulfonic acid, alkali metal salt
Do
83 -898
Sun Chemical Corp.
G
Polyesther CR1226B
Do
83 -912
CBI
G
Substituted amine salt
Do
83 -927
Do
G
Amino aliphatic propoxylate
Do
83 -928
Do
G
Polyglycolamine
Do
83 -929
Do
G
Mixed phthalic-glycol polyester polymer
Do
83 -958
Do
G
Dialkylphenyl substituted amine
48 FR 33532
7/22/83
83 -963
Do
G
Modified dialdehyde starch
Do
83 -969
Sybron Corp.
G
Terpolymer of alkyl methacrylates and divinyl benzene
Do
83 -970
CBI
G
Aromatic aliphatic branched polyester resin
Do
83 -971
Do
G
Alkyl metallic halide
Do
83 -986
Do
G
Amino silane
48 FR 34506
7/29/83
83 -987
Do
G
Do
Do
83 -988
Do
G
Hydroxy functional silane
Do
83 -990
ICI Americas, Inc.
3-Aminonaphthalene-1,5-disulfonic acid monosodium
48 FR 35713
salt
8/5/83
REGULATION OF HAZARDOUS
SUBSTANCES.. .SECTION 6
Under section 6, EPA is authorized to control a chemical
as a hazardous substance if the Agency finds that the
chemical will present an unreasonable risk of injury to
human health or the environment. Under 6(a), EPA in
required to apply one or several requirements of the
law to the extent necessary to protect against the risk.
4,4'-MDA Subject to Regulatory Action
Two Federal agencies are proposing regulatory action
to determine and implement the most effective means
of controlling exposure to 4,4'-methylenedianiline
(4,4'-MDA). EPA announced, in a September 20, 1983
Advance Notice of Proposed Rulemaking (48 FR 42898),
that it and the Occupational Safety and Health Adminis-
tration (OSHA) plan regulatory action under section 6 of
TSCA, or under the Occupational Safety and Health Act,
or both. OSHA issued a similar notice the same day. At
present there is no mandatory OSHA workplace expo-
sure limits for 4,4'-MDA.
Recent biossays reported that the chemical causes can-
cer in mice and rats. These data led EPA to conclude
that 4,4'-MDA presents a significant risk to humans, and
in an April 27, 1983 notice EPA triggered an 180-day
section 4(f) review of the chemical [see page 1 for an
explanation of section 4(f)]. In the September 30 notice,
EPA stated that available evidence indicates that the po-
tential for 4,4'-MDA exposure occurs in the workplace,
where 99 percent of the substance is used as an inter-
mediate in the production of methylene diphenyl
diisocyanate (MDI) or polymeric MDI(PMDI). In turn
these substances are used to produce rigid or semi-
rigid polyurethanes. An estimated 200 to 400 million
pounds of 4,4'-MDA were produced in 1982 by five
companies in four States.
PCB Regulatory Background
Under section 6(e), EPA is required to control the
manufacturing, processing, distribution in com-
merce, use and disposal of polychlorinated bi-
phenyls (PCBs). On May 31, 1979, EPA issued a
comprehensive PCB rule. On October 30, 1980,
the U.S. Court of Appeals for the District of Co-
lumbia Circuit set aside portions of the May 31,
1979 rule. The court remanded the set-aside
portions to EPA for further action. In accordance
with the court order, EPA amended the May 31,
1979 rule on August 25, 1982 for electrical equip-
ment, and October 21, 1982 for dosed and con-
trolled waste manufacturing processes. EPA is
now engaged in the third and final court ordered
rulemaking involving low concentrations of inad-
vertently generated and recycled PCBs, and is-
sued a proposed rule on December 8, 1983.
