United States
Environmental Protection
Agency
Toxic Substances
Third Report
of the Interagency
Toxic Substances
Data Committee
July 1979
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STATUS REPORT *3 ON THE
CHEMICAL SUBSTANCES INFORMATION NETWORK
PREPARED BY
THE PUBLIC LIAISON SUBCOMMITTEE OF THE
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
U. S. ENVIRONMENTAL PUDTECTICN AGENCY
WASHINGTON, D. C.
1979
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INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Council on Environmental Quality
7» J«*»on PI*M, N.W.
WMNngton. D.C. 20006
U.S. Environmental Protection Agency
Office of Toxic Substanctt
Washington, O.C. 20460
Dear Colleague,
This is our third report on the Interagency Toxic Substances Data
Committee, and its efforts to create a Chemical Substances Information
Network. We hope you will find this information useful in keeping up
with our progress. If you have any comments, please address them to:
Cathleen Brooks
EPA PM-218
401 M Street, S.W.
Washington, D. C. 20460
Thank you,
Morris Yaguda, Chairman
Public Liaison Subcommittee
of the Interagency Toxic Substances
Data Committee
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Table of Contents
Minutes of April 3, 1979 Meeting
Minutes of May 1, 1979 Meeting
Minutes of June 5, 1979 Meeting
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INTEHAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Council en Environmental Quality
722 Jaekm Pm. N.W.
US. Environmental Protection Agency
OMe» of Tmic Sutmnem
Wmhngan. O.C. 20MO
MEMORANDUM
SUBJECT: Minutes of Anril 3, 1979, Meeting
/W^*« *^0f- £*gf?^~t tf-A
FROM: Roger M. Conno<7 Executive Secretary
TO:
Members, Interagency Toxic Substances
Data Committee
Enclosed are the minutes of the April. 3, 1979, 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 May 1, 1979,
please call me at 202/755-6956.
Enclosures
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INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Minutes-April 3, 1979
The meeting, chaired by Dr. Marilyn C. Bracken and
Ms. Carroll Leslie Bastian, convened at 9:30 a.m., in room 2010
of the New Executive Office Building, 17th Street and
Pennsylvania Avenue, Washington, D. C. 20006.
1. Approval of Minutes of February 6, 1979.
The minutes of the February meeting were approved as
written.
2. Correction to Minutes of March 6, 1979.
Ms. Drago pointed out that on page 3, paragraph two, line 1,
"sinse" should be "sense".
3. Report on the National Toxicology Program (NTP) and the.
Committee to Coordinate Toxicology and Related Programs"
(CCTRP).
Dr. David P. Rail, Director, National Institute of
Environmental Health Sciences, delivered the report.
The CCTRP, founded in 1974 and chartered as an intra-agency
committee of the Department of Health, Education and Welfare
(DHEW), has the following functions:
1) Provide advice to DHEW on issues related to toxicology
2) Promote cooperation and coordination within DHEW on
toxicology programs.
3) Provide for information sharing within the Department.
The committee meets approximately ten times a year to
discuss a wide range of topics such as interaction with state and
local agencies on existing or emerging toxicological problems,
and the carcinogenic potential of saccharine for laboratory test
animals and humans.
Much of the activity of the CCTRP is carried on by two kinds
of subcommittees:
1) Standing subcommittees, such as the Environmental
Mutagenesis Subcommittee and the Toxicology Information
Subcommittee (See these minutes for Dr. Kissman's
report).
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2) Ad Hoc Committees created to address immediate issues,
e.g., the subcommittee created to coordinate the
response of the Public Health Service to the
polybrominated biphe'nyl (PBB) incident in Michigan.
The CCTRP Charter is presently being revised to the reflect
the existence of the National Toxicology Program (NTP) and to
emphasize that the CCTRP will be the focus for interactions
between DHEWs Public Health Service and other Federal, state and
local agencies, and private groups.
The NTP grew out of a need perceived by Dr. Rail and other
officials of DHEW to integrate and coordinate the large number of
programs of toxicological research and testing ongoing within the
Department. Dr. Rail provided a fact sheet on NTP, which is
attached.
Dr. Bracken offered to have representatives of ITSDC brief
NTP's Executive Committee on the development of CSIN to date, as
CSIN and the work of NTP are clearly related.
In response to questions and comments, Dr. Rail addressed
issues, which included the following:
— The role of the National Cancer Institute's (NCI)
Clearinghouse on Environmental Carcinoge—;sis in the
development of NTP.
— The NTP requirements for data and information management.
— Activities of the NTP which would be supportive of regulatory
agencies and/or meet the needs of the research and
methodology development communities.
— The methods used to select or prioritize chemical substances
for testing.
— The relationship between the Executive Committee of the NTP
and the Policy Board of the National Center for Toxicological
Research (NCTR).
— The relationship between CCTRP and NTP.
— Preparation of monographs on chemicals tested.
— The McGuire Amendments to the Public Health Service Act.
4. Section 10(b)(l) Subcommittee Report
Ms. Suzanne Rudzinski, chairperson of this subcommittee,
reported on the March 15, 1979, meeting. The subcommittee
reviewed a draft rule under Section 12 (b) of TSCA concerning
export notifications to foreign governments. Copies of the rule
can, if desired, be made available to the Committee.
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The subcommittee addressed the question of whether and how
to develop an interagency mechanism for exchange of substantial
risk information, particularly for information received under
Section 8(e) of TSCA and Section 15(b) of the Consumer Product
Safety Act. The Section 8(e) Policy Statement published last
year states that when a formal exchange mechanism is established,
the policy statement will be revised to exempt companies from
reporting information to EPA which had been submitted to other
specified agencies. Since there is no apparent reporting
overlap, it is unlikely that this aspect of the Policy Statement
will be revised. Dr. Bracken suggested that this activity be
coordinated with the Regulatory Development Group of the
Interagency Regulatory Liaison Group (IRLG).
Mr. Joe Fitzgerald of the Office of Program Integration and
Information briefed the subcommittee on Office of Toxic
Substances programs with other agencies.
Dr. Bracken stressed that a major thrust of the activities
of this subcommittee is to keep agencies abreast of TSCA
development as well as to learn, early on, of reporting
activities initiated by other agencies, and report them to the
appropriate EPA offices. She also encouraged members of the
parent committee to participate on the subcommittee. Anyone
interested should contact Ms. Rudzinski (426-8640).
Ms. Bastian suggested the subcommittee be a conduit for all
information requests on specific chemicals such as the 29
chemicals or groups of chemicals which are being considered as
candidates for testing under TSCA Section 4. Ms. Rudzinski will
discuss the comment with the subcommittee.
5. Report on the Toxicology Information Subcommittee (TIS)
of the CCTRP.
Dr. Henry Kissman, NLM, delivered the report, speaking from
a set of transparencies, reproductions of which are attached.
6. Report on CSIN Subcommittee Activities.
Dr. Sidney Siegel, chairperson of this subcommittee
delivered the report.
Dr. Siegel discussed an all-day meeting held at the Council
on Environmental Quality on March 29, 1979, to discuss _A_
PRELIMINARY REPORT ON RECOMMENDATIONS FOR THE DEVELOPMENT OF A
CHEMICAL STRUCTURE AND NOMENCLATURE SYSTEM (CSNS), prepared as
work being performed under contract by the University of
Pennsylvania for the Council on Environmental Quality (CEQ). A
copy of the agenda is attached.
In attendance were members of the CSIN Subcommittee and
other invited and interested parties from both the Federal and
private sectors.
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The meeting focused on technical issues related to the
development of a CSNS and included the following:
— System reliability
— Operational efficency
— Compatibility with the CAS registry system
— File size scale-up
— File design
— Bit mapping
— Efficiency and effectiveness of data and information
retrieval.
— Size of the CSNS data base needed, short term and long term.
— Test questions
— Weighting criteria
— Completeness and usefulness of the matrix used to describe the
CSNS
At the March 29 meeting there was a long and animated
discussion of these issues. It was agreed that some experiments
described in the report woVtld be repeated in order to establish
the most authentic and accurate matrix of performance
characteristics of a system.
Anyone wishing to comment on the technical issues should
send their comments to Ms. Bastian at CEQ, with a direct copy to
Dr. Siegel.
After the CSIN subcommittee reviews technical aftd
administrative issues, Dr. Siegel believes that during early
summer, he, as network administrator, will be able to bring to
the parent committee, subcommittee recommendations as to the
development of the CSNS component of CSIN.
Ms. Bastian urged representatives of Federal agencies which
have not yet been involved with the CSIN Subcommittee activities,
to participate in order to ensure that CSIN develops in ways
useful to their organizations.
Also discussed were the relationships to be established
between the parent ITSDC, the CSIN subcommittee, and the CSIN
network administrator; and the establishment of links to Federal
agencies to commit resources to CSIN development.
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7. Other items
There were no additional agenda items, and the meeting was
adjourned at 11:54 a.m.
o Next meeting on May 1 in Room 2008, which is adjacent to
the usual room, 2010.
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ATTENDEES-APRIL 3, 1979
FEDERAL
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Name
Leigh E. Doptls
Martin Aronoff
Bruno M. Vasta
Fred Clayton
Jim Sontag
Roger Connor
Winston R. deMonsabert
Vera Hudson
Jerry Calderone
John Wilson
David Rail
Henry Kissman
Sid Siegel
Don Hummel
Bernard Greifer
Dorothy Drago
Carrol L. Bastian
Patricia Breslin
Suzanne Rudzinski
Richard J. Lewis, Jr.
George E. Cushmac
Marilyn C. Bracken
ORGANIZATION
Naval Medical R&D
Command
NBS
EPA
OSHA
NCI
OTS/EPA
FDA
NIOSH
DHEW/OASH
DOE
NIEHS-UTP
NLM/NIH
OTS/EPA
NLM
DOC
CPSC
CEQ
OSHA/IRLG
OTS/EPA
NIOSH
DOT/MTB
OPII/OTS/EPA
PHONE
202/295-1028
301/921-3861
202/426-9819
202/523-8020
202/496-5100
202/755-6956
202/443-3773
202/443-2100
202/472-5194
202/353/4684
8-629-3201
202/496-3147
202/755-8040
496-1131
202/377-3234
202/492-6470
202/395-4980
202/523-7115
202/426-8640
513/684-8317
202/755-4906
202/755-8040
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ATTENDEES-APRIL 3, 1979
NON-FEDERAL
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Name ORGANIZATION PHONE
P. J. Beattie General Moters Corp. 313/556-1597
Christine Shine Monsanto Company 212/452-8880
Judith E. John Philip Morris 804/271-3317
James M. Vail Chem. Specialities
Manufacturers Assn. 202/871-8110
Cheryl Russel BNA 202/452-4583
R. G. Dunn CAS 614/421-6940
Lynne Neufeld Calculon Corp. 215/491-8333
Wendy Byer Calculon Corp. 215/491-8277
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DEPARTMENT OF HEALTH, EDUCATION,, AND WELFARE
THE NATIONAL TOXICOLOGY PROGRAM
FACT SHEET
On November 15, 1978, Secretary Calif ano announced the establishment of
the National Toxicology Program. The broad goal of this Program is to
strengthen the Department's activities in the testing of chemicals of
public health concern, as well as in the development and validation of
new and better integrated test methods. Specific goals for the program
are:
1) To broaden toxicological characterization of the. chemicals
being tested.
2) To increase the rate of chemical testing, within the
limits of available resources.
3) To develop and begin to validate- a series of protocols
more appropriate for regulatory needs.
To accomplish these goals the "Program was established as a Department-
wide effort to provide needed: information to regulatory and research
agencies and to strengthen the science base. TN=- Program is at present
comprised, of the relevant activities of the Food and Drug Administration,
the National Cancer Institute, the Center for Disease Control/National
Institute for Occupational Safety and Health, and the National Institute
of Environmental Health Sciences. It is- being planned, programmed, and
carried out as a coordinated whole under the direction of Dr. David p.
Kail who continues to serve as Director, National Institute of Environ-
mental Health Sciences , and for the purpose of this Program reports to
the Assistant Secretary for Health.
FEATURES OF THE PROGRAM
1. An Annual Plan.
2. An Executive Committee which reviews and recommends approval of the
Annual Plan; it also monitors the Annual Plan.
