AN APPROACH TO THE CONTROL

                          OF

                   TOXIC SUBSTANCES
November 12, 1973
     HMC/OTS

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                              PREFACE

     This Report is an initial  step toward development of a long-term
strategy for controlling toxic substances.  While a number of policy
directions are suggested, further refinement of these approaches is
clearly in order.   Therefore, the Report will be revised periodically,
and initially on a semi-annual  basis.

     The Report is directed primarily to chemical substances exhibit-
ing adverse effects on man or the environment at relatively low con-
centration levels.  At the same time it is recognized that almost any
substance can be toxic if exposure levels are sufficiently high, and
therefore it is .not practical .to specify which .chemicals or chemical
classes are or are not included.  Additionally,  the concern here is
only for toxic effects resulting from sustained chemical or biological
activity, and other hazardous effects, such as fire, explosions, and
radioactivity, are not considered.

     The EPA approach to controlling toxic substances must be carefully
integrated with the myriad of related activities of other Federal and
State agencies --  including regulatory, monitoring, and research
activities.  While better integration of all national efforts is a
central concern, this Report does not present the activities of other
interested organizations.

     A principal purpose of this Report is to provide a broad perspective
for the activities of the Office of Toxic Substances.  Also, it should
provide useful guidance in shaping the activities of a number of other
EPA offices.  However, the activities of these other offices are
described in other Agency reports, and they are not set forth in this
Report.

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APPROACH TO CONTROL OF
   TOXIC SUBSTANCES

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                    TABLE OF CONTENTS

                                                              Page

  I.   GENERAL APPROACH	1
         Problem 	   1
         General Program Goals  	   1
         Strategy 	   2
             Table 1  - Food Contamination	4
             Table 2 - Environmental  Damage  .	4
             Table 3 - Diseases	5
             Table 4 - Industrial  Trends   	   6

 FI.   RESTRICTIONS 	   7
         Problem 	   7
         General Program Element Goal 	   8
         Industrial  Stewardship  	   8
         Regulatory  ,t	•	9
         Criteria  .  .'	11
         Problem Assessment	,	11

III.   TESTING	14
         Problem	14
         General Program Element Goal 	  15
         Industrial  Stewardship  	  15
         Regulatory	16
         Experimental 	  17
         Public Awareness 	  17

 IV.   INDUSTRIAL REPORTING AND DATA PROCESSING  	  19
         Problem	19
         General Program Element Goal 	  19
         General	20
         Premarket	21
         Existing Suspected Chemicals 	  22
         Early Warning	22
         Public Access  	  23

  V.   EARLY WARNING	25
         Problem	25
         General Program Element Goal 	  26
         Criteria	26
         Expert Opinion 	  27
         Data Analysis	27

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                TABLE OF CONTENTS (con't)

                                                              Page

  VI.  MONITORING	29
          Problem	29
          General Program Element Goal  	 30
          Regulatory Actions  	 30
          Early Warning	31

 VII.  CRISIS RESPONSE	34
          Problem	34
          General Program Element Goal  	 35
          Problem Assessment  	 35
          Regulatory	36

VIII.  STRATEGY AND COORDINATION	38
          Problem	38
          General Program Element Goal  	 39
          Program Coherence   ..'....:	39
          Problem Assessment  	 40
          Regulatory Actions	 41

  IX.  RESEARCH NEEDS	43
          Problem	43
          Estimation of Exposure  	 45
          General Program Element Goal  	 46
          Test Methods	46
          Trend Assessment	48

Appendix 1 - EPA Regulatory Authorities of Particular
             Relevance to Toxic Substances  	 50

Appendix 2 - Regulatory Authorities of Other Agencies
             of Particular Relevance to Toxic Substances  ... 53

Appendix 3 - Examples of Monitoring Networks Supported by
             Other Agencies	54
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                    I.  GENERAL APPROACH
PROBLEM
     More than 20,000 chemical substances are commercially produced
and used in the United States, with 500 to 700 new substances
entering commerce annually.  They find a wide variety of uses as
industrial  chemicals, in consumer products, and in specialized uses
such as drugs, food additives, and pesticides.  In 1972, the value
of the products of chemical manufacturers and processors exceeded
$200 billion, which represents a sizeable portion of U.S. manufac-
turing .activities.

     The problems presented by the presence in the environment of
some of these substances are all too well knov;n (e.o. mercury,
lead, asbestos).  Other substances are believed to pose a latent
health or environmental threat, while the risks associated with the
vast majority of chemicals, acting individually or synerqistically,
are almost completely unknown.  However, it seems clear that the
problems associated with the presence of many chemical substances
in the environment -- such as food and drinking water contamination,
destruction of biota, and water and soil degradation -- will un-
doubtedly continue to grow in number, severity, and complexity in
the years ahead.

    '' Some of the hazards associated with chemical substances have
been recognized and are controlled by the Government, e.g. pesticides
and drugs.   Other aspects of the toxic substances problem have only
recently been identified, and appropriate regulatory measures do
not yet exist.  Still other pieces of the problem have yet to be
identified.  Many gaps remain in understanding why, how, and when a
substance can have a neaative impact on health or the environment,
and how best to control or prevent such hazards.

     Thus,  the concern of EPA with toxic substances is twofold:
identification and assessment of the risks associated with the
manufacture, distribution, use, and disposal of chemicals which
could adversely affect health and environmental quality; and
practical steps, including regulatory actions as appropriate, to
prevent or mitigate the problems posed by such chemicals.

GENERAL PROGRAM GOALS

     --  Clarification of the risks to health end the environment
         associated with the manufacture, distribution, use, and
         disposal of new and existina chemical substances, with
         particular regard to chemical properties, production levels
         and trends, and exposure of the chemical to man and the
         environment;

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     --  More effective utilization of regulatory authorities and
         related tools available to the Agency to mitiqate such
         risks, taking into account the economic and social  impact
         of restrictions on toxic substances; and

     --  Increasing the concern of and appropriate actions by the
         chemical and related industries to reduce risks to health
         and the environment associated with their activities.

STRATEGY

     Almost every EPA office with program, research, or legal
responsibilities is involved in some way with efforts to control
toxic substances.  Since the toxic substances activities of most
offices are integrated into the overall program strategies of the
respective offices, the strategy reflected in this Report is
limited to the approaches of the Office of Toxic Substances.  In  a
sense the strategy of this Office can be considered as a core
strategy of the overall Aaency's efforts to control toxic substances.

     The Office of Toxic Substances emphasizes the health and
environmental effects of individual and combinations of toxic sub-
stances.  This approach contrasts with earlier emphases of the
Agency and its predecessor organizations on the broader gross
pollution effects.  The Office's sustained overview of the many
dimensions of toxic pollutants involvino a critical mass of special-
ists includes the following types of activities:

     --  Staff function;  coordination and support of Aaency-wide
         efforts in toxic substances, with particular attention to
         multi-source and multi-media pollutants, consistency and
         interrelationships of standards set under different
         authorities, and coordinated anproaches with other agencies
         (e.a. FDA, Consumer Products Safety Commission).

     —  Line function:  lead responsibility for gap areas includ-
         ing assessment of risks of and controls for new oroducts,
         monitoring strategy, and research need assessment.

     --  Crisis function:  mobilization of Agency resources to
         clarify the dimensions of the problem, development and
         implementation of control strategies, and coordination
         with other agencies.

     These activities are carried out through the following program
elements which are described in some detail in subsequent sections
of the Report:

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     --  Restrictions

     —  Testina

     —  Reportinq

     —  Early Warning

     --  Konitoring

     --  Crisis Response

     --  Strategy and Coordination

     --  Research Needs

Each program element is designed to make substantial  contributions
to realization of one or more of the long-ranae goals.   The dis-
tribution of effort among these activities will vary, according to
legislatively mandated deadlines, unexpected crises,  and shifting
Agency priorities.  No precise formula can be used in determining
resource distribution amona proaram elements beyond assurance that
a nucleus of staff resources will be directed to each area at all
times.  As experience is gained in this program, and  if the Toxic
Substances Control Act is enacted, it may be appropriate to dis-
tribute the emphasis among program elements in a more rigid fashion,

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                                      TABLE  1
                EXAMPLES OF  FOOD  CONTAMINATION FROM TOXIC SUBSTANCES
TDUD

 Fish



 Cattle


 Grains  and  Cereals


 Poultry

 Fruits

 Leafy Vegetables
                  SUBSTANCE

                  Mercury
                  Phthalates
                  Copper, Zinc

                  HCB
                  Lead, Zinc

                  Arsenic
                  Cadmium

                  -PC-Bs

                  Phenols

                  Nitrates
                  Lead, Cadmium
SOURCE

Chemical Industry Effluent
Dump
Mine Runoff

Chemical Industry By-product
Mine Runoff

Dump
Fertilizer Contaminant

Heat Exchange Fluid

Petrochemical By-product

Fertilizers
Sewage Sludge
     EFFECT
                       TABLE 2
EXAMPLES OF ENVIRONMENTAL DAMAGE FROM TOXIC

                     SUBSTANCE
 AQUATIC  DAMAGE

 Fish -Kills
 Change Lake  Ecology
 Destroy  Fish Population
 WILDLIFE DAMAGE

 Bird Reproduction
 Duck & Geese Populations
 Botanical  Species

 LAND DEGRADATION

 Forest Destruction
 Groundwater Contamination
 Soil Fertility

 DESTRUCTION OF ANIMALS

 Cattle
   rses
                  Hypochlorites, Fly Ash
                  Copper, Zinc
                  Phenols, Ethanol
                  PCBs
                  Lead
                  Sulfuric Acid
                  Lead, Zinc
                  Arsenic, Cyanide
                  Chlorides
                  Fluorides
                  Tetraethyl Lead
SUBSTANCES

      SOURCE
Lagoon Ruptures
Mine Runoff
Refinery Products &
  By-products
Plasticizers
Shot
Chemical Industry Wastes
Smelters
Disposal Sites
Landfills
Phosphate Lagoon Wastes
Landfills

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                                            TABLE 3
        EXAMPLES OF TOXIC SUBSTANCES IMPLICATED IN SELECTED DISEASES  IN  THE  UNITED  STATES
CAUSE OF DEATH
      IN
    HUMANS
PERCENT
  OF
DEATHS
DEATH RATE PER
   100,000
  POPULATION
SUBSTANCE WHICH CONTRIBUTES
            TO
        SOME DEATHS
Heart Diseases
Cancer
38.5


16.8
  366.1
  160.0
Cadmium
Benzidene, nitrosamines, beta
  naphthalamine, benzopyrene,
  asbestos, chromates
Infant Mortality


Lung Diseases
 2.2


 1.6
   21.4


   15.4
Heavy metals, nitrates, nitrites
Asbestos, beryllium, toluene
  diisocyanate, cadmium
Liver Diseases
 1.6
   14.8
Carbon tetrachloride, chlorinated
  phenols
Congenital Anomalies


Kidney Diseases
 0.9


 0.5
    8.4


    4.7
Mercury
Lead, ethylene glycol, cadmium
  sulfate

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                                         TABLE 4
                        ANNUAL VALUE ADDED TO SELECTED CLASSES OF
                               CHEMICAL AND RELATED PRODUCTS
$64 Billion
                                                                      $112 Billion
                                                                            Stone,Clay,Glass*
                                                                            Paper  &. Allied*

                                                                            Metals*

                                                                            Textiles*

                                                                            Plastics
                                                                               &
                                                                            Elastomers
                                                                            Paints, Dyes,
                                                                            Inks
                                                                            Inorganics
                                                                            Synthetic
                                                                            Organics
                                                                            Other Chemicals
       1962                                                               1972

          *0nly that portion of industry involved in chemical processes included.

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                  II.  RESTRICTIONS
PROBLEM
    During the past several  years the necessity of Federally imposed
restrictions to reverse environmental degradation and to protect
human health has been repeatedly demonstrated.  The main problem in
the area of toxic substances is to select the substances of greatest
concern and then to determine how the hazards associated with these
substances can be most effectively controlled or reduced, given the
dearth of information about the behaviour of toxic substances and
their distribution in the environment.  The Toxic Substances Control
Act would give the Agency far reaching authority to intervene in the
chemical industry in a variety of v/ays.  Care must be taken to insure
that such intervention does not disrupt the industry unnecessarily.
Of particular concern .is the continued viability of the technological
base undergirding the industry's momentum.

    Intertwined with the reaulatory authorities and actions of the
Government are the attitudes, activities, and voluntary actions of
industry in assessing the safety of products and exercising restraint
in the development and marketing of products which miaht pose risks.
Given the size of the sector of industry involved in commercial
chemicals not currently subject to reaulatory authorities -- with an
annual value of products exceeding $150 billion -- it seems totally
unrealistic to expect direct Governmental intervention to regulate
a large fraction of these products.  In a sense, each of the more
than 20,000 commercial chemicals is a unique case -- both with re-
gard to chemical behaviour and in marketing and economic consider-
ations.

    Central to consideration of regulatory options is the balancing
of the risks with the benefits related to specific actions.  The
diversity of the tradeoffs make this a formidable task.  For example,
the benefits from employment of workers in chemical plants must be
balanced against occupational risks; U.S. competitive ability in
world markets weiahs against environmental testing costs or require-
ments of expensive effluent or emission controls; and quality of
life benefits from chemical substances bear on the degree of risks
which can be tolerated.  Restrictions placed on existing activities
will affect past investments and established patterns of commerce
and employment.  With respect to those chemicals which have yet to
be offered for commercial use, barriers to market entry could be
created through premarket testing and screening requirements.  If
research and development of new chemicals becomes so difficult that
it is no lonaer profitable, the advantages to society, in terms both
of new products and development of less toxic alternatives to existing
products, are lost.  In short, environmental protection is not free.

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Attention must be given to the impact of corrective actions on the
direction, configuration, and diversity of the chemical industry as
well as on the benefits to society of chemical products.

GENERAL PROGRAM ELEMENT GOAL

    To miticiate, through direct reoulatory actions and through
encouragement of voluntary actions, the most serious environmental
problems posed by currently uncontrolled entry into the environment
of chemical substances.

INDUSTRIAL STEWARDSHIP

    Subgoal

         To heighten industrial concern over the necessity to
    clarify the risks to man and the environment associated with
    chemical substances' and to take appropriate action to reduce
    these risks.

    Strategy

         A principal thrust of the Aaency's efforts to reduce the
    probability of adverse incidents affectina health or the environ-
    ment as the result of chemical substances enterina the environ-
    ment is to encourage voluntary steps by the chemical and allied
    'industries to identify and limit those activities that pose a
    risk.  Ideally, such voluntary steps should become a fundamental
    consideration in the decision-makina process of industry concern-
    ing the desirability of developing and manufacturing chemical
    substances.

         The Agency's approach involves both the carrot and the
    stick — i.e., public recognition of positive steps taken by
    industry to reduce environmental risks (e.ci. Monsanto restrictions
    on PCS production) and regulatory actions to force a reorientation
    of industrial decision-makinq processes (e.q. limitations on
    mercury discharges into navigable v/aterways).  When necessary,
    EPA will take direct restrictive actions.  More often, efforts
    will be directed to encouraging industrial actions on a much
    broader front than is usually feasible through specific
    regulatory measures.  The approach to industrial stewardship
    relies heavily on the following types of activities:

         --  Repeated articulation in speeches, news conferences,
             and published articles by senior agency officials of-
             (a)  the responsibility of industry in insuring the
                                  8

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             safety of  its  products,  and  (b)  the  successes  and
             failures of  industry  in  this  regard.

         —   Encouraaement  of  trade associations  and   professional
             societies  such as the Manufacturina  Chemists Association
             and  the American  Chemical  Society  to provide leadership
             in stimulatina  a  qreater degree  of industrial
             responsibility, both  in  a  general  sense  and with regard
             to specific  toxic substance   problems that are partic-
             ularly significant.

         —   Consultations  with individual  companies, and particularly
             'the  medium-sized  and •smal I companies, 'to sharpen their
             awareness  of the  need for  a  greater  degree of  steward-
             ship at both the  v/orkinq and decision-making levels.

         The measurement  of the current decree  of industrial concern,
    changes  in this concern as the result of  Agency efforts, and
    the reflection of this  concern in activities  in the market
    place as well as in the plant  will  of course  be difficult.
    However, assessments  will  be a valuable adjunct to efforts  to
    stimulate industrial  stewardship.

