TSCA Section 8(e) Reporting Guide
June 1991
HOTICB TO ADMINISTRATOR OF SUBSTANTIAL RISKS. Any person
who manufactures, [imports,] processes, or. distributes in
commerce a chemical substance or mixture and who obtains
information which reasonably supports the conclusion that
such substance or mixture presents a substantial risk of
injury to health or the environment shall immediately
inform the [EPA] Administrator of such information unless
such person has actual knowledge that the Administrator
has been adequately informed of such information.
— Section t(e), Toxio Substances Control Act (1976)
Office of Toxic substance*
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
Washington, D.C. 20460
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preface
This "reporting guide" has been compiled by EPA's Office of Toxic
Substances (OTS) to assist potential respondents who manufacture,
import, process or distribute chemical substances in complying with
Section 8(6), the substantial risk information reporting provision
of the Toxic Substances Control Act (TSCA) .
There are two major objectives for presenting this guide. First,
the guide will make certain information pertaining to Section 8(e)
reporting even more accessible to members of the the regulated
community and others. Second, the guide will provide reference to
both general and specific examples of submitted information as veil
as EPA's comments regarding such submissions. The examples are
intended to help persons who are subject to Section 8(e) understand
better the types of information that should be submitted to the
Agency under this very important mandatory hazard/risk information
reporting provision of TSCA.
Most of this TSCA Section 8(e) reporting guide is presented in a
basic question and answer format reflecting primarily the most
common questions asked about Section 8(e) of TSCA. In addition,
this reporting guide contains EPA's comments regarding the TSCA
Section 8 (e)-applicability/reportability of a number of toxicologic.
"case studies" provided by the Chemical Manufacturers Association
(CMA) . The guide also contains an index of Section 8(e) "status
reports" reflecting Section 8(e) reporting guidance (Appendix A)
and an index of all status reports prepared to date arranged by
submitted information type (Appendix B) .
EPA recommends that this TSCA Section 8(e) reporting guide be used
as a tool in conjunction with EPA's March 16, 1978, Section 8(e)
policy statement ("Statement of Interpretation and Enforcement
Policy; Notification of Substantial Risk" 43 FR 11110) . EPA's TSCA
Section 8(e) policy statement is included as Appendix C at the back
of this reporting guide. Also included is Appendix 0 which contains
a copy of a February 1, 1991 Federal Register notice that announced
EPA's TSCA Section 8(e) "Compliance Audit Program" (CAP) and copies
of EPA's April 26, 1991 and encoded June 20, 1991 Federal Register
notices announcing certain modifications to the CAP.
This reporting guide is being distributed publicly through the TSCA
Assistance information Service (TSCA Hotline) in the Environmental
Assistance Division (EAD/OTS) . Persons wishing to obtain a copy of
the guide should contact the TSCA Hotline. The telephone numbers,
telefax numbers and/or addresses of the TSCA Hotline, other EPA
Offices, and other organizations cited throughout this guide are
presented for the reader's convenience on the next few pages.
Charles M. Auer, Director
Existing Chemical Assessment Division/OTS
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lot Una
Phone:
(202) 554-1404
Telefax: (202) 554-5603
Address: TSCA Assistance Information Service
Environmental Assistance Division
Office of Toxic Substances (TS-799)
U.S. Environmental Protection Agency
401 "M" street, S.W.
Washington, D.C. 20460
Address: Document Processing Center (TS-790)
(Attn: Section 8(e) Coordinator)
Office of Toxic Substances
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
"Tor Your Information** (VYI) Doeuaent Proeeaaina Center
Address: Document Processing Center (TS-790)
(Attn: FYI Coordinator)
Office of Toxic Substances
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Name: Michel Stewart
Phone: (202) 382-3532
(202) 260-1532 (after 8/24/91)
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T8CA Confidential Business Information (CBI)
Address: Confidential Data Branch
Information Management Division
Office of Toxic Substances
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Phone: (202) 475-7425
(202) 260-0425 (after 8/24/91)
T8CA Section 8(el Coordinator
Name:
David Williams
Phone: (202) 382-3468
(202) 260-3468 (after 8/24/91)
FYI Coordinator
Name:
Jacqueline Favilla
Phone: (202) 475-8823
(202) 260-8823 (after 8/24/91)
Address: OTS Public Docket
Room 6-004, NorthEast Mall
U.S. Environmental Protection Agency
401 "M" Street S.W.
Washington, D.C. 20460
Hours of Operation:
8-12 and 1-4 Monday through Friday
(Closed on Federal Holidays)
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Freedom of Information Office/EPA
Address: Freedom of Information Office (A-101)
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Office of Compliance Monitoring
Address: Office of Compliance Monitoring (EN-342)
U.S. Environmental Protection Agency
401 "M" street, S.W.
Washington, D.C. 20460
Phone: (202) 382-3807
(202) 260-3807 (after 8/24/91)
Office of General Counsel
Address: Pesticides and Toxic Substances Division
Office of General Counsel (LE-132-P)
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Phone: (202) 382-7505
(202) 260-7505 (after 8/24/91)
Office of
Address: Pesticides and Toxics Enforcement Division
Office of Enforcement (LE-134-P)
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
Phone: (202) 475-8690
(202) 260-8690 (after 8/24/91)
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national ttesoonae Center
Toil-Free:
(800) 424-8802
Local:
(202) 426-2675
SPA Regional Office 24-Hour Phogf
Region 1
Region 2
Region 3
Region 4
Region 5
(617) 223-7265
(201) 548-8730
(215) 597-9898
(404) 347-4062
(312) 353-2318
Region 6
Region 7
Region 8
Region 9
(214) 655-2222
(913) 236-3778
(303) 293-1788
(415) 744-2000
Region 10 (206) 442-1263
national Technical Information Service
Address: National Technical Information Service (NTIS)
U.S. Department of Commerce
5285 Port Royal Road
Springfield, Virginia 22161
Phone:
(703) 487-4600
national Library cf Medicine (VIM)
Address: National Library of Medicine
U.S. Department of Health and Human Services
8600 Roclcville Pike
Bethesda, Maryland 20894
Phone:
(301) 496-6193
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InforMtl?H svstw. Inc. (CIS)
Address: Chemical Information Systems, Inc.
7215 York Road
Baltimore, Maryland 21212
Phone: («dO) CIS-USER (Toil-Free)
(301) 321-8440 (Local)
vi
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Contents
Preface i
Important Addresses and Telephone Mumbers ii
Reporting Under Section 8(e) of T8CA 1
What is the Statutory Language of TSCA Section 8(e)? 1
Why is Section 8 (e) Reporting Important? 1
How was EPA's Section 8(e) Policy Statement Developed? .. 1
What is "Substantial Risk" Information? 2
Who is Subject to Section 8 (e) Reporting? 3
What Chemicals are Subject to Section 8(e) Reporting? ... 5
What does the Term "Obtains Information" Mean? 6
What are the Sources Of 8(e)-Reportable Information? .... 7
What Information is Not Reportable Under Section 8(e)? .. 8
How does 8(e) Relate to Section 4, 5 t 8(d) Reporting? .. 10
Does a "For Your Information" Notice Satisfy 8(e)? 10
DOAS Reporting to Another Agency Satisfy 8 (e) ? 11
When Must Section 8(e) Information be Reported to EPA? .. 11
Where Must Section 8(e) Information be Reported? 12
How Must Section 8(e) Information be Reported? 13
How can Confidential Data be Claimed/Sent Under 8(e)? ... 14
How does EPA Track/Identify Section 8(e) Notices? 14
How does OTS Review/Use Section 8(e) Information? 15
Do Status Reports Represent EPA's Bottom-Line on Risk? .. 19
Has EPA Issued Other Section 8(e) Reporting Guidance? ... 20
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Reporting Under Section 8(e) of T8CA (Continued)
How can the Public Obtain Section 8(e) Submissions? 24
Is there a Section 8(e) Enforcement Response Policy? .... 25
Has EPA Taken Formal Section 8(e) Enforcement Actions? .. 27
Does 8(e) Implementation Encourage Pollution Prevention? 27
Case Studies 29
A. Numerical Reporting Guidance for Lethality information .. 29
B. Acute Tests with Non-Lethal Neurobehavioral Findings .... 31
C. Skin/Eye Irritation and Skin Sensitization Tests 34
D. Subchronic Toxicity 36
APPENDIX A
Index of •(•) status Reports Containing Policy/Outdance 39
I. Toxioologieal/Exposura Findings 39
A. Acute Toxicity (animal) 39
B. Acute Toxicity (human) 39
C. Subacute Toxicity (animal) 40
D. Immunotoxicity (animal) 40
E. Neurotoxicity (animal) 40
F. Neurotoxicity (human) 40
G. Oncogenicity (animal) 40
H. Oncogenicity (human) 41
I. Reproductive/Developmental Toxicity (animal) 41
J. Reproductive/Developmental Toxicity (human) 41
K. Genotoxicity (in vitro) 41
L. Genotoxicity (in vivo) 42
viii
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I. Toxicological/Bxposure Finding* (Continued)
M. Aquatic Toxicity/Bioconcentration 42
N. Emergency Incidents of Environmental Contamination . 42
0. General (NonEmergency) Environmental Contamination . 42
II. General Section •(e) Reporting Issues 42
A. Intracorporate Reporting Procedures 42
B. Subject Persons 43
C. Subject Chemicals 43
0. Research 6 Development Chemicals ; 43
E. Drug Export 43
F. Pesticide Export 43
G. Previous Manufacture/Import/Process/Distribution ... 44
H. Obtaining Information 44
I. Pre-1977 Information 44
J. Actual Knowledge by EPA 44
K. Published Scientific Literature 45
L. Information Obtained from Other Federal Agencies ... 45
M. Information Corroborating Wall-Established Effects . 45
N. Relationship to other TSCA Reporting Requirements .. 45
0. Relationship to Other EPA Administered Authorities . 46
P. Relationship to Non-EPA Administered Authorities ... 46
Q. Section 8 (e) Reporting Procedures 47
APPBKDIl B
Index of All Section t(e) Status Reports
Arranged by submitted Information Type 49
ix
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APP8NDI1 C
T8CA Section 8(•) Policy Statement 91
(March 16, 1978; 43 PR 11110)
Technical Amendment citation 98
(May 29, 1987; 52 FR 20083)
APPENDI1 D
T8CA Section 8(e) compliance Audit Program Notice 99
(February l, 1991; 56 FR 4128)
Compliance Audit Program Modificatione 104
(April 26, 1991? 56 FR 19514)
Compliance Audit Program Modifications 107
(encoded version June 20, 1991; 56 FR Part IV)
APPBKDIl •
Support Information for Confidentiality Claims ill
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REPORTING UNDER SECTION 8(E) 07 TSCA
OF T8CA
Section 8(e) of the Toxic Substances Control Act (TSCA) states that
"any person who manufactures [including imports], processes, or
distributes in commerce a chemical substance or mixture and who
obtains information which reasonably supports the conclusion that
such substance or mixture presents a substantial risk of injury to
health or the environment shall immediately inform the [EPA]
Administrator of such information unless such person has actual
knowledge that the Administrator has been adequately informed of
such information.11 [90 Stat. 2029, 15 U.S.C. 2607(e) ]
WHY IS SECTION 8(BJ REPORTING IMPORTANT?
In general, EPA considers Section 8(e) of TSCA to be a critically
important information gathering tool that serves as an "early
warning" mechanism for keeping the Agency and others apprised of
new-found serious chemical hazards and/or exposures; Section 8(e)
data are extremely valuable input for the hazard identification and
risk assessment activities within and outside EPA.
HOW WXfl EPA'fl SECTION 8 (El POLICY STATEMENT DEVELOPED?
The Section 8(e) information reporting requirement took effect on
January 1, 1977, the effective date of TSCA. Although Section 8(e)
contains self-implementing reporting requirements, EPA sought
public comment and input in order to make more informed decisions
regarding implementation of Section 8(e). Following receipt and
consideration of numerous public comments on a September 9, 1977
proposed policy statement, EPA published its March 16, 1978 final
Section 8(e) policy statement ("Statement of Interpretation and
Enforcement Policy; Notification of Substantial Risk" 43 FEDERAL
REGISTER 11110). The 1978 policy statement clarifies the types of
information that are required for submission under Section 8(e),
and describe* the procedures for reporting such information to EPA.
A minor technical amendment to EPA's 1978 TSCA Section 8(e) policy
statement involved a change in the address to which Section 8(e)
notices are to be sent (52 FEDERAL REGISTER 20083; May 29, 1987).
For easy referral when using this reporting guide, the Agency's
Section 8(e) policy statement has been reproduced as Appendix C at
the back of the guide.
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WHAT IS "SOBSTAKT C" INFORMATION?
The term "substantial risk" information refers to that information
which reasonably supports a conclusion that the subject chemical or
mixture presents a substantial risk of injury to health or the
environment ; however, such information need not and most typically
does not establish conclusively that a substantial risk exists.
In deciding whether information is "substantial risk" information,
one must consider 1) the seriousness of the adverse effect, and 2)
the fact or probability of the effect's occurrence. In determining
TSCA Section 8(e)-applicability/reportability, these two criteria
should be weighted differently depending upon the seriousness of
the effect or the extent of the exposure, i.e., the more serious
the effect, the less heavily one should weigh actual or potential
exposure, and vice versa. For example, in cases where serious
effects such as birth defects or cancer (as evidenced by benign
and/or malignant tumors) are observed, the mere fact that the
implicated chemical is in commerce (including chemicals at the
research and development stage) constitutes sufficient evidence of
exposure to submit the new-found toxicity data.
EPA has also received numerous Section 8(e) submissions alerting
the Agency that chemical substances already known to be capable of.
causing serious health and/or environmental effects were detected
in significant amounts in environmental media (e.g., soil, surface
waters, groundwater, air (including workplace air)) or in products
not known previously by the Agency to contain such chemicals. In
such cases, the discovery of previously unknown and significant
human and/or environmental exposure, when combined with knowledge
that the subject chemical is already recognized or suspected as
being capable of causing serious adverse health effects (e.g.,
cancer, birth defects, neurotoxicity) or serious environmental
effects (e.g., non-trivial aquatic species toxicity), can provide
a sufficient basis to report the new-found exposure data to EPA
under Section 8(e) of TSCA.
The decision-making process for Section 8(e)-reportability should
focus primarily on whether the toxicity or exposure information
offers reasonable support for a conclusion of substantial risk
under the criteria described above, but should not focus at all on
whether the information is conclusive regarding the risk. A
•Substantial risk" information must be reported to EPA
unless the subject person has actual knowledge that the Agency
has been adequately informed of such information. A detailed
discussion of the types of information about which EPA considers
itself to be adequately informed is presented on Page 8 of this
reporting guide under WHAT IMTORMATIOM II MOT BgPQRTMLB
flgCTIQM Sfll?
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decision to report information to the Agency under Section 8(e)
should not involve exhaustive health and/or environmental risk
assessments of the subject chemical(s). Further, determining
reasonable support for a conclusion of substantial risk should not
include any evaluation of either the economic or social benefits of
the use(s) of the subject chemical substance(s). Finally, deter-
mining whether reasonable support exists for "substantial risk" is
not synonymous with the determination of an "unreasonable risk" as
that term is used elsewhere in TSCA.
WHO IB SUBJECT TO SECTION 8(8) REPORTING?
For the purposes of Section 8(e), the term "person" includes the
following: any natural person, corporation, firm, company, sole-
proprietorship, joint-venture, partnership, association, or any
other business entity, any State or political subdivision of a
State, any municipality, any interstate body, and any department or
agency of the Federal Government.
Such "persons" are subject to TSCA Section 8(e) only to the extent
they are engaged in commercial activities involving manufacture,
importation, processing or distribution of chemical substances or
mixtures under the jurisdiction of TSCA and therefore covered by
Section 8(e) of TSCA. While it is clear that entities such as
labor unions, trade associations, contract testing laboratories and
agencies of the Federal Government are "persons" covered by TSCA
Section 8(e), the mandatory obligation to report substantial risk
information is incurred only to the extent that the entity is
engaged commercially in manufacturing, importing, processing or
distribution of the chemical substance or mixture about which
substantial risk information is obtained; however, these particular
entities are not typically involved in such commercial activities.
Under Section 8(e), there are no exemptions for small businesses,
small production or importation volumes, or commercial activities
such as manufacture for export only or research and development.
However, Section 8(e) does not require a subject person to submit
information about a chemical substance or mixture that the person
does not manufacture, import, process or distribute commercially.
Further, a person who obtains substantial risk information about a
chemical or mixture that the person did at one time, but does not
any longer, manufacture, import, process or distribute in commerce,
is not required to submit the information under Section 8(e).
Despite these limitations in coverage, EPA has received numerous
Section 8(e) submissions from respondents who obtained otherwise
reportable Section 8(e) information but for some technical reason
did not have any statutory obligation to submit the information to
EPA pursuant to Section 8(e). EPA believes that such submissions
are of significant benefit, in many cases, to others who currently
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handle the subject chemical(s) and who can take actions that are
designed generally or specifically to reduce or eliminate health or
environmental hazards/risks. A formal TSCA Section 8(e) or "For
Your Information11 (FYI) notice under these circumstances is a clear
demonstration of the respondent's stewardship. EPA encourages and
welcomes these technically voluntary submissions either pursuant to
Section 8(e) or on an FYI basis.
In implementing Section 8(e) of TSCA, EPA strives to ensure that
pertinent information is reviewed promptly, and given appropriate
consideration, by subject persons for submission to EPA, while at
the same time minimizing duplicative or ill-considered notices.
The Agency believes these objectives are served best by allowing
commercial establishments to assume the exclusive responsibility to
submit substantial risk information that is obtained by individual
employees and officials. Accordingly, EPA's Section 8(e) policy
statement explains that individual officers/employees are viewed as
having discharged their individual Section 8(e) responsibilities
once they notify a designated supervisor or official in full about
pertinent information, provided that the employing entity has an
established, internally publicized and affirmatively implemented
procedure governing such notices. The Agency's Section 8(e) policy
statement specifies that such procedures, at a minimum, must:
(1) specify the information that must be reported;
(2) indicate how the reports are to b« prepared and submitted
internally;
(3) note the Federal civil and criminal penalties for failure to
report substantial risk information; and
(4) provide a mechanism for the timely notification of officers
and employees who submitted reports about the disposition of
those reports. Such notification should inform the reporting
employee/officer as to whether or not the information was
submitted to EPA, and if not, inform the employee or officer
of their protected right (under Section 23 of TSCA) to report
the information directly to EPA.
The Agency, believes that the above procedures serve to ensure
prompt and appropriate processing and consideration of pertinent
information by persons subject to Section 8(e) of TSCA. It is
important to note, however, that despite the establishment of such
procedures, those employees and officers who are responsible for
actual management of the organizations's Section 8(e) reporting
obligations retain personal civil and/or criminal liability for
ensuring that substantial risk information is submitted to the
Agency. In the absence of such established internal procedures,
all employees and officers retain their individual responsibilities
and liabilities for ensuring that substantial risk information is
reported to EPA.
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Chemical* not under TSCA jurisdiction and therefore not covered by
Section 8(e) are discussed in Section 3 of TSCA and include:
(1) pesticides (as defined in the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA)) when manufactured, processed, or
distributed in commerce for use as a pesticide;
(2) tobacco and tobacco products;
(3) source materials, special nuclear materials and byproducts (as
defined in the 1954 Atomic Energy Act (AEA) and regulations
issued under the AEA);
(4) foods, food additives, drugs, cosmetics, and devices (as
defined in the Federal Food, Drug and Cosmetic Act (FFDCA))
when manufactured, processed or distributed in commerce as a
food, food additive, drug, cosmetic or device.
Except for those chemicals specifically excluded by definition from
TSCA jurisdiction, Section 8(e) of TSCA pertains to all chemical
substances and mixtures including but not limited to the following:
(1) research and development (R&D) chemicals (including those
intended for use as pesticides prior to application for an
Experimental Use Permit (EUP) or a registration under FIFRA);
(2) laboratory reagents;
(3) low volume chemicals;
(4) polymers;
(5) chemicals that are manufactured solely for export;
(6) intermediates (including non-isolated intermediates
as well as pesticide intermediates);
(7) catalysts;
(8) byproducts;
(9) impurities;
(10) TSCA-covered microorganisms and products therefrom.
Specifically with regard to "pesticides," a chemical substance that
is manufactured, processed or distributed in commerce solely as a
pesticide is excluded by Section 3 of TSCA from TSCA regulation.
However, a ohemioal substance vhioh is ia the process of research
and development (R*D) as a pesticide is subject to T8C* u&£il such
time as the manufacturer or importer demonstrates the intent to
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produce a pesticide by submitting to the Agency an application for
an "Experimental use Permit" (10P) or registration under 7ITRA.
For further information about this TSCA/FIFRA jurisdictional issue,
the reader is directed to EPA's initial TSCA Chemical Substance
Inventory reporting regulation (43 PR 64585; December 23, 1977;
Appendix A Comment 37, 38 and 39) and the 1986 amendments to the
TSCA Section 5 "Premanufacture Notification Rule" (51 FR 15098;
April 22, 1986). Prior to the FIFRA EUP or registration stage,
such RfcD materials are chemical substances under the jurisdiction
of TSCA including Section 8(e).
It is important to note also that while some rules promulgated by
EPA under other sections of TSCA, or under other authorities which
are administered by EPA, may exempt certain chemical substances
and/or mixtures or certain types of commercial activities, such
exemptions typically apply only to the rule issued by the Agency
and not to TSCA in general or Section 8(e) of TSCA specifically.
WHAT DOES T** TERM "OBTAINS INFORMATION" MEAN?
Section 8(e) pertains to information that a person possesses or
about which the person knows. The Section 8(e) policy statement.
explains that an establishment obtains information at the time any
officer or employee who is capable of appreciating the significance
of the information obtains that information. "Known" information
includes that information about which a prudent person of similar
training, job function, etc., could be reasonably expected to know.
Although Section 8(e) of TSCA does not compel subject persons to
actively search for reportable information or to undertake extra-
ordinary efforts to retrieve reportable information, negligence or
the intentional avoidance of information does not absolve a person
of his/her individual Section 8(e) reporting obligations. TSCA
Section 8 (e) -reportable information that is "obtained" by a company
includes:
a) information obtained before January 1, 1977
and reviewed after January 1, 1977, but prior
to March 16, 1978 (the publication date of
EPA's TSCA Section 8(e) policy statement);
b) information obtained for the first time after
January 1, 1977 but before March 16, 1978; or
c) information obtained by the company for the
first time after March 16, 1978.
NOTE; For information regarding the specific time frames
for reporting such "obtained" information, the reader's
attention is directed to THEM MOST TSCA SBCTIQM im
IMTOMtXTIOM BB REPORTED TO 1PA? on Page 11 of this guide.
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With regard to a), b) and c) on the preceding page, Section 8(e)-
reportable information includes not only written reports, memoranda
and other such documents examined after January l, 1977, but also
information referred to in formal or informal discussions and con-
ferences in which a company participated after January 1, 1977.
Specifically with regard to a public scientific conference/meeting,
visually or verbally obtained information from such a meeting is
subject to Section 8(e) reporting unless the obtained information
is captured accurately/adequately in a meeting transcript, abstract
or other such written record or document that is to be formally
released to the public within a reasonable time frame. Information
obtained from a private conference or meeting, however, should be
considered for reporting under Section 8(e) within 15 working days.
TSCA Section 8 (e)-reportable information can come from a variety of
sources including, but not limited to draft, interim or final
written reports (including study reports, letters, telegrams, telex
reports) or verbal reports (received at meetings or by phone) that
involve observations (including preliminary observations) from, for.
example, controlled or uncontrolled:
(1) human or animal studies/events (including but not limited to
studies/events that involve high dose levels or non-routine
routes of exposure); or
(2) environmental events/studies (including but not limited to
aquatic toxicity studies, bioaccumulation studies, chemical
monitoring studies (supplemented if need be by information
derived from computer modeling studies based on actual or
reasonably anticipated chemical exposures and exposure-related
parameters)). It is important to note, however, that modeling
studies, including those based solely on theoretical exposure
data (e.g., "worst-case" scenarios), are not considered by EPA
to be sufficient in and of themselves to meet the Section 8(e)
reporting requirements. Further, environmental or health risk
assessments (including those using computer modeling) based on
either 1) theoretical exposure data, or 2) actual exposure
data submitted on a mandatory basis under an EPA-administered
statute typically need no£ be reported under Section 8(e).
The evidence that offers reasonable support for a conclusion of
substantial risk need not be complete nor definitive but should
provide a plausible link between 1) an observed serious effect and
one or few chemicals (e.g., in a discrete process/operation), or 2)
a specific product/activity and a previously unrecognized exposure
to a chemical that is known or reasonably anticipated to cause
serious adverse health or environmental effects.
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EPA'« March 16, 1978 section 8(e) policy statement ("Statement of
Interpretation and Enforcement Policy; Notification of Substantial
Risk" 43 FR 11110) also requires immediate reporting of "Emergency
Incidents of Environmental Contamination" (EIEC). An EIEC is an
environmental contamination (accidental or intentional in nature)
involving a chemical known to be a serious human or environmental
toxicant and which because of the extent, pattern and amount of the
contamination (1) seriously threatens humans with cancer, birth
defects, mutation, death or serious or prolonged incapacitation
(e.g., neurotoxicologic effects, serious reproductive system
effects), or (2) seriously threatens non-human organisms with
large-scale or ecologically significant population destruction.
WHAT INTORMATIOM IB MOT REPORTAJU TOPER SECTION i(B)?
There are several kinds of information about which the Agency
considers itself to be adequately informed already for the purposes
of Section 8(e) of TSCA. For example, information that otherwise
meets the criteria for Section 8(e) reporting need not be submitted
if the information meets one or more of the following criteria:
(l) is contained in an EPA study or report.
(2) is published in the open scientific literature.
(3) has been submitted already to EPA under another mandatory
reporting provision of 1) TSCA, or 2) some other authority
that is administered by EPA.
(4) is contained in a formal publication/report or a formal
statement made available to the general public by another
Federal agency.
(5) is corroborative (in terms of, for example, route of exposure,
dose, species, time to onset, severity, species, strain, etc.)
of a> well-established adverse effect.
It is important to note, however, that information that newly
identifies a serious toxic effect at a lover dose level for
example, or confirms a serious effect that vas previously only
suspected, is net considered by EPA to be corroborative and
should be reported under Section 8(e) of TSCA.
(6) is information for which the EPA Administrator has waived
compliance with TSCA in general or Section 8(e) specifically
upon a request and determination of the President of the
United States that such a waiver is required in the interest
of the national defense; Section 22 of TSCA outlines the
procedures by which such waivers are to be requested/issued.
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With regard to item (2) on the preceding page, EPA believes that
for the purposes of Section 8(e) reporting, a subject person need
not report information that is obtained from well-established/well-
recognized scientific journals, such as those typically abstracted
in a) major computerized abstract data bases, or 2) publications
such as Current Contents published by the Institute for Scientific
Information (ISI), Inc. (Philadelphia, Pennsylvania). Similarly,
information that is obtained from malar U.S. news publications
(e.g., newspapers or news magazines with national circulation) or
nationally broadcast U.S. radio and/or television news reports
typically need not be submitted to EPA under Section 8(e) of TSCA.
However, with regard to information obtained from lesser known
scientific journals, or from other magazines, newspapers, radio or
television reports, a subject person must have actual knowledge
that EPA has been adequately informed about such information.
Specifically with regard to item (3) on the preceding page, it is
clear that information submitted or otherwise formally reported
(within 15 working days of obtaining the information) pursuant to
a mandatory reporting requirement of a statute administered by EPA
need not be submitted duplicatively under Section 8(e) of TSCA.
Part VII(b) of EPA's March 16, 1978 Section 8(e) policy statement
is illustrative in that it provides a list of only a few such EPA-
administered statutes. The following is a more current list of the
statutes administered by EPA.
Toxic Substances Control Act (TSCA)
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
Clean Air Act (CAA)
Clean Water Act (CW&)
Safe Drinking Water Act (1DWA)
Federal Water Pollution Control Act (7WPCA)
Marine Protection, Research and Sanctuaries Act (MFRSA)
Resource Conservation and Recovery Act (RCRA)
RCRA Hazardous and Solid Waste Amendments (HBWA)
Comprehensive Environmental Response,
Compensation and Liability Act (CIRCLA; 1UPBRFUVD)
Superfund Amendments Reauthorization Act (fARA)
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Specifically with regard to item (4) on Page 8, it fiajmojt be
automatically assumed that the Agency has been adequately informed
about information in a report or study by another Federal or other
governmental agency if the report or study has not been formally
published or otherwise released to the general public. Therefore,
if a person obtains (i.e., possesses or knows of), for example,
certain unpublished Section 8(e)-reportable information from a
study that is conducted by or for an agency of the U.S. Government
(other than EPA), that person must consider the need to immediately
submit those findings under Section 8(e). Since 1977, EPA has
received a number of Section 8(e) notices filed by companies who
had obtained unpublished results of studies conducted by or for
other Federal or other governmental agencies. In most cases, such
submissions are limited to 1-2 pages and the Agency immediately
establishes direct contact with the responsible agency to minimize
or eliminate the company's Section 8(e) reporting burden.
