TSCA Section 8(e) Reporting Guide
June 1991
NOTICE TO ADMINISTRATOR OF SUBSTAKTIAL 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 8(6), Toxic substances Control Act (1976)
Office of Toxic Substances
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
Washington, D.C. 20460
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Pr«fac«
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(e) , 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 well
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 D 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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TSCA Hot1in*
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
TSCA S<
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
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
TSCA Section 8
mt Control Off!
Name: Michel Stewart
Phone: (202) 382-3532
(202) 260-1532 (after 8/24/91)
ii
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TSCA confidantial Busineas Information CCBI) Ifsues
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)
TSCA Section 8(el Coordinator
Name:
David Williams
Phone: (202) 382-3468
(202) 260-3468 (after 8/24/fl)
FYI Coordinator
Name:
Jacqueline Favilla
Phone: (202) 475-8823
(202) 260-8823 (after 8/24/91)
Public Docket/Office of Toxic Substances
Address: OTS Public Docket
Room G-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
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 "MH Street, S.W.
Washington, D.C. 20460
Phone: (202) 382-7505
(202) 260-7505 (after 8/24/91)
Office of Enforcement
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)
IV
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national Response Center
Toll-Free:
(800) 424-8802
Local:
(202) 426-2675
ffice 24-1
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 (214) 655-2222
Region 7 (913) 236-3778
Region 8 (303) 293-1788
Region 9 (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 of Medicine (NLM)
Address: National Library of Medicine
U.S. Department of Health and Human Services
8600 RocJcville Pike
Bethesda, Maryland 20894
Phone: (301) 496-6193
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Chemical Information Systems. Inc. (CIS)
Address: Chemical Information Systems, Inc.
7215 York Road
Baltimore, Maryland 21212
Phone: (800) CIS-USER (Toll-Free)
(301) 321-8440 (Local)
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Contents
Pr«f *o» »• i
Important Addresses and Telephone number* ii
Reporting Under section 8(e) of TSCA 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 & 8(d) Reporting? .. 10
Does a "For Your Information" Notice Satisfy 8(e)? 10
Does 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 TSCA (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 8 (a) Status Reports Containing Policy/Guidance 39
I. Toxicological/Exposure 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/Exposure Finding* (Continued)
M. Aquatic Toxicity/Bioconcentration 42
N. Emergency Incidents of Environmental Contamination . 42
O. General (NonEmergency) Environmental Contamination . 42
II. 6*n*ral Section a(*) Reporting Issues 42
A. Intracorporate Reporting Procedures 42
B. Subject Persons 43
C. Subject Chemicals 43
D. Research & 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 Well-Established Effects . 45
N. Relationship to Other TSCA Reporting Requirements .. 45
O. Relationship to other EPA Administered Authorities . 46
P. Relationship to Non-EPA Administered Authorities ... 46
Q. Section 8(e) Reporting Procedures 47
APPENDIX B
index of All Section 8(e) Status Reports
Arranged by Submitted Information Type 49
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APPENDIX C
TBCA Section 8(*) Policy Statement 91
(March 16, 19781 43 FR 11110)
Technical Amendment citation 98
(May 29, 1987; 52 FR 20083)
APPENDIX D
TSCA Section 8(e) Compliance Audit Program Notice 99
(February 1, 1991? 56 FR 4128)
Compliance Audit Program Modifications 104
(April 26, 1991,- 56 FR 19514)
Compliance Audit Program Modification* 107
(encoded version June 20, 1991; 56 FR Part IV)
APPENDIX E
support information for Confidentiality Claims .......... ill
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REPORTING UNDER SECTION 8(El OF T8CA
WHAT IS THE STATUTORY LANGUAGE OF *BCA SECTION 8(E)?
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." [90 stat. 2029, 15 U.S.C. 2607(e)]
WHY IS SECTION 8(B) 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 WAS EPA'8 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 describes 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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TOM IS MSUBSraiiTIAL RISK" IHFORMATIOH?
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 o be « weighted, di f t erently- depending., upon -the .seriousness of
th« «ff*ct or the extent of tb* 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 IHFORMMflQll IS HOT RiPORTaBLg TOPER
SECTION 8(El?
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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 IB)
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 BO 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, 1PA 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 Information" (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 be 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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WHAT CHEMICALS ARE SUBJECT TO SECTION 8(B) REPORTING?
Chemicals 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 'tftEA)-1 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, m chemical substance which is in th* process of research
and development (RID) as a pesticide is subject to TSCA until such
time mm tn« manufacturer or importer demonstrates th« intent to
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produce a pesticide by submitting to the Agency ma application for
an "Experimental Us* Permit" (EDP) or registration under FIFRA.
For further information about this TSCA/FIFRA jurisdictional issue,
the reader is directed to EPA's initial TSCA Chemical Substance
Inventory reporting regulation (43 FR 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 RID 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, !ESCAr ..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 THE 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 WHEN MUST TSCA SECTION em
INFORMATION BE REPORTED TO EPA? 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 1, 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.
WHAT ARE THE SOURCES OF SECTION 8 CE1-IMPORTABLE IMFORMATIOK?
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 not 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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!PA*s 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 INFOBMATIOM IS MOT IMPORTABLE PHDER SECTION 8(Ei?
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:
(1) 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 lower dos« l«v«l for
example, or confirms a serious effect that was previously only
suspected, is pot 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 major 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-t>ther*Hagazines," 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 b* 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 (CWA)
Safe Drinking Water Act (SD1A)
Federal Water Pollution Control Act (FWPCA)
Marine Protection, Research and Sanctuaries Act (MPRSA)
Resource Conservation and Recovery Act (RCRA)
RCRA Hazardous and Solid Waste Amendments (HSWA)
Comprehensive Environmental Response,
Compensation and Liability Act (CBECIA; SOP1RFOHD)
Superfund Amendments Reauthorization Act (SARA)
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Specifically with regard to item (4) on Page 8, it cannot 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•-•o» ^other-goverfisiental'-agene-ies. Inmost-leases, --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 8(E) RELATE TO TSCA SECTIONS 4. 5 t 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 not 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.
DOBS A "FOR YOUR INFORMATION" SUBMISSION SATISFY 8(El REQUIREMENTS?
Section 8 (e)-reportable information submitted to EPA on a "For Your
Information" (FYI) basis does pot satisfy 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 MOST SECTION 8 (El INFORMATION BE REPORTED? and
HOW MUST SECTION 8 (El INFORMATION BE REPORTED? found on Page 12 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
which can be found on Page 27 of this reporting guide.
DOES REPORTING TO ANOTHER AGENCY SATISFY SECTION 8 (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 toEPA." (emphasis added)
WHEN MUST SECTION 8(El INFORMATION BE 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 DOES TEE TERM
"OBTAIMS myORMATIop" ffMt? 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 working days of the date on
which the information is (was) obtained by the company for the
first time after March 16, 1978.
WHERE MOST SECTION 8(El INFORMATION BE REPORTED?
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
(800)-424-8802 or 202-426-2675 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 EI1C 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 DOES A FOR YOUR INFORMATION SUBMISSION SATISFY SECTION
8(E) REQUIREMENTS? found on Page 10 of this reporting guide.
HOW MUST SECTION 8(El INFORMATION BE 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 CAH CONFIDENTIAL DMA BB CLAIMED/SEHT TOPER SECTION 8(B)?
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 IPA 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 "CONFIDENTIAL". The
other copy should liave, 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 DOES EPA IDENTIFY/TRACK INCOMING SECTION 8(El NOTICES?
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;
PtWP: 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/USE SECTION 8(E) 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.2 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 "summaries11
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.
Office of Water (OW/EPA)
preparing/revising Water Quality Criteria Documents and
Drinking Water Standards.
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 Res«
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 of Air and Radiation (OAR/EPA)
• determining the need for and revising rules which govern
chemical substances released to the air from stationary
and/or mobile sources.
Office of Pes1
tOPg/OPTS/BPAi
assessing or reassessing the toxicity of or exposure to
active ingredients/inerts in pesticides under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA).
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EPA Regional Offices
EPA1 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 and Health (NI08H)
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 o_£ Toxic Effects o_£
Chemical Substances (RTECS) publication and on-line
computerized data base.
(£§11)
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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consumer Product Safety Commission (££§£)
determining the need for new CPSC regulatory efforts or
the revision of existing CPSC regulationsi and
internal and external information circulation as part of
CPSC's "Current Awareness Activities."
National Library o_f_ Medicine (ELM)
•input • -of --toxicologic/exposure *±nf ormation to 'the % NUf' s
publicly accessible computerized data bases.
National Toxicology Program
evaluating chemicals for toxicologic testing;
monitoring results of non-NTP toxicity studies; and
* supplementing results of ongoing NTP studies.
Interagency Testing Committee (ITC)
determining need for recommending chemicals for TSCA
Section 4 health/environmental effects testing.
DO STATUS REPORTS REPRESENT EPA'8 "BOTTOM LIKE" REGARDING RISK?
When reviewing TSCA Section 8(e) status 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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HAS EPA ISSUED OTHER SECTION 8(E) GUIDANCE-RELATED INFORMATION?
The 1978 Section 8(e) policy statement, as frequently cited and
quoted in 1) publicly available EPA "Question and Answer11 (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 tvo-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 Nupber Submission
PB# 80-221609 8EHQ-0777-0001 to 8EHQ-0679-0291
PBf 81-145732 8EHQ-0779-0292 to 8EHQ-0180-0330
PB| 83-187815 8EHQ-0280-0331 to 8EHQ-1282-0467
PB# 87-129409 8EHQ-0183-0468 to 8EHQ-1284-OS41
PB# 87-176004 8EHQ-0185-OS42 to 8EHQ-1286-0648
PBf 89-182687 8EHQ-0187-064f to 8EHQ-1288-0778
It should be noted that a seventh Section 8(e) status report volume
covering initial Section 8(e) submission numbers 8EHQ-0189-077§ to
8EHQ-0989-1084 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 "Chemicals-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 "Pr»fac«" to this guide.
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With the exception of certain TSCA Section 8(e) Q&As that were made
available by EPA in July 1989, all of the Agency's 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 Q&As 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- *toeen --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
toxicity 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 toxicity
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 ma-le/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(e) 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 only as the result of gross and/or histo-
pathological examination. 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 IPA 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 j,n vitro mutagenicity assays
trigger Section 8(e) reporting?
A. Serious in vivo genptoxicological 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, IPA 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 vitr_o 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 IPA under other sections of TSCA) should
contact the TSCA Hotline at the address or the telephone/telefax
numbers listed in the "Fr«f»c«" to this reporting guide.
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HOW CAM THE PUBLIC OBTAIN SECTION B(E) SUBMISSIONS?
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 "*r«fmce" to this guide.
Information on each new initial Section 8(e) and F¥I 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 "Chemicals-In-Progress Bulletin" 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 "Prafao*" to this guide.
As explained in more detail in HAS EPA ISSUED OTHER SECTION BfEl-
RELATED 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 (NLH)
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.
volumes of Section 8(«) 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"
'(fOTA) requests that are received by 13TS 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.
IS THERE A SECTION 8 CD ENFORCEMENT RESPONSE POLICY?
On May 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 "PREFACE" 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 vere 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 *>f- 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 1) 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) (1) 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 well as ongoing compliance with Section 8(e).
For the reader»s ease, complete copies of IPA's Federal Register
announcements of the Section 8(e) CAP and the CAP modifications are
presented in chronological order in Appendix D at the back of this
reporting guide.
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HAS EPA TAKSH FORMAL 8ECTIOH S(E) ENf-QRCgMBgT ACTIONS?
Since 1977, EPA has initiated a number of formal enforcement
actions relating to Section 8(e) of TSCA. In almost all cases,
IPA'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 "Pr«fao«" to this guide.
DOES EPA»8 8(1) IKPL1MEHTATION gHCOim&Gl gOLLPTIOH PR1V1MTION?
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
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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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TSC& SBCTI01I 8Cl)-RlP01CTABII.ITlf OF TOXICOLQglC CASE STUDIES
A. NUMERICAL REPORTIMO GUIDANCE POR LBTHM.ITY INFORMATICS
Case Study
"An -acute "oral'(gavage) ED5t> study was "conducted -on ~a tromiaercial
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
EPA's 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 LD50 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 ng/1) to <200 ppm (or <2 mg/1) should be recognized
as indicating -"higli" *-toxicity-and^should-b» '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 R&D),
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 mg/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 TOXIC)
Only to Some
Reasonable Degree
(HIGHLY TOXIC)
Yes
(MODERATELY TOXIC)
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,11 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 showing the chemical to be highly
toxic should be reported immediately under Section 8(e) of TSCA.
B. ACUTE TOXICITY TESTS WITH NON-LETHAL NEUROBEHAVIORAL 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 lower 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 IFA to verify that statistically or
biologically significant "frank" neurotoxicologic effects seen in
acute or other animal studies should be reported immediately.
1PA 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 cannot 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 EPA's 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
LD50 values/ranges listed in Table 1 (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)yreportability 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. SKIN/EYE IRRITATION AND SKIM SENSITIZATION 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 Test
"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, light 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
35
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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)j 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. 8UBCHRONIC 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-Ef feet-Level) ] was determined to be 100 Big/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 reportabildty 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 dermally
exposed to the chemical, simply enhance the reportability of the
observed serious toxic effects in the liver.
*****
37
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38
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APPENDIX A
This index is divided into the following two (2) major areas:
"TOZICOLOGICAL/EXPOSURE FINDINGS" 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. TOXICOLOGICAL/EXPOSURE FINDINGS
A. ACUTE TOXICITY (ANIMAL)
0259
0282
0380
0408
0428
0429
0430
0431
0432
0433
0436
0456
048?
0531
0540
0638
0665
0669
0985
1059
B. ACUTE TOXICITY (HUMAN)
39
0258
0315
0344
0493
0502
-------
B. ACOTK TOXICITY (HUMAN)
0508
0612
0622
0632
0694
0885
0905
0929
C. SUBACUTE TOXICITY (ANIMAL)
0325
0653
P. IMMUNOTOXICITY (ANIMAL)
0585
E. NEUROTOXICITY (AMIMAD
F. NEUROTOXICITY {HUMAN)
g. ONCOGENICITY (ANIMAL!
0369
0706
0815
0867
1041
1043
1065
0641
1041
1065
0234
0401
0503
0509
0583
0600
0619
0681
0763
0847
40
-------
H. OMCOGEMICITY tHTJMMi)
J. REPRODUCTIVE/DEVELOPMENTAL (HUMAN)
0641
0211
0213
0572
0626
J0653
0764
0807
0820
0835
0842
0872
0999
1042
1043
0551
GENOTOXICITY (IN VITRO)
0213
0214
0383
0396
NOTE: Almost all of the TSCA Section 8(e) status reports
pertaining to in vitro genotoxicity test findings contain
the following language:
"Although a positive in y|tro genotoxicity test result,
when considered alone, nay not be sufficient to offer
reasonable support for a conclusion of substantial risk
(as that term 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.H
GENOTOXICITY (IN VIVO)
0208
0213
M. AQUATIC TOXICITY/BIOCONCENTRATION
0209
0249
0899
0994
N.