    Three-Year Mjlestones

         Assess  to the  extent  possible  the scope  and  effectiveness
    of voluntary  industrial restrictions  on the manufacture, use,
    distribution, and disposal of  chemical  substances.

         Assess  the trends  within  selected companies  to  incorporate
    environmental considerations into the decision-making process
    concerning the introduction of new  products into  commerce.

REGULATORY

    Subgoal

         To  restrict  a  selected number  of activities  associated
    with the manufacture, use, distribution,  and  disposal of
    chemical substances in a way that will not only reduce  serious
    environmental problems but will  also  demonstrate  the favorable
    benefit/cost ratio  of such restrictive actions, trigger both
    industrial and public concern  over  other  related  activities,
    and generally focus broader attention on  the  toxic substance
    problem.

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Strategy

     Restrictive actions under the Toxic Substances Control  Act
durinq the initial years can serve several purposes.   They
should be designed to (a) mitiqate severe environmental  problems
not currently being addressed by other regulatory authorities,
(b) prevent future environmental problems of larae magnitude,
(c) demonstrate a number of types of restrictions that are
appropriately promulgated under the law, and/or (d) address
activities involving a wide spectrum of industrial firms.   In
short, in addition to addressing environmental  problems,
deliberate efforts should be made in selectina  restrictive
actions to test the parameters of the law, thus clarifyinq
whether there is need for further legislative refinements, and
to awaken industry to the EPA's commitment to toxic substances,
thus stimulating voluntary steps on the part of the industry.

     Among the hioh priority candidate substances to be con-
sidered for possible regulatory action are:

     --  Organic Chemicals:  PCBs, NTA, HCB, HCBD, bis(chloroethyl)
         ether, polytetrafluoroethylene, tributyltin

     --  Toxic Metals:  cadmium, mercury, arsenic, vanadium

     —  Chemical Classes:  haloqenated aromatic hydrocarbons,
         phosphate esters, benzenepolycarboxylates, fluoro-
         carbons, azo compounds, aromatic hydrocarbons

     —  Use Classesj  detergent builders, plasticizers, print-
         inq ink pigments, hydraulic fluids, heat transfer
         media, highway de-icers, dry cleaning  solvents

     --  Other:  asbestos

     As discussed below, criteria for selecting substances for
regulation and for determining the shape of the regulation will
be developed.  Initially, these criteria will probably be crude.
They will be continually refined as experience  is gained.

Three-Year Milestones

     Promulgate 15 sets of restrictions on existing chemicals.

     Promulgate five sets of restrictions on new chemicals.
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CRITERIA

    Subaoal
         To develop and refine the procedures, techniques, and
    criteria for determining the need for, the character of,  and
    the impact resulting from restrictions on the production, use,
    distribution, and disposal -- as well  as associated activities  --
    of toxic substances.

    Strategy

         The ground rules for determining  the need for, the
    character of, and impact resulting from restrictions required
    or recommended by EPA should be clearly understood in advance
    by Government, industry, and other interested parties.  In
    the absence of such understanding, in  many instances industry
    probably v/ould be basinq R and D and other investment decisions
    on wrong assumptions concerning those  factors affectinq sub-
    sequent Governmental decisions,  l-'hether or not industry agrees
    with Governmental decision-making criteria, it should be aware
    of the criteria in order to make intelligent investment decisions,
    On the other hand, industry, as well as other interested groups,
    should have an input into the development of the criteria.

         The new legislation sets forth in general terms the
    criteria to be used (e.g. health effects, environmental effects,
    economic considerations, alternative materials).  The initial
    approach in elaborating these criteria will be development of
    weighted checklists,  these checklists will be distributed for
    comment and periodically refined as experience is accumulated.
    In the future, development of a more elaborate approach to
    criteria may be possible, but in any event1the useability of the
    criteria must be a paramount concern.

    Three-Year Milestones
         Publish an initial criteria document, and a subsequently
    revised version, articulating the considerations involved in
    determining the need for, character of, and impact resulting
    from restrictions on chemicals.

PROBLEM ASSESSMENT

    Subqoal

         To assess the environmental risks and societal benefits
    associated with selected chemical substances as a basis for
    determining the appropriateness of restrictions.
                                 11

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Strategy

     As chemicals, chemical classes, and use classes that
should be of particular regulatory concern are identified,
in-depth analyses of the appropriateness of restrictions will
be conducted, usinq the criteria described above.  In some
cases, such as PCBs and mercury, most of the analytical work
may have been completed by other organizational units and the
principal task will be the packagina of the information into
a form which will facilitate reaulatory decisions.  At the
other extreme it may be necessary to carry out laboratory work,
field surveys, -and literature searches to Generate the data
needed for sensible decision-makinc.

     These analyses will include considerations of factors
such as:

     —  risks posed by the substance, in terms of toxicity,
         exposed populations, and geographic distribution

     --  current and projected market trends

     --  available and projected technologies for controlling
         the substance

     --  extent and effectiveness of current regulations on
         the substance imposed at the Federal, state, and
         local levels

     —  available regulatory options and the practicality,
         effectiveness, and irppact of each

     --  current level of voluntary restrictions and
         feasibility of encouraging additional voluntary actions.

     The central purpose of these assessments is determination
of the appropriateness of regulatory action.  They are not in-
tended to be scientific publications to advance aeneral under-
standing, but rather will be decision oriented studies.  At the
same time they must have technical credibility so they can
serve as supporting documentation if regulatory action is taken.

     Related to these in-house and EPA-funded contract activities
will be a parallel effort to stimulate industry to increase its
efforts to assess the need for restrictions.  This approach
will include sharing with industry the methodoloaies used in
problem assessment, publication of EPA supported assessments,
and encouragement of publication by industry of its methodologies
and assessments.
                            12

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Three-Year Milestones

     Analyze the need for, character of, and impact resulting
from possible restrictions on thirty chemicals.
                             13

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                     III. TESTING
PROBLEM
    The inadequacies of current testing activities are reflected
in (a)  the lack of data for settinq standards and tolerances on a
number of substances of near-term concern (e.g. benzidine, HCB,
asbestos), (b) environmental incidents revealing previously un-
suspected harmful properties of chemicals (e.g.-'PCB, dioxin, methyl
mercury), and (c)  the conspicuous absence of inforniation for
identifying potentially harmful substances that can cause future
incidents.  The .prob.lem .is two-fold:  lack of .test data and
deficiencies in capabilities to interpret the test data.

    At the same time, the testing programs of some of the larger
companies are impressive, recognizing that their basis for assessing
test results and incorporating such assessments into corporate
decision-making is profit-oriented.  The testing programs of the
medium-sized and smaller firms are not well developed due to the
lack of R&D resources.  Much industrial test data is riot released
by industry, thus limiting the capability of the Government and
public to participate in assessments of risks of commercial
chemicals.  For some chemicals in wide usage no single company is
willing to finance the cost of testing.

    Testing by Government laboratories and by the university
community is more often than not science oriented, with results
that are difficult to adapt to regulatory decisions.  When Governmental
testing of specific substances for reaulatory ourposes is needed,
there are freguently delays in acguirina funding and the needed
priorities to displace on-going testing.

    Testing covers a broad gamut of activities — the standard
toxicological test methods are relatively well understood but tests
for stability, degradation and breakdown products, biosccumulation,
environmental transport, and ecological effects are uncertain areas
at best.  In addition, determining which types of tests to be
applied to which substances is usually far from obvious.

    In the past, problems with toxic substances have usually been
identified after the fact.  With hundreds of new chemicals being
introduced into commerce each year, and with production levels of
many others orowina rapidly, the need for greater reliance on pre-
dictive testing seems clear.  Hhile the burden of testing of specific
products falls squarely on industry, EPA has a responsibility to
insure that the extent, quality, and timeliness of such testing is
commensurate with potential environmental problems.
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GENERAL PROGRAM ELEMENT GOAL

    To improve the approaches by Government, industry, and the
scientific community to testing of chemical substances entering
commerce.

INDUSTRIAL STEWARDSHIP

    Subgoal

         To encourage increased industrial concern and appropriate
    action in testing both new and existina chemicals

    _S_tr_at_e_oy

         Continuing consultations v/ith representatives of industry
    will  provide a basis for assessing the extent and effectiveness
    of industrial  testino procedures, for sensitizing industry to
    EPA testing concerns, and for determinino the types of mandatory
    test reguirements which can have the most significant impact
    on industrial  testing practices.  During these consultations
    efforts will be made to identify nodel industrial test patterns
    and practices  which should be publicized and otherwise dissemi-
    nated.  Also,  industry will be encouraged to increase its
    efforts to publish and otherwise make available test data.

         There will be continuino discussions with industry con-
    cerning proposed EPA approaches to test reguirements.  These
    discussions should enable EPA to draw on industrial experience
    in developing  EPA regulations, stimulate industrial concern
    over testing with or without EPA regulatory actions, and
    broaden industry's perspective as to the range of environmental
    concerns.  More specifically, EPA will establish a few broadly
    based model testing recommendations which should affect at
    least one product of most of the laroe and intermediate-size
    chemical manufacturers.  Industry will then be reguested to
    provide comments as to how it would assess the results of such
    model  tests, thus assisting EPA in determining the adequacy of
    the prepared approaches.

    Three-Year Milestones

         Complete assessment of the effectiveness and adequacy of
    testing activities of large and medium-size manufacturers.

         Complete assessment of the trends in industrial concern
    for adequate testing as indicated by factors such as the types
    and number of tests, the types and number of chemicals subjected
    to tests, and  the role of test results in decision-making.
                                 15

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REGULATORY

    Subgoal

         To require or encourage, as appropriate, industrial
    testing of specific chemicals for v.'hich inadequate data con-
    cerning the risks associated with the chemicals are available
    but which are suspected to pose a hazard to man or the environ-
    ment.

    Strategy

        --The -two key tasks are 'the determination of -the cherricals
    which are to be subjected to testina, and the actual test
    requirements.  A related testing issue concerns division  of
    industrial responsibility for testing of substances of interest
    to more than one firm.

         Selection of the initial chemicals and chemical classes
    requiring testino will be based largely on subjective judge-
    ments within very cieneral criteria such as known problem sub-
    stances of current concern, production levels and trends,
    inadequacy of available test data, widespread presence of the
    chemical in the environment, and environmental incidents
    involving the chemical.  Meanwhile, methods for prioritizing
    chemicals that should be subjected to testing will be developed
    to provide a better basis for subsequent selections.

         In general, the Agency will not prescribe test reguire-
   -ments in great detail but rather will provide Guidelines con-
    cerning the types of test data needed for decision-making.
    Thus, several different specific tost protocols could satisfy
    the test requirements for a specific chemical although each
    protocol would have to consider the types of effects of concern
    to the Agency.

         Supporting these activities will be continuing reviews of
    test methodologies.  These reviews should be helpful both in
    developing test requirements and assisting concerned parties
    in being aware of the most effective test approaches to
    determining different effects.

    Three-Year Milestones

         Promulgate 10 to 15 standards for test protocols for
    selected chemicals, chemical classes, and use classes.
                                16

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         Assess results and reach decisions concerning the need
    for restrictions for three of the chemicals, chemical classes,
    or use classes for which standards were promulciated.

EXPERIMENTAL

    Subqoal

         To provide experimental  data needed to determine appropriate
    standards or restrictions for specific chemicals of near-term
    concern.

    Strategy

         Through participation on interaqency committees, and through
    redirecting EPA supported testinq activities, efforts will  be
    made to orient Governmentally suoported testinq irore sharply
    to regulatory needs.  Both the types of experiments and the
    structuring of experiments are of concern.  The activities  of
    NCTR will be particularly important in this regard.

         In addition an on-call  testina capability at one or more
    industrial  laboratories will  be developed to provide the response
    capability needed for addressing specific chemicals which become
    of near-term concern.  This capability will be used to demonstrate
    structuring of experiments th.it are more responsive to standard
    settinci needs.  In addition,  this capability will provide
    opportunities for experimenting with proposed requlatory
    approaches to assess their feasibility.  Finally, it will be
    available to qenerate supplemental data if questions arise
    concerning the test results submitted by industry under
    regulatory authorities.

    Three-Year Milestones

         Provide test data needed to set standards or to take other
    restrictive actions on three  chemicals of near-term regulatory
    interest.

         Demonstrate how two or three types of routine testing  can
    be more sharply oriented to providing data of maximum value in
    arriving at requlatory decisions.

PUBLIC AWARENESS

    Subgoal

         To bring test data concerninq the safety of chemicals  into
    public view, in a way that will not compromise trade secrets,
                                17

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to facilitate a broader base of understanding and inputs for
evaluating the necessity for restrictions for such chemicals.

Strategy

     Low-key but conscious efforts will be made to better
acquaint the public with the strengths and weaknesses of testing
and with the relationship of testing to visible environmental
problems.  As specific problems arise, the public will be made
aware of available test results and of the significance of these
results (e.g. as was the case with hexachlorobenzene).

Three-Year -Miles-tone

     Establish a smoothly operatina system for responding to
public requests for test and related data that does not contain
trade secrets, for identifying trade secrets, and for resolving
uncertainties as to what constitutes trade secrets.
                            18

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       IV.  INDUSTRIAL REPORTING AND DATA PROCESSING
PROBLEM

     An essential input to identifying and evaluating those
potentially troublesome chemicals or classes of chemicals which
should be given high priority attention is authoritative and timely
information on their levels of production, use, and by-products and
on the geographical distribution and the trends of these activities.
Such information, together with information on the physical and
biological properties of the chemicals, serves as the basis for
•assessing risks and weighing the appropriateness of alternative
control strategies.

     Limited information is currently routinely available from the
reports of the Bureau of Census, Bureau of Mines, FTC, Tariff
Commission, and Stanford Research Institute, as well as from the
EPA permit program.  Also, individual company reports include a
vast amount of unaggregated data.  However, the information is not
packaged in a manner oriented to regulatory decision-making, with
the exception of the waste stream information in the permit program.
It is diffuse, often out of date, and spotty.  It seldom, if ever,
relates to new chemicals.  Finally, while EPA access to much of the
data is difficult, public access is further complicated by lack of
awareness of available sources and by bureaucratic reluctance to
release unpublished information prior to actual publication.

     At present, regulatory decisions are being made on specific
chemical substances using only a small fraction of the data on
industrial activities and trends that should undergird such decisions.
Data are not readily available to support analyses of known problem
substances which are candidates for regulatory actions.  Similarly,
industrial data are not available in a useable form for rapid
identification of previously unsuspected chemicals that should be
of regulatory concern.

     In short, available data bases on industrial activities are
seriously deficient.  On a case-by-case basis more detailed industrial
data can be obtained at considerable time and expense, but even then
such data are more often than not inadequate.  At the same time, if
the Agency decides to exercise its full authority for industrial
reporting under the Toxic Substances Control Act, the volume of
data could be so overwhelming as to make the data almost useless.

GENERAL PROGRAM ELEMENT GOAL

     To improve the ready availability in a useable form of
authoritative information concerning the manufacture, use, distribution,
                             19

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and disposal of chemical substances which together with data on
the physical and biological properties of chemicals is needed to
assess the necessity for, character of, and impact resulting from
possible steps to restrict or to encourage voluntary restrictions
on chemical substances which pose a risk to man or the environment.

GENERAL

     Subgoal

          Promulgate the regulations required to implement the annual
     reporting, premarket notification, and related sections of the
     Toxic Substances Control -Act.

     Strategy

          Within six to twelve months following passage of the
     Toxic Substances Control Act proposed regulations will be pro-
     mulgated setting forth the ground rules for industrial reporting
     to EPA of information concerning the manufacture, distribution,
     use, and disposal of chemical substances.   A number of terms
     will be defined with more precision (e.g., manufacturer,
     commercial quantity, new use, intermediate, chemical substance,
     by-product), confidentiality aspects will  be elaborated, and
     reporting requirements for exports and imports will be set
     forth.  Both annual and premarket reporting requirements will
     be covered.  In short, the regulations will cover who reports,
     what is included in the reports, when reports are made, and
     what format is to be used for reports.

          Initially, the general approach will  be to delimit the
     reporting requirements to data that will be directly useable
     for premarket screening, regulatory, or early warning purposes
     as described below.  The emphasis will be on obtaining data
     that will be used rather than obtaining data to cover every
     substance that has been in commerce for some time.  The cost/
     effectiveness benefits from this emphasis should more than out-
     weigh the information gaps that are not filled.