HOW DOES tt (El RELATE TO T8CA SECTIONS 4, S i 8(D) REPORTING?
The TSCA Section 8(e) reporting requirement applies to "substantial
risk" information obtained during any study conducted under TSCA
Sections 4 or 5, or any study "listed" under TSCA Section 8(d) as
being underway unless such information is otherwise required to be
reported immediately to EPA under 1) Sections 4, 5 or 8(d) of TSCA,
2) some other section of TSCA, or 3) some other authority that is
administered by EPA. To date, the Agency has received numerous
TSCA Section 8(e) notices concerning the interim results of studies
conducted pursuant to Sections 4 or 5 of TSCA, or listed under
Section 8(d) of TSCA. The Section 8(e) reporting that took place
in these instances typically occurred because the obligation to
report under Section 8(e) was incurred before reporting of the
study findings was required under Sections 4, 5 or 8(d) of TSCA.
If other required reporting occurs before or coincidental with
incurring a Section 8(e) reporting obligation, that information
does nojt need to be reported also under Section 8(e) of TSCA. This
exemption does not change substantially the Section 8(e) reporting
obligation; it is designed merely to avoid duplicative notices
except in cases where timeliness considerations become paramount.
DOES A *fQM TOOK INFORMATION" SOBIII88IOM SATISFY JfEl REQUIREMENTS?
Section 8 (e) -reportable information submitted to EPA on a "For Your
Information11 (FYI) basis does not •atisfy the requirements for the
submission of information under Section 8(e). TSCA Section 8(e)
information must be reported to EPA in full accordance with the
procedures outlined in Part IX of the Agency's March 16, 1978
Section 8(e) policy statement ("Statement of Interpretation and
Enforcement Policy; Notification of Substantial Risk" 43 FR 11110)
10
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and its technical amendment (52 FR 20083). The TSCA Section 8(e)
policy statement/technical amendment appear at the back of this
reporting guide as Appendix C. In addition, the reader's attention
is directed to WHERE MUST SECTION 8(B) INFORMATION BE REPORTED? and
Page 13 of this reporting guide, respectively. Finally, it should
be noted that EPA's Office of Compliance Monitoring (OCM/OPTS) has
issued a number of "Notices of Non-Compliance" to companies that
have submitted TSCA Section 8(e)-reportable information in a timely
manner but simply on an FYI basis and not under Section 8(e). For
further information with regard to EPA's enforcement activities
relating to TSCA Section 8(e), the reader's attention is directed
also to HAS EPA TAKEN FORMAL 8ECTIOM j(El ENFORCEMENT ACTIONS?
which can be found on Page 27 of this reporting guide.
DOBS REPORTING TO ANOTHER AOENCY 8 ATI STY MECTIOM B(E) REQUIREMENTS?
Mandatory or other reporting of information to another agency does
not satisfy a company's obligation to immediately inform EPA under
Section 8(e) of TSCA. EPA's TSCA Section 8(e) policy statement
("Statement of Interpretation and Enforcement Policy; Notification
of Substantial Risk" 43 FR 11110), which appears as Appendix C at
the back of this guide, explains clearly that "substantial risk
information must be reported to IPX." (emphasis added)
WHEN MUST flECTIOM SfEl INFORMATION Bl REPORTED?
A person is considered to have discharged the TSCA Section 8(e)
reporting obligation if the information is received at EPA
Headquarters in writing within 15 working days after the person
obtained the information. Relevant or significant supplemental
data obtained after an initial Section 8(e) submission should also
be reported in writing to EPA immediately (i.e., within 15 working
days). The reader's attention is directed to WHAT poll THE TERM
"OBTAlMfl iCTORMATIpM" MM? found on Page 6 of this reporting
guide.
For an "Emergency Incident of Environmental Contamination" (EIEC),
a telephone call to the appropriate EPA Regional Office must be
placed immediately (i.e., as soon as reasonably possible); these
phone numbers are given in the next section of this guide. A
written follow-up report must also sent to EPA Headquarters within
15 working days of the date on which the telephone report was made.
Specifically with regard to 1) Section 8(e)-reportable information
obtained before January 1, 1977 and reviewed after January 1, 1977,
but prior to March 16, 1978 (the publication date of EPA's TSCA
Section 8(e) policy statement), or 2) Section 8(e)-reportable
11
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information obtained for the first time after January 1, 1977 but
before March 16, 1978, such information should have been submitted
already to EPA on or before the 60th day following March 16, 1978.
TSCA Section 8(e)-reportable information (including pre-1977
information) that is (was) obtained by a company for the first time
following March 16, 1978 should be submitted (or should have been
submitted already) to EPA within 15 worJcing days of the date on
which the information is (was) obtained by the company for the
first time after March 16, 1978.
As explained in a technical amendment (52 FR 20083; May 29, 1987)
to EPA's Section 8(e) policy statement, Section 8(e) submissions
(including written follow-up reports for "Emergency Incidents of
Environmental Contamination" (EIEC)) must be transmitted to EPA at
the following address:
Document Processing Center (TS-790)
(Attn: Section 8(e) Coordinator)
Office of Toxic Substances
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
The initial phone report for an EIEC should be placed immediately
(i.e., as soon as is reasonably possible) to the EPA Regional
Office in whose jurisdiction the EIEC occurred or was discovered;
the current 24-hour phone numbers for EPA's 10 Regional Offices are
as follows.
Region 1
Region 2
Region 3
Region 4
Region 5
(617) 223-7265
(201) 548-8730
(215) 597-9898
(404) 347-4062
(312) 353-2318
Region 6
Region 7
Region 8
Region 9
(214) 655-2222
(913) 236-3778
(303) 293-1788
(415) 744-2000
Region 10 (206) 442-1263
In the event that a respondent cannot reach the EPA Regional Office
in whose jurisdiction the EIEC occurred or was discovered, the
respondent should immediately call the national Response Center at
(•00)-424-8802 or 202-42C-2C75 and provide all known information
12
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requested by the officer on duty. Under these circumstances, the
respondent will be considered to have satisfied the initial phase
of the Section 8(e) reporting obligation; a written "follow-up"
report regarding the EIEC, however, Bust still be submitted to EPA
Headquarters within 15 working days of the EIEC phone report.
Persons wishing to submit data to EPA's Office of Toxic Substances
simply on a "For Your Information" (FYI) basis and not pursuant to
Section 8(e) of TSCA should send the information to:
Document Processing Center (TS-790)
(Attn: FYI Coordinator)
Office of Toxic Substances
U.S. Environmental Protection Agency
401 "M" street, S.W.
Washington, D.C. 20460
Persons submitting information to EPA on an FYI basis should be
aware that the Agency's processing of documents received under
mandatory reporting provisions of TSCA always takes precedence over
those submitted simply as FYI. The reader should also be aware
that the submission of data to the Agency on an FYI basis does not
satisfy a TSCA Section 8(e) reporting obligation. For further
information on this particular subject, the reader's attention is
directed to DOBS a TOE TOUB IMTORMATIOII suBMiaaioM s ATI STY SECTION
a (El REQUIREMENTS? found on Page 10 of this reporting guide.
HOW MUST SECTION KB) INTORMATIOM BB REPORTED?
Section 8(e) submissions must be transmitted to EPA in a manner
that permits the Agency to verify receipt of the submission (e.g.,
certified or registered mail). In addition, the submission must
state clearly that it is being provided under Section 8(e) of TSCA.
Further, the submission must contain the name, title and telephone
number of the person sending the information, the name and address
of the establishment with which the reporting person is affiliated,
the name(s) (including Chemical Abstract Service (CAS) Registry
Number(s), if known) of the subject chemical(s), and a summary
describing the nature of adverse effects or exposure being reported
together with the source of any supporting technical data.
For an "Emergency Incident of Environmental Contamination" (EIEC),
the initial telephone report must provide the time and location of
the incident and as much of the above information as is known at
the time. A written EIEC follow-up report to EPA Headquarters must
contain the same types of information that are required in a non-
EIEC initial Section 8(e) submission.
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HOW CAM CQMTIDEliTIAL DATA BE CLAIMBD/SglTT UNDER SECTIQM 8(B1?
In claiming any submitted information to be "Confidential Business
Information" (CBI) under TSCA, respondents should be aware that all
of the information reported under specific TSCA requirements (e.g.,
Section 8(e)) or in support of TSCA is subject to 1) provisions of
Section 14 of TSCA, and 2) EPA's regulations on confidentiality of
business information (40 CFR Part 2). Any person who submits CBI
to EPA under Section 8(e) should be aware that two copies must be
provided. The first copy should be complete, with all CBI marked
carefully and clearly by boxing, circling or underlining; all of
the pages containing CBI should be stamped "COHTIDBHTIAL". The
other copy should have all of the confidential information excised;
this "sanitized" version is required for EPA's public files. Any
person who submits CBI to EPA under Section 8(e) of TSCA should
also be aware that the Agency does request a detailed written
substantiation for all TSCA CBI claims. (A copy of a two-page
document entitled "Support Information for Confidentiality Claims'*
is included as Appendix E to this reporting guide.) Finally, a
person who submits TSCA CBI to EPA under Section 8(e) should also
be aware that the Agency is under no formal obligation to review,
and typically does not review, company-sanitized documents for
errors made in sanitizing those documents.
HOW DOBS 1PA IDENTIFY/TRACK IHCOMINQ BBCTIOM jfl) MQTICB8?
A Document Control Number is used by EPA to identify TSCA Section
8(e) submissions and takes the following form: 8EHQ-0000-0000.
Starting at the left, the first four symbols identify the informa-
tion as a Section 8(e) submission received by EPA Headquarters; the
next four digits identify the month and year (e.g., -0591-) of the
Agency's receipt of the information; the final four digits identify
the submission's chronological number. In addition to the basic
numerical sequence, additional characters may be added to the right
end of the Document Control Number to convey other information.
These additional characters and their meaning are as follows:
S: indicates that the Section 8(e) notice was sanitized to
delete information claimed by the submitter to be TSCA
Confidential Business Information (TSCA CBI);
P: indicates that the Section 8(e) notice contained a name
or other identification (e.g., a Social Security Number)
of an individual, the release of which may violate the
Privacy Act; such documents are sanitized by EPA to
remove such identifiers;
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*: indicates that based on EPA's preliminary evaluation, the
submission was either considered to be unwarranted for
reporting under Section 8(e) of TSCA or that it was not
clear to EPA that submission was warranted and further
clarifying information was requested from the submitter.
INIT: denotes that the submission is an initial submission;
FLWP: indicates that the submission is a followup response; and
SUPP: indicates that the notice is a supplemental submission.
By definition, follow-up response submissions contain information
submitted directly in response to a specific EPA request, whereas
supplemental submissions are those that contain information not
specifically requested by the Agency.
HOW DOBS OT8 REVIEW/USl BBCTIOM «fE) INFORMATION?
Although EPA's receipt of information under Section 8(e) of TSCA
does not necessarily trigger immediate regulatory action under TSCA
or another authority administered by EPA, the submitted information
is processed and evaluated on a priority basis to determine an
appropriate level of concern and initial course of Agency action.
Thus far, EPA and the chemical industry have devoted significant
efforts in fulfilling their respective responsibilities under
Section 8(e) of TSCA. Since January 1, 1977, over 1250 initial
Section 8(e) notices covering a broad range of toxicity and
exposure-related data on a wide variety of chemicals have been
received by OTS and been given priority evaluation and follow-up
attention.
In general, each initial TSCA Section 8(e) submission is promptly
reviewed and evaluated by OTS scientific staff to determine both
the degree of concern that should be attached to the submitted
information and the initial course of any warranted OTS follow-up
action(s). A "status report" is prepared containing a brief
description of the submitted information, the results of the OTS
preliminary evaluation, a statement regarding production and use of
the subject chemical (s) and recommendations for appropriate follow-
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up actions. Upon approval of the status report, recommended
follow-up actions are initiated. A letter forwarding the status
report and any EPA requests for additional information is sent to
the submitting organization. In addition, copies of all status
reports are transmitted to EPA's public files, other designated EPA
Program Offices and Federal Agencies, and to the OTS Environmental
Assistance Division (EAD/OTS) for further distribution.
Other OTS follow-up actions include the consideration of further,
more in-depth assessment of the reported chemical's hazard or risk.
OTS staff also immediately reviews, evaluates, and initiates
appropriate follow-up actions or activities on information that is
contained in "follow-up" and "supplemental" TSCA Section 8(e)
submissions; over 2000 TSCA Section 8(e) supplemental and follow-up
submissions have been received and promptly evaluated by OTS staff
since January 1, 1977.
OTS utilizes TSCA Section 8(e) submission data for hazard/risk
identification purposes primarily in the initial stages of the OTS
Existing Chemical Program (ECP). OTS also uses these data in
ongoing health and exposure assessments of both existing and new
chemicals and in support of regulation development under TSCA,
e.g., development of chemical testing rules under TSCA Section 4.
EPA's proactive implementation of Section 8(e) of TSCA has resulted
in heightened overall awareness of the risks posed by exposure to
chemical substances and mixtures. Many benefits and impacts are
evident from EPA's dissemination of TSCA Section 8(e) and related
information to other EPA Offices, other Federal agencies, the
general public and the international community. This heightened
awareness has led, in many cases, to specific activities designed
to directly or indirectly protect health and/or the environment.
OTS has established high level scientific and administrative
contacts in each of the major EPA Program Offices and Regional
Offices to provide a mechanism for the timely and prioritized
dissemination of information about newly discovered chemical
hazards or risks. These other EPA Program and Regional Offices
effectively and routinely utilize TSCA Section 8(e) information in
As of October 1, 1990, OTS began to issue "summaries"
rather than "status reports" for incoming initial Section 8(e)
submissions. These summaries contain a detailed accounting of
toxicologic and other information (e.g., voluntary pollution
prevention/risk reduction information, exposure data) presented
in the initial TSCA Section 8(e) submission. The summaries do
not reflect, however, the Agency's evaluation or disposition of
the reported information. Copies of Section 8(e) submission
summaries can be obtained in the same manner used to obtain
copies of Section 8(e) status reports.
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implementing their regulatory programs. The following examples
illustrate just some of the actions/activities initiated by other
EPA Offices in response to Section 8(e) and related data.
offica of water (OW/EPA1
preparing/revising Water Quality Criteria Documents and
Drinking Water Standards.
Otti.au of Solid Wastif ejfl n»«faeacy Response (O8WER/KPA)
determining the need for/revision of listing and
delisting actions under the Resource Conservation and
Recovery Act (RCRA); and
establishing/revising "Reportable Quantities'* (RQs) and
"Threshold Planning Quantities" (TPQs) for the chemicals
that are under the jurisdiction of the Comprehensive
Environmental Response, Compensation, and Liability Act
(CERCLA; "Superfund").
Office of Keseay^fc ipd Development (ORD/EPA)
preparing/revising Health and Environmental Effects
Profiles (HEEPs), Health Effects Assessments (HEAs) and
Acceptable Daily Intakes (ADIs) for use by other EPA
Program Offices; and
determining the need for new EPA research or impact on
ongoing EPA research activities.
Office Qf A.jr Mfl HfdiatioB
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IPX Regional
EPA's 10 Regional Offices routinely receive copies of all
updated indices for OTS holdings of Section 8(e) and FYI
notices. In addition to providing new information about
reported chemical hazards/risks, Regional receipt of this
information has led numerous cases to compliance inspec-
tions under TSCA and other EPA administered authorities.
EPA has also established high level scientific and administrative
contacts in other Federal agencies in order to provide a mechanism
for the timely and prioritized dissemination of new information on
chemical hazards/risks. The following examples illustrate some of
the activities that have been initiated by other Federal agencies
in direct response to TSCA Section 8(e) and related information
supplied to those agencies by EPA.
national Institute for occupational Safety ipfl Btiltti (MI08H)
preparing/revising Current Intelligence Bulletins;
determining the need for workplace investigations leading
to published Health Hazard Evaluations;
recommending to OSHA the need for new workplace standards
or revisions to existing workplace standards;
determining the need for new research or the impact on
ongoing chemical research activities; and
* input of data into the Registry oj[ Toxic Effects af
Chemical Substances (RTECS) publication and on-line
computerized data base.
Occupational lafetv §jfl Health l^JBJftration (Q8HA)
internally reviewing and distributing information to OSHA
Regional/Area Offices and inspectors;
filling data gaps in ongoing OSHA assessments/studies or
determining the need for such assessments/studies; and
determining the need for new OSHA workplace standards or
revising existing workplace standards.
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O7Btum.tr Product Safety commission (CPSC)
determining the need for new CPSC regulatory efforts or
the revision of existing CPSC regulations; and
internal and external information circulation as part of
CPSC's "Current Awareness Activities."
national Library o_f_ Medicine (NLMi
input of toxicologic/exposure information to the NLM's
publicly accessible computerized data bases.
national Toxicology PrTiril (HX£)
evaluating chemicals for toxicologic testing;
monitoring results of non-NTP toxicity studies; and
supplementing results of ongoing NTP studies.
Interagency Testing 79llit^ff (I2£)
determining need for recommending chemicals for TSCA
Section 4 health/environmental effects testing.
DO BTATUB R1PQRTB REPRESENT IPX'8 "BOTTOM LIKE" REGARDING RISK?
When reviewing TSCA Section 8(e) statue reports, the reader should
realize that the purpose of the OTS preliminary evaluation is to
determine the significance of the submitted information in terms of
a need for possible follow-up action by EPA. This determination
involves a critical analysis of the submitted data to assess the
extent that the reported hazard/risk is supported by the provided
information. The scope of this initial evaluation, however, is
generally limited to the submitted documents and to any closely
related information known by and/or readily available to the OTS
staff reviewer. Neither a literature search to identify other
reported effects nor an in-depth analysis of possible sources of
exposure to subject chemicals is part of the initial evaluation
process. Therefore, a status report should be viewed only as a
preliminary evaluation of the submitted information and not as a
comprehensive assessment of the chemical substance or mixture for
which a TSCA Section 8(e) notice has been filed.
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EM EPA ISSUED OT CTION 8(1) OPIDANCK-RBLATgD INFORMATION?
The 1978 Section 8(e) policy statement, as frequently cited and
quoted in 1) publicly available EPA "Question and Answer" (Q&A)
documents on TSCA implementation issues raised at periodic public
and individual meetings with Agency staff and management, and 2)
numerous publicly available Section 8(e) "status reports" that
provide illustrative examples of Section 8 (e) -applicability,
continues to serve as a sound and adequate basis for potential
respondents to determine their mandatory reporting obligations
under Section 8(e) of TSCA. In addition, EPA's publication of
bound volumes of Section 8(e) status reports serves a two-fold
purpose. First, volumes of status reports with indices help to
make the information reported under Section 8(e) more readily
accessible. Second, these Section 8(e) status report volumes, by
providing easy access to specific examples of submitted information
and EPA's preliminary evaluation of the information, help subject
persons to understand better the kinds of information that should
be reported to EPA under Section 8(e) of TSCA. The six (6) bound
Section 8(e) status report volumes published by the Agency to date
can be purchased directly from the National Technical Information
Service (NTIS) . The NTIS publication numbers of, and the TSCA
Section 8(e) submission numbers covered by, these volumes are as
follows:
NTIS Publication N^mb^r Submission
PBI 80-221609 8EHQ-0777-0001 to 8EHQ-0679-02J1
PBI 81-145732 8EHQ-0779-0292 to 8EHQ-0180-0330
PBI 83-187815 8EHQ-0280-0331 to 8EHQ-1282-0467
PBI 87-129409 8EHQ-0183-04M to 8EHQ-1284-0541
x PBI 87-176004 8EHQ-0185-0542 to 8EHQ-1286-Oi4t
PBI 89-182687 8EHQ-0187-OC49 to 8EHQ-1288-077S
It should be noted that a seventh Section 8(e) status report volume
covering initial Section 8(e) submission numbers 8EHQ-0189-077i to
8EHQ-09S9-10i4 should be published by EPA in the summer of 1991;
notice of the availability of this new status report compendium
will be given in the OTS "Cheaicals-in-Progress Bulletin." EPA
plans to print only a limited number of copies of the new status
report volume for distribution by the TSCA Hotline. After that
supply is exhausted, copies of the new compendium can be purchased
from NTIS. The addresses and telephone numbers for NTIS as well as
the TSCA Hotline can be found in the "Preface" to this guide.
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With the exception of certain TSCA Section 8(e) QtAs that were made
available by EPA in July 1989, all of the Agency'* other published
Section 8(e)-related Q&As (1986 and 1987) are embodied in full or
in part in other sections of this reporting guide. For the sake of
completeness, the specific QfcAs from that July 1989 Section 8(e)
Q&A document follow.
Q. Does Section 8(e) of TSCA intend the submission of animal
test information: (a) when a determination of "substantial
risk" has been made, or (b) where merely a finding of positive
animal test results useful in the further assessment of human
risk has been determined?
A. TSCA Section 8(e) requires the timely submission of
evidence (including preliminary evidence) from animal
studies that implicates the tested chemical as causing
serious toxicologic effects (e.g., cancer, neurotoxicity,
birth defects). A decision to report the observance of
such serious toxicological effects should not hinge in
any way on a judgement of either the actual or potential
exposure to the chemical or a judgement about the degree
of relevancy of the findings to an overall assessment of
human risk. In other words, the decision to report under
Section 8(e) in such cases should be based simply on the
observance of the serious toxicologic effects.
Q. What criteria should be used to determine if the results
from cancer bioassay studies in animals should be submitted to
the Agency under Section 8(e) of TSCA? For example, when
should animal studies showing only a significant increase in
benign tumors over controls be submitted?
A. Reporting of benign and/or malignant tumors should
take place, for example, when either statistically or
biologically significant increases over controls are
observed. The observation of such increases are made in
many cases at interim sacrifices performed typically
during long term exposure studies in animals.
Q. How should reproductive or developmental toxicity data be
evaluated for possible Section 8(e) submission if maternal
toxieity is also present?
A. Statistically or biologically significant increases
in teratogenic effects or other serious embryotoxic or
fetotoxic effects (e.g., significant embryo or fetal
lethality, spontaneous abortion) should be reported under
Section 8(e) regardless of the level of maternal toxioity
observed in the study.
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Q. What are the criteria that should be used to determine
which reproductive/developmental effects observed in animal
tests are reportable under Section 8(e)? For example, should
reversible developmental effects, such as reduced birth weight
and/or incomplete ossification, trigger TSCA Section 8(e)
reporting?
A. In addition to teratogenic effects, serious adverse
developmental effects (e.g., significant embryo or fetal
lethality, significantly reduced fetal/birth weights,
significantly retarded/incomplete skeletal ossification)
should be reported. In addition, serious adverse effects
on the male/female reproductive system (e.g., significant
testicular or ovarian atrophy, significantly reduced fer-
tility, sterility) should be reported under Section 8(e) .
Q. What criteria should be used in determining if results of
acute toxicity studies constitute information that reasonably
supports a conclusion of substantial risk?
A. Criteria used to determine Section 8(e) reporting in
the case of acute/subacute toxicity findings will depend
on the nature of the effects observed and the dose at
which the effects occurred. For example, information
that shows a tested chemical to be extremely toxic (e.g.,
causes lethality at very low doses) by, for example,
inhalation, dermal application or oral administration
should be reported. On the other hand, the reporting of
information showing a chemical to be moderately toxic
will depend on the degree of actual or potential exposure
to the tested chemical. Information showing a chemical
to be slightly or minimally toxic on an acute/subacute
basis is not considered typically to be reportable. In
addition to extreme toxicity, certain other serious
toxicologic effects (e.g., neurotoxicity, adverse repro-
ductive system effects) seen in an acute or subacute
animal study should be reported under Section 8(e).
Q. When evaluating subchronic animal studies, what criteria
should be used to determine reportability of adverse effects?
For example, should increased or decreased organ(s) size in
the absence of histopathological changes be reported to EPA
under Section 8(«) of TSCA?
A. Serious toxic effects (e.g., neurotoxic effects,
serious reproductive system effects) observed during the
conduct of subchronic studies should be reported. This
includes readily observable serious effects or serious
effects seen on: as the result of gross and/or histo-
pathological exa. lation. As is the case for acute and
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subacute toxicity studies, the degree of the observed
toxicity is important. The more serious (or significant)
the observed effect, the less heavily one should consider
actual/potential exposure for Section 8(e) reporting and
vice versa.
Q. What criteria constitute evidence of reportable neuro-
toxicity in animal studies? For example, are reversible
effects such as narcosis or effects observed in the presence
of marked systemic toxicity considered reportable?
A. Typically, neurotoxic effects seen in dying animals
are not, in and of themselves, considered by EPA to be
reportable under Section 8(e). in many cases, however,
already reportable data regarding extremely or highly
toxic (lethal) substances will be accompanied by infor-
mation concerning observed neurotoxic effects. In short
or long term exposure studies in which serious neurotoxic
signs and symptoms (e.g., convulsions, sleep induction,
motor dysfunction, narcosis, behavioral dysfunction) are
seen in non-moribund animals, however, specific reporting
of the neurotoxic effects should occur.
Q. What criteria should be applied in determining whether
positive results of in vivo or in vitro mutagenicity assays
trigger Section 8(e) reporting?
A. Serious in vivo genotoxicological effects (e.g.,
gene or chromosomal mutations) are reportable in and of
themselves under Section 8(e). On the other hand, a
positive in vitro genotoxicity test, when considered
alone, is usually insufficient to cause reporting under
Section 8(e). However, EPA believes that such information
is of value in assessing the possible risk(s) posed by
exposure to the tested chemical or mixture. Further, the
Agency believes that a positive in vitro genotoxicity
test result, in combination with other information (e.g.,
knowledge of actual/potential exposure to and/or high
production of the tested chemical), would suggest the
need, in many cases, to conduct further studies designed
to determine the toxicity of or the exposure to that
chemical. EPA expects the results of such additional
studies to be considered also for 8(e) submission.
Any person wishing to obtain full copies of the 1986 and 1987 Q&A
documents (which also contain numerous Q&As related to rules that
have been promulgated by EPA under other sections of TSCA) should
contact the TSCA Hotline at the address or the telephone/telefax
numbers listed in the "Preface1* to this reporting guide.
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HOW CAM TH» PUBLIC QpTAIN SECTION tit) BUBMIflfllONS?
Non-confidential versions of TSCA Section 8(e) initial, followup
response and supplemental submissions, status reports, submission
summaries, and EPA followup letters can be viewed/copied in the OTS
Public Docket. Copies of non-confidential Section 8(e) documents
can also be obtained by writing to EPA's Freedom of Information
Office. The addresses of the OTS Public Docket and the Freedom of
Information Office are given in the "Preface" to this guide.
Information on each new initial Section 8(e) and FYI submission
(i.e., submission number, name of the subject chemical (s), and
nature of the information received) is presented in index form in
the OTS NChemicals-In-Progress Bulletin1* published periodically by
the Environmental Assistance Division (EAD/OTS) and sent by the
TSCA Assistance Information Service (TSCA Hotline) to over 9,000
individuals in industry, environmental groups, labor, academia and
Federal, State, and Local Governments. Persons who wish to receive
the "Bulletin" should contact the TSCA Hotline via the addresses or
phone/telefax numbers in the "Preface" to this guide.
As explained in more detail in HAS IPX ISSUED OTHER SECTION
REIATED GUIDANCE? on Page 20 of this reporting guide, volumes of
TSCA Section 8(e) status reports have been published by OTS on a
biannual basis; six volumes have been published to date and contain
status reports covering the first 778 initial TSCA Section 8(e)
submissions) and a seventh volume is scheduled to be published by
OTS during the summer of 1991. Persons interested in obtaining
copies of these TSCA Section 8(e) status report volumes should
contact the TSCA Hotline or the National Technical Information
Service (NTIS) at the addresses and phone numbers given in the
"Preface" to this reporting guide.
Data from TSCA Section 8(e) and FYI submissions are entered into
TSCATS (Toxic Substances Control Act Test Submissions) , a publicly
available computerized data base that serves as an on-line index of
unpublished health and safety studies submitted to EPA under or in
conjunction with TSCA. The submitted studies themselves are stored
on microfiche. Persons who wish to obtain access to the on-line
TSCATS should contact either the National Library of Medicine (NLM)
located in Rockville, Maryland, or Chemical Information Systems,
Inc. (CIS) located in Baltimore, Maryland. Microfiche copies of
the submitted studies cited in TSCATS can be obtained from either
CIS or the National Technical Information Service (NTIS) located in
Springfield, Virginia. The addresses/telephone numbers for NLM,
CIS and NTIS are presented in the "Preface" to this reporting
guide.