EMERGENCY INCIDENTS OF ENVIRONMENTAL CONTAMINATION
0255
0260
0277
0466
0566
0769
O. GENERAL/NON-EMERGENCY ENVIRONMENTAL CONTAMINATION
0209
0720
II. GENERAL REPORTING ISSUES
INTRACORPORATE REPORTING PROCEDURES
0358
0672
0681
0698
0701
0705
0835
42
-------
B. SUBJECT PERSONS
C. SUBJECT CHEMICALS
P. RESEARCH i DEVELOPMENT CHEMICALS
0543
0546
0551
0577
0587
0642
0689
0818
0823
-0824
0846
0325
0543
0545
0546
0551
0583
0587
0698
0701
0705
0706
0763
0818
0823
0824
0835
0545
0583
0763
0815
0824
0835
i. DROP EXPORT
0818
F. PESTICIDE EXPORT
0823
43
-------
G. PREVIOUS KANUPACTURE/IMPORT/PROCESS/DIBTRIBUTION
0698
0701
0705
0847
H. OBTAINING INFORMATION
PRB-1977 INFORMATION
ACTPAL KNOWLEDGE BY EPA
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 PTOWLEDGE BY IP* CCOll'Ti
0704
0706
0712
0713
0718
0720
0807
0809
0835
0847
PUBLISHED SCIENTIFIC LITERATURE
0383
0588
0600
0641
0672
L. INFORMATION OBTAINED FROM OTHER FEDERAL AGENCIES
0467
0689
0704
M. INFORMATION CORROBORATING WELL-ESTABLISHED EFFECTS
0509
0706
0807
0835
RELATIONSHIP TO OTHER T8CA REPORTING REQUIREMENTS
0493
0600
0612
0622
0632
0667
0675
0694
0706
0718
45
-------
5NT8 (CON'T)
0720
0769
0797
0800
0813
0817
0824
0846
0856
0876
0884
0900
0905
0929
O. RELATIONSHIP TO OTHER EPA 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
TO AUTHORITIES MOT APMIHIBTEREP 1Y 8P&
0551
0706
1043
46
-------
Q. SECTION 8(B) REPORTING PROCEDURES
0234
0324
0330
0369
0400
0543
0546
0566
0587
0626
0653
0681
0698
0701
0705
0855
*****
47
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48
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APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
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8EHQ-1178-
8EHQ-0179-
0004
0039 P
0050
0065
0072
0088
0092
0131
0143
0152
0155
0162 S
0169 S
017S
0178
0193
0196
0199
0204
0207
0217
0224
0227
0259
0271
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
M
X
X
M
X
8EHQ-0977-B005
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8EHQ-0278-0062
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8EHQ-0278-0074
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X
X
X
X
X
X
X
X
X
M
X
X
X
X
X
X
X
8EHQ-0377-0035
8EHQ-0278-0042
8EHQ-0278-OQ64
8EHQ-027S-0070
8EHQ-0378-0087 x
8KH(i-037S-0091 «
8EHQ-0378-0103 *
8EHQ-0478-0137 x
8r:HQ-0578-0151
8EHQ-0578-0154 P
8EHQ-0578-0159 S x
8EH$-0578-0166
8EHQ-0678-0174 X
8F.H9-0678-0177 X
8I;HQ-0678-0185 X
8«£Hi)-0678-0195 X
8UH$-0678-0198 x
r
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H
H
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M
O
H
W
W
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O
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O
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H
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o
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8EHQ-0281-0382
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8EHQ-1182-0462
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8EHQ-0282-0432 *
8EHQ-0282-0436 K
8EHQ-0382-0440 5
8EHQ-1082-0459
8EHQ-0183-0468
8EHQ-0583-0478 S
8EHQ-0783-0485 S H
8EHQ-0883-0490
8EHQ-1083-0495
8EHQ-1283-0501
8EHQ-0584-0519
8EHQ-0984-0531 S X
8EHQ-1284-Q540 S «
8EHQ-0485-0550
8EHQ-0785-0563
8EHQ-0479-0282
8EHQ-0779-0296
8EHQ-0480-0340
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8EHQ-0581-0398
8EHQ-0981-0409
8EHQ-0282-0427
8EHQ-0282-0430
8EH(J-0282-0433
8EHQ-0282-0437
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8EH9-1082-0460
8EHQ-0283-0471
8EHQ-0583-0479
8EHQ-0783-0486
8EHQ-0983-0492
8EHQ-1083-0496
8EHQ-0484-0510
8EHQ-0884-0528
8EHQ-1084-0532
8EHQ-0485-0548
8EHQ-0585-0556
8EHQ-0885-0565
S
S
S
S
S
S
S
5
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APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
VJl
ACUTi TOXICITY (ANIMAL)
SUBMISSION f: 8EHQ-09B5
8EHQ-1185
8EHQ-1285
8EHQ-0186
8EHQ-0486
8EHQ-0786
8EHQ-OS86
8EHQ-1086
8EH9-1186
8EHQ-0287
8EHQ-03S7
8EHQ-0387
8EHQ-0487
8EH9-0487
SEHQ-0587-
8EHQ-1087-
8EHQ-1287-
8EHQ-038S-
8EHQ-0688-
8EHQ-0988-
8EHQ-1088-
8EHQ-0189-
8EHQ-0389-
8EHQ-0789-
8EHQ-0889-
-0568 5
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-0584
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-0621
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-0669 *
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•0762
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8EHQ-1185-0575
8EHQ-1285-0580
8EHQ-0186-0585 S
8EHQ-0486-0597
8EHQ-0786-0609 S
8EHQ-0986-0631 S
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8EHQ-1186-0647
8EHQ-0287-0654
8EHQ-0287-0657 S
8EHQ-0487-0661 S
8EHQ-0487-0666 S
8EHQ-0487-0670 S
8EHQ-06S7-0680
8EHQ-1287-0700
8EHQ-0188-0714
8EHQ-0588-0732
8EHQ-0788-0742 X
8EHQ-0988-0754
8EH9-HS8-0768 S
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8EHQ-0789-0808 S
8EHQ-0889-0818 5
8EHQ-1085-0571 S
8EHQ-1285-0578
8EHQ-1285-058I
8EHQ-0386-0589 S
8EHQ-0486-0599
8EHQ-0786-0616
8EHQ-1086-0636 S
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8EHQ-0287-0652 S
8EHQ-0287-0655 S
8EHQ-03B7-0659
8EHQ-0487-0663
8EHQ-0487-0667 S
8EHQ-0587-0673
8EH9-0787-0686 S
8EHQ-1287-0706
8EHQ-0388-0721
8EHQ-0688-0739
8EHQ-0788-0744 S
8EHQ-1088-0760 S
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8EHQ-0590
8EHQ-0690
8EHQ-0690
8EHQ-0790
8EHQ-0890
8EHQ-089Q-
8EHQ-0990
8EHQ-0990
8EHQ-0990
0826
0834
0841
0850
0859
0893
0920
0958
0985
1004
1016
1031
1040
1048
1057
1060
1068
S
S
'
s
s
X
S
s
s
s
s
8EHQ-1089-0830
8EHQ-1089-0837
8EHQ-1189-0845
8EHQ-1289-0852
8EHQ-0190-0860
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8EHQ-0890-1045
8EH9-0890-1052
8EHQ-0990-1058
8EHQ-0990-1061
8EHQ-0990-1076
S
S
S
S
S
S
S
s
s
s
8EHQ-1089-0833 S
8EHQ-1089-0838 S
8EHQ-1189-0848 S
8EHQ-1289-0857 S
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1
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5-0145 *
1-0154 P
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1-0217
1-0260 M
1-0315 *
1-0333
1-0344 P *
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8EHQ-0978-0238 a
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8EHQ-0484-0513
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8EHQ-0990-1071
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x
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¥
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8EHQ-0489-
8EHQ-0989-
8EHQ-1289-
8EHQ-0490-
8EHQ-0990-
0482
0495
0580
0597
0657 S
0686 S
0711
0733
0768 S
0795
0826 S
0852 S
0919 S
1069
SEHQ-0783-0486
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8EHQ-0186-0585 S
8EHQ-1186-0647
8EHQ-0487-0661 S
8EHQ-0887-0690
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8EHQ-0688-0739
8EHQ-1288-0777
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8EHQ-0290-0876
8EHQ-0790-1033
8EHQ-0990-1082
8EH9-0883-0490
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8EH9-0386-0589 S
8EHQ-0287-0653
8EHQ-0687-0680
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8EHQ-12B8-0778
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8EHQ-0283-0471 S
8EHQ-0186-0585 S
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8EHQ-0290-0885
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EH9-
8EHQ-
8EHQ-
0578-0164
0678-0182 P
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ALLERGENICITY (HUMAN)
SUBMISSION I: 8EHQ-Q890-1039 S
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
ui
ui
CELL TRANSFORMATION (IN VITRO)
SUBMISSION Is 8EHQ-1277-0022
8EHQ~0378-fl89S
8EHQ-0578-0141
8EHQ-0179-0268 S
8EHQ-0579-0286
8EHQ-0579-0289
8EHQ-0280-0334
8EHQ-0681-0404
8EHQ-1081-0418
8EHQ-0883-0't90
8EHQ-1083-0498
8EHQ-0584-0516 S
8EHQ-0685-0558 S
8EHQ-0786-0613
8EHQ-0986-0630
8EHQ-0690-1018
8EHQ-0278-0071
X 8EHQ-0378-0100 *
* 8EHQ-0578-0164
8EHQ-0479-0278
8EHQ-0579-0287
SEHQ-0679-0291
8EHQ-0281-0385
8EHQ-0981-0412
8EHQ-0982-0455
8EHQ-1083-0495
8EHQ-0'i84-0511
8EHQ-1184-0536
8EHQ-0785-0561 S
8EHQ-0886-0620
8EHQ-0687-0679
8EHQ-0378-0094
8EHQ-0478-0132
8EHQ-0578-0166
8EH9-0479-0279
8EHQ-0579-0288
8KHQ-0779-0294
8EHQ-1280-0401 S
8EHQ-1081-0415
8EHQ-0583-0477 S
8EHQ-1083-0496
8EHQ-0484-0512
8EHQ-1184-0537
8EHQ-0786-0610
8EHQ-0886-0621
8EHQ-0889-OB14
CHEMICAL/PHYSICAL PROPERTIES
SUBMISSION I: 8EHQ-0178-0034
8EHQ-0879-0301
8EHQ-0't80-03'iO
8EHQ-1080-0366
8EHQ-0278-0044
8EHQ-1179-0317
8EHQ-0680-03«i8
8EHQ-0481-0397
8EHQ-0279-0274
8EHQ-02SO-0333
8EHQ-0780-0353
8EHQ-0382-0440 S
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
ui
cr>
CHEMICAL/PHYSICAL PROPERTIES
SUBMISSION ft 8EHQ-0483-0475
CHRONIC TOXICITY (ANIMAL)
SUBMISSION «: 8EHQ-1277-0026 S
8EHQ-0578-0148
8EHQ-0678-0202
8EHQ-0778-0215
8EHQ-1078-0248
8EHQ-1078-0253
8EHQ-0279-Q274
8EHQ-0779-0297
8EHQ-04S1-0397
8EH
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
CHRONIC TOXICITY (ANIMAL)
SUBMISSION I: 8EHQ-1287-Q710
8EHQ-0588-0730
8EHQ-0988-0752 S
8EHQ-1288-0774
8EHQ-0889-0812
8EHQ-1289-OS56
8EHQ-0290-0S81 S
8EHQ-0490-0930 S
8EHQ-0590-0968
aEHQ-0890-1043
8EHQ-0890-1056 S
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
0188-
0788-
1088-
1288-
0989-
1289-
0390-
0490-
0590-
0890-
0713
07
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
ui
03
SUBMISSION Is 8EHQ-0483-0476 5
CLASTOGENICITY (IN VITRO)
SUBMISSION •: 8EHQ-0579-0287
8EHQ-1082-046D
8EHQ-0384-0506 S
8EHQ-0584-8515 S
8EHQ-0784-0522
8EHQ-0685-055B S
8EHQ-0586-0602 S
8EHQ-0886-0621
8EHQ-1186-0647
8EHQ-0787-0686 S
8EHQ-1088-0758 S
8EHQ-0789-0805 5
8EHQ-0890-1051 S
8EHQ-0779-0294
8EHQ-0683-0481
8EHQ-1083-0509
8EHQ-0584-0516 S
8EHQ-1084-0533 S
8EHQ-1285-0580
8EHQ-0786-0608 S
8EHQ-0986-0630
8EHQ-0687-0679
8EHQ-0987-0693
8EHQ-0389-0780
8EHQ-0889-0814
8EHQ-0990-1079 5
8EHQ-1082-0459
8EHQ-1283-0500
8EHQ-0484-0510
8EHQ-0584-0518
8EHQ-1284-0539
8EHQ-0386-0595
8EHQ-0786-0610
8EH|3-1186~06^6
8EHQ-0787-0685
8EHQ-0288-0715
8EHQ-0389-0791
8EHQ-1189-0847
S
S
S
S
DNA ADDUCT (IN VITRO)
SUBMISSION I: 8EHQ-Q386-0592
DNA DAMAGE/REPAIR
SUBMISSION ts 8EHQ-0478-0132
8EHQ-0678-0206
8EHQ-8579-0285
8EHQ-0583-0477 S
8EHQ-0384-0506 S
8EHQ-0484-0512
M
X
8EHQ-0578-0165
8EHQ-0778-0213
8EHQ-0579-0288
8EHQ-0683-0481
8EHQ-1083-0509
8EHQ-1184-8536
8EHQ-0678-0191
8EHQ-0778-0221
8EHQ-0679-0291
8EHQ-1283-0503
8EHQ-0484-0111
8EHQ-1184-0537
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
DNA DAMAGE/REPAIR
SUBMISSION I: 8EHQ-0785-0561 S
8EHQ-0886-0621
8EHQ-0687-0679
8EHQ-0288-0715
8EHQ-1289-0853 S
8EHQ-0586-0602 5
8EHQ-1186-06<»6 S
8EHQ-0787-0685
8EHQ-0688-0737
8EHQ-0890-1051 S
8EH$-07S6~0613
8EHQ-0187-0649 S
8EHQ-0987-0692
8EHQ-0889-08H
DNA REPAIR (IN VITRO)
SUBMISSION i: 8EHQ-0280-033£>
8EHQ-0980-0359
8EHQ-1080-0366
ECOTOXICITY/AQUATIC TOXICITY
SUBMISSION 1: 8EHQ-0178-0032
8EHQ-0278-0059 *
8EHQ-0378-0108 X
8EHQ-0478-0119 *
8EHQ-Q478-012* *
8EHQ~047S~0132 N
8EHQ-0578-0150 *
8EHQ-0678-0185 X
8EHQ-0778-0223 *
8EHQ-0881-0407
8EHQ-1083-0495
8EHQ-0487-0666 S
8EHQ-0390-0899 M
8EHQ-0590-0994 M
8EHQ-0990-1083 S
8EHQ-0278-0048
8EHQ-1277-0060 »
8EHQ-0378-0111 X
8EHQ-0478-0120 *
8EHQ-0478-0125 »
8EHQ-0578-0141 X
8EHQ-0678-0171 »
8EHQ-0678-0201 *
8EHQ-1078-0249
8EHQ-0783-V486
8EHQ-0<»86-0597
8EHQ-0288-0718 *
8EHQ-0390-Q906 S
8EHQ-0690-1017
SEHf-0278-0058
8EHQ-0278-0061
8EH4-0378-011
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
Ch
o
EMERGENCY INCIDENT OF ENV. CONTAMINATION
SUBMISSION is 8EHQ-0378-0084 *
8EHQ-0978-0240
SEHQ-0379-0277
8EHQ-1179-0319
8EHQ-0580-0343
8EHQ-1182-0466 *
8EHQ-0786-0617
SEHQ-0
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
ENV. OCCURRENCE/RELEASE/FATE
SUBMISSION ft 8EHQ-1081-0416
cr>