          The reporting requirements will be reviewed and updated
     annually. During these reviews the desirability of broadening
     or narrowing the reporting requirements based on past usage of
     data will be considered.
                            20

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PREMARKET

     Subgoal
          To provide information needed to identify those new
     chemical  substances entering commerce which deserve in-depth
     analyses  to determine whether they pose a threat to man or
     the environment.

     Strategy

          Given the uncertainty of ,the risks associated -with new
     chemical  products which may have toxic properties and the lack
     of available information about these products, the premarket
     notification authority in the legislation will be invoked to
     the fullest practical extent.  This information must be clearly
     identifiable when it arrives at the Agency, be expeditiously
     handled,  and be quickly but carefully analyzed.  In addition,
     industry  will be encouraged to provide the Agency with as much
     notice as possible concerning new chemical substances and uses
     and any available information in addition to the mandatory
     information.

          EPA  should have a unique repository of current information
     on new chemicals entering commerce and on new uses of old
     shemicals.  Given the Congressional and environmental concerns
     over new  commercial chemicals and the uniqueness of this EPA
     data capability,  the data processing complications associated
     with obtaining all available information on these new products
     are warranted .  However, the data system must be able to
     provide the information to the analysts in a useable form, and
     in particular be able to flag chemicals (a) belonging to chemical
     classes that have caused past problems, (b) being used in a
     way that  there is large exposure to man or the environment, or
     (c) being produced in large quantities.

     Three-Year Milestones

          Develop methodologies for identifying in advance to the
     extent practicable the types of new chemicals or new use
     categories of particular concern, for presenting data in a form
     that will allow rapid premarket screening to determine the
     need for  more intensive analyses, and for obtaining additional
     information needed for carrying out such detailed analyses.

          Provide the data needed to analyze 10 to 20 new chemicals
     of particular concern.
                            21

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EXISTING SUSPECTED CHEMICALS

     Subgoal

          To provide information on selected chemicals currently in
     commerce which due to their properties, production levels, and/
     or uses might pose a threat to man or the environment.

     Strategy

          For chemicals strongly suspected of posing environmental
     risks, and hence prime candidates for regulatory actions,  ex-
     tensive data from a variety of sources will  be necessary.   The
     identification and prioritization of these substances will
     initially be based largely on the use of best judgement within
     rather general criteria, with parallel efforts initiated to
     develop more refined criteria.  The reporting requirements
     levied on industry will reflect a reporting  emphasis on pre-
     determined classes of particularly troublesome chemicals.

          The types of industrial  data of particular interest in-
     clude aggregated data on production levels including trends,
     uses and the environmental exposure associated with each use,
     and manufacturing processes which produce the substances of
     concern as by-products.  In addition, to assess the impact of
     restrictive actions, information on individual manufacturers
     will be necessary.  Initially, aggregated data will come largely
     from other Government organizations while the detailed  breakdown
     of this data will come from the required annual industrial
    'reports and also voluntary information submitted to EPA by
     industry.

     Three-Year Milestones

          Establish and have operating a system that presents both
     aggregated data and data broken down as appropriate which  can
     provide the industrial information base needed for making
     regulatory decisions.

          Provide the industrial information needed to reach re-
     gulatory decisions on 10 to 20 suspected chemicals.

EARLY WARNING

     Subgoal

          To provide information concerning other chemical  substances
     in commerce which, due to their levels of production,  uses, and/
                            22

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     or chemical and biological properties, may warrant in-depth
     analyses to determine whether they pose a threat to man or the
     environment.

     Strategy

          At one extreme the amount of data submitted by industry
     on unsuspected chemicals which are in commerce could be over-
     whelming, and hence almost useless.  On the other hand, some
     type of broad data net is needed to identify the potential
     problem substances.  Therefore, a close match must exist between
     data analyst's procedures and capabil-iti.es and reporting re-
     quirements.  The basic approach is to provide enough information
     to alert a trip-wire, rapid screening process which signals
     the substances that warrant in-depth analysis.  Specifically,
     the industrial information should help pinpoint chemicals with
     production and use -patterns which should be of concern.  Thus,
     the mandatory industrial reporting requirements will cover all
     substances exceeding a certain production level or destined
     for particular uses.

          The format of early warning data is critical if it is to
     be useful for rapid screening.  Reporting requirements will
     specify such a format.

     Three-Year Milestone

          Establish and have operating a system that provides the
     industrial information needed to identify previously unsuspected
     chemicals that should be of environmental concern.
PUBLIC ACCESS

     Subgoal
          To provide easy and rapid access by other agencies and
     by the public to data submitted to the Agency without com-
     promising trade secrets.

     Strategy

          Adequate resources will  be provided to process rapidly
     public requests for data submitted by industry although it is
     highly unlikely that regular Agency reports containing collected
     data will .be possible.   -The procedures used by the EPA fuel
     additive program for responding to requests for information
     claimed to be trade secrets by industry will  be adopted.   In
     short, the data identified by industry as confidential will be
                              23

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considered confidential.  If public requests are received
for such data, determinations will be made by EPA on a case-
by-case basis as to whether the requested information is indeed
in the category of trade secrets or can be freely disseminated.
The affected company will be provided an opportunity to submit
supporting documentation for his claim of confidentiality prior
to the determination.

Three-Year Milestones

     Establish and have in operation procedures for providing
rapid public access to industrial information that does not
involve trade secrets, for sorting out trade secrets, and for
resolving uncertainties as to what constitutes trade secrets.
                        24

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                     V.  EARLY WARNING
PROBLEM
    More than 20,000 chemical substances are presently in
commercial production.  Many of these are entering the environment
in substantial amounts, and there is some environmental exposure to
most of them.  In most cases, the potential toxicity of these
materials is unknown.  Even when pertinent data are available,
they are frequently buried in the scientific literature or in in-
dustrial or government reports and have never been collected and
analyzed wi.th a view to implications they,may have reaardina
threats to health or the environment.

    Review of all data on all chemicals, or even limited data on
most chemicals, is not practical.  The time and resources required
would be astronomical.- It is necessary to concentrate resources
on a few chemicals, hopefully those with the greatest potential  for
causing mischief in the environment.

    The purpose of the early warnina activity is to survey the
universe of chemicals and to select those which warrant special
attention.  Substances selected would be those showina potential
for causing adverse effects.  Determination of the need for
regulatory action is not the immediate purpose in this activity;
it is limited to the preliminary step of identifyina substances
for more careful investigation and evaluation.  If the selections
are well made, a rather large fraction of the substances recommended
for further investigation should prove to be good, candidates for
regulatory action.

    The system should serve to alert the Agency to incipient crises
which may soon reach levels of public concern.  In some cases, there
may be enough lead time to permit the Government to take steps to
avert the crisis; in others, at least the Agency would not be
caught totally unaware when the crisis breaks.  However, it is not
suggested that the system could eliminate unanticipated crisis
situations.

    The need for such an activity and the lack of ongoing efforts
in this area have been cited by a number of groups.  For example,
the Panel on Hazardous Trace Substances of the CEO-OST Committee
on Environmental Health Research (the "Rail Committee") has recommended
the establishment of an ''Assessment Program for Hazardous Environ-
mental Chemicals" to help fill this void.  Suoport for such a
program has been voiced by MAS, NSF, CEO, USDA, and MIH.  While
recognizing the difficulty of the task, all of these groups agree
that a major effort to identify unsuspected hazardous environmental
chemicals is needed.
                            25

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GENERAL PROGRAM ELEMENT GOAL

    To identify and prioritize previously unsuspected chemicals
entering the environment which are most likely to pose a significant
hazard to man or the environment in the near future.

CRITERIA

    Subgoal

         To develop criteria and techniques for determining on the
    basis of minimal information which chemical substances should
    be of greatest concern.

    Strategy

         Two types of chemical properties are of concern:   those
    properties which are likely to cause trouble in the environment,
    and those properties that can serve as early warm'no indicators.
    These two sets of properties  will not be the same, although
    sound correlations between them may exist.  The search for
    these correlations and for correlation methodologies is the
    essence of the early warning activity.  For instance,  per-
    sistence may be a property of environmental concern, hut infor-
    mation on persistence is not sufficiently available to make it
    directly useful for early warm"no searches.  However,  if
    correlations can be established between persistence and certain
    structural or physical properties which are readily ascertain-
    able, these properties could serve as the keys for early warning
    "on persistent chemicals.

         Past toxic substances incidents (e.g. dioxin, DDT, PCB, HCB,
    mercury) will be reviewed to identify the salient features
    that might be useful in anticipating future crises.  When
    possible, convenient measures or indicators of these features
    will be developed and verified, and then applied  against other
    materials or situations to determine where similar situations
    may exist or be created.

         Supporting efforts to develop selection systems which are
    relatively objective, using formal ranking schemes, mathematical
    modelling, or other approaches will be undertaken.

    Three-Year Milestones
         Assess the utility of several  quantitative and pseudo-
    quantitative techniques for predicting future problems with
    toxic substances.
                            26

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         Identify and beqin to prioritize those properties of
    chemicals which are suggestive of health or environmental
    threats based on correlations that can be derived from past
    experience and from theoretical  considerations.

EXPERT OPINION

    Subgoal

         To mobilize and use expert opinion to assist in rapidly
    ,screening large numbers ,of chemicals and in .predicting potential
    problem substances.

    Strategy

         A panel of experts conversant with environmental  problems,
    industrial technolony, and chemically-induced health effects
    will  meet on a reoular basis to assess possible problem areas,
    to flaq chemical problems on the horizon, and to advise on areas
    which may warrant early investigation.

         A series of seminars on various industries which  are
    potential sources of toxic substances (e.g. detergents, plastics)
    will  also be supported in cooperation with other interested
    agencies.  These will consider innovations in the industry,
    those activities or products that may be troublesome,  and
    measures that could be taken to reduce environmental exposure
    to these products.  These seminars could include retrospective
    case histories.  The seminar reports should be useful  guide-
    books for future analyses of the selected industries.

    Three-Year Milestone

         Establish and convene on a reaular basis a panel  of experts
    to provide advice on unsuspected chemicals which deserve
    investigations and on the significance of the results  of such
    investigations.

DATA ANALYSIS

    Subgoal

         To collect, collate, and analyze data from sources such as
    monitoring, trend assessment, and industrial reporting, as well
    as the open literature, on those chemicals which appear to
    deserve the highest priority in a manner that will facilitate
                            27

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 judgements  as  to v/hether the chemicals  should be candidates
 for further investigations,  testing,  and/or control.

 Strategy

      Data analysis  includes  (a)  awareness  of current  happenings
 on a limited scale,  and  (b)  trend  analysis of likely  future
 developments.   Both  of these depend on  indicators and para-
 meters  developed in  the  criteria activity.

      Current problem awareness  includes (a) surveys of engineering.
 trade,  and  business  journals and government reports,  (b)  data
 collected from other federal  agencies which have specific
 relevant responsibilities such  as  reports  of occupational
 incidents to the Department  of  Labor, reports of animal or crop
 damage  incidents to  the  Department of Aariculture, and reports
 of human disease incidents to the  Center for Disease  Control of
 HEW, and (c) reports of  local incidents obtained by extension
 services of universities, newsletters of local  environmental
 organizations, and  EPA offices.  The  third type of information
 is the  most difficult to acquire because it is  so disperse,  and
 the feasibility of  developing either  a  network  manned by  trained
 regional personnel  or a  centralized clearing house will be ex-
 plored.

      Trend  analysis  requires data  pertaining to less  specific
 economics,  growth,  and new-product indicators.   Economic  data
 are obtained from standard published  sources as well  as directly
 from the Department  of Commerce.  Growth data are obtained from
 market  journals and  federal  effluent  permits.  New product data
 are available  through the General  Services Administration and
 the Department of Defense (Defense Services Administration)
 primarily through their  new  product applications and  specifications
 program.

      When this network signals  an  alert, an analysis  of infor-
 mation  pertinent to  the  problem will  be undertaken.   The  depth
 of these analyses will depend on the  nature of  the data and  the
(apparent urgency of  the  problem.  If  this  analysis confirms  the
.'presence of a  significant problem, it will be referred to the
{restrictions or crisis response activity as appropriate.

:Three-Year  Milestones
      Establish  a  current awareness  network  covering  scientific,
 trade,  and business  journals  and  Government reports  to  identify
 potential  problems  and  to analyze trends  in technology  and
 commerce that could  result in new types of  problems.

      Complete preliminary analyses  on twenty substances.
                        28

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                   VI.  MONITORING
 PROBLEM
    Adequate, timely, and reliable monitorinq data  is critical to
 the assessment of the risks posed by existino substances already
 in the environment and by new substances enterino the environment.
 Such data are required to determine the need for and effectiveness
 of standards and tolerances for specific chemical substances, to
 shape responses to actual or alleqed crises, and to target enforce-
 ment activities.  In short, monitorinn data provide the most reliable
 barometer of the potential impact of substances in  the real world on
•man and the environment whether viewed on a national or a limited
 geographic basis.  Also, such data can indicate the incremental
 change in the status of the environment as the result of Agency
 actions.

    Despite extensive Federal and State monitoring  programs, at
 present there is little useable information on backoround levels,
 geographic description, and trends for most toxic substances.  At
 standard settina time the monitoring data needed to assess the in-
 cremental impact that the standards will have on ambient levels are
 not generally available.  This void is particularly noticeable when
 information on organic chemicals and many heavy metals is sought.
 Buildups of toxic substances in the environment are almost always
 signaled after the fact by environmental incidents; only then is
 monitoring activity focused on the problem substances.  Virtually
 no effort has been directed to the systematic use of monitoring
 data for early warning purposes.

    A principal deficiency within EPA is the lack of a sustained
 effort to (a) articulate prioritized proaram needs  for monitorinci
 data on toxic substances in relation to standard settina activities,
 and particularly the types of information needed, the specific sub-
 stances of concern, and the timetable, (b) incorporate into existing
 networks these and other toxic substances requirements, and (c)
 extract, analyze, and present in a useable form information from
 the monitoring data banks that can respond to program needs.

    To a large extent the Agency's principal monitorina concerns
 have centered on criteria pollutants and on gross pollution effects.
 Only recently has attention been given to specific toxic substances --
 and this attention is largely single media oriented.

    V'hile many Federal and State agencies have active monitorina
 programs, the feasibility of influencina these programs is difficult
 at best.  Also, as the Agency shifts the central responsibility for
 monitorinq to the States and to permit recipients,  the practicality
                            29

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of effectively orchestratina a unified multimedia national monitoring
approach targeted on selected toxic substances will become even more
difficult.  However, a better job of ferretinq out data available
from existing proqrams and usinq this information to meet Agency
needs is clearly in order.  A selective approach to specific sub-
stances and specific Geographical areas within the confines of
acceptable sampling and analytical methodology is essential lest
the Agency's toxic substances program drown in a sea of uninter-
pretable data.

GENERAL PROGRAM ELEMENT GOAL

    To identify and quantify to the extent practicable the levels,
distribution, and buildup of toxic substances in man and the environ-
ment.

REGULATORY ACTIONS

    Subgoal

         To provide in a useable form data needed to assess the
    necessity for and character of steps to control toxic substances
    of particular concern.

    Strategy

         Clearly, comprehensive mom'tori no for all toxic substances
    in all media, or even a significant fraction of these substances
    in most media, is impractical.  Thus, a close correlation between
    the targetting of the monitoring effort and the perceived risk
    posed by various substances as well as opportunities for re-
    gulatory actions to linit these substances is imperative.  In
    short, the end user of the data should have a significant input
    in determining what data are collected.

         Monitoring activities should be designed to determine the
    appropriateness of regulatory actions.  Such activities may be
    characterized as follows:

         —  reasonably comprehensive monitoring efforts targetted
             on substances that are prime candidates for regulatory
             actions under the Toxic Substances Control Act, the
             Hazardous Waste Management Act, or the toxic and
             hazardous pollutant provisions of the Clean Air Act
             and Fl-JPCA during the next several years; such efforts
             would cover a broad geographic area, using to the
             fullest extent possible data from existing networks.
                            30

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         --  more limited monitorinq, using selected networks in
             selected geoaraphical areas, for other toxic substances
             which are also of particular concern and which could be
             regulated under other Federal and State statutory
             activities.

