Office of Pesticides & Toxic Substances
Vol. 1, No. 1	 April 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, (TS-799) OPTS, U.S.E.P.A.,
Washington, D.C., 20460, or call toll-free 800-424-9065 or, in
Washington, 554-1404.
Section 4(a) rules must specify the chemical, the
suspected risk and responsible commercial activity,
the insufficiency of data and experience on the risk
and the testing necessary to determine the risk. For
ITC-recommended chemicals, EPA will publish either
a proposed rule or a negative decision document. Both
will appear in the Federal Register and have comment
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 pre-
scribed: 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
A document has been drafted related to Section 4(a)
rule-making covering Chloromethane, Chlorinated
Benzenes (mono- through penta-) and Acrylamide. The
document is undergoing Agency review and is ex-
pected to be published in the Federal Register in June.
The following testing requirements for health effects
are proposed: for Chloromethane, two-year on-
cogenicity and morphologic teratogenicity; for
selected Chlorinated Benzenes, two-year oncogenici-
ty, morphologic teratogenicity, reproductive effects
and 90-day subchronic/chronic effects. The Agency is
evaluating the need to require environmental effects
testing for Chlorinated Benzenes and will subsequent-
ly either propose such testing or set forth its reasons
for not doing so. For Acrylamide no health effects
testing is proposed. The document presents in detail
the Agency's reasons for this decision and states that
Acrylamide will be the subject of a pre-regulatory
assessment based on its neurotoxicity.
EPA has published a series of proposals on the follow-
ing health effects. These may be considered as model
test standards which may be modified when promul-
gated for specific chemicals in testing requirement
rules under Section 4(a).
May 9, 1979, 44 FR 27334:
General Requirements for design and conduct of studies
Oncogenicity, Non-oncogenic chronic effects and Combined
chronic effects
Good Laboratory Practices
July 26, 1979, 44 FR 44054:
Acute oral, dermal and inhalation toxicity; primary eye and dermal
irritation; and dermal sensitization
Subchronic oral dosing; 90-day dermal and inhalation toxicity
Gene mutations, heritable chromosomal mutations, ONA repair or
recombination, teratogenicity and reproductive effects
General metabolism

The comment period for these proposals ended Octo-
ber 16, 1979. These TSCA standards will be promul-
gated in final form at the same time as the comparable
ones under FIFRA. Joint FIFRA/TSCA teams are ana-
lysing the comments and striving to make the two sets
of standards as alike as possible so as to achieve
scientific consistency and similar requirements for
those complying with EPA testing. The planned com-
pletion dates for this comment/response and final
drafting effort are: July for acute effects; August for
subchronic effects; and November for the remainder.
Other test standards planned for the fourth quarter in
1980 are: selected physical/chemical properties and
environmental good laboratory practices. Details on
this series of proposals will appear in the Bulletin's
next issue.
On December 7, 1979, the fifth report of the ITC was
published (44 FR 70664). This report added 2 sub-
stances and 3 categories with testing specified as
Recommended Studies
Human	mental
Carcino- Terato- Health Epidemi-	fate and
Substance or category genicity genicity Effects ology	effects
Benzidine-based dyes		x
dyes	 x 		x
o-Tolidine-based dyes	 x 		x
Hydroquinone	 x x 	 x	x
Quinone	 x x 		x
Under Section 4(c), as well as Section 5, there are pro-
visions for sharing the costs of testing and equitable
reimbursement over a period of time. The law envi-
sions a voluntary arrangement among persons subject
to a chemical's rule, with EPA acting only when such
an arrangement cannot be concluded. A consultation
with the Federal Trade Commission is required in
promulgating rules for fair and equitable reimburse-
On September 18,1979 (44 FR 54284), EPA gave in an
Advance Notice of Proposed Rule-making (ANPR) the
factors and approaches to be considered in formu-
lating a reimbursement rule. The comment period
ended February 7,1980.