EPIDEMIOLOGY/CLINICAL
SUBMISSION f: 8EHQ-1177
8EHQ-0378-
8EHQ-0478-
8EHQ-0578-
8EHQ-0578-
8EHQ-0978-
8EHQ-0280-
8EHQ-1080-
8EHQ-0381-
8EHQ-0282-
8EHQ-0383-
8EH9-0285-
8EHQ-0585-
0416
0466 x
0508 P K
0593
0653
0735
0769 *
0882
0933
1038
0016
0096 x
0123
0146
0168
0241
0332
0367
0390
0427 S
0473
0546
0557
8EHQ-0982-0457
8EHQ-0983-0491 S
8EHQ-0784-0521 S
8EHQ-0486-0597
8EHQ-0487-0662
8EHQ-1088-0759
8EHQ-0589-0799
8EHQ-0390-0905 S *
8EHQ-0490-0953
8EHQ-0990-1077
8EHQ-1277-0021
8EHQ-0378-0105
8EHQ-0478-0128
8EHQ-0578-0149
8EHQ-0678-0192 S
8EHQ-0978-0246
8EHQ-0580-0341
8EHQ-1180-0374 S
8EHQ-0381-0394 S
8EHQ-0382-0440 S
8EHQ-1083-0497
8EHQ-0485-0551 *
8EHQ-0985-0567
8EHQ-1182-0462
8EHQ-1083-0495
8EHQ-0985-0566
8EHQ-0786-0617
8EHQ-0487-0671
8EHQ-1088-0761
8EHQ-0989-0826
8EHQ-0490-0921
8EHQ-0790-1032
8EHQ-0278-0056
8EHQ-0478-0117
8EHQ-0478-0135
8EHQ-0578-0167
8EHQ-0878-0230
8EHQ-0379-0280
8EH4-1080-0366
8EHQ-0281-0382
8EHQ;-1280-0401
8EHO-0582-0444
8EHQ-0884-0523
8EHQ-0485-0552
8EHQ-0186-0585
S
S
P
S
S
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
EPIDEMIOLOGY/CLINICAL
SUBMISSION I: 8EHQ-0286
8EHQ-0586-
8EHQ-0786-
8EHQ-Q986-
8EHQ-0487-
8EHQ-1187-
8EHQ-0288
8EHQ-1188
8EHQ-1089
8EHQ-0190
8EHQ-0390-
8EHQ-0490-
8EHQ-0890-
8EHQ-0990-
0588 x
0601
0615
0634
0671
0698
0722
0772
0831
0864
0915
0929 S x
1053
1072
8EHQ-0386-0589 S
8EHQ-0786-0611
8EHQ-0986-0629
8EHQ-1Q86-0641
8EHQ-0887-0688
8EHQ-1287-0699
8EHQ-0688-0736
8EHQ-0889-0818 S
8EHQ-1089-0832
8EHQ-0290-0886
8EHQ-049Q-0917
8EHQ-0590-0991 S
8EHQ-0990-1065
8EHQ-0990-1078
8EHQ-0486-0598
8EH4-0786-0612
8EH
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APPENDIX (D)s STATUS REPORTS BY INFORMATION TYPE
a\
HUMAN EXPOSURE (ACCIDENTAL)
SUBMISSION t: 8EHQ-0278-0080 P
8EHQ-0578-0146
8EHQ-0678-0180
8EHQ-0978-024IJ
8EHQ-0379-0277
8EHQ-1279-8322
8EHQ-0580-0341
8EHQ-0981~0
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APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
cr\
HUMAN EXPOSURE (MONITORING)
SUBMISSION f: 8EHQ-0680-0345
8EHQ-1080-0368
8EHQ-0981-0413
8EHQ-D982-0457
8EHQ-1083-0495
8EHQ-0784-0521 S
8EHQ-0285-0546
8EHQ-0485-0551
8EHQ-0985-0566
8EHQ-0986-0633 S
8EHQ-0487-0671
8EHQ-0288-0722
8EHQ-1088-0761
8EHQ-0489-0793
8EHQ-1289-0856
8EHQ-J490-0924
8EHQ-0490-0962
8EHQ-0890-1053
8EHQ-0680-Q348
8EHQ-1280-0376
8EHQ-0382-0440 S
8EHQ-1182-0162
8EHQ-1Q83-0497
8EHQ-1084-0535
8EHQ-0385-0547
8EHQ-0485-0553
8EHQ-0286-0588 *
8EHQ-1286-0648
8EHQ-0587-0672 S
8EHQ-0688-0735
8EHQ-0289-0784
8EHQ-0589-0801
8EHQ-0190-0863
8EHQ-0490-0933
8EHQ-0690-1018
8EHQ-0990-1077
8EHQ-1080-0367
8EHQ-1280-0401
8EHQ-0482-04'f2
8EHQ-0383-0'i73
8EHQ-0184-0504
8EHQ-0185-0542
8EHQ-0485-0550
8EHQ-0585-055-t
8EHQ-0586-0601
8EHQ-0487-0662
8EHQ-0687-0682
8EHQ-0988-0752
8EHQ-0389-0789
8EHQ-0889-0818
8EHQ-0290-0882
8EHQ-0490-0953
8EHQ-d890-1038
8EHQ-0990-1078
S
S
S
S
S
HUMAN EXPOSURE (PRODUCT CONTAMINATION)
SUBMISSION Is 8EHQ-1077-0012
8EHQ-0478-0117 X
8EHQ-0778-0219 «
8EHQ-0779-0292
8EHQ-0280-0331 S
8EHQ-0378-0104
8EHQ-0478-0133
8EHQ~1278-026<»
8EHQ-1179-0320
8EHQ-0380-0336 S
8EHQ-0378-0113
8EHQ-0578-0139
8EHQ-0579-0284
8EHQ-0979-0326 S
8EHQ-0680-0348
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APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
HUMAN EXPOSURE (PRODUCT CONTAMINATION)
SUBMISSION f: 8EHQ-0780-0352
8EHQ-0381-039B
8EHQ-0482-0442
8EHQ-0383-0473
8EHQ-0585-0554 S
8EHQ-1088-0761
8EHQ-0*90-0962
8EHQ-0880-0358
8EHQ-0981-0409
8EHQ-0682~04<»9 S
8EHQ-0784-0521 S
8EHQ-0885-0564 S
8EHQ-0288-0720
8EHQ-0589-0799
8EHQ-1280-0376
8EHQ-1281-0420
8EHQ-0283-0469 S
8EHQ-0185-Q542 S
8EHQ-1186-06<»3
8EHQ-0688-0735
8EHQ-0689-08IK
VJ1
IMMUNOTOXICITY (ANIMAL)
SUBMISSION 1: 8EHQ-0186-05S5 S
8EHQ-0889-0817
8EHQ-0386-0594 S
8EHQ-0588-0732
IMMUNOTOXICITY (HUMAN)
SUBMISSION •: 8EHQ-0290-0876
MATERIAL SAFETY DATA SHEETS/LABELS
SUBMISSION t: 8EHQ-0190-Q867
8EHQ-0490-0945
8EHQ-0590-0983
8EHQ-0690-1017
8EHQ-D990-1071
8EHQ-0390-0903 5
8EHQ-0590-0967
8EHQ-0590-0991 S
8EHQ-0690-1018
8EHQ-0990-1078
8EHQ-0490-0919 S
8EHQ-0590-0969
8EHQ-0590-1001 S
8EHQ-0990-1Q62
METABOLISM/PHARMACOKINETICS (ANIMAL)
SUBMISSION I: 8EHQ-0780-0350
8EHQ-1280-0401 S
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APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
METABOLISM/PHARMACOKINETICS (HUMAN)
SUBMISSION »: 8EHQ-0578-0149
8EHQ-0285-0546
8EHQ-0379-0277
8EHQ-0485-0551
8EHQ-0484-0513
8EHQ-0486-0600
(Tv
MUTAGENICITY (IN VITRO)
SUBMISSION »: 8EHQ-1077
8EHQ-0178
8EHQ-0278
8EHQ-0278
8EHQ-0478
8EHQ-0578
8EHQ-0678-
8EHQ-0778
8EHQ-1078-
8EHQ-0179
8EHQ-0
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APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
cr\
MUTAGENICITY (IN VITRO)
SUBMISSION I: 8EH9-1081
8EH9-1281
8EH9-0982
8EH9-1082
8EH9-0283
8EH9-0583-
8EH9-0783
8EH9-1083
8EH9-1283
8EH9-0484
8EH9-0584
8EH9-0584-
8EH9-1084-
8EHQ-1284-
8EH9-0785-
8EHQ-1285-
8EHQ-0486-
8EHQ-0786-
8EHQ-0886-
8EHQ-1286-
8EHQ-0187-
8EHQ-0687-
8EHQ-0787-
8EHQ-1287-
8EHQ-0288
0^15
0426
(K55
0460
0470
0477 5
0486
0495
0503
0510
0515 S
0519
0532
0539
0561 S
0580
0597
0608 S
0620
0645
0649 S
0677
0686 S
0706
0719
8EHQ-1081-0417
8EH9-0282-0427 5
8EHQ-0982-0458
8EH9-1182-0465
8EHQ-0283-0471 S
8EHQ-0683-0481
8EHQ-0883-0489
8EHQ-1083-0496
8EHQ-0384-0506 5
8EHQ-0484-0511
8EHQ-0584-0516 S
8EHQ-0784-0522
8EHQ-1084-0533 S
8EH9-1284-0541 S
8EHQ-1085-0571 5
8EHQ-0186-0584
8EHQ-0586-0602 S
8EHQ-0786-0610
8EHQ-0886-0621
8EH9-1186-0646 S
8EH9-0287-0653
8EH9-0687-0679
8EH9-0987-0692
8EH9-1287-0709 5
8EHQ-0688-0737
8EH9-1081-0418
8EHQ-0682-0448 S
8EH9-1082-0459
8EH9-0183-0468
8EH9-0483-0476 S
8EH9-0683-0482
8EH9-0883-0490
8EH9-1283-0500 S
8EH9-1083-0509
8EH9-0484-0512
8EH9-0584-0518 S
8EH9-0984-0530
8EH9-1184-0537
8EH9-0685-0558 S
8EHQ-1285-0579 S
8EH9-0186-0585 S
8EH9-0786-0606 S
i
8EH9-0786-0613
8EH9-0986-0627
8EH9-1186-0647
8EH9-0287-0654
8EH9-0787-0685
8EH9-0987-0693
8EH9-0288-0715
8EH9-0788-0743
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APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
cr>
CD
MUTAGENICITY (IN VITRO)
SUBMISSION •: 8EHQ-1088-0758 S
8EHQ-0389-0791 S
8EHQ-0889-0814
8EHQ-1289-0854 S
8EHQ-0390-0916 S
8EHQ-0490-0960
8EHQ-0690-1016 S
8EHQ-0990-1066 S
MUTAGENICITY (IN VIVO)
SUBMISSION I: 8EHQ-0278-0082
8EHQ-0678-0208
8EHQ-0179-0267
8EHQ-0579-0288
8EHQ-1179-0321
8EHQ-0980-0359
8EHQ-0381-0387
8EHQ-1281-0
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APPENDIX (D)s STATUS REPORTS BY INFORMATION TYPE
VD
NEUROTOXICITY (ANIMAL)
SUBMISSION •: 8EHQ-0382
8EHQ-0583
SEHQ-0684
8EHQ-108S-
8EHQ-0486-
8EHQ-0587-
8EHQ-0588-
8EHQ-0788-
8EHQ-0489-
8EHQ-OSS6-
8EHQ-1189
8EHQ-1189-
8EHQ-0390-
8EHQ-0490-
8EHQ-0490-
8EHQ-0490-
8EHQ-0590-
8EHQ-0690-
8EH9-0690-
8EHQ-0890-
8EHQ-0990-
04^0 S
0478 S
0520
0571 S
0599
0678
0733
0744 S
0793
0815
0841
0848 S
0898
0919 S
0936
0958 S
0964
1002
1005 S
1041
1057
8EHQ-0682-0451
8EHQ-1083-0494 *
8EHQ-1084-0532
8EHQ-Q186-0584
8EHQ-0886-0628
8EHQ-1287-0706
8EHQ-0688-0739
8EHQ-1088-0757
8EHQ-0489-0794 S
8EHQ-1089-0837 S
8EHQ-1189-0843 S
8EHQ-0190-0867 *
8EHQ-0390-0913 S
8EHQ-0490-0931 S
8EHQ-0490-0954 S
8EHQ-0490-0959 S
8EHQ-0590-0996
8EHQ-0690-1003
8EHQ-0690-1007
8EHQ-0890-1043
8EHQ-0990-1063
8EHQ-1182-0462
8EHQ-1283-0501
8EHQ-0585-0556 S
8EHQ-0386-0590
8EMQ-0287-0655 S
8EHQ-0188-0714
8EHQ-0688-0740 S
8EHQ-1288-0776
8EHQ-0889-0811 S
8EHQ-1089-0838 S
8EHQ-1189-0846
8EHQ-0290-0893
8EHQ-0390-0914 S
8EHQ-0490-0934 S
8EHQ-0490-0957 S
8EHQ-0490-0963
8EHQ-0590-1001 S
8EHQ-0690-1004 S
8EHQ-0790-1028 S
8EHQ-0890-1052 S
8EHQ-0990-1076 S
NEUROTOXICITY (HUMAN)
SUBMISSION I: 8EHQ-1277-0021
8EHQ-0578-0146
8EHQ-0378-0105
8EHQ-0480-0338
8EHQ-0478-0118 P
8EHQ-0786-0611
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NEUROTOXICITY (HUMAN)
SUBMISSION I: 8EHQ-1086-Q641
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
8EHQ-059Q-0991 S
8EHQ-0990-1065
-a
o
ONCOGENICITY (ANIMAL)
SUBMISSION Is 8EHQ-0877
8EHQ-1177
8EHQ-0178
8EH9-0278
8EHQ-0578
8EHQ-0578-
8EHQ-0778
8EHQ-0878
8EHQ-1078
8EHQ-0279
8EHQ-0779
8EHQ-1079-
8EHQ-0180-
8EHQ-0580-
8EHQ-0980-
8EHQ-0381-
8EHQ-1280-
8EHQ-0981-
8EHQ-0282-
8EHQ-0682-
8EHQ-1082-
8EHQ-0283-
0002
0016
0028
0046 M
0140
0170
0212
0236 *
0251
0274
0297
0314
0327
0342
0360
0393
0401 S
0411
0434
0447
0461
0469 S
8EHQ-1077-0006
8EHQ-1177-1019
8EHQ-0178-0029
8EHQ-0278-0083
8EHQ-0578-0148
8EHQ-0678-0202
8EHQ-0778-0215
8EHQ-0978-0246
8EHQ-1078-0253
8EHQ-0479-0281
8EHQ-0979-0305
8EHQ-1179-0316
8EHQ-0180-0328
8EHQ-0780-0350
8EHQ-1080-0370
8EHQ-0481-0397
8EHQ-0681-0402
8EHQ-1281-0422
8EHQ-0282-0439
8EHQ-0882-0453
8EHQ-1182-0463
8EHQ-0283-0472 S
8EHQ-1077-0012
8EHQ-1277-0026 S
8EHQ-0278-0044
8EHQ-0478-0117
8EHQ-0578-0165
8EHQ-0778-0209
8EHQ-0878-0234
8EHQ-1078-0248
8EHQ-1278-0262
8EH9-0579-0283
8EHQ-0979-0306
8EH9-1179-0318
8EHQ-0480-0337
8EHQ-07BO-0353
8EHQ-0381-0389
8EHQ-0581-0400
8EHQ-0981-0410
8EHQ-1281-0423
8EHQ-0482-0'»<«3
8EHQ-0882-0454
8EHQ-1282-0467
8EHQ-0383-0474
-------
APPENDIX (D): STATUS REPORTS ilY INFORMATION TYPE
ONCOGENICITY (ANIMAL)
SUBMISSION I: 8EHQ-0683-
8EHQ-0783-
8EHQ-0384-
8EHQ-0584-
8EHQ-0984-
8EHQ-0485-
8EHQ-0985-
8EHQ-0486-
8EHQ-0786-
8EHQ-1086-
8EHQ-0786-
8EHQ-0887-
8EHQ-1287-
8EHQ-0188-
8EHQ-0788-
8EHQ-1088-
8EHQ-1288-
8EHQ-0989-
8EHQ-1289-
8EHQ-0490-
8EHQ-0790-
0480
0488
0507
0517
0530
0553
0567
0600
0614
0642
0681
0691 S
0704
0713
0741
0763 S
0775
0822
0858 S
0952 S
1029
8EHQ-0683-0483 S
8EHQ-1083-0497
SEHQ-1083-0509
8EHQ-0884-0525
8EHQ-1284-0538
8EHQ-0785-0561 S
8EHQ-0685-0583 S
8EHQ-0686-0604
8EHQ-0886-0618 S
8EHQ-0187-0650
8EHQ-0787-0684 S
8EHQ-0987-0692
8EHQ-1287-0708 S
8EHQ-0388-0725
8EHQ-0788-0745 S
8EHQ-1288-0773
8EHQ-0789-0809 X
8EHQ-1189-0847
8EHQ-0290-0873 S
8EHQ-0490-0960
8EHQ-0890-1050 S
8EHQ-0783-0486
SEHe-1283-0503
8EHQ-0584-0514
8EHQ-0884-0526
8EHQ-0485-0550
8EHQ-0785-0562
8EHQ-0386-0592
8EHQ-0786-0606
8EHQ-0386-0619
8EHQ-0587-0675
8EHQ-0887-0687
8EHQ-1187-0697
8EHQ-1287-0710
8EHQ-0588-0730
8EHQ-1088-0760
8EH9-1288-0774
8ENQ-0889-0812
1
8EHQ-1289-0856
8EHQ-0290-0881
8EHQ-0590-0993
S
S
S
S
5
ONCOGENICITY (HUMAN)
SUBMISSION Is 8EHQ-0777-0001
8EHQ-0478-0135
8EHQ-0378-0096
8EHQ-0578-0167 P
8EHQ-0478-0117
8EHQ-0578-0168
-------
APPENDIX (D)t STATUS REPORTS BY INFORMATION TYPE
ONCOGENICm (HUMAN)
SUBMISSION is SEHQ-0878-0230
8EHQ~0582-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITIONXCHEMICAL IDENTITY
SUBMISSION t: 8EHQ-1178-0260 *
8EHQ-Q179-0268 S
8EHQ-0279-0275
8EHQ-0579-0283
8EHQ-0779-0293
8EHQ-1179-0321
8EHQ-0280-0331 S
8EHQ-0380-0336 S
8EHQ-1I80-0373 S
SEHQ-0381-0394 S
8EHQ-0781-0406 S
SEHQ-0882-045
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION •: 8EHQ-1185-0576
8EHQ-0685-0583 S
8EHQ-0486-0597
8EHQ-0786-0606 S
8EHQ-0786-0610
8EHQ-0986-0623 S
8EHQ-0986-0626 S
8EHQ-0986-0632
8EHQ-1086-0637
8EHQ-1186-0643
8EHQ-0187-0649 S
8EHQ-0387-0656
8EHQ-0487-0665 S *
8EHQ-0487-0669 *
8EHQ-0587-0674 S
8EHQ-0787-0686 S
8EHQ-1287-0708 S
8EHQ-0288-0716 S
8EHQ-0388-0724 S
8EHQ-0488-0728
8EHQ-0588-0733
8EHQ-0688-0740 S
8EHQ-0988-0749 S
8EHQ-0988-0752 S
8EHQ-1088-0758 S
8EHQ-1285-0577
8EHQ-0386-0589
8EHQ-0586-0602
8EHQ-0786-0608
8EHQ-0786-0614
8EHQ-0986-062
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
ui
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION I: 8EHQ-1Q88-0763 S
8EHQ-1188-0766 S
8EHQ-11S8-0770 S
8EHQ-03S9-0780
8EHQ-Q289-D784
8EHQ-0389-0788 S
8EHQ-0389-0791 S
8EHQ-0589-0799
8EHQ-0789-0806 S
8EHQ-0889-0816 S
8EHQ-0989-0821 S
8EHQ-0989-0827 S
8EHQ-1Q89-0834 S
8EHQ-1089-0838 S
8EHQ-11S9-0843 S
8EHQ-1189-OS48 S
8EHQ-1289-0853 S
8EHQ-1289-D858 S