         The first step is to identify those chemical substances
    of concern.  Criteria for selection of toxic pollutants which
    should be regulated are set forth in a variety of Agency
    documents, and include such factors as toxicity, persistence,
    production levels, and a history of past problems.   To these
    criteria should be added practical monitoring cons.iderations
    that determine cost/effectiveness ratios, such as state of
    monitoring technology, geographical distribution of sources, and
    opportunities to piggyback on existing programs.

         Once the initi-al list of target substances has been
    developed -- a list that will be continuously refined and up-
    dated -- a specific monitorina strategy for each substance
    will be developed.  These strateqies will be integrated to the
    extent possible.  In addition to using existina monitoring net-
    works, careful consideration will be given to use.of the permit
    program and the attendant opportunities for reguirinq monitorinq
    of toxic substances.

    Three-Year Milestones

         Identify, characterize, and quantify to the extent possible
    background levels and current releases into the environment on
    both a national and localized basis of 10 to 15 toxic substances
    of near-term regulatory concern.

         Develop and have in operation a systematic approach to in-
    corporating toxic substances nonitoring requirements into exist-
    ing monitoring networks and to exploitina data collected from
    these networks for toxic substances regulatory purposes.

EARLY WARNING

    Subooal

         To alert the Agency and other interested parties to the
    presence or buildup in the environment of previously unsuspected
    chemicals which might pose a significant threat to  man or the
    environment.
                           31

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Strategy

     The search for unsuspected problem substances, which in-
dividually or in combination may create environmental problems,
will require a great deal of ingenuity and perception.  Monitoring
and analytical technology is often substance-specific, and the
indicators of problems may vary from substance to substance.

     The basic approach is for the EPA regional offices to serve
as the initial trip wire, following up leads from a variety of
monitoring sources.  Buttressina this trip-wire mechanism will
be 'the "following cfctivittes:

     --  development, initially on a pilot basis, of a system
         of biota indicators which can serve as the basis for
         keepinn abreast of environmental trends on a national
         basis of selected classes of chemicals

     --  development, initially on a pilot basis, of an approach
         to selecting aeooraphical areas that are likely candidates
         for environmental problems and to searching out the
         latent chemical substances that should be of concern
         in these areas

     --  provision of teams of monitorino and assessment
         specialists who can respond to trip-wire alarms and
         assist in determining if an environmental problem is
         indeed developino.

     This combination of field sense, tuned to the idiosyncrasies
of specific geographic areas, together with adequate back-
stopping from headquarters, hopefully will uncover physical
evidence that can lead to better anticipation of environmental
incidents.  Of particular interest in this reaard are a variety
of localized monitoring efforts, often classified as research,
funded by EPA, other Federal agencies, the States, and universities
which can be of considerable help in pinpointing problem areas.
Clearly, physical monitoring data are only one input -- but an
essential input -- to an early warning system.

Three-Year Milestones

     Develop and have in operation on a pilot basis a system of
biota indicators which can serve as the basis for identifying
environmental trends indicating adverse environmental effects
resulting from specific chemical substances entering the environ-
ment.
                       32

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     Develop and implement in one geographic area a physical
monitoring approach to locating and assessing potential "hot
spots" due to the unsuspected buildup of chemical substances.
                        33

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                  VII.  CRISIS  RESPONSE
 PROBLEM
     The  increasing  frequency  during  the  past  several years of
 incidents of environmental contamination  from  toxic  substances
 strongly  suggests  that  in  the  months  and  years  ahead a quick response
 to  such incidents  must  become  a way of  life  in  EPA.  The sources of
 such problems may  be traced to natural  occurrences of the substances;
 to  the use, misuse,  or  disposal of commercial  products; or to industrial
 or  transportation  activities involving  chemical  substances.  The sub-
 stances may contaminate air, water, soil, or living  organisms; may
•cause problems  tn'food  or  drinking "water;-and  may be-tiomagrrified.

     The  EPA regional offices  are the Agency's  principal response
 capability.  These offices have developed considerable experience
 in  dealing with air  pollution  alerts, spills of oil  and hazardous
 materials in waterways,' and misuse of pesticides.  However, they are
 not equipped to handle  effectively many other  contaminants, and
 particularly the less familiar contaminants  that build up over time
 and contaminants which  tend to fall between  program  areas.

     Usually, responding to a  toxic substance  crisis involves three
 related types of activities:   assessing the  immediate risks posed
 by  the substance and taking steps to  reduce  the risks, identifying
 the source and  extent of the problem  substance  and taking steps to
 turn-off  the source,  and developing and stimulating  appropriate
 actions to help insure  that the problem does not reoccur in other
 areas of  the country.   More often than  not the  problem substance
 will be ubiquitous,  persistent, and toxic; will  come from poorly
 defined multiple sources;  and  will be affecting animals, fish,
 plants, and other  biological components of the  environment.  Also,
 the scientific  data  needed for specific regulatory actions will
 probably  be sparse.

     Further complicating  responses are the  regulatory, programmatic,
 and other bureaucratic, ambiguities and overlaps within EPA and
 among Government agencies.  Also, the responsibilities and response
 capabilities of the  States will vary.   In each  case  these must be
 sorted out -- usually a relatively easy task in  the  field but a more
 difficult task  in  Washington.

     The  experiences with  PCBs, HCB,  and  asbestos involved all of the
 foregoing considerations.  In  each case the  immediate crisis response
 has been  followed  with  longer  range action plans involving reallocation
 of  Agency resources.  In this  regard, the absence of Agency continoency
 funds (notwithstanding  the revolving  fund for water  spills) can cause
 considerable delay in responding and  program disruption through shift-
 ing 'priorities.
                               34

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GENERAL PROGRAM ELEMENT GOAL

     To provide an effective on-call capability for (a) assisting
EPA regional offices to respond to unanticipated buildups in the
environment of chemical substances that pose a substantial  hazard
to man or the environment, and (b) developing and carrying  out long-
term action programs to mitigate recurrent problems involving the
same substances on a nation-wide basis.

PROBLEM ASSESSMENT

     Subgoal

          To mobilize and deploy appropriate specialists for
     clarifying the character and extent of specific crisis
     problems and evaluating the short- and long-term impact
     of the problem substances on man and the environment.

     Strategy
          In developing a quick response capability for
     assisting the regional offices, the States, and other
     interested parties to assess the extent and severity of
     newly erupted problems, the following requirements will
     be emphasized:

          --  Versatile monitoring and data analysis capability
              for determining the distribution and levels of the
              problem substance.

          —  Rapid access to relevant reports and scientific
              data concerning the properties of the substance,
              its sources, and past incidents.

          —  Standing arrangements with other interested
              Federal agencies that will facilitate rapid
              coordination, division of labor, and sharing
              of information.

          --  Availability of a range of specialists who can
              analyze highly technical aspects of the problem.

          Except in unusual cases the regional offices will  take the
     lead in orchestrating EPA's involvement in a localized  problem.
     The headquarters on-call capability will be available to assist
     with a limited number of problems, with the number dictated
     by budgetary and manpower constraints.
                              35

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          On the other hand, coordination of the longer range effort
     to reduce the probability of similar incidents in other parts
     of the country will be centered in headquarters.   In addition
     to insuring consistency among the efforts of EPA offices and
     of Federal Agencies, the following types of considerations may
     be important:

          —  Necessity for guidelines for identifying and
              sampling potential  hot spots around the country.

          --'  Availability of adequate laboratory capability to
              analyze mon.itoring samples.

          --  Needed research to clarify the properties of
              the substance.

          --  Opportunities for using the contaminated area
              as a research test bed.

          —  Mobilization of the best expertise to assess
              the problem on a national basis.

          --  Priority that the problem deserves relative to
              other toxic substances problems.

     All  regional offices will be invited to participate in
     development of the nation-wide plans, and special efforts will
     be made to keep them advised of developments in one region
    -that may be relevant to another region.

     Three-Year Milestones

          Develop the necessary analytical and monitoring resources
     needed to assess a wide variety of unanticipated incidents
     involving the buildup of chemicals in the environment.

          Develop and carry out action programs to clarify the risks
     posed on a nation-wide basis by six crisis chemicals.
REGULATORY

     Subgoal
          To identify the regulatory and related steps needed for
     reducing or eliminating the source of crisis problems,  develop
     the necessary information for carrying out the most appropriate
     steps, and encourage the appropriate remedial actions.
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Strategy

     The choice of the appropriate regulatory tools for
alleviating localized toxic substance problems must be tailored
to the specific situations.  Frequently, State authorities or
voluntary actions on the part of the polluter will be more
effective and rapid than cumbersome Federal approaches.  However,
in addressing the nation-wide problems, a Federal approach may
have many advantages.

     As in the case of the problem of assessment, the regional
office should usually take the lead in sorting out the most
appropriate near-term response for .a.-localized problem, with
headquarters providing the necessary support and also a per-
spective of national implications of the various options.   With
regard to the national problem, headquarters should take the
lead in collaboration with other interested agencies and with
opportunities for regional office inputs.

Three-Year Milestone

     Foster development and implementation of restrictive
actions (either under Federal  or State laws or on a voluntary
basis) to reduce the source of the problems associated with
six crisis chemicals.
                        37

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                 VIII.  STRATEGY AND COORDINATION
PROBLEM
     Responsibility for toxic substances activities is fragmented
within the Agency, and the policies governing these activities are
largely determined by the broader responsibilities and interests of
the concerned Assistant or Regional AdministraLor.  More often than
not toxic substance activities are considered as just one subset of
more general pollution concerns, and relatively little effort has
been made to link the common toxic substance interests of different
offi'ces.  'Program offices tend to concentrate on  that portion 'of
the problem which directly relates to their statutory authorities.
This focus of attention is usually dictated by deadlines, with
resources deployed to address the urgency of setting standards or
responding to crises.  Typically, rotating specialists work in
spurts on toxic substance problems, usually without the opportunity
to evaluate the total hazard posed by a given substance.  Communica-
tion among offices working on the same problems has not been good,
coordinated planning scarcely attempted, and the usefulness of the
work of one office to other offices usually minimal.

     At present several EPA offices are independently assigning
priorities to problem substances, carrying out in-depth studies, and
promulgating regulations, with minimal attention to coordination
until' most of the work has been completed.  With the enactment of
new authorities, the Agency effort may become further fragmented.
Given the constraints on available Agency resources and the complexity
of toxic substance problems, the Agency can ill afford wasted motion
in this area.

     There are many interfaces among existing regulatory authorities,
and the passage of new legislation will further extend the options
for addressing specific problems.  Implementation of the air and water
acts, for example, involves selecting the most appropriate legislative
provisions within these acts for addressing particular problems.  The
pesticide act controls the use of certain pesticides while point
source discharges of these same chemicals are being considered for con-
trol under the water act.  Further complicating effective choice of
regulatory options is the tendency to search for problems to be con-
trolled under specific authorities, rather than searching for the
best authorities to most effectively control specific problems.  This
approach of controlling the "accessible" aspects of the problem,
which may or may not be the "critical" aspects, can hamper efforts to
focus on the core  of environmental and health risks posed by the
manufacture, use, and disposal of toxic substances.
                             38

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     The setting of standards and tolerances, the issuing of permits,
and the taking of other types of regulatory actions inevitably
involve the balancing of risks and benefits.  There are no Agency
guidelines as to how this balancing is to be carried out with regard
to toxic substances -- a particularly difficult area in view of the
uncertainties as to the health and environmental impact of the sub-
stances and the incremental environmental gains which might reasonably
be attributed to actual or proposed EPA actions.  This problem is
further complicated by differences in the language of different laws
and uncertainties concerning legislative intent.  As a result,
different criteria are being used depending on the specific legislative
framework and the biases of the concerned office.

GENERAL PROGRAM ELEMENT GOAL

     To improve the Agency's approach to control of toxic substances
through more effective utilization of statutory authorities and man-
power and financial resources.

PROGRAM COHERENCE

     Subgoal

          To insure that diverse program efforts designed to clarify
     and mitigate the risks associated with toxic substances are con-
     sistent and mutually reinforcing.

     Strategy

          The Steering Committee/Work Group process provides the best
     existing mechanism for (a) insuring consistency in the standard
     setting and related regulatory approaches of different offices,
     and (b) stimulating improved interactions among offices at the
     working level.  Hov/ever, if this process is to be effective the
     following aspects need particular emphasis:

          ~  better and more comprehensive Development Plans which
              are rigorously followed

          —  greater opportunities through the Work Group process for
              interested offices to participate in developing, rather
              than merely rubber stamping, proposed standards

          —  minimizing current tendencies to circumvent the Steering
              Committee process

          The Toxic Substances Control Act calls for an Annual Report
     to Congress on efforts to control toxic substances under a variety
     of authorities.  Whether or not the legislation is enacted, such
     an Annual Report (albeit not necessarily to Congress) should pro-
     mote greater coherence to these presently fragmented  program
                              39

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     activities.  At a minimum it can serve as a catalog of on-going
     programs.  More importantly, it can provide an opportunity to
     articulate policies that affect all programs.

          An area of particular concern is the apparent gap in a
     number of areas between the activities at the EPA research
     facilities and program interests.  The reality and extent of the
     gap are frequently blurred in the welter of bureaucratic documents
     surrounding the research process.  Therefore, a more systematic
     effort by program offices to visit and assess research efforts
     on a continuing basis should improve not only the process for
     setting research priorities but also foster better working level
     interactions between ,program, and research personnel at the working
     levels.

     Three-Year Milestones

          Publication cvf two Annual Reports on EPA activities in toxic
     substances.

          Completion of two annual in-depth evaluations of current and
     potential contributions of EPA research facilities to program
     needs in toxic substances.

PROBLEM ASSESSMENT

     Subgoal

          To improve problem assessments through more deliberate
     ordering of priority substances,  better problem definition,
     and improved interaction  among program elements supporting
     assessment activities.

     Strategy

          As a number of EPA offices and other agencies devote an
     increasing amount of resources to in-depth analyses of toxic
     substances -- particularly in  support of regulatory and early
     warning activities --  there  is a  need for more deliberate pro-
     cesses  for selecting the  substances of priority concern.  While
     each program office must  establish its own list of priority
     substances to be regulated under  different legislative authorities,
     each can benefit from  a clearer understanding of the criteria
     being used by other offices  for selecting the substances.  Also,
     it is important that the  results  -- both published and un-
     published — of such analytical  efforts be broadly distributed
     on a timely basis within  the Agency.
                              40

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          An early order of business in implementing the Toxic
     Substances Control  Act will  be selecting the toxic substances
     that deserve priority attention and assessing the appropriate-
     ness of the new legislation  as the regulatory vehicle for
     addressing these substances.   This activity should serve as a
     catalyst in stimulating Agency-wide efforts toward more deliberate
     priority ranking of toxic substances.

          In addition to activity directed to implementation of the
     new legislation, the following steps are planned;

          --  a series of seminars on the efforts of EPA and
              other agencies, as  appropriate, directed to analyzing
              for regulatory purposes, specific substances and on
              EPA efforts to develop criteria for prioritizing sub-
              stances.

          —  annual  summaries of the principal EPA efforts in this
              area with  appropriate bibliographies.

          —  more deliberate attention during the Steering
              Committee/Work Group process to criteria for selecting
              toxic substances for regulatory consideration.

     T nree - Y eja r Mi Je s t o ne

          Have in place  and operating a system of seminars, annual
     summaries, and Agency review procedures which will help insure
     that selections of  toxic substances for in-depth evaluations
     are made within the context  of the totality of the Agency's
     interests and activities.

REGULATORY ACTIONS

     Subgoal

          To develop and implement control strategies that (a)
     address the most critical aspects of toxic substance problems,
     and (b) balance in  a consistent manner the costs of control
     with the reduction  in risks  from such control.

     Strategy

          Closely related to problem assessment is the choice of
     the most appropriate regulatory authority to reduce the problem.
     Insofar as choice among EPA  authorities for addressing the
     most critical aspects of problems of national dimensions is
                               41

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concerned, the Steering Committee/Work Group process is the
best existing mechanism, subject to the previously noted
caveats.  Also, implementation of the Toxic Substances Control
Act should give impetus to a more deliberate selection process.

     While different laws set forth differing criteria for
standards, tolerances, and other limitations on toxic substances,
all the existing lav/s give EPA some flexib.lity in this regard,
and there should be some consistency in the Agency's overall
approach.  To this end Agency-wide guidelines are needed,
particularly with regard to balancing uncertain health and
environmental impacts of toxic substances w'ith'both direct
and indirect economic impacts of regulations.

