Vol. 1, No. 4 NOVEMBER 1980
This bi-monthly 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 Industry Assistance Office (IAO), (TS-799) OPTS, U.S.E.P.A., Washington, D.C.,
20460 or call toll-free 800-424-9065 or, in Washington, D.C., 554-1404.
REGULATORY & REQUIRED ACTIONS
PREMANUFACTURE NOTIFICATION (PMN)...
SECTION 5
Under Section 5(aXV a person who intends to in-
troduce into commerce a chemical substance not on
the TSCA Inventory must notify EPA at least 90 days
before beginning manufacture. This rule would apply
also to importers. The notice must give the chemical
identity, production volume, uses, byproducts, occu-
pational exposure and other health and environ-
mental effects information in the submitter's pos-
session. EPA is to use the review period to deter-
mine if the substance might present an unreasona-
ble risk that should be remedied through either an
order to develop sufficient information or an im-
mediately effective rule. Upon such a determination,
EPA issues an order to prohibit manufacture and
then applies to the court for an injunction to this ef-
fect. This order must be issued 45 days before the
notification period ends. The original period may be
extended by EPA for up to 90 days for good cause
noted in the Federal Register. Absent such an order
or immediate rule, the manufacturer may proceed
with his plans. EPA publishes in the Federal Regis-
ter a summary of each PMN five days after its re-
ceipt and a status report on all current receipts at
the beginning of each month. Copies of the revised
proposed forms for manufacturers, importers and
exporters are available from IAO for use by submit-
ters during the interim period (See 44 FR 28564, May
15, 1979 and 44 FR 59764, Oct. 16, 1979).
The latest PMN status reports are reproduced below.
The July report appeared on August 26, 1980 (45 FR
56906), the August report on October 10,1980 (45 FR
67455).
JULY 1980 PMN STATUS REPORT
PMN No. Identity/Generic Name FR Citation Expiration
Date
Premanufacture Notices Received During the Month
80-154 Generic name: Reaction products of [(amino-disubstituted- 45 FR 51647 9/30/80
carbomonocyclic)azo] carbomonocyclesulfonic acid and 8/4/80
[(amino-monosubstitutedcarbomonocyclic)azo] carbo-
monocyclesulfonic acid with carbonic dichloride
80-155 Cyclohexanehexacarboxyiic acid, penta sodium salt 45 FR 51262 9/30/80
8/1/80
80-157 Generic name: Halogenated polyimide 45 FR 51264 10/4/80
8/1/80
-------
80-15$ '¦ Polymer of epoxy resin, maleic anhydride, butanoi, styrene,
methacryljc acid
80-159 Generic name: Resin from monocarboxylic acids, polyhydric
alcohols, dibasic acid anhydride, polycarboxylic acid an-
hydride, and a silicone resin
80-160 Generic name: Hydrolyzed starch-poly-(acrylonitrile) copoly-
mer
80-161 Polymer of 2,2-dimethyl, l,3-propanediol, 2,2,4-trimethyl, l,3-
pentanediol butendloic acid
80-162 Generic name: Lignosulfonate reaction product with an alke-
noic acid and an inorganic salt
80-163 Generic name: Monosubstituted dialkyl aniline
80-164 Generic name: Disubstituted indole
80-165 Ethanedioic acid, di-n-butyl ester
80-166 Generic name: Carbocyanine dye
80-167 Generic name: Arylhydrazide
80-168 Generic name: Disubstituted pyrazoloquinazolone
80-169 Generic name: Disubstituted pyrazoloquinazolone carboxal-
dehyde
80-170 Zinc dibutyl dithiocarbamatedibutylamine complex
80-171 Generic name: Polyester plasticizer
80-172 Generic name: Polyisobutenyl succinic anhydride reaction
products with substituted ethanol
80-173 Generic name: Polyester of adipic acid, phthalic anhydride,
trimethylol propane, ethylene glycol, and diethylene glycol
80-174 Generic name: Polyester reaction product with toluene diiso-
cyanate acrylate terminated
80-175 Generic name: Alkyd resin polymer, fatty acid, and urethane
modified
80-176 Generic name: Oxirane, ploymer with methyl oxirane, 1,1'-me-
thylenebis (4-isocyanatocyclohexane) and (2-hydroxyethyl)-
2-propenoate
80-177 Generic name: Oxirane, polymer with methyl oxirane, 1,3-di-
isocyanatomethylbenzene and (2-hydroxyethyl)-2-propeno-
ate
80-178 Generic name: isocyanate terminated urethane prepolymer..
80-179 Generic name: Polymer of mixed alkyl acrylates
80-180 Generic name: Polymer of Carbomonocyclic carboxyllc acid,
alkanediol and 2,5-furandiol
80-181 Benzenemethanaminium, ar-bromoethenyl-N.N.N-trimethyl-
chloride (or sulfate), polymer with diethenylbenzene, diiso-
propenylbenzene and 2-methyl-1,3-butadiene
80-182 Generic name: Alkanedioic acids mixed alkanolamines salt
80-183 Generic name: Dimethyfaminopropyl fluoroalkyl adducts ...
80-184 Polymer of Castor oil fatty acid, benzoic acid, epoxy resin,
fumarlc acid, styrene, and N,N-dimethyl ethanol amine
80-185 Generic name: Polymer of hydroxyethyl acrylate, styrene, 2-
ethylhexyl acrylate, alkyl methacrylate, substituted
alkyl acrylate, alkyl mercaptan
80-186 N-Methyl-2,4-dinitro-N-phenyl 6-(trlfluoromethyl) benzenea-
mined
80-187 Generic name: 1-amino-4-sub8tltuted-9,10-dlhydro-9,10-dloxo-
2-anthracenesulfonic acid and monosodium salt
80-188 Generic name: Primary amyl nitrates
45 FR 51264
8/1/80
In prep.
