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Vol. 6, No. 2
May 1985
INSIDE
What's Happening In OTS by Don R. Clay, OTS Director
Updating the TSCA Inventory
Page 2
REPORT on FORMALDEHYDE INVESTIGATION
Page 4
TSCA TESTING ACTIVITIES
New Data Available on Nine Substances
EPA Reports on PDAs
Page 4
Page 2
TSCA NEW CHEMICAL REVIEW
Expedited PMN Review for Low Volume Chemicals
Page 2
TSCA REPORTING REQUIREMENTS
Latest Substantial Risk Notices
New FYI Submissions
Page 4
Page 5
SIGNIFICANT NEW USE RULES (SNURs)
Propose SNUR for MBOCA
Page 3
FOR YOUR INFORMATION
EPA Seeks Data on CHIPs
Page 5
INVENTORY
Plan Removal of 106 Substances
EPA Adds 56 Chemicals
Page 2
Page 6
1
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What's Happening In OTS - Don R. Clay
I n March, we issued a proposed rule to update the TSCA Inventory data base. I thoug ht I would
share with you our thinking on this proposed rule.
As most of you know, the Inventory was originally composed of over 60,000 chemicals in
commercial use in 1977. Since then, about 2,000 new chemicals were added. The proposed
rule would not change the chemicals that are listed on the Inventory. Rather, it wou Id update
certain production information on those chemicals. This rule is important because the infor-
mation we now have is obsolete; it is primarily a snapshot of the chemical industry in the
mid-1970s. Since then, the industry has changed significantly. We therefore need to update the
information to set priorities for the chemicals; investigate the health and environmental effects
of chemicals; determine commercial status of chemicals; communicate with manufacturers on
risks associated with chemicals; and help Federal and State agencies carry out their responsi-
bilities. The rule, as proposed, would require initial reporting on all of the reportable substan-
ces and recurring reporting every second year, but only if there is a major change in production
or use patterns.
Don R. Clay, Director,
Office of Toxic Substances
OTS is seeking an update only for the types of chemicals for which we think we really might
need the information. Based on information available from the current Inventory, we estimate
that this will cover about 15,000 chemicals. Excluded from the proposed reporting require-
ments are chemicals such as polymers which are generally regarded as low-risk chemicals. In addition, if the production volume of
the chemical is under 10,000 pounds, it need not be reported. If we need information on an excluded chemical, we can obtain the
information under a separate rule.
Since this rule is being proposed under section 8(a) of TSCA, the small manufacturers exemption that is applicable to section 8(a)
rules will apply in this case as well.
The comment period closed on May 13, and we anticipate issuing a final rule before the end of this year.
OTS FACES
Linda A. Travers, Acting Director of OTS' Information Man-
agement Division, is responsible for the proposed updating of
the TSCA Inventory data base. Linda's division is the hub of
EPA's chemical information data sources. She developes and
manages the automatic data processing systems that support
all TSCA activities, from data
collection and dissemination
to analysis and rulemaking.
Under her direction, a staff of
about 80 people receive and
control all documents resulting
from TSCA rulemaking activi-
ties. Linda is responsible for the
security of all TSCA confidential
business information. Her staff
operates a chemical information
library that is a primary EPA
chemical information source.
EPA to Drop 106 Substances from TSCA Inventory
EPA will soon be issuing a Federal Register notice proposing
to remove 106 chemical substances from the TSCA Chemical
Substance Inventory. In general, the identities of these chem-
ical substances were found to be incorrectly reported and
listed; therefore, they appear ineligible for continued inclu-
sion in the TSCA Chemical Substance Inventory. For each of
the substances with an incorrectly reported identity, the orig-
inal submitter has provided EPA with the correct identity
which has been added to the Inventory. The purpose of this
notice is to determine whether these incorrectly reported
substances have been actually manufactured by persons
other than the original submitters. Contact the TAO at (800)
424-9065 for details regarding this notice.
Expedited PMN Review tor Low Volume Chemicals
Beginning on June 10,1985, manufacturers and importers of
new low volume chemicals will be eligible for an expedited
PMN review under section 5 of TSCA. The term "low volume''
is defined as 1,000 k ilograms (approximately 2,000 pounds) or
less a year. The TSCA rule was published on April 26,1985 (50
FR 16477).
