PB-238 196
IDENTIFICATION SYSTEMS FOR SELECTING CHEMICALS OR

CHEMICAL CLASSES AS CANDIDATES  FOR EVALUATION
BATTELLE  COLUMBUS LABORATORIES
PREPARED  FOR
ENVIRONMENTAL PROTECTION AGENCY
ROPERTY OF
  A  LIBRARY
  RTP,  NC

NOVEMBER 1974
                         DISTRIBUTED BY:
                         National Technical Information Service
                         U. S. DEPARTMENT  OF  COMMERCE

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BIBLIOGRAPHIC DATA
SHEET
1. Report No.
  EPA-560/1-74-001
                                                     2.
4. Title and Subtitle
  Identification Systems For Selecting Chemicals or Chemical
   Classes as Candidates for Evaluation
         PB   238   196
            5. Report Date
              November  1974
                                                 6.
7. Author(s)
 James  E.  Flinn, Theodore J. Thomas, Mllo  D.  Bishop
                                                 8. Performing Organization Kept.
                                                   No.
9. Performing Organization Name and Address
  Battelle, Columbus Laboratories
  505  King Avenue
  Columbus, Ohio 43201
                                                 10. Project/Task/Work Unit No.
                                                 11. Contract/Grant No.

                                                    68-01-2108
12. Sponsoring Organization Name and Address
   Environmental  Protection Agency
   Office of Toxic  Substances
   401  "M"  Street,  S.W.
   Washinqton. D. C.   20460	
                                                 13. Type of Report & Period
                                                    Covered

                                                    Final  Report
                                                 14.
15. Supplementary Notes
16. Abstracts
   Please see attached Abstract
                                                                               \
17. Key Words and Document Analysis.  17a. Descriptors
   chemical  compounds;  screening  (selection);  systems;  toxicity;  hazardous  materials;
   public  health
17b. Identifiers/Open-Ended Terms
    identification/selection systems; Environmental Protection Agency; toxic  sub-
    stances;  environmental effects;


                                                             PRICES SUBJECT TO CHANGE

i7c. COSATI Field/Group Biological and  Medical Sciences; Environmental  biology;  Toxicology
18. Availability Statement
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              INFORMATION SERVICE
                US D*p*rtn»nt of Commerce
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 -RM NTis-ss (REV. 10-73)  ENDORSED BY ANSI AND UNESCO. ',
19.-Security Class (This
   Report)
     UNCI.AgS.FlER
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(21.
                                                              No. of Pages
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                                                                                 USCOMM-DC 82eS-P74

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                                ABSTRACT .

          This report summarizes the state of the art on systems, either
existing or conceptual, that can be used or adapted for use to select,
assess, and prioritize chemicals for their health or environmental effects.
It is found that, while numerous systems can be identified, none have been
formulated with sufficient breadth to permit accomplishing all the functions
                                                    (.  i   ».
desired by EPA's Office of Toxic Substances.  These functions include:

          (1)  Identification of chemical hazards to man and his
               environment
          (2)  Selecting chemicals not already in use
          (3)  Assessing potentially hazardous degradation products
               or synergistic effects
          (4)  Assessing hazards to plants, animals, and the non-
               living environment.
          Effective combinations of limited scope systems have been
assembled by Federal agencies to achieve the chemical identification/assess-
ment/prioritization functions needed for such public concerns as the work-
place environment; human health (cancer, child poisoning, birth defects);
air, water, and land contamination; and consumer-product hazards.
Examination of the operational basis of a number of the individual systems
within these combinations suggests that all are variations of a relatively
few number of approaches to chemical selection.
          A seminar on "Early Warning Systems for Toxic Substances", held
in conjunction with this study effort, confirms many of the findings
reported herein.

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This report has been reviewed by the
Office of Toxic Substances, EPA, and
approved for publication.  Approval
does not signify that the contents
necessarily reflect the views and
policies of the Environmental Pro-
tection Agency, nor does mention of
trade names or commercial products
constitute endorsement or recommenda-
tion for use.

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                                ABSTRACT

          This report summarizes the state of the art on systems, either
existing or conceptual, that can be used or adapted for use to select,
assess, and prioritize chemicals for their health or environmental effects.
It Is found that, while numerous systems can be Identified, none have been
formulated with sufficient breadth to permit accomplishing all the functions
desired by EPA's Office of Toxic Substances.  These functions include:

          (1)  Identification of chemical hazards to man and his
               environment
          (2)  Selecting chemicals not already in use
          (3)  Assessing potentially hazardous degradation products
               or synergistic effects
          (4)  Assessing hazards to plants, animals, and the non-
               living environment.
          Effective combinations of limited scope systems have been
assembled by Federal agencies to achieve the chemical identification/assess-
ment/prioritizatlon functions needed for such public concerns as the work-
place environment; human health (cancer, child poisoning, birth defects);
air, water, and land contamination; and consumer-product hazards.
Examination of the operational basis of a number of the individual systems
within these combinations suggests that all are variations of a relatively
few number of approaches to chemical selection.
          A seminar on "Early Warning Systems for Toxic Substances", held
in conjunction with this study effort, confirms many of the findings
reported herein.
                                   iii

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                                   CONTENTS

Section

  I       Conclusions                                                    1

  II      Recommendations                                                3

  III     Introduction                                                   *

  IV      Study Approach                                                 6

  V       Results                                                        9

  VI      Appendices

          A.  Bibliography of Machine-Searched Literature                A-l
          B.  Contacts for Information Gathering Purposes                B-l
          C.  Seminar on Early Warning Systems for Toxic Substances      C-l
          D.  Identification/Assessment Systems                          D~1
          E.  Chemical Information Systems and Centers                   E-l
          F.  Management Summary from CPEHS Study                        F-l
          G.  Summary from an OVERVIEW Study                             G-l
          H.  Newsletters, Periodicals, and Other Publications
                Pertinent to the OVERVIEW Program                        H-l

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                                SECTION I

                               CONCLUSIONS

          Numerous systems exist which have as their objective the identi-
fication of adverse chemical effects on human health and/or the environment.
Nearly all have been formulated within a relatively narrow framework of
applicability or use; as such, they are not readily adaptable to the needs
of EPA1s Office of Toxic Substances (OTS).  Nevertheless, many of these
systems could represent important adjuncts to any OTS efforts to monitor
public exposure to various chemicals.  For example, many of these systems
have well established sensor networks which are valuable early indicators
of problem substances.
          Existing systems can be classified in several ways.  Early in
the program it became apparent that a major system class was the information
repositories for chemical data - especially toxicity data.  These information
centers are numerous, frequently provide automated storage and retrieval
and generally have a defined albeit limited scope.
           Systems  other  than  information centers  can be  classified with
 respect to whether their principal  function  is  to Identify chemical sub-
 stances before  general exposure  of  the  public and environment occurs
 (input surveillance), or after such occurs  (output surveillance).  Each
 of these  types  can be further aubcategorized  into those  which baoically
 seek  to identify  new or  unrecognised  chemical stressors  and  those which
 •eek  to evaluate  the hazard of a recognized  stressor.
           Systems  differ  in the  manner  in which • candidate  lift of substances
 for evaluation  is  Identified   and  comprise     (1) systematic literature
scanning,  (2) licensing,  (3) test protocols,  (4)  expert  panels,  (5) data
base  sampling,  accumulation, or  analysis,  (6) incident reports, etc.
Conversely, an  examination of the design basis of existing systems
suggests  only a few  basic approaches  for assessment/prioritlzatlon  (or
categorization) functions.  Three of  these are  the use of  experts, a
 numerical index of measure or'hazard,  and  subjective weighing factors  or
assigned  values for  selected parameters  felt to be of importance.

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          Finally,  most existing systems are deficient with respect to
satisfying OTS's specified needs in that they generally:
          (1)   Focus on acute effects rather than long-term (chronic)
               effects
          (2)   Have a limited domain of concern
          (3)   Are  not designed to identify hazards from degradation
               products, synerglstic effects or effects on the non-
               living environment.

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                              SECTION II

                            RECOMMENDATIONS

          The following recommendations are based on the results of this
study and the associated seminar.
          •  Efforts to identify pertinent activities of Federal, State,
             industrial, and, perhaps, private organizations with needs
             relating to chemical identification and assessment should
             continue.  For example, chemical firms and their associa-
             tions, Federal agencies like the Department of Transpor-
             tation, Atomic Energy Commission, Department of Defense,
             etc., and organizations privately developing chemical data
             systems might be examined.
          •  A comprehensive sensor network should be planned as an
             essential element of OTS's efforts to identify candidate
             substances for regulation.  To the maximum extent
             possible this network should be integrated with the well-
             established networks of other Federal agencies.
          *  A study should be made of the more important existing
             information systems and centers to assess, In the context
             Of OTS's needs, (a) the existence of useful data for
             chemical selection and evaluation, (b) the format and
             accessibility of the data, and (c) the costs of retrieval
             (and manipulation) of needed data.
          •  OTS should seek to interface with current U. S, and foreign
             efforts to develop computericed chemical data storage and
             retrieval systems (e.g., RADICAL and ECDIS*) because of
             the potentially important role such systems could play
             in identification/assessment 'efforts.
          •  A systematic and comprehensive examination should be made
             of all known chemical, physical, toxicological, economic,
             environment, etc., parameters (indices) that might find
             use in identification, assessment, or early warning efforts.
             Relating such parameters to available data sources should
             be an essential part of the study.
*See Appendix E,

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                               SECTION III

                              INTRODUCTION

          Technological advances have resulted in the introduction of
large numbers of chemical substances into widespread use.     The majority
of these are used in ways that are directly or indirectly beneficial to
man.  Others, like cadmium, mercury, polychlorinated biphenyls, hexachloro-
benzene, vinyl chloride, and DDT, have raised serious public concern over
their uncontrolled adverse health and environmental effects.  Consequently,
new approaches are being sought for the identification, assessment, and
regulation of chemicals either presently in use or which may be coining
into the marketplace.

                                The Need

          The Office of Toxic Substances (OTS), established by EPA in
                                                                (2)
anticipation of legislation for the control of toxic substances,    has
initiated this study of existing or potential Identification/assessment
systems that might be adapted as an approach to the problem.  The
specific questions raised by OTS are the following:
          (1)  How can a given system select both chemicals and
               classes of chemicals that are hazardous to man
               and his environment?
          (2)  How can a given system preselect chemicals not
               already in use, before they become widely
               dispersed and more difficult to control?
          (3)  How can a system select chemicals based on the
               potential hazard of their degradation products
               or their synergistic properties?
          (4)  How should the system consider hazards to plants,
               animals, and the nonliving environment?
          The need to answer these questions takes on added Importance when
the magnitude of the problem Is considered.  On the basis of the Chemical
Abstract Service Registry Number System alone, some 2 million chemical

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entities can be identified.   It has been estimated that another 250/000
are added each year, and that several hundred are introduced into
commercial use annually.  U.S. production of synthetic organic chemicals
for various classes of consumer products amounted to nearly 60 million
tons in 1969.     Federally registered pesticide formulations amount to
more than 60,000.     The widely diverse uses and disposal of commercially
available bhemicals and their proliferation into new product lines or
formulations further complicate the problem.  Furthermore, a plethora of
pathways exists by which these chemicals or their degradation products
find their way into the environment.
          The selection of specific chemicals for regulation, testing for
health and/or environmental hazards, or the development of standards for
control of exposure levels must be done in most instances with either
incomplete, inadequate, or nonexistent data on long- and short-term health
and ecosystem effects.  To acquire such data on every chemical as an aid
to selection is considered much too costly.  Costs ranging up to $440,000
for animal toxiclty. testing of a single chemical have been estimated by
the. chemical Industry.     Furthermore, selection without such data might
unnecessarily inhibit the commercialization of chemicals of potential
benefit to the general society, since their associated risks could not be
adequately assessed in the absence of such data.

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                               SECTION IV

                             STUDY APPROACH
                                       •
          To answer these questions a literature and state-of-the-art
search was made to Identify systems - either in use or only conceptual -
in two general areas of society: health planning (including environmental,
occupational, and general health) and environmental management.  The
term "system" was broadly defined to Include not only formalized organi-
zational structures, models, methodologies, but also legs formal tools,
methods, working groups, etc., which have been conceived, formulated,
and applied to the identification, prediction, assessment, or prioritization
of chemical substances or effects.  A variety of activities comprised the
total Information gathering effort and these will be briefly described.

                            Literature Search

          A proprietary computerized health Information system was
utilized to conduct a literature search for identification systems for
selecting chemicals or chemical classes as candidates for evaluation.
This system incorporates every available major medical bibliographic
resource and major medical library information resource including the
National Library of Medicine  (MEDLINE).  In addition, searches of other
data bases such as Food and Drug Administration Abstracts, Chemical and
Biological Abstracts, American Society of Pharmacists.Abstracts, and
previously developed information data bases of the Environmental
Protection Agency together with the medical information services maintained
at The Ohio State University were Included.  Reference sources included
published health periodicals, monographs, published books, proceedings
of symposia, and legal periodicals.  The Indexing system used la
compatible with The National Library of Medicine.  Terms used for
specific indexing are based on health effects.
          The comprehensive health-systems Information system covers
1940 to 1972, with major emphasis on the last 10 years in predominantly

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English language publications.  ' A special search utilizing the TOXLINE
data base covers 1965 to 1972.   Current inclusions in information aystains
have a recognized lag of 8 to 10 months behind publication dates.
          Other information was obtained from Battelle-Columbus' own
resources, especially the Ecology Information and Analysis Center, and a
machine search of recent NTIS holdings.
          The articles and abstracts compiled from the machine-searched
literature were provided in Battelle's Task A report dated October 26, 1973.
Of the 300 or so articles identified, approximately 70 were selected as
having some particular relevance to this program.  A bibliography of these,
keyed to a subject index, can be found in Appendix A.

                                Contacts

          Contacts were made by telephone and visits to Federal  agencies
in acquiring inputs to this study.  Appendix B provides a listing of
these by agency, section  (where known), and individual.  The  approach
generally was to telephone a contact who would either provide on-the-
spot information, forward written material for review, or agree
to a visit for further discussion.  A concurrent  seminar effort  (see next
heading) provided a more  expanded range of contacts than would have been
possible otherwise.

                                 Seminar
  4
          Supplementing this effort was a seminar program on  "Early Warning
Systems for Toxic Substances" which provided additional insights Into  the
questions raised.  This seminar, partially funded as an addendum to this
program by OTS  (NSF,  NIEHS,  and Battelle were also cosponsors) in described
in detail in a "Task  C" report  Issued separately  under this contract.  A
portion of that report is Included as Appendix C.  Because the seminar effort
was accomplished concurrently with this program,  considerable cross-
fertilization between the two  efforts occurred, thus aiding materially in
the formulation of the study results.

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          The premise of the seminar was that a number of governmental,
industrial, and private organizations today are faced with the need, in
their sphere of concern, for new approaches to identifying and assessing
before-the-fact chemical substances which pose a hazard to man or the
environment.  Since such efforts must be accomplished within the limitations
of finite dollar and manpower resources, a means of assigning priorities
to potentially hazardous chemical substances is needed.  Furthermore, the
priorities must be assigned in most cases on the basis of incomplete or
nonexistent data on long-term and low-level toxic effects; risk involved;
and related factors.  Thus, the seminar was formed to examine the tools
which exist for identifying and assessing chemical hazards as well as for
alerting the public to these in a controlled manner.

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                                SECTION V

                                 RESULTS

          In this study no one system has been found with the capabilities
Implicitly or explicitly referred to In the four questions raised as the
basis of this study.  Rather a great many systems have been identified
which singly or in combination provide some of the functions desired In
the selection of chemicals with respect to their hazards to man and the
environment.  Nearly all of these do so within a limited domain of concern,
i.e., the workplace, the air, water or land environment, an ecosystem, or
an aspect of human health (cancer, poisoning, aging, birth defects).  From
the standpoint of the mission of EPA's Office of Toxic Substances, this
diversity of systems represents an asset, one to be capitalized upon in
seeking the identification and hazard evaluation of chemicals for which
regulatory actions ought to be Imposed.  Conversely, this same diversity
complicates the problem of effectively gaining access to all the data
necessary to provide a regulation which properly balances public risk,
cost, and benefit.
          Tables 1 lists a number of systems which were Identified in
the course of this study.  Most of these were described in the Task A
report Issued separately under this contract.  An expanded version of the
Task A descriptive material on the Identified systems is included as
Appendix D.
          It has been found useful to separate the Identified syaterns into
two major categories depending upon whether  their principal purpose was
to identify or evaluate environment or health atressors either prior to
general exposure of the public and environment (Category I) or after
widespread exposure or use occurs (Category  II).  The first category was
referred to as input surveillance (and assessment) and the latter as output
surveillance.  Each of these categories can be further subcategorized
depending on whether the system activity is primarily related to identifying
the existence of a possible health or an environmental stressor.   In Table 1
the identified systems are listed with a Judgment regarding their appropriate
categories as follows:

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                                   10
          I.  Input Surveillance
A.  New Stressor
    Identification
B.  Hazard Assessment of
    Recognized Streseors
         • II.  Output Surveillance
A.  New Stressor
    Identification
B.  Hazard Assessment of
    Recognized Stressors
          One large class of systems identified in this program is the
information repositories or data banks, some automated for storage and
retrieval, others simply collections assembled in one location.  Table 2
lists a number of these selected from an initial list of approximately 650
                                         (4)
information centers in the United States.     Appendix E contains an
expanded description of the data sources of Table 2,  The list, not meant
to be complete, is divided into groups with or without computerized
access and further as primarily chemical, medical, or general sources of
information.  The listing suggests that considerable amounts of information
for chemical identification or assessment purposes is available.  The
problem is to determine what is available, its form, and its accessibility
for identification/assessment purpose.  More extensive examination of these
type systems was felt beyond the scope of this study.
          Efforts under way In the U.S. and Europe to develop new infor-
mation systems specifically aimed at the problem of toxic substance
identification/assessment needs have been identified.  Two of these are
the (1) RADICAL and (2) ECDIS.  Descriptions of these are also included in
Appendix E.
          Following this summarization of the systems previously Identified
in the Task A report a number of systems that have chemical identification/
assessment as a primary function will be reviewed in more detail.  These will
be described in the context of their sphere of usage as follows:
          e  Occupational Health

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                           TABLE 1.  IDENTIFICATION/ASSESSMENT SYSTEMS*
         System Identifer
                                                   Sponsor
                                   IA
Category
IB    IIA
I IB
(1)  Carcinogen Screening

(2)  Animal (Rat) Toziclty Test
(3)  Short-Term (Hamster) Cancer
       Test
(4)  Biological Materials
       Surveillance
(5)  Surveillance of Poisons
(6)  Radiological Product
       Surveillance
(7)  National Evaluation of X-Ray
       Trends
(8)  Biologies Licensing
(9)  Drug Surveillance
(10)
              Hazard Identification
(11) Poison Control Centers
(12) Epideaic Intelligence Service
                                       International Agency for Research
                                         Against Cancer
                                       Center for Disease Control
                                       National Cancer Institute
                                       Bureau of Biologies, Food and
                                         Drug Administration
                                       National Clearinghouse for
                                         Poison Control, Food and
                                         Drug Administration
                                       Bureau of Radiological Health,
                                         Food and Drug Administration
            Ditto
Department of Health, Education,
  and Welfare
Bureau of Drugs, Food and Drug
  AHm-tnia tra t ion
National Cancer Institute
State Departments of Health
Center for Disease Control
                                   X
                                   X
                                         X
X

X

X

X

X
              X
                                                X
       X
       X

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                            TABLE 1.  IDENTIFICATION/ASSESSMENT SYSTEMS*
                                           (Continued)
         System Identifier
            Sponsor
LA
Category
IB    HA
IIB
(13) Rational Electronic Injury
       Surveillance System

(14) National Surveillance Network -
       National Occupational
       Health Survey

(15) Toxic Substance List

(16) Prioritization of Workplace
       Chemicals

(17) Hazard Evaluation Program

(18) Walter Reed Disease Forecasting
       System

(19) Coiammity Health Effects
       Surveillance Studies

(20) Cancer Surveillance,
       Epidemiology and End
       Results Reporting Program

(21) Subclinical Toxicity Survey

(22) Technical, Intelligence, and
       Project Information System

(23) OVERVIEW System

(24) National Emissions Data System
       (Air)
Consumer Product Safety
  Commission    •

National Institute of Occupa-
  tional Safety and Health


            Ditto
             X


             X


             X
               II

               II
           D.S. Army

Research Triangle Park, Environ-
  mental Protection Agency
National Cancer Institute -

Center for Disease Control


         (Conceptual)

            Ditto


Environmental Protection Agency
X
X

X


X
 X

 X


 X


 X



 X

 X



 X
                                                                   ro

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                            TABLE 1.   IDENTIFICATION/ASSESSMENT SYSTEMS*
                                           (Continued)
                                                                                 Category
         Sys
Identifier
Sponsor
IA
IB    IIA
IIB
 (25) General Point Source File  (Water)  Envir
 (26) International Decade of Ocean
       Exploration
                                 tal Protection Agency
 (27) Marine Resources

 (28) Rational Stream Quality
       Accounting Network
 (29) International Biological
       Program
 (30) SAB0AD
 (31) STORET
 (32) Environmental Monitoring
 (33) Rational Fuels Surveillance
       Hetwork
 (34) Wlswesser Line Rotation
 (35) Environmental Information
       System Office
 (36) OHM-TADS
 (37) Rational Pesticides Monitoring
       Program
 (38) Priorities for Synthetic
       Organic f^g^ffvplg
 (39) Toxicology Information
       Program
                       National Science Foundation
                       National Oceanic and Atmospheric
                         Administration
                       U.S. Geological Survey
                       Rational Science Foundation
                       Environmental Protection Agency
                                   Ditto
                       Council on Environmental Quality

                       Environmental Protection Agency    X
                                                          X

                       Oak Ridge Rational Laboratories
                       Environmental Protection Agency

                                 Interagency
                       Syracuse university Research
                         Corporation

                       National Library of Medicine
                            X
                                    X

                                    X
                                    X


                                    X


                                    X
                                    X
                                    X
                    X
                    X
                            X
                    X
                    X

                    X

                    X

                    X
* Systems are described in Appendix D in the order listed.

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                                      14
                    TABLE 2.  CHEMICAL TOXICITY DATA SOURCES
A.  Sources with Automated Storage and Retrieval Facilities

      Chemical

      Sadtler Research Laboratories, Inc.
      American Chemical Society
      Columbia University RADICAL System
      Commission of the European Communities - ECDIS

      Medical
      University of Rochester
      North Carolina State University
      Midwest Research Laboratories
      National Library of Medicine
      Biological Abstracts

      General

      The John Crerar Library
      Argonne Code Center
      Battelle Memorial Institute (Columbus and Northwest)
      Atomic Energy Commission - Division of Technical Information Extension
      Nuclear Safety Information Center
      Pesticides Information Center

B.  Other Information Centers

      Chemicals
      Household Substances Data File, FDA
      The Soap and Detergent Association
      American Petroleum Institute
      Industrial Hygiene Foundation of America, Inc.
      Tobacco Literature Service

      Medical
      National Center for Chronic Disease Control
      Army Munitions Command - Toxicologlcal Information Center
      New York Academy of Medicine
      National Clearinghouse for Poison Control
      Pharmaceutical Information Service
      Pharmaco-Medlcal Documentation

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                               15
            TABLE 2.  CHEMICAL TOXICITY DATA SOURCES
                           (Continued)     '
General

International Association of Water Pollution Research
National Academy of Science-Engineering
World Life Research Institute
Institute for Scientific Information

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                                  16
          •  General/environmental Health
          •  Environmental Management.
                                          \
In this way, the supportive relationship of combinations of systems becomes
more apparent, as does the basis for their development.  At the same time,
the state of the art of existing systems for chemical Identification and
hazard assessment will be more clearly apparent.  Also, a basis for
discussing commonalities, differences, and sometimes the disttnctiveneas
among systems will be provided.  Finally, the deficiencies of current and
proposed systems in relation to OTS's apparent needs - as implied by the
four basic questions posed at the outset - will be highlighted.

                           Occupational Health

          In accordance with the Section 20(a)(6) of the Occupational
Safety and Health Act of 1970, Public Law 91-596, the National Institute
for Occupational Safety and Health (NIOSH) conducts a number of programs
which have as their basis the identification and hazard assessment of
toxic substances.  Among these programs are the following:
          •  Annual publication of a list of known toxic substances
          •  Development of a priority listing of toxic substances
             and physical agents for purposes of criteria document
             development
          •  National Surveillance Network - National Occupational
             Hazard Survey
          •  In-plant hazard evaluation program
          •  Computerized retrieval system for chemical data
             sheets supplied by industry
          •  Access to medical, mortality, exposure data
          e  Active participation on the Threshold Limit Value (TLV)
             Committee of the American Conference of Governmental
             Industrial Hygienlsts (ACGIH).
In toto, these programs represent a fairly comprehensive sensor system for
identifying chemicals of concern, although the emphasis is on chemicals
in the working place.

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                                   17
Toxic Substances List

          An annual catalogue of known toxic substances    is compiled
and is available on tape for computerized searching.   The first such list
was compiled for publication in June, 1971; this list was revised in 1972
and 1973.  The 1973 list contains 11,000 names of chemicals together with
14,000 synonyms.  It is anticipated that future revisions will contain
100,000 chemicals with 500,000 chemical descriptions.
          A chemical which appears on the list has a documented, potential
hazard to man and/or animals.  The hazard may be that of lethality, carcino-
genicity, teratogenicity, or mutagenicity.  No statement concerning the
effect on vegetation can be made, nor can any conclusion be drawn from
the absence of a chemical from the list.
          The information in the lists has been gathered from the literature,
from company technical data sheets, from promotional material, and from
unpublished sources.  The bibliography from which the 1973 list was derived
is quite extensive.