45 FR 51262
8/1/80
45 FR 51646
8/4/80
45 FR 51274
8/1/80
45 FR 51910
8/5/80
45 FR 51910
8/5/80
45 FR 51272
8/1/80
45 FR 51908
8/5/80
45 FR 51908
8/5/80
45 FR 51908
8/5/80
45 FR 51908
8/5/80
In prep.
In prep.
45 FR 52241
8/6/80
In prep.
45 FR 52243
8/5/80
In prep.
In prep.
10/4/80
11/3/80
10/6/80
10/6/80
10/6/80
10/13/80
10/13/80
10/13/80
10/13/80
10/13/80
10/13/80
10/13/80
10/14/80
10/14/80
10/14/80
10/15/80
10/15/80
10/16/80
10/19/80
In prep.
10/19/80
In prep.
In prep.
In prep.
10/19/80
10/19/80
10/22/80
In prep.
10/19/80
In prep.
In prep.
In prep.
10/21/80
10/22/80
10/28/80
In prep.
10/28/80
In prep.
10/20/80
In prep.
10/28/80
In prep.
10/28/80
Premanufacture Notices for Which the Notice Review Period Ended During the Month:
(Expiration ol tho nolle* p«rlod dooo not •Ignlly that tho chomlcol hit boon iddod to tho Inventory.)
80-34 Generic name: Phosphorodlthioic acid, dialkyl ester, 45 FR 35001 7/23/80
C12.14tert-alkylamine salts 5/23/80
Generic name: Substituted phenol, reaction products with 45 FR 35001 7/23/80
C22-30 alkenes 5/23/80
2
-------
80-73
80-75
80-76
80-77
80-78
80-80
80-81
80-82
80-83
80-84
80-85
80-86
80-87
80-88
80-89
80-90
80-91
80-92
Generic name: Salt of formaldehyde, 4-(phenylamino)- substi-
tuted-benzene polymer and 2-butenedioic acid, 1,4-cyclo-
hexane-dimethanol,2,4-diisocyanato-1-methylbenzene, 1,2-
ethanediol,2-oxepanone, and 5-substituted-1,3-benzenedi-
carboxylic acid polymer
Polymer of 12-hydroxy stearic acid and epoxy resin
Generic name: Alkyd resin TV79-0777
Generic name: Alkyd resin X4-779 ...
45 FR 30127
5/7/80
7/2/80
Generic name: Bis(Substituted alkyl) 1,2-cyclohexanedicar-
boxylate
Amides from diethylenetriamine and methyltallowate com-
pounds with diethylsulfate
Generic name: Methylphenylsubstitutedheteromonocylic
salt
Polymer of Epoxy resin, diallyl amine, 2-ethyl hexyl metha-
crylate, hydroxy ethyl acrylate, dimethylamino propyl me-
thacrylamide and dimethylolpropionic acid
Generic name: Unsaturated polyester resin based on six
monomers including maleic anhydride, phthalic anhyd-
ride, an alkylene glycol and an alkylene ether glycol
Generic name: Polyester reaction product with isophorone
diisocyanate and hydroxypropyl acrylate
Generic name: Copolymer of substituted ethenylheterocycle
and substituted ethenylbenzene
Generic name: Alkene dicarboxylic acids, alkane dicarboxy-
lic acid, resin, pentaerythritol and dlaminoalkane polya-
mide
Generic name: Alkene dicarboxylic acid, alkane dicarboxylic
acid, alkane carboxylic acid and diamlnoalkanes polya-
mide
Generic name: Cyanoalkyl carbomonocyclicsulfonate
Copolymer of isononanoic acid, phythalic anhydride, maleic
anhydride and pentaerythritol polymer (subject of PMN
80-55) and formaldehyde; butylated and 2-ethylhexylated
urea polymer
Generic name: Dimethyl (substituted) heteromonocyclic salt.
Generic name: 1,3-naphthalenedisulfonlc acid, 6,6'-[1,2-eth-
enediylbls [(3-sulfo-4,1-phenylene)azo]]bls-[4-amlno-5-hy-
droxy, compounded with tris-(subst!tuted ethyl)-ammoni-
um hydroxide (1:6)
Polymer of tall oil fatty acid, styrene-allyl alocohol
copolymer, acrylic acid and styrene
AUGUST 1980 PMN STATUS REPORT
45 FR 30127
7/2/80
5/7/80
45 FR 30127
7/2/80
5/7/80
45 FR 30127
7/2/80
5/7/80
45 FR 30131
7/7/80
5/7/80
45 FR 30130
7/7/80
5/7/80
45 FR 30131
7/8/80
5/7/80
45 FR 31489
7/17/80
5/13/80
45 FR 32772
7/28/80
5/19/80
45 FR 30132
7/20/80
5/7/80
45 FR 31489
7/21/80
5/13/80
45 FR 30687
7/21/80
5/9/80
45 FR 30687
7/21/80
5/9/80
45 FR 32772
7/2280
5/19/80
45 FR 32426
7/22/80
5/16/80
45 FR 32426
7/23/80
5/19/80
45 FR 32772
7/30/80
5/19/80
45 FR 32771
5/19/80
7/30/80
PMN No.
