United States
          Environmental Protection
          Wash., D.C.
          Toxic Substances
The Chemical Substances
Information Network
by the Public Liaison
Subcommittee of the
Interagency Toxic Substances
Data Committee

November 1978

Council on Environmental Quality
722 Jackson Place. N.W.
Washington, DC 20006
U.S. Environmental Protection Agency
             Office of Toxic Substances
              Washington, D.C. 20460
   Dear Colleague,

   I appreciate your interest in the Public Liaison Subcommittee of
   the Interagency  Toxic Substances Data Committee.  As you  have re-
   quested,  I have  placed your name on the mailing list to be kept
   informed  of TSCA and TSCA related information activities.

   The purpose of this letter is to provide you with copies  of the
   minutes of the monthly meetings of the Interagency Toxic  Sub-
   stances Data Committee, a copy of the presentation on  the status
   of the Chemical  Substances Information Network by Marilyn Bracken,
   Co-Chairperson of the Interagency Toxic Substances Data Committee
   and to pass along some further information and material on one of
   the CSIN  component prototypes, the NIH-EPA Chemical Information
   System  (CIS). The CIS is now an operational and publicly avail-
   able system which I believe may be of interest and use to your

   I would welcome  any comments on the minutes, which I will continue
   to send to you.   Also, should you decide to use the CIS,  I would
   greatly appreciate any feedback that you could provide me, so that
   further refinements or changes could be undertaken.

   Yours truly,
   Morris Yaguda,  Chairman
   Public Liaison  Subcommittee
   Interagency Toxic Substances Data Committee

   EPA, PM-218
   401 M Street, S.W.
   Washington, D.  C. 20460


              NIH/EPA  Chemical Information  System

        The Chemical Information System (CIS)  consists of a collection of chemical
 Q m    data bases, together with programs for interactively searching, displaying
  • ui    and analyzing subsets of user-specified  data.
 C? vO
 O  I
bo CM
         In  response to CIS prompts, the user inputs  simple descriptive commands
         which provide option selection, entering  of  the unknown spectra, and
 _f* CM
 m o     control of the operation.
   a specific compound is ascertained, it can be used to discover what
   files contain the compound and to locate and retrieve data pertaining
   to the compound.

   EPA's Oil and Hazardous Materials - Technical Assistance Data System
   (OHM-TADS) provides information pertinent to emergency spill response
   efforts.  The OHM-TADS data base includes a wide variety of physical,
   chemical, biological,  toxicological and commercial data on these
   materials, with emphasis placed on their deleterious effects on water
   quality.  Up to 126 different fields of information are maintained for
   more than 1000 materials.

   The retrieved data can be analyzed by:

   Mathematical Modeling  Laboratory (MLAB)  - Major mathematical routines

     Differential and integral calculus   Statistical analysis
     Curve and distribution fitting       Linear and non-linear regression
     Two- and three-dimensional plots
       on CRT's and hard  copy
                           CIS Price Schedule

 Access to the entire CIS is available through one subscription.   The
 annual subscription fee is $300.00, payable to Interactive Sciences Cor-
 poration.   To obtain additional information and application form,  contact
 CIS  Project,  Chemistry Department,  Brookhaven National  Laboratory,  Upton,
 Long Island,  New York 11973 (telephone:  516-345-4379).

 Component  Name                                                  Hourly  Rate*

 The  Mass Spectral Search System (MSSS)                             $36.00
 The  X-Ray  Crystallographic Search System (CRYST)                   $36.00
 The  Carbon-13  NMR Search System (CNMR)                             $36.00
 The  Registry of  Toxic Effects  of Chemical Substances  (RTECS)       $36.00
 The  Oil and Hazardous Materials - Technical  Assistance  Data
  System  (OHM-TADS)                                                $36.00
 The  Structure  and  Nomenclature Search System (SANSS)               $60.00
 The  Powder Diffraction Search-Match System  (PDSM)                  $60.00
 The  Mathematical Modeling  Laboratory (MLAB)                        $60.00
 The  Conformation Analysis  of Molecules in Solution by Empirical
  and Quantum-Mechanical Techniques  System  (CAMSEQ)                $60.00

 *  Hourly rates  include CRU's  and Connect Minutes accumulated  in a
   program.  Time  is  accounted in minute increments.  There is a $3.00
   minimum per Session  (Session = one log-in  and one log-out).

 Interactive Sciences  Corporation makes no warranty, express or implied,
as to the accuracy and validity of information contained in the  data
base.  The user of the data is expected to make the final  evaluation as
to the usefulness and accuracy of the data.

                           OF THE
                      February 28, 1978
  Marilyn C. Bracken, Deputy Assistant Administrator for
  Carroll Leslie Bastian, Senior Staff Member for Environmental Health
  and Toxic Substances, CEQ

  Marion P. Suter, CEQ
  Morris B. Yaguda, EPA
  Connie Criscuolo, Secretary

Participants *

  Philip C. Kearney
US Arms Control & Disarmament
  Margaret G.  Finarelli
  Bernard Griefer
  John Ambler
  Max Shor
  E. June Thompson
  George W. Siebert
  Joe Nash
  Ed Brooks
  Gooloo Wunderlich
  Bob Bell
  James M. Sontag
  Terri Damstra
  Bill Rhode
  Vera Hudson
  Richard J. Lewis, Sr.
  Henry Kissman
DOI/Bureau of Mines
  Raymond E. Corcoran
  Calvin M. Menzie
International Trade Commission
  Tom O'Connell
  William Mead
National Science Foundation
  Marvin E. Stephenson
  Alan I. Roberts
  Alfred W. Grella
Treasury/Customs Service
  Harrison C. Feese
  Robert Dixon
  Patricia Breslin
* Addresses and phone numbers attached to back of Minutes

                              - 2 -
 Marilyn Bracken opened the meeting with a description of  the role  of EPA
 in this Committee as stated in Section 10(b)  of TSCA.  She  gave  a  summary
 of EPA actions under Section 8 of the Act.

 Carroll Leslie Bastian stated CEO's role in the Committee including its
 statutory responsibility under Section 25 (b)  of TSCA.  She  also  explained
 the role of this Committee in carrying out  certain responsibilities of
 the Toxic Substances Strategy Committee.  This  Data Committee  replaces
 the now defunct data committee referred to  in Task IIB of the  Toxic
 Substances Strategy Committee Work Plan published  in the  Federal
 Register November 4, 1977.

 Mrs.  Bastian stated that a mode of operation  is needed which will  give
 flexibility to respond to isolated issues brought  to the  Committee for
 resolution (Congressional or other requests), as well as  to  develop a
 comprehensive Federal data network and to address  other long-range
 toxics data issues.

 Ms.  Suter presented a summary of the  scope  and  recommendations of  the
 Mitre report entitled,  "Chemical Substances Information Network" (CSIN)
 prepared under contract  to  HEW,  EPA and CEQ to  determine  user  information
 needs as well as how existing and proposed  new  systems would meet  the
 needs identified.  Mitre  recommended development of  a Chemical  Substances
 Information System (diagram attached)  with  a  Chemical Data Base  Directory
 at  the center of the system.   Five of  the 10  core  component  systems are
 now under further development:   Chronic Testing Support System,
 Regulated Chemicals  System,  Chemical Data Bases Directory, the Chemical
 Information System,  and  the EPA TSCA data system.

 Morris Yaguda further discussed  the Chemical  Information  System.

 Mrs.  Bastian pointed out  that  so far in the discussion the emphasis was
 on  the Federal  systems network.   The recommendations  in the  Mitre  report
 and the intent  of  this Committee is to  have a Federal system that  will
 be  accessible to non-Federal  users  and  one  in which  their data can also
be  entered.

Another  subcommittee under  TSSC  (chaired  by Bob Nicholas  at  CEQ) is
 looking  at  policy  issues  in trade  secrets and confidentiality.  This TS
Data Committee,  in contrast, will  address related systems issues such as
 the mechanisms of exchanging  such  information and methods of maintaining
confidential  data separately  from  related non-confidential files.

Dr.  Bracken  introduced Patricia  Breslin and noted that  the IRLG was
established  8 months ago  to enable  FDA, CPSC, EPA, and OSHA  to work
together and look at activities  that overlap.

                              - 3 -
Ms. Breslin reported on the IRLG and how the working groups of that
four agency group fit into this Committee.  The six relevant projects of
the information subgroup are:  development  of common identification
codes for related information among all four agencies;  development
of common procedures for safeguarding confidential information;
joint monograph (criteria document) planning and production; de-
velopment of criteria for coordination of reporting requirements;-
and feasibility studies for (a) a regulated chemicals ;system and
(b) a chemical testing support system.

The meeting was opened for discussion and the following points made:
One Committee function will be to advise EPA  of the TSCA-related information
needs of other agencies.  Another will be to make recommendations for
data format and standardization of terminology (where appropriate).

In response to a question on authority of the Committee Dr. Bracken
pointed out that the Committee can make recommendations that standardization
be adopted, but it cannot dictate to Federal agencies nor to holders of
public files such as the Merck Index.

Dr. Bracken directed attention to the draft Charter, noting that Item G.
on p. 4 regarding development and managment of the Chemical Substances
Information System has priority and that CEQ must report to Congress in

After some discussion additional comments were requested to be sent  to
Marion Suter by March 10.

Agencies were asked to send a letter to Marilyn Bracken stating who
their member and alternate will be as well as any other participants the
agency wishes to designate.

Mrs. Bastian stated there have been requests for open meetings of this
Committee. She stated most of what would be discussed could be open with
a provision for closed executive session at the end of a meeting as
necessary. The first Tuesday of every month was set as a tentative
meeting day and 9:30 a.m. to noon the suggested time. This will be
confirmed or changed at the next meeting when official agency representatives
will have been designated.  The next meeting is to be held April 4 at
9:30 a.m. in Room 2010 of the NEOB.

EPA is to establish a position for Executive Secretary of  the Committee.
Some of the activities of the Committee may be funded by EPA, but others
night be more appropriately funded by other agencies.

This will be a major topic for discussion at the April meeting.


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                Interagency Toxic Substances  Data  Committee
Distribution List
                                                        April 10, 1978
      Mr.  John Ambler          763-7536
      Bureau of the Census
      Department of Commerce
      Washington,  D.  C.   20233

      Mrs, Carroll  Leslie Bastian 633-7107
      Senior  Staff  Member for Environmental
       Health and  Toxic Substances
      Council on Environmental  Quality
      722 Jackson Place, N.  W.
      Washington, D.  C.  20006

      Mr.  Robert A. Bell      443-3290
      Food and Drug Administration
      5600 Fishers  Lane
      Room 961
      Rockville, MD  20857

      Dr. Marilyn Bracken      755~8040
      Deputy  Assistant Administrator
       for Program Integration
      Room 711 East Tower (TS 788)
      Environmental Portection  Agency
      401 M  Street, S. W.
      Washington, D..  C.  20460

      Patricia Breslin        523-7115
      Dept.  of Labor
      Room N 3700
      200  Constitution Avenue,  N.  W.
      Washington,  D.  C.   20210

      Mr.  Edward M. Brooks      755-0932
      Office of Toxic Substances (WH 557)
      Environmental Protection  Agency
      401  M Street, S.W.
      Washington,  D.  C.   20460
      Mr.  Raymond E.  Corcoran
      Bureau of Mines
      Department of the Interior
      2401 E Street,  N.W.
      Room 1005
      Washington, D.  C.  20241
      Terri Danstra
      National Institute
        of Environmental Health
      P.O. Box 12233
      Research Triangle Park,
        North Carolina  27709
                Dr.  Robert Dixon              456-6272_
                Office of Science and Technology
                Executive Office of the President
                Washington, D. C.  20500
 Mr. Harrison  C. Feese
 Office  of Operations
 Room  4114
 U.S.  Customs  Service
 Department  of the  Treasury
 1301 Constitution Avenue, N.W.
 Washington, D. C.  20229
                Mrs.  Margaret G.  Finarelli       632-0872
                U.S.  Anns Control & Disarmament Agency
                MA/AT - Rni.  5499
                320 21st Street,  N. W.
                Washington,  D. C. 20451

                Mr. Alfred W. Grella             426-2311
                Office of Hazardous Materials  Operations
                Materials Transportation Bureau
                Department of Transportation
                2100 2nd Street,  S. W.
                Room 6214
                Washington,  D. c. 20590
                Dr.  Bernard Griefer
                OEA,  Room 3425
                Main Commerce Building
                14th & Constitution Ave.
                Washington, D. C.  20230
Mr. Richard A. Hartfield         492-7834
Acting Director
Office of Management Information
  and Program Control
U.S. Nuclear Regulatory Commission
Washington, D. C.  20555

Vera W. Hudson                   443-2100
Biologist, Priorities
  and Research Analysis Branch
Division of Criteria Documentation
  and Standards Development
National Institute for Occupational
  Safety and Health
5600 Fishers Lane
Rockville, Maryland  20857

  Dr.  Aimison Jonnard              523-0423
  Energy and Chemicals  Division
  U.S.  International Trade  Commission
  Room 110A
  701  E Street,  N.  W.
  Washington, D.  C.  20436

  Dr.  Philip C.  Kearney           447-8488
  Office of the  Secretary OEQA
  Administration Bldg
  Room 307A
  U.S.  Dept.  of  Agriculture
  Washington, D.  C.  20250

 Dr. Henry M. Kissman      496-3147
 Associate Director for Specialized
   Information Services
 National Library of Medicine
 8600  Rockville  Pike, Rm. C6B
 Bethesda, Maryland  20014