Under Section 4(e), an Interagency Testing Committee
(ITC) was established to recommend to EPA sub-
stances which should be tested for specified effects to
determine their hazardous potential to human health
or the environment. Committee members are: Council
on Environmental Quality (CEO), Department of Com-
merce (DOC), Environmental Protection Agency (EPA),
National Cancer Institute (NCI), National Institute of
Environmental Health Sciences (NIEHS), National In-
stitute for Occupational Safety & Health (N/OSH), Na-
tional Science Foundation (NSF), and the Occupational
Safety 8- Health Administration (OSHA). The commit-
tee may list up to 50 chemicals or categories and is to
consider revising or adding to its list every 6 months.
The EPA must respond within one year to each recom-
mendation by initiating rule-making under Section 4 or
stating its reasons for not doing so. Both ITC reports
and EPA responses appear in the Federal Register.
This report brought the total to 23 chemicals and 15
categories for which the ITC has made testing recom-
mendations, as given below. A listing with CAS
Registry numbers is available from the Industry
Assistance Office.
Designated for
The TSCA Section 4(e) Priority List	action by
Acetonitrile 	April 1980
Acrylamide	April 1979**
Alkyl epoxides	October 1978*
Alkyl phthalates	October 1978*
Aniline and bromo, chloro, and/or nitroanilines . .April 1980
Antimony (metal)	April 1980
Antimony sulfide	April 1980
Antimony trioxide	April 1980
Aryl phosphates	April 1979**
Benzidine-based Dyes	November 1980
Chlorinated benezenes, mono-and di-	October 1978*
Chlorinated benezenes, tri-, tetra- and penta- .. • .October 1979
Chlorinated naphthalenes	April 1979**
Chlorinated paraffins	October 1978*
Chloromethane 	October 1978*
Cresols	October 1978*
o-Dianisidine-based Dyes	November 1980
Dichloromethane	April 1979**
1,2-Dichloropropane 	October 1979
Cyclohexanone 	April 1980
Glycidol and its derivatives	October 1979
Halogenated alkyl epoxides	April 1979**
Hexachloro-1,3-butadiene	October 1978*
Hexachlorocyclopentadiene 	April 1980
Hydroquinone 	November 1980
Isophorone	April 1980
Mesityl oxide	April 1980
4,4'-Methylenedianiline	April 1980
Methyl ethyl kotone	April 1980
Methyl isobutyl ketone	April 1980
Nitrobenzene	October 1978*
o-Tolidine-based Dyes	November 1980
Polychlorinated terphenyls	April 1979"
Pyridine 	April 1979**
Quinone 	November 1980
Toluene 	October 1978*
1,1,1-Trichloroethane 	April 1979**
Xylene 	October 1978*
•Designated by the Committee In its Rr«t Report and re-
sponded to by the Administrator in 43 FR 50134-60138.
** Designated by the Committee in its Second Report and
responded to by the Administrator in 44 FR 28095-28097.

On March 5, 1980, the Agency submitted a compli-
ance schedule for the first three ITC lists as required
by the Court of the Southern District of New York.
This is the result of a ruling in favor of the Natural
Resources Defense Council (NRDC) which sued EPA
for non-compliance with Section 4(e) by virtue of not
having initiated rule-making within the one year dead-
lines. On March 28th intervenors in the case present
their comments on the schedule, and, on April 11th,
NRDC presents its comments on all submissions to
the court.
Section 4(a) Schedule—EPA Affidavit, 3/5/80

Health Effects
Environmental Effects
1st ITC List
Alkyl Epoxides
Alkyl Phthalates
Chlorobenzenes (mono & di)
12 81
2nd ITC List

Aryl Phosphates
Polychlorinated Terphenyls
1 82
1,1,1 -T richloroethane
3rd ITC List

Chlorobenzenes (tri-penta)

Glycidol Group
ANPR = Advance Notice of Proposed Rule-making
PR = Proposed Rule-making
All dates may refer to an FR notice of a decision not to require testing.