In order to assure that the public sector is kept apprised about
new adverse health effects and exposure information, OTS actively
disseminates TSCA Section 8(e) and FYI submission information to
many individuals and organizations in the following ways.
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all non-confidential TSCA Section 8(e) and FYI notices,
status reports, summaries and follow-up letters are
placed in public files located at EPA Headquarters.
Yoluaes of Section 8(e) status reports are published by
OTS on a biannual basis; six volumes have been published
to date and contain status reports covering the first 778
initial TSCA Section 8(e) submissions); a seventh volume
is scheduled to be published by the Agency during the
summer of 1991.
in response to numerous "freedom of Information Act"
(FOIA) requests that are received by OTS and that mention
a chemical that is the subject of a TSCA Section 8(e) or
FYI submission, OTS staff provides appropriate citations
for, and in some cases full copies of, all such relevant
documents;
American Conference of Governmental Industrial Hygienists
(ACGIH) publishes on occasion complete copies of selected
Section 8(e) "Status Reports'* in the ACGIH scientific
journal, Applied Industrial Hygiene.
The international community is routinely notified by EPA about the
availability of TSCA Section 8(e) and FYI submissions via the OTS
"Chemicals-In-Progress Bulletin." Approximately 1000 persons in
international organizations, foreign governments, agencies and
companies are on the mailing list. The "Bulletin" is also used to
routinely solicit unpublished chemical toxicity/exposure data from
the international community. Under the established "Freedom of
Information Act" (FOIA) procedures as well as the Organization for
Economic Cooperation and Development (OECD) information-gathering
"Switchboard" project, OTS responds to numerous international
requests for unpublished health and safety data on chemicals of
concern to OECD members.
18 TH^RB A S1CTIOM 1(Bl 1NTORCBMBNT BB8POMSB POLICY?
On Kay 15, 1987, EPA's Office of Compliance Monitoring (OCM) issued
a final •Enforcement Response Policy" (ERP) covering Section 8(e)
as well as the record-keeping and reporting rules issued by EPA
under Sections 8, 12 and 13 of TSCA. This ERP describes various
enforcement alternatives (including notices of non-compliance,
civil penalties, criminal action and injunctive relief) available
to the Agency in enforcing these TSCA record-keeping/reporting
provisions. Copies of the TSCA Sections 8, 12 and 13 ERP can be
obtained from OCM or the TSCA Hotline; the addresses and/or phone
numbers for these EPA offices are presented in the "PRIFAC1" to
this reporting guide.
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On Friday, February 1, 1991, EPA announced in the Federal Register
(56 FR 4128), a one-time voluntary TSCA Section 8(e) "Compliance
Audit Program" (CAP). The Section 8(e) CAP, which incorporates
stipulated monetary penalties and an overall monetary penalty
ceiling, is designed primarily to 1) achieve the Agency's goal of
obtaining any outstanding Section 8(e) information, and 2) provide
maximum encouragement to companies to voluntarily audit their files
for Section 8(e)-reportable information.
Modifications made to the section 8(e) CAP were announced by EPA in
the Federal Register on Friday, April 26, 1991 (56 FR 19514). The
major modifications were 1) an extension of the CAP registration
and termination dates, 2) addition of an opportunity to petition
EPA for a case-by-case extension of the CAP termination date, 3)
modification of the CAP "Agreement" provision involving admission
of a Section 8(e) violation, and 4) an announcement of the Agency's
plans to prepare and disseminate this TSCA Section 8(e) reporting
guide.
Additional modifications to the Section 8(e) CAP were announced in
the Federal Register on Thursday, June 20, 1991 (56 FR Part IV).
The additional modifications announced by EPA were l) an extension
of the Section 8(e) CAP registration deadline, 2) announcement of
the availability of this Section 8(e) reporting guide, 3) addition
to the CAP of a "listing" provision and reduced stipulated penalty
for certain types of Section 8(e)-reportable information now in
EPA's possession as the result of either i) formal submission under
a mandatory reporting provision of TSCA or other EPA-administered
statute, or ii) submission to EPA and filing within EPA's Office of
Toxic Substances formal "For Your Information" (FYI) submission
filing system, and 4) suspension of Parts V(b) (l) and V(c) of EPA's
TSCA Section 8(e) policy statement for purposes of judging the
reportability of information concerning "widespread and previously
unsuspected distribution in environmental media* and "emergency
incidents of environmental contamination" under the Section 8(e)
CAP.
With regard to Parts V(b)(1) and V(c) of the Section 8(e) policy
statement, the June 20, 1991 Federal Register announcement also
informed the regulated community that until such time as the Agency
determines with greater specificity what types of environmental
release, environmental detection and environmental contamination
information should be submitted under Section 8(e) of TSCA, the
statutory language of Section 8(e) was to be utilized to determine
reportability of such information for purposes of the Section 8(e)
CAP as veil as ongoing compliance with Section 8(e).
For the reader's ease, complete copies of EPA's Federal Register
announcements of the Section 8(e) CAP and the CAP modifications are
presented in chronological order in Appendix 0 at the back of this
reporting guide.
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ACTIONS?
Since 1977, EPA has initiated a number of formal enforcement
actions relating to Section 8(e) of TSCA. In almost all cases,
EPA's actions have dealt with the late reporting of animal study
findings that offer reasonable support for the conclusion that the
tested chemical substance(s) presents a substantial risk of injury
to health. Persons interested in reviewing the filings pertaining
to specific Section 8(e) enforcement-related actions should contact
either the Office of Compliance Monitoring (OCM) or the Office of
Enforcement (OE) at the addresses in the "Preface" to this guide.
DOBS EPA'B 8(E1 IMPfrBMJlTATIOM BNCOURAQ1 POLLUTION PREVENTION?
EPA's longstanding proactive implementation of Section 8(e) of TSCA
has resulted in heightened overall chemical industry awareness of
risks posed by exposure to chemical substances and mixtures. This
heightened awareness has led, in many cases, to specific voluntary
pollution prevention/risk reduction activities designed to directly
or indirectly protect health and the environment. It can be argued.
that EPA's Section 8(e) implementation encourages these voluntary
actions to occur earlier than they might occur otherwise. The
following discussion describes some of these voluntary actions.
The chemical industry's increased awareness of the potential
hazards/risks posed by chemical substances is evidenced in part by
the voluntary reporting of over 800 initial "For Your Information"
(FYI) submissions containing valuable toxicity and exposure data.
In direct response to OTS followup efforts, many chemical companies
have established review committees responsible for evaluating
chemical toxicity and exposure information to consider the need to
report to EPA (e.g., under Section 8(e) of TSCA) or to initiate
actions designed to minimize or eliminate chemical exposure. Many
companies have also established information distribution networks
to facilitate the flow of health/safety data to workers, customers
and other producers. Many companies have reported that in direct
response to new chemical toxicity or exposure data reported under
Section 8(e) or on an FYI basis, the following types of health
and/or environmental protection measures have been initiated on a
voluntary basis:
Notification
formal notification of workers, customers, others
changes made to product labels and/or Material Safety
Data Sheets (MSDSs) to ensure proper and safe handling
27
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Further study
additional studies performed in order to determine better
the toxicity of and/or the exposure to chemicals
Pollution Prevention/Exposure Reduction
engineering changes made in manufacturing and processing
facilities to reduce/eliminate chemical exposure
chemical manufacture or use halted temporarily or
discontinued altogether.
*****
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T8CA SECTION 8 (11-MPQRTXBILITY Of TOIICOLOQie CASE STUDIES
Case Study
"An acute oral (gavage) LD50 study was conducted on a commercial
chemical. Following administration of the test material, rats were
observed for 14 days for clinical signs of toxicity. At the end of
this observation period, all surviving rats were sacrificed and
examined for gross pathological changes. Rats found dead were also
subjected to gross pathological examination. The oral LD50 was
calculated to be 40 mg/kg. Nonspecific clinical signs were initi-
ally observed in all treated rats; all signs had receded by Day 14
in those animals which survived. Gross pathology revealed nothing
unexpected."
The case study did not contain any other relevant information for
EPA to consider in judging the Section 8(e)-reportability of this
acute oral toxicity study of a commercial chemical substance. Also
at issue for this particular case study is the perceived need to
have 1) numerical guidance for reporting lethality seen in acute
and other types of animal toxicity studies, and 2) reaffirmation of
EPA1s policy on whether and how exposure should be considered by
companies in evaluating acute lethality data for reporting.
EPA Discussion
The Agency believes that the following general "rules-of-thumb"
should be used in determining the Section 8(e)-reportability of
significant lethality observed in any animal study (including
acute, sub-acute and other types of studies such as teratology
studies) of a TSCA-covered chemical substance (including a research
and development [R&D] chemical):
o Significant lethality which is observed at a dose or
concentration comparable to an acute oral LD50 value of
<5 mg/kg, an acute dermal LD50 value of <20 mg/kg, or an
acute (generally 4-hour) inhalation LC50 value of <50 ppm
(or <0.5 mg/1) should be recognized immediately as being
29
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indicative of "extreme" toxicity and should be considered
for immediate reporting to EPA under Section 8(e) of TSCA
without any consideration of actual or potential exposure
or other factors.
o significant lethality observed at a dose or concentration
comparable to an acute oral LD50 value in the range of >5
mg/kg to <50 mg/kg, an acute dermal L050 value in the
range of >20 mg/kg to <200 mg/kg, or an acute (generally
4-hour) inhalation LC50 value in the range of >50 ppm (or
>.0.5 mg/1) to <200 ppm (or <2 mg/1) should be recognized
as indicating "high" toxicity and should be considered
for immediate reporting under Section 8(e) if there is
actual or reasonably anticipated exposure to the subject
chemical substance.
o Significant lethality observed at doses greater than
those cited previously (i.e., doses indicating "moderate"
toxicity) should be considered for reporting to EPA under
Section 8(e) based on the company's review of additional
information (including but not limited to information
about actual or potential exposure to the tested chemical
substance or mixture).
Specifically regarding findings of "high" toxicity, EPA expects a
company to be especially prudent and to err on the side of caution
for reporting (i.e., there is a clear bias toward reporting). EPA
also believes that the greater the toxicity, the less heavily one
should weigh the actual or potential exposure to (or other factors
involving) the tested chemical. Further, if the tested chemical is
a "commercial11 substance (e.g., not one that is exclusively RfcD),
there must be a strong presumption of actual or potential exposure
for reporting toxicity data in this range. On the other hand, many
exclusively R&D chemical substances with toxicities in the "high"
range, would not typically be reported under Section 8(e) of TSCA.
It should be noted also that any consideration of exposure and
additional information in cases involving the "high" toxicity range
should be accomplished expeditiously and should not be exhaustive
nor equated in any way with the need to conduct a full scale risk
assessment for the tested chemical(s).
The preface to Part V of the Agency's March 16, 1978 Section 8(e)
policy statement provides further guidance regarding the types of
additional factors to consider in determining the need to report
information under Section 8(e) of TSCA. For the reader's ease in
use, the specific lethality values/ranges discussed herein are
presented in Table 1 at the top of the next page.
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Table 1 Factors to Consider in Determining Reportability
of Lethality Information Under TSCA Section 8(e)
LD50
Oral
Dose
<5 Bg/kg
>5 mg/kg
to
<50 mg/kg
>50 mg/kg
LD50
Dermal
Dose
<20 mg/kg
>20 mg/kg
to
<200 mg/kg
>200 mg/kg
4 -Hour LC50
Inhalation
Dose
<50 ppm (<.5 mg/1)
>50 ppm (>.5 mg/1)
to to
<200 ppm (<2 mg/1)
>200 ppm (>2 mg/1)
Consider
Exposure/Other
Factors?
No
^EXTREMELY TOXIC1
Only to Some
Reasonable Degree
( HIGHLY TOXIC 1
Yes
(MODERATELY TOXICS
EPA Conclusion
Based on the preceding discussion and EPA's review of this acute
animal lethality study, the oral LD50 value of 40 mg/kg indicates
that the tested chemical substance is "highly" toxic (i.e., an oral
LD50 of less than 50 mg/kg but greater than 5 mg/kg). Considering
that the tested chemical is "commercial,* and in the absence of any
relevant exposure-related information to the contrary, EPA makes
the prudent assumption that there is or there reasonably could be
exposure to the tested chemical. Therefore, EPA believes that
these acute lethality findings shoving the chemical to be highly
toxic should be reported immediately under Section 8(e) of TSCA.
*OTICTTY ¥9898 WITH HOtf-LSTK&L IRITItOBlKXVTORXZ. FINDINGS
Case Study
"An oral LD50 study is conducted in which animals [(rats)] are
administered 50, 200, 500, 1000, or 2000 mg/kg of a test material.
Shortly after dosing, intermittent lethargy, ataxia and convulsions
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are observed in the 1000 and 2000 mg/kg groups. Salivation, ataxia
and lethargy are observed in animals in the 200 and 500 mg/kg
groups. No effects are observed in the 50 mg/kg dose group. All
rats died at the 2000 mg/kg dose level. The lover dose animals
survived to necropsy."
The case study did not contain any other relevant information for
EPA to consider in judging the Section 8(e)-reportability of the
findings from this acute oral toxicity study. Also at issue for
this study is the need for EPA to verify that statistically or
biologically significant Nfrank" neurotoxicologic effects seen in
acute or other animal studies should be reported immediately.
EPA Discussion
In reviewing these results of this acute oral toxicity study, EPA
made the following assumptions about the study conduct/findings:
1. the study had a 14-day post-dosing observation period;
2. no animals in the 50, 200, 500 or 1000 mg/kg dose groups
were found moribund during the 14-day observation period;
3. "shortly" means a time period of less than a day;
4. "intermittent" means on a number of occasions throughout
the observation period;
5. the terms "convulsions" and "ataxia" accurately reflect
the observations made during the study; and
6. a significant (biologically or statistically) number of
rats in the study were affected.
Given the above assumptions, EPA believes that the findings from
this acute oral toxicity study can be meaningfully interpreted.
Shortly after dosing and at some unknown time prior to death, the
animals in the 2000 mg/kg group exhibited intermittent lethargy,
ataxia and convulsions; all of the animals in the 2000 mg/kg dose
group died at some unknown point after dosing. Although interpre-
tation of the findings for the 2000 mg/kg dose group animals would
depend upon whether the adverse effects were observed in moribund
or non-moribund animals, by considering the information provided
for the lower dose groups, it is possible to determine that the
tested chemical substance caused distinct neurotoxicologic effects.
Based on EPA's assumption that no animals in the 1000 mg/kg dose
were found moribund during the study, the observations that a
significant number of animals at this dose exhibited intermittent
lethargy, convulsions and ataxia, show that the tested chemical
caused serious neurotoxicologic effects. Furthermore, although the
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animals in the 200 and 500 mg/kg dose groups did not exhibit
convulsions, the animals in both of these groups exhibited a
combination of signs indicating a neurotoxicologic effect (i.e.,
salivation, lethargy and ataxia.) Considering that the oral LD50
of the test material is somewhere between 1000 and 2000 mg/kg, the
finding of distinct neurotoxic effects at doses that are perhaps
between 10% and 25% of the lethal dose further heightens concern
for the tested chemical substance.
In general, the Agency would agree that it may not be possible to
distinguish or attribute neurobehavioral effects or neurological
signs in moribund animals to a direct neurotoxic action of the
tested chemical substance. However, statistically or biologically
significant neurotoxic effects observed in non-moribund animals
(including animals in groups receiving doses equal to or greater
than lethal doses) in any type of study q^qpfrt be dismissed simply
as reflecting a "system overload" and should be considered for
immediate reporting to the Agency under Section 8(e) of TSCA.
Further, EPA believes that good product stewardship dictates that
studies designed to more specifically assess neurotoxic effects
should be considered for any chemical found to produce possible
neurotoxic effects during an acute or other general toxicity test.
EPA Conclusion
Based on the preceding discussion and EPA1* review of this acute
oral toxicity case study, the distinguishable neurotoxicological
effects caused by the subject chemical should be reported under
Section 8(e). The reportability of the findings would simply be
enhanced if the tested chemical was already on the market.
To provide a sense of scale for the Section 8(e)-reportability of
neurotoxic/neurobehavioral findings from acute and other types of
animal toxicity studies (e.g., 28-day studies, teratology studies),
the Agency is most interested in receiving reports that involve
"serious or prolonged effects." In general, the acute toxicity
L050 values/ranges listed in Table l (found on Page 31 of this
reporting guide) should be consulted first and an appropriate level
of consideration should be given to exposure and/or other factors
in determining reportability based solely on lethality in acute or
other types of animal toxicity studies. In those cases involving
biologically or statistically significant evidence of serious
neurotoxicological effects (e.g., paralysis, convulsions, ataxia),
virtually no consideration of exposure or other factors should be
given in determining the TSCA Section 8(e)-reportability of such
serious toxic effects. As neurotoxicologic observations become
more limited or as confidence in the accuracy of such observations
becomes more uncertain, the Section 8(e)-reportability of such
findings diminishes. In some studies, for example, it may not be
possible to determine with any degree of precision if observations
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such as ataxia accurately characterize the study findings or the
testing laboratory simply recorded ataxia as indicating a state
other than normal. In the above case study, however, the observed
convulsions and ataxia were judged by the Agency as being serious
neurotoxic effects and the other effects (lethargy and salivation)
were viewed as providing additional evidence of neurotoxicity. In
the absence of other more serious effects, however, observations of
lethargy and/or salivation, in and of themselves, would not be
viewed typically as providing reasonable support for a conclusion
of substantial risk. Similarly, the Section 8(e)-reportability of
effects such as convulsions or ataxia would be diminished if such
effects 1) were seen only in moribund animals or in only one or a
few isolated cases in non-moribund animals, or 2) were found simply
to be transient rather than either intermittent or continuous in
nature.
C. SKIM/KYB IMITATION AND SKIM 8EN8ITI2ATIQM TESTS
Note
For the following case study involving three tests on a "moderately
acidic" chemical, it was reported that the tests were "performed
during the development phase of a new product for primary use as an
industrial intermediate, with some consumer use probable." It was
also reported that the "present production quantities are therefore
quite small, but [are] expected to increase." Also at issue for
this particular case study is the need for EPA to 1) reaffirm its
position that results from acute skin or eye irritation tests do
not routinely warrant submission under Section 8(e) of TSCA, 2)
discuss the reportability of skin sensitization study findings, and
3) reaffirm that lethality caused at doses indicative of extreme
toxicity or serious or prolonged adverse effects in organs/systems
away from the site of exposure may indeed warrant the immediate
reporting of such findings.
Skin Irritation Test
"A skin irritation assay is conducted on rabbit skin (In vivo*• A
series of ten applications are applied to the skin of the abdomen.
After three applications, the skin is described as having moderate
degrees of hyperemia, edema and necrosis. At the end of the 14 day
observation period, the skin reaction is still present, and now
includes scab and scar formation. Gross pathological examination
reveals no systemic toxicity but does confirm the topical corrosive
lesion at the site of application."
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Eye Irritation
"An eye irritation study is conducted in the rabbit eye. Instilla-
tion of 0.1 ml into the washed and unwashed eye elicits immediate
pain and irritation of the conjunctiva, cornea, and iris after days
1, 2, and 9. The animal appears to not to be able to see through
the treated eye and is sent to necropsy on day 9 because of the
advanced state of inflammation in the treated eye."
Skin Sensitization Test
"A guinea pig [dermal] sensitization assay is performed. The test
material is applied to the clipped integument of 10 guinea pigs
during the induction phase. This is followed by a rest period of
10 days. A challenge application is applied to a previously
untreated skin site. The skin response is evaluated at 25 and 48
hours after application. Eight of the 10 animals are considered to
have been sensitized by the test material based on the presence of
erythema at the challenge site."
EPA Discussion
As stated in EPA's March 16, 1978 Section 8(e) policy statement, as
well as numerous Section 8(e) "status reports," the Section 8(e)-
reportability of irritation and/or corrosivity findings from acute
animal eye or skin irritation studies is quite limited. This should
not be interpreted to mean, however, that EPA is not concerned in
general about the irritation/corrosion findings from such studies.
Further, previously unknown or unexpected effects that occur and
are observed/determined during such routine tests may have to be
submitted under Section 8(e) if the effects are serious and meet
the reporting criteria outlined in Part V of EPA's Section 8(e)
policy statement (e.g., lethality, neurotoxicity). Therefore, when
evaluating the results of skin and eye irritation studies, EPA
expects a company to consider such factors as lethal dose, pH of
the test material, the route(s) of administration, occurrence of
unexpected serious effects (which can be determined via "cage-side"
observation or during necropsy), and the extent and pattern of the
actual or potential exposure to the tested chemical or mixture.
When evaluating such information for possible TSCA Section 8(e)
reporting, the greater the acute toxicity, the less heavily one
should weigh the actual or potential exposure to the test materials
and vice versa.
With regard to sensitization studies, it must be noted that
sensitization is a systemic reaction that is manifested in many
cases locally (i.e., directly at the site of re-exposure) but may
be manifested also away from the site of exposure. Further, the
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nature of the reaction can vary from slight to severe and can, in
some cases, result in death, in reviewing results of sensitization
studies for submission under Section 8(e), EPA expects companies to
evaluate a variety of factors including, but not limited to, the
severity of the response, the site(s) of the response, the number
of animals affected, and/or the actual or potential exposure to the
tested chemical substance(s). In general, the more severe the
observed sensitization response(s) and the greater the number of
animals affected, the less heavily one should weigh the actual or
potential exposure to the tested chemical(s) and vice versa.
EPA Conclusion
Based on an evaluation of the eye and skin irritation studies and
the skin sensitization study, and considering the above discussion,
it is the Agency's opinion that, based on the provided information
on current exposure, the results of these studies do not appear to
be reportable now under Section 8(e) of TSCA. The findings may be
reportable, however, at some future date under Section 8(e); this
would depend upon an evaluation of new information reflecting a
significant change in the magnitude/type of exposure and/or the
consideration of other factors such as those previously cited.
D. 8OBCHRONIC TOXICITY
Case Study
"A subchronic dermal repeated dose study in rats was conducted at
doses of 0, 100, 300, and 1000 mg/kg. The tested material is
extensively used in consumer products and exposure to the chemical
is exclusively dermal. A statistically significant 25% increase in
liver weight was observed at the high dose. A statistically sig-
nificant incidence of clear signs of liver pathology typical of
cirrhosis was observed at the mid and high doses. The NOAEL [(No-
Observable-Adverse-Effect-Level)] was determined to be 100 mg/kg.
No other effects were observed."
As background, it was reported that acute and range-finding data on
the tested chemical indicate "it is relatively nontoxic" and the
high dose, which was chosen for the subchronic dermal study, was
the OECD ([Organization for European Cooperation and Development)]
recommended limit of 1 g/kg. Also at issue for this case study is
the need for EPA to reaffirm its position that organ weight changes
in the absence of concurrent pathology may not routinely reflect
serious or prolonged incapacitation and that other factors (e.g.,
histopathologic findings, dose, or actual/expected exposure, etc.)
36
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may need to be considered in deciding whether to report such organ
weight changes. There is also a need to discuss and reaffirm EPA's
position that a statistically or biologically significant histo-
pathologic finding indicating a serious or prolonged incapacitation
should be immediately reported with little if any consideration of
factors such as exposure.
EPA Discussion
Although an organ weight change, in an of itself, may not reflect
a serious or prolonged incapacitation, the reportability of such
a finding could depend upon an evaluation of one or more factors,
such as, but not limited to, the overall magnitude of the organ
weight change, the biological significance of the change, blood
chemistry, dose, route of administration, actual or expected
exposure, etc. However, the more significant the magnitude of the
organ weight change (e.g., severe atrophy of the testes, thymus,
kidneys), much less consideration should be given to such factors
in determining reportability of the findings, on the other hand,
a statistically or biologically significant histopathologic finding
indicating a serious or prolonged incapacitation should be reported
with little if any consideration given to factors such as exposure.
When the histopathologic findings are of a less serious or less
significant nature, other relevant factors (e.g., actual/expected
exposure, dose, etc.) should be considered in determining the TSCA
Section 8(e)-reportability of the study results.
The subchronic dermal application case study results clearly show
a statistically significant, dose-dependent, relatively rare, and
serious toxic effect (cirrhosis) in the liver, accompanied by a 25%
increase in liver weight in the high dose animals.
EPA Conclusion
\
Based on an evaluation of the provided toxicologic findings, and
considering the above discussion, it is EPA's position that the
results of the subchronic dermal application study are reportable
pursuant to Section 8(e) of TSCA. The facts that 1) the tested
chemical is a commercial substance, and 2) consumers are dermalIv
exposed to the chemical, simply enhance the reportability of the
observed serious toxic effects in the liver.
*****
37
-------
38
-------
APPENDIX A
This index is divided into the following two (2) major areas:
"TOlICOLOQICAL/KPQflOM FIMDIMGS" and "GENERAL ISSUES." In using
this particular index, please note that the numbers in the column
on the right represent the last four (4) digits of the chronologi-
cal Section 8(e) submission file number displayed on all status
reports; the ascending numerical sequence, therefore, is also
chronological. Please note that due to the fact that the majority
of the first 200 Section 8(e) notices were submitted by a single
company and EPA had asked that company for additional information
about the Section 8(e)-applicability of the provided findings, the
Agency has chosen to not include in this index any status reports
pertaining to those first 200 notices.
I. TOIICOLOQICAL/EIPOSPRE FIMDIMQ8
A. ACUTE T01ICITY (AMIKALI
0259
0282
0380
0408
0428
0429
0430
0431
0432
0433
0436
0456
0487
0531
0540
0638
0665
0669
0985
1059
TOTTCTTY
39
0258
0315
0344
0493
0502
-------
XCUTE TQI^CITY (HUMAN) [COM'TI
0508
0612
0622
0632
0694
0885
0905
0929
C. flUBACUTS TOXICITY (AKIMAL1
0325
0653
D. IMMUKOTOXICITY fAMIMXLl
0585
«. MEUROT01ICITY (ANIMAL 1
Q. QMCOQ11IICITY (AMIMXL)
0369
0706
0815
0867
1041
1043
1065
0641
1041
1065
0234
0401
0503
0509
0583
0600
0619
0681
0763
0847
40
-------
H. OMCQQBHICITY
0641
0211
0213
0572
0626
0653
0764
0807
0820
0835
0842
0872
0999
1042
1043
0551
K. QENOTOIICITY flM VITRO1
0213
0214
0383
0396
MOTE: Almost all of the TSCA Section 8(e) status reports
pertaining to ip vitro genotoxicity test findings contain
the following language:
"Although a positive in vitro genotoxicity test result,
when considered alone, may not be sufficient to offer
reasonable support for a conclusion of substantial risk
(•• that ten is defined in EPA's Section 8(e) policy
statement ("Statement of Interpretation and Enforcement
Policy; Notification of Substantial Risk" 43 FR 11110;
March 16, 1978)), EPA does believe that such information
is of value in assessing the possible risk(s) posed by
exposure to the tested chemical or mixture. Further, the
Agency believes that a positive genotoxicity test result,
in combination with other important information (e.g.,
knowledge of the actual/ potential exposure to and/or
high production of the tested chemical or mixture),
41
-------
suggests the need, in many cases, to conduct further
studies that are designed to determine the toxicity of
and/or exposure to that chemical substance or mixture.
EPA expects the results of such additional studies to be
considered also for submission pursuant to Section 8(e)
of TSCA."
