March 11, 1977
          Washington, D.C.

Executive Summary	       1
   I.  Introduction .....	       5
  II.  Statement of the Problem	       7
 III.  Analysis of the Problem and a Proposed
        Response 	      14
  IV.  Priorities Identifying and Banking Toxics
        Problems	.	      19
   V.  Management Approaches to Facilitate An
        Integrated Strategy	      28
  VI.  Accomplishing the Integrated Strategy	      40
 VII.  Analysis of Three Intermedia Toxics
        Problems	      43
APPENDIX  A - Suggested Principles for Ranking Toxics
              Problems	       50
APPENDIX  B - Guidelines for Selecting the Action Priority
              List	       53
APPENDIX  C - Sunraary Comparison of Management Approaches ..       55
APPENDIX  D - Members of the Integrated Toxics Strategy
              Work Group	       58

                              EXECOTIVE SUMMARY

     The public health and environmental  hazards associated with ever-increasing
production, use, and disposal of toxic chemicals have received wide national
attention in recent years, resulting  in enactment of the Toxic Substances
Control Act.  The problems posed by "toxics"  (other than the traditional "cri-
teria pollutants") are exceedingly complex,  for  several reasons.  Scientific
data on cause/effect relationships for health effects are severely inadequate,
especially for chronic exposures at low levels.   Most toxic pollutants are
not amenable to media-specific control measures; and yet, most of the Agency's
enabling legislative authorities in the past have been media-specific.  Such
authorities have fostered the establishment  of a fractured management approach,
by which advocates of partial solutions  (e.g., the "water program" or the "air
program") are not required to develop Agency-wide, multimedia (i.e., "integra-
ted") responses to toxics problems.  As  a result, there is" not enough effective
information exchange and coordination between the various Headquarters and
Regional offices, causing insufficient attention to some problem areas, dupli-
cation in others, and occasionally the expenditure of effort which will not
solve a particular environmental problem but merely transfer it to other media.
Another weakness  in the current management of toxics is the absence of a
system of Agency priorities.  All too often the  Agency's actions have been
externally  induced by  "pollutants-of-the-month."
     One of the principal conclusions reached by the Work Group is that much
more than  "coordination" between program offices is needed to solve'the serious
management  problems the Agency has encountered in the toxics area. . What is
required is a strong, well-managed toxics integration program which will tie
together EPA's  currently  fragmented efforts.  Such an integrated approach to

         ^nanagement should aieet  four main objectives:
            1.   Identify and rank toxics problems on an Agency^ide basis so
                that EPA i. placed in a more anticipatory position.
            2.  Adopt a  management system which integrates the Agency approach
               to toxics-problems and  which  effectively coordinates  EPA activi-
               ties so  that Agency rescues are efficient!, utilised and sound
               actions result.
           3.  Develop procedures that direct the efficient utilization of all
               EPA regulatory authorities and ensure the integration of these
               authorities with the Toxic Substances Control Act.
           4.   Develop and improve EPA's ability to n«ke sound and consistent
               hazard assessments  based  on health and environmental data.
      To attain the  first objective of  integration, the Work Group has concep-
, tualizea . process by which Agency-wide toxics priorities could be established
 A well-defined system of priorities would result in several benefits,  such  as
 the alleviation of tfa. current dUe™ of resource allocations between  costing
 programs and the proper focusing  of key toxics  control  functions (such  as infor-
 mation gathering, RsD,  monitoring, and  enforcement) to areas where they are
 most needed.   The recommended priority establishment process entails the
 compilation of a toxics problem "threat list," through the consideration" of
scientific criteria, applied with subjective judgement.   The threat list would
then be  used by the individual regulatory, program offices to generate their
respective  "action priority lists,"  through the  application  of administrative -
criteria, such as the practical  feasibility and cost-effectiveness of control
of each pollutant.   The  separate regulatory office priority lists ^w ulti.
mately b* culled to  compile  one Agency-vide action priority list.  There would

be active public participation in the priority establishment process.
     The management system recommended by the Work Group will satisfy the
second objective of an integrated approach to the toxics problem.   Moreover,
the recommended management system will provide the Agency with a sound and
consistent hazard assessment capability,  which is the fourth objective of
integration.  The proposed system is characterized by a staff office for
toxics program integration.  The main functions of this staff office would be
to (a) assess the relative hazard of toxics through development of the threat
list; (b) assist the program offices in the development of their action
priority lists; (c) recommend an Agency action priority list; and (d)  perform
an overall toxics coordination function between the various Headquarters and
Regional offices and other Federal agencies.  The staff office would have an
advisory role only and would report to a committee of Assistant Administrators
and Regional Administrators.  The principal functions of such a committee
would be to resolve issues relating to toxics program integration and to
approve the Agency-wide action priority list.  The report discusses organiza-
tional variations of the suggested committee approach.
     The Work Group has analyzed the available options for achieving the third
objective of integration, namely, the optimum utilization of TSCA in conjunc-
tion with other regulatory authorities.  It recommends the use of TSCA as an
umbrella-like legislative authority, which would be available to the various
regulatory program offices of the Agency.  Under such an arrangement, each
regulatory program office would have the option of using its own legislative
authority or TSCA {or a combination of both) for a particular regulatory
activity.  The recommended staff office for toxics program integration
act as the overall coordinator of this process and would ensure that '.
is utilized in a consistent manner by CTS and the other offices.


     The Work Group examined some "real-life" intermedia toxics problems in
considerable detail in order to test the practical applicability of an inte-
grated management approach.  The problems were selected to explore the
feasibility of applying fundamentally different approaches to their solution.
The first approach.would attempt to solve the problem posed by a class of
toxic chemicals (N-nitroso compounds), the second would analyze the workabi-
lity of controlling an industry category (electroplating), and the third
would examine how the toxics pollution problem could be attacked on a geo-
graphic location basis (in two adjacent counties of Northern New Jersey).
It was concluded that the overall integrated management approach recommended
by 'the Work Group is generally compatible with each of the three special
approaches examined; however, the "geographic approach," although it is a
valuable tool for defining and assessing environmental health problems,
is not recommended for the estabishment of Agency priorities.


                          I. INTRODUCTION

     On October 22, 1976, the Deputy Administrator established three work

groups to develop an Agency strategy for the control of toxic substances in

the environment:

     A.  Toxics Strategy Coordination Group

     B.  Toxic Substances Control Act (TSCA) Strategy Work Group

     C.  Integrated Toxics Strategy Work Group

     Working with the Assistant Admins itr a tors, Group A was established to

oversee the activities of the other groups and to provide guidance to them.  The

charge of Work Group B was to develop an implementation strategy for TSCA.  Work

Group C was formed to facilitate the coordination of all of the Agency's toxics


     The Integrated Toxics Strategy Work Group identified three objectives:

(1) develop a process by which the Agency can anticipate, identify, and rank

those toxics problems in the environment that require attention; (2) develop

a management procedure to ensure that coordinated action is taken on identified

toxics problems; and (3) develop management plans for three specific inter-media

.problems posed by toxics.                                    -  . -     	

     This report has been prepared to address the above objectives.  It is

structured into several chapters that discuss the various elements requiring

the Agency's consideration.  Chapter II constitutes a statement of the toxics

problem.  Chapter III analyzes the problem and discusses the various tradeoffs

required for an integrated Agency response.  Chapter IV treats the key question

of how  to establish  toxics priorities.  Chapter V compares the major management

approaches toward an integrated strategy.  Chapter VI discusses how TSCA

may be  used to further advance an integrated strategy.  Chapter VII analyzes

three intermedia toxics problems:  (1) N-nitroso compounds; (2) the electro-
plating industry; and (3) a two-county area in Northern New Jersey.  These
three topics were selected to test how toxics management procedures can be
applied to basically different types of practical problems.  Special Task
Forces were established to study these three problems; a full report on
each will be issued at a later date.  Appendix A suggests principles for
ranking- toxics problems.  Appendix B contains guidelines for developing the
Agency's action priority list.  Appendix C constitutes a sumary comparison
of several toxics management approaches.  Appendix D lists the names of the
Work Group and Task Force members who contributed to this report.