A chemical eligible for this exemption will undergo an expe-
dited 21-day review rather than a 90-day PMN review by EPA,
and information requirements will be reduced from the full
PMN requirements. EPA can deny an exemption during the
shortened period if there are significant unresolved issues
concerning risk. The Agency can also revoke the exemption
at any time if new data indicate the substance does not meet
the exemption criteria. If, after an exemption is granted, there
is a desire to change a manufacturing site or use of the chemi-
cal, then the rule requires the filing of a new exemption notice.
A full PMN must be submitted before production exceeds
1,000 kg/yr.
Approximately 20 percent of all new chemicals have esti-
mated production volumes of less than 1,000 kg/yr and there-
fore are potentially eligible for abbreviated review. The
Agency has issued a limited exemption for these chemicals
because of their low production volume and therefore rela-
tively low exposure potential.
-------
EPA Proposes SNUR for MBOCA
EPA is proposing a significant new use rule (SNUR) for a
chemical on the TSCA Inventory. The chemical is 4,4'-
methylenebis(2-chloroaniline) or MBOCA (CAS 101-14-4).
The rule proposes that the manufacture of MBOCA in the
United States be identified as a significant new use of the
substance [April 26,1985 (50 FR 16519)]. The final rule would
require persons intending to manufacture MBOCA in the
United States to submit a SNUR notice to EPA at least 90 days
prior to commencement of manufacture. For purposes of this
proposed rule the term "manufacture" would not include the
importation of MBOCA into the United States.
EPA believes MBOCA is a potential human carcinogen. Sev-
eral studies indicate that the substance causes malignant
tumors in mice, rats, and dogs when administered orally.
MBOCA can be absorbed dermally, and studies indicate that
the substance is distributed rapidly through the body and
extensively metabolized. MBOCA has not been manufactured
in the United States since 1979, but it has been imported in
recent years. The primary use of imported MBOCA is as a
hardener or curing agent in the manufacture of polyurethane
plastics. There appears to be no consumer exposure to
MBOCA.
Did you know?
SNURs may be written for new or existing chemicals.
A SNUR may be issued for a chemical that has gone through
the premanufacture notice review process of TSCA (referred
to by EPA as a "new" chemical, even though the substance
may be added to the TSCA Inventory). A SNUR also may be
issued for a chemical that was on the original TSCA Inventory
(referred to by EPA as an "existing" chemical). SNURs ensure
that EPA will receive information on significant new uses of
potentially hazardous substances before such uses occur.
See page for a report on a proposed SNUR rule for an
existing chemical, MBOCA. For a more detailed explanation
of SNURs, see page 7.
New Significant New Use Notices
EPA has recently published these new proposed SNUR rules covering a total of 10 chemicals. For an explanation of SNURs, see
page 7 and "Did you know?" (above).
5(e) 5(a)(2)
PMN Chemical Identification Consent Proposed
or or Final
Unilateral SNUR
Order
G = Generic Name*
84-105
106 & 107
G
G
Substituted tetrafluoro alkene
Disubstituted tetrafluoro alkane
6/13/84
Proposed
50 FR 11384
3/21/85
50525
84-176
177
G
a
Alkanetrlol dlmethacrylate, substituted
Pofyrtlis»kw#g|ycol.mono-methacrylj^,
substituted
181
182
183
184
G
G
G
G
Polyalkyl-alkanediol mono-acrylate,
substituted
Alkanetrlol polyalkylene glycol ester
acrylate, substituted
Alkylene glycol mono-methacrylate,
substituted
Polyalkyl-alkanediol mono-methacrylate,
substituted
5/25/84
Proposed
50 FR 12046
3/27/85
50524
84-417
G
Methylphenol, bis (substituted alkyl)
8/13/84
Proposed
50 FR 11391
3/21/85
SOS 28
**
4,4'-Methylenebis(2-chloroanillne)
(MBOCA)
Proposed
50 FR 16519
4/26/85
50523
*A generic name In this list may be different from the generic name listed when the PMN was first published In the Pectoral Register.
During SNUR negotiations a more specific generic chemical Identification may have been assigned.
"SNUR on MBOCA Is an "existing chemical SNUR," therefore there Is no PMN.
