1/19/81
                     TOXICS  INTEGRATION WORKPLAN  '





     This workplan describes a set  of  activities related  to develop-



ment of an  EPA-wide strategy for  toxics  control.  The plan covers



the remainder of FY 1981.   It is  based on  the  work  to date of  the



Toxics  Integration Strategy Committee  and  the  concept paper pre-



pared by  the DAA's serving on the committee.   The plan  leads to



initial design"of an integrated toxics strategy  that can  be fleshed



out  and refined (along with initial implementation  steps)  in FY '82»



It reflects commitments made to OMB in £?A's reply  to the .budget



passback :



      1.  Design of operational mechanisms  to  coordinate regulation,



          data gathering, and analysis of toxic substances.



      2.  Design and testing of prototype geographic._and industry-



          wide approaches to toxic pollutant problems.           .''"  '  •'



      3.  Identification of  legislative changes needed to effec-



          tively integrate  toxics control.



      4.  Organizational changes  needed  to  implement the Agency's



          integrated toxics  strategy.



      5.  Resource allocation  recommendations  for FY '82 and FY '83. ..:



      In the  second year/ we will complete  the analysis of integration



 strategies,  and begin implementation.

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                                 -2-
^ I


GOALS

     The  goals of EPA's toxics integration strategy will be:

           0   to set priorities for regulation of toxic sub-

              stances in a manner that is logically consistent

              across programs and based on coordinated re-

              search and analysis of scientific, health, and

              economic data.
              4
           0  to develop a systematic agency process for identifying

              and responding to toxic substances so that the combined

              effect of Agency actions on specific areas and industries

              achieves  the ir.ost important environmental objectives

              at  reasonable  costs.

           o   i.—  ^_n^___t._ J- V - —_->—..--. _-. i _— ^.JT  c< »>» v. - . j_
               w w  w C .1. .*. * J C C* w C  wi*C £*i_W^C*. i.wj.C3 v^4.  u r^rx Ud^rttsa

               quarters, SPA  regions, and  state/local

               governments  in dealing with toxi.c problems.

      The rationale for developing  a  strategy  is simply that the

 worst  threats  to health  and environment should be  controlled  first;

 that this needs  to be  done, as much  as  possible, on an Agency-wide
           *»
 basis; and  that  limited resources  are  most  likely  to  make a, signi-

 ficant .impact if used  as part of a well thought out  Agency-wide

 strategy.

 ACTIVITIES

      The FY 1981 workplan consists of six activities:

      1.   Analysis of Toxics Control in Different Agency Programs
      2.   Analysis of Exposure and Risk Assessments
      3.   Analysis of Integration Based on Specific Pollutants
      4.   Analysis of Integration Based on Industrial Categories
      5.   Analysis of Integration by Geographic Area
      6.   Preparation of Recommendations to the Administrator

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                                -3-
Activity 1;Analysis  of Toxics Control in DifferentAgency Programs


     This  is an  analysis of how different EPA programs deal with


toxic substances.   Seven programs will be analyzed:  air'quality,


water quality, drinking water, hazardous waste, toxic substances


control, pesticides,  and radiation.


     The objective of this study  is  to identify similarities and


differences in" procedures  which programs use to regulate-toxics and


ascertain  how .these can help  or hinder Agency efforts to develop


an  agency-wide  toxics, strategy.   The analysis will include evalua-


tion of each program's completed  regulatory action, its current


work in progress,  and longer  term plans  for toxics control.


 Program-specific regulatory schedules, timetables, and priority


 activities will be identified in  order to  determine compatibility
                                            • -4     -----

 with other .program plans.


      As part of the study, the Office of General  Counsel will  pro-


 vide a quick analysis of  the enabling statutes  to determine  legis-


 lative differences and opportunities for toxics integration.


      The  task will lead to identification of  problems and  oppor-


 tunities  and recommendations for legislative,  organizational,


 and procedural  changes which will be used in Activity 6.


      Issues to  be addressed  in this activity include:


      0 what are the  major procedural differences among programs


        in controlling toxic  substances?


      e what has been each program's  regulatory record to date in

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      controlling toxic substances, what activities are currently
                                              • \


      underway, and what is planned beyond FY 81?




    0 to what  extent have different programs developed non-




      regulatory approaches to the control of toxic sub-



      stances?




    0 which program activities are mandated or discretionary



      and  what flexibility does the agency have in this regard?

                                                        *

    0 what are the  implications for changing the Steering



      Committee process?




    c are  toxic or  hazardous  substances  defined differently



       in the  enabling  statutes?



     0  do the  statutes  give  different  weights to consideration



       of health,  welfare  and  economic concerns including benefits



       and costs in dealing  with  toxic substances?



     0  to what extent are  programs reacting .to  emergency  situ-




       ations  or able to take  anticipatory action?



   --~°  how are the conclusions to be integrated with  legislative



       reauthorization studies?



     0  how do different programs  involve EPA regions  and state




       and local governments?



     Activities 1 and 2 need to work closely together since both




deal with  scientific and economic data collection and analysis.




Details will be worked out in the workplan for each activity.




     Schedule:
     —       ""•                                        o


           Task 1  Analyze current EPA approaches to toxic

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                          -5-


            pollutant control in the various programs.

            Based on OTI work currently undervay analyzing

            toxics decisionmaking in major SPA programs.

            Interim report by 3/15/81; Final Report, by 4/30/81.

    Task  2  Analyze major EPA legislation to identify

            and  compare  legislative mandates for toxics

            control, based on OTI-OGC evaluation

            of EPA  legislation  related to toxics issues.

            Complete by  3/15/81, revised by 5/15/81.

    Task  3   Identify  constraints to  integration and

             features  that  facilitate  or promote inte-
                                                  •
             gration.   Complete  by4/15/81.

    Task  4   Identify  the organizational, procedural,

             resource  allocation/ and legislative changes

             that could eliminate or reduce  th.e

             constraints.  Complete  by 6/1/81.

     Task 4  Review and revision of  report.

          '  Complete by .7/1/81.
     "      •                                                    ''
Staff Requirements:  Full time leader from OTI      (24 work-mos.)
                     One half-time  person from OPE  '(4 work-mos.)
                     One person for one months each
                       from seven program offices   (7 work-mos.)
                     One work-month from OGC        (1 work-mos.)
                     Total:  36 work-months
               *                       •              *      * %
Contract  Resources:  $80,000                 •     ' •

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                             -6-
Activity 2:  Analysis  of  Exposure  and  Risk  Assessments Employed

             to  Determine Adverse  Health  and Ecological Effects



     Program offices  have developed  different  approaches  in



assessing health and  environmental dangers  and economic benefit-cost



impacts  as  a  step in  preparing regulatory decisions.  The program's



also differ in their  use  of outside  experts for reviewing data and



assessments.



     The goal  of this activity is  to review existing  approaches  to



the conduct of science, health, and  risk and economic assessments,



risk reduction efforts, document differences and their  causesf



 identify possible changes to promote integration, and prepare



 recommendations that will be used in tne output of Activity 6.



      Issues to be addressed in this activity include:



      *• what are the methods used by different program offices
                                            • 
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                           — 7 —




8  are there meaningful differences in methods used to measure
                                    *      » i

  or estimate dose,


0  are there meaningful differences in methods used to interpret


  and extrapolate results of bioassays,


0  are there significant differences in methods used to interpret


  and extrapolate results of long-term whole animal tests,


0 are there significant differences in methods used to interpret


  and extrapolate acute toxicity data,


0 are there significant differences in methods used to collect


  .and interpret  clinical  and epidemiological data.  (Examples


  of interpretative issues  are:   the  use  of such concepts as


  the lowest  observed effect  level  (LOEL); the treatment of


  negative results  as compared  to positive results; "and the


  discrimination made among populations according to  age,


  sex,  susceptibility and life-stype  £h identifying effects


  and estimating risks.)/                                    ' •"


 0 are there significant differences in models used  to translate


  emissions- into exposure estimates,


 e- are there differences in methods used  to  translate  exposure


   to dose,


 0 how are results of assessments used for information to .


   regions, states, and the public?


 0 how should the agency be organized to prepare short-term


   risk assessments which are needed  in support of regional


   responses to  environmental .incidents?  can we prepare a



   model  for this purpose?

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                         -8-


0 could acceptable criteria be proposed for determining

  the level of acceptable quality for risk assessments?

0 should formal  risk assessments be prepared for all toxics

  programs?

 0 should assessments be done  in more than one office, and

  if  so, how  do  we ensure consistency and credibility?

 0 what  risk assessment methodologies are acceptable; are

  relative- risk  analyses acceptable?

 0 could acceptable  criteria  be proposed for determining the

  level cf acceptable  quality for  risk assessments?

 Schedule :
                                                    — « .
              collecting effects data.   Complete  by  3/15/81.

      Task 2  Analysis of the reasons for differences in

              approaches to risk assessment.   Complete by 4/15/81.

      Task 3  Analysis of needs for changes.   Interim

              report by 5/15/81.  Complete by 8/1/81.
                                                   ••"-"•""       _  •••'
      Task 4  Analysis of approaches used by FDA, CPSC, OSHA

              and NCI.  Complete by 5/15/81.