QENOTOIICITY (TM 7170)
0208
0213
AQUATIC TOIICITY/BIOCONCBNTRATIOM
0209
0249
0899
0994
EMERGENCY INCIDENTS OF BNVIROMMgMTXL CONTAMINATION
0255
0260
0277
0466
0566
0769
QENERAL/ltON-EMERaENCY IN7IRONMENTAL CONTAMINATION
0209
0720
0358
0672
0681
0698
0701
0705
0835
42
-------
1QBJ1CT
C. SUBJECT
DRDO
0543
0546
0551
0577
0587
0642
0689
0818
0823
0824
0846
D. MESKARCH ft DEVEIiQPMKIIT CEBMTCATiff
0325
0543
0545
0546
0551
0583
0587
0698
0701
0705
0706
0763
0818
0823
0824
0835
0545
0583
0763
0815
0824
0835
0818
T. PE8TICID1 1IPORT
43
0823
-------
PREVIOUS MlKTTTAgTm>»/TMT>r>PT/PRQCgfla/DISTRIBUTIOM
0698
0701
0705
0847
H. OBTAINING INFORMATION
I. PRE-1877 INFORMATION
BY IPX
0315
0325
0358
0503
0543
0546
0572
0587
0619
0626
0653
0681
0698
0701
0704
0705
0713
0847
1041
1043
1065
0213
0369
0847
1041
1043
1065
0467
0509
0600
0641
0672
0689
44
-------
J. ACTUAL PIQWTjpqi BY BPA
0704
0706
0712
0713
0718
0720
0807
0809
0835
0847
0383
0588
0600
0641
0672
L. INTORMATIOM OBTAINED FROM OT^R FBPBPAL AGENCIES
0467
0689
0704
M. IMTORMATIOM CORROBORATIKfl WBLL-BSTABLIBHBP BWBCT8
0509
0706
0807
0835
M. MLATIOMMIP TO OT**> T8CA KKPORTIHQ FBOOIRBMEHT8
0493
0600
0612
0622
0632
0667
0675
0694
0706
0718
45
-------
P8 (CON'T)
0720
0769
0797
0800
0813
0817
0824
0846
0856
0876
0884
0900
0905
0929
O. RELATIONSHIP TO OTHER BPX ADMINISTERED AUTHORITIES
0466
0485
0494
0502
0508
0542
0566
0583
0600
0706
0712
0718
0720
0726
0769
0797
0800
0813
0815
0818
0823
0824
0835
1034
P. MLATIQMBHIP TO AUTHORITIES HOT XDMIMIflTERgD BY IPX
0551
0706
1043
46
-------
Q, 8BCTIOM «f«l MPQRTIHO
0234
0324
0330
0369
0400
0543
0546
0566
0587
0626
0653
0681
0698
0701
0705
0855
* * * * *
47
-------
48
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
-P-
V£>
ACUTE TOXICITY (ANIMAL)
SUBMISSION I: 8EHQ-0977
BEHQ-1178-
BEH9-0278-
8EHQ-927B-
8EHQ-0278-
8EHQ-0378-
8EH9-0378-
BEHQ-0478-
8EHQ-0578-
8EHQ-057B-
8EHQ-0578-
8EHQ-0578-
8EHQ-0578-
8EH4-0678*
BEHQ-0678-
8EH4-0678-
8EHQ-0678
8EHQ-0678-
8EH4-0678-
8EHQ-0678-
8EH9-0778
8EHQ-8778
BEHQ-0778
8EHQ-1178
8EHQ-0179
0004
0039 P
• 050
•065
• •72
• 088
• •92
• 131
0143
0152
0155
0162 S
0169 S
0175
0178
0193
0196
0199
0204
0207
• 217
0224
0227
0259
0271
K
M
M
N
M
N
N
N
N
N
M
N
N
M
N
M
M
N
M
M
BEHQ-0977-0005
8EH9-0178-0041
8EHQ-0278-0062
8EH9-0278-0066
BEH9-0278-0074
8EH9-037B-0090
BEHQ-0378-0094
8EM9-0478-0134
8EH9-0576-0144
8EH9-0578-0153 S
8EH9-0578-0158 S
8EHQ-057B-0163
8EH9-0678-0172
8EH9-0678-0176
8EH9-0678-0184
8EHQ-067B-0194
BEH9-0678-0197
8EH9-0678-0200
BEH9-0678-0205
8EH9-0778-0209
8EHQ-077B-0220
8EH9-0778-0225
8EH9-0778-0229
8EHQ-1178-0261
8EHQ-0179-0273
N
N
N
K
N
N
N
M
M
N
N
N
N
N
N
N
M
M
N
8EHQ-0377-0035
8EHQ-0278-0042
8EHQ-0278-0064
8IZHQ-0278-0070
8IZHQ-0378-0087 M
8I:HQ-0378-0091 N
8l:HQ-037a-0103 M
8EHQ-0478-0137 M
8I:HQ-0578'01SI
8nHQ-057B-015«
8EHQ-0778-0222 *
8EH9-0778-0226 *
8EHQ-1178-0256
8EHQ-1278-0263 M
BIIHQ-0279-0274
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
VJl
o
ACUTE TOXICITY (ANIMAL)
SUBMISSION •: BEH9-0479
8EH9-0579
8EH9-M79
8EHQ-I68I-
8EH9-09B*
8EH9-118*
8EH9-0281
8EH9-0581
8EH9-1881
8EH9-0282-
8EH9-0282-
8EH9-0282-
8EH9-0382-
8EH9-0982-
8EH9-1182-
8EH9-0483-
8EH9-0683-
8EH9-0783-
8EHQ-1083-
8EH9-1083-
8EH«-0«84-
8EHQ-0984-
8EHQ-1084-
8EHQ-048S-
8EHQ-0685-
0278
0284
0311
• 347
• 362
• 372
• 382
•40«
•417
• 428 N
0431 *
0435
0438 S
0456 S *
0462
•476 S
•482
•487 S M
• 494 N
• 497
0513
0530
0535
0549 S
0559
8EH9-0479-0279
8EH9-0779-0293
8EH9-0380-0335 S
BEH9-0680-0349
8EH9-0980-0365
8EH9-0181-0380 *
8EH9-0381-0392
8EH9~0881'-0408 S *
8EH9-1081-0418
8EH9-0282-0429 N
8EH9-0282-0432 «
8EH9-0282-0436 M
8EH9-0382-0440 S
8EH9-1082-0459
8EH9-0183-0468
8EH9-0583-0478 S
8EH9-0783-0485 S M
8EH9-08B3-0490
8EH9-1083-0495
8EH9-1283-0501
8EH9-0584-0519
8EH9-0984-0531 S N
8EH9-12B4-0540 S »
8EH9-0485-0550
8EH9-0785-056.3
8EH9-0479-0282 5
8EH9-0779-0296
8EH9-0480-0340
8EH9-0980-0359
8EH9-0780-0369
8EH9-01B1-0381
8EH9-05B1-0396
8EH9-0981-0409
8EH9-0282-0427 S
8EH9-0282-0430
8EH9-02B2-0433
8EH9-0282-0437
8EH9-0682-0448 S
BEH9-10B2-0460
8EN9-0283-0471 S
8EH9-0583-0479 S
8EH9-0783-0486
8EH9-0983-0492 S
8EH9-1083-0496
8EH9-04B4-0510
8EH9-0884-0528
BEH9-1084-0532
8EHQ-0485-05
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
ACUTE TOXICITY (ANIMAL)
SUBMISSION I: 8EHQ-0985
8EH9-1185
8EH4-12S5
8EH4-OU6-
8EHQ-0486-
8EH9-0786
8EH9-B886
8EH4-1086-
8EHQ-I186
8EHQ-0287
8EMQ-0387-
BEHQ-0387
8EHQ-0487
8EHQ-0487-
8EH9-9587
8EH9-1087
8EH9-1287
8EH9-0388
8EHQ-0688
8EHQ-098B
8EHQ-1088
8EH4-0189
8EHQ-03B9
8EHQ-0789
8EHQ-0889
-0568 S
-0573
-1579 5
-•58*
-1596
-•«•? S
-•621
-1638 N
-1*44
-0653
-•656
-0660
-0665 S *
-0669 x
-•678
-•696
-07«7 S
-0723
-0740 S
-•753 S
-0762
-0779
-I 788 S
-0806 S
-0810 S
8EHQ-1085-0569
8EHQ-1185-0575
8EHQ-I285-05BO
8EH9-0186-0585 S
8EHQ-0486-0597
8EHQ-0786-0609 S
8EHQ-0986-0631 S
8EHQ-10S6-0639 S
8EHQ-11B6-0647
8EHQ-0287-0654
8EHQ-0287-0657 S
8EHQ-0487-0661 S
8EH9-0487-0666 S
SEHQ-04B7-0670 S
8EHQ-0687-06BO
8EHQ-12B7-0700
8EHQ-01B8-0714
8EHQ-0588-0732
8EHQ-0788-0742 x
8EHQ-0988-0754
8EHQ-1188-0768 S
8EH4-0389-0780
8EHQ-0589-0800
6EMQ-0789-0808 S
8EHQ-0889-0818 S
8EHQ-1085-0571 S
8EHQ-1285-0578
8EHQ-1285-058I
8EHQ-0386-0589 S
BEHQ-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
VJ>
ro
ACUTE TOXICITY (ANIMAL)
SUBMISSION I: 8EHQ-0989
8EH9-1089
8EH9-1189
8EHQ-120.9
8EH9-1289
8EH9-0290
8EH9-0490
8EH9-0490
8EH9-0590-
8EH9-0690-
8EH9-0690-
8EH9-0790-
8EH9-0890-
8EH9-0890-
8EH9-0990-
8EH9-0990-
8EH9-0990-
ACUTE TOXICITY (HUMAN)
SUBMISSION I: 8EH9-0178-0036
8EHQ-017B-0040
8EH9-0278-0067
8EH9-0278-0077 P
8EH9-0278-0080 P
8EH9-0378-0097
•0826 S
0834 S
•0841
0850
•0859
•893
• 920 S
• 958 S
0985 *
1004 S
1016 S
1031 S
1040
1048 S
1057
1060 S
1068
0036 N
0040 P
0067 P K
8EH9-1089-0830
8EH9-1089-0837 S
8EH9-1189-0845
8EH9-1289-0852 S
8EH9-0190-0860 S
8EH9-0390-0898
8EH9-0490-0954 S
8EH9-0490-0959 S
8EH9-0590-0991 S
8EH9-0690-1005 S
8EH9-0790-1021
8EH9-0790-1035
8EH9-0890-1045
8EH9-0890-1052 S
8EH9-0990-1058 S
8EH9-0990-1061
8EH9-0990-1076 S
8EH9-0178-0038
8EH9-0278-0052 P
8EH9-0278-0075 P *
8EH9-1089-0833 S
8EH9-1089-0838 S
8EH9-1189-0848 S
8EH9-1289-0857 S
8EH9-0190-0867
8EH9-0490-0919 S
8EHQ-0490-0957 S
8EH9-0590-0964
8EH9-0690-1003
8EH9-0690-1009
8EH9-0790-1023 S
8EHQ-0790-1036 5
8EH9-0890-1047
8EH9-0890-1054 S
8EH9-0990-1059 S
8EH9-0990-1062
8EH9-0990-1084
8EH9-0178-0039 P
8EHQ-0278-0063
8EH9-0278-0076 P
M
N
M
M
K
8EH9-0278-0078 P «
BEHQ-0278-0081 P *
8EH9-0378-0105
8EHQ-0278-0079 P
8EHQ-0378-0086
8EHQ-0478-0118 P
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
VJl
ACUTE TOXICITY (HUMAN)
SUBMISSION It 8EH9-0478-0138 P
8EH4-B578-0145
8EH«-i37«-«154 P
8EH4-li7ft-il81
8EH9-«778-t2l7
8EH9-1178-8260
8EH9-1079-0315
8EHQ-0280-0333
6EH9-0680-0344 P
8EH9-0981-0409
8EH9-0783-0486
8EH9-03B4-0508 P
8EH9-1084-0532
8EH9-0985-0566
8EH9-t98*-M32
8EH9-1287-0700
8EHQ-0889-0818 S
8EH9-0390-0905 S
8EHQ-089I-1042
N
N
N
N
N
N
N
M
8EH9-0578-0141 M
8EH9-0578-0146
8EH9-0578-0165
8EH9-0678-0182 P M
8EH9-097B-0238 N
8EH9-0179-0273
8EH9-1279-0322 *
8EH9-0480-0338
8EHQ-0880-0355
8EH9-1182-0466 N
8EH9-0983-0493 S *
8EH9-0484-0513
8EH9-1084-0535
8EH9-0186-0585 S
8EHQ-M87-0666 S
8EH9-06B8-0736
8EH9-1089-0832
BEH9-0190-0929 S M
8EH9-0990-1071
8EH9-0578-0142
8EHQ-0578-0149
8EH9-0678-0180
8EH9-0678-0184
BEH9-1178-0258
8EH9-0879-030^
8EH9-0180-0324
8EH9-0580-0341
8L:HQ-0881-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
VJl
-P-
ALLERGENICITY (ANIMAL)
SUBMISSION I. 8EHQ-0683
8EHQ-1083
BEH4-12B5
8EH4-04B6
8EHQ-0287-
8EH9-0787-
8EH9-12B7-
BEHQ-0588-
8EHQ-1188-
BEHQ-0489-
8EH9-0989-
SEH9-1289-
8EHQ-0490-
8EHQ-0990-
ALLERGENICITY (HUMAN)
SUBMISSION I: 8EHQ-1I77-0017 PS
0482
0495
0580
0597
0657 S
0686 S
0711
0733
0768 S
0795
0826 S
0852 S
0919 S
1069
0017 PS M
0040 P
0165
0184 *
0280
0427 S
0550
0612
0728
8EHQ-0783-0486
BEHQ-1084-0532
8EHQ-0186-0585 S
8EH9-1186-0647
8EH9-04B7-0661 S
8EH9-OB87-0690
8EHQ-0188-0712 «
8EHQ-0688-0739
8EHQ-1288-0777
8EHQ-0589-0796
8EHQ-1189-0839
8EH4-0290-0876
8EHQ-0790-1033
8EHQ-0990-1082
8EHQ-1177-0018 PS x
8EH4-0278-0081 P M
8EH9-0678-0181 N
8EHQ-0678-0185 N
8EH9-0779-0292
8EHQ-0283-0471 S
8EHQ-0186-0585 S
8EHQ-0886-0622 S
8EHQ-0290-0885
BEHQ-0883-0490
8EHQ-0485-0550
8EHQ-0386-0589 S
8EHQ-0287-0653
8EHQ-0687-0680
8EHQ-1287-0700
8EH9-0388-0721
8EHQ-0688-0740 S
8EHQ-12B8-0778
8EHQ-06B9-0802
8EHQ-1189-0845
8EHQ-0290-0894
8EH4-0990-1062
8EHQ-0178-0031 P
8EHQ-0578-0164
8EHQ-0678-0182 P
8EHQ-0279-0274
8EHQ-0880-0355
8EHQ-108<»-0532
8EHQ-0386-0589 S
8EHQ-0987-069'*
8EHQ-0590-0991 S
-------
ALLERGENJCITY (HUMAN)
SUBMISSION I: 8EHQ-OS90-1039 3
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
CELL TRANSFORMATION (IN VITRO)/
SUBMISSION I: 8EHQ-1277-0022
8EHQ-0378-M98
8EHQ-0578-tMl
8EHQ-0179-9268 S
8EHQ-0579-8286
8EHQ-0579-0289
8EH4-0280-0334
8EHQ-0681-0404
8EHQ-1081-0418
8EH9-0883-M90
8EHQ-1083-0498
8EH4-i584-t516 S
8EH4-0685-0558 S
8EHQ-0786-0413
8EHQ-0986-0630
8EHQ-0690-1018
8EHQ-0278-0071
M 8EH9-0378-0100 *
* 8EH9-0578-0164
8EH9-0*79-0278
8EH9-057.9-0287
8EM9-0679-0291
8EH9-0281-0385
8EH9-0981-0412
8EH9-0982-0455
8EH9-1083-0495
8EH9-0484-0511
8EH9-1184-0536
8EH9-0785-0561 S
8EH9-0886-0620
8EH9-0687-0679
8EH9-0378-0094
8EH9-0478-0132
8EH9-0578-0166
8EH9-0479-0279
8EH9-057-9-0288
8IEH9-0779-029«
8EH9-1280-0401 S
8EH9-1081-0'tl5
8EH9-0583-0477 S
8EH9-1083-0496
8EH9-0<»8't-0512
8EN9-1184-0537
8EH9-0786-0610
8EH9-0886-0621
8EH9-0889-OB14
CHEMICAL/PHYSICAL PROPERTIES
SUBMISSION •: 8EH9-0178-0034
8EHQ-0879-0301
8EHQ-0480-03
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
VJI
CD
SUBMISSION •< 8EHQ-0483-0476 5
CIA5TOGENICITY (IN VITRO)
SUBMISSION I: •EH4-V579-I287
8EH«-It02-M&0
8EH4-I3S4-I5I6 S
8EHQ-B584-0515 S
8EHQ-0784-I522
8EHQ-0685-I558 S
8EH«-058t-ttl2 S
8EHQ-0886-I621
BEHQ-1186-1647
BEHQ-0787-1686 S
8EHQ-lt88-0758 S
8EH«-8789-«805 S
8EHQ-0890-1051 S
8EHQ-0779-0294
8EH9-0683-0481
8EHQ-1083-0509
8EHQ-0584-0516 S
BEHQ-1084-0533 S
8EHQ-1285-0580
BEHQ-0786-0608 S
8EHQ-0986-0630
8EHQ-0687-0679
8EH9-0987-0693
8EHQ-0389-0780
8EHQ-0889-0814
8EHQ-0990-1079 S
8EHQ-10B2-0459
8EHQ-1283-0500
8EH9-0484-0510
8EHQ-0584-0518
8EH4-1284-0539
8EHQ-0386-0595
8EHQ-0786-0610
8EHQ-1186~06'i6
8EHQ-0787-0685
8EHQ-0288-0715
8EHQ-0389-0791
BEHQ-1189 08^7
S
S
S
S
DMA ADDUCT (IN VITRO)
SUBMISSION I: 8EH9-0386-I592
DMA DAMAGE/REPAIR
SUBMISSION •: 8EHQ-047B-0132
8EH«-B678-f206
BEHO-0579-«285
8EHQ-0583-0477 S
8EHQ-03B4-0506 S
K
N
8EHQ-0578-OU5
8EHQ-9778-0213
8EHQ-0579-0288
8EHQ-0683-0481
8EHQ-1083-0509
8EIIQ-1 184-0536
8EHQ-0678-0191
8EHQ-0778-0221
8EHQ-0679-029I
8EHQ-1283-0503
AEHQ-O'tB'i-OSll
0537
-------
DNA DAMAGE/REPAIR
SUBMISSION I: 8EHQ-07B5-0561 S
8EH«-M87-«679
8EH9-1289-9853 S
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
BEHQ-0586-0602 S
8EHQ-1186-0646 S
8EHQ-0787-0685
8EH4-0688-0737
8EHQ-0890-1051 S
8EHQ-0786-0613
8EHO-0187-06
-------
APPENDIX (D)t STATUS REPORTS BY INFORMATION TYPE
EMERGENCY INCIDENT OF ENV. CONTAMINATION
SUBMISSION 8: 8EHQ-8378-B08* *
BEHt-8978-8248
BEH9.-0379-8277
BEHQ-1 179-83 19
8EH9-8588-8343
8EH9-1182-0444 N
BEH9-B784-8417
BEH9-B49B-S933
ENV. OCCURRENCE/RELEASE/FATE
g SUBMISSION 8: 8EHQ-1077-8888
8EH9-B178-8B3S
8EH9-0278-8B5*
8EH9-0378-8893 *
BEH9-0478-8129
8EH4-8578-0148
8EH«-8478-8AB4 «
8EHQ-0778-8289
8EH4-1878-8245
8EH«-1178-8254
BEHQ-8179-8244
8EHQ-B879-»300 N
BEH9-0188-8330
6EHQ-0880-0358 M
8EHQ-0881-0407
8EHQ-0678-0183
8EHQ-1878-0255 «
8EHQ-8779-0299 «
8EHQ-1279-0322 ••
BEHQ-8181-0378
8EHQ-8985-0564
8EHQ-1 188-0769 M
8EH9-8790-1832
BEHQ-1177-0013
8EHQ-827B-0043
8EHQ-837B-08B5
8EHQ-8378-8099
8EH9-8578-0144
8EH9-8678-0179 M
8EH9-8678-8189 P
BEHQ-0878-0237
8EH9-1078-0249
8EH9-1178-0260 N
8EH9-8379-0277
8EH9-8979-0310
8EH9-0580-0343
8EMQ-1080-0368
BEH9-09B1-0409
8EHQ-0878-0237
8EH9-1178-0260
8EH9-OB79-0300
8EH9-1279-0329
8EH9-08B1-0407
8EH9-0386-0593
8EH9-0490-0921 S
8EH9-0178-0037
8EH9-0278-0045
8EH9-0378-0089
8EH9-0378-OUO
8EH9-0578-01
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
ENV. OCCURRENCE/RELEASE/FATE
SUBMISSION I: 8EH9-1081-0414
BEH9-1182-t*64
8EH9-B384-0508 P
8EH9-8384-I593
8EH9-8287-8453
8EH9-»4B8-«735
BEH9-1188-8749
8EH9-8298-8882
8EH9-8B9B-1B38
EPIDEMIOLOGY/CLINICAL
SUBMISSION I: 8EHQ-1177-8I14
BEH9-B378-8B94
8EM9-M78-B123
8EH9-I578-8144
8EH9-t578-B16B
BEH9-828B-B332
8EHQ-1080-I347
8EH9-8381-I3M
8EHQ-0282-0427 S
8EHQ-S383-0473
8EH9-02B5-0546
8EHQ-0585-OS57
8EHQ-0982-0457
X 8EHQ-0983-0491 S
M 8EH9-8784-0521 S
8EHQ-M84-0597
8EH9-0487-0442
8EHQ-1988-0759
»» 8EHQ-8589-8799
8EHQ-0390-0905 S M
8EHQ-8490-8953
8EHQ-0990-1077
8EHQ-1277-0021
M 8EHQ-8378-0105
8EHQ-8478-0128
8EHQ-8578-B149
8EHQ-867B-0192 S
8EHQ-8978-0244
8EHQ-8580-0341
8EHQ-1180-037* S
6EH9-0381-0394 S
8EH9-0382-044B S
8EH9-1083-0497
8EH9-0
-------
APPENDIX (0): STATUS REPORTS BY INFORMATION TYPE
o\
EPIDEMIOLOGY/CLINICAL
SUBMISSION I: BEHQ-0286
8EH«-«3t4
8EHQ-B786
BEHQ-0984
8EHQ-M87
8EH9-1187
BEHQ-0288
BEHQ-1188
8EH4-1I89
8EHQ-019*
8EHQ-039B
8EHQ-Q49*
BEH«-«89«
8EHQ-I99I
• 588 a
• 611
•615
•634
•471
•498
• 722
• 772
•831
•864
• 915
•929 S M
1«53
1*72
8EHQ-0386-0589 S
8EH4-0786-0611
8EH4-0986-0629
8EH4-1086-0641
8EH9-0887-0688
8EHQ-1287-0699
8EHQ-C6B8-0736
8EHQ-B889-0818 S
8EHQ-1089-0832
8EHQ-B290-0886
8EHQ-0490-0917
8EHQ-A590-0991 S
8EHQ-I999-1065
BEHQ-0990-1078
BEHQ-0486-0598
8EHQ-0786-0612
8EHQ-0986-0612
8EHQ-0187-065I
8EHQ-09B7-0694
8EHQ-1287-0701
BEHQ-1088-0755
8EHQ-0989-OB21 S
8EHQ-0190-0863
8EHQ-0 390-0905 S
8EHQ-0-«953
BEHQ-0990-U77
HUMAN EXPOSURE (ACCIDENTAL)
SUBMISSION •: 8EHQ-1077-I008
8EHQ-0278-I067 P
8EHQ-0278-0077 P
M
N
8EHQ-I678-0189 P
BEHQ-B6BO-0345
BEHQ-B487-0662
8EHQ-1077-OI11
8EH9-027B-0075 P
8EINJ-0278-007B P
8EHQ-0979-0310
8EHQ-I060-0368
8EHQ-10B8-0759
8EHQ-0178 0038
8EHQ 0278-0076 P
8EHQ-0278-0079 P
-------
APPENDIX (0)> STATUS REPORTS BY INFORMATION TYPE
HUMAN EXPOSURE (ACCIDENTAL)
SUBMISSION It 8EH9-0278-BB80 P
8EH4-B578-0146
BEM«-8t78-ei80
8EH9-*97B-«240
8EH9-8J7t-8277
8EH9-1279-I322
8EH9-Q588-B341
8EH9-I981-8413
8EH9-«384-05«B P
8EH9-0786-8617
8EH9-1BB9-BB32
8EH9-0490-8929 S
8EH9-8990-m5
8EH9-
BEH9-
8EH9-
8EH9-
8EH9-
8EH9-
8EH9-
8EH9-
8EH9-
8EH9-
BEH9-
8EH9-
0378
0578
0778-
1178-
0879
0180
• 580
1081-
0484-
0487-
0290
0490
0086
0149
0217
(>26«
0304
0324
0343
0416
0513
0671
0885
0933
8EH9-0478-0118 P
BEH9-057B-0154 P
8EH9-0978-0238
BEH9-0179-0273
8EH9-1079-0315
8EH9-0480-0338
8EH9-0381-0390
8EH9-0985-0566
8EH9-06B8-0736
8EHQ-0390-0905 5
8EH9-0490-0962
HUMAN EXPOSURE CHONITORINO
SUBMISSION •: BEHQ-1277-8021
8EH9-0378-I11*
8EH9-B478-B115
8EHQ-0578-I168
8EH«-0678-fI89 P
8EH9-B778-B213
8EH4-I278-I264
8EH«-0779-t292
8EHQ-1179-0320
BEHQ-0280-0331 S
8EHQ-0378-0096 N
8EHQ-0378-0112 *
8EHQ-B578-0146
8EHQ-0578-0170
8EHO-0678-0298
8EH9-0778-0219 *
8EH9-0179-0267
8EH9-0779-0293
8EH9-0979-0326 S
8EHQ-0380-03J6 S
8EII9-0378-0109
8EH9-0378-0113
8EH9-0578-0147
BEH9-0678-0179
8EH9-0778-0209
BEH9-077B-0228
8EH9-0
-------
APPENDIX (D)s STATUS REPORTS BY INFORMATION TYPE
en
HUMAN EXPOSURE (MONITORING)
SUBMISSION I: 8EH9-0680-I345
8EHQ-1060-0368
8EH4-B9B1-0413
8EH9-0982-0457
8EH4-I083-0495
8EHQ-0784-I521 S
8EH4-0289-0546
8EHQ-0485-0S51
8EH4-0985-05ti
8EHQ-09B6-0633 S
AEHQ-0487-1671
BEHQ-0288-0722
8EHQ-1088-0761
8EHQ-1289-I856
8EH4-I490-I924
8EHQ-0890-I05J
8EH9-0680-0348
8EH9-1280-0376
8EH9-0382-0440 S
8EH9-1182-0462
8EH9-10B3-B497
8EH9-1084-0535
8EH9-0385-0547 '
8EH9-B485-0553
8EH9-0286-05B8 M
8EH9-1286-0648
8EH9-0587-0672 S
8EH9-0688-0735
8EH9-0289-07B*
8EH9-0589-0801
8EH9-0190-0863
8EH9-0490-0933
8EH9-0690-1018
8EH9-0990-1077
8EH9-1080-0367
8EH9-1280-0'i01
8EH9-0482'0^2
8EH9-0383-0473
8EH9-0184-0504
8EH9-0185-0542
BEH9-048S-0550
aEHQ-0-,85 0->^
8EH9-0586-0601
8EH9-0487-0662
8EH9-0687-06B2
8EH9-0988-0752
8EH9-0389-0789
8EH9-0889-081B
8EH9-0290-0882
8EH9-0490-0953
8EH9-0890-1038
8EH9-0990-1078
S
S
S
5
S
HUMAN EXPOSURE (PRODUCT CONTAMINATION)
SUBMISSION Is 8EHQ-1B77-0012
8EHQ-0*78-0117 «
8EHQ-077B-B219 M
8EHQ-0779-0292
8EHQ-0280-0331 S
8EHQ-037A-0104
BEHQ-0^78-0133
8EHQ-1278-026*
8EHQ-I179-032B
8EHQ-0380-0336 S
8EH9-0378-0113
BEH9-0578-0139
8EHQ-0579-028'i
8EHQ-0979-0326 S
8EHQ-0680-03'i8
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
HUMAN EXPOSURE (PRODUCT CONTAMINATION)
SUBMISSION •: 8EHQ-0780-0352
8EHQ-t381-0390
8EH4-I383-M73
BEHQ-118t-at
-------
HEIABOLISM/PHARMACOKINETICS (HUMAN)
SUBMISSION I: 8EHQ-0578-eU9
8EHt~»285-«546
APPENDIX (D)i STATUS REPORTS BY INFORMATION TYPE
6EHQ-0379-0277
8EHQ-0485-0551
8EHQ-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
nUTAGENICITY (IN VITRO)
SUBMISSION 0: 8EM9-1081-
8EH9-12B1
BEH«-«982
•EH*-m2
8EH9-8283
8EH9-05B3
8EH9-8783
8EH9-1083
8EH9-1283
8EH9-0484
BEHQ-0584
8EH9-0584
8EHQ-1084
8EHQ-1284
8EHQ-0785
8EHQ-1285
8EH9-0486
8EH9-0786
8EHQ-0886
8EH4-1286
8EHQ-0187
8EH9-0687
8EH9-0787
8EH9-1287
BEH9-028B
• 415
•426
•455
•460
•47»
•477 S
•486
•495
0503
0510
• 515 S
0519
•532
•539
•561 S
•580
•597
•608 S
•620
•645
•649 S
•677
0686 S
0706
0719
8EHQ-1081-0417
BEH9-0282-0427 S
8EHQ-0982-0458
8EHQ-1182-0465
8EHQ-0283-0471 S
8EHQ-0683-0481
8EH4-0883-0489
8EH4-10B3-0496
8EHO-0384-0506 S
8EHQ-0484-0511
8EHQ-0584-0516 S
8EHQ-0784-0522
8EHQ-1084-0533 S
8EHQ-1284-0541 S
8EHQ-1085-0571 S
8EHQ-8186-0584
8EH«-0586-0602 S
8EHQ-0786-0610
8EHQ-0886-0621
8EH«-1186-0646 S
8EH4-0287-0653
8EHQ-0687-0679
BEHQ-0987-0692
8EH4-1287'0709 S
a£HQ-0688-0737
SEHQ-10B1-041B
BEHQ-06B2-0
-------
APPENDIX (0): STATUS REPORTS BY INFORMATION TYPE
cr»
oo
nUTAGENICITY (IN VITRO)
SUBMISSION •: 8EHQ-1088-I758 S
8EH4-B389-B791 S
8EH4-8889-8814
8EH«-1289r8854 S
8EH4-8398-89U S
8EH4-8498-8948
8EH9-0699-1916 S
8EH4-8998-1846 S
nUTAGENICITY (IN VIVO)
SUBMISSION l> BEH4-8278-8882
8EHQ-0678-B208
8EHQ-8I79-8267
8EH4-0579-8288
8EHQ-1179-8321
8EH9-0988-8359
8EHQ-0381-8387
8EH4-1281-8426
8EHQ-I78S-C560
8EH«-0290-0892
8EHQ-1088-0760 S
8EHQ-0589-0798 S
8EHQ-8989-0826 S
8EHQ-I289-BB58 S
BEHQ-0490-0930 S
8EHQ-0690-1009
8FH9-0890-10S4 S
8EHQ-0990-1067
8EHQ-0378-0187 M
8EHQ-I778-0213
8EHQ-0579-0285
8EHQ-8679-0291
8EH9-1279-0323
8EHQ-1080-0366
8EH9-6981-0412
8EHQ-0483-0476 S
BEHQ-1285-0577
8EHO-0390-091& S *
8EHQ-0389-0780
8EHQ-0789-0805
8EHQ-1089-0837
8EHQ-0390-0903
8EHQ-0490-0932
8EH9-0690-1015
8EHQ-0890-1051
8EH9-0990-1079
8EH9-0578-0170
8EHQ-1078-0248
8EHQ-0579-0287
8EHQ-0879-0301
8EHQ-0780-0350
8EHQ-0281-0364
8EHQ-I081-0418
8EH9-I083-0499
8EHQ-07B6-0613
BEHQ-0590-0981
S
S
S
S
S
NEUROTOXICITY (ANIMAL)
SUBMISSION I: BEMQ-1177-««15 S
8EHQ-067B-OI88
8EH9-OBBO-0356
8EHQ-0278-0055
8EHQ-0778-B218
BEHQ-0880-0357
8EHQ-067B-0173
8EHQ-0279-0275
BEHQ-07BO-0369
-------
APPENDIX CD)i STATUS REPORIS BY INFORMATION TYPE
o\
VO
NEUROIOXICITY (ANIMAL)
SUBMISSION I: 8EHQ-0382
8EHQ-05B3
BEHQ-0684-
BEH9-1085
8EH«-«486
8EHQ-C587
8EHQ-I588
8EH4-6788
BEHQ-0489
8EHQ-OB86
8EHQ-1189
BEHQ-1189
8EHQ-0390
BEHQ-0490
BEHQ-0490
BEHQ-0490
8EHQ-059I
8EHQ-0690
8EHQ-0690
8EMQ-089I
8EH9-B990
0440 S
• 478 S
• 52ft
•571 S
•599
•678
•733
• 744 S
• 793
0815
0841
0848 S
0898
• 919 S
• 936
• 958 S
• 964
•1M2
1005 S
•1041
1057
8EHQ-0682-0451
8EHQ-1083-0494 «
