TSCA
Chemicals-in-Progress
Bulletin
Office of Pesticides & Toxic Substances
(OPTS)
Vol. 3, No. 3 October 1982
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 Industry Assistance Office (IAO), (TS-799) EPA,
Washington, D.C. 20460, or call toll-free 800-424-9065 or, in Washington, D.C., or from outside
continental USA, (202) 554-1404.
REGULATORY & REQUIRED ACTIONS
PREMANUFACTURE NOTIFICATION ... 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 least 90 days before begin-
ning manufacture or import. On May 15, 1979 (44 FR
28564) EPA published a statement of interim policy
concerning section 5, premanufacturing notification.
EPA Proposes PMN Changes
Under section 5(h)(4), EPA may, upon application and by
rule, exempt a category of new chemical substances
from one or all of the section 5 premanufacture notifica-
tion (PMN) requirements if the Administrator deter-
mines that the substance will not present an unreason-
able risk of injury to health or the environment.
On August 4, 1982, EPA proposed two rules (47 FR
33896) that call for the partial exemption of certain new
site-limited intermediates, low volume chemicals and
polymers from full PMN requirements. EPA was re-
sponding to a petition from the Chemical Manufacturers
Association and others.
Based on its 3-year PMN experience, EPA estimates half
of the 1,000 new chemicals subject to the PMN require-
ments each year may be eligible for exemption if the two
proposed rules become final. The Agency said the
changes would permit EPA to concentrate its resources
on new chemicals of potential concern, encourage
chemical innovation in low risk chemicals, allow more
rapid introduction of low risk chemicals into the market
after EPA review, and reduce regulatory burdens on
manufacturers of new chemicals without reducing pro-
tection of public health or the environment. "Together,
these elements will allow EPA to focus its resources on
chemicals of potential concern and will go far toward
ensuring that new chemicals introduced into commerce
do not present unreasonable risks," said Dr. John A.
Todhunter, the EPA Assistant Administrator for Pesti-
cides and Toxic Substances, at a July 28th press confer-
ence. He said that the proposed PMN program also is
similar in goals and spirit to the new chemical program
of the European Economic Community.
For new site-limited intermediates (chemicals that are
reacted to produce other chemicals but never leave the
manufacturing site) and low volume chemicals [chem-
icals manufactured at 10,000 kilograms (22,000 pounds)
or less a year] manufacturers would submit a short
exemption notice for EPA review 14 days before manu-
facture begins. The manufacturer also would be required
to have a qualified expert assess the risks of the chem-
ical and conclude that it would not present a hazard.
During the 14-day review period, EPA would review the
notice to ensure ail the requirements of the exemption
are met. For chemicals produced at 1,000 kilograms
(2,200 pounds) or less a year there would be a 14-day
review period, but review by a qualified expert would not
be required.
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For chemicals in specific categories of polymers that EPA
identified as presenting low risk, the proposed exemp-
tion for polymers would only require manufacturers to
notify the Agency when manufacture begins. Manufac-
turers of other potentially exempt polymers would be
required to submit a brief PMN for review 14 days before
manufacture begins.
COMMENCEMENT OF MANUFACTURE NOTICES
In the May 15, 1979 statement of interim policy con-
cerning section 5, EPA said any person who submits a
PMN under the interim policy and who (after the 90-day
period) begins to manufacture or import the new sub-
stance for commercial purposes must inform EPA on or
about the date when manufacture or import commen-
ces, so that the Agency can add the substance to the
TSCA Inventory. This reporting requirement is imposed
under section 8(b). Listed below are the lastest com-
mencement of manufacture notices EPA has received.
NEW CHEMICAL SUBSTANCES FOR WHICH EPA HAS RECEIVED COMMENCEMENT
OF MANUFACTURE NOTICES
{since publication of the August 1982 Chemicals-in-Progress Bulletin)
PMN No.
Submitter
CBI=Confidentia( Business
information
Chemical Identification
GsGeneric Name
FR Citation
Do=Ditto
80-155 Amchem Products
Inc.
80-348 Mobil Chemical Co.
81-47 CBI
81-114 Do
81-119 Union Carbide Corp.
81-120 Do
81-128 ¦ CBI
B1-139 Do
81 -188 . .. American Hoechst
Corp.
