Office of Toxic Substances
(OTS)
Vol. 5, No. 4 September 1984
This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (TSCA) about recent
developments and near-term plans. For further information or to request copies of documents mentioned, write the TSCA
Assistance Office (TAO), (TS-799) EPA, Washington, D.C. 20460. The TAO also has a toll-free telephone number (800) 424-9065.
In the Washington D.C. area, or from outside the continental United States call (202) 554-1404.
REGULATORY & REQUIRED ACTIONS
TESTING OF CHEMICAL SUBSTANCES
AND MIXTURES . . . SECTION 4
Section 4 of TSCA gives EPA authority to require manufac-
turers or processors of chemicals to test the toxic effects
of a designated substance. To require testing EPA must
find that the chemical may present an unreasonable risk;
that there are insufficient data available with which to per-
form a reasoned risk assessment; and that testing is neces-
sary to generate such data. A test rule may also be based on
an EPA finding of substantial production and exposure to
humans or the environment, in addition to findings of insuf-
ficient data and need for testing.
Under section 4(e) an Interagency Testing Committee (ITC)
was established to recommend chemicals to EPA for prior-
ity consideration for the promulgation of section 4 test
rules. The ITC can designate up to 50 chemicals or cate-
gories of chemicals for testing and must make revisions to
this section 4 priority list as needed. In turn, EPA must re-
spond within one year after the ITC adds a substance to the
priority list by starting rulemaking under section 4 or giving
reasons for not doing so.
The ITC is made up of appointed members from eight Fed-
eral agencies, as specified in TSCA. Representatives from
six additional Federal agencies serve in a liaison capacity.
EPA to Adopt TMBP Negotiated Test Plan
EPA has decided to make final a preliminary decision to
accept an industry environmental testing plan for
4-(1,1,3,3-tetramethybutyl)phenol (TMBP) [July 20, 1984 (49
FR 29449)]. The industry testing plan was submitted by the
Octylphenol Program Panel (the Panel) organized under the
auspices of the Chemical Manufacturers Association.
The Agency was responding to an ITC recommendation that
TMBP be considered for health and environmental effects,
bioconcentration and chemical fate testing. In a November
15,1983 notice (48 FR 51971) EPA said it made a preliminary
decision not to start rulemaking to require aquatic toxicity
testing of TMBP because of the Agency's tentative accept-
ance of a testing proposal submitted by the Panel. In the
November notice EPA said that it was not requiring health
effects, bioconcentration or chemical fate testing because
adequate data had become available which enabled the
Agency to reasonably predict TMBP's fate and bioconcen-
tration in the environment and health effects. EPA also
asked for comments on the Panel's plan for environmental
effects testing and received none. EPA concludes that it is
appropriate to accept the negotiated testing agreement as
proposed.
New Test Data End Need for 2 ITC Proposed Rules
EPA decided not to proceed with health or environmental
effects test rules for two ITC recommended chemicals for
which the Agency had proposed rulemaking in June 1981.
The chemicals are nitrobenzene and dichloromethane. In a
June 19, 1984 notice (49 FR 25009) EPA also said a third
chemical 1,1,1-trichloroethane, included in the June 1981
notice will be addressed at a later date. In the withdrawal
notice EPA said recent health and environmental data and
ongoing tests by industry and government were the reasons
for withdrawing the June 1981 proposals for
dichloromethane and nitrobenzene.
EPA Receives Data on ITC Chemicals
EPA has received test data on two chemicals and three
classes of chemicals, all of which are subjects of section 4
negotiated testing agreements [July 26,1984 (49 FR 30114)].
1
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Each of the chemicals and categories originally was recom-
mended to EPA for priority consideration for testing by the
ITC. The chemicals and classes of chemicals with the
approximate number of pages of each report are:
alkyl phthalates 80 pages
2-phenoxyethanol 5 pages
calcium naphthenate 80 pages
chlorinated paraffins 500 pages
chloromethane 230 pages
Persons interested in an outline of the studies received
should request the July 26, 1984 Federal Register notice
from the TAO. Persons who want copies of the data submis-
sions should write: EPA, Freedom of Information, Ms. Jerri
Green, (A-101), Washington, D. C. 20460. There is no charge
for duplicating the first 49 pages of a study, but at page 50
of a request for duplication there is a $10.00 fee and a 20
cent charge for each additional page (e.g. 51 pages cost
$10.20).
