v>EPA
United States
Environmental Protection
Agency
Wash., D.C.
Toxic Substances
The Chemical Substances
Information Network
by the Public Liaison
Subcommittee of the
Interagency Toxic Substances
Data Committee
November 1978
-------
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
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
I4BT8
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
organization.
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
Enclosures
-------
CIS
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
include:
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.
-------
MINUTES OF THE FIRST MEETING
OF THE
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
February 28, 1978
Co-Chairmen
Marilyn C. Bracken, Deputy Assistant Administrator for
EPA
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 *
USD A
Philip C. Kearney
US Arms Control & Disarmament
Agency
Margaret G. Finarelli
ODC/OEA
Bernard Griefer
DOC/Census
John Ambler
Max Shor
CPSC
E. June Thompson
DOD/OS
George W. Siebert
DOE/EV
Joe Nash
EPA/OTS
Ed Brooks
HEW/PHS/OASH
Gooloo Wunderlich
HEW/FDA
Bob Bell
HEW/NCI
James M. Sontag
HEW/NIEHS
Terri Damstra
HEW/NIH/OD
Bill Rhode
HEW/NIOSH
Vera Hudson
Richard J. Lewis, Sr.
HEW/NLM
Henry Kissman
DOI/Bureau of Mines
Raymond E. Corcoran
DOI/FWS
Calvin M. Menzie
International Trade Commission
Tom O'Connell
DOL/BLS
William Mead
National Science Foundation
Marvin E. Stephenson
DOT/MTB/OHMO
Alan I. Roberts
Alfred W. Grella
Treasury/Customs Service
Harrison C. Feese
OSTP
Robert Dixon
IRLG
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.
CHARTER
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
July.
After some discussion additional comments were requested to be sent to
Marion Suter by March 10.
MEMBERSHIP:
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.
MODUS OPERANDI
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.
BUDGET AND STAFF SUPPORT
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.
SHORT AND LONG RANGE GOALS:
This will be a major topic for discussion at the April meeting.
-------
...-•'
X / / /
/ / /
-• *" J
/ / /
/ / .-
fdzn^f / /
i """ ^j i /
\ \\ x\ \. £F
•
I I •«"*! I IMKA',1 (ItWWIJ*, HUMI M.I * I (Jilt * OttA
\ \ \\ '""F111^
v > *# v. I timvfi)' inn*)!!',. I
\ '••-.. ^ 1_ ^
•-
'*•
-------
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
OSHA
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
634-1313
Terri Danstra
National Institute
of Environmental Health
Sciences
P.O. Box 12233
Research Triangle Park,
North Carolina 27709
8-727-0450
Dr. Robert Dixon 456-6272_
Office of Science and Technology
Policy
Executive Office of the President
Washington, D. C. 20500
566-3651
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
377-3234
N.W.
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
Statistics
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
Statistics
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
755-4880
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
Evaluation
National Institutes of Health
Bethesda, Maryland 20014
Mr Alan I. Roberts 426-0656
Office of Hazardous Materials
Operations
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
ODASD (MR&L) EES
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
Prevention
National Cancer Institute
Bethesda, Maryland 20014
496-5108
-------
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
Commission
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
Statistics
Office of the Assistant Secretary for Health
Room 709B, Hubert H. Humphrey Bldg.
Washington, D. C.' 20201
755-4871
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
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: May 2, 1978, Meeting
FROM: Barbara Ostrow, Executive Secretary
TO: Members, Interagency Toxic Substances Data
Committee
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.
Enclosures
-------
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
adopted.
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
-------
Co-Chairman
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
755-4880
Members
-------
Patricia Breslin (IRLG-Information Exchange)
(Fred Clayton-Alternate Room N 3629)
OSHA/DOL N 3700
200 Constitution Ave.
Washington, DC 20210
523-7115
Edward Brooks
EPA TS 788
Washington DC 20460
755-6841
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
8-629-3471
Robert Dixon
(Carl Gerber - Alternate)
Office of Science & Technology Policy
Washington, DC 20500
456-6272
Margaret G. Finarelli
(Robert Mikulak - Alternate)
U.S. Arms Control and Disarmament Agency
Washington, DC 20451
632-0872
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
496-3147
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
436-7081
Joseph Nash
(Richard Stevenson - Alternate)
Department of Energy
E201 20 Massachusetts Ave.
Washington, DC 20545
376-9073
William Rhode (1)
(Lenore Wagner - Alternate) (2)
National Institutes of Health
Bethesda, MD 20014
(1) 496-9285
(2) 496-9291
-------
. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\. ,0<^ WASHINGTON, D.C. 20460
'
OFFICE OF TOXIC SUBSTANCES
MEMORANDUM
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.
Enclosures
-------
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
1978.
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
meetings.
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
responsiblities.