8EHQ-1084-0532
8EH4-0186-05B4
8EHQ-«886~0628
8EHQ-1287-0706
8EHQ-0688-0739
8EHQ-10B8-0757
8EHQ-0489-0794 S
8EHQ-1089-0837 S
BEHQ-1189-0843 S
8EHQ-0190-0867 *
8EHQ-0390-0913 S
8EH4-0490-0931 S
8EHQ-0490-0954 S
8EH9-0490-0959 S
BEHQ-0590-0996
8EH4-0690-1003
8EH«-«690-1007
BEH4-OB90-1043
8EH«-0990-1063
8EHQ-11B2-0^62
8EHQ-12S3-0501
BEHQ-0585-0556
8EH9-03B6-0590
8EHQ-0287-0655
BEHQ-018B-071
-------
NEUROTOXICITY (HUMAN)
SUBMISSION I: 8EH9-10B6-0641
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
8EH9-0590-0991 S
8EH9-0990-1065
ONCOGENICITY (ANIMAL)
SUBMISSION It 8EN4-B877
8EH9-1177
8EH9-0178
8EH4-B278
8EH9-B578
8EH9-0578
8EH9-0778
8EH9-OB78
8EH9-1078
8EH9-0279
8EH9-0779
8EH4-1879
8EH9-I1B*
8EHQ-8580-
8EHQ-B98B-
8EHQ-I3B1-
8EH4-12BO-
8EH«-B981-
8EHQ-0282-
BEHQ-06B2'
8EHQ-1082
8EHQ-0283
•8002
8816
•8828
8846 N
8148
0170
0212
0236 N
0251
0274
0297
0314
0327
0342
0360
8393
0401 S
0411
0434
0447
0461
0469 S
8EH9-1077-0006
BEH9-1177-1019
8EH9-017A-0029
8EH4-0278-0083
8EH4-0578-0148
8EH9-0678-0202
8EHQ-8778-0215
BEH9-0978-0246
8EH9-1078-0253
8EH9-0479-0281
8EH9-0979-0305
8EH9-1179-0316
8EH9-0180-0328
8EH9-0780-0350
8EH4-1080-0370
8EH9-84B1-0397
8EH9-0681-0402
8EH9-1281-0422
8EH4-0282-0439
BEH9-0882-0453
BEHQ-1182-0463
BEM«-028J-0*72 S
BEH9-1077-0012
8EH9-1277-0026 S
BEH9-0278-004
-------
APPENDIX (D)i STATUS REPORTS
INFORMATION TYPE
ONCOGENICITY (ANIMAL)
SUBMISSION I: BEHQ-06B3-
8EHQ-0783
8EH«-«384
8EHQ-«5B«<
8EN4-M84-
8EH4-MB5-
8EHQ-M85
8EHQ-MB6
8EHQ-0786
BEHQ-1IB6
BEHQ-0786
8EHQ-08B7
8EHQ-1287
BEHQ-0188
BEHQ-0788
8EHQ-1I88
BEH«-I288
8EH9-0989
BEHQ-1289
BEHQ-0499
8EH9-079I
0480
• 488
• 507
• 517
1531
• 553
•567
•600
•614
•642
•681
•691 S
0704
• 713
•741
• 763 S
• 775
•822
•858 S
• 952 S
1029
8EHQ-0683-0483 S
8EHQ-1083-0497
8EH4-1083-0509
8EHQ-08B4-0525
BEH4-12B4-0538
8EHQ-0785-0561 S
BEHQ-0685-0583 S
BEHQ-0686-0604
8EHQ-OB86-061B S
8EH9-0187-0650
8EHQ-0787-06B4 S
8EH4-0987-0692
8EHQ-1287-0708 S
BEH9-038B-0725
8EH9-07BB-0745 S
BEH4-1288-0773
8EHQ-i789-0809 M
8EH4-1189-0847
8EHQ-0290-0873 S
8EHQ-0490-096B
8EH9-0890-1050 S
8EHQ 07B3-0486
8EHQ-1283-0503
8EHQ-05B'i-051
-------
ONCOGENICITY (HUMAN)
8EHQ-0878-023*
8EH4-8582-B444
8EH4-f2f5-B546
BEH«-B584-«601
8EH4-«986-f634
8EH4-1187-B498
8EH4-1188-8772
8EH4-*29*-«884
BEHO-0490-0924
8EH«-«99t-l*8« S
8EH4-0978-0241
BEHQ-0383-0473
8EHQ-0585-0557
8EHQ-«786-0615
8EHQ-B187-0651
8ENQ-1287-C699
8EHQ-0190-0863
8EH4-0390-0915
BEHQ-0790-1034
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
8EHQ-0978-0246
8EHQ-0884-0523
8EHQ-0486-0598
8EHQ-0986-0629
8EHQ-0887-0688
8EHQ-1287-0701
8EHQ-0190-0864
8CHQ-0490-0917
8EHQ-0890-1053
-J
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PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION I: 8EH9-1I77-BM8
8EHQ-1177-M16
8EHQ-«278-M4*
8EH4-C378-M85
8EH«-«378-«lf*
8EH4-I578-I153 S
8EH«-8578-IU4
8EHQ-0678-I187
8EHQ-B778-B2M
8EHQ-0778-»22«
8EHQ-1078-Q245
BEHQ-1078-0253
8EHQ-1«77-«011
8EH9-1277-C021
8EH«-«278-«045 N
BEH9-U78-8089 N
8EHQ-«378-01«5
8EHQ-0578-«139
BEH9-I578-0155 N
8EH9-«578-«165
8EHQ-I67B-0200 N
8EH4-077B-0214
8EHQ-0778-0228 *
8EHQ-1078-0249
8EHO-1078-0255. *
8EHQ-1177-0014
8EHQ-1277-0026 5
8EHQ-0278-0054
8EHQ-037B-0093
BEHQ-0478-0117
8EHQ-0578-0150
8EHQ-0578-0163
8EHQ-0578-0169 S
8RHQ-067B-0205
8EHQ-0778-0219
8EHQ-0978-0240
8EHQ-1078-0251
8EMQ-1178-0256
M
M
H
M
M
M
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/'CHEMICAL IDENTITY
SUBMISSION I: 8EH9-1178-826Q N
8EH9-8179-8268 S ,
8EH9-8279-8275
BEH«~l579-a2B3
8EH4-8779-8293
8EH«-1179~9321
8EH9-82B8-8331 S
8EHQ-8388-8336 S
BEHQ-1188-8373 S
BEH9-I3B1-I394 S
8EH4-07B1-8406 S
8EHQ-0882-M5*
8EH9-02B3-047L S
BEHQ-86B3-8488
8EH9-8783-8«85 S M
8EHQ-I983-8492 S
8EH«-1283-8581
P »
BEHQ-tSB^-8517
8EHQ-M85-I553
8EH4-1178-026I
8EH4-8179-0269 S
8EH9-8479-0278
8EHQ-0579-0288
8EH4-OB79-0301
8EH9-1279-0323
8EH4~02BO-I333
8EH9-0780-8358
8EH9-1180-8374 S
8EHQ-04B1-0397
8EH9-0482-0442
8EH9-8982-0456 S x
8EH9-§5B3-0*77 S
8EH4-0683-8483 S
BEH9-8783-0487 S N
BEH9-0983-I493 S N
8EHQ-1283-0502 P N
8EH9-1278-0264
8EH4-0179-0272
8EH4-0379-0280
8EH4-0779-0292
8EM9-1179-0317
8EH9-0180-032B
8EHQ-0380-8335
8EH9-0880-0358
8EH4-1180-0375
8EH4-OS81-0399
8EH4-0682-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION •: 8EHQ-1185-057*
8EHQ-I485-0583 S
8EIM-M84-I597
8EH4-I7B4-I406 S
8EHQ-I784-I4U
8EH9-I984-I423 S
8EH9-I984-I424 S
8EH4-8984-I432
8EHQ-ltB4-l437
8EHQ-1184-I443
8EH9-I1B7-I449 S
BEHQ-I387-I454
8EHQ-M87-I445 S
8EH4-I487-I449
8EHQ-B5B7-847* S
8EHQ-I787-I684 S
8EHQ-1287-B798 S
8EHQ-8288-I714 S
8EHQ-I388-I724 S
8EHQ-0488-I728
8EH9-0588-0733
8EHQ-0688-8740 S
8EHQ-09B8-0749 S
8EHQ-0988-07S2 S
8EHQ-1088-0758 S
8EHQ-1285-0577
8EHQ-0386-0589 S
BEHQ-0586-0602 S
8EHQ-I786-06B8 S
8EHQ-8784-0614
8EHQ-I986-062* S
8EHQ-I9B6-0427
8EHQ-I986-0633 S
8EHQ-1086-0639 S
8EH9-1186-0644
8EHQ-0287-0652 S
BEHQ-0^87-0661 S
M BEH4-0487-0667 S *
M BEHQ-0^87-1670 S
8EHQ-I687-0680
8EHQ-1187-8497
8EHQ-12B7-87»9 S
8EH
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION I: 8EH9-1088-0763 S
8EH9-1188-I766 S
8EH9-U8B-t770 S
8EH9-8389-I780
8EH9-8289-8784
BEHfl-0389-1788 S
8EH9-I389-I791 S
8EH9-0589-0799
8EH9-0789-088* S
8EH9-0889-8816 S
8EH9-0989-8821 S
8EH9-09B9-BB27 S
8EH9-10B9-0834 S
8EH9-1089-083B S
8EH9-1189-1843 S
8EH9-1189-0848 S
8EHQ-1289-I853 S
8EH9-1289-C858 S
8EHQ-019I-9862 S
8EHQ-0190-1868 S
8EHQ-0190-t871 S
8EHQ-0290-0874 S
8EHQ-0290-0880
8EHQ-0290-0887 S
BEHQ-0290-0890 S
8EH9-1088-0764
8EH4-1188-0767
8EHQ-1188-0771
8EH4-0289-0782
8EH9-0289-0785
8EH4-0389-0789
8EH«-t489-l794
8EHQ-0689-0804
8EH4-I789-0808
8EH4-0889-0817
8EH9-0989-OB24
8EHQ-0989-0828
8EH9-1089-0835
8EHQ-1189-0840
8EHQ-1189-0844
8EHQ-1289-0849
8EH4-1289-0854
8EH9-1289-8859
8EHQ-8I90-0865
8EHQ-8190-0869
8EH9-0290-0872
8EH9-0290-0875
BEH9-t290-0881
8EH9-0290-OB88
8EH9-0290-0891
S
S
S
S
S
S
S
S
S
S
S
S
S
S
S
S
S
S
S
S
8EH9-118B-0765 S
BtHQ-1188-0768 S
BEN9-1288-0776
8LH9-0289-0783 S
8EH9-0389-0787 S
8EH9-0389-0790 S
8EH9-0589-0798 S
8CHQ-0789-0805 S
8EH9-0889-0811 S
BEH9-08B9-0819 S
8EH9-0989-0825 S
8EH9-1089-0833 S
8EH9-10B9-083? S
8EH9-1 189-0842 S
8EH9-1189-08't7
BEH9-1289-OB51 S
8EH9-1289-0857 S
8EH9-0190-0861 S
8EH9-0190-0866 S
8EH9-0190-0870 S
8EH9-0290-0873 S
8EH9-0290-0879 S
8EHQ-0290-0883 S
8EHQ-0290-0889 S
8EHQ-0390-0895 S
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
-g
a\
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION I: 8EHQ-0390-0896 S
8EH«-»39»-l9«5 S
8EH«-t39B-«908 s
8EH«-»39I-M16 S
8EHQ-M9I-I920 S
8EHQ-M9B-9923 S
8EH4-l*9l-t927 S
8EH«-|*9l-l93d S
8EH4-049C-I934 S
8EHQ-I49I-I952 S
8EHQ-B49I-M57 S
8EH«-l*9t-99tl S
8EHQ-I590-I9B* S
8EHQ-t59l-l989 S
8EHQ-0590-M93 S
8EHQ-0590-0998 S
8EHQ-0490-1005 S
8EHQ-0690-t011 S
8EH4-0690-1014 S
8EHQ-«7»«-ll23 S
8EHQ-I790-1028 S
8EHQ-0790-1936
8EHQ-0890-1042
8EHQ-OB90-1049 S
8EHQ-0890-1054 S
S
S N
s
S N
s
s
s
s
s
s
s
s
s
s
s
s
s
s
s
s
s
$
s
s
8EH9-0390-0897 S
8EH9-0390-0906 S
8EHQ-0390-0913 S
8EHQ-M90-0918 S
8EHQ-M90-B921 S
8EHQ-0490-0925 S
8EHQ-I490-0928 S
8EHQ-B490-0931 S
8EH4-0490-0935 S
8EHQ-0490-0955 S
8EHQ-0490-0958 S
8EH4-B490-0962
8EHQ-0590-0987 S
8EHQ-0590-099I
8EH9-I590-0995 S
8EHQ-I590-1001 S
8EHQ-B690-1BB6 S
8EHQ-0690-1012 S
8EHQ-0690-1B16 S
8EHQ-«790-lt2S S
8EH9-0790-1029
8EMQ-0790-1037 S
8EHQ-0890-1044 S
8EHQ-0890-105B S
flEHQ-0890-1056 S
8EHQ-0390-0903 S
8EHQ-0390-0907 S
8EHQ-0390-091
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION I: 8EHQ-0990-1059 S *
8EH4-0990-1063
BEHQ-0990-1071
•EHO.-M90-1076 $
8EHQ-099I-I083 S
8EHQ-0990-1060 S
8EHQ-0990-1066 S
8EHQ-0990-1073 S
8EH9-0990-107B
8EHQ-0990-1062
8EH«-0990-1070 S
8EHQ-0990-I075 S
8EHQ-0990-1079 S
PRODUCTION/USE/PROCESS
SUBMISSION •: 8EHQ-1277-
8EH9-0378
8EH9-037B-
8EHQ-0478-
8EH9-0478-
8EH9-0578
8EHQ-0578
8EHQ-0578
8EHQ-0578
8EHD-0578
8EH«-*«78
8EHQ-0678
8EHQ-077B-
8EHQ-9978
8EHQ-1078
8EHQ-1I78
8EHQ-1278
8EHQ-0179
•026 S
• 184
• 110
• 115 M
• 123
• 146
0155 M
0159 S M
• 164
• 167 f
• 179 M
• 202
•219 M
•239
8247
•253
0264
0270
8EH9-037B-0096 X
BEH4-0378-0105
8EM4-0378-0112 M
8EHQ-0478-0117 *
8EHa-0478-0138 P N
8EH9-0578-0148
8EHQ-0578-0157 M
8EHQ-0578-0162 S N
8EH4-0578-0165
8EH9-0578-0168
8EHQ-0678-0180 N
8EHQ-0778-0209
8EHQ-0778-0228 N
BEHQ-1078-0245
BEH9-1078-0251
BEHO-1178-0256
BEHQ-0179-0267
8EHQ-0179-0271
BEHO-0378-0097
8ENQ-0378-0109
8EHQ-0378-0113
8EHQ-047B-0118 P
8EHQ-0578-0139
8EH9-0578-0152
8EHQ-OS78-0158 S
BEHQ-0578-0163
8EHQ-0578-0166
BtHQ-0578-0169 S
8EHQ-0678-0200
8EH9-0778-0217
8EHQ-0878-0230
8EHQ-0978-0246
8EHQ-1078-0252
8EHg-ll78-0261
8EHQ-0179-0268 S
8EHQ-0179-0272
M
M
M
N
N
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
-J
CD
PRODUCTION/USE/PROCESS
SUBMISSION •: BEH9-A279-9275
•EH4-I479-8282 S
8EM9-«479-»291
8EHQ-I779-I294
8EH9-«5B3~M77 S
8EH9-«683~*481
8EH9-«783-«487 S N
8EH9-0983-8493 S N
8EH9-l*B3-«496
8EH9-12B3-85M S
8EH9-12B3-8583
8EH9-0384-«5«6 S
BEH9-8484-8513
8EH9-8584-8516 S
8EH9-8684-852*
8EH9-0884-8523
8EH9-08B4-8528
8EH9-1884-8532
8EH9-1884-8535
8EH9-0285-I545 S
8EH9-0485-8548
BEH9-84B5-8551 "
8EH9-0585-8554 S
BEH9-0585-B557
8EH9-0785-B561 S
8EH9-0479-0278
BEH9-0579-0283
8EH9-0779-0292
8EH9-0779-0296
8EH9-05B3-0479 S
8EH9-96B3-Q483 S
8EH9-0883-0490
8EH9-1083-0494 N
8EH9-10B3-0497
BEH9-1283-0591
8EH9-8184-0504
8EHQ-1083-0509
8EH9-85B4-8514
6EH9-C5B4-0517
8EH9-«784-0521 S
8EH9-9884-0524
8EH9-8984-9529
8EH9-1084-0533 S
BEH9-B185-0542 S
8EH9-8285-B546
8EH9-B485-0549 S
8EH9-0485-0552
8EH9-0585-0555
8EH9-0685-0558 S
8EHQ-0785-0562 S
8EHQ-0379-0280
8EH9-0579-0288
8EH9-0779-0293
8EH9-0779-0297
8EH9-B683-0480
8EH9-0783-0485
8EH9-0983-0492
8EH9-1083-0495
8EH9-1083-0498
8EH9-1283-OS02
8EH9-0284-0505
8EH9-04B
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCTION/USE/PROCESS
SUBMISSION •: 8EHQ-0885
8EH4-0985
•EU4-108
8EH4-1185
8EHQ-12B5
BEHQ-1285
8EHQ-B685
BEHQ-0186
BEHQ-t38t
8EHQ-0486
8EHQ-05B6
8EH4-0786
8EHQ-0786
BEHQ-0786
8EH4-0886
8EH4-0986
8EH9-8986
8EHQ-09B6
BEHQ-1986
8EHQ-1B86
8EHQ-1186
8EH9-0187
8EHQ-0387-
-0564 S
-0568 S
-•571 S
r0574
-•577
-0580
-•583 S
-•586 S
-•591
-•597
-•601
-0606 S
-•609 S
-•615
-•622 S
-•625 S
-•630
-0634
-•637
-•641
-•644
-•649 S
^0655 S
-0659
-0664 S
8EH4-0885-0565 S
8EHQ-1085-0569
8EH4-0585-0572
8EH9-1185-0575
8EH9-12S5-057B
8EH4-1285-0581
8EHQ-0186-0584
8EHQ-0286-0588 N
BEHQ-0386-0594 S
8EHQ-0486-0599
8EH9-0586-0602 S
8EHQ-0786-0607 S
8EH4-0786-0613
8EHQ-0786-0616
8EH4-0986-0623 S
8EH9-0986-0627
8EHQ-0986-0631 S
BEHQ-1086-0635
8EH9-1086-0639 S
8EHQ-10B6-0642
8EH4-1286-0645
8EHQ-0267-0653
8EHQ-02B7-0657 S
8EHQ-0487-0661 S
8EH4-0487-0665 S N
8EHQ-0985-0566
8EHQ-10B5-0570
8EHQ-1185-0573
8EHQ-1185-0576
8EHQ-12B5-0579
BEHQ-OI86-05B2
6EHQ-0186-05B5
8EHQ-03B6-0589
BEHQ-0486-0596
8EHQ-0486-0600
8EHQ-0686-0603
BEHQ-0786-0608
BEHQ-0786-0614
8EH4-0886-0621
8EHQ-09B6-0624
BEHQ-0986-0629
BEHO-0986-0633
8EH9-1086-063&
BEH9-1086-06
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCTION/USE/PROCESS
SUBMISSION •: 8EHQ-B487'
8EH4-B587
8EH4-8587
8EHQ-«587
8EHQ-86B7
8EHQ-8787
8EH4-OB87
8EHQ-IB87
8EHQ-1IB7
8EH«-1287
8EHQ-1287
8EH9-01B8
8EHQ-8288
8EHQ-0388
BEHQ-03B8
8EHQ-0588
8EHQ-8588
8EHQ-I688
8EH4-I788
BEHQ-0888
8EH4-0988
8EHQ-0988
8EH9-1088-
8EHQ-1088
•669 N
•672 S
•675 N
•678
•682
•685
•688
•691 S
•695
•?••
• 716
• 714
• 717 S
• 721
• 724 S
9731
• 733
0738
• 742 x
• 746
• 749 S
• 75.2 S
0755
0758 S
0763 S
8EHQ-0487-0670 S
8EHQ-B5B7-0673
8EHQ-85B7-0676
BEHQ-0687'0679
8EHQ-0687-0683
8EHQ-0787-0686 S
8EH9-0887-0689 M
8EH4-09B7-0692
8EHQ-1187-0698
BEHQ-1287-0701 M
8EH9-1287-0709 S
8EHQ-0288-0715
8EHQ-0288-0719
SEHQ-028B-0722
8EHQ-0388-0725
8EHQ-«588-0731 S
8EHQ-9688-0734 S
BEHQ-0688-9739
BEHQ-0788-0744 S
8EMQ-0888-0747
8EHQ-0988-0750 S
BEHQ-0988-0753 S
BEHQ-10BB-0756
8EHQ-1088-I.759
8EHQ-11B8-0765.S
BEHQ-0187-0671
8EHQ-05B7-067
-------
APPENDIX (0): STATUS REPORTS BY INFORMATION TYPE
CD
PRODUCTION/USE/PROCESS
SUBMISSION I: BEH9-1188-
BEtw-iiaa-
8EH9-1288-
8EH9-0289-
8EH9-0289-
BEH9-0389-
«EH9-a489
8EH9-0589
BEH9-0689
8EH9-0789
8EH9-0889
8EH9-0889-
8EH9-OBB9
8EH9-0889
8EH9-0989
8EH9-I989
8EH9-1089
6EH9-1IB9
8EH9-1889
BEH9-1189
8EHQ-1189
8EH4-12B9
8EHQ-1289
8EHQ-I2B9
BEHO-0190
0767 S
• 771 S
/
• 778
»782 S
• 785 S
•789
•792
• 798 S
0812
•886 S
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•814
•817
0820
•824 S
•827 S
•831
•834 S
•0838 S
•841
•0845
••849 S
•0852 S
0856
-0861 S
8EH9-U88-076B S
8EHQ-1288-0775
BEHQ-0189-0779
8EHQ-0289-0783 S
8EHQ-0389-0787 S
BEHQ-0389-0790 S
8EHQ-0489-0793
8EHQ-0589-*0799
8EH9-0689-0804
8EH9-0789-0807 S
8EH4-0889-0811 S
8EH9-0886-0815
8EH9-OBB9-0818 S
8EH4-0989-0821 S
BEH4-09B9-OB25 S
8EH4-«989-OB28 S
BEH9-1«89-0832
8EH9-1»89-0835 S
8EHQ-1189-0839
BEH9-11B9-0842 S
BEHQ-1189-0847
BEHQ-1289-0850
8EHQ-12B9-0853 S
BEHQ-12B9-0857 S
BEHQ-0190-0862 S
BEHQ-1188-0770 5
BEH9-1288-0776
BEHQ-0189-0781 5
8l:HQ~0289-078
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCTION/USE/PROCESS
0)
ro
8EHQ-0190-OB64
8EH«-*19«-I867 N
8EH4-I198-U70 S
8EHQ-8299-P87* S
8EH4-*29*-«879 S
8EHQ-*29«-«883 S
8EHQ-029«-«B87 S
8EHQ-0290-8898 S
8EH4-0396-I89B
8EHQ-0390-0901
8EHQ-039»-I9«7 S
8EH4-039C-M15
8EHQ-S490-I91S S
8EH4-0490-M25 S
BEHQ-0490-0930 S
BEH«-M9«-«933
8EHQ-«49«-«936
8EHQ-049»-I939
8EHQ-MM-MO
8EHQ-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCTION/USE/PROCESS
SUBMISSION 1: BEHQ-0590-0983
8EHQ-«59*-«99<» N
8EH«-«5M-«997 S "'
8EH4-059I-1M1 S
8EH4-0*9*-1M* s
8EHQ-t*90-l«10 S
8EHQ-0690-1U3 S
BEHQ-0690-1016 S
8EHQ-079I-1021
BEH«-0790-1«25 S
8EHQ-0790-102B S
01 8EH4-0790-1033
8EHQ-079t-1037 S
8EH4-0890-1M1
8EH«-«890-1«4* S
8EH9-OB90-1047
8EHQ-089I-1050 S
8EH«-OB9I-105^ S
8EH9-0990-1058 S
8EH4-0990-1I62
BEHQ-0990-1066 S
8EHQ-099I-1071
8EHQ-0990-1074
BEHQ-0990-1078
8EHQ-0990-1081
8EHQ-0590-0985 »
8EHQ-0590-0995 S
8EHQ-0590-0998 S
8EII9-0690-1002
8EHQ-0690-1005 S
8EHQ-0690-1011 S
BEHQ-0690-1014 S
8EHQ-0690-1018
8EH9-0790-1023 S
8EHQ-0790-1026 S
8EHQ-0790-1029
8EH4-0790-1034
8EHQ-IB90-1039 S
8EHQ-0890-1042
8EHQ-0890-1045
8EHQ-0890-1848 S
BEHQ-0890-10S2 S
8EHQ-0890-1055 S
BEHQ-0990-1060 S
8EHQ-0990-1I63
8EH4-0990-1069
8EHQ-0990-1072
8EHQ-0990-1075 S
8EHQ 0990-1079 S
8EHQ-0990-1083 S
8EHQ-0590-0992 S
8EHQ-0590-0996
8EHQ-0690-0999
8EHQ-0690-1003
8EH9-0690-1006 S
8EHQ-0690-1012 S
8EHQ-0690-1015
BEHQ-0690-1019
BEHQ-0790-1024
8EHQ-0790-1027
8EHQ-0790-1031 S
8EHQ-0790-1036 S
8EHQ-0890-1040
8EHQ-0890-10
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
REPORTING RATIONALE
SUBMISSION •: 8EHQ-1078-0249
0EH4-1M3-I49*
8EH4-1217-0706
8EH4-0009-0013
8EHQ-08BO-0358
8EH9-0384-0508 P
8EH9-0488-0729 S
8EH9-0886-0815
8EH9-07B3-0485 S
8EH9-0587-0672 S
8EH9-1188-0772
8EH9-0490-0933
CD
REPRODUCTIVE TOXICITY/TERATO. {ANIMAL)
SUBMISSION ft 0EH9-1077-0007
8EH9-0378-0095
0EH9-0478-0122
8EH9-0570-0160 S
8EHQ-0678-0208
8EH9-0978-I244
8EHQ-1078-t248
8EHQ-0179-02&9 S
8EHQ-1180-I373 S
8EHQ-I181-0S79
8EHQ-I381-0588 S
8EH«-I781-I4I5 S
8EHQ-1281-M2*
8EH«-1083-M99
8EHQ-0185-9543
8EH9-1277-P027
N 8EH9-0378-0101 *
* 8EH9-0470-0129
H 8EH9-0678-0185 K
8EH9-0778-0209
8EH9-1078-0245
8EH9-1078-0252
8EHQ-0779-0293
8EII9-1180-0374 S
8EH9-02B1-03B4
8EH9-0381-0394 S
8EHQ-1081-04M
8EH9-0302-0440 S
8EH9-0882-0452
8EH9-0^83-0475
8EH9-0284-0505
8EH9-1084-0532
8EH9-0278-0049
8EH9-037B-0103
8EH9-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
oo
REPRODUCTIVE TOXICITY/TERATO . (ANIMAL)
SUBMISSION •> 8EHQ-0785-I562 S
BEH4-12B5-B577
/
8EH«-Bt8ft-Bt2t S
8EH4-8287-M53
8EH«-MB7-8«4i S
8EHQ-8687-B682
BEH4-828B-87U S
8EH4-03B8-072* *
8EHQ-0588-I731 S
6EHQ-0988-B74B
8EHQ-0988-Q751 S
8EHQ-10B8-I744 S
BEHQ-118S-I767 S
BEHQ-1288-1776
8EH4-8389-B7B4 S
BEHQ-0489-8794 S
8EH4-e889-tBll S
BEHQ-BB89-Q820
8EH4-I989-B825 S
8EH«-1089-f829
BEHQ-1289-C852 S
8ENQ-0190-0861 S
8EHQ-OI90-0868 S
8EH4-0190-0871 S
8EH9-1085-0570
8EHQ-0186-0587
8EHQ-0886-0628
8EHQ-0287-0658
8CH9-0587-0672
8EHQ-1087-0695
BEHQ-0288-0717
8EH9-048B-0727
8EHQ-0688-0738
BEHQ-0988-0749
8EHQ-1088-0758
BEHQ-1188->765
8EHQ-1188-0770
8EHQ-t289-0783
8EHQ-83B9-8798
8EHQ-0789-0807
BEHQ-8889-0813
BEHQ-0989-0823
8EHQ-0989-0827
8EHQ-1889-OB35
BEHQ-1289-0849
8EHQ-1289-0855
8EHQ-0190-0862
8EH9-0190-OB69
8EHQ-0290-0872
S
S
S
S
S
S
S
S
S
S
S
S
S
S
.S
8EHQ-0585-0572
8EHQ-09S6-0623 S
8EHQ-0986-06JJ S
8EHQ-0487-066
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
O>
REPRODUCTIVE TOXICITY/TERATO. (ANIMAL)
SUBMISSION I: 8EH9-I29I-0875 S
8EH9-I290-I879 S
8EH9-t29t-MB4
8EH9-I290-M89 S
8EH9-0290-M92
8EHQ-I39I-I897 S
8EH9-I39I-891I S
8EH9-M9I-I918 S
8EH9-M9I-I925 S
8EH9-M9I-M30 S
8EH9-I49I-I935 S
8EH9-849I-I939
8EH9-049I-0942
8EH9-049I-0945
8EH9-M9I-I948
8EH9-f49l-l951
8EHQ-M9I-9961 S
8EH9-f59t-M67
8EH9-i59l-097l
8EH9-»59l-»973
8EH9-0599-I976
8EM9-059I-I979
8EH9-«59l-«982
8EH9-0590-I986 S
BEHQ-OS90-0989 S
S
S
S
S
S
S
S
S
S
BEH9-0290-0877
8EH9-0290-0881
8EH9-0290-0887
BEH9-0290-OB9I
8EHQ-0390-0895
8EH9-0390-0904
8EH9-0390-0911
8EH9-0490-0922
8EHQ-0490-0927
8EH9-0490-0931
8EHQ-0490-0937
aEHQ-0490-0940
S
S
S
S
S
S
S
S
8EH9-i59t-i945
8EH9-0598-D968
8EH9-0590-8971
BEH9-B590-0977
8EH9-0590-09BO
BEH9-0590-0983
8EH9-0590-09B7 S
8EH9-0590-0990
8EH9-0290
8EH9-0290
8EH9-0290
8EH9-0290
8EH9-0390
8EH9-0390
8EH9-0390
8EH9-0490
8EH9-0490
8EH9-0490
8EH9-0490
8EH9-I^90
8EH9-0490
8EH9-OS90
8EH9-0490
8EH9-0490
8EH9-0590
8EH9-0590
8EH9-0590
8EH9-OS90
8EH9-0590
8EH9-0590
8EH9-0590
8FHQ-0590
8FHQ-0590
-0878
-0883 S
-0888 S
-0891 S
-0896 S
-0907 S
-0912 S
-0923 S
-0928 S
-0932
-0938
-09
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
REPRODUCTIVE TOXICITY/TERATO. (ANIMAL)
SUBMISSION ft 8EH4-0590-8995 S
8EH4-M98-8999 M
8EH«-t*ft-1803
8EH«-t*9«-mi S
8EH4-069S-1S13 S
8EHQ-0798-1825 S
8EH«-t798-lB37 S
8EH9-089B-1I46
8EHQ-8998-186*
8EHQ-0590-0997 S
8EHQ-0690-1000 S
8EHQ-0690-1006 S
8EHQ-0690-1011 S
8EHQ-0690-1014 S
8EHQ-0790-1026 S
8EHQ-Q890-1042
8EH4-0890-1055 S
8EH9-0990-1073 S
8EHQ-0590-099B 5
8EHQ-0690-1002
8EHQ-0690-100A
8EHQ-0690-1012 S
8EH«-0790-102<»
8EHQ-0790-1030
8EH«-0890-10't3
8EHQ-0990-1063
BEHQ-0990-1075 S
REPRODUCTIVE TOXICITY/TERATO. (HUMAN)
SUBMISSION fi 8EHQ-0877-880J
BEH4-0478-I123
8EH«-«*78-«192 S
8EH4-8382-M4I S
8EHQ-8989-8821 S
8EHQ-1277-0021
8EHQ-I478-8128
8EH9-1078-0245
8EHQ-0286-«SBa
BEH9-027A-0056
8EHQ-0578-01't6
8EH9-1080-0367
8EH4-0288-0722
SUBACUTE TOXICITY (ANIMAL)
SUBMISSION I: 8EH4-1277-8023
8EH«-0178-8I69
8EHQ-S678-8184
8EHQ-0679-I291
8EH9-068I-03S6
8EHQ-8181-I177
8EHQ-1081-0419
8EHQ-1277-0824
8EHQ-0578-0157
8EHQ-0678-OI85
8EHQ-0779-0293
8EIIQ-I080-0366
8EH4-0281-838*
M
N
8EHQ-017B-0068
8EHQ-0678-0178
8EMQ-0279-027^
8EHQ-1279-0325
8EMQ-0780-0369
8fHQ-03«l-0392
8lHQ-0382-0
-------
APPENDIX (D): STATUS RETORTS BY INFORMATION TYPE
CD
CD
SUIACUTE TOXICITY (ANIMAL)
SUBMISSION It 8EH9-05B2-I44S
8EHQ-M83-I476 $
/
BEH9-04B3-MB4 S
8EH9-1883-M98
8EH9-1884-8532
8EH9-M85-8549 S
8EH9-l785-05tl S
8EH9-ll8t-05B5 S
8EH9-B4Bi-l597
8EH9-07B6-I6I8 S
8EH9-1I86-I637
6EH9-I587-I674 S
8EH9-I787-MB6 S
8EH9-1287-I7I5
8EHQ-««88-f727
8EH4-12B8-I777
8EHQ-t2B9-8782 S
BEHQ-«989-tB2* S
8EHQ-I29I-I889
8EH9-049I-I926 S
8EHQ-869I-0999
8EHQ-«69t-l«19
8EHQ-079I-1027
8EHQ-0798-1057 S