     The problems which EPA faces in the area of toxics control stem in
part from four causes:  (1) the complex nature of the toxics problem;
(2)  EPA's present approach to reducing the risks from toxics; (3) the laws
that have been enacted to control toxics; and (4) EPA's present method of
implementing those laws under its jurisdiction.  This chapter reviews each
of these areas.
     The initial programs of the Agency have addressed pollution problems
principally by regulating a small number of gross pollution parameters.
With the passage of time and the increased experience in implementing
the requirements and authorities of air and water pollution control,
interest has changed from standard pollution parameters, such as parti-
culates, carbon monoxide, suspended solids and BOD, toward materials
and pollutants which are harmful in small quantities and in low concen-
trations.  The. nation's growing concern for protection of public health
and the environment from the ever-increasing production, use, and dis-	 _
posal of toxic chemicals was manifested in the recent enactment of the
Toxic Substances Control Act and the hazardous waste control .provisions
of the Resource Conservation and Recovery Act of 1976.
     These initiatives for controlling "toxics11 in the environment pre-
sent the Agency with both conceptual and strategic issues.  At present,
there is no accepted methodology for evaluating either the net effect
of environmental toxic' materials on human health or for establishing
a relative measure of environmental toxicity arising from individual

tnree intermedia toxics problems:  (1) N-nitroso compounds;  (2) the electro-
plating industry; and (3) a two-county area in Northern New Jersey.  These
three topics were selected to test how toxics management procedures can be
applied to basically different types of practical problems.  Special Task
Forces were established"to study these three problems; a full report on
each will be issued at a later date.  Appendix A suggests principles for
ranking toxics problems.  Appendix B contains guidelines for developing the
Agency's action priority list.  Appendix C constitutes a sumary comparison
of several toxics management approaches.  Appendix D lists the names of the
Work Group and Task Force members who contributed to this report.

substances or individual waste releases.  The lack of understanding

of the relationship between human health and exposure is compounded

.by the extremely large variety of suspect materials and sources.

     The Agency's approach to reducing risks from toxics problems is heavily

oriented toward specific control technologies, especially in the water pollu-

tion program.  Substances entering the environment have often been regulated

to those levels that can be reached by the employment of accepted control

technology (BPT, BAT, PACT, etc.).  Although this approach has strong

merit and should continue to be used, it can be argued that not enough

emphasis is currently being placed on incorporating health and environmental

effects data into our control strategies.  Information on health effects

does not often play a greater role because it is severely lacking, inade-

quate or not in a usable form.  Since control technologies are medium-

specific, this way of approaching the toxics problem may not give ample

consideration to all media.  For example, PCBs, regulated in the water

medium, may also be discharged into the air.  Similarly, vinyl chloride,

which is regulated in the air, has been discharged into surface impound-

ments from where it entered groundwater supplies.

     A related problem is the Agency's limited capability to make a sound

hazard assessment on toxics.  To date, a limited number of overall assess-

ments has been made by the,.Cancer Assessment Group, OPD and OTS.  However,

not all individual program offices have the capability to make hazard assess-

ments.  In addition, there is no centralized organizational entity easily

_.cessible to program offices to advise or make the necessary assessment.

At a minimum, coordination of individual assessments is necessary to assure

  In general, the legislative mandates* administered by EPA may be viewed

collectively as covering all media with regard to the control of toxics.

However/ except for TSCA and PIFRA/ these laws were enacted originally to

deal with a specific set of environmental problems related to only one medium

such as air and were enacted by Congress in response to problems presented in

single-medium terms — the Houston Ship Channel's water pollution, Los Angeles'

smog, etc.

     Most significant among the deficiencies of the medium-specific authori-

ties themselves is that, in general, such laws do not provide direct control

over the manufacture and use of toxic substances.  FIFRA is an exception,

but it can only be used to prevent a pesticide from being introduced into the

domestic market.  Only TSCA can place limitations directly on all phases and

aspects of manufacturing and thus can prevent completelely the toxic from

entering the environment through any medium.  With the  exception of FIFRA

and Section 211 of the Clean Air Act regulating fuel additives, the other

authorities do not require the manufacturer to test potentially dangerous

new chemicals to determine their effects on health and  the environment before

they__enter the market.                      :
*The Federal Water Pollution Control Act, the Clean Air Act, the Marine
Protection, Research and Sanctuaries Act, the Federal Insecticide, Fungicide &
Rodenticide Act, the Resource Conservation and Recovery Act, the Safe Drinking
Water Act, and trie Toxic Substances Control Act.


     In broad terms, EPA's toxics management problem is that toxic chemicals

    and do appear in more than a single environmental medium and are, there-

fore, not always amenable to single-medium solutions.  As Congress enacted
each of the media-oriented laws, EPA (and its predecessors) established sepa-

rate organizational entities to carry out the legislation.  These entities have

become advocates of the "water program" or the "air program," and as a result

of the passage of TSCA, the Agency is about to establish a full-time advo-

cate of the "toxics program."  This places an extra burden on the Regions,

the Office of Enforcement/ and other offices trying to coordinate their

actions under the different authorities.  The basic organizational structure

of EPA, however, is not at issue in this study and may or may not be the

most rational system for controlling toxics problems.  The management problem

to be examined in this report is how to make the current system work better and

how to make it more responsive to the toxics threat.

     Program responsiveness is intrinsically bound to the program priorities.

In recent years, EPA's resolution of serious toxics problems has suffered from

a lack of Agency priorities.  In some of the major programs, such as construc-

tion grants and NPDES, the toxics control aspects did not receive a high

priority and were, therefore, not adequately funded.
     At the same time, the Agency has not established an overall system for

ranking toxics and -consequently has found itself often in a reactive mode to

toxics problems — e.g., Kepone, PCBs, vinyl chloride, etc.  Since the Agency

has adopted no formal way of anticipating them, these problems are often

brought to its attention by the news media or other external sources and

become the "pollutants -of -the-month . "  This method of operating is not totally

         .   In fact, any toxics management system must contain sufficient
flexibility to accommodate these situations.   The basic danger in operating
primarily in this fashion, however/ is that the "pollutants-of-the-month,"
while serious, may be nowhere near as hazardous asvsome others which might be
less obvious.
     In keeping with the reactive posture to toxics, no single unit within
the Agency has been given authority or responsibility for carrying out a com-
prehensive approach to toxics problem management.  Program offices which pro-
pose regulations have not always adequately considered the intermedia effects
of their regulations.  A toxic regulated in one medium is ocassionally ignored
in another — or worse yet, deposited in another medium as a result of EPA
regulation.  For example, restricting the discharge of electroplating effluents
into surface waters generated sludges which were, placed in landfills, causing
contamination of groundwaters by the toxic metals.  Furthermore, individual
program offices may not have broad enough responsibility to resolve a toxics
problem even within a single medium.  In the New Jersey example studied here,
strict effluent guidelines may make it favorable for industries to discharge
their wastes through municipal treatment plants where toxics receive little
treatment.  Since no pretreatment standards exist at the present, toxics are not
adequately controlled.
     Cinder the present management system, Agency actions could be subject to
two major drawbacks:  duplication of activities and incomplete regulation..
For example, two EPA offices could each collect data on similar problems and
independently characterize the same pollutant differently.  Other serious toxics
problems may not be characterized at all.  In the N-nitroso compounds example,
some offices in Headquarters acted independently while others cooperated with

one or wore other offices during the early stages of identifying the problem.

Some offices were not even aware of activities in other offices until quite late

in the development of policy.
   -                                                  v


     The problems cited above have had negative impacts on EPA's management

of toxic substances control.  The almost exclusive use of the medium-by-medium

approach has raised serious doubts as to whether the overall health and environ-

mental impacts of toxics have been adequately assessed and controlled.  EPA's own

resources, moreover/ are not conserved when the management of toxics programs by

different offices and Regions is not adequately coordinated due to the lack of

overall priorities.  The ORD, for example/ clearly heeds such guidance if it is

to be responsive to Agency-wide research needs.  Not all of EPA's actions have

been fragmented.  It is worth noting that a number of recent efforts, such as

the PCS regulations under TSCA and the Section 307 toxics regulations under the

EWPCA, are considering the multi-media impact of these regulations.

     Overall/ however/ adequate mechanisms are not available for the coordination

of offices and Regions which are working on different aspects of the same prob-

lem.  In addition/ there is no single place in EPA where a Headquarters office/

a laboratory, or a Regional office can find out what work is being conducted on

a particular toxics, problem.  Nor is there a single office in the Agency charged

with providing consistent hazard assessments.

     Although information is scarce in the toxics area, neither the national'
             •-_,                                                      ff
air- nor the national water-monitoring networks have given priority to toxics

monitoring until the very recent past.  In summary/ until the passage* of TSCA,

toxics problems were often given high priority or were considered by EPA only

in a crisis atmosphere.   Although most  of  the EPA staff have  recognized  .
the need to approach problems in a less reactive manner,  a process to achieve
this end has not been adopted.   The passage of TSCA makes it  mandatory.
     The next chapter analyzes the problems described above and proposes an
integrated toxics control strategy to begin to solve them.