Criteria Document Development from Priority Listing of Chemicals

          The actual hazard of a chemical, and thus the basis for the
establishment of standards for occupational exposure, is developed by NIOSH
as a criteria document for the chemical.  A criteria document is prepared
from a critical evaluation of all published medical, biological, engineering,
chemical, and trade data.  Professional bias, which may occur in the
preparation of the document, is  removed by a two-stage advocacy-adversary
process.
          The criteria document which results from this process is used
several ways.  First, as a publication, it is a source of information on
exposure limits and expected symptoms.  Second, as an unbiased compilation
of all known data, it serves as  the basis for the establishment of
regulatory standards.
          Candidates for criteria document development consideration
are identified from a variety of sources.  The various industrial hygiene

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                                   18
surveys conducted in the past by NIOSH have served to identify by name a
large number of toxic substances and physical agents in widespread
industrial use.  Additions to the list also came from the several states
who participate in £he National Surveillance Network (to be described).
Further, requests for hazard evaluations and new developments and trends
                                                  4
in Industry provide items for consideration.
          Resources are not available to allow criteria documents to be
simultaneously developed on all identified candidates, hence a prioritization
scheme    was devised to select the most important candidates.  The basis for
prioritization of the candidate list is NIOSH's evaluation of the potential
for health impairment associated with job hazards.  NIOSH would like to
evaluate job hazards by
          (1)  Number of workers at risk
          (2)  Production rates
          (3)  Trend in use
          (4)  Severity of effect of exposure
          (5)  Likelihood of disease resulting from exposure.
As quantification of all the above for each chemical is a large task, NIOSH
reduced the above elements to just two
             •  Expected exposure - based on (1), (2), and (3) above
             •  Likelihood of disease and severity - based on (4) and (5)
and. formed a priority index from the product of these.
          Estimates of exposure were obtained from NIOSH surveys and states
participating in the National Surveillance Network.  These were subjectively
adjusted by NIOSH staff when estimates obtained from narrow-based surveys
were questioned.  The severity rates war* obtained by subjective (Delphi)
assessment employing some 50 occupational health professionals.  The
severity rates were rated on an ANSI Injury work-lost-days severity seals.
          The prioritized 1973 list presents the chemicals by some 17
priority classes.  Within each class, the sensitivity of the procedure is
not fine enough to allow ranking distinctions to be made.  The list for
1973 was truncated at a level where the priority rating system ceased to
be sensitive, so that the end result was a list of 471 items.  Excluded
were substances for which criteria documents have already been developed

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                                  19
(e.g.,  asbestos,  beryllium,  carbon monoxide,  etc.).  Not Included on  the
list are the seven items for which criteria documents have  already been
initiated,  nor 14 suspected  carcinogens  which have been recommended for
control by a permit system.   These 14 chemicals  are:
          2-Acetylaminofluorene       N-Nitrosodimethylamine
          4-Aminodlphenyl             beta-Propiolactone
          Benzidine                   Bis(chloromethyl)ether
          3,3'-Dichlorobenzidine      Chloromethyl  Ether
          4-Dimethylamlnoazobenzene    4,4'-Methylenebie(2-Chloroaniline)
          alpha-Napthylamine          Ethyleneimine
          beta-Napthylamine            4-Nitrodiphenyl
National Surveillance Network - National
Occupational Hazard Survey
          NIOSH is surveying a sample of 10,000 to 15,000 workplaces.  Each
plant survey consists of a brief interview with the manager followed by a
walk-through investigation.  A 2-year study will develop basic descriptive
information on the working environment in all nonagricultural industries
covered under the Occupational Health and Safety Act of 1970.  This
information will be used to assist in setting priorities for research and
compliance, for directing research teams in future investigation efforts,
for measuring and to some extent forecasting trends, and for developing
criteria for standards which will describe the potential health hazards
typical of a particular industry or occupation.  All data will be
                                                      (23)
classified, key punched, and stored on magnetic tapes.

Hazard Evaluation Program

          At the specific request (written) of employee or employer repre-
sentatives, NIOSH will perform a field evaluation of the potential toxicity
of substances used or found in the Workplace.  Appropriate literature
•earchlng, sampling, analytical and medical testing measures are undertaken

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                                   20
on the information and findings are passed along to the employer, U.S.
Department of Labor, and the employee's representatives.  The emphasis
is on acute or short-term incidents, and the results have mostly served to
substantiate or negate established criteria rather than provide the basis
for new criteria documents.

Retrieval System and Chemical Data Sheets

          NIOSH has an established arrangement with industry whereby
material safety data sheets, containing data on hazardous products used
in workplaces, are supplied voluntarily.  These data sheets include these
information categories:
          (1)  Identifiers - Company, product name (trade and generic),
               and formula
          (2)  Ingredients - Name, percentage, TLV
          (3)  Physical Data - Vapor pressure, solubility, color,
               etc. (9 items)
          (4)  Fire and Explosion Hazard Data
          (5)  Reactivity Data - Stability, incompatibility
          (6)  Health Hazard Data - Ingestion, eye and skin contact,
               inhalation, effects, etc.
          (7)  Spill or Leak Procedures
          (8)  Special Protection Information
          (9)  Special Precautions
The potential number of such sheets are large.  One chemical company has
submitted an estimated 6000.  Access to the data sheets held In NIOSH
files is provided by a computerized retrieval system based upon identifiers
for company name, chemical tradename, data sheet I.D. number, and ingredients.
NIOSH notes that practically no information is available to them from small
companies whose outputs Include Innumerable products.

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                                   21
Access to Medical Mortality and Exposure Data

          Continuing studies of chemical hazards are made by NIOSH'e
Division of Field Studies and Special Investigation which attempts to tie
together environmental, medical, and biometrics! (epidemiology and
statistics) elements.  Five exposure categories established by this group
for hazard evaluations include:
          •  Carcinogens
          •  Respiratory diseases
          •  Cardiac disease
          •  Teratogens/mutagens
          •  Nerve diseases.
In support of these evaluations the Division contracts with the University
of Cincinnati for computerized handling of medical mortality and exposure
data.  The data file contains these subgroups: (1) identifiers [name, age,
occupation, etc.], (2) questionnaire abstraction [health history, job
history, etc.], (3) physiological information [urine, blood data, etc.].
NIOSH has found that whereas good and extensive data on chemical exposure
and morbidity generally exist,  there are few good correlations between
exposure and morbidity.

TLV Committee of ACGIH

          Threshold limit values (TLV) refer to airborne concentrations of
substances and represent conditions under which it is believed that nearly
all workers may be repeatedly exposed day after day without adverse effect.
TLV values are now official federal standards for industrial air/ '
Additions to the TLV list (500-600 substances are now on the liet) are made by
                                          i
a 15-member committee of which more than one are currently NIOSH staff
members.  Appointment to this committee is Independent of a member's
affiliation.  NIOSH cites this  Involvement with the industrial community
as a key mechanism for staying abreast of problem chemicals in the work-
place.  Much information, not officially obtainable, can be accessed by
the informal relationships established over the years between Industry and

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                                   22
and this agency.  Approximately 1500 ACGIH industrial hygienista serve  '
as a sensor system to feed candidate substances to the 15-member TLV
committee.  Many more 'substances appear on the list than NIOSH will ever
be capable of putting out criteria documents on for the simple reason
that such documents require extensive documentation based on data that
are seldom available in the detail required.  In essence what exists is
a well recognized and accepted (by 35 states) listing of substances
whose hazard criteria are developed on the basis of the best professional
judgments on available data.  The data bases for these judgments are
published in a document separate from the TLV listing by ACGIH.
          In summary, NIOSH has assembled a number of subsystems which
enable them to identify, assess, prioritize, and alert the public to
chemical hazards in the workplace.  An established sensor system and
informed Judgments appear to be the major Ingredients in the results
achieved.

                        General/Environmental Health

          In concentrating its resources on cancer, a leading cause of
death in the U.S., the National Cancer Institute (NCI) has developed,
spawned, or is supporting a number of systematized and somewhat inter-
related approaches for Identifying and assessing chemical substances with
respect to carcinogenic!ty.  These programs include:
          •  Survey of Compounds which have been Tested for
             Carcinogenic Activity (PHS Publication 149)
          •  Study of Structure-Activity Hazard Assessment of
             Carcinogens and Mutagens
          •  Program to Acquire and Analyze Information on
             Chemicals that Impact on Man and His Environment
             [formerly the Chemical Hazard Ranking Information
             System (CHRIS)]
          •  Cooperative Efforts with the International Agency
             for Research Against Cancer

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                                   23
          •  Surveillance, Epidemiology,  and End Results Reporting
             (SEER Program).
The basis of much of NCI's efforts to acquire information of chemical
carcinogens is the suspicion that a large percentage of cancer cases are
based on chemical rather than biological (e.g., viral) causes.

PHS Publication 149

          NCI continues to support (under contract with Tracer JITCO) the
extraction, computerization, and publication of updated volumes of this
data source entitled "Survey of Compounds Which have been Tested for
Carcinogenic Activity".  This is probably the most complete collection
of data and references on chemical carcinogensls.  The contractor
retains the hard copy of each article abstracted and referenced since
1961 and makes available a computerized data presentation of the following
described characteristics.

          Contents.  Data and literature references contained in seven
volumes of PHS 149:
          Original - 1M7
          Supplement #1 1948 - 1953
                     92 1954 - 1960
                     #3 1961 - 1967
                     M 1968 - 1969
                     #5 1970 - 1971
                     #6 1972 - 1973.

          Format.  Literature reference, animal species/strain, route/
site of treatment, tumor  site, details and duration of  experimentation,
dosage, chemical compound, CAS Registry numbers, Wlcvesser Line Notation,
etc.

          Accessibility.  A master index of  the entire  series is main-
tained on tape in offline machine readable form in NCI headquarters in
Bethesda, Maryland.

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                                   24
Structure-Activity Hazard Assessment Study

          NCI Is funding (50 percent) in cooperation with the National
Institute of Environmental Health Sciences (NIEHS) a study effort to
identify and correlate a relationship between molecular structure and
biologic activity for chemical substances.  Specifically, a correlation
between mutageniclty and carclnogenlcity is being Bought allowing a
structure activity approach to assessing these chemical hazards as opposed
to current bioassay techniques.  The latter techniques require 2-4 years
and the maintenance of secrecy to preclude premature public disclosure
prior to full completion of the bioassay period.

Program to Acquire Information on Chemicals

          Stanford Research Institute, in a continuing program sponsored
by NCI, is developing a system to collect, analyse, and systematize
Information on the chemical description, production, distribution, and
human exposure to carcinogenic chemicals which the public may come    .
into contact with in significant amounts.
          Until recently (1973) this program was identified as the CHRIS
system (Chemical Hazard Ranking Information System).  Dropping of this
designator was due to NCI's feeling that "hazard ranking" per se is no
longer considered appropriate, i.e., it is not currently considered
                                                                      /n\
technically feasible to pursue prediction through structural analyses.
It is, however, considered desirable to pursue the potential of hazard
identification through structural analyses.  Consequently, this program
now is proceeding under the title of "A Research Program to Acquire and
Analyze Information on Chemicals that Impact on Man and His Environment".
                               (9)
In a recent abstract of a paper    under this title, the authors described
the system as follows:
          "This effort provides information to aid the National
          Cancer Institute Carclnogenesis Program in selecting
          chemicals to test to which the U.S. population is exposed.
          The criteria used by NCI's Chemical Selection Committee
          for selecting chemicals for carcinogenic testing are:

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                                   25
                  The degree of overall  human exposure
                  Projected new or Increased human exposure
                  Exposure of subpopulatlons Important  to society
                  Epidemiological clues  (high cancer incidence
                    subpopulations)
                  Relation to known carcinogens
                  Gaps in knowledge.
          The present data base contains information on 3200 chemicals
          in the following categories:
               Intentional food additives    Air pollutants
               Pesticide residues in food    Water pollutants
               Proprietary drugs             Soaps and detergents
               Prescription drugs            Trade sales paints
               Cosmetics
          These categories are subdivided into 900 product types
          representing 18,000 chemical-product combinations.
          The data are in computer-readable form and contain the
          following information:
             Product                    Each. Ingred intent Chemical
Product name                       CAS number and name
Quantity available for exposure    Strength  (percent) in each product
Exposure routes—oral, dermal,     Degree of uncertainty associated
  respiratory, and parenteral        with quantitative data
Exposure factor by route           References to data sources
          In addition to the information on  the 3200 chemicals In
          the above nine exposure categories( a data bank of approxi-
          mately 25,000 chemicals has been developed which includes
          many of the substances to which the human population is
          most likely to be exposed.  These  chemicals were drawn from
          eighteen recognized sources of Information on such products
          as cosmetics, food additives, medlcinals, etc.  For each
          of the 25,000 chemicals in this data bank, the CAS number,
          structure, chemical name, and synonyms are stored in
          computer readable form.

          A computerized chemical classification scheme has also been
          developed  that contains 220 nodes  or end points.  This
          development has allowed a node assignment to be made for
          each of the chemicals  for which exposure estimates have been
          made.  As  additional biological data become available it
          may eventually be possible to make Informed guesses as to
          a molecule's carcinogenic potential based on such a chemical
          classification scheme."

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                                   26
International Agency for Research Against Cancer (IARC)

          This agency, a spinoff of the World Health Organization based
In Lyon, France, is supported by NCI in its efforts to identify chemical
carcinogens.  It is composed of a group of Internationally recognized
scientists who:
          (1)  Receive Information on candidate chemicals from
               many sources including NCI
          (2)  Evaluate carcinogenic risk to man of chemicals
          (3)  Publish their conclusions in monograph form.
The basis of this effort is thus a general sensor system to identify candidate
substances coupled with expert opinion hazard assessments based on the
state-of-avallable knowledge (testing, chemical, etc., data).

SEER Program

          A variety of NCI* programs are concerned with the collection,
analysis, and utilization of data on the Incidence of cancer, the
characteristics of patients and their disease, treatment, and end result.
The SEER program     integrates a number of data sources (nine registries
in U.S. covering 10 percent of population) with the objective of contri-
buting to the assessment of (1) the risk of developing cancer in groups
and in individuals and (2) the presence, extent, and probable course of
existing cancers.  Data collected annually from these sources have
permitted long-term trends (approximately 1935 - present) in cancer
incidents and mortality to be developed as a function of population groups
(sex, age group, etc.), afflicted site (lung, esophagus, etc.), and other
factors.  This program could serve to Identify trends In cancer incidence
associated with the impact of changes in the environment and human behavior.
It does not specifically relate incidence to chemicals, although clues
to chemically based causative agents are possible.  For example, Table 3
illustrates an attempt based on SEER data to relate environmental factors
to deaths from cancer as a function of the afflicted site.
* See Appendix D.

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TABLE 3.  ESTIMATED CANCER DEATHS FOR 1973 (Both Sexes)
                                                        (10)
Site
Lung
Colon-Rectum
Pancreas
Leukemia
Stoaach
Bladder
Oral Cavity
Liver (Primary)
Esophagus
Skin
Larynx
Total These Sites
Other Sites
TOTAL All Sites
Total Deaths
72,000
47,400
19,200
15,300
14,700
9,200
7,600
7,200
6,400
5,200
3,000
207,000
143,000
350,000
Extent Attributed to Environmental Factors
INI Tobacco, Asbestos, Air Pollutants,
Occupational
-H-f Diet, Other Environmental
•H-? Tobacco, Diet (?)
+ Radiation, Chemicals
-H-+ Diet, Other Environmental
•H-f Occupational, Tobacco, Diet (?)
Other Environmental
•H- Tobacco, Chemicals, Diet (?)
-H- Diet, Other Environmental
•H- Environmental
•H-f-f Ultraviolet Light, Chemicals,
Occupational
•H-f Tobacco, Air Pollutants
•H-f
+,? (Includes Hormonal Factors)
•H-

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                                   28
          In summary, NCI's carclnogenesis program has developed both
                                                *
Informal and formal systems for identifying and assessing carcinogenic
health hazards.  Identification appears to rely heavily on three sources:
(1) medical experts identified by NCI, (2) systematized searches of the
literature for chemical production, use, toxicology and descriptive data,
and (3) epidemlological data.  Hazard assessments rely on available animal
test data, estimates of human exposure, and systematized expert judgment.

                        Environmental Management

          In accordance with air, water, pesticide, and other Federal
legislation, the Environmental Protection Agency has underway many programs
that Involve the systematic identification, evaluation, and prioritization
of environmental pollutants* many of which are chemical in nature.  Other
agencies besides EPA — Coast Guard, National Science Foundation, USDA,
etc. — either on their own or in collaboration with others ~ also have
developed systems of interest to this study.  A sampling of the more
pertinent ones Identified will be discussed to illustrate the extent of
chemical identification/assessment efforts in this area of concern.  These
Include:
          •  Systematized approaches to identify hazardous airborne
             pollutants (EPA)
          •  Identlfication/prioritizatlon and data retrieval systems
             for chemicals spilled into watercourses (EPA)
          •  Chemical Hazard Ranking Identification System (Coaat
             Guard)
          •  OHM-TADS, a hazardous material information automated
             data file (EPA)
          •  National Pesticide Monitoring Program (Interagency)
          •  Selection Methodology for Hazardous Solid Wastes (EPA)
          •  Identification and Assessment of Chemicals Effects on
             Ecosystems (NSF).

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                                   29
Identification of Airborne Pollutants

          The Clean Air Act (amended 19*70) requires the EPA Administrator
to publish a list of hazardous air pollutants for which emissions standards
are to be established.  This requirement has resulted in the development
                           i
by EPA of systematized approaches for identifying such pollutants.  To
date a listing of 38 pollutants has been generated.  Nine of these have
had concentration limits in ambient air set and 3  (mercury, beryllium,
and asbestos) have been declared hazardous under Section 112 of the Act.
Considering the extensive TLV listing by ACGIH (500-600 substances), a
continued screening by EPA of potential pollutants Is to be expected.  One
screening basis being pursued by the Control Systems Laboratory (CSL) at
NERC/RTP is a precursory listing of "materials of concern"     derived
from  the following four sources:
           (1)  The current EPA hazardous  and ambient air quality
               listing  (nine substances)
           (2)  A tentative listing  of  29  hazardous pollutants by
               EPA's  Office of Air  Quality and Planning Standards
           (3)  200 airborne contaminants  from the  NIOSH Toxic
                                                     3
               Substances List with TLV's of 10 mg/m  or less
           (4)  A list of  all known  airborne polynuclear aromatic
               hydrocarbons and  other  carcinogenic substances.
This  list  is  the first  step.  Evaluation  and prioritlzation will  follow as
efforts  to  Identify critical substances for regulatory action proceed.
          CSL  also has  more comprehensive efforts  underway to identify
emission sources of potentially  hazardous pollutants.  These efforts will
permit a data  base  to be  derived from  a methodology  for tracing  potential
harmful  airborne pollutants to their industrial source.  The method would,
conceptually,  detail  the  input of primary and secondary raw materials,
intermediate products,  and end products for selected industries  as  shown
in Figure  1.   Each  Industry will also  be  further detailed  into processes
with  air, water,  and  solid emission points Identified.

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                              30
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n4 1 ^^ PP EP = end product
	 ^
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SHM'ji
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                                   31
Hazardous Water Pollutants
            u
          Several agencies are Interested in identifying hazardous
pollutants entering watercourses.  EPA, whose efforts are based on the
requirements of the Water Pollution Control Act of 1972 and the Coast
Guard (see CHRIS section to follow) are most prominent in such efforts,
particularly with respect to episodic-type spills, e.g., these due to accidents
and industrial effluents.          '
          EPA, in seeking to satisfy a requirement of 1972 Act (Section 311),
                         » "       "
is developing criteria for use in designating hazardous waterborne sub-
stances which "...pose an imminent and substantial danger to public health
or welfare, including but not limited to fish, shellfish, wildlife,
shorelines, and beaches."  The following sequential criteria are under
              (24)
consideration.
           (1)  Radioactive - "Any radioactive substance which meets
               the following inclusive criteria possesses the requisite
               danger potential  to be designated as a hazardous
               substance:
               (a)  Half-life -  10 years, and
               (b)  Bioconcentration factor - 100, and
               (c)  Radiotoxicity: Radlonuclldes which, as a result
                    of the energy emitted, the biological effectiveness
                    of the radiation, and the effective half-life in
                    the  organism, result in an ICRP concentration
                                  -A
                    limit « 5 x  10   microcurlea/ml.*
           (2)  Biologically Concentrated - "Any element or compound
               other than identified in Criterion 1, which Is a
               biologically concentrated poison showing a concentration
               factor greater than 1000 and which is produced or handled
               in excess of research quantities, possesses the requisite
* Concentration limits for all radionuclides,  as recommended by the
  International Commission on Radiological Protection (ICRP) for continuous
  168 hour exposure to the critical organ(fl),  are published in ICRP Publications
  2 (Report of Committee II on Permissible Dose for Internal Radiation)
  and 6 (Recommendations of the ICRP,  as amended and revised 1962).

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                         32
     danger  potential  to be  designated  as  a  hazardous
     substance.   The concentration factor  Is that  value
     obtained  by dividing  the  net  weight concentration
     of material in  the whole  organism  by  the concen-
     tration of  material lit  the  surrounding  waters or in
     the preceding link 'in the food chain."
(3)   Lethal  -  "Any element or  compound  produced  in excess
     of research quantities  which  is lethal  to:
                                    •
     (a)  one-half of  a test population of aquatic animals
          In 96  hours  or less  at a concentration of 1000
          parts  per  million  (ppm); or
     (b)  one-half of  a test population of animals in  14
          days or less when  administered as  a single oral
          dose less  than 50  milligrams  per kilogram of
          body weight; or
     (c)  one-half of  a test population of animals in  14
          days or less when  dormally exposed to  less than
          200  milligrams per kilogram of body weight for
          24 hours;  or
     (d)  one-half of  a test population of animals in  14
          days or less when  exposed to  a vapor concen-
          tration less than  200 ppm in  air for one hour;
          or
     (e)  aquatic flora as measured by  a 50  percent decrease
          In cell count, blomass,  or photosynthetic ability
          in 14  days or less at concentrations less than
          100  parts  per million, possesses sufficient  danger
          potential  to be  designated as a  hazardous substance."
(4)   High Oxygen Demand -  "Any element  or  compound stored  or
     transported in  tanks  or containers containing equal to or
     greater than 20 metric  tons (Approx.  44,000 Ibs or  5,000
     gal) which  can  produce  a  severe stress  on the aquatic
     environment by  exerting an oxygen  demand greater  than 25
     percent of  Its  theoretical oxygen  demand as measured  by

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                                   33

               the 5-day  biochemical oxygen  demand  test  or  its
               equivalent has the requisite  danger  potential  to
               be designated as  a hazardous  substance."
          05)   Nuisance Growth Stimulating - "Any element or  compound
               stored or transported  in tanks or containers containing,
               equal to, or greater than 20  metric  tons  (approximately)
               44,000 Ibs or 5,000 gal) which can stimulate the  growth
               of nuisance aquatic flora has sufficient  danger
               potential to be designated as a hazardous substance."
          A tentative list of designated hazardous  materials  by  these
criteria was limited to those materials which have  a potential  for
accidental spillage into water.   About 800 chemicals were identified as
being potential hazards.  Technical documentation of the technique and
                              (12)
results is available from GPO.
          A study performed for EPA by Battelle in 1970  entitled "Control
of Spillage of Hazardous Polluting Substances" identified and prioritized
                                                                     (13)
a list of chemicals based on their hazard to the aquatic environment.
The list of chemicals to be prioritized was obtained from a previously
published list of transported hazardous chemicals.   The  chemicals were
ranked by a deterministic indicator calculated from (1)  production and
transport volumes by rail, barge, and truck, (2) spill probabilities by
transport mode, and  (3) critical threshold toxic concentrations.  This is
represented schematically in Figure 2.  The resulting ranking parameter
physically represented the volume of water necessary to  dilute the annual
expected spillage to a safe concentration.
          The Analytical Quality Control Laboratory (AQCL)  of the EPA's
Office of Water Programs contracted the development and  maintenance of an
Analytical Methodology Information Center (AMIC).   *15'  The Center has
six responsibilities namely:  (1) acquisition, (2) processing (abstracting
and Indexing) documents, (3) preparation of a monthly current awareness
(abstract) bulletin  ("Reviews of Current Literature on Analytical Methodology
and Quality Control"), (4) provision of a computerized  (on-line interactive)
computer system,  (5) assisting the Analytical Quality Control Laboratory
in its role as a "center of competence" for the Water Resources Scientific

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                                          34
                                            X
                                        CRITICAL
                                      CONCENTRATION
   REQUIRED VOLUME TO
DILUTE EXPECTED SPILLAGE
  V - (Q.  + QB + QT)/X
             IV    li
                                                                       RANKING
                                                                     'PARAMETER
 EXPECTED ANNUAL
SPILLAGE BY BARGE
    SHIPMENTS
     EXPECTED ANNUAL
    SPILLAGE BY RAIL
        SHIPMENTS
       QT
 EXPECTED ANNUAL
SPILLAGE BY TRUCK
    SHIPMENTS
                                    ANNUAL PRODUCTION
                                  FRACTION TRANSPORTED
                                 ACCIDENT PROBABILITIES
       FIGURE 2.  GRAPHIC REPRESENTATION OF HAZARDOUS WATERBORNE SUBSTANCES MODEL

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                                   35
Information Center, (6)  provision of certain information services.
          The scope of information contained in the AMIC data base Includes
the fields represented by the five activities of the AQCL
          •  Physical and Chemical Methods
          •  Biological Methods
          •  Microbiological Methods
          •  Methods 'and Performance Evaluation
          •  Instrument Development
plus these topics of general interest to the AQCL staff
          •  Special problems related tq the analysis of marine samples
          •  Sample preservation and storage
          •  Optimizing sampling frequency
          •  Computer programs for data processing
          •  Data interpretation
          •  Water quality criteria, standards, and enforcement
          »  Quality control
          •  Development and improvement of specific methods.

Chemical Hazard Ranking Information System

          The Coast Guard commissioned A. D. Little, Inc., In 1972 to
perform a study on "An Appraisal of the Problem of Handling, Transportation,
and Disposal of Toxic and Hazardous Materials".      This study focused upon
identification, prioritization, and evaluation of information elements as
opposed to chemicals.  However, the methodology should be of Interest to
OTS.  The result was termed the "Chemical Hazard Ranking Information
System" (CHRIS).
          The study contains an analysis of information requirements for
the five stages of a spillage Incident, namely
          (1)  Detection, evaluation, notification
          (2)  Containment and countermeasures
          (3)  Cleanup, disposal
          (4)  Restoration
          (5)  Adjudication.

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                                   36
A tentative list containing some 144 perceived information needs was generated
(a laundry list).  This list was truncated to 78 elements by subjective
elimination and aggregation.  The list then contained eight major cate-
gories
          (1)  Chemical (16 elements)
         (II)  Shipping and Carrier (8 elements)  i
        (III)  Environment  (16 elements)
         (IV)  Resource (8  elements)
          (V)  Incident (13 elements)
         (VI)  Procedures and Background (4 elements)
        (VII)  Hazard Evaluation (7 elements)
       (VIII)  Response Model (6 elements)
Nine categories of information users were defined, as were three actions
of users and four media by which Information could be provided.
          Subjective analysis then provided further variables.  A score of
0 to 5 was provided as a consequence of a wrong decision by each of the
nine users based on each of the 78 information elements.  An incremental
reduction in the likelihood of the wrong decision by each of the nine
users due to the provision  of each information element was subjectively
assessed.  A weighting factor was provided to modify the consequence of
each wrong decision by the  action of the user.  An RCR score (Risk
Consequence Reduction) was  then computed for each information element —
user pair.
          In this manner the Information needs of CHRIS were prioritized.
It was found,  for example,  that the top 19 information elements provided
a 50 percent reduction in RCR.  The most critical Information elements
for each phase could also be determined with this technique.  It should
be emphasized, however, that the prioritlzation is based upon subjective
data.

OHM-TADS

          Data have been gathered on the physical, chemical, toxlcological,
and commercial aspects of over 850 hazardous materials and placed in an

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                                   37

automated data file.  The file,  referred to as OHM-TADS,  is employed as the
technical data source for the EPA Office of Oil and Hazardous Materials
and is used by EPA personnel when they are called on to respond to a spill
of a hazardous material.  The file complements another file (SITREP) which
is employed to store data and reports on past spills of hazardous materials.

National Pesticide Monitoring Program
                                   >                   i
          The NPMP consists of an integrated interagency effort to restrict,
control, and monitor the pesticides and their decay products in the environ-
ment.  The program consists of three basic functions.
          (1)  Criteria - developed by published information, company
               data, brainsterming
          (2)  Registration - to control the quantity of pesticides
                                                            ?
               entering the environment
          (3)  Technical Services - to develop monitoring techniques
               and  to coordinate the efforts of the many environmental
               monitoring programs currently in existence.
Originally, NPMP was directed toward insecticides, specifically, the
chlorinated hydrocarbons, organophosphates, and mercury-containing compounds.
After several years of operation its scope was expanded to Include poly-
chlorobiphenyls and polychlorodibenzo-p-dloxlns.
          The generation of the list of chemicals for monitoring is an
interesting feature of NPMP activities.  Cognizant personnel in Federal
agencies are asked  to individually compile  lists of  candidate  chemicals,
based upon toxlcity, quantity, persistence, and, of course, subjective
opinion.  These lists are merged and condensed  (in keeping with the
minimum scope of the NPMP) to produce a chemicals monitoring guide.  The
NPMP board meets once a month and, through a somewhat informal process,
decides on list updating.  The monitoring agencies participating in NPMP
are directed to use this list as a guide, modifying  the list as needed  to
account for local conditions.
          Government agencies linked into  this effort include: (1) EPA,
(2) Department of Agriculture, (3) Department of Interior,  (4) Department

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                                   38
of Defense, (5) National Science Foundation, (6) Tennessee Valley Authority,
(7) Department of Commerce,* and (8) Department of Health, Education, and
Welfare.