EPA Issues Proposed Regulation For Uncontrolled
PCBs
EPA has issued a rule that proposes three actions
with regard to the manufacturing, processing, dis-
tribution in commerce, and use of PCBs on De-
cember 8, 1983 (48 FR 55076). First, EPA is
proposing to exclude under certain circumstances
inadvertently generated and recycled PCBs from
the section 6(e) ban on manufacturing, process-
ing, distribution in commerce. In support of this
proposed regulation, EPA completed risk assess-
ments for reproductive/developmental effects,
carcinogenicity, and environmental effects. Based
on this information, EPA is proposing several cri-
teria for excluding inadvertently generated and
recycled PCBs from the statutory ban. These crite-
ria are:
7
-------
(1) PCB concentrations in the components of de-
odorant bars, soaps, plastic building materials,
and plastic building products are limited to less
than 5 ppm. Other products are limited to an an-
nual average of 25 ppm with a 50 ppm
maximum.
(2) PCB air emissions are limited to less than 10
PPm.
(3) PCB water discharges are limited to less than
0.1 ppm for any resolvable gas chroma-
tographic peak.
(4) All process wastes containing PCBs at 50
ppm or greater are to be disposed of in accord-
ance with the PCB disposal requirements of 40
CFR 761.60.
(5) The quantitation of inadvertently generated
PCBs under items (1) through (4) above is to be
calculated after discounting the concentration
of monochlorinated biphenyls by a factor of 50,
and the concentration of dichlorinated biphen-
yls by a factor of 5. These discount factors may
not be applied in quantifying recycled PCBs.
(6) In order to qualify for this exclusion, a firm
must comply with certain reporting and certifi-
cation requirements.
EPA has determined that, given these criteria, the
manufacture, processing, distribution in com-
merce, and use of inadvertently generated and
recycled PCBs would not present an unreasonable
risk of injury to human health or the environment.
This regulation also proposed to defer action on
50 PCB exemption petitions to manufacture, proc-
ess, and distribute in commerce (see following
story). Finally, this regulation proposes use au-
thorizations for PCBs in heat transfer and hydrau-
lic systems at concentrations of less than 50 ppm.
EPA has concluded that these use authorizations
would not present an unreasonable risk of injury
to human health and the environment. EPA is so-
liciting comments on these proposed actions. The
Agency will hold informal hearings on this pro-
posed rule in Washington, D.C. early in 1984.
EPA Addresses PCB Exemption Petitions
EPA has proposed a rule to address 172 pending
individual and class petitions for exemption from
the prohibition against the manufacture, process-
ing, and distribution in commerce of PCBs. The
proposed rule [November 1, 1983 (48 FR 50486)]
identifies 49 petitions that EPA will grant and 73
petitions it will deny if the rule becomes final.
EPA proposes to defer action on 50 additional pe-
titions which will be affected by EPA's rulemaking
involving inadvertently generated and recycled
PCBs.
The 122 petitions EPA proposes to grant or deny
cover PCB small capacitors, PCB equipment,
transformers, research and development involv-
ing PCBs, microscopy involving PCBs and the
importing and exporting of PCBs.
EPA is soliciting comments on these proposed ac-
tions by January 3, 1984, and the Agency will hold
informal hearings in early 1984 in San Francisco,
Chicago, and Washington, D.C., if there is public inter-
est. For additional information on the public hearings or
on how to submit written comments, please contact the
TAO by telephone or letter.
EPA Issues Two Proposed PCB Use Authorizations
EPA has proposed a rule to authorize the indefinite use
of PCBs as a mounting medium in art and historic con-
servation, and in small quantities for research and de-
velopment (November 17, 1983 (48 FR 52402)). The
Agency determined that the use of PCBs in research and
development and in art and historic conservation does
not pose unreasonable risks to public health and the en-
vironment. Although EPA has proposed to limit the use
of PCBs in microscopy to use as a mounting medium in
art and historic conservation, the Agency is soliciting
information on other uses in the field of microscopic
mounting that may be considered essential. EPA is so-
liciting comments on these proposed use authorizations
by January 3, 1984, and will hold an informal hearing, if
requested, on or about January 16, 1984, in Washing-
ton, D.C.