3. A Toxicology Program Board of Scientific Counselors (a public
advisory group) ,. which is responsible for reviewing the scientific
merit of the program. The Board is composed of eight non-govern-
mental scientists selected by the Secretary.
4. A Program Director.
The Annual Plan
The Annual Plan includes :
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A review of current DHEH research as it relates to toxicology.
Specification of the program activities and resources to be
managed by the Program Director:
Current toxicology testing capacity (i.e. dollars, positions,
and space) and .how that capacity is being, utilized..
Amount of test capacity which may be available in the
coming- year.
Plans for test development and validation of test systems
which take into account research.opportunities and needs
of the field.
The compounds to be tested, the test procedures to be followed,
and a schedule for the tests.
The regulatory and scientific opportunities which were considered
in the development of the plan.
Recommendations of the Program Director as to the resources
needed for the Department's toxicology program capacity.. (This
section will first be included in the second plan, to be completed
by September 1, 1979.)
The Executive Committee
The members of the Committee are:
Commissioner of Food and Drugs, Food and Drug Administration;
Assistant Secretary for Occupational Safety and Health, Depart-
ment of Labor;
Chairman, Consumer Product .Safety Commission;
Administrator, Environmental Protection Agency;
Director, National Institute for Occupational Safety and
Health;
Director, National Institutes of Health;
Director, National Cancer Institute;
Director, National Institute of Environmental Health Sciences;
Assistant Secretary for Health, Department of Health, Education,
and Welfare (non-voting);
Scientific Director, National Institute of Environmental
Health Sciences (consultant);
- 2 -
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Divisioa ©£ Caus© sad Prevention,. National
a-
Representative frosa the Center for Disease Control/National
XnstitHte for Occupational Safety and Health {consultant} i
Tesd,e©loepr Program Board of Scientific Counselors
This Board , eeaposed ©f a©a«»g©v©samental scientists s©l@et@d by the
Secretary, advisas the Exseative Csmittee and the program Director -
on oat-tars of scientific prograsi -content and policy, both present
and future, as they relate to the Program. It conducts periodic
reviews ©f the Program and its eomponests in the several participating
agencies, and evaluates their scientific " merit assd the overall-
goalifey ©f the Program*
Proram
Prepares the Annual Plan« Ttois includes proposing total resourees
to be dedicated to the Program by @aeh ageney.
Presents the Jtosual plan to the Bxaeutive Craamittee.
Traiisadts the reeonanended Annual Plan to the -Seeretary, through the
Assistant Secretary for Health,, for approval.
Publishes the Program's approved Annual Plan.
Reports to the Executive Cossmi'frtge on progress and problems in
implement ajig the Annual Plan.
Proposes aajor changes is the approved Annual Plan to the Committee.,
Directs the performance of the Program under the plan.
Prepares and issues reports sun^arising work in progress, and
announcing the results of tests eondueted by the Program.
Upon request of the Assistant Seeretary for Health makes recommen-
dations to him on agency chemical toxicology testing budget submissions.
Transmits the approved program Annual Report to the Assistant
Seeretary for Health and to the Secretary.
OPERATION OF THE PROGRAM
The NCI, NIEB3, NIOSH, and. the FDA haw dsdieated program resources to
this Program* When agency resources are identified, memoranda of
understanding are prepared and signed by the head of each agency and the
National Toxicology Program (NT?) Director » These memoranda:
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1. Specify those resources to be devoted to the Program.,
2. Identify Program components by organizational title.
3. Identify supporting elements of participant agencies, and
their responsibilities (e.g., technical services).
These memoranda are updated upon approval of each Annual Plan to reflect
shifts of dedicated resources into and out of the Program.
These memoranda provide that the identified organizational elements in
each agency are under the immediate direction of the NTP Director,
subject to the concurrence of the agency head.
These memoranda provide that management actions in support of the
Program's, operations are the responsibility of the contributing agency.
RESOURCES
In its first year of operation, the Program totals approximately $41.0
.million drawn from currently available resources/ comprised of the
contributions shown below:
National Cancer Institute $21.8 Million
National Institute of Environmental Health.
Sciences 10.2 Million
rood and Drug Administration 7.0 Million
Center for Disease Control/National
Institute for Occupational Safety
and Health 2.0 Million
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TOXICOLOGY INFORMATION SUBCOMMITTEE
OF THE
DHEW COMMITTEE TO COORDINATE TOXICOLOGY AND RELATED PROGRAMS
REPORT TO THE INTERAGENCY Toxic SUBSTANCES DATA COMMITTEE
APRIL 3, 1979
HENRY M, KISSMAN, Pn.D,
ASSOCIATE DIRECTOR
SPECIALIZED INFORMATION SERVICES
NATIONAL LIBRARY OF MEDICINE
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TOXICOLOGY INFORMATION SUBCOMMITTEE
OF THE
DHEW COMMITTEE TO COORDINATE TOXICOLOGY AND RELATED PROGRAMS
o ORGANIZED IN 1974 -•
o NEW CHARTER IN 1976
o 17 AGENCIES REPRESENTED
o CHAIRED BY TOXICOLOGY INFORMATION PROGRAM, NATIONAL LIBRARY
OF MEDICINE
o MEETS EVERY 6 WEEKS
o OBJECTIVES:
1, CREATE AND MAINTAIN TOXICOLOGY INFORMATION PROJECTS
OF IMPORTANCE TO AGENCIES AND TO SCIENTIFIC COMMUNITY
2, MAINTAIN INTERAGENCY COMMUNICATIONS ABOUT ONGOING
INFORMATION ACTIVITIES IN TOXICOLOGY AND RELATED
FIELDS
o PROJECTS FUNDED BY PARENT COMMITTEE (OASH/DHEW), INDIVIDUAL
AGENCIES (CPSC, NCI, NCTR, NLM) AND AGENCY GROUPS (IRLG)
o PROJECTS MONITORED BY FULL SUBCOMMITTEE OR TASK GROUPS
o DETAILED MEETING REPORTS
o ANNUAL SUMMARY REPORT TO PARENT COMMITTEE
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TOXICOLOGY INFORMATION SUBCOMMITTEE
MEMBER ORGANIZATIONS
CENTER FOR DISEASE CONTROL
CONSUMER PRODUCT SAFETY COMMISSION
COUNCIL ON ENVIRONMENTAL QUALITY
DEPARTMENT OF ENERGY
DEPARTMENT OF THE INTERIOR
EDGEVIOOD ARSENAL, DEPARTMENT OF
THE ARMY
ENVIRONMENTAL PROTECTION AGENCY
FOOD AND DRUG ADMINISTRATION
NATIONAL CANCER INSTITUTE
NATIONAL CENTER FOR TOXICOLOGICAL
RESEARCH
NATIONAL INSTITUTE OF ENVIRON-
MENTAL HEALTH SCIENCES
NATIONAL INSTITUTE OF GENERAL
MEDICAL SCIENCES
NATIONAL INSTITUTE OF MENTAL
HEALTH
NATIONAL INSTITUTE FOR OCCU-
PATIONAL SAFETY AND HEALTH
NATIONAL LIBRARY OF MEDICINE
OAK RIDGE NATIONAL LABORATORY
OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, DEPARTMENT
OF LABOR
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TOXICOLOGY INFORMATION SUBCOMMITTEE
PROJECTS
o LABORATORY ANIMAL DATA BANK (LADB)
o TOXICOLOGY RESEARCH PROJECTS DIRECTORY (TRPD)
o TOX-TIPS (TOXICOLOGY TESTING IN PROGRESS)
o TOXICOLOGY DOCUMENT AND DATA DEPOSITORY. OD3)
o CHEMICAL MONOGRAPH REFERRAL CENTER (£BEMRiC)
o PARTICIPATION IN:
o INFORMATION RESPONSE TO CHEMICAL CRISES (IRCC)
PROJECT
o CHEMICAL SUBSTANCES INFORMATION NETWORK (CSIN)
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IARQRATORY ANIMAL DATA BANK (LADE)
OBJECTIVES;
(A) PROVIDE BIOLOGICAL DATA ON-LINE TO FACILITATE EXPERIMENTAL
DESIGN
(B) EVALUATION AND COMPARISON OF ANIMAL EXPERIMENTS AND ANIMAL
MODELS
(0 PROVIDE AID IN SELECTION OF LEVEL OF BIOLOGICAL TEST SYSTEM
PROCEDURE;
PROVIDE BASE-LINE VALUES FROM EXPERIMENT CONTROL ANIMALS THROUGH
AN INTERACTIVE ON-LINE DATA BANK, (UNPUBLISHED DATA)
SPONSORED BY;
DHEW COMMITTEE TO COORDINATE TOXICOLOGY AND RELATED PROGRAMS
NATIONAL CANCER INSTITUTE
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
NATIONAL LIBRARY OF MEDTCINE
INTERAGENCY REGULATORY LIAISON GROUP (CPSC, EPA, FDA, OSHA)
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LABORATORY ANIMAL DATA BANK (LAPS)
PROVIDES
ON-LINE RETRIEVAL
STATISTICAL ANALYSIS
OF
BASE-LINE INFORMATION ON:
HEMATOLOGY
CLINICAL CHEMISTRY
PATHOLOGY
GROWTH AND REPRODUCTION
FROM
EXPERIMENT CONTROL ANIMALS ACCORDING TO SPECIES
OR STRAIN
BY MAJOR ANIMAL GROUPINGS
AGE, SEX, OBSERVATION YEAR
AND BY SUBGROUPINGS
ENVIRONMENT
HUSBANDRY
NUTRITION
GROUP (COLONY) DESCRIPTORS
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ANIMAL DATA BANK (LADB)
STATUS
CONTRACTS :
o DEVELOPMENT, ENRICHMENT, TESTING - BATTELLE COLUMBUS LABS,
(TERMINATES
o EVALUATION - ILAR (NATIONAL ACADEMY OF SCIENCES)
(TERMINATES SEPTEMBER 1981)
o PEER REVIEW - FASEB (TERMINATES JANUARY 1981)
FUTURE PLANS
A, NEW THREE-YEAR PROCOREMENT (IN PREPARATION), RFP H/4J &>ue our.
