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)
                                iii

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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)
                               vi

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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
                               vii

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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
                               ix

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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.
                                13

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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;
                                14

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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-
                                15

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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.
                                16

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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).
                                17

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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.
                                18

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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.

                                19

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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.

                                20

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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.

                                21

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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

                           22

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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.

                               23

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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.

                                24

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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.

                                25

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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.


                                26

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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


                                27

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Further Study
     additional studies performed in order to determine better
     the toxicity of and/or the exposure to chemicals
Pollution Prevention/Exposure Reduction

     engineering changes made in manufacturing and processing
     facilities to reduce/eliminate chemical exposure

     chemical manufacture or use halted temporarily or
     discontinued altogether.
                       *****
                          28

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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.
                                30

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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
                                31

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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

                                32

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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

                                33

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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."

                                34

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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

-------
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

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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

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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

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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

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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

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                                                 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

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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
ACUTE TOXICITY (ANIMAL)
 SUBMISSION I: 8EHQ-0977
               8EHQ-0178
               8EHQ-027S
               SEHQ-0278
               8EHQ-0278
               8EHQ-0378-
               8EHQ-0378
               8EHQ-0478-
               8EHQ-0578
               8EHQ-0578
               BEHQ-0578-
               8EHQ-0578-
               8EHQ-0578-
               8EHQ-0678-
               8EHQ-0678-
               8EHQ-0678-
               8EHQ-0678-
               8EHQ-0678-
               8EHQ-0678-
               8EHQ-0678-
               8EHQ-0778-
               SEHQ-0778-
               SEHQ-0778-
               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
8EHQ-0178-0041
8EHQ-0278-0062
SEHQ-0278-0066
8EHQ-0278-0074
8EHQ-0378-0090
8EHQ-0378-0094
8EHQ-0478-0134
8EHQ-0578-0144
8EHQ-0578-0153 S
8EHQ-0578-0158 S
8EHQ-0578-0163
8EHQ-0678-0172
8EHQ-0678-0176
8EHQ-0678-0184
8EHQ-0678-0194
8EHQ-0678-0197
8EHQ-0678-0200
8EHQ-0678-0205
8EHQ-0778-0209
8EHQ-0778-0220
8EHQ-0778-0225
8EHQ-0778-0229
8EHQ-1178-0261
8EHQ-0179-0273
X
X

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
en
H
H
cn
M
O
H
W
W
K
H
B
O
1
O
a
H
-------
                                                APPENDIX (D):  STATUS REPORTS BY INFORMATION TYPE
Ul
o
ACUTE TOXICITY CANIMAL)
SUBMISSION f: 8EHQ-0479-0278
8EHQ-0579-0284
8EHQ-0979-0311
8EHQ-0680-0347
8EHQ-0980-0362
8EHQ-1180-0372
8EHQ-0281-0382
8EHQ-0581-0400
8EHQ-1081-0417
8EHQ-0282-0428 *
8EHQ-0282-8431 *
8EHQ-0282-0435
8EHQ-0382-0438 S
8EHQ-0982-0456 S *
8EHQ-1182-0462
8EHQ-0483-0476 S
8EHQ-0683-0482
8EHQ-0783-8487 S *
8EHQ-1083-0494 *
8EHQ-1083-0497
8EHQ-0484-0513
8EHQ-0984-0530
8EHQ-1084-0535
8EHQ-0485-0549 S
8EHQ-0685-0559

8EHQ-0479-0279
8EHQ-0779-0293
8EHQ-0380-0335 S
8EHQ-0680-0349
8EHQ-0980-0365
8EHQ-0181-0380 X
8EHQ-0381-0392
8EHQ-0881-0408 S *
8EHQ-1081-0418
8EHQ-0282-0429 »
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
8EHQ-0980-0359
8EHQ-0780-0369
8EHQ-0181-0381
8EHQ-0581-0398
8EHQ-0981-0409
8EHQ-0282-0427
8EHQ-0282-0430
8EH(J-0282-0433
8EHQ-0282-0437
8EHQ-0682-0448
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
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                                               APPENDIX  CD):  STATUS REPORTS BY INFORMATION TYPE
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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-
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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
8EHQ-1086-0639 5
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
8EHQ-0389-0780
8EHQ-0589-0800
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
8EHQ-1086-0640 S
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
8EHQ-1288-0778
8EHQ-0389-0787 5
8EHQ-0689-0803
8EHQ-0789-0809
8EHQ-0889-0819 S