Identification of Candidate Hazardous Solid Wastes

          EPA, in fulfilling the requirements of the Resource Recovery Act
of 1970, studied under contract the feasibility of a national system of
hazardous waste disposal sites.      As a first step it was necessary to
identify the nature and quantities of the hazardous wastes to be handled
at these sites.  In addition to a comprehensive evaluation of toxic and
hazardous pure substances, candidate Industrial waste substances believed
to be hazardous were identified.  A scheme for screening these candidates
was developed and applied by Battelle.  The scheme, shown in a generalized
form in Figure 3, employed 11 tests each of which (if positive) served
to classify a substance for treatment of a disposal site.  These tests
were:
          •  Radioactivity
          •  Biocpncentration
          •  Flammabllity
          •  Reactivity
          •  Oral Toxicity
          •  Inhalation Toxicity
          •  Dermal Irritation
          •  Aquatic Toxicity
          •  Phytotoxicity
          •  Genetic Changes.
Some 15 classes of wastes were designated as hazardous with a priority for
concern.
RANN Programs on Identification/Effects of
Trace Contaminants
          The National Science Foundation, through its Research Applied
 to National Needs  (RANN) program, supports an "Environmental Aspects of

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                        39
                            Candidate Waste
                   True
                    True
                     True
Classes II and
III Waste
 Class I
Hazardous
 Waste
  FIGURE  3.  GRAPHIC REPRESENTATIVE OF THE HAZARDOUS
            WASTE DECISION MODEL

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Trace Contaminants Program".  Th® Trace Contaminants Program I® principally
                                                 t
concerned with determining thfe levels of toxic substances in the environ-
ment, assessing the effects of these levels on plant© ©ad animalsB sad
relating these findings to assessment.
          Trace substances selected in tna racent past were considered
on the basis of
          (1)  Intrinsic biological risk
          (2)  Geographic dispersion
          (3)  Quantity and persistence in environment
          (4)  Suspected accumulation technology
          (5)  Difficulty of avoidance.
Hence the program has recently devoted its resources to lead, mercury,
molybdenum, arsenic, cadmium-zinc, and nitrates.  Development of a microcosm
approach to evaluation of ecosystem effects of chemicals (species
eradication, bloaccumulatlon, etc.), is proposed as part of the continuing
program to monitor such substances.  Preliminary efforts of this nature
have been described.
          A parallel NSF program la to be initiated in mid-1974 on synthetic
organic chemicals.  As the number of these compounds is quite large, NSF
will initially support a formal identification/priorltization study to
select 100 candidate substances.  The preliminary selection will be based
upon production levels and extent of dispersion into society and ultimately
the environment.  A final prioritization will employ parameters relating
to dispersal of wastes and effluents, persistence, toxicityB and accuoulation
in the environment.

Summary

          Current governmental programs, growing out of public concern
about and legislation on the environment, require the identification and
assessment of toxic and hazardous chemicals.  Systematic approaches -
usually restricted to & single media such as air, water, or land - have been
proposed or applied for screening candidate lists of substances.  While
the utility  to OTS of any single approach appears limited, the parameters

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                                   41
used and the lists generated are of interest -  if  for no other raaeon
than that they emphasize the complexity and extent of the toxic substance
problem.  As these efforts come to fruition, a  number of useful data bases
ought to become available to OTS.

             Health/Environmental Management -  CPEHS/OVERVIEW

          Two conceptual identification/assessment systems have been formu-
lated in recent studies for Federal agencies.  Because of their pertinence
to the objectives of this studyp they will be described in more detail.
Technical. Intelligence, and Project Information
System for CPEHS
          Battelle Memorial Institute performed a study in 1970 for the
Consumer Protection and Environmental Health Service (CPEHS) entitled
"Technical, Intelligence, and Project Information System for the
                              (19)
Environmental Health Service".   '  Although CPEHS was disbanded shortly
after the study was completed, the objectives of this study were to
examine, research, and develop program planning needs within the EHS
and to develop a management assistance system for the EHS.  Since a
well-organized and readily accessible information base is essential to
such planning, existing information capabilities and facilities within EHS
were surveyed and an environmental health information network was devised.
Two model case studies for two environmental stressors, lead and persistent
pesticides i were performed to serve as examples during the project and to
exercise the elements of the management assistance system.
          The reports in this series were:
             Volume I - EHS Management Assistance and Planning
             Volume II - EHS Information Network Analysis
             Volume III - Lead Model Case Study
             Volume IV - Pesticides Model Case Study
             Volume V - Directory of EHS Information Facilities with
                          Selected Supplementary Resources

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The Management Summary from this study Is presented In Appendix F.   In
the discussions which follow,  this work will be referred  to  as  the  "CPEHS"
system.

OVERVIEW

          The CPEHS study followed a similar one in 1967  for the U.S.
Public Health Service, Office of Environmental Health,  entitled "An Overview
of Environmental Contaminants".      A summary of this  report presented in
Appendix G.  Hereafter the term "OVERVIEW" will be used to refer to this
system.
          In considering the problem of a system designed to maintain
an overview of the public health hazards of chemicals in the environment,
the Battelle staff analyzed the nature of the questions which scientific
evaluators might have to consider.  The following are representative of
some of the more important questions:
          What chemicals are of economic Importance?  In what
          quantities are they produced?  Where are they used?
          Are they toxic?...in what amounts?...under what conditions?
          Does a given chemical present a potential public-health
          hazard?  Is this hazard recognized?  What changes are
          taking place in total production?...in the relative use
          patterns?...as new uses?  Of what consequences are
          these changes to public health?  Are there changes in
          per capita consumption of toxic materials?  Are toxic
          materials accumulating in the environment?  Are
          relatively harmless materials being replaced by more
          toxic materials?
          The broad nature of the OVERVIEW considerations and the depth of
knowledge required to properly evaluate possible threats to the environment
are immediately evident.  Given sufficient time and effort, it would be
possible to answer most of the questions posed above for each material of
Interest.  However, in view of the many materials that should be considered
and the broad scope of the Information required to answer such questions,

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                                  43
it was considered mandatory to identify those factors most critical in
determining or rating a possible threat.  The identification of these
factors would, in turn, reduce the total amount of information and data
over which surveillance would have to be maintained.
Discussion of CPEHS and OVERVIEW

          The CPEHS approach emphasized problem identification, evaluation,
and priority setting of potential threats to man and the environment
from the perspective of environmental "stressors" - a stressor being
defined as a chemical compound or element, biological agent, or physical,
social, or psychological condition.  OVERVIEW, on the other hand, focused
on systematic surveillance of critical indicators to identify potential
chemical threats to public health.  The approaches to threat or etressor
identification, evaluation, and prioritization for each study are worth
reviewing.

          Identification.  The threat identification and evaluation scheme
developed for CPEHS was one of three functions of the conceptualized
management assistance system.  The first function was that of overall
environmental health planning, which had as an objective coordinated and
comprehensive R&D planning.  The second function was to provide assessment
of the environmental impacts of technology.  The CPEHS final report
states...
          "Thss* functions would be complemented by the third
          function, threat identification and evaluation, which
          has •« its focua the potantial threats to men and his
          environment through Intensification or extension of
          current use patterns of products and services or through
          the introduction of new chemical, biological, or
          physical stressors into tha environment.
          Thraat evaluation Involves two phases, threat identifi-
          cation and threat assessment.  The threat-identification
          function would be performed by a small group of individuals!
          representing physical, chemical„ and biological disciplines.
          It would be the purpose of this group to question trends
          or patterns in given industrial, urban, occupational,
          domestic, and recreational areas and to evaluate in a cursory

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                                  44
          manner the available information that might suggest
          the possibility of a threat.  An Environmental Health
          Information Network (EHIN) would be used for this
          purpose.  If a possible threat were identified, a
          threat evaluation mechanism could be set in motion by
          EHS.  Depending upon the magnitude of the potential
          threat, a center of technical competence6may be
          established."
          The threat identification scheme identified in the CPEHS study
would appear to be'workable under conditions where the total number of
potential threats is small, so that the expert group is not overwhelmed.
Hence, the scheme might be applicable to the consideration of broad classes
of chemicals (pesticides, POMs, etc.) but not to individual chemicals,
          OVERVIEW describes a more direct means of identification based
upon  (1) the fact that current concerns of materials will be reflected in
current publications and (2) that the alternative of a direct survey as
a means of determining the materials of current concern to environmental-
health specialists would be a costly and time-consuming operation.  The
first approach was tested through the use of the latest available Indexes
to abstract journals to identify materials causing concern as expressed in
the primary journal literature.
          The 1964 subject index of Industrial Hygiene Digest, and the
1965  subject index of Public Health Engineering Abstracts were assumed to
represent, in part, a compilation of those chemical terms related to
materials of significance to environmental public health.  Names of
elements, compounds, and a few broader terms appearing in these Indexes
ware  selected and the number of citations for each was tallied.  Other
•ntrioM mich •• the un« of chemical* for insect control or water treatment
were  omitted except where there was an established adverse public-health
aspect.  From this analysis 286 chemicals were recognized during the period
1964  - 1965 as being potential hazards and, therefore, of possible concern.
          This approach has a shortcoming in the sense that it is passive.
Using this technique identification of a potentially hazardous material
will  be delayed until the publication of some number of documents, which in
turn  depends upon the prior arousal of the concern of the scientific community
about the potential hazard.  Thus, a time delay of several years is introduced

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                                   45

during which production and utilisation of slgnficant amounts of the
material can occur.

          Evaluation.  An element of the CPEHS study was the development of
a coordinated, agglomerated Environmental Health Information Network (EHIN)
which would serve in part as a threat evaluation tool (the threat having
been previously Identified).  Figure 4 presents the scheme oT the proposed
EHIN.  The nomenclature of Figure 4 has the following meanings:
          MSIIS - Monitoring, Surveillance, and Intelligence
                    Information System
          STIS  - Scientific and Technical Information System
          PIRS  - Project Information Retrieval System
          IRIS  - Information Resource Identification System
          CTC   - Centers for Technical Competence.
It should be stressed that EHIN would not have been a capping organization.
Rather, It would be a coordinated network of available and proposed resources
all of which could be accessed to assure a total and direct assistance of
all pertinent resources on any environmental project.
          Evaluation of a hazard in the OVERVIEW study would be
accomplished by a literature review.  In order to maintain surveillance over
materials of concern, a list of critical indicators was compiled.  Par-
ticular emphasis was placed upon rapid evaluation of possible threats to
the environment.
          Table 4 is a composite list of the critical Indicators divided
Into  five major categories.  In addition to their role as critical indicators
these terms also served as a basis for organizing literature and
other communications of direct concern to OVERVIEW.
          Based upon several case studies  (Hg, V, Ni, fluorocarbons, pulp
and paper chemicals) and the critical Indicators of Table 4, it was
found that a limited, well-defined body of literature should permit
a comprehensive surveillance of the contamination of man's environment by
chemicals.  This list of publications is given in Appendix H under the
heading of "Chemistry and Industry".

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                                                                                National
                                                                                    Sur-
                                                                               veillance*
                                                                              Epidemiology
                                                                                System
                     Air-
                   Pollutioo
                   Technical
                   Information
                      nter
Scientific
Reference
 Service
                      Water
                    Resources
                    Scientific
                   Information t
                                                                               National
                                                                                Water
                                                                               Quality
                                                                               Register
                                                                                                  National
                                                                                                 Occupational
                                                                                                 Health Mon-
                                                                                                    itoring
                                                                                                    System
  Solid
  Wastes
Information
  Retrieval
  S
                     Fuel
                   Additives
                    Register
/   Unit
 Information  j
  System -
 \ noc  /
                          National \
                          Institutes .
                         of Health/
                          i Information J
                            Exchange /
                            V      /
                                                                            Referral
                                                                           Center for
                                                                            Science &
                                                                         \  -»•«»—-  /
                                                                          \Technologyy'
        FIGURE  4.
                               THE  ENVIRONMENTAL HEALTH INFORMATION  NETWORK  SHOWN IN THE
                               AGGLOMERATED, COORDINATED  CONFIGURATION

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                                     47


                    TABLE 4.   LIST OF CRITICAL INDICATORS
(1)   Environmental contamination

     (a)  Geographical distribution
     (b)  Distribution between soil, water, air, and life
     (c)  Biogeochemical cycle of major formulations

(2)   Toxicological manifestations

     (a)  Physiological interaction with man
     (b)  Toxicity level
     (c)  Symptomatology
     (d)  Epidemiology

(3)   Primary production
     (a)  Description of processes
     (b)  Number and location of plants
     (c)  Annual production records
     (d)  Distribution by use categories
                                                        f
(4)   Secondary-product formulation

     (a)  Description of processes
     (b)  Number and location of plants
     (c)  Capacities and production by end product

(5)   End-product distribution and use

     (a)  Historical records
     (b)  Current annual use data
     (c)  Identity and properties of most Important formulations
     (d)  Industry forecasts

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                                   48
          On the other hand,,  the areas of ecological and toxicological
Information and the reporting of new pharmacological and biochemical
                                                                     . » •
discoveries of possible importance Here found to be not so amenable to
surveillance.  In Table 4P thes$ areas are represented by the critical
indicators listed under (1) environmental contamination and (2) toxicolo-
gical manifestation.                               „
          It was found to be virtually impossible to identify and segregate
a limited body of primary journals that would permit the maintenance of
an adequate overview of these latter areas.  New information and data in
these areas of "OVERVIEW" concern are diffused throughout English and
foreign- language publications.  This means that in order to be alert to
these events, a broader coverage of United States' and the world's
literature, and a greater reliance on abstracting services, has to be main-
tained than is necessary for "Chemistry and Industry".  Accordingly, a
limited list of source materials that would permit a reasonable surveillance
to be maintained has been developed.  This final selection is represented
by the remaining six sections of Appendix H.
          Appendix H, then, represents a minimal list of publications to
be screened and judged to provide a high degree of coverage of the world's
literature as related to OVERVIEW concerns.  Fourteen principal abstract
journals were included to permit surveillance of this body of literature.
In addition, applicable "newsletters" were included in this list. •
          It is estimated that this list of journals, abstracts, and
information sources should permit coverage of 70 percent or more of the
desired information.  Surveillance of this body of literature for the
indicators in Table 4 of the chemicals of concern should provide the
Information necessary for the scientific review of the potential hasard
of each chemical.

          Priorltlgation.  Only the CPEHS study considered the problem of
prioritlzation.  Three basic approaches were examined.  One, a relevancy
matrix, was based on subjective assignment of an impact level (e.g., A,
B, C, or D) to a given problem or stressor for a number of quality of
life indices  (esthetics, land use, danger to health, etc).  A second was the

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                                   49

             »*
use of a formalized, expert weighting scheme.   The third approach considered
was a numerical rating index, i.e., a health potential index (HPI) .
          The health potential index (HPI) incorporated in a single
product the population-at-rj.sk and the severity of the effect at a single
point in time, e.g., the present.  The value of the HPI was directly
related to the availability and accuracy of the input data, especially.
the toxicologlcal data.  If no health effects have been observed from a
stressor, or if the concept of a threshold dose for acute symptoms Is not
valid, then the HPI has little meaning.  Many potentially important  *
health effects may be missed with the HPI because missing or negative
information cannot be included.  Synergisms are also not included.  The
HPI, however, represents a rapid means of evaluating the health components of
environmental problems.  The fact that one is forced to state the potential
explicitly is a step toward rigorous and defensible priority setting.
          The health potential index is based upon the assumption that
the chronic exposure to a stressor can be expressed as the ratio of the
body burden of the stressor  (in concentration units) to the threshold
body burden  (in concentration units) at which acute effects are  observed.
The weighting factor for the acute effect was arbitrarily defined as
unity; chronic effects were by definition less than unity.  The  health
potential index is a combination of the populatlon-at-risk and the
severity index.  Separation of the population into two groups based upon
body burdens should have been done in a reasonable manner for each stressor.
As defined,  the HPI represents the current status.  To provide further
information  to the  decision maker, the health index should be
followed by  a plus  if, in the judgment of the expert, the Indue will Increase
with time over the  planning horizon; and with a minus if it is decreasing, or a
zero if no change is expected.  The health potential index for a stressor,
a, was defined as
where   ,
           N  • number  of people exhibiting acute symptoms
           S  - severity indicator  for acute effect - 1

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                                  50
          N   " number of people with body burden of the strsasor at
            1                                            *
                  concentration C.
                                                              C
          S_  » severity indicator at body burden C. » 	j	
           _
           C
            J
                                                        threshold,  acute
          It is seen that three separate ranking schemes were proposed to
EHS.  The first two relied upon variations of the "wise man" approach,,
                                                    (?
i.e., a consensus of experts, to determine priorities for R&D planning.
The third ranked specific problems by the application of an objective
deterministic indicator (HPI) .      ,
          In summary, both the CPEHS and OVERVIEW studies have addressed
the questions of identification and evaluation of environmental hazards,
and the CPEHS study provides Insight into the prlorltization problem.
Both studies conclude that an information network is an essential aspect
of any planned system, in one case utilizing a subset of published,
Information, and in the other utilizing a variety of monitoring,
surveillance, and technical Information centers.

                          Discussion of Results

          A large number of systems (including Information systems) exist which
are predicated on the identification, assessment, and prioritization needs
of specific, mission-oriented organizations.  While systems used by govern-
mental agencies in the health and environmental areas were emphasized In
this program, there are probably as many Industrial and private systems
that could be identified.  For example, it became apparent during the
early warning seminar that even public- Interest groups, such as the Center
for Science in the Public Interest, function as a system for alerting
the public to the hazards of toxic substances by contributing their members,
as sensors of potential problem substances, to an active study-assessment effort.
The larger Industrial chemical firms undoubtedly have internal systems

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                                   51
for the Identification and assessment of new chemical hazards.  (It Is
believed that these are the subject of at least one other OTS study.)
          A sufficient number of system types has been Identified In this
program to provide convincing evidence that
          (1)  No system exists which In Itself will accomplish
               all the selection and assessment functions for
               toxic chemicals implied in the question posed by
               OTS.  A few provide some of these functions in
               limited areas, such as carcinogenic, workplace,
               or environmental hazards.  A basis for adapting
               these to include all functions (such as assessing
               synergistlc effects) is not readily apparent.
          (2)  While many additional systems could be identified
               through continued search efforts, these would
               turn out to provide essentially the same general
               functions as those reported in this study.  In
               general, these functions Include surveillance,
               surveying, monitoring, screening, reporting,
               sampling, testing, data compilation, or manipu-
               lation, etc., for identification, assessment,
               or priorltzation purposes.
          The evidence for the first item should be apparent from  the
systems described in preceding sections.  Further examination of some
underlying commonalities and differences between the various system-
methodologies tends to support the latter statement.

Commonalities/Differences

          In searching the systems of Appendix D for an existing methodology
applicable to the four questions posed by OTS, some underlying commonalities
of methodology were recognized.  For example, the scope of the existing
eyaterns directed at chemicals is without exception more specific than  the
perceived needs of OTS.  Existing systems have their scope limited by:

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                                   52
          (1)  class of chemicals
          (2)  the source of chemicals
          (3)  the transport media leading to exposure, and/or
          (4)  the affected species.
In addition, existing systems focus implicitly upon acute rather
than chronic effects, due mainly to the orientation of published
literature towards acute effects.  Thus, while the systems identified might
be recognized as partial solutions to OTS' needs, the expansion of the scope
of any existing system is obviously not easily accomplished.
          Another area of commonality lies within the goals of existing
systems.  Almost every system studied has as a basic goal the deter-
mination of a potentially hazardous subset of chemicals or chamical
classes from a larger list of candidates.  This process may be accomplished
in a single step, or a hierarchy of steps may be employed, with each step
again consisting of the determination of a potentially more hazardous subset,
          Each step may be viewed as a process in which information Is
gathered for the list of chemical candidates and combined in some manner
to produce an assessment of the estimated hazard on a univariate .scale.
The utilization of judgment to provide a true/false answer to the question
of hazard is an example of the combination/assessment process.
          The first step does not have a preceding step to provide a
candidate list.  Many existing systems have developed sensor networks to
generate the chemicals on the original candidate list.  One frequently
employed sensor network for existing systems is the use of the literature,
i.e., either monitoring the raw literature or condensations of literature.
The NTOS1I Toxic Substances List,  ' for example, relies upon Chemical
Abstracts an a source of chemical names and Information,  Further infor-
mation needed for the list is obtained from the open literature.  Some
systems studied, however, relied upon previously published candidate lists,
hence the first step had been previously accomplished for these
systems.  Another example of a sensor network for the generation of an
original candidate list, typified by the approach used by the National
Pesticide Monitoring Program, was the collected judgment of professionals,
queried and resolved by the Delphi  technique.  This approach is feasible

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                                   53
when the candidate list is relatively small.
          Some sensor networks are monitoring networks in the real environ-
ment.  The NIESS system (Appendix D) of the Consumer Product Safety
Commission, for example, generates its candidate list for hazards from
hospital emergency room reports.  This approach is useful when a direct,
measurable cause-effect result can be observed after the fact.
          After their sensor networks establish candidate lists of
chemicals, existing systems determine a potentially hazardous subset of
chemicals through a single or repeated application of information
collection and decision-making.  The large number of sources of chemical
information was referred to earlier (Table 2).
          After the Information is collected, existing systems manipulate
the  information to form a design basis by which priorltlzation/classification
decisions can be made.  A general framework has been structured which
expresses the design basis of most existing prloritlzation systems.  This
general basic system for prioritization or categorization accepts from
the  universe of knowledge a small subset of information.  This information
subset IB then processed and combined to produce categories or priorities.
Graphically, the process is as follows.
ITHMS TO BE
CATEGORIZED
OR PRIORITIZED

>.
'


p 	 T- 	 ,
PRIORITIZATION
OR
CATEGORIZATION
SYSTFM

                                                               CATEGORIZED
                                                                   OR
                                                               PRIORITIZED
                                                                  ITEMS

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                                   54

To design or adapt a prioritization/categorization system, it is necessary
to specify
          (1)  The subset of information to be used by the system
          (2)  The algorithm by which the subset of information
               will be manipulated and combined.                   I
Examination of the existing systems suggest three approaches to the
design of a pribritization/categorization algorithm
          (1)  The "wise man" approach, a subjective design
               where the system framework is established on the
               basis of perceived needs and an assessment of
               available resources.  The National Pesticide
               Monitoring Program, and many contemporary systems
               appear to have been formulated this way.
          (2)  The "index" approach, a design based upon a
               specific ranking parameter formed algebraically
               and/or logically from other data.  This would
               be exemplified by a system for ranking hazardous
               waterborne substances by the volume of water
               necessary to dilute expected annual spillage
               to a safe or limiting concentration.
          (3)  The "optimized" approach, designs wherein the
               parameters are selected for producing categories
               or priority ranking on the basis of assigned
               values and weightings.  This was the technique
               employed in the Coast Guard's Chemical
               Hazard Ranking Information System (CHRIS).
          These approaches can be exemplified by reference to a few of the
existing systems.

          "Wise Man Approach".  A classic example of the "wise man"
approach Is given by the National Pesticide Monitoring Program.*  Its
list of pesticides of concern was constructed via a collective set of
opinions, based on toxlclty, quantity, and persistence.
  See Appendix D.

-------
                                   55
          Index Approach.   An index can be constructed by two methods.   In
a stochastic construction* statistical techniques are used to derive
indices from a wide variety of data or observations.   A large amount of
data are generally required for the stochastic approach.  The determinis-
tic construction identifies or deduces (subjectively) relevant indices
from the area of concern.   The indices may be algebraic and/or logical
combinations of data.  Frequently an index may have a physical meaning.

                                                           (25)
          Stochastic Index.  In 1971, Synectics CorporationN  ' developed
a system for allocating priorites to industrial waste treatment R&D projects.
In this study, three priority indicators were derived by the stochastic
technique from existing, Implicit EPA priorities.
          Each of the indicators was derived by the utilization of past
Federal funding to provide rank order as a dependent variable.  The
Independent variables for the three indices (location, constituent, and
industry) are presented in Table 5.  A statistical technique was used to
derive the three indices from the gathered data.  These indices were
then utilized to prioritize future EPA expenditures by state and by Industry.
          The scheme presented by Synectics typifies the construction of a
stochastic index to perform prioritization.  The data utilized to construct
the index, however,  (Federally funded) must be viewed as subjective data
representing at best a consensus opinion of experts.

          Deterministic Index.  Many examples of deterministic indices
are available.  Such an indicator was proposed in the CPEHS study in
which a conceptual system was derived to examine research and development
program planning needs, and to develop a management assistance program.
The prioritizatiori scheme of the study is based on a deterministic index.
          As the study did not have the data to perform priority ranking,
and such data would not be available to CPEHS for several years after
Implementation, the ranking was never performed.  An intermediate alternative
method was proposed, however.  This was in essence a "wise man" approach,
utilizing value judgments from experts.

-------
                          TABLE 5.  INDEPENDENT VARIABLES  FOR STOCHASTIC INDICES
                                    IN EPA PRIORITIZATION  OF  FUNDING
Locatlonal (State as Case)
Effluent Constituent (State as Case)
 Industrial  Volume  (sic  2 digit
	code as  Case)
Industrial Waste Water Volume
Population
Valve added by Manufacturer
Annual Runoff
Water Area
Population Density
Industrial Water Use
Effluent Volume
State Standard
Economic Effects
EPA Regional Standard
Public Notice
Low Concentration Limit
High Concentration Limit
Relative Cost of Removal
 Industrial  Effluent  Volume
 Water Use
 Value added by Manufacture
 Employment
 Number  of States with  Plants
 Total Plants
 Plants  using >20 mgy

-------
                                    57
          Other examples of deterministic indicators are available,
These include
          (1)  A water hazard ranking scheme which utilizes
               volume transported! accident probabilities,
               and critical concentrations to provide a rank
               based upon the expected volume of water polluted
                                                     (13)
               to the critical concentration annually
          (2)  A solid waste hazard screening system which
               classifies a material as very hazardous If
               the material meets any one of eleven criteria.
               This is an example of a logical (as opposed to
               algebraic) indicator*17*
                                           (21)
          (3)  An air hazard ranking scheme     analogous to
               (1) above, but including stationary sources.
               Stationary sources produced an index based upon
               a record of accidents with arbitrary scoring,
               while mobile sources produced an index analogous
               to (1) above, but with considerations of vola-
               tility and hazard ratings.  The two indices
               were combined logarithmetically to produce a
               hazard ranking index, for accidental air
               pollution episodes.
          (4)  The Office of Water Programs has developed a
               list of hazardous substances based upon a
               logical deterministic index.  Data considered
               includes half-life, bloconcentratlon, radio-
               toxlcity, lethality (in aqueous, oral, dermal, or
               vaporous), oxygen demand, and nuisance aquatic
                                  (22)
               growth stimulation.
          (5)  Each year NIOSH provides a priority list for
               Criteria Development for Toxic Substances and
               Physical Agents/5*

-------
                                   58
          "Optimized" Approach.   The Coast Guard CHRIS system described
earlier     Is an example of the "optimized" approach.  The study contains
an analysis of information requirements for an accidental npillage
incident.  The prioritizatlon of the information needs demonstrated that
19 of the 144 perceived needs satisfied SO percent of the total need.