8EHQ-0190-0862 S
8EHQ-0190-0868 S
8EHQ-0190-0871 S
8EHQ-0290-0874 S
8EHQ-0290-0880
8EHQ-0290-0887 S
8EHQ-0290-0890 S
8EHQ-1088-0764
8EHQ-11S8-0767
8EHQ-1188-0771
8EHQ-0289-0782
8EHQ-0289-0785
8EHQ-0389-0789
SEHQ-0489-079*
8EHQ-0689-0804
8EHQ-0789-0808
8EHQ-0889-0817
8EHQ-0989-OS24
8EHQ-0989-0828
8EHQ-1089-0835
SEHQ-1189-0840
8EHQ-1289-08
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
cr>
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION i: 8EHQ-0390-Q896 S
8EH9-0390-0905 S x
8EHQ-0390-0908 S
8EHQ-0390-0916 S *
8EH9-0490-0920 S
8EHQ-0490-0923 S
8EH9-0490-0927 S
8EHQ-0490-0930 S
8EH9-0490-0934 S
8EHQ-0490-0952 S
8EH9-0490-0957 S
8EH9-0490-0961 S
8EH9-0590-0986 S
8EHQ-0590-0989 S
8EHQ-0590-0993 S
8EHQ-0590-0998 S
8EHQ-0690-1005 S
8EHQ-0690-1011 S
8EH9-0690-101* S
8EHQ-0790-1023 S
8EHQ-0790-1028 S
8EHQ-0790-1036 S
8EHQ-0890-1(K2
8EH9-0890-1049 S
8EH9-0890-1054 S
8EHQ-0390-0897
8EHQ-0390-0906
8EHQ-0390-0913
8EH9-0490-0918
8EH9-0490-0921
8EH9-0490-0925
8EH9-0490-0928
8EHQ-0490-0931
8EHQ-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
SUBMISSION I: 8EHQ-0990-1059 S *
8EHQ-0990-1063
8EHQ-0990-1071
8EHQ-0990-1076 S
8EHQ-0990-1Q83 S
8EHQ-0990-1060 S
8EHQ-0990-1066 S
8EHQ-099Q-1073 S
8EHQ-0990-1078
8EHQ-0990-1062
8EHQ-0990-1070 S
8EHQ-0990-1075 S
8EHQ-0990-1079 S
PRQDUCTION/USE/PROCESS
SUBMISSION I: 8EHQ-1277
8EHQ-0378
8EHQ-0378
8EHQ-0478
8EHQ-0478
SEHQ-0578
8EHQ-0578
8EHQ-0578
8EHQ-0578
8EHQ-0578
8EHQ-0678
8EHQ-0678
8EHQ-0778
8EHQ-0978
8EHQ-1078
SEHQ-1078
8EHQ-1278
8EHQ-0179
-0026 S
-0104
-0110
-0115 *
-0123
-0146
-0155 *
-0159 S *
-0164
-0167 P
-0179 *
-0202
-0219 *
-0239
-0247
-0253
-0264
-0270
8EHQ-0378-0096 *
8EHQ-0378-0105
8EHQ-0378-0112 *
8EHQ-0478-0117 M
8EHQ-0478-0138 P *
8EHQ-0578-0148
8EHQ-0578-0157 M
8EHQ-0578-0162 S *
8EHQ-0578-0165
8EHQ-0578-0168
8EHQ-0678-0180 *
8EHQ-0778-0209
8EHQ-0778-0228 *
8EHQ-1078-0245
8EHQ-1078-0251
8EHQ-1178-0256
8EHQ-0179-0267
8EHQ-0179-0271
8EHQ-0378-0097 x
8EHQ-0378-0109
8EHQ-0378-0113
8EHQ-0478-0118 P *
8EHQ-0578-0139
8EHQ-0578-0152
8EHQ-0578-0158 S «
8EHQ-0578-0163
8EHQ-0578-0166
8EHQ-0578-0169 S *
8EHQ-0678-0200 »
8EHQ-0778-0217
8EHQ-0878-0230
8EHQ-0978-0246
8EHQ-1078-0252
8EHQ-1178-0261
8EHQ-0179-0268 S
8EHQ-0179-0272
-------
APPENDIX (D)s STATUS REPORTS BY INFORMATION TYPE
03
PRODUCTION/USE/PROCESS
SUBMISSION It 8EHQ-0279-0275
8EHQ-0479-0282 S
8EHQ-0679-0291
8EHQ-0779-0294
8EHQ-0583-0477 S
8EHQ-0683-0481
8EHQ-0783-0487 S *
8EHQ-0983-0493 S *
8EHQ-1083-0496
8EHQ-1283-0500 S
SEHQ-1283-0503
8EHQ-0384-0506 S
8EHQ-0484-0513
8EHQ-0584-0516 S
8EHQ-06S4-Q520
8EHQ-0884-0523
8 EHQ- 088 4-0528
8EHQ-1084-0532
8EHQ-1084-0535
8EHQ-0285-0545 S
8EHQ-0485-0548
8EHQ-0485-0551 *
8EHQ-0585-0554 S
8EHQ-0585-0557
8EHQ-0785-0561 5
8EHQ-0479-0278
8EHQ-0579-0283
8EHQ-0779-0292
8EHQ-0779-0296
8EHQ-0583-0479 S
8EHQ-0683-0483 S
8EHQ-0883-0490
SEHQ-1083-0494 *
8EHQ-1083-0497
8EHQ-1283-0501
8EHQ-0184-0504
8EHQ-1083-0509
8EHQ-0584-0514
8EHQ-0584-0517
8EHQ-0784-0521 S
8EHQ-0884-0524
8EHQ-0984-0529
8EHQ-1084-0533 S
8EHQ-0185-0542 S
8EHQ-0285-0546
8EHQ-0485-0549 S
8EHQ-0485-0552
8EHQ-0585-0555
8EHQ-0685-0558 S
8EHQ-0785-0562 S
8EHQ-0379-0280
8EH9-0579-0288
8EHQ-0779-0293
8EHQ-0779-0297
8EHQ-0683-0480
8EHQ-0783-0485
8EHQ-0983-0492
8EHQ-1083-0495
8EHQ-1083-0498
8EHQ-1283-0502
8EHQ-0284-0505
8EHQ-0484-0510
8EH9-0584-0515
i
8EHQ-0584-0519
8EHQ-07S4-0522
8EHQ-0884-0526
8EHQ-0984-0531
8EHQ-1084-0534
8EMQ-0285-0544
8EHQ-0385-0547
8EHQ-0485-0550
8EHQ-0485-0553
8EMQ-0585-0556
8EHQ-0685-0559
8EHQ-0785-0563
S
S
P
S
S
S
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
PRODUCTIQN/USE/PROCESS
SUBMISSION •: 8EHQ-0885
8EHQ-0985
8EHQ-1085
8EHQ-1185
8EHQ-1285
8EHQ-1285
8EHQ-0685
8EHQ-0186
8EHQ-0386
8EHQ-0486
8EHQ-0586
8EHQ-0786
8EHQ-0786
8EHQ-0786-
8EHQ-0886
8EHQ-09S6-
8EHQ-0986-
8EHQ-0986-
8EHQ-1086-
8EHQ-1086-
8EHQ-1186-
8EHQ-0187-
8EHQ-0287-
8EHQ-0387-
8EHQ-0
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
03
O
PRODUCTION/USE/PROCESS
SUBMISSION I: 8EHQ-0487-
8EHQ-0587-
8EHQ-0587-
8EHQ-0587
8EHQ-0687-
8EHQ-0787-
8EHQ-0887-
8EHQ-0887-
8EHQ-1087-
8EHQ-1287
8EHQ-1287
8EHQ-0188-
8EHQ-0288-
8EHQ-0388-
8EHQ-0388-
8EHQ-0588-
8EHQ-0588-
8EHQ-Q688
8EHQ-0788-
8EHQ-0888-
8EHQ-0988-
8EHQ-0988-
8EHQ-1088-
8EHQ-1088-
8EHQ-1088-
0669 *
0672 S
0675 *
0678
0682
0685
0688
0691 S
0695
0700
0706
0714
0717 S
0721
072<» S
0730
0733
0738
0742 *
0746
0749 S
0752 S
0755
0758 5
0763 S
8EHQ-0487-0670 S
8EHQ-0587-0673
8EHQ-0587-0676
8EHQ-0687-0679
8EHQ-0687-0683
8EHQ-0787-0686 S
8EHQ-0887-0689 »
8EHQ-0987-0692
8EHQ-1187-0698
8EHQ-1287-0701 *
8EHQ-1287-0709 S
8EHQ-0288-0715
8EHQ-0288-0719
8EHQ-0288-0722
8EHQ-0388-0725
8EHQ-0588-0731 S
8EHQ-0688-0734 S
8EHQ-0688-0739
8EHQ-0788-0744 5
8EHQ-0888-0747
8EHQ-0988-0750 S
8EHQ-0988-0753 S
8EHQ-1088-0756
8EHQ-1088-C.759
8EHQ-1188-0765 S
8EHQ-0487-0671
8EHQ-0587-0674
8EHQ-0687-0677
8EHQ-0687-0680
8EHQ-0787-0684
8EHQ-0887-0687
8EHO-0887-0690
8EHQ-0987-0694
8EHQ-1287-0699
8EHQ-1287-0704
8EH5I-1287-0710
8EHQ-0288-0716
8EHQ-0288-0720
8EHQ-0388-0723
8EHQ-0488-0729
8EHQ-0588-0732
8EHQ-0688-0735
8EHQ-0688-0740
8EHQ-0788-0745
8EHQ-0988-0748
8EHQ-0988-0751
8EHQ-0988-0754
8EHQ-1088-0757
8EHQ-1088-0760
8EHQ-1188-0766
S
S
S
5
S
S
S
S
S
-------
APPENDIX (D)i STATUS REPORTS BY INFORMATION TYPE
PRODUCTIQN/U5E/PROCESS
SUBMISSION f: 8EHQ-1188
8EHQ-1188
8EHQ-1288
8EHQ-0289
8EHQ-028i-
8EHQ-0389-
8EHQ-0489
8EHQ-0589-
8EHQ-068f-
8EHS-0789-
8EHQ-0889-
8EHQ-0889-
8EHQ-0889-
8EHQ-0889-
8EHQ-0989-
8EHQ-0989-
8EHQ-1089-
8EHQ-1089-
8EHQ-1089-
8EHQ-1189-
8EHQ-1189-
8EHQ-1289-
8EHQ-1289-
8EHQ-1289-
8EHQ-0190-
0767 S
0771 S
0778
0782 S
0785 5
0789
0792
0798 S
0802
0806 S
0810 S
0814
0817
0820
0824 S
0827 S
0831
0834 S
0838 S
0841
0845
0849 S
0852 S
0856
0861 S
8EHQ-1188-0768
8EHQ-1288-0775
8EHQ-0189-0779
8EHQ-0289-0783
8EHQ-0389-0787
8EHQ-0389-0790
8EHQ-0489-0793
SEHQ-0589-0799
8EHQ-0689-0804
8EHQ-0789-0807
8EHQ-0889-0811
8EHQ-0886-0815
8EHQ-0889-0818
8EHQ-0989-0821
8EHQ-0989-0825
8EHQ-0989-0828
8EHQ-1089-0832
8EHQ-1089-0835
8EHQ-H89-0839
8EHQ-1189-0842
8EHQ-1189-0847
8EHQ-1289-0850
8EHQ-1289-0853
8EH9-1289-0857
SEHQ-0190-0862
S
S
S
S
S
S
S
S
S
S
S
5
S
S
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8EHQ-1188-0770
8EHS-1288-0776
8EH9-0189-0781
SEHQ-0289-0784
8EHQ-0389-0788
8EH^-0389-0791
8EHQ-0489-0794
8EH<}-0589-0800
8EH(}-0789-0805
8EH4-0789-0808
8EHQ-0889-0813
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8EHQ-0889-0816
8EH<^-0889-0819
8EH4-0989-0823
8EHQ-0989-0826
8EH4-1089-0829
8EHI-1089-0833
8EHQ-1089-0836
8EHQ-1189-0840
8EH4-1189-0843
8EHQ-1189-0848
8EHQ-1289-0851
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8EHQ-1289-0854
8EH4-1289-0858
SEHQ-0190-0863
5
S
S
5
S
S
S
S
S
S
S
S
S
S
S
S
S
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
CD
IXJ
PRODUCTION/USE/PROCESS
SUBMISSION •: 8EHQ-Q190
8EHQ-0190
8EHQ-0190
8EHQ-0290
8EHQ-0290
8EHQ-0290
8EHQ-0290
8EHQ-0290
SEHQ-0390
8EHQ-0390
8EHQ-0390'
8EHQ-0390
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0490
8EHQ-0590
8EHQ-0590
0864
0867
0870
0874
0879
0883
0887
0890
0898
0901
0907
0915
0918
0925
0930
0933
0936
0939
0943
0950
0955
0958
0962
0971
0975
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S
S
s
s
s
s
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s
s
5
S
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8EHQ-0190-0865
8EHQ-0190-OS68
8EHQ-0190-0871
8EHQ-0290-0875
8EHQ-0290-0881
8EHQ-0290-0885
8EHQ-029Q-0888
8EHQ-0290-0891
8EHQ-0390-0899
8EH9-0390-0902
8EHQ-039Q-0913
8EHQ-0390-0916
8EHQ-0490-0919
8EHQ-0490-0926
8EHQ-0490-0931
8EHQ-0490-0934
8EHQ-0490-0937
8EHQ-0490-0940
8EHQ-0490-0944
8EHQ-0490-0951
8EHQ-0490-0956
8EHQ-0490-0959
8EHQ-0590-0964
8EHQ-0590-0972
8EHQ-0590-0976
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S
S
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8EHQ-0190-0866
8EHQ-0190-0869
8EHQ-0290-0872
8EHQ-0290-0877
8EHQ-0290-0882
8EHQ-0290-0886
8EHQ-0290-0889
8EHQ-0290-0894
8EHQ-0390-0900
8EHQ-0390-0903
8EHQi0390-0914
8EHQ-0490-0917
8EHQ-0490-0924
8EHQ-0490-0928
8EHQ*0490-0932
8EHQ-0490-0935
8EHQ-0490-0938
8EHQ-0490-0941
8EHQ'-0490-0945
8EHU-0490-0954
8EHQ-0490-0957
8EHQ-0490-0960
8EHQ-0590-0968
8EHQ-0590-0974
8EHQ-0590-0981
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S
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s
s
s
s
s
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-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
o>
PRODUCTIOH/USE/PROCESS
SUBMISSION I: 8EHQ-0590
8EHQ-0590
8EHQ-0590
8EHQ-0590-
8EHQ-0690
8EHQ-0690-
8EHQ-0690
8EHQ-0690
8EHQ-0790
8EHQ-0790
8EHQ-0790
8EHQ-0790
8EHQ-0790
8EHQ-0890
8EHQ-0890-
8EHQ-0890-
8EHQ-0890-
8EHQ-0890-
8EHQ-0990-
8EHQ-0990-
8EHQ-0990-
8EHQ-0990-
8EHQ-0998-
8EHQ-0990-
8EHQ-0990-
0983
0994 *
0997 S
1001 S
1004 S
1010 S
1013 S
1016 S
1021
1025 S
1028 S
1033
1037 S
1041
1044 S
1047
1050 S
1054 S
1058 S
1062
1066 S
1071
1074
1078
1081
8EHQ-0590-0985
8EHQ-0590-0995
8EHQ-0590-0998
8EHQ-0690-1002
8EHQ-0690-1005
8EHQ-0690-1011
8EHQ-0690-1014
8EHQ-0690-1018
8EHQ-0790-1023
8EHQ-0790-1026
8EHQ-0790-1029
8EHQ-0790-1034
8EHQ-0890-1039
8EHQ-0890-1042
8EHQ-0890-1045
8EHQ-0890-1048
8EHQ-0890-1052
8EHQ-0890-1055
8EHQ-0990-1060
8EHQ-0990-1063
8EHQ-0990-1069
8EHQ-0990-1072
8EHQ-0990-1075
8EHQ-0990-1079
8EHQ-0990-1083
*
S
S
S
s
s
s
s
s
s
s
s
s
s
s
s
8EHQ-0590-0992
8EHQ-0590-0996
8EHQ-0690-0999
8EHQ-0690-1003
8EHQ-0690-1006
8EHQ-0690-1012
8EHQ-0690-1015
8EHQ-0690-1019
8EHQ-0790-1024
8EHQ-07iO-I027
8EHQ-0790-1031
8EHQ-0790-1036
8EHQ-0890-1040
8EHQ-0890-1043
8EHQ-0890-1046
8EHQ-0890-1049
8EHQ-0890-1053
8EHQ-0890-1056
8EHQ-0990-1061
8EHQ-0990-1065
8EHQ-0990-1070
8EHQ-0990-1073
8EHQ-0990-1076
8EHQ-0990-1080
S
S
S
S
S
S
S
s
s
s
s
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
REPORTING RATIONALE
SUBMISSION I: 8EHQ-1078-0249
8EHQ-1083-(K9
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
oo
VJl
REPRODUCTIVE TOXIGITY/TERATO. (ANIMAL)
SUBMISSION *s 8EHQ-0785-0562 S
8EHQ-1285-0577
8EHQ-0986-0626 S
8EHQ-0287-0653
8EHQ-04S7-0666 S
8EHQ-0687-0682
8EHQ-02S8-0716 S
8EHQ-0388-0726 *
8EHQ-0588-0731 S
8EHQ-0 988-07*8
8EHQ-0988-0751 S
8EHQ-1088-076«i S
8EHQ-1188-0767 S
8EHQ-1288-0778
8EHQ-0389-07S6 S
8EHQ-0489-0794 S
8EHQ-0889-0811 S
8EHQ-0889-0820
8EHQ-0989-0825 S
8EHQ-10S9-0829
8EHQ-1289-0852 S
8EHQ-0190-0861 S
8EHQ-0190-0868 S
8EHQ-0190-0871 S
8EHQ-1085-0570
8EHQ-Oi86-0587
8EHQ-0886-0628
8EHQ-0287-0658
8EHQ-0587-0672
8EHQ-1087-0695
8EHQ-0288-0717
8EHQ-0488-0727
8EHQ-0688-0738
8EHQ-0988-07
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
o>
REPRODUCTIVE TOXICITY/TERATO. (ANIMAL)
SUBMISSION I: 8EHQ-0290-0875 S
8EHQ-0290-0879 S
8EHQ-0290-0884
8EHQ-0290-0889 S
8EHQ-0290-8892
8EHQ-0390-0897 S
8EHQ-0390-0910 S
8EHQ-0490-0918 S
8EHQ-0490-0925 S
8EHQ-0490-0930 S
8EHQ-0490-0935 S
8EHQ-1H90-0939
SEHQ-0490-0942
8EHQ-0
-------
APPENDIX (D>: STATUS REPORTS BY INFORMATION TYPE
REPRODUCTIVE TOXICITY/TERATO. (ANIMAL)
SUBMISSION fs 8EHQ-0590-0995 5
8EHQ-0690-0999 *
8EHQ-0690-1003
8EHQ-0690-101Q S
8EHQ-0690-1013 5
8EHQ-0790-1025 5
8EHQ-IJ79IJ-1(J37 S
8EHQ-0890-ICK6
8EHQ-0990-1Q6*
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-8890-1042
8EHQ-0890-1055 S
8EHQ-0990-1073 S
8EHQ-0590-0998 S
8EHQ-0690-1002
8EHQ-0690-1008
8EHQ-0690-1012 5
8EHQ-0790-102<»
8EHQ-0790-1030
8EHQ-0890-1043
8EH9-0990-1063
8EHQ-0990-1075 S
oo
REPRODUCTIVE TQXICITY/TERATO. (HUMAN)
SUBMISSION I: 8EHQ-0877-0003
8EHQ-0478-0123
8EHQ-0678-0192 S
8EHQ-0382-04'fO S
8EHQ-0989-0821 S
8EHQ-1277-0021
8EHQ-0478-0128
8EHQ-1078-02«»5
8EHQ-0286-0588
8EHQ-0278-0056
8EHQ-0578-01'i6
SEHQ-IOSO-OSS?