 Richard J. Lewis       513-684-8317
 Associate Editor
 Registry of Toxic Effects  of
   Chemical Substances
 Division of Techical Substances
 National Institute for Occupational
   Safety and Health
 Robert A. Taft  Laboratories
 4676  Columbia Parkway
 Cincinnati,  Ohio

 William Mead              523-9275
 Chief,  Div.  of  Periodic Surveys
 Occupational Safety &  Health
 Bureau of Labor Statistics
 Dept.  of Labor
 Washington,  D.  C.  20212

 Dr. Gavin Menzie          632-5316
 Fish and Wildlife  Service
 Department of the  Interior
 Washington,  D.  C.  20240

 Mr. Richard  G. Muranaka   492-7735
 U.S. Nuclear Regulatory Commission
 Washingtion,  D.  C.  20555

 Robert  S.  Murphy          436-7081
 Chief,  Survey Planning  &
  Development Branch
 Div. of  Health Examination
 National Center  for
  Health Statistics
Room 2-58
 3700 East-West Highway
Hyattsville, Maryland   20782
 Mr.  Joseph H.  Nash         376-9073
 Division of Policy Analysis
 Room 6134
 Department of  Energy
 20 Massachusetts Avenue, N.W.
 Washington, D.  c.   20545
Barbara Ostrow
Executive Secretary
Interagency Toxic Substances
  Data Committee (TS 788)
Environmental Protection Agency
401 M Street, S. W.
Washington, D. C. 20460

 Dr.  William Rhode           496-9285
 Acting Director
 Division of Resources  Analysis
 Office of Program  Planning  and
 National Institutes of Health
 Bethesda, Maryland  20014

 Mr Alan I.  Roberts        426-0656
 Office of Hazardous Materials
 Materials Transportation Bureau
 2100 2nd St.,  S.W.
 Washington, D.  C.   20590

 Mr.  Max Shor              763-7298
 Bureau of the Census
 Department of Commerce
 Room 3061
 Federal Office  Bldg. 3
 Washington, D.  C.  20233

 Mr.  George W.  Siefaert      697-5947
 Office of Sec.  of  Defense
 Room 3B252  Pentagon
 Washington, D.  C.   20301

 Mr.  Glenn Simpson          492-6647
 Directorate for Hazard Identification
   and Analysis
 U.S.  Consumer Product  Safety Commission
 Washington, D.  C.   20207
 Dr.  James  Sontag
 Assistant  to  the  Director
 Division of Cancer  Cause  and
 National Cancer Institute
 Bethesda,  Maryland   20014

Dr. Marvin E. Stephenson       632-5734
AENV, Km. 1136
National Science Foundation
1800 G Street, N. W.
Washington, D.C.  20550

 Marion P.  Suter
 Staff Member,  Environmental Health
   and Toxic Substances
 Council  on Environmental Quality
 722  Jackson Place,  N. W.
 Washington, D.  C.   20006

E. June Thompson               492-6477
Consumer Product Safety
Room 700, 5401 Westbard Ave.
Bethesda, Md  20207

Mr. Irvin Weiss                492-6470
Directorate for Hazard Identification
  and Analysis
U.S.  Consumer Product Safety Commission
Washington, D. c. 20207

Dr. Gooloo Wunderlich          472-7398
Acting Director, Office of Statistical Policy
Office of Health Policy, Research, and
Office of the Assistant Secretary for Health
Room 709B, Hubert H. Humphrey Bldg.
Washington, D. C.'  20201

Mr. Morris B. Yaguda
Chief,  Computer Systems Development
  and Evaluation Branch (PM 218)
Environmental Protection Agency
401 M Street, S.W.
Washington, D. C.  20460


                     WASHINGTON. D.C. 20460
                                         OFFICE OF TOXIC SUBSTANCES

SUBJECT:  May 2, 1978, Meeting

FROM:     Barbara Ostrow, Executive Secretary

TO:       Members, Interagency Toxic  Substances  Data
     Enclosed are the minutes of  the April  4,  1978,  meeting
of the Interagency Toxic Substances Data Committee,  and an
updated membership list.

     If you have any corrections,  additions, or  business
items which should be considered  at our next meeting on
May 2, please call me at 202-755-4880.

    Interagency Toxic Substances Data Committee
              Minutes - April 4, 1978

     This meeting of the Interagency Toxic Substances Data
Committee, co-chaired by Marilyn C.  Bracken and Carroll
Bastian, convened at 9:30,  at the New Executive Office
Building, 17th and Pennsylvania Avenues,  Room 2010,  Washington,
D.C.  20026.  The following business items were discussed:

     o    The Executive Secretary, Barbara Ostrow of EPA,
was introduced to the Committee.  She can be reached by
telephone on 202-755-4880.

     o    An official membership list was distributed.  The
attendees will review the list for accuracy and submit
any required changes to the Executive Secretary.  This
updated list will be published in the Federal Register.

     o    A regular monthly meeting date  was established.
The Committee will meet on the first Tuesday of each month
at 9:30 a.m. at the New Executive Office  Building.  An open
meeting policy will be in effect unless otherwise specified.
This information will be published in the Federal Register.

     o    An updated version of the Committee's Charter,
which incorporated previous suggested changes, was officially

     o    A discussion draft for the TSCA Advisory Committee,
TSCA Strategy was distributed, and questions concerning this
document will be discussed at the May 2,  1978 meeting.

     o    Two draft IRLG studies:
          1.  Chemical Regulations and Guidelines System
          2.  Chemical Testing Support System
will be made available to this Committee after IRLG review.

     o    Next on the agenda was a discussion of some various
short-term issues which confront this group.
          Ed Brooks, EPA, briefed the Committee on the back-
ground and the unique aspects of TSCA.  This will assist
the Committee in developing a mechanism to provide input
to EPA so that the requirements of Section 10(b)(l)
of TSCA may be implemented.

     o    The parent Committee designated three sub-committees.
These were:

     1.   Processes Sub-Committee - Ed Brooks, Chairman.
This group will explore different options and make re-
commendations on how the responsibilities of 10(b)(l)
can be implemented.

      2.    Mitre  Report/Network Management Sub-Committee.
 Terry Damstra, Chairman.   The parent Committee accepted
 the Mitre  Report, Chemical Substances Information Network
 (CSIN)  as  the .blueprint  for action concerning the feasibility
 of a  Federal-wide Chemical Substances Data Network.  This
 sub-committee will determine if there are any additions
 or overlooked sources  in  the report and investigate sub-
 sequent  steps which will  be necessary to develop and manage
 such  a network.  The components development aspect of the
 CSIN  will  be deferred.  At the next Committee meeting, a
 representative from the Mitre Corporation will brief the
 group concerning the contents of their report as it presently
 exists.  In addition,  the status of the present.contract
 and the  future prospects  will be discussed.

      3.    Non-Federal  Interface Sub-Committee - Chairman
 to be designated.  The CSIN will include non-Federal users,
 both  national and international.  These groups will have
 input before the elements of the CSIN are in place.  This
 will  serve to keep all these information sources in the main-
 stream,  and will prevent  duplication of requests for infor-
 mation from various sources to industry.

      There will  be a brief status report from each sub-
 committee  chairman at  the next meeting.  Additional sub-
 committee  members are  needed.  These representatives need
 not be the official agency representative to the parent
 Committee.  Please call the Executive Secretary if you have
 a candidate for  sub-committee membership.

      o     The Committee must decide on a uniform chemical
 classification system.  At present the CAS Registry
 System seems the only practical alternative.  A workable
 business arangement with  CAS seems likely.  The IRLG also
 has a chemical classification actively in progress.

      o     The long-term issues which must be considered
 by this Committee are essentially similar to the short-
 term  issues.

     o     There were no additions to the agenda and the
meeting was adjourned.  The Committee will reconvene on
May 2, 1978 at 9:30 a.m.

                          Barbara Ostrow
                          Executive Secretary

    Interagency Toxic Substances Data Committee

                Attendees - 4/4/78

Carroll L. Bastian - CEQ
Marilyn C. Bracken - EPA
Patricia Breslin - OSHA/IRLG
Ed Brooks - EPA
William Burns - DOT
Raymond E. Corcoran - DOI, Bureau of Mines
Terry Damstra - NIEHS
Robert Dixon - Office of Service & Technology Policy
Margaret Finarelli - Arms Control Disarmament Agency
Bernard Greifer - Dept. of Commerce
Richard A. Hartfield - NRC
Vera Hudson - NIOSH
Aimison Jonnard - U.S. International Trade Commission
Henry Kissman - NLM,NIH
Joseph Nash - DOE
Barbara Ostrow - EPA
Ray Stendall - Dept. of Interior, Fish & Wildlife
Marion Sueter - CEQ
William Rhode - NIH
Irvin Weiss - CPSC
Gooloo S. Wunderlich - DHEW
Morris Yaguda - EPA

Marilyn C. Bracken                Carroll Leslie Bastian
U.S. Environmental Protection     Council on Environmental
Agency TS-788                     Quality
Washington, DC  20460             Washington, DC  20006
755-8040                          633-7107
               Executive Secretary

                  Barbara Ostrow
   U.S. Environmental Protection Agency - TS 788
               Washington, DC  20460


Patricia Breslin (IRLG-Information Exchange)
(Fred Clayton-Alternate Room N 3629)
200 Constitution Ave.
Washington, DC  20210

Edward Brooks
EPA TS 788
Washington DC  20460

Alan Dutchman  (1)
(Martin Convisser - Alternate) (2)
(William Burns - Alternate) (3)
Department of Transportation
Washington, DC  20490
(1) 426-2222
(2) 426-4476
(3) 426-4357

Terri Damstra
(Ray Shapiro - Alternate)
Office of Health Hazard Assessment NIOSH
P.O. Box 12233 Research Triangle Park,
North Carolina  27709

Robert Dixon
(Carl Gerber  - Alternate)
Office of Science & Technology Policy
Washington, DC  20500

Margaret G. Finarelli
(Robert Mikulak - Alternate)
U.S. Arms Control and Disarmament Agency
Washington, DC  20451

Sidney R. Galler (1)
(Bernard Greifer - Alternate)  (2)
U.S. Department of Commerce
Washington, DC  20230
(1) 377-4335
(2) 377-3234  (2186)

Richard A. Hartfield  (1)
(Richard G. Muranaka - Alternate)  (2)
U.S. Nuclear Regulatory Commission MNBB 12105
Washington, DC  20555
(1) 492-7834
(2) 492-7735

 Aimison Jonnard
 (Edmund Cappuccilli-Alternate)
 U.S.  International Trade Commission
 701 E Street KW
 Washington,  DC  20436
 (1)  523-0423
 (2)  523-0387

 Henry Kissman

 National Library of Medicine
 National Institutes of Health
 Bethesda,  MD  20014

 Richard J. Lewis
 National Institute for Occupational Safety  and  Health
 Cincinnati,  Ohio  45226
 (1)  513-684-8317
 (Vera W.  Hudson - Alternate)
 National Institute for Occupational Safety  and  Health
 8 A-5 3
 Rockville, MD  20857
 (2)  301-443-2100

 Calvin M. Menzie
 Fish  & Wildlife Service
 HP Room 511
 U.S.  Department of the Interior
 Washington,  DC   20241
 (1) 632-5316
 (Raymond E.  Corcoran - Atlernate)
 Bureau of Mines U.S.  Department of  the  Interior
 Washington,  DC   20241
 (2) 634-1313

 Robert S. Murphy
 (Kurt Maurer  -  Alternate)
 National Center for Health Statistics
 3700  East-West  Highway
 Hyattsville,  MD  20782

 Joseph Nash
 (Richard Stevenson  -  Alternate)
 Department of Energy
 E201  20 Massachusetts  Ave.
 Washington, DC   20545

William Rhode  (1)
 (Lenore Wagner  - Alternate)  (2)
National Institutes of  Health
Bethesda, MD  20014
 (1) 496-9285
 (2) 496-9291


\.   ,0<^                  WASHINGTON, D.C. 20460
                                            OFFICE OF TOXIC SUBSTANCES

   SUBJECT:   Minutes of May 2, 1978 Meeting

   FROM:      Barbara Ostrow, Executive Secretary

   TO:        Members, Interagency Toxic Substances
             Data Committee (ITSDC)

        Unclosed are the minutes of the Kay 2, 1978, meeting
   of the ITSDC.

        If there are any corrections or additions to the
   agenda or items for inclusion on the agenda of our next
   meeting on June 6, 1978 9:30 AM, Room 2010 New Executive
   Office Building,  please call me at 202-755-4880.


          Interagency Toxic Sustances  Data Committee

                     Minutes - May 2,  1978

      This meeting of the ITSDC,  co-chaired by  Marilyn C.

 Bracken and Carroll L.  Bastian,  convened  at 9:30,  in

 Room 2010 of the New Executive Office Building,  17th and

 Pennsylvania Avenues,  Washington,  D.C.  20026.   The  following

 items were discussed:

 1.    MITRE Corporation CSIN Presentation

      Representatives from the MITRE Corporation  briefed

 the  Committee on the concept of  the Chemical Substances

 Information Network (CSIN),   the development of  the  Chemical

 Data Bases Directory (CDBD),and  the present work involving

 functional specifications for the  Network.   The  outline of

 this briefing is attached (Attachment A).

      A question  and answer period  followed this  presen-

 tation.   It was  pointed out that there will be no  attempt

 in the CDBD to eliminate areas of  overlap,  since this will

 take away  the intergrity of individual data bases.   The

 Directory  is  an  information locator,  not  an editor.

      The  cost involved  for the MITRE  contract,including

 (ammendments  #1  and #2),total  approximately $242,000.  The

 contract period  has  been from  April,  1977  through  December


     The CSIN Subcommittee  will  address the problems  which

were raised by the  MITRE  team.