MANUFACTURING AND PROCESSING NOTICES ... SECTION 5
Section 5 of TSCA gives EPA authority to quickly review and control, it necessary, new chemicals to prevent large scale
distribution before a new substance's effects on health or the environment are fully determined. Below and on the next few
pages are subsections of section 5 highlighted because of recent EPA actions.
Commencement Of Manufacture Notices
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 beginning manufacture or import. Listed below on the next few pages are the latest com-
mencement of manufacture notices EPA has received.
NEW CHEMICAL SUBSTANCES FOR WHICH EPA HAS RECEIVED COMMENCEMENT
OF MANUFACTURE NOTICES
(since publication of the July 1984 Chemicals-ln-Progress Bulletin)
FR
PMN no.
Submitter
Chemical Identification
Citation
CBI = Confidential Business Information
G = Generic Name
Do = Ditto
80-65
CBI
Poly(oxy(methyl-l,2-ethanedlyl)), alpha-(di-3,3'-
45 FR 28199
carboxyl-1-oxosulfopropyl)-omega-2-propanol-1,1
4/28/80
(1-methylethylidene)bis(4-1-phenoxy)) bis-, disodium
salt
81-515
Do
G
Polymer of styrene and acrylic acid with substituted
46 FR 50841
acrylates and methacrylates
10/15/81
81-572
Shell Oil Co.
Magnesium alkyl (C..-Cn) salicylate
46 FR 58038
11/13/81
82-275
Goodyear Tire & Rubber Co.
G
Saturated linear butylene mixed acids copolyester
47 FR 17666
4/23/82
82-276
CBI
G
Bis(substltuted-6,6,6-triacryloyloxymethyl-4-
Do
oxahexyl)ethyl-methyl-dlsubstituted
heteromonocycle
82-277
Ash land Chemical Co.
G
Polymer of aliphatic and aromatic dlacids and an
Do
aliphatic diol
82-579
CBI
G
Unsaturated polyester
47 FR 37954
82-689
Exxon Chemical Americas
G
Alkyl amino ethoxy ethanol
8/27/82
47 FR 43160
Ashland Chemical Co.
9/30/82
83-106
G
Polymer of aliphatic and aromatic diaclds and an
47 FR 52222
aliphatic dlol
11/19/82
83-115
American Hoechst Corp.
G
Naphthalenedlsulfonic acid disodium satt, ((2-((3odlum
Do
sulfooxyethyl)sulfonyl)aryl)azo)and
monochlorotriazinyl amino, substituted, copper
complex
83-397
CBI
G
Amine salt ol a phosphonlc acid
48 FR 5304
83-482
Modified polyester of a carbomonocyclic anhydride
2/4/83
Do
G
48 FR 7299
and a substituted alkane dlol
2/18/83
83-488
Do
G
Polymer of alkyt diamine and substituted oxlranes
48 FR 9385
83-526
Do
G
Isocyanate derived polyamlde
3/4/83
48 FR 10468
2
3/11/83
-------
83-552
Monsanto Co.
G
Phenol formaldehyde butanol resin
48 FR 12590
3/25/83
83-639
CBI
G
Trisubstituted benzoxazolium salt
48 FR 17385
4/22/83
83-644
Do
G
Do
48 FR 20487
5/6/83
83-678
Do
G
Dibutyitin mercaptoacetate derivative
48 FR 20490
5/6/83
83-753
E.I. du Pont de Nemours &
G
Styrene acrylic copolymer
48 FR 24967
Co., Inc.
6/3/83
83-757
CBI
G
Functionalized acrylic polymer
Do
83-758
Do
G
Do
Do
83-790
American Cynamid Co.
G
Heterocycle carboxylic acid
48 FR 26884
6/10/83
83-833
E.I. du Pont de Nemours &
G
Coconut oil epoxy polymer
48 FR 29054
Co., Inc.