     With the passage of the Toxic Substances-Control Act, the Agency is
mandated to coordinate actions taken under TSCA with actions taken under
             • •
other Federal laws, especially those administered by EPA.  As described in
the previous chapter/ EPA does not have an adequate management system in
place to accommodate this requirement of TSCA.
     Better coordination of EPA programs, however, is not in itself going to
solve the toxics management problems.  The Agency's program to control toxics
problems also must focus on setting priorities, and on the multimedia nature of
toxics contamination.  Good data must be available from all sources to formulate
assessments and support EPA's regulatory decisions.  To reduce the emphasis on
"pollutants-of-the-month," an anticipatory management system must be formulated
and installed.  Coordination, therefore, must be carried out with a positive
purpose in mind and not as in the past where coordination often meant that
one program would be given the opportunity to protect itself from incursions
by other programs.  We need a positive goal.
     The Work Group proposes that the goal of the EPA's management system for
toxics should be to ensure that the Agency can anticipate toxics problems and
provide the optimum solution to those problems, taking into account the multi-
media nature of toxics.  This is the basis of an integrated approach to toxics

     An integrated approach for controlling risks to health and the environment
that are the result of exposure to toxic substances has three major character-

        0  All pathways and routes of exposure to the toxic contaminant/
           regardless of media, are explicitly considered in the analysis
           (e.g., air, water, land, consumer products).
        o  The tradeoffs for controlling exposure to a- toxic from one medium
           as opposed to another are explicitly considered (e.g., toxics removed
           from air emissions by scrubbers can become a water problem).
        o  The residuals and by-products of controlling  a toxic in one medium
           are explicitly considered (e.g., sewage sludge presents a serious
           waste disposal problem).
     There are considerable advantages to implementing a process that entails
an integrated approach to toxics problems.  To begin with, the analysis would
be conducted from a multimedia standpoint.  If the analyses of the contamina-
tion, the level of exposure, and the fate of the toxic are conducted from
this point of view, the results would be an improved assessment of the overall
risk to health and the environment.  All assessments, whether made by an
individual program office or a centralized organizational entity, would be
based on health and environmental data from all media.  This assessment
must be supported by a data system that -makes needed information data readily
accessible.  Health and environmental data must be updated regularly to pro-
vide this vital base.  Priorities established after such an analysis would
be more defensible.
     In addition, the feasible methods of control for all media could be
considered simultaneously rather than piecemeal, in order to. el-iminate the prob-
lem of control technology merely transferring the problem from one medium to ano-
ther, as has happened in the electroplating industry.  Significant program resour-
ces could be saved by efficient coordination, minimizing redundant efforts in
both regulatory and research support areas.  Data on health effects, exposure,

 £jd impacts could be utilized to a greater extent by all appropriate offices.

Moreover, an integrated approach provides the latitude to choose the most

appropriate authority or authorities to control a problem from all the

statutes the Agency adminsters.


     Any scheme to achieve an integrated approach to the toxics problem should

meet the following four objectives:

        1.  To identify and rank toxics problems on an Agency-wide basis

            so that EPA is placed in a more anticipatory position.

        2.  To adopt a management system which integrates the Agency approach

            to toxics problems and which effectively coordinates EPA and other

            Federal activities so that resources are efficiently utilized and

            sound actions result.

      •  3.  To develop procedures that direct the efficient utilization of

            all EPA regulatory authorities and ensure the integration of

            these authorities with the Toxic Substances Control Act.

        4.  .To develop and improve EPA's ability to make sound and consistent

            hazard assessments based on health and environmental data.

     In arriving at a solution to a toxics problem, various internal and

external inputs must be carefully weighed and incorporated.  Along with

individual program office needs, the views of the public, industry and other

interested parties must be factored in.  Any scheme must allow for both routine

operating situations and for emergency responses.  Furthermore, the overall

          ,ov management system should be to allow the Agency to make well-
       ot any
         and coordinated decisions which will place the Agency in a prosoec-
              to toxics control.  The management system, moreover, must have
    support and attention of top Agency personnel to operate successfully.

     The establishment of an integrated toxics strategy would involve a
certain number of tradeoffs.  To begin with, whenever coordination is em- ..
phasized, delays are likely to occur, and action may be slower than for a
situation in which each program office and Region is completely free to make
its own decisions and set its own priorities.  The more coordination one
chooses (i.e., intra-Agency, inter-Agency, State/Local), the more time and
resources are expended for this process.  At the same time, no matter how
much effort is put into coordination, individual offices and Regions can
never be totally synchronized.  In fact, they function best with some degree
of flexibility.  This balancing between the amount of coordination, time,
and making more effective decisions has been carefully considered in this
     Another tradeoff occurs in deciding how much Agency-wide priority setting
is beneficial.  If an Agency-wide priority system for toxics is adopted, indivi-
dual offices might de-emphasize some ongoing programs to conform to Agency-wide
priorities.  However, regulatory program offices are often the most knowledgeable
about a specific problem in their area and have the best expertise to handle the
problem.  Their existing programs may be fashioned to reflect their concerns
and priorities.  If the Agency priority system is not sufficiently flexible

 Fr does not adequately provide for the input of the individual offices,
serious neglect of important problems could result.  Similarly, toxics prob-
lems are often geographically specific, and the magnitude of their effect can
be greater in one Region of the country than in another.  Flexibility must be
provided to allow Regions to respond to their specific needs as well.
These concerns are very real/ and to the best of our ability are reflected
in this report.
     This chapter analyzed the toxics management problem and identified the
objectives of an integrated control strategy.  The remainder of the report
will discuss in more detail the options available to meet these objectives and
will present the Work Group's recommendations.


         first objective of the integrated toxics strategy is to ensure that
 _  nas an adequate system for identifying and ranking toxics problems.
     chapter presents the Work Group's recomnendation for a ranking process
by which the Agency could establish priorities for its toxics control activities.
The problems arising from the current lack of such an EPA process have been
described in the preceding chapters of this report.  The benefits that would
accrue from an Agency-wide system for establishing toxics priorities include:
     (1)  Program planning by all Headquarters and Regional offices would
          be greatly facilitated.
     (2)  High priority toxics problems would be identified and "pollutants-
          of-the-month" could be put in proper perspective.
     (3)  Research needs would be better identified.
     (4)  The problem of resource allocation between competing projects
          would be alleviated.
     (5)  The Agency's annual budget request would be better supported, and
          EPA, resource allocations would be facilitated.
     (6)  The courts could be provided with a rationale for reviewing EPA's
          decisions relating to toxics problems.
     (7)  Regional and State permitting and enforcement activities could be
          better focused on the most severe environmental problems.
     (8)  The Regional Offices would have better guidance on what specific
          toxics problems to investigate.
     (9)  The Agency would be in a position to review its various toxics  .?
          programs for consistency.
    (10)  Related efforts of other Federal agencies could be better coordi-

     The Work Group has identified two distinct phases in the development
0£ a toxics ranking scheme.  In the first phase, a toxics problem "threat
list"  would be developed/ based on scientific judgment regarding the rela-
tive severity of each problem, examining such factors as health effects,
human exposure levels, and ecological damage.  The "threat list" process
embodies a formal comparative hazard assessment function which would cen-
tralize Agency decisions concerning prior it ization of toxics.  In the second
phase, an Agency "action priority list" which ranks toxic problems in their
order of importance for research and regulatory action would be developed.
This list would be based not only on the degree of hazard to health and the
environment, but also on such factors as the feasibility, cost-effectiveness
and current progress toward control of each pollutant on the threat list.
The entire ranking process is cyclical; the first iteration may require
as much as 18 months for completion.  The following iterations will consist
consist mainly of revising and updauing the lists, which is expected to occur
periodically and in concert with the formal Agency planning process.  For
example, .it is expected that the "action priority list" would be included
in the toxics section of the Agency Guidance.
     To conduct the ranking process, we recommend the establishment of an
EPA core group with technical assistance and advice provided by an external
panel of experts.  Furthermore, we recommend that public participation be
encouraged to the maximum extent in order to attain broad acceptance of the
     In the following discussion, the nature of the proposed two priority
lists will be examined, as well as the technical and administrative aspects
of the ranking process.

1.  Nature of the Priority Lists
     In the Work Group's deliberations on the proposed threat list the ques-
tion arose as to whether there should be one or more such lists.  The princi-
pal drawback of one threat-list is that ranking health effects against environ-
mental effects is extremely subjective and can be sensitive to policy consi-
derations.  For example, in some regions of the nation, environmental as
opposed to human health considerations could be the dominant ranking
criteria while in other places the opposite may be true.  The best solution
appears to be to rank human health and environmental effects separately,
and then make the more policy-oriented decisions of how to compare these
basically different types of threats against one another.   The responsibility
for these policy decisions and compiling the one threat list should be held
solely by EPA.
     Another issue pertaining to the number of toxics proolem threat lists
is whether there should exist a separate chemical threat list, industry
threat list, and geographic location threat list.  The ranking of geographic
locations is not endorsed.  We believe that designating "hazardous locations"
could be accompanied by external pressure either to take a location off the
list, because it is bad for local business, or to put locations on the list
because a community wanted EPA to address, a relatively insignificant environmen-
tal problem.  On the other hand, an industry approach to toxics control could-.
be efficient and cost-effective.  We recommend that there  be only one toxics
threat list which includes chemicals, classes of chemicals,  and industrial


     As in the consideration of the threat list/ there is a range of choices

regarding the number of action priority lists.  The Work Group has considered

the following options:

     (1)  One Agency-wide action priority list derived directly from the
          toxics problem threat list.