Three-Year Milestone

     Prepare annually Agency-wide guidance concerning the
balancing of risks and economic impact in setting standards
and tolerances, issuing permits, and imposing other limitations
on toxic substances.
                          42

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                        IX.  RESEARCH NEEDS
PROBLEM
     As regulatory activity for toxic substances continues to expand
in scope and complexity, the results of mission-oriented EPA research
efforts take on added significance.  Not only is there a need for
research into new areas, but of equal importance is the need to
orient more sharply current research efforts tc program needs.  Also,
much of the EPA research effort traditionally identified as related
to toxic substances has been oriented to specific single-media
problems of very limited scope while equally important multimedia
concerns-have -been -largely -neglected.

     The most significant gaps in current Agency research programs --
taking into account research activities supported by other organiza-
tions as wel1 — are development of  (a) improved test methods that
are more responsive to 'near-term and longer-term regulatory needs,
(b) techniques for estimating the level of human and environmental
exposure to specific chemicals entering the environment, and (c) tech-
niques for assessing economic, technological, and market trends that
will provide insight into the severity of future problems that are
associated with chemical substances entering the environment.

     Classical evaluation of toxic effects involves acute, subchronic,
and chronic tests on experimental animals, and extrapolation of results
to 'the effects (or "no effects") on man.  This extrapolation relies
very heavily on the incorporation of "safety factors".  Such tests
have proven useful in the past and will certainly continue to be in
the immediate future.  However, many of them are very expensive and
time consuming.  Structuring of tests for specific research purposes
often results in inconsistencies among different investigators so that
applicability to regulatory activity is limited.  Similarly, there is
a definite lack of tests optimally designed for generating results
useful in the development of numerical standards.  Seldom are animal
and epidemiological investigations conducted on the same materials
to improve the extrapolation process.  Finally, the substances being
tested frequently have little relevance to the substances of regula-
tory interest.

     The Agency's approach to toxic substances regulation places the
prime responsibility for the testing of substances with the producers
of those substances or others who derive economic benefit from them.
At the same time, the Agency has an interest to insure that tests per-
formed to comply with regulations are meaningful, reliable, and
standardized to the point that the results can be interpreted within the
established regulatory framework.  Thus, although a certain amount of
                              43

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testing must still be done by the government, the major responsibility
of EPA in this area is to insure that reliable and practical testing
procedures exist and are being used.  Therefore, the primary objective
of the research effort should be the development and verification of
new or improved test methods, rather than the collection of data on a
large number of compounds.

     Rapid and relatively low cost testing methods for predicting
chronic effects including carcinogenic, mutagenic, and teratogenic
potential are particularly needed.  Such testing would allow for an
initial screening of many more chemicals to identify those chemicals
which require'more elaborate testing.

     Similarly, there is an urgent need for development of new test
methods which will indicate environmental effects from chemicals.
Such tests at present are few in number or nonexistent, and substan-
tial research resources will be necessary to close this gap.  Given
the potential magnitude of these activities, special efforts must be
made to insure close coupling of research work and priority program
needs.

     Extensive efforts have been made to estimate the levels of human
exposure to chemicals which are ingredients in foods, drugs, and
cosmetics.  Little serious effort has been made to estimate levels of
human exposure to these or other chemicals via other routes such as
inhalation, drinking water contamination, food contamination, and skin
absorption of pollutants.  Even less effort has been directed to
assessing exposure of environmental flora and fauna to chemicals.  This
is a difficult area, and meaningful quantification will be the excep-
tion rather than the rule.  For example, primitive steps have been made
in considering human exposure to mercury, but only very crude estimates
were possible.  Research is needed to develop techniques for estimating
exposure levels of the known problem substances and for signalling high
exposure levels of potential problem substances.

     Economic and market forecasts are central to the activities of all
aggressive companies.  Similarly, the research for better manufacturing
and related technologies is never ending.  However, these industrial
activities are inevitably cast in profit-making and not environmental
impact terms.  Economic and technological forecasting techniques which
combine both profit and environmental concerns are particularly impor-
tant in a field dependent on long lead-time R&D requirements.  It is
important that the Agency learn how to use such techniques to anticipate
activity that may lead to environmental degradation.
                              44

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GENERAL PROGRAM ELEMENT GOAL

     To improve the experimental and analytical techniques and data
base needed to assess the necessity for, character of, and impact
resulting from regulatory and other steps to restrict chemical
substances.

TEST METHODS

     Subgoal

          To stimulate .development of more .rap.ld, less expensive,
     and/or more reliable test methods with particular emphasis on
     approaches that provide data needed for specific types of
     regulatory actions.

     Strategy

          The approach to improving toxicological test methods
     through EPA research activities should emphasize development of

          —  short-term and low cost methods for rapidly screening
              large number of chemicals and for identifying those
              biologically active chemicals which should be subjected
              to more detailed testing.

          --  improved methods for extrapolating from animal test
              results to human health effects, including the design
              and execution and toxicological and epidemiological
              studies on the same substances.

          --  better models for extrapolating toxicological test
              results to lower levels on the dose/response curve with
              particular attention to orienting the activities at
              NCTR more sharply toward regulatory requirements.

          —  tests for detection of chronic and delayed effects
              other than carcinogenesis and mutagenesis.

          --  standardization of tests for chronic and delayed
              effects such as teratogenesis and mutagenesis.

          Environmental test activities should center on improved
     methods for assessing (a) the impact of selected chemical
     classes on different types of plants and animals, (b) the move-
     ment of chemicals through the environment -- and particularly
     through the soil and across media interfaces, (c) the ability

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     of chemical insults to cause serious imbalances in natural  eco-
     systems, and (d) the utility of micro-ecosystem models to
     evaluate the interaction of selected chemicals with the eco-
     system.   Methods that could be adopted and used by industry
     as a basis for predicting environmental  fate of toxic substances
     should be emphasized.  Clearly, cost and reliability will be
     central  considerations.

          Critical  to a successful  research effort in this field is
     participation  in selection and design of tests by program
     offices  -- to  help insure their relevance, -and by industry --
     to'help  insure that the results of the research will be used.

     Three-Year Milestone

          Have under development three new approaches to testing
     that will provide an improved basis for assessing the risks
     associated with chemical substances.

ESTIMATION OF EXPOSURE

     Subgoal

          To  develop and apply methods and background data needed
     for assessing  the extent of environmental  and human exposure
     to selected chemical substances, including consideration of
     environmental  transport, persistence, routes of entry into
     the environment, magnification and bioaccumulation, environ-
     mental degradation, and retrospective monitoring through
     sample banking.

     Strategy

          The approaches involved are of two types:  those more
     general  approaches which consider factors  common to all types
     of chemicals for assessing exposure, and specific approaches
     which are directed to particular chemicals or classes of
     chemicals.

          Analytical models which make use of monitoring and other
     types of data  should be designed and developed for both general
     and specific approaches to exposure estimation.  Factors such
     as production  quantity, use patterns, persistence, environmental
     transport characteristics, and degradation patterns will be
     considered and should form the basis for various proposed
     models.   Experimental and theoretical techniques for predicting,

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assessing, and verifying environmental properties such as per-
sistence and transport characteristics are generally lacking,
and should be developed to support this effort.

     The development of analytical models of predictive value
involves relating experimentally obtained values of different
types to one another.  For example, a physical-chemical
measurement such as a partition coefficient may have a statistical
correlation to the degree of storage of a compound in certain
biological compartments.  This approach can be applied to many
chemicals and chemical classes, but may develop particular
sign.iflcance for a specific group such .as chlorinated hydro-
carbons.

     Development of new monitoring methodology and monitoring
data to assess the presence and distribution of chemicals in
the environment is^a vital input to these approaches.  Such
activities should involve research on methods to monitor
actual exposures to humans and natural ecosystems to environ-
mental chemicals.

     Comparative analysis of theoretical and actual exposure
levels is a concurrent activity which can serve to strengthen
both general and specific approaches to exposure estimation by
revealing the consistencies or inconsistencies of observed
correlations.  Verification of analytical models will necessitate
the development of monitoring strategies, and in many cases
will demand extremely sensitive analytical chemical techniques
which may not be readily available.  Feedback from this activity
will impact on both monitoring method and analytical model
development.

     A sample bank system should be established to provide base-
line information on actual exposures in selected locations.
Initially, the sample bank should be limited to human tissues
but later expanded to environmental samples such as crops, soils,
water, or selected plant and animal tissues.

     In addition, these efforts should include some input from
related EPA activities such as the CHESS program and pesticides
community studies.

Three-Year Milestones

     Develop and test on a limited number of chemical substances
a system for estimating and/or producting the level of human and
                          47

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     environmental exposure to such substances, taking into account
     use patterns, environmental transport, degradation, and food
     chain effects.

          Establish and maintain a sample bank for retrospective
     monitoring of selected chemical substances.

TREND ASSESSMENT

     Subgoal,

          To Improve assessments and forecasts^'of'technoTogical
     developments, economic and market trends, and material production
     and use patterns which can assist in anticipating environmental
     problems resulting from chemical  substances entering the environ-
     ment.

     Strategy

          Well  established market and related economic forecasting
     techniques provide the framework for this activity.  Technological
     forecasts  within this framework can serve as the basis for
     estimating the character and direction of the chemical and
     allied industries in the years ahead.   The major effort should
     then be directed to estimating the interaction of these pro-
     jected trends with environmental  concerns.  The following types
     of considerations are particularly relevant:

          --  At what levels will known problem substances be
              entering the environment?

          —  What currently unsuspected chemicals will  be
              entering the environment and  at what levels?

          --  What will be the geographic distribution of
              manufacturing and use?

          —  Which types of manufacturing  and use activities
              lead to appreciable amounts entering the
              environment?

          —  Which types of technological  innovations
              heighten environmental concerns and which  types
              reduce concerns?

          --  What risks are involved with  substitute and
              alternative materials?
                              48

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     »  To what extent will economic trends and other
         market factors influence technological develop-
         ments and how will these developments interact
         with environmental concerns?

     —  To what extent can use patterns be predicted
         from economic and growth indicators?

     Initially, conceptual approaches and analytical techniques
should be developed.  They would then be available to assess
specific industries, specific chemical classes, and specific
use classes.

Three-Year Milestone

     Develop and apply to a range of selected industrial
classes economic and market indicators that can signal those
chemical substances which should be of particular concern.
                         49

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                                                        Appendix 1


             EPA REGULATORY AUTHORITIES OF PARTICULAR
                  RELEVANCE TO TOXIC SUBSTANCES


 CLEAN AIR ACT

      Ambient Air Quality - National air quality standards based
 on geographic regions establish the maximum amount of each
 pollutant that will be permitted in the atmosphere consistent
 with public health and welfare.  Standards have been set for
sulfuroxides, particulate matter, carbon monoxide, hydrocarbons,
 photo chemical oxidants, and nitrogenoxides.

      New Statipnary^Sources - EPA directly regulates new
 stationary sources by setting uniform national standards for
 new air polluters.  Standards have been devised to require the
 application of the best available technology for five sources:
 fossil fuel fired steam generators, incinerators, cement plants,
 and sulfuric and nitric acid manufacturing operations.

      Hazardous Air Pollutants - EPA has the authority to set
 national standards for materials discharged into the atmosphere
 that have a proven relationship to severe human health problems.
 Standards have been set for mercury, asbestos, and beryllium.

      Fuel and Fuel Additives - EPA may regulate fuel and fuel
 additives which endanger public health, such as leaded gasoline.

 FEDERAL WATER POLLUTION CONTROL ACT

      Effluent Limitations - EPA is directed to publish regu-
 lations establishing guidelines for effluent limitations which
 identify the best practicable control technology for various
 industrial categories.  Industrial discharges must meet these
 standards by 1977.  Also, EPA must identify the best
 available technology which will reduce discharge of
 pollutants with industrial discharges obliged to meet these
 standards by 1983.  Among the industries of particular
 relevance to toxic substances are plastics, petroleum,  rubber,
 organic chemical, asbestos, fertilizers and phospates,
 soaps and detergents, and inorganic chemical.

      Water Quality Standards - States must submit to EPA'
 water quality standards which are consistent >?ith Federally
 established water quality criteria, including criteria for
 limitations on toxic substances.  In addition, where
 effluent limitations will not be stringent enough to meet
 water quality standards, States are required to establish
                             50

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maximum daily loads of pollutants in waters that will allow
the propagation of fish and wildlife.

     New Source Performance Standards - EPA is required to
set standards for nevrindustrial point sources, based on best
available demonstrated control technology.

     Toxic and Pretreatment Effluent Standards - EPA is
directed to publish a list of toxic pollutants and effluent
limitations, including prohibition if appropriate, for these
substances.

     Oil Spills and Hazardous Substances - EPA is directed to
clean up spills of oil and hazardous substances, make the
polluter pay the cost of clean up, and levy fines and
penalties against him.  As a first step in the area of
hazardous substances 5 a list of pollutants is to be promulgated
with subsequent determination of penalty rates.

PUBLIC HEALTH SERVICE ACT

     Drinking Water Quality - EPA has responsibility for
drinking water standards for public water supplies used by
interstate carriers.

M&EENE PROTECTION, RESEARCH, AND SANCTUARIES ACT

     Ocean Dumping - EPA issues permits for dumping in the
ocean of sewage sludge, garbage, and chemical and construction
wastes and approves permits for dredged materials.

FIFRA, FEPCA, AND FOOD, DRUG, AND COSMETIC ACT

     Registration - Under FEPCA, the distribution, sale,
offer or holding for sale, shipment, delivery, or receipt
within any State of any pesticide which is not registered is
prohibited.  Additionally, FEPCA calls for labelling of
registered pesticides and the registration of pesticide-
producing establishments.

     Certification of Applicators - EPA is authorized to
prescribe applicator certification standards requiring that
the individual to be certified is competent to handle the
pesticide.  A related provision is the prohibition against
the use of a pesticide in a manner inconsistent with its
labelling.
                          51

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     Tolerances - Under the Food, Drug, and Cosmetic Act, if
the pesticide in normal use leaves residues on crops that
provide food for man and animal, a tolerance must be
established.  Where the supporting data is inadequate or a
health hazard may be present, EPA must establish a "zero"
tolerance.

     Cancellation - Cancellation is the major tool in imple-
menting the decision that the benefits of using a pesticide
are outweighed by its risks.  Cancellation can result in
removal -from -the market.  -Other enforcement -sanctions
include: a change in classification from general to
restricted use:  stop sale, use, or removal orders; seizures;
and civil and criminal penalties.
                          52

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                                                      APPENDIX 2

      REGULATORY AUTHORITIES OF OTHER AGENCIES OF PARTICULAR
                 RELEVANCE TO TOXIC SUBSTANCES

     There arc a number of regulatory authorities bearing on
toxic substances administered by other agencies.  The most
significant laws and administering agencies are:

     Food, Drug, and Cosmetics Act - Department of Health,
     Education, and Welfare

     Lead Based Paint Poisoning Prevention Act - Department
     of Health, Education and Welfare

     Federal Meat Inspection Act - Department of Agriculture

     Egg Products Inspection Act - Department of Agriculture

     Poultry Products Inspection Act - Department of Agriculture

     Flammable Fabrics Act - Federal Trade Commission

     Occupational Safety and Health Act - Department of Labor
     and Department of Health, Education and Welfare

     Federal Hazardous Substances Act - Consumer Product
     Safety Commission

     Consumer Product Safety Act - Consumer Product Safety
     Commission
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                                                     Appendix 3
         EXAMPLES OF MONITORING NETWORKS SUPPORTED
                     BY OTHER AGENCIES
Food and Drug Administration:

      surveys of raw agricultural products and market basket
      purchases


Department of Agriculture:

      sampling of livestock feed, livestock, and selected
      crops


Forest Service:

      surveys of toxic effects on trees and on nearby areas


Geological Survey:

      base line monitoring of rivers and streams and periodic
      sampling for specific substances


Bureau of Sport Fish £ Wildlife:

      analyses of contamination of fish and wildlife, including
      sampling for heavy metals


Bureau of Mines:

      surveys of mine tailings and related runoffs


National Oceanographic £ Atmospheric Administration:

      monitoring of near shore, estuarine, and lake quality
      including spot sampling for heavy metals


Smithsonian Institution:

      analyses of marine and wildlife biology


Department of Health, Education, and Welfare:

      Communicable Disease Center's efforts in epidemiological
      monitoring, including diseases related to heavy metals
                        54

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STRATEGY FRAMEWORK

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            FRAMEWORK FOR AN EPA STRATEGY

                       FOR THE

              CONTROL OF TOXIC SUBSTANCES
July 12, 1973
   HMC/OTS

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                       PREFACE
     This Report is an early step toward development
of an EPA strategy for controlling toxic substances.
It is intended to serve as the framework for a more
comprehensive and definitive strategy statement to be
prepared during the next several months.  Thus, at
this stage the Report is largely descriptive of pro-
blems and activities relevant to such a strategy
statement.  In some cases general policy approaches
are suggested although further refinement of these
approaches is clearly in order.