6/24/83
83-834
Do
G
Coconut oil alkyd
Do
83-942
CBI
G
Ethylene polymer with mixed alpha olefins
48 FR 33532
7/22/83
83-964
Dow Chemical Co.
Magnesium aluminum hydroxy anion chloride
Do
83-966
Do
Magnesium aluminum hydroxy anion bicarbonate
Do
83-976
CBI
G
Fluoroalkylamine
48 FR 34506
7/29/83
83-1025
Do
G
Amino disubstitutedsulfamoyl carbomonocycle
48 FR 37699
8/19/83
83-1027
Do
G
Haloalkyl diphosphorohalidic acid
Do
83-1080
Do
G
Silylated silica gel
48 FR 39689
9/1/83
83-1103
Do
G
Esterified copolymers of alpha olefins and maleic
48 FR 41638
anhydride
9/16/83
83-1187
Do
G
Vinyl interpolymer containing hydroxyl and carboxyl
Do
groups
83-1201
Allied Corp.
G
Diyne diurea
48 FR 43397
9/23/83
83-1232
CBI
G
Polymer of aliphatic diamines, an alkanediol polyester,
Do
a monoalcohol polyether, a metal salt of an
alkanediol polyether and aliphatic dilsocyanates
83-1240
Do
G
Copolymer of alkyl methacrylates and vinyl
Do
monoheterocycle
83-1312
Do
G
Urethane acrylate
48 FR 45842
10/7/83
83-1316
Do
G
Alkyl fatty ester
Do
83-1318
Do
G
Methyl fatty acid eaters
Do
84-11
Do
G
Alkylated cycloalkanone, bis[(4-azidophenyl)methylene]-
48 FR 46851
10/14/83
84-27
Do
G
Polyol carboxylate ester
48 FR 48863
10/21/83
84-29
Do
G
Ethylene terpolymer
Do
84-48
E.I. du Pont de Nemours &
G
Acrylic styrene copolymer
48 FR 50961
Co., Inc.
11/4/83
84-55
CBI
G
Ethoxylated nonylphenol urethane derivative
Do
84-80
A.E. Staley Manufacturing
Co.
Cellulose, acetate {(l-oxo-2-propenyl) amino) methyl
Do
ether
84-81
Do
Cellulose, acetate butanoate, [(l-oxo-2-propenyl)amino]
Do
methyl ether
84-92
CBI
G
Polymer of 1,2-propanedlol, 1,6-hexanedloic acid and
Do
tetra substituted benzene dlcarboxyllc acid
derivative
84-97
Do
Ethanol, 2-amino-hydrobromide
48 FR 50944
11/4/83
84-103
Do
G
Modified polyacrylate polymer
Do
84-104
Do
Q
Starch grafted polyacrylate polymer
Do
84-110
Do
G
Polyurea
DO
84-211
Do
G
3,7-bi8(dl-Substltuted amlno)-S-(8ubstltuted phenyl)
48 FR 53162
phenazinlum salt
11/25/83
84-212
Do
G
DO
Do
84-214
Kaneka Texas Corp,
<3
Reaction products of quinone and amine
Do
84-236
CBI
G
Dilsocyanate polymer with polyether poiyols
48 FR 55332
12/12/83
9
-------
84-264
Chevron Chemical Co.
G
Alkyl sulfonate
48
FR 57618
12/30/83
84-276
CBI
G
Diarylazomethine N-oxide
Do
84-319
Q O Chemicals Inc.
Crude oat oil
49
FR 2526
1/20/84
84-320
CBI
G
Saturated polyester
Do
84-322
Do
G
Organosiloxane copolymer
Do
84-323
Do
G
Urea-aldehyde resin
Do
84-324
Do
G
Isoindolyl derivative of aromatic heterocycle
Do
84-331
General Electric Co.
G
Terephthalic acid, polymer with polytetramethylene
49
FR 3523
ether glycol and alkane diols
1/27/84
84-336
Westinghouse Electric Corp.