      Task 5  Recommendations for organizational, procedural

              and resource allocation changes that would

              facilitate consistency, integration and

              efficiency.  Complete by "6/1/81.
                                                  «
      Task 6  Submission of  final report. Complete by  8/1/81.

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                               -9-
     Staff Requirements:  One full-time leader from OPE (9 work-mos.)
                          One full-time person from ORD (9 work-mos.)
                          One quarter-time person from
                            OANR, OTS, OWwM, SAB        (9 work-mos. )
                          Total:  27 work-months

Activity 3:  Analysis of  Integration Based on Specific Pollutants

     The agency has  in  the past made decisions on what chemicals to

control on an  uncoordinated basis,, with each program reacting to a

different  set  of  pressures, constraints, and environmental insults.

It  is  therefore not  surprising  that  instances can be cited in--which

EPA action has merely  transfered  pollutants from one environmental

medium to  another/  in  which minor emissions of a chemical are

stringently  contrplled  while  major emissions are untouched, in which

the lact  envircr.me.itai medium to  be  regulated receives a waste,

etc.  A symptom  of this problem is that the programs' priority lists

for new regulatory actions show unexplained variations.
                                           • 1     :-_
      The  focus of this activity will be on development of a mechanism

to identify  gaps and inconsistencies among the  actions of the programs

with, respect to particular chemicals.   Once these  are  identified,

 the Agency will heed an  issue resolution  process to ensure  consistent

 non-duplicative Agency action.

      The focus of this activity  is on consistent priority setting,

 regulation,  enforcement, and information on a chemical by chemical

 basis.  The effort will  attempt  to define: (1)  the decision criteria

 for selecting priority chemicals (or groups of chemicals);

 (2) the feasibility of developing agencywide regulatory strategies

 for individual chemicals,  (3)  what  kinds of gaps and inconsistencies -

 among  control action  we  wish  to  detect and how they, can be found,
        •                   .
 (4) what  internal  institutional  mechanism should perform the analysis.

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                               -10-



(5) the role  of  external  review and public participation in the process

being developed, (6)  the  role  of  non-regulatory control mechanises such

as the  setting  of action  levels,  and  (7)  the potential for coordination

of information  gathering  and analysis (especially contracted work)

functions among program offices.

      To start this process, EPA has  set up  several working groups to

develop an intermedia analysis for particular  substances.  The DAA

Toxics  Integration Strategy Committee, in addition,  is working on an

 interim list of about 20 chemical substances  on which  it will prepare

 chemical support documents, primarily for use  by  programs  and regions

 for FY '.82.  The FY  1982 "guidance package will reflect the coordinated

 approach toxic  substances  across EPA.  Other current Toxic Substances

 Priorities Committee "(TSCP) projects  (control options  analyses,  dioxin

 coordination)  under  this activity, such as the respective  program

 treatment of substitutes and  volatility of solvents.

      Issues  to be  addressed in this  activity include:

    .- ° how  should  "new"  chemicals be identified?           .. ,  ..,. ..

      0 what  has been the experience  to date with priority listing

        of  individual .chemicals?

      0 what should be the relative weight of various criteria for

        priority ranking, such as toxicity, exposure, health risk, or

         economic benefits and costs  of regulation?

       * how can priority ranking  established either  by interagency or

         agency-wide groups be meshed with program-specific activities?
                                                       «
       0 should  groups of chemicals,  rather  than  individual sub-

         stances, be identified for priority action?

       e what information on priority chemicals should  be passed  on


         to EPA  regions and  state and local governments?

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                          -11-

 0 how  does the chemical-by-chemical -approach relate to
  alternative strategies, such as those discussed under
  Activities 4 and 5?
 Schedule:
      Task 1  Assess current practices for identifying
              and ranking of priority chemicals by EPA and
              other federal.agencies.  Complete by 3/15/81•
      Task 2  Finish current work on recommendations"for
              agency cancer policy criteria  for priority-
              set-ting and regulation (based  on considera-
              ; tion  of toxicity, risk, exposure and eco-
              nomic impact),  but  scoped to cover sll
              effects  (not  just carcinogens).
               Complete  by 4/1/81.       . ^
       Task 3  Complete  first  round  of agency-wide work group
               process  for developing strategies  for  chemicals
-~             and chemical, categories.   Complete  by  5/1/81.
               Additional work groups to complete  their assess-
               ments by 10/1/81.
       Task 4  Develop chemical support  documents identifying
               health and environmental  effects of selected
               priority chemicals and Agency-wide as well as
               program-specific regulatory actions and plans.
               Complete first two model documents by 2/1/81.
               Prepare additional chemical support documents by
               8/1/81..

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                              -12-


         Task 5  Based on experience of Tasks 3 and 4 make recora-
                                  /
                 mendations on whether and how'EPA should develop

                 Agency-wide  strategies for  specific pollutants

                 and  a  suggested  approach to selecting and

                 scheduling them.   As part of this assessment

                 alternatives to  matrix and  work  group approaches

                  for integrating  agency actions on chemicals

                  will be considered-.  Complete  interim report by

                  6/1/81.  Final  report  by  8/1/81.

     Staff Requirements':  (OTT staff requirement does not  include
                          CTI  sraff cevcrec  re TPSC manageroer.r. and
                        •  work groups.)                              .
                          "Full-time task leader/support     (36 work-mos.]
                            staff from OTI
                          Full-time person  from  OAQRT      (9 work-mos.}
                            6 months from other  offices
                            (0PM, OTS, OWWM,  ORD)           (6 work-mos.}
                          Total:   51 work-months

     Contract Resources:  $150,000.        '*
                                          •            . -  *  '  ^ • -   *
Activity 4:  Analysis of Integration Based on Specific Industrial
             Categories

  *'"" This  activity  will  attempt to  develop an approach to priori—
          *                              '               •*..•-.-
tizing multi-pollutant,  multi-program concerns for given industries'

to assure  that  the  most  important  waste stream or chemical problems

are  dealt  with  first in limited resource situations and to ensure

consistent regulation across  programs.  'One  or two approaches to

assessing the  combined effects of multiple current and future '      ' •
                  •
regulations on an industry will  be designed  and applied to two '

sample  industries  (organic chemicals and copper smelters).  They

will draw on the experience of the alternate Fuels Group  in dealing

with multi-program guidelines for controlling pollution  from  synfuel

plants.

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                              -13-


     Both of  the  industry  studies will  identify the nature and

magnitude of  the  toxic  pollutant problems  specific to-.the industry,
                                                *
identify available information  on exposure and risk from these

pollutants, assess the  environmental  and,  particularly, the economic

impact  of various levels of regulation,  and  attempt to draw conclusions

on  the  need  for priority-setting  among  media and pollutants.  Each

industry  study should lead to design  of a  sample intermedia strategy

for the particular industry.  The most  important use  of the case

studies will b'e to assess the utility of the approach taken and to

decide whether EPA should develop a general  strategy  for coordination

of and priority-setting among multiple regulations  affecting  an

 industry- and,  if  so, to suggest an approach  for doing so.   A special

 effort will  be made to  explore the industry-by-industry approach

 with representatives from industry.
                 &
      Issues  to be addressed  in this activity include:
                                          •a-
      0 what  are  meaningful  industry categories for the purpose

        of this approach?

    -_  «  can effective  industry  prioritization be carried out on the
                           *

        basis of  available information?

       0  how  can the industry-specific approach be made consistent

         with  the  pollutant-specific and  geographic-specific

         approaches?

       « what data requirements limit  the applicability of this

         approach?  how can those  data deficiencies be overcome,

         and  at what cost  to industry  and the Agency?

       0 can  the agency  identify industries which cannot afford all

         the  toxic and non-toxic requirements we migh.t place an them

         and  concentrate on the'most important?  How should EPA

         deal with  industries in order to make these assessments.

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                           -14-



0 how would the  industry strategy relate to OSHA, CPSC, FDA

  or other regulations?                   -t
                                           «

0 does the industry  strategy provide a vehicle for com-


  bining media-,  effluent-, and product-oriented controls?

0 do we need  more emphasis on  research and development

  efforts .on  ways to reduce toxics problems through


  changed  industrial processes or materials?

 0 what  roles  would EPA regional offices play in  implementing

  the  industry strategy?


 0 how  can the industry-wide  strategy be best advanced in

  consultation with industry  representatives and organizations?


 0 which Industries should be  selected  for second-round studies


   (during FY '82)?


 Schedule;


      Task 1  Define data needs and conceptual" approaches

              to  industry-by-industry strategy.  Assess
                          i
              experience of alternate fuels group.   Initial


              analysis complete by 2/1/81.


      Task 2  Design .and conduct industry assessment studies,

               including benefits and costs of current and


               likely future environmental requirements for the-  -


               organic  chemicals industry and the copper smelting

               industry.   Complete study designs  by 2/15/81.


               Interim report by 6/1/81..  Complete studies by


               8/11/81.