     The Report is directed primarily to chemical sub-
stances exhibiting adverse effects on man or the
environment at relatively low concentration levels.
At the same time it is recognized that almost any sub-
stance can be toxic if exposure levels are sufficiently
high, and therefore it is not practical to specify
which chemicals or chemical classes are or are not
included.  Additionally, the concern here is only for
toxic effects resulting from sustained chemical or
biological activity, and other hazardous effects, such
as fire, explosions, and radioactivity, are not
considered.

     The EPA approach to controlling toxic substances
must be carefully integrated with the myriad of related
activities of other Federal and State agencies --
including regulatory, monitoring, and research activi-
ties.  While better integration of all national efforts
is a central concern, this Report does not set forth in
detail the activities of other organizations which are
described in various reports of these organizations.

     One purpose of this Report is to provide a broad
perspective for the toxic substance activities of a
number of interested EPA offices, and particularly the
recently established Office of Toxic Substances.  There-
fore, the most relevant activities of .these offices and
the additional activities required to implement the
pending Toxic Substance Control Act are briefly outlined,
with more detailed statements of specific activities
presented separately in EPA program documents.

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                    TABLE OF CONTENTS

                                                           Page

  I.   THE PROBLEM OF CONTROLLING TOXIC SUBSTANCES            1

 II.   AGENCY GOALS                                           5

III.   THE STRUCTURE TO DEAL WITH TOXIC SUBSTANCES            7

      A.   Regulatory Authorities                             7

      B.   Research, Monitoring, and Data Systems             8

      C.   Interests of EPA Headquarters Offices             11

      D.   Role of the Office  of Toxic Substances           12

 IV.   POLICY ISSUES                                         14

      A.   The Level of Agency Resources Devoted to
            Toxic Substances                                14

      B.   Organizational Responsibilities and
            Coordination within EPA                         14

      C.   Selection of Problem Substances for
            Detailed Attention                              15

      D.   Selection of Appropriate Regulatory Authority     16

      E.   Limited Reliance on State Capabilities            17

      F.   Improved Approaches to Research, Monitoring,
            and Data Systems                                18

      G.   Priorities in Implementing the Toxic
            Substances Control Act                          19

  V.   FUTURE STEPS                                          21

      Appendix 1 - EPA Regulatory Authorities of
                    Particular Relevance to Toxic
                    Substances

      Appendix 2 - Regulatory Authorities of Other
                    Agencies of Particular Relevance
                    to Toxic Substances

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I.   THE PROBLEM OF CONTROLLING TOXIC SUBSTANCES

    More than 10,000 chemical substances are commercially
produced and used in the United States, with 500-700 new
substances entering commerce annually.  They  find a wide
variety of uses as industrial chemicals, in consumer pro-
ducts, and in specialized uses such as drugs, food addi-
tives, and pesticides.  1972 sales of chemicals and allied
products were about $70 billion, or about eight percent
of total U.S. manufacturing sales.

    The problems presented by the presence in the environ-
ment of some of these substances are all too well known
(e.g. mercury, lead, asbestos).  Others are believed to
pose a latent health or environmental threat, while the
effects associated with many of the remaining chemicals,
acting individually or synergistically, are almost com-
pletely unknown.  However, it seems clear that the problems
associated with the presence of many chemical substances in
the environment -- such as food and drinking water con-
tamination, destruction of biota, and water and soil
degradation -- will undoubtedly continue to grow in number,
severity, and complexity in the years ahead.

    Some of the hazards associated with .chemical substances
have been recognized and are controlled by the Government,
e.g. pesticides and drugs.  Other aspects of the toxic
substances problem have only recently been identified, and
appropriate regulatory measures do not yet exist.  Still
other pieces of the problem have yet to be identified.
Many gaps remain in understanding why, how, and when a
substance can have a negative impact on health or the
environment, and how best to control or prevent such
hazards.

    Thus, the concern of EPA with toxic substances is two-
fold: identification and assessment of the risks associated
with the manufacture, distribution, use, and disposal of
chemicals which could adversely affect health and environ-
mental quality; and practical steps, including regulatory
actions as appropriate, to prevent or mitigate the problems
posed by such chemicals.

    The risks associated with toxic substances are related
to many factors including the size of the dose, duration
of exposure, form of the substance when released, and
presence of other substances that also contribute to envi-
ronmental stresses.  Problem assessment is further compli-
cated by the many unknowns that surround the characteristics

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and behaviour in the environment of most toxic sub-
stances, including such aspects as persistence,
dogr-cul.itJon, accumulation, and movement am^ng environ-
mental media.  Good information is not readily available
concerning levels, distribution, and trends in the
environment of many substances of concern.  With regard
to the adverse effect of toxic substances, testing
approaches for measuring chemical properties and acute
toxicity are reasonably well developed.  However,
similarly well developed test methods  For determining
chronic toxicity and for estimating environmental impact
are not in hand.

    The success of past efforts to reduce these defi-
ciencies and uncertainties has been spotty.  Monitoring
systems generally lack the capability to relate effects
to specific substances, and research efforts are only
now beginning to address many core issues.  Lack of
effective integration of the many Federal monitoring and
data systems further impedes rapid progress.

    In seeking to control specific toxic substance pro-
blems, the Government can draw on three types of regula-
tory authorities:

        Consumer protection statutes which have as  their
        primary mission the prevention of acute risks to
        human health.  They, however, do not address
        problems of environmental protection nor human
        exposure to toxic substances through environmental
        routes.

        Media-oriented statutes which focus primarily on
        problems at the point where they become environ-
        mental contaminants, typically, after they are
        manifested at the end of an outfall pipe or
        smokestack.

        Statutes dealing with a particular phase of the
        existence or use of a toxic substance such as
        risk to workers, transportation-related accidents,
        and use of pesticides which are toxic by design.

    Pending legislation is directed to enabling EPA to
deal with problems which do not currently fall within
the existing regulatory framework, and particularly with
regard to drinking water standards, disposal of toxic
wastes, and problems associated with use and distribution

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of chemical substances.  In addition, EPA would have
authority to control certain types of problems before
they appear in the environment.  In the absence of
such legislation, efforts to cooperate with industry
on a voluntary basis in addressing specific problems
beyond the reach of current authorities must continue
although the results of past efforts have been some-
what uneven.

    There are many interfaces among existing regulatory
authorities, and the passage of new legislation will
further extend the options for addressing specific
problems.  Implementation of the air and water acts,
for example, has involved selection of the most appro-
priate legislative provisions within these acts for
addressing problems of toxic substances in addition to
development of criteria to determine if regulation is
needed or appropriate under specific provisions.  Another
example is the control of the use of certain pesticides
under the pesticide act while point source discharges
of these same chemicals are being considered for control
under the water act.  Further complicating effective
choice of regulatory options is the tendency to search
for problems to be controlled under specific authorities
rather than searching for the authorities that will most
effectively control problems.  This approach of control-
ling the "accessible" aspects of the problem, which may
or may not be the "critical" aspects, can hamper efforts
to cope with the core of the environmental and health
risks posed by manufacture, use, and disposal of toxic
substances.

    Central to consideration of regulatory options is the
balancing of the risks with the benefits related to the
action.  The diversity of the tradeoffs make this a
formidable task.  For example, the benefits from employ-
ment of workers in chemical plants must be balanced
against occupational risks; U.S. competitive ability in
world markets weighs against environmental testing costs
or requirement of expensive effluent or emission controls;
and quality of life benefits from chemical substances bear
on the degree of risks which can be tolerated.  Restric-
tions placed on existing activities will affect past
investments and established patterns of commerce and
employment.  With respect to those chemicals which have
yet to be offered for commercial use, barriers to market
entry could be created through pre-testing and screening
requirements.  If research and development of new chemicals
becomes so difficult that it is no longer profitable, the

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advantages to society, in terms both of" new products
and development of less toxic alternatives to existing
product's,,  are lost.  In short, environmental protection
is not Tree.  Care must be exercised in accessing  the
impact oF  corrective actions on the direction, configu-
ration, and diversity of the chemical industry as well
as on the  benefits to society of chemical products.

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II.   AGENCY GOALS

     The overall EPA goal in the toxic substance area
is the prorection of man and his environment from
adverse effects which may result from the manufacture,
use, distribution, and disposal of chemical substances
without unduly jeopardizing the societal benefits
derived from such substances.  While this goal is very
broad, and not uniquely the responsibility of EPA, it
can serve as the standard for measuring the success of
EPA efforts in this area.

     The following subgoals are directed to an enhanced
EPA capability to assess the risk and benefit aspects
of toxic substances and to take appropriate steps to
control existing or potential problems posed by these
substances:

          (1)  Development of improved methods to iden-
tify and assess problems, including anticipation of
problems before severe environmental or human health
problems arise.  Monitoring and testing data must be
combined with analytical efforts and expert judgements
in forecasting likely problem areas as well as clarify-
ing known problems.

          (2)  Articulation of actual or potential health
and environmental effects of particular concern.  In
individual cases careful consideration must be given to
the concepts of a permissible level vs. a no effects
level, to protection of individual organisms vs. protec-
tion of populations of organisms, and to irreversible vs.
temporary effects.

          (3)  Improved use and coordination of monitor-
ing and data systems to ensure that maximum benefit is
derived by all concerned program elements from such
activities.   Ready access to a broad range of available
scientific,  technical, and economic data can greatly
improve and facilitate decisions concerning specific
toxic substance problems.

          (4)  Stimulation of priority research activi-
ties, both in the public and private sector, to clarify
the problems associated with toxic substances and to
develop less hazardous alternatives to these substances.

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          (5)  Improved understanding of the oconomic
framework surrounding the production, use, distribu-
tion, 
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IIT.   THE STRUCTURE TO DEAL WITH TOXIC SUBSTANCES

      A.  Regulatory Authorities

          There are a variety of existing authorities
which can be used to contro] toxic substances.  Some
cover a broad range of pollutants while others have
been specifically designed to address toxic substances.
Appendix 1 describes the relevant provisions of the
following statutes administered by EPA:  Clean Air Act;
Federal Water Pollution Control Act; Public Health
Service Act; Marine Protection, Research, and Sanctu-
aries Act; and FIFRA, FEPCA, and Food, Drug, and
Cosmetic Act.  Appendix 2 identifies a number of statutes
covering various aspects of the toxic substance problem
which are administered by other agencies.

          The proposed Toxic Substances Control Act of
1973 would give EPA new authority for (H~5information
acquisition, and (b) restrictive actions.  EPA could
require testing of chemical substances (both existing
and new) which are suspected to pose unreasonable risks
and also require other information from manufacturers
including the name of the substance, chemical formula,
amounts produced, actual or intended uses, and known
by-products.  EPA could then restrict the use and
distribution of chemical substances found to pose unreason-
able risks.   The Agency could prescribe the amounts of
a chemical which may be sold to processors, limit the
type of processor to whom it may be sold, restrict the
amount a given type of processor may use, or limit the
sale or manner in which a substance may be used, handled,
labelled, or disposed by any person.

          This new authority is important from two stand-
points.  First, the Federal Government is given direct
authority to restrict substances presently in commercial
use that are known to cause health or environmental
hazards, and (when effects) information is lacking, to
require testing of the sujbstance by the manufacturer to
assess human or environmental impact.  Second, for
substances not yet in commercial production, the Agency
could require premarket testing and review of chemicals
suspected to be hazardous.  The Agency would have the
opportunity to assess the risks before the new
substances are commercially produced and to take appro-
priate regulatory action to prevent toxic incidents.

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          The, proposed Hazardous Waste Management Act
of 1973 would create a joint federal-State program to
regulate the treatment and disposal of hazardous wastes.
This, legislation would authorize EPA to designate waste
substances or waste streams of particular concern and
to specify performance and design standards for disposal
Facilities.  Wastes not identified as posing the most
serious hazards, but which still present disposal
problems, would be controlled by State programs
established in accordance with Federal]y specified
guidelines.

          This new authority is particularly important
as presently established regulation of air and water
discharges and of ocean dumping makes land disposal of
toxic wastes more attractive.   The Agency could require
generators of hazardous wastes to use environmentally
sound disposal techniques and could insure compliance.

          The pending Safe Drinking Water Act would
expand Federal coverage of drinking water standards
from the current 700 systems serving interstate carriers
to 40,000 community water supplies and 200,000 non-
community systems serving the travelling public.  Manda-
tory national primary standards would apply to all health
related constituents as well as certain operating and
monitoring requirements.  Enforcement authority would
rest primarily with the States, subject to EPA support
if State programs fail to meet Federal guidelines.  A
more direct Federal role would exist in the presence of
an imminent hazard.

      B.  Research, Monitoring, and Data Systems

          Three EPA research areas of particular signi-
ficance are: Transport Processes, including the fate of
pollutants in ground water and fresh surface water and
the mechanisms of formation and decay, Health Effects,
including development of improved toxicological tests;
and Ecologica] Effects, including the impact of toxic
substances on fish and wildlife.  A number of other
Federal agencies also support research on toxic sub-
stances, including the Department of Health, Education,
and Welfare (e.g. Food and Drug Administration and
National Institutes of Health), the Department of
Agriculture (e.g. Agriculture Research Service, Forest
Service), the Department of Interior (e.g. Bureau of
Mines, Bureau of Sport Fish and Wildlife, Geological

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Survey), the Department of Commerce (e.g. MOAA, National
Bureau of Standards), and the National Science Foundation.

          In a number of cases entire research programs
or laboratories are directed to toxic substances, such
as the NST program on trace metals, the National Center
on Toxicological Research, severs] laboratories of the
National Environmental Research Cent ere., a number of pro-
grams of the National Institute of Environmental Health
Sciences and the National Cancer Institute, and a number
of other Federally supported university programs.  In
addition, attention to highly toxic materials is frequently
subsumed in programs encompassing a broader range of pollu-
tion concerns.

          Similarly, many Federal and State agencies are
involved in monitoring.  For example:

              FDA surveys of raw agricultural products and
              market basket purchases

              USDA sampling of livestock feed, livestock,
              and selected crops

              Forest Service surveys of toxic effects on
              trees and on nearby areas

         • --  USGS base line monitoring of rivers and
              streams and periodic sampling for specific
              substance

              Bureau of Sport Fish and Wildlife analyses
              of contamination of fish and wildlife,
              including sampling for heavy metals

              Bureau of Mines surveys of mine tailings and
              related runoffs

              NOAA monitoring of near shore, estuarine,
              and lake quality including spot sampling for
              heavy metals

              Smithsonian Institution analyses of marine
              and wildlife biology

              HEW CommunicabDe Disease Center's efforts
              iii epidemiological monitoring, including
              diseases related to heavy metals.

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The objectives, and hence the geographic spread and
data collection requirements, of these networks vary
considerably.   Nevertheless, they offer extensive
opportunities for environmental sampling on either a
routine or an ad hoc basis.  In some cases toxic
pollutants are a principal concern of the network
collection activities.  In other cases, toxic sub-
stances are but a subset of a broader range of
pollutants that are analyzed.  Timely access by EPA
to the monitoring data is often difficult, however,
and adjustments of the systems to accommodate quick
responses to short-term EPA needs is usually not
feasible.  In short, when the needs of EPA mesh with
the needs of the other agencies, the systems are very
valuable.  However, when there is not a good meshing,
there are considerable difficulties in acquiring and
using the needed data.