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New Data Available on Nine Substances
OTS received new test data submissions on nine chemicals
and categories of chemicals that are subject to negotiated
testing agreement programs under TSCA [February 8,1985
(50 FR 5421)]. The data are available for inspection at the
Office of Toxic Substances (OTS) Public Reading Room, first
floor, East Tower, Waterside Mall, 401 M Street, S.W., Wash-
ington, D.C.
Persons wishing to obtain copies of the data may write: EPA,
Freedom of Information, Ms. Jeralene Green, (A-101), Wash-
ington, D.C. 20460. There is a 20 cent charge for duplicating
each page. The data on each chemical listed below number
over 100 pages.
The chemicals are:
Alkyl phthalates*
Acrylamide
4-Chlorobenzotrifluoride
2-Chlorotoluene
Methyl isobutyl ketone/methyl ethyl ketone
Isophorone
4-(1,1,3,3-Tetramethylbutyl) phenol
Tris(2-ethyIhexyl) trimellitate
Bis(2-ethylhexyl terephthalate
79-06-1
98-56-6
95-49-8
108-10-1
and
78-93-3
78-59-1
140-66-9
3319-31-1
6422-86-2
"Submissions cover 13 alkyl phthalates, see Federal Register
notice cited above for the substances' names.
EPA Reports on PDAs
EPA reaffirmed an earlier decision not to require health and
environmental testing of 34 of 47 phenylenediamine (PDA)
category members under TSCA. The notice [January 30,1985
(50 FR 4287)] said the other 13 PDAs will be the subject of
future TSCA section 4(a) actions for proposed health effects,
chemical fate or environmental effects testing.
The entire PDA category was recommended to EPA for test-
ing under TSCA by the ITC in 1980. In 1982 EPA responded to
the designation by issuing an Advance Notice of Proposed
Rulemaking (ANPR). In that notice EPA said 34 PDAs had low
or no production subject to TSCA. Therefore the Agency
could not make the appropriate finding under section 4(a) for
test rule development. The ANPR did propose that 13 other
high volume PDAs would be considered for test rule devel-
opment because of potential exposure and available toxico-
logical information. EPA also asked for comments on Its deci-
sion. The comments received persuaded EPA to subdivide the
13 high production PDAs into two subcategories for future
test rule consideration under TSCA. Based on the comments,
EPA was able to reaffirm that it could not make the approp-
riate section 4(a) finding with respect to the 34 low production
PDAs.
Did you know?
If you manufacture, import, or process a substance listed in
the section 8(d) model Health and Safety Data Reporting Rule
and initiate a study of this substance, then you must notify
OTS of your actions. The section 8(d) model rule requires you
to notify OTS within 30 days of Initiating certain studies of
listed substances and requires you to submit a copy of the
study whenever it is completed. Persons interested in learning
more about the section 8(d) model rule requirements are
encouraged to review 40 CFR Part 716, or call or write the TAO
for a Federal Register reprint of the section 8(d) model ru le (47
FR 38780) and an up-to-date list of section 8(d) substances.
EPA REPORTS ON REGULATORY INVESTIGATION OF
FORMALDEHYDE
On May 23,1984, EPA determined under section 4(f) of TSCA
that there may be a significant risk of widespread harm from
formaldehyde exposure to residents of mobile and conven-
tionally-built homes made with urea-formaldehyde wood
products and employees manufacturing durable-press
apparel. In the Federal Register notice announcing this deci-
sion (49 FR 21898), EPA stated that it would report semian-
nually on the progress of its formaldehyde investigation. This
is the second such report; the first appeard in the November
1984 issue of Chemicals-in-Progress Bulletin.
In March, the Office of Pesticides and Toxic Substances
(OPTS) reviewed progress on the formaldehyde project.
OPTS decided to further assess the non-cancer health risk
before determining whether formaldehyde exposure risks are
unreasonable. A draft risk assessment covering cancer risks
had been completed by the Existing Chemical Assessment
Division and is now being revised to incorporate discussion of
the non-cancer health effects.
in its residential exposure work since November, OPTS has
received, reviewed, and placed in the docket a contractor
report on possible substitutes for formaldehyde-emitting
wood products and a contractor report on cost estimates for
control options for wood products. OPTS has received and is
reviewing an exposure assessment for wood products: this
document Is scheduled to be completed and placed in the
docket in mid-June.