o AVAILABILITY OF LADB TO PUBLIC,
o ENRICHMENT OF LADB WITH ADDITIONAL DATA, (INTERACTION
CONTROLS, ETC,),
o DEVELOPMENT AND IMPLEMENTATION OF ADDITIONAL STATISTICAL
AND SEARCH CAPABILITIES ,
B, CONTINUED PEER REVIEW AND EVALUATION OF LADB,
o DATA REVIEW
o DATA DESCRIPTORS AND COLLECTION CRITERIA,
o PROGRAM EVALUATION (INCLUDING USER EVALUATION),
C, INTERACTION WITH NEW NATIONAL TOXICOLOGY PROGRAM TO INTERFACE
LADB WITH TDMS (TOXICOLOGY DATA MANAGEMENT SYSTEM),
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TOXICOLOGY INFORMATION SUBCOMMITTEE
PROJECT: TOXICOLOGY RESEARCH.PROJFCTS DIRECTORY
o EXTRACT TOXICOLOGY RESEARCH PROJECT REPORTS FROM DATA BANK OF
SMITHSONIAN SCIENCE INFORMATION EXCHANGE (SSIE)
o SUBJECT SCOPE DEVELOPED BY SUBCOMMITTEE
o PUBLICATION WITH MONTHLY ISSUES CONTAINING:
CA. 1,000 ABSTRACTS
SUBJECT INDEX
INVESTIGATOR INDEX
PERFORMING ORGANIZATION INDEX
SPONSORING AGENCY INDEX
ABSTRACTS ENHANCED WITH "BROWSING CODES"
FUNDING DATA (WHERE AVAILABLE)
o AVAILABLE ON SUBSCRIPTION FROM NTIS (S100/YEAR)
o ABSTRACTS TO BE AVAILABLE ONLINE IN TOXLINE
o IRLG SPONSORS ANNUAL EPIDEMIOLOGY RESEARCH PROJECTS DIRECTORY
(ALSO DERIVED FROM SSIE FILE)
EPIDEMIOLOGY RECORDS TO BE ADDED MONTHLY TO ONLINE FILE
o USE ONLINE FILE TO RETRIEVE INFORMATION ABOUT ONGOING AND PLANNED
RESEARCH AND, ALSO/ TO FIND "SUBJECT EXPERTS" IN CERTAIN
GEOGRAPHIC AREAS VIA SEARCHABLE ZIP CODE (FOR CHEMICAL CRISES
RESPONSE)
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TOXICOLOGY INFORMATION SUBCOMMITTEE
PROJECT; TQX-TIPS (TOXICOLOGY TESTING IN PROGRESS)
o MONTHLY CURRENT AWARENESS BULLETIN ON LONG-TERM TOXICITY
TESTING (CA, 20 TESTS/REPORTS PER ISSUE)
o PLANS FOR ONGOING AND PROJECTED TESTS OBTAINED FROM INDUSTRY,
AGENCIES AND RESEARCH INSTITUTES
o SOME INPUT FROM FOREIGN ORGANIZATIONS
o PROJECTS DESCRIBED BY;
CHEMICAL BEING TESTED (WITH CAS REGISTRY NUMBER)
TEST ANIMAL
ROUTE OF ADMINISTRATION
DURATION OF TEST
TESTING ORGANIZATION
SPONSORING ORGANIZATIONS
SHORT BIBLIOGRAPHIES OF RECENT PUBLICATIONS ON CHEMICAL
(TOXICITY AND TESTING)
o ISSUES INDEXED BY CHEMICAL, INSTITUTION(S) AND INVESTIGATOR(S)
o CHEMICAL INDEX (CUMULATED QUARTERLY) ALSO CARRIES REFERENCES
TO PUBLISHED TESTS (LITERATURE, NCI REPORTS)
o AVAILABLE ON SUBSCRIPTION FROM NTIS ($25/YEAR)
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TOXICOLOGY INFORMATION SUBCOMMITTEE
PROJECT: TOXICOLOGY DOCUMENT AND DATA DEPOSITORY (TD3)
OBJECTIVE: FACILITATE STORAGE/ RETRIEVAL AND DISTRIBUTION OF ITEMS
CONTAINING TOXICOLOGICAL INFORMATION THAT DO NOT
NORMALLY REACH SCIENTIFIC COMMUNITY THROUGH REGULAR
CHANNELS (E.G./ JOURNALS).
PLAN:
o BUILD TD3 PROJECT ON NTIS CAPABILITIES
o IDENTIFY "TOXICOLOGY" SET IN NTIS HOLDINGS
0 EXTRACT SUBSET THROUGH USE OF TOXICOLOGY PROFILE ON
NTIS DATA BASE
0 EVALUATE BY INSPECTION
0 PREPARE TD3 TAPE
o INCLUDE TD3 TAPE IN TOXLINE
o PREPARE SUBJECT-BASED ANNOUNCEMENT PUBLICATIONS
o DISSEMINATE ITEMS ON REQUEST THROUGH NORMAL NTIS CHANNELS
(I.E./ MICROFICHE)
o ENRICH NTIS HOLDINGS-ANIL THEREFORE, TD3--THROUGH SYSTEM-
ATICALLY CHANNELING NEW (TO NTIS) ITEMS (REPORTS/
PROCEEDINGS/ DATA COLLECTIONS/ ETC.) INTO NTIS
o MAKE TD3 ARCHIVAL BACKUP FOR OTHER DATA AND INFORMATION
SYSTEMS (E.G./ CHEMICAL REGULATIONS AND GUIDELINES SYSTEM,
LADB)
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TOXICOLOGY INFORMATION SUBCOMMITTEE
PROJECT? CHEMICAL MONOGRAPH REFERRAL CENTER (CHEHRiC)
o DEVELOPED AND OPERATED BY CONSUMER PRODUCT SAFETf
COMMISSION
o COLLECT AND DISSEMINATE INFORMATION ABOUT ONGOING OR
PLANNED PROJECTS TO PREPARE
o REFER MONOGRAPH PRODUCERS/SPONSORS TO OTHERS WORKING
IN SAME AREA, AT PLANNING STAGE, TO AVOID UNKNOWING
DUPLICATION,
o BUILD DATA BASE
o ANSWER QUERIES
STATUS:-
o DATA BASE BRIEFLY DESCRIBING SOME 500 MONOGRAPH
PROJECTS
o QUERIES BEING ANSWERED
o PROBLEMS IN OBTAINING INPUT FROM AGENCIES
FOR INFORMATION, CONTACT:
MR, MARK T, SUTHERLAND
CHEMRiC PROJECT OFFICER
CONSUMER PRODUCT SAFETY COMMISSION
5401 WESTBARD AVE,
BETHESDA, MD 20207
PHONE: 301/492-6477
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TOXICOLOGY INFORMATION SUBCOMMITTEE
PROJECT: PARTICIPATION IN THE INFORMATION RESPONSE TO CHEMICAL
CRISES (IRCC) PROJECT
OBJECTIVE: 1, ORGANIZE SYSTEM FOR EXPRESS LITERATURE SEARCHES TO
SERVE SPONSORING AGENCIES IN EVENT OF CHEMICAL CRISIS,
2, EXPEDITE INTERAGENCY AWARENESS OF EXISTENCE OF
CHEMICAL CRISIS,
PLAN:
o PROJECT INITIATED BY EPA
o GROUP OF SPONSORING AGENCIES; EACH CONTRIBUTING $10,000/YEAR
INTO IRCC PROJECT FUND
o NLM-SPONSORED TOXICOLOGY INFORMATION RESPONSE CENTER (TIRO,
OAK RIDGE NATIONAL LABORATORY, SELECTED TO PERFORM LITERATURE
SEARCHES
o TIRC TO STAFF IRCC PROJECT WITH 2 PEOPLE
o IRCC PROJECT STAFF TO BE AVAILABLE AT ALL TIMES FOR:
o RESPONSE TO AGENCY REQUEST WITH EXPRESS BIBLIOGRAPHY
IN 48 HOURS
o FOLLOW-UP, IN-DEPTH BIBLIOGRAPHY, IF REQUESTED
o IN BETWEEN CRISES, FULL (PUBLISHABLE) BIBLIOGRAPHIES
ON TOPICS SELECTED BY AGENCIES
STATUS:
o FY 79 PARTICIPANTS
DHEW-CCTRP $40,000
EPA , , , , , , , 20,000
NIEHS 10,000
NOAA , , 10,000
USDA , 10,000
o FUNDS TRANSFERRED THROUGH STANDARD (IRCC) INTERAGENCY AGREEMENT
• n -
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SOJECT: PARTICIPATION IN THE INFORMATION RESPONSE TO CHEMICAL
CRISES (IRCC) PROJECT (CONTD.)
o IRCC PROJECT STAFF AVAILABLE
o DRAFT IRCC OPERATING MANUAL BEING CIRCULATED
o IRCC PROJECT COMMITTEE MEETS IN CONJUNCTION WITH TIS MEETINGS
o IRCC PROJECT STAFF DID "MOCK" CRISIS SEARCH ("TCDDs"), WORKS ON
FIRST NON-CRISIS BIBLIOGRAPHY ("1,2-DICHLOROETHYLENE"),
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TOXICOLOGY INFORMATION .SUBCOMMITTEE
PROJECT: PARTICIPATION IN CHEMICAL SUBSTANCES INFORMATION
NETWORK (CSIN) PROJECT
o TIS ADOPTS CONCEPT OF BUILDING CHEMICAL COMPOUND
INFORMATION SYSTEM - A SYSTEM OF LINKED ONLINE
FILES — AS PROJECT IN 1976
o SUPPORTS FIRST MITRE STUDY (CEQ, EPA, NLM FUNDING)
o DHEW-CCTRP SUPPORTS SUBSEQUENT MITRE CONTRACT
(FY '78) AND OTHER CSIN SUPPORT CONTRACTS
o TIS CONTINUES TO CARRY REPORTS ON CSIN ON ITS
MEETING AGENDAS
-------
Meeting to Review the University of Pennsylvania Reports
A PRELIMINARY REPORT ON RECOMMENDATIONS FOR THE DEVELOPMENT
OF A CHEMICAL STRUCTURE AND NOMENCLATURE SYSTEM (CSNS)
Produced under Contract No. EQ8AC027
Council on Environmental Quality
April 3, 1979
AGENDA
Introduction
Summary of Systems: Evaluation
Break
Discussion of System Evaluation
Lunch
Summary of a CSNS Development Plan.
Discussion of System Evaluation
(continued)
Break
Discussion of a. CSNS Development
Plan
Concluding Remarks
S. Siegel
D. Lefkovitz
Participants
D. Lefkovitz
Participants
All Participants
S. Siegel
-------
0ATA
Cito ^ TosSs Sufcsfewsss
MEMOHANDUM
SUBJECTS Minujfces of May 1, 1979, Meeting
te-s^^-^*?. &»-++~~
FRCMs Roger M. Connor, Executive Secretary
Members, Interagency Toxic Substances
Data Committee
Enclosed are the minutes of the April 3, 1979, 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 June 5, 1979,
please call me at 202/755-6956.
Enclosures
-------
INTERAGENCY TOXIC SOBSTANCES DATA COMMITTEE
Minutes—May 1, 1979
The meeting, chaired by Ms. Carroll Leslie Bastian, convened in
room 2008 of the New Executive Office Building, 17th St. and
Pennsylvania Avanue, Washington, D.C. 20006
1. Approval of minutes of April 3f 1979.
The minutes of the April meeting were approved as written.
2. Report on the National Occupational Hazard Survey (NOHS).
Dr. Patricia Breslin, Occupational Safety and^ Health
Administration, delivered the following report.
The NOHS, conducted during the years 1972-74, was an attempt
to inventory the chemical substances present in American
industry. It was based on a random sample of industries compiled
by the Bureau of Labor Statistics. Its purpose was to identify
chemicals to which a worker might be exposed. In addition to
exposure to chemical substances, the survey included information
on noise, radiation, heat, and cold.
Attempts to quantify exposure, were not made except in the
most crude terms, e.g., did a person work with the substance full
time or part time.
The collected data were coded onto a form which included
Data 2 information about:
the establishments: Number-of workers? City water and
sanitation facilities available? Medical exams and services?
etc.
the employees: Job title? Substance(s) handled? Full or
part time? Form of the substance(s) (vapor, liquid, solid)? etc.
safety controls used: Gloves? Respirators? Ventiliators?
etc.
The finished survey is on seventy-two magnetic tapes with
nine million data elements. It includes information on 80,000
chemical substances, about half of which are generic compounds.
There are about 40,000 trade name products.
There are three volumes of reports from the Survey available
through the National Institute for Occupational Safety and Health
(NIOSH). Volume 3 estimates how many workers are exposed to
various substances.
-------
In commenting on the design Data collection problems in
doing the survey. Dr. Breslin mentioned it is at present the
only such inventory. A new survey is being considered, which
would make use of the latest techniques in survey design and data
processing capabilities to more efficiently meet the user
community needs. The funding of a feasibility study for this is
currently being discussed.
3. CSIN Subcommittee Report.
Dr. Sidney Siegel, EPA, delivered the report.
Dr. Siegel reported that Dr. Henry Kissman, National Library
of Medicine (NLM), will accept the chairmanship of the CSIN
Subcommittee. There was unanimous approval of this appointment
by Subcommittee members. Ms. Bastian, speaking for the parent
committee, expressed delight with Dr. Kissman's acceptance of the
position.
Dr. Siegel and Dr. Kissman have already had discussions
about how to coordinate, wherever possible and appropriate, the
activities of the CSIN Subcommittee and the Toxicology
Information Subcommittee (TIS) of the Committee to Coordinate
Toxicology and Related Programs (CCTRP), of which Dr. Kissman is
chair.
Dr. Siegel reported that some of the experiments performed
by Dr. David Lefkovitz of the University of Pennsylvania to
establish performance characteristics of a Chemical Structure and
Nomenclature System (CSNS), will be redone side-by-side with Dr.
Bill Milne of DHEW. This will ensure that the most accurate and
complete technical array of performance characteristics possible
is available to the subcommittee for its evaluation.