 2.   Subcommittee Reports

     a)  10 (b) (1) Committee

         Ed Brooks, chairman,  reported that seven  agencies

are presently represented on the 10(b)(1)  Committee.   A

tentative agenda for the first meeting will be submitted

within two weeks.  Suzanne Rudzinski (755-0932)  will be

assisting Mr. Brooks in coordinating this group's activities.

Participation by additional agencies is requested.  Call

Ms. Rudzinski if you wish to serve on this subcommittee.

     b)  CSIN Committee

         Terri Damstra, chairman, reported that the first

meeting of this subcommittee occurred on April 26, 1978.

Additional representation by appropriate agencies is also

required by this group.  Call Ms. Damstra to volunteer.

     A draft subcommittee statement was presented indorsing'

the CSIN concepts described in the MITRE Report.  The parent

Committee concurred with the draft statement, which is incor-

porated in these minutes.   (Attachment B)

     Ms. Damstra reported that the subcommittee discussed

the difficulties inherent in the implementation of CSIN.

They decided that they would first focus on the task of

network management and concern themselves with investigation

of the individual components later.

     The subcommittee sought guidance from the parent

committee on several questions:

     Q-  Does the parent committee have a mechanism to
     provide funding for contract support?

     A-  EPA has budgeted some funding for ITSDC  activity.
     Some of this can be used for the hiring of consultants
     and for small feasibility study contracts.   However,
     since this is envisioned as an interagency cooperative
     effort, the Committee  anticipates funding support  from
     the other involved agencies.  These agencies should
     estimate funding and manpower allocation for the work
     of the ITSDC and use this estimate for long  range

      planning purposes.   There  are  presently  sufficient
      funds  for FY-78-79  network development activities.
      There  will not be enough to support  the  components
      development phase of the CSIN.

      Dr.  Kissman stated  that results  from the activities

 of  this  committee must be visible early.  There needs  to

 be  something  up and functioning to  illustrate that  this is

 a feasible  approach.   The benefits  of  the CSIN must be

 obvious  soon.   We cannot wait for all  the pieces  to be in

 place prior to the initial functioning.   It is necessary

 for  the  Committee to  develop a  budget  and plan to meet

 its  funding needs beyond FY 78.   This  involves commitments

 from the  other agencies.   Required  resources  should be

 roughed  out for the next 5 years.                   '

     Q-   Is it appropriate for  the  subcommittee to  schedule
     presentations on CSIN to the parent  Committee?

     A-   Twenty minute presentations  for  the  information
     of  the parent Committee, which will  focus on network
     management issues,  will be  presented at  the  monthly

     This subcommittee also plans to  invite experienced

 people from various groups involved in network management

 activities  to  address  them at their meetings.

     c)   Non-Federal/Public Interface Committee

         Morris  Yaguda,  EPA volunteered to serve  as chairman

 for  this subcommittee.   This task group will  make recom-

mendations  to  the  parent  Committee concerning  the organization

and methods of  handling  this aspect of the Committee's


     The Committee agreed  that the membership  of  this sub-

committee should  involve  the research agencies as well as

the regulatory agencies.  If members wish their agencies

to participate, call Mr. Yaguda.

     A question was asked concerning the specific functions

of each subcommittee.  In order to clarify this, each sub-

committee chairman will draft a charter which will be

presented at the June 6, parent Committee meeting.

     Dr. Kissman reminded the Committee that a body which

monitors and advises on the network will be required

once the method of network management is determined.

3.   Chemical Abstracts Services (CAS)  Registry Number Agreement

     Morris Yaguda briefed the Committee on the background,

general nature of the CAS service, and the status of present

negotiations with Chemical Abstracts Service.  A draft document,

"General Conditions Proposed by the CAS for USG Contracts

for CAS Registry Service" was distributed and explained.

(Attachment C)

     CEQ plans to use the language in this proposal for their

report to Congress.  Each ITSDC member agency has been

requested to review the proposal so that CEQ can report

some concurrence in this approach.

     A question was raised concerning the authority of the

ITSDC to decide upon these terms and conditions for every

government agency.  It was pointed out that this proposal

was only designed to be a prototype document, and would

not provide formal and official conditions for all of

government.  It does represent the results of the negotiations

with CAS.  As such, it will be used as a precedent document

for other contracts in dealing with CAS.  Each agency will

still negotiate directly with CAS and arrange their own terms,

     In effect, an endorsement of the CAS Registry Number

Chemical Classification System will force the producers -

of all chemical files to use CAS numbers in order to part-

icipate in the network.

4.   CEQ Report to Congress

     CEQ will distribute a draft of their report .to

Congress to ITSDC members.  They request that comments

concerning this report be returned to them prior to our

June 6 meeting.

     This will essentially be a progress report describing

the terms and conditions of the CAS Registry Number agree-

ment and a discussion of activities subsequent to the MITRE

report.  This includes related IRLG activities and activities

planned by the ITSCD.

     CEQ would like to include a statement to the effect

that this Congressional report received full discussion

and represents an agreement in principle by the various

ITSDC members.

5.   There were no additions to the agenda and the meeting

was adjourned.  The Committee will reconvine on June 6,

1978 at 9:30 AM, Room 2010, New Executive Office Building.
                              Barbara Ostrow
                              Executive Secretary


              ATTENDANCE MAY 2, 1978


Carroll Leslie Bastian - CEQ - (Toxic Substances Strategy Committee)
Marilyn C. Bracken - EPA
Irvin Weiss - CPSC
Marion Suter - CEQ
Jerry Coffey - 0/FSPS  (DOC)
Silvia Goldblatt - DHEW/PHS/OASH
Gooloo Wunderlich - DHEW/OASH
Allen Heim - FDA
Ed Brooks - EPA/OTS
Suzzanne Rudzinski - EPA/OTS
Cliff Moore - GAO
Michael Bollinger - GAO
Eric Martz - GAO
Jon Sell - GAO
John Ambler - Bureau of Census - Commerce
E.W. Milar - NIH
Leonore Wagner - NIH
Steve .Heller - EPA
Pat Breslin - OSHA  (IRLG)
Erskine Harton - DOT/MTB/OHMO
R.Et Corcoran - DOI/Bureau of Mines
Kathy Hunting -,CEQ
Barbara Ostrow - EPA
Calvin Menzie - FWS/Res.-USDI
Morris Yaguda - EPA
Henry M. Kissman - NLM/NIH'-(Committee to Coordinate Toxicology
                             andJrelated Programs)
Terri Damstra - NIEHS/NIH
Vera Hudson - NIOSH
Bill Rhode - OD/NIH
Joe Nash -, DOE/EV
Richard Muranaka - ,NRC
Linda A. Johnson - NRC
Don Hummel - NLM/NIH
Richard J. Lewis Sr. - NIOSH


Beth McNally -* Chemical Regulation Reporter

                                           •             Attachment A


 Briefing  on the  Chemical  Substances Information  Network  (CSIN)

 Mitre Corporation  -  May  -2,  1978

 1. Introduction of Mitre staff

     Terry Kuch
     Erika Graf-Webster
     Karen Levitan
     Shashi  Sood

 2.  Pre-TSCA toxic  chemicals information coordination as  background to CSIN

 3.  Genesis  of the CSIN concept

     •  The  TSCA impact - legislative  mandates
     * The  Mitre survey   [CEQ/EPA/NLM contract]
     •  The  CSIN concept emerging  from the survey:  coordination  of data
       sources,  identification of missing  data, its generation,  etc.
     •  Publication of  the CSIN Report

 4.  Contract efforts following publication  of the  CSIN Report

     •  The  Sigma Data report
     •  The  CSIN Directory [Contract  amendment #l]
     •  Functional concepts and usage patterns  [Contract amendment #2]

 5.  Future initiatives   - contracts

     •  Monitoring and overview proposal  - focal point for network
     •  Full feasibility study  of networking [Amendment #2,  "part  2"]
     •  Consideration of long-term  financial commitments
     •  Implementation contracts with for-profit firms

6. Future initiatives  - general

     •  State  involvement
     •  International implications
     •  Policy implications
     •  The "autonomy  problem"
     •  Possibility of close  coordination with  CICIS development

7. Organizational relations

     .  With sponsors  (CEQ,  EPA,   NLM)
     •  With Interagency Toxic Substances  Data Committee
     •  With ITSDC Subcommittee (Terri Damstra)

    • With IRLG Information Exchange Group
    • With organizations sponsoring  CSIN components

8. Conference  on the  Future of Toxic Chemicals Networks'[possible]

    • In collaboration with the Conservation  Foundation (Terry Davies)
    • Leading  role  played by the  ITSDC  Subcommittee

9. QUESTIONS AND ANSWERS (as long as the Committee desires)

                    WASHINGTON, D.C. 20460
                                        OFFICE OF TOXIC SUBSTANCES


SUBJECT:  Minutes of June  6,  1978 Meeting

FROM:     Barbara Ostrow,  Executive  Secretary

TO:       Members, Interagency Toxic Substances
          Data Committee  (ITSDC)

     Enclosed are the minutes of the June  6, 1978, meeting
of the ITSDC.

     If there are any corrections or additions to  the
agenda or items for inclusion on the agenda of our next
meeting on June 21, 1978,  9:30 AM, Room 2010 New Executive
Office Building, please call me at 202-426-4790.


Council on Environmental Quality
722 Jackaon Pteo*. N.W.
WMNngton. O.C. 20006
                                  U.S. Environmental Protection Agency
                                             CMC* et Torie SubMneM
                                              WMNngfcn. O.C. 204W
                   Minutes - June 6, 1978

         This  meeting of the ITSDC, co-chaired by Marilyn
    C.  Bracken and Carroll L. Bastian, convened  at  9:30,  in
    Room 2010  of the New Executive Office Building,  17th  and
    Pennsylvania Avenues, Washington, DC  20026.  The  following
    items were discussed:

    1.  Changes in Minutes of May 2, 1978 Meeting

         Ms. Bastian suggested the following additions and
    corrections to the minutes of the previous meeting:
Section 1-MITRE Report-
After:  "... integrity of individual data bases.1
Add:  However, areas  of  overlap will be examined
at a later date.

At the Bottom of  Section 1 -
Add:  The CSIN Sub-Committee will give the
parent Committee  some estimate of the contract
costs involved in carrying out the work of this
Section 2b - CSIN  Committee.
of the page
After:  EPA
Add:  CEQ and NLM.
At the bottom
    2.   June  Meeting Date

         The date agreed upon for the next  ITSDC meeting was
    June 27, 1978,  since the first Tuesday  in  July is a holiday.
    A Federal  Register notice will be published to announce this
    change.  In addition, the June date will allow the committee
    time to carefully review and comment on the CEQ 25(b) report
    to Congress prior to its required submission date.

    3.   Sub-Committee Reports

           a.   10(b)(l) Committee.

               Ed Brooks reported on the activities of this sub-
               committee and distributed its draft charter.  The


     charter was  reviewed and approved and the final
     version incorporating some suggested changes will
     be available at the next meeting.  Active partici-
     pation by DOT and DOD will be solicited.

This sub-committee will:

          Review proposed Section 8 regulations to assure
          that the needs of other agencies will be addressed,

          Identify and coordinate other Federal agency
          reporting requirements in an attempt to avoid

          Explore particiation of an IRLG representative
          on this sub-committee in order to minimize
          overlap by this and other related committees.

     -    Plan to identify common information needs.

b.   CSIN Sub-Committee

      Terry Damstra reported for this committee.  She
announced her resignation because of a heavy work-load,
and her inability to do all the required traveling.
Sid Siegel of NCI will be the new chairman.

      There are presently two versions of this sub-  -
committee's charter.   These will be discussed at the
sub-committee's next meeting and a final draft will
be presented to the parent Committee at the next meeting.

This group is:

     -    focusing on the CSIN management initially,
          specifically the qualification of the network

     -    reviewing a report prepared by a smaller work-
          group on the structure,  function,  and operation
          of the CSIN steering-committee.  Comments on
          this  report are due back to Sid Siegel by
          the next meeting.

     -    discussing  contract needs.   There  are two
          views - a)  get the contracts initiated now
          or, b)  wait for the selection of network
          manager.  There will be  some idea  of contract
          requirements presented to the parent committee
          by the next meeting.


     c.  Non-Federal Interface Committee -

          Morris Yaguda reported that this group has had
     one meeting to date, and the membership is still
     unsettled.  Participation by additional agencies is
     requested.  Especially desireable is participation by
     non-regulatory agencies.  Minutes and a draft charter
     were distributed and sections were discussed.  This
     draft charter has not yet been reviewed by the sub-committee.

     This group discussed:

     -    organizational topics such as the substance of
          their charter and the duration of this sub-committee.

     -    which organizations should be reached and specific
          mechanisms for reaching them.

     Ms. Bastian stated that preliminary recommendations
for non-Federal participation should be developed soon since
many inquiries are now being received.  These recommendations
should address at least two kinds of users.  One group might
include organizations who could be users of the system if
they were aware of it, and the other group would include
system managers who would like to link into the network.  It
was suggested that a technically oriented, permanent organization
could be established to inform these groups of this activity and
enlist their cooperation.  A feedback mechanism from these
organizations also needs to be set up.

     Dr. Kissman felt that the focus of this group as defined
may be too narrow.  He suggested that this sub-committee
deal with all aspects of the Federal/non-Federal interface
of data activities. Some difficulties of this interface
were discussed.  It was noted that most of the relevant
chemical information is located in the larger chemical
companies, and these companies need to be involved.  It
was also suggested that the activities of the Chemical
Institute of Industrial Toxicology be examined as a potential
source of information.  In order to encourage a dialog
with various interested non-Federal groups and institutions,
it was suggested that a short period of time be reserved
at the end of meetings for comment by non-members.