REPORTING RULES
SUBSTANTIAL RISK ... SECTION 8(e)
Under section 8(e) persons who obtain new information
which reasonably supports the conclusion that a sub-
stance presents substantial risk of injury to human
health or the environment must notify EPA within 15
days. These notices are then reviewed by the Office of
Toxic Substances (OTSj and an initial evaluation is pre-
pared containing, if appropriate, followup questions to
the submitter, referrals to other agencies, and recom-
mended OTS IEPA 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 no-
tice within 15 days of obtaining the information. EPA
publishes its evaluations of these notices to make this
section 8(e) information widely available and under-
standable to a broad public. The submissions and the
initial evaluations are located in the OTS Public Reading
Room, first floor, East Tower, Waterside Mall, 401 M
Street, SW, Washington, D.C.
Persons wishing to obtain a copy of section 8(e) notices
may write: EPA, Freedom of Information, Ms. Jerri
Green, (A-101), Washington, D.C. 20460. There is no
charge for duplicating the first 49 pages, but at page 50
of a request for duplication there is a $10.00 fee and a
20(2 charge for each additional page (e.g., 51 pages cost
$10.20).
Single copies of the 8(e) initial evaluation (not the full
submission) are available from the TSCA Assistance
Office.
Recent Section 8(e) Notices of Substantial Risk
Log No. 8EHQ -
0983 -0491 S
Chlorinated paraffin
Results from acute and chronic toxicity studies
0983 -0492 S
Aliphatic carbamate
Summary of an acute inhalation study
8
-------
0983 -0493 S
Mixture of metallic oxides
Report of flu-like symptoms in workers
S at the end of Log Number means a sanitized version
is available.
N.B.: All toxicity, oncogenicity, teratogenicity and mutagenicity studies
involve animals unless otherwise stated. Additional tests (e.g., bacterial
cell) are noted or are included in the term "battery."
TSCA Section 8(e) Fact Sheet
The law Section 8(e) of the Toxic Sub-
stances Control Act (TSCA) states
that "any person who manufac-
tures, processes, or distributes in
commerce a chemical substance or
mixture and who obtains informa-
tion which reasonably supports the
conclusion that such substance or
mixture presents a substantial risk
of injury to health or the environ-
ment shall immediately inform the
[EPA] Administrator of such infor-
mation unless such person has ac-
tual knowledge that the Adminis-
trator has been adequately
informed of such information."
The history Section 8(e) became effective on
January 1, 1977, the date TSCA be-
came law. However, in order to
clarify the types of information to
be submitted and the procedures
for doing so, EPA (after receipt of
public comments) published its
section 8(e) policy statement
("Statement of Interpretation and
Enforcement Policy; Notification of
Substantial Risk"; 43 FR 11110;
March 16, 1978).
Information required The information subject to section
under 8(e) 8(e) reporting is considered by EPA
to be any new information that
provides reasonable support for
the conclusion that a chemical
presents a substantial risk of injury
to health or the environment, but
need not necessarily conclusively
indicate such risk. A determination
of substantial risk does not include
an evaluation of economic or so-
cial benefits of the chemical's use
and therefore, is not synonymous
with the term "unreasonable risk"
as used in other sections of TSCA.
Therefore, receipt of information
pursuant to section 8(e) does not
necessarily trigger immediate reg-
ulatory action. However, some
submitted information has trig-
gered further data gathering and
evaluation that may lead to future
proposed regulation.
Th« 8(e) experience Thus far, both the chemical indus-
try and EPA have devoted signifi-
cant efforts to fulfilling their re-
spective responsibilities under
section 8(e). Since January 1, 1977,
over 500 section 8(e) notices have
been received. The notices cover a
wide range of chemical toxicity/ex-
posure information and have been
given priority evaluation and ap-
propriate followup attention by the
OTS.
How EPA In general, each section 8(e) sub-
handles 8(e) mission is promptly reviewed and
submissions receives a preliminary assessment
by OTS' scientific staff in order to
determine the degree of concern
that should be attached to the sub-
mitted information and the course
of warranted followup action by
OTS. A status report is prepared
which contains a description of the
submitted information, the OTS
preliminary assessment, a state-
ment regarding production and
use(s) of the subject chemical(s)
and recommendations for appro-
priate OTS followup actions. Upon
approval of the status report, the
recommended followup activities
are initiated. A followup letter con-
taining the status report is sent to
the submitting company. In some
cases this letter will request addi-
tional information or clarifications.