Dr. Siegel will ask formal permission to allow similar
performance characteristics studies to be done on the National
Cancer Institute's Division of Cancer Therapy Chemical
Information System.
When the testing is complete, technical arrays will be
developed for study by the CSIN Subcommittee. The subcommittee
will then develop recommendations for consideration by the parent
committee. The recommendations will include an outline of CSNS
functional and performance characteristics which the subcommittee
feels are essential. All evaluations will be performed by the
subcommittee.
The issue has been raised again of the possibility of
conflict of interest involving Dr. David Lefkovitz, due to his
past involvement with the National Cancer Institute, in the
development of the chemical information system for its Division
of Cancer Therapy. CEQ is preparing a formal statement on this
issue which will be made available to the members of the ITSDC,
the CSIN Subcommittee and other interested parties.
-------
Regarding the composition of the CSIN Subcommittee, the
feeling now is that its membership needs to be solidified. A
focal point is needed in each relevant agency, who can speak for
that Agency on a policy level, or at least have contact with such
individuals. Ms. Bastian suggested that the issue of membership
solidification and coordination between,-the parent ITSDC, the
CSIN Subcommittee and the TIS be dealt with now. She thinks a
letter should be sent to the Assistant -Secretary level in
relevant agencies delineating the type of people and the type of
committment that are needed in each of these committees.
Dr. Siegel is working with Ms. Erika Graf-Webster on a five
year plan for CSIN development. Within a month or two, a draft
of the plan will be circulated for comment to the members of the
parent committee and the CSIN Subcommittee.
Dr. Siegel is also working on interagency agreements for
further funding of activities related to CSIN development.
EPA ,is developing a "road show" on the overall concept of
CSIN to present to high level officials of agencies which might
be interested in contributing to the development of CSIN, with
emphasis as to how their agencies would benefit.
4. Report on EPA provisions for the Physical Security of TSCA
Confidential Business Information.
Mr. Roger Connor, EPA, delivered the report.
When it became apparent, in 1977, that EPA under TSCA's
initial inventory regulation, would be collecting large amounts
of confidential business information from the chemical industry,
representatives of that industry expressed grave concern about
EPA's ability to safeguard such information from unauthorized
disclosure. In response to that concern, Steve*Jellinek,
Assistant Administrator for Toxic Substances, established the EPA
Data Security Task Force and charged it with the responsibility
to develop procedures to safeguard any confidential business
information collected under TSCA. The Task Force developed the
TSCA Confidential Business Information Security Manual which
contains detailed and specific procedures for handling TSCA
Confidential Business Information.
EPA has developed a training program for personnel who will
have access to such information. The most important component of
that training program at this time is a security briefing. The
briefing consists of 1) introductory remarks by Mr. Connor, 2)
a videotape of Mr. Jellinek speaking about the need for constant,
careful adherence to established security procedures by all
personnel, 3) a slide/lecture presentation on procedures to be
followed, and 4) a question and answer session. Copies of the
TSCA Confidential Business Information Security Briefing Booklet,
which parallels the slide presentation, are distributed at each
briefing.
-------
Mr. Connor delivered a security briefing to the committee
much as he would have delivered to it to. an .audience at EPA. The
following topics were covered as they relate to the security of
TSCA Confidential Business Information:
— Official EPA Policy
— Treatment of Violations
— Employee Responsibilities
— Handling of Incoming Mail
— Secretarial Procedures
— Gaining Access to TSCA Confidential Business Information
— Meetings
— Transmission
— Generation of Documents
— Notes Containing Confidential Business Information
— Lost or Unaccounted for Documents
Mr. Connor stressed that two factors were crucial to the
success of any security system:
1) Firm, positive, unequivocal support from the top people in
the organization.
2) A training program to provide opportunities for employees to
learn exactly what is expected of them.
5. Report on EPA Provisions for Computer Security of TSCA
Confidential Business Information.
Mr. Chris Harvey/ EPA, delivered the report. He spoke from
a detailed outline, which is attached.
6, Other items.
There were ho additional agenda items, and the meeting was
adjourned at 11:30 a.m.
o Next meeting on June 5 in room 2010, New Executive office
Building.
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ATTENDEES-MAY 1, 1979
FEDERAL
INTERAGENCY TOXIC SUBSTANCES DATA COMHTTEE
Name
Erika Graf-Webster
Martin Aronoff
Don Hummel
Carroll L. Bastian
Roger Connor
Patricia Breslin
Richard J..Lewis Sr,
Bernard Greifer
Dorothy Drago
Vera Hudson
Jerry Calderone
George R. Kelly
Terri Damstra
Bill Rhode
Sid Siegel
Henry M. Kissman
Chris Harvey
George E. Cushmac
ORGANIZATION
EPA
NBS
NLM
CEQ
EPA
OSHA/IRLG
NIOSH/HEW
DOC
CPSC
NIOSH
OASH/DHEW
DOE/EV
NIEHS/HEW
OD/NIH/HEW
EPA/OTS/OPII
NLM/NIH
EPA
DOT/MTB
PHONE
395-5763
921-3861
496-1131
755-6956
523-7119
513/684-8317
377-3234
492-6470
443-2100
472-5194
376-9073
629-3471
496-9285
755-8040
496-3147
426-4790
755-4906
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ATTENDEES-May 1, 1979
NON-FEDERAL
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Name ORGANIZATION• PHONE
Rita Bergman Sigma Data Computer
Corporation 395-5763
Patricia Lortz CSMA 872-8110
Jon Simplicio Allied Chemical 201/455-5866
Ron Grandier Pesticide Toxic
Chemical News ST3-7472
George R. Hoffmann Nat'l Acad. of Sciences 389-6351
Fred A. Tate CAS 614/421-6940
Ron G. Dunn CAS 614/421-6940
Christine Shine Monsanto Co. 452-8880
Pat Beattie General Motors Corp. 313/556-1597
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Need for Security in Data Systems
A.. OMB Circular no. 171 -
Promulgates policy and responsibilities for the
development and implementation of computer security
programs by executive branch departments and,agencies.
1. Specific requirements on agency:
a. Responsibility for security of each computer
installation to be assigned to a responsible
management official knowledgeable in data
processing and security matters.
b. Personnel security policies for screening
all involved individuals to be established.
c. Management control- process to be established,
to include at a minimum;
1) Definition and approval of security
specifications prior to programming
2) Conduct and approval of design reviews
and application systems tests prior
to using the systems operationally.
d. Agency program for conducting periodic
audits or evaluations and recertifying the
adequacy of the security safeguards.
e. Procurement actions to include specifications
for appropriate security requirements.
f. Responsibility for the conduct of periodic
risk analyses to be assigned. Risk analyses
to be performed
1. Prior to approval of design specifications
for new computer installations
2. At the time of significant changes
3. At periodic intervals not to exceed
five years.
-------
g. Appropriate contingency plans to be developed
and maintained.
B. TSCA
Sam© security requirements exist for computer systems
as for manual systems.
C. Computer Security
1. The threat:
Intentional or accidential disclosure,,
destruction or alteration of "computer
based information resources - hardware,
software, communications, facilities,
people procedures, and sensitive data.
2. The goal;
To prevent, detect, minimize or recover
from the threat.
3. Computers operate in an environment that must
be considered hostile. Due to the primary
emphasis on performance and user services, the
system architecture of most existing computer
systems is inadequate for secure operations.
4. Key assets of the system must be protected.
We must:
a. Protect system from users
b. Protect users from each other
c. Protect users from themselves
d. Protect system from itself
e. Protect system from the environment.
5. Security safeguards decomposes into four areas:
a) Physical safeguards
b) Technical safeguards
c) Administrative safeguards
d) Personnel safeguards.
-------
Fundamental principles of protecting automated
information system help define an approach to
security.
a) Identification of resources must be unique,
tamper-proof and machine readable.
1, Users
2. Terminals
3. Programs
4. Computer
5. Operating system
6. Storage Devices
7. Data Files
8. Data Elements
b) There must be formal access controls, which
set up sender/receiver relationships and
control user access based on these relation-
ships.
c) The system must be able to separate explicit
kinds of resources, users, and information
from each other.
d) The system must possess integrity, i.e., the
following qualities exist:
1. Logical correctness, reliability, and
tolerance to error of the hardware and
software resources, processes, and
functions.
2. Logical completeness of hardware and
software that implement the protection
mechanism.
3. Consistency of data structures and
accuracy of stored data.
4. Cohesive operation of hardware, software,
communications and their human interfaces,
e) Surveillance of the system must be maintained.
The system must constantly monitor the
proper functioning of protective mechanisms.
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IMTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
May 23, 1979
Council on Environmental Quality
722 JueHton PUw*. N W.
WHNngHn, O.C. 200M
U.S. Environmental Protection Agency
Oflte* of Toxle SubtttnCM
WMNngton. D.C. 20460
MEMORANDUM
SUBJECT:
FROM:
TO:
Designation of TSCA Section 4(a) Interagency Toxic
Substances Data Coordinators , /.^
Marilyn C. Bracken, Co-chairperson jn^AJ^jr'^
Interagency Toxic Substances Data Committee
Interagency Toxic Substances Data Coordinators
You have been designated by the ITSDC at the request of EPA
to act as your agency's coordinator for information gathering
activities for chemicals which are currently (or will be in
the relatively near future) under consideration as candidates
for testing rules under Section 4(a) of the Toxic Substances
Control Act (TSCA). To a large extent, these toxic substances
have been selected by the Interagency Testing Committee
(ITC) for the'test rule review process under TSCA. In order
to avoid proposing a test rule based upon insufficiency of
data when another Federal agency has in its possession
sufficient health and environmental effects data to determine
the hazards of the substances under consideration, EPA has
requested that the member agencies of the Interagency Toxic
Substances Data Committee identify and in some cases, make
available relevant information in its possession to EPA.
This information will differ from that used in the ITC
selection process in its higher degree of comprehensiveness
and detail, which is necessary for supporting rule development.
Your attendance is requested at an initial briefing by EPA
staff scheduled for June 5, 1979 at 1:30 pm in the New
Executive Office Building, 726 Jackson Place, N.W., Room
4203, Washington, D.C. This briefing will serve to further
inform you of the interagency coordination necessary to
fully satisfy the statutory requirements of data gathering
for test rule development under TSCA, and provide a forum
for questions or comments related to implementation at the
agency level.
-------
Because of the time constraints under which the ITC candidate
toxics are reviewed, we would appreciate your full support
in the initial efforts to develop an effective interagency
interchange of information. In order to make the best use
of available time, we recommend that the survey be initiated
prior to the briefing, given the following suggested procedures:
1) To the extent practical, locate and survey, in'a cursory
fashion, existing agency files in order to ascertain whether
any information concerning health or environmental effects,
presence in environmental media, or human exposure of the
chemicals on the attached list exists.
2) To the extent practical, complete the attached chart and
indicate on which of these chemicals your agency has information,
and generally the type of data (e.g., health effects study,
monitoring data, etc.) available. Please bring this chart
to the June 5 meeting.
3) If possible at this time, identify the person(s) within
your agency who should be contacted to arrange for EPA
access to this information.
Initiating the survey described at this juncture will serve
the, dual purpose of "catching up" with the test rule appraisals
required for toxics which have already been,designated for
such evaluation (two sets totalling 41 toxics), and to
identify issues related to information gathering for discussion
at the briefing. If problems do arise during the course of
the initial searching, please call Steven Newberg-Rinn,
Assessment Division, Testing Rules Development Branch, at
755-1500.
Attachments: TSCA Section 4(a) Candidate List
List of Interagency Toxic Substances
Data Coordinators
March 26, 1979, Letter to ITSDC Members
cc: Executive Secretary, Interagency Toxic Substances
Data Committee
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Chemical Name
Antimony trioxide
Antimony sulfide
Aryl phosphates
Chlorinated benzenes,
mono- and di-
Chlorinated benzenes,
tri-, tetra- and penta-
Chlorinated naphthalenes
CAS Registry No.'s
1309-64-4
134S-04-6
26444-49-5, 115-86-6,
133-078-5, etc.
108-90-7, 95-50-1,
541-73-1, 106-46-7
87-61-6, 120-82-1,
108-70-3, 634-66-2,
95-94-3, 608-93-5,
634-90-2
90131, 1321659,
1321648, etc.