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                     -15-
Task 3  Organize industry consultation's on the con-

        cept and implementation plan for industry-

        wide control strategies.  On-going with

        other  tasks.

Task 4  Assess potential of  industry-wide approach and

        design appropriate strategy.  Develop addi- .

        tional study program for  FY  '82.

        Complete by 8/15/81.
                                                 (9 work-mos.)


                                                 (.9 work-mos.}


                                                 (9 work-mos.}


                                                 (4 work-mos.)
     Staff Requirements:  Full-time leader from'0PM
                          Full-rinis person fro- a pro-
                            gram office staff
                 :           (OAQPS)
                          Full-time technical person
                            from another major pro-
                            gram office (OE?)
                          Two months of time from two
                            other relevant program
                            offices (ORD & OTS?)
                          Total:  31 work-months

     Contract Resources:  ?450,000  ($225,000 for each of
                             two studies)

Activity  5:  Analysis  of  Integration by Geographic Area -
                 •
     Attacking  toxics  problems  nationally substance-by-substance,

program-by-program may not  resolve  many of the problems posed "by

local concentrations of toxics  and  toxic exposures.  Control of

toxics problems in specific geographical areas— and by regional,

state and local governments located in those areas— can provide

another  alternative to national regulatory  action.  The working
           •
hypothesis underlying this  Activity is that many toxic problems

are  not  amenable to solution  via national  regulations.  "National

perspectives and priorities may overlook localized  problems and

solutions.

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                              -16-
     One approach  to  geographic control is to determine the
distribution  loadings and  locations of critical redlaws of toxic
pollutants  in specific geographical areas and evaluate the likely
benefits of national  regulatory programs now in place or currently
under  development.  Several  geographic toxics assessments are
currently  underway and will  be useful  in developing the approach.
We  would  then determine whether further action is needed, looking
at  the full range of federal,  state, and local actions such as
regulation,  monitoring, data collection, and public awareness.
Under what conditions and how this approach might work will be
explored by conducting two pilot  studies.  Each study will assess
the nature and magnitude of the  toxics problem in the area selected
 for study, the scientific data base currently- available, and the
 options for  further  cleah-up if  necessary.   The pilot studies will
 be used to develop a  general strategy for  the geographic approach.
 Different models  need  to be identified, both for  a general use  of
 the geographic approach and its use in response to contamination
 incidents.
       The main purpose of  this activity is to conceptualize and
 evaluate  the geographic approach  and determine its utility and
 feasibility.   Subsequently, we must determine if the approach
 should be  routinely applied  to a  number of.areas or held in reserve
 for  use when clear problems arise.

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                          -17-


Other issues to be addressed in this, activity include:

 0  to what extent are regional and local toxics problems

   regulated nationally but not controlled locally?  what

   are the reasons  for this?

 0  alternatively, are  localized regulations necessary to deal

   with special  situations?  what  role should EPA assume?

 0  what are  the  roles  of  EPA headquarters, regional offices,

   other  federal agencies, and  state and local governments in

   response  to different  situations, such  as toxics incidents

   o'f  known  nat:ur.e. incidents  that are not understood, for

   their  principal causes,  and high concentrations of  media or

   effluent  toxic pollutants  due  to particular  local

   circumstances?
               *
 0 what is the agency's policy for preparation  and release  of

    information to the public with regard to  local toxics . "...

    problems?

~ ° what data exists for  "desk top" studies at the Federal,
       "     •                                      - -i^ .....
'"•"'"'"""' State, and local levels?                       " J-• -    ,.:..

  Schedule:

       Task  1  Explore concept and  approach to geographic

               regulation with regional, state and local

               representatives.  On-going  with other tasks. :


       Task  2  Design  and conduct  two pilot studies of

                specific geographical areas.  Coordinate with

                ongoing geographic  pilot  studies,  such  as

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                        -18-



            Great Lakes, Chesapeake Bay, and Kanawha
                                         •i

            Valley projects.  Design completed by 3/1/81,_

            interim reports complete by 6/15/81, 2 pilots

            complete by 8/1/81.


    Task 3  Develop a catalog of regional, state and local •

            approaches  that don't require national regula-

            tion.  Complete by 7/1/81.


    Task 4  Analyze success of the  2 pilot studies"and

            design general  strategy.   Complete by 8/31/81.


    Task 5  Complete  the  analysis  of ncxic  "5ci.  Spors"

             in the aquatic  environment and  integrate with

             output  from Task  2.   Interim  report  by  5/15/51.

             Revised  report  by 8/1/81.

       Task 6   Analyze several case studies  of emergency toxic
                                      . -a.     :-_.
             problems to determine where Agency responses

             were integrated and where  they  were not.


             Identify the factors that contributed to both - "" -

             integrated efforts and failure to integrate. "--;-.:

             Recommend  approach to  integrated emergency response,


             Complete by  8/1/80.                  .
                                                              *


Staff Requirements:   Full-time leader  from OWWM   (9 work-mos.)
                      Full-time person  from Region
                        III                        (9 work-mos.)
                      Full-time person  from ORD    (9 work-mos.}
                      Half-time person.from OPM    (4 work-mos.)
                      Total:   31 work-months
                                                 e

Contract Resources:   $450,000 ($225,000 for each of
                           two studies)

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                               -19-
Activity 6:  Recommendations to the Administrator

      The various activities listed above will be used in developing

a report on toxics  integration for the Administrator.  This will be

the central document  which discusses the concept of toxics integra-

tion, its  applicability  to the mandate, of the Agency, and various

 approaches to  implement  the strategy.  The report will recommend
*                                                         • <»
 an agency-wide strategy  and steps 'for its implementation. ' ^'"addi-

 tion, a workplan and  resource  allocation plan for the next two

 fiscal  y-ears will be  prepared.   OPS/OPM will assist tne project

 manager in preparing  resource  allocation estimates and operating

 plans  for  ail  activities.  The report will be based on the results

 of  Activities  1 through 5 above and will require a strong effort

  to  weave together the various  study results  and to identify clearly

  the legislative, organizational, and procedural changes that will

  lead to the new strategy.  The direction of  the report, as well  as

  the goals of  the agency's integrated toxics  strategy,  will be

  developed in  close consultation with the  DAA's  committeeVr

  Schedule;

            Task  1  Work  on key issues jointly with other task

                     forces.  January thru September 1981.

            Task  2   Explore key concepts and approaches to toxics

                     integration with outside experts.   Ongoing

                     with  other  tasks.

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                          -20-


    Task 3  Develop  strategy  and prepare  report  to  the

            Administrator.  The timetable for  this  task

            is  as  follows:

            February 15  Complete outline  of  report.  Revise
                         workprograms  for  activities 1-5  as
                         necessary  to  bring them  in  line  with
                         development of central strategy.

            April  1      Revise  outline of report.   Incor-
                         porate  progress reports  from
                         Activities 1-5.          ._/

            May 1        Drafting  of report begins
                                           •
            July 15      draft report  submitted to  the Toxic
                         Integration Strategy Committee

             August 1    work begins on final draft of the
                         report.

             Sept. 15    Toxics Integration Committee forwards
                         report to the Administrator.  Agency
                         and  regional briefings.  -
                                       . -a     r-_  :.
     Task 4  Resources Allocation plan for FYs '82 and '83.

             Work on  components ongoing with other tasks.

             Comprehensive plan' due September  1. ..-;.       ..   -.-;•••

    .Task 5  Preparation of workplan  on toxics integration . -    J

             for. FY'f.82.  To  be completed September 1, 1981.

Staff requirements:   Project  manager                 (9 work-mos.)
                      Full-time  (or equivalent)   _- ~
                      person from OTI                 (9 work-mos.)
                      Full-time  person from OPS  •    (9 work-mos.).
                      One-half person  from ORM     \   (4 work-mos.)
                      Full-time  secretary  (OE?)      (9 work-mos.)
                      Total:   40 work  months


Contract Resources:   $150,000

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                                 -21-


Resources and  Management Plan;

(a)  Staff  and Contract. Resources  requirements are as follows:

          Activity 1       36    work-months              $80/000

          Activity 2       27    work-months             •   	

          Activity 3       51    work-months              150,000

          Activity 4       31    work-months              450,000

          Activity 5       31    work-months              450,000
               *                                          h™
           Activity 6       40    work-months  (in-       ... 150JQOO
                                 eludes project mgr.)

                    TOTAL  216    work-months     •      $1,280,000
        »

 (b)  Project Manager: The project manager will  oversee  the develop-

 ment and imp lenient at ion of the workplan.  He will serve as execu-

 tive secretary of the Toxics Integration Strategy Committee and

 will direct the  staff working on toxics integration.
    ?
 (b )  Toxics Integration Strategy Committee:*     --—

      The Committee, with  representation at the DAA level  from all

 program offices  and one DRA, will act as the steering committee

 for the various  activities related to toxics integration.   In

 oarticular, the  committee will  approve  the workplan,  review the

 reports prepared by the different task  forces, and approve the

 final  report  on  toxics  integration to the Administrator.