Copies of the status report are also
transmitted to EPA's public files
and to other designated EPA of-
fices and Federal agencies.
Where to read 8(e) The 8(e) submissions and the sta-
status reports and tus reports are on view at:
submissions OTS
Public Reading Room
1st Floor, East Tower
Waterside Mall, S. W.
Washington, D.C.
How to obtain 8(e) EPA has published section 8(e) sta-
status reports tus reports in three volumes cover-
ing the January 1977 -June 1979,
July 1979-January 1980 and Feb-
ruary 1980-December 1982 peri-
ods. Single copies of recent sec-
tion 8(e) status reports are also
available. The volumes or the later
single copies may be acquired by
calling EPA at 800-424-9065 (in
Washington, D.C., 554-1404) or by
writing, EPA, TS -799, Washington,
D.C. 20460.
How to obtain 8(e) Persons wishing to obtain a copy
submissions of a section 8(e) submission may
write; EPA, Freedom of Informa-
tion, Ms. Jerri Green (A-101),
Washington, D.C. 20460. There is
no charge for duplicating the first
49 pages, but at page 50 of a re-
quest for duplication there is a
$10.00 fee and a 200 charge for
each additional page, e.g., 51
pages cost $10.20.
9
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SUPPORT ACTIVITY
Moore Heads OPTS
John A. Moore, D.V.M., has been sworn in as the Assist-
ant Administrator for Pesticides and Toxic Substances.
He was appointed by President Reagan and confirmed
by the United States Senate.
Dr. Moore is responsible for implementing the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) and
the Toxic Substances Control Act (TSCA).
Prior to his EPA appointment. Dr. Moore was deputy di-
rector of the National Toxicology Program, a position
he held since the start of the program in 1978. During
that period he also served as director of Toxicology Re-
search and Testing, at the National Institute of Environ-
mental Health Sciences. Dr. Moore is a board certified
toxicologist and is a graduate of Michigan State Univer-
sity, where in 1963 he also received a Doctorate of Vet-
erinary Medicine.
OTS Reorganization Approved
The OTS reorganization was approved and became ef-
fective on October 30, 1983. The change formalizes the
way the OTS has been operating during fiscal 1983. Un-
der the new structure six division directors and two
staff directors report to the OTS Office Director. The six
divisions are: Existing Chemical Assessment, Health
and Environmental Review, Chemical Control, Exposure
Evaluation, Information Management, and Economics
and Technology. The Office of Program Management
and Evaluation and the Office of TSCA Assistance are
the two staff offices.
ITC Selects 82 Chemicals
The ITC selected 82 additional chemicals for in-depth
review and is asking the public for information on the
substances. Future ITC recommendations for section 4
test rules will be selected from this list of candidates.
In releasing the chemical names on November 9, 1983
(48 FR 51519), the ITC asked the public to submit writ-
ten comments and unpublished technical data about
the substances no later than January 14, 1984. Re-
sponses and further questions should be directed to:
Martin Greif (202) 382-3810
ITC Executive Secretary
EPA TS -792
Washington, D.C. 20460
Of particular value, the ITC notice said, would be infor-
mation from technical bulletins and material safety data
sheets. It also is interested in current annual production
levels and trends, numbers of workers exposed, con-
centrations, controls, use of open versus closed sys-
tems, environmental impact data and toxicology data
about the named substances. Information received will
become part of the public record unless clearly desig-
nated as confidential business information.