     (2)  No Agency-wide action priority list, but each regulatory program

          office (and perhaps OFD and OE) would have its own priority list.

          These separate lists would be derived from the toxics problem

          threat list, but would also contain substances other than toxics

          and various items that are legally mandated (e.g., by consent decree)

          or relate to long-term projects.

     (3)  One Agency-wide priority list, which would be compiled from the

          separate priority lists established in the preceding option.

     Under the third option, each Headquarters regulatory program office (and

perhaps OED and OE) would propose an action list as part of its annual  program

plan.  An independent EPA staff* would then propose a more limited Agency-

wide action list based on these inputs.

     The Work Group is divided on the issue of whether an Agency-wide priority

list is necessary or even desirable.  The chief argument for separate program

office action lists is that the regulatory offices, by nature of their  speci-

alized experience, are the most suitable entitles for the establishment of

priorities.  On the other hand, an Agency-wide action list would provide

better guidance for program planning by all Headquarters and Regional Offices.
*Discussed further in Chapter V.


 fpe third alternative identified above is recommended,  therefore, as a com-

promise which offers the benefits of both competing options.  An Agency-

wide action priority list derived from regulatory program lists offers EPA

sufficient flexibility to meet its manifold commitments.   The derivation

of such an action priority list would take into account vthe views of all

EPA Headquarters and Regional offices, as will be discussed further in Chap-

ter V.

     In both the action priority list and the threat list there is a need to

consider what kind of precision one wishes the list to  imply.  In view of the

uncertainties in defining precisely the factors needed  to make such a ranking

(effects, exposure, abatement costs, benefits, data credibility, etc.), we

recommend a coarse ranking, such as high, medium and low  priorities, rather

than a strict ordinal array for both the action and threat lists.  Furthermore,

since resource constraints will probably limit EPA's actions to only the highest

category, it is also recommended that a finer subdivision of this group be given

where possible.

2. Technical Considerations for a Ranking System

     There is general agreement in the Work Group that  a  technical process

for producing an Agency toxics problem action priority  list must proceed as

follows:  (1) select toxics problem candidates, (2) gather and format the avail-

able data, (3) from the data, derive health and ecological effects, (4) de-

scribe and rank the seriousness of the threat from health and ecological effects

to produce a threat list, and (5) derive the programmatic and the Agency

:action lists by combining the knowledge on threats with such factors asj EPA's

ability to abate the threat, cost-effectiveness of EPA's  actions, etc.  Many

opt ions, have been proposed for each of the above five areas; this chapter

will discuss only the major options and recommendations.


     There are two issues involved in candidate selection.  The first is

from what pool will toxics problems be drawn, and the second is how many

toxics problems.should be sexiously,evaluated.

     The spectrum of choices for the "from what pool" issue range from a

systematic consideration of all chemicals and industries to consideration

of candidate nominations by a select set of professionally competent groups.

After consideration of the many options proposed, we recommend an open nomi-

nation process whereby any candidate submitted by anyone, including EPA

offices, other Federal agencies, and the interested public, would be con-

sidered. This nomination process would include the list of candidates for

testing, as submitted by the committee of Federal agency representatives

established under Section 4(e) of TSCA.

     Candidate selection would be accomplished by two methods.  The first

is to consider submissions by anyone when accompanied by a quantitative

argument for its inclusion, and the second is to compile a list of say 250

chemicals and 5 to 10 industrial sources with the highest release rates.

These candidates would then go through an initial screen to limit their num-

ber to a manageable size.  The initial screen would rely on an EPA group and

an advisory group of technical experts (in which other Federal agencies as

well as the general public would be represented) to jointly select, from

the candidates proposed, those toxics problems meriting serious evaluation.

     The,.choices for the issue of how many toxics problems should be seriously

evaluated range from thousands to fewer than a hundred.  It is felt that con-

sidering fewer seriously (say less than 100) would cover the greater part

of toxics problems reasonably well without using inordinate resources.  Thus,

it is our recommendation that no more than 100 toxics problems be seriously

evaluated in any given ranking exercise.


     Data will have to be assembled (through literature search only) and for-

matted so that work on deriving effects can proceed efficiently.  This will

be a time-consuming albeit perfunctory effort.  It is reconroended that it be

done under contract because of the job's routine and manpower-intensive

character istics.


     The actual process for deriving the health and ecological effects

from the assembled data is currently being studied by a number of groups,

including the National Science Foundation and the Stanford Research Institute,

and hence the Work Group did not address the issues involved here.


     While the derivation of a threat list is something that is appropriate

for scientists to do, it is not a purely scientific process.  A mechanical

process of moving from effects or risk estimates to a ranking by assigning

values to various parameters (as often proposed) is not appropriate for this

exercise.  It is felt that such a process cannot account for the complicated

judgments involved in ranking one problem against another.  Hence, we recom-,

mend a less mechanical and more judgmental system.  Because of the subjective

component inevitable in any ranking exercise, it is essential to state expli-

citly the broad principles to be followed in making these judgments.  A

A suggestion for these principles is given in Appendix A.


     The technical issues in deriving an action list are similar to those

for the derivation of the threat list.  Either a routinized process (apply-

ing for example cost-effectiveness criteria) or a judgmental system could be

adopted.  Again, the Work Group favors the adoption of the judgmental process,

allowing for adequate review and public participation.  It must be stressed

that application of judgment will be required after formulation of programmatic

priority lists, and after estimation of cost effectiveness, amenability

to control, immediacy of problem, and public interest.  These judgments

should be rendered by the politically accountable officials rather than the

EPA staff or the external advisory panel.   The Work Group's suggestions for

guidance principles for the derivation of the action list are in Appendix B.

3.  Administrative Considerations for a Ranking System

     The issues to be considered here are the degree of public participa-

tion, the role of the expert panel, and functions of the EPA staff group

responsible for the development of the ranking lists.


     As mentioned earlier, public review and participation is necessary

for getting broad acceptance of the ranking process.  Thus, public partici-

pation is recommended for candidate selection, development of the ranking

guidelines, selection of the expert panel, and review of the draft threat

list and the draft Agency priority list.


     The Work Group envisions an expert panel in an advisory role,  working

jointly with an EPA staff group in the candidate selection process and in the

assessment and comparison of the health and ecological  effects of toxics

problems.  However, the final authority for producing the threat list must

rest with the EPA.  In the development of the  action priority list,  no direct

involvement of the panel of outside experts is suggested since these compari-

sons are removed from the effects data and depend on Agency resources and



     The functions and organizational structure of the  EPA staff group that

would develop the priority lists will be discussed in the next chapter of

this report.



     The second objective of an integrated toxics strategy is the develop-

ment of an integrated management system.  This chapter will examine six

alternative management approaches.  These range fronua decentralized organi-

zational structure (i.e./ the status quo) to a conceivable option where one

Assistant Administrator^ directs all of the Agency's toxics control functions:

        1.  Status Quo

        2.  Information Office — a staff office which would function as a

            a clearinghouse for the Agency's toxics control activities.

        3.  Information Office plus Active Coordination — a staff office

            with certain advisory functions regarding priorities and lead

            office responsibilities.

        4.  Centralized Information Gathering — a consolidation of the

            Agency's information-gathering and toxics hazard assessment


        5.  Toxics Program Integration — a staff office with advisory func-

            tions backed up by sufficient achieve integrated

            Agency action.

        6.  Centralized Toxics Management — one Assistant Administrator's
            office performing most of the Agency's toxics control activities.

     The alternatives described here should be regarded as six discrete points

on a management spectrum which ranges from the status quo to a highly central-

ized and authoritarian toxics control approach.  The table in Appendix C con-

stitutes a rough summary of how the various toxics control functions could be

performed under each of the six management approaches.

     In the following, the six alternative approaches will be discussed in

varying degrees of detail.  The recommended management approach (Alternative

15) will receive special emphasis.  To avoid repetition,  some of the alterna-

tive approaches will be discussed only in terms of how they differ from the
ones already described previously.

1.  STATUS QUO                                                    -ff

     The status quo is characterized by the absence of Agency-wide prospec-

tive planning for toxics control.  The Agency is largely in a reactive mode,

necessitating ad hoc  responses to "pollutants-of-the-month."  Apart from

emergency responses, the individual program offices establish their own

priorities for toxics control, based on available resources and specific

mandates under the applicable environmental legislation.