81-167 Do
81-188 CBI
81-203 ............. Do
81-238 ............. Do
Cyclohexanehexacarboxylic acid, penta sodium
salt
Sunflower oil, polymer with pentaerythritol
phthalic anhydride, soybean oil and
trimethylolethane
G Naturalized polymer from a modified epoxy resin
G Modified epoxy resin
G Alky) aluminum halide
G Do
G Unsaturated alicyclic ether
G Polymer of carbomonocycllc acids, carbomono-
cyclic anhydride and modified vegetable oil
2-Naphthalenesulfonyl chloride, 2-acetamino
Ethanol, 2-(8-acetaminonapth-2-yl sulfonyl)
G Polyester polyurethane
G Substituted alkyl cyanoacrylata ester
G Pdyhfi^i slkanote ecld chterWe
45 FR 51262
8/1/80
46 FR 5058
1/19/81
46 FR 15944
3/10/81
46 FR 20765
4/7/81
46 FR 22260
4/18/81
Do
46 FR 22648
4/20/81
46 FR 24683
5/1/81
46 FR 24990
5/4/81
do
46 PR 27170
6/18/81
46 FR 29624
6/2/81
46 FR 31346
6/15/81
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81-251 Monsanto Co. 2-Chloro-4-trifluoromethyl-5-thiazolcarboxylic acid, 46 FR 35345
phenylmethyl ester 7/8/81
81 -252 Do G Disubstituted thiazolecarboxylic acid, ester Do
81-441 CBI G Mixed mono and dialkyi-dithio-thiadiazoles 46 FR 47003
9/23/81
81-444 Do G Substituted heterocyclic-phenyl-azo dye Do
81-446 Do G Polydimethylsiloxane, alkyl and terpenyl 46 FR 47005
substituted 9/23/81
81 -453 Do G Modified phenolic novolak resin Do
81-460 Do G Substituted heteropolycycle 46 FR 47658
9/29/81
81-468 Day-Glo Color Corp. 4-Chloronaphthalene 1,8-dicarboxylic acid 46 FR 47855
anhydride 10/5/81
81-483 Do 4(2'-aminophenyl thio) 1,8-naphthalic anhydride 46 FR 48979
10/5/81
81 -492 Goodyear Tire & 1,3-bis(1 -methylethenyl) benzene 46 FR 49944
Rubber Co. 10/8/81
81-494 CIBA-GEIGY Corp. G (AlkylamlnoalkylMsubstltutedJ-banzotriazole Do
81-508 Goodyear Tire & G Benzenedicarboxylic acid saturated mixed glycol 46 FR 50410
Rubber Co. polyester 10/13/81
81-517 CBI G Alkenyl tetracarboxylate 46 FR 50841
10/15/81
81-547 Goodyear Tire & 1,4-bis(1-methylethenyl) benzene 46 FR 55001
Rubber Co. 11/5/81
81 -554 CBI G Metal alkyl thiocarbonate Do
81 -573 Reliance Universal G Polyacrylate 46 FR 56661
Inc. 11/18/81
81-576 Sandoz Colors & G 1,2,4 substituted anthraquinone 46 FR 56662
Chemicals 11/18/81
81-583 CBI G Fatty acid ester with a polyol and oleic acid 48 FR 67126
11/20/81
81 -888 Do 0 2-2'^Wdcl(l#th#W^8lltyl sueeJnW acid 46 FR 57632
11/24/81
81 -594 Do 6 Mixed aromatic disszo dye 48 FR 58368
12/1/81
81-817 Do g Substituted benzene sulfonic acid derivative 46 FR 80981
12/14/81
81-640 Do 8 OliUbstltUtiiptHKioJ 48FR 62928
12/29/81
%
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81-648 ... Do G Tetrasubstituted benzenamine 47 FR 336
1/5/82
81-649 Do G Do Do
81-651 Do G Do Do
81-656 Do G Halogenated riitrotoluene derivative 47 FR 1019
1/8/82
81-657 Do G N-alkylated toluidine derivative Do
81-658 Do G Halogenated toluidine derivative Do
81-667 Do G Substituted furan 47 FR 1411
1/13/82
82-16 Do G Substituted cyclic amide-aldehyde condensation 47 FR 3592
product 1 /26/82
82-30 Do G Polysubstituted alkyl polyamine 47 FR 3591
1/26/82
82-39 Do G Polymer of a diisocyanate, polyglycol and poly- 47 FR 4144
substituted alkyl amine 1 /28/82
82-45 Do G Substituted pyridinium bromide 47 FR 4736
2/2/82
82-48 Huels Corp. G Polymer of cycloalkene 47 FR 5330
2/4/82
82-49 CBI G Modified polyester polyurethane 47 FR 5328
2/4/82
82-50 Do G Polyester from an alkanedioic acid and Do
polyetherdiols
82-61 Monsanto Co. G Polyoxypropylene ester acyl caprolactam 47 FR 5932
2/9/82
82-70 CIBA-GEIGY Corp. a[(1,3-dioxolan-2-ylmethoxy)imino] 47 FR 7310
benzeneacetonitrile 2/18/82
82-74 CBI G Carbomonocyclic diester 47 FR 7487
2/19/82
82-90 Dow Corning Corp. G Siloxanes and silicones, aminoalkyl me; di-me 47 pr 3570