The chemicals and their Chemical Abstract numbers
are:
75-63-8
78 -67 -1
78 -79-5
78-88-6
79 -94 -7
80 -43 -3
81 -55 -0
Bromotrifluoromethane
2,2'-Azobls(isobutyronitrile)
2-Methyl-1,3-butadisne
2,3,-Dichloropropene
Tetrabromobisphenol A
Cumene peroxide
1,8-Dihydroxy-4,5 -dinitroanthraquinona
84 -65-1
85 -22 -3
87 -59 -2
87 -60 -5
87 -83 -2
88 -24 -4
95 -14-7
95 -31 -8
95 -33 -0
95 -69 -2
96 -37 -7
97 -80 -3
98 -94 -2
99 -65 -0
100 -37 -8
101 -68-8
102 -08 -9
102 -36 -3
103-74 -2
107-18-6
107 -22-2
108-89 -4
109-70 -6
110-05-4
112-41 -4
116-82-5
117-62-4
119-61 -9
119-64 -2
120 -78-5
122 -39 -4
126 -33-0
126-73 -8
128 -39 -2
128 -80 -3
135-88 -6
142-59 -6
145-49 -3
150 -39 -0
529 -34 -0
592 -41 -6
592 -76 -7
616-45 -5
872 -05 -9
1072-52 -2
1163 -19-5
1634 -04-4
1837-91 -8
2176-62 -7
3081 -01 -4
3734 -48 -3
6419-19-8
8007 -18-9
15096 -52 -3
19660-16-3
25339 -56 -4
26006 -22 -4
26447 -40 -5
27215-95 -8
27515 -66 -8
38051 -10-4
55667 -43 -1
59808-78-5
61791 -36-4
61931 -82-6
03451 -40 -1
Anthraquinorie
Pentabromoethy I benzene
2, 3-Xylidine
3-Chloro-o-toluidine
Pentabromomet hylbenzene
2, 2'-Methylenebis [6-tert-butyl-4-ethylphenol I
1H-Benzotriazole
N-tert-Butyl-2-benzothiazolesulfenamide
N-Cyclohexyl-2-benzothiazolesulfenamide
4-Chloro-o-toluidine
Methylcyclopentane
2-|Methy!(1-oxo-9 -(Z) -octadecenyl)
aminolethanesulfonic acid
N,N-Dimethylcyclohexylamine
m-Dinitrobenzene
2-(Diethylamino)ethanol
1,1'-Methylenebis(4-isocyanatobenzene)
Thiocarbanilide
1,2-Dichloro-4-isocyanatobenzene
2-Pyridine ethanol
Allyl alcohol
Ethanedial
4-Methylpyridine
1-Bromo-3-chloropropane
Di-tert-butyl peroxide
1-Dodecene
1-Amino-2-bromo-4-hydroxyanthraquinone
2-Amino-1, 5-naphthalenedisulfonic acid
Benzophenone
1,2,3,4-Tetrahydronaphthalene
2,2'-Dithiobisbenzothiazole
Diphenylamine
Tetrahydrothioptiene 1, 1-dioxide
Tributyl phosphate
2,6,-Di-tert-butyl phenol
1.4-Di-p-toluidinoanthraquinone
N-Phenyl-2-naphthylamine
1.2-Ethanediylbis(carbamodithioic acid)
disodium salt
1.5-Diamino-4,8-dihydroxyanthraquinone
N-(2-hydroxyethyl) ethylenedinitrilotriacetic
acid
3.4-Dihydro-1 (2H)-naphthalenone
1-Hexene
1-Heptane
2-Pyrrolidinone
1-Decene
1-Aziridine ethanol
Decabromodiphenyl ether
tert-Butyl methyl ether
1,2,3,4,5,6-Hexabromocyclohexane
Pentachloropyridine
N-(1, 4-Dimethylpentyl)-N'-phenyl-1,
4-benzenediamine
4,5,6,7,8,8-Hexachloro-3a,4,7, 7a-tatrahydro-4,
7 -methano-1H-indene
Nitrilotris(methylphosphonic acid)
C.I. Pigment yellow 53
Cryolite
2.3-Qibromopropyl acrylate
Heptene, mixed isomers
Ethanaminium, N,N,N-trimethyl-2 -((2-methyl-l-
oxo-2-propenyl)oxy]-, methyl sulfate,
polymer with 2-propenamide
1,1'-Methylenebis(isocyanatobenzene)
Nonene
Bis(2-methylpropyl)phenol
2,2 -Di(chloromethyl)-1,3-propanediyl
diphosphate tetrakis (2-chloroethyl)ester
1,1-Dichloro-4-methyl-i, 3-pentadiene
Tetrachlorocyclopentane
4.5-Dihydro-1H-imidazole 2-nortall-oil alkyl
derivatives
N-(1,3-Dimethylbutyl)-N-phenyl-1,4-
benzenediamine
4-(Phenylimino)-2,5-cyclohexadien-1-one
oxime, sodium salt
10
-------
67700-99-6 Di-(Ci4-Ci B)-allcylmethyl3mines
68122 -86-1 Imidazolium compounds, 4,5-dihydro-l-methyl-
2-nortallow alkyl-1-(2-tallow amidoethyl),
methyl sulfates
68153-35-5 Ethanamiriium, 2-amino-N-(2-aminoethyl)-
N-(2-hydroxyethyl)-N-methyl-, N,N'-
ditallow acyl derivatives, methyl sulfates
(salts)