Identity/Generic Name
FR Citation Expiration
Date
Premanufacture Notice* Received During the Month
80-189 Bisphenol A-epoxy resin, 1,4-butanediol, para amino benzioc
acid and phthalic anhydride polymer
80-190 copolymer from dimethyl terephthalate, alpha, omega-hy-
droxy terminated aliphatic hydrocarbons and a
polyalkylene glycol
80-191 Polymer of Methylene bls(4-cyclo hexyl Isocyanate), poly pro-
pylene glycol, hydroxy ethyl acrylate and polyoxy pro-
pylene diamine
80-192 Generic name: Very short oil non-oxldizlno alkyd resin
80-193 Neophentyl glycol, 1,6-hexanediol, adipic acid, phthalic anhy-
dride, and trimellitic anhydride
45 FR 54854 11/2/80
8/18/80
45 FR 56429 11/2/80
8/25/80
45 FR 59196 11/3/80
9/8/80
45 FR 58201 11/3/80
9/2/80
45 FR 58194 11/3/80
9/2/80
3
-------
SO-194 2,2,4-TrimethyM,3-pentanediol, 1,6-hexanediol phthalic anhy-
dride
80-195 Generic name: Substituted alkyl oxamide, hydroxylated alkyl
amide and functionally substituted amide
80-196 Generic name: Trisubstituted monocyclic alkenal, monocy-
clic alkenal, alkenal, ethyl-(trimethyl monocyclic)
80-197 Generic name: Trisubstituted monocyclic alkenol, monocy-
clic alkenol Trimethyl monocyclic ethyl alkenol
80-198 Generic name: Styrene acrylic terpolymer
80-199 Generic name: Methyl, aminoheteropolycycle
80-200 Generic name: 1-Substituted-1-(p-substitutedphenyl)ethane
80-201 Generic name: 1-Substituted-1-(4-(substitutedheteromonocy-
clic)phenyl)ethane
80-202 Generic name: 1-Substituted-1-(4-(substitutedheteromonocy-
clic)phenyl)ethane
80-203 Generic name: p-(Methylsubstituted)(substitutedbenzene),
triethylammonium salt
80-204 Generic name: 1-Substituted-4-(methylsubstituted)benzene..
80-205 Generic name: 1-Methylsubstituted)-4-(substitutedheteromo-
nocyclicjbenzene
80-208 2-oxepanone, polymer with 1,4-butanediol, benzene, 1,3-diiso-
cyanatomethyl and 2-propenoic acid, 2-hydroxyethyl ester
80-209 Generic name: Bis(1-polyamino-2-alkyl imidazoline)
80-210 Generic name: Bis(1-polyamino-2-alkyl imidazolene)
80-211 Generic name: Polytetramethylene glycol, aliphatic polygly-
col and alkyl diisocyanate
80-212 Generic name: Adduct of polytetramethylene glycol, alipha
tic polyglycol, aliphatic diisocyanate and an alkyl diisocy-
anate
80-213 Generic name: Halogenated copolyester resin
80-214 Generic name: Polyester of aliphatic polyols and aromatic di-
acids
80-215 Generic name: Styrene-acrylate copolymer
80-216 Generic name: Methyl fatty acid ester
80-217 Generic name: Trlsazo dye
80-218 Generic name: Aromatic trlsazo diester dye
80-219 Generic name: An aliphatic ester
80-220 Generic name: Polybasic acid ester of mixed short alkyl
mono alcohol and a polyol
80-221 Cyclohexanecarbonitrile, 1,1'azobis
80-222 Cyclohexanecarbonitrile, 1-amlno
80-223 Polymer of: 1,6-Hexanediol, terephthalic acid, neopentyl gly-
col, trimelletlc anhydride, adlpic acid and Isophthalic acid
80-224 Polymer of: Isophthalic acid, tall fatty acid, trimelletlc anhy-
dride, terephthalic acid, neopentyl glycol and trimethyl
propane
80-225 Generic name: Mono di, and tri esters of polybasic acids
80-226 Dimethyl 1,4-cyclohexanedicarboxylate, maleic anhydride,
neopentyl glycol phthalic anhydride, trimethylol ethane
polymer
80-227 Benzoic acid fatty acids C14 unsaturated, maleic anhydride
and pentaerythrltol polymer
80-228 Benzene propanoic acid, 3,5-bis(1,1dimethylethyl)-4-hydroxy-
(1,2-dloxo-1,2-ethanediyl) bis (imlno-2,1-ethandiyl) ester
80-229 Generic name: Dlchloro dimethoxy diethyl amino, azoben-
zene, sodium salt
80-230 Generic name: Fatty acid ester
80-231 Napthalene, 1,2,3,4-tetrahydro-1,2,4,4-tetramethyl
80-332 2-Napthaleneethanol,5,6,718-tetrahydrobeta, 5,5,8,8-penta ..
methyl
80-233 Polymer of adipic acid, benzoic acid, neopentyl glycol, phta-
llc anhydride, propylene glycol, trimethylol ethane, tall oil
fatty acids
45 FR 58194
11/3/80
9/2/80
45 FR 58194
11/3/80
9/2/80
45 FR 59196
11/5/80
9/8/80
45 FR 59196
11/5/80
9/8/80
45 FR 58194
11/6/80
9/2/80
45 FR 60003
11/6/80
9/11/80
45 FR 60003
11/6/80
9/11/80
45 FR 60003
11/6/80
9/11/80
45 FR 60003
11/6/80
9/11/80
45 FR 60003
H/6/80
9/11/80
45 FR 60003
11/6/80
9/11/80
45 FR 60003
11/6/80
9/11/80
45 FR 59200
11/9/80
9/8/80
45 FR 60006
11/11/80
9/11/80
45 FR 60006
11/11/80
9/11/80
45 FR 60006
11/11/80
9/11/80
45 FR 60006
11/11/80
9/11/80
45 FR 60008
11/16/80
9/11/80
45 FR 60009
11/16/80
9/11/80
In prep.