          EPA's highest priority monitoring needs are
currently associated with characterization of known
geographical problem areas and the contributing
pollution sources and with the evaluation of compliance
with standards.  Monitoring to assess overall environ-
mental quality, national or regional environmental
trends, and new pollutants emerging as problems is of
secondary priority.  Responsibility for the National
Air Sampling Network is being transferred to the
Regions, with emphasis on evaluation of state air
monitoring networks, review of adequacy of state-
collected data, and special surveys.  Similarly, the
major responsibility for water quality monitoring is
being placed on the States, with the EPA emphasis on
characterization of water segments where water quality
standards dictate discharge permit conditions.  In the
years ahead, the States are expected to begin providing
the majority of information on the overall status and
trends in water quality.  None of these efforts are at
present deliberately oriented toward acquiring data on
toxic substances although in specific air or water
bodies where problem substances are suspected, they
obviously are prime targets.  With the designation of
toxic pollutants under Section 112 of the Clean Air
Act and Section 307(a) of FWPCA, monitoring for these
substances should increase.  Pesticide residue monitor-
ing (for soils, crops, biota, surface runoff, human
tissues) provides data for evaluation of label regula-
tion applications and residue tolerance petitions, rather
than an overall assessment of pesticide levels in the
environment.
                         10

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          Many feclei^ally funded data systems potentially
provide a rich reservoir of information on toxic sub-
stances (e.g. TOXICON, SIE, NTIS).  A number of data
systems are used in EPA to "handle information collected
through monitoring activities and from other sources (e.g.
ENVIRON, STORET, NEDS, SAROAD, Pesticide Data Base).  How-
ever, these systems have been developed largely independ-
ently of one another, and there is little commonality
among them, thus inhibiting integration of data from
various systems.  Despite the numerous attempts at
bibliographies, common indexing, and formal and informal
coordination mechanisms, effectively tapping available
data banks remains a formidable task.

      C.  Interests of EPA Headquarters Offices

          Toxic substances currently permeate the activi-
ties of many EPA program offices with responsibilities
for administering existing legislation.  They are of major
concern to the Offices of Pesticides, Solid Waste Manage-
ment (and particularly the Division of Hazardous Wastes),
Air Quality Planning and Standards, Mobile Source Air
Pollution Control, Water Programs Operations (and
particularly the Division of Oil and Hazardous Materials),
and -Water Planning and Standards.  Each of these offices
is involved in developing control strategies, standards,
and/or guidelines.  In addition, these offices are con-
cerned with technical assistance to the states and respond-
ing to emergency problems and inquiries bearing on toxic
substances.  Other offices, and particularly the Offices
of Research and Development, Toxic Substances, Technical
Analysis, and Program and Evaluation also devote consider-
able resources to direct support of legislative require-
ments and enforcement activities.

          Several examples illustrate the spread of EPA
activities.  More than twenty EPA working groups are
currently addressing both policy aspects and technical
details of particularly troublesome toxic substances,
including consideration of unleaded gasoline, fuel
additives, drinking water standards, toxic water pollu-
tants, and spills of hazardous materials.  With regard
to crisis response, the Office of Technical Analysis is
currently heavily involved in asbestos problems, the
Pesticides Office in Agent Orange, and the Office of
Toxic Substances in hexachlorobenzene:  Two of the longer
range EPA activities involve current analyses of problems
associated with disposal of specific hazardous wastes
                          11

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being conducted by OSWMP and strategy planning of OAWP
for coping with toxic air pollutants, including a
series of supporting studies of specific pollutants
by the National Academy of Sciences.

      D.  Role of the Office of Toxic Substances

          In 1971 several EPA task forces recommended
establishment of a central office to serve as a focal
point for shaping an overall EPA approach to the assess-
ment and control of toxic substance problems.  A particu-
lar need was identified for analyzing the effects of
toxic substances on the total environment  and relating
these effects to regulatory authorities, strengthened
research and monitoring activities, coordination of the
activities of various EPA offices concerned with toxic
substances, and cooperation with other Government agencies

          The initial framework for the Office's activi-
ties reflects these concerns.  At present the Office's
efforts are directed to:

              supporting the activities of other EPA
              offices responsible for regulating toxic
              substances under existing statutory
              authority with particular attention to
              criteria for determining when, and under
              what authority, toxic substances should
              be controlled.

              developing and improving techniques for
              anticipating and identifying problem areas,
              including monitoring approaches and inves-
              tigations of specific chemicals suspected
              to pose risks to health and the environment.

              improving the analytical base for decision-
              making, with particular attention to the
              adequacy of existing test methods, the
              economic  and related    framework for the
              manufacture, use and distribution of
              chemicals, and the timely availability of
              technical data to decision makers.

              clarifying the most important research
              needs including assessment of the value and
              uReability of past research efforts and
              identification of priority research gaps.
                         12

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              support of EPA field units, through provi-
              sion of technical information tailored to
              specific problems and timely response to
              ad hoc requests'.

              support for the "Toxic Substances Control
              Act. of 1973" with particular attention to
              the industrial reporting requirements, the
              character and scope of test requirements,
              and relationship of the proposed legislation
              to existing laws.

              response to crisis situations such as the
              problems associated with hexachlorobenzene
              that do not neatly fall into a single
              program area.

          Many of these activities are still embryonic,
and the Office's involvement in each area is increasing
rapidly.  In particular, the role of supporting other
EPA offices will continue to expand as additional regula-
tions are developed to control toxic substances.  Should
the Toxic Substances Control Act be enacted, a major new
dimension will be added to the Office's responsibilities.
                          13

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IV.   POLICY ISSUES

     A.   The Level of Agency Resources  Devoted  to  Toxic
         Substances

         The increasing frequency of emergency  situations
 involving toxic substances, as  well as the  implementation
 of  the  Toxic Substances Control Act and the Hazardous
 Waste Management Act, will undoubtedly require resources
 beyond  those currently devoted  to this area.   Indeed,
 the level of additional resources programmed  into the"
 area of toxic substances will have a decisive  effect on
 the character and scope of implementation of  an Agency
 strategy.   Since it  is unlikely that a sizeable incre-
 ment of new resources will become available to EPA for
 toxic substances, the Agency will probably  have to
 support a significant part of the resultant activities
 from within its existing base.

         Although a portion of the Agency's  resources are
 currently directed toward the toxic substances area--in
 regulatory and research and supporting activities—the
 current commitment is not sufficient to support even
 minimal' implementation of either bill.  The resource con-
 straints dictate that toxic substances related programs
 clearly define their priorities and carefully  consider
 means of making maximum use of  existing analytical,
 research, and monitoring facilities as well as regulatory
 and enforcement personnel and resources.

     B.   Organizational Responsibilities and Coordination
         within EPA

         The EPA program offices tend to concentrate on
 that portion of the  toxic substances problem which
 directly relates to  their statutory authorities.   The
 focus of this attention is usually dictated by deadlines
 as  resources are deployed to address the immediacy of
 standard setting or  crises.  As a result, a number of
 rotating specialists are working in spurts  on  toxic sub-
 stance  problems usually without the opportunity to
 evaluate the total hazard which may be posed  by a given
 toxic substance.  Related to these activities  of  the
 program offices is a myriad of  activities of  the
 Regional Offices, the Enforcement Offices,  and ORD,
 including the MERCs.  Many of these activities are
 directly tied to program concerns; others are  not. The

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disparate nature of EPA toxic substances responsibilities
complicates an already complicated problem, and better
organizational unity seems essential if resources are to
be wisely used, and if the total environmental approach
is to be a reality.

        The EPA Regional Offices should further develop
a strong capability to cope with single media problems
and some capability to address a wide range of toxic sub-
stance concerns.  Hopefully, this capability will grow as
the Regions gain experience without the necessity of
deploying significant additional resources directed
specifically to toxic substances.  However, a strong
centralized system for policy and standard setting and
for assessing highly specialized problems is essential.
Both headquarters personnel and specialists from the NERCs
can play an important role in this regard.  The pesticides
program exemplifies how decentralization of enforcement
and local response capabilities are backstopped by
specialized central staffs.  Also, in the air monitoring
area, the regions are assuming new responsibility but
much of the specialized analyses will undoubtedly continue
to be guided by centralized staff.

        Related to these organizational concerns is the
responsibility within EPA for technical assistance and
for responding to crises, and particularly crises which
involve multi-source and multi-media pollutants.  Many
EPA offices -- and particularly the Regional Offices --
are continuously involved.  Clearly, an important objec-
tive of an EPA response capability should be to use
efficiently the best available expertise with the minimal
disruption to ongoing activities.  Usually, much, but not
all, of the relevant headquarters expertise resides with
the headquarters office that has primary responsibility
for resolving the problem.  At the same time the office
is generally so engaged with the problem that it is not
difficult to overlook the interests, capabilities, and
resources of other offices.  Toxic substances represent
a formidable and complicated array of problems, and there
are a number of EPA units which can contribute to solving
specific problems.

    C.  Selection of Problem Substances for Detailed
        Attention

        Identifying and assigning priority to problem sub-
stances is fundamental to the success of several Agency
programs.  At present several EPA offices are independently
                          15

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carrying out studies of various toxic substances with
minimal attention to coordination.  With the enactment
of new authorities, the Agency effort may become
further fragmented.

        When assessing new chemicals which have not yet
been introduced into commerce, the traditional tools,
such as monitoring and reliance on past human experience,
are not available.  Test results and other predictive
measures to assess potential impact must be used.  It is
in this area that the Toxic Substances Control Act is
uniquely appropriate, and the Office of Toxic Substances
is a logical focus for such concerns.

        With respect to existing chemical substances,
monitoring and epidemiological experience can be used to
complement test and other analytical information for
identifying those substances which are causing health
or environmental problems.  Responsibility for identify-
ing and assigning priorities to problem substances in one
of the media or with regard to a specific use rests with
the office responsible for the relevant authority.  Never-
theless, a more conscientious effort must be made by all
offices to (1) communicate throughout the Agency their
efforts to identify and establish priorities at an early
date, and (2) define more precisely criteria for identi-
fying hazardous chemicals.  The Office of Toxic Substances
and the Office of Research and Development can play strong
supporting roles in this second area.

    D.  Selection of Appropriate Regulatory Authority

        Related to the selection and analyses of specific
substances and problems attendant to the presence of
these substances in the environment is identification  of
the best approach in resolving the problems.  In many
cases, this relates to a choice of regulatory authorities.

        At present the starting point for almost all EPA
efforts to control toxic substances is a legislative
authority, and that authority in large measure dictates
the problem or piece of the problem to be solved.  In
many cases, of course, this approach goes to the core of
the problem.  In other cases, however, only a small piece
of a tar broader problem posed by a substance can be
addressed.  Even with individual laws, such as TWPCA and
the Clean Air Act, there are several routes for control-
ling single media problems.  In some instances regulation
under more than one authority may be desirable.
                          16

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        In selecting the appropriate authority, a
variety of factors should be kept in mind such as
maximizing reduction of the problem while minimizing
adverse economic impact, ease of enforcement, and
precedents set by the use'of a particular authority.
Schemes developed in addressing one class of problems
may have direct relevance to other classes.  Meanwhile,
the current limited efforts to isolate the key elements
of toxic substances problems and then to search out
the most appropriate regulatory authorities should
become a useful complement to the approaches of other
offices.

    E.  Limited Reliance on State Capabilities

        It seems neither wise nor practical to place
primary reliance on the States for controlling toxic
substances -- certainly not in the near term and
probably not in the longer run.  While the States are
assuming an ever greater role in monitoring and regu-
lating the activities of many types of polluters,
several of the characteristics of toxic substances
suggest that in this area a program which is in large
measure Federally directed is essential.

            The use, sale, and distribution of chemical
            substances are generally interstate in
            character, and consistency of regulation is
            necessary to prevent economic imbalances
            and to enable meaningful enforcement.

            Given the scientific and technical uncertain-
            ties surrounding the behaviour and detection
            of many toxic substances, it is highly
            unlikely that many States can develop the
            capability to address these problems in a
            credible fashion.

            The hazards associated with toxic substances
            are potentially of such magnitude that, the
            Federal Government has a special obligation
            to take steps to mitigate these hazards.

        While State participation in some aspects of
monitoring and enforcement should be encouraged, clearly
the Federal Government must assume the leadership in
these areas as well as in standard setting and general
policy direction.
                          17

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    r.   Improved Approaches to Research, Monitoring, and
        Data Systems               ~

        There has been relatively little effort to review
the pieces of the total research activity in toxic sub-
stances for determining where duplicative work might be
alleviated, or for identifying neglected areas.  The toxic
substances-related research needs of the various EPA pro-
gram offices have not been consolidated into an effective
plan to fill in critical gaps.  Both within the Agency
and in the overall federal research effort, a concerted
rather than a fragmentary approach to toxic substances
problems is needed.

        Federal record keeping (e.g. Tariff Commission
production data), data gathered through regulatory efforts
(e.g. EPA's pesticides and water permit programs), and the
results of federal monitoring programs (e.g. FDA's market
basket surveys) are all potential sources of valuable
information on the manufacture, use, distribution and dis-
posal of toxic chemicals.  To date, however, these sources
have served primarily the parochial interests of the
office conducting the effort.  Potential users of such
information are discouraged by specialized systems,
barriers to access to information such as confidentiality
requirements, and general agency reluctance to allow out-
side use of information.  Even more fundamentally, it is
often difficult to ascertain what kinds of information
exist within the federal system.  At the very least, EPA
must ensure that information collected by one office will
be available to the rest of the Agency.  With its own
house in order, the Agency can then call for increased
linking within the overall federal information acquisition
and storage system.

        The following approaches should be developed and
articulated in support of further elaboration of the over-
all strategy for controlling toxic substances:

            A framework for identifying the highest priority
            research needs, including elaboration of the
            areas of greatest concern, analysis of the
            effectiveness of on-going programs, and esti-
            mates of the payoff of new approaches if they
            are successful.

            A detailed approach to monitoring toxic sub-
            stances in the environment, identifying with
            some precision specific types of monitoring
                         18

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            activities that should be augmented, and
            estimating the anticipated usefulness of
            the data from such augmentation.

            Steps for more effectively utilizing exist-
            ing information sources on toxic substances,
            with particular emphasis on how one or more
            centralized information switching points can
            facilitate access to relevant data.

    G.   Priorities in Implementing the Toxic Substances
        Control Act

        Given the extensive scope of the legislation, the
number of areas of initial emphasis will depend to a
significant degree on the staff and resources available
for implementation activities.  In selecting areas for
priority attention consideration should be given to Con-
gressional mandates, severity and urgency of existing
problems which can be alleviated by the new authority,
opportunities to reduce future problems of major dimen-
sions,  and necessity for establishing long-term viability
of implementation procedures.

        While the final version of the legislation may
influence the choice of initial activities, it seems
clear that the following activities should be high on
the agenda for early attention:

            Elaboration and articulation of the criteria
            or sets of criteria to be used in weighing
            risks versus benefits, and in determining
            when regulatory action is needed.  Clear
            understanding by both industry and Government
            of the ground rules for restrictions is
            essential to the viability of industrial
            R £ D activities.

            Determination of the character and scope of
            initial testing requirements, including the
            possibility of umbrella testing requirements
            for a broad range of chemical classes and
            identification of specific chemicals or
            classes of chemicals of particular immediate
            concern.  While the selection of substances
            covered by the standards for test protocols
            that are initially promulgated will in large
            measure reflect intuitive judgements concern-
            ing likely hazards and inadequacy of current

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            data, concurrent work is needed to provide
            a basis over the longer term for selecting
            areas of concern.

            Development of regulations setting forth
            timing, coverage, content, and format of
            the reporting requirements for chemical
            manufacturers and processors, including both
            annual reporting and premarket notification.

            Establishment of a data system for handling
            the industrial reports and test results that
            are submitted.  Experience in the pesticide
            area underscores the importance of early
            attention to establishing efficient and
            decision oriented procedures to be effective
            when the first reports arrive.

        There are, of course, a considerable number of
other requirements that will require attention from the
outset.  However, if choices must be made, less exten-
sive efforts would be devoted to the following:

            Development of a detailed system for classi-
            fying chemicals.

            Analyses of the risks associated with exist-
            ing chemicals.

            Establishment and meaningful operation of the
            Toxic Substances Board.

            Analyses of exports of chemicals.

            Annual report on coordination of activities
            under this legislation with activities under
            other authorities.
                          20

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V.   FUTURE STEPS

     As a step toward a more coherent approach to the
control of toxic substances -- and particularly to
clarify consistency of policy directions of different
offices, to assist in selection of regulatory tools
for addressing specific toxic substance problems, and
to ensure most effective use of limited resources being
devoted to toxic substances -- the strategy described
in previous sections will be further developed during
the coming months.  In elaborating the overall approach
careful attention will be directed to (a) various
methodologies currently being used within EPA for
setting tolerances and standards, (b) complimentary
and duplicative efforts within EPA to analyze problems
associated with specific substances, and (c) the
rationale for selecting the appropriate legislative
authority for solving specific problems.