68187 -41 -7 Phosphorodithioic acid, 0,0-di (Ci-Cn)-
alkyl esters
68258-91 -3 Hexachlorocyclopentane
68334 -67 -8 1,1,2,3,4-Pentachloro-4-(1-methylethoxy)-1,
3-butadiene
68457 —79 -4 Phosphorodithioic acid, 0,0-bis (mixed iso-bu
and pentyl) esters, zinc salts
68974-78-7 Thiobis |(tetra propenyl) phenoll, magnesium
salt
69227 -21 -0 (Ci 2 -Ci ») Alkyl alcohol ethoxylate propoxylate
OTS Seeks Vinyl Acetate Data for CHIP
OTS is asking the public for unpublished information
about vinyl acetate (108-05-4). EPA has selected vinyl
acetate for a preliminary risk assessment review. Infor-
mation should be sent as soon as possible to:
TSCA Document Control Officer
TS -799
Attn: T. O'Bryan
Washington, D.C. 20460
Persons who have unpublished data about vinyl acetate
but who also want answers to questions prior to re-
sponding should contact Justine Welch of the OTS
Chemical Screening Branch, (202) 382-3470, as soon as
possible.
The OTS review of vinyl acetate when published will be
called a 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 information indicating a poten-
tial for adverse health or environmental effects along
with the evidence of significant production or some
type of exposure.
When OTS searches the literature in preparing a CHIP it
generally limits the search to automated data bases and
reference works. But OTS encourages individuals and
firms to submit unpublished or recently published re-
ports and all other hard-to-obtain studies on the chemi-
cal selected for a CHIP. Relevant studies from the public
could include data on health effects, environmental ef-
fects, commercial production and uses, exposed popu-
lations, 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 as-
sessment activities by other organizations.
The TAO will notify individuals and organizations by
letter every time OTS starts a new CHIP. Persons who
think they can aid the CHIP information-gathering proc-
ess will have their names added to the list if they con-
tact the TAO. 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 han-
dle all confidentiality claims in accordance with its pro-
cedures governing the confidentiality of business
information.
The TAO is now distributing copies of the following re-
cently completed CHIPs:
Methylcyclopentadienyl 12108 -13 -3
manganese tricarbonyl
Propionitrile 107-12-0
Ziram 137-30-4
OTS encourages comments on the accuracy and thor-
oughness of information presented in its CHIPs.
New and Revised Test Guidelines Available
Several new and revised test guidelines, made available
by OTS, can now be bought from the National Technical
Information Service (NTIS). The guidelines cover health
effects, environmental effects and chemical fate testing.
The revised publications update some state-of-the-art
methods that can be cited in chemical-specific test
rules. Detailed explanation of the new and revised
guideline material is listed in the September 30, 1983
Federal Register, on page 44898. EPA is asking for com-
ments on the new and revised guidelines no later than
January 13, 1984. To aid those who want to comment,
the TAO will send the above notice and also a Septem-
ber 22, 1982 test guideline notice issued when the first
guidelines were published by NTIS. The prices quoted
in the notices are subject to change, and NTIS is the
only source for up-to-date prices.