     There was a discussion concerning the various sub-
committees and their relationships.  It was concluded that
there is bound to be some overlap and related responsibilities
between the groups.  It was decided that the responsibilities
of the Committee as identified in the charter have been assigned
to one of the various Sub-committees.


 4.    Status  of  CAS Agreement

      The  completed, updated proposal was distributed by
 Morris  Yaguda.  This version is  expected to be approved
 by  the  ACS board of directors.

 5.    CEQ Draft  Report to Congress

      This draft status report describes the activities that
 have  been  undertaken by CEQ and  other Federal agencies
 in  response  to  the requirements  imposed by Section 25
 (b) of  TSCA.

      The staff  of CEQ has requested comments on the draft
 report  from  the members of the ITSDC, however no official
 agency  sign-off is required.  Several comments were offered.
 For example, it was suggested that the report be modified to
 take  national security considerations into account.  Substantive
 or  editorial comments were requested to be provided to Marion
 Suter by June 16, 1978.  A redraft of this document will be
 distributed prior to the June 27 meeting.

      Dr Bracken pointed out that although the CEQ report does
 not need concurrence by individual agencies, recommendations
 are being  made  regarding development and implementation of
 the CSIN.  Therefore, agencies must be conscious of the
 ramifications of these recommendations, since resource
 allocations will probably be involved in the long run.

 6.    Other Items

      Dr.  Bracken stated that it is important for the sub-
 committees to plan to invite speakers who can address
 matters of interest to the entire Committee.  This is
 especially important for the non-Federal Interface Committee,
 since this will serve to sensitize the parent Committee to
 the concerns of outside groups.  The Committee requested
 briefings on the Section 5 TSCA premanufacturing notification
 process, and the international aspects of chemical control
 and data sharing.

     There were no other additions to the agenda and the
meeting was adjourned.   The Committee will reconvene on
June 27, 1978,  at 9:30 am, Room 2010, New Executive Office
                       Barbara Ostrow
                     Executive Secretary


Kurt Maurer
Ted C. Briggs
Calvin M. Menzie
Margaret Finarelli
-Erskine Harton
Richard Muranaka
Linda A. Johnson
Vera Hudson
Terri Damstra
Eric Marts
Sharon Cekala
Donald Hummel
Doug Sellers
Kathy Hunting
Robert Bell
M. Roth
Patricia Breslin
Cathleen Brooks
Lisa Hemmer
Bill Milne
Stephen R. Heller
Carroll Leslie Bastian
Bill Rhode
Henry Kissman
Sid Siegel
Joseph D. Bloom
Bernard Greifer
Jerry Coffey
Joe Nash
Irv Weiss
Morris Yaguda
Marion Suter
Marilyn Bracken
Barbara Ostrow


Dick Titus
Tom Guay
Fred A. Tate
Charles A. Harris
William L. George
Rita Bergman
Tom Sliter
Dale R. Schmidt
Robert L. Harness
W.B. King
Twyla Bishop
              U.S. ITC
              DHEW, NIH, NLM
              OSHA  (IRLG)
              NLM - NIH
              NIH - NCI
              Toxic Materials News
              Johnson & Johnson
              Chicoper Mfg. Co.
              Sigma Data Computing Corp.
              Gov't. Research Corp.
              Nat'l Elec. Mfrs. Assoc.
              Monsanto Co.
              Armstrong Cork Co.
              Mitre Corp.


Lori Gribbin                  Rohm & Hass
Amy Shepard                   American Petroleum Institute
Leyla Erk                     Rubber Manufacturers Assoc.
Karen Levitan                 Mitre Corp.
Mary McGrane                  Baker, Hostetler
Sherry Boltz                  Nat'l Paint & Coatings
Angela Bannon                 3M Co.

Council on Environmental Quality
722 J«ckjon Placa. N.W.
Wuhington. O.C. 20008
U.S. Environmental Protection Agency
          Otflc* ot Toxic Substancn
            Wathngton, D.C. 20460
                       Minutes - June 21, 1978

        This meeting  of the IT3DC, co-chaired by Marilyn
   C. Bracken and Carroll L.  Bastian, convened at 9:30, in
   Room 2010 of  the New Executive Office Building, 17th and
   Pennsylvania  Avenues,  Washington, DC  20026.  The following
   items were discussed:

   A.  Part I -  Public Meeting

   1.   Minutes  of Last Meeting

        The Committee approved the minutes of the June 6,  1978

   2.   Change in Agenda

        Dr. Bracken announced a change in the agenda.  She  stated
   that the CSIN Sub-Committee report would be delivered  at the end
   of the meeting.  This portion of the meeting would be  closed to
   non-Federal attendees, since funding and contract support were to
   be discussed.

   3.   Sub-Committee Reports

        10(b)(l) Sub-Committee

        Ed Brooks reported that this group has not met since the
   previous parent Committee meeting.  However, their charter has
   been revised  in accordance with the comments made at the June
   6, ITSDC meeting.   Representatives from DOT and Commerce have
   also joined this Sub-Committee.

        Suzanne  Rudzinski of the 10 (b) (1) Sub-Committee attended a
   meeting of the IRLG, Information Exchange Group  (IEG)  to discuss
   the planned activities of the 10 (b) (1) Sub-Committee and to
   determine if  there is any overlap or duplication of  effort with
   the Reporting Sub-Committee of the IEG.  It was decided that
   the areas of  overlap between these two groups were minimal
   for the following  reasons:

   *    IEG includes  the membership of  four regulatory  agencies,
        while 10(b) [1) involves all pertinent agencies.


      *     IEG is  concerned with all  regulatory  activities
           which require reporting, while   10(b)(l)  is
           concerned  only with those  reporting requirements
           relevant to  toxic substances.

      *     IEG is  primarily interested  in  reporting  requirements,
           while 10(b)(1)  is interested in both  reporting and
           record-keeping requirements.

      *     The primary  emphasis  of these groups  is different.
           IEG is  concerned with the  exchange of information
           between the  four regulatory  agencies,  while  10 (b) (1)
           is  concerned with the coordination and avoidance of
           duplicative  reporting and  record-keeping  requirements
           across  all  Federal agencies.

      The  IEG  Reporting Committee report will be submitted to
the  10(b)(1)  Sub-Committee,  and then the  IEG will either phase
out  this  activity or focus on areas  other than  toxic chemicals.

      Ed Brooks also  reported that a  draft report containing
abstracts  of  14 Federal statutes which require  recordkeeping
and  reporting with respect to toxic  substances  will be sent
to 10 (b) (1) Sub-Committee members for  review.   He requested
that this  review  include discussion  with  the appropriate
people in  the proper agencies to insure that nothing substantial in
these statutes has been omitted or changed.  Dr. Bracken suggested
that the OGC  for  each  involved  agency  also be asked to review
this document.  After  this first draft is  revised,  the entire
ITSDC membership  will  have the  opportunity to review it for
accuracy and  completeness.   The purpose of this  activity is to
systematically determine  what regulatory  authorities are
available  for 10 (b) (1)  implementation.

           Non-Federal  Input  Committee

     Morris Yaguda announced that the  new  name  for  this Sub-
Committee  will be the  Public Liaison Sub-Committee which is
more descriptive  of  its  function.

     The minutes  and revised charter of this Sub-Committee
were distributed.   Mr.  Yaguda announced that representation
to this group  has expanded and  now includes the  Office of Science
and  Technology  Policy,  CPSC,  NIH, and  Commerce,  along with EPA
and CEQ.   Also  in attendance  at this last meeting were two
invited non-Federal representatives  from Fein-Marquart Associates
and  the George  Washington  University.

     This  Sub-Committee is presently focusing attention on
the  following  short-term activities:

     *    Developing an initial mailing list of  the non-Federal
           community.   A sample  letter  to be sent as the initial
          mailing was distributed for  review.  Any comments


          concerning this letter are to be returned to Mr.  Yaguda.

     *    Providing a discussion of Committee activities at
          several conferences which are meeting in the next
          few months, (for example, Gordon Conference, National
          Governors Conference, National Association of States).

4.   CEQ Report to Congress

     Section 25 (b) of TSCA requires CEQ to report to Congress
concerning "the feasibility of establishing (1) a standard
classification system for chemical substances and related
substances, and (2) a standard means for storing and for obtaining
rapid access to information respecting such substances".  CEQ
consulted with the ITSDC during the preparation of this report.

     Carroll Bastian distributed a second draft of this report
and informed the Committee that comments received as a result
of review of the previous draft were incorporated into this
version, and only editing changes are contemplated.  The
published version will be distributed to ITSDC members and
the public.  She assumes that further discussion concerning
the implementation of the recommendations made in this report
will be a responsibility of the ITSDC.

     Marion Suter announced that the CAS Registry agreement with
the Federal government has been negotiated.  Dr. Bracken thanked
Mr. Yaguda for his successful efforts in these negotiations.

5.   International Aspects of Chemical Control and Data Sharing

     Dr. Bracken, Chairperson of the U.S. delegation to the OECD
Chemicals Group meeting in Paris, presented this briefing.  She
distributed the report prepared to brief the IRLG on this same
subject,  (see attachment A).  She stressed that this briefing
surveyed international activities with respect only to toxic
substances, and did not include other areas of cooperation.

     In addition, she discussed a recent meeting held on June
21-23  (see p.3, attachment A) to establish a Part II activity
involving the control of toxic substances.  The proposed Part
II projects were discussed at this meeting.  It appears that
funding for all the projects might not be possible, and
consequently, two projects will receive priority attention.
These projects are: a) development of consistent standards
for good laboratory practice and effective means of enforcing
them, and b) mechanisms to facilitate information exchange
and the possibility for sharing of confidential data.

     There were several questions related to the mechanisms
for the formulation of a unified US position.  Dr. Bracken
informed the group that there is a State Department committee
responsible for coordinating the US position on the international
aspects of toxics, and stressed that members of the ITSDC
should alert their agencies to the existence of this committee
if they are involved in international toxics activities.

TSCA Section 5 Premanufacturing Process

     This briefing could not be presented on schedule, since
the speaker, Blake Biles, was detained.  However,  there will
be a public meeting on July 12 and 13 on this subject.  (Mr.
Biles arrived later and briefed the Committee during the closed


B.   Part II - Closed to Public

1.   CSIN Sub-Committee

     Dr. Sidney  Siegel, chairman of this Sub-Committee outlined
his concerns about the problems facing the group and discussed
the major issues.   Briefly these were:

     *    The Sub-Committee has not moved forward on its charter,
          primarily because there must be greater definition
          of what the committee's responsibilities are and
          how they should go about getting their work

     *    Its members have a broad range of backgrounds and
          experience, and need to be brought up to the same
          level of understanding.  To begin this process,  at the
          last Sub-Committee meeting, Don Hummel of NLM gave
          a presentation explaining the Chemical Data Bases
          Directory now being developed under contract by the
          Mitre Corporation.

          He raised the following questions:

     *    Where should the administrative home for CSIN be and
          when shall this be determined?  Dr. Siegel recommended
          that an initial home be selected now in order to give
          this project momentum.

     *    Who will manage the CSIN?  Should there be an initial
          manager?  Should this management be a single person
          or is joint management desireable?

     *    What will the relationship of this manager be to the
          CSIN Sub-Committee?  Will the manager report directly
          to the CSIN Sub-Committee?

     *    What kind of support could be offered the CSIN manager
          in helping resolve technical and other issues?

     *    How should CSIN be reviewed periodically?

     Dr. Siegel had these personal recommendations and suggested
their implementation as rapidly as possible.

     1.   The initial administrative home of CSIN should be NLM,
          but management would be provided by the parent
          Committee and Sub-Committee, not NLM.

     2.   There should be joint management of CSIN, with Drs.
          Milne and Kissman serving in these positions.  The
          Sub-Committee would attempt to resolve problems
          brought before it by these managers and bring recommen-
          dations to the parent Committee for decisions.


      3.    There will be need for contractor support in order
           to help CSIN carry out its activities.  CEQ should
           be the coordinating agency in these contractual

     Morris Yaguda, seconded by Dr. Rhodes, complimented Dr.
 Siegel on  the excellent job he has done in attempting to
 define and resolve the issues.

     A question and answer period followed Dr. Siegel's presen-
 tation.  A synopsis of this exchange follows:

 *    Network. Management

           For an interim period, Drs. Kissman and Milne will
     serve as co-project officers on an operational basis.
     The CSIN managers and the project officers will be
     one and the same.  The managers will be responsible
     for providing necessary documentation to the Sub-
     Committee and the parent Committee and to offer advice
     on the direction of CSIN.  However, the CSIN manager's
     role  would continue to be defined during this initial

 *    Systems Development

           The initial managers of the system should pursue the
     further identification of nodes of information capability
     and begin to handle early implementation efforts.   It
     will  not be possible to define all the problems initially,
     but it is felt that the pilot Directory of Chemical
     Data  Bases will serve to alert the Committee to systems
     problems and serve as a model for other component
     development.   It was decided that it is important to
     begin short range planning to develop a functioning
     system soon,  but simultaneously begin to examine the
     long  term aspects of systems development.  NLM will
     implement this initial phase,  while the Sub-Committee
     will address  the long-range planning.

*    Financial Considerations

          The Sub-Committee must develop a 3-5 year financial
     plan detailing the development costs for the network.
     This plan is  necessary to assist agencies in determining
     the resources  they would be required to commit.  These
     plans, however,  must be flexible in order to accomodate
     changes in design as experience in network development
     is gained.