11/17/80
In prep.
11/17/80
In prep.
11/18/80
In prep.
11/18/80
In prep.
11/18/80
In prep.
11/19/80
In prep.
11/24/80
In prep.
11/24/80
In prep.
11/24/80
In prep.
11/24/80
In prep.
11/24/80
In prep.
11/19/80
In prep.
11/24/80
In prep.
11/24/80
In prep.
11/24/80
In prep.
11/25/80
In prep.
11/26/80
In prep.
11/26/80
In prep.
11/26/80
4
-------
80-234 Adipic acid, dimethyl 1,4-cyclohexane dicarboxylate, maleic
anhydride, neopentyl glycol, phthalic anhydride,
trimellitic anhydride, trimethylol ethane polymer
80-235 2-Pyridinamine, N, N-dimethyl
80-236 Generic name: Aliphatic polyurethane water borne disper-
sion
In prep. 11/27/80
In prep.
In prep.
11/27/80
11/27/80
Premanufacture Notices for Which the Notice Review Period Ended During the Month
(Expiration of the nolle* period does nol signify thai Ih# chemical ha* bean added to the Inventory.)
80-26 Generic name: Substituted heteromonocycle derivative of 45 FR 44397 8/4/80
1,4-hexadiene, polymer with ethene and 1-propene 7/1/80
80-27 Generic name: Substituted heteromonocycle derivative of 45 FR 44397 8/4/80
1.4-hexadiene, polymer with ethene and 1-propene 7/1/80
80-93 4,7-Methano-1H-inden-5-ol-3a,4,5,6,7,7-a-hexahydro-dimethyl 45 FR 34999 8/3/80
5/23/80
80-94 Generic name: Monosubstitutedbenzene-sulfonamide 45 FR 34999 8/3/80
5/23/80
80-95 Generic name: Monosubstitutedbenzene-sulfonyl chloride 45 FR 34999 8/3/80
5/23/80
80-96 Generic name: Monosubstitutedbenzene-dlazonlum chloride 45 FR 34999 8/3/80
5/23/80
80-97 Generic name: Trisubstitutedtriazine 45 FR 34999 8/3/80
5/23/80
80-98 Generic name: Monosubstituted alkanimldic acid, alkyl ester 45 FR 34999 8/3/80
5/23/80
80-99 Generic name: Hydroxy functional acrylic 45 FR 37280 8/5/80
6/2/80
80-100 Dimethyl 1,4-benzenedlcarboxylate, polymer with 1,6-hexan- 45 FR 37280 8/5/80
ediol, 2,2-dlmethyl-1,3-propanedlol, 1,3-benzene dlcarboxy- 6/2/80
lie acid, and 1,6-hexanedloic acid
80-101 1,3-lsobenzofurandione, polymer with 1,6-hexanediol, 2,2-di- 45 FR 37280 8/5/80
methyl-1,3-propanedloi,2-ethyl-2-hydroxymethyl-1,3-pro- 6/2/80
panedlol, and 2,2-dimethyl-3-hydroxyproplonate
2,2-dlmethyl 1-3-hydroxypropionate
80-102 Generic name: 5-[6-(3-substituted phenylamino)-4-chloro-(1, 45 FR 37279 8/12/80
3.5-triazin-2-yl)-amino]-3-(3-substltuted-2-hydroxy-5-sulfo- 6/2/80
phenylazo)-4-hydroxynaphthalene-2,7-disulfonic acid, cop-
per complex salt
80-103 Generic name: Styrene-malelc anhydride-methyl methacry- 45 FR 41058 8/17/80
late polymer 6/17/80
80-104 Generic name: Polymer of cyclo aliphatic dilsocyanate, 2-ox- 45 FR 37728 8/17/80
2ohexanethyleneimine, hydroxy alkyf alkyl alkanediol 6/17/80
80-105 Monoethanolamine salt of 1-hydroxyethylldene-1,1-dlphos- 45 FR 37727 8/19/80
phonic acid 6/17/80
80-106 Diethanolamine salt of 1-hydroxyethylldene-1,1-diphosphon- 45 FR 37727 8/19/80
ic acid 6/17/80
80-107 Trlethanolaminesalt of 1-hydroxyethylidene-1,1-diphosphon- 45 FR 37727 8/19/80
ic acid 6/17/80
80-108 Hydrogenated petroleum hydrocarbon resin 45 FR 41060 8/20/80
6/17/80
80-109 Generic name: 3-(1-amlno-2-sulfo-4-anthraquinylamlno)-ben- 45 FR 41060 8/20/80
zene sulfon-3-substltuted anllide 6/17/80
80-110 Generic name: 2-((2-Methylsubstituted)ethyloxycarbonyl)8ub- 45 FR 42018 8/25/80
stituted) phenyl, dlsulfo, diheteropolycycllc heteropolycy- 6/23/80
cle
80-111 Generic name: 2-((2-Methyl8ub8tltuted)ethyloxycarbonyl)8ub- 45 FR 42018 8/25/80
stituted) phenyl, dlsulfo, diheteropolycycllc heteropolycy- 6/23/80
cle
80-112 Generic name: 2-<{2-Methylsubstltuted)ethyloxycarbonyl)sub- 45 FR 42018 8/25/80
stituted) phenyl, dlsulfo, diheteropolycycllc heteropolycy- 6/23/80
cle
80-113 Generic name: (2-
-------
80-115 Generic name: (Diojco, methylheleropofycycllc},dihetefo-
polycyclic heferopolycycle
30-116 Generic name: {2-Substitutedphenyl), diheteropolycyciic he-
teropolycycle
80-117 .. Generic rtame: Sail form of acrylic acid-acrylate copolymer..