BEHQ-089A-1055 S
8EHQ-0682-0446 S
BEHQ-a583-0478 S
8EHQ-a7B3-04B5 S N
8EHQ-0284-0505
8EHQ-1084-0534
8EHQ-0485-0550
8EHQ-0785-0562 S
8EHQ-03B6-8590
8EIIQ-0686-0603
BEHQ-09B6-0627
8EHQ-0287-0653
8EH9-8687-068e
8EH9-1287-0700
8EHQ-0188-0714
8EHQ-f«88-»73« S
8EH9-0389-0780
8EH9-0389-0789
8EH9-1B89-0837 S
8EH9-0290-0884
8EH9-0490-0931 S
8EH9-0690-1003
BEH9-0690-1020
BEHQ-0790-1028 S
8EHQ-OB90-1041
BEHO-0890-1056 S
8FHQ-llB2-0't62
BLH9-0683-0483 S
8LHQ-10B3-0495
8LH9-06B4-0520
BFHQ-0385-05',7
BEH9-05B5-0556 S
BEH9-10B5-0571 S
8EHQ-0386-0591
8FH9-0686-0605 S
8FH9-0986-0633 S
8EH9-04B7 0664 S
8EH9-0687-0683
BEH9-1287-0703
8^9-0388-0724 S
8fHQ-1088-0757
8EH9-01B9-07B1 S
BEH9-06B9-0803
BEH9-11B9-0845
8FH9-0390-0908 S
8EH9-0490-093
-------
SUBACUTE TOXICITY (ANIMAL>
SUBMISSION •< 8EH9-0990-1062
APPENDIX (0): STATUS REPORTS BY INFORMA1ION TYPE
8EHQ-0990-1078 S
SEHQ-0990-1081
CD
SUBCHRONIC TOXICITY CANIMAL)
SUBMISSION I: 8EH«~1177-8*14
8EH9-t578-8141 S
8EH9-I778-I289
8EH9-027f-8275
8EH9-0788-0354
8EH9-A682-044* S
BEH9-8184-8504
BEH9-8984-0529
8EH9-1185-0574
8EH9-I186-05B6 S
8EH9-*587-d*76
8EHQ-8988-0748
8EH9-10B8-67*3 S
8EH9-1089-083*
8EHQ-1189-8846
BEH9-0290-0881 S
8EH9-0490-0932
S
8EHQ-0178-0033
8EH9-0678-0184 M
8EHQ-0878-0231 M
8EII9-I079-0312
1
8EH9-0980-036*
8EH9-06B3-0483 S
8EH9-03B4-0507
8EH9-0785-0561 S
8EH9-1185-0576
8EH9-03B6-0594 S
BEH9-1286-0648
8EH9-12B7-0702
BEH9-07B8-0744 S
8EH9-1088-0756
8EH9-0489-C793
8EH9-1189-8B48 S
8EH9-1289-0855
8EHQ-8490-0930 S
8EH9-0490-0936
8EH9-0990-1063
8EH9-0578-0160 S »
8EH9-0678-0190 M
8EH9-0279-0274
8LH9-0680-0347
BEH9-02B1-0384
BFH9-1083-0
-------
APPENDIX (0): STATUS REPORTS BY INFORMATION TYPE
SUBMISSION It 8EH9-0378-M97 x 8EHQ-047B-0118 P M 8EH9-0478-0129
BEH9-«478-»135 8EH9-1084-0532 8EH9-0386-0589 S
8EH9-I7B4-I612 8EH9-0886-0622 S 8EHQ-0986-0632
8EH9-IM7-B698 8EHQ-9987-069H M 8EH9-0889-081B S
8EH9-B989-I821 S 8EHQ-0390-6905 S M 8EH9-0490-0929 S
8EH9-B59I-I991 S 8EH9-B990-1C71 8EH9-0990-1078
-------
THURSDAY, MARCH 16, 1978
PART V
ENVIRONMENTAL
PROTECTION
AGENCY
TOXIC SUBSTANCES
CONTROL ACT
Statement of Interpretation and
Enforcement Policy; Notification
of Substantial Risk
91
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lino
NOTICES
1*540-01]
ENVItONMENTAL MOTICTION
AGENCY
-2)
TOXK WHTANCII COMTtOl ACT
N*Mfl«tl** •«
*(•)
Un4«r
AGENCY: Environmental Protection
Agency.
ACTION: Statement of Interpretation
and enforcement policy.
SUMMARY. This action itatet EPA i
Interpretation of. and enforcement
policy concerning, section B(e> of the
Toxic Substances Control Act (TSCA)
(M SUL 3029. 15 U.S.C. 3607). The
provision* of that acctlon went Into
effect on January 1.1977.
Section Me) states that "any person
who manufacture*, processes, or dis-
trlbutts In commerce a chemical »ub-
•Unc< or mixture and who obtain* in*
formation which reasonably support*
the conclusion that such substance or
mixture prcMnu. a substantial rick of
injury to health or the environment
shall Immediately inform the Adminis-
trator of such Information unleat such
person ha* actual knowledge that the
Administrator ha* been adequately In-
formed of »uch information."
DATES: The policy expressed in this
document la in effect a* of the date of
publication.
FOR FURTHER INFORMATION
CONTACT:
Frank O. Rover. Assessment Dlvt-
aion. Office of Toxic Substance*
(WH-5S7). Environmental Protec-
tion Agency. 401 M Street SW..
Washington. O.C. 304M. 303-755*
3110.
SUPPLEMENTARY INFORMATION:
On September «, ItTT. the Agency pro»
poaed guidance (43 FR 45303) on Itt In-
terpretation of and policy concerning
the provisions of atetion Me). Al-
though the propoted "guidance" wa*
an Interpretive rule and statement of
policy exempt Iron the notice and
public comment provisions of the Ad-
ministrative Procedure Act (S U.S.C.
M3). the Agency solicited eommenu
on atvtnl Issues to make more In-
formed decisions. On October 11. the
comment period wa* extended from
October 15 to October 31.1VTT (43 FR
54457). On November 4.19TI. a supple-
mental notice to the proposed guid-
ance wa* published (43 FR 57744). de-
leting the November 15 date for re-
porting certain information obtained
before 1977 and stating that a new
date would be established in the final
guidance.
In developing this policy statement.
two meetings have been held (Febru-
ary 1. 1977. and October 2«. 1977) with
selected representatives of Industry
and environmental and other Inter-
ested group*. Comments tubmlited
pursuant to the February 1 meeting
were addressed In the preamble to the
September 9 proposal Over 100 writ-
ten comments have been submitted
pursuant to the September 9 proposal
from trade associations, businesses, en-
vironmental group*, labor unions.
State and Federal agencies, and other
Interested parties. Appendix B de-
scribe* significant issues raised in
these comment* and the Agency's re-
sponse to them.
The major modifications to the Sep-
tember 9 proposal are summarized in
point* 1 through 7 below.
(1) Pursuant to some question over
the definition and nature of "guid-
ance." this document Is now described
more accurately as a "policy state-
ment." It is exempt from the notice
and public comment provisions of the
Administrative Procedure Act, as well
as provisions concerning delayed effec-
tive dates.
(3) Many commenters expressed the
view that to apply these requirements
to officers and employees of a business
organization would result in ill-consid-
ered, premature reports and would un-
fairly subject employees to conflicting
responsibilities as Individual respon-
dents and as corporate agents. Other
commenters expressed support for the
view that certain employees have a re-
sponsibility to report pertinent infor-
mation, and felt that the phrase "ca-
pable of appreciating pertinent infor-
mation" appropriately described those
employees.
The September 9 proposal would
have applied section We) requirements
to commercial establishments as well
as to employee* capable of appreciat-
ing pertinent information, but stipu-
lated enforcement priorities intended
to encourage corporate processing and
centralized reporting of such informa-
tion (43 FR 45343). The Intent was to
ensure that pertinent Information ob-
tained by employees to promptly and
appropriately considered, while mini-
mising dupllcatlve or Ill-considered
submissions.
The Agency now feels that these ob-
jectives would best be served by allow-
ing commercial establishments—under
certain conditions designed to ensure
full disclosure—to assume exclusive re-
sponsibility for reporting to EPA any
substantial-risk information obtained
by individual officers or employees.
Accordingly, this polsey statement
stipulates that individual officers and
employees will have fully discharged
their section We) obligations once they
have notified the designated responsi-
ble company supervisor or official of
pertinent information, provided, that
the employing company or firm has
established, internally publicizes, and
affirmatively Implements procedures
governing such notifications. These
procedure*, at t minimum, must:
Specify the information th»t must be
reported; (2) indicate how the notifica-
tions are to be prepared and submit-
ted: (3) note the Federal penalties for
falling to report: and (4) provide a
mechanism for promptly notifying of-
ficers and employees who have submit-
ted report* of the company's disposi-
tion of those reports, including wheth-
er or not they were submitted to EPA
(and If not. Informing employees of
their right to report to EPA. as pro-
tected by TSCA section 23). EPA be-
lieves these (our criteria will ensure
prompt and appropriate processing of
pertinent information.
Establishment of such procedures
notwithstanding, all officials responsi-
ble and having authority for the orga-
nization's execution of lu section 8(e>
obligations retain personal liability for
ensuring that substantial-risk informa-
tion Is reported to EPA.
(3) The September 9 proposal stated.
in Part III. that a person obtains In-
formation when he Is aware that it
"may suggest" substantial risk. Nu-
merous commenters questioned the
Administrator's authority to compel
the reporting of Information which
"may suggest" substantial risk. The
Administrator agrees that section 8(e)
addresses information that "reason-
ably supports the conclusion" of sub-
stantial risk and has deleted the "rosy
suggest" provision, but emphasizes
that "reasonably support* the conclu-
sion" of substantial risk is not identi-
cal to a conclusive demonstration of
substantial risk. The former typically
occurs, and must be reported, at an
earlier stage. Part VI in this policy
statement provides Agency interpreta-
tion of the types of information that
"reasonably support" sucn a conclu-
sion.
(4) Numerous commenters requested
clarification of different aspects of
Part V of the September 9 proposal
("Information Which Reasonably Sup-
ports a Conclusion of Substantial
Risk"), particularly concerning envi-
ronmental effects, and suggested dif-
ferent interpretations of what consti-
tutes a "substantial risk". The Agency
continues to focus in this policy state-
ment on the effects set forth In the
September 9 proposal, but clarifies
that the substantiality of a risk is a
function of both the seriousness of the
effect and the probability of its occur-
rence (see Part V).
(5) Numerous commenters main-
tained that section K*> only applies
prospectively to information obtained
after January 1.1977. The Agency dis-
agrees, as explained in the preamble
to the September 9 proposal. This
policy statement continues to apply
section 8 to Information obtained
before 1977 of which s person ha*
KOtlAl MOKTU. VOL 41. MO. SI-IMUttPAT. MAS.CM IS. If71
92
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NOTICES
Hill
been aware since January l, 1977. jn
rtsporue to requests (or clarification.
the statement defines what constitutes
auch awareness. In thli manner. EPA
Intend* to limit the need for searches
of historical record* and files.
(8) This policy statement now pro-
vides that any Information published
In scientific literature, In any lan-
guage, is exempt if It is referred to in
abstracts published by specified ab-
stracting services.
(7) This policy statement describes
In a new Part X how to submit claims
of confidentiality.
Accordingly, the Administrator's In-
terpretation of and policy towards sec-
tion 8(e> is set forth below.
Dated: February 24.1978.
DOOCLAS COSTLt
AdminutmLor.
1. DtnNmoNS
The definitions set forth in TSCA
section 3 apply to these requirements.
In addition, the following definitions
are provided for purposes of this
policy statement:
The term "manufacture or process
•for commercial purposes' " means to
manufacture or process: (1) For distri-
bution in commerce, including for test
marketing purposes. (2) for use as a
catalyst or an Intermediate. (3) for the
exclusive use by the manufacturer or
processor, or (4) for product research
and development.
The terra "person" Includes any nat-
ural person, corporation, firm, com-
pany, joint-venture, partnership, sole
proprietorship, association, or any
other business entity, any State or po»
UticaJ subdivision thereof, any munici-
pality, any Interstate body and any de-
partment, agency, or Instrumentality
of the Federal Government.
The term "substanttaJ-rtsk Informa-
tion" means information which rea-
sonably supports the conclusion that a
chemical substance or mixture pre-
sents a substantial risk of injury to
health or the environment.
II. POISONS SUBJECT TO THI
REQUIREMENT
Persons subject to section Me) re-
quirements include both natural per-
sons and business entities engaged in
manufacturing, processing, or distrib-
uting In commerct a chemical sub-
stance or mixture. la the cast of busi-
ness entitles. the president, chief ex-
ecutive officer, and any other officers
responsible and having authority for
the organization's execution of Its sec-
tion 8 obligations retain personal liabil-
ity for ensuring that the appropriate
substantial-risk Information is report-
ed to EPA.
Business organizations that do not
establish such procedures cannot re-
lieve their individual officers and em-
ployees of the responstblity for ensur-
ing that substantial-risk information
they obtain is reported to EPA. While
officers and employees of such organi-
zations may also elect to submit sub-
stantial-risk information to their supe-
riors for corporate processing and re-
porting, rather than to EPA directly.
they have not discharged their individ-
ual section Xe) obligation until EPA
has received the Information.
Nott.—li respective of a business orgaaba-
tlon's decision to establish and publicist the
procedures describe* above, it is responsible
for becoming cognisant of any substantial-
risk Information obtained by Its offleen and
employe**, and for etuurtns that such infor-
mation Is reported to EPA wiutin IS work-
ing days.
III. WHEN A PDSON Wiu. Bi REGARDED
AS HAVING OSTAIMED INFORMATION
A person obtains substantial-risk in-
formation at the time he first comes
Into possession of or knows of such In-
formation.
Sort.— ThU include* Infnrmttion
which » prudent penon ilmilarly mil
could rewontbly be expected to pouJ
have knotrledf e.
An establishment obtains Informa-
tion at the time any officer or em-
ployee capable of appreciating the sig-
nificance of such Information obtains
it.
IV. RNUiKmtNT THAT A POISON "IM-
MEDIATELY InrORM" THI AOkUMISTKA-
TO*
With the exception of Information
on emergency Incidents of environ-
mental contamination (see Part V(c)]
a person has "Immediately Informed"
the Administrator If information Is re-
ceived by EPA not later than the 15th
working day after the date the person
obtained such Information. Supple-
mentary Information generated after a
section Xe) notification should, if ap-
propriate. be immediately reported.
For emergency incidents of environ-
mental contamination, a person shall
report the Incident to the Administra-
tor by telephone as soon as he has
knowledge of the Incident (see Part EX
for appropriate telephone contacts).
The report should contain as much of
the information required by Part CX
as possible. A written report In accor-
dance with Part IX (a) through (f) Is
to be submitted within IS days.
Information currently In the posses-
sion of a person who is subject to re-
porting must be reported wlthln
days of publication of this policy
ment.
V. WHAT CONSTHUTU SuisTAjrrui
RISKS
A "substantial risk of Injury to
health or the environment" Is a risk of
considerable concern because of (a)
the seriousness of the effect (see Sub-
parts (a), (b), and (e) below for an il-
lustrative list of effects of concern].
and (b) the fact or probability of its
occurrence. (Economic or social bene-
fits of use. or costs of restricting use.
are not to be considered In determin-
ing whether a risk is "substantial".)
These two criteria are differentially
weighted for different types of effect*.
The human health effects listed in
Subpart (a) below, for example, are so
serious that relatively little weight Is
given to exposure: the mere fact the
Implicated chemical is in commerce
constitutes sufficient evidence of expo-
sure. In contrast, the remaining ef-
fects listed In Subparts (b) and (c)
below must Involve, or be accompanied
by the potential for. significant levels
of exposure (because of general pro-
duction levels, persistence, typical
uses, common means of disposal, or
other pertinent factors).
Note that: (1) The effects outlined
below should not be reported if the re-
HOCtAi MQISTII. VOL 43, NO. SJ—TMUISOAT, MASCM It. WS
93
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11112
NOTICES
ipondent hu actual knowledge that
the Administrator U already Informed
of them.
(ID Information respecting these ef-
fects can be obtained either directly.
by observation of their occurrence, or
Inferred from designed studies as dis-
cussed in Part VI.
The Agency considers effects for
which substantial-risk Information
must be reported to include the fol-
lowing:
(a) Human health of the
Federal Water Pollution Control Act.
VTH. IXTOBMATION FIRST RECEIVED rr
A PERSON PRIOR TO rn ETTECTIVX
Dan or TSCA -
Any substantial risk Information
possessed by a person prior to January
1.1977. of which he is aware after that
date shall be reported within 60 days
of publication of this policy statement.
The Agency considers that a person Is
-aware" of:
(a> Any Information reviewed after
January 1. 1977. Including not only
written reports, memoranda and other
documents examined after January 1.
1977. but also Information referred to
In discussions and conferences in
which the person participated after
January 1.1977:
puttM uomn, voi «, NO. SI-TMMSOAV, MAICH u. im
-------
NOTICfS
11113
'
(a) Be sent by certified mall, or In
any other way permlttinc verification
of its receipt by the Agency,
(b) State that It Is being submitted
In accordance with section 8(e),
(c) Contain the job title, name, ad-
dress, telephone number, and signa-
ture of the person reporting and the
name and address of the manufactur-
ing. processing. or distributing estab-
lishment with which he is associated.
(d) Identify the chemical substance
or mixture (Including, if known, the
CAS Registry Number).
(e) Summarise the advene effecu
being reported, describing the nature
and the extent of the risk involved.
and
(f ) Contain the specific source of the
Information tec ether with a summary
and the source of any available sup-
porting technical data.
For emergency Incidents of environ-
mental contamination (see Part V(c».
a person shall report the incident to
the Administrator by telephone aa
soon as he has knowledge of the Inci-
dent (ate below for appropriate tele*
phone contacts). The report should
contain at much of the Information re-
quired by Instructions (b) through (f)
above as possible. A written report. In
accordance with instructions (a)
through (f) above, to to be submitted
within IS days. Twenty-four hour
emergency telephone numbers arc
Region I (Maine, Rhode Island. Conntetl-
cut. Veroont. Msssartiinitfi New Bamp-
shirt). S17-333-TJ4*.
Region n (New Tort. New Jersey. Puerto
Rico, Vtrgm Us**). Ml-Ms-fTX.
Regloa m (PsneaHi Hill, West Virginia.
Virginia. Manrlane, Delaware, District of
Columbia). lU-MT-atea,
Region IV (Kentucky. Tinnsssii. Norm
Carolina. South Carolina. Georgia. Ala-
bama. Mississippi. Florida). 404-SS1-40SS.
Region V (Wisconsin, miaoH. Indiana.
Michigan, Ohio. Minnesota). 113-U3-
3311.
Region VI (New Mexico. Tesas. Oklahoma,
Arkansas. Louisiana). 314-74S-JS40.
Region VII (Nebraska, Iowa, Missouri.
Return VIH (Colorado, Utah. Wyoming.
Montana, North Dakota. South Dakota).
jO}-SJ7-jasO.
Region IX (California. Nevada. Arizona.
Hawaii. Guam), 415-554-4354.
Retion X (Wuhincton. Oregon. Idaho.
AlAJtt). 206-44 MJOO.