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                                   59
                              REFERENCES


 (1)   "Chemicals and Health" - Report of the  Panel on Chemicals  and  Health
      of  the President's Science Advisory Committee, National  Science
      Foundation, September, 1973.

 (2)   "Toxic Substance Control Act  of  1973",  U,  S. Senate  Bill No. 426,
      House of  Representatives Bill No. 5356.

 (3)   "CPI Airs Views on Toxic Substances Bills", Chemical and Engineering
      News, pp  12-14, March 26,  1973.

 (4)   "A  Directory  of Information Resources  in the United  States -
      GENERAL TOXICOLOGY", compiled by  the Library of Congress for  the
      National  Library of Medicine, June, 1969.

 (5)   '"Hie Toxic Substances List, 1973  Edition",  H.  E.  Christensen,  Ed.,
      U.  S. Department of Health, Education  and Welfare, June, 1973.

 (6)   Unpublished;  communication to authors  by NIOSH.

 (7)   Federal Register, _36  (105), May  29, 1971.

 (8)   Personal  communication with the  National Cancer  Institute.

 (9)   McCce, A. A., and McCaleb, K. E., Talk presented  at  n seminar  on
      "Early Warning Systems  for Toxic  Substances",  January 30 - February 1,
      1974, Battelle's Seattle Research Center,  Seattle, Washington.

(10)   Murray, J. L.,  and Cutler,  S. J., "National Cancer  Institute  Program
      of  Cancer Surveillance, Epidemiology and End  Results Reporting (SEER
      Program), paper presented  at  seminar on "Early Warning Systems for
      Toxic Substances", January 30 -  February 1, 1974, at Battelle's Seattle
      Research  Center.

(11)   IKillinger, J.,  et  al.,  "Proposed Air Pollution Control Priorities",
      Interim I  report to  1)1 roc tor,  NKRC-RFP, July 31,  1973.

(12)   "Technical Document/it Ion  for  Hazardous Substances",  KPA Office of
      Water  Programs,  1973, Available  from U. S. Government Printing Office.

(13)   Onus on,  G.,.. et al.,  "Control  of  Spillage of Hazardous Polluting
      Substances",  Study  for  EPA by Battelle Memorial  Institute's Pacific
      Northwest Laboratories, November,  1970.

(14)   "Design  and  Operation  of an Information Center on Analytical  Methodology",
      Study  for EPA by  Battelle  Memorial  Institute's Columbus Laboratories,
      June,  1971.

-------
                                  60


                         REFERENCES (Continued)
(15)   Darby,  R.  L.,  and Little,  R.  L.,  "Operation of the Analytical
      Methodology Information Center",  Study for EPA by Battelle Memorial
      Institute's Columbus Laboratories,  April,  1973.

(16)   Const Guard CHRIS, "Preliminary  System Development - Chemical Hazards
      Response Information Center",  Study for U. S.  Coast Guard Office of
      Research and Development by A. D. Little,  Inc., May, 1972.

(17)   "Program for the Management of Hazardous Wastes", Battelle Memorial
      Institute, Pacific Northwest Laboratories, Report to EPA, March, 1973.

(18)   MeLcalf, R. L.,  "A Laboratory Model Ecosystem as an Element in Early
      Warning Systems  for Toxic Substances", paper presented at seminar on
      "ICarly Warning Systems for Toxic Substances",  January 30 - February 1,
      1974, at Battelle's Seattle Research Center, Seattle, Washington
      (proceedings to  be published).

(19)   Morrison,  1). L., et al., "Technical,*Intelligence, and Project
      Information System for the Environmental Health Service", Vol. I-V,
      HKW  Contract CPS 69-005,  1970.

(20)   Lutz, G. A., et  al., "Design of an Overview System for Evaluating the
      Public Health Hazards of Chemicals in the Environment", USPHS Contract
      DA-86-66-165 (1967).

(21)   "Accidental-Episode Manual", Resources Research, Inc., April, 1972.

(22)   "Effects of Chemicals on Aquatic Life", Water Quality Criteria Data
      Book - Vol. 3. Battelle Memorial Institute, Columbus Laboratories,
      May, 1971.

(23)   "The Federal Environmental Monitoring Directory", prepared by the
      Council on Environmental Quality, May, 1973.

(24)   "Hazardous Substances", Draft document prepared by "HATS" Task Force,
      Office of Water Progrnms,  TCPA.

(25)   Hrnmer, H. C., et al., "A System for Industrial Waste Treatment RD&D
      Project Priority Assignment, Synectics Corporation, February, 1971.

-------
                APPENDIX A . I
BIBLIOGRAPHY OF MACHINE-SEARCHED LITERATURE

-------
                               APPENDIX A
               BIBLIOGRAPHY OF MACHINE-SEARCHED LITERATURE
                              Subject Index
        Subject
Accident Reporting System
Air Pollution

Analytical Methods

Antibiotics
Carcinogens

Consumer Protection
Cost-Benefit Analysis
Cumulation
Detergents
Disease
Domestic Animals
Drugs
Early Warning System
Ecology
Environmental Chemicals
Environmental Hazards
Environmental Health

Environmental Quality
Fertilizer
Fish
Food Additives
Forecasting
Geochemistry
     Reference
2
7, 11. 16, 37, 46, 47, 50, 51,
  55, 59
1. 3, 4, 5, 6, 9, 10, 11, 15, 22,
  23, 30, 33, 36, 52, 53
36, 38
1, 3, 4, 11, 20, 22, 23, 26, 31,
  36, 55
37, 50
2, 43
5, 19, 22, 31, 32, 33, 61
7, 11
14, 16, 28, 44, 46, 47
17, 49, 53
17, 22, 36, 38, 41
13, 51
7. 14, 17, 44, 48, 52
17, 24, 26
1, 6, 13, 18, 26, 31, 37, 40, 43,  58
7, 11, 13, 14, 16, 19, 21, 27,  33,
  42, 44, 47, 49, 57
1, 4, 17, 25. 39, 44, 49, 50, 54
7
5, 18, 20, 53
4. 12, 23, 36. 41, 60
5, 9, 10, 18, 42, 60, 61
14

-------
                                   A-2
        Subject
Health Planning
Hospitals
Hygiene
Indicators
Industrial Chemicals
Industrial Psychology
Industrial Waste
Information System
Lead
Legislation
Lethal Effects
Long-Range Effects
Management System
Market Survey
Maximum Permissible Exposure
Models
Mutagens
Occupational Health
Pesticides
     Reference
8, 35, 39, 47, 51, 52
44
7, 16, 25
13,
19,  36, 55
6
7
2, 3, 13, 33, 42, 53, 57
9, 15, 28, 50
3, 25, 30, 34, 46, 52, 53, 56, 58
22,  32, 36, 38
20,  26, 29, 34, 51, 54, 56
8, 31, 42, 62
20,  34, 41
11,  16, 20, 32, 33
3, 16, 28, 42, 48
1. 12, 21, 22, 26, 31, 36, 38
6. 10. 19. 37. 45. 46. 47
Pharmaceuticals
Physical Factors
Physiological Factors
Plants
Plastics
Poison Control
Poisoning
Population Trends
Public Health

Registration
15
6, 7, 9, 15, 28, 50, 52
37, 39, 48, 51, 54
1, 3, 15, 17, 22, 24, 25, 31, 34, 35,
  36, 38, 39, 40, 42, 46, 47, 48, 49,
  50, 51, 52, 62
18, 34, 52, 53, 58

-------
                                   A-3
        Subject                              Reference
Regulations                             2, 3, 15, 18, 20,  24,  34,  S3,  55,
                                          56, 58, 59, 60
Risk-Benefit Analysis                   5, 17, 26, 31,  35, 43,  52
*>_r_ r
-------
                                      A-4
                                  References
 (1)   Anonymous,  "Research  Into  Environmental  Pollution.   Report  of  Five WHO
      Scientific  Groups", World  Health  Organ.  Tech.  Report,  406,  83  (1968).

 (2)   Anonymous,  "CPI  Split on New  Rules  for Risky Cargo", Chem.  Eng.  News,
      47  (38),  34-35  (1969).

 (3)   Anonymous,  "Mrak Committee Molds  Pesticides' Future",  Farm  Chem.,  132
      (12),  24-25 (1969).

 (4)   Anonymous,  "Food and  Drug  Administration Advisory Committee on Protocols
      for Safety  Evaluation:  Panel  on Carcinogenesis Report  on Cancer Testing
      in  the Safety Evaluation of Food  Additives  and Pesticides", Toxicol
      Appl.  Pharmacol., 20, 419-438 (November, 1971).

 (5)   Alabaster,  J. S., "Evaluating Risks of Pesticides to Fish", Proc.  Brit.
      Insecticide-Fungicide Conf.,  £» 370-379  (1969).

 (6)   Bachmann, W., Grund,  W., Haublein,  H. G., Kupper, J.,  Schulz,  G.,  Zschunke,
      E., "Developmental Trends  in  Occupational Medicine in  the German Democratic
      Republic",  Z Geaamte  Hyg., 17_, 801-809  (November, 1971).

 (7)   Bak'acs,  T.,  "Environmental Hygiene. Its Present Evaluation and Prospects
      in  Hungary",  Acta. Med. Acad. Sci.  Hung., .24,  237-262  (1967).

 (8)   Banks, H. 0., "Comprehensive  Health Planning in Relation to Environmental .
      Problems: Environment:  Conflict and Compromise", Am. J.  Public Health,
      61  (10),  1972-1979 (1971).

 (9)   Barltrop, D., "The Detection  of Children Abnormally Exposed to Lead",
      ARH. HIG. RAD.  TOKSIKOL.,  21  (3), 225-232 (1970).

(10)   Bartek, P., Gaume, J. G.,  Rostami,  H. G., "Cytogenic Studies on Subjects
      Occupatlonally  Exposed to  Low Doses of  Ionizing Radiations.  Dynamics
      Analysis for Time of  Useful Function (TUF)  Predictions in Toxic Combus-
      tive Environments", AEROSP. MED., 41 (12),  1392-1395 (1970).

(11)   Boklna, A.  I.,  Pushklna, N. N., Oslntseva,  V.  P., Dmitriev, M.T.,
      "Review of  Current Methodological Approaches  to Health Studies", Veatn.
      Akad., Med. Nauk. Sssr., ^1 65-70 (January, 1972).

(12)   Bridges,  B. A.,  "Screening for Environmental Agents Causing Genetic
      Damage: Introduction",  Lab. Pract., 21  (6), 411-412 (1972).

(13)   Butrico,  F. A.,  "Early Warning Systems  Concerned with  Environmental
      Contaminants",  Am. J. Public  Health, 59_ (3), 422-427 (1969).

-------
                                       A-5
(14)   Cannon,  H.  L.,  Hopps,  H.  C.,  "Geological Society of America Memoir,
      123.   Environmental—Health and Disease", GEOL.  SOC. AM.  MEM., 230 (1971).

(15)   Challop, R., McCabe, E.,  Reece, R.,  "Breaking the Childhood Lead
      Poisoning Cycle, A Program for Community Caseflnding and Self-Help",
      Amer. J. Public Health, 62 655-657  (May, 1972).

(16)   Chizhikov,  V. A., "Use of Animal Disease Models  in Studies on Hygienic
      Standardisation", Gig. Sanit., 35 ,  19-23 (May,  1970).

(17)   Coulston, F., Korte, F.,  Environmental Quality and Safety.  Chemistry.
      Toxicology, and Technology. Vol. I.   Global Aspects of Chemistry.
      Toxicology, and Technology as Applied to the Environment, p 267 (1972).

(18)   DeVaney, T. E., "Registration of. Pesticides—A Review", Procedings of
      the Second Gulf Coast Conference on Mosquito Suppression.

(19)   Eckardt, R. E., "Innovations in Occupational Health: Toxicological
      Evaluation of Industrial Chemicals", Am. J. Public Health, 60, 2011-2015
      (October, 1970).

(20)   Eisler, M., "Pesticides: Toxicology and Safety Evaluation", Trans. N.Y.
      Acad. Sci., 31  (6), 720-730 (1969).

(21)   Epstein, S. S., Legator, M. S., The Mutagenicity of Pesticides; Concepts
      and Evaluation. The MIT Press, Cambridge (1971), p  220.

(22)   Epstein, S. S., "Chemical Mutagens in the Human Environment", Nature
      (London),  219 (5152), 385-387  (1968).

(23)   FDA Advisory Committee on Protocols, "Food and Drug Administration
      Advisory Committee on Protocols for Safety Evaluation: Panel  on Carcino-
      genesls Report  on Cancer Testing in the Safety Evaluation of  Food
      Additives  and Pesticides", Toxicol. Appl. Pharmacol., 20  (3), 419-438
      (1971).

(24)   Friedman,  L., "Problems of Evaluating th* Health Significance of the
      Chemicals  Present in Foods",  Int. Congr. Pharmacol.,  263  (1972).

(25)   Gartner, H., Environmental Hygiene Tasks of the Public Health Service.
      OEFF GESUNDHEITSWES, 103-107  (1971).

(26)   Golberg, L., "Evaluation of Benefit Versus Potential  Hazard in Environ-
      mental Toxicology", Int. Congr. Pharmacol., 260-261  (1972).

(27)   Goulding,  R. L., "Considerations Preliminary to Development of a Waste
      Pesticide Management System, A Report of the Waste  Management Task Group
      Environmental Health Sciences  Center, Oregon'State  University, Corvallis,
      Oregon", J. Environ. Health,  34 (1), 55-57 (1971).

-------
                                       A-6


(28)   Coyer, R.  A., "Lead Toxicity:  A Problem in Environmental Pathology",
      Am.  J. Pathol., 64 167-183 (July, 1971).

(29)   Greenfield, S. M., "Monitoring the Environment",  J.  Ass. Offie.  Anal. Chem.,
      55 (2), 235-238 (1972).

(30)   Gunteher,  F. A., "Pesticide Residues in the Total Environment - Reliable
      Detection and Determination, Mitigation, and Legislative Control and
      Surveillance Programmes", Pure Appl. Chem., 21. 355-376 (1970).

(31)   Hueper, W. C., "Public Health Hazards from Environmental Chemical Carcino-
      gens, Mutagens, and Teratogens", Health Phys., 21 (5), 689-707 (1971).

(32)   Kagan, I.  U. S., "The Use of the Coefficient of Cumulation for Selecting
      the Value of the Safety Factor in Establishing the Maximum Permissible
      Concentatlons of Substances",  Gigiena Truda 1 Prof.  Zabolevaniya, 13 (7),
      15-18 (1969).

(33)   Kagan, I.  U. S., Sasinovlch, L. M., Ovseenko, G.  I., "Application of
      Correlation Analysis to Toxicity and Cumulative Indices for the Health
      Standardization of Pesticides in the Air of Working Zones Using
      Electronic Computers", Gig. Tr. Prof. Zabol., 16 21-25 (August, 1972).

(34)   Kunter, K., "The Pesticide Approval Scheme of Turkey and Its Influence
      on The Pesticide Industry", PANS, 15_ (4), 531-534 (1969).

(35)   Kurz, A. T., Jr.,  "Comprehensive Health Planning in Relation to Environ-
      mental Problems. III. Health Department Participation in Planning for
      Action", Am. J. Public Health, 61 (10), 1982-1987 (1971).

(36)   Legator, M. S., Jr., "Chemical Mutagenesis Comes of Age: Environmental
      Implications", J.  Hered., 61 (6), 239-242 (1970).

(37)   Linton, R. M., "Protecting Our Environment", Arch. Environ. Health,
      IB (2), 235-239 (1969).

(38)   Mailing, H. V., "Chemical Mutagens as a Possible Genetic Hazard in Human
      Populations", Am.  Ind. Hyg. Association J., .31 657-666 (November-December, 1970)

(39)   Meekison, W. G., "Public Health and Environmental Planning: The Cariboo
      Experience", Can.  J. Public Health, Q  (1), 31-34 (1972).

(40)   Minard, D., "The Bretton Woods Symposium: Physiological Characterization
      of Health Hazards in Man's Environment", Environ. Res., 2_ 324-330
      (October, 1969).

(41)   Mollenhauer, P. H., "Toxicologic Evaluation and Food Consumption
      Questionnaires for Establishing Permissible Maximum Quantities of Chemical
      Substances in Foods", Arch. Lebensmittelhyg., 23. (8), 169-172 (1972).

-------
                                       A-7
(42)   Morrison,  D.  L.,  Menzel,  D.  B.,  Nielsen,  K.  L.,  Levin,  A.  A., Hamilton,
      C.  W.,  "Technical,  Intelligence, and Project Information System for the
      Environmental Health Service,  Volume I,  Management Assistance and
      Planning", HEW Contract CPS  69-005 (1970).

(43)   National Research Council, Proceedings of the Conference on Hazard
      Evaluation and Risk Analysis Held in Houston, Texas, on August 18-19, 1971.

(44)   Phillips,  D.  F.,  "Hospitals  and the Environment: Ecological Logic",
      Hospitals, 46 (20), 53-58 (1972).

(45)   Popova, T. B. Ponomareva, N. I., L'Vovskaia, E.  N., Lopukhova, K. A.,
      Milkov, L. E., Dzhezhev, A.  M., "Some Data on the Status of Health
      of Workers Engaged in Processing Plastics by Pressure Molding", Gig. Tr.
      Prof. Zabol., 10, 19-23 (December, 1966).

(46)   Prindle, R. A., "The Rationale of Environmental  Standards", Arch. Environ.
      Health, 18 (2), 240-243 (1969).

(47)   Purdom, P. W.. Environmental Health. P 584 (1971).

(48)   Raghavan,  N.  G. S., Singh, N., Das, M., Wattal,  B. L., "The Building
      Blocks for Integrated Pest Control Programme in Public Health", J.
      Commun. Dls., 2 (1-4), 16-24 (1970).

(49)   Rail, D. P.,  "Current and Future Research Needs for Evaluation of the
      Safety of Environmental Chemicals", Int. Congr.  Pharmacol., 262 (1972).

(50)   Russell, C. M., "Environmental Quality and the Community Health Educator",
      Health Serv.  Rep., 87., 947-954  (December, 1972).

(51)   Saylor, L. F., "Air Pollution, Health Effects, and Urban Growth", Calif.
      Med., 115  (1), 106-107 (1971).

(52)   Simmons, S. W., "The Pesticides Program Activities of the Public Health
      Service", Public Health Report, 83  (11), 967-973  (1968).

(53)  Spencer, D. A., "The Comprehensive Regulation of Pesticides", N.A.C. News
      Pest. Rev., 27. (2), 8-10 (1968).

(54)   Stewart, W. H.. "Pesticides and Public Policy",  N.A.C. News, 25 (4), 7-9
      (1967).                                                      """

(55)   Stoklnger, H. E., Jr., "Sanity  in Research and Evaluation of Environmental
      Health", Science, 174  (4010), 662-665 (1971).

(56)  Swackhamer, A. B., "Pesticide Residues in Canada", Residue Rev., .23.,
      37-48 (1968).

(57)   Valley, S. L., "Index to the Report of the Secretary's Commission on
      Pesticides and Their Relationship to Environmental Health", Rep. Monogr.
      Non. Serials, 1-310 (1972).

-------
                                       A-8
(58)   Walls, R.  E., Jr.,  "Pesticide Pollution", Texas Law Rev., 48 (6), 1130-1168
      (1970).

(59)   Walther, E. G., "A Rating of the Major Air Pollutants and Their Sources
      by Effect", J. Air Pollut. Control Aasoc., 22, (5). 352-355 (1972).

(60)   Weil, C. S., "Guidelines for Experiments to Predict the Degree of Safety
      of a Material for Man", Toxicol. Appl. Phannacol., 21 (2), 194-199 (1972).

(61)   Weil, C. S., "Statistics Versus Safety Factors and Scientific Judgment In
      the Evaluation of Safety for Man", Toxicol. Appl. Phannacol., 21 (4).
      454-463 (1972).
                                                              •
(62)   Witt, J. M., Capizzl, Staton W. S., Goulding, R. L., "Considerations
      Preliminary to Development of a Waste Pesticide Management System",
      proceedings of National Working Conference held July 1, 1970.

-------
                APPENDIX B,(
CONTACTS FOR INFORMATION GATHERING PURPOSES

-------
                          TABLE B~l.  CONTACTS FOR INFORMATION GATHERING PURPOSES
                                                                                Type of Contact
         Agency/Unit
Persons
Telephone    Correspondence    Visit
(1)  National Cancer Institute
     a. Carcinogen Bloassay and Program
          Resources Branch
     b. Biometry Branch
(2)  Center for Disease Control
     a. Toxicology Program
     b. NIOSH -Cincinnati, Ohio
        1. Director of Programs
        2. Industrial Hygiene Services

        3. Hazard Evaluation Section
        4. Medical Investigation Branch
        5. Division of Laboratories and
             Criteria Development
        6. Toxicology Branch
     c.  NIOSH - Rockville,  Maryland
        1.  Priority Evaluation Branch
        2.  Office of Research and
             Standards Development
Dr. Sidney Siegel
Dr. James L. Murray

Dr. William Barthel

Dr. Bobby F. Craft
Mr. Thomas Ananfa
Mr. Richard Lewis
Mr. Jerry Flesch
Dr. William Parnes

Mr. William Kelly
Dr. Lewis Trent
Mr. William Wagner
Dr. Xintaras

Mr. Richard James

Mr. Vern Rose
                       X
                   X
                   X
                       X
                   X
                       X
X
X

X
X
X
X
X

X
X
X
X

X

X

-------
                           TABLE B-l.  CONTACTS FOR INFORMATION GATHERING PURPOSES
                                                 (Continued)
Type of Contact
Agency/Unit
Persons Telephone
Correspondence
Visit
 (3)  Food and Drug Administration
      a. Bureau of Drugs
      b. Division of Electronic Products

      c. Bureau of Biologies
      d. Bureau of Foods
      e. Division of Toxicology
 (4)  National Center for Toxlcological
        Research
 (5)  Consumer Product Safety Commission
      a. Bureau of Product Safety

 (6)  Department of the Army
      a. Walter Reed Army Medical Center
 (7)  National Heart and Lung Institute
 (8)  Bureau of Veterinary Medicine
      a. Division of Compliance
 (9)  National Institute of Allergy and
        Infectious Diseases
(10)  Stanford Research Institute   .
Mr. Henry Vernhulst
Dr. Roger H. Schneider
Dr. Robert L. Elder
Mr. Lawrence Stern
Dr. Fischbach
Dr. W. 6. Flaan

Dr. John M. Clayton

Dr. John Locke
Mr. Theodore Woronka

Dr. Anne C. Fred
Dr. C. J. M. Lentant

Mr. Frledlander

Dr. Frank Neva
Mr. Arthur A. McGee
Mr. Stephen Brown
X
X
X
X
X
X

X

X
X

X
X

X

X
X
              X
              X
X

X

X
X
X
         r
X
X
X
X
X

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                          TABLE B-l.  CONTACTS FOR INFORMATION GATHERING PURPOSES
                                                (Continued)
Type of Contact

(11)

(12)
(13)
(14)

Agency /Unit
National Science Foundation
a. RANN Trace Contaninants Program
New York University Medical Center
National Research Council
National Academy of Sciences
a. Environmental Studies Board
Persons Telephone

Dr.
Dr.
Dr.

Mr.

Robert Rabin
Norton Nelson
Ralph Wands

J. Charles Baunmer, Jr.

X
X
X

X
Correspondence Visit

X

X X


(15)  Oak Ridge National Laboratories
        Toxic Materials Information Center
(16)  National Institute of Environmental
        Health Sciences
(17)  Environmental Protection Agency
      a.  Office of Toxic Substances
      b.  Office of Pesticides Programs
      c.  NERC-RTP
      d.  NERC-Las Vegas
Mrs.  Emily Copenhaver
      t*
Dr. Douglas  Lee
Dr. Otto Bessey

Mrs.  Benlgna Carroll
Dr. Robert O'Brien
Dr. Anthony  Colucci
Dr. Gordon Hueter
.Dr. Douglas  Hammer
Dr. Harry  Landon
Dr. Edward Schuck
X
X

X
X
X
X
X
X
X
                                      T
              X

              X
X
X

-------
           TABLE B-l.  CONTACTS FOR INFORMATION GATHERING PURPOSES
                                 (Continued)
Agency/Unit
                                                                 Type of Contact
                                            Persons
                                                                     Telephone    Correspondence
Visit
e. Office of Air Programs, SAROAD
f. Office of Water Programs
(18)   Department of Agriculture
      a.  Agricultural Research Service
      b.  Forest Service
(19)   Department of Commerce
      a.  NOAA
      b.  NOAA-MARMAP
(20)   Department of the Interior
      a.  Geological Survey
         1.  National Stream Quality
              Accounting Betwork
      b.  Bureau of Land Management
      c.  Bureau of Mines
      d.  Bureau of Bpclnmarinn
      e.  Office of Water Resources
          Research
(21)   International Joint Commission -
       United States and Canada
                             Mr. Gerry Akland              X
                             Mr. Alan Vastier              X
                             Mr. Jerry Tempchin            X
                             Mr. Bob Worn                  X

                             Mr. Milt Schechter            X
                             Mr. R. Keith Arnold           X

                             Dr. Richard E. Hollgren       X
                             Mr. Howard Schuck             X

                             Mr. Ernest L. Hendricks       X

                             Mr. R. H. Langford            X
                             Mr. Paul Howard               X
                             Mr. Joseph Corgan             X
                             Mr. Elwood A. Seaman          X

                             Mr. Raymond A. Jensen         X

                             Mr. Eugene W. Weber           X
                                                                                  X
                                                                                                          T

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                         TABLE B-l.  CONTACTS FOR INFORMATION GATHERING PURPOSES
                                               (Continued)
                                                                               Type of Contact
              Agency/Unit                         Persons            Telephone    Correspondence    Visit

(22)  Rational Aeronautics and Space
        Admin1stration
      a. Earth Observation Programs        Or. John H. DeHoyer           X
(23)  National Science Foundation
      a. International Decade of Ocean
           Exploration                     Mr. Feenan D. Jennings        X
(24)  Smithsonian Institute
      a. Office of Environmental Sciences  Mr. William Eilers            X                                      w
      b. Center for Short-Lived Phenomena  Mr. Robert A. Citron          X                                      °*

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                     APPENDIX  C - t
SEMINAR ON EARLY WARNING SYSTEMS  FOR TOXIC  SUBSTANCES

-------
                             APPENDIX C-

        SEMINAR ON EARLY WARNING SYSTEMS FOR TOXIC SUBSTANCES
                             INTRODUCTION

          This appendix summarizes the activities and results of a seminar
on "Early Warning Systems for Toxic Substances" held January 30 - February 1,
1974, at Battelle's Seattle Research Center in Seattle, Washington.  The
sumlnur was funded Jointly hy Battelle, EPA's Office of Toxic Substances,
the National Science Foundation, and the National Institute of Environmental
Health Sciences.
          The relationship of this seminar to the current program (Contract
68-01-2108) was described in the Battelle-Columbus proposal of June 1, 1973,
in response to RFP WA-73-R337.  At that time, it was noted that the suggestion
for n seminar on early warning methodologies for toxic and hazardous pollu-
tants had been put forth internally at Battelie and that such a seminar might
provide a good forum for critiquing some of the systems to be identified.
          Battelle1s motivation for organizing a seminar on this topic had Its
roots in two major programs^ ' ' conducted for HEW from 1967-1970.  Both of
these programs examined approaches for Identification, assessment, priority  set-
ting, and the alerting of the public to health and environmental stressors due
to toxic substances and other conditions.  Consequently, it was with consider-
able tMitliiiN liimn mid Interest thnt thin effort was undertaken.  OTS' decision
in November,  1973, to partially fund the seminar was most  welcome, and  from
that point on EPA's inputs were a continuing part of the planning of the
seminar.
 (I)  bit/, i:. A., et al., "Design of an Overview System for Evaluating
     the I'ublic Health Hazards of Chemicals in the Environment", USPHS
     Contract DA-86-66-165  (1967).
 (2)  Morrison, D. L., Levin, A. A., et al., "Technical, Intelligence, and
     Project Information System for the Environmental Health Service",
     Vol. I-V, HEW Contract CPS 69-005 (1970),

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                                   C-2
                         DESCRIPTION OF SEMINAR

                          Objectives and Scope

          Many governmental, industrial, and private organizations today have
either goals or legal requirements to regulate, limit, or control the short-
and long-term exposure of man and the environment to substances which have or
are likely to have an adverse impact.  The number of candidate substances is
quite large, and new ones regularly come into existence and commercial use.  A
need exists to identify, from among the candidates, those substances which
constitute the more significant hazards so that the allocation of limited
resources for their control and study can be made in a rational manner.
          The seminar focus then was on (1) approaches, methodologies, or
systeins--conceptual or currently operational-applicable to the early identi-
fication, assessment, and prioritization of toxic substances; and (2) discussion
of the problem of providing adequate early warning in the absence of data on
the health or environmental impact of many substances in question.  Early
warning was defined at the outset as having these aspects:
          (1)  The identification of hazards associated with chemicals  ,  ,  •
               now in use, before such usage increases the level of hazard;
          (2)  The identification of hazards likely to be presented by
               the incorporation of an existing commercial chemical into
               a new product-line or use category   .
          (3)  The identification of potential hazards associated with
               new chemicals at a reasonably early point in the laboratory--
               pilot scale--commercialization sequence.
          Thus, the objective of the seminar was to elucidate and critically
examine  the tools that exist for identifying and assessing a priori toxic or
hazardous substances and to assess their practicality for the early warning need.