Chlorinated paraffins
Chloromethane (methyl
chloride)
2-Chloro-l,3-butadiene
(chloroprene)
Cresols
cyclohexanone
Dichloromethane
1,2-Dichloropropane
Ethylbenzene
74-87-3
126-99-8
95-48-7, 108-39-4,
106-44-5
108-94-1
75-09-2
78-87-5
100-41-4
Information
'Available
(Yes/No)
Type of Information
(health effects,
exposure, etc.)
Contact Person/Phone
-------
NAME:
AGENCY:
Chemical Name
Acatonitrile
Acrylic acid and
2-methylacrylic acid
and their esters
Acrylamide
Alkyl epoxides
Alkyl phthalates
Aniline and Chloro-
Bromo-, and/or Nitro-
Anilines
CAS Registry No.'s
75-05-8
79-10-7
etc.
79-06-1
75-21-8, 75-56-9,
106-88-7, 564-00-1, etc.
117-81-7, 26761-40-0,
etc.
142-04-1, 95-82-9,
133-57-3, 137-04-2,
141-85-5, 147-82-0,
527-20-8, 554-00-7,
606-22-4, 608-27-5,
615-36-1, 626-43-7,
634-67-3, 95-51-2,
108-42-9, 106-47-8,
95-76-1, 634-93-5,
106-40-1, 88-74-4,
99-09-2, 100-01-6,
5388-62-5, 6283-25-6,
97-02-9, 121-87-9,
89-63-4, 99-30-9,
3531-19-9, 827-94-1,
1817-73-8, 99-29-6,
10250-71-2, 634-83-3,
634-93-5, 635-22-3,
636-30-6, 697-86-9,
769-11-9, 825-41-2,
1635-61-6, 1940-29-0,
3481-20-7, 3698-54-2',
5344-44-5"
Information
Available
(Yes/No)
Type of Information
(health effects,
exposure, etc.)
ATTACHMENT
Contact Person/Phone
Antimony
7440-36-O
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Information Type of Information
. Available (health effects,
Chemical Name CAS Registry No.'s (Yes/No) exposure, etc.) Contact Person/Phone
Glycidol and its 556-52-5, 106-90-1,
derivatives 106-91-2, 106-92-3,
2426-08-6, 2186-24-5,
122-60-1, 1675-54-3, etc.
Halogenated alkyl 106-89-8, 3132-64-7, etc.
epoxides
Hexachloro-1,3-butadiene 87-68-3
Hexachlorocyclopentadiene 77-47-4
Hydroquinone 123-31-9
lodomethane (methyl 74-88-4
iodide)
isophorone 78-59-7
Mesityl oxide 191-79.-7
4,4' -Me thylenedlianiline 101-77-9
Methyl ethyl ketone 78-93-3
Methyl isobutyl ketone 108-10-1
Nitrobenzene 98-95-3
p-Phenylenediamine 1Q6-50-3
Polychlorinated 61788-33-8 12642-23-8,
terphenyls 11126-42-4, etc.
pyridine 11O-86-1
Toluene 1Q8-88-3
-------
Information Type of Information
Available (health effects,
Chemical Name CAS Registry No.'s (Yes/No) exposure, etc.) Contact Person/Phone
v
1,1,1-trichloroethane ' 71-55-6
(methyl chloroform)
Vinylbenzene (Styrene) 100-42-5
Xylenes 95-47-6, 108-38-3,
106-42-3
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ATTACHMENT
Lt. Comm. A.A. Stefanyshyn (MSC)
Bureau of Medicine & Surgery
Department of the Navy
Attn: Code 3142
Washington, D.C. 20372
254-4230
Mr. Winston De Monsabert
Food and Drug Administration
Room 11-30
5600 Fisher Lane
Rockville, MD 20857
443-4504
Mr. Ed Cappuccilli
U.S. International Trade Commission
701 E Street, NW
Washington, D.C. 20436
523-0387
Dr. Patricia Breslin
OSHA
200 Constitution Avenue
Roont N 3700
Washington, D.C. 20210
202-523-7115-
Mr. George Cushmac - DMT-221
DOT/RSPA
Materials Transportation Bureau
2011 2nd Street, NW
Washington, D.C. 20590
755-4906
Ms. Terri Damstra
Office of Health Hazard Assessment
NIEHS
P.O. Box 12233
Research Triangle Park, North Carolina 27709
8-629-3471
Ms. Dorothy Drago
Comsumer Product Safety Commission
5401 Westbard Avenue, Room 646
Bethesda, MD 20207
492-6470
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John Wilson
Department of Energy
20 Mass. Avenue, Rm. 6134
Washington, D.C.
353-4684
Vera Hudson
NIOSH
5600 Fishers Lane
Room 8A-30
Rockville, MD 20857
Kurt Maurer
National Center for Health Statistics
3700 East-West Highway
Room 2-58
Hyattsville, MD 20782
436-7081
Dr. Kenneth Chu
National Cancer Institute
Carcinoginesis Testing Program
Landow Building, Room 3A06
Bethesda, MD 20014
Dr. Bernard Greifer
DOC
Room 3425
Washington, DC 20230
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INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Council en Envbonnwntal Quaflty
7a.MaanPlM.KW.
Environmental Pretoetlon Agency
One* of Tade SubcHnew
ftuHngan, D.C. 20*60
MEMORANDUM
SUBJECT: Minutes of June 5, 1979, Meeting
PROM: Roger M. Connor, Executive Secretary
TO:
Members, Interagency Toxic Substances
Data Committee
Enclosed are the minutes of the June 5, 1979, 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 July 10, 1979,
please call me at 202/755-9336.
Enclosures
-------
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Minutes—June 5, 1979
The meeting, chaired by Dr. Sidney Siegel, convened in room
2010 of the New Executive Office Building, 17th and Pennsylvania
Avenue, Washington, B.C. 20006
1. Corrections to Minutes of May ly 1979.
Mr. Connor made the following corrections: On page 1, item
2, paragraph 4, line 2, the "2" should be "and". On the same
page/ paragraph 8., "80,000" should be "8,000".
On page 2, first paragraph, strike the first two sentences,
and in their place put, "Dr. -fires!in acknowledged a number of
problems with the original survey and stated that while it has
its limitations because of these problems, it is still the only
such survey1*.
Ms. Hudson suggested that on page 1, last line, "various" be
replaced by "200", since that is the exact number of substances.
2. Chemical Substances Information Network (CSIN) Subcommittee
Report.
Dr. Sidney Siegel, EPA, delivered the report.
The Toxicology Information Subcommittee (TIS) of the
Committee to Coordinate Environmental and Related Programs
(CCERP) and the CSIN Subcommittee will meet back-to-back on the
same day. Since the areas of responsibility, interest and the
membership of the two subcommittees overlap, this will allow a
more efficient use of human resources for both the public .and
private sectors. TIS will meet in the morning and CSIN in the
afternoon of June 28 at the National Library of Medicine (NLM).
Dr. Kissman, who chairs TIS, will formally assume
Dr. Siegel1s responsibility as chair of CSIN at the June 28
meeting. This will allow Dr» Siegel to have a more logical
administrative structure in which to function as the CSIN Network
Adm in i s tr a tor.
A letter will be sent from Dr. Rail of CCERP, Ms. Bastian of
CEQ, and Dr. Bracken of EPA to the heads of relevant agencies
asking them to review membership and/or name-commit individuals
from their organizations to the ITSDC, the CSIN Subcommittee and
the TIS.
Dr. Siegel reported on meetings he has attended recently or
will soon attend:
- 1 -
-------
-•—Presented the CSIN concept to a subset of EPA's Science
Advisory Board which deals with monitoring data. They were
especially interested in .having the capability in the not-too-
distant future to identify, gather, collate, analyze, evaluate,
store and retrieve data and information on chemical substances of
interest.
-—In a presentation at the Laboratory Animal Data Bank (LADE)
colloquium stressed that heavy emphasis will be given in CSIN
modules dedicated to the capture and monitoring of toxicology
experimentation to quality assurance and quality control of the
data and information going into such modules or systems of CSIN.
-—Participated in a meeting of the National Academy of Sciences
(HAS) to discuss the relationship of the Chemical Abstracts
Service (CAS) registry system to CSIN development. Compatibility
between CSIN and the CAS registry system is of critical
importance.
-—On June 13 will make a a presentation on CSIN to the Senior
Environmental Information Group at the Department of Energy
(DOE).
A five-year plan for CSIN development has been prepared in
draft form. It will soon be submitted to the CSIN Subcommittee
for comment.
Dr. Siegel is also working on a document 'to supply
information to OMB as to what kind of administrative, technical
and dollar support array presently exists for CSIN activities.
It also is in draft form and when completed will be distributed
to the CSIN Subcommittee and the parent committee.
"An Overview of the Chemical Substances Information
Network," prepared by the Computer Corporation of America (CCA),
was distributed.
A chaperoned test will soon be conducted of the National
Cancer Institute's Division of Cancer Therapy Chemical
Information System to help in establishing a matrix of components
of various Chemical Information Systems which could aid in the
design and building of the CSNS component of CSIN.
Dr. Kissman stated that a problem area in chemical
registration is the fact that the CAS registry system which was
implemented in 1967 carries the linkage of abstracts and
registration of compounds from that time forward. Compounds that
have not appeared in the literature at least once since then are
not included in the system. A mem© will be prepared to ask CAS
to provide an outline of how this problem could be addressed.
2 -
-------
3. Identification% Classification and Exposure Estimates for
Environmental Carcinogens.
Dr. Herman Kraybill, National Cancer Institute, delivered the
report.
Dr* Kraybill spoke on issues he and others addressed in a
paper, "Biomedical Aspects of Biorefractories in Water,"
delivered in the Netherlands in 1977. The Introduction and
Summary of that paper are attached. '
4. Report on Body Burden Studies.
Dr. Vincent J» DeCarlo, EPA, delivered the report.
r->
For the past several years, via an interagency agreement,
EPA and MCI have been developing a data base to house information
on chemicals found in humans. In the beginning, an interagency
committee sought to find if anyone had such data in an accessible
format. The committee found that no one had tried yet to pull
all such data together. Working with Oak Ridge National
Laboratory, automated biblographic data bases were accessed to
search for relevant material. This approach generated tcomany
non-pertinent references and was deemed to be impractical.
Therefore, a retrospective five-year manual searching
program to produce a product titled "Chemicals Identified in
Human Biological Media Data Base" was set up at Oak Ridge. It is
possible that the Oak Ridge could become a repository for tissue
burden information and that investigators in this field will
routinely send manuscripts for inclusion in such a data base.
A recent Quarterly Report out of Oak Ridge is attached.
5c Overview of STORET Water Quality Data Base.
Mr» Sam Conger, EPA, delivered the report.
Mr. Conger spoke on STORET, EPA's Computerized Water Quality
Data Base. The capabilities of that computer system are
discussed in a brochure, which is attached.
6. Other Items.
There were no additions to the agenda -and the meeting was
adjourned at 11:30 a.m. The committee will reconvene on July 10,
1.979, at 9:30 a.m., CEQ Library, 722 Jackson Place, N.W.,
Washington, D.C.
- 3 -
-------
Attendees-June 5, 1979
Federal
Name
Kenneth Chu
Herman F.
Vincent De
Bill Rhode
Terri Damstra
Sid Siegel
Vera Hudson
Henry Kissman
Roger Connor
Sam Conger
George E.