For apparel, OPTS has received draft reports on substitutes
for formaldehyde-emitting resins, ventilation, and cost esti-
mates for control options. These reports will be entered into
the docket after internal review.
A decision by the Agency on all regulatory options is now
scheduled for August. OPTS will expand and revise its risk
assessment, including its assessment of non-cancer health
risks, with scheduled completion by mid-May, and will have it
peer-reviewed. The documents covering technical options,
exposures, and coats of exposure reduction options are
scheduled to be completed by mid-June.
Section 8(e).. .Substantial Risk
Below is a list of recent initial section 8(e) notices placed in
EPA's public file. For an explanation of section 8(e)ah(JTfiSW
copies of notices can be acquired see page 8.
[CAS No.]
Log No. 8EHQ
1284-0540 S
A mixture of imidazole and 2-ethyl-4-
methylimidazole
288-32-4
and
931-36-2
Summary results from three acute dermal
application studies in rabbits
1284-0541 S
Benzofurazan-1-oxide 480-96-6
Summary results from two in vitro genotoxicity
studies
0185-0542 S
Nitrite-containing metalworking cutting fluids
Information concerning nitrosamlne formation
in nitrite-containing metalworking cutting fluids
continued on next page
4
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0185-0543
Vinyl acetate 108-05-4
Summary results from a two-generation
reproduction study in rats
0285-0544
[[[3,5-bis(1,1-Dimethylethyl)-4- 80387-97-9
hydroxyphenyl]methyl]thio]acetic acid,
2-ethylhexyl ester
Summarized final results from an oral range-finding
study in rats and summarized preliminary results
from an ongoing teratology study in rats
Latest FYI Submissions
EPA has received in recent weeks 11 FYI (For Your Informa-
tion) submissions. The notices are listed below. For additional
information on FYls see page 7.
Document Control No. FYI-
Chemlcal Name(s) CAS No.
OTS-0185-0378 et. seq.
Dicyandiamide/Diethylenetriamine/ 67953-54-2
Epichlorohydrin (DDE) Resin
Information for CHIP in preparation
OTS-0185-0379 et. seq.
Dimethyl Hydrogen Phosphite 868-85-9
Information for CHIP in preparation
OTS-0285-0380 et. seq.
Tri (Alkyl/Alkoxy) Phosphates Chemical Class
Information for CHIP in preparation
^X-0285-0381
Raw and Hydrotreated Shale Oils 68308-34-9
Final results from a 28-day subchronic
dermal toxicity study in rats
AX-0285-0382
Gasoline Unknown
Feasibility analysis for an epidemiological study
OTS-0285-0383
p-Chloroanlline 106-47-8
Preliminary results from a carcinogenicity
bioassay in mice and rats
AX-0285-0384
Vanadium 7440-62-2
Chemical literature review
OTS-0285-0385
Coal Tar Chemicals Chemical Class
Final results from an epidemiological study
OTS-0285-0386 S
CGA-448 (an R&D Pesticide) Confidential
Summary results from a rat teratology study
OTS-0385-0388 et. seq.
DDE Resin 67953-54-2
Information for CHIP in preparation
AX-0385-0389
Middle Distillate Fuels Chemical Class
Toxicity and exposure profile
OTS-0385-0390
Acrylonltrlle 107-13-1
Methacrylonitrile 126-98-7
Chemical literature review, including antidotal information
OTS Seeks CHIP Data
OTS is asking the public for unpublished information about
the following chemicals:
Chloromethylpropene 563-47-3
Vinylcyclohexene 100-40-3
4-Nonylphenol (para) 104-40-5
(ortho) 136-83-4
(mixed) 25154-52-3
C. 1. Basic Red 9 monohydro-
chloride (salt) 569-61-9
(free base) 479-73-2
The chemicals have been selected for preliminary assessment
review. Information should be sent to:
TSCA Document Control Office (TS-793)
ATTN: Mr. Terry O'Bryan
Washington, D.C. 20460
Persons who have unpublished data about the chemicals, but
who also want answers to questions prior to responding
should contact John Leitzke of the OTS Chemical Screening
Branch, (202) 382-3507, as soon as possible.