                                Format

          The seminar comprised three discrete and distinct sessions held on
three successive days.  Each session was a combination of formal papers, a
panel discussion, and time for the airing of viewpoints, comments, questions
and answers, etc., for all participants.  The seminar program and timetable
are included at the end of this appendix.  A brief summary of each session  follows.

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                                   C-3

Session I.  Effects. Legislation,  and Incidents

          This session was designed to examine the extent of the toxic
substance problem in terms of (1)  health and environmental effects, (2) the
basis of and need for legislation, and (3) early warning needs.  A panel
discussion on institutional perspectives was held with the intention of
displaying the varying viewpoints  of the participants towards the
need for early warning, its definition, and the toxic substance problem in
general.

Session IT.  Early Warning System Elements

          This session attempted to focus on concepts, approaches, existing
tools, needs, and other considerations related to the establishment of an
early warning system.  As a framework in identifying appropriate speakers,
three conceptual elements of an early warning system were defined for
examination:  (1) identification of chemicals or classes of chemicals as
candidates for evaluation; (2) assessment of short- and long-term health
or environmental hazards, cost benefit  tradeoffs, etc., as  a step  in  selecting
substances for emphasis in testing, development of control measures,
regulation, etc.; and  (3) alerting the public to identified hazards in a
controlled manner.  A panel discussion was held to summarize what the various
speakers  said relative to these three elements and supplement this information
with thoughts from  the participants at  large.

Session  III.  Early Warning Systems/Subsystems

          The intention of this session was to present information about a
few actual or conceptual systems which have some of the early warning aspects
reviewed  in Session II.  A final closing panel discussion was designed to
raise  the questions (I) where do we go  from here, (2) what  are some of the
R&D needs, and (3) how can an early warning system be implemented?

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                                   C-4

                             Participants

          About 65 persons participated in the seminar.  Among those
represented were (1) U. S. government agencies--NCI, AEC-ORNL, NSF, EPA,
NIEHS, NIOSH, FDA, DOD; (2) Canada—Environmental Protection Service,
Environmental Health Centre, Brock University; (3) industry--Dow, DuPont,
Monsanto, Eastman, Esso, Hercules, Cyanamid; (4) universities—-Columbia
Oregon State, Utah, Colorado State, Washington, New York University Medical
Center;  (5) research Institutes—Battelle, Stanford, Syracuse, MAS; and
(6) a public interest group--Center for Science in the Public Interest.
Thus, the participants represented a fair cross-section of the institutions
concerned with the problem.

                                RESULTS

          It is not possible to adequately assess the results of a seminar
like this from the viewpoint of one or a few participants.  Nevertheless,
it is Battelle's belief that the seminar was highly successful in achieving
the desired aim Of examining in a public forum the tools and viewpoints
that exist relative to the need for early warning.  A good many issues
regarding the need for workability and practicality of early warning were
raised.  At the risk of misstating the real consensus of the seminar's
participants, a few comments which may reflect the  results of  three days
of discussion will be attempted.
          (I)  On the need for and nature of an eventual early warning
               system--a K°"d case, Indeed a good definition of early
               warning beyond that stated as a premise for the seminar
               for development of a single comprehensive early warning
               system was not made.  Rather It was pointed out that quite
               a number of institutional programs are in existence today
               which serve to alert the public to toxic substance hazards.
               These Include:   (1) public interest groups, such as the
               Center for Science in the Public Interest; (2) systematic
               assessment programs such as those carried out by the

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                                C-5
            National Cancer Institute, and based on the accumulation
            and examination of data regarding human exposure, chemical
            toxlclty,  and  epidemiology; and  (3) the Consumer Product  Safety
            Commission's Surveillance of product related hazards
            (including chemicals) via their  NEISS* program.  Conse-
            quently, early warning is more likely to be achieved
            through a  variety of  integrated  approaches, systems,  and
            institutional  responses to specific heeds.  There are
            questions  as to who the users of such a system might  be
            as well as what kind  of agency should operate it
             (regulatory, advisory, etc.)
        (2)  On the availability and access to data for chemical
            hazard asse88ment--there are many reservoirs of available
            data  on toxicity, persistence, production, use patterns,  and
            environmental  health  hazards.  Numerous data banks are in
            existence  and  a number are being developed.  On the  other
            hand, gaps in  data-needs exist,  e.g., there  is a dearth
            of information on long-term,  low-level effects of chemicals.
            The problem  for the available data  is gaining access  within
            the time-frame of need.  The notion that  industry is  sitting
            on a  mountain  of data needed  for early warning or toxic  sub-
            stance assessments was disputed. The problem seems  to be
            more  of not  knowing precisely what  data are  needed or
            necessary, thus making blanket requests for. the  turnover of
             industry's data unrealistic.   Industry  association*  may be
            * vehicle  for  the  Interfacing of public needs with
           .  industrial proprietary data.  The cost of generating
            comprehensive  long- and  short-term  toxlcological data on
           : new  substances is an  issue with  industry.  A stepwlse
             approach  related  to  level  of  introduction into use  or use
             category  seems needed.
National Electronic Injury Surveillance System

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                        C-6

(3)   On toxic substance legislation—it is not a matter of "if"
     but of "when".   Pending energy legislation appears to
     be delaying progress  on the Toxic Substance Control Act.
(4)   On alerting the public—there is general  agreement that it
     is essential to prevent premature arousal of the public
     to possible hazards.   The role of the public interest
     group in this regard  is sensitive.  Forcing premature
     decisions (banning) which may have to be  reversed later can
     affect public confidence in future warnings.
(5)   On risk-benefit-costs—theoretical approaches to assessing
     these tradeoffs exist, but their practical application is
     difficult,  especially with respect to longer-term
     quantification.  There seems little doubt that assessment
     of^these factors should be a part of early warning efforts.

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                                                                                                     PROGRAM
                             SEMINAR

                                ON



       EARLY WARNING SYSTEMS FOR TOXIC SUBSTANCES

                          Cosponsored by

                BATTELLE MEMORIAL INSTITUTE
           ENVIRONMENTAL PROTECTION AGENCY-
                 OFFICE OF TOXIC SUBSTANCES
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
               NATIONAL SCIENCE FOUNDATION



                  January 30 - February 1,1974
           BATTELLE'SSEATTLE RESEARCH CENTER
                    4000 Northeast 41st Street
                    Seattle, Washington  38105
 Tuetdcy - January 29. 1974
      7:00- 9:00   Registration and Mixer at the Center
 Wednesday - January 30, 1 974
      8:30- 9:00   Registration at the Center
          9:00   Welcome, T.W. Ambrose, Battelfe's Seattle Research
                   Center
           9:05   Introductory Remarks, Mr. Frank Butrico. Battelle
                   Memorial Institute
           9:1 5   Keynote, Dr. Norton Nelson. New York University
                   Medical Center
 SESSION I        EFFECTS, LEGISLATION, AND INCIDENTS
                 Chairman Farley Fisher, Office of Toxic Substances.
                 Environmental Protection Agency
           9:45   Session Chairman's Comments
           9:50   Human Health Aspects — Anthony Colucci and Paul
                   Brubaker. NERC-Research Triangle Park,
                   Environmental Protection Agency
          10:20   Coffee Break
          10:50   Environmental Aspects  — John Fortesque, Brock
                   University, Canada
          1 1 :20   Legislation and Laws — Michael B. Brownlee. U.S.
                   Senate Commerce Committee Staff
          12:00   LUNCH
           1 :00   An Incident of Industrially Related Toxic Peripheral
                   Neuropathy— Bobby F. Craft. National Institute
                   of Occupational Safety and Hearth
           1 :30   An Industry's  Experience — Elmer P. Wheeler, Monsanto
                   Company
          2:00   Coffee Break
          2:20   Panel Discussion on Institutional Perspectives of Early
                   Warning— Chairman Otto Bessey. National
                   Institute of Environmental Health Sciences
Thursday — January 31. 1974
SESSION M        EARLY WARNING SYSTEM ELEMENTS
                 Chairman Ronald S. Goor, National Science Foundation
          9:00   Session Chairman's Comments
          9:05   General System Requirements— Benigna S. Carroll,
                  Environmental Protection Agency
          9:35   Establishing Priorities for Synthetic Organic Chemicals-
                  Philip H. Howard, Syracuse University Research
                  Corporation

-------
           10:05

           10:35
           10:55

           11:25

           T1:55
           12:30
            1:30
           2:00
           2:30

           3:00
           3:20
           5:30
           6:30
Friday — February
SESSION III
           9:00
           9:05
           9:35
          10:05
           10:35
 Proposed International Registry on Potentially Toxic
    Chemicals—Cyrus Levinthal. Columbia University
 Coffee Break
 Model Ecosystems and Toxic Substances-Robert L.
    Met calf. University of ll!oo;s
 Anticipating Hazards of Low Level Exposure to Toxic
    Substances—Cyrus Levim^al. Columbia University.
 Methods for Detection of Te-stogenic Agents-Thomas
    H. Shepard, A. Far.te'. 7. ^eoimbal. University of
    Washington
 LUNCH
 Environmental Health Criteria and Monitoring Programs
    of the World Health Organization-F. Gordon Hueter,
    Environmental Protection Agency
 Should Assessment Include Cost-Benefit Tradeoffs-
    Dennis P. Tihansky and Harold V. Kibby, Environmen-
    tal Protection Agency
 Problems with Early Warning Systems for Toxic Materials—
    W. Fulkerson, Oak Ridge National Laboratories
 Coffee Break
 Panel Discussion on Early Warning System Elements-
    Chairman John L. Buckley, Environmental Protection
    Agency
 SOCIAL HOUR
 BANQUET-Speaker. Glenn L Schweitzer, Director.
    Office of Toxic Substances, Environmental Protection
    Agency
1,1974
 EARLY WARNING SYSTEMS/SUBSYSTEMS
 Chairman James E. Flinn, Battelte's Columbus
    Laboratories
 Session Chairman's Comments
 Review of Health/Environment Systems with Potential
    Early Warning Applications—Theodore J. Thomas
    and James  E. Flinn,  Battelle's Columbus Laboratories
 Program to Acquire and Analyze Information on
    Chemicals Impacting Man and Environment-
    Arthur A. McGee and Kirtiand E. McCaleb, Stanford
    Research Institute
 NCI Program of Cancer Surveillance, Epidemiology,
    and End Results Reporting (SEER Program)—James
    E. Murray,  National Cancer Institute, Department of
    Health, Education, and Welfare
 Coffee Break
10:55   Environmental Impact of Chemicals—Robert J.
          Moolenaar, Dow Chemical Company
11:25   Environmental Stressor Matrix System for Early Warning
          David L. Morrison, Battelle's Columbus Laboratories
11:55   Public Interest Methods for Assessing Chemicals-
          Albert Fritsch, Center for Science in the Public
          Interest
12:30   LUNCH
 1:30   Panel Discussion on the Concept of Early Warning,
          Existing Systems, Research Needs, and Implementa-
          tion-Chairman David  L. Morrison, Battelle's Columbc
          Laboratories
 4:00   ADJOURN

-------
          APPENDIX D -
IDENTIFICATION/ASSESSMENT SYSTEMS
               •in

-------
                              APPENDIX D ~ I -

                   IDENTIFICATION/ASSESSMENT SYSTEMS
          Those systems identified during this study are listed here with
respect to the following general classification scheme:
          I.   Input Surveillance
               A.  New Stressor Identification
               B.  Hazard Assessment of Recognized Stressors
          II.  Output Surveillance
               A.  New Stressor Identification
               B.  Hazard Assessment of Recognized Stressors
The systems described are listed in the same order as given earlier in Table 1.

(1)  Carcinogen Screening (IB. IIB)
                                                %

          The International Agency for Research Against Cancer, based in Lyon,
France, Is a spin-off of the World Health Organization.  It la a periodic
meeting of a group of internationally recognized scientists who (1) receive
information from many sources including the National Cancer Institute's
Carcinogenesis Program,  (2) evaluate the carcinogenic risk of chemicals to man,
and  (3) publish their conclusions in the form of a monograph.

(2)  Annual  (RAT) Toxlcity Testing (IA. IIA)

          A major animal test approach used by the Center for Disease Control,
Atlanta,  is called the 1,1)50 Rat Feed Process.  This process was worked out
by Thomas Caines (currently with the Food and Drug Administration  in Pine Bluff,
Arkansas).  The LDSO is  the amount of a particular toxic substance needed for
half of the test rats to die.  Three approaches apply  the LDSO concept.  One
approach  Identifies the  acute single dosage required to cause the  LDSO effect.
Another approach administers subacutc dosages repeatedly over a period of
time to assess the chronic disease impact of the toxin.  A third approach
observes  breeding and examines the offspring.

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                                   D-2
(3)  Short-Term ^Hamster) Cancer Test (IA)

          Dr. Joseph A. DiPaolo and his colleagues at the National Cancer
Institute are working on a process for testing substances that will take
about two weeks, compared to two to four years taken by current methods.
The process involves the injection of test substances into pregnant hamsters,
thus exposing the embryos to both the chemical and its metabolic by-products.
After two weeks, embryonic cells are examined under a microscope for cancerous
transformations.

(4)  Biological Materials Surveillance (IA. IIB)

          The Rvire;ui of Biologies of the Food and Drug Administration
maintains surveillance of all experimental biological materials under study
for potential commercial use.

(5)  Surveillance of Poisons (IB)

          The National Clearinghouse reviews advertising in a wide assortment
of trade journals in search of products for which they have no information.
If such a product is discovered, they follow up with the manufacturer.

(6)  Radiological Product Surveillance (IB)

          'Hie Division of Klectronic Products, Bureau of Radiological Health,
Food and Drug Administration, maintaluH the Radiological Health Regulations.
About two regulations are added each your.  In addition, they are responsible
for surveillance of compliance as described below.
          The manufacturer must affix a label, the design.of which is approved
by the Bureau of Radiological Health, to the product stating that the product
compiles with Radiological Health Regulations.  He cannot introduce the
product into commerce without this label.  He cannot attach this label until
he has provided the Bureau a complete description of the quality control and
product testing.program for that product.  The Bureau judges the completeness
of the report.  Public Law 90-602 specifies criminal and civil penalties for
noncompliance.

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                                   D-3
          The Bureau receives data from State Health Departments having
Radiological Health r.roups whenever questionable products are discovered.
The Bureau tests products in its own laboratories for compliance with
regulations and does exploratory testing of products for which they have
reason to believe there is a requirement for a regulation.
          Manufacturers must provide the Bureau with a written report on
every new model and must provide, an annual summary of the results of his
testing program.

(7)  National Evaluation of X-ray Trends (IB)

          The NEXT system amounts to a surveillance of X-ray trends by State
Health Departments.  A conference of Federal, and state officials called
the Conference of Radiation Control Program Directors organized the NEXT
Tost Force.  The NKXT Task Force developed a testing and reporting format
that has been superimposed on the state testing programs.  The Bureau of
Radiological Health maintains a data base derived from the NEXT system reports.
This data base is available to the states for comparison of results among
states and for the evaluation of trends over time.

(8)  Biologies Licensing  (IB)

          The Bureau of Biologies of the Food and Drug Administration is
responsible for setting standards for the production and testing of
biological products and for the surveillance of compliance to the regulations
they publish.
          Following Bureau of Biologies review, the Department of Health,
Education, and Welfare issues licenses for the manufacturing establishment
and for the product.

(9)  Drug Surveillance (IB. IIB)

          'Hie Bureau oC Drugs of the Food and Drug Administration provides
surveillance of products prior to marketing through regulations requiring

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                                   D-4
manufacturers to submit a "notice of intent" to market a new drug.  The
manufacturer is required to test the product in accordance with regulations
prior to marketing.

(10)  Chemical Hazard Identification (IIA)

          Originally, the National Cancer Institute contracted with Stanford
Research Institute for a program called Chemical Hazard Ranking Information
System (CHRIS).  Though the project Initially was described as "hazard
ranking", this IB no longer considered appropriate.  It is not currently
considered technically feasible to pursue prediction through structural
analysis.  Nevertheless, it is considered desirable to pursue the potential
of hazard identification through structural analysis.  Consequently,  the
program has been renamed A Research Program to Acquire and Analyze  Information
on Chemicals that Impact on Man and His Environment.
          The process of chemical selection currently used in the SRI program
is described as follows.  SRI first identifies chemicals now in use within
the following nine categories:  (1) intentional food additives, (2) pesticide
residues in food, (3) proprietary drugs,  (4) prescription drugs,  (5)  cos-
metics,  (6) air pollutants, (7) water pollutants,  (8) soaps and detergents,
and (9)  trade sales paints.  After the chemicals have been identified, the
products containing those chemicals are identified.  Then the means of man's
exposure is established in terms of the four kinds of exposure:   (1)  dermal
contact, (2) oral contact, (3) inhalation, and (4) any other.  Finally, a
"mini of exposure" is defined.  This information then is presented to  the
Clipinlcftl Selection Committee of the NCI CoreluoneneslH I'mgram.   The  role of
this committee IB to gather information on chemicals and  Identify candidates
for hloJissny.  The committee bases  its decision on a three-stage  dossier.  The
dossier approach Is used to provide a rational progression of information
selection to the formal bioassay program.

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                                   D-5
(II)  Poison Control Centers (IIA)

          The National Clearinghouse for Poison Control in the FDA Bureau
of Drugs serves as a communication depot for Poison Control Centers in
state departments of health.
          When the ingestion of a questionable substance has been reported
to a state Poison Control Center, the state Center (1) responds by providing
information regarding the substance and the appropriate treatment (if known)
and (2) sends a punch card report to the National Clearinghouse.  The infor-
mation then is transferred from card to tape and is stored off-line with
24-hour retrieval capability.
          lite National Clearinghouse provides the following related services:
          (1)  Publishes "Poison Control Statistics" annually.  This
               publication is used primarily by Federal government
               agencies.
          (2)  Publishes a bimonthly bulletin reporting poison
               experiences.  This is circulated to approximately
               3000 organizations including industry, hospitals,
               poison Control Centers, and professional groups.
          (3)  Prints and distributes a 5 x 8 information card on
               each substance for the state Poison Control Center's
               manual files.

(12)  Epidemic .Intelligence Service  (IIA)

          Tho ('.outer  lor IHHONNO Control IH nuide up of '« number of bureaus,
our of whirl)  is  the Iliiremi of Kpldrmlology.  The KpldemJc Intelligence
Service is a  component of this bureau.  KIS officers are assigned to each
state.  Their Job (H  to follow up unusual incidences of infections or toxic
illness to determine  cause and asseHH the impact on the community.

(U)  National Klectrontc Injury Surveillance System  (IIA)

          NEISS  is  in the Bureau of  Product Safety of  the Consumer Product
Safety Commission.  A paper dated February 27,  1973,  titled "Identifying

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                                   D-6
Product Safety Priorities" by John W.  Locke,  Acting Executive Director of
the Consumer Product Safety Commission,  describes NE1SS.   Following is an
attempt to extract the key factors in NEISS from that paper.
          NEISS is a system for establishing priorities for initiating
governmental efforts to eliminate product hazards.  It is a decision model
utilizing a whole series of factors, some of which are
          •  Frequency of injury,
          •  Severity of injury,
          •  Exposure (degree to which consumer comes in contact
             with product)»
          •  Citizen willingness to incur risk.
          •  The likely success of a standard in reducing hazards,
          •  The cost of reducing the hazard,
          •  The cost of injuries t  and
          •  Citizen concern.
(14)  National Surveillance Network - National
      Occupational Health Survey (IIB)
          NIOSH is surveying a sample of 10,000 to 15,000 work places.
Each plant survey consists of a brief interview with the manager followed
by a walk-through investigation.  A 2-year study will develop basic
descriptive information on the working environment in all nonagricultural
industries covered under the Occupational Health and Safety Act of 1970.
This information will be used to assist in setting priorities for research
and compliance, for directing research toams In future Investigation efforts,
for measuring and to some extent foreran ting trends, and for developing
criteria for standards which will describe the potential health hazards
typical of a particular industry or occupation.  All data will be classified,
key punched, and stored on magnetic tapes.

(15)  Toxic Substance List (IIA. 1IB)

          The Occupational Safety and Health Act of 1970 (Public Laws 91-596)
requires NIOSH to publish an annual list of toxic substances.  The 1973

-------
                                   D-7
edition contains 25,000 listings of chemical substances, including 11,000
names of different chemicals with applicable toxic dose information and
14,000 additional listings consisting of synonym and codes taken
largely from ACS Chemical Abstract Service (CAS) listings.
          It is the purpose of this publication to identify all known toxic
substances which may exist in our environment and to provide pertinent
data on the toxic effects from known doses entering the body by any route
described.  Data included are the:
          (1)  Chemicnl substance's prime name
          (2)  CAS registry number
          (3)  Molecular weight and formula
          (4)  Synonyms
          (5)  Wiswesser  line notation •.
          (6)  Toxic dose data, including
               a.  Qualifying toxic dose
               b.  Route  of exposure
               c.  Species exposed
               d.  Description of exposure
               e.  Units  of dose measurement
               f.  Notations descriptive of toxicology
          (7)  Cited reference
          (8)  U. S. occupational standards
          (9)  NIOSH criteria documents
       I Vlojr i tjea 1 1 on  o f Work  Place C.lxMnU-al H  (1IB)
          A methodology has  been  developed  by  NIOSH  to  prioritize  a candidate
 list  oC  substances  for which criteria  documents might be  developed.  The
 candidate  list  is assembled  from  a  variety  of  sources,  plant  surveys,  new
 Industrial trends,  the National Surveillance Network, etc.
          The prioritized  1973  list presents the  chemicals  by some 17 priority
 classes.  Within each class, the  sensitivity of the  procedure is not fine
 enough  to allow ranking distinctions to  be  made.   The list  for 1973 was
 truncated at a  level where  the  priority  rating system ceased  to be sensitive

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                                   D-8
so  the end result was a list of 471 items.  Excluded were substances for
which criteria documents have already been developed  (e.g.,.asbestos,
.beryllium, CO, etc.).  Not  Included on  the list are the seven  items for
which criteria documents hove already been initiated, nor 14 suspected
carcinogens which have been recommended  for  control by  a  permit system.

(17)  Hazard Evaluation Program (IIB)'

          Section 20(a)(6) of the Occupational Safety and Health Act
of  1970 charges  the Department of Health, Education, and Welfare with the
responsibility for evaluating the potential toxicity of materials used
or  found in the workplace, upon receipt of written requests by  employers
and employee representatives.  HEW's National Institute for Occupational
Safety and Health (NIOSH) is the agency which provides these on-site
toxicity determinations.  While these activities are the responsibility
of  the Division of Technical Services, several other Institute  Divisions
and programs contribute at various stages to the overall program.
Coordination of on-site toxicity determinations is handled  by  the Division
of  Technical Services' Hazard Evaluation Services Branch in Cincinnati
and supported by regional industrial hygienists.  This hazard evaluation
service is provided at no cost to the party  making the  request.
          The request, along with the packet of technical information, is
sent to a NIOSH  regional industrial hygienist who then contacts plant
management and employee representatives to schedule an initial  field
visit.  Kmployeo representatives requesting such evaluations may have
their names held confidential if tltey HO desire.  An observational
survey of the workplace is conducted with these representatives to
elucidate the extent of the problem and to determine the number and type
of  environmental samples to be collected.  Employee interviews  are
conducted to Identify adverse symptomatology experienced by the workers.
Findings from the survey are reported to headquarters and a strategy
developed for the environmental-medical evaluation.  Sampling,  analytical,
and medical tests arc derived and conducted by NIOSH to determine the

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                                  D-9
concentration of substances found and the potentially toxic effects to
affected employees.  Study results are assessed, and a final determination
made.
          Affected employees are notified of the determination.  A full
report of the study including recommendations for controlling observed
hazards, if appropriate, is sent to the employer, employee representatives,
and the U. S. Department of Labor.
          Health Hazard Evaluation reports will be utilized in developing
new standards where toxic substances are found but for which no standards
exist.  Information derived from health hazard evaluations will also be
used in assessment of the validity of existing standards.

(18)  Walter Reed Disease Forecasting System (IIB)

          The Walter Reed Army Institute of Research has undertaken the
organization of information on certain diseases to estimate their
potentials for man.  The potential is the estimated number of cases of
a disease per 1,000 (one thousand) man-days in a particular terrain.
          Their mechanism for arriving at the estimates for threats of
specific disease entities is called a Disease Forecasting System.  It
is composed of two parts:
          (1)  Disease  Information System
          (2)  Disease  Forecasting System.
Those are mutually interactive.
          The Disease Information System facilitates  tin- transition from
information in documents to concepts of disease potentials.  Like other
information systems, it associates data with sources  (extracts with
documents).  This differs  from systems of abstracts in that abstracts
condense and shrink an  article around its ideas.  In  their system, the
extracts dissect the data and save those data applicable to arriving at
an estimate of the number of cases of the specific disease entity per
1,000 man-days exposure to particular place and time.

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                                 D-10
          The logic of this system is based on the idea that diseases
can be defined as biologic phenomena, so that all influences on each
biologic phenomenon are influences on the dynamics of that disease
and thus its risk factor.
          Pertinent data for this system include observed occurrence in
man and animals (reported cases, prevalence, and incidence); the animal
populations involved in each disease entity (biologic phenomenon), the
climactic, topographic, hydrologic, vegetational, chemical, and other
factors influencing these populations.  A device for integrating the
effects of multiple factors has been developed to make general estimates
of disease-risk based on world data for the influential factors.
          There are some 25,000 extracts on eight different diseases
currently in the computer.