Glenn Simpson
Richard J. L
Jerry Coffey
Marty Aronoff
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Organization
i NCI
[raybill NCI
:arlo EPA
OD/NIH
:ra NIEHS/NIH
EPA/OTS/OPII
l NIOSH
ian NLM
>r EPA
EPA
lushmac DOT/MTB
;on CPSC
Lewis, Sr. NIOSH
sy OFSPS
>ff NBS
1 Greifer Dept. Commerce
Phonet
496-1152
496-1625
426-4065
496-9285
629-3471
755-8040
443-2100
496-3147
755-9336
426-7792
755-4906
492-6647
684-8317
673-7974
921-3861
377-3234
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Attendees-June 5, 1979
NON-FEDERAL
INTERAGENCY TOXIC SUBSTANCES DATA COMMITTEE
Name Organization Phonefl
Fred Tate CAS 421-6940
R. G. Dunn CAS 421-6940
Rita Bergman Sigma Data 395-5763
George Hoffman NAS 389-6351
Pat Beattie General Motors 556-1597
W. P. Boyer Consultant 353-8417
Cheryl Russell BNA 452-4583
E. P. Bartkus Dupont Co. 655-0062
Lynne Neufeld Calculon Corp. 491-8333
Jon Simplicio Allied Chemical 455-^5866
Wendy Byer Calculon Corp. 491-8277
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BIOMEDICAL ASPECTS OF BIOREFRACTORIES IN WATER
by
H. F. Kraybill, Ph. D.
National Cancer Institute
Bethesda, Maryland 20014
C. Tucker Helmes, Ph. D.
Caroline C. Sigman, Ph. 0.
Stanford Research Institute
Menlo Park, California
Presented at^ the Second International Symposium on Aquat.c Pollutants,
Noordwijkerhout, Amsterdam, The Netherlands, September "36-28, 1977.
J^ Aquatic Pollutants Transformation and Biological Effs ts. Editors -
0. Hutzinger, L. H. Van Leylveld and B. C. J. Zoeteman, ergamon Press,
New York, New York, 1978, pp. 419-459.
-------
S«eoad International Symposium on Aquatic Pollutants, Noordwijkerhout,
Amsterdam, The Netherlands, September 26, 27, 28, 1977.
BXOMEDICAL ASPECTS OF BIOREFRACTOSIES IN WATER by H. F. Kraybill, Ph. D.,
Hatlonal Cancer Institute, Bethesda, Maryland; C. Tucker Helmes, Ph. D.
and Caroline C. Sigman, Ph. 0., Stanford Research Institute, Menlo Park,
California.
i.
It has been postulated that a high percentage of human cancers have
their origin in the environment and thus could be avoided if preventive
measures and control procedures were instituted. Consequently, sophisti-
cation of analytical procedures and biological methods for measurement
of effects have been underway relative to micro-pollutants is zhe
environment. In this area of concern, the modern instrumentation being
used cam detect parts per billion and parts per trillion levels of
volatile organics in raw and potable water. Many reports have appeared
is. the literature on the detection, identification and classification of
carcinogens (1,2,3,4). One of the most comprehensive conferences
covering identification, biological effects, and epideaiological aspects
of water biorefractories was that held in New York City in September
1976, sponsored by The New York Academy of Sciences, entitled "Aquatic
Pollutants and Biological Effects with Emphasis on Neoplasia" (5) .
Under the power of the Safe Drinking Water Act of 1974 (PL 93-523), the
Environmental Protection Agency requested the National Acadesv of Sciences
to conduct a study of the adverse health effects attributable co the
carcinogenic and/or noncarcinogenic contaminants in drinking -ater.
This report, issued in 1977, gave attention to all potential contaminants
la water, chemical and biological (6). Recognizing that there are several
million chemicals in the universe (3) , those of natural origin and those
from industrial technologies, it is evident that the polluticv: problem
becomes a difficult one to control. Newer methods and approii.hes are
needed for assessment of the carcinogenic potential of a whoi- class of
chemicals and mixtures of chemicals in the water, atmosphere, diet and
the workplace. These conceptual approaches are described elsewhere by
Krayblll (7).
-o-
-------
of- the nose intriguing possibilities is to use the marine animal
an>experlmental model for bioassay of single chemicals and a slmulat
mixtuSseof chemicals as they appear as biorefractories in di
vater. %his approach- has one advantage in that observavations a^e based
on a specxus that inhabits an environment where such exposurea/are
relevant anoScontinuous. Observations on tumorigenicity anjr incidence
of various tumors could be correlated with chemical profiles on waters
and fish tissues analyzed for body burden of chemicals Encountered.
Brown and coworkersXl23) approached this procedure somewhat less
elegantly, but perhapsSmore pragmatically, when they found that there
was a higher frequency otytumors In fish in policed waters of the Fox
River watershed as comparedsto fish in relatively non-polluted waters.
The incidence of tumors foundS^n 2121 fish examined from the polluted
watershed was 4.48 percent compared to a cdmor incidence of 1.03 percent
in 4369 fish taken from non-polluthd wafers. The fish bioassay also
permits an opportunity to conduct ccorarative pathology betwesn the fish
model and mammalian model, the rodeirc, selevant to dose-respozse relation-
ships in terms of tumorigenlcity,/Such afeh^approach is in the planning
stages at the National Cancer Institute.
The acquisition of such dajra in an ecological system is a forerunner to
studies on epizootics where feral populations (fisn%
-------
Th« results of surveys of raw and treated water, and of contaminants in
e£fluents aod sediments have revealed a vide spectrum of recognized and
suspected carcinogens as well as compounds of unknown carcinogenic!ty.
At the present time, there are 22 recognized carcinogens, 42 suspected
carcinogens, 27 chemicals with promoter or cocarcinogenie activity, 314
for which there are inadequate test results and the bulk, or remainder,
of 1323 chemicals which have never been tested for carcinogenicity.
From this total group of 1728 surveyed for carcinogenicity and mutagenlcity,
65 were classified with mutagenic activity (50 mutagens and 15 suspect
mutagens). Twenty-seven of these 65 mutagens or suspected mutagens fall
into the class of unknown carcinogenicity either because of no or inadequate
tests. A first priority is then to match these 27 against any recent
testing data. If no new data in uncovered, they would be good candidates
for carcinogenicity bioassay, especially if any of this group of 27 were
produced In large amounts or were exposure chemicals elsewhere in the
environment (air, diet, workplace, etc.).
Since biological data, specifically dose-response data in the area of
low-level exposures, is not available, risk assessments for the human
population are made by extrapolating from experimental animal dose-
response data on tumorigenicity to cancer Incidence for a. prescribed
number for the population. Estimates derived from the application of
various mathematical models provide calculated risk factors in terms of
probable cancer cases for 100 million, 1 million, or other selected
population size. While these risk factors are suggestive of potential
risk for levels of exposure in the microgram per liter range, they are
based on certain assumptions which may or may not hold relative to
actual pharaacoklnetlc, pharmacological, or biochemical mechanisms which
may prevail in a mammalian response to an environmental insult. Until a
clearer biological picture Is available as to events which can occur in
the shallow portion of the dose-response curve, one is left to deal, with
such mathematical extrapolations. Whether the mammalian organism response
to a high level insult in the milligram per kilogram of body weight or
diet basis is the same as for an intake or stress of micrograa or fraction
of a microgram per liter exposure remains to be resolved pharmacologically
and biochemically. There are Illustrative cases which would indicate
that the effects on the cells of the liver may not be similar and the
metabolic pathways may be different under conditions of a metabolic
overload compared to a lower concentration stress. Perhaps the most
significant, buc often overlooked factor, is the integrated effect of
all carcinogens and mutagens which additively could provide total exposures
in the milligram per liter range. While standards and tolerances are
developed for a single contaminant, it is conceivable that they may be
reduced to provide for a certain margin of safety when multiple stresses
are considered.
The series of epidemiological studies conducted relevant to site, sex,
and race-specific cancer mortality rates, correlated with levels of
drinking water contaminants in the United States, can serve ss a working
hypothesis towards more definitive analytical studies and perhaps provide
some guidance in the regulation of these contaminants. Canctr mortality
rates must be corrected for variants other than the water contaminant
exposures. To the degree that it is possible to correct for other
influences, such as socio-economic status, degree of urbanizstlon and
-------
manufacturing activity - all of which have a contributing effect - such
derived associations will be dependent on how well such influences can
be corrected. For establishment of a high index of credibility one
needs reliable data on the other environmental exposure variables of
interest, as well as information on other possible confounding variables,
to permit for their correction in the statistical analysis. loprovement
in the present generation of correlation studies is therefore dependent
on the acquisition of a data base on a more extensive range of municipal
supplies-. Measures of monitoring other than those now in existence may
be requisite to serve as useful and more accurate predictors of human
toxiclty where long-term, low-level exposures to aquatic contaminants
(organic and inorganic) are concerned. Reservations on the applicability
of such statistical associations in terms of cancer mortalities are
commented upon when some epidemiologists advance the view that human
studies on the carcinogenic effects of long-term, low-level closures to
drinking water contaminants are most difficult to perform so rhat the
effort yields information which has some applicability in the etiology
of cancer.
Recognizing some of the deficiences in these statistical studies, it
seems appropriate to develop ancillary studies in the experimental area,
using marine animal models to acquire data on tumor response chat may be
correlated with environmental profiles on chemicals that reflect qualita-
tively and quantitatively the extent of exposures. Epizootics can make
a significant contribution in support of the statistical hums.-! effects
studies. Such an approach is proposed for the acquisition of suggestive
evidence from the aquatic environment as a forerunner of human population
studies or concurrently a resource for augmentation of such h-jian studies
in the quest for statistical associations that have great relavance with
respect to causation. The achievement of such goals on causality relevant
to long-term, low-level exposures requires the input from a £ .iltidisclpline
approach reflecting project participation and collaboration cf many govern-
mental agencies, industrial groups, and International organizations.
Acknowledgements
The authors would like to acknowledge the assistance and cooperation in
collating some of the information from the Environmental Prot Action
Agency (Dr. R. G. Tardiff); the Environmental,Hutagen Information Center
(Dr. Michael D. Shelby) and the Stanford Research Institute £ caff
(Dr. V. F. Simmon, L. Cheney, P. C. Hall, B. A. Lewin, M. A. rower,
P. A. Sullivan and J. M. Walker). Appreciation is also exprtised to
Dr. E. K. Weisburger, National Cancer Institute for advice or. classifi-
cation of some of the carcinogens.
-s-
-------
MUTAGENICITY ASSAY
BACTERIAL SYSTEMS
CELL CULTURES
DRINKING H20 BIOREFRACTORIES
a) SINGLE CHEMICALS
b) MULTIPLE CHEMICALS
A. EXPOSURE TYPES - INGESTION
1. DRINKING H20 BIOREFRACTORIES
2. FISH RESIDUES - PROFILES ON CONTAMINANTS (BODY BURDEN)
B.. EXPOSURE MONITORING - DOSE ESTIMATION
I
I
I
W RODENT BIOASSAY
RESPONSE
STATISTICAL ASSOCIATIONS
NEOPLASIA - MAN
DRINKING H20 BIOSEFBACTORIIS
«) SINGLE CHEMICALS
b) MULTIPLE CHEMICALS
I
I
I
PRESUMPTIVE AND ASSOCIATED EVIDENCE - EPIZOOTICS
(TUMOR INCIDENCE - AQUATIC ANIMALS)
A. FERAL POPULATIONS - CONTAMINANTS IN RAW HjO
IDENTIFICATION - QUANTIFICATION
B. FISH AS EXPERIMENTAL ANIMALS - CAKCINOUENICITY BIOASSAY
1) SINGLE CHEMICALS
2) MULTIPLE CHEMICALS
Fig. 1. RELATIONSHIPS - ENVIRONMENTAL CANCER (AQUATIC ENVIRONMENT)
-------
CHEMICALS IDENTIFIED IN HUMAN
BIOLOGICAL MEDIA DATA BASE
Quarterly Report
February 1979
Health and Environmental Studies Program
Information Center Complex
Information Division
Oak Ridge National Laboratory
J. T. Ensminger, ORNL/DOE Principal Investigator
Cindy Stroup, EPA Project Officer
Interagency Agreement
US Environmental Protection Agency
US Department of Energy
EPA-78-D^X-383; DOE-40-712-78
Interagency Agreement
US Environmental Protection Agency
National Cancer Institute
EPA-78-R-X0257; NCI-Y01-CP-80205
-------
INTRODUCTION
A more relevant health exposure assessment to toxic
chemicals will be achieved by the systematic acquisition
of data on chemicals that have been identified in human
biological media (tissues and body fluids). These data
are a reflection of exposures to food, air and water
contaminants, as well as drugs. The establishment of a
data base of this information will provide a valuable
resource to the Environmental Protection Agency and other
regulatory agencies, the National Cancer Institute in
their carcinogenesis bioassay program, and other federal
and private agencies.