Polymer of melamine, formaldehyde, o,p-
Do
toluenesulfonamide, methyl glucoside, sodium
hydroxide, guanidine carbonate, magnesium bromide
84-337
Do
Polymer of phenol, nonyl phenol, formaldehyde, methyl
Do
glucoside, sodium carbonate, ammonium sulfamate
84-339
Do
Polymer of phenol, nonyl phenol, formaldehyde Reax
Do
27D, methyl glucoside, sodium carbonate
84-340
Do
Polymer of phenol, nonyl phenol, formaldehyde Reax
Do
27D, sodium carbonate
84-345
CBI
G
Unsaturated aliphatic ester
49
FR 4256
2/3/84
84-352
Do
G
Cellulose ester
Do
84-353
Do
G
Quinone-imine dye
Do
84-354
Do
G
Substituted substituted benzenesulfonic acid
Do
84-355
Do
G
Do
Do
84-356
Do
G
Disubstituted dichloro sulfonated heteropolycycle
Do
84-357
Do
G
Substituted arylamino substituted benzenesulfonic
Do
acid
84-359
American Hoechst Corp.
2,2-bis(4-(3-di(cocoalkylpolyoxyethyl)amino-2-
49 FR 6160
hydroxypropoxy)phenyl)propane, ethoxylated
2/17/84
84-361
CBI
G
Substituted cyclohexane
49
FR 4980
2/9/84
84-368
Do
G
Substituted styrene, substituted acrylate, derivatized
Do
copolymer
84-369
Do
Benzenemethanaminium, 4-ethenyl-N-dodecyl-N,N-
Do
dimethyt chloride
84-372
EM Chemicals
G
4-{Substituted cycloalkyl)-alkoxy-benzene
Do
84-373
Do
G
Do
Do
84-374
CBI
Polymer of neopentyl glycol; phthalic anhydride; adipic
Do
acid; isophthalic acid; benzoic acid, trimethylol
propane
84-384
Do
G
Substituted cyclohexane and cyclohexene esters
49
FR 6160
2/17/84
84-388
Do
G
Reaction of product of a phenol-formaldehyde polymer,
Do
a carbocyclic anhydride and an amine
84-405
Do
G
Ammonium salts of substituted alkyl phosphoric acids
49
FR 6991
2/24/84
84-406
BASF Wyandotte Corp.
Lead cyanamide
Do
84-408
EM Chemicals
G
4-(Alkylphenylcarbonyloxy)-benzoic acid, alkylphenyl
Do
ester
84-409
Do
G
4-(Alkylphenylcarbonyloxy acid, (4-alkylphenyl) ester
Do
84-410
Do
G
Alkylbenzoic acid, 4-alkylphenyl ester
Do
84-411
Do
G
Do
Do
84-412
Do
G
Do
Do
84-413
Do
G
Do
Do
84-414
Do
G
Do
Do
84-419
CBI
G
Triazine derivative
49
FR 7654
3/1/84
84-422
Do
G
Blocked isocyanate
Do
84-423
Do
G
Polyamideimide resin
Do
84-424
Do
G
Polyester resin
Do
84-429
Do
G
Saturated aromatic and aliphatic polyester poiyols
Do
84-459
Do
G
Modified metal carboxylate
49 FR 9013
3/9/84
84-465
Do
G
Substituted urea
Do
84-470
Do
G
Salt of aminoethylethanolamine phosphonic acid
49 FR 9954
3/16/84
4
-------
84-474 Milliken&Co.
84-479 Fairchild Chemical Co.
84-486 CBI
84-504 Do
84-511 Bofors Nobel Inc.
G
G
G
Chromophore substituted poly(oxyethylene)
p-(Methylthio)aniline
Unsaturated oxime
49
Substituted phenylenediimino-bis(chlorotriazinyl imlno-
substituted phenyleneazo-naphthalenetrisulfonic
acid, mixed sodium-lithium salt 49
Bis-butyl quaternary ammonium bromide salt
Do
Do
FR 11009
3/23/84
FR 13746
4/6/84
Do
*The generic name is the name that was provided by the submitter when the corresponding PMN was filed. A different generic
name may be assigned to the compound by EPA when published in the TSCA Inventory of Chemical Substances.
REGULATION OF HAZARDOUS SUBSTANCES ...