-------
                                                APPENDIX CD):  STATUS REPORTS  BY INFORMATION  TYPE
VJI
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ACUTE TOXICITY CANIMAL)
 SUBMISSION I: 8EHQ-0989
               8EHQ-1089
               8EHQ-1189
               8EHQ-1289
               8EHQ-1289
               8EHQ-0290'
               8EHQ-0490
               8EHQ-0490
               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
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8EHQ-1089-0830
8EHQ-1089-0837
8EHQ-1189-0845
8EHQ-1289-0852
8EHQ-0190-0860
8EHQ-0390-0898
8EHQ-0490-0954
8EHQ-0490-0959
8EHQ-0590-0991
8EHQ-0690-1005
8EHQ-0790-1021
8EHQ-0790-1035
8EHQ-0890-1045
8EH9-0890-1052
8EHQ-0990-1058

8EHQ-0990-1061
8EHQ-0990-1076

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8EHQ-1089-0833 S
8EHQ-1089-0838 S
8EHQ-1189-0848 S
8EHQ-1289-0857 S
8EHQ-0190-0867
8EHQ-0490-0919 S
8EHQ-049Q-0957 S
8EHQ-0590-0964
8EHQ-0690-1003
8EHQ-0690-1009
8EHQ-Q790-1023 S
8EHQ-0790-1036 S
8EHQ-0890-1047
8EHQ-0890-1054 S
8EHQ-0990-1059 S
1
8EHQ-0990-1062
8EHQ-0990-1084
         ACUTE TOXICITY (HUMAN)
          SUBMISSION  •:  8EHQ-0178-0036
                        8EHQ-0178-0040  P
                        8EHQ-0278-0067  P
                        8EHQ-0278-0077  P
                        8EHQ-0278-0080  P
                        8EHQ-0378-0097
                                              8EHQ-0178-0038
                                              8EHQ-0278-0052 P
                                              8EHQ-0278-0075 P
                                              8EHQ-0278-0078 P
                                              8EHQ-0278-0081 P
                                              8EHQ-0378-0105
8EHQ-0178-0039 P
8EHQ-0278-0063
8EHQ-0278-0076 P
8EHQ-0278-0079 P
8EHQ-0378-0086
8EH9-0478-0118 P

-------
                                               APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
ui
ACUTE TOXICITY (HUMAN)
 SUBMISSION i: 8EHQ-0478
               8EHQ-0578
               8EHQ-0578
               8EHQ-0678
               8EHQ-0778
               8EHQ-1178
               8EHQ-1079
               8EHQ-0280
               8EHQ-0680
               8EHQ-0981
               8EHQ-0783
               8EHQ-0384
               8EHQ-1084
               8EHQ-0985
               8EHQ-0986
               8EHQ-1287
               8EHQ-0889-
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5-0145 *
1-0154 P
1-0181 *
1-0217
1-0260 M
1-0315 *
1-0333
1-0344 P *
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-0532
-0566
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-0700
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-0905 S *
-1042
8EHQ-0578-0141 a
8EHQ-0578-0146
8EHQ-0578-0165
8EHQ-0678-0182 P a
8EHQ-0978-0238 a
8EHQ-0179-0273
8EHQ-1279-0322 «
8EHQ-0480-0338
8EHQ-0880-0355
8EHQ-1182-0466 x
8EHQ-0983-0493 S *
8EHQ-0484-0513
8EHQ-1084-0535
8EHQ-0186-0585 S
8EHQ-0487-0666 S
8EHQ-0688-0736
8EHQ-1089-0832
8EHQ-0490-0929 S X
8EHQ-0990-1071
8EMQ-0578-0142
8EHQ-0578-0149
8EHQ-0678-0180
8EHQ-0678-0184
8EHQ-1178-0258
8EHQ-0879-0304
8EMQ-0180-0324
8EHQ-0580-0341
8CriQ-0881-0407
8EHQ-0283-0471 S
8EHQ-1283-0502 P
8EHQ-0984-0529
8EHQ-0485-0552
8nHQ-0886-0622 S
8EHQ-0487-0671
8EHQ-1088-0755
8E^Q-0290-0885
8EHQ-0590-0991 S
8E^Q-0990-1078
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         SUBMISSION  i:  8EHQ-0578-0152
                       8EHQ-0678-0184
                       8EHQ-0480-0340
                       8EHQ-0682-0448  S
                                             8EHQ-0578-0156
                                             8EHQ-0678-0185
                                             8EHQ-1180-0371
                                             8EHQ-1182-0462
8E^Q-0578-0166
8EHQ-0678-0206
8EHQ-0282-0427 S
8EHQ-0283-0471 S