3/1/82
82-129 GAFCorp. G Esterfied copolymer of a vinyl compound and an 47 FR 8675
unsaturated carboxylic acid 3/1 /82
82-134 CBI Propanoic acid/methylenebutaneidioic acid Do
copolymer, sodium salt
82-136 Do Polymer of 2-propenoic acid and 47 FR 8675
methylenebutanedioic acid 3/1/82
82-139 Do Polymer of hexanedioc acid and 47 FR 8840
2-(methylamlno)ethanol 3/2/82
82-150 Do Polymer of methyl methacrylate, acrylamide, 47 FR 10073
butyl acrylate, acrylic acid, methacrylic acid 3/9/82
4
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82-166 Do G Disubstituted-6,13-dichloro-4,11-trippenodioxazirie 47 FR 10900
disulfonic acid 3/12/82
82-170 Do 1,6-hexariedioic acid, polymer with 1,2-ethanediol, Do
1.3-benzenedicarboxylic acid,
1.4-benzenedicarboxylic acid and 1,6-hexanediol
82-172 Milliken & Co. G Chromophore substituted poiy(oxyaikyiene) Do
82-177 CBI G Metal salt of sulfur analog of carboxy alkyl 47 FR 11957
carbonic acid 3/19/82
82-189 American Color & G Benzene 2-[(hexahydro-2,4,6-trioxopyrimidyl)azo]- Do
Chemical Co. 5-(2-benzothiazolyl)
82-196 Celanese Plastics & G Polyalkylene glycol alkyl glycidyl ether Do
Specialties Co.
82-197 Do G Polyoxalkylene aryl alkyl phenyl ether Do
82-199 CBI G Poly-imidazoline derivative Do
82-205 Do G Polyetherpolyol reaction with toluene diisocyanate 47 FR 13037
hydroxypropyl acrylate blocked 3/26/82
82-215 Do G Halogenated silicon magnesium oxo-titanium Do
alkoxides
82-219 Do G Polyetherpolyol reaction with isophorone 47 FR 14218
diisocyanate-HEA blocked 4/2/82
82"226 Do G Substituted phenyl, substituted naphthalenyl azo dye Do
82"233 Do G Organic salt of phosphorus 47 FR 15406
4/9/82
82~245 Do G Modified polyurethane 47 FR 16403
4/16/82
82 247
American Color & G 2-anthracenesulfonic acid, 1-amino-4-aub8tituted Do
Chemical Corp. phenylamino-9,10-dihydro-9,10-dioxo-sodium salt
82"267 CBI G Acid blocked amlroe Do
82"268 Do G Do Do
82"286 Do G Substituted aryl alkyl siloxane 47 FR 17666
4/23/82
82"8°3 3MCo. Inert fluorocarbon 47 FR 18652
4/30/82
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REGULATION OF HAZARDOUS SUBSTANCES ... SECTION 6
Under section 6, EPA is authorized to controla 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 requirements of the law
to the extent necessary to protect against the risk.
PCB Background
Under section 6(e), EPA is required to control the manu-
facturing, processing, distribution in commerce and use
of PCBs. On May 31,1979 EPA promulgated a PCB rule.
However, on October 30,1980, the United States Court
of Appeals for the District of Columbia Circuit, respond-
ing to a petition filed by the Environmental Defense
Fund (EDF), set aside that portion of the PCB rule that
characterized intact nonleaking PCB-containing trans-
formers, capacitors and electromagnets as totally en-
closed. The court also struck down the provision limiting
application of the rule to PCBs in concentrations of 50
ppm or greater for manufacturing, processing, distribu-
tion in commerce and use. The court remanded both
parts of the May 31,1979 rule to EPA for further action.*
The effect of this court decision on electrical equipment
would have been to make the use of capacitors, electro-
magnets and transformers (other than railroad trans-
formers) containing any concentration of PCBs a viola-
tion of section 6(e). An immediate ban of these uses
would have disrupted electrical service throughout the
United States causing severe economic hardship both to
the general public and industry. Therefore, EPA con-
cluded that it was impractical to take no action and allow
a total ban on the use of this equipment to go into effect.
EPA Amanda PCB Rule
EPA issued a rule amending the May 31,1979 PCB rule.