     EPA and NIH have budgeted for sufficient funding support
for CSIN development for the next 2 years,  but they will require
financial assistance from other agencies by 1981.   Other
agencies, therefore, must begin to consider their  role in
network development now.  In order to get cooperation and
develop an early working relationship with other agencies,
the ITSDC must demonstrate that they are engaged in a
worthwhile activity.

     It is also necessary to consider that the commitment of
people, as well as funding, will be required from various
agencies.  This aspect is especially important if  an agency
has a data file which will become part of the network.

     Dr. Siegel's approach was endorsed by the Committee.  The
Sub-Committee is to prepare a written paper describing the
proposed management function and the eventual role of the
manager, for the next ITSDC meeting.

     Documentation concerning possible contractor needs will
also be presented at the next Committee meeting.  Dr. Kissman
distributed a document, Suggestions for CSIN - Related contracts
(FY'78 Funding) (Attachment B).  Dr. Bracken asked the Committee
to review Dr. Kissman"s paper and return any comments to Dr.
Siegel as soon as possible.

2.   Section 5 TSCA Premanufacturing Notification Process

     Blake Biles,  of EPA, then briefed the Committee on the
general provisions of the TSCA section 5 premanufacturing notifica-
tion process.  Section 5 briefly:

     *    requires industry to notify EPA 90 days prior
          to the manufacture of a new chemical.  The manufacturer
          can then produce this chemical if EPA doesn't respond
          within this required period.  EPA is considering
          exemptions for mixtures and research and development

     *    applies to manufacturers and importers only.

     *    test data in the manufacturers possession must be
          submitted and other test data which they know about
          not in their possession must be described.

     *    cannot require specific tests.  However, if testing
          rules are promulgated under TSCA section 4  they
          will apply.

     *    can delay commercial production of a chemical based
          on information such as exposure or structural simi-
          larity.  A court order is required to make  this

     *    has authority to regulate existing chemicals which are
          put to new uses.

3.   Other agenda items

          There were no additions to the agenda and the meeting
was adjourned.  The Committee will reconvene on August 1, 1978,
at 9:30 am, Room 2010, New Executive Office Building.
                       Barbara Ostrow
                     Executive Secretary

                           Attendance Sheet

Carroll Leslie Bastian
Marion Suter
Ed Brooks
Morris Yaguda
Jerry Coffey
Robert Dixon
Vera Hudson
Allen Heim_
Sid Siegel
Henry Kissman
Leigh E. Doptis
Fred A. Tate
John Ambler
Don Deutsch
Robin Heisler
Doug Sellers
Suzanne Rudzinski
Barbara Ostrow
Glenn Simpson
Irvin Weiss
Calvin Menzie
Richard J. Lewis
Kurt Maurer
Terri Damstra
William E. Rhode
Linda A. Johnson
Bernard Greifer
Deborah A. Zaun
Cathleen L. Brooks
Bill Milne
David Lide
Marilyn Bracken


Mark C. Cummins
Phil Holladay
R.J. Pickening
Rita Bergman
Michael F. McBride

Tom Gauy
Barry Dandoff
W.B. King
Irena Fuk
John Beale
Christine Shine
Mary McGrane
Sherry Boltz

Girard Ordway

Bureau of Census
Shell Oil Co.
Sigma Data
LeBoeuf, Lamb, Leibyt
Allied Chemical
Armstrong Cork Co.
Interdevelopment,  Inc.
Dow Chemical
Monsanto Co.
Baker & Host etler
National Paint &
Chemical Regulation



Name                          Organization             Phone

Ron Gaudon                    Pesticide & Toxic News   783-7472
Angela Bannon                 3 M Co.                  331-5581
Ann E. Baker                  Allied Chemical          201-455-2506
Carl J. Wessel                Tracor-Jitco             881-2305
Deborah L. Mullor             Society of the Plastics  331-0340
Thomas Gilding                National Agriculture     296-3341
                              Chemicals Assoc.

                                                    Attachment A

                          WASHINGTON. D.C.  20460

                              May  26, 1978
                                                                   OFFICE OF THE

TO:       Interagency Regulatory Liaison  Group

THRU:     Administrator
FROM:     Alice Brandeis Popkin TJ
          Associate Administrator
          Office of International  Activities
          Marilyn C.  Bracken
          Deputy Assistant Administrator
            for Integration and Information
          Office of Toxic Substances

SUBJECT:  Status Report:   International  Meetings  on  Toxic  Substances

I.   Stockholm, April  11-13

     A.   Participants:  Six international  organizations,  Australia,
          Austria, Belgium, Canada,  Denmark,  Federal  Republic  of Germany,
          Finland, France, Italy, Japan, Netherlands, Norway,  Sweden,
          Switzerland, UK, US.

     B.   Participants agreed on six  priority areas  for  future inter-
national work, as identified by Doug  Costle in his opening speech,

         -development of consistent  data requirements and  testing methods

         -development of consistent  standards for good laboratory practice
          and effective means of enforcing them

         -mechanisms to facilitate information exchange  for both data
          and regulatory actions


          -confidentiality of data

          -need to develop consistent  methodologies  for analyzing the econo-
           mic and trade impacts of actions  regulating toxic chemicals

          -development of an  international  glossary  of key terms

      C.    Participants designated the OECD  as the appropriate forum to
 undertake this work in the near term.  The  OECD Chemicals Group is already
 engaged  on a  project to harmonize test methods.  It has also begun work
 on  an information exchange procedure  and economic analyses.  Participants
 agreed that the OECD should  sponsor intergovernmental technical working
 groups to accomplish the remaining tasks and that it should be asked to
 establish a steering committee  for administrators to give direction to
 those working on all  six priority tasks.

 II.   OECD Chemicals Group, April  18-20, Paris

      A.    Dr.  Bracken led the U.S.  delegation, which included represen-
 tatives  of FDA,  Commerce, State,  and  EPA.

      B.    The  group seconded the  priority work areas identified in
 Stockholm and  prepared work  proposals  for  five of them.  (No proposal
 was  needed in  the test methods  area,  since  this work is already well

      C.    The  Chemicals  Group felt  that it  itself, meeting at high level,
 in special  session  if necessary,  should fulfill  the steering committee
 function  referred to  above.

      D.    The  group agreed that extra-budgetary ("Part II") funds might
 be necessary to  support  new chemicals  activity.  Note:  OECD countries
 interested in  funding special projects can contribute supplementary--
 "Part  II"--funds  over and  above their  budget contributions.  The projects
 then  go  forward  under OECD auspices,  but non-contributing countries are
 not necessarily  involved.   The group  recommended that high-level  admin-
 istrators  from contributing countries  meet as a  "management committee"
 to oversee any Part  II work.
III. OECD Environment Committee, April 24-26, Paris

     A.   Assistant Secretary of State Mink led the U.S. Delegation,
which included representatives of State, Commerce, HUD, and EPA.  Note:
the Environment Committee is parent of the Chemicals Group.

     B.   Committee agreed to Stockholm priorities as fleshed out by
Chemicals Group.  It recommended that Part II funds be used to support
new work on confidentiality, good lab practices, glossary of key terms,

and information exchange.  It agreed that trade and test methods  pro-
jects should be funded out of regular Chemicals Group budget.   The
Committee also, in effect, agreed to the institutional  arrangements
recommended by the Chemicals Group.

     C.   Committee agreed that countries interested in supporting the
fo^ir proposed Part II projects should meet in June to work out details
of substance and procedure.  Steve Jellinek will lead the U.S. delega-
tion to the meeting, now scheduled for June 21-23.

IV.  World Health Organization Meeting to define WHO environmental
     health program, Geneva, May 1-5.

     A.   U.S. representation included experts from EPA and NIEHS.

     B.   Meeting proposed that WHO undertake a major role in preparing
international risk assessments (i.e., evaluations of intrinsic toxicity).
WHO's proposed program would address risk assessment methods, a chemical
selection process, and the development of test methods.  The latter  would
build on the shorter-term OECD effort.  Particular emphasis would be
given to efforts in epidemiology and epidemiological methods.

                                                  Attachment  B

                          PUBUIC HEALTH SERVfCE


                          BETHESDA. MARYLAND 20014
                           June 26, 1978              NATIONAL LIBRARY OF MEDICINE


    A.   Data Collection and Encoding

        The contractor shall  collect data and information  regarding
        automated, chemically orientated Government files  according
        to detailed specifications to be provided by NLM.   These
        data and information  to be collected will  characterize the
        identification, scope, ownership, availability, access,  size,
        growth and data element definitions,  frequency and nature of
        changes, for each file surveyed.  The data element definition
        effort will describe  the contents or values contained  in  that
        element, the size,  format and recording  characteristics,  and
        a statement as to the occurrence of the  element relative  to
        the number of records in the file.

        Data collection will  be accomplished by  means of:  (1)  the
        review and interpretation of systems documentation; (2)
        interpretation of manuals, print-outs and file dumps;  and
        (3) personal  interviews with the data base sponsors, generators
        or other personnel  having knowledge of the file.

        The collected data  will be organized, encoded and  converted  to
        a machine readable  format by the contractor.   Proofed, corrected
        copy will  be reviewed with the contractor responsible  for
        indexing and with the data base owner to assure accuracy  and
        intelligibility of the collected information.

        The type of personnel  required for this  task would be  technical
        information specialists, preferably paired such that one  has
        subject matter expertise and the other data structure  and EDP
        expertise.  It is anticipated that an average level of production
        would be one file per man month of effort.

    B.    Subject  Catalog Enrichment and  Indexing

          The contractor shall undertake  to continue the development
          of the Subject: Catalog component of the CSIN prototype in
          line with the priginal effort of the Mitre Corporation.
          Since much of the effort to date has been done in the absence
          of actual data element information from existing files, it
          is anticipated that many modifications (hopefully minor) will
          be required  to accommodate indexing actual data elements.

          The specific tasks of the contractor will be to: (1) apply
          subject  catalog codes and/or terms to the data elements
          obtained from the efforts of the data collection activity;
          (2)  enter file and element names into the Subject Catalog;
          (3) resolve  indexing conflicts  and amend the catalog as required;
          (4) enrich the Subject Catalog  to accommodate data elements  for
          which  no suitable category exists;  (5) check all indexing with
          the data collectors and/or the  file owners;  (6) develop cross
          reference entries and scope notes to assist  users of the Subject
          Catalog; and (7) prepare a procedures manual which describes the
          methodology  and policies used  to maintain and expand the Subject

          Personnel required  to accomplish  these tasks would be  librarians
          with scientific training or chemical or  biological scientists
          with technical  information expertise.  A level  of effort of
          one and  one  half to  two man months  of effort per month will
          be  required.


          Although there  will  be  a number of  efforts  which will  require
          contractor  support  as  soon  as  possible,it may  be advisable
          to  await the policies  to be  established  in  the  near  future
          by  the CSIN  subcommittee of  the Interagency  Toxic Substances
          Data Committee  before  taking any  contractual action.   However,
          one activity which  should be undertaken  now, which may help
          the CSIN Subcommittee  in  its efforts,  is a  detailed  evaluation
          of  the chemical component of the  CSIN  (i.e., the Chemical
          Substance  and  Nomenclature  System,  CSNS) and particularly
          the two  existing primary candidate  systems  that could, in
          combination, become the  core of the CSNS (i.e., NIH-EPA/SSS
          and CHEMLINE).- There  could  be a  variable number of  tasks
          included in  this effort  depending on  the availability  of funds.
          The suggested  tasks are  as  follows:


 1.   Evaluate  existing chemical  search  systems  (e.g., NIH-EPA/SSS,
     CHEMLINE  (with  Swiss  Screens),  NCI-Division of Cancer Treatment
     system, etc.).

     (a)  Assess  the degree of retrieval precision for each search

         i.    Unique compound  retrieval  (by nomenclature, synonym,

         ii.   Compound class retrieval (name of chemical class)

         iii.  Structural characteristic  retrieval.

     (b)  Assess  the degree of complexity  involved in using
          each search  element for:

         i.    various levels of competency regarding chemistry

         ii.   various types of terminals  (TTY—intelligent)

         iii.  degree  of difficulty in interpreting output.

     (c)  Assess  the degree of redundancy  associated with each possible
         pair and/or logical combinations of search elements (e.q.,
         Wiswesser  Line Notations,Screens,  Name Fragments, Segments, etc.)

     (d)  Define  the hardware and softv/are restrictions, limitations,
         and advantages of each system (e.g., transportability of
         software,  processing time as a function of   the number of
         records, user interface, output media, maximum number of
         simultaneous  users supported effectively).

     (e)  System  utility based upon number of users, number of searches,
         hours of use, use of system output, user's reaction to and
         evaluation  of system.

     (f)  Prepare final report with recommendations for the content,
         search  facilities, and hardware/software requirements in
         keeping within the overall constraints imposed by the Mitre
         CSIN report and policies developed by the CSIN subcommittee.

2.  Conduct a user  study of the required contents and capabilities
    of the chemical  catalog (CSNS) of CSIN.
                                    Donald J. Hummel
                                    fien/y/M. Kissman, Ph.D.

Council on Environmental Quality
722 Jacfcxm Pt*». N.W.
Washington, D.C. 20006
U.S. Environmental Protection Agency
           O1fc» ot TttbC Sutxtancw
            WMhmgton, O.C. 20400
                      Minutes - August 1, 1978
        This meeting,  co-chaired by Marilyn C.  Bracken and
   Marion Suter  (substituting for Carroll Bastian),  convened
   at 9:30, in Room 2101 of the New Executive Office Building,
   17th and Pennsylvania Avenues, Washington, DC  20026.
   The following  items were discussed:

   1.   Minutes of  Last Meeting

        The Committee  approved the minutes of the June 27,
   1978 meeting.

   2.   September Meeting Date

        The next  Committee meeting will be September 12, 1978.
   This change from the first Tuesday of the month will be
   announced in a Federal Register notice.