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
-------
INTERAGENCY TOXIC SUBSTANCES COMMITTEE
ATTENDANCE MAY 2, 1978
NAME AND AGENCY - FEDERAL
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
NON - FEDERAL
Beth McNally -* Chemical Regulation Reporter
-------
• Attachment A
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
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)
Attachments
-------
tt
\
% UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF TOXIC SUBSTANCES
MEMORANDUM
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.
Enclosures
-------
INTERAGENCY TOXIC SUBSTANCE DATA COMMITTEE
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:
a)
b)
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
sub-committee.
c)
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
-------
-2-
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
duplication.
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
manager.
- 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.
-------
-3-
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-
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
-------
NAME
FEDERAL
MEETING ATTENDANCE SHEET - June 6, 1978
ORGANIZATION
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
NON-FEDERAL
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
NCHS
U.S. ITC
FWS/U.S.D.I.
ACDA
DOT/MTB/OPS
NCR
NRC/MPA
NIOSH
NIEHS
GAO
GAO
DHEW, NIH, NLM
EPA
CEQ
FDA
GAO
OSHA (IRLG)
EPA
CEQ
NIH
EPA
CEQ
OD/NITL
NLM - NIH
NIH - NCI
DOD
DOC/OEA
OFSPS
DOE/EV
CPSC
EPA
CEQ
EPA
EPA
SPI
Toxic Materials News
CAS
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.
-------
Cont'd.
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.
-------
1NTERAGENCY TOXIC SUBSTANCE DATA COMMITTEE
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
meeting.
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.
-------
-2-
* 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
-------
-3-
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.
-------
-4-
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
session.)
-------
-5-
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
accomplished.
* 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.
-------
-6-
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
agreements.
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
period.
* 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.
-------
-7-
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
chemicals.
* 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
finding.
-------
-8-
* 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
Name
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
Non-Federal
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
Organization
CEQ
CEQ
EPA/OTS
EPA/MIDSD
OFSPS
OSTP
NIOSH
FDA
NCI
NLC/NIH
DOD
CAS
Bureau of Census
NBS
EPA
EPA
EPA/OTS
EPA/OTS
CPSC
CPSC
FWS/USDI
NIOSH/HEW
NCHS
NIEHS
OD/NIH
NRC/MPA
DOC/OEA
OSTP
EPA/MIDSD
NIH
NIH
EPA/OTS
RMA
Shell Oil Co.
USGS
Sigma Data
LeBoeuf, Lamb, Leibyt
MacRae
TMN
Allied Chemical
Armstrong Cork Co.
Interdevelopment, Inc.
Dow Chemical
Monsanto Co.
Baker & Host etler
National Paint &
Coatings
Chemical Regulation
Reporter
Phone
633-
633-
426-
755-
673-
456-
443-
443-
496-
496-
295-
614-
763-
921-
755-
755-
426-
755-
492-
492-
632-
684-
436-
629-
496-
492-
377-
456-
755-
496-
496-
755-
7107
7107
9819
0988
7953
6272
2100
3773
1152
3147
1028
421-6970
7536
3491
1836
•1838
•9819
•4880
•6647
•6470
•5316
•8317
•7081
•3471
•9285
•7735
•3234
•6272
•0811
•3341
•3341
•8040
296-3633
860-6834
881-4451
457-7500
587-6300
201-455-4326
296-2830
521-1020
517-636-2067
452-8880
857-1582
462-6272
452-4585
-------
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
Industry
Thomas Gilding National Agriculture 296-3341
Chemicals Assoc.
-------
Attachment A
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
May 26, 1978
OFFICE OF THE
ADMINISTRATOR
MEMORANDUM
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,
namely:
-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
-------
-2-
-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
advanced.)
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,
-------
-3-
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
DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
PUBUIC HEALTH SERVfCE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014
June 26, 1978 NATIONAL LIBRARY OF MEDICINE
SUGGESTIONS FOR CSIN-RELATED CONTRACTS (FY'78 FUNDING)
I. CONTRACT NEEDS FOR CSIN PROTOTYPE
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.
-------
2.
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
Catalog.
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.
II. CONTRACT NEEDS FOR ACTUAL CSIN IMPLEMENTATION
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:
-------
2.
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
methodology:
i. Unique compound retrieval (by nomenclature, synonym,
structure)
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.
-------
INTERAGENCY TOXIC SUBSTANCE DATA COMMITTEE
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
Catalog.