All information 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 confident-
iality, in accordance with the provisions of section 14 of
TSCA. EPA will handle all confidentiality claims in accord-
ance with its procedures governing the confidentiality of bus-
iness information.
The OTS review of the chemicals when completed will be in
reports called Chemical Hazard Information Profiles (CHIPs).
A CHIP is a brief summary of readily available information
concerning the health and environmental effects and poten-
tial exposure to a chemical. CHIP candidates 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 refer'
ence works. But OTS encourages individuals and firms to
submit unpublished or recently published reports and all
other hard-to-obtain studies on a chemical selected for a
CHIP. Relevant studies from the public could include data on
health effects, environmental effects, commercial productioh
and uses, exposed populations, environmental levels, or any
other material that could aid In the assessment of the chemi-
cal's impact on health or the environment. OTS is also inter-
ested in information on 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 our CHIP list if they contact the TAO,
(800) 424-9065.
The TAO is distributing copies of the following recently com-
pleted CHIP:
Dlallyl Phthalate
131-17-9
OTS encourages comments on the aocuracy and thorough-
ness of information presented In the CHIP.
5
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New Chemicals Added to TSCA Inventory
EPA has received commencement of manufacture notices for 56 chemicals since publication of the
March 1985 Chemicals-in-Progress Bulletin. These chemicals, listed below, have been added to the
TSCA Chemical Substance Inventory. See page 8 for an explanation of commencement of manufacture
notices.
FR
PMN no. Submitter Chemical Identification Citation
CBI ~ Confidential Business Information G = Generic Name' Do = Ditto
81-605 CBI G
82-10 Minnesota Mining &
Manufacturing Co.
82-141 Takeda U.S.A., Inc.
82-216 Do
82-423 CBI G
82-635 Do G
82-645 Do G
83-408 Rhone-Poulenc, Inc. G
83-534 CB) G
83-628 Do
83-664 American Cyanamid Co. G
83-667 CBf G
83-861 Do G
83-899 Do G
83-989 Do G
83-1166 E.I. du Pont de Nemours G
& Co., Inc.
64-7 The Sherwln Williams
Company
84-111 CBI G
84-250 Amchem Products,
Division of H«nKel
Corporation
84-314 CBI G
84-437 Adhesive Engineering G
Company
84-464 Ethyl Corporation G
84-473 CBI G
84-507 Cordova Chemical
Company of Michigan
84-594 CBI G
84-658 Do
84-675 Aceto Chemical Co., Inc.
84-676 CBI ®
84-695 MeWhorten, Inc. «
Substituted benzophenone reacted with
methyl silsesquioxane
2-Ethyimercapto-3-ethylbenzthiazole iodide
Adduct of bis(isocyanatomethyl) benzene with
2-ethyl-2-(hydroxyme1hyl)-1,3-propanediol
Adduct of 1,3-bis(isocyanatomethyl)-cyclohexane
with 2-ethyl-2(hydroxymethyl)-1,3-propanedioi
Polyhaloalkoxyalkylphenone
Alkyl acid esters
Condensate of formaldehyde and an organic base
T rlazine trisisocyanate
Etheric aromatic eater
Reaction product of diglycidyl ether of bisphenol A,
dimer acid, soya fatty acid, dimethyloi propionic acid
Substituted benzoic acid
Pentasubstituted benzimidazolium salt
Substituted vinyl polymer
Alkyl(hydroxy aryloxy) atkanoate
Substituted carboxylated cocoimidazollne
Monosubstitutedphenyl magnesium bromide
N,N,N\N'-tetraglycidy-1-'f,3-bisaminomethyl
cyclohexane
Substituted aromatic polymer
Nickel fluorotttanate
Partially oxidized polysaccharide
Amine adduct of epoxy resin
Halogenated aromatic ether
Isocyanate modified phenolic resin
Polymer of dodecane, 1-amine (laurylamine),
ethyienlmlne, hydrochlotic acid
Dimer acids, dlcartjoxyllc acid,
diamines poiyamlde resin
Polymer of epsllon caprolactam, 2,4-toluene
dilsocyanate, epsilon caprolactone triol
4-Benzoyl-N1N,N-trlmethylbenzene
methanaminimum chloride
Methacrylate copolymer
Oil modified polyester
46 FR 60055
12-6-81
47 FR 2399
1-15-82
47 FR 10073
3-9-82
47 FR 13037
3-26-82
47 FR 26234
6-17-82
47 FR 39884
9-10-82
47 FR 41165
9-17-82
48 FR 5304
2-4-83
48 FR 11499
3-18-83
48 FR 17385
4-22-83
48 FR 20490
5-6-83
Do
48 FR 30434
7-1-83
48 FR 32381
7-15-83
48 FR 35713
8-5-83
48 FR 41638
9-16-83
48 FR 46851
10-14-83
48 FR 50944
11-4-83
48 FR 55916
12M0-83
49 FR 1787
1-13-84
49 FR 7654
3-1-84
49 FR 9013
3-9-84
49 FR 9954
3-16-84
49 FR 13746
4-6-84
49 FR 18833
4-20-84
49 FR 19110
5-4-84
49 FR 20000
5-11-84
Do
49 FR 22128
5-25-84
6
-------
84-727
84-731
E.I. du Pont de Nemours
& Co., Inc.