     This management alternative is a minor yet significant variant'of the

status quo.  It involves the establishment of a staff office which would

function as an information clearinghouse for the Agency's toxics control       '
                                                                   " •' '•*
activities.  The information office would monitor the toxics activities of each

EPA program office and would refer toxics information requests to the proper

expert(s) within the Agency-  A staff office with such limited responsi-

bilities would not require more than 2 or 3 professionals.  Of course,

the responsibilities of an information office could be expanded considerably

to include a capability to respond directly to information requests by

furnishing critically evaluated toxics data.  Such an expanded information

office would require a staff of at least 15 professionals.

     An information office/ even with minimum staffing, could provide answers

to-the basic question of who is doing what about toxics in EPA.  Particularly

the Regional Offices would find such a centralized information source useful.

However, this management option hardly goes beyond the status quo since it

does not facilitate the establishment of Agency priorities, nor an integrated

approach to toxics management.


     This management alternative is a logical extension of the information

office.  Its basic organizational feature is a staff office which would

attempt to coordinate the Agency's various toxics management activities

without the authority to force compliance by the individual program offices.

The staff office would develop and maintain the toxics problem "threat list"

and Agency "action priority list" discussed in the previous chapter and

recommend lead office responsibilities for the handling of each individual

toxics problem.  The various program offices would establish their own action

priority lists; however, the staff office would review these and make

recommendations regarding any changes it considered advisable. The

staff office would also review the toxics management activities of the

various EPA program offices and would identify weaknesses and gaps

in any of the toxics control functions. It is estimated that such a

staff office could operate with about 10 or 20 professionals.
     .,,.:«                                                       -~f..
     Although this management alternative may be partially successful in

effecting interoffice coordination by means of persuasion, it would not

significantly further the Agency's integrated response to inter-media

toxics problems. Individual regulatory program offices,  whose activities

are mandated by media-oriented legislation, are unlikely to substantially

change their programs or revise their priorities upon the recommendations

of a staff office.  Under this management option, the attention of the

Administrator would have to be secured on a routine basis to bring

about integrated Agency response to toxics problems.


     This option is based on the premise that EPA's toxics control activities

are in disarray not so much because regulatory authorities are fragmented

among several relatively autonomous program offices, as  because each

of those program offices independently compiles, interprets, and responds

to toxics data according to its own parochial vantage point.  Accordingly,

this management approach would go one step further toward integration than

Alternative #3, by consolidating into one non-regulatory office all toxics-

related information-gathering authorities under the CAA, FWPCA, FIFRA, SCWA,

MPR&SA, TSCA, and PCRA.  This centralized information-gathering office would


compile, process, store, retrieve, review, analyze, and disseminate data on

toxic substances, their sources, transport routes, and effects.  Under this

management option, the individual regulatory program offices would in effect

relinquish their own information-gathering functions; however, the staff

office described in Alternative #3 would still be operational and develop the

"threat list" and the Agency "action priority list."

     The consolidation of all information-gathering activities regarding

toxics into one office would seem to foster not only cost-efficient operation

but also more holistic assessments of  intermedia environmental problems.  On

the other hand,  it is difficult  to conceive how the  individual regulatory

programs could function without  the capability of generating the types and

amounts of  information they perceive as necessary.   Furthermore, a rather

convincing  argument could be made that any information compiled by those
who are not the  intended users is inherently inadequate.


     One of the  principal conclusions  reached by this Work Group during

its four months  of deliberations was that much more  than "coordination"

between offices  is needed to solve the serious management problems

the Agency  has encountered  in the toxics area. What  is required is

a strong, well-managed toxics integration program which will tie together

EPA's currently  fragmented  efforts. The following toxics management

approach was drafted by the Work Group with this consideration in mind.

     The proposed  management approach  is essentially a hybrid of Alternative

£3 and Alternative 14. It is characterized by a staff office for toxics

program integration; however, unlike in Alternative  f3, the staff office

is backed up by sufficient  authority to effect Agency-wide compliance

to its* recommendations. Also, the recommended approach would offer

the Agency independent hazard assessment capability  (as inherent in

Alternative $4);  however, without impairing the operation of the individual

program offices through centralization of all information-gathering


    The staff office for toxics  program integration could be located

 in the Administrator's Office, in GTS,  in 0PM,  or perhaps somewhere else •
within the Agency.* Under the organizational option recommended by the majori-
ty of the Work Group, the staff office  would report to a "toxics steering
committee," comprised of Assistant Administrators and some representatives of
the Regional Administrators.  The principal functions of such a committee  would
be to resolve program integration problems and  to adopt an Agency-wide
action priority list; in addition, it would offer the opportunity for each
program office and the Regional offices to be directly involved in the
decision-making process.
     It should be emphasized that there are some organizational variants
of the Toxics Program Integration approach which should receive careful
consideration.  One is where the staff  office for toxics program integration
would report to the Assistant Administrator for Toxic Substances.  The AATS
would assume all of the functions of the toxics steering committee.  Through
such an arrangement, key policy decisions on the recommendations of the staff
office could be made more easily than through a committee; however, concern
was expressed by some members of the Work Group.that one Assistant Administrator
might not be able to wield enough authority to  effect Agency-wide integration of
toxics management.  This apparent weakness might be avoided by an organizational
nuance in which the Assistant Administrator for Toxic Substances would still be
in overall charge of toxics program integration; however, he/she would periodi-
cally convene the toxics steering committee for resolution of the most difficult
issues of integration.
*The Work Group has not made a recommendation in this regard.

     Integrated toxics management under the proposed management approach can

be best described perhaps by examining how the various toxics control func-

tions would be accomplished.

     Prospective Planning and Problem Identification;  The staff office for

toxics program integration would make an intensive effort to identify toxics

problems before they became critical.  It would be responsible for the develop-

ment and maintenance of the "threat list" discussed in the previous chapter.

In essence, this staff office would provide an independent hazard assessment

capability for the Agency, similar to the function now performed on a limited

basis by the Cancer Assessment Group.  The staff office would contain health

affects expertise which would be available to those within the Agency who

are responsible for taking regulatory actions.

     Information Gathering and Pollutant Characterization;  The individual pro-

gram offices would continue to perform these important functions; however, the

staff office for toxics integration would furnish guidance (based on the

threat list development effort)  regarding,  (a)  those pollutants which require

preferential characterization,  and (b)  the specific data required for integra-

ted Agency each problem.  The staff office could greatly reduce

the existing duplications and omissions in the  area of information gathering,

and it could also assure that the expended  efforts yield the most needed data

for the Agency.   Another function of the staff  office would be to establish
ind chair  a standing work group  on toxics data  management which would include

representatives  from all Headquarters and Regional offices and from other Federal

agencies.   That work group would review Agency  policy and practices regarding

toxics data management in the broadest sense,  including data collection,  storage,

and retrieval.

     Priority Establishment;   The staff office would  recommend Agency toxics pri-

orities through development and maintenance of the  "action priority list" dis-

cussed in the previous .chapter.  A revised  list would be submitted periodically

to the appropriate decision-makers for approval.  The establishment of toxics

priorities would be in close accord with the Agency's annual planning process

and would be reflected in the Agency Guidance.

     Control Strategy Development;  This toxics control function is the logical

extension of the problem ranking process.   The staff  office would review the

toxics program strategy plans of all Headquarters and Regional offices and

would assemble the Agency's annual integrated  toxics  program plan, with

recommendations of lead office responsibilities.  The staff office would

routinely analyze the Agency's regulatory and  non-regulatory options for

responding to intermedia toxics problems and would  make its recommendations

to the appropriate decision-makers.

     Emergency Response;  The staff-office  would act  as the Agency's principal

point of contact for "pollutant-of-the-month"  problems.  It would propose

action plans to the appropriate program offices and lead office responsibili-

ties.  The staff office would also follow up EPA's  response to the emergency

and evaluate the effectiveness of the response.


     R&D and Monitoring;  Due to the fragmentation  of these control functions

along organizational and geographical lines, and especially because of the  f

basically long-range nature of R&D, it is difficult to keep them in accord  .;

with ever-changing Agency toxics priorities.  Therefore, the staff office
would periodically identify those specific R&D and monitoring needs which
require increased (or decreased) emphasis and would recommend the performance
of relatively minor projects directly to the pertinent program offices.  Major
revision of priorities would be accomplished via the approval of the Agency's
decision-makers on toxics.  It should be noted that under this management
approach the Office of Research and Development would perform its annual
planning function only after the Agency-wide toxics action priority list has
has been adopted.
     Rulemaking;  The current "1000.6 approach" would be considerably improved
through the Control Strategy Development function described in this discussion.
The Agency's annual integrated toxics program plan will help assure the promul-
gation of environmental standards and regulations with the optimum safeguards
against adverse intermedia repercussions.  Also, the proposed staff office
will promote consistency in rulemaking under the various legislative authori-
ties (e.g., testing requirements under FIFRA and TSCA).
     Enforcement;  The staff office for toxics program integration will review
the enforcement actions of the EPA and of other Federal agencies.  It will
provide the Office of Enforcement on items requiring priority
attention by the Agency.
     Regional and Federal Agency Coordination:  The.staff office would actively
promote more efficient communication and cooperation with the EPA Regions and
other Federal agencies on toxics management problems.  The proposed Regional
representation on a toxics steering committee could be a significant step
toward achieving a united front within the Agency.  The integration of all
Federal toxics programs will be more difficult to achieve;  however, that

problera will have to be addressed in order  to  fulfill  the intent of the Toxic

Substances Control Act.