   3.   Subcommittee Reports-

        Section 10(b)(1) Subcommittee

        Ed Brooks reported on the July 18 subcommittee meeting.
   The subcommittee was briefed on the following TSCA information-
   gathering rules  and policy statements:

   *    section 8(e) Policy Statement, published March 16, 1978,
        regarding notices of substantial risk.

   *    section 8(d) rule, published July 18, 1978,  to obtain
        health and  safety studies for the four  chemicals and
        six categories of chemicals recommended for  testing by
        the Interagency Testing Committee; and

   *    draft subsection 12(b) procedural rule, to be proposed
        in December, concerning export notifications.

                             - 2  -
      Discussion of the  subsection 8(e)  Policy Statement
 addressed means of implementing  the  commitment in  the
 Policy  Statement to coordinate interagency  exchange  of
 substantial  risk information.  At that  meeting/ the
•subcommmittee  recommended  referral of the problem  to the
 Information  Exchange Group (IEG)  of  the IRLG.   However,
 due  to  subsequent discussions with Dr.  Patricia Breslin,
 chairman  of  the IEG,  the issue will  be  reconsidered  by
 the  Section  10(b)(1)  Subcommittee.

      As indicated at the last meeting,  Mr.  Brooks  is in
 the  process  of developing  a  compendium  which  abstracts
 the  information-gathering  authorities of 15 federal,
 environmental  and consumer statutes.  Copies  of the
 pertinent abstracts were sent to  appropriate  Section
 10(b)(1)  Subcommittee members for review and  comment.
 The  final version of  the compendium  will be completed
 in September at which time copies  will  be made"available
 to the full  committee.

      Dr.  Bracken asked  if  the Committee  would be interested
in detailed briefings on TSCA section 8  rules as they are
being developed.   The Committee decided  that  the Section
10(b)(1)  Subcommittee should receive such briefings, but
that  copies of  related  material should be distributed to
the  full  Committee.  Consideration will  be  given to  providing
a detailed briefing of  major Section 8 rules to the  full
Committee  immediately prior to proposal  in  the Federal Register,

     CSIN Subcommittee

     Dr. Sid Siegel reported on the subcommittee's recent
activities. These activities focused on outlining three
contract tasks to support CSIN development.   Specifically,
they are:

     1.    Continuing development of the Chemical Data
          Base Directory including (a)  collection of
          additional data on data bases and files for
          inclusion in the CSIN Descriptive Catalog,
          and characterization of this data; and (b)
          continuing development of the CSIN Subject

     2.    Further development of the CSIN Chemical
          Structure Nomenclature System  (CSNS) including,
          (a) study of private and federal data systems

                            - 3 -
          in order to increase the definition of the number
          and kind of elements which could be used to
          identify chemicals, chemical substructures/ and/
          or classes of chemicals contained in CSIN com-
          ponents; and (b) review of these identification
          elements with potential CSIN users.

     3.   Identification and determination of avail-
          ability of specific coherent chemical data sets
          to support specific functions of potential CSIN
          users and evaluation of alternative approaches
          to CSIN implementation.

     Task No. 2 does not yet have full subcommittee
consensus.  Morris Yaguda presented the subcommittee's
minority opinion concerning this task, which favored use
of the enhanced NIH/EPA Chemical Information System  (CIS)
as the core compent for CSIN.  Copies of a memorandum
from Willis Greenstreet,  Director, Management Information
and Data Systems Division (EPA) to Dr. Bracken on this
subject were distributed.  Dr. Bracken offered to make
copies of her response available to the Committee.  Dr.
Siegel requested Committee approval for the subcommittee
to commit these tasks to contracting.  The subcommittee
will further define each task.  The motion carried.
To aid definition of details, copies of pertinent documents
will be sent to subcommittee members for review.

     Mr. Yaguda offered to present, at the next ITSDC meeting,
the ideal requirements for a chemical nomenclature and
substructure system and to demonstrate CIS-capabilities
in this regard.

     Dr. Siegel also indicated that an interagency agreement
between EPA, CEQ, and major NIH components is being developed.
This activity could result in a CSIN Steering Committee.

     The subcommittee charter will be presented at the next
ITSDC meeting.

     Public Liaison Subcommittee

     Morris Yaguda presented the subcommittee report and
distributed copies of the proposed mail-out to the non-
Federal community.  Comments on this revised draft were
requested.  Marion Suter recommended including a reference
to the CEQ report to Congress.  In response to Henry
Kissman's suggestion that specific reference to CHEMLINE

                             - 4  -
 be deleted.  Dr.  Bracken recommended referencing Vol.  II
 of the MITRE report rather than include  specific  names
 and addresses in the body of the letter.   Dr. Bracken
 also suggested amending the letter  to  clarify how the
 public can participate  in the Committee's  meetings.   The
 Committee  then approved the principle  of the letter.

      Mr. Yaguda  also reported that  the subcommittee will
 soon begin work  on (a)  a presentation  for  non-Federal
 symposia and meetings,  and (b)  examining various  legal
 issues such  as implied  warranty of  data.   The next
 subcommittee meeting will be held August 25 at 9:30 am
 at EPA.

 4.    CEQ Report  to Congress

      Marion  Suter distributed copies of the CEQ report
 to Congress  required under subsection  25(b) of TSCA.
 The report,  submitted to Congress in July, is currently
 being printed by GPO.

 5.    TSCA  Security Procedures for Handling Confidential

      Under section 14 of TSCA,  EPA  can share confidential
 business information with other Federal agencies  which
 administer a statute for  protection of health or the
 environment.   The section also  provides that Federal
 employees  who  willfully disclose confidential information
 are  subject  to criminal penalties.  Therefore procedures
 for  handling  such data  must  be  established.

      Jeanette Wiltse, an attorney on Dr. Bracken's staff,
 briefed the  Committee on OTS  security  procedures  for
 handling confidential information.  OTS is currently
 developing an  Intergovernmental Agreement  (IAG)  for
 use with those agencies  which may require  regular  access
 to TSCA confidential data.  All lAGs must  specify  the
 purposes for which the  data will be needed, data  request
 procedures, security procedures for handling the  data,
 procedures for handling  breaches of security, additional
 legally permissible disclosures of the data by the
receiving agency, and provisions for inspecting other
agencies to ensure that  security procedures and facilities
are adequate and properly maintained.  The terms of
each IAG will be published in the Federal Register.

                            - 5 -
Dr. Bracken requested that each Committee member determine
their agency's need to access TSCA confidential information
and contact Ms. Wiltse, 426-9819, in order to begin work
on the necessary IAG.

     There were no additions to the agenda and the meeting
was adjourned.  The Committee will reconvene September 12,
1978, at 9:30 in Room 2010, New Executive Office Building.
                                   Suzanne Rudzinski
                                   Acting Executive Secretary

                                             August 1, 1978
                       Attendance Sheet

 Marilyn Bracken
 Pat Breslin
 Ed Brooks
 Jerry Coffey
 Terri Damstra
 Bernard Greifer
 Henry M.  Kissman
 Richard J.  Lewis,  Sr.
 Kurt Maurer
 William E.  Rhode
 Suzanne Rudzinski
 Doug Sellers
 Sidney Siegel
 Glenn Simpson
 Marion Suter
 Bruno M.  Vasta
 Irvin Weiss
 Jeannette Wiltse
 Morris Yaguda


Angela Bannon
Rita Bergman
Twyla Bishop
Sherry Boltz
Mary Cushmac
Leyla Erk
Robert F. Hanlon
Dan Harlow
Pat Johnson
Mary McGrave
John Simplicio
Joshua I. Smith
Sigma Data
L. Miranda Assoc.
Baker and Hostetler
Allied Chemical

Council on Environmental Quality
722 Jackson Ptac*. N W.
Washington. DC. 20006
U.S. Environmental Protection Agency
           Office o» Toxic SutatancM
            Washington. D.C. 20460

SUBJECT:  Minutes of September 12, 1978 Meeting

FROM:     Barbara Ostrow,  Executive Secretary

TO:        Members, Interagency Toxic  Substances Data Committee
      Enclosed are the minutes of the  September  12,  1978,
meeting of  the Interagency Toxic Substances Data  Committee,

      If you have any corrections, additions, or business
items which should be considered at our next meeting on
October 3,  please call me at 202-755-4880.

Council on Environmental Quality
722 Jtctaon Plan. N.W.
     , O.C. 20CC*
U.S. Environmental Protection Agency
           Olflc* ol Toxic Sub*tw>c««
                . DC. 20*60
                  Minutes -  September 12,  1978
      This meeting, co-chaired  by Marilyn C.  Bracken and
 Marion Suter (substituting  for Carroll  Bastian),  convened at
 9:30,  in Room 2010 of the New  Executive Office Building,
 17th and Pennsylvania Avenues,  Washington,  DC  20026.  The
 following items were discussed:

 1.    Minutes of Last Meeting

      The Committee approved the minutes of  the August 1, 1978

 2.    Change In Agenda

      Dr. Bracken announced  that agenda  items 2 (NIH/EPA Chemical
 Information System) and 3 (Other Agenda Items)  would be reversed.

 3.    Subcommittee Reports

      *CSIN Subcommittee

     Dr. Sidney Siegel, chairman of this  Subcommittee,  distributed
 the  following three documents  to members  of  the ITSDC:

      1 - Draft CSIN Subcommittee Charter.

     2 - Functions of the Network Administrator of the  CSIN (Draft)

     Both of these draft documents were reviewed  and discussed
by the subcommittee at their meeting on September 11.  However,
additional comments on these documents  were  requested by
Dr.  Siegel.   Any comments are to  be given to him  by September
15,  1978.

     Dr.  Siegel stressed that while the functions of the
network  administrator are difficult to"define at  this stage,
some initial guidance is required.  The Administrator's role
will be  more clearly defined as  the CSIN  content  requirements
and  svstems  alternatives come into focus.

     3 - CSIN Activities

     This document consists of several sections:

     I.   On Going Activities

          A.   Data Collection and Encoding
                    Descriptive Catalogue

          B.   Enrichment and Indexing
                    Subject Catalogue

     II.  Proposed Activities (Request for Proposals)

          A.   Content and systems requirements of the
               Chemical Structure/Nomenclature System
               (CSNS) of CSIN (RFP)

          B.   A study of systems alternative for CSIN (RFP)

     Review panels for the RFP's have been set up.  Responses
for RFP/A are due on September 18, 1978 and RFP/B responses
are due on September 25, 1978.

     Dr. Hummel of the National Library of Medicine informed
the group that 12 data bases have been encoded to date and 31
additional data bases will be encoded under the next phase of
the contract.  Mitre Corporation representatives, the contractor
for this project, will give a presentation concerning the
development of the CSIN Chemical Data Base Directory at the
October 3 ITSDC meeting.

     Dr. Bracken reported that there was a great deal of
interest demonstrated by members of the American Chemical
Society (ACS) in the CSIN activity, when she delivered an
informational talk to ACS at their annual conference in
Miami on September 11, 1978.

     *Public Liaison Subcommittee

     Morris Yaguda distributed the minutes of this Subcommittee's
July 28 and August 25 meetings.   Also distributed was a copy
of the letter which was mailed to government, industry, universities,
foreign governments, public interests groups and others.  To date
approximately 30,000 letters have been mailed and 100 letters
from organizations requesting information have been received.
The group is also working on a public briefing which possibly
will include slides, video tape and a prepared narrative.
An outline of this proposed public briefing was distributed,
and comments on this briefing were requested by Mr. Yaguda.

      It was suggested that perhaps a quarterly  newsletter,
 should also be produced.   This suggestion  will  be  considered
 by the Subcommittee.

      Dr.  Rhodes asked if  any member of the Subcommittee
 planned to  attend  the upcoming American Association  for  the
 Advancement of Science (AAAS)  meeting.  Dr.  Bracken  suggested
 that the Subcommittee volunteer to participate  in  the AAAS
 Section T activity program.   Mr.  Yaguda will explore this as
 a publicity possibility.

      There  have been  no requests  so far by the  private
 sector for  agenda  time, and no indications that they would
 like to discuss their own data systems  or  data  system needs
 with the  ITSDC.  Dr.  Bracken encouraged industry's
 participation  since the Parent Committee is  interested in
 learning  how information  needs are handled by various companies.

      There  was  a question concerning the methods which are
 planned to  train personnel in the use of the system.  The
 Public Liaison  Subcommittee  chairman will  address  this
 problem with help  from members of the Parent Committee and
 the  CSIN  Subcommittee.

      4  -  Other  Agenda Items

      o    Dr. Bracken asked  the ITSDC members if the Committee
 needs  to  meet each  month,  since much of the  activity occurs
 in the  subcommittees.  She stressed,  however, that it is
 important for the parent  committee to be kept well informed.
 She  called  for  comments on this question.

      Some members felt that  perhaps  less frequent meetings were
 appropriate.  It was  noted that ITSDC meetings  should be
 coordinated with the  Toxic Substances Strategy  Committee
 (TSSC) meetings.  The  ITSDC  will  have to provide a comprehensive
 report of its activities  at  the December TSSC meeting, since
 the TSSC must soon  issue  a report to  the President through

     Because of this,  we want  to  plan for  subcommittees to
 present comprehensive reports  of  their activities at the
 November meeting.   It was  decided that an October meeting,
 under these circumstances, would  be worthwhile.   This October
meeting will also be used  to bring ITSDC members up-to-date
 on the status of the Mitre contracts  and the RFP responses.