8EHQ-0288-0722
SUBACUTE TOXICITY (ANIMAL)
SUBMISSION f: 8EHQ-1277-0023
8EHQ-0178-0069
8EHQ-0678-018<»
8EHQ-0679-0291
8EHQ-0181-0377
8EHQ-1081-0119
8EHQ-1277-0021
8EHQ-0578-0157
8EHQ-0678-0185
8EHQ-0779-0293
SEHQ-1080-0366
8EHQ-0281-0384
SEHQ-1281-^425 5
K
M
8EHQ-0178-0068
8EHQ-0678-0178
8EHQ-0279-0274
8EHQ-1279-0325
8EHQ-07SO-0369
8EHQ-0381-0392
8EHQ-0382-0438 5
-------
APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
CD
CD
SUBACUTE TOXICITY (ANIMAL)
SUBMISSION ti 8EHQ-0582-
-------
SUiACUTE TOXICITY (ANIMAL)
SUBMISSION I: 8EHQ-Q990-1062
APPENDIX (D)s STATUS REPORTS BY INFORMATION TYPE
8EHQ-0990-1070 S
8EHQ-0990-1081
03
VD
SUBCHRONIC TOXICITY (ANIMAL)
SUBMISSION f: 8EHQ-1177-0014
8EHQ-0578-0161 S *
8EHQ-0778-0209
8EHQ-0279-0275
8EHQ-0780-0354
8EHQ-0682-0446 S
8EHQ-0184-0504
8EH9-0984-0S29
8EHQ-1185-0S74
8EHQ-0186-0586 S
8EHQ-1086-0635
8EHQ-0587-0676
8EHQ-04S8-0729 S
8EHQ-0988-0748
8EH«-108t-0763 S
8EHQ-1089-0836
8EHQ-1189-0846
8EHQ-0290-0881 S
8EHQ-0490-0932
8EHQ-0890-1049 S
8EHQ-0178-0033
8EHQ-0678-0184 x
8EHQ-0878-0231 *
8EHQ-1079-0312
8EHQ-0980-0364
8EHQ-0683-0483 S
8EHQ-0384-0507
8EHQ-0785-0561 S
8EHQ-1185-0576
8EHQ-0386-0594 S
8EHQ-1286-0648
8EHQ-1287-0702
8EHQ-0788-0744 S
8EHQ-1088-0756
8EHQ-0489-0793
8EHQ-1189-0840 S
8EHQ-1289-0855
8EHQ-0490-0930 S
8EHQ-0490-0936
8EHQ-0990-1063
8EHQ-0578-0160
8EHQ-0678-0190
8EHQ-0279-0274
8fcHQ-0680-0347
8EHQ-0281-0384
8EHQ-1083-0494
8EHQ-0884-0524
8EHQ-0785-0562
8EHQ-0186-0582
8EHQ-0486-0600
8EHQ-0487-0668
8EHQ-1287-0706
8EHQ-0888-0747
8EHQ-1088-07&0
8EHQ-0889-0817
8EHQ-1189-0843
8EHQ-0190-0866
8EHQ-0490-0931
8EHQ-0690-1002
8EHQ-0990-1074
S
S
S
S
S
S
S
TSCA 8(C) ALLEGATION
-------
APPENDIX CD): STATUS REPORTS BY INFORMATION TYPE
SUBMISSION I: 8EHQ-0378-0097
8EHQ-0478-0135
8EHQ-0786-0612
8EHQ-0887-069B
8EHQ-0989-Q821 S
8EHQ-0590-0991 S
8EHQ-0478-0118 P
8EHQ-1084-0532
8EHQ-Q88S-0622 S
8EHQ~0987-069'i
8EHQ-0390-0905 S
8EHQ-0990-1071
x
x
8EHQ-0478-0129
8EHQ-0386-0589 S
8EHQ-0986-0632
8EHQ-0889-0818 S
8EHQ-0490-0929 5
8EHQ-0990-1078
vo
o
-------
APPENDIX C
THURSDAY, MARCH 16, 1978
PART V
ENVIRONMENTAL
PROTECTION
AGENCY
TOXIC SUBSTANCES
CONTROL ACT
Statement of Interpretation and
Enforcement Policy; Notification
of Substantial Risk
. 91
-------
11110
NOTICES
(6560-01]
ENVIRONMENTAL PROTECTION
AGENCY
CFRL 849-2]
TOXIC SUUTAHCiS COffTlOL ACT
H*Hfk«M*« of SubitimlM Utk Under
$*cM*«i •(•)
AGENCY: Environmental Protection
Agency.
ACTION: Statement of interpretation
and enforcement policy.
SUMMARY: This action states EPA's
„ Interpretation of, «and ^enforcement
policy concerning, section 8(e) of the
Toxic Substances Control Act (TSCA)
(90 Stat 2029. 15 U.S.C. 2607). The
provisions of that section went into
effect on January 1,1977.
Section 8ta-
polnts 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.
(2) 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 B(e) requirements
to commercial establishments as well
as to employees capable of appreciat-
ing pertinent Information, but stipu-
lated enforcement priorities intended
to encourage corporate processing and
centralized reporting of such informa-
tion (42 FR 4S363). The intent was to
ensure that pertinent information ob-
tained by employees Is promptly and
appropriately considered, while mini-
mizing duplicative 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 policy statement
stipulates that individual officers and
employees will have fully discharged
their section 8(e) 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
procedures, at a minimum, must: (1)
Specify the information that must be
reported; (2) indicate how the notifica-
tions are to be prepared and submit-
ted; (3) note the Federal penalties for
failing to report; and (4) provide a
mechanism for promptly notifying of-
ficers and employees who have submit-
ted reports 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 four 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 its section 8(e)
obligations retain personal liability for
ensuring that substantial-risk informa-
tion is reported to EPA.
(3) The September 9 proposal stated,
to 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 "may
suggest" provision, but emphasizes
that "reasonably supports 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" such 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 8(e) 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(e) to information obtained
before 1977 of which a person has
FIDflAl tKMSTiK, VOL. 43, NO. 5J—THUISOAT, MAtCH It, 1971
92
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NOTICES
11111
been aware since January 1, 1977. In
response to requests for clarification,
the statement defines what constitutes
such awareness. In this manner, EPA
intends to limit the need for searches
of historical records and files.
<6> 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 re-
quirements Include both natural per-
sons and business entities engaged in
manufacturing, processing, or distrib-
uting in commerce a chemical sub-
stance or mixture. In the case of busi-
ness entities, 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 must ensure that
the organization reports substantial-
risk Information to EPA. The business
organization is considered to have ob-
tained any Information which any of-
fleer or employee capable of appreciat-
ing the significance of that informa-
tion has obtained. It is therefore In-
cumbent upon business organizations
to establish procedures for expedi-
tiously processing pertinent informa-
tion In order to comply with the
schedule set forth in Part IV.
Those officers and employees of
business organizations who are capa-
ble of appreciating the significance of
pertinent information are also subject
to these reporting requirements. An
employing organization may relieve Its
individual officers and employees of
any responsibility for reporting sub-
stantial-risk Information directly to
EPA by establishing, internally publi-
cizing, and affirmatively Implementing
procedures for employee submission
and corporate processing of pertinent
mfonuation.^These* procedures, »t" a""
minimum, must: (1) Specify the Infor-
mation that officers and employees
must submit; <2) indicate how such
submissions are to be prepared and
the company official to whom they are
to be submitted; (3) note the Federal
penalties for failing to report; and (4)
provide a mechanism for promptly ad-
vising officers and employees In writ-
Ing of the company's disposition of the
report, Including whether or not the
report was submitted to EPA (and If
not Informing employees of their right
to report to EPA, as protected by
TSCA section 23). An employee of any
company that has established and
publicized such procedures, who has
internally submitted pertinent Infor-
mation in accordance with them, shall
have discharged his section 8(e) obli-
gation. Establishment of such proce-
dures notwithstanding, all officials re-
sponsible and having authority for the
organization's execution of its section
8(e) 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 8(e) obligation until EPA
has received the information.
NOTE —Irrespective of • business organiza-
tion's decision to establish and publicize the
procedures described above, it la responsible
lor becoming cognizant of any substantial-
risk information obtained by Its officers and
employees, and for ensuring that such infor-
mation is reported to EPA within 15 work-
ins days.
III. WHEN A PERSON WILL BE REGARDED
AS HAVING OBTAINED INFORMATION
A person obtains substantial-risk in-
formation at the time he first comes
into possession of or knows of such in-
formation.
Now,—Thta Includes Information of
which a prudent person similarly situated
could reasonably be expected to posses* or
have knowledge.
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. REQUIREMENT THAT A PERSON "IM-
MEDIATELY INFORM" THE ADMINISTRA-
TOR
With the exception of Information
on emergency incidents of environ-
-mentahcontamination'[see'Part V 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: (i> The effects outlined
below should not be reported if the re-
HDERM IEGISTEK, VOL. 43, NO. SI—TMUISDAY, MAICH 16, 1971
93
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11112
NOTICfS
spondent has actual knowledge that
the Administrator Is already informed
of them.
(11) 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 effectt—d) Any
Instance of cancer, birth defects, mu-
tagenlcity, death, or serious or pro-
longed Incapaciution. including the
loss of or Inability to use a normal
bodily .function with-a_consequent r»l-,.,
atlvely serious impairment of normal
activities, if one (or a few) chemicaHs)
Is strongly Implicated.
(2) Any pattern of effects or evi-
dence which reasonably supports the
conclusion that the chemical sub-
stance or mixture can produce cancer,
mutation, birth defects or toxic effects
resulting in death, or serious or pro-
longed LncapaclUtlon.
(b) Environmental effect*—U> Wide-
spread and previously unsuspected dis-
tribution in environmental media, as
Indicated In studies (excluding materi-
als contained within appropriate dis-
posal facilities}.
(2) Pronounced bioaccumulatlon.
Measurements and indicators of pro-
nounced bioaccumulatlon heretofore
unknown to the Administrator (includ-
ing bioaccumulatlon in fish beyond
5,000 times water concentration in a
30-day exposure or having an n-oc-
tanol/water partition coefficient
greater than 25,000) should be report-
ed when coupled with potential for
widespread exposure and any non-triv-
ial adverse effect.
(3) Any non-triyial adverse effect,
heretofore unknown to the Adminis-
trator, associated with a chemical
known to have bloaccumulated to a
pronounced degree or to be wide-
spread in environmental media.
(4) Ecologically significant changes
in species' interrelationships; that Is,
changes in population behavior,
growth, survival, etc. that in turn
affect other species' behavior, growth,
or survival.
Examples include: (i) Excessive stim-
ulation of primary producers (algae,
macrophytes) in aquatic ecosystems,
e.g., resulting in nutrient enrichment,
or eutrophication. of aquatic ecosys-
tems.
(»i) Interference with critical biogeo-
chemical cycles, such as the nitrogen
cycle.
(5) Facile transformation or degra-
dation to a chemical having an unac-
ceptable risk as defined above.
(c) Emergency incident* of environ-
mental contamination—Any environ-
mental contamination by a chemical
substance or mixture to which any of
the above adverse effects has been as-
cribed and which because of the pat-
tern, extent, and amount of contami-
nation (1) seriously threatens humans
with cancer, birth defects, mutation,
death, or serious or prolonged Inea-
pacitation, or (2) seriously threatens
non-human organisms with large-scale
or ecologically significant population
destruction.
VI. NATUHE AND SODHCES or INFORMA-
TION WHICH "REASONABLY SUPPORTS
THE CONCLUSION" or SUBSTANTIAL
RISK
Information attributing any of the
effects described in Part V above to a
'Chemical-substance or mixture 4s to be
reported if it is one of the types listed
below and If it is not exempt from the
reporting requirement by reason of
Part VII of this policy statement. A
person is not to delay reporting until
he obtains conclusive Information that
a substantial risk exists, but is to im-
mediately report any evidence which
"reasonably supports" that conclusion.
Such evidence will generally not be
conclusive as to the substantiality of
the risk; it should, however, reliably
ascribe the effect to the chemical.
Information from the following
sources concerning the effects de-
scribed In Part V will often "reason-
ably support" a conclusion of substan-
tial risk. Consideration of corrobora-
tive information before reporting can
only occur where it is indicated below.
(1) Designed, controlled ttudiet. In
assessing the quality of information,
the respondent is to consider whether
it contains reliable evidence ascribing
the effect to the chemical. Not only
should final results from such studies
be reported, but also preliminary re-
sults from incomplete studies where
appropriate. Designed, controlled stud-
ies include:
In vivo experiments and tests.
(11) In vitro experiments and tests.
Consideration may be given to the ex-
istence of corroborative information. If
necessary to reasonably support the
conclusion that a chemical presents a
substantial risk.
(ill) Epidemiologies! studies.
(iv) Environmental monitoring stud-
ies.
(2) Reports concerning ond studies
of undeiiynetL, uncontrolled circum-
ttances. It is anticipated here that re-
portable effects will generally occur In
a pattern, where a significant common
feature is exposure to the chemical.
However, a single instance of cancer,
birth defects, mutation, death, or seri-
ous incapacitation in a human would
be reportable if one (or a few)
chemlcal(s) was strongly implicated.