The following ITC reports and EPA responses have ap-
peared to date:
ITC Report	Date in FR	FR Reference
1	Oct. 12, 1977	42 FR 55026
2	Apr. 19, 1978	43 FR 16684
3	Oct. 30, 1978	43 FR 50630
4	Jun. 1,1979	44 FR 31866
5	Dec. 7, 1979	44 FR 70664
EPA Response
To 1	Oct. 26, 1978	43 FR 50134
To 2	May 14,1979	44 FR 28095
Under Section 5(a)(1) a person who intends to intro-
duce 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 environmental
effects information in the submittor's possession. EPA
is to use the review period to determine if the sub-
stance might present an unreasonable risk that should
be remedied through either an order to develop suf-
ficient information or an immediately effective rule.
Upon such a determination, EPA issues an order to
prohibit manufacture and then applies to the court for
an injunction to this effect. 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. Ab-
sent such an order or immediate rule, the manufac-
turer may proceed with his plans. EPA publishes in the
Federal Register a summary of each PMN five days
after its receipt and a status report on all current
receipts at the beginning of each month.
On January 10, 1979, EPA proposed a rule for Pre-
manufacture Notification (44 FR 2242), and on October
16th the Forms for PMN were re-proposed (44 FR
59764) based on comment received. On May 15th (44
FR 28564) an interim policy statement was published
to guide submittors until a final rule is promulgated.
Copies of the revised proposed Forms for manufac-
turers, importers and exporters are available from IAO
for use by submittors. A final rule is expected in

EPA's procedure for review of each PMN consists of
the following steps. A notice manager is assigned to
each PMN who has overall responsibility to see that a
proper evaluation is done as quickly as possible. A pre-
liminary screening is made within 35 calendar days
which includes a profile of the company-submittor, a
search of the chemical literature, an engineering re-
view of the production process, and assessment of ex-
posure and health and environmental effects. A man-
agement review of this preliminary screening results in
(1) dropping all further evaluation because no unreas-
onable risk is foreseen, (2) taking no further action
other than follow-up on a few minor points, or (3)
undertaking a more thorough assessment toward a
possible Section 5(e) order to prohibit manufacture
pending development of additional information.
During 1979, a total of 37 PMN's and 3 requests for
test marketing exemptions (TME's) were received by
EPA. Of these, no regulatory action has been taken on
the 12 PMN's and 2 TME's whose review period has
expired. The 37 PMN's came from 21 companies, both
small and large. Significantly, over 20 of the new
chemicals were polymers intended for uses such as
adhesives, plastics, etc.
On February 25, 1980, EPA published the following
status report on PMN's received or acted upon dur-
ing January (45 FR 12295). Earlier status reports may
be requested from I AO.
PMN No.	Identity/Generic name	FR citation Expiration
I. Premanufacture Notices Received During the Month
5AHQ-0180-0096 	 Generic name: 3-Alkoxy (C10-C14)-2-hydroxypropyl ester of dimer/ 45 FR 3967	Apr. 1, 1980.
trimer acids (fatty ester).	(1/21/80).
5AHQ-0180-0099 	 Fatty acid, tall oil, epoxidized mixed Cj-Cg alkyl ester	 45 FR 6999	Apr. 8, 1980.
5AHQ-0180-0032A	 Neopentyl glycolcyclohexane-dimethanol-trimethylpropane-O- 45 FR 6833	Apr. 15, 1990.
phthalate-adipate.	(1/30/80).
5AHQ-0180-0051A	 Generic name: Dialkyl (C12-C14) substituted polycarboxylate	do		Do.
5AHQ-0180-0105 	 Polyester with dipropylene glycol of byproduct from manufacture of ....do		Do.
the dimethyl ester of 1,4-benzenedicarboxylic acid.
5AHQ-0180-0111 	 Polymer of dehydrated castor oil, trimethyloethane, phthalic anhy- In preparation	Apr. 28, 1980.
dride, and benzoic acid.
5AHQ-0180-0112 	 Generic name: Substituted-N-alkylquinoline	do		Apr. 20, 1980.
5AHQ-0180-0113 	 Generic name: 1,2-Disubstituted-4,5-dimethoxybenzene	do		Do.
5AHQ-0180-0114 	 Generic name: Substituted ketone pyran 	do		Do.
5AHQ-0180-0115	 Generic name: Monosubstituted-4,5-dimethoxy phenyl ethanol	do		Do.