     Dr. Kissman expressed his  view  that a monthly meeting
 is necessary since  it is expected  that the scope of activities
of the Parent Committee will broaden.

     o    Dr. Bracken requested that  Committee members read


the FR notice which concerns the development of a use
classification scheme.  It is believed that use information is
a necessary parameter for calculating exposure to chemical
substances.  OTS recognizes that the present proposal is not
totally comprehensive and is seeking comment from ITSDC members
by September 28.  A copy of the FR notice can be obtained by
calling 800-424-9865.

     o    Mr. Yaguda reminded the Committee that the CEQ report
to Congress states that the ITSDC will be responsible'for
implementing and promoting the use of CAS Registry Numbers
throughout the government.  A task group was formed to explore
the nature and scope of the problem and various methods of
assisting agencies in getting into the CAS system.  Their ideas
will be brought to the Parent Committee for discussion.  Present
task group members include:

     Bernard Griefer     Dept of Commerce
     Henry Kissman       NLM
     Sidney Siegel       EPA
     Morris Yaguda       EPA

     Others with expertise in this area are encouraged to

     5 - NIH/EPA Chemical Information System

     Dr. Bill Milne of NIH gave a presentation concerning
the historical development - present and possible future
capabilities-of the Chemical Information System (CIS), which
is presently supported by NIH and SPA.  Dr. Milne distributed
the following items to the ITSDC committee members:

     o    The Structure and Nomenclature Search System of the
          NIH/EPA Chemical Information System  (SANSS)-
          September 12, 1978.

     o    NIH/EPA Chemical Information System.  Report #7
          June 30, 1978.

          Dr. Milne's talk touched on the following subjects:

     1.   Overview of the Chemical Information System  (CIS)

     2.   Overview of CIS by Index Systems, Inc.

     3.   The Mitre Corporation, and Sigma Data reports as they
          related to chemical structure and nomenclature
          search needs for proposed users of CSIN.

     There we£e_n^_guestions and Dr. Bracken thanked Bill Milne
for TiTsT SrTef ing. As a resuTt of the briefing, the ITSDC now
has an understanding of the capabilities of CIS.  She suggested
that ITSDC members get some "hands-on" experience with CIS
in order to determine if it meets the needs of their specific

     Dr. Bracken adjourned the meeting at 11:00 a.m. in
Room 2010, New Executive Office Building.  The Committee will
reconvene on October 3, 1978 at 9:30 a.m.
                              Barbara Ostrow
                              Executive Secretary,

                      Attendance - Sept. 12, 1978


Cherie Fisk

Herbert J. Bernstein

Don Hummel

Doug Sellers

Richard J. Lewis, Sr.

Morris Yaguda

Leigh E. Doptis

Irvin Weiss

John J. Migliore

Vera W. Hudson

Richard Muranaka

Terri Damstra

Henry Kissman

Brian Farrell

William E. Rhode

Sidney Siegel

Bernard Greifer

Jerry Coffey

Marion Suter

National Inst. of Health

Brookhaven National Lab.





































pg.  2

Name                     Organization                  Telephone

Bill Milne               NIH

Steve Heller             EPA

Marilyn Bracken          EPA                           755-8040

Barbara Ostrow           EPA                           755-4880

Aim Jonnard              US Intl. Trade Comm.          523-0423

Pat Breslin              DOL/OSHA                      523-7115

Cathleen L. Brooks       MIDSD/EPA                     755-0811

Mary Lou Melley          EPA                           755-4935

Calvin Menzie            USDI/FWS                      632-5316

                      Attendance - Sept. 12, 1978


Deborah Million

Mary McGrone

Angela Bannon

R. Gary Marquart

Ron Grandon

Terry Kuch

Mike Koenig

Rebecca Brown

Rita F. Bergman

Leonard Slosky

Mary Cushmac

Cheryl Russell

Camilla Collova

Charles F. Kay

Pat Johnson
     Organi zation
The Society of Plastics

Baker, Hosteller, Frost
& Towers

3M Company.

Fein-Marquart Associations,




Pesticide & Toxic Chemical News



Bonner-Thompson (F.E.M.A.)

Sigma Data Computing Corp.


L. Miranda & Assoc.

Bureau of National Affairs

Armstrong Cork

Atlantic Richfield Co.

Maxima Corp.











Council on Environmental Quality
722 Jackson Place. N.W.
Washington, O.C. 20006
-U.S. Environmental Protection Agency
            Office of Toxic Substances
             Washington. D.C. 20460

   SUBJECT:  Minutes of October 3, 1978

   FROM:      Barbara Ostrow,  Executive Secretary

   TO:        Members, Interagency Toxic  Substances  Data Committee
         Enclosed are the minutes of the  October  3,  1978, meeting
   of the  Interagency Toxic  Substances Data Committee.

         If you have  any corrections, additions,  or  business  items
   which should be considered  at our next meeting on November  7,
   please  call me at 202/755-4880.

Council on Environmental Quality
722 Jacfcson Place. N.W.
Washington. D.C. 20006
U.S. Environmental Protection Agency
           Office a* Toae Substances
            Washington, D.C. 20460
                      Minutes - October 3,  1978

        This meeting, co-chaired by Marilyn C.  Bracken and
   Marion Suter,  convened at 9:30, in Room 2010 of the New
   Executive Office Building, 17th and Pennsylvania Avenues,
   Washington,  DC  20026.  The following items  were discussed:

   1.   Minutes of Last Meeting

        The Committee approved the minutes of the September 12,
   1978 meeting.
   2.   Change  In Agenda

        Dr. Bracken announced that agenda  item 4
   committee  report)  would be discussed first.

   3.   *CSIN Subcommittee Report
   (CSIN Sub-
        Dr.  Sidney Siegel, Chairman of this  Subcommittee, gave
   a brief progress report concerning the  results of the RFP
   review panels.   The contract to explore the content and
   systems requirements of the Chemical  Structure/Nomenclature
   System  (CSNS) of CSIN has been awarded  to Dave Lefkowitz
   of the University of Pennsylvania.  The contract for a study
   of systems  alternatives for CSIN has  been awarded to the
   Computer  Corporation of America.

        Dr.  Siegel then distributed the  following documents
   to members  of the ITSDC:

        o -  CSIN  Subcommittee Charter.

        o -  Functions of the Network Administrator of the

        Both of these documents were reviewed, discussed and
   accepted  by the subcommittee at their meeting on September 29
   However,  the acceptance of these documents was based on an

      Both of these documents were reviewed,  discussed and
 accepted by the subcommittee at their meeting on September 29.
 However, the acceptance of these documents was based on an
 understanding that the duties specified for  the network
 administrator were only the initial mandate  and may  be
 revised as the Administrator's role becomes  more clearly
 defined.  This role redefinition will occur  as the data and
 information contents of the various data bases and systems
 alternatives for CSIN come into better focus in part as the
 result of the above activities.  Until then,  it is critical to
 maintain flexibility during the developmental phases of

      The following topics  relating to these  documents were

      o    What hierarchy of authority is envisioned  for
           the CSIN?

      o    What extent of control will the network admin-
           istrator exercise over development of the  CSIN

      o    How will the  network administrator be selected
           and performance  evaluated?

      o    Who will be responsible for the content and
           operation of  the individual component systems of
           the CSIN?

     o     Should  the CSIN  be run by- an expert  board?

     o     Should  the system contain all  known  effects of a
           chemical substance,  or only those  effects which are
           considered to  be toxic?  "(all  effects"  was  agreed upon)

     The  ITSDC accepted  the CSIN Subcommittee  Charter and
Network Administrator's  Functions paper  after  minor changes
based on  the  previous discussion were made.

4.   Development of  the  CSIN Directories

     Mr. Don  Hummel  of the National Library of Medicine
 (NLM) and Mr. Terry Kuch of the  Mitre  Corporation, the
contractor for this  project, described the current status  of
the Directories of  the CSIN.  The purposes of  these Directories
are to:

     o    Identify and locate CSIN components which contain
          information related to chemical substances.

     o    Integrate these components  by  indexing  their
          respective data elements and file characteristics.

                             - 2 -

     o    Provide users in the Government and private
          sectors with a single point of access to the various
          components of the CSIN.

     Development of a CSIN prototype directory is currently
underway at NLM, and will be available for test in March

5.   Status of the Inventory Process

     Bruno Vasta, Director of the Chemical Information
Division, OTS/EPA, gave a presentation concerning the status
of the EPA inventory process which is mandated under Section
8(b)  of the Toxic Substances Control Act (TSCA).   Essentially
the purpose of this initial inventory is to establish a
list of chemicals currently in commerce, their production,
and their site of manufacture.

     The status of the inventory processing was discussed by
Ron Dunn of the Chemical Abstracts Service.  At the present
time 7120 plant sites have submitted over 58,247 inventory
reporting forms, containing an estimated 105,957 non-unique
chemical substances.  Of the forms received, 8,981 could not
be processed as submitted due to errors, ambiguities or
insufficient information.  Requests for corrections and
clarification have been sent to submitting companies.  Also
included in the forms received are over 39,844 which report
products of variable composition.  These require manual
review and processing by nomenclature specialists.  In
addition, over 2,000 forms submitted by 200 companies claim
confidential identities for the substances reported.  These
are processed manually by chemicals under highly controlled
secure conditions.

     The Initial Inventory will be printed and distributed
to the public early in 1979.  At this time, the computer
readable data base will be delivered to EPA for inclusion
into the Chemicals In Commerce Information System  (CICIS) .

6.   Development of Use Classification

     Mr. Vasta then continued his talk and discussed the
development of use classification by EPA.  Under TSCA, EPA
is responsible for identifying and regulating commercial
chemical substances which may pose an unreasonable risk to

 human health or the environment.   In order to carry out this
 mandate,  the Agency will require  many different kinds  of
 information on chemical substances,  such as use,
 known or  potential toxicity,  production levels, persistence
 in the environment, transport,  environmental fate,  physical
 and chemical data,  and other  related information.

      EPA  is assessing the merits  of  utilizing a use classi-
 fication  system,  such as the  Chemical Use List for  the
 purpose of assisting industry in  clearly and uniformly
 reporting use information.  The Agency will require reporting
 of use information on selected  chemicals or certain categories
 of chemicals.   For example, EPA intends to promulgate  rules
 which will require the reporting  of  use information when
 such information  is needed for  purposes of supporting  the
 findings  for a testing requirement under Section 4,  or for
 assessing unreasonable risk and determining the availability
 of substitutes under Section  6.

      To date,  76  responses have been received by Mr. Vasta's
 office commenting on the July 25,  1978 Federal Register
 Notice which lists  the proposed coding scheme.

      Mr.  Vasta stated that the  use classification system
 should be sufficiently comprehensive to encompass all
 categories of  usage that fall within the jurisdiction  of TSCA,
 but  should not include superfluous categories.  It  was
 pointed out by an ITSDC member  that  this approach would not
 give  an accurate  picture of exposure,  since foods,  drugs or
 other  chemicals which are specifically prohibited from
 regulation under  TSCA would be  excluded.   Dr.  Pat Breslin,
 the OSHA/IRLG  representative  to the  Committee,  stated  that
 the IRLG  could propose that these  use  categories be  included
 so that the utility of the  system  to other  agencies  can be

 7.   Other  Agenda Items

     Marion  Suter informed the Committee  that  the Toxic
Substances  Strategy  Committee (TSSC)  requested  the  ITSDC
prepare a report on  its  accomplishments  for  inclusion
in the TSSC's report  to  the President.  Ms.  Suter will  write
this report with the  assistance of the various  Subcommittee
chairpeople.   A draft report will be  circulated for comment
to ITSDC members.
                          _ 4 _

     There were no other additions to the agenda and Marion
Suter adjourned the meeting at 11:45 a.m.  ..The Committee
will reconvene on November 7, 1978 at 9:30 a.m. in Room 2010,
New Executive Office Building.
                                   Barbara Ostrow
                                   Executive Secretary
                          - 5 -

                   ITSDC MEETING - October 3
Mary Lou Melley
Cathleen Brooks
Chene Z. Fisk
Bernie L. Berger
Marty Aronoff
Erika Graf-Webster
Leigh E. Doptis
Barbara Ostrow
Vera Hudson
Richard Muranaka
Linda Peck
Margaret Finarelli
Joe Nash
Henry Kissman
Sidney Siegel
Bernard Greifer
Jerry Coffey
Ed Brooks
Pat Breslin
Don Hummel
Bruno M. Vasta
Marion Suter
Marilyn C. Bracken
Richard Lewis, Sr.
EPA - OPM                755-4935
EIA/MIDSD                755-4936
NIH - NIAMDD             496-1024
FWS/USDI                 632-5316
Nat. Bur. of Standards   921-3861
EPA                      755-4880
Dept. of Defense    (202) 295-1028
EPA                      755-4880
NIOSH                    443-2100
NRC                      492-7735
NRC                      492-7735
ACDA                     632-0872
DOE/EV                   376-9073
NLM/NIH                  496-3147
EPA                      755-8040
DOC/OEA                  377-3234
OFSPS                    673-7974
EPA/OTS                  755-0932
OSHA - IRLG              523-7115
DHEW - NLM               496-1131
EPA/OTS                  426-9819
CEQ                      633-7107
EPA                      755-8040
NIOSH, HEW               684-8317

                    ITSDC Meeting - Oct 3

Sherry Boltz
Cheryl Russell
Mary McGune
Deborah Muller

Michael Keller
Rita Bergman
Tatiana Roodkowsky
Sood, Shashi
Twyla Bishop
Terry Kuch
Leola Erk
Leinard Slosky
Ron Grandon
Larry Roslinski
Robert L. Santoro
John F. Dickinson
Roy Fagin, M.D.
W. R. Taylor
Charles L. Hoebel
R. B. Cleaver
Ronald G. Dunn
NPCA                          462-6272
Bur. of Nat'l Affairs         452-4583
Baker & Hostetler             857-1582
Society of the Plastics       331-0340
Versar                        750-3000
Sigma Data Computing Corp.    633-7081
Chamber of Commerce, U.S.     659-6173
MITRE                         827-6656
MITRE                         827-6656
MITRE                         827-6149
RMA                           782-2602
ISETAP                    (303)839-2471
Pesticide Tox Chem News       ST3-7472
Ford Motor Co.            (313)323-3182
Grumman Aerospace             575-8442
Grumman Aerospace Corp.   (516)575-6413
Grumman Aerospace, Corp.  (516)575-2101
Diamond Shamock Corp.         223-8625
Carrier Corporation           296-1280
Nat'l. Cotton Council         833-2S43
Chemical Abstracts Service

Status of the Chemical Substances Information Network


                 Marilyn C. Bracken

           Deputy Assistant Administrator

       for' Program Integration and Information

           Environmental Protection Agency

                       at the

              American Chemical Society

              J76th National Meeting

                   Miami,  Florida
                 September 11,  1978

     Section 25 of TSCA tasks CEQ to conduct a study of the

feasibility of establishing  (1) a standard classification

scheme for chemical substances, and  (2) standard means for

storing and obtaining rapid access to information respecting

such substances.  As a first step in fulfilling its mandate

under TSCA, CEQ, together with NLM and EPA, funded a contract
with the Mitre Corporation to survey the various federal

data systems, ascertain information needs, and prepare

appropriate data management systems to meet identified user


     To aid in characterizing user requirements, a comprehen-

sive understanding of the potential applications of chemical

information is necessary.  Examining these applications

together with budget categories of research and regulatory

agencies could identify common functional responsibilities

and chronological sequences of actions.