In addition, it is possible that effects
less serious than those described in
Part V(a> may be preliminary manifes-
tations of the more. serious effect*
and, together with another triggering
piece of information, constitute repor-
table information; an example would
be a group of exposed workers experi-
encing dizziness together with prelimi-
nary experimental results demonstrat-
ing neurological dysfunctions.
Reports and studies of undesigned
circumstances include:
(I) Medical and health surveys.
(II) Clinical studies.
(ill) Reports concerning and evi-
dence of effects in consumers, workers,
or the environment.
VII. INFORMATION WHICH NEED Nor Bi
RETORTED
Information need not be reported if
it
(a) Has been published by EPA In re-
.ports;
(b) Has been submitted in writing to
EPA pursuant to mandatory reporting
requirements under TSCA or any
other authority administered by EPA
(including the Federal Insecticide,
Fungicide and Rodenticide Act, the
Clean Air Act, the Federal Water Pol-
lution Control Act, the Marine Protec-
tion, Research, and Sanctuaries Act,
the Safe Drinking Water Act, and the
Resource Conservation and Recovery
Act), provided that the information:
(1) Encompasses that required by Part
IX (c) through (f); and (2) is from now
on submitted within the time con-
straints set forth in Part IV and iden-
tified as a section 8(e) notice in accor-
dance with Part IX(b);
(c> Has been published in the scien-
tific literature and referenced by the
following abstract services: (1) Agric-
ola, (2) Biological Abstracts, (3)
Chemical Abstracts, (4) Dissertation
Abstracts, (5) Index Medleus, («) Na-
tional Technical Information Service.
(d) Is corroborative of well-estab-
lished adverse effects already docu-
mented In the scientific literature and
referenced as described in (c) above,
unless such Information concerns
emergency incidents of environmental
contamination as described in Part
V(c), or
(e) Is contained In notification of
spills under section 3It(b)(S) of the
Federal Water Pollution Control Act.
VIII. INFORMATION FIRST RECEIVES *r
A PERSON PRIOR TO THE ETOCTIVI
DATE 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;
KDHAt ttoirrn, VOL. «, NO. sj—THURSDAY, MAICH u, 1971
94
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NOTICiS
H113
(b) Any Information the contents of
which a person has been alerted to by
date received after January 1,1977, In-
eluding any Information concerning a
chemical for which the person Is pres-
ently assessing health and environ-
mental effects;
(c) Any other Information of which
the person has actual knowledge.
IX REPORTING REQUIREMENTS
Notices shall be delivered to the
Document Control Officer, Chemical
Information Division, Office of Toxic
Substances (WH-557), Environmental
Protection Agency, 401 M Street SW.,
Washington, D.C. 20460. r * * * * -t
-A notice^should: *• J
(a) Be sent by certified mail, or in
any other way permitting 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) Summarize the adverse effects
being reported, describing the nature
and the extent of the risk involved.
and
(f} Contain the specific source of the
information together 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 as
soon as he has knowledge of the inci-
dent (see below for appropriate tele-
phone contacts). The report should
contain as 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, Is to be submitted
within 15 days. Twenty-four hour
emergency telephone numbers are:
Region I (Maine. Rhode Island, Connecti-
cut, Vermont, Massachusetts, New Hamp-
shire). 817-223-7265.
Region n (New York. New Jersey, Puerto
Rico, Virgin Islands). 20l-S48-«730.
Region III (Pennsylvania, West Virginia,
Virginia, Maryland. Delaware, District of
Columbia), 215-597-9898.
Region IV (Kentucky, Tennessee, North
Carolina, South Carolina, Georgia, Ala-
bama, Mississippi. Florida), 404-881-4062.
Region V (Wisconsin. Illinois, Indiana,
Michigan. Ohio, Minnesota), 312-353-
2318.
Region VI (New Mexico. Texas, Oklahoma,
Arkansas, Louisiana), 214-749-3B40.
Region VII (Nebraska, Iowa, Missouri.
Kansas), 818-374-3778.
Region VIII (Colorado, Utah. Wyoming.
Montana. North Dakota, South Dakota).
303-837-3880.
Region IX (California, Nevada, Arizona,
Hawaii, Guam). 415-556-4254,
Rtglon X (Washington, Oregon, Idaho,
Alaska), 206-442-1200.
X, COHriDEHTIAUTT CUMMS
(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, set
forth In 40 CFR Part 2 (41 FR 36902,
September 1.1976).
(b) If no claim accompanies the
notice at the .time, it ,1s 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 page with a label
such as "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 all 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
are 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." '
XI. FAILURE To REPORT INFORMATION
Section 15(3) of TSCA makes It un-
lawful for any person to fail or refuse
to submit information required under
section 8(e). Section 16 provides that a
violation of section 15 rendeis a
person liable to the United States for
a civil penalty and possible criminal
prosecution. Pursuant to section 17,
the Government may seek judicial
relief to compel submtttal of section
8(e) Information and to otherwise re-
strain any violation of section 8(e).
AFFENDIX A.— QUICK Rtmtntci BmnuutY
FOK EMweracr In CIEMENTS or Exvinomav-
A. WHAT SHOULD ai REPORTED AS All
An emergency Incident of environment*!
contamination U "any environmental con-
tamination by a chemical substance or mix-
ture . . . which, because of the pattern,
extent and amount of contamination, (1) Se-
riously threatens humans with cancer, birth
defects, mutation, death, or serious or pro-
longed Incapacltation. or (2) seriously
threatens non-human organisms with large
scale or ecologically significant population
destruction", (See Part V(c) lor complete
description.)
• - • i. TTHJIT jntrn HOT at atroBna AS A*
EMERGENCY INCIDENT
Information contained in notification of
ipllls under section SlKbMB) of the Federal
Water Pollution Control Act (FWPCA).
(For a complete list of exemptions to report-
big, see Part VII.)
c. wan Aim WBEU TO KZPO*T EKEBCXHCY
Emergency incidents of environmental
contamination are to be reported immedi-
ately by telephone to the appropriate EPA
Regional 24-hour telephone emergency line
listed below.
Region I (Maine. Rhode Island. Connecti-
cut, Vermont, Massachusetts. New Hamp-
shire), 817-223-7265.
Region n (New York, New Jersey, Puerto
Rico, Virgin Islands). 201-648-8730.
Region III (Pennsylvania. West Virginia,
Virginia, Maryland, Delaware, District of
Columbia), 215-597-9898.
Region IV (Kentucky, Tennessee, North
Carolina, South Carolina, Georgia, Ala-
bama, Mississippi, Florida), 404-881-4062.
Region V (Wisconsin, Illinois, Indiana.
Michigan. Ohio, Minnesota), 312-353-
2318.
Region VI (New Mexico, Texas, Oklahoma,
Arkansas. Louisiana), 214-749-3840.
Region VII (Nebraska, Iowa, Missouri.
Kansas), 818-374-3778.
Region VIII (Colorado, Utah, Wyoming,
Montana, North Dakota, South Dakota),
303-837-3880.
Region IX (California. Nevada, Arizona,
Hawaii, Ouam), 415-55fl-«254.
Region X (Washington, Oregon, Idaho,
In addition, a written report. In accord-
ance with instructions (a) through (f) of
Part IX is to be submitted within IS days to
the Document Control Officer, Chemical In-
formation Division, Office of Toxic Sub-
stances (WH-557). 401 M Street SW., Wash-
tagton, D.C. 20460.
Amanix B— SioNiricAHT COMMENTS AMI
RESPONSES
A. PK&tOHl SUBJECT TO THESE UQDIKXMXNT*
Comment 2: Employees cannot be held
subject to these requirements, since: (a)
They only have a partial role In the manu-
facture, processing, or distribution of chemi-
cals, (b) In other sections of TSCA, the term
"person who manufactures, processes, or
distributes" chemicals clearly refers to busi-
ness organizations; "persons" should be con-
sistently defined, and (c) the application of
criminal penalties mandates a strict inter-
pretation of this word.
See NOTE on last page of Appendix C
FEOflAl MOISTM, VOL 43, NO. 52—THURSDAY, MAICH 16, 1971
-------
11114
NOTICES
Response' The Agency considers that dlf-
lerenl sections of TSCA, having different
purposes; are appropriately directed to dif-
ferent respondents. In the case of section
8(e), offlcen and employees who ire capable
of appreciating the significance of informa-
tion have a legitimate responsibility to be
alert to and report substantial-risk informa-
tion. The guidance ha* been modified to
that natural persons and business entities
can fulfill their section 8 obligations in
different waya. Most officers and employees
can discharge their section 8(e) obligations
by submitting pertinent Information to cor-
porate superiors, provided that the com-
pany has established the risk-evaluation
procedures characterized in Pan II, In the
case of a business organization, Us presi-
dent, chief executive officer, and other offi-
cials, responsible, and having, Authority 4pr
the business organization's execution of Its
section We) obligations must ensure that
the organization reports substantial-risk In-
formation to EPA.
Comment 2: Even If employees can be held
subject to these requirement!, they should
not be. To do so would force employees and
employers 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.
Response: The Agency considers that em-
ployees have a legitimate role In risk report-
ing: it is imperative that risk Information
obtained by employees be appropriately
considered. Officers and employees can ful-
fill their role in the reporting of substantial-
risk information, without the disadvantages
described above, by reporting information
to superiors for corporate consideration,
and, having done so, will have discharged
their obligation to EPA. This is contingent
upon the establishment by the business or-
ganization of certain procedures for risk-
evaluation, thereby assuring the appropri-
ate consideration of such reports. Those of-
ficers responsible and having authority for
the organization's execution of its section
8(e) obligations must ensure that the orga-
nization reports substantial-risk informa-
tion to EPA.
Comment 3: Clarify which employees are
covered, and the extent of their obligation.
Are employees "capable of appreciating per-
tinent information" by virtue of rank, or
knowledge? Are rank and file employees
subject to these requirements, or just super-
visory and managerial personnel, company
lexicologists, etc.? la an employee absolved
of further responsibility if he report! to his
supervisor?
Response: The Agency considers that the
phrase "capable of appreciating the signifi-
cance of pertinent information" appropri-
ately describes those officers and employees
who have a responsibility to be alert to and
report substantial-risk information, includ-
ing not only relatively senior corporate offi-
cers but also many corporate employees.
The policy statement modifies the Septem-
ber 8 proposal, in response to the concerns
expressed in Comments 2 and 3, to permit
most officers and employees to discharge
their obligation by submitting information
to corporate superiors, subject to the condi-
tions described in Part II.
Comment 4: Consultants and Independent
labe should not be subject to these require-
ments.
Response Contractors and independent
labs are not responsible for reporting infor-
mation they have obtained directly to EPA;
rather, their client manufacturers, proces-
sors and distributors are responsible for
reporting such Information.
s. nit "orrAnrma" or INFORMATION
Comment S: The "may suggest" criterion
In Part III of the proposal serves to compel
further examination of Information that by
Itself is not subject to section 8ce> require-
ments. The statutory language calling for
"reasonable support" doe* not support this.
Further, risk assessment often requires any-
where from months to several years of
study after preliminary results "suggest"
risk, far exceeding the 16-day compliance
period.
Response: The Agency does not Intend to
compel under section 8(e) examination of
-taforraatJorr-thmt by Itself Is'not-subject to
section B(e) requirements and has deleted
the "may suggest" provision, providing iu
Interpretation of what constitutes evidence
that "reasonably supports the conclusion"
of substantial risk in a new Part VI,
Comment S: Section We) obligations are
incurred upon obtaining conclusory substan-
tial-risk information.
Response: The Agency disagrees, 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 must be reported, at aa earlier
stage.
Comment 7: The statement, in Part in of
the proposal that a person has obtained in-
formation if he ". , , should know of the ex-
istence of such information not in his pos-
session but which would be delivered to him
on request," tends to compel an active
search for substantial-risk information
rather than the reporting of substantial-risk
Information a person "obtains." This is of
particular concern to Importers with limited
access to information possessed by their
suppliers.
Response: The Agency considers that sec-
tion 8 IKTOIUIATIOB THAI MUSI at
RETORTED
Comment 12: The reporting of "any In-
stance" of cancer, birth defects, etc., in
humans is too broad and such information
will be of little use; chemical workers, like
the general population, develop cancers and
other ailment! of uncertain etiology,
Responte: This policy statement clarifies
that the reporting of single occurrences of
human cancer or other serious effects will
depend upon evidence strongly implicating
one (or a few) chemlcal(s).
Comment 13: Dermal ailments and nausea
are poorly chosen examples of precursor
symptoms. Deleting these examples will
avoid unduly emphasizing them when other
symptoms may be more important, yet will
not eliminate the obligation to report them
if they are suspected precursors.
Response: The Agency agrees.
Comment H: How are importable data dis-
tinguished from routine testa including
range tests such as UXi's?
Response: This policy statement directs
the reporting of specified effects when un-
known to the Administrator. Many routine
tests are based on a knowledge of toxicity
associated with a chemical; unknown effects
occurring during such a range test may have
to be reported if they are those of concern
to the Agency and if the information meets
the criteria set forth In Parts V and VI.
Comment IS: The most widespread "in
vitro" test is the Ames test, which is subject
to considerable debate. Clarify the circum-
stances under which positive results of in
vitro tests must be reported.
Response: Part VI clarifies that the re-
porting of In vitro tests will depend upon
the existence of corroborative information
If necessary to reasonably suppoit the con-
clusion of substantial risk.
Comment it: The description of "extreme
persistence" as a substantial risk Is an exam-
ple of the need to redefine Part V(c) ("Envi-
ronraental Effects"). Persistence and bin-
accumulation should be considered risks
only when coupled with toxicity and signifi-
cant exposure.
FEDERAL IE
-------
NOTICES
11115
Reiponif Part V now clarifies those ef-
fects for which reporting depends upon t
significant exposure potential. Persistence
by Itself i* no longer Itemized as a report-
able effect but rather 1* considered to be a
component of exposure, potential; It may
also underlie the measurements described In
Part V(b)(l). Laboratory Indicators of pro-
nounced bioaccumuUtlon are to be reported
when coupled with potential for widespread
exposure and any non-trivial adverse effect.
Comment 17: The n-octanol/water parti-
tion coefficient addresses a physico-cheml-
cal property, not biological effects, and is
not alone an indicator of substantial risk;
further, the value* stated for the coefficient
and the bloaccumulatlon factor in fish do
not correspond.
Response.' The Agency acknowledges the
• numeric*} error and has-araended the values-
to correspond. This policy statement now
direct* the reporting of an experimental
measurement of bioaccumulation 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 is too broad and contradicts
the statutory language of "reasonably
•upporta",
Retponte: The Agency has provided in a
new Part VI its interpretation of "reason-
ably supports".
Comment 19: A determination that infor-
mation "reasonably supports 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;
in particular, the criteria should reflect a
distinction between normal and abnormal
met of chemicals.
Retponte: The Agency considers that the
Appropriate components of a "substantial
risk" with respect to a chemical are (a) the
seriousness of the effect, and (b) total expo-
sure potential. The method and manner of
using a chemical Is one of several factors de-
termining Its exposure potential. As de-
scribed In 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 to Part
V(a) are so serious that relatively little
weight is given to exposure; the effects de-
scribed in Parts V (b) and (c) Involve a sig-
nificant 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
chemical.
B. nrroRMATion THAT NEED HOT BE REPORTED
Comment 28; Information published in
scientific literature In languages other than
English should be exempted If published in
summary form by abstracting sen-ices. Can
the accuracy of English language abstracts
and commercial translations of foreign lit-
erature be assumed?
Response: This policy statement now pro-
vides that information published in scien-
tific literature, whether In English or an-
other language, is exempt from reporting if
published in summary form by certain
specified abstract services.
Comment 21: Information exchange sys-
tems with other Federal agencies should be
Immediately established so that respondents
need not report Us EPA information already
reported to other Agencies, and vice versa.
Such duplicative reports are unduly burden-
some.
Kfspnnst: EPA is coordinating this pro-
gram with other agencies now. When this
coordination is successfully completed, the
policy statement will be amended to exempt
from the reporting 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.
F. IJirORMATIOH FIRST RZCtmB FRIOK TO THI
EFFECT! V* DAT! Or TSCA
Comment 22.' The tense of the verb "ob-
tains" reveals that section 8(e) was intended
to be applied prospective!? to Information
newly acquired after January 1, 19TI, Utilize
section 8(d) or other rules to acquire infor-
mation obtained before then. .....
Rapcnte.- As discussed in the preamble to
the September 9 proposal, the Agency con-
alders section 8(e) to apply to risk informa-
tion possessed by or known to a person
before, on, or after January I, 1977. 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 I,
1977, for the reasons discussed la the Sep-
tember 9 preamble.
Comment 23: The term "aware" IB too
vague to be of any help in responding to
these requirements. Since many corporate
employees are potentially subject to these
requirements, and given uncertainty over
the extent to which they ought to be aware
of pre-1977 information, this provision tend!
to compel the very file search It was intend-
ed to avoid. The term "aware" should be
further defined, possibly in terms of actual
knowledge.