C19)  Community Health Effects Surveillance Studies (IIB)

          The CHESS system observes the correlation between the presence
of pollutnnts and incidence of disease through the use of a mailing
questionnaire.  This system is administered by the Human Studies
Laboratory at Research Triangle Park, North Carolina, for the Environmental
Protection Agency.
(20)  Cancer Surveillance. Epidemiology and
      End Results Reporting (IIB)
          Tho 8KER program WHH developed for the National Cancer
 Institute.  Dr. Mnrvin Schwlilernmn nwy be contacted for more information.
Tho following statement describing SEER was provided by the National
Cancer Institute.

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                                 D-ll
          "The SEER program provides information on trends in
          the incidence of various forms of cancer in the
          United States, variation in the occurrence of cancer
          among different population groups and in different
          geographic areas, changes in diagnostic and treatment
          practices and the associated end results in the general
          run of cancer patients.  Data are obtained from a
          selected number of population-based cancer registries
          that provide uniform information on a continuing basis
          and participate in aid hoc, studies designed to identify
          and assess etiologic and prognostic factors."

          The following list of essential characteristics has been
provided by the National Cancer Institute in describing the population-
based tumor registry.  The tumor registry is described as ...

          "A reporting system designed to obtain information on
          every newly diagnosed case of cancer (except non-
          melanotic skin cancer) and on every death with cancer,
          among members of a defined population  (usually one to
          three million people).  The cooperation of every
          general hospital and of the state office of vital
          statistics is necessary to assure completeness of
          reporting.

          "The gonl is  to produce relinble and timely data
          on  the incidence of cancer among the residents of
          the area  to provide information on changes over
          time and  on variation in  the occurrence of cancer
          among subgroups of the population.  All, or a majority
          of  the hospitals, participate in a patient follow-up
          system to provide information on end results, i.e., the
          relationship  of the characteristics of  the patient,
          the nature of the tumor,  extent of disease at diagnosis,
          and treatment to patient  survival.

          'The collected «lnfn ore utlll/.eil to  Identify INRUSH
          that warrant  investigation  through special studies
          which may be  carried out  within a single geographic
          area or as a  collaborative  project by  two or more
          areas."

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                                 D-12
(21)  Subclinical Toxicitv Survey (IIB)

          The CDC in Atlanta is developing a subclinical toxieity survey
process for predicting the effect of stressors through correlation
with steroids and metaboloids in urine.
(22)  Technical. Intelligence, and Project
      Information System (IA. IB)
          This is a conceptual system derived in a study for HEW to
examine research and development program planning needs within the now
disbanded Environmental Health Service (EHS) and to develop a management
assistance system for the EHS.  Problem identification from the pers-
pective of environmental stressors and priority setting were determined
to be important functions to be performed in the planning cycle.  No
single method for planning and priority setting was found to be totally
applicable to the mix of complex problems encountered by EHS.  Continuation
of categorical planning activities was recommended to serve as the
foundation for the development of an integrated planning system based
upon quantitative assessments of the impact of technology upon man and
his environment.  Full implementation of the integrated planning system
requires the availability of a hierarchy of mathematical models for the
assessments.
          Demonstration of the integrated planning system concept was
provided through case HLutli.es for lend and DDT, and for lead, a preliminary
IdcnlJ ncation of elements to be Included in ti par tin I program plan was
made.
          The concept of urgency as a means to establish priorities
for EHS was investigated.  The urgency consists of the people affected,
the severity of the effect, and the rate of change of these quantities
with time.  Where datn on these quantities are not available, a simpler
index based upon number of people affected and severity may be used as
a cursory estimate of priority.

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                                 D-13
          An investigation also was made of existing EHS information
resources including monitoring and surveillance activities.  A directory
of EHS information facilities and selected supplementary resources was
prepared.  An environmental health information network was devised which
would provide EHS ready access to technical, project, and monitoring
information.

(23)  Overview System (IB. IIB)

          This conceptual study derives from a study derives from a
study made to develop a mechanism that would allow the Public Health
Service to maintain an active overview of chemical contaminants that are
now, or likely to be, present in the environment.  A system design study
verified the mechanism utilizing an overview information center to
provide the necessary hazards-identification, evaluation, and alerting
system.  Specific attention was given to the contamination potentials
of mercury, vanadium, nicklo, f luorocarbona, and pulp and paper production.

(24)  National Air Emissions Data System (IB)

          The Office of Air Programs, EPA, maintains the National
Emissions Data System.  The NEDS represents an attempt to collect,
store, and have retrieval capability for all emission data in the country.
The system is composed of several data files:
               Point
           (2)  Area source
           (3)  Federal facilities source
           (4)  Emission factor
           (5)  Hazardous pollutants source
           (6)  Geographical ID
           (7)  Control equipment ID
           (8)  IPP  (Implementation I'lnnning Programs)
               process identification
           (9)  Population data.
Information for all point and area sources nre stored and can be
retrieved by the following kinds of programs:

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                                 D-14
           (1)  Nationwide inventory programs - outputs data so that
               point and area source emissions may be reported by
               source classification and geographical area
           (2)  1PP modeling conversion program - selects dntn
               elements i:rom the source files to be used Tor
               modeling «nd places the data in an acceptable
               format for IPP programs

           (3)  Area source gridding programs - appropriations area
               source emissions to grids for IPP modeling
           (4)  Trend/projection analysis programs - utilize
               existing data to ascertain trends on projections
               of emissions by source and geographic area.
(25)  General Point Source Water File  (IB)


          The General Point Source File which is maintained by the

Office of Water Programs, EPA, represents a comprehensive information

system to record all point sources and discharging facilities in the

water environment.  It is being prepared for early 1973 and will have

the capability to perform many varied analyses.  Map location indicators

are being included in the system, and ultimately, discharges will be

related to ambient water quality.


(26)  International Decade of Ocean Exploration (All)


          The National Science Foundation represents the United

States in the International Decade of Ocean Exploration Program.  The

IDOE program is part of the United States' contribution to the Long-

Term and Expanded Program of Oceanic Exploration and Research (LEPOR).
The program is designed to support oceanographic research efforts that

will contribute to a better understanding of the total ocean environ-

ment on the part of both U.S. interest and other nations of the world.

          The objectives of the IDOE program are:

          (1)  Determine the quality of the ocean environment
               through accelerated scientific observations of
               the ocean's natural state

          (2)  Evaluate the impact of man's activity on that
               environment

          (3)  Establish n scientific basis lor corrective
               actions necessary to preserve the ocean environment
*Environment Reporter. The Bureau of National Affairs, Inc., Washington, D.C.,
 1973.

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                                 D-15
          (4)  Provide the scientific basis needed to improve
               environmental forecasting
          (5)  Assess the sea floor for its resource potential
          (6)  Provide the basic scientific knowledge of biological
               processes necessary to the intelligent utilization
               of living marine resources
          (7)  Improve the scientific framework necessary to reach
               sound international agreements on man's uses of the
               oceans and the resources located therein.
The program is carried out by universities and nonprofit institutions,
industries, and government agency laboratories.

(27)  Marine Resources (IIA)
          The Marine Resource Monitoring, Assessment and Prediction
program (MARMAP) provides for continuing research studies to develop a
program plan, specialized equipment, and expertise required to (1)
understand the biological characteristics requirements of living marine
resources; (2) provide 1'ederal and state regulatory agencies with baseline
inventories and structural analyses of communities of marine organisms;
(3) determine levels of various contaminants in the marine environment in
order to set water quality standards and assess the results of industrial
and other pollutants entering the marine environment; and (4) develop
a public service program under state-federal partnership for the management
of commercial and sport fisheries in the grants-in-aid program.  NOAA
plans to expand research for comprehensive assessment of living marine
resources  on a  continuing  basis;  operation  and maintenance  of  vessels
concerned  with  biological  investigations, such ns  engine, hull,  and structure
repairs;  conducting basic  ecological  studies  and  effects of environmental
alteration on marine organisms;  grants-in-aid to  states  to  assist in the
federal-state partnership  in commercial  and sport  fishery management;
environmental impact analysis  of water  resources;  and an analysis of the
overall  requirements of  an aquaculturc.  system.
  Environment  Reporter, The  Bureau of National Affairs,  Inc., Washington, D.C.,
  1973.

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                                 D-16
(28)  Nattona^ Stream Quality Accounting Network (IIA)

          The Geological Survey maintains a National Stream Quality
Accounting Network.  The NSQAN is collecting and analyzing water supply,
         *.
quality, and quality data to provide a gross estimate (for Level I
             <•*
accounting network) of water resources.  The kinds of information being
reviewed relate to:
          (l)» Specific conductance
          (2)  Temperature
          (3)  Bacteriology
          (4)  Dissolved solids
               Turbidity
               Potassium
          (7)  Sodium
          (8)  Phosphorus
          (9)  Nitrates
         (1Q)  Dissolved Oxygen
         (11)  Mercury
         (12)  Cadmium
         (13)  Lead
         (14)  Arsenic
         (15)  Organics.

C29)  International Biological Program (All)

          The International Biological Program  (IBP) has as its worldwide
theme "The Biological Basis of Productivity and Human Welfare".  The
U.S. response to the central theme of IBP has taken the form of multi-
investigator integrated research projects to develop a good understanding
of how total ecosystems operate.  Tho overall goal is to understand more
clearly the interrelationships within and among ecosystems, by providing
bases for predicting the consequences of environmental stress, whether
man-made or natural, and enhancing the ability  to better manage natural
resources.
 Environment Reporter. The Bureau of National Affairs, Inc., Washington, D.C.,
 1973.

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                                  D-17

          The new dimension added by IBP is the integrated attack on
complex ecological systems by teams of investigators representing a
variety of disciplines.  A mujor objective is to achieve a fuller under-
standing of the processes and rates of nutrient cycling, water movement,
energy flow, and population dynamics in natural and man-dominated eco-
systems that can be obtained by individual investigators working
independently.
          The IBP effort, in part, includes deciduous forest, coniferous
forest, grassland, desert, tundra, and tropical forest.  These studies
arc designed to provide basic information which will be useful for solving
problems of biological production, resource management, and environmental
quality.  The goals of these studies are to establish a scientific base
for programs to function, relate the derived principles to characteristics
of ecosystems, and develop and refine a generalized adaptable simulation
model  for use in planning studies for new development projects.
          Each of the  IBP biomestudies is attempting to elucidate the
characteristics of an  ecosystem; the processes covering transfer of matter
and energy among components, and the controlling variables; to ascertain
the response to natural and man-induced stresses appropriate to each
biome;  to understand the  land-water interactions characteristic of each
biome; and to synthesize  the results of these and other studies into
predictive models of temporal and spatial variation, stability, and other
ecosystem characteristics necessary for resource management in each biome.

(30)   SAROAU  (.LIB)

          SAROAD  (Storage and Retrieval of Aerometric Uata) is the data-
handling system adopted by the Environmental Protection Agency Office
of Air Programs.
          SAROAD consists of a set of standard formats for recording
validated measurements for different pollutants and associated meteo-
rological observations witli various averaging times and a set of standard
codes  for identifying  pollutants, site locations, and methods of sampling

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                                  D-18
and analysis.  At its inception, SAROAD entailed six basic forms:  a
single form for identifying site location and five data forms.  In
several years of use, state and local agencies have suggested improve-
ments to the site form and several of the data forms.
          The aerometric data are stored within NADB, The National
Aerometric Data Bank.

(31)  STORET (IIB)

          The Office of Water Programs of EPA maintains a Storage and
Retrieval (STORET) system for water quality data.  STORET, developed
in 1964, is programmed to perform statistical summations of data as well
as retrieve raw data.  It is based in Washington, D.C., with approximately
200 consoles located throughout the country.  The data are provided to
the system by Federal, state, local, nnd private users covering approxi-
mately 102,000 stations.  If the code for the data is known, the information
is retrievable.  The system assembles and identifies data according to
a River Mile Index, which is constructed on the basis of the stream
configuration of the watersheds from the headwaters to the ocean.  It
also identifies data stations by latitude, longitude, and political
boundaries.

(32)  Environmental Monitoring  (IA)

          Tho Council on Knv:l ronmrnH) I QuflJJty \\i\a bren iisHignecl duties
nnd responsibilities under I'uhllc I.MWH () I - 11)0 mid 41-224 find Executive
Orders  11507 and 11514.  These duties nnd responsibilities require the
council 'to prepare an .-mnunl environmentnl quality report; prepare
recommendations to the President on policies for improving environmental
quality; analyze conditions and trends in the quality of the environment;
conduct investigations relating to the environment; appraise the effect
of federal programs and «ctivities on environmental quality; evaluate
the effects of technology; recommend to  the President and to Federal

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                                 D-19
agencies priorities in environment.il programs;  promote the development
and use of indices and monitoring systems; advise and assist the President
and agencies in achieving international environmental cooperation--under
the foreign policy guidance of the Department of State; and review the
implementation of Executive Order 11507 and, from time to time, report
to the President thereon.
          The CEQ funds contract studies to develop indicators of
environmental quality covering land use, water and air pollution, rec-
reation, pesticides, and wildlife.  One such study, performed in 1971
by MITRE Corporation, presented a design concept for a system to monitor
the nation's environment.  It described a proposed set of approximately
110 environmental indices and indicators and identified major data gaps
in current monitoring programs which must be reduced to allow for routine
computation of the indices.  The system concept featured maximal ex-
ploitation of existing monitoring resources for collection of environmental
data.  An analysis of alternatives for computing environmental indices
identified advantages and disadvantages of centralized versus decentralized
processing configurations.

(33)  National Fuels Surveillance Network  (IA)

          The combustion of petroleum based fuel in motor vehicles
represents an important emission source of both particulate and gaseous
pollutants to the environment.  The potential health hazard associated
with  the combustion  products from fuels and fuel additives was recognized
in the Clean Air Act as amended in 1970,  Section 211, which empowers
the Environmental Protection Agency (EPA)  to require manufacturers of
fuels and fuel additives to register their products.  As an integral
part  of this program, EPA established a National Fuels Surveillance
Network (NFSN) in 1972 for the collection and analysis of fuels and fuel
additives throughout the country.

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                                 D-20
          The NFSN collects gasoline and other fuels through the 10
Regional Offices of the Environmental Protection Agency.  Physical,
chemical, and trace element analytical determinations are made on the
collected fuel samples to detect components which may present an air
pollution hazard or poison exhaust catalytic control devices now under
development.

(34)  Wiswesser Line Notation (IA)

          As demonstrated within the Task A report, a chemical may be
identified in several fashions, including structured notation, common
name, and chemical formula.  A deep need exists for a compact notation
for complex compounds.  Such a notation should also support structure-
activity studies.
          These needs may be fulfilled by Wiswesser line notation.  This
notation allows for a unique mapping from structure notation to a line
formula.
          As an example, aspirin has the chemical formula of CH-COOC-H, COOH.
The Wiswesser notation is IVOR BVQ.  Toluene, which has the chemical
formula C,H-CH_, is simple 1R in Wiswesser.
         o 5  j

(35)  Environmental Information System Office (IIA. IIB)

          The ORNL has organized an Environmental Information System
Office  (EISO) to develop the information activities of environmental
research projects.  To do this, EISO has developed several information
data bases which contain abstracts of relevant publications and activities.
The following list represents the major data bases:
          (1)  Mercury
          (2)  Ecological sciences information center
          (3)  Solid waste data base
          (4)  Environmental mutagen information center
          (5)  Material resources and recycling

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                                 D-21

          (6)   Regional  modeling
          (7)   Energy data base
          (8)   Toxic materials
          (9)   Deciduous forest biome  1972 aubproject
         (10)   Heavy metals
         (11)   Environmental plutonium data base
         (12)   Thermal effects
         (!!!)   Rndionuclidc cycling in soils and plants.

(36)  OHM-TADS (IB. I1U)

          Data has been gathered on the physical, chemical, toxico-
logicai, and commercial aspects of over 850 hazardous materials and placed
in an automated data file.  The file,  referred to as. OHM-TADS, is employed
as the technical data source for the EPA Office of Oil and Hazardous
Materials and is used by EPA personnel when they are called on to
respond to a spill of a hazardous material.  The file complements the
S1TREP file which is employed to store data and reports on past spills
of hazardous materials.

(37)  National Pesticides Monitoring Program (IB. IIB)

          The MPMP consists of an integrated interagency effort to
restrict, control, and monitor the pesticides and their decay products
in the environment.  The program consists of three basic functions:
          ^1)  Criteria — developed by published information,
               company datn, hrninsterming
          (2)  Registration—to control the. quality of pesticides
               entering the environment
          (3)  Technical Services--to develop monitoring techniques
               and to coordinate the efforts of the many environ-
               mental monitoring programs currently in existence.

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                                 D-22

(38)  Prioritization of Synthetic Organic Chemicals (IIB)

          Dr. Philip llownrd, Syracuse University Research Corporation,
li«« examined approaches lor eMt/tlHlshlng priorities for synthetic organic
chemic;tls which impact adversely on the environment.  In a recent paper*
;md in private communications, he has suggested the following information
categories would provide the parameters needed for determination of
environmental hazard:  (1)  chemistry and chemical structure, (2) exposure
in terms of production quantities and use categories, (3) toxicity, and
(4) environmental stability.  Conceptual in nature, this systematic
approach is workable only for substances where adequate data are available,
e.g., in the case of a commercially produced substance.

(39)  Toxicology Information ProRram (IB. IIB)

          The Toxicology InTo muttJon Program was organized at the National
Library of Medicine in 1967, following recommendations in a 1966 Presidential
Science Advisory Committee report on the "Handling of Toxicological
Information".  It has two overall objectives:  to create automated
toxicology data banks using data from the scientific literature and the
files of collaborating government, industrial, and academic organizations;
and to establish toxicology information services for the scientific
community.
          In order to fulfill the latter objective, the Toxicology
Inl onudt Ion Program sponsors the production of review articles on topics
ol M|u'cl:il current Inlornsl in toxicology, with pnrllc.nl t\r omplmsis on
environmental toxicology.  Recognized experts submit proposals for writing
such reviews; these proposals are evnl.uated and ranked in order of impor-
tance by the Toxicology Study Section of the National institutes of Health.
The preparation of the actual article is funded by a contract between
the author and the Toxicology Information Response Center (TIRC) at the
Oak Ridge National Laboratory.  This center is affiliated with, and wholly
*  Howard, P.H., "Establishing Environmental Priorities for Synthetic Organic
   Chemicals:  Focusing on the Next PCB's", paper presented at Seminar on
   Early Warning Systems for Toxic Substances at Battelle's Seattle Research
   Center, January 30 - February 1, 1974.

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                                 D-23
funded by, the Library's Toxicology Information Program.  Completed
manuscripts are then submitted, in the usual manner, to the editor of
Environmental Health Perspectives,
          The Toxicology Information Program has ulao devised two other
modes of disseminating toxicology information to the scientific
community:  (1) TIRC performs literature searches in toxicology, on demand,
n partin 1 cost recovery fee of $50 being charged for each search; (2)
the Toxicology Information Program operates an on-line, interactive
toxicology information retrieval service called TOXLINE, provided via
a nationwide communications network.  It gives users access on their
own terminals to citations, abstracts, keywords, and index terms for some
250,000 journal articles in toxicology and related fields from 1965 to
the present.

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               APPENDIX E_»
CHEMICAL INFORMATION SYSTEMS AND CENTERS
                    £-1

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                               APPENDIX E - 1 -
                CHEMICAL INFORMATION SYSTEMS AND CENTERS*

                                   (1 2 3)**
SADTLER RESEARCH LABORATORIES, INC.  '

3316 Garden Street
Philadelphia, Pennsylvania 19104
Tel: (215) 382-7800

Toxicology-Related Interests:  Reference spectra for blochemlcals (infrared
and ultraviolet), surface active agents (including detergents), pharma-
ceuticals (infrared and ultraviolet) , monomers and polymers (including
adhesives), agricultural chemicals (infrared), and industrial solvents.

Holdings:  Books, periodicals, and reprints, primarily related to the
area of analytical chemistry; a large and up-to-date collection (80,000
entries) of infrared, ultraviolet, and nuclear magnetic resonance spectra.

Publications:  Sadtler Standard Infrared, Ultra Violet, ATR, and Nuclear
Magnetic Resonance spectra, and DTA thermograms (available for sale on
microfilm, magnetic computer  tapes, or in printed volumes).


AMERICAN CHEMICAL SOCIETY*1 »3^

Chemical Abstracts Service
The Ohio State University
2041 North College Road
Columbus, Ohio A 3210
Tel: (614) 293-5022  Library  293-6356

Toxicology-Related Interests:  Inorganic and organic chemicals; lethal dose
drug studies; food toxicology; pesticides; chemical hazards and safety;
forensic analysis; venoms; antigens;  toxicons; air and water pollution.

Holdings:  The Chemical Abstracts  Service library has about 12,000 chemical
and chemical engineering journals  from 100 countries and patents issued by
25  countries, all regularly monitored in the preparation of Chemical Abstracts.

Publications:  Chemical Abstracts; Basic Journal Abstracts; CA Condensates;
Chemical-Biological Activities; Polymer Science and Technology; Ring Index;
SOCMA Handbook of Commercial  Organic  Chemical Names; Steroid Conjugates.
 *  Refer  to Table  2  in  report; also Reference 4, page 59.

 **Acces8ibility and cost code where this information is known:
   1 = on-site public use of facilities; 2 = information services for a fee;
   3 = answers to  inquiries; 4 « information services for free.
                                                      ,i

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                                   E-2
RADICAL SYSTEM

Professor Cyrus Levinthal
Columbia University
New York, New York 10025

The RADICAL System (Retrieval And Display of ChemicALs) is an information
retrieval system specifically designed to handle data relating to chemical
compounds.  It is designed to produce information similar to that contained
In the NIOSH Toxic Substance List, while allowing computer aided searches
for specific criterion or combinations of criteria.  The system is designed
but is not fully operational.


EUROPEAN ENVIRONMENTAL CHEMICALS DATA AND INFORMATION SYSTEM (ECDIS)

Dr. Mitro Boni
Commission of the European Communities
Ispra (Varese) Italy

This system Is intended to be a "data bank on environmental chemicals",
generated through close relationship to existing information centers in
member states of the "Commission of the European Communities".  A pilot
program is in operation in Ispra, Italy, which employs Professor Levinthal'a
(Columbia University - see RADICAL System) data base and a local retrieval
system with the acronym SIMAS.  The file contains physical data, manufacturers,
toxiclty data, and structure information on some 1500 chlorinated aromatic
compounds.  The compounds were taken from the U.S. Tariff Comission and
CRC Handbook for Chemistry and Physics.

The goal of this pilot study Is the development of a data base applicable
to the problems resulting from the large-scale production of synthetic
chemicals.


UNIVERSITY OF ROCHESTER(1'3'4)

Department of Pharmacology
University of Rochester Medical Center
260 Crlttenden Blvd.
Rochester, New York 14620
Tel: (716) 275-3141

Toxicology-Related Interests:  Clinical toxicology; chemical accldentogenesis;
chemical ingredients of commercial products; toxlcity of chemical ingredients;
toxiclty rating of general formulations (sample formulas); prevention of
pedlatrlc poisonings by study of mineral and vitamin deficiencies (possible
cause of pica).

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                                   E-3
Holdings:  Over 50,000 cross-indexed documented tradename items filed by
tradename, chemical ingredients, use, and manufacturer; large collection
of related reference data; 10,000 reports; books, periodicals.

Publications:  Clinical Toxicology of Commercial Products; monthly bulletins.

                                (1,2,3)
NORTH CAROLINA STATE UNIVERSITY

Institute of Biological Sciences
School of Agriculture and Life Sciences
North Carolina State University
Box 5306
Raleigh, North Carolina 27607
Tel: (919) 755-2665

Toxicology-Related Interests:  Molecular toxicology; basic biological
mechanism reactions in toxicology on a molecular level; biological signi-
ficance of pesticidal residues In soils, plants, and streams.

Holdings:  The central North Carolina State University Library holds most
of the periodicals and books pertinent to this area of work.

Publications:  Tobacco Abstracts; journal articles; annual report.


MIDWEST RESEARCH INSTITUTE(I'2'3)

425 Volker Boulevard
Kansas City, Missouri 64110
Tel: (816) 561-0202

Toxicology-Related Interests:  Toxicities of chemicals, including Pharmaceuticals,
cosmetics, food additives, and agricultural and industrial chemicals, toxic
effects on reproduction;  teratogenlclty; tumorigenlcity and cocarcinogenicity;
interactions of chemicals; biochemical effects and mode of toxic action;
factors affecting toxiclty; drug metabolizing enzymes; absorption;; distribution,
excretion, and metabolism; pollution and pollution mechanisms; analytical
methodn.

Holdings:  7000 books; 800 periodical titles; 8000 reports.  The Institute
is situated adjacent to Linda Hall Library of Science and Technology, which
has 370,000 books and receives 11,000 serials and 250,000 reports published
in 36 languages.

Publications:  Books, reports, bibliographies, periodicals, abstracts, indexes,
directories.

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                                   E-4


NATIONAL LIBRARY OF MEDICINE( ' *

8600 Rockville Pike
Bethesda, Maryland 20014
Tel: (301) 656-4000

Toxicology-Related Interests:   Drug-Induced abnormalities; drug allergies;
drug reactions; poisoning; toxins, venoms; chemicals; drugs; analytical,
diagnostic, and therapeutic technics and equipment;  medicine, biological
sciences; disease; general toxicology; pharmacology.

Holdings:  Over 1,300,000 books, journals, theses, pamphlets, prints,
microfilms, and other audiovisual materials.  (The Library collects
material exhaustively in some 40 biomedical subject areas and, to a lesser
degree, in a number of related areas such as general chemistry, physics,
zoology, botany, psychology, and instrumentation.)  The History of Medicine
collection numbers more than 60,000 volumes, including over 500 titles
published before 1501.

Publications:  Index Medlcus;  Cumulated Index Medicus; Toxicity Biblio-
graphy; Medical Subject Headings; National Library of Medicine Current
Catalog; Bibliography of Medical Reviews; List of Journals Indexed in
Index Medicus.
                                                       (2)
BIOSCIENCES INFORMATION SERVICE OF BIOLOGICAL ABSTRACTS

2100 Arch Street
Philadelphia, Pennsylvania 19103
Tel: (215) 568-4016

Toxicology-Related Interests:  Pharmacological toxicology; pharmacology;
industrial toxicology; veterinary toxicology; food residues, additives,
and preservatives; poisons in psychopathology; addiction; antidotes;
carcinogens; toxicity of chemotherapeutic and neoplastic agents; teratogens;
pesticides; environmental pollution; ecological poisons; mutegenlc agents;
toxins of microbial origin; toxic effects of radiation; toxic diseases;
rtllargic responses.

Holdings:  Journals, abstracts, magnetic tapes, microfilm, bibliographic
references.

Publications:  Biological Abstracts; BioResearch Index; Abstracts of Mycology.

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                                   E-5


                       (1,2)
THE JOHN CRERAR LIBRARY

35 West 33d Street
Chicago, Illinois 60616
Tel: (312) 225-2526

Toxicology-Related Interests:  All branches of science, including toxicology,
pharmacology, medicine, botany, chemistry, and nuclear science.

Holdings:  Over one million volumes and pamphlets, and current subscriptions
to more than 13,000 periodicals and serial publications, devoted exclusively
to science, technology, and medicine.  The Library has a complete collection
of reports from the U.S. Atomic Energy Commission and the National Aeronautics
and Space Administration, a partial collection of U.S. Department of Defense
unclassified reports, and selected reports of other U.S. Government agencies.