This action, published on August 25,1982 (47 FR 37342)
authorizes the use of PCBs in capacitors and the use and
servicing of PCBs in electromagnets, circuit breakers,
voltage regulators, reclosers, cables and switches (in-
cluding sectionaizers and motor starters). Transformer
use (other than railroad transformers) also is covered by
this rule. In addition the rule provides for the distribution
in commerce and disposal of all these types of electrical
equipment.
Among other provisions the August 25,1982 final PCB
rule;
1. Prohibits the use of PCB Transformers** and PCB-
filled electromagnets (with concentrations of BOO ppm
or greater) posing an exposure risk to food and feed after
October 1, 1985. Until that date weekly inspection of
this equipment is required.
2. Authorizes the use of all other PCB Transformers for
the remainder of their usef ul lives and requires a quar-
terly inspection of this equipment for leaks of dielectric
fluids.
On January 21,1981, EPA, EDF (the plaintiff) and some
industry groups filed a joint motion with the court asking
for a stay of the mandate setting aside the classification
of transformers, capacitors and electromagnets as to-
tally enclosed. If the motion was stayed, EPA told the
court, the Agency would conduct a rulemaking on the
use of PCBs in electrical equipment. In addition, if the
stay was granted the Edison Electric Institute (EEI)
through the Utility Solid Waste Activities Group
(USWAG) agreed to develop some of the factual material
necessary for the rulemaking, the court was told. All
parties to the motion also agreed on a series of interim
risk-reduction measures.
On February 12,1981, the court granted the requests of
the joint motion and entered an order. The order allowed
the May 31, 1979 totally enclosed classification to re-
main in effect for the duration of the stay. But the court
ordered EPA to promulgate a final rule within 6 months
of receipt of a study from EEI/USWAG. Since the final
report of the EEI/USWAG study was received February
19,1982, EPA was required to promulgate the final rule
on the use of PCBs in electrical equipment by August 19,
1982. EPA met that deadline.
Electrical Equipment
3. Authorizes the use of large PCB Capacitors that are
located in restricted access electrical substations for the
remainder of their useful lives.
4. Authorizes the use of large PCB Capacitors that are
located in restricted access indoor installations for the
remainder of their useful lives.
5. Prohibits the use of all other large PCB Capacitors
after October 1,1988.
6. Eliminates any proposed inspection requirements for
all large PCB Capacitors,
7. Authorizes the continued use of each piece of PCB-
containing mineral oil filled electrical equipment for its
remaining useful life.
8. Allows oil filled cable to be assumed to contain less
than SO ppm if the actual PCB concentration is unknown.
9. Allows nonleaking PCB Large High Voltage Capaci-
tors and PCB-Contamlnated Electrical Equipment stored
for disposal to be held outside of qualified storaga facil-
ities after January 1,1983.
• See the August 1982 iaeue of the Chemlcala-ln-Proaraaa Bulletin for EPA-» proposed PCB rule on ctoaed and controlled wean processes.
*« The definitions of eleotriosl equipment ere given In the August 26,1882 rule,
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10. Requires records of inspections and maintenance
history to be retained for at least 3 years after the dis-
posal of a PCB Transformer.
11. The rule also clarified the meaning of disposal and
also what constitutes electrical equipment posing as
exposure risk to food and feed.
The A ugust25, 1982 Federal Register notice on the PCB rule on electrical i^nfinfftha^Anhut *thJrl /<
without charge. Three support documents are cited in the notice. These are a vaz/afc/e fhroug^e M Obut there is
a charge of .20 cents a page for them. Telephone or write the IAO for the cost of the documents.
REPORTING RULES
ASBESTOS REPORTING RULE... SECTION 8(a)
Under section 8(a) EPA may require manufacturers and
processors to submit information on named chemicals
of the following types: production, use, occupational
exposure and environmental release.
EPA Requires Asbestos Information
Asbestos miners, millers, importers and processors are
now required to report to EPA certain information on
their industrial and commercial asbestos activities, On
July 30, 1982, EPA published a rule (47 FR 33198)
under section 8(a) seeking data on the quantities of
asbestos used in making products, data on employee
exposure, waste disposal and pollution control
equipment.
The purpose of gathering this information is to provide a
data base for identifying unreasonable risks from expo-
sure to asbestos and to develop initiatives to protect
public health, said Dr. John A. Todhunter, the EPA
Assistant Administrator for Pesticides and Toxic
Substances.
in early August EPA mailed asbestos reporting forms to
more than 3,200 companies believed to be required to
submit data. Additional forms are available through the
IAO.