     Public Participation:  There would be  active public participation in the

development of the toxics problem threat list  and the  Agency action priority


list, as discussed in Chapter IV.

     Overview Activities:  The staff office would monitor and critically review

the Agency's performance on the various toxics control functions.  When the

need for corrective action is perceived, it would be brought to the attention

of the affected program office, and if necessary, the  Agency's decision-

makers on toxics.

     There is no doubt that successful implementation  of all the described

aspects of the proposed toxics program integration  approach will require

adequate time and personnel resources.  It  is  estimated that a staff of 30

professionals, over a period of two years,  could make  the proposed management

approach work effectively (assuming an adequate budget for data gathering

through contract).  However, a more modest  program  aimed primarily at the

establishment of Agency toxics priorities would require perhaps half the time

and resources.  A staff office with about 15 professionals could be established

in a relatively short time to accomplish the most essential tasks of toxics

integration.  After acquiring the necessary operational experience, this staff

office could be gradually increased for maximum effectiveness.

6.  Centralized Toxics Management

     Under this management approach, one Assistant  Adminsitrator's office

(for the purposes of this discussion, the Office of Toxic Substances)  would

essentially plan and carry out the Agency's entire  toxics control program.


Each existing program office, with the exception of OPD and OE, would relin-

quish to the GTS those parts of its program that relate to toxic substances.

This management approach could be regarded as the ultimate extension of

Alternative 14, in which only the information-gathering functions under the
various legislative mandates for toxics were centralized.  Under this kind

of arrangement, there is no longer a need for the staff office proposed in

Alternative #5, since the identical organizational unit would be responsible

for performing most of the major toxics control functions, especially those of

priority establishment, control strategy development, and rulemaking.  The

research, monitoring, and enforcement functions would still remain the respon-

sibilities of ORD and OE;  however, these organizational units would now have

to coordinate their toxics control activities only with OTS rather than with

several regulatory program offices.

     Centralized toxics management would undoubtedly provide the maximum

integration of the Agency's toxics control activities.  Toxics problems would

be attacked .over a broad front versus the traditional media approach, although

media-specific enabling legislation would still have to be used for regulatory

purposes.  Toxics problem priorities could be established routinely by one

organizational unit of the Agency, with sufficient authority to marshal

resources to those problem areas where they are most needed.
     The disadvantages of a centralized toxics management approach appear to

be quite formidable.  First of all, it is extremely difficult to see how all

of the Agency's toxics control activities could be centralized in one office.

The main obstacle is the lack of a precise orieven semi-precise definition

of what constitutes a toxic material.  The line of demarcation between a toxic

    a non-toxic material is so ambiguous that it  is almost hopeless to make

a rational decision on what specific activities should be transferred from the

various regulatory program offices to the OTS.  For example,  how can the Office

of Solid Waste relinquish its toxics activities while it is pursuing a legally

mandated effort, under an 18-month deadline,  to define a hazardous waste?

     Even if it were feasible to make a rational  judgment on  what specific

toxics activities should be transferred from  the  existing regulatory program

offices, it would appear highly questionable  to remove media-oriented efforts

from those offices where the available media  expertise is located.  To do so

would truncate the individual program offices to  such an extent that the overall

operating capability of the Agency would be diminished.  Finally, the creation

of one office sufficiently large to perform most  of the Agency's toxics func-

tions would appear to constitute poor organizational management.  Considering

these shortcomings of the centralized toxics  management approach, one can

reasonably conclude that its implementation would result in toxics management

integration at the expense of program efficiency  and cost effectiveness.


     upon considering the six management options  described in this chapter,

we recommend a phased implementation of the toxics program integration approach

(Alternative $5).  That management approach appears to be the most effec-

tive — and at the same time the most realistic — means to achieve a truly

integrated Agency response to toxics problems.


     The two previous chapters have reviewed the available options for

meeting the first two objectives of the integrated ^toxics strategy, i.e.,

a system to identify and rank toxics problems, and a coordinative

management system.  The third objective, reviewed in this chapter, is to

maximize the use of TSCA as an integrative tool, and to ensure that all

of the Agency's  regulations and rule-making authorities are effectively

utilized to control toxics in an integrated manner.

     The provisions of TSCA mandate an integrated approach to controlling toxics

problems.  Sections 6 and 9 of the Act require coordination of actions taken

under TSCA with actions taken under other Federal laws.  They also require

EPA to use other authorities administered by EPA unless it is in the public

interest to use TSCA.  In order to make the public interest determination,

the Agency will be required to consider the strengths and weaknesses of control-

ling a particular problem utilizing an appropriate medium-specific authority

or utilizing TSCA.  Basic to this determination is an analysis of the impact

of any action taken on all media.

     Section 9 of TSCA can also be interpreted as to require EPA to use

to use TSCA if its other legislative authorities are inadequate to solve

a medium-specific toxics problem.  According to this approach, TSCA would be

used not only to control the entry of new chemicals into the market, but also

to give EPA an umbrella-like legislative mandate for pollution control.
       -•,,-•"                                                        'T-
     Section 6 of TSCA could be used to control toxic substances in air or

water if EPA determined that it was in the public interest to do so. This

section gives EPA the authority to prohibit or limit the manufacturing, proces-

sing, distribution, use or disposal of a chemical substance that presents an

unreasonable risk of injury to health or the environment.   For  example,
regulatory action under TSCA could be used to limit the entry of phosphates
(e.g., detergents) into the water environment if it were determined that
phosphates present an unreasonable risk to the environment.  Activities
to date under the Federal Water Pollution Control Act to control phosphate
contamination have lead to mixed results.  If permissible  under a  medium-
oriented statute, a judgment could be made that it  is not  the best tool  avail-
able for controlling a toxic and that TSCA should be utilized instead, either
exclusively or in conjunction with that statute.
     The question to be addressed here is how EPA should use TSCA  for its
regulatory purposes.  One option is to give rulemaking authority exclusively
to the Assistant Administrator for Toxic Substances who would,  upon the  advice
of individual program officies and after adequate coordination, develop  and
promulgate a regulation for the chemical — phosphates, for example.  Alterna-
tively, the authority to initiate and develop a Section 6  regulation for the
control of a toxics problem could be available to all Headquarters offices.
Under this option, the office that has the most technical  expertise or involve-
ment with a particular problem would prepare the development plan and take
the lead responsibility for the rulemaking activity, working with  OTS and
OGC in drafting the regulation.  All of the established procedures for-pro-
posed rulemaking  (EPA order 1000.6) would remain in effect.  The Work Group
has not made a recommendation regarding the relative merits of the available
     The intent here, of course, is not to diminish in any way the authori-
ties or programs  of CTS but rather to provide a positive alternative to the

other program offices.  The Office of Solid Waste, for example, regulates
the disposal of solid wastes under RORA.  Under this option, OSW could
propose rules under either TSCA or !OA after an analysis of the particular
residuals problem, according to the principles of the integrated strategy
(taking legal restraints into account).  The staff office for toxics program
integration, as recommended in Chapter V, would act as the overall coordi-
nator of this process and would work with OTS and the other offices to ensure
that TSCA was being utilized in a consistent manner by CTS and the other
     This approach has a number of advantages.  It would provide more re-
sources for TSCA regulatory activities and reduce the burden on the Office of
Toxic Substances.  In addition, this approach would force each program office
to coordinate its rulemaking activity more thoroughly with the other regula-
tory program offices and open the lines of communication on a regular basis.
     The next chapter will review the major findings of the three special
problem Task Forces (N-nitroso compounds, the electroplating industry, and
Northern New Jersey) and will examine the applicability of the integrated
toxics management approach to the identified problems.



     The Work Group examined some "real-life" intermedia toxics problems in

considerable detail in order to test the practical applicability of an

integrated management approach.  The problems were selected to explore the
feasibility of applying fundamentally different approaches to their solution.

The first approach would attempt to solve the problem  posed by a class of toxic

chemicals (N-nitroso compounds), the second would analyze the workability

of controlling an industry category (electroplating),  and the third would

examine how the toxics pollution problem could be attacked on a geographic

location basis (in two adjacent counties of Northern New Jersey).