80-118 Generic name: A polymer of styrene, hydroxy functional mon-
omers, esters of acrylic and methacrylic acid
80-119 Generic name: 2-/di-(dimelfiyl, substitutedcarbonomonocy-
c(ic)alkyl) (methyl, carboxysubstitutedjbenzene, (mettiyl-
subsiitutedjetbyl ester
80 120 Generic name: Methyl, trisubstituted-heteropnlycycle
80-121 Generic name: l-Substittited^S-dimelhyM-substitutedben-
zene
80-122 Genericname:2-(di-(3,5-dime(fiyM-substifutectphenyl|hydrox-
alkylHmethyt, carbaxysubstituted)benzerie{mettiylsub-
stituted) ethyl ester
80-123 Generic name: 2-(di-|3,S-dimettiyl-4-subatitutedpher>yl>hy-drox-
alkyf)-(metivylsLjbsiiluted) benzene
45 FR 42018
8/25/80
6/23/8Q
45 FR 42016
8/25/00
6/23/80
45 FR 41064
8/26/80
6/17/80
45 FR 42017
8(27/80
6/23/80
45 FR 42013
6/27/80
5/23/60
45 FR 42013
8/27/80
6I23/&0
46 FR 42013
3/27/80
6/23/80
45 FR 42013
8/27/60
6/23/80
45 FR 42013
8/27/30
6/23/80
New Chemical Substances that EPA Has Added to the Inventory During the Month
PMN Mo.
Submitter
Chemical Identification
FR Citation
80-18 Confidential Generic name: i-p-flitrobenzc>lyl-1(4-carbox:ypyrkiyl) 45 FR 13521
hydrazide 2/29/80
80-76 General Printing Generic name: Alkyd resin TV79-0777; Alkyd poiy- 45 FR 30127
Irk Co. mer TV79-0777; polyester resin 5/7/80
80-77 General Printing Generic name: Alkyd resin X4-779; alkyd polymer X4- 45 FR 30127
ink Co. 779; polyester resin 5/7/60
80-33 Confidential Generic name: Unsaturated polyester resin of male- 45 FR 32772
-------
substance and the total amount to be imported. (2) A
notice of import of a new chemical substance may
only be submitted by a person incorporated, licens-
ed, or doing business in the United Sfiates.
PREMANUFACTURE ORDER-SECTION 5(e)
Under Section 5(e) EPA may, after determining that
there is insufficient information in a PMN to eval-
uate a potential unreasonable risk, order that manu-
facture of the new substance be prohibited until ade-
quate data are developed. The manufacturer has 30
days from the order's receipt to object. If he does ob-
ject, EPA then has 15 days to obtain a court order
prohibiting manufacture until adequate data are de-
veloped. The company is under no time limit to sub-
mit the information, but until it does so, EPA's
manufacturing ban remains in effect.
On September 5th, EPA issued an order under Sec-
tion 5 to block manufacture of a new chemical sub-
stance pending development of additional informa-
tion on its human health risks. The information was
needed to address concerns that the chemical might
cause severe skin reaction to people exposed to it.
The substance described as "substituted benzene,
reaction products of 022-C30 Alkenes" was to be us-
ed as a lubricant additive. Confidentiality was claim-
ed for the specific chemical identity, the exact pro-
posed use of the new substance and the manufac-
turer's name. Since the September 5th order the
manufacturer has withdrawn the PMN. This was the
second time EPA used its priority under TSCA to halt
introduction of a new substance suspected of caus-
ing health or environmental problems.See:
Chemlcals-ln-Progress Bulletin Vol.1, No.2,
June1980, page 9.
INDUSTRY ASSISTANCE ... SECTION 26(d)
Under Section 26(d) EPA established an Industry
Assistance Office as an identifiable office to provide
technical and other nonfinancial assistance to
manufacturers and processors of chemical
substances and mixtures in complying with TSCA.
To assist small manufacturers, importers and pro-
cessors of chemical substances in complying with
PMN requirements, EPA has contracted with Triton
Corporation, a Washington, D.C. consulting firm, to
establish field consultants especially qualified on
PMN's in two trial areas. Beginning October 1,1980
chemical firms in a large radius around Chicago and
around Newark, N.J. may obtain assistance at no
cost on how to prepare required PMNs from these
specialists. In the N.J. area (including eastern Penn-
sylvania, New York City area, and Connecticut) firms
should contact Mr. Alan Schneider, 23 Glendale
Road, Summit, N.J. 17901 (201-277-0060). In the
Chicago area, call Ms. Nancy Ross or Ms. Maricel
Qulntana (312-454-0536). Should this free consulting
service be well used In these areas, EPA plans to ex-
pand the service to other chemical industry centers.
SUBSTANTIAL RISK ... SECTION 8(e)
Under Section 8(e) persons who obtain Information
which reasonably supports the conclusion that a
substance presents substantial risk of Injury to
human health or the environment must notify EPA
within 15 days. These notices are then reviewed by
OPTS preliminarily and an Initial evaluation Is
prepared containing, if appropriate, follow-up ques-
tions to the submitter, referrals to other agencies
and decisions to list the chemical for a Section 8
reporting rule or to undertake a formal risk assess-
ment. The submissions and the initial evaluations
are in the Public Reading Room, 447 East Tower,
Waterside Mall, 401 M Street, S.W., Washington,
D.C.