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
Information
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
Name
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
Organization
EPA
OSHA/IRLG
EPA/OTS
OFSPS
NIEHS
DOC/OEA
NLM
NIOSH
NCHS
OD/NIH
EPA/OTS
EPA
EPA
CPSC
CEQ
NLM
CPSC
EPA/OTS
EPA
Phone
755-
523-
755-
673-
629-
377-
496-
513-684-
436-
496-
426-
755-
755-
492-
633-
496-
492-
426-
755-
•8040
•7115
•0932
•7974
•3471
3234
•3147
8317
7081
9285
7861
1836
4880
6647
7107
6217
6470
9819
0988
Non-Federal
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
3MC
Sigma Data
MITRE
NPCA
L. Miranda Assoc.
RMA
MITRE
CSMA
MAXIMA
Baker and Hostetler
Allied Chemical
MAXIMA
331-5581
881-4451
827-6656
462-6272
554-1403
785-2602
872-6175
872-8110
587-0060
857-1182
455-5866
587-0600
-------
INTERAGENCY TOXIC SUBSTANCE DATA COMMITTEE
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
MORANDUM
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.
Enclosures
-------
INTERAGENCY TOXIC SUBSTANCE DATA COMMITTEE
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
meeting.
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.
-2-
-------
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
CEQ.
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
-3-
-------
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
participate.
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
agency.
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,
-------
ITSDC
Attendance - Sept. 12, 1978
FEDERAL
Name
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
Organization
National Inst. of Health
Brookhaven National Lab.
DHEW, NLM
E.P.A.
NIOSH - HEW
E.P.A.
DOD
CPSC
FDA
NIOSH
NRC
NIEHS
NLM
DOE
OD/NIH
EPA/OPII
DOC/OEA
OFSPS
CEQ
Telephone
496-1024
666-4379
496-1131
755-1836
684-8317
755-0988
295-1028
492-6470
443-3290
443-2100
492-7735
541-3471
496-3147
452-9222
496-9285
755-8040
377-3234
673-7974
633-7107
-------
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
-------
ITSDC
Attendance - Sept. 12, 1978
NON-Federal
Name
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
Industry
Baker, Hosteller, Frost
& Towers
3M Company.
Fein-Marquart Associations,
Inc.
Telephone
331-O340
857-1582
331-5581
(301)821-5980
Pesticide & Toxic Chemical News
MITRE
MITRE
Bonner-Thompson (F.E.M.A.)
Sigma Data Computing Corp.
ISETAP
L. Miranda & Assoc.
Bureau of National Affairs
Armstrong Cork
Atlantic Richfield Co.
Maxima Corp.
ST3-7472
827-6149
827-6554
659-4660
881-4451
(301)839-2471
554-1404
452-4583
296-2830
(215)557-2409
587-0060
-------
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
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
MEMORANDUM
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.
Enclosures
-------
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
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
CSIN.
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
CSIN.
The following topics relating to these documents were
discussed:
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
directories?
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
1979.
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
increased.
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
NAME
Organ!zation
Phone
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
NAME
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
ORGANIZATION
PHONE
NPCA 462-6272
Bur. of Nat'l Affairs 452-4583
Baker & Hostetler 857-1582
Society of the Plastics 331-0340
Industry
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
(614)421-6940
-------
Status of the Chemical Substances Information Network
by
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
needs.
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
-------
-2-
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,
etc.
-------
-3-
. 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
examined.
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.
-------
-4-
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
-------
-5-
«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
CSNS.
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
Research.
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
-------
-7-
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
-------
-8-
«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
-------
-9-
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
-------
-10-
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
-------
-11-
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.
-------
APPENDIX
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
etwork
• 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
Regulated
Chemicals
Standards
System
Chronic Testing
Support System
Chemical
Structure/
Nomenclature
System
Bibliographic
Literature
Searching System
Chemical Data
Laboratory
Animal
DataBase
Other Private
Adas of Cancer
Mortality
Drat
& 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
-------
THE CONCEPT OF DIRECT LINKAGE:
THE COMBINATION OR ASSOCIATION
OF TWO OR MORE DATA SYSTEMS SO THAT
THEY APPEAR AS A SINGLE, COHERENT
ENTITY TO THE USER
-------
TDS
(OTHERS)
NREX
USERS
CONCEPTUAL REPRESENTATION OF THE CSIN
INTEGRATED NETWORK SYSTEM
-------
D
I
R
E
C
T
o
R
Y
\
(NETWORK CONNECTIONS)
CSNS
DESCRIPTIVE
CATALOG
fc ^ ^ *
SUBJECT
CATALOG
NETWORK
COMMUNICATIONS
QUERY GENERATION
TRANSLATION
DATA LOCATOR
CSIN USER LANGUAGE
SERVICE
FUNCTIONS
DATA INTEGRATION/
TRANSLATION
WORK SPACE FOR
DATA INTEGRATION
TRANSLATION
THE FUNCTIONS OF THE
NETWORK RESOURCE EXECUTIVE
-------
RELATED NETWORKING ISSUES
• NETWORK COMMUNICATIONS
HARDWARE AND SOFTWARE
• BACKUP AND RECOVERY
• SECURITY
------- |