     Three special Task Forces were formed to study each problem area and

to report their findings to the overall Work Group. The full reports of these

Task Forces will be completed and distributed at a later date. This chapter

will briefly summarize the major findings and will attempt to show how the

Work Group's recommended integrated toxics management  approach could alleviate

some of the problems identified.

1.  N-Nitroso Compounds

    N-Nitroso compounds comprise the classes of chemicals known as nitrosamines~

and nitrosamides.  They are by-products of several industrial processes, parti-

cularly the manufacture of certain pesticides and cutting fluids.  In addition,

N-nitroso compounds form whenever their precursors, nitroso groups and amine

or amide groups, combine.  These precursors are abundant both in nature and

in industrial products.  Because N-nitroso compounds can form in vivo, human
exposure to the precursors may be of equal concern as  exposure to the

N-nitroso compounds themselves.

     N-nitroso compounds are generally regarded as extremely potent animal

carcinogens and are suspect human carcinogens.  The Task Force study con-

firmed what was pointed out in Chapter II of this report:  that one of the


most formidable problems in toxics management is the general lack of

sufficient health effects data to support regulatory action.  Regarding the

Agency's past performance in the handling of the N-nitroso compounds problem,

the study concluded that there is much room for improvement in the functions

of data gathering/ hazard assessment, and coordination between the various

program offices.

     The toxics management approach proposed in Chapter V, had it been in

effect, could have significantly strengthened the Agency's capability to

respond to the N-nitroso compounds problem in an anticipatory fashion.  The

staff office for toxics program integration would have been involved already

in the early stages of problem identification and hazard assessment.  N-nitroso

compounds would have been put in their proper perspective relative to other

problems by utilization of the threat list and the Agency action priority

list, with active public participation.  The staff office would have avoided

considerable duplication of effort within and outside the Agency by coordina-

ting the many independently performed activities in information-gathering,

research, and monitoring.  The carefully planned and systematic performance

of the various hazard assessment functions would have significantly strength-

ened the Agency's data base for regulation.  With the recent enactment of

TSCA, the assigned lead office would be currently in the position to request

pertinent health effects and technical data from the affected industries.

 After thorough evaluation of the Agency's available regulatory and non-

 regulatory options, an  integrated control strategy would be developed and

 submitted for the approval by EPA's appropriate decision-makers.

 2.  Electroplating Industry

      The electroplating industry in the United States consists of 2,250

 to 3,600 "job shops" and 9,000 to 15,000 "captive shops."  The waste

 effluents of these establishments contain beryllium, cadium, chromium,

 copper, cyanide, lead,  nickel, zinc, chlorinated hydrocarbons, and other

 toxic materials.

      To carry out the mandate of the Federal Water Pollution Control Act,

 in 1974 and 1975 the Agency promulgated effluent guidelines and standards

 applicable to the electroplating industry (which ultimately were suspended

 or revoked).  Unfortunately, the intermedia implications of these regula-

 tions were not adequately considered.  An adverse result of controlling the

 discharge of electroplating effluents  into surface waters was that a large

 amount of these wastes  was diverted nationwide to municipal sewage systems,

 and the  inadequately treated sludge with high toxic metal content was either

 dumped into the ocean or on land (with a potential for surface— and ground-

 water contamination).

      The above problem  exemplifies one of the findings of Chapter II,

 namely,  that EPA's problems in the area of toxics control partly stem

^>;from the media-specific nature of most environmental legislation.  Because

 of this  circumstance, a well-coordinated and integrated approach to toxics

 management  is of special importance.   As was pointed out in Chapter III,

one of the characteristics of an integrated approach is that residuals

and by-products of controlling toxics in one medium are explicitly

considered.  The Task Force on the electroplating industry has concluded

that the Agency is aware of the intermedia repercussions of controlling

industrial surface water effluents and is already doing something about

them.  For comprehensive regulation of electroplating discharges, EPA now

has the authority to control land disposal of sludges through the recently

enacted Resource Conservation and Recovery Act.  In its current effort

to comply with a consent decree, under which effluent limitations and

pretreatment standards must be developed for 21 industry categories, the

Agency is developing the required regulations with full consideration of

the associated sludge problem, through coordination with the Office of

Solid Waste.

     The proposed approach for integration of toxics management would

provide a forum where intermedia pollutant transfer problems, similar to

the one illustrated here, could be discussed and thoroughly analyzed.  The

public health and environmental impact as well as the economic costs

associated with the various control options would be carefully considered.

The Agency's decision to adopt a particular regulatory option would be

taken only after the various tradeoffs required for an integrated manage-

ment approach have been made.

3. .Northern New Jersey
   j .• I . • • • ••, ._«». i i ii i  i	-*•_

    .The Task Force selected and profiled two adjacent counties of high

industrial concentration and population density:  Union and Middlesex.

Existing EPA files in the study area were investigated to identify probable

sources of toxic pollutants; however/ no attempt was made to establish a
link between the area's environmental problems and its reported high mortality

rate, as reflected in statistics on cancer and other diseases.

     The Task Force recognized several deficiencies in EPA's existing program

with respect to toxics management in the study area.  Perhaps the most serious

shortcoming lies in the lack of adequate data base for hazard assessment.

The problem posed by the scarcity of information is compounded by its out-

dated quality and difficulty of retrieval.  About 2,100 industrial facilities

were surveyed in the two counties.  Of these, only one-third are covered

in EPA files, although a significant portion of the remainder emit toxic

substances to the environment.  The lack of adequate information on toxics

was also illustrated by the scarcity of ambient air quality data for other

than criteria pollutants, although at least 20 percent of all facilities sur-

veyed were considered potential sources of toxic substances.  Data from the

NPDES files were limited primarily to 1971 applications.. Effluent limitations

and monitoring requirements were limited primarily to chromium and zinc.

Most of the data compiled by the Task Force had to be sorted out manually

from miscellaneous sources.

     Another,significant finding of the Task Force was that about 50 pecent
             "'*                                                       ~.'s$2.-

of all industrial wastewater in the study area, containing substantial amounts

of toxic substances, are discharged in an untreated condition to municipal

wastewater treatment facilities, where they do not receive adequate treatment

prior to ocean dumping or land disposal.

     The study also confirmed the problem that has been emphasized in Chapter II

of this report:  the general lack of health effects data.  For example,  it is

exceedingly difficult to estimate the risk to public health posed by those

toxic substances that have been identified in the ambient air at certain

concentrations.  Also, the cancer mortality data do not allow the establish-

ment of a cause-effect relationship because of a large number of complicating

factors, such as the long latency period for cancer and the myriad of poten-

tial environmental causes.

     The integrated toxics management approach advocated in this report  would

alleviate some of the problems identified in the Northern New Jersey study.

The Agency's information-gathering and hazard assessment capabilities would

be significantly improved by the proposed staff office, which would systematize

the collection, storage, and retrieval of toxics data.  This staff office

would help identify significant data gaps and recommend the monitoring.of

certain toxics which presently seem to be emitted to the environment without

control.  If a potentially serious problem is identified by the monitoring

effort, the problem could be placed on the threat list and the Agency action

priority list.  Through such a procedure, the primary goal of the reconmended

toxics management system could be approached:  anticipation of toxics problems

before they become critical.

     The staff office for toxics program integration would initiate and  manage

special fact-finding projects similar to the Northern New Jersey study.

Major conclusions from such projects (e.g., the finding in this study that     •

50 percent of  industrial effluents are discharged into sewers without pre-

treatment) would be channelled routinely to the Agency's policy decision-
makers for consideration.
  .   The Task Force concluded that employing a "geographic approach" as part
of an integrated toxics management strategy (i.e., performing studies simi-
lar to the one in Northern New Jersey) would be a valuable tool for defining
and assessing environmental health problems.  However/ it concurred with the
Work Group's recommendation that only pollutant-specific and industry-specific
approaches be used for the establishment of Agency priorities.
     Management plans with recommendations for specific actions on N-nitroso
compounds, the electroplating industry, and Northern New Jersey are currently
being prepared by the respective Task Forces.  The three full reports on these
special problems will be issued under separate cover at a later date.