     Clearly, the further delineation of needs and
opportunities in research, monitoring, and data systems
that has been described previously should support the
development of a more definitive strategy statement.
Also, the preparation of FY 1975 program documents,
including the program submission for the Office of
Toxic Substances, should assist in further'illuminating
the spread of EPA interests and activities in toxic
substances and in assessing the effectiveness of
current efforts toward more effective meshing of the
efforts of a large number of offices.  Meanwhile,
standard,setting through the Steering Group mechanism
can be improved through greater involvement of all
interested offices early in the working group process,
particularly in relation to developing the methodologies
for standard setting.

     Should the two pending bills be enacted, major new
dimensions will be added to EPA responsibilities.  Thus,
prompt attention should be given to analysis and resolu-
tion of

     -- the principal policy and implementation issues
        associated with the Toxic Substances Control
        Act, including the extent and character of
        industrial testing requirements for both new
        and existing substances, criteria for determining
        whether and how substances should be controlled,
        criteria for designating a substance as an
                          21

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        "unreasonable threat" and subject to industry
        testing, cind criteria for determining whether
        the new law is the most appropriate law for
        controlling a substance.

     -- the principal policy and implementation issues
        associated with the Hazardous Waste Management
        Act, including clarification of State responsi-
        bilities, disposal site standards, and initial
        funding requirements.

     In addition to the foregoing policy issues there
is need for a better organizational approach which will
add coherence to broadly dispersed regulatory attacks
and supporting activities on pieces of the same problem.
The newly established Office of Toxic Substances — with
responsibility for broad overview of EPA activities in
toxic substances and for coordination of such efforts —
should give high priority to improving such organizational
cohesion.
                           22

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                                                        AppendJx
             EPA REGULATORY AUTHORITIES OF PARTICUIAR
                  RELEVANCE TO TOXIC SUBSTANCES


 CLEAN AIR ACT

      Ambient: Air Quality - National air quality standards based
 on geographic regions establish the maximum amount of each
 pollutant that will be permitted in the atmosphere consistent
 with public health and welfare.  Standards have been set for
sulfuroxides, particulate matter, carbon monoxide, hydrocarbons,
 photo chemical oxidants, and nitrogenoxides.

      New Stationary Sources - EPA directly regulates new
 stationary sources by setting uniform national standards for
 new air polluters.  Standards have been devised to require the
 application of the best available technology for five sources:
 fossil fuel fired steam generators, incinerators, cement plants,
 and sulfuric and nitric acid manufacturing operations.

      Hazardous Air Pollutants - EPA has the authority to set
 national standards for materials discharged into the atmosphere
 that have a proven relationship to severe human health problems.
 Standards have been set for mercury, asbestos, and beryllium.

      Fuel and Fuel Additives - EPA may regulate fuel and fuel
 additives which endanger public health, such as leaded gasoline.

 FEDERAL WATER POLLUTION CONTROL ACT

      Effluent Limitations - EPA is directed to publish regu-
 lations establishing guidelines for effluent limitations which
 identify the best practicable control technology for various
 industrial categories.  Industrial discharges must meet these
 standards by 1977.  Also, EPA must identify the best
 available technology which will reduce discharge of
 pollutants with industrial discharges obliged to meet these
 standards by 1983.  Among the industries of particular
 relevance to toxic substances are plastics, petroleum, rubber,
 organic chemical, asbestos, fertilizers and phospates,
 soaps and detergents, and inorganic chemical.

      Water Quality Standards - States must submit to EPA
 water1 quality standards which are consistent with Federally
 establashed water quality criteria, including criteria for
 limitations on toxic substances.  In addition, where
 effluent limitations will not be stringent enough to meet
 water quality standards, States are required to establish

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maximum daily loads of pollutants in waters that will allow
the propagation of fish and wildlife.

     New Source Performance Standards - EPA is required to
set standards for1 new industrial point sources, based on best
available demonstrated control technology.

     Toxic and Pretreatment Effluent Standards - EPA is
directed to publish a list of toxic pollutants and effluent
limitations, including prohibition if appropriate, for these
substances.

     Oil Spills and Hazardous Substances - EPA is directed to
clean up spills of oil and hazardous substances, make the
polluter pay the cost of clean up, and levy fines and
penalties against him.  As a first step in the area of
hazardous substances, a list of pollutants is to be promulgated
with subsequent determination of penalty rates.

PUBLIC HEALTH SERVICE ACT

     Drinking Water Quality - EPA has responsibility for
drinking water standards for public water supplies used by
interstate carriers.

MARINE PROTECTION, RESEARCH, AND SANCTUARIES ACT

     Ocean Dumping - EPA issues permits for dumping in the
ocean of sewage sludge, garbage, and chemical and construction
wastes and approves permits for dredged materials.

FIFRA, FEPCA, AND FOOD, DRUG, AND COSMETIC ACT

     Registration - Under FEPCA, the distribution, sale,
offer or holding for sale, shipment, delivery, or receipt
within any State of any pesticide which is not registered is
prohibited.  Additionally, FEPCA calls for labelling of
registered pesticides and the registration of pesticide-
producing establishments.

     Certification of Applicators - EPA is authorized to
prescrj.be applicator certification standards requiring that
the individual to be certified is competent to handle the
pesticide.  A related provision is the prohibition against
the use of a pesticide in a manner inconsistent with its
labelling.

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     Tolerances - Under the Food, Drug, and Cosmetic Act, if
the pesticide in nomial use leaves residues on crops that
provide food for man and animal, a tolerance must be
established.  Where the supporting data is inadequate or a
health hazard may be present, EPA must establish a "zero"
tolerance.

     Cancellation - Cancellation is the major tool in imple-
ment iJig~the~decTsion that the benefits of using a pesticide
are outweighed by its risks.  Cancellation can result in
removal from the market.  Other enforcement sanctions
include: a change in classification from general to
restricted use:  stop sale, use, or removal orders; seizures;
and civil and criminal penalties.

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                                                      APPENDIX 2

      REGULATORY AUTHORITIES OF OTHER AGENCITS OF PARTICULAR
                 RELEVANCE TO TOXIC SUBSTANCES

     There are a number of regulatory authorities bearing on
toxic sut>stances administered by other agencies.  The most
significant laws and administering agencies arc:

     Food, Drug, and Cosmetics Act - Department of Health,
     Education, and Welfare

     Lead Based Paint Poisoning Prevention Act - Department
     of Health, Education and Welfare

     Federal Meat Inspection Act - Department of Agriculture

     Egg Products Inspection Act - Department of Agriculture

     Poultry Products Inspection Act - Department of Agriculture

     Flammable Fabrics Act - Federal Trade Commission

     Occupational Safety and Health Act - Department of Labor
     and Department of Health, Education and Welfare

     Federal Hazardous Substances Act - Consumer Product
     Safety Commission

     Consumer Product Safety Act - Consumer Product Safety
     Commission

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MONITORING STRATEGY

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                                    Ed Brooks
                                    Howard Leathers
                                    Glenn Schweitzer
                                    June 19, 1973
      TOXIC SUBSTANCES MONITORING STUDY
If not closely and carefully pre-considered, a monitoring
effort can easily become a white elephant.  This study will
attempt to realistically determine whether, in fact, there
are any special, significant, and feasibly met monitoring
needs peculiar to toxic substances; special to warrant a
unique effort; significant "to warrant the allocation of
scarce resources; and feasible to avoid a search  for the
Holy Grail.  The first step, through staff discussions
and studies, will be to enumerate those anticipated infor-
mation requirements that might, at least theoretically,
be met by monitoring.

Presently, several offices within EPA are involved in
monitoring (e.g., Offices of Air, Water, and Pesticides).
This study will seek to clarify and where possible establish
priorities for EPA in the area of toxic substance monitoring,
Short term steps to respond to these needs will be recommend-
ed.

 A.  Specifically, we will assess the .extent to which
     and exactly how, monitoring might:
               i
      1.  Anticipate toxic substance problems by;
               i
           a.  ;Locating substances of possible or
               known toxicity in the environment,

               Measuring the concentrations of these
               substances in the environment,

               Signaling changes in the concentrations
               of these substances,

           d.  Measuring accumulated concentrations of
               • toxic substances in human and animal
               tissue, and

           e.  Observing biological effects (especially
               on "indicator species").

          Identify the chemical causes (where unknown)
          of observed toxic crises by;

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 a.  Locating substances of possible
     toxicity in the environment,

 b.  Measuring accumulated concentra-
     tion levels of known or suspected
     toxic substances in human and
     animal tissuej

 c.  Observing anomolies in concentration
     levels or trends of these substances.

Provide background data to aid in setting,
justifying, and defending standards and r.egula-
lations by;

 a.  Correlating observed biologic effects with
     concentration levels and trends in tissue
     samples and environmental media,

 b.  Gathering information on use, distribution,
     and transport patterns,

 c.  Discovering sources and paths of toxic
     substances into the environment,

 d.  Gathering specific data regarding physical
     and/or chemical properties (e.g., bioaccumu-
     lation) of individual substances,

 e.  Measuring the effectiveness of regulations
     and their enforcement -- are the target
     concentration levels reached?  Do anticipated
     environmental effects occur?

Detect violations and enforce compliance by;

 a.  Frequent trend monitoring near known sources
     of toxic substance pollution,

 b.  General level monitoring to establish when
     prescribed concentration levels in "specific
     media are being exceeded.

Gain an overview of the extent and components
of toxic substance contamination by;

 a.  Locating known toxic substances in the
     environment,

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                b.  Measuring concentration levels and
                    trends of these substances,

                c.  Monitoring for inter-media differences
                    and trends in the same geographical
                    area and for inter-areal differences
                    and trends in the same medium.

      B.   The alleged potential advantages of each tentatively
          indicated monitoring use category will be rigorously
         " and critically evaluated.  Illustratively, monitoring
          has been touted'as an ''early warning" system to
          detect emerging toxic threats in the environment.

           1.  Is this practical - e.g., if such a system
               had been in place would it have alerted us
               to the NTA, PCB, mercury or HCB problems
               any earlier?  If so, to what advantage?

           2.  For such an enterprise to be worthwhile, how
               many, and specifically which, chemicals sub-
               stances, organisms, media and tissues would it
               be necessary to monitor?

           3.  Assuming an "early warning" system is deemed
               both workable and within the bounds of reason,
               would it necessarily be our best choice?

                a.  Are there either more efficient or less
                   jcostly ways to discover potential toxic
                   ithreats -- e.g., via the production and
                   !test data anticipated from industry after
                    passage of the Toxic Substances Control
                    Act?

                b.  How essential is such monitoring?  To what
                    extent would offices and. operations within
                    EPA be defined differently' in the absence
                   'of such data?  Are the alternative defini-
                    tions clearly less desirable?

II.   Once the priority information requirements of EPA have been
     enumerated, and those amenable to monitoring identified, the
     next step will be to survey the real world of available
     monitoring programs, facilities and activities to determine
     their capacity and willingness to meet our needs.  This will
     involve consultation with, and evaluation of, among others,
     the monitoring programs operated by:

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A.  Within EPA, Offices of;

     1.  Monitoring,

     2.  Air,

     3.  Water, and

     4.  Pesticides.

B.  Other Agencies;

     1.  National Oceanic and Atmospheric Administration,

     2.  Bureau of Sport Fisheries and Wildlife,

     3.  Geological Survey,

     4.  Department of Agriculture (animal inspection),
         and

     5.  Food and Drug Administration (market basket surveys
         and agricultural surveillance).

C.  States;

     1.  Air,

     2.  Water, and

     3.  Soil.

    These programs will be examined for:
             !


D.  Comprehensiveness.

     1.  What chemicals, substances, organisms, media and
         tissues are sampled?  How extensively and inten-
         sively are these samples analysed?

     2.  How many sampling sites are there in the U.S.,
         and how are they distributed geographically'in
         the land, air and (ground, surface, navigable,
         and contiguous) waters?

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E.   Consistency and timeliness;

     1.  Are these sites sampled;

          a.  Periodically,

          b.  Consistently,

          c.  Frequently, and

          d.  In a standard, prescribed manner?

     2.  Are the data reasonably current?  What is the
         typical lapsed time from sample collection
         through analysis to data processing and
         storage?

F.   Comparability and compatibility.

     1.  Are the data derived from these several
         monitoring efforts comparable through time?

     2.  Are they uniformly collected, analysed,
         processed and reported from sampling site
         to sampling site?

     3.  Are the data reported in compatible terms from
         one system to another?

G.   Availability,
             i
     1.  Are ithe derived data processed and stored on
         computer tapes or discs?

          a.  If so, can EPA have access to these data,

               i.  via terminal hook-up,

              ii.  by periodically acquiring copies of
                   the tapes, discs  and related software,
                   or

             iii.  in hard copy responses to ad hoc
                   requests?

          b.  If not, can the data be made available to
              EPA in any form?

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            2.   Assuming the data can be made available in
                some form;

                 a.   How long would it take from request to
                     receipt, and

                 b.   How much would it cost?

       H.   Form of presentation - is it tailored to decision
           makers needs?

III.   Environmental Monitoring is a burgeoning field; its
      ability to meet information requirements of EPA will
      depend not only upon the present state of existing
      monitoring systems, but also upon future developments
      in these  systems.   Our survey will therefore try to
      anticipate the probable near term qualitative and quantita-
      tive increments to currently available monitoring informa-
      tion that can be expected to accrue from such factors as;

       A.   More demanding legislation, as exemplified by the
           increased monitoring requirements imposed by;

            1.   Section 305(a) and (b) of the Federal Water
                Pollution Control Act Amendments of 1972, and

            2.   Section 110(a)(2)(C) and Section lHt(a)(1)(C)
                and (D)  of the Clean Air Act of 1970, and

       B.   Improved instrumentation and technology;

       C.   Implementation of proposals to integrate -- or at
           least rerider compatible — the several data systems
           established to service the independently operated
           monitoring programs.

 IV.   Once we have a fairly accurate fix on what information EPA
      will require, and the existing and probable near term
      national  monitoring capabilities, means will be sought
      to increase, enhance, modify and exploit these capabilities,
      Possible  avenues to be explored, here, using both staff
      and contract resources, include:

       A.   Encouraging integration of the diverse information
           systems into a universal network;

       B.   Promoting legislation to require the conduct of
           autopsies (the result of which would be sent to a

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         nationally centralized data bank) in all deaths
         where toxicity is a suspected cause.  Special
         emphasis would be placed upon gaining such infor-
         matipn in deaths due to diseases of chronic
         exposure (such as mesothelioma);

     C.   Exploring the desirability of collecting and
         storing data from regularly reported bioassays
         on rats, pigeons, dogs, cats, etc., living in
         urban, industrial, and other contaminated environ-
         ments.  These data would be used to ascertain base
         levels and detect changes in the accumulated toxic
         bur.den in these animals as means of;

          1.  Estimating the total doses to man in these
              specific locales, and

          2:  Signaling, early on, potential threats to
              man due either to the sudden and inadver-
              tent introduction of a toxic substance
              into the environment, or to the gradual bio-
              accumulation of such a substance, in that
              area, to dangerous levels.

     D.   Establishing a national water, air, soil, food and
         tissue "bank: to receive, identify, index, and store
         samples that would be regularly collected and sub-
         mitted from locations throughout the nation.  Samples
         from such banks should be 'of inestimable value to
         epidemiological studies initiated in the future in
         response to toxic catastrophes, by allowing retro-
         spective comparative analyses of the toxic exposures
         in a particular area, through time;

     E.   Articulating data needs more carefully in a more
         elaborate strategy statement;

     F.   Encouraging research to improve monitoring techniques,

V.   Finally, our estimates of (1) EPA toxic substances informa-
    tion needs, (2) the ability of monitoring programs to
    meet them, and (3) the likelihood of our favorably
    modifying that ability, will all be incorporated into,
    an overall Plan for Monitoring Toxic Substances.  This
    plan will set forth those categories of information to
    be addressed through monitoring and, for each such
    category, a detailed indication as to:

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A.  Exactly how the data will be collected, analysed
    and reported, and

     1.   By whom,

     2.   With what (and whose) resources, and

     3.   Within what time frame, and

B.  Precisely how, and for what purposes, the received
    data will be utilized.

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