5AHQ-0180-0116	 Generic name: Monosubstituted-4,5-dimethoxy benzyl chloride	do		Do.
5AHQ-0180-0117 	 Generic name: Tetrasubstituted quinoline	do		Do.
5AHQ-0180-0118	 Generic name: Tetrasubstituted-N-alkyl quinoline	do		Do.
5AHQ-0180-0119	 Generic name: Trisubstitutedacetophene	do		Do.
5AHQ-0180-0128 	 Stearyl stearamide	do		Apr. 21, 1980.
5AHQ-0180-0131 	 Anhydro 3,10-bis(2-(4-(3-pyrodinio)-6-(2,5-disulfophenylamino)-	do		Do.
1,3,5-triazin-2-ylamino) ethylamino)-6,13-dichloro-4,11-disulfotri-
phenodioxazine dihydroxide, hexasodium salt.
5AHQ-0180-0133 	 1-p-Nitrobenzoyl-1-(4'carboxypyridyl) hydrazide	do		Do.
5AHQ-0180-0134 	 Polymer of fumaric acid, isophthalic acid, adipic acid, neopentyl	do		Do.
glycol, diethylene glycol, and propylene glycol.
5AHQ-0180-0034A	 Generic name: Polymer of alkyl amino methacrylic acid ester, alkyl	do		Apr. 27, 1980.
acrylate, and alkyl methacrylate.
5AHQ-0180-0137 	 Copolymer of methacrylic acid and diacetone acrylamide	do		Apr. 28, 1980.
II. Premanufacture Notices Received Previously and Still Under Review at the End of the Month
5AHQ-1179-0007A	 Alkyl hydroxymethyl alkanediol polymer with chloromethyi oxirane	44 FR 70216 Feb. 13, 1980.
alkenoate.	(12/6/79)'
5AHQ-1179-0010A	 2-Ethyl hexyl-2-propenoate polymer with 2-methyl-2-propenoate and	do		Do.
5AHQ-1179-0070 	 Claimed Confidential		44 FR 76885 Feb. 14, 1980.
5AHQ-1179-0073 	 1,3-Benzenedicarboxylic acid, polymer with E 2-butenedioic acid,	44 FR 70921 Feb. 21, 1980.
1,2-propanediol, and 1,3-butadiene.	(12/10/79)
5AHQ-1179-0074 	 1,3-Benzenedicarboxylic acid, polymer with E 2-butenedioic acid, —do	 Do.
1,2 propanediol, and 1,3 butadiene acryionitrilie.
5AHQ-1279-0039A	 Polymer of styrene, 2-ethylhexyl methacrylate, isobutoxymethyl	45 FR 1676 Mar. 5, 1980.
acrylamide, dimethylaminopropyl methacrylamide.	(1/8/80)
5AHQ-1279-0076 	 Generic name: 4-Amino-N-substituted benzene sulfonamide	do	 Mar. 9, 1980.

5AHQ-1279-0079 	 Polymer of phthalic anhydride, ethylene glycol, heptanol, and 44 FR 76856 Mar. 12, 1980.
2-ethylhexanol.	(12/28/79)
5AHQ-1279-0080 	 Polymer of phthalic anhydride, 1,2-propylene glycol, 1,4-butanediol, ....do		Do.
1-octanol, and 1-decanol.
5AHQ-1279-0081 	 Polymer of phthalic anhydride, ethylene glycol, heptanol, 1-octanol	do	 Do.
and 1-decanol.
5AHQ-1279-0082 	 Polymer of phthalic anhydride, 1,2-propylene glycol, 1,4-butanediol	do		Do.
and 2-ethylhexanol.
5AHQ-1279-0083 	 Polymer of phthalic anhydride, 1,3-butylene glycol, 1-octanol, and 44 FR 76856 Mar. 12, 1980.
1-decanol.	(12/28/79)
5AHQ-1279-0084 	 Polymer of phthalic anhydride, 1,3-butylene glycol, and 2-ethyl-	do		Do.
5AHQ-1279-0077 	 Magnesium acrylate	 45 FR 1674	Do.