-------
                                                 APPENDIX  (D)s STATUS  REPORTS  BY  INFORMATION  TYPE
Ul
-t-
ALLERGENICITY (ANIMAL)
 SUBMISSION I: 8EHQ-0683-
               SEHQ-1083-
               8EHQ-1285-
               8EHQ-04S6-
               8EHQ-0287-
               8EHQ-0787-
               8EHQ-1287-
               8EHQ-0588-
               8EHQ-1188-
               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
8EHQ-1084-0532
8EHQ-0186-0585 S
8EHQ-1186-0647
8EHQ-0487-0661 S
8EHQ-0887-0690
8EHQ-0188-0712 *
8EHQ-0688-0739
8EHQ-1288-0777
8EHQ-0589-0796
8EHQ-1189-0839
8EHQ-0290-0876
8EHQ-0790-1033
8EHQ-0990-1082
8EH9-0883-0490
8EHQ-0485-0550
8EH9-0386-0589 S
8EHQ-0287-0653
8EHQ-0687-0680
8EHQ-1287-0700
8EHQ-0388-0721
8EHQ-0688-0740 S
8EHQ-12B8-0778
8EHQ-0689-0802
8EHQ-1189-0845
86HQ-0290-0894
86HQ-0990-1062

         ALLERGENICITY (HUMAN)
          SUBMISSION t: 8EHQ-1177-0017 PS
                        8EHQ-0178-0040 P
                        8EHQ-0578-0165
                        8EHQ-0678-0184
                        8EHQ-0379-0280
                        8EHQ-0282-0427 S
                        8EHQ-0485-0550
                        8EHQ-0786-0612
                        8EHQ-0488-0728
                                              8EHQ-1177-0018 PS
                                              8EHQ-0278-0081 P
                                              8EHQ-0678-0181
                                              8EHQ-0678-0185
                                              8EHQ-0779-0292
                                              8EHQ-0283-0471 S
                                              8EHQ-0186-0585 S
                                              8EHQ-0886-0622 S
                                              8EHQ-0290-0885
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EH9-
8EHQ-
8EHQ-
0578-0164
0678-0182 P
0279-0274
0880-0355
1084-0532
0386-0589 S
0987-0694
0590-0991 S

-------
         ALLERGENICITY (HUMAN)
          SUBMISSION I: 8EHQ-Q890-1039 S
                                                APPENDIX (D):  STATUS REPORTS BY INFORMATION TYPE
ui
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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
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* 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
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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
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 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


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        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


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8EHQ-0278-0061
8EH4-0378-011
-------
                                               APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
Ch
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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
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-------
                                               APPENDIX CD):  STATUS REPORTS BY INFORMATION TYPE
       ENV. OCCURRENCE/RELEASE/FATE
        SUBMISSION  ft 8EHQ-1081-0416
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        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-
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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






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-------
                                        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
-------
                                                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
-------
                                                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

-------
                                               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

-------
                                               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
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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
-------
                                               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

-------
                                               APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
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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
-------
                                               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

-------
         NEUROTOXICITY (HUMAN)
          SUBMISSION I: 8EHQ-1086-Q641
                                                APPENDIX (D): STATUS REPORTS BY INFORMATION TYPE
                                              8EHQ-059Q-0991 S
8EHQ-0990-1065
-a
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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
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8EHQ-1289-0856
8EHQ-0290-0881
8EHQ-0590-0993






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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


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-------
                                       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


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-------
                                       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



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S


S
S
S
S

S

5



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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
•i
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
V
8EHQ-1289-0854
8EH4-1289-0858
SEHQ-0190-0863
5

S

S
5
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S

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S
S
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-------
                                               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


s

s
s
5





S
S



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
S
S
S
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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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-------
                                              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
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S
S

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s
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s
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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

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-------
                                                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
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           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
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                                              SEHQ-1080-0366
                                              8EHQ-0281-0384
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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

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                                               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

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               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

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 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

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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

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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

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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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                    Federal  Register / Vol. 56, No.  22 / Friday, February  1, 1991  ' Notices
                                                                        4131
of this CAP Agreement shall be
interpreted by EPA as a waiver by the
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
                                                          103

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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
104

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19514
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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                     Federal Register / Vol.  56. No. 81 / Friday,  April 26. 1991 / Notices
                                                                      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
                                                   106

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   Thursday
   June 20, 1991
 (Encoded Version)
   APPENDIX D

(CAP Modifications)
   Part  IV



   Environmental

   Protection  Agency

   Registration and Agreement for TSCA
   Section 8(e) Compliance Audit Program
   Modification; Notice
107

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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.
                            Ill

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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.
                       112

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