  (c) Task Forces;

      For each of the  six  activities  listed  above a task force will

 be established,  consisting of  a task force  leader and  staff, as

 necessary.  Task force leaders will  spend full  time  on their assign-

 ment.  They will be part of the central group in charge of work on

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                                    -22-
t



toxics  integration.  Other staff members will  join the core group


or will remain attached to their individual program offices.  Each


task  force will develop a detailed workplan.


 (d)   Consultants and Contract Work;


      Each task force will develop plans for the use of- outside


 advisers and consultants.  Use of expert advice in defining dif-


 ferent approaches  to toxics integration is encouraged.   In particu


 lar,  new strategies for  industry-wide and geographical controls


 will be discussed  with industrial and state and local government
 reresentatives .
 ( e )  Management  and  Integration Mechanisms.


      ive anticipate holding  monthly meetings of uhe Toxics Integra-


 tion Committee  from  January through June, and bi-weekly meeting's


 from July  through  September.   Marilyn  Bracken, Roy Gamse, and .the
                                             . ^     7~J.1I!  - -

 project manager will meet with the Task  Force leaders at a


 regularly  scheduled  weekly meeting.  The project manager will work


 on a._daily basis with the Task Forces  and as needed with the TISC



 members.   "                                             •


  (f)  Update of Workplan;


      Once  the various activities  described  in the workplan are


  fully  staffed, the project manager and the  task  force  leaders will


 review the workplan and make changes as necessary.  The  Toxics


 Integration Committee will be kept fully informed.


  (g)  Scheduling Problem;


      How to develop FY  '83 resource needs in time  to  affect  the
                                                                   o

  Z3B  process this summer.  May need to assume a  continuation  of


 FY  '82 levels if we can't solve this problem.

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                    INTEGRATED TOXICS STRATEGY

                     Workplan for Activity 1;
                L£._2l Toxic Substances in Agency Programs
Statement of Objectives

One focus of the  Integrated Toxic Strategy workplan is
determining a means  to  integrate Agency activities pertaining to,
toxic substances  given  the  current  environmental statutes and EPA
organization; therefore  a comprehensive analysis of current  toxic
substances activities within  Agency programs  is a requisite  first
step.  The specific  objective of Activity 1 is to identify
similarities and  differences  in procedures used to regulate  toxic
substances and  to ascertain how these  can help or hinder efforts
to develop an Agency-wide  toxics strategy.

The analysis will evaluate  the completed regulatory action  of
each program, current work  in progress, and longer term plans for
toxics control.   Program-specific  regulatory  schedules and
priority  activities  will be identified in order to determine
compatibility with other program plans.  Activity 1 will  identify
various constraints  and opportunities  in toxic substances
activities and  will  suggest legislative, organizational,
programmatic, and procedural  changes pursuant •_.  _he  preparation
of  recommendations to  the Administrator in ^Activity 6.
      GENERAL SCHEDULE:
interim drafts
final drafts
finished report
      GENERAL STAFFING:
      Full time Leader from OTI
      OTI staff support
      One half-time person from OPE
      One person for one month each
         from seven program offices *
      One work-month from OGC *
      Total:  36 work-months

      CONTRACT RESOURCES:   $80,000

      *  Wot currently being used.
              9
             18
   4/30
   6/1
   7/1
work-months
work-months
              4 work-months

              7 work-months
              1 work-month

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TASK 1:_    AHALYZE  CURRENT  APPROACHES .

Analyze  current  EPA approaches  to  toxic pollutant control  in  the
various  programs.

Task 1-A:  Analyze  Toxic Substances, Assessment and Control
           Processes

Address  past  allegations of ineffective policy and procedures  in
each sub-task.   Notable  among  these  alleged  shortcomings are:
lack of  consensus  on health and environmental risk, inconsistent
response to risk,  overlapping  pre-regulatory assessment
activities, differences  in  weighing  costs  and benefits of
regulation, missed  opportunities for integrated enforcement,
uncoordinated monitoring strategies,  and  a tendency to respond to
the first exposure  route encountered  rather  than  the most
significant one.

Develop  program-specific profiles  (for  the air, water quality,
drinking water,  solid waste, pesticides and  toxic substances
programs) and conduct item-specific  comparisons of key program
activities.   The general focus of  these profiles  will be:
regulatory history, selection of chemicals for regulation,
selection of  control options,  regulatory  strategy, and analysis
of  risk.  The emphasis of this task  will  be  to identify
inconsistent  and overlapping activities within EPA.  Specific
areas  of examination include:

     0    Procedures for Setting Priorities "*     7~~
          Compare the priority setting  processes  used by  each
          major program.   Distinguish between priority  setting for
          assessment and for control  action.   Identify
          opportunities for  improving consistency  across  programs.

     0    Assessment Processes
          Identify consistencies/inconsistencies.  This  sub-task
          must be coordinated with Activities 2 and  3.

     8    Procedures for Economic Analyses
          Examine various types of economic analyses  performed
          during assessment  and control processes, and  the weight
          placed on analysis of costs and  benefits during
          regulatory decision-making.

     o    Toxic Substances Control Processes
          Examine the following areas:
          - the regulatory development processes
          - non-regulatory alternatives (e.g., incentives,
            information bulletins, etc.)
          - incident response processes
          - implementation mechanisms/processes
          - inter-program coordination efforts
          - fate of chemicals or problems dropped from the
            regulatory queues.

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                               -  3 -
     °   Status  of  Control  Activities
         Examine the  current  status  of  toxic  substances control  -
         activities in  major  EPA  programs.  Specify:
         -  progress made  toward regulation  of  toxic substances
         -  regulatory plans
         -  -scope of future  of remaining  problems

     °   Agency  Monitoring  Systems
         Compare monitoring and other  related  problem
         identification processes across EPA  programs; use the
         Integrated Monitoring Strategy as  a  primary resource.

     0   EPA Enforcement Programs
         Compare toxic  substances enforcement processes across
         media.   Examine the  program office/Office of Enforcement
         relationship in setting  priorities for enforcement  under
         each statute.

This .information will be developed  from interviews of senior
management  in each program  office.   The interview material will
be  developed into progam profiles,  which will be  the information
base  for Tasks 3 and 4.  Furthermore,  information and ideas  from
the interviews will be  used to refine  the areas of analysis  to be
conducted  in Tasks 3 and 4.

      SCHEDULE:      draft prof iles  _.,3/15
                     final report    ' 4/30 •

Task  1-B:   Intergovernmental" Coordination'

Examine in each major EPA program current and possible roles of
EPA Regional Offices, State governments and local governments in
problem identification, assessment, development and
implementation of controls,.and enforcement.   Input  should be
solicited  from Regional Offices,  State government and local
government sources.  Describe involvement of  headquarters offices
in  regional or other activities involving toxi.c substances
integration.  Describe  and critique plans of  current regional
integration efforts.  Review and  summarize the National
Governors'  Association  report on  state toxics integration
activities.  Discuss possible models for integration progress.
propose ways of coordinating the  ongoing toxics  integration
efforts with Regional,  State, and local authorities, and identify
expected problems  in doing so.

      SCHEDULE:          draft report           3/30
                         final report           4/30

Task 1-C:   Current Integration Mechanisms^

Identify and analyze basic mechanisms in-place within EPA to
integrate  regulatorv .development activities.   Present
programmatic-perspectives on the success of such integration
.mechanisms.

Examine the role of  the Work Group/Steering Committee/Red Border

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                              - 4 -
process as an  integration  mechanism.   Identify weaknesses and
strengths of  the  process,  and opportunities for improving the
process.

Examine the Toxic Substances Priorities Committee  (TSPC) as  an
integration mechanism.   Identify  strengths, weaknesses and
opportunities  for improvement.  Describe and analyze the
Integrated Waste  Management  (OWPO)  and  Integrated  Risk Assessment
(OHEA)  initiatives and  examine  their  relationship  to the
integrated toxics strategy.

     SCHEDULE:      draft  report    3/15
                     final  report    4/30

Task 1-D:  Enhanced EPACASR—  Developing  an Industry File

The Chemical  Activity Status Report (EPACASR)  is an  interactive
data base, accessible by chemical name/CAS number, containing a
description  of each Agency activity relating to chemical
substances.'  The  types  of  activities  listed  include:
regulations,  technical  assistance information, preregulatory
assessments,  chemical and  biological  testing and monitoring
programs  arid  labeling requirements -  both  completed  and
ongoing.   Making  this data base accessible by  industrial  cross-
reference would provide valuable  assistance in assessing  impacts
of  industry-specific regulations.

The  task  manager will identify, develop,.and select  means  of
accessing EPACASR by industry and will subsequently  begin
compilation  of necessary information.

      SCHEDULE:      preliminary reports       4/81
                     begin compilation         5/81
  -                   no completion date identified

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                               -  5  -
TASK 2;  ANALYZE  EPA  LEGISLATION

Analyze major  EPA legislation to  identify  and  compare  legislative
mandates for  toxics  control.   Survey  toxic substances  control
mechanisms  available  to the Agency and  describe  definitions  of
toxic  substances  as  .established by statute and as  interpreted  by
the Agency.   This analysis will  identify constraints to  and
opportunities  for integration in  the  statutes  EPA  implements.