5AHQ-1279-0O57A	 Polymer of 5-substituted-1,3-benzenedicarboxylic acid; ethylene 45 FR 2387 Mar. 17, 1980.
glycol; and e-caprolactone.
5AHQ-1279-0059A	 Polymer of 5-substituted-1,3-benzenedicarboxylic acid; 1,4-cyclo- ....do		Do.
hexanedimethanol; ethylene glycol; e-caprolactone; tolylene-2,4-
diisocyanate; and 2-butenedioic acid.
5AHQ-1279-0060A	 Polymer of 1,4-cyclohexane dimethanol and 2-butenedioic acid	do		Do.
5AHQ-1279-0085 	 Generic name: Alkenyltrialkoxysilane	do		Do.
5AHQ-1279-0086 	 1,3-benzenedicarboxylic acid, a polymer with 2,2-dimethyl-1,3-pro- 45 FR 2387 Mar. 17, 1980.
panediol; 2-ethyl-2-(hydroxymethyl)-1,3-propanediol; nonanoic (1/11/80).
acid; and 3a,4,7,7a-tetrahydro-1,3-isobenzofurandione.
5AHQ-1279-0087 	 Generic name: Polyacrylate	 45 FR 6159 Mar. 17, 1980.
5AHQ-1279-0089 	 Generic name: Amido amine	 45 FR 2387 Mar. 26, 1980.
5AHQ-1279-0088 	 Generic name: Ring halogenated cyclic dicarboxylic salt	 45 FR 3967 Apr. 1, 1980.
III. Premanufacture Notices for Which the Notice Review Period Has Ended During the Month
5AHQ-1079-0035 	 2-tert-Butvl-4-sec butvlphenol	 44 FR 59954 Jan. 1, 1980.
5AHQ-1079-0037(A)	 Dodecenyl succinic acid mono alkylester	 44 FR 65673 Jan. 27, 1980.
IV. New Chemical Substances That EPA Has Added to the Inventory During the Month
Under Section 6, EPA may find that a chemical will
present an unreasonable risk to human health or the
environment and, thus, must be controlled as a hazar-
dous substance. EPA may apply one or more of the
following controls to the extent necessary adequately
to protect against the risk, using the least burdensome
requirement and balancing social and economic fac-
tors, including benefits and substitutes' availability:
prohibit or limit production or distribution or the
amount handled; prohibit or limit the use of concentra-
tion or the amount used; require marking with warn-
ings or instructions for handling; require record-
keeping of production processes, monitoring or test-
ing for compliance; regulate disposal. AH rule-making
must include hearings with an opportunity for cross-
examination if required.
Under the authority of Section 6(a) a proposal now in
draft would require all manufacturers and importers
(including those who repackage and relabel) to deter-
mine the hazard of all their chemical substances and
mixtures and prepare and affix labels for all their con-
tainers used in commerce. A hazard is defined to in-
clude substances which are carcinogenic, highly toxic,
toxic, corrosive, irritants, sensitizers, extremely flam-
mable, flammable, combustible, pyroforic, reactive,
strong oxidizers, asphyxiants or compressed gas. For
each type, a label text and hazard class (Danger, Warn-
ing, Caution) is specified. A staggered schedule would
require compliance for carcinogens after one year,
other hazards after two and mixtures after three years.
Details will appear in the next issue.
A workshop-style conference will be held July 14-16 at
the Sheraton-National Hotel, Arlington, Va. on the
question of substitutes for Asbestos; it will be open to
anyone interested. IA0 will publicize it during the next
two months.
Under Section 8(e) persons who obtain information
which reasonably supports the conclusion that a sub-
stance presents substantial risk of injury to human
health or the environment must notify EPA witNn IB
days. These notices are then reviewed by OPTS pre-
liminarily and an initial evaluation is prepared contain-

ing follow-up questions of the submittor, referrals to
other agencies and decisions to list the chemical for a
Section 8 reporting rule or to undertake a formal risk
assessment in OPTS. The submissions, often exten-
sive, and the OPTS initial evaluations are in the Public
Reading Room, 447, East Tower, Waterside Mall, 401
M Street, S.W., Washington, D.C.