SECTION 6
Under section 6 of TSCA, EPA is authorized to control a
chemical as a hazardous substance if the Agency finds that
there is a reasonable basis to conclude that the chemical
presents or will present an unreasonable risk of injury to
human health or the environment. Under section 6(a), EPA
may apply one or more of several different regulating meas-
ures to the extent necessary to protect adequately against
the risk.
Under section 5(f)(2) EPA can issue an immediately effective
proposed rule under section 6(a) to apply to a chemical that
is the subject of a section 5 premanufacturing notice (PMN)
if the Agency finds there is a reasonable basis to conclude
that the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical presents or will pre-
sent an unreasonable risk of injury to human health or the
environment before a final rule promulgated under section 6
can protect against such risk,
EPA Issues Immediately Effective Rule
Using authority under section 5(f)(2), EPA issued an immedi-
ately effective section 6(a) proposed rule on June 14, 1984
(49 FR 24658) to prevent a possible carcinogenic risk to
metalworkers. The proposed rule applies to a new chemical
substance that Is the subject of a premanufacturing notice
(PMN 84-310). The proposed rule prohibits the addition of
nltrosatlng agents, such as nitrates, to the chemical sub-
stance known generically as triethanolamine salt of a sub-
stituted organic acid when used in metalworking fluids.
If PMN 84-310 Is used in metalworking fluids without nitro-
sating agents as Intended by the PMN submitter, nltrosa-
mines will not be formed.
EPA believes nltrosatlng agents may be added to water-
based cutting fluids containing the new additive. The EPA
action is prompted by a concern over the formation of
nltrosamlnes In water-based metalworking fluids which
contain PMN 84-310 should nltrosating agents be added to
such fluids.
PCB Regulatory Background
Under section 6(e), EPA Is required to control the manufac-
turing, processing, distribution In commerce, and use of
polyohlorlnated biphenyls (PCBs). On May 31, 1976, EPA
promulgated a comprehensive PCB rule. On October 30,
1980 In response to a petition, the U.S. Court of Appeals for
the District of Columbia Circuit set aside portions of the
May 31, 1979 rule. The court remanded the set aside por-
tions to EPA for further action. Responding to the court
order, EPA, on August 25, 1982, amended the May 31, 1979
rule by authorizing the use of PCBs in electrical equipment.
The 1979 rule was further amended on October 21, 1982
when EPA excluded the production of PCBs In closed and
controlled waste manufacturing process from the ban im-
posed by TSCA.
Four Rules Issued on PCBs
On July 10, 1984, EPA issued four notices in the Federal
Register concerning PCBs. One notice is a final rule that ex-
cludes f rom the TSCA ban on PCBs certain processes that
inadvertently generate PCBs In low level concentrations. A
second final rule and a rule-related notice were also Issued
on over 100 pending exemption petitions to manufacture,
process and distribute PCBs in commerce. Finally, the
Agency Issued an authorization for the use of PCBs In cer-
tain limited microscopy, and research and development sit-
uations. EPA believes that the PCBs permitted by these
activities would not present an unreasonable risk to human
health or the environment.
Modify PCB Definition of "Totally Enclosed Manner"
EPA Is proposing (Juty 23,1984 (49FR 29625)[ to modify the
May 31, 1979 PCB rule by redefining the term "totally en-
closed manner" for PCB related activities and changing
other portions of the rule to clarify the Agency's position on
what constitutes "significant exposure" to PCBs. The pro^
posed modification reflects a settlement agreement
between EPA and the Edison Electric Institute, the National
Electrical Manufacturers Association and the American
Paper Institute on litigation on the PCB Electrical Equip-
ment Rule, which was published on August 25,1982 (47 FR
37342). These modifications are consistent with the pro-
cedures the Agency currently follows In assessing PCB
exposure.
REPORTING RULES
SECTION 8(a),.. PRELIMINARY ASSESSMENT INFORMA-
TION RULE
Manufacturers (including Importers) of chemical sub-
stances Haled In the section 8(a) rule must report certain
production, use, and exposure data to EPA using the rule's
Report Form, EPA may add chemicals to the rule when the
Agenoy wishes to obtain Preliminary Assessment Informa-
tion of those substances,
EPA Adds 18 Chamleals to List
On June 25, 1984, EPA published two regulations In the
Federal Register which added 18 substances to the list of
ohemioals subject to the Preliminary Assessment Inrorma-
tion Rule. One chemical (mesltyl oxide) was recommended
$
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for testing consideration by the ITC in its Fourth Report.