Control mechanisms and their bases will be described for each
statutory  provision  as follows:

         purpose of  the provision
       -   control mechanism employed
          criteria for development of  the control mechanism
          the point at which the  control mechanism  is applied in
          the life cycle of the toxic  chemical
       -   deadlines imposed by statute.

The definition of a toxic substance will be described:

          in the language of the statutes
          as interpreted by the' agency

          SCHEDULE:  interim draft    3/30
                     final report     5/15

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                              -  6 -
TASK 3:  IDENTIFY  LEGAL  AND  ADMINISTRATIVE  CONSTRAINTS/
         OPPORTUNITIES

Identify legal  and administrative  constraints  to  integration  as
well as opportunities  to facilitate  or  promote  integration  in the
Agency programs pertaining  to toxic  substances.   This  analysis
will cut across Agency  procedures  for setting  priorities,
assessment  processes,  procedures  for economic  analyses,  control
processes,  agency  monitoring systems, and  enforcement  programs.

The  specific analyses  to be performed in this  task  are based  in
part upon  the information gathering  of Tasks  1 and  2 and will
therefore  be developed in parallel with them.   A dialectical
comparison of procedural and statutory aspects identified in
preceeding tasks will  serve as the basis for  the recommendations
of Task  4.   Because the candidates for analysis are expected  to
be numerically unmanageable, a subset will be  chosen  for
immediate  attention based upon: 1) potential  for near-term impact
on Agency  activities,  2) relevance to other parts of  the
Integrated Toxics Strategy, and 3) managability given  current
resources.

      SCHEDULE:      compare and contrast
                       profiles to identify
                       issues                   3/30
                     selection of analyses      4/6
                     draft analyses              ', 1
                     final report         •      6/1

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                              -  7 -
TASK 4:   IDENTIFY  DESIRABLE  MODIFICATIONS

Identify  changes  in  organization,  procedures,  resource
allocation,  and  legislation  that could  lead  to improved
integration  of  toxic substances  assessment and control
activities.   Analyze Tasks 1-3  to develop  recommendations  for
changes  to  improve Agency integration efforts  involving  toxic
substances.   These recommendations will be developed  in  concert
with Activities  2, 3, 4, and 5.

     SCHEDULE:       draft report               6/1
                     final report -              7/1

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i
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

              WASHINGTON, D.C. 20460

                    8 0 FEB 1931
                                                              RESEARCH AND DEVELOPMENT
 SUBJECT:  Draft Work Plan for Activity 2 Under  the Toxic Integration Program
 FROM:     James W. Falco, Director
           Exposure Assessment Group (RD-689)

 TO:       See Below

     Attached is a draft work plan for activity 2  of  the Toxic Integration
 Program.  Please review this draft in preparation for  a work group meeting to
 be held on Monday, February 23, 1981 at 9:30  am in Room 3802.  At this meeting
 I would like to receive any recommendations for changes you wish to offer.  I
 have also attached a copy of the overall program work  plan for your
 information.   I look forward to working with you on  this project.

      Please contact me  if you have any questions.

 Attachment s)

 Addressees:

 Allen  Hirsh  (RD-682)
 Daphne Kamely  (PM-223)
 Jack Fowle  (RD-689)
 Bob  McGaughy {RD-689)
 Peter  Yoytek { RD-689)
 Courtney  Riordan  (RD-680)
 rDan  Beards! ey  (PM-208)
 Ted  Just  (RD-674)
 Charlie Ris  {RD-689)

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          Detailed Work Plan for Acccxnpl ishment of Activity 2 Under

                       the Toxics Integration Work: Plan




    To accomplish the objectives of activity 2 of the Toxics Integration


Project, the following work  plan is proposed.  The time and resources


allocated for the accomplishment of these  goals require that the exposure and


risk assessment  activities  conducted  by each operating program within the


Agency be aggregated into fairly broadly defined categories.  These categories


of assessment activities  can be evaluated  and compared with similar activities


in other operating  programs.  In  addition  to evaluating the Agency's exposure


and  risk assessment activities in  a manner that  is consistant with the


Agency's resources, the aggregation of activities  in  to broad categories


should provide  a reasonable number of recommendations that  have a significant


 impact on  improving the quality and efficiency  of the Agency's operation.


     We propose  that a separate report be written for  each  of  the tasks


 outlined in the Toxics Integration Work Plan under Activity 2.  Each of  these
                                                    . ^.      :-	

 reports would be written in a  style and format such that  at the end  of  the


 project one final  report could be published by assembling each  task  report  as


 a chapter and adding a summary chapter.


     We  propose  to  address  the  following issues in task reports.






 Task 1  Report - EPA's Approach to  Exposure and Risk  Assessment


     This report will contain  a brief description of  the requirements for


 exposure and risk  assessment specified by each major legislative act.  Major


 operating programs involved in the implementation of exposure and risk



 assessments will be identified.

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    The report will also  contain  as  individual sections a description of the
implementation strategy employed  to  satisfy regulations.  Specific topics
included for each major exposure  and risk  assessment category are:
    1.  Description of procedures for conducting cancer risk assessments.
    2.  Description of procedures for conducting mutagenicity risk
        assessments.
    3.  Description of procedures far conducting risk assessments for other
        health effects.
    4.   Description  of procedures for conducting exposure assessments.
     5.   Description  of procedures for conducting environmental risk
         assessments.
     6.   Description of procedures for independent  review of  assessments and
         quality assurance of data.
     This report will   also identify  the program offices  that  collect  and
 analyze economic data and that assess benefits and costs.  Methods used  to
 perform economic evaluations will also be described'.*     "~

 Task_2 - Analysis of  the Reasons for Differences in Approaches  to Exposure  and
 Risk Assessments                '
     This report will  highlight the  differences in management and technical
 approaches  for conducting  exposure  and  risk  assessments.  Specific topics will
 i nclude:
     1.  Description  of differences  in reliance on outside experts and weight
         given to  their testimony and statement of reasons for differences.
     2.  Description  of differences  in methods used to  measure or estimate
         exposure  based on  monitoring data and statement of  reasons  for
         differences.

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  3.   Description of differences in methods  used  to measure or estimate dose
       and statement of reasons for differences.
  4.   Description of differences in methods  used  to  interpret and
       extrapolate results of bioassays and statement  of  reasons  for
       differences.
   5.   Description of differences in methods  used  to  interpret and
       extrapolate results of long-term whole animal  tests and statement of
       reasons for differences.
   6.  Description of differences in methods used to interpret and
       extrapolate acute  toxicity data and statement of reasons  for
       differences.
   7.  Description of  differences  in methods used to collect and interpret
       clinical  and  epidemiological  data  and statement of reasons for
       differences.
   8.  Description of  differences  in models  used  to translate emissions into
       exposure  estimates and statement of reasons'for differences.
    9.   Description of differences  in other methods used in exposure and risk
        assessments and economic evaluations  discovered during task  1 and-
        statements of reasons for these differences.

Task 3 -  Analysis of Needs for Changes
    This  report will briefly describe how each major  category of  exposure  and
                        t
risk assessments  is used  by the Agency.   It will  also  define needs  for
administrative and technical changes.  Specific topics to be discussed
i nclude:
    1.  Description of use of exposure and risk assessments by each program

-------
    office highlighting needed changes  related  to  this use.
   2.  Description  of use of exposure and  risk  assessments by regions
       highlighting needed changes related to this use.
   3.  Description  of use of exposure  and  risk  assessments by states
       highlighting needed changes related to this use.
   4.  Description  of use of exposure  and  risk assessments by the  public
        highlighting needed changes related to this use.
    5.   Description of other needed changes that become  apparent during task 1
        and task 2.

Task 4 -,Report Analysis  of Approaches Used by FDA, CPSC, OSHA,  and NCI
    This report will  briefly describe the legislative requirements  for
exposure and risk requirements  for exposure and risk assessment that must  be
addressed by FDA, CPSC,  OSHA,  ad  MCI.  Guidelines  and procedures used by each
Agency will be described.  Specific topics addressed will include:
                                                   - 4-      --—
    1.  Description of procedures for conducing cancer assessments
    2.  Description of procedures for conducting mutagenicity assessments
    3-.  Description of procedures for conducting risk assessments for other
      ... health effects.
    4.  Description of procedures fo conducting exposure-assessments.
    5.  Description of procedures for  independent  review and quality
        assurance of data.
    6.   Description of economic analyses performed.
    This  report would highlight similarity and differences in management  and
 technical  approaches among agencies and the reasons for  those differences.