Response: The Agency in Part VIII of this
policy statement now defines the pre-1977
information of which a person is considered
to be aware.
c. cownoomu. nrroRMATtoii
Comment 24: 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 26: EPA should automatically
publish section 8(e> notices.
Response to Comments 24 through 28:
EPA has included a new Part X which de-
scribes how to submit a claim of confiden-
tiality and states that any or all of the in-
formation submitted may be claimed as con-
fidential. Such information will be disclosed
by EPA only to the extent, and by means of
the procedures, set forth In 40 CFR Part 2.
Comment 27: What is the statutory basis
or need for guidance? What Is its exact
status under the Administrative Procedure
Act?
Response: This policy statement seU forth
EPA's interpretation of and policy concern-
ing TSCA section 8 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 tu occurrence. As opposed to
other risks addressed by TSCA. economic or
social benefits of use, or costs of restricting
use, are not to be considered in determining
whether a risk is "substantial".
Comment 30: To what extent are "users"
of chemicals subject to these requirements?
Retponte.- The Agency considers that
many Industrial uses of chemicals actually
fall within the •cope of "processing" chemi-
cals. A manufacturer, processor, or distribu-
tor who obtains substantial-risk information
concerning chemicals he handles should be
alert to the possibility he may have to
report it
Comment 31: Are chemicals manufac-
tured, processed and 'distributed la com-
merce In small quantities solely for purposes
of research and development subject to
these requirements?
Response in general, the Agency consid-
ers that much manufacturing, processing,
and distribution in commerce of chemicals
In small quantities solely for purposes of re-
search and development is conducted for
"commercial purposes". Such purposes
would Include the sale and distribution of
such materials, as well as 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 materials or
others on a larger scale.
As described in Part V, the Agency consid-
ers that "substantial risks" depend in part
upon an exposure potential. Thus, the oc-
currence of the effects described in Part
V(a) presuppose exposure to the chemical
and must be reported; reporting of the
other effects will depend upon a potential
for significant levels of exposure.
Comment 32; Are raw materials, interme-
diates, and inert ingredients produced or
used in the manufacture of a pesticide sub-
ject to TSCA?
Retponte: The Administrator consider*
that raw materials, Intermediates and inert
Ingredients produced or used in the manu-
facture of a pesticide are substances or mix-
tures which can be regulated under TSCA.
In order to be considered a pesticide, a
substance must be intended for use at a pes-
ticide. Raw materials, intermediates, and
Inert ingredients produced or used in the
manufacture of a pesticide are not them-
selves regulated under PIPRA (unless they
happen to be pesticides themselves) and,
therefore, are subject to TSCA. The pesti-
FIDHAl tlGISTH, VOL 43, NO. 52—THUtSDAT, MAiCH 1*, 197*
97
-------
1111*
Nonas
dde refutation! at 40 CFR 102.4 are consis-
tent with this view.
Comment 33: Are Intermediate* and cata-
lysts intended solely for use In the produc-
tion of a food, food additive, drat, cosmetic.
or device subject to TSCAT
Raj>on*t: The Administrator consider*
that Intermediates and catalysts Intended
solely (or use In the production of a food,
food additive, drus, cosmetic., or device are
excluded from regulation under TSCA. The
definitions of the FFDCA provide that
chemical substances which are Intended for
use as a component of a food, food additive,
drug, cosmetic, or device are encompassed
within the meaning of such terms, respec-
tively. The FDA considers intermediates
and catalysts to be such components. There-
fore. they are subject to regulation under
,theJ*FDCA. Any «uch.substance is excluded •
from regulation under TSCA insofar as it I*
actually manufactured, processed, or dis-
tributed ID commerce solely for use In the
production of a food, food additive, drug.
cosmetic, or device.
Comment 34: Employees should have the
option to submit reports anonymously.
Response* EPA considers that any person
may report Information to EPA under
TSCA. Those who are required to do so
under section We) are persons who manu-
facture, process, or distribute In commerce
chemical substances or mixtures. Including
not only business entitle* but also such em-
ployees as described In Part II. In order to
establish that such persons have discharged
their obligations, and In order to encourage
responsible review of the quality of informa-
tion and the substantiality of risks, EPA be-
lieves that notl/lers should Identify them-
selves. Section 23 will adequately protect
employees from discrimination pursuant to
-notifications- they have made under •section
Me).
CFR Doe, 7S-70M Piled S-15-18; 8:45 ami
BOTE
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
FCDttAL tfOISTfI, VOL. 49, NO, 12—THUtiOAV, MAICH 14, 1971
98
-------
Friday,
February 1, 1991
APPENDIX D
(CAP Notice)
Part II
Environmental
Protection Agency
Registration and Agreement for TSCA
Section 8(e) Compliance Audit Program;
Notice
99
-------
4128
Federal Register ' Vol. 58, No. 22 / Friday, February 1, 1991 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[OPTS-40015; FRL-3844-4]
Registration and Agreement for TSCA
Section 6(9) Compliance Audit
Program
AGENCY: Environmental Protection
Agency (EPA).
ACTION; Notice.
SUMMARY: This Notice, pursuant to
sections 15 and 16 of the Toxic
Substances Control Act (TSCA), 15
.U.S.C.. 2801 et seg.,, announces the
opportunity to register for EPA's TSCA
Section 8(e) Compliance Audit Program.
This Notice also contains the text of an
Agreement for the TSCA Section 8(e)
Compliance Audit Program ("CAP
Agreement"). The TSCA Section 8(e)
Compliance Audit Program and the
registration provisions and CAP
Agreement conditions are described
below.
DATES: The Registration period for the
TSCA Section 8(e) Compliance Audit
Program commences February 1,1991,
and closes May 2,1991. Persons
interested in registering for the
voluntary TSCA Section 8(e)
Compliance Audit Program must request
a CAP Agreement and submit a signed
CAP Agreement to EPA no later than
May 2,1991.
ADDRESSES: Copies of the CAP
Agreement may be obtained from the
TSCA Assistance Information Service,
Environmental Assistance Division (TS-
799), Office of Toxic Substances,
Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460, [202)
554-1404, TDD: (202) 554-0551.
FOR FURTHER INFORMATION CONTACT:
Michael M. Stahl, Director,
Environmental Assistance Division (TS-
799), Office of Toxic Substances,
Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460, (202)
554-1404, TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION:
I. Background
Section 8(e) of TSCA states that "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."
"Substantial risk information"
reportable to EPA under section 8(e) of
TSCA refers to new information that
reasonably supports a conclusion that a
chemical substance or mixture presents
a substantial risk of injury to health or
the environment, (The term new
information refers to information
(including preliminary data) about
which EPA has not already been
adequately informed.) Such information
need not and most typically does not
establish conclusively that such a risk
exists. In other words, reasonable
support for a conclusion is not
^synonymous with the conclusion itself
and usually precedes the conclusion.
In deciding whether new information
reasonably supports a conclusion of
substantial risk, one must consider (1)
The seriousness of the adverse effect,
and (2) the fact or probability of the
effect's occurrence. These two criteria
should be weighed differently depending
upon the seriousness of the effect and
the extent of the exposure: i.e., the more
serious the effect, the less heavily one
should weigh the actual or potential
exposure, and vice versa.
In some cases, e.g., the observance of
certain types of serious toxicologic
effects in animals or humans, exposure
to the chemical substance(s) or mixtures
is presupposed and will constitute
sufficient evidence of exposure for a
determination to be made to submit the
new-found toxicological data. Such
serious effects include, but are not
limited to, (1) Birth defects and/or
serious developmental effects (including
those observed in the presence of
maternal toxicity), and (2) cancer (as
evidenced by benign and/or malignant
tumors).
Any decision-making process for
determining section 8(e)-reportability
should focus primarily on whether new
toxicologic or exposure data offer
reasonable support for a conclusion of
substantial risk and should not focus to
any great extent, if at all, on whether the
information is conclusive regarding the
risk. Therefore, a decision to report
pursuant to section 8(e) should not
involve (1) Exhaustive health or
environmental assessments, or (2) any
evaluation of the economic or social
benefits of the use(s) of the subject
chemical(s).
In reviewing recent enforcement
cases, EPA has found that some
companies may be misinterpreting
TSCA section 8{e) and EPA's
"Statement of Interpretation and
Enforcement Policy; Notification of
Substantial Risk," ("Section 8(e) Policy
Statement," March 16,1978, 43 FR
11110). Some companies obtaining
information on certain serious health
effects appear to be further evaluating
and wrongly discounting the
significance of the information on the
basis of a "weight-of-the-evidence" risk
assessment. It is EPA's position.
however, that if certain serious health
effects are discovered, the information
should be considered for immediate
reporting under section 8(e) without
further evaluation. The following are
examples of information that should be
considered immediately for reporting
under section 8(e) of TSCA.
1. New information concerning
statistically or biologically significant
•'increesas'in benign and/or.malignant
tumors in an animal study; a "weight-of-
the-evidence" risk assessment should
not be used to discount the findings.
2. Statistically or biologically
significant increases in teratologic or
other serious reproductive effects
observed in animals; the level of
maternal toxicity observed in the study
should not be used to discount the
findings.
3. Serious toxic effects (e.g., cancer,
birth defects, and neurotoxicity)
observed in tests of chemical substances
or mixtures at the research and
development stage; such findings should
not be discounted because the company
believes that there is no exposure to the
chemical(s).
Up-to-date information on hazard and
exposure is vital in supporting EPA
efforts to protect human health and the
environment from risks from toxic
chemicals. EPA has the responsibility
under TSCA to perform needed risk
assessments on chemicals. Section 8(e]
is a very important part of TSCA's
section 8 information reporting and
recordkeeping provisions that enable
EPA to obtain and disseminate
information needed to set priorities and
perform risk assessments that may be
national in scope. Companies that do
not report vital information are
undermining the effectiveness of the
early warning system intended under
section 8(e).
In the past year, some companies
have alleged that EPA has changed its
interpretation of TSCA section 8(e)
thereby creating vulnerability that was
not previously contemplated for
reporting. These same entities have said
that EPA's TSCA Sections 8,12, and 13
Enforcement Response Policy contains
significant disincentives (namely very
high monetary penalties) to dissuade
auditing of past studies and reporting
them to EPA.
EPA has not changed its interpretation
of TSCA section 8(e). EPA's
implementation of the TSCA section 8(e)
program is based on sound guidance
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4129
that is and has 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 files for studies
reportable under section 8(e). This
program is known as the TSCA Section
B(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 the Registration /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 of Pesticides anil Toxic Substances
Registration and Agreement for TSCA
Section 8(e) 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 consented 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(e).
B. To register for the TSCA Section
8(e) Compliance Audit Program, the
Regulatee must, 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 20480.
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 UxEPA no later than October
28,1991.
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 Consent 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 consider
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 facts, the Regulatee
admits that EPA has jurisdiction over
the subject matter of the terms of this
CAP Agreement and any study or report
submitted pursuant to this GAP
Agreement.
3. The Regulatee waives its right to
request a judicial or administrative
hearing on any issue of law or fact that
has arisen or may arise during the
conduct of the TSCA Section 8(e)
Compliance Audit Program conducted
pursuant to the terms of this CAP
Agreement, or 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
16(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.
6. 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 Il.B.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 was 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 is subject to the EPA
TSCA Sections 8,12, and 13
Enforcement Response 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
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Federal Register /Vol. 56, No. 22 / Friday^ ^hruary 1. 1991 / Notices
Substantial Risk" (43 FR11110) ("TSCA
Section 8(e) Policy Statement") to
determine whether the reviewed study
or report is:
a. Not importable under TSCA Section
8(e}', The Regulatee will not submit the
study or report.
b, Reportable under TSCA Section
8(e): The Regulatee will submit the study
or report.
Upon Registration for the TSCA
Section 8(e) Compliance Audit Program,
the Regulatee wiU receive a copy of the
TSCA Section 8(e] Policy Statement, the
publication numbers of publicly
available anipreviously. 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 submitted under
this TSCA Section 8{e) Compliance
Audit Program as TSCA section B(e)
data:
a. $15,000 per study for any submitted
study or report involving effects in
humans.
b. $6,000 per study for any other
submitted study or report submitted as
TSCA section B(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 Regulatee.
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 Regulatee shall provide EPA with a
Final Report certifying that the TSCA
Section 8(e) Compliance Audit Program
has been completed. Such Final Report
shall be signed and certified by the
appropriate corporate official with
authority to settle claims on behalf of
the Regulatee. Such Final Report shall
also comply with the requirements of
Unit II.C.4 of this CAP Agreement.
5. Following termination of the audit,
EPA will present the Regulatee with a
Consent Agreement and Consent 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 days 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 II.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
20480, 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 terms of this
CAP Agreement shall be accompanied
by a separate cover letter containing the
following information:
a. Company name, address and
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 tested
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^) or
premanufacture notiflcation(s) (PMN(s))
submitted by the Regulatee on the
subject chemical substance(s) or
mixture or component(s) of such
mixture.
4. Each study or report submitted to
EPA by the Regulatee under the terms of
this CAP Agreement shall be listed in a
Final Report. Such Final Report shall list
each submitted study or report by title
pursuant to the categories established in
Unit II.B.Z.a and b of this CAP
Agreement, and shall display the
identification number established by
Unit I.C 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 a s 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
regulations 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 II.C.4 of
this CAP Agreement has been submitted
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 18 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 II.C of this CAP
Agreement.
5. All of the terms and conditions of
this CAP Agreement together comprise
one agreement, and each of the terms
and conditions is in consideration for all
of the other terms and conditions. In the
event that this CAP Agreement (or one
or more of its terms 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
agrees that the failure to assert a claim
of confidentiality for studies, reports, or
information submitted under the terms
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4131
of this CAP Agreement shall be
interpreted by EPA as a waiver by the
Regulates of the right to assert 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 II.D.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 O.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
II.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 H.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 in 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 Counsel for Pesticides
and Toxic Substances.
III. 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 25,1991.
Linda I. Fisher,
Assistant Administrator for Pesticides and
Toxic Substances.
(PR Doc. 91-2299 Filed 1-31-91; 8:45 am]
BILLING CODE M60-IO-F
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Friday
April 26, 1991
APPENDIX D
(CAP Modifications)
Part VI
Environmental
Protection Agency
Registration and Agreement for TSCA
Section 8(e) Compliance Audit Program
Modification; Notice
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Federal Register / Vol. 56, No. 81 / Friday. April 26, 1991 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[OPTS-80015A; FRL-3891-6]
Registration and Agreement for TSCA
Section 8{e) Compliance Audit
Program Modification
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: This Notice, pursuant to
sections 15 and 16 of the Toxic
Substances Control Act (TSCA), 15
U.S.C. 2601 et seq.. announces
modifications to EPA's TSCA Section
8(e) Compliance Audit Program and the
Agreement for the TSCA Section 8(e)
Compliance Audit Program ("CAP
Agreement"). The modifications to the
TSCA Section 8(e) Compliance Audit
Program and the CAP Agreement
include extension of the registration and
termination dates, the opportunity to
petition EPA for a case-by-case
extension of the termination date,
modifications to the CAP Agreement
provisions regarding admission of a
violation of TSCA section 8(e) and
waiver of right to a hearing, and EPA's
development of a TSCA section 8(e)
reporting guide.
DATES: The Registration period for the
TSCA Section 8(e) Compliance Audit
Program closes on June 18,1991. Persons
interested in registering for the TSCA
Section 8(e) Compliance Audit Program
must request a CAP Agreement and
submit a signed CAP Agreement to EPA
no later than June 18,1991.
ADDRESSES: Copies of the CAP
Agreement may be obtained from the
TSCA Assistance Information Service.
Environmental Assistance Division (TS-
799), Office of Toxic Substances,
Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460, (202)
554-1404, TDD: (202) 554-0551.
FOR FURTHER INFORMATION CONTACT:
David Kling, Acting Director,
Environmental Assistance Division (TS-
799), Office of Toxic Substances,
Environmental Protection Agency, 401 M
St., SW.. Washington, DC 20460, (202)
554-1404, TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 1,
1991 (56 FR 4128), EPA announced the
opportunity to register for the TSCA
Section 8(e) Compliance Audit Program.
The TSCA Section 8(e) Compliance
Audit Program is a one-time voluntary
compliance audit program developed in
order to achieve EPA's goal of obtaining
any outstanding TSCA section 8(e) data.
The TSCA Section B(e) Compliance
Audit Program has been initiated to
foster compliance with the statutory
obligations of TSCA section B(e), and to
obtain critical information about
potential risks of chemical substances.
In designing the TSCA Section 8(e)
Compliance Audit Program EPA's
objective was to provide, in the context
of an enforcement initiative, positive
incentives for companies to conduct
audits of their data and to submit to the
Agency the type of information requited
under section 8(e) of TSCA.