As of January 1980, 323 Section 8(e) notices have
been received. The initial evaluations for the period
January 1977 through June 1979 will be published in
the second quarter of 1980. This compilation will have
several indices for convenient reference by persons in
the chemical business to aid them in interpreting and
understanding their obligations under Section 8(e).
June-December 1979
Log No. 8EHQ-	 [CAS No.l
0679-0291 6/4/79 Trimethyl Phosphite	[125-45-9]
"Interim Report on Mutagenicity Study (Ames)
"Interim Report on Subacute Inhalation Toxicity
-0291A 6/27/79
"Interim Report on Teratogenicity Study
-0291 Supp. 12/4/79
"Final Report on 6/4 and 6/27 Studies
"Preliminary Report on Replicate Mutagenicity &
Toxicity Studies
0779-0292 6/22/79 Epichlorohydrin & Uncured
Epon 828
"Occupational Report on Worker Exposure (Air)
0779-0293 7/2/79 n-Alkyl Glycidyl Ethers with
Alkyl Groups (C2-C10)
"Preliminary Report on Mutagenicity Study (Ames)
"Preliminary Report on Inhalation, Oral &
Intraperitoneal Acute & Subchronic
Percutaneous Toxicity Studies
-0293 Supp. 12/4/79
"Final Report of 7/2 Studies
0779-0294 7/18/79 Morpholine Nitrates &
Nitrosating Agents
"Preliminary Report on Mutagenicity Study (Ames)
-0294 Follow-up 2/13/80
"Final Report on 7/18 Study
0779-0295 7/9/79 Direct Black 38 Dye	[1937-37-7]
"Preliminary Report on Skin Absorption Study
-0296 Follow-up 11/13/79
"Final Report on 7/9 Study (Also Direct Black 19)
0779-0296 7/18/79 Ethyltriphenylphosphonium
Acid Acetate, Tetrabutylphos-
phonium Acid Acetate,
Chloride, Ethyltriphenyl-
phosphonium Iodide
"Final Report on Acute Oral, Dermal Er Eye
Toxicity Studies
0779-0297 7/16/79 Solvent Refined Coal
(SRC-11) Heavy Distillate
"Interim Report on Chronic Toxicity Study
-0297 Follow-up 11/12/79
"Interim Report on 7/16 Study
-0297 Supp. 2/14/80
"Interim Report on 7/16 Study
0779-0298 VOIDED
0779-0299 7/23/79 Furadan	[1563-66-2]
[Active Ingredient:
"Uncontrolled Environmental Release: Aerial Spill
0879-0300 8/2/79 Acrylonitrile
"Uncontrolled Environmental Release: Spillage
0879-0301 8/13/79 Number Two Home Heating
"Interim Report on Mutagenicity Study (Ames)
-0301 Supp.
"Interim Report on Mutagenicity Study (Ames)
0879-0302 VOIDED
0879-0303 VOIDED
0879-0304 7/26/79 Polyvinyl Fabrics, Cements,
Zinc Stearate, Toluene,
Heptane, MEK, 1205 Solvent,
1288 Solvent
"Employee Report on Occupational Exposure
0979-0305 9/13/79 Ethylene Oxide	[75-21-8]
"Preliminary Report on Chronic Toxicity Study
-0305 Supp. A 10/6/79
"Preliminary Report on 9/13 Study
-0305 Supp. B 6/9/79
"Preliminary Report on 9/13 Study
0979-0306 9/14/79 Experimental Pyrolysis Fuel
Oil Fraction (From Texas
Lignite). Experimental Pyrolysis
Untreated Fuel Oil Fraction
(From Arkansas Lignite),
Experimental Distillate Fuel
Oil (From Direct Liquefaction
of Wyoming Sub-Bituminous
Coal), Experimental Distillate
Fuel Oil (Same as Previous
"Interim Report on Carcinogenicity Study
0979-0307 VOIDED
0979-0308 VOIDED
0979-0309 VOIDED
0979-0310 9/14/79 Trichloroethylene & Other
Volatile Organic Chemicals
"Preliminary Report on Water Monitoring Study
0979-0311 9/21/79 Mixture Containing Dialkyl
Diglycol Carbonate
"Interim Report on Acute Eye Toxicity Study
0280-0312 2/5/80 Isopar C & Varsol 40
"Final Report on Subchronic Inhalation Toxicity
1079-0313 VOIDED
1079-0314 10/19/79 Formaldehyde
"Preliminary Report on Chronic Toxicity Study
•0314 Supp. A 1/24/80
"Interim Report on 10/19 Study
-0314 Supp. B 1/31/80