The collected data will be used by EPA and other Federal
agencies that are members of a newly formed Federal
Asbestos Task Force. "This plan to coordinate Federal
regulatory activities through cooperative interagency
efforts demonstrates the Administration's commitment
not only to protect public health but also to provide cost
effective programs in the most economical way pos-
sible," Todhunter said.
HEALTH AND SAFETY RULE... SECTION 8(d)
Section 8(d) authorizes EPA to promulgate rules on spe-
cifically listed chemicals that would require manufac-
turers and processors to submit lists and copies of
health and safety studies that they have conducted or
were initiated by them.
EPA Requires Health and Safety Studies
On September 2, 1882, EPA published (47 FR 38780) a
final rule requiring chemical manufacturers and pro-
cessors to provide the^geney with unpublished health
and safety information on specific" chemicals, the
Agency will use the studies to aid Its investigation of
risks posed by chemicals and to help it determine
whether to require industry to test chemicals under
section 4 of TSCA.
Most of the chemicals named in the rule previously had
wen selected for testing by the Interagency Testing
Committee, (ITC). This committee, made up of represent-
atives from 8 Federal agencies, has recommended 39
of the 40 chemicals and categories of chemicals (about
17B substances) Hated in the rule. EPA added asbestos
to the list, • • -
"These studies will not only heipusdeterminethe need
for further testing but, al»p provide guidancefor the
particular tests needed, should testing be necessary/'
said Or. John A. Todhuhter, the EPA Assistant Adminis-
trator for Pesticides and Toxic Substances.
fiorecurremwttipuMcatfon of the final rule, EPA pro*
posed an Amendment that would add 88 chemicals
more recently selected by the ITC.
SUBSTANTIAL RISK.SECTION 8(e)
f/Mfar sactiw mi parsam who obtain informaiion
vtfhfoh reasonably supports the conclusion that a
atarm pmamaubstantiafriak of itiury to human
hea/th & tha environment must notify SPA within 18
dam These notices are then reviewed by OTSanden
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initial evaluation is prepared containing, if appropriate,
followup questions to the submitter, referrals to other
agencies, and recommended OTS/EPA followup ac-
tions. 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 days of obtaining
the information. EPA publishes its evaluations of these
notices in order to make this section 8(e) information
widely available and understandable to a broad public.
The submissions and the initial evaluations are located
in the OPTS Public Reading Room, first floor, East Tower,
Waterside Mall, 401 MStreet, SW, Washington, D.C.
Persons wishing to obtain a copy of section 8(e) notices
may write: Ms. Jerri Green, EPA (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 200 charge for each addi-
tional page (e.g., 51 pages cost $10.20).
Recent Section 8(e) Notices of Substantial Risk
Log No. 8EHQ [CAS NO]
0682-0448 S 1 -2 (Hydroxyethyl)-2- 3445-11 -2
pyroiidine
Summary results from several short term in vitro
mutagenicity and acute in vivo toxicity tests.
0682-0449 S 1 -4 dioxane 123-91 -1
dichloroethyl ether 111 -44-4
Report on detection of 1-4-dioxane in technical
grade dichloroethyl ether
0682-0450 2-Ethoxyethanol acetate 111-15-9
Preliminary summary results for reproductive
toxicity test
0682-0451 Triphenyl phosphite 101-02-0
Final summary results from neurotoxicity test
S at the end of Log Number means a sanitized version is
available.
STUDIES & SUPPORT ACTIVITY
TEST GUIDELINES AVAILABLE
Test guidelines, sources of methodologies that can be
sited in chemical specific TSCA section 4(a) test rules,
are now available through the National Technical Infor-
mation Service (NTIS). The guidelines cover state-of-
the-art methods for providing information on health
effects, environmental effects and chemical fate (phys-
ical, chemical and persistence). Support documents are
included in some of the guidelines. In reporting their
availability in a July 30,1982 notice (47 FR 33001), EPA
said the guidelines may be modified in the future or new
ones added as new information becomes available. In
this event, the Agency will solicit public comment.
To order the guidelines now available, write NTIS, 5385
Port Royal Rd., Springfield, VA 22151. NTIS will also
accept credit card telephone orders. The NTIS order
number is (703) 487-4650. To buy a complete set of the
three types of guidelines, order PB82-232976. The cost
is $125. Each type may be bought separately: Health
Effects (PB82-232984), $40; Environmental Effects
(PB82-232992), $60; and Chemical Fate (PB82-
233008), $40. To order the guidelines from outside the
United States write NTIS for the cost.
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 CHEMICALS-IN-PROGRESS BULLETIN
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