CBI
G
84-740
Do
G
84-741
Do
G
84-785
Do
G
84-845
Kay-Fries, Inc.
G
84-890
CBI
G
84-911
84-1066
Naarden International
USA, Inc.
CBI
G
84-1071 Ajinomato U.S.A., Inc.
84-1101 The Dow Chemical
Company
84-1109 CBI
84-1155 Do
84-1156 Do
84-1157
84-1158
84-1159
84-1180
84-1222
85-1
85-9
85-14
85-26
85-38
Do
Do
Do
Do
Do
Do
G
G
G
G
G
G
G
G
G
G
Ethox Chemicals, Inc.
Petrarch Systems, Inc.
5-[(3,5-Dinltrophenyl)methylthio]-1-
phenyl-1 H-tetrazole
Polymer of aliphatic diacid, aliphatic
polyamines and substituted alkane
Substituted dianhydride and cyclic amine polymer
Substituted dianhydride, cyclic amine and substituted
amine terminated polymer
Disubstituted naphthoic acid
Vinyl trialkoxy silane
Substituted polystyrene
Cyclododecane, (2-methoxyethoxy)-
Substltuted trlsazo dye, salt
Alkoxy aluminum alkylacetoacetate
Type I anion exchange resin, bicarbonate/carbonate
form
Modified resin
Quaternary polyamlne
Quaternary ammonium chloride of an
oxyalkylated polyamine
Oxyatkyiated phenolic ester
Quaternary ammonium chloride of an
oxyalkylated polyamine
Oxyalkylated tetrol-2-butenedioic acid ester
Propoxylated imidazoline
Polymer of substituted methacryiic acid
and polydlmethylsiloxane
Aromatic oxime
Fatty alcohol, ethoxylated, propoxylated,
fatty acid ester
Dimethy (s((a-17-crown-6
CBI
Do
G
G
Substituted phenyl disulfide
Hydroxyl terminated polyurethane
85-40
85-64
85-65
Do
Do
Do
Do
Do
49 FR 22865
6-1-84
Do
49 FR 23916
6-8-84
49 FR 25676
6-22-84
49 FR 28614
7-13-84
49 FR 28616
7-13-84
49 FR 33721
8-24-84
Do
49 FR 35414
9-7-64
Do
49 FR 37458
9-24-84
Do
Do
Do
Do
Do
49 FR 39370
10-5-84
49 FR 41100
10-19-84
Do
49 FR 41102
10-19-84
Do
49 FR 43105
10-26-84
Do
Do
DO
% S5SS5T.W*""'
0 Sub.muMWto.IK.non. WM„w. A
•Tn.p-ov"* sub——,.
name may be assigned to the compound by EPA when pu
Below are explanations of sections of TSCA that are cited in this
provisions, call (800) 424-9085 or write the TAO.