The other 17 chemicals were included in the ITC's Eleventh
Report. Manufacturers subject to these rules are required
to submit data to EPA by October 8, 1984. The reporting
forms may be obtained by telephone through the TAO. The
chemicals are:
77-58-7 Stannane, dlbutylbls [(l-oxododecyl)oxy)-
108-67-8 Benzene, 1,3,5-trimethyl-
140-66-9 Phenol, 4-(1,1,3,3-tetramethylbutyl)-
526-73-8 Benzene, 1,2,3-trimethyl-
646-06-0 1,3-Dioxolane
1185-81-5 Stannane, dibutylbis(dodecylthio)-
3319-31-1 1,2,4-Benzenetricarboxylic acid,
tri s(2-ethylhexyl) ester
6422-86-2 1,4-Benzenedicarboxylic acid,
bis(2-ethylhexyl) ester
13414-54-5 Benzene, 1-[(2-methyl-2-propenyl)oxy]-2-nitro-
13414-55-6 Benzofuran, 2,3-dlhydro-2,2-dimethyl-7-nitro-
25168-21-2 2-Butenoic acid, 4,4'-[(dibutylstannylene) =
bls(oxy)]bis[(4-oxo-, diisooctyl ester, (Z,Z)-
25168-24-5 Acetic acid,
2,2 '-[(dibutylstannylene)bis(thio)]bis-,
diisooctyl ester
25551-13-7 Benzene, trlmethyl-
25852-70-4 Acetic acid, 2,2',2"-[(butylstannylidyne) =
tris(thlo)]tris-, trlisooctyl ester
26636-01-1 Acetic acid,
2,2 '-[(dimethylstannylene)bis)thlo)]bis-,
diisooctyl ester
54849-38-6 Acetic acid, 2,2',2"-[(methylstannylidyne) =
tris(thio)]tris-, triisooctyl ester
68298-46-4 7-Benzofuranamine, 2,3-dihydro-2,2-dimethyl-
141-29-7 Mesctyl oxide
SECTION 8(e). .. SUBSTANTIAL RISK
Under section 8(e) persons who obtain new information
which reasonably supports the conclusion thai 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 the Office of Toxic Substances (OTS)
and an initial evaluation is prepared containing, if appropri-
ate, foilowup questions to the submitter, referrals to other
agencies, and recommended OTSIEPA foilowup actions.
The 8(e) notices represent a company's first review of a sit-
uation 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 to make this
section 8(e) information widely available and understand-
able to a broad public. The submissions and the Initial eval-
uations are located In the OTS Public Reading Room, first
floor, East Tower, Waterside Mall, 401M Street, SW, Wash-
ington, D.C.
Persons wishing to obtain a copy of section 8(e) notices
may write: EPA, Freedom of Information, Ms. Jerri Green,
(A-101), Washington, D.C. 20460. There Is no charge for
duplicating the first 49 pages, but at page 50 of a request for
duplication there is a $10.00 fee and a 20c charge for each
additional-page (e.g., 51 pages cost $10.20).
Single copies of the 8(e) initial evaluation (not the full sub-
mission) are available from the TAO.
Recent Section 8(e) Notices of Substantial Risk
Log No. 8EHQ— JCASNOl
0584-0514
n-Pentanolc acid
109-52-4
heptanoic acid 111-14-8
Nonanoicacid 112-05-0
Summary results from a chronic skin-painting study
0584-0516 S
Oxirane/methyloxirane polymer 9003-11-6
Final results from a battery of genotoxicity tests
0584-0517
Solvent-cutback type rust-preventive product
Summary results from a chronic skin-painting study
0584-0518 S
Eposy Resin Mixture (EPON 815)
Preliminary results from several genotoxicity studies
0584-0519
2,2 '-[(2-Carboxy-p-phenylene)bis 20328-87-4
(iminovinylene)](3-ethyl)-2- thiazolium diiodide
Pina Sensitizer KF 501
Summary results from an acute toxicity study
0684-0520
2-Methyl-l-[(4-methyl-thio)phenyl]- 71868-10-5
2-(4-morpholinyl)-l-propanone (Irgacure 907)
Final report from a sub-acute oral toxicity study
S at the end of a Log Number means a sanitized version is available.