X. CoNriDorruuTT CLAIMS
(a) Any person submitting a notice
to EPA under section 8(e) of TSCA
may assert a business confidentiality
claim covering all or part of the Infor-
mation contained In the notice. Any
Information covered by a claim will be
disclosed by EPA only to the extent.
and by means of the procedures, let
forth in 40 CFR Part 2 (41 FR 36902.
September 1.1976).
(b) If no claim accompanies the
notice at the time It U submitted to
EPA. the notice will be placed In an
open file to be available to the public
without further notice to the submit-
ter.
(c) To assert a claim of confidential-
ity for information contained In a
notice, the submitter must submit two
copies of the notice.
(1) One copy must be complete. In
that copy the submitter must indicate
what Information. If any. Is claimed as
confidential by marking the specified
information on each pace with a label
such M "confidential." "proprietary,"
or "trade secret."
(2) If some information In the notice
Is claimed as confidential the submit-
ter must submit a second copy. The
second copy must be complete except
that ail Information claimed as confi-
dential In the first copy must be de-
leted.
(3) The first copy of the notice will
be disclosed by EPA only to the
extent, and by means of the proce-
dures, set forth In 40 CFR Part 2. The
second copy will be placed in an open
file to be available to the public.
(d) Any person submitting a notice
containing Information for which they
an asserting a confidentiality claim
should send the notice in a double
envelope.
(1) The outside envelope should bear
the same address outlined In section
IX of this policy statement.
(2) The Inside envelope should be
clearly marked "To be opened only by
the OTS Document Control Officer." '
XL TuLon To RXTCBT Iirrouunon
Section 1*3) of TSCA makes It un-
lawful for any person to fall or refuse
to submit Information required under
section He), flection 16 provides that a
violation of section IS rendeis a
person liable to the United States for
a civil penalty and possible criminal
prosecution. Pursuant to section IT.
the Government may seek Judicial
relief to compel submittal of section
8 wnouiir
threaten* non-human organism* nth lane
teale or ecologically (Igiufleant population
destruction", (flee Pan V-3»40.
Region VH (Nebraska. Iowa. Missouri.
Kansas). llg-374-JTTg.
Region Vin (Colorado. Otah. Wyoming.
Meatana. North Dakota, South Dakota).
Ml-417-MaO.
Region IZ (California. Nerada. Artaona.
Hawaii Ouam), 415-994-4354.
Region X (Washington. Oregon. Idaho.
Bissau. lirTua-noo.
la addition, a written repon. in tccard-
aaee with Instructions (») through of
Part CC. Is to be tubmitted within 15 dayt to
the Document Control Officer, Chemical In-
formation Division. Office of Toxic Sub-
stances (WH-U7). 401 M Street SW.. WMA-
lagtoa, D.C. 30440.
Ammx •— BioitmcAifT Coionjm un
Rawomai
A. mson svann TO man
Cosieiinl 1: Employees cannot be held
•abject to these requirement*, since: <»)
They only have a partial role in the manu-
facture. praectttns. or dlitrtbution of chemi-
cals. (b) la other tectlons of TSCA. the term
"person who manufacture*, proceem. or
distributes" chemical* clearly refen to bun-
ness ortanlxauons; -personf ihould b« con-
sistently defined, and (c) the Application of
criminal penalties mandate* t itrtct inter-
pretation of this word.
(•"**) See NOTE on last page of Appendix C
rtOMAl U04STH. VOL 41. MO. S3-TNUt»AV, MAIO4 I*. IfTS
95
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HIM
NOTICES
Ktnentr: The Agency consider* that dif-
ferent sections of TSCA. having different
purpose*, are approprtawly directed lo dlf
ferent respondents. In the cue of section
tit}, officer* and employees who are capable
or appreciating the ilfnlflcanee of Informa-
Don have • letillmate responsibility to be
alert to and report substantial-risk informa-
tion. The guidance hat been modified to
that natural persons and business entitles
can fulfill their section lie) obligations In
different ways. Most officers and employee*
can discharge their section lce> obligations
by submitting pertinent Information to cor-
porate superior*, provided that the com-
pany has established the risk-evaluation
procedure* characterised in Part II. In the
case of a business organization. Us presi-
dent chief executive officer, and other offi-
cials responsible and having authority for
the bnilnets organization's execution of its
section Ke> obligations must ensure that
the organization reports subsuntial-nst In-
formation to IP A.
Comment 1: Even If employees can be held
subject to th«M requirements, they should
not be. To do so would force employees and
employer* Into conflicting positions. Inviting
Internal corporate dissension and over- re-
porting. Further, individuals often do not
have the overview necessary to reach con-
sidered, well-supported decisions. Corporate
reporting by designated officials will pro-
vide EPA with more reliable data.
Kttpomt: The Agency consider* that en-
ployee* have a legitimate role in rtak report-
mi: it la imperative that risk Information
obtained by employee* be appropriately
considered. Officers and employee* can ful-
fill their role In the reporting of substantial-
risk information, without the disadvantages
described above, by reporting information
to superior* for corporate consideration.
and. having dont to, will have discharged
their obligation to EPA. This Is contingent
upon the establishment by the busmen or-
ganization of certain procedures for risk-
evaluation, thereby assuring the appropri-
ate consideration of such report*. Those of-
ficers responsible and having authority for
the organization's execution of It* section
8(*> obligations must ensure that the orga-
nization report* substantial-risk Informa-
tion to EPA.
Comment 3: Clarify which employees art
covered, and the extent of their obligation.
Are employee* "capable of appreciating per*
tlnent Information." by virtue of rank, or
knowledge? Are rank and We employee*
subject to the** requirement*, or just super-
visory and managerial penonneL company
toxieotogisu. etc.? Is an employ** absolved
of further responsibility If ht report* to hi*
supervisor?
JUsfotu*.- Th* Agency considers that the
phrase "capable of appreciating the atgnifl-
cane* of perunttrt information" appropri-
ately describe* tn*s» officer* and employee*
who have a rtt**jat«Miny to be alert to and
report substamtal-rtok Information. Includ-
ing not only relatively senior corporate offi-
cers but ai*o many corporate employ***.
The- policy statement modifies the Septem-
ber • proposal. In rapom* to the concern*
exprissed in Comment* 2 and 3. to permit
most officers and employe** to dueharg*
their obligation by submitting information
to corporate superior*, subject to the condi-
tion* described in Part II.
Co*tm«*t *V Consultant* and Independent
late should not be subject to these require-
ments
Atttont*. Contractor] and Independent
lab* are not responsible for reporting infor-
mation they have obtained directly to EPA:
rather, their client manufacturer*, proces-
sor* and distributor* are responsible for
reporting such information.
(. TKl "OtTAlHIHQ" Or tUPOaiUTlOlf
Comment 5. The "may suggest" criterion
In Pan III of the proposal serves to compel
further examination of information that by
luelf Is not subject to section « require-
ment*. The statutory language calling for
"reasonable support" does not support this.
Further, risk assessment often require* any-
where from month* to several yean of
study after preliminary rwsulu "suggest"
risk, far exceeding the 14-day compliance
period.
AstpoiMV The Agency doe* not Intend to
compel under section Ke> examination of
Information that by lutlf Is not subject to
section Ke> requirements and ha* deleted
the "may suggest" provision, providing It*
Interpretation of what oonstltuu* evidence
that "reasonably rapport* the conclusion"
of substantial nsk in a new Part VI.
Comment tv flection Me) obligations are
incurred upon obtaining eoncluaory substan-
tial-risk information.
JUspoiut The Agency disagree*, and con-
siders that "reasonable support" of a con-
elusion of substantial risk is not Identical to
the conclusion itself. The former typically
occurs, and mutt be reported, at aa earlier
•tag*.
Comment r The statement. In Part in of
the proposal that a person hat obtained In-
formation If he ". . . should know of the ex-
istence of such Information not In his poo-
station but which would be delivered to him
oa request." Undt to compel an active
starch for substantial-risk information
rather than the reporting of substantlal-nsk
Information a person "obtain*." This It of
particular concern to Importers with United
aeetss to Information po*t***ed by their
suppliers.
Jtwpofij*; The Agency considers that sec-
tion Kt) applies to information which a
pmon possesses or of which he know*. It I*
not Inunded to compel searches for Infor-
mation or extraordinary effort* to acquire
information. Th* Agency further eonsMert.
however, that "known" Information In-
cludes Information which a prudent perton
similarly tttuaud could reasonably be ex-
pected to know. Negligence or inunUonal
avoidance of Information do** not absolve a
ptnon of his atction Kt) obligation. Pan
III hat b*tn modified to nprttt the** in-
tention*.
Com**** I; Clreumstane** can exist when
coming "Into po*****lon" of risk Informa-
tion dot* not eorreapond to an understand-
Ing of the implications of tht information:
"obtain*" should be defined In Urn* of pea-
station of Information and awarinsst of It*
Import.
Jtatponsr Th* "obtaining" of Information
occur* via persons who are "capable of ap-
preciating the significance of pertinent in-
formation." There will likely b* circum-
stance* la which tht evaluation of Informa-
tion claim** it* full import: UM ettabush-
ment of corporate procedure* tor processing
risk-Information prescribed In Part II will
(corporau proeeailag. mailing, holidays.
etc.).
Ketpontt. The Agency has changed the
compliance period to IS business d»yi It is
Imperative that procedures be established to
expedite the reporting of mbatamiii ruk in-
formation. not that reporting conform to
existing procedures.
Comment 10: Allow from 30 to 90 days for
the second phase of reporting: alternatively.
do not prescribe a lime limit for additional
reporting.
JtMponj* Having deleted the "may sug-
gest" criterion. the Agency lees no need to
provide a second phase to the reporting
period. Supplemental information that I*
generated after a section 8 c Envi-
ronmental Effects"). Persistence and bin-
accumulation should be considered risk*
only when coupled with toxtclty and iignif I-
cant exposure.
•ttftAi IfOISTn. VOL 49. NO. n-.1MUtS0AY. MAiCH 1*. IfTl
96
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NOTICES
1111!
Ituponif Ptrt V now cl»nfic» those ef-
fecu for which reporting depends upon t
significant exposure potential, persistence
by luelf It no lonfer lUmued u a report-
able effect but rather I* considered to be a
component of exposure potential, it ma*
also underlie the measurements described in
Put VibMi). Laboratory Indicators of pro-
nounced btoaccumuJallon are 10 be reported
when coupled with potential for widespread
czpcture and any non-trlvla) advene effect.
Commtnl 17: The n-octanol/'water parti-
tion coefficient addresses t physico-chemi-
cal property, not biological effecu. and is
net alone an indicator of substantial rUk:
further, the value* stated for the coefficient
and the bioaccumuiaiion factor in fish do
not correspond.
JUtponjc The Agency aeknowiedtes the
numerical error and ha* amended the value*
to correspond. ThU policy statement now
dlneu the reporting of an experimental
measurement of bloaecumulatlon when
coupled with an advene effect and potential
for widespread exposure.
Comment It: The requirement that infor-
mation which "links" an effect to a chemi-
cal be reported li too broad and contradict*
the natatory language of "reasonably
supports".
Jtetpoiuc: The Agency hai provided In a
new Pan VT tu interpreuuon of "reason-
ably support*"-
Comment it: A deterailnatlon that Infor-
mation "reasonably support* the conclu-
sion" of substantial risk cannot be made in-
dependently of considerations of use since
the method and manner of using a chemical
may Influence the occurrence of an effect:
IB particular, the criteria should reflect a
distinction between normal and abnormal
uses of chemicals.
JUtsour The Agency considers that the
appropriate components of a "substantial
risk" with respect to a chemical are the
seriousness of the effect and (b) total expo-
sure potential. The method and manner of
using a chemical Is one of several factor* de-
termining It* exposure potential. As de-
scribed m Part V. the importance of expo-
sure potential as a component of "substan-
tial risk" depends upon the kind of effect of
concern. Thus, the effects described In Part
V(a) are so serious that relatively little
wetsht Is fiven to exposure: the effects de-
scribed In Parts V (b) and (e) involve a slg-
nlftcant exposure or exposure potential.
The Agency further considers that a defi-
nition of "normal" use for a particular
chemical will often depend upon a knowl-
edge of the risks associated with the
k WOT Sg HPOA1D
I. motKATioit nut i
Comment 2ft Information published In
scientific literature m languages other than
English shouM tw exempted U published in
summary form by abstracting services. Can
the accuracy of Cnglish language abstracts
and commercial translations of foreign lit-
erature be assumed?
JUfponsr This policy statement now pro-
Tide* that Information published In scten-
Ufle literature, whether In English or an-
other language. Is exempt from reporting If
published In summary form by certain
specified abstract services.
Comment il: Information exchange sys-
tems with other Federal agencies should be
Immediately established so that respondents
need not report to EPA information already
reported to other Agencies, and vice versa.
Such duplicative report* are unduly burden-
some.
Rrtporue EPA Is coordinating this pro-
trim with other agencies now. When this
coordination U successfully completed, the
policy statement will be amended to exempt
from the reportlni requirement information
that has been submitted to other specified
agencies. In the meantime, substantial-risk
information must be reported directly to
EPA: such a report does not discharge any
reporting obligation to other agencies.
r. ixrouiATiOK nxrr IKTTTTD mot to TU
smcn'vc OATI or TSCA
Comment it The tense of the verb "ob-
tains" reveal* that section »(*) was Intended
to be applied prospectlvely to Information
newly acquired after January 1. It77. Utilise
section Kd) or other rules to acquire Infor-
mation obtained before then.
JUspoiuc.- As discussed in the preamble to
the September 9 proposal, the Agency con-
siders section Me) to apply to risk Informa-
tion possessed by or known to a person
before, on. or after January 1. 1OT. Con-
cerning Information first obtained before
1977. this policy statement continues to re-
quire reporting of information received if a
person has been aware of It since January 1.
1977, for the reasons discussed in the Sep-
tember 9 preamble.
Comment 23: The term "aware" Is too
vague to be of any help In responding to
these requirement*. Since many corporate
employees are potentially subject to these
requirement*, and given uncertainty over
the extent to which they ought to be aware
of pre-1177 Information, this provision tends
to compel the very file search It was Intend-
ed to avoid. The tern "aware" should be
further defined, possibly la terms of actual
knowledge.
KttvontK The Agency In Put VTO of this
policy statement now defines the pre-1177
information of which a person Is considered
to be aware.
0. CONf UIOTTIAL UV FOIMATtOli
Comment 2«V EPA should delay guidance
until procedures are published governing
the treatment of confidential submissions.
Comment 25: EPA should treat all submis-
sions as confidential until the Information Is
verified.
Comment 2*V EPA should automatically
publish section Me> notices.
Jtefponse to Commend U ttrovsn 2tr
EPA has Included a new Put X which de-
scribes how to submit a claim of confiden-
tiality and states thai any or all of the la-
formation submitted may be claimed as con-
fidential. Such information will be disclosed
by EPA only to the extent, sad by means of
the procedures, set forth la 40 CPU Put 2.
Comment 27: What Is the statutory basts
or need for guidance? What is It* exact
status under the Administrative Procedure
Act?
Aetscfw*.- This policy statement set* forth
EPA's interpreuuon of and policy concern-
ing TSCA section Me). As sa Interpretive
rule and statement of policy it Is not subject
to the comment period and delayed effec-
tive date provisions ef the Administrative
Procedure Act (S C.3.C. SM>. Although
TSCA does not mandate a policy statement.
the Agency of necessity must develop the
criteria which will govern enforcement ac-
tivities. Trade associations and businesses
were among those who previously expressed
Interest In such a statement to guide their
compliance.
Comment 21: Clarify whether these re-
qulremenu toply to chemicals
but no longer manufactured.
distributed in commerce by i
Rttfont*. Information ,^^
1977 must be reported If the person" na*
been aware of It since January I. ifl. a*
prescribed by Ptrt VIII. Concemlni chemi-
cals which a person has discontinued manu-
facturing, processing, or dlsirlbuuri since
January 1. 1977. information obtained
before the time of discontinuation U subject
to these requlremenu. It is expected that
the acquisition of Information after that
time will be minimal: however, should addi-
tional Information be acquired. It msy trig-
ger the reporting described In Part VIII.
Comment tt: Clarify the meaning of "sub-
stantial risk" relative to other ruuu ad-
dressed by TSCA.
Jterpon**: A substantial risk Is defined la
Ptrt V(a) of this policy statement as a risk
of considerable concern because of (a) the
seriousness of the effect, and (b) the fact or
probability of IU occurrence. A* opposed to
other risk* sddresssd by TSCA. economic or
social benefits of use. or costi of restricting
use. are not to be considered in determining
whether a nsk is "substantial".
Comment 30: To what extent are "users'*
of chemicals subject to these requiremcnu?
JUtpoiu*; The Agency considers that
many Industrial uses of chemicals actually
fall within the scope of "processing" chemi-
cals. A manufacturer, processor, or distribu-
tor who obtains substantial-risk Information
concerning chemical* he handles should-be
alert to the possibility he may have to
report It
Comment 31: Are chemicals manufac-
tured, processed and distributed In com-
merce In small quantities solely for purposes
of research and development subjsxL to
these requirements?
JUtponir la general, the Agend
ers that much manufacturing, pi
and distribution la commerce of
In small quantities solely for purposes of re-
search and development Is conducted for
"commercial purposes". Such purposes
would Include the sale sad distribution of
such materials, as well at their use by the
manufacturer or processor In activities (for
example, product research and development
and studies assessing the feasibility and
safety of using chemicals) preceding his or a
client's commercial use of such material* or
others on a Isirgsr scale.
As described la Pan V. the Agency consid-
ers that "substantial risks" depend in pan
upon aa exposure potential. Thus, the oc-
currence of the effecu described In Pan
V(a) presuppose exposure to the chemical
and must b* reported: reporting of the
other effecu will depend upon a potential
for significant levels of exposure.
Comment 22." An raw material*, interme-
diates, and Inert Ingredlenu produced or
used la the manufacture of a pesticide sub-
ject to TSCA?
JUtaoiuc The Administrator consider*
that raw materials, laurmediates and inert
Ingredlenu produced or used in the manu-
facture of a pesticide art substances or mix-
tures which can be regulated under TSCA.
In order U be considered a pesticide, a
substance must be intended for us* as a pes-
ticide. Raw maurials. Intermediate*, and
inert Ingredlenu produced or used in the
manufacture of a pesticide are not them-
selves regulated under FIFRA (unless they
happen to be pesticides themselves) and.
therefore, are subject to TSCA. The pesti-
IIOISTH. VOL 43, NO. $1—TMOISOAT, MAICH It, IV7I
97
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11114
Nonas
elde reflation* tt 40 CFR 112.4 are eon*!*-
tent witn thl* view.
Comma** )): Are Intermediate* and eata-
lytu Intended lolely for UM In the produc-
tion of i food, food additive, druc. eoametlc,
or device lubject to TSCA?
Kttfonte: The Administrator eonflden
that intermedimtcf and eatalyiu Intended
eolely for UM in the production of a food.
food additive. dru<. coametle.. or devtee are
excluded from regulation under TSCA. The
definition* of the PFDCA provide that
chemical eubiuncee which ve intended for
UM u a component of » food, food tddJUve.
drui. cocmeuc. or device m eneompMMd
withla the meaninc of nch tern*, rvpec-
Urely. The rDA eonklden Inurnedlatei
»nd euajyiu to be lueh component. There-
iore.they are iub)ect to reculauon under
the FFDCA. Any luch nbeunee It excluded
from reiulauon under TSCA Inaofar ai It I*
actually aanufactured. prooMeed. or dl*-
tributed In commerce tolely for UM in the
production of a food, food addlUve druc
owmeile, or device.
Commtnt 14: ftnployeee thould have UM
option to fubmic report! anonymoudy.
*«poiwt n>A ooMlden that any penon
•ay report Information to EPA under
TSCA. Thoee who are required to do to
under eeeuon Ke) are penon* who manu-
facture, procea*. or dljtrlbuK in commerce
chemical tubiuneee or mixture*, includtnc
not only buitnee* entitle* but al*o *uch em-
ployee* a* described In Pan II. in order to
eeubUah that tuch peraoo* have dlacharted
their obltntlen*. and in order to encourace
resgonalble review of the quality of informa-
tion and the nibttanUallty of rtalu. EPA be-
Ueve* that ootl/len ahould Identify them-
Mlvea. Section 23 will adequately protect
employee* from dlecrunlnauon punuant to
notifleauon* tney have made under section
Me).
OH Doe. 7»-TM4 ned 3-15-T8:145 am]
•OTB
According to technical amendments published
by EPA in the May 29, 1987 FEDERAL REGISTER
(52 FR 20083), TSCA Section 8(e) submissions
are to be addressed to the Agency as follows:
Document Processing Center (TS-790)
(Attn: Section 8(e) Coordinator)
Office of Toxic Substances
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D.C. 20460
PIOttAl UOUTtt, VOC 4). NO. S1-THUI10AT, MAIO4 I*. lfT«
98
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Friday,
February 1, 1991
APPENDIX D
(CAP Notice)
Part II
Environmental
Protection Agency
Registration and Agreement for TSCA
Section 8
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4128
Federal Register ' Vol. 56, No. 22 / Friday. February i. 199; ; Notices
ENVIRONMENTAL PROTECTION
AGENCY
(OPTS-M015; FRI-M44-4]
Registration and Agreement for TSCA
Section 8
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Federal Register / Vol. 58, No. 22 ' cnday. February 1. 1991 / Notices
4129
that is and hat been consistent with the
statutory language and intent of section
8(e), as well as EPA's Section 8(e) Policy
Statement. Nevertheless, to achieve the
Agency's goal of obtaining any
outstanding section 8(e) data. EPA has
developed this one-time voluntary
compliance program designed to
strongly encourage companies to
voluntarily audit their Mies for studies
reportable under section 8(e). This
program is known as the TSCA Section
8(e) Compliance Audit Program.
The TSCA Section 8(e) Compliance
Audit Program has been developed to
encourage industry reporting by setting
forth guidelines that identify in advance
EPA's enforcement response and allow
companies to assess liability prior to
electing to participate. Companies that
do not participate in the TSCA Section
8(e) Compliance Audit Program should
be aware that EPA intends to actively
pursue violations of the TSCA section
8(e) reporting requirement.
II. Text of tht Rafistratfon/CAP
Agreement
The text of the Registration and CAP
Agreement for the TSCA Section 8(e)
Compliance Audit Program:
UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
Office ol Peattdde* and Toxic Subatance*
Registration and Agreement for TSCA
Section 8fe) Compliance Audit Program
The United States Environmental
Protection Agency ("EPA") and the
Regulatee. the Parties herein, wishing to
register for and enter into this
Agreement for a Toxic Substances
Control Act ('TSCA") Section 8(e)
Compliance Audit Program ("CAP
Agreement"] and having contented to
the terms of this CAP Agreement do
therefore agree to fully comply with the
terms of this CAP Agreement.
L Registration Requirements
A. The Regulatee agrees to conduct a
TSCA Section 8(e) Compliance Audit
Program to determine its compliance
status with TSCA section 8{«j.
B. To register for the TSCA Section
8(e) Compliance Audit Program, tht
Regulatee mutt, no later than May 2.
1991. sign and return this CAP
Agreement by certified mail-return
receipt requested to: Michael F. Wood.
Director. Compliance Division (EN-342).
Office of Compliance Monitoring.
Environmental Protection Agency. 401 M
St.. SW, Washington. DC 20460.
C. After EPA receives this signed CAP
Agreement from the Regulatee. EPA will
sign this CAP Agreement and enter the
following identification number
( ) to the copy of
this CAP Agreement which will be
returned to the Regulatee. The Final
Report and all other documents
submitted pursuant to Unit II.C of this
CAP Agreement must display the
identification number established by
this paragraph.
D. The TSCA Section 8(e) Compliance
Audit Program shall commence no later
than May 2.1991.
E. The TSCA Section 8(e) Compliance
Audit Program shall terminate within
180 days of May 2.1991. Thus, all
submissions under this TSCA Section
8(e) Compliance Audit Program must be
delivered to EPA no later than October
29.1991.
II. Terms of Agreement
EPA and the Regulatee mutually
initiated this TSCA Section 8(e)
Compliance Audit Program in response
to a February 1.1991. Federal Register
notice announcing the opportunity to
participate in the TSCA Section 8(e)
Compliance Audit Program. As part of
this CAP Agreement. EPA and the
Regulatee agree to the following:
A. General Provisions
1. This CAP Agreement and the
Consent Agreement and Content Order
in this matter shall be a complete
settlement of all civil and administrative
claims and causes of action which arose
or could have arisen under TSCA
section 8(e) in connection with any
study or report submitted pursuant to
the terms of this CAP Agreement
Pursuant to TSCA. EPA will contider
ability to pay/effect on ability to
continue to do business claims during
the course of development of the
Consent Agreement and Consent Order
in this matter. The Regulatee will be
responsible for submitting adequate
documentation of such claims to EPA at
the time of submission of the Final
Report required by this CAP Agreement.
2. For purposes of this CAP
Agreement and any subsequent
proceeding, without trial or any
adjudication of the fact*, the Regulatee
admits that EPA hat jurisdiction over
the subject matter of the terms of this
CAP Agreement and any study or report
submitted pursuant to (hit CAP
Agreement.
3. The Regulatee waives ita right to
request a judicial or administrative
hearing on any issue of law or fact that
hat arisen or may arise during the
conduct of the TSCA Section 8(e)
Compliance Audit Program conducted
pursuant: 'he terms of this CAP
Agreemen- >r that may arise in any
subsequent proceeding involving the
Consent Agreement and Consent Order
resulting from and entered into pursuant
to the terms of this CAP Agreement.
including but not limited to the
Regulatee's right under TSCA section
18(a)(2)(A) to request a hearing.
4. The Parties agree that any study or
report submitted by the Regulatee under
this TSCA Section 8(e) Compliance
Audit Program and pursuant to the
terms of this CAP Agreement constitute
a violation of TSCA sections 8(e) and
15(3)(B), for which a civil penalty will be
assessed against the Regulatee. Any
study or report submitted under TSCA
section 8(e) prior to the date of
commencement of the TSCA Section
8(e) Compliance Audit Program is not
subject to the terms of this CAP
Agreement or the TSCA Section 8(e)
Compliance Audit Program.
5. EPA reserves its rights under TSCA
section 16 to take appropriate
enforcement action if EPA determines
later that the Regulatee was required to
submit under TSCA section 8(e) a study
or report determined by the Regulatee to
be not reportable and therefore not
submitted under the TSCA Section 8(e)
Compliance Audit Program. In such
event, the terms of the EPA TSCA
Sections 8.12. and 13 Enforcement
Response Policy will apply to such
proceeding.
e. EPA reserves its rights to challenge
the categorization of studies or reports
submitted under this TSCA Section 8(e)
Compliance Audit Program pursuant to
the requirements of Unit ILB.2.a and b of
this CAP Agreement
7. EPA agrees that any submissions
made pursuant to the terms of this CAP
Agreement and the TSCA Section 8(e)
Compliance Audit Program will be
viewed by EPA as "prior such
violations" under TSCA section
16(a)(2)(B) for future violations of TSCA
section 8(e) only.
8. The Final Report submitted
pursuant to Unit H.C.4 of this CAP
Agreement shall be the controlling
document for purposes of determining
what wat submitted under the TSCA
Section 8(e) Compliance Audit Program
and this CAP Agreement.
9. Any submission made by the
Regulatee to EPA that does not meet all
of the requirements of the TSCA Section
8(e) Compliance Audit Program and this
CAP Agreement it tubject to the EPA
TSCA Sections 8,12. and 13
Enforcement Retponte Policy.
B. TSCA Section 8(e) Compliance Audit
Program and Civil Penalties
1. In conducting the TSCA Section 8(e)
Compliance Audit Program, the
Regulatee shall use EPA's March 16.
1978. "Statement of Interpretation and
Enforcement Policy; Notification of
101
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Federal Register / Vol. 56, N'o. 22 / Friday._ r«hruary_l. 1991 / Notices
Substantial Risk" (43 FR11110) ("TSCA
Section 8(et Policy Statement") to
determine whether the reviewed itudy
or report is:
a. .Vof reportable under TSCA Section
B(e): The Regulate* will not submit the
study or report.
b. Reportable under TSCA Section
S(e): The Regulatee will submit the study
or report.
Upon Registration for the TSCA
Section 8(e) Compliance Audit Program,
the Regulatee will receive a copy of the
TSCA Section 8(e) Policy Statement, the
publication numbers of publicly
available and previously published
volumes of Section 8(e) "Status Reports"
available through the National
Technical Information Service, copies of
Question and Answer documents
developed in response to specific
questions involving section 8(e), and a
document entitled "Substantiating
Claims of Confidentiality."
2. The Regulatee agrees to pay the
following stipulated civil penalties for
all studies or reports suomitted under
this TSCA Section 8(e) Compliance
Audit Program as TSCA section 8(e)
data:
a. $15,000 per study for any submitted
study or report involving effecti in
human*.
b. $6.000 ptr study for any other
submitted study or report submitted as
TSCA section 8(e) data.