For Your Information
For Your Information (FYI) submissions are notices received
by the Office of Toxic Substances on chemical toxicity and for
exposure. FYla are submitted by chemical manufacturer*,
processors and distributors, trade associations, labor organi-
sations, Federal, State and local agencies, foreign govern-
ments, academia, public Interest and environmental groups,
as well as the general public. These submissions are provided
to epa on a voluntary basis and not in reaponae to a manda-
tory reporting provision ot TSCA. Microfiche copies of these
submissions are located In the OTS Public Reading Room,
first floor, East Tower, Waterside Mall, 401 M Street, S.W.,
Washington, O.C. To obtain s copy of an FYI, follow the
procedure outlined In section 8(e) Substantial Risk Informs-
t/on on a*m6.
Issue of the Bulletin, For additional Information about TSCA's
Significant New Ua* Rules
Under section 5(a)(2) EPA may determine by rule that certain
uses of chemical substances are significant new uses. .These
rules are referred to as Sign Meant New UseHule»{8HyRt),ln
making me determination, the Agency oo«»W*rtthe potential
exposure associated with the use.andbther relevant factors
such as the toxicity assficlated with the GhemlcaJ, and
whether the use Is ongoing at the tlm# the rt?le is proposed.
Persona subjected to a SNUR must notify EPA st least 90 days
before manufacturing, importing, or processing the chemical
substance Identified in the SNUR for the defined significant
new use or uses.
A SNUR may be issued for any TSGA chemical substance.
SNURs may be written for indivldual ehemfcals, forvhtmleal
categories, and fomew or existing chemicals. Nfymchemlcsl
SNURs may be written In conjunction with section 5(e)
orders.
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Section 8(e).. .Substantial Risk
Under section 8(e) persons who obtain new 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 the Office of Toxic Substances (OTS)
and an initial evaluation is prepared containing, if appro-
priate, followup questions to the submitter, referrals to other
agencies, and recommended OTS/EPA followup actions. The
8(e) notices represent a company's first review of a situation
and a judgment in compliance with the statute to submit a
notice within 15 days of obtaining the information.
EPA publishes its evaluations of 8(e) notices to make this
information widely available and understandable to a broad
public. The submissions and the initial evaluations are located
in the OTS Public Reading Room, first floor, East Tower,
Waterside Mall, 401 M Street, SW, Washington, D.C.
Persons wishing to obtain a copy of section 8(e) notices may
write: EPA, Freedom of Information, Ms. Jeralene Green, (A-
101), Washington, D.C. 20460. There is no charge for duplicat-
ing the first 49 pages, but at page SO of a request for duplica-
tion there is a $10.00 fee and a 20$ charge for each additional
page (e.g., 51 pages cost $10.20).
Single copies of the 8(e) initial evaluation (not the full submis-
sion) are available from the TAO.
Testing ot Chemical Substances
and Mixtures.. .Section 4
Section 4 of TSCA gives EPA authority fo 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 perform a reasoned
risk assessment; and that testing is necessary to generate
such data. A test rule may also be based on an EPA finding of
substantial production and exposure to humans or the envir-
onment, in addition to findings of insufficient data and need
for testing.
Under section 4(e) an Interagency Testing Committee (ITC)
was established to recommend chemicals to EPA for priority
consideration for the promulgation of section 4 test rules. The
ITC can designate up to 50 chemicals or categories of chemi-
cals for testing and must make revisions to this section 4
priority list as needed. In turn, EPA must respond within one
year after the ITC adds a substance to the priority list by
starting rulemaking under section 4 or giving reasons for not
doing so.
The ITC is made up of appointed members from eight Federal
agencies, as specified in TSCA. Representatives from six
additional Federal agencies serve in a liaison capacity.
Manufacturing and Processing Notices
...Sections
Section 5 of TSCA gives EPA authority to quickly review and
control, if necessary, new chemicals and new uses of chemi-
cals to prevent large scale distribution before a substance's
effects on health or the environment are fully determined.
Commencement ot Manufacture Notices
Under section 5(a)(1)(A) a person who intends to introduce
into commerce a chemical substance not on the TSCA inven-
tory must notify EPA at least 90 days before beginning manu-
facture or import.
TSCA Assistance Office (TS-799) °,,ic'al
Office of Pesticide & Toxic Substances or priva,e u"
U.S.E.P.A.
Washington, D.C. 20460
First Class Mall
Postage and Fees Paid
EPA
Parmlt No. G-35
THE TSCA CHEMICALS-IN-PROGRESS
BULLETIN
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