Publications:  Leukemia Abstract; bibliographies; pamphlets describing the
Library's services.
 ARGONNE NATIONAL  LABORATORY
                            (3)
 Argonne  Code  Center
 Argonne  National  Laboratory
 9700 South Cass Avenue
 Argonne,  Illinois 60439
 Tel:  (312) 739-7711  Ext.  4365  or  4366

 Toxicology-Related Interests:   Computer  programs  for radiological  safety
 analysis (atmospheric diffusion,  potential doses  from radioactive  fission
 products).

 Holdings:   291 program packages and  120  ENEA  (European Nuclear  Energy
 Agency)  program packages  containing  source decks, object decks,  sample
 problems,  and documentation  and/or data  libraries required  to make the
 program  usable at another installation.

 Publications: Compilations  of program abstracts  describing each computer
 program  currently available  in the Center library (ANI.-7411); a collection
 of bench-mark problems prepared by the Mathematics and Computation Division
 of the American Nuclear Society (ANL-7416); bibliographies  of relevant
 computer programs.

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BATTELLE MEMORIAL INSTITUTE
                                   E-6


                           (2,3)
Pacific Northwest Laboratories
Post Office Box 999
Richland, Washington 99352
Tel: (509) 942-111 Ext. 3611

Toxicology-Related Interests:  Anesthetics; carcinogens; aerosols; cigarettes;
virology; particles; radioactive chemicals; analytical methods; blood
abnormality; cancer; teratism; pollution; absorption; injection; Inhalation;
emphysema.

Holdings:  25,000 books; 1000 periodicals; 50,000 reports.


BATTELLE MEMORIAL INSTITUTED >3)

Columbus Laboratories
505 King Avenue
Columbus, Ohio 43201
Tel: (614) 299-3151

Toxicology-Related Interests:  Biochemistry; biophysics; carcinogenesis;
chemistry; drug screening; endocrinology; Immunology; microbiology; natural
products; pathology; pharmacology; toxicology; animal physiology; tissues
and tissue culture.

Holdings:  115,000 bound volumes; 3000 periodical titles; 50,000 reports.
The holdings Include extensive collections of scientific and technical
literature of Eastern Europe  and the U.S.S.R.

Publications: Science Policy  Bulletin.


ATOMIC ENERGY COMMISSION(2'3)

DivlHion of Technical Information Extension
Pout Office Box 62
Oak Ridge, Tennessee 37830
Tel: (615) 483-4352

Toxicology-Related Interests:  Metabolism, physiology, and toxicology of
radiolsotopes, actinide elements, and fission product elements.

Holdings:  The master collection of AEC and AEC-contractor technical reports;
related reports from other U.S. Government agencies and their contractors;
reports from all countries actively engaged in atomic energy research and
development; English translations of atomic energy literature in foreign
languages; engineering drawings and specifications.

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                                   E-7
Publications:  Nuclear Science Abstracts;  Technical Progress Reviews;
Abstracts of Limited Distribution Reports.
NUCLEAR SAFETY INFORMATION CENTER

Oak Ridge National Laboratory
Post Office Box Y
Oak Ridge, Tennessee 37830
Tel: (615) 483-8611 Ext. 7253

Toxicology-Related Interests:  Radioactive chemicals; heavy metals;
contamination by radioactivity; beryllium.

Holdings:  Reference file, indexed in depth, of information in the above
areas; documents on nuclear safety, such as reactor safety analysis reports.

Publications:  Nuclear Safety; bibliographies; state-of-the-art reports.
PESTICIDES INFORMATION CENTER

National Agricultural Library
U.S. Department of Agriculture
Beltsville, Maryland 20705
Tel: (202) 388-3434

Toxicology-Related Interests:  Peat control (biological, chemical,, cultural,
ecological, mechanical, and integrated methods); pests  (insects, nematodes,
parasites, weeds, etc.) affecting plants, animals, man, and natural resources,

Holdings:  Computer-based data bank containing data from 20,000 periodical
articles for  the period 1960-1966 and from 1100-1500 articles every two
weeks since January, 1967; International Tree Disease Register (INTREDIS)
on magnetic tape; Herbicides Data File on magnetic tape.

Publications:  Pesticides Documentation Bulletin; special bibliographies.


DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Food and Drug Administration.
Office of Product Safety
Division of Hazardous Substances, Household Substances  Data File
Room 5844, FB-8
Washington, D.C. 20204
Tel: (202) 963-5571

Toxicology-Related Interests:  Toxicology of primary chemical substances
which may be  potentially hazardous.

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                                   E-8
Holdings:  Several thousand laboratory reports, 5000 to 8000 books and
Journals, SOO research and/or development reports, 400 clinical reports.


THE SOAP AND DETERGENT ASSOCIATION (1'3»4)

485 Madison Avenue
New York, New York 10022
Tel: (212) 751-6080

Toxicology-Related Interests:  Detergents; soaps; glycerine; fatty acids;
water pollution (product residues); household chemicals; cleaning agents;
surface-active agents.

Holdings:  Books, journals, abstract literature, bibliographies, pamphlets,
clippings, research data.

Publications:  Division newsletters; Water in the News; Scientific and
Technical Reports.


AMERICAN PETROLEUM INSTITUTE^1'3'4 •

Time-Life Building
1271 Avenue of the Americas
New York, New York 10020
Tel: (212) 586-4200 Ext. 288 (Library)

Toxicology-Related Interests:  Aromatic petroleum naphtha; benzene; butadiene;
copper naphthenate; crude oil; cyclohexane; gasoline; kerosene; naphthalene;
naphthenic acids; styrene; sulfur dioxide; sulfuric acid; toluene; xylene.

Holdings:  The Institute's main library, located at the New York office, has
about 3500 books, 14,000 bound journals, 15,000 reports, 300 bound API
publications, and various pamphlets and papers.

Publications:  Toxicological Reviews; Proceedings of API; Drilling and
Production Practice; API Abstracts of Refining Patents and API Abstracts
of Refining Literature; Index of Papers Sponsored by Division of Production;
Petroleum Facts and Figures; Weekly Statistical Bulletin; Annual Statistical
Review.

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                                   E-9
INDUSTRIAL HYGIENE FOUNDATION OF AMERICA,  INC.

5231 Centre Avenue
Pittsburgh, Pennsylvania 15232
Tel: (412) 687-2100

Toxicology-Related Interests:  The health conservation of all occupational
employees and Improvement of work environment.  Development of health-
conservation programs in Industry.  Environmental health research.

Holdings:  130 journal titles, 2000 books » 40,000 abstracts in Industrial
Hygiene Digest.                                                "

Publications:  Publishes Industrial Hygiene Digest and Index, Transactions
of the IHF Annual Meetings, annual reports, books, publication lists,
technical bulletins.


TOBACCO LITERATURE SERVICE   '  '

205 D. H. Hill Library
North Carolina State University
Raleigh, North Carolina 27607
Tel: (919) 755-2836 or 755-2837

Toxicology-Related Interests:  Tobacco, including chemical and physical
properties, diseases (general, bacterial, flowering plants, fungus, nematodes,
virus), insects, physiology, and biochemistry.

Holdings:  31,000 abstracts; 248 reprints.  The Tobacco Literature Service
uses the collections of the D. H. -Hill Library at the University, which has
426,375 volumes, 1,520 maps, 205,185 microprints and microcards, 45,171
microfiche, 3,683 miqrofllm reels, 10,300 pamphlets and newspaper clippings,
29,640 bound and 400,000 unbound Federal and  State documents, and 16,000
periodical titles.

Publications:  Tobacco Abstracts; Tobacco Reprlnta Series.


NATIONAL CENTER FOR CHRONIC DISEASE CONTROL ^'3*

National Clearinghouse for Smoking and Health
Parklawn Building, Room ll-A-45
5600 Fishers Lane
Rockville, Maryland 20852
Tel: (301) 443-1374

Toxicology-Related Interests:  Biomedical evidence linking smoking (tobacco)
to health, including published and unpublished items and Information on
research  in progress.

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                                  E-10
Holdings:  Over 12,000 items, including books, articles, unpublished papers,
etc. (collection centers on the period from the late 1950's to date).

Publications:  Smoking and Health Bibliographical Bulletin; Smoking and
Health Bibliography; Directqr of Ongoing Research in Smoking and Health;
Health Consequences of Smoking, a Public Health Service Review; various
brochures, films, filmstrlps, etc.

                      (3 4)
ARMY MUNITIONS COMMAND  '

Research Laboratories
Industry Liaison Office
Toxicological Information Center
Edgewood Arsenal, Maryland 21010
Tel: (301) 671-2503

Toxicology-Related Interests:  Toxicology; biochemistry; pharmacology;
physiology.

Holdings:  300,000 reference-abstract cards and about 100 brochures on chemical
compounds.

Publications:  Reports, critical reviews.


NEW YORK ACADEMY OF MEDICINE^1>2>3)

Two East 103d Street
New York, New York 10029
Tel: (212) 876-8200

Toxicology-Related Interests:  Drugs; drug habituatlon; narcotics; legal
medicine; legal chemistry; industrial medicine; allergy; insecticides;
pathology.

Holdings:  380,000 bound monographs and journals; 200,000 pamphlets and
other Items, including Government documents, portrait*, and manuscripts.

Publications:  Bulletin of the New York Academy of Medicine; History of
Medicine Series; descriptive brochures of the library; accessions list.

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                                  E-ll
NATIONAL CLEARINGHOUSE FOR POISON CONTROL CENTERS

Crystal Plaza 15
2211 Jefferson Davis Highway
Arlington, Virginia 20204
Tel: (703) 557-2226

Toxicology-Related Interests:  Poisoning from household products and drugs
or medicines; antidotes and recommended treatment; ingredients of drugs and
hazardous household products.

Holdings:  Thousands of poison reports.  Data on antidotes and ingredients
of new products are supplied by more than 200 manufacturers of drugs and
household products.

Publications:  Bulletin of the National Clearinghouse for Poison Control
Centers; Director of Poison Control Centers.
PHARMACEUTICAL INFORMATION SERVICE
                                   (.3,4)
Philadelphia College of Pharmacy and Science
43d Street and Kingsesslng Avenue
Philadelphia, Pennsylvania 19104
Tel:  (215) 386-5800

Toxicology-Related Interests:  Toxlclty and adverse effects of drugs;
poisonous plants; pharmaceutical, pharmacological, and clinical aspects of
drugs; foreign drug products and their U.S. equivalents.

Holdings:  15, 000- card index listing information about drugs.
PHARMACO-MEDICAL DOCUMENTATION   '

Post Office Box 401
Chatham, New Jersey 07928
Tel: (201) 635-9582 or 635-9644

Toxicology-Related Interests:  Drugs; pesticides; all biologically-active
compounds and substances.

Holdings:  Books, periodicals, reports.

Publications:  Unlisted Drugs; Unlisted Drugs on Cards; Indexes, biblio-
graphies, reports, critical reviews.

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                                  E-12


INTERNATIONAL ASSOCIATION OF WATER POLLUTION RESEARCH (2>

c/o Mr. Robert Canham
Secretary, U.S. National Committee IAWPR
3900 Wisconsin Avenue, N*W.
Washington, D.C. 20016

Toxicology-Related Interests:  Water pollution research; acute and chronic
effects of Water pollution oh aquatic biota.

Publications:  Water Research; Proceedings bf international Conference on
Water Pollution Research *
NATIONAL ACADEMY OF SCIENCES - NATIONAL ACA6EM? OF ENGINEERING - NATIONAL
RESEARCH
Advisory Center on toxicology
Division of Chemistry and Chemical Technology
National Research Council
2101 Constitution Avenue, N.W.
Washington, D.C. 20418
Tel: (202) 961-1380

Toxicology-Related Interests:  General toxicology; toxicology of commercial
products; toxicology of pollutants.

Holdings:  Various data from governmental, industrial, and academic sources;
books, periodicals, reports*
Publications:  Reports*
WORLD LIFE RESEARCH INSTITUTE
                              (2)
International Blotoxlcological Center
23000 Grand Terrace Road
Colton, California 92324
Tel: (714) 825-4773 or 783^0077

Toxicology-Related Interests:  Marine blotoxictflogyi phytotoxicology;
venomous reptiles, amphibians, and arthropods.

Holdings:  Extensive collection On biotoxicology, including data from
ancient civilizations and in all major languages of the world; extensive
files of unpublished documents covering such areas as China, tropical
South America, and tropical Africa.

Publications:  Poisonous and Venomous Marine Animals of the World; biblio-
graphies, books, reviews.

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                                  E-13


                                    (2)
INSTITUTE FOR SCIENTIFIC INFORMATIONv '

325 Chestnut Street
Philadelphia, Pennsylvania 19106
Tel: (215) 923-3300

Toxicology-Related Interests:  Worldwide scientific and technical literature,
including biological, medical, and agricultural sciences;  chemistry; pharma-
cology; and nuclear physics.

Holdings:  250 journals plus a large basic reference collection.   The Institute's
combined services annually cover some 400,000 current items published in
over 3000 source journals.

Publications:  Current Contents Life Sciences; Current Contents Physical
Sciences; Current Contents Chemical Sciences; Current Contents Education;
Current Contents Behavioral, Social, and Management Sciences; Index Chemlcus;
Encyclopedia Chimlca Internationalis; Permuterm Subject Index; Science
Citation Index; International Directory of Research and Development
Scientists; reports, articles, state-of-the-art reviews.

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            APPENDIX F. |






MANAGEMENT SUMMARY FROM CPEHS STUDY

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                                 APPENDIX F. (.
                      MANAGEMENT SUMMARY FROM CPEHS STUDY*
      Implicit in the charge to EHS to establish a better understanding of the ecological
system through consolidation of existing knowledge and the acquisition of new knowledge
is its R&cD function.  This particular study is addressed to the concepts embodied in the
development and implementation of a comprehensive R&D and program planning capabil-
ity for EHS.  Because the mission of EHS represents a new approach to improving man's
environment, i.e. , considering man and his  total ecosystem, a comprehensive system
for planning  and action must evolve over a period of several years rather than be  imple-
mented immediately.  The multidisciplinary  and  multiechelon nature of environmental
programs also influences  the rate at which comprehensive planning and action can be
achieved.  In this study the kinds of components needed were identified and means for
their implementation are recommended.

      Since man is continuously subjected to  stresses from many sources in his environ-
ment, it is convenient to plan in terms of environmental stressors.  The environmental
stressor is that chemical compound or element,  biological agent,  or physical,  social,
or psychological condition, reduced to its simplest terms, that has a resultant effect
upon man.  Within the man-total environment concept,  the source (s) of the stressor, the
path(s) through which it is transported, the receptor(s) of the stressor, and the ultimate
effect(s) upon man must be considered.  The chain from source to effect is termed the
pollution chain and the  source -transport path-receptor  portion of it will be referred to
as the subenvironment.  While  actions can be taken to treat the effects of stressors, the
solution to environmental problems and the improvement of the quality of man's environ-
ment lies at the stressor base.  Removal of  the cause of an environmental health  prob-
lem requires elimination or control of a stressor which may transcend many compart-
ments in the environment.

      Problem  identification from the perspective of environmental stressors is the first
important function that EHS must perform in its  R&D planning cycle.   Once  the problems
have been identified, some order of priority  must be adopted for their detailed examina-
tion and solution.  Intuitively, those problems that have the greatest impact upon  man
within the broad EHS mission should receive primary attention.  In practice, this in-
volves  the application of a value system that  includes health, bioenvironmental, and non-
health factors.  Given the rank ordering of problems, it is then necessary for EHS to
develop plans to solve these problems which most effectively use the funds available.
This encompasses the ability of EHS and its  components to  state the objectives and plan-
ning assumptions pertaining to each of the problems, to list and evaluate alternative
meana  to accomplish the objectives, and to select an optimum mix of alternatives to
form an action  p
*Morrlson, U.  L.,  et al., "Technical,  Intelligence,  and  Project Information System
  for the Environmental Health Service", Vol. l-V,  HEW Contract CPS 69-005  (1970).

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                                       F-2
      No single method for planning and priority setting was found to be totally applicable
to the mix of complex problems encountered by EHS.  Rather, the current categorical
planning activities should serve as the foundation for the development of an integrated
planning system based upon quantitative assessments of the impact of technology upon
man and his environment.   Full implementation of the integrated planning system will
require the availability of comprehensive mathematical models to make the assessments
and the development of selection or decision criteria based upon the quality of life.  A
hierarchical modeling approach has been outlined in this study which can take full
advantage of submodels developed as a part of on-going research programs of EHS.
Although there appears to  be a consensus of the attributes of the,quality of life,  there is
presently no good measurement of some  of these indicators and no acceptable means to
inter compare health, nonhealth,  economic,  and ecologic impacts.  Efforts to develop a
value system and  metrics  for it are required.  Until these are available,  judgment must
be used on the  comparability of values in the planning process.

      The concept of urgency as a means to establish priorities within the environmental
health field was examined.  For a given  stressor or stressor-subenvironment combina-
tion, the urgency  to act consists of the number of people affected,  the  severity of the
effect, and the rate of change of each of these quantities with time.  Where data on these
quantities are not readily available, a simpler index based upon the number of people
affected and the severity of the effect may be used as a cursory estimate of priority.

      Improvements to categorical planning within EHS can be made through  the applica-
tion of explicit methods to evaluate projects.  The objectives  of EHS should be decom-
posed into a hierarchy of successively more specific objectives to which specific pro-
jects can be related.   Each alternative can then be evaluated with respect to  the
objective, cost, and other external restraints, and a quantitative  performance measure
can be assigned to the project.  The ultimate goal is to achieve a planning system that
minimizes strictly subjective inputs and  provides quantitative measures of performance
of listed alternatives to the decision maker.

      A well-organized information base is  essential to supply inputs to the planning
process.  Existing EHS information resources, including the  monitoring and  surveil-
lan< '• activities, were investigated.  A survey was conducted  of the documentation sys-
tems and libraries to determine their operational characteristics as  related  to an infor-
mation network.

      The results  of this survey,  including a limited number of external information re-
st urces, are contained in a separate volume entitled "Directory of Information Sources
for the Environmental Health Service".

     Additional data were obtained through limited personal and telephone interviews
at all levels of EHS and its Administrations  and through study of EHS documentation.

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                                      F-3
       On the basis of the study, the establishment of an Environmental Health Informa-
 tion Network (EHIN) has been structured,  incorporating the existing information and data
-sources, and also new resources such as the Information Resource Identification Sys-
 tem (IRIS) and the Project Information Retrieval System (PIRS).

       In structuring the proposed EHIN, it is recognized that other agencies of the
 Federal Government have established information and data bases which relate to EHS
 responsibilities.  Mechanisms for interfacing and utilizing these resources are sug-
 gested.   Further, it is  recognized that an operational EHIN, structured as a  result of
 this study,  may not be immediately achievable.  Rather, EHIN represents a concept
 which EHS  should build toward as it is able in order to assist in constantly strengthening
 its role in protecting man's environment.

       Very little analytical response (e.g. ,  state-of-the-art reports, technical compila-
 tions, data or design handbooks, and direct answers to technical inquiry) can be ex-
 pected from the present information resources, both within EHS and outside  EHS.  EHS
 should establish  Centers of Technical Competence  (Information Analysin Centers) for
 various  high-priority threat areas in order  to provide the needed analytical capability.
 In addition, there is a  lack of accurate,  documented information relative to the identifi-
 cation of sensitive population groups, to the determination of the number of people cur-
 rently and potentially affected by a stressor, and to the nature and severity of the effect.
 This  represents  an information gap which should be filled on a selective  basis.  Ac-
 cepted thesaurus building rules should be enforced in all EHS information activities in
 order to establish some compatibility of the various thesauri in  terms of cross-
 reference  techniques and similar devices. Growth  of special-purpose  information sys-
 tems, however,  should not be stifled by the creation of a unified vocabulary.

       Necessary information resources and capabilities for effective analysis and eval-
 uation of threats are so great in magnitude  and variety that they cannot be concentrated
 within any single agency.  To cope effectively with the  complexities  of today's environ-
 mental problems,  a wide variety of  information resources should be utilized.  Various
 facilities probably can justify, and should have, a  stand-alone computer capability in
 addition to access to the central computer facility,  primarily for data processing and
 research purposes.  However, with regard to information systems,  every effort
 should be made to strive for compatibility of operations.  The computer facility provided
 for EHS administrative operations,  including information storage and  retrieval opera-
 tions, should equal or  exceed the capability of the  equipment currently employed by the
 central  computer facility, if that facility cannot be made available to EHS.

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                                      F-4
      The specific elements of the management-assistance system recommended to pro-
vide support to the R&tD and program planning functions and to provide scientific,  tech-
nical,  intelligence, and project information are:

      (1)  Overview Environmental Health Planning (OEHP)
      (2)  Inpact Assessment
      (3)  Threat Identification and Evaluation
      (4)  Environmental Health Information Network.

      The objective of the overview environmental health planning function is to provide
coordinated and comprehensive planning in the man-centered ecosystem.  OEHP  repre-
sents a series of steps undertaken at the Service level with the assistance and support
of the  components  of EHS and  outside contractors.  The activities to be performed as a
part of OEHP are to develop problem statements, obtain  stressor matrix input,  estab-
lish decision criteria,  construct a relevancy matrix, establish weights of decision cri-
teria,  obtain a rank ordering of problems, and determine problem assignments.   The
final plan is to be reviewed by EHS and the program selection is to be made.  A high
rate of professional staff effort is required to launch OEHP and would involve 15  people
the first year and 17 the second.  The  level of effort by professionals the third and
fourth years arc 8 and 6 man-years  per year, respectively.  The  program should con-
tinue at 6 man-years per year effort.  This activity could be conducted entirely within
EHS, entirely  by outside contractors,  or by a combination of EHS staff and contractors.
After the third year, the sole  use of EHS staff is recommended.


     Assessment of the  impact of technology upon'man 'and his environment is important
to provide EHS management evaluations upon which policies can be established, planning
can be performed,  and actions can be implemented.  The  impact-assessment function
would include the collection and development of mathematical models, the analysis of
interactions between stressors, and  the assessment of the impact  of a stressor or com-
bination of stressors on man and various sectors of his environment.  If the assessment
function is to be limited to EHS needs only, a minimum level of effort by senior profes-
sional  staff of 3-1/2 man-yearn per y«nr Is recommended.  Approximately 1  man-year
per year of computer programming  support is also  required.  This activity could be
performed within EHS.   However, since the level of effort to meet the demands for
assessments fluctuates, contract  support would be recommended.   The assessment
function could also be broadened to serve other elements of government and industry.
A Center  of Technical Competence for Assessment Technology could be established.
Since its mission would be broader,  a larger staff would be required and would include
4-1/2 to 5 senior professionals, 2 junior professionals, 2 computer programmers, and
secretarial support.  Operation of the center by  a contractor is recommended to accom-
modate fluctuating work loads  efficiently.

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                                       F-5
      The third component of the management-assistance system would be  directed at
the identification and evaluation of potential threats to man and his environment through
intensification or extension of current use patterns of products and services or through
the introduction of new chemical, biological, or physical stressors into the environment.
The threat-identification function could be performed by a small group of individuals
representing physical,  chemical, and biological disciplines.  Trends or patterns in
industrial, urban, occupational, domestic,  and recreational areas would be examined to
determine whether potential threats existed. If potential threats were identified, detailed
evaluations would be made.   This latter  function could be combined with the previous
function for the evaluation pha'-o.  The minimum level of effort that would be required
on a continuing basis for the threat-identification aspects would be 3 to 5 man-years  per
year, assuming that EHIN were operational. This identification function could be per-
formed within EHS,  but complementary assistance by outside contractors or consultants
who may be more closely attuned to trends  in the areas noted would be desirable.

      The following recommendations are made for the establishment of an Environ-
mental Health Information Network (EHIN):

      (a)  The network  should be a coordinated network consisting of a Project
          Information Retrieval System (PIRS), a Monitoring,  Surveillance,
          and Intelligence  Information System (MSIIS), and a Scientific and
          Technical Information System  (STIS),  supplemented by an Information
          Resources Identification System (IRIS).

          (1)  PIRS  should be a centralized  system, operating within EHS.  The
              early establishment of PIRS is urged and should include;

              a. Inventory all current and  past internal projects.

              b. Inventory all current and  past external contracts and grants.

              c. Inventory all results (reports) produced to date,  both inter-
                 nally and by contract and  grant.  For all future projects, at
                 least one copy of each  report should be sent to this facility.

              d.  Organize the above  in such a manner as to make them both
                 accessible and useful to the entire EHS community  including
                 EHS management, EHS operational levels,  and EHS
                 contractors.

         (2)   IRIS should be a relatively  small operation, maintaining an inven-
              tory of information resources  and providing switching and referral
              service both for the use of  the entire staff  and for referral of other
              agencies desiring information to the proper portion of the EHIN
              network.  Implementation of IRIS should begin as soon as practicable.

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                                      F-6
          (3)  MSIIS and STIS should each remain a federation of centers in a
              coordinated network structure.  Each center or activity should
              report to the highest authority consistent with its mission, scope,
              and user audience.

      (b)  Within the EHS headquarters element, a Director of EHIN should be
          appointed to represent and to coordinate the interests of the network,
          not  only at the EHS level, but also in interagency and other Federal
          activities,

      (c)  The Director of EHIN should be assisted by an Advisory Council com-
          posed of the coordinating managers  of PIRS, MSIIS,  and STIS  plus five
          representatives from the operating levels.  The Advisory Council would
          assure the  vitality of the network, determine network requirements for
          equipment, and  recommend establishment, consolidation, or disestab-
          lishment of activities within the network.

      (d1  The Director of EHIN and his Advisory Council should investigate the
          extent to which information resources dealing with program assistance,
          training, and demonstration and testing  should be established  and  incor-
          porated into the network.

          Structuring of an environmental thesaurus oriented to the needs of EHS
          should begin.  It is strongly urged that the thesaurus be based upon actual
     ;    content of projects and reports (and eventually S&T literature), rather
          than be constructed by a conference of experts.  While the latter  is
          possible, it is expensive and may result in generalized decisions which
          may or may not be of practical value in actual practice.  Further,  it is
          almost certain that many vocabulary terms of real value to the user S&tT
          community will be missed  by such a conference and will need  to be inte-
          grated at later stages.

      Two model case studies  were  undertaken for the environmental stressors lead and
p«er*is fent pesticides to  investigate and develop the operational plan and staffing table
de*£ri>bed above.  The effectiveness  of the system was tested by the case studies,  and  '
ar«A-& of improvement were detected.  Examples of the type of information on environ-
mental stressors that are currently available  were provided and the R&D efforts needed
to ektfcin additional data to eliminate or control the hazards from lead in the environment
w«re explored in n preliminary manner.   My delecting a specific stressor for study,
mattemnticnl  modeling, priority rnting,  nnd the environmental utreasor matrix concept4

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                                      F-7

which were evolved as a part of the overall management-assistance system could be den,
onst rated and evaluated.  Both model case studies also represented a comprehensive re
view of the environmental aspects of the stressors.  The salient features of the two
model  case studies are described below.

     .Lead usually occurs as either sulfide ores (galena, PbS) or  oxide or carbonate
ores (anglesite, PbS©4, and cerussite, PbCOs). Minerals of iron, zinc, silver, cop-
per, gold, cadmium,  antimony, arsenic, bismuth,  and others may be associated,  in
varying proportions,  in lead ore deposits. The average grade of  lead ores mined con-
tains between 3.0 and 8. 0 percent lead.  Mining, smelting and refining, Secondary
recovery, and  imports are the four main sources of lead in this country.  In  1969,
mine production of recoverable lead was approximately 500,000 (short tons), with
Missouri accounting for 350,000 tons and Idaho 65,000 tons.  Mine production in the
U.  S.  during the  last ten (10) years has exceeded 250,000 tons annually.  The 1969  U. S.
supply from mining,  primary refining, secondary smelters, and recovery from copper-
based  scrap amounted to about 1,540,000 tons.   During the last decade, the U. S.  supply
annually has  been near or beyond 1,000,000 tons.  Extending this  rationale to the do-
mdstic lead consumption of primary, secondary, imports, and  lead in lead ore entering
directly into the manufacture of lead pigment and salts, a figure of 1,333,000 tons  is
obtained for  1969-  These figures suggest that even though only a  small percentage  of
lead may enter the environment from the production and consumption cycle, a certain
background level of lead would be expected.