Because of the high volume of telephone requests
for copies of the Section 8(e) notices, which often
are either a one-page letter or an extensive package
of data and articles, the Public Document Room will
no longer be able to take telephone requests for co-
pying. Persons wishing to request a copy of these
notices may write: U.S.E.P.A., Ms. Jerri Green
(A-101), Freedom of Information office, Washington,
D.C. 20460. Requestors will be charged 20' per page
for the duplication of documents. However, there
will be no charge if the total fee in connection with a
request is less than $10.00 (i.e., less than 50 pages).
At page 50 of a request for duplication, a charge of
20 * per page is levied for ail subsequent pages and
also for the first 49 pages of the request. The
reader's attention is called to the fact that many 8(e)
notices represent a company's first review of a
situation or datum and a judgment in compliance
with the statute to submit an notice within 15 days
of obtaining the information. The EPA publishes its
evaluations of these notices in order to make widely
available this Section 8(e) information in an ex-
planatory form that makes it understandable to a
broad public.
SECTION 8(e) NOTICES OF SUBSTANTIAL RISK:
JULY-SEPTEMBER 1980
Log No. 8EHQ- [CAS No.]
0780-0352 7/14/80 Polychlorlnated Bi- [1336-36-3]
phenyls
"Datum: PCBs In Friction-Proofing Fluid for Hy-
draulic Elevator Systems
0780-0353 7/14/80 Aromatic Pitch Pe- [68187-58-6]
troleum
•Interim Report on Life-Time Carcinogenicity
Study
0780-0354 7/24/80 Silica Gel [1343-98-2]
*1967 German Subchronic In Vivo Toxicity Study
0880-0355 7/29/80 Methylthioacetaldehyde Oxine
•Occupational Exposure: Acute Effects to Em-
ployees
0880-0356 8/11/80 2-Hydroxyethylacry- [818-61-1]
late
•Preliminary Summary Report on Neurotoxicity
0880-0357 8/11/80 Methylene bio Aco- [110-26-9]
ylamlde
•Preliminary Summary Report on Neurotoxicity
0880-0358 8/1/80 Ferric Chloride Solution
•Employee Report of Radioactivity
0980-0358 Followup 9/19/80
•Report on Source, Sampling & Water Acts Com-
pliance
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0980-0359 8/28/80 Diallyl Tetrabromo- [49693-09-6]
phthalate
•Interim Report on Mutagenicity Battery
0980-0360 9/4/80 Benzotrichloride, [98-07-7]
p-Chlorobenzotrich- [5216-25-1]
loride
Benzoyl Chloride [98-88-4]
•Japanese Studies on Possible Carcinogenicity
0980-0361S 9/3/80 Cobalt Phthalocya- [29383-29-7]
nine Disulfonate &
Cobalt Phthalocya-
nine Tetrasulfonate [14285-59-7]
"Summary Report on Mutagenicity Battery
0980-0362 9/9/80 Hydrochloride Salt [57138-85-9]
of a Polymer of An-
iline & Formalde-
hyde
'Final Report on Acute Inhalation Toxicity Study
0980-0363 9/12/80 Solvent Refined Coal: SRC-I Re-
cycle Solvent
•Final Report on Mutagenicity Study (Ames)
0980-0364 9/15/80 Dicyclopentadiene
•Preliminary Report on Subchronic Inhalation
Toxicity Study
*S means a Sanitized version with Privacy Act items
N.B.: All toxicity, carcinogenicity, teratogenicity and mutagenicity studies in-
volve animals. Additional tests (e.g., bacteria, ceil) are noted or are included
In the term "battery."
SECTION 8(e) COMPENDIUM
EPA has published a second volume of initial evalu-
ation of substantial risk notices as required by Sec-
tion 8(e). The submissions received and evaluated by
EPA are for July 1, 1979-January 31, 1980. The
volume is part of the TSCA Chemical Assessment
Series and persons who have previously subscribed
to the series should have received this latest
volume. By now persons who had asked to be noti-
fied of each volume in the series also should have
received notice of availability of this latest volume.
A limited number of both the first (January 1, 1977
-June 30, 1979) and the latest volumes are still
available.
Some difficulty has been encountered by persons at-
tempting to cross reference individual status reports
in the firstvolume with the various appendixes. Each
status report in a volume is in numerical order based
on the last four figures in the status report number
(submission number). Every arrangement of status
reports in the appendix also lists the submission
number. By noting the last four numbers in the sub-
mission number a reader can easily find the status
report which is listed in numerical order according
to the last four numbers.
TEST DATA STANDARDS—SECTION 4(b)
Under Section 4(a), EPA must prescribe standards
for development of the test data required in the
chemical testing rule. Section 4(b) spells out what
shall be prescribed: how studies are designed and
conducted to ensure reliable and adequate data; the
time period to do the testing; the persons subject to
the rule, and what resources and costs are deemed
available and reasonable.
EPA will publish shortly supplementary rules to its
Good Laboratory Practice Standards proposed on
May 9, 1980 (45 FR 27334). When made final, these
standards will be included as requirements, if ap-
propriate, every time specific chemical testing rules
are promulgated. The good laboratory practice stan-
dards will assure reliability and adequacy of data
submitted in compliance with a Section 4 testing
rule.
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 is required to apply one or several re-
quirements of the law to the extent necessary to pro-
tect against the risk.
On September 17, 1980 (45 FR 61966) EPA proposed
a rule to reduce risk of human exposure to asbestos-
containing material in school buildings throughout
the United States. The proposal would require public
and private elementary and secondary school of-
ficials to identify, record and give notice of friable
asbestos-containing materials in school buildings.