•Interim Report on 10/19 Study
1079-0315 10/23/79 Liquified Combination of
Polygard [Tri (mixed mono-
and dinonylphenyl) Phosphite]
and Argus Q-328 [a thiodi-
propionate ester complex]
"Employee Report of Occupational Exposure
1179-0316 10/22/79 Experimental Hydrotreated
Fuel Oil Fraction from Coal
•Interim Report on Carcinogenicity Study
-0316 Follow-up 2/28/80
•Interim Report on 10/22 Study
1179-0317 4/3/79
Kronitex" 50, Kronitex" 100,
Kronitex" 200 (Mixtures of
Tricresylphosphate &
Isoprophenyl Phenyl
•Datum: Octanol/Water Partition Coefficient
1179-0318 10/30/79 Strontium Chromate
•Preliminary Report on Carcinogenicity Study
1179-0319 11/5/79 Transformer Oil & PCBs
•Report of Environmental Release: Spillage
1179-0320 11/13/79 1,4-Dioxane
•Data: GLC Results for Ethoxylation
1179-0321 11/15/79 Disperse Turquoise TLF
•Final Reports on Mutagenicity Studies (Ames)
1279-0322 12/4/79 Chlorine
•Uncontrolled Environmental Release: Air
1279-0323 9/24/79 Jet Fuel A
•Final Reports on Mutagenicity Studies (Ames)
N.B.: All toxicity, teratogenicity, carcinogenicity and mutagenicity studies
involve animals. Additional teats are noted.
Under Section 8(a) EPA may require manufacturers
and processors to submit information on named
chemicals of the following types: production, use, oc-
cupational exposure, byproducts, disposal and health
and environmental effects. The rule only applies to in-
formation already in their possession. A "LevelA"rule
is meant to gather basic information, not otherwise
available, for a preliminary sorting of candidates for
TSCA consideration under either Section 4 testing or
Section 6 control. Level A is one of three projected
types of multi-chemical Section 81a) reporting rules,
with Levels B and C representing "genera!" and
"detailed" assessment information respectively.
On February 29, 1980 (45 FR 13646), EPA proposed
the first Section 8(a)-Level A reporting rule covering
2300 chemicals. The comment period ends May 14;
in addition to providing written comment, persons
may request a meeting with responsible program offi-
cials through IA0. Available, besides reprints of the
proposal, are the economic impact analysis and small
business definition analysis and also a synonyms list
for the 2300, which are published in the proposal with
the CAS Registry number and TSCA preferred name.
The list of 2300 was derived from the following sorts:
an early ITC master list for those with high exposure
potential plus inclusion on the TSCa Inventory (300);
the ITC list for biological activity plus inclusion on the
TSCA Inventory; the Inventory for high-volume pro-
duction (1700); in-house subjects whose assessment
were incomplete because of inadequate available in-
formation (including Section 8(e) notices); and, finally,
chemicals recommended by the ITC for Section 4 test-
ing rules. Manufacturers, importers, miners and, in
some cases, processors would be subject to this rule.
In another rule-making, EPA plans to propose in Oc-
tober of this year a Section 8(a) reporting rule for
follow-up of selected new chemicals that have passed
through Premanufacture Notification. The likely time
in the chemical's life when such a rule would apply is
three years after commercialization.
For chemicals high on the Office's regulatory agenda,
often well-characterized and long-standing cases
within EPA and OSHA/N/OSH, a single chemical re-
porting rule may be promulgated to procure particular
data to support particular regulatory options.