      An examination of the use pattern for 1969 and the immediate years preceding in-
dicates how lead is added to the environment.  Although there have been fluctuations in
quantities in the use categories reported,  no major changes in the categories themselves
have been reported during the  last decade. That is, the major  uses oif lead during  1969
continued to be (in decreasing  order) in the production of storage  batteries and acces-
sories,  gasoline antiknock additives (mostly tetraethyllead), red lead and litharge pig-
ments, ammunition,  solder, cable covering, and calking lead.  An inspection of the
materials requirements and manufacturing processes  for the lead-acid storage bat-
teries, e.g., preparation of pasted plates, preparation and assembly of grids, and
particle size distribution and grinding of lead oxides revealed cases of lead intoxication
in 66 battery-based industries  in Pennsylvania.  The use of old battery cases for fuel
and the resulting lead- containing ash also were identified as environmental hazards of
air and soil.

       Examination f the exhausted lead be-
> of lead swirls into the at-
of lead and other metals
ut the U. S. indicated
with the amount

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                                      F-8

of gasoline consumed in the area in which the sample was collected.  The above two in-
vestigations  suggest that leaded gasolines contribute notably to the environmental (soil
and water) burden.  Red lead and litharge-based paints were identified &s an environ-
mental hazard during shipscrapping because  of the high temperatures involved in burning
off (volatilizing) the spent paint.                                                     .   i

      Further exploration of the  lead-pigment use pattern brought to light the ban on the
use of lead pigments in indoor paints.  More important,  however,  it revealed themany
instances of  pediatric plumbism  (pica) in substandard housing areas of our eastern cit-
ies,  e.g., New York,  Baltimore,  Cleveland,  and Chicago.  Factors such as the elimina-
tion of lead paint from walls, continuous education and enforcement activities of the city
health department, efforts of local pediatric  services, establishment of comprehensive
health care clinics for children in  the susceptible age living in high risk areas, family
planning, and an improved social climate have resulted in a drop of almost 50.percent
(286  to 141) in pediatric plumbism in Baltimore during two  consecutive 3-year periods
(1964 to  1966,  and 1966 to 1969).

      As Chisolm points out,  these corrective measures deserve attention when it is
realized that total treatment costs for an institutionalized child suffering from severe
permanent brain damage  may cost approximately $250,000  during a 60-year period.

      An examination of the methods of obtaining lead and the diverse uses of lead sug-
gested that the effects of lead on man may be exercised through contact,  inhalation, and
ingestion.  In order to determine stressor  —«•  source  —*• transport  —*•  path   *"*"
effect (on man) relationship, an environmental stressor matrix was formulated for lead.
The stressor matrix approach appears-sufficiently flexible  to collect and display infor-
mation to define the effects that any stressor may exercise, since  it permits specifica-
tion of the medium, the compartment,  the portal of entry, target site of actioji,  conse-
quences,  and control.                                                 ...

      Lead is very slowly absorbed from environmental  sources, e. g. , soil, water,
food,  and air,  but the gradual accumulation of the element in the body is  the basis for
progressive  toxicity.  It was formerly believed that considerable amounts of lead could
gain access to the body percutaneously, but this has been refuted; instead, inhalation
and ingestion are the two main routes of entry.  The average man ingests about 5 mg/yr
from  drinking water, 100  mg/yr from his diet, and about 15 mg/yr through respiration.
Generally, health authorities agree that lead concentration  in respired air should be be-
low 150 /Lig/m^ and tetraethyllead (TEL) should be below 50 jug/m^.  Concentration  of
lead in ambient air may vary from approximately 0. 01 jug/m3 to 50 jUg/m^ (the  latter in
air along heavily traveled highways).

      Although the  principal site of lead in  the body is the skeleton, many other soft
tissues,  e.g.,  brain, lung, heart, liver, kidney, spleen, and muscle have been found to
contain 20 to 120 jig of lead/ 100 g fresh tissue.  Teeth are confirmed to have a higher
concentration of lead than any of the bonei*,  and the average lead concentration  increasta
with age, e.g.  , "10 year* CA 17 MH/K <•' *")) rt'u' 30 to ft() yrara »«  116 jUg/g of ash.  lUood
has shown the following lead distribution:  erythrocytea .24 jug/100 g, and plasma
1. 5 Mg/100 g-  Blood-lead levels approaching 50 /ug/100 g of blood  warrant therapy in
order to avoid  the central nervous system CNS syndrome of adult or pediatric  plumbism.
Lead  is normally found in hair in higher concentrations (on a weight-per-weight basis)

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                                        F-9

 than in any other tissue.   The determination of lead in scalp hair is a valuable aid in
 diagnosing chronic or mild intoxication,  using atomic absorption spectroacopy.  In the
 distribution of lead in fetal tissues, lead seems to pass from the mother through the
 placenta to the fetus  at the expense of blood.                                          •

       The average individual is in lead balance, and the body burden of lead is established
 early  in life and does not change appreciably"through the life span.  Feces and urine
.excretions, perspiration,  and miscellaneous processes, ,jn decreasing order, help to
 maintain balance.  Lead is primarily excreted by the bowel as unabsorbed lead (90 per6-
 cent), with urinary excretion being about 10 percent of the amount ingested.  The
 amount of lead in the feces is practically equivalent to that obtained through food and
 lead intake, plus the unresolved portion  secreted into the alimentary tract in the biliary,
 digestive,  and mucous secretions.

       Both acute and chronic lead poisoning have been recognized in children and adults.
 Acute intoxication results from the ingestion of metallic lead,  soluble lead compounds,
 and lipophylic compounds  (TML and TEL).  Symptoms include leg  cramps, muscle
 weakness, coma, impairment of renal function, depression, and death.  A syndrome
 identical'with chronic intoxication may develop  if sufficient lead is retained after acute
 plumbism.  Chronic intoxication consists of three types:  gastrointestinal or abdominal,
 neuromuscular, and the central nervous system (CNS) syndrome.  These may occur
 separately or in combination.  The neuromuscular and CNS  syndromes result from in-
 tense  exposure to lead, whereas the abdominal  syndrome tends to  result from a slow
 and insidious developing intoxication.  The  CNS syndrome has been termed  lead enceph-
 alopathy and  is the most serious manifestation of lead poisoning in children. Blood-lead
 levels above  SO Mg/ 100 g of blood and a lead concentration in hair of 42 to 975 Mg/g sug-
 gest chronic  plumbism.  It occurs  rarely in adults and then  only following massive ex-
 posure to lead fumes or TEL.

       Interference by lead in the biosynthetic pathway for the formation of heme may re-
 sult in encephalopathy.  Diagnostic techniques  for lead intoxication in children include
 urinary coproporphyrin, serum delta-aminolevulinic acid, lead in hair,  whole  blood,
 X-rays of bone, and urinalysis.  Combinations  of 2, 3-dimercaptopropanol (BAL),
 ethylenediaminetetracetic acid (EDTA),  and edathamil calcium disodium are recom-
 mended for treatment of childhood  plumbism.  Plumbism  in adults generally can be de-
 tected by blood and urine  analyses, determination of delta-aminolevulinic acid (ALA),
 and urinary coproporphyrin assay.  Blood-lead values above 80 jug/100 ml and urinary
 lead values above 20 jug/100 ml are indicative of active plumbism and require immediate
 therapy.  Adult plumbism, which results primarily from inorganic and TEL intoxica-
 tion,  is treated with EDTA-type  chelating agents or penicillinamine.

       An appraisal was made of the costs associated with acute lead poisoning of children
 to determine whether the  effects on an environmental stressor  upon main could be  trans-
 lated  into pecuniary  values.  Coat estimates were developed for long-term treatment of
 patient*  miftWIiiK brain 
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                                       F-10
      A mathematical model was developed to represent the environmental transport
of the stressor lead from several sources with the subsequent intake of lead by man.
In particular, the submodels for airborne transport of lead and the lead in the body were
developed.  The model developed for the airborne transport of lead is used to calculate
the airborne concentrations of lead in the atmosphere due to emissions of lead from
several sources.  The  predicted output  is for an average steady-state airborne lead con-
centration,  as the model was not developed to predict time-varying airborne  lead
concentrations.

      The submodel, which represents the flow of lead into, within, and out of an in-
dividual, was developed in order to predict the distribution and quantity of lead in several
body organs.  Since measurement  of the blood-lead level of an individual is at clinical
method of investigating the effect of lead on an individual,  the blood-lead levels due to
several modes of intake of lead, including inhalation of various concentrations of air-
borne lead and ingestion of normal and above normal amounts of lead, were calculated.

      The lead model study indicates that environmental sources of lead constitute a
major source of lead intake, and lead in the ambient air may not contribute materially
to the body burden of lead.  Considerable information concerning the toxicology of
pediatric and adult plumbism was appraised.   The biochemical,   clinical, metabolic,
diagnostic,  and therapeutic parameters  of plumbism have been discussed.

      In this model case study, the stressor  lead was investigated specifically.  The
relative importance of  lead compared with other stressors was not evaluated.  Thus,
the following recommendations are made to implement environmental health criteria
concerning lead,  based only  upon this model  case study for lead  without the relative
importance  of lead to other stressors being determined at  this time:

      (1)  Conduct research to determine the  chronic effects of lead in the
          atmosphere on health. To date, definitive information on the effects
          of airborne lead on health has not been  obtained.

      (2)  Lead overexposure can change certain biochemical functions,  but
          techniques have not been developed to employ these  changes for
          biological monitoring. For example, further studies on ALA
          metabolism could lead to the development of a technique for detect-
          ing subtle biochemical changes caused by intake  of lead either by
          inhalation or  ingestion.  This  ALA  screening should be developed so
         •that elevated ALA  levels would indicate recent intake of higher than
          normal quantities of lead.
                                                                   •
      (3)  Research  should be conducted to develop more effective therapeutic
          agents  for plumbism, as some chelating agents may produce more
          harmful effects than the  stressor itself. This is extremely important
          in pica therapy and massive overdoses  of lead in industry.

      (4)  Reexamine the effect of shifting technology in the utilization of lead,
          e.g. ,  the  large-aiale use of lead storage batteries in  electric cars.
          Con. pivrtbly,  thin » nultl l»»a»'l to a rciim'tinn in thr* environmental bur-
          den of lead from gasoline additives.  The advantage A and disadvantage1«
          of this  shift should be explored from an environmental  health point  of
          view and second-order or higher-order factors should  be evaluated.

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                                      F-ll

      (5)  Synergistic effects.  Before the environmental character of .lead can be
          finalized,  there is need to determine possible synergistic effects of           ;
          other stressors.  For example, oxides of sulfur, nitrogen, and metals
          that comprise the environmental burden need to be investigated.               j

      The severity of the health and associated economic effects from the ingestion of
lead-based paints by children having pica has been recognized.  Several large cities
have screening programs under way to detect high levels of lead in children.  In addition
to the several recommendations pertaining to research programs  for the stressor lead,
the elimination of ingestion of lead by ghetto children having pica  is highly desirable,
as this mode of intake was shown  by the preliminary lead model to yield body-lead
concentrations as compared with other modes  of intake.  Programs should be initiated
to locate and remove lead-based paints from ghetto houses and  screen all children who
may be expected to have elevated  lead body burdens.
   j
      The preliminary mathematical model developed for "this model test case for the
stressor lead can be used to quantitatively investigate some  of the previous recommenda-
tions and as a tool for R&D planning.  The model should eventually be developed into a
more comprehensive detailed model which will require better data than are available at
the present time. Some of these data are:

      (a) Chemical forms of lead inhaled and  ingested

      (b) Assimilation of lead upon entering the body

      (c) Elimination rates  by  body organs
      (d) Particle size distribution of inhaled lead

      (e) Emission rates of lead  sources

     . (f) Meteorological data,  specifically in mining, reclamation, and
          manufacturing areas.

      Because of numerous technical difficulties,  DDT was found  to be the most reason-
able model compound for study.  This decision was dictated primarily because of paucity
of data regarding environmental effects of other classes of pesticides.  DDT is useful
because  it has been in widespread use longer than any other material and has demon-
strated a wide interaction with  all of the potential transport pathways for man-made
chemicals in the environment.  Because it was necessary to restrict the  study to DDT,
one major conclusion is obvious:  sufficient information  is not now available  about the
quantitative mechanisms of redistribution of pesticides in the environment.   Specifically,
major deficiencies exist in the  aerial transport and uptake of pesticides by man,  the;
environmental reservoirs  of pesticidt .storage, the chronic effects of pesticides upon
man and wildlife (from the molecular view rather than simply mortality estimates),  and
the ultimate fate of pesticides.

      In  the pesticide study it was useful to divide human exposures into two  major
pathways.  The first,  the direct pathway, deals with the direct  uptake from primary
• ovircp»  of prwtU icln rplrawt'.  Primary N our cm wern manufactur* and application,
Hvtnmn rxponmr WAS by inhalation.   Dermal uptake and m^csllon  arc secondary fea-
tures. Accidental poisonings remained about the same even though the frequency of
application and the acute toxicity of tin  new pesticides has increased.  These trends

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                                     F-12


suggest that a very credible job of education is being done at the iadsoteisl level. Sirae©
most of the victims of death from, accidental poisoning were children,  £ur$h@i? reduction©
could be made by reduction of the total toxicant content® of the home package to below
the child lethal dose, where possible, and elimination of those chemicals ghat cannot be
used within the safety margin (e.g.,  substitution of carb&mates and pyyefchsrlans  lor
organophosphate insecticides).  Prescription and dispensing pesfeicidoo by framed pro-
fessionals  would also reduce accidental deaths.  Aerial application account© for  the
largest number of deaths and either elimination  or control of this method appeals worth
study.               ^                                                   '          ..   !.

      The second pathway, the indirect pathway, involves human exposure by tran©loca-
tion through the air, water, or food.  While more complicated to consider and model,
the indirect pathway involves the total biosphere.  The general population of the  U.  S.
is exposed by this means. Serious conflicts exist in the data as to which indirect path-
way leads to the major store of pesticides in man.  On a worldwide basis, the persistent
pesticide content of .man is remarkably constant. Within the U. S. there are,  however,
significant racial and geographic differences.  Such differences are difficult to explain
if food is the major transport pathway to man.  The southern population and the  southern
negro have greater levels of pesticides than the  northern equivalent populations.  On the
basis of this,  together with some indirect evidence from residues in animals,  it is  likely
that only 50 percent of the body burden is from food; the remainder may come from in-
halation of insecticide aerosols or dust laden with insecticides. If these observations
are  correct, then  control of the human burden of pesticides by control of food residues,
as is now practiced,  is at best only partially effective.

      There is, at present, no evidence to attribute a  direct shortening  of human life
from pesticide exposure.  There are suggestions that  large amounts of pesticides will
increase the frequency of certain tumors in animals.   Whether or not pesticides induce
cancers in man cannot be settled at present, because there appears to be a dose depen-
dence in cancer induction.  Whether tumors or cancers in man can be induced at the
low  levels  presently in foods is not known.  These studies  suffered from the relatively
small numbers of all toxicological experiments and the short term of  exposure.

      In any event, man is not the animal in the  environment most sensitive to pesti-
cides.   Animals of the aquatic environment are particularly sensitive bo cause the trans -
location pathways  are highly conservatory of persistent compounds.  Persistent com-
pounds  become concentrated rather than diluted  as residues pass up the food chain.  Fish
and  birds are inherently more sensitive to pesticides than mammals.  Fish appear  to
lack the basic microsomal oxidase enzyme systems,  found in all mammals, which de-
toxify many pesticides.  Birds appear to be  very sensitive to the steroidal hormone
mimicking effects of the chlorinated hydrocarbons.  Hormonal effects in man are not
known.

      Only the soil system appears to be a "safe" repository for pesticides.  Conversion
to nontoxic metabolites can also be promoted in  the soil by anaerobic  conditions. The
aquatu  m t»byat«-M\ i an be protected from peeticidet* by modifications of agriculture
prat'th'p (u PHRUIP that p*»«M» U!PP ai*» retained and ilpyratlntl within the ©all
Little hazard to man through the ground water

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                                       F-13
      Finally,  while it is possible to model crudely the distribution of DOT in the en-
vironment and to suggest ways to reduce the environmental burden of DDT, these efforts
will have little direct  effect on human health.  Advances in protection for aquatic birds
and fish can be accomplished.  This study suggests that regulation of pesticides on the
•basis of their hazard to human health is less important than regulation on the  basis of
their hazard to wildlife.  Human health will most likely be improved rather than degraded
by  emphasis on wildlife,  sin.ce regulations based upon harmful effects to wildlife will in-
evitably reduce human exposure.  This does not mean that careful evaluation of pesticides
for human health hazards is unnecessary.  On the contrary, more information is needed.
This study suggests that the rate of application and hence long-term residual levels in
the environment are best regulated  with more concern to wild-life survival.  The margin
of safety between levels evoking chronic effects in man and environmental levels will
increase by this procedure.  Man will hence be "safer".

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          APPENDIX G- I
SUMMARY FROM OVERVIEW STUDY

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                                     APPENDIX G-

                             SUMMARY  FROM OVERVIEW STUDY*
      The need for "an early warning system" or "overview of environmental contami-
nants" has been expressed recently by members of Congress and various committees
studying environmental health problems.  However, the Bureau of Disease Prevention
And Environmental Control recognized this need over a year ago when it initiated,  with
Battelle-Columbus, the design for an overview system that would assist in maintaining
* continuous surveillance of chemical contaminants in the environment.  The needs for
such a system are many.  The continued and rapid  growth of industrial use and produc-
tion of chemicals  poses uncertain risks and hazards to the general public.  In addition,
there exists a critical need for evaluating the state of knowledge of the interaction of
chemicals with man's environment to predict significant and hazardous conditions,  as
well as changes in future levels of contamination from the presently available state of
knowledge.  The extent and degree of these hazards are largely unknown.  The  data that
are derived from  such a system will also be helpful to the Bureau in establishing
priorities for intramural and extramural research  and training programs and in the
setting of standards and controls and initiation of control  measures.

      To assess properly the difficulties and problems that would confront a surveillance
program, as well  as to provide data on the operation  of such a system,, five  specific
chemicals or  groups of industry were selected mutually by the Battelle investigating
team and the United States Public Health Service.   These  five, including mercury,
nickel, vanadium,  fluorocarbons, and  the chemicals involved  with the pulp and  paper
industry,  were treated an urgent surveillance problems.

      The results  of the case studies were derived  from data collected by Battelle staff
during travel  and  discussion with key scientists in specific disciplines, interviews with
appropriate staff members  of governmental agencies,  and analysis of  operations of
existing and contemplated information  centers and of  existing  governmental and private
laboratories engaged predominantly in environmental-health activities.  In addition,
Battelle's information analysis staff utilized available information sources,  including
those referred to  above, for its analysis of the literature  dealing with specific tasks.

      The studies  revealed potentially hazardous situations.  For example,  the report
on mercury showed a substantial increase in recent quantities of mercury used in the
electrolytic production of chlorine.   Significant quantities of mercury  are released  to
the environment each year which apparently cannot be traced and which to date  cannot
be accounted for.   There exists a striking lack of fundamental information on national
levels of mercury in our air, water, and food.

      The study of vanadium showed a  significantly increased  usage of volatile compounds
of vanadium in industrial Applications,
  Lutz, G. A., et al., "Design of an OVERVIEW System for Evaluating the Public
  Health Hazards of Chemicals in the Environment",  USPHS Contract DA-86-66-165
  (1967).

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      The nickel study raised the question of possible chronic effects ©£ email quantities
of nickel in food  from the use of large quantities of nickel equipment in food processing
and the demonstrated transfer of some nickel to food during
      A need was demonstrated for the establishment of the environmental fate of
carbons used in aerosols and refrigerants and for the toxicological characteristics of
combustion prodvicts of fluoroplastics.
       Finally,  & review of current analysis information on the chemical processes cm-'
 ployed by the pulp and paper industry demonstrated the need for surveillance of the
 atmospheric pollutants resulting from increased use of kraft pulping operations, for
 toxicological data on paper modified with additives, and for the identification of combus-
 tion products of paper and paper-board fortified with additives currently in use.

       Through  experience developed in dealing with these groups of potential contami-
 nants, information needs were found to fall into predictable categories:

       (1)  Chemical production

       (2)  Secondary-product formulation

       (3)  Pattern of chemical usage
       (4)  Chemical toxicology and pharmacology
       (5)  Environmental  health hazards.

       Based on experience derived from these studies and from the national resources
 available  in information,  skills, and competencies to this program, Battelle has
 designed a system of continuous surveillance of chemical threats to environmental
 health.

       Four  separate features were recognized as essential to an Overview Center to
 provide the necessary functions defined by a surveillance and early alarm role:

       (1)  It must possess a good  scientific library and information-handling
           capabilities and professional and clerical staff knowledgeable and
           experienced in  information-analysis methods.

       (2)  It must possess ready and convenient access to a sufficiently large
           pool  of scientific competence to facilitate the rapid preparation of
           responses to specific queries.

       (3)  An organizational solution must be presented for the  integration of
           the widely scattered and often unrelated pockets of information and
           competencies residing in federal,  state, and local agencies  and with
           the individual scientists whether in the academic, private, or
           governmental sectors of environmental-health research.

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                                            G-3
      (4)  It must possess to a strong degree tl.c characteristics of immediacy
          combined with the ability to tap the required skills whenever neces-
          sary, to marshal appropriate skills to the level demanded by the
          urgency of the current problem,  and to deliver in-depth competence on
          demand.   This  requires the managerial ability to fuse all the required
          functions necessary for an Overview Center into a viable, functional
          operation, focused strictly upon its mission-oriented objectives.

      It was  found that 70  percent, or more, of the desired information relative to
 changes in the level of contamination of our environment by chemicals (together with
 relevant information from the fields of ecology,  physiology, toxicology, and public
 health) could be obtained  from n preliminary surveillance of 61 key publications and 1Z
 industrial and  governmental contacts.  It is estimated that this preliminary surveillance
(including information acquisition and processing and technical surveillance) will require
27 professional man-months.  Approximately 38 professional man-months of effort
would then be required to identify and evaluate "hot" leads on possible threats to public
health due to chemicals in the environment.  It was estimated that up to 24 in-depth case
studies per year  (involving approximately 85 man-months of effort) of critical hazards
should be undertaken in the overview program.  The total program for & comprehensive
overview of chemical threats to environmental health is judged to require 187 profes-
sional man-months of effort plus consultant assistance.  This total includes project
management and  information support activities in addition to those mentioned above.

      Battelle recommends, therefore, that an Overview Center be established within
an existing institutional structure possessing the qualifications necessary to provide both
the information-analysis specialities and a  significant multidisciplinary block of profes-
sional scientists  to immediately provide an internal core for such a Center.

      An office, established and staffed by personnel of the Bureau of Disease Prevention
and Environmental Control,  would provide continuous and intimate relationship to the
Overview Center, permit the Bureau staff to immediately establish information and
research priorities, and establish and maintain an integrated national network of skills
and expertise which could  participate both in the evaluation of potential threat! to human
health and in contributing research efforts toward their solution.

      The report identifies the necessary components of the Center itself, as wall as
specific recommendations for the Bureau of Disease Prevention and Environmental
Control's participation in the integration of appropriate skills and resourced into the
Overview Center.

      Finally,  the report deals with the requirements, costs, and recommended methods
of operation of the total Overview Program, following the successsful completion of the
period of preliminary pilot phase  of the recommended operation. A continuation of  the
present program at Battelle would provide access to Battelle staff in  the initiation of the
final Center following the pilot phase already defined.

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                       APPENDIX H.
NEWSLETTERS.  PERIODICALS. AND OTHER PUBLICATIONS PERTINENT
                           H-l

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                              APPENDIX H* I -
      NEWSLETTERS. PERIODICALS. AND OTHER PUBLICATIONS PERTINENT
                       TO THE OVERVIEW PROGRAM
          The following publications should have been reviewed regularly
to obtain information on environmental hazards that were pertinent to
OVERVIEW.  These publications are identified under seven categories as
follows

Chemistry and Industry

          Chemical and Engineering News
          Chemical Week
          Chemical Engineering
          C.nylor's Survey
          Search
          Bureau of Mines bulletins, circulars, and yearbooks
          Modern Plastics
          Ceramic Industry
          Hydrocarbon Processing
          Paper Trade Journal
          Chemical Abstracts
 I'uhllc Health and
          Today's Health
          Medical World News
          New England Journal of Medicine
          American Journal Public Health
          World Health
          United States Public Health Service publications
          American Journal of Epidemiology

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                                   H-2

Public Health and Epidemiology (Continued)

          Index Medicus
          Biological Abstracts
          Public Health Engineering Abstracts
          Excerpta Medica - Public Health, Social Medicine and Hygiene

Industrial Hygiene and Occupational Medicine

          Occupational Health Newsletter
          Environmental Health Letter
          Industrial Hygiene Digest
          Industrial Hygiene Review
          Journal of Occupational Medicine
          Archives of Industrial Health
          Index Medicus
          Biological Abstracts
          American Industrial Hygiene
          Association abstracts
          Air Pollution Control Abstracts
          Water Pollution Abstracts
Toxicology
          Drug News
          Toxicology and Applied Pharmacology
          Journal of Pharmacology and Experimental Therapeutics
          Food and Cosmetic Toxicology
          Archives of Environmental Health
          National Clearinghouse for Poiaon Control Center Bulletins

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                                   H-3

Toxicology (Continued)

          Archives of Industrial Health
          Bulletin of Environmental Contamination and Toxicology
          Journal of Forensic Sciences
          Index Medicus
          Chemical Abstracts
          Biological Abstracts
          Biological and Agricultural Index
          Pharmaceutical Abstracts
          Industrial Hygiene Digest
          International Abstracts of the Biological Sciences
          Excerpta Medica - Pharmacology and Toxicology

Environmental Health

          Environmental Health Newsletter
          Occupational Health Newsletter
          Archives of Environmental Health
          Environmental Health Research
          Bulletin of Environmental Contamination and Toxicology
          Index Medicus
          Biological Abstracts
          Chemical Abstracts
          Public Health Engineering Abstracts
          Air Pollution Control Association Abstract
          Water Pollution Abstracts

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                                   H-4

Pollution - Air. Water. Waste Control

          Air/Water Reports
          Environmental Health Newsletter
          Water Newsletter       ,'- ••>::
          Journal of the Water Pollution Control Association
          Air Pollution Foundation Report
   •K
      t i
          Bulletin of Environmental Contamination and Toxicology
       "•  Water and Sewage Works
          Water Pollution Research
          Journal of Sanitary Engineering
          Water Resources Research
          Biotechnology and Engineering
          Environmental Engineering, Quarterly
          Air Pollution Control Association Abstracts
                                               ./V1;-
          Water Pollution Abstracts              ;'
                                               • •**'
          Chemical Abstracts
          Engineering Index
          Applied Science and Technology

Ecology (Animal and Plant Epidemiology)

          Ecology
          Ecological Monographs
          Journal of Kcology
          Journal of Animal Keology
          Journal of Applied F.cology
          Biological Abstracts

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