EPA has coordinated this proposed rule with the
United States Department of Education's (DOE) pro-
posed regulations under the Asbestos School
Hazard Detection and Control Act. A copy of the pro
posed DOE rule is available through the IAO. On
November 17,1980, EPA will begin an informal hear-
ing on the proposed rule. Requests to participate in
this informal meeting should be sent to Gordon Mc-
Curdy, EPA-OPTS, TS-794, 401 M St., S.W.,
Washington, D.C. 20460.
CHLOROFLUOROCARBONS...
SECTION 6
On October 7,1980 (45 FR 66726), EPA published an
Advance Notice of Proposed Rulemaking (ANPR)
stating it is considering restricting production of
chlorofluorocarbons (CFCs) because of their de-
structive effect on stratospheric ozone. Two emis-
sion control methods are being considered, a man-
datory control approach and an economic incentive
plan. The first would limit CFC production by man-
datory controls or by technology based standards.
The second method would control CFC production
through the distribution of marketable permits.
Within each approach EPA is considering several op-
tions. The Agency is seeking written comments on or
before January 5,1981 about the ANPR's proposals.
INTERAGENCY TESTING COMMITTEE (ITC)...
SECTION 4(e)
Under Section 4(e), the ITC was established to
recommend to EPA substances which should be
tested for specified effects to determine the
substances hazardous potential to human health or
the environment. Committee members are: Council
on Environmental Quality (CEQ), Department of
Commerce (DOC), Environmental Protection Agency
(EPA), National Cancer Institute (NCI), National In-
stitute of Environmental Health Sciences (NIEHS),
National Institute for Occupational Safety & Health
8
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(NIOSH), National Science Foundation (NSF), and
the Occupational Safety & Health Administration
(OSHA). The committee may list up to 50 chemicals
or ca tegories and is to consider revising or adding to
its list every 6 months. The EPA must respond within
one year to each recommendation by initiating
rulemaking under Section 4 or stating its reasons for
not doing so. Both ITC reports and EPA responses
appear in the Federal Register.
On March 5, 1980 EPA submitted a compliance
schedule for the first three ITC lists as required by
the Federal Court of the Southern District of New
York. This summission was a consequence of a rul-
ing in favor of the National Resources Defense
Council which had sued EPA for non-conpliance with
Section 4(e) by virtue of not having initiated rulemak-
ing within the one-year deadline. EPA has offered to
revise its proposed Section 4 test rule schedule for
chemicals listed in the first six Interagency Testing
Committee (ITC) reports. The new EPA schedule, as
filed with the court, commits EPA to propose either
test rules or announce EPA's decision not to test the
ITC listed chemicals within four years rather than
seven years as previously proposed to the court by
EPA in March 1980. In the affidavit, EPA listed the
revised schedule which appears below.
No. of Single ITC
Chemicals or Lists
Date Categories Action Chemicals (1-6)
5/81
1981
Proposed rules and/ or
decisions not to test
Proposed rules and/or
decisions not to test
1982
13
Proposed test rules and/or
decisions not to test
1983
13
Proposed rules and/or
decisions not to test
Nitrobenzene 1
Dichloromethane 2
1,1, 1-trlchloroethane 2
Eight of the following
chemicals
Acetonitrlle 4
Alkyl phthalates 1
Antimony 4
Antimony trloxlde 4
Antimony sulfide 4
Aryl phosphates 2
Benzidine based dyes S
Chlorinated paraffins 1
Chlorinated naphthalenes 2
Cresols 1
o-Dianisidine dyes 5
Hexachloro-1,3-butadiene 1
4,4-Methylenedlanlllne 4
o-Tolldine dyes 5
Phenylenediamlnes 6
Polychlorlnated terphenyls 2
(1) The eight remaining
chemicals in the 1981 list
(2) Five of the following:
chemicals
Alkyl epoxides 1
Acrylamlde (environ- 2
mental test rule)
Anilines 4
Chlorinated benzenes 1.3
(Environmental test rule)
Cyciohexanone 4
1,2-Dlchloropropane 3
Haloalkyl Epoxides 2
Pyridine 2
Toluene 1
Xylenes 1
(1) The 5 remaining
chemicals on the 1982 list
(2) The following eight chemicals:
Qlycldol and its derivatives 3
Hexachlorocyclo-pentadiene 4
Hydroquirone s
Isopherone 4
Mesltyl oxide 4
Methyl ethyl ketone 4
Methyl Isobutyl ketone 4
Qui none 5
9
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REPORTING RULES
SINGLE CHEMICAL REPORTING RULES-
SECTION 8(e)
Under 8(a), the Administrator is authorized to pro-
mulgate a rule requiring advance notice of the
manufacture or importation of a named chemical
substance and notice of any current manufacture or
importation.
On October 24,1980 (45 FR Part 5) EPA promulgated
a rule, effective 30 days after publication in the
Federal Register, requiring that EPA be notified of
any manufacture or importation of poiybrominated
biphenyls (PBBs) and tris 2,3-dibromopropy1
phosphate (Tris). There is significant evidence that
PBBs and Tris may present risks to health and the
environment. The substances apparently have gone
out of production in the United State. PBB impreg-
nated plastic granules used in the manufacture of
electrical equipment are imported, but it is expected
that no exposure to PBBs results from this use.
The purpose of this rule is to confirm that PBBs and
Tris are no longer being manufactured or imported
per se and to ensure that EPA has the opportunity
to investigate the circumstances of any resumption
of manufacture or importation.