Asbestos was the subject of an ANPR on October 17,
1979 (44 FR 60061) in which EPA announced its inten-
tion to regulate Asbestos under Section 6. To support
the analysis of possible controls, a Section 8(a) report-
ing rule will be proposed. Many illustrative questions
were included in the ANPR, and comment was asked
on the feasibility and appropriateness of the queries.
Comments were due February 18, 1980. Health and
safety study reporting under Section 8(d) for unpub-
lished holdings was proposed on December 31st (44
FR 77470). The Section 8(a) proposed rule is planned
for July, 1980.
Under Section 8(d) persons may be required to submit
lists and/or copies of health and safety studies that
have been conducted by or for them at any time. The
purpose of this authority is to secure for EPA data
otherwise unavailable. The term "study" means any
study of any effect on health or the environment, in-
cluding underlying data. Examples are epidemiologi-
cal, occupational exposure, toxicological, ecological
and clinical studies and any test performed pursuant
to TSCA.
On December 31,1979 (44 FR 77470), EPA proposed
a rule for health and safety study reporting for 61
chemicals (comprising 387 named, discrete sub-
stances), most of which are dyes. Firstly, this proposal
would require all manufacturers, processors and dis-

tributors to submit copies of any final reports they pos-
sess of unpublished studies on any chemical listed in
the rule. Two alternatives for limiting this copy submis-
sion requirement are raised in the proposal: (a) to ap-
ply it only to those handling a listed chemical but re-
quire them to search and submit for all chemicals
listed; or (b) to apply it to those handling a listed chem-
ical since 1950 but only for their own products. Sec-
ondly, the proposal would require all current manufac-
turers etc., to submit only for their own products a list
of studies known to them (but not in their possession)
and ones currently being conducted by or for them.
This obligation to list on-going studies continues for
five years after a chemical appears on the Section 8(d)
list. All reports would be due 60 days after promulga-
tion of a final rule. Underlying data and records is not
being asked for. The comment period ends April 14,
1980. Promulgation is expected in September.
The Chemical Information System (CIS), initiated
under TSCA by EPA as a joint project with the Na-
tional Institutes of Health, now has the TSCA Chemi-
cal Substances Inventory on it. This interactive com-
puter system is accessible to the public possessing a
data processing terminal with an acoustic coupler by
signing up with the CIS project manager, Mrs. Pool, at
Interactive Sciences Corp. (800-424-9600). There is a
$300 per year subscription charge plus various hourly
rates for different kinds of searches. N.B.: None of the
manufacturer or production information reported to
EPA for the inventory is entered on CIS.
With the Inventory now entered on CIS, persons may
search it by name, name fragments, molecular weight
or formula and chemical structures. Through the
"Structure and Nomenclature Search System"
(SANSS), one can proceed from these elements to the
CAS Registry number and other data bases on the
system. These include the RTECS-Acute Toxicity
Data, X-ray diffraction data, CNMR and mass spectra.
The CIS plan includes adding a data base with all the
Federal Register citations for all federal authorities
regulating chemicals and the public health.
The IRLG consists of CPSC, EPA, HEW/FDA,
USDA/FSQS IFood Safety & Quality Service),
DOL/OSHA and aims to optimize coordination among
those federal authorities responsible for regulating
chemicals and the public health.
On January 25, 1980, the Interagency Regulatory
Liaison Group published a "Report on IRLG: Recent
Accomplishments and 1980/81 Plans" (45 FR 6276).
Areas covered were economic analysis, testing stan-
dards and guidelines, compliance and enforcement,
regulatory development, risk assessment, laboratories
and analytical methods, regional coordination, epi-
demiology, research planning, information exchange,
and public information and education.
Previous IRLG reports of importance to the TSCA
community are: Scientific Report on Estimating Risk
and Potential Carcinogens (44 FR 39858, July 6,1979);
Draft IRLG Guidelines on Selected Acute Toxicity
Tests (August 1979); and the Draft IRLG Guideline for
Epidemiology (September 1979).
Industry Assistance Office (TS-799)
Office of Pesticides & Toxic Substances
Washington, D.C. 20460
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