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Feb. 23              March Z3          I April 23                May 23               June 30            Aug  1
                               Task 2	j
                                             •	Task 3
                                        Task 4	
                                                                          Task 5
                                                                                        j	Task 6	
                                 FIGURE 1.  SCHEDULE OF COMPLETION OF ACTIVITY

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Task 5 -.Recommendations for Changes
    This  report will  suggest changes in organizational, procedural and
resource  allocations that v.-ould improve consistency,  integration and
efficiency, of exposure and risk assessments conducted by the Agency.  Specific
issues  that will be addressed in this report are as follows:
     1.   Organization to prepare short-term risk asseessnents that are needed
         to support regional responses to environmental  incidents.
     2.   Development of criteria to determine the level  of  acceptable quality
         for exposure and  risk assessment.
     3.   Organization and  management of program office (offices) involved in
         exposure and risk assessment to  insure consistency and credibility
     4.   Recommenced chages to minimize legislative barriers to consistency of
         assessment  and  efficiency  of conducting assessments.
     5.   Definition  of changes to improve and expand economic evaluations.
     6.   Definition  of changes  needed to  address other problems discovered in
          tasks  1 through 4.                        .*••=-_..."
     Task  6  will  involve review  and editing  of  each task report  to form  an
  integrated  final  report.
     table 1 lists  the responsibilities for completion of each  task.  The
  assignment of responsibilities reflect the need  to organize work to maximize
  efficient execution of the tasks and to retain responsibility for decisions
  within the Agency.   Figure 1 shows the schedule  of completion of tasks.
  Although this schedule shows tasks completion dates  for individual tasks later
  than originally proposed, it indicates a final report delivery date of August
  1,  1981.  Thus, completion of activity 2 will  occur  on target if this schedule
  is  approved.

-------
            •  '    '  TABLE  1.   ASSIGNMENT  OF  RESPONSIBILITIES


    Task 1 -  This task  will  be'done by  Clement  Associates.  In-house activity
2 team will review  and  comment on this  report and  offer technical information
in their areas  of expertise.
       »
    Task 2 -  This task  will  be the responsibility  of  the  in-house team.
Clement Associates  will assist the team by summarizing team opinions into a
report and providing  professional technical  consultation  in,their areas of
expertise.                        •  .

    Task 3 -  This  task  will  be the responsibility  of  the  in-house team.
Clement Associates  will assist the team by summarizing team opinions into a
report and  providing professional technical  consultation  in their areas of
expertise.
                            •
    Task  4  -  This task will be done by Clement Associates.  The  in-house team
 will  review and comment on this  report and offer technical information in
 their arees  of expertise.

     Task  5 - Thi-s task will be the  responsibility of the  in-house team.
 Clement Associates will assist the  team  by summarizing  team opinions into a
 report and providing professional  technical consultation  in their areas of
 expertise.

     Task 6 - The in-house team and Clement Associates will  be jointly
 responsible  for editing the five task  reports  to form the final  report.

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                                                      2-/IX/— ll

                   INTEGRATED TOXICS STRATEGY

                        Analysis of the
        Cneraical  Approach to Toxics  Integration/Control

:TIVITY 3 —  WOHKPLAN

ie intent of  this activity is to- evaluate EPA's  optiaal
:nenucal" approach (including chemical "classes")  *o
-ope-S^i-CS^^^RS Jo*1"' Particularly with'r^ard to the
.ope,  Tni.,   wi uh ouher feasible integration aoproacn.es   *ince
his  activity  is especially intertwined with the  sCb^cts oT
ctiviries one and two, there should  be a considerabl^ amount of
ubswantive  interchange among then.                    «nounw o,

:.    Evaluation of Traditional Agency Practices
  e
..,=  inzent of this  section  is  zo  assess to scse degre-" the  •
:ro-.i£-SLrAs iaportant
to. note  that the Solvents work group is  the first coordinated  "
Agency-wide effort to develop an Agency  Control Strat-egy for  a
whole use  class of najcr chesicals.  Likewise, the I?? process is
the" first  tiae the Agency has integrated its -s'sjor activities and
resolved- outstanding issues on the Agency's 20 egreeG-upon
priority cheaicals.

III.  Recommendations for FY  1SS2 and Beyond

This will be the major  section of  the final report.   The first
two  sections will support the development of options  for
improving the  Agency's  present toxics-related progress.  Options
wili-.be developed that  range  frcs  incremental isprovevents to
present procedures  ro'cajor  charges  to  the  Agency's policies,
laws,  and organization.

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 7IVITY 3 --  TASK OUTLINE
              ^^^^^^^^^^^^^^^™*^^^^^"^^*^^™^^^^^
       »

 -K- ^ — Evaluation of present chemical oriority settinz
 aczice-s or  £?A                                  - SL
•
  _ intent, of this task is to H) describe how -?A srogrsni
 fices  presently set their toxic chenical priorities, (2)
 lalyze  differences in their priority- setting and (3) define the
 itegration problems that have arisen as a result of these
 fforts.   The following subtasks  are  intended to provide  base-
 ine  information on- rsajor areas requiring greater* Integration
 ttention.

 ASK  1A  -- Priority List  Developaent  Evaluation   CThis task will
 e closely coordinated with  Activity  T)

 'his  task will  address how  the
TASK  '\3. --  Analysis for consistency of ell -•a.'ior  Hger-cy documents
cr.  whrea  cher.i calls (cadniiuia.  arsenic. ~.r ichlorethylene) ,

This  .subtask is being conducted by Elaine 3ild anc .John
Gevertz. .  The first draft will be completed by March 15th.  Ail
•ca.jor support documents have been gathered, and a-= being reviewed
to  Identify specific a-nd generic redundancies and Inconsistencies
aniong program offices.  This analysis will be provided to the
Activity  2 leader to assist in the overall risk assessment reiev.

TASK'1C — Consistency of  Cost ?er Unit of Pollution/Risk  .-••-..
Reduction                   .                         . .
                              •                          '
 "Vs subtask will  assess  the  cross-program, cr-css-aedis
 consistency of costs  iraposed  by  EPA  program office regulations on
 cheaica'is of concern.   Realizing the critical constraints  (such
 as different exposure  pathways,  risks,  and legai^suthorities), we
 will t;
 Thi:

     ooiicv rccccaendations if the consistency is  less  unan
 appropriate.   Bollis Call of OTI will lead  this contract study.

 Schedule/Cost
 c=-sleted  by

-------
TASK -ID  -.-

               get Populations
This  subtask addresses issue of whether or not I?A offices are
consistent in defining the "target populations" (populations st
risk)  that they are intended to protect (e.g., in teras of aaount
of  food  and water intake, adult and child weight classes,
etc.).   Tnis subtask will identify any inappropriate
inconsistencies and policy needs.  The completed task will
provide  a 3sjor input to Task 2.  Sar.di lee and Avis Robinson, of
OTI will conduct -this analysis.  The initial craft should  be
completed by March  15th.
 TASK 2 — Agency  Cancer Policy (and other health effects).
 This task was initiated  as -a ccansittee effort in 1980 under the
 auspices of the TSPC,  and is addresseing aajor cancer-r^ ateci
 issues, including:       •        '                   :  ' c-ei-c«

           Should  the  Agency have  a generally agreed upon
    -   ,    carcinogen  risk "ceiling" and "floor" to assist s»tHrg
           priorities  ssong chemicals?

           Should-  the  Agency set  toxics priorities based on
           individual  or  aggrgate  population risk?

 Since  this  is  a rsajcr,  ongoing  task vith high level Agency staff
 participating.  and  lies  conceptually  soaevh«re between activities
 2  and  3, it will  in fact function  as  an autonomous activity
 "feeding .into"  activities  2 and  3      .
 TASK' 5  —  TS?C  Task Group Pilot                     .        •  : .

       3 A --. "S?C Solvents Task Group               .  .    ..; :. _  _?
    * '-                                 »         •    ~ '
 The TSPC Solvents Task Group, chaired*by  Arnie  Zdelaan  of  OTl,:r is
 c.  pilot effort  initiated in August,  1950  to.  assess  the  cross—
 Agency  integration issues involved  vith  these 5 organic solvent
 degreasers.   After the task group's  initial  issue/status report
 to the  TSPC in  December, the work group  was  charged to  develop an
 Agency  control  strategy for these checicais  and to  act  as  a
 "sini-steering  cosaittee" to ensure  that any related,  regulations
 are  consistent  with the developing  control  strategy.  The
 solvents work group will also act a as a. sounding board in
 reviewing/assisting OTI .analyses of (1)  intentional and
 unintentional intermedia transfer of chesicals, especially
 volatiles; and-  (2) the effect of £?A controls on the  use of
 chemical substitutes  that r.sy be cf equal or greater risk.

 The  TSPC Solvents  task group is a -ajor,  pilot  attempt  .to

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            r01"*-^0 ,regUlat°ry and ^"-regulatory approach. ..
wi'th the  mc             aUen5pt t0 coordinste its activities
Schedule
The^solvents.vork group's draft work plan entails $100 X in Oil
nn^n!n/U??0rtTJ!£ an. additional -$190 K in needs.   The schedule
is Dependent on TSPC approval and funding.   If tasks are not
-n^la^  1D Msrch> fin£l work Sroup results will not be unt
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n* these c^<  ^ c^rscteristics. .regulatory,  and  action levels
?iS-?"^   i°-ls.t0  aSS1St  £?A  *€Sions  to  set  prograo
xi!l%U;es.an? lo infora  ^e  public  how  EPA  is  responding to   •
^n^-?"10;1 r*Sks'   In  a«ition,  071  will  identify ^ajo^
.:!:!?•:?;i'fnd  ?°\ic>'  issues  f°r  the  Integrated  Toxics Strategy
.0001 u-ee to resolve,  assign  program.office  responsibilities  for
•esolving, or  establish additional  7S?C  work group(s) to resolve.