N.B. All toxicity, oncogenicity, teratogenicity and mutagenicity
studies involve animals unless otherwise stated. Additional tests
(e.g., bacterial cell) are noted or are included in the term "battery."
Significant New Use
Under section 5(a)(2) EPA determines certain uses of chemi-
cal substances are significant new uses. A determination is
made by a significant new use rule (SNUR) promulgated
after considering all relevant factors, these factors Include
the projected manufacturing (import) and processing vol-
ume of the substance, the extent to which the substance's
new use changes the type and form of exposure to humans
or the environment, the extent to which the substance's use
increases the magnitude and duration of exposure to
humans or the environment, and the anticipated manner
and methods of manufacture, processing, distribution in
commerce, use, or disposal of the substance. Under sec-
tion 5(a)(1)(B), persons must notify EPA at least 90 days
before manufacturing or processing a chemical substance
tor a significant new use as determined by EPA. If the sub-
stance is imported, the importer must comply with certifica-
tion requirements of TSCA section 13. In addition, persons
who intend to export, for any purpose, a substance that Is
subject to a proposed or promulgated SNUR must notify
EPA under section 12(b).
EPA proposes SNURs for chemical substances which are
on the TSCA chemical inventory. A SNUR may be proposed
in conjunction with a 5(e) order issued during the PMN
review period or may be proposed at any time following ad-
dition of a chemical to the chemical Inventory. Section 5(e)
orders thai allow use of a PMN substance under controlled
conditions are usually followed by a proposed SNUR
because the order applies only to the original submitter.
When the PMN submitter sends EPA a notice of commence-
ment of manufacture (see page 2) the Agency adds the PMN
substance to the chemical inventory. A SNUR Is necessary
In order to assure that controls imposed by the 5(e) order
will also apply to anyone else who may decide to manufac-
ture or process the new chemical in question.
6
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Section 5(e) Action Pending Development of Information
The Administrator may issue a section 5(e) order to take
effect at the end of the PMN review period. The order may
limit or prohibit manufacture (Import), processing, distribu-
tion in commerce, use, or disposal of the PMN substance.
The action can be taken if information available to EPA is in-
sufficient to permit a reasoned evaluation of the risks, and
If the substance may present an unreasonable risk to either
health or the environment. A 5(e) order may also be issued if
there Is Insufficient information and the substance may be
produced in large quantities and may result In significant or
substantial human exposure, or substantial release to the
environment.
A 5(e) order can be a consent order or a unilateral order. In a
consent order, EPA negotiates the terms of the order with
the company that submitted the PMN. The company agrees
to be bound by the order and waives its rights to file objec-
tions to the order. This waiver does not affect any other
rights that the company may have under TSCA. The com-
pany at a later date can request a modification of the con-
sent order. In an unilateral order EPA takes action to restrict
or prohibit the manufacture or use in commerce of the PMN
substance.
PMN
83-603
84-176
84-180
84-181
84-182
84-183
84-184
G = Generic Name
G Substituted nitrite
Chemical Identification
Do = Ditto
G
G
G
G
Q
G
i-inpi «v v..~.
Polyester acrylate ester
Aliphatic acrylate ester
Polyester acrylate
Aliphatic ester methacrylate
Aliphatic ester methacrylate
5(e)
Consent Order or
Unilateral Order
Modification of
Consent Order
3/26/84
Consent Order
5/28/84
5(a)(2)
(SNUR)
Pending
84-105
84-106
84-107
G
G
G
Halogenated alkene
Halogenated alkanes
Do
Consent Order
6/19/84
Pending
84-111
to
84-117
G
Substituted aromatic polymer
Consent Order
7/26/84
Pending
Pending
SUPPORT ACTIVITY
OECD Proposed Guideline* Available
The TAO Is distributing proposals for four health effect#
testing guidelines for genotoxIcJty and one physical chem-
istry guideline. The proposed guidelines have been devel-
oped for the Organization for Economic Cooperation and
Development (OECD) of which the United States Is a
member.