. .-• EPA. recognizes .that proper
application of section 8(e) requires the
exercise of scientific judgement. EPA is
not interested in creating an atmosphere
in which companies view a "data dump"
strategy as the best course of action for
meeting their obligations. The Agency
hopes that cooperative consultation
among EPA. data submitters, and other
interested parties can lead to a more
successful TSCA Section B(e)
Compliance Audit Program and
ultimately a better understanding of the
section 8(e) program. Based on written
communications with the regulated
industry. EPA has made the following
modifications to the TSCA Section 8(e)
Compliance Audit Program and CAP
Agreement that was published on
February 1,1991.
n. Modifications to the TSCA Section
8(e) Compliance Audit Program and the
CAP Agreement
A. Registration Requirements
The registration deadline/audit
commencement date has been extended
for 45 days to June 18,1991. Thus. Units
I.B and D of the CAP Agreement have
been modified to read as follows:
E To register for the TSCA Section 8(e)
Compliance Audit Program, the Regulate*
must no later June 18,1991, sign and retain
this CAP Agreement by certified mail-return
receipt requested to....
D. The TSCA Section 8(e) Compliance
Audit Program shall commence no later than
June 18,1991.
The audit termination date/deadline
has been extended for approximately 90
days, to February 28,1992. Procedures
for case-by-case extensions have also
been added. A Regulatee can petition
EPA in writing no later than November
29,1991, for an additional extension of
the audit termination date (i.e., beyond
February 28,1992). Extension petitions
must contain an adequate justification
for the request and will be favorably
viewed if based on difficulties
experienced by a Regulatee with the
volume of information being reviewed
and not because the Regulatee delayed
initiation of the audit Companies are
urged to submit studies or reports as
they are determined to be reportable,
and extension petitions will be viewed
with disfavor if a Regulatee has not
submitted any information by the
November 29.1991, deadline for
extension requests. In this way EPA
encourages the phased receipt of
information over time while recognizing
the need for appropriate time extensions
fat Regnlatees that have a large amount
of records to review. Thus, Unit I.E of
the CAP Agreement has been modified
to read as follows:
" RTheTSCA Sectionfl(e) Compliance
Andit Program shall terminate on February
2B. 1992. and all submissions under this
TSCA Section 8(e) Compliance Audit
Program must be delivered to EPA no later
than February 28,1992. The Regulatee may
petition EPA in writing at the address
specified in Unit I.B of this CAP Agreement
for an extension of the February 28.1992,
termination date. Extension requests must be
received by EPA no later than November 29,
19B1, and must contain an adequate
justification for the extension.
No other modifications to the
"registration requirements" portion of
the CAP Agreement have been made.
B. Terms of Agreement-General
Provisions
The provision of the CAP Agreement
regarding an admission of violation or a
"violation of TSCA'rhas been changed
and Unit II.A.4 of the CAP Agreement
has been modified to read as follows:
4. The Regulatee neither admits nor denies
that the submission of studies or reports by
the Regulatee under this TSCA Section B(eJ
Compliance Audit Program and pursuant to
the terms of this CAP Agreement constitutes
admission of a violation of TSCA sections
8(e) and 15(3)(B), but agrees to pay a
stipulated civil penalty for each study or •
report in accordance with Unit II.B.2 of this
CAP Agreement. 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.
The provision of the CAP Agreement
regarding waiver of rights has been
changed and Unit II.A.3 of the CAP
Agreement has been modified to read as
follows:
3. The Regulatee waives its right to request
a judicial or administrative hearing, under
TSCA section 16(a)(2)(A) or other provisions
of law, on any issue of law or fact that has
arisen or may arise regarding the application
of TSCA section 8(e) to any study or report
submitted pursuant to Unit H.B.l of this CAP
Agreement
The provision of the CAP Agreement
regarding "prior violations" has been
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19515
modified slightly to make it clear that
submissions under the CAP Agreement
will count as one "prior violation" of
8{e) only. Thus, Unit HA.7 of the CAP
Agreement has been modified to read as
follows:
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 a« one "prior
such violation" under TSCA section
16(a)(2)(B) for future violations of TSCA
section 8(e) only.
No other modifications to the "terms
of agreement—general provisions"
portion of the'CAP Agreement have
been made.
C, Terms of Agreement-TSCA Section
8(eJ Compliance Audit Program and
Civil Penalties
In order to facilitate participation in
the TSCA Section 8(e) Compliance
Audit Program as well as to improve
section 8(e) compliance in general, EPA
is preparing and plans to disseminate a
section B(e) reporting "guide" comprised
primarily of approximately 150 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 150 "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.
to 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 a 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 timerrame 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 ILB.l has been
modified to read as follows:
....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 involv'ng
section 8(e), a document entitled
"Substantiating Claims of Confidentiality,"
and the TSCA section B(e) reporting guide.
EPA believes that the actions
described above emphasize the
Agency's strong commitment to making
the TSCA Section 8(e) Compliance
Audit Program a successful initiative.
EPA hopes that providing the selected
case histories and the section 8(e]
reporting guide will enhance
understanding of the TSCA section 8(e)
program, and assist the regulated
community as they participate in the
TSCA Section 8[eji Compliance Audit
Program.
III. Conclusions
EPA has announced modifications to
the TSCA Section 8(e) Compliance
Audit Program and the CAP Agreement.
Any further information regarding this
Audit Program or the CAP Agreement
may be obtained from the contact
person noted above.
Dated: April 24,1991.
Victor J. Kimm,
Acting Assistant Administrator for Pesticides
and Toxic Substances.
[FR Doc. 91-10065 Filed 4-2&-91; 8:45 am]
NUJNQCOOt tSSO-40-F
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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
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Federal Register / Vol. 56, No. 119 / Thursday, June 20, 1991 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[0PTS-8M15B; FRL-3832-1]
Registration and Agreement for TSCA
Section 8(e} Compliance Audit
Program Modification
AGENCY: Environmental Protection Agency
(EPA).
ACTION: Notice.
SUMMARY: This Notice, pursuant to sections
15 and 16 of the Toxic Substances Control
Act (TSCA), 15 U.S.C. 2601 et seq.,
announces the availability, of,thfc,TSCA
section 8(e) reporting guide and modifications
to EPA's TSCA Section 8(e) Compliance
Audit Program and the Agreement for the
TSCA Section 8(e) Compliance Audit
Program ("CAP Agreement"). The
modifications to the TSCA Section 8(e)
Compliance Audit Program and the CAP
Agreement include the extension of the
registration deadline until July 1,1991, the
addition of provisions for listing of certain
types of previously reportable TSCA section
8(e) information now in EPA's possession,
and modification of EPA's guidance for
reporting information concerning
"widespread and previously unsuspected
distribution in environmental media" and
"emergency incidents of environmental
contamination" under TSCA section 8(e).
DATES: The Registration period for the TSCA
Section 8(e) Compliance Audit Program
closes on July 1, 1991. All persons interested
in registering for the TSCA Section 8(e)
Compliance Audit Program must request a
CAP Agreement and submit a signed CAP
Agreement to EPA no later than July 1,1991.
ADDRESSES: Copies of the modified CAP
Agreement and the TSCA section 8(e)
reporting guide may be obtained from the
TSCA Assistance Information Service,
Environmental Assistance Division (TS-799),
Office of Toxic Substances, Environmental
Protection Agency, 401 M St., SW.,
Washington, DC 20460, (202) 554-1404,
TDD: (202) 554-0551.
FOR FURTHER INFORMATION CONTACT:
David Kling, Acting Director, Environmental
Assistance Division (TS-799), Office of
Toxic Substances, Environmental Protection
Agency, 401 M SL, SW., Washington, DC
20460. (202) 554-1404, TDD: (202) 554-
0551.
SUPPLEMENTARY MFORMATON:
I. Background
In the Federal Register of February 1,
1991 (56 FR 4128X EPA announced the
opportunity to register for the TSCA Section
8(e) Compliance Audit Program, The TSCA
Section 8(e) Compliance Audit Program is a
one-time voluntary compliance audit program
developed to obtain outstanding TSCA
section 8(e) data and foster compliance with
the statutory obligations of TSCA section
8(e).
On April 26,1991 (56 FR 19514), EPA
modified the TSCA Section 8(e) Compliance
Audit Program and the CAP Agreement. The
modifications included extension of the
registration and termination dates, the
opportunity to petition EPA for a case-by-
case extension of the termination date,
modifications to the CAP Agreement
provisions regarding admission of a violation
of TSCA section 8(e) and waiver of right to
a hearing, and EPA's development of a TSCA
section 8{e) reporting guide.
, JLJESCAJSectloB 8
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Federal Register / Vol. 56, No. 119 / Thursday, June 20, 1991 / Notices
•lady or report pursuant to Unit n.B.3 of this CAP
Agreement Only information that meets the
requirements of Unit ILB.l.c is eligible for this
hjtmg proviwon.
Unit H.B3 has becai added to the CAP
Agreement to read as follows;
3. The following proviiioni shall govern the lift
required to be wbniUed under Unit ILB.l.c of thii
CAP Agreement:
a. For each nndy or report lilted, the lilting must
comply with the requirements of Unit HC of tbif
CAP Agreement, mint describe the dale of the
submission and (i) die mandatory reporting
requirement of TSCA or another IPA -administered
statute under which the study or report wai
submitted, or fii) the Office of Toiic Substance!
"FYI" filing lynern number for die rabmisrion. - '
Within 360 days after tubmisskn of the list, EPA
may request the Regulatee to submit any of the
listed information in order to determine if the
Regulatee correctly Kited rather than submitted the
study or report.
b. Toe Regulatee agrees to pay the following
stipulated civil penalty for information listed under
this audit as data mat would have been reporuble
under TSCA Section 8(e) when initially obtained
by the Regulatee, and dial subsequent to the section
8(e) reporting deadline, as specified in Part IV of
the TSCA Section 8(e) Policy Statement (and
before June IS, 1991), were (i) submitted in writing
to and received by EPA pursuant to a mandatory
reporting requirement under TSCA or another
statute admmisteied by EPA, or (ii) received by the
Office of Toxic Substances (OTS) on an "FYI"
basii and included in the formal OTS "FYI" filing
system: $5,000 per study or report,
C. Additions to the TSCA Section 8(e)
Reporting Guide
In response to a written request from the
Chemical Manufacturers Association (CMA)
for additional guidance on the section 8(e)
reportability of certain types of health effects
and environmental effects/release
information, EPA agreed to perform an
expedited review of • limited number of case
studies submitted by CMA. The Office of
Pesticides and Toxic Substances (OPTS)
established a panel of EPA lexicologists,
biologists, chemists, medical and public
health experts, environmental scientists,
TSCA policy staff, and legal and enforcement
staff to perform an expedited review of the
case studies which were submitted by CMA.
EPA reviewed die case studies involving
reportability of health effects information, and
provides an analysis of the toxkologic
significance and TSCA section S(e)-
reportability of the health effects case studies
in the TSCA section 8(e) reporting guide
described above and referenced in the CAP
Agreement.
D. Reporting of Information Referenced In
Ports V(b)(l) and V(c) of EPA''s Section 8(e)
Policy Statement
TSCA section 8(e) requires reporting of
information which reasonably supports the
conclusion mat a chemical substance or
mixture presents a substantial risk of injury
to the environment. EPA provided guidance
on how persons could fulfill their section 8(e)
reporting obligations in the TSCA Section
8(e) Policy Statement, However, in reviewing
this guidance in connection with the TSCA
' Section $(e) Compliance Audit"PRrgranvEPA
has determined that Part V(bXl)
("widespread and previously unsuspected
distribution in environmental media") and
Part V(c) ("emergency incidents of
environmental contamination") of the TSCA
Section 8(e) Policy Statement need additional
clarification and that possible
misinterpretation with regard to the guidance
in these sections could lead to overreporting
under the TSCA Section 8(e) Compliance
Audit Program.
Therefore, EPA plans to initiate a review
of the reporting of information on widespread
environmental distribution and emergency
incidents of environmental contamination
under TSCA section 8(e) and other Federal
statutes in order to determine what
information of these types should continue to
be considered for subminal under section
8(e). The review may involve discussions
with other EPA program offices, EPA
Regional offices, other Federal Agencies,
State Governments, members of the regulated
industry, environmental interest groups, and
others. All interested persons will have the
opportunity to comment on any proposed
revisions to Parts V(bXl) and V(c) of the
TSCA Section 8(e) Policy Statement that
result from this review.
In the interim, regulatees auditing their
files for reportable environmental risk
information tinder the TSCA Section 8(e)
Compliance Audit Program should be guided
by the statutory language of section 8(e) and
Part V(bX2) through (bX5) of EPA's TSCA
Section 8(e) Policy Statement. In assessing
whether information or studies involving
widespread and previous unsuspected
environmental distribution, emergency
incidents of environmental contamination, or
other previously unknown situations
involving significant environmental
contamination should be submitted under the
TSCA Section 8(e) Compliance Audit
Program, or under section 8(e) in general,
regulatees should make a reasonable
judgement whether such information meets
the statutory standards of TSCA section 8(e)
instead of relying on Parts V(bXl) or V(c) of
the TSCA Section 8(e) Policy Statement.
Even though EPA is suspending the
applicability of Parts V(bXD and V(c) of the
TSCA Section 8(e) Policy Statement, persons
are still responsible under TSCA section 8(e)
to report information that reasonably supports
a conclusion of substantial risk of injury to
• the environment; This'is* a continuing
statutory obligation. Thus, to reflect this
change. Unit UJB.l of the CAP Agreement
has been modified to read as follows:
1. In conducting the TSCA Section 8(e)
Compliance Audit Program, the Regulatee iball
follow the statutory language of TSCA section 8(e)
and EPA's guidance on section 8(e) in the March
16, 1978, "Statement of Interpretation and
Enforcement Policy; Notification of Substantial
Risk" (43 PR 11110) ("TSCA Section 8(e) Policy
Statement"), with the exception of Parts V(bXl)
and V(c) of the TSCA Section 8(e) Policy
Statement, to determine whether the reviewed study
or report is:
No other modifications to the "Terms of
Agreement" provisions of the CAP
Agreement have been made.
IV. Conclusion
EPA believes that the actions described
above emphasize the Agency's strong
commitment to making the TSCA Section
8(e) Compliance Audit Program a successful
initiative. EPA believes that providing the
section 8
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APPENDIX E
1 of 2
Support Information for Confidentiality Claims
Information submitted under specific reporting requirements
of the Toxic Substances Control Act (TSCA) or in support of TSCA
is subject to the provisions of Section 14 of TSCA and to EPA's
Regulations on the Confidentiality of Business Information (see
4Q'CFR Part 2). You must comply with the following procedures to
assert a claim of confidentiality for the information solicited
in the attached letter. Failure to follow these procedures fully
at the time you submit the information to EPA will be interpreted
by the Agency as a waiver of your claim of Confidentiality.
Asserting a Claim
Information claimed as confidential must be clearly marked
by boxing, circling or underlining. All pages containing such
information should also be stamped "CONFIDENTIAL". Care should
be taken to ensure that these markings do not obscure the sub-
mission's text.
Sanitized Copy
Two copies must be submitted of any documents containing
information claimed as confidential. One copy should be com-
plete, with the information being claimed as confidential marked
in the manner described in the preceding paragraph. The other
copy should have all of the information claimed as confidential
excised. This version will be placed in EPA's Public Files.
Substantiating Claims of Confidentiality
Detailed written responses to the following questions must
be provided at the time you submit information for any portion of
the information you claim as confidential. Your responses should
be as specific as possible, with examples as appropriate, and
should provide substantiation arguments for all types of informa-
tion (e.g., sales or production/importation volumes, chemical
identity, company identity) you claim as confidential.
1. For what period of time do you assert this claim of
confidentiality? If a claim is to extend until a
certain event or point in time, please indicate that
event or time period. Explain why the information
should remain confidential until such event or time.
2. Have there been any confidentiality determinations made
by EPA, other Federal agencies, or courts in connection
with this information? If so, please enclose copies.
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2 of 2
3. Has any of the information that you are claiming as
confidential been disclosed to individuals outside your
company? Will it be disclosed to such persons in the
future? If so, what restrictions, if any, apply to use
or further disclosure of the information?
4. Briefly describe any physical or procedural restrictions
within your company relating to the use and storage of
the information you are claiming as confidential. What
other steps, if any, have you taken to prevent undesired
disclosure of the information during its use or when an
employee leaves your company?
5. Does ••-the^information-claimed -as icon'f-iden.tial>-%appear • or
is it referred to in any of items listed below;
- advertising or promotional materials for the chemical
or the end product containing it;
- safety data sheets or other similar materials for the
chemical or the end product containing it;
- professional or trade publications; or
- any other media available to the public or to your
competitors.
If you answered yes to any of the above questions, you
must indicate where the information appears and explain
why it should nonetheless be treated as confidential.
6. Would disclosure of this information be likely to result
in substantial harm to your competitive position? If
so, you must specifically 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,
7. If the information in question is "health and safety
data" pursuant to 40 CFR Part 2.306(3){i), do you assert
that disclosure of the information you are claiming as
confidential would reveal:
a) confidential process information;
b) confidential proportions of a mixture; or
c) information unrelated to the effects of the
substance on human health or the environment?
If your answer to any of the above questions is yes, you
must explain how such information would be revealed.
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