As a matter of policy under this TSCA
Section 8(e) Compliance Audit Program,
EPA agrees to a $1.000,000 cap on the
total civil penalty for the Regulate*.
3. The Regulatee shall be exempt from
any additional late and/or nonreporting
TSCA section 8(e) civil liability which
arose or could have arisen for any study
or report submitted under this TSCA
Section 8(e) Compliance Audit Program.
4. Upon termination of the TSCA
Section 8(e) Compliance Audit Program.
the Regulate* shall provide EPA with a
Final Report certifying that the TSCA
Section B(e) Compliance Audit Program
has been completed. Such Find Report
shall be ligntd and certified by the
appropriate corporate official with
authority to settle datea on behalf of
the Regulatee. Such Final Report shall
also comply with the requirement* of
Unit U.C.4 of thii CAP Agreement
S. Following termination of the audit
EPA will present the Regulate* with a
Consent Agreement and Conaent Order
summarizing the results of the TSCA
Section 8(e) Compliance Audit Program
and specifying the terms of payment of
stipulated civil penalties. The Regulatee
will have 30 calendar day* from its
receipt of an executed copy of the
Consent Order to pay any stipulated
civil penalties.
C. Information Submission and Final
Report
1. All studies or reports submitted to
EPA by the Regulatee under the terms of
this CAP Agreement shall be identified
pursuant to the categories established in
Unit U.B.2.a and b of this CAP
Agreement, and shall be sent to the
following address: Document Processing
Center (TS-790), Office of Toxic
Substances. Environmental Protection
Agency, 401 M St.. SW.. Washington. DC
20460. Attn: Section 8(e) Coordinator
(CAP Agreement).
2. The Regulatee shall submit one
original and two full copies of all cover
letters, studies, reports, substantiations
of confidentiality claims, and. as
appropriate, sanitized copies of cover
letters, studies, reports, or
substantiations of confidentiality claims.
3. In accordance with Part IX of the
TSCA Section 8(e) Policy Statement.
each study or report submitted to EPA
by the Regulatee under the term* of this
CAP Agreement shall be accompanied
by a separate cover letter containing the
following information:
a. Company name, address ana
telephone number.
b. The signature and printed name,
title and telephone number of the person
submitting the study or report.
c. A clear statement that the
document, identified on the cover letter
by the identification number established
by Unit I.C of this CAP Agreement, is
being submitted pursuant to the TSCA
Section 8(e) Compliance Audit Program
and this CAP Agreement.
d. The exact identity of each teited
chemical or mixture or component of a
tested mixture including the CAS
Registry Number, if known.
e. The title of the accompanying study
or report.
f. A full summary of the reportable
adverse effect(s) or exposure(s)
observed in the accompanying study or
report. In addition, the cover letter
should identify by EPA Document
Control Number any previous TSCA
section 8{e) submission(s) or
premanufacture notification!*) (PMN(i))
submitted by the Regulatee on the
•ubject chemical substance(s) or
mixture or component(s) of such
mixture.
4. Each study or report submitted to
EPA by the Regulatee under the term* of
this CAP Agreement shall be listed in a
Final Report. Such Final Report shall list
each tubmitted study or report by title
pursuant to the categories established in
Unit H.B.2.a and b of this CAP
Agreement, and shall display the
identification number established by
Unit 1C of this CAP Agreement. Such
Final Report shall certify that the TSCA
Section 8(e) Compliance Audit has been
completed and include the following
statement: "I certify that the information
contained in or accompanying this Final
Report is true, accurate, and complete.
As to any identified portion(s) of this
Final Report for which I cannot
personally verify its truth and accuracy.
I certify as the company official having
supervisory responsibility for the
person(s) who, acting under my direct
instructions, made the verification, that
this information is true, accurate, and
complete." The Final Report will be the
controlling document as to what was or
was not submitted under the terms of
this CAP Agreement and shall be sent to
the address specified in Unit I.B of this
CAP Agreement.
D. Other Matters
1. Nothing in this CAP Agreement
shall relieve the Regulatee from
complying with all applicable TSCA
regulation* or other applicable
environmental statutes.
2. This CAP Agreement shall be
binding upon the Parties and in full
effect pursuant to the requirements
specified in Unit I. of this CAP
Agreement.
3. The Regulatee's obligations under
this CAP Agreement shall end when the
Final Report required by Unit I1.C.4 of
this CAP Agreement has been tubmitted
to EPA and stipulated civil penalties
paid. .
4. Failure to comply with the terms of
this CAP Agreement permits EPA to
proceed under TSCA section 16 to
impose the civil penalties allowable
under the existing EPA TSCA Sections
8.12. and 13 Enforcement Response
Policy for any study or report submitted
pursuant to Unit Il.C of this CAP
Agreement.
5. All of the term* and conditions of
this CAP Agreement together comprise
one agreement and each of the terms
and condition* i* in consideration for all
of the other term* and condition*. In the
event that this CAP Agreement (or one
or more of it* term* and conditions) is
held invalid, or is not executed by all of
the signatory parties in identical form.
then the entire CAP Agreement shall be
null and void.
6. The Regulatee may assert claims of
confidentiality under TSCA section 14
for submissions under this CAP
Agreement. The Regulatee must, at the
time of submission, provide
substantiation for all information
claimed as confidential. The Regulatee
agree* that the failure to assert a claim
of confidentiality for studies, reports, or
information submitted under the terms
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Federal Register / Vol. 56. No. 22 / Friday. February 1. 1991 ' Notices
4131
of this CAP Agreement shall be
interpreted by EPA as a waiver by the
Regulatee of the right to asiert a claim
of confidentiality.
7. Submissions containing information
claimed as TSCA Confidential Business
Information (TSCA CBI) shall contain
cover sheets bearing the typed or
stamped legend "company confidential."
"proprietary," or "trade secret."
Information contained in the submission
which is claimed as TSCA CBI must be
clearly marked by boxing, circling, or
underlining the specific text so claimed.
All pages containing such information
shall also be marked
"CONFIDENTIAL" Care should be
taken to ensure that these markings do
not obscure the text of the submission.
Submissions directed to EPA in this
manner should be sent by certified mail-
return receipt requested or in any other
way which will permit verification by
the Regulatee of its receipt by EPA.
8. If the Regulatee chooses to assert a
confidentiality claim, the Regulatee shall
provide two sets of each such
submission: one set shall have the TSCA
CBI material marked in the manner
contemplated under 40 CFR 2.203(b) and
Unit ILD.7 of this CAP Agreement: the
second set shall have the TSCA CBI
material excised. The Regulatee is
advised that the second, "sanitized" set
will be available for public review
without further notice to the Regulatee
and therefore care should be exercised
in the creation of this set. Each sanitized
and unsanitized submission must
comply with Unit I1.C.2 of this CAP
Agreement and thus will consist of one
original and two copies.
9. The Regulatee is advised to review
carefully the confidentiality claim
procedures at 40 CFR 2.201. Specific
information concerning TSCA section
8(e) confidentiality claims is contained
at Part X of the TSCA Section 8(e)
Policy Statement.
10. The Regulatee agrees that if the
specific chemical identity is claimed as
confidential in a submission, a generic
nonconfidential chemical identity will
be included on the sanitized version of
the submission. Guidance for developing
appropriate generic chemical identities
may be obtained by consulting the
TSCA Chemical Substance Inventory:
1985 Edition, or by contacting the Office
of Toxic Substances' Chemical
Inventory Section at (202) 382-3527.
11. The Regulatee agrees that
confidentiality claims will be honored
by EPA only if each claim is
accompanied by responses to the
questions in the document provided with
this CAP Agreement entitled
"Substantiating Claims of
Confidentiality." The Regulatee shall
provide an original and two copies of
these responses in accordance with Unit
I1.C.2 of this CAP Agreement. The
Regulatee shall also, in the event the
Regulatee desires information in these
responses to be considered TSCA CBI.
provide a sanitized original and two
copies in accordance with Unit I1.C.2
and Unit II.D.8 of this CAP Agreement.
12. The Regulatee agrees that failure
to adhere to each requirement pertaining
to TSCA CBI may result in forfeiture of
the CBI protection for the submission
and its subsequent availability m its
entirety for public review.
WE AGREE TO THIS:
For Regulatee:
(Signing official]
[Title/
(Company name/
(Signing official)
(Title]
[Company name/
For EPA:
Michael F. Wood.
Director. Compliance Division. Office of
Compliance Monitoring.
Michael I. Walker.
Associate Enforcement Counttl for Pesticides
and Toxic Subttances.
m. Conclusions
EPA has announced the opportunity to
register for the TSCA Section 8(e)
Compliance Audit Program. Any further
information regarding this Audit
Program or the CAP Agreement may be
obtained from the contact person noted
above.
Dated: January 23,1991.
Linda ]. Flsbet.
AuistantAdminiitntorforPetticidesand
Toxic Subttances.
[FR Doc. 91-2290 Filed 1-31-91: 8:45 am]
103
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Friday
April 26, 1991
APPENDIX D
(CAP Modifications)
Part VI
Environmental
Protection Agency
Registration and Agreement for TSCA
Section •<•) Compliance Audit Program
Modification; Notice
104
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19514
Federal Register / Vol. 56. No. 81 / Friday, April 26. 1991 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[OPTS-M01SA; FHL-3W1-6J
Registration and Agreement (or TSCA
Section 8
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Fedanl Regiiter / Vol. 56. No. 81 / Friday, April 26. 1991 / Notices
19515
modified ilightly to moke it clear that
submissions under the CAP Agreement
will count as one "prior violation" of
8(e) only. Thu«. Unit D.A.7 of the CAP
Agreement hti been modified to read as
follows:
7. EPA agrees thil tny submission) made
pursuant to the terms of thit CAP Agreement
ind the TSCA Section S(e) Compliance Audit
Pragrim will b« viewed by EPA 11 one "pnor
•ueh violition" under TSCA lection
16(t|(2)(B) for future violttions of TSCA
tection 8(e) only.
No other modificationi to the "terms
of agreement-general provisions"
portion of the CAP Agreement have
been made.
C. Terms of Agnement-TSCA Section
8(e) Compliance Audit Program and
Civil Penalties
In order to facilitate participation in
the TSCA Section 8(e) Compliance
Audit Program ai well as to improve
section 8(e) compliance in general. EPA
is preparing and plans to disseminate a
section 8(e) reporting "guide" comprised
primarily of approximately ISO existing
TSCA section 8(e) submission "Status
Reports" which contain useful reporting
and implementation guidance. This
guide will include two indices. The first
index, which pertains to the ISO "Status
Reports." will be arranged by
toxicologic study type and other
important subheadings related to
reporting criteria. The second index will
be cumulative and arranged by type of
study for all initial submissions received
under section 8(e) to date. An additional
component of the guide will be a
consolidated presentation of section 8(e)
question and answer (Q*A) documents
arranged under subheadings similar to
the indices described above.
In response to a written request from
the Chemical Manufacturers
Association (CMA) for additional
guidance in the areas of neurotoxic
effects and environmental effects/
releases. EPA agreed to perform an
expedited review of * limited number of
case histories to be submitted by CMA
in early May. The Office of Pesticides
and Toxic Substances (OPTS) is
establishing a panel of EPA staff
scientists to perform the expedited
review of the case histories which are
submitted. While the EPA panel can
address endpoints of concern. CMA was
asked to prioritize the submissions to
focus attention on the key scientific
questions, especially neurotoxicity/
acute toxicity concerns. The EPA review
will focus primarily on whether the case
studies would be reportable under
section 8(e). The rationale for EPA's
conclusions and responses concerning
the appropriateness of reporting will be
provided as part of the section 8(e)
reporting guide which has been
described above. EPA will make every
effort to complete the guide in early June
and release it prior to the revised June
18.1991. registration deadline/audit
commencement date.
EPA requested that the environmental
effects/release cases focus on areas that
industry believes are problematic in
terms of what is reportable under
section 8(e). In order for EPA to respond
more completely about the section 8(e)
reportability of the provided
environmental effects/release
information cases. EPA also asked if the
information is required to be submitted
to another governmental authority and.
if so. the identity of that authority and
the timeframe for the reporting. The
rationale for EPA's conclusions and
responses concerning the
appropriateness of reporting will be
provided as part of the section 8(e)
reporting guide described above. EPA
will make every effort to complete the
guide in early June and release it prior to
the revised June 18.1991. registration
deadline/audit commencement date.
However, if necessary because of a
delay in completion of the guidance on
the environmental effects/release
information, reporting of this
information under the TSCA Section 8(e)
Compliance Audit Program will be put
on a specific schedule which will be
determined later based on when EPA
completes and disseminates the
guidance in this area.
Thus, to reflect the availability of the
TSCA section 8(e) reporting guide, the
second portion of the CAP Agreement
' language at Unit U.B.1 has been
modified to read as follows:
....Upon Regiitration for the TSCA Section
8
-------
Thursday
June 20, 1991
(Encoded Version)
APPENDIX D
(CAP Modifications;
Part IV
Environmental
Protection Agency
Registration and Agreement for TSCA
Section 8(e) Compliance Audit Program
Modification; Notice
.»?.' a,1-1. ;..-
••U •"
107
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ENVIRONMENTAL PROTECTION
AGENCY
[OPTS-M01SB; FRL-3932-1]
Registration and Agra»m*jnt for TSCA
Section 8{«) Compllane* Audit
Program Modification
AGENCY: Environmental Protection Agency
(EPA).
ACTION: Notice.
SUMMARY: This Notice, punuant to sections
15 and 16 of the Toxic Substances Control
Act (TSCAX 15 U.S.C. 2601 et seq.,
announces the availability of the TSCA
section 8(e) reporting pride and modification*
to EPA's TSCA Section 8
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Federal Register / Vol. 56, No. 119 / Thursday. June 20, 1991 / Notices
3
•ady or report panaam to Unit 0.8.3 of tfau CAP
A|reane«. Only nformahon dial meeu the
requirements of Una UB. l.c is tlifibie for this
hjun| provinan.
Unit n.B J his been added to the CAP
Agreement to read u follows:
3. The follow™*, provuicai ihafl fovcrn the Un
required to be oiomilied Older Unit IB.l.c of (hit
CAP Af recment:
a. For each nady or report lined, (fae lutm| miut
eompty with the reqairemenu of Umc HC of thii
CAP Agreement, must detchbe the date of tin
nbmisrion and (i) UK mandatory repomna,
requirement of TSCA or Mother EPA-administered
•attic aoder which iht Mudy or report was
mhmnifd, or (n) die Office of Touc Substances
"KYI" filinf ryotm aumber for the wbmunon.
Wuhin 360 deyt after MbmiMioa of the liA. EPA
may request the "•["'"tr to submit any of the
baud iafonutkM m order to determine if dte
Refoiatee correcuy lifted mher than nbmioed the
ctudy or report.
b. The Regulate* agrees topey the followine,
mpulaierl civil penalty for information h'sted under
dut audit aa data diet would have been reporubk
onder TSCA Seem •(*) when aroaUy obtained
by the Rafulaiae. end that robaequem to dte Motion
t(c) reporon*. deedliae u epeeified in Pan IV of
the TSCA Section l(e) Policy Siiiement (end
before fane 11,1991), were (i) mbrattiad n wntm»
«o and received by EPA panuant to a mandatory
reponaBS. reejutreBMBi under TSCA or wi"*^TT
funac adminiaMd by EPA. or (ii) received by the
Office of Tack SecMancet (OTS) OB en "FYI"
beau end included in dte formal OTS "FYI" fibof
rynam: S5.000 per study or repon.
C. Additions lo tht TSCA Section 8(t)
Reporting Guide
In response «o • wrinen request from the
Chemical Manufacturers Association (CMA)
for additional guidance on the section 8(e)
reponabiliry of certain types of health effects
arid environmental effects/release
mformation, EPA agreed to perform an
expedited review of a limited number of case
studies submitted by CMA. The Office of
Pesticide* and Toxic Substance* (OPTS)
established a panel of EPA loucotogists,
biologists, chemists, medical and public
health experts, environmental scientists.
TSCA policy staff, and legal and enforcement
staff to perform an expedited review of the
d by CMA.
EPA reviewed dw<
reponabiliry of ht
involviAg
,and
provideesnanalynclelHanicologk
significance and TSCA eeeaon 8(*)-
reoorubiliry of the health effects cat
in the TSCA section Ke) nportmg guide
described above end referenced in the CAP
Agreement.
0. Rqxrtmg of Information Refertnctd i*
Parts V(bXl) and V(c) of EPA'i Section 8X5) of EPA's TSCA
Section 8(e) Policy Statement In assessing
whether information or studies involving
widespread and previous unsuspected
ornronmenul distribution, emergency
nriiWnts of environmental contamination, or
other previously unknown situations
involving significant environmentij
contamination should be submitted u
TSCA Section 8(e) Compliance Audit
Program, or under section 8(e) in gene*
regulatees should make i reasonable
judgement whether such mformation meets
the statutory standards of TSCA section 8(e)
instead of relying on Peru V(bXD or V(c) of
the TSCA Section 8(e) Policy Statement.
Even though EPA is suspending the
applicability of Paru V(bXD and V(c) of the
TSCA Section 8(e) Policy Statement, persons
are still responsible under TSCA section 8(e)
10 repon information that reasonably supports
a conclusion of substantial risk of injury to
the environment. This U a continuing
statutory obligation. Thus, to reflect this
change. Unit n.B.1 of the CAP Agreement
has been modified to read as follows:
1. In conducnin the TSCA Section 8(e)
Compliance Audit Procnm, OM Regulaiec thill
follow die nanuory Unfu*»e of TSCA ucuon 8(e)
and EPA'i suidanee on section 8(e) in the Much
16, 197S, "Statement of Interpretation and
Enforcemam Policy; Notification of Subttantiil
Risk" (43 FR 11110) ("TSCA Seaion 8(e) Policy
Statement"), with the exception of Paru V(bXl )
and V(c) of the TSCA Section K*> Policy
frf'tniim. to determine whether the reviewed nudy
or report is: —
No other modifications to the 'Terms of
Agreement" provisions of the CAP
Agreement have been made.
IV. ConchBkm
EPA believes that the actions describ)
above emphasize the Agency's strong
commitmmt to making the TSCA Section
8(e) Compliance Audit Program a successful
initiative. EPA believes that providing the
section 8(e) reporting guide as well u the
results of the Agency's review of several
uxicotogic case studies will enhance
understanding of the TSCA section 8(e)
program, and assist the regulated community
as they pankipaM in the TSCA Section 8(e)
Compliance Audit Program. Any further
mformation regarding this Compliance Audit
Program or the CAP Agreement may be
obtained from the contact person noted above.
Dated: Jone 11,1991.
VkserJ.
ActMf AjfiflM Admvuttrmer/or futieidu and
[FR Doc. 91-7Tm POed 77-77-41; 8:45 em)
109
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110
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Jil »•) !L .rt'.^ s.^:ilSi» 5 L
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APPENDIX E
1 cf 2
•5assert Inf?r~'3'
~ :': •.-'tt-5: -.T^x-.ic; 5 ucs ta-.ces . Co.- trol Ac-
i-.is .suc'eor to tee - prcv.is ions -of .Section 14 of TSCA
- .•Ps.T'ul-aTt i3;r.s-;.--on -the Confidentiality of Business In f err. a tier, 'see
•i4j^-£F3:~.;?a;ri-2") . c-Vo,u must -comply with the following procedures to
reassert -a~ Aia'im-^of .confidentiality for the information solicited
i-. the attached:-lefter. .Failure to follow these procedures fully
at the time you submit the information to EPA will be interpreted
...by r.th'e 5A-g-enc>-y.. asea. wa iver of your claim of confidentiality.
Asserting a Claim
In format-ion .claimed as confidential must be clearly -ar:': iCOpy- shouidr,ihave.'.all of the information claimed as confidential
excised. This version will be placed in EPA's Public riles.
.' : , i: Substantiating Claims of Confidentiality
<::«:•.•..1.•:••:: detailed".written responses to the following questions must
'-.?,,,-be provided --at the time you. submit"-information for any portion of
the in format ion r-you-claim as confidential. Your responses should
be as specific as possible, with examples as appropriate, and
£v.,i shdal'd^provide1-substantiation arguments for all types of informa-
ic-v cfciori i it&'tf>.*-r- • %al%sr: or production/importation volumes, chemical
iftl? iaentity, rcofflptfftyiidentity) you claim as confidential.
1. For what period of time do you assert this claim of
tnc.uaa.teoftfide'fttiality? If a- claim is to extend until a
certain event or point in time, please indicate that
ao ts^..-jjj;;f- * '^vifte^W^-time period. Explain why the information
Should remain confidential until such event or time.
i.1! "-'.;• or-s fc»s" ;•..
na ».;2. '-"H^e'ieft«r*r-bcen- any''*cbnfidentiality determinations made
by EPA, other Federal agencies, or courts in connection
8Rc:5«sM.ipwfrfc'S«fch>§5isformatibn? "'If so, please enclose copies.
111
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2 3f 2
3. Has any of the information that you are clain-.a 33
confidential been disclosed to individuals outside '•/"-'
company? will it .oe -disciosed . to such persons ir. t.-«
future? If so, what r'es'trTctTor.s, if any, apply to _s~
or further disclosure of the information?
4. Briefly describe-any physical.or procedural restrictions
within your company.relating to the"use and storage c:
the information .you. are claim'i'ng* 'as. -confidential. What
other steps, if. any, have you t a ken---to- prevent undesired
disclosure of the information'-d-'ur-ing its use or when an
employee leaves your company?'' ?•"•.:" * = •
5. Does the information claimed!. asvcorff irde'ntial appear or
is it referred to in any of items listed below:
~ - r-. L - p " : :• ^J_c,£f
- advertising or promotional materials'for the chemical
or the end-product containing"1 it;:?'
.. . : • . 1:' •:. '.' r-, x •;: yr.
- safety data sheets or •othAri-.-slmiiar-materials for the
chemical; or-;the ;end product-contai-rei-nsr i£>;
- professional or trade publications; or
- any other media available to the" pubTicTor to your
competitors* ,s • • -~ e» •- rw?
If you answered yes to -any of.-the /above- ^questions, you
must indicate where the • iniarmatlonr: appears and explain
why it should nonetheless.^* -treated --as confidential.
- - "ry. ;• ,.'" . r&s ; DX--
Would disclosure of this information be likely to result
in substantial harm to- ypur competitivej5_position? If
so, you must specif icaiTy" describe "the alleged harmful
effects and indicate why they^ should .-be considered to be
substantial. Also, you must describe how disclosure of
the information would cause the. harm., - i: e:.:
7. if the information in -question : is:;.,"he*afcth- and safety
data' pursuant to.40 CFR Pariti. 306_{3?):( i ho.do you assert
that disclosure of,-thereofo,r-m*fcvon\you-*arej claiming as
confidential would'reveal:
a) confidential processbiRtormation;
b) confidential, pr-opojcrtiont^qf a mixture; or
c) information unrelated to the effects of the
substance on human->health,;-pr ,the environment?
If your answer-to.-anyrOf/tfefnfboW.questions is yes, you
must explain how such information would be revealed.
112
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EPA Announces TSCA Section 8(e) Modifications
EPA last month announced
the final modifications to its
Compliance Audit Program
involving section 8(e), the sub-
stantial risk information
reporting provision of the
Toxic Substances Control Act.
EPA also announced the
availability of a TSCA section
8(e) reporting guide.
Section 8(e) applies to any
person who manufactures,
imports, processes or distrib-
utes a TSCA-covered chemical
substance or mixture and who
obtains information that rea-
sonably supports a conclusion
that the substance of mixture
presents a substantial risk of
injury to health or the envi-
ronment.
In the Feb. 1 Federal Regis-
ter, EPA announced the oppor-
tunity to register for the TSCA
Section 8(e) Compliance Audit
Program.
The CAP is a one-time vol-
untary compliance audit pro-
gram developed to obtain out-
standing TSCA section 8(e)
data and compliance with the
statutory obligation of TSCA
section 8(e).
The final modifications to
the CAP include the extension
of the registration deadline
from June 18 to July 1, the
addition of provisions for list-
ing certain types of previously
reportable TSCA section 8(e)
information now in EPA's pos-
session and modification of
EPA's guidance for repdiiing
information concerning wide-
spread and previously unsus-
pected distribution in environ-
mental media and emergency
incidents of environmental
contamination under TSCA
section 8(e).
Since EPA announced pre-
vious modifications to the CAP
in an April 26 Federal Register
notice, it completed develop-
ment of a TSCA section 8(e)
reporting guide. The guide
makes certain information
pertaining to section 8(e)
reporting more accessible to
members of the regulated com-
munity and others. It also
provides reference to both gen-
eral and specific examples of
submitted information as well
as EPA's comments regarding
such submissions.
Notice of the modifications
to the Registration and Agree-
ment for the CAP appeared in
the June 20 Federal Register.
For more information or copies
of the revised CAP Agreement
and TSCA Section 8(e) Report-
ing Guide, contact: TSCA
Assistant Information Service,
Environmental Assistance
Division (TS-799), Office of
Toxic Substances, EPA, 401 M
St., SW, Washington, D.C.
20460; (202) 554-1404. / .
Reilly Excuses Himself From TSCA Case Appeal
EPA Administrator William
K. Reilly has excused himself
from involvement in an
appeal of a controversial
enforcement case under the
Toxic Substances Control
Act.
In order to avoid an
appearance of impropriety,
the administrator formally
withdrew from the 3M
appeal, said Vincent Gior-
dano, an attorney in EPA's
toxic litigation division.
The result is that Reilly
will not be in the "decision
loop" for the appeal, Gior-
dano said. Reilly's action also
eliminates the opportunity
for a petition for reconsidera-
tion, the third step in
administrative litigation, the
EPA attorney explained.
In the first action on the
case last November, which is
on appeal before the adminis-
trator, an administrative law
judge reduced the agency's
proposed fine for violations of
TSCA's new chemical rules
by 95 percent.
Both EPA and 3M
appealed the decision to the
EPA administrator. This sec-
ond decision is almost always
written by the administra-
tor's designate, the chief judi-
cial officer. EPA appealed the
dramatically reduced fine
and 3M appealed the viola-
tions, arguing that they were
time-barred. The CJO's deci-
sion is forthcoming.
The third step in an
administrative proceeding is
a petition to the administra-
tor for reconsideration.
Either party can file this
request after receiving an
adverse ruling from the CJO.
Giordano said this step has
been .eliminated by the
administrator's action.
Giordano said Reilly wrote
a memorandum to excuse
himself from the appeal. The
administrator reported that
someone from the company
approached him about this
matter during an April visit
to the company's St. Paul
headquarters. Although
Reilly declined to discuss the
case, Girordano said in light
of that contact, the adminis-
trator excused himself from
the proceedings.
The EPA attorney would
neither confirm nor deny if
the administrator had been
warned to be on the alert for
such contact during his visit.
Alumax's Part Of Stringfellow Dump Case Is Settled
A company accused of dump-
ing hazardous wastes into the
Stringfellow acid pits near
Los Ajigeles has agreed to pay
$18 million as its share of a
massive civil lawsuit.
The Stringfellow settle-
ment, which is subject to
approval by a state court
judge, releases defendant
Alumax Inc., an aluminum
processing company based in
Norcross, Ga., from any fur-
ther liability in connection
with its disposal of industrial
soaps and other wastes at the
dump.
Stringfellow is considered
one of the most toxic sites in
the nation and was targeted
for cleanup under the $1.6
billion federal Superfund.
Leakage from the acid pits
has been cited as a possible
threat to drinking supplies in
some areas of Los Angeles.
The cost of cleaning up the
area has been estimated at
$750 million.
The settlement, which is to
be distributed among some
3,800 residents of the area, is
believed to provide for one of
the largest assessments
against a single company in a
toxic dumping case. By com-
parison, plaintiffs in the Love
Canal case in New York
received about $20 million
from toxic-dumping defen-
dants, including Los-Angeles
based Occidental Petroleum
Corp.
The plaintiffs said they suf-
fered a variety of injuries and
illnesses as a result of dump-
ing that took place from 1955
to 1972.
Melvyn Weiss, who repre-
sented the plaintiffs, said that
Alumax's deposits accounted
for 10 percent of all the wastes
at the site.
Stringfellow has been the
subject of complex litigation
for seven years. In 1983, the
state of California and the
Justice Department filed suit
under the federal Superfund
law against about two dozen
companies that deposited
waste at the now-defunct
dump.
Some of the companies that
allegedly dumped relatively
small amounts of toxics have
already settled with the plain-
tiffs for a total of $7 million.
Other defendants that remain
include Riverside County, the
state of California and 13
corporations. .•" " '' > Jit
.«.,;—: T .;
JULY 15. 1991
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