The establishment of a data base on chemicals
identified in human biological media is being accomplished
under an Environmental Protection Agency-Department of
Energy interagency agreement. The interagency agreement
is funded through a cooperative agreement between the
Environmental Protection Agency and the National Cancer
Institute. The work is being done by the Health and
Environmental Studies Program (HESP), Information Center
Complex (ICC), Information Division, Oak. Ridge National
Laboratory (ORNL). To date, efforts have concentrated on
the development of efficient procedures including review
and selection of data sources for routine manual searching,
data extraction, appropriate data storage and retrieval
systems, and a format for the tabular display of data in
an annual publication.
DEVELOPMENT OF PROCEDURES
Data Sources Identification
Staff of the Toxicology Information Response Center
(TIRC), ICC, ORNL are establishing a core list of pertinent
periodicals for routine manual searching at ORNL libraries
and the University of Tennessee. A provisional listing of
journals has been identified as follows:
Acta Pharmacologica and Toxicologica
Air Pollution Control Association Journal
Ambio
American Industrial Hygiene Association Journal
American Journal of Clinical Nutrition
American Journal of Obstetrics and Gynecology
American Journal of Public Health
Analytical Biochemistry
Analytical Chemistry
-a-
-------
- 2 -
Annals of the New York Academy of Sciences
Annals of Occupational Hygiene
Archives Internationales de Pharmacodynamie
et de Therapie
Archives of Environmental Contamination
and Toxicology
Archives of Environmental Health
Archives of Toxicology
Biochemical Journal
Biochemical Medicine
British Journal of Industrial Medicine
British Journal of Pharmacology
British Medical Journal
Bulletin of Environmental Contamination
and Toxicology
Chemosphere
Clinical Pharmacology and Therapeutics
Current Contents - Life Sciences
Ecotoxicology and Environmental Safety
Environment
Environmental Health Perspectives
Environmental Monitoring Series
Environmental Pollution
Environmental Research
Environmental Science and Technology
European Journal of Toxicology and
Environmental Hygiene
Experienta
Food and Chemical News
Food and Cosmetics Toxicology
International Journal of Environmental
Analytical Chemistry
International Journal of Environmental Studies
Japanese Journal of Pharmacology
Journal of Analytical Toxicology
Journal of Chronic Diseases
Journal of Clinical Pharmacology and Chemotherapy
Journal of Environmental Health
Journal of Environmental Pathology and
Toxicology
Journal of Environmental Science and Health
Journal of Epidemiology
Journal of Laboratory and Clinical Medicine
Journal of Epidemiology and Community Health
Journal of Nutrition
Journal of Occupational Medicine
Journal of Pediatrics
Journal of Pharmacology and Experimental Therapeutics
Journal of Toxicology and Environmental Health
Journal of the American Medical Association
-------
- 3 -
Journal of the Association of Official Analytical
Chemists
Lancet
Mosquito News
Nature
Naunyn-Schmiedegerg's Archives of Pharmacology
New England Journal of Medicine
New Zealand Medical Journal
Nutrition Reports International
Obstetrics and Gynecology
Pesticide and Toxic Chemical News
Pesticides Monitoring Journal
Pollution
Proceedings of the Society of Experimental Biology
and Medicine
Public Health Reports
Research Communications in Chemical Pathology and
Pharmacology
Residue Reviews
Science
Science of the Total Environment
Talanta
Toxicological and Environmental Chemistry Reviews
Toxicology
Toxicology and Applied Pharmacology
Toxicology Letters
Xenobiotica
In addition to published data, unpublished data and
information from on-going research will be included in the
data base with appropriate accompanying caveats. Foreign and
domestic researchers in pertinent fields are being identified
for contact regarding inclusion of the results of their work
in the data base.
Contacts with federal agencies (EPA, USDA, FWS, APHIS, FDS,
NIEHS, NCI) have been initiated in an effort to identify
pertinent information for inclusion in the data base. Existing
data bases will be evaluated for appropriateness.
Literature Collection
Manual searches of the literature for articles containing
information on chemicals identified in human biological media
currently cover a period from 1974 to the present; increased
retrospective searching is being considered. TIRC is estab-
lishing a file of hard copies of the selected references. Some
-------
of the compounds included in the approximately 500 documents
which have been collected are:
aldrin dieldrin
antimony fluoride
arsenic fluorine
bromine gold
cadmium heptachlor apoxide
cesium hexachlorobenzene
chlorine iron
chromium lanthanum
copper lead
ODD magnesium
DDE manganese
o,p'-DDE mercury
DDT mirex
o,p'-DDT molybdenum
nickel
nicotine
octachlorostyrene
pentachlorobenzene
platinum
polychlorinated biphenyls
rubidium
samarium
selenium
tetraethyl lead
tetramethyl lead
tungsten
vanadium
zinc
Data Extraction
Pertinent data extracted from collected articles are
entered on forms specifically designed for this data base.
The wide variety of information extracted includes chemical,
analytical, toxicological, pathological, demographic, and
bibliographical data. The data fields, along with descriptions,
are listed below. A sample of the data sheet currently being
used also follows.
INPUT TEAM
LITERATURE TYPE
LANGUAGE
HEADER
PUBLICATION
DATE
Input team — Identifies the group, data
base, and person completing the form.
Identifies type of publication. Uses the
following terms as required: report, journal,
letter, book, conference, dissertation.
Language other than English.
Accession number. This number appears on the
hard copy and in the alphabetical author card
file. The first two numbers indicate the year
and the remainder, the document number, e.g.,
78-1.
Year of publication.
-S-
-------
TITLE
AUTHOR
CORPORATE
AUTHOR
SPONSOR
PUBLICATION
DESCRIPTION
CHEMICAL
CAS PREFERRED
CAS NUMBER
FORMULA
WISWESSER
USE
SOURCE
TISSUE LEVELS
Title of the source document.
Last name first, comma, initials; if more than
one author, separate with semicolons.
e: Holleman, J.W.; Hammons, A.S.
If the document is a chapter in, or part of,
a larger publication, enter the author(s) in
[AUTHOR] field and the editor(s) in [PUB DESC]
along with the name of the whole publication.
Editors should be indicated as follows:
Hammons, A.S. (Ed.); Holleman, J.W. (Ed.).
Similar format should be used for translators:
Hammons, A.S. (Translator).
Generally, name(s) of place(s) where research
was done. Include address if available. .Use
standard state abbreviations, zip codes, when
available.
Sponsoring agency when different from corporate
authority.
Literature citation.
The chemical name as used in the publication.
This may be a trade name or a proper chemical
name. Include any synonyms or trade names that
appear in the document.
Chemical Abstracts preferred name.
Chemical Abstracts registry number
Chemical formula, Hill configuration.
Wiswesser line notation.
Major uses if given; use to which chemical was
being put in situation being reported.
Immediate source, or possible source of chemical;
e.g., leaky valve, auto exhaust, etc.
Tissue or organ and concentration; where given,
this will include mean and range.
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- 6 -
ANALYSIS
ROUTE
HALF-LIFE
CASES
SEX
DEMOGRAPHY
HEALTH
PATHOLOGY -
MORPHOLOGY
SUBJECT
CATEGORY
KEYWORDS
COMMENT
Analytical technique(s) used for measurements.
Use terms from EPA thesaurus.
Route of exposure: inhalation; ingestion; injection.
Use terms from EPA thesaurus.
Half-life
Number of cases in arable numerals. If control
values, follow # which (C), i.e., 20; 22(C).
Use letters: F, M.
Demographic data.
Descriptive key words for health effects, e.g.,
carcinogenesis. Use terms from EPA thesaurus.
Descriptive key words for pathology and morphology,
e.g., cirrhosis; necrosis. Use terms from EPA
thesaurus.
Subject category; broad field description.
Important descriptors (in upper case), e.g., REVIEWS,
ABSTRACTS; POISONING, SUICIDE, OCCUPATIONAL DISEASES;
CARBOHYDRATES, ENZYMES, PROTEINS; MUCOPOLYSACCHARIDES;
EXPERIMENTATION; METALS; AIR POLLUTANTS; LEAD; LUNGS;
URBAN AREAS. Use terms from EPA thesaurus.
Comments which clarify or add pertinent information
to that found in other fields.
--7-
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- 7 -
DATA SHEETS
INPUT TEAM
LITERATURE TYPE
LANGUAGE
HKADER
DATE
TITLE
AUTHOR
CORPORATE AUTHOR
SPONSOR
PUBLICATION DESCRIPTION
CHEMICAL
CAS PREFERRED NAME
CAS NUMBER
FORMULA
UISWESSER
•DSE
SOURCE
-------
- 8 -
DATA SHEETS
Pag* 2
TISSUE LEVELS
ANALYSIS
HALF-LIFE
ROUTE
CASES
SEX
DEMOGRAPHY
HEALTH
PATHOLOGY - MORPHOLOGY
-------
- 9 -
DATA SHEETS Page 3
KEYWORDS
COMMENTS
SUBJECT CATEGORY
-------
- 10 -
Annual Publication
The data base will be routinely updated and published annually in a
tabular format which is currently being designed. An example of the
proposed format is appended. A complete bibliographic listing will
also be included in addition to the tabular data. A distribution
list will be developed in consultation with the EPA project officer.
Additional reports will be made available through the National Technical
Information Service.
Response Activities
To facilitate searches of the data base, cross-referenced files will be
organized. Searches will be initially performed by either author,
chemical, or tissue. It is anticipated that the data base will be
established so that responses can be made to requests for specialized
searches by October 1, 1979.
PERSONNEL
Health and Environmental Studies Program
At the present time, there are two part-time and one full-time employees
involved in organizing material for the data base. These people hold
Masters degrees in Public Health Nutrition and Biology, respectively.
Two have had teaching experience at the college level. Their work experi-
ence includes laboratory research and writing of appropriate papers and
reports in the areas of developmental biology, respiratory carcinogenesis,
and immunology. For the past several years, all three have been involved
in establishing and maintaining a variety of data bases in the Ecological
Sciences Information Center at ICC, ORNL. These data bases deal primarily
with energy related literature, such as the environmental and medical
aspects of the nuclear fuel cycle. The staff has considerable expertise
in selection of appropriate documents as well as interpretation of data
and summarizing them for the data bases.
Toxicology Information Response Center
The staff has varied technical backgrounds in the sciences — chemistry,
biology, and ecology. Several staff members have advanced degrees and
working experience in a laboratory environment. In addition, they have
extensive experience in searching the technical literature. TIRC main-
tains a toxicology reference library and subject files. It also has
access to the ORNL library system as well as libraries at nearby univer-
sities and hospitals. These provide an abundance of valuable resources.
PUBLICATIONS
ORNL quarterly reports will contain a summary of the progress-to-date on
the establishment of the data base. In addition, quarterly reports will
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- 11 -
list all the chemicals/compounds that have been identified in the
literature and incorporated into the data base. Distribution of the
quarterly reports will be to members of the Task Group on Chemicals
in Human Tissues under the aegis of the ICGEC and a limited number of
private researchers.
The data base will be routinely updated and selected data published
annually in tabular format (proposed format below). In addition to a
.tabular format, a complete bibliographic listing and series of
indices will assist the user in searching the published data. The
first annual report will include data collected.through August 1979
and will be available by October 1979. Annual reports will have wide
distribution among federal agencies and private investigators as well
as be available for purchase from the National Technical Information
Service.
SAMPLE OF PROPOSED FORMAT FOR ANNUAL REPORT
r.\s ::»ae,
Ni:-ber
Lead
7i 39-92-1
Tissue
Blood
Blood
Ratine
a) 7-80 -jg/100 ml
b) 9-20 ug/100 ml
a) 28-57 ug/100 nl
b) 15-63 pg/100 ml
Mean
a) 25.4 ug/100 nl
b) 15.2 ug/100 ml
a) 40 ug/100 nl
b) 32 ug/100 nl
Number
of
Cases
a) 34
b) 10
215 chil-
dren, 105
•others
Exposure
Route
Ingestion
Inhalation,
Ingcttclon
Analytical
Method
AAS
AAS
Comment a
a) autistic, atypical
b) normal
Levels significantly higher In
flucistic than in atypical and
normal children. Differences
between atypical and normal not
significant.
a) 0-100 M from smelting works
b) 4.00-500 M fron snelting works
Levels of 40 us or more/ 100 ml
blood suggests excessive exposure.