The  overall 1?? process will  be  evaluated in terras  of its
effectiveness, in  promoting greater  toxics integration and  -
potential "stronger"  variants of the process that could be aore
effective.
Staffing
           071 — 2 workyears plus'$115 K in 071 contract support
           Support in identifying and abstracting infonaat*oA" on
           tne 20 chemicals from CAQrS, On:?.S, ODW, CSV. "ORD  O7S"
           and Or?

 Schecu'l e- ( s c h e.c u 1 e a t z a c h e d)

           The benzene and arsenic cocusents are in draft fs.-3 and
           should be in final by the e.r:c of February
           7he regaining packages will be completed by Augus-t.

 7ASK  5 —. Potions for Better Integration of Agency 7oxics
 Aetivj-ties

 The previous four tasks will provide  a basis* for 'assessing  (1) :
 where and to what extent the Agency.-is not  properly integrating,
 its toxics-related . activities,  and  (2) the  utility of the  '".    "~'-V
 ongoing, pilot  integration  efforts  (or modifications cf these
 pil"bts5 for  broader  application in  FY 1982  and  beyond.    '.  : ;,:,  ,
                                                             ^   
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3-    Intermedia priority pollutant process' for additional
      chemicals of concern.

C.    Require control options analvses on all toxics
      regulations prior to AN??,M

D     Keiew and evaluate  agency toxics-related  contracts  for
      overlap and potential  inconsistencies

E.    Require each  program  to rcaintsin  its toxics-reacted
      activities  up-to-date  in  a  central  data systes~(a  la


      Pro

            Besults  in least distrubance to  present programs

      Con            ••                             "JL

            Suffers  frcns  sever* -eckr. esses of Agency vork
            groups (regulatory or  ~S?C); lack of interest and
            'attention frora other I?A offices.

  Increased Integration Authorities

  A.    Develop detailed guidance  for all materials balance,
       exposure, health,  and risk cssessr-er.ts cone by £?A.
  .•
•   •
            One central office  to reviev/approve. sll such
                                                 '"
on
               •                              _,*""
  B.   fora  2  series of standing, -ork  groups  (based
       chesicsl  "classes"  and/or  industries)  responsible  for •
       all reguiation-developaent in  that, category. _    •  ...

       *     Incorporate responsibilities  as  z aajor  cos-ponent.
 •'*?•---        of perforsance stand-arcs  »*     .       '•"•"""   •."-:'- •  •

  C. -   Hecuire sore specific and directed analyses "of
  •  '    interaeois iopsct of regulations prior to their
        proposal and prosulgation.                ..' -  .

         P_                   '                     • • ."••- •
         • O                  •     •                 - ; .- '-

             Provides enhanced  capability  for integration
        Con
             5T.iil  does  not  ensure  integration  among  work
             groups  or  supporting  prcgra." offices

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I!. .Cent, -feii^u  toxics integration Function
 •    .     •
   .'A.    Toxics  priorities for entire Agency set by one office
         (probably Oil)  '

               Individual  prograa  offices then assigned specific
               or lead  responsibilities

     3.    All toxics-related  assessment  activity conducted by one
          office  (probably -in ORD)

     C.    All toxics-related  analyses conducted  by  one  office
          (probably  in OPE)

     D.    Standing control work groups using products  of  3.  and
          C.                '                          ."
                             •                          **. • ~  ~ *
                Each work  group to develop s control options •
                analysis  for  rsview/evsluaticn/cpprovsi by A.
                before  developing  an  Agency-wics control strategy

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                 DRAFT WORK  PLAN FC? ACTIVITY 4:
NALYSIS OF TOXICS  INTEGRATION  BASED ON  INDUSTRY-SPECIFIC APPROACHES
    This activity  will  attempt tc  develop  industry-specific
trategies fcr control of  conventional  and  toxic pollutants.
he goal^of these strategies is to  identify the most cost-effective
ay to minimize  health and environmental  risks associated with
ndustrial discharges.   The FY 81  focus of  this activity will be
wo case studies,  one dealing with  a portion of 1±e organic
hemicals industry and the other with a subsector of nonferrous
etals.                          •

    Each of  these studies will characterize the nature and
acnitude of  the pollution problems specific to the given industry,
centify available information on  exposure  and risk from the
ollutants, assess the combined environmental and economic  impact
f various  levels of regulation, and attempt to' craw conclusions
n the  need for  priority-setting among environmental media  and
ollutants.   Each study will lead-to the  development of a sample
nternecia  strategy.  Together, they should enable EPA to design
  preliminary strategy fcr coordination and priority-setting
 none  the various regulations that could  be imposed on any  industry.

        *
                                             A.     --	.
                                             ^f     —•—

ASK 1  Select Appropriate Subsectors for Analysis

     Criteria for  selecting  the subsectors will include:

     «»~~ Availability of data on-the economics of  manufacturing
        operations and data  on  environmental loadings,  exposure,
      •  'and effects;

     8  Existence  of intermedia tradeoffs;

     0  Existence  of interpollutant tradeoffs;

     0  Possible  tradeoffs  among different parts of the subsector
        (e.g.,  "big" versus  "little guys");  and

     0  'Locical  factors that make  the  candidate subsectors either
        particularly coherent or interesting.


     Staffinc:   All  members of the project team plus delegates of
                 each of the major  program  offices (Air, Water,
                 Solid Waste,  Hazardous Kaste, Tcxics, and
                 Drinking  Water).

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   ' Schedule:

                0   Separate meetings will be held on February 18
                   for  organic  chemicals and nonferrous metals.

                   3y February  23,  a memo providing analysis of
                   options  and  recommendations will be sent to
                   Dan  Beardsley,  Roy  Ga~.se, and K-arilyn SracXen.

                0   3y  February  27,  the selection of subsectors
                   will be  finalized.


['ASK 2  Collect Data for Each Selected Subsector

    Both  the data for the risk assessment  and  the economic analysis
should be  developed according to three scenarios:

     0  Assume that no Federal pollution controls vere mandated.

     0  Assume that only controls already installed are  required
        in the future.        ,

     0   Assume that all Federally-required  controls are  installed
        according  to schedule.

     0   Assume that (for organics) that generic controls replace
        chemical-by-cheniical controls in the. air media..

     To the extent they -may te relevant, the study teams should
also "consider the  environmental .effects of other Federal programs
(such as OSKA regulations) .
           scenarios will  enable the study team to determine:

     e  :What "baseline"  emissions would be in the absence of
        JFederal pollution  control regulations;

        The magnitude  of current untreated pollution or
        residuals;  and

        The magnitude  of pollution  problems in the- future"
        according  to a "business as usual" scenario.

        The maonitude  of the air pollution problem if generic
        controls  replace cheraical-by-cheiaical controls on  the
        organics  industry.

3y assessing the  cost  implications  for these  scenarios,  it will
oe oossible to  determine the "economic burden" of  current  and
projected pollution controls that might be  shifted to more
V.-ortant health  and  environmental  problems without  increasing
Iv£ ,ni,-r-< sated level  of control-related expenditures.

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 ,   «iven that the various subsectcrs of  the nonferrous  metals
ndustry are less  diverse  (fever plants,  products,  and  ollutants)
 a- z.ie suosectors o
                     erse   fever  plants,  products, and  pollut
                     f  the  organic chemicals  incustrv,  analysis
. zhe former will probably deal  with specific  facilities  while
r,a lysis o* tne  latter  will probably focus on surrocates,  such
s "generalized  plant configurations":

    Staffing:     1.  The  following EPA offices will  develop
                     information on environmental loadings for
                     . each of the above scenarios:

                  — For air emissions: . Office of Quality  Planning
                   and Standards  (OANR) .

                  — For effluents:  Effluent Guidelines Division
                     (OWNM)  .     '    '                    -.

                  --For drinking water quality: Office of  Drinking
                   'water  (OV7WJ5)  .

                  --For solid waste:  Office of Solid Waste (OWWM) .

                  --For hazardous  waste:  Office of  Enforcement.

                  2.   Health effects  date, and information  on
                      population  exposure will be provided primarily
                      by the Office  of Research and  Development and
                       the  Office  of  Pesticides and Toxic Substances.
                                             . JQ-    r~L-M   - -
                  3.    Co.st data will be provided by the individual
                       program offices-.and will be further refined
                      by Putnam,  Hayes, and  Bartlett, Inc. and
                       appropriate subcontractors.  Fred Talcott •
     .--                and  Jim Titus,  both of 0PM, • will supervise
                       the  economics  effort for organic chemicals .
                       and  nonferrous metals, respectively.