STUDIES & SUPPORT ACTIVITY
TSCA PUBLICATIONS SERIES
Under Section 9, EPA is required to integrate and
coordinate various Federal activities involved with
controlling toxic substances whenever regulatory
action is contemplated or initiated under TSCA. To
this end, EPA is now publishing information under
two series, the Toxic Integration Information Series
and the Toxic Integration Policy Series. The Informa-
tion series booklets contain a collection on the
status of assessment and regulation of chemical
substances throughout EPA and a listing of groups
and agencies involved in chemical substances re-
search, assessment and requlatory authority. The
policy series publications provide a forum for
discussion and development of policy and imple-
mentation approaches for integration in manage-
ment of chemical substances at both the State and
Federal level. Persons interested in publications in
either series should write to the IAO giving name,
organization and full address. Booklets in the Sec-
tion 9 series are presently available: Perspectives on
the Top 50 High Production Chemicals; Directory of
Federal Coordination Groups for Toxic Substances
(March 1980); State Administrative Models for Toxic
Management and Federal Activities in Toxic
Substances.
LITERATURE SEARCH
A computerized literature search for data on cad-
mium and lead in human blood and kidneys has been
compiled and is available as a booklet through the
IAO. This limited search, was developed under EPA
and the National Cancer Institute direction for the
World Health Organization (WHO). The search will
aid a WHO program of testing cadmium and lead
levels in the blood of high school teachers in several
cities throughout the world and in analyzing cad-
mium levels in kidney cortex tissues. Autopsies of
sudden death victims who had no history of kidney
disease will provide the kidney specimens.
CHEMICAL ASSESSMENT SERIES
EPA has recently published a report on benzidine, its
congeners and their derivative dyes and pigments.
This volume, a summary and analysis of information
on the known sources and effects of exposure to
benzidine, identifies the specific problems the
chemical is likely to create. The benzidine volume is
the third in a series of reports and studies made by
scientists in the course of implementing TSCA. The
general heading of the series is "TSCA Chemical As-
sessment Series" The first two volumes were pub-
lished in April 1980. Persons who have previously
subscribed to the series have now received the fol-
lowing volumes:
Chemical screening: Initial Evaluation of
Substantial Risk Notices, Section 8(e)
Chemical Hazard Information Profiles
(Chips)-August 1976-August 1978.
Preliminary Risk Assessment:
Phase 1 - Benzidine
Persons may receive volumes either by subcribing to
the entire series or by asking to be notified of each
volume as it appears.
A TSCA POLICY STUDY
This study, informally called the Ashford Report,
designs, analyses and assesses alternative policies
that could be used to address the problems TSCA
might create for innovation. The Ashford Report will
be available shortly. A copy may be reserved by call-
ing the IAO.
CHEMICAL SUBSTANCES INFORMATION NET-
WORK (CSIN)
Section 25(b) of TSCA required the Council on En-
vironmental Quality (CEQ), in consultation with EPA
and other Federal agencies, to coordinate a study to
determine the feasibility of establishing both a stan-
dard classification system for chemical substances
and a means to increase the efficiency and effective-
ness of both storage and retrieval of the collected in-
formation. Additionally, Section 10 requires that
EPA, with the aid of other Federal agencies, design,
establish and coordinate a system for the retrieval
of chemical, toxicological and other scientific data
and information useful in carrying out the purposes
of TSCA.
To carry out the provisions of these mandates, the
CEQ and EPA, in February 1978, established the
10
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Interagency Toxic Substances Data Committee
(ITSDC) as a permanent mechanism for coordinating
policy and the design and implementation of re-
sources for the use and analysis of data and infor-
mation relating to chemical substances.
About 300 information resources were examined by
the ITSDC to determine their usefulness in respond-
ing to the requirements of TSCA and how the use of
such resources could be coordinated. The concept
of a Chemical Substances Information Network
(CSIN) was proposed to provide efficient and effec-
tive identification, access, and use of voluminous
amounts of data and information to a broad base of
users.
A prototype or experimental version of CSIN should
be in operation in early 1981. Resources available
through CSIN will include the Medlar files of the Na-
tional Library of Medicine; the Chemical Information
System, which is supported by EPA and the National
Institutes of Health; and the Chemicals in Com-
merce Information System, which contains all the
non-confidential business information collected
under TSCA.
The ITSDC, representing over 30 Federal agencies,
reported that CSIN "appears to be the best means
for satisfying long-term needs of Federal agencies
and other user groups." The ITSDC also said that
CSIN will increase the ability of decision makers In
government, industry, and academia to predict bene-
fits or hazards associated with the use or proposed
use of chemical.
Dear Reader:
This is the fourth issue of the Chemicals-in-Progress Bulletin. We have sent all
four issues of the Bulletin to you and to all 25,000 people on our TSCA mail list.
However in the interest of good distribution, this will be the last issue we will send
to you unless you tell us you want to continue to receive the Bulletin. If you want to
continue, check the box below h&Jf page along with the mailing label
on the reverse side of your sentus a reproduction of your
label. Send the label Changes if necessary) to:
0*fieeTP799
Street, S.W.
Washington, D.C. 20460
Thank you,
John B. Ritch, Jr.
~ Yes, I want to continue to receive the Chemicals-in-Progress Bulletin.
11
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TSCA ALERT LIST
Actions Expected in November-December
• Sec 5 and 8 New Chemical Followup Rules
¦ Sec 12(b) Final Export Reporting Rule
Industry Assistance Office (TS-799)
Office of Pesticides & Toxic Substances
U.S.E.P.A.
Washington, D.C. 20460
Official Business
Penalty for Private Use
$300
First-Class Mail
Postage and Fees Paid
EPA
Permit No. G-35
THE TSCA C H EM ICALS-IN-PROGRESS BULLETIN
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