EPA is the read agency of the U.S. Government In aiding the
OECD updating program on chemicals. Interested persons
are requested to review these guidelines and provide EPA
with comments regarding their relevance to hazard assess-
ment and technical merit. Comments will be used In redraft-
ing the proposed guidelines Into final OECD guidelines,
The proposed guidelines now available for comment are:
Genetic Toxicology: In vitro Sister Chromatid Exchange Ae-
say; Genetic Toxicology: Saccharomycea cerevlslae, Gene
Mutation Aaaay; Genetic Toxicology: S. cerevislae, Mitotic
Recombination; Genetic Toxicology: S. cerevislae, MKotic
Aneuptoldy; and Physical-Chemical Properties: Partition
Coefficient (N-octanol/w«ter); Liquid Chromatography.
Persons who wish to comment on the proposed guidelines
should telephone the TAO for copies because comments
should be received by EPA no later than September 30,
1984.
OTS Seeks CHIP Data
OT8 is asking the public for unpublished Jnformatlon about
the following chem teats:
Phenylethanoi (& Acetate)
Phthalimlde
60-12-8
(103-45-7)
85-41-6
Thesechemicala have been selected for preliminary assess-
ment review. Information should be sent at soon as posei-
bletb;
TSCA Document Cam«a $ttle6 (TS-79®
ATTN: T. Q'Bryan
Washington, D.C, 20460
Persona whohave unputolfehia^tii^^
Icals, but who also want answers to questions prior to'
responding shouidcontact John uitwe ofthe OTSCheml-
cat 8am0nfna $mncht (2QH) 38Si-Q5Q7j as soon as possible.
The OT8 rfvi#w of the chemicaiawhan publ}shed w«i be in*
cludetMnreports Ohemte# Hif»r{finfom»t)onPro.
I
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files (CHIPs). A CHIP is a brief summary of readily available
information concerning the health and environmental ef-
fects and potential exposure to a chemical. CHIP candi-
dates are chosen on the basis of information indicating a
potential for adverse health or environmental effects along
with the evidence of significant production or some type of
exposure.
When OTS searches the literature in preparing a CHIP it
generally limits the search to automated data bases and
reference works. But OTS encourages individuals and firms
to submit unpublished or recently published reports and all
other hard-to-obtain studies on the chemical selected for a
CHIP. Relevant studies from the public could include data
on health effects, environmental effects, commercial pro-
duction and uses, exposed populations, environmental
levels, or any other material that can aid in the assessment
of the chemical's impact on health or the environment. OTS
is also interested in knowing of current testing of a CHIP
candidate or assessment activities by other organizations.
The TAO will notify Individuals and organizations by letter
every time OTS starts a new CHIP. Persons who think they
can aid the CHIP information-gathering process will have
their names added to the list if they contact the TAO. All in-
formation submitted in response to the solicitations will be
placed in a public file and made available for public inspec-
tion, unless the submitter is able to assert a claim of con-
fidentiality, in accordance with the provisions of section 14
of TSCA. EPA will handle all confidentiality claims in ac-
cordance with its procedures governing the confidentiality
of business information.
The TAO is distributing copies of the following
recently completed CHIPs:
Alkylated Phenol Sulfides
Epoxy/Chlorohydroxypropyl-
trimethylammonium Chloride
Methylene Diphenyldiisocyanate
Sulfolane
Toluene Diisocyanate
OTS encourages comments on the accuracy and
thoroughness of information presented in the CHIPs.
First Class Mail
Postaoe and Fees Paid
EPA
Permit No. G-35
TSCA Assistance Offfee (TS-799)
Office of Pesticide & Toxic Substances
U.S.E.P.A.
Washington, D.C. 20460
Official Business
Penalty for Private Use
$300
THE TSCA CHEMICALS-IN-PROGRESS BULLETIN
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