     The typical decision-making pattern initially identifies

a hazard, conducts a "hazard analysis" (which, in some

cases, must be conducted within a short time), and develops

testing protocols and research necessary to adequately

assess the hazard to humans and the environment from exposure

to chemicals.  Once the hazards are clearly identified, a

"decision package," examining alternative regulatory options,

is prepared and forwarded to an action group for regulatory

decision-making.  Monitoring data may be needed to determine

the extent of exposure.  Should the decision be made to


 regulate (be it label, ban, limit or control the manufacturing,

 etc.) the substance/item, a comprehensive data-gathering

 activity, including a more thorough analysis of the economic

 and environmental impacts associated with individual regulatory

 -actions is conducted.  In some cases, more research, monitoring

 and data analyses are required to support the regulation

 preparation stage.  Finally, following compliance and enforce-

 ment activities,  the Agency must evaluate the effectiveness

 of the regulation in reducing the risk to the public and the

 environment from exposure to that chemical substance.

      Extensive interviews were conducted with representatives

 of a number of research and regulatory agencies,  industry,

 consumer groups and other private sector groups.   These

 groups were asked to describe their activities,  assess the

 .kinds of data they needed to do their job,  and list their

 current information sources.   The data categories identified

 are as follows:

      - Substance  identification—chemical name, CASf, synonyms,

•chemical structure,  a method for substructure search, and,

'for a large number of substances,  physical/chemical properties

and composition data,  etc.

     _ Production aspects—production quantity, plant location,

production  process,  applicable control technology/  byproducts.

     . ^Marketing—use, users,  place  of use,  substitutes,



     . Exposure—estimates of exposure (occupational, environ-

mental and consumer).

     - Epidemiology—health and safety studies or records of

case histories resulting from exposure.

     About 300 existing data systems (230 of them maintained

by Federal agencies) were examined for their potential

contributions to meeting the information needs of Federal

regulatory agencies, and of EPA in particular, in implementing

TSCA.  Several approaches to unifying data systems were


     A Chemical Substances Information Network was proposed

as the most efficient and least costly way of providing

large volumes of information to a great many potential

users.  The Network would build on existing systems and

provide enhanced analytical capabilities, thus enabling

users to make predictions concerning a chemical's potential

for toxicity through the interplay of various types of data

vith appropriate application packages.

     Let me describe the "core components" of the Network,

bearing in mind that these components are designed to be

built on existing systems as appropriate and, where information

does not exist or is inadequate, to recommend new systems.

In addition, in order to facilitate cross-exchange of data

and retrieval of particular data, the core components should

be maintained using common computer software.


      We also recognized that other data bases and systems

 must also exist to provide access to information on addi-

 tional chemical substances and other categories of data.

 Access to these "non-core" components will be by referral,

 with coordination provided by the Chemical Data Bases

 Directory (CDBD).  The CDBD file is pivotal in that it

 provides detailed information on the nature of the data

 bases/systems in the network.   It directs the user to data

 systems which will satisfy his requirements for information.

 If the user is concerned with obtaining LD   data, for

 example/  the index would indicate that I»Dc0 data are avail-

 able in the NIOSH ROTX data base.  It would show the specific

 mode of access/ including file names, telephone numbers,

 file ownership, file location, system characteristics,  size

 of file,  update frequency,  searching capability,  and output

 media.   This file is presently being constructed with

 support from DHEW,  CEQ,  and EPA.

      The  Chemical Structure/Nomenclature System is the

 second  critical element  of  the network and will provide data

-for approximately 500,000 chemical substances.   It provides

a  sub-structure searching capability and a locator designator

which points to other files in the system containing information

 on the  particular chemical  substance.   For example,  it will
say data on  trichloroethylene  are in ROTX,  CBDS,  and the

TSCA Inventory  file.   The size of the file is  important.

Because this file must serve all  agencies concerned with


«ither the study or regulation of chemicals, it was felt

that structure information  is necessary for at least 500K

^compounds.  It must contain chemicals that are used as

^rugs, pesticides,  and for  industrial purposes, as well as

•those that are of research  interest.  The file must be

searchable by CAS Number, CAS preferred name, synonyms,

structure, structure fragment, molecular weight, etc.

System output must  include  display of the structure.  The

EPA/NIH CIS/SSS Systems has been designated as a prototype


      The TSCA Chemical Data System is also a major component

of the network and  essentially provides much of the critical


 chemicals tested using mutagenic screening tests and  compare

 the results with in vivo carcinogenic testing.   Verfication

 of methodologies across laboratories and/or s'pecies will  be

 facilitated.  The system as envisioned contains  the type  of

 study, methodology, race/age/sex,  species/strain,  route,

 site,  effects,  investigator,  length of test,  and a reference.

 The system will evolve by combining,  restructuring and

 enhancing capabilities currently available.

     The Chronic Testing Support System provides a software

 capability and  storage and retrieval  module for  the results

 of long term chronic toxicity monitoring  studies.  The

 system may be used by government agencies  in  conducting

 long-term carcinogenesis bioassays  (e.g.,  NCTR,  NCI), by  EPA

 in carrying out its testing responsibilities  under TSCA or

 its other Acts,  and by industry  when  required to conduct

 chronic tests in response to  government regulation.  The

 system design would,  for example, incorporate the  requirements

 of the Carcinogenesis Bioassay Program of  the National

 Cancer Institute and the integrated laboratory support

 capability required by the National Center  for Toxicological


     The primary intent  of the system  is to provide a computer

utility for collecting, monitoring, evaluating,  and reporting

bioassay information.  The system permits collection of data

on:  chemicals and chemical preparations; the experimental

procedures and test environment; the observation data; and

complete pathology reports on individual animals.  The

system interfaces with various statistical application

programs and a report generator.  Use of such a system by

government agencies would encourage standardization of

testing protocols, force standardization of reporting, and

incorporate the concept of good laboratory practice.

     Another major component of the distributed Network is a

Bibliographic Literature Scanning System containing references

to toxicological and biomedical journals.  It is structured

around TOXLINE and MEDLINE, and is designed to assist

xesearchers and other health professionals to ascertain what

has been published on any specific biomedical subject.

     The Laboratory Animal Data System is also recommended

for inclusion in the network.  This existing system contains

information on control animals, including species, strain,

colony, and observed terminal pathology collected from

numerous government and private sources.  It provides

baseline information on control animals and is useful in

designing test systems and selecting appropriate species.

     Also incorporated in the Network is the Regulated

Chemical Standards System which provides the user with

information on standards which have been proposed or promulgated

concerning individual chemical substances or classes of


 «hemicals.   The  system incorporates occupational standards,

 transportation,  packaging, and labeling requirements, threshold

 JLevels,  and  various procedural regulations which impose

 industrial reporting requirements.  This system could incor-

 porate international standards as well and be very helpful

 to multi-national firms, particularly as other countries

 develop  toxic legislation.

      The Network as proposed will collect, store, and make

 publicly available large amounts of data; it provides for

 -efficient storage of data and eliminates data redundancy,

 permits comparison of diverse elements of information, and

 allows informed estimates about toxicity and health effects.

      So where are we in the development of the Network?  In

 February, the Interagency Toxic Substances Data Committee,

 "jointly chaired by EPA and CEQ under the authority of the

 "TSCA section 10(B) (1)  and 25 (B)  was formed.   Primary func-

 tions of the Committee are (1)  to make recommendations

 regarding the use of TSCA information-reporting authorities

 and to coordinate plans and activities so as to reduce

 xeporting burdens,  and (2)  to make recommendations concerning

 ihe process  of building a comprehensive information network.

"The Data  Committee  is  directing the development of the data

Biases being  funded  by  EPA and DHEW.   The Committee is also

 vorking closely with the Interagency Regulatory Liaison

 Group, comprising CPSC, EPA,  OSHA,  and FDA.   The Information

 Exchange  Workgroup  of  the IRLG  is supporting feasibility


 studies for the Chemical Testing Support System and  the

 Regulated Chemicals Standard System.   These  feasibility

 ^studies have been completed and contractor reports are under

 review.  Decisions about development  will be made soon.

      Primary responsibility for the development of CSIN

 xests on the CSIN Subcommittee of the Data Committee which

 is chaired by EPA and has representatives from the other

 agencies.  Much of the development work  of the Committee

 will be carried out by private contractors.

      Important steps that are being initiated  in the near

 future are:

      — Analysis of functional steps  of  the  chemical regula-

 tion process so that specific usage patterns are determined.

 This concept of a user-driven system  is  important.

      — The concept of direct linkage is being examined.

 How important is it that these systems be directly linked?

 By directly linked we mean the combination or  association of

 two or more data systems so that they appear as a single

--entity to the user.

      A conceptual representation of CSIN is  shown on the

next slide.  We show the users directly  communicating with  a

network Resource Executive who will then communicate with

*the various directories and data systems,.  The technical

problems associated with linkage systems which may utilize


 different data management software are, as you can well

 -imagine, not trivial.  These kinds of problems, various

 options for addressing network design, and development of

 the Network Resource Executive concept, are the subject of a

 contract to be released by the Committee this fall.

      Some of the functions envisioned for the Network Resource

 Executive are displayed on this next slide.   Primary functions

 include providing:  a CSIN user language for communicating

 with the network;  a data locator;  a query generator  translator;

 and a data integration translator.

      Not only are  the technical problems complex,  but admin-

 istering the project will require  special intergovernmental

 and public liaison efforts.   The Committee is planning to

 -designate an interim Network Manager to be responsible for

 day-to-day operations.   Related issues associated  with the

 Network that will  continue to require extensive attention

 are:   communications hardware and software;  backup and

 recovery of  all  the data bases on the net;  security;  timeliness

 of  data;  and accuracy and completeness of the data.

     We recognize  that  it is important for the public  to

 keep abreast of and comment  upon Network  development activities

 and issues.   Consequently, meetings  of the Interagency Data

 Committee, held the first Tuesday of every month,  are  open

-to  the  public.  Meeting are announced  in "the Federal Register;

    public can request time on the agenda.  We have also


created a Public Liaison Subcommittee which is actively

seeking comments and looking toward establishing mechanisms

for involving the private sector.  Some of you may have

recently received a communique from that group informing you

of the Network.  If you are interested in receiving this

letter, leave your cards with any of the EPA speakers and we

will see that you receive it.

     Thank you.

Slides Shown to Support Bracken Speech to the
American Chemical Society's 176th National
Meeting in Miami, Florida on September 11, 1978

Data Categories Needed to Support
          Functional Activities
            © Substance identification
            @ Production aspects
            9 Marketing
            * Exposure
            * Epidemiology
            a Biological
            ® Environmental
            ® Standards/regulations
            • Managerial/administrative

Functions of Regulatory Agencies
 • Hazard identif ication/prioritization

 • Hazard analysis

 • Research/development

 © Decision packaging development (criteria documents)

 • Monitoring/analysis

 • Preparation of regulations and guidelines

 * Enforcement/compliance

Chemical Substances  Information
 • A set of individual components which, when viewed
   together can be used to meet effectively information
   needs of agencies involved in the study and
   regulation of chemicals.

 * The network builds on existing systems where
   appropriate and provides additional analytical
   capabilities necessary to support research and
   decision-making activities.

Recommended Long Term Chemical Substances Information  Network Concept
                                              Chronic Testing
                                              Support System
Searching System
                           Chemical Data
                                                                              Other Private
                                                               Adas of Cancer
                                   & DBMS
                                    & DBMS
                                Nomenclature & DBMS

 Benefits  of  Network Design
• Collects, stores, and makes publicly available
  large amounts of data

• Permits efficient storage of data and eliminates
  data redundancy

• Protects confidential data

• Promotes prediction by making interaction of
  data resources possible



                                    (NETWORK CONNECTIONS)
fc ^      ^ *

                    QUERY GENERATION
                     DATA LOCATOR
                                    DATA INTEGRATION/
                       WORK SPACE FOR
                       DATA INTEGRATION
               THE FUNCTIONS OF THE