                               Appendix A

Suggested Principles for Ranking Toxics Problems
    Because of the subjective component inevitable in any ranking of the
relative importance of environmental toxicants, it \s essential to state
explicitly the broad principles used in making these judgments.  There are
two general types of principles for evaluating the risk associated with
changes in the environment.  These principles are:  (i) principles for
ranking human health effects, and (ii) principles for ranking environmental
    The underlying premise which guides the stipulation of principles for
ranking health and environmental effects is:  the importance associated with
human health or environmental effects is proportional to the magnitude of the
impact experienced by both human and non-human populations.  To assess the
magnitude of the impact, it is necessary to estimate and make trade-offs
among the levels of exposure, the number of persons exposed (in the case of
human health, effects), as well as the degree of disability or damage
    Although some of the principles which follow might be given greater weight
than others, they are not listed in order of their relative importance.  The
importance of the human health and environmental effects may be proportional
to all or some of the following variables:

Human Health
    o The number of persons expected to. experience the disability or are
      suceptible to such a disability.

    o The disabling capacity of the health effect—for example,  an effect

      on the reproductive function is obviously more  important than an

      irritant effect.

    o Man-years lost due to premature death or permanent disability.

    o Degree of irreversibility of the health effect.
    o Duration of reversible impairment.

    o Potential to induce a serious health effect  such as  death or

      permanent disability.

    o Potential to induce or cause intergenerational  health effects.

Environmental Effects

    o Effects on organisms which fill critical ecological  roles such as

      algae (primary producers) and fungi (decomposers).  These organisms
      are particularly significant since  alterations  in  their number and

      diversity can lead to substantial perturbations of the biological


    o Effects on the biogeochemical cycles of important  nutrients.

    o Effects which impair or alter reproductive functions of wildlife species.

    o Environmental changes which may lead to alterations  in climate patterns.

      Such changes exhibit a low potential—however/  not zero—for catastrophe.

    o Geographic extent of environmental  effects.

    o Degree of irreversibility of the adverse effect.

    o Economic and social significance of environmental  changes.  For example,

      an effect which may lead to alterations In agricultural and/or forest

      species would be very serious.

    o Amounts of energy, food, natural resources and  other amenities which   |

  would not be available as a result of changes in environmental quality.
o  Effects which may place stress upon the populations of endangered

                                 — 3 J —
                               Appendix B

Guidelines for Selecting the Action Priority List
    To identify the toxics problems which receive Agency-wide attention, it
will be necessary to strike a balance among the perceived threats to health
or the environment, the non-toxics demands placed on the program offices, and
the public interest.  While a list of guiding principles for making these
judgments cannot be explicitly stated, it is clear that good management prac-
tices urge the adoption of a cost-effectiveness approach for the distribution
of limited EPA resources.  To select toxics problems for the Agency action
priority list and for program action lists it will be important to consider
in addition to the specification of the hazard each of the following factors:
    1,  Amenability to control
    2.  Cost-effectiveness of EPA action
    3.  Immediacy of the problem
    4.  Current program priorities
    5.  Public interest in toxics problem
For the first three categories, a series of questions will be presented
that should be addressed when selecting problems deserving Agency attention.
The last two categories are discussed in Chapters 17 and V of the Report.
Amenability to Control
    A.  Controllable Actions:  Does EPA have the authority to take actions
which can influence the distribution of the toxics problem in the environ-
    B.  Intentional Effluents and Unintentional Effluents:  Is the toxic!
material due to fugitive or direct effluent sources?  Does the toxic material
                ••                                                       f
represent a quality control problem, is it a by-product of the process, found
in the waste stream, or an active ingredient of the process?

    A.  End Uses:  Can the various use categories which emit the toxic
pollutant be separated into dispersive and non-dispersive uses?  Can '
selective regulation of end uses significantly limit the health hazards?
    B.  Substitutes:  What is the total economic significance of the pro-
duct or process which causes the toxics problem?  Are the substitute products
available in similar quality?  Can the process be "reformulated" to produce
process streams without the toxic effluents?
    C.  Research/Regulatory Issues:  Does an adequate basic knowledge data
set exist which can fill information gaps that influence decision-making?
Can unanswered questions be resolved with a practical amount of time and
    D.  Feasibility of Meeting a Standard:  Can the cost of pollution
abatement equipment and compliance with a standard be roughly estimated by
comparison to s»iiriilar situations where detailed cost analyses have been com-
pleted?  If .the toxics problem is chemical in origin, is the substance a
new or an existing chemical?  Existing chemicals have established markets
and the cost of regulation can generally be expected to be higher.
    E.  Reduction in Hazard per Dollar Spent:  Using a rough estimate of
the cost and the likely reduction in release to the environment, a rough cal-
culation can be made relating costs to hazards reduced.  This estimate can be
used for comparitive purposes for selecting the high yield toxic problems.
Immediacy of the Problem                                                  ..,-
    Are the environmental consequences expected in the near term or long
                    ;                                  '                     i
term?  Can short-term research results provide information to fill the data
gaps or is a long-term research program needed to significantly alter the.t
state of knowledge?

                   Appendix C (continued)
Sunraary Comparison of Toxics Management Approaches
R & D
By program office
Integration on an
ad hoc basis
By each program
office. Sana
duplications of
effort and emis-

' 13 M '
Integrated re- '
sponse to emer- ;
gencics formulated
by EPA staff
office i
! '
11, with reduced ' s Centralized files
'duplications and j / ; maintained
omissions ( !.
j ' i
1 •
.. j
By ORD and regu- • f 1, with benefit
latory program .of info, about
offices. Insuf- -ongoing toxics .
ficiant adherence; activities
to needs and j
Individually by
media offices,
ORD, OB, and
1000.6 approach.
Coordinated, but
not integrated.
^Revised priorities
^suggested by EPA ', 4 '
staff office j '
' ! 1
; Revised priorities
• -^suggested by EPA |
''staff office r 	 "" ^
; .','•!• -;
i t
. . i
1 	 . ; S
^Integrated re- 'j
•gulatory approach.'
uu^jtjtfatuu uy c*i t\ •• - - ' " ' . -•
ptaff office j
"^" """"^""' Centx'alized " "
• files
• maintained

|2 ' Centralized
•; files
1 maintained
i 	 i
' * i
^Revised priorities' Research u<
reviewed and priorities ^
'approved by reoonmended •
Appropriate ' c/^Y W^5
deciaion-makera .
* •
{Revised priorities
;reviewed and ap- •.
tproved by
'Integrated ap- •
proach reviewed i
;and approved by •
rleciaionrinakera j
1 i
recommended by
for toxics

            Appendix C  (continued)
Sunrary Ocnparison of. "toxics Management Approaches
Regional &
Federal Agency
Enforcement \
strategy developed,
and implemented i
by OE
n «4 |K 1
•• i
i ; i
• ' • i
• '. •!
Rather ineffective) Improvement over
(• 11, but sUll
i ' •
!AS mandated by
Participation i media legislation
1 '
• Acave •'
t * •
» _m ' J
;. . ....;...
j j • ,' Active public
• • ... .»»av.».4 ,
By OTS, with
provision to
ensure cor-
recave action

                               Appendix D

Members  of  the  Integrated Toxics Strategy Work Group
 BIGLANE, Kenneth


 CAWLEY, William



 DENNEX, Richard

 JANI3, Jim  (Chairman)

 KUZMACK, Arnold


 LEHR, Jim


 MILLER, Leonard

 McCABE, Joseph

 NOTZON, Edmund

 PADGETT, Joseph

-PLOST, Charles

 REZNEK, Steve

 RIOFDAN, Courtney

 SIMCN, Conrad










(Region VIII)

(Region IV)








(Region II)

 Drafting and editing staff support to Work .Group was provided by the  following

 members of the Office of Planning and Evaluation:

 IAZAR, Emery



Appendix D (cont'd)
Invaluable clerical support was provided by:
FORD, Willa
MINOR, Edith
BAILEY, Bonita

Members of the Three Task Forces on Special Problems

N-Nitroso Compounds
ALEXANDER, Tom                        (OPE)
AYER, Charlie                         (OTS)
BACHMANN, John                        (OAQPS)
COHEN, Stuart                         (OE)
CQNEOY, Gus (Chairman)                (OE)
HADZI-ANTICH, Theodore (Co-Chairman)  (CE)
BOLLOWAY, Tom                         (OPP)
McGADGHY, Robert                      (ORD)
ROSENBEBG, W.illiara                    (OPE)
SEITZ, John                           (OE)
SHEARER, Dave                         (ORD)
SWABY, Lou                            (ORD)
WALLACE, BUI                         (OSW)

Electroplating Industry
DAGE, Elbert                          (GTS)
JAKOBSON, Kurt                        (ORD)
LAZAR, Eroery                          (OPE)
RILEY, John (Chairman)                (0«PS)
EOUSS, Jim                            (OE)
STRAUS, Matt        (OSW)
STRUZESKI, Ed       (OE)
WAGNER, Marty       (OPE)
WILLIS, Carroll     (OE)

    ndix D (cont'd)

   ;them-New Jersey

 JDIS, Lorraine





HARVEY, Patrick




LAZAR, Emery


LIBSTER, Leonard


MILLER, Leonard (Chairman)

SEITZ, John .

SIMON, Conrad


WE3L, Steve
















(OE)	__.