There is no significant relation-
ship between intelligence and
behavior disorder and current Pb
level.
Reference
Cohen, D.J.
Johnson, W.I.
Caparulo, B.I.
1976
Lansdown, R.G.
Clayton, B.E.
Graham, P.J.
Shepherd, J.
Delves, H.T.
Turner, U.C.
1974
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EPA's
Computerized
Water Quality
Data Base
the right
answer
U. S. Environmental Protection Agency
Office of Water arrd Hazardous Materials
Washington, D. C.
-------
Sto lT€t provides
water
quality data
on the
right
parameters
Some 1800 unique water quality parameters are defined within rtoret Ap-
proximately 80% of the 40 million individual observations available
within the system pertain to approximately 200 of these pa-
rameters which are grouped into the general cate-
gories shown in the table to the right A single
observation represents a measurement
of a single parameter at a spe-
cific location, or station,
at a specific point
in time.
MAAMETER GROUPS
at the
right
stations
storet contains data on samples taken from
more than 200.000 unique collection points
located on essentially all of the Nation's rivers.
lakes, streams, and other waterways. The shadings
of the map reflect the relative concentrations of
sampling and monitoring stations. The blow-up
of the Saginaw River Basin shows its drainage
area and the specific locations of sampling points.
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collected
and used
by the right
people
— State Agencies
— Cities and Counties
— Interstate Commissions
— Water Quality Managers
— Environmental Planners
— Sanitary Engineers
- EPA Regional Offices
— EPA Laboratories
— Federal Agencies
— Canadian Agencies
— U. S. Territories
These individuals and organizations actively
participate in the collection, storage, retrieval and
analysis of water quality data. All utilize store*
for these efforts, contributing to the quality and
quantity of the parameter observations described
on the opposite page. Several Federal agencies-
including the U. S. Forest Service, the U. S. Army
Corps of Engineers, the Bureau of Reclamation,
the U. S. Geological Survey, and the Tennessee
Valley Authority—complement the efforts of those
having specific geographical interests. Over 40
states, as well as many other organizations, have
direct access to storat for both storage and
retrieval, thereby contributing significantly to the
timeliness of storat's data.
and
presented
in the right
formats
and storet
can help
you
The array of representative reports pictured here
exemplifies the versatility of storat and its water
quality data to help users prepare a myriad of
detailed, summary, or exception reports relative
to their specific areas or locations of interest Data
reported can reflect the latest most current infor-
mation available, or it can draw upon the histori-
cal depth of the data, going back as far as the
late '50s. Most users obtain their reports from
small portable computer terminals conveniently
located in or near their offices.
These two pages have presented an overview of
the data available! within store! The inside
pages describe several examples of how various
users today, utilize storet to achieve a variety
of objectives relating to water quality assessment
and management. __
-------
A river basin Is the area drained by a single river
and its tributaries. A water quality management
basin plan is a management document mat iden-
tifies the water quality problems of a particular
basin, or portion of a basin, and sets forth an
effective remedial program to alleviate those
problems. Overall basin needs and priorities are
assessed, actions scheduled, and the necessary
coordination with concerned organizations
planned.
basin
planning
The needs and priorities are based largely upon
water quality data and the analysis of this data.
For example, fecal coiiform bacteria is a common
indicator of pollution problems in areas affected
by major municipal/industrial activity. A plot of
coiiform along a stretch of a river can quickly
ascertain the presence of a bacterial source and
the extent of a pollution problem.
The development of an effective planning proc-
ess is crucial to effective water quality manage-
ment This is particularly true for river basin
planning as required under various sections of
PL 92-500. River basin plans are primarily the
responsibility of the states, and the law delineates
the rather extensive amount of information that
must be provided.
•^
;
_«*,
.]
research
In order to achieve our national objective of
having water that is clean enough both for recre-
ational activity and for the protection of fish and
wildlife, numerous research and development
efforts have been initiated to acquire a thorough
understanding of the complex and variable bio-
logical systems that characterize our waterways.
Research tells us what a specific level of a specific
pollutant does to humans, animals, and crops. It
establishes thresholds at which we might expect
adverse effects from environmental pollutants.
alone or in combination. (And from these
thresholds, criteria for water quality standards can
be established.) It provides the basic scientific
knowledge we need to safeguard the public health
and to balance the benefits of a specific product
against its environmental risks.
A representative effort is that of the EPA Grosse
lie Laboratory's Research Program to improve the
water quality of the Great Lakes. This Lab is in-
volved with a number of other agencies in devel-
oping the scientific information needed to assess
the effectiveness of implemented programs on
Great Lakes water quality, to form the basis for
needed control actions, and to develop the scien-
tific information needed to support the Canadian/
U. S. Agreement for the Great Lakes. Over a
dozen 0. S. and Canadian agencies, universities.
and joint commissions are participating in this
extensive program launched in 1972.
Since this is an on-going, international program
involving both water quality management and
research, it is essential that ail data gathered on the
water quality of the Great Lakes be readily accessi-
ble by all investigators. Accordingly, all participants
are required to enter all collected data into store!
thereby greatly expediting the use and analysis of
the information through sharing of data. This sig-
nificant multi-organizational research program not
only illustrates the value of storet in research-
oriented endeavors, but also it demonstrates how
the use of an accepted central system can foster
cooperation among a group of organizations
sharing common interests.
CHLOROPHYLL A IN LAKE ONTARIO
TWO PERSPECTIVE VIEWS
-------
monitoring
& surveillance
The data in storat originates from samples taken
as part of individual monitoring programs con-
ducted by the states and other organizations.
Several objectives of these monitoring efforts are
to identify and assess quantitatively the magnitude
of existing and potential water pollution problems.
and to detect any trends or changes over a period
of time. Reports such as the trend plots shown
here, which show presence of phosphates and
ammonia as a function of time, vividly point out
where problems do and do not exist
npdes
permit
program
Far-reaching goals were established by PL 92-500:
By 1983, water dean enough for swimming,
boating, and protection of fish, shellfish, and wild-
life; arid by 1985, no discharges whatsoever of
pollutants into the Nation's waters! To achieve
these ambitious but essential goals, the law estab-
lished a national permit program, known as
NPDES-the National Pollutant Discharge Elim-
ination System, to control the discharge of pol-
lutants into any waterway. This program is the
mechanism for insuring that effluent limits are
met that the necessary technology is applied, and
that all requirements of the 19721aw for con-
trolling discharges and complying with water
quality standards are met on schedule. Permits
are to be granted to individual dischargers only
after they show that their effluents will not con-
taminate a waterway in excess of established water
quality standards, or will not lower its existing
quality.
The law allows polluters time to improve facil-
ities, but provides that corrective programs must
meet the "best practicable" and "best available"
standards of water pollution control technology
by 1977 and 1983 respectively.
sa.*s~S!a :- ~ —
•r=.-j-ssr,••*;, -- -a
sajusas. -, --,. -_
..—<-• T ssr ,=i sT.'w
EFFLUENT VIOLATIONS HCPORT
-------
progress
reporting
Under Section 305(b) of PL 92-500, states are
required to submit annual reports to EPA on
sources of pollution—their nature, extent recom-
mendations for control and the cost of these
controls. (An excerpt from the State of Michigan's
305(b) report is shown below.) As practices be-
come more sophisticated, these reports should
reflect the effects of these sources on the pollu-
tion of groundwaters, and provide an inventory of
wells which can be used to determine ground-
water quality within a state's jurisdiction.
A new activated sewage treatment plant was built
on Fountain Creek below Colorado Springs in
late 1972. The data in storat collected prior and
subsequent to the implementation of the new
plant were compared. The number of violations
tor dissolved oxygen had dropped from 53% to
7%, for dissolved solids from 59% to 33%, for
BOD from 85% to 73%, and for fecal coliform
from 89% to 58%. Similar improvement occurred
and was demonstrated when a sewage treatment
plant was built in the Fargo, North Dakota area.
These examples show the applicability of using
the data in storat to demonstrate progress either
from an over-all point of view or from the view-
point of a single effort
am AT nemo:
I "••
51
s «.<
S «*•
iurar auujrr
r nif — a if*x*fD ir rm warn aantirr tmat
IT T* '«
CF~ OBSERVATION
standards
& criteria
Associated with specific water uses are the water
quality standards which must be met in order for
the water to be used for its intended purposes.
consistent with the 1983 goals of water quality.
Once standards have been established by states
in accordance with national criteria, it is necessary
to monitor the effect of water pollution abatement
and control activities relative to those criteria. A
number of storrt report programs can be used.
such as the ones pictured below, to track the
progress of water quality improvement efforts.
£ viuuwiwna- vwtnt • J • •* «?**/'-•''
- SUPPORTING PARAMETERS --" '
-v^V^ V
'XA •-^"VIOLATIONS
-------
Although many substances are potentially toxic to
aquatic life and other organisms when present in
sufficient concentration for a sufficient period of
time, the term toxic substances generally refers to
those substances which are dangerous even in
very low concentration. Consequently, the 1977
and 1983 deadlines for limiting pollutant dis-
charges do not apply in the cases of these deadly
substances, such as mercury, cadmium, and
toxaphene. Steps required to meet standards
established for toxic substances must be taken
quickly to protect the public health and welfare.
To this end. EPA is empowered to restrain dis-
charges of any pollutants which present an im-
minent and substantial endangcrment to the
health or livelihood of the public.
All toxic substances for which water quality anal-
yses have been performed are defined .vithin
store! and the system can easily accommodate
the inclusion of additional substances jpon their
discovery- Reports such as the one shown below/
(from a Council on Environmental Quality report)
can be readily obtained from stotwtdata to dem-
onstrate the presence or absence of 'oxic ^ub-
stances in any body of water for which data
are available.
in
the
answer
These have shown a number of male
of and its wealth of water quality data, by
a variety of governmental agencies and other
organizations. To further underscore the role that
can play to help you fulfill your water
quality assessment and management objectives,
consider the following additional answers that
t can provide.
• Help evaluate cost-effectiveness of previous-
ly implemented water quality programs
Help promote water quality programs by
substantiating the effectiveness of other
similar programs
• Help justify budget requests for water
quality programs
• Help cut sampling costs by coordinating
efforts with other organizations
- Provide a repository for your data collec-
tion efforts
• Help identify where monitoring efforts are
needed, thereby determining where funds
need to be allocated
• Help design overall programs based upon
the successes of others
• Help complete water quality management
basin plans
- Help prepare fact sheets required by
permit applications
• Detect changes in pollutants that could
change existing permits
How can help you?
-------
epa
The Environmental Protection Agency was
created in 1970 to foster an integrated, coordi-
nated attack on environmental pollution in
cooperation with state and local governments. EPA
endeavors to abate and control pollution system-
atically by proper integration of a variety of
research, monitoring, standard setting, and en-
forcement activities. Through Public Law 92-500,
EPA has the overall responsibility to provide water
that is clean enough both for recreational activity
and for the protection of fish and wildlife. In-
herent in this charter is the requirement of main-
taining an information inventory concerning the
quality of the Nation's waters.
storet
storet is a computerized data base utility main-
tained by EPA for the storage and retrieval of
parametric data relating to the quality of the
waterways of the United States. The system was
conceived and initiated under the auspices and
administration of the Public Health Service in the
early 1960s. Since its early days when storet
input and output was achieved via the mails, the
system has evolved into a comprehensive infor-
mation data base, accessible by hundreds of users
via computer terminals located throughout
the country.
storet—
the right
answer
This publication was prepared to provide an over-
view of the content and capabilities of the storet
system, and to describe a number of uses made
of this information by those organizations con-
cerned and involved with the abatement and
control of water pollution within the United States.
for more
For further information on how storet can help
you fulfill your needs with respect to the collec-
tion, reporting, and analysis of water quality data.
contact your local storet representative.atoret
User Assistance in Washington. D*C. (20?-
426-7792) can give you names and phone
numbers. i« _
------- |