The new and revised guidelines are separated into
three units, health effects, environmental effects and
chemical fate, but all three can be bought in print form
from NTIS at a reduced price by citing one number,
PB83-257683. However, to have the complete 1982 set
of test guidelines also requires buying PB82 -232976
(the nonrevised portions of the 1982 guidelines).
Microfiche of the test guidelines can only be bought
from NTIS by citing the following numbers:
1983 Health Effects PB83 -257691
1983 Environmental Effects PB83 -257709
1983 Chemical Fate PB83 -257717
1982 Health Effects PB82 -232984
1982 Environmental Effects PB82 -232992
1982 Chemical Fate PB82 -233006
NTIS is located at 5282 Port Royal Drive, Springfield,
VA., 22161 (703) 487-4650. NTIS accepts American Ex-
press, MasterCard and Visa. NTIS will quote prices on
the above guidelines.
PMN Volume for FY 83 Sharply Higher
EPA received 1,343 PMNs in fiscal 1983, which ended on
September 30, 1983. The total number of valid PMNs for
FY 1983 was sharply higher than in any year since the
beginning of the PMN program in 1979. However, com-
parison of year-to-year PMN totals is difficult to make,
because EPA in 1982 switched the recording of PMNs to
the Federal fiscal year (October 1 -September 30) basis.
Additionally, the PMN submission totals for any period
include some PMNs that are later voided or withdrawn.
In that 9-month 1982 reporting period, EPA received 709
PMN submissions. That is a monthly average of 79
PMNs. The monthly average was 112 PMNs in fiscal
1983. These figures indicate a 30 percent increase in
PMNs filed in fiscal 1983 over 1982 totals. From 1979 to
September 30, 1983, EPA has received about 3,150 PMN
submissions.
11
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Premanufacture
Notifications
(PMNs) . . .
3 New
Videotapes
The Videotapes
• Questions and Answers About
the Final PMN Rule (21 Minutes)
This videotape answers commonly
asked questions regarding PMN re-
quirements of the final rule. These
include research and development
exemptions, confidential business
information, and the EPA review
process. A transcript is included.
• PMN Seminar Highlights ...
6/23/83 (44 Minutes)
An edited selection of the June
seminar's highlights, this tape ex-
plores the diverse positions of en-
vironmentalists, labor, and the
chemical industry on the final rule
requirements. Policy positions are
also presented by EPA officials. A
transcript'»included.
• How to Complete the PMN
Form (18 Minutes)
A step-by-step explanation of the
PMN form, this tape is to be used
as an overview and companion to
the Instructions Manual. A
transcript is included.
• The Premanufacture
Notification Rule Series
This package includes all 3 video-
tapes, 3 transcripts, and a PMN
"notebook." Note that all 3 video-
tapes will be in the same format if
ordered as a package. To obtain
the 3 videotapes in different for-
mats, order them separately.
To Order
Fill out the order form indicating the
number of videotapes you need, the
Name
Title _
Order Form
Company-
Address
3/4"
1/2"
1/2"
U-matic
Beta 2
VHS
• Q's and A's about
EPA's Final PMN Rule
~
~
~
A10284
A10309
A10310
• Highlights of the PMN Seminar
~
~
~
A10347
A10348
A10349
* How to Complete the PMN Form
~
~
~
A10368
A103B9
A10370
• The PMN Series (3 Videotapes,
~
3 Transcripts, 1 "Notebook")
~
~
A103G0
A10351
A10362
format, and the amount enclosed.
Make checks or money orders payable
to The National Archives Trust Fund.
Mail the order form and payment to:
National Audiovisual Center
Order Department
Washington, D.C. 20409
Allow 4-6 weeks for delivery.
«90 = »_
.@~115 = $_
W0 = »_
_@$250 = $_
TOTAL = »_
TSCA Assistance Office (TS-799) 011icia\ Business
Office of Pesticides & Toxic Substances Penalty for private Use
U.S.E.P.A. $300
Washington, D.C. 20460
First Class Mail
Postage and Fees Paid
EPA
Permit No. G-36
THE TSCA CHEMICALS-IN-PROGESS BULLETIN
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