     Schedule:

                 1.   Complete the environmental  assessment by  April  1

                 2.   Compile basic health effects data by April 15.

                 3.   Develop baseline manufacturing costs  for  the
                     nonferrous metals subsector  by April  21.   To
                     the extent  possible,  provide information
                     specific to  individual facilities.

                 4.   Develop "generalized plant configurations" for
                     the selected subsector of the organic chemicals
                     industry by  April 1.

                 5.   Develop-' .the  cost inforrr.atior. on the other three
                     regulatory  scenarios by late .-.pril.

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   "3  Calculate  and  Prioritize  the P.isks  to  Public  Health  and
       other  -nv iron-en tal  Values  for Each Pcllutar.t Stream
    This effort will build on the data collected  
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jrcen" and a possibly higher level of resource  constraints,
ttecks-_the worst  public health and other environmental problems
rrst,  (b) treats  public health threats consistently between
 vircn-ental media,  (c) considers economic impacts'on both the
rosperous and  less prosperous, segments of the" industry,  and
c) reflects  the differences in environ-.ental risks associated
•ith  different  plants due to their individual locations.   This
:2sX  is meant to pull together Tasks 1 through 3.   It will require
merging the  risk assessment with the economic analysis, and will
•rr.phasize concepts such as cost-effectiveness and  trade offs
Between various pollutants.  This will be a major  focus cf the
discussions  with industry and  the individual program offices.
To be.most useful, it should clearly articulate all major
assumptions,  alternatives, and caveats.

     Designing the sample intermedia  strategies (including process
changes that could be ordered  under the  Toxic Substances Control
Act)  may  require  the  development of new  control cost, estimates.
To the extent  this is cone,  it rr.ay be  necessary to use crude
ccorcxima tior.s, rely  on the  experience cf  other industries, or
r-ake orders of .magnitude, judgments.   The basis for such estimates
should be clearly  articulated.

     Staffing:  This  aspect  of the study will involve  the whole
                work  group.   The  managers and consultants
                responsible  for  the risk assessments and economic
                analyses will be  particularly important in this
                exercise, as will George Proverzsno  of the Office
                of Research and  Development, who will  provide
                guidance on how best  to  merge"*the  tvo  types of
                 assessments for each  industry.

      Schedule:  This activity will produce s. draft report  by
                mid-June and a final  report by  late  July.
                               ^                               •

T*SK-5" "Evaluate  the .-.pblicability of the .-.pproach.es Taken and
         Develop Recc-umendations for a General Industry-wide Approach

      Based  on the preceeding  tasks,.it  should be  possible  to:  .

      •  Identify industries that should be studied in FY32 to
         •continue this  research effort,  and

      •  Develop general  conclusions about toxics  integration that
         will be useful.

-„ *var-  -incustrv case  studies should  be more representative of the
to'alranc'eo" industries and provide a better basis for generalizing
about needed  changes in  regulatory,  statutory, or analytical
-^roachls.   The coal  of  such studies will be to develop well-
suooorted conclusions  for improved integration of toxic control
strategies in FY  83.

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     3y  .Vcgust 1981, however,  it  should be possible to offer
 relir.ir.ary conclusions  for  consideration by senior management
at e?.~. and tr e Office of Management and Budget.  For exair.ple,
for the  industries  studied,  it should  be possible to state
whether  control of  conventional pollutants should be de-emphasized
to free up resources for better control of toxic pollutants in
certain circumstances.   It should also be possible to identify
ctat gaps  that prevent  analyses of this  sort from being as
complete as  one might  like for regulatory purposes; analyze
whether toxics problems can adequately be addressed through a
multi-media  regulatory  development approach; and shed light en
resource and other  implications of adopting  such an approach
across  other industries.

      Staffing:   the whole project team and  the consultants.

      Schedule :

                • 1.   Develop a  draft report su--,arizing, the
                     results this  task and the  preceedirg  ones
                     by late July.

                 2.   Issue a final version of the report by
                     August  11, 1981.

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                                                                            Os
                          TOXICS INTEGRATION PROJECT

                          Geographic study: Workplan


I.    General- Goals of the Geographic Approach

     The general goal of the  geographic approach is to define and test a
methodology whereby geographic  studies could be made a prime means through
which the agency's toxics control  activities are carried out.

     Both the pollutant-by-pollutant and the industrial approach to integ-
ration seek internally  consistent  and  nationally appropriate systems of
regulations.  The  geographic  approach  looks at the  issues from the opposite
direction, seeking unique and locally  appropriate solutions to toxics problems.
These solutions may or  may  not  depend  on the existing  national control pro-
.grarns to achieve their  goals: certain  aspects  of existing programs may be...
either irrelevant  or  even counterproductive in responding to local problems"
cS defined by this approach.

     This  activity wi 11 therefore  develop  a methodology through which state
end  local  participation—and  control  authority—night  be enlisted nore
effectively  to  serve  national pollution  control  goals.  It will seek ways
to integrate  the  federal  and  non-federal  resources  in  such a way as to ir;aximize
public  health benefits  locally, and minimize  costs  to  all participants {industry
as well  as all  levels of government).

      In  the  current  year,  the project will be  concerned both with the general
methodology  for organizing  and administering  a geographic  study, and with
the  analytical  tools necessary to conduct them.   Methodological  studies  will
concentrate  on  administrative, political  and  legal  designs  of  geographic
 studies— how intra-  and intergovernmental  roles  and responsibilities can be
 defined, how administrative  and political  ties with states  can be tightened,
 how  state and local  laws can be utilized to support national  public  health and
 environmental goals.   Analytical studies will  concentrate  on the task  of
 producing cost-effective tools for analyzing local  toxics  problems  accurately,
 and  for. defining efficient controls.  These are discussed  in turn below.


      Kethodological  Studies

      EXHIBIT A shows our prototype methodology in  schematic form.   Absent
 from this flow diagram is  any  discussion  of technical assessment issues:
 these are presented  in the following  section under "Analytical Studies."
 The  key here is to define  the  interrelationships of EPA with the states and
 local governments, and in  the  later stages of strategy development, with
 industry and the  public.

      Since toxics problems are known  to be usually most severe in metropolitan
 industrialized areas,  where  concentrations of industries discharge effluents
 into confined  ecosystems near  concentrations  of population, testing of  the
 methodolgical  approach will  emphasize urban situations— both  in terms of  meth-
 odology development  and analytical  techniques.  But  ultimately the methodology
 should be generally  applicable, even  to  contexts where toxics  problems .are

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minimal .and existing  control  programs  (perhaps)  excessively  stringent..

     Costs are  discussed as a methodological  issue because of the  crucial role
 ,hey play  in  allocating emphasis, and  responsibility,  between seoments  of this
methodology.  Cost estimates for most  elements of a geographic  study  will come
 from the analytical  studies (pilot studies) conducted, but the  overall  method-
 ology  must offer strategic guidance on how to allocate limited  resources between
 activities.   Overall  estimates of costs are also critical  in determining a
 general strategy for when and where to do geographic studies (Step A) and
 how often.   It  may be that such studies could become a regular  part—even a
 predominant  part—of agency activities, or it may be that  they  would  be
 employed  very seldom.

     The  following sections briefly discuss the methodological  and study issues
 involved  in  each of the prototypical steps listed on EXHIBIT A,


      STEP A

      Before geographic  studies  can  be  routinely conducted as part  of  a  toxics
 control- program,  a methodology  or  procedure for identification  of  potential
 problem areas will need to  be devised.  THe methodology would essentially
 consist of a procedure  that  would,  through the use  of existing  data,  screen
 out. those geographic  areas  that are likely to have  sub-population  groups ex-
 posed to higher than  tolerable  levels  of  toxics (however defined)  in  one
 or more medi a.

       Sone constraints  on  formulation  of the methodology would be:

       o    it should  not require collection of new data, i.e., should  utilize
           existing  data bases.
       o    potential  problems should be quantified such that priority lists
           can  be  developed.
       o    in view of the  fact that the selection  methodology will  be applied
           in a  large number of  cases,  it  should  be relatively simple and
           non  resource intensive.
                                                    *
      •                                             -^

       Study  Issues for FY 81:

       o   Study technical factors to  be  used in formulating the selection
           criteria
       o  • Examine the adequacy of existing data bases for making  site  selections
       o   Define the role of federal  agencies (EPA and others), states and
            locals in the  sites  selection  process.   (Should the  selection process
            be left to the states with EPA and other federal  agencies  merely
            providing technical  support and input?)


       STEP B

       Following selection of a  site (using procedures in Step A),  the next
  step  would  attempt a preliminary analysis of existing data  designed  to show
  probably sources, pathways  and exposure  levels for a selected  group  of

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toxics.   The group or list of chemicals to be subjected to further studies
should be identified in this step, and will likely be taken from the list
of 20 intermedia priority pollutants and any other local chemicals of interest.
 hese  table-top" analyses should also provide indications of the problem
inedia around which field sampling and data collection efforts would be
designed.

     While it would  seem logical for EPA to take the lead in the development
of standardized modeling and forecasting techniques, the role t>f local and
state governments would probably be greater in actual application of the
techniques and the ensuing analysis of data and results.  States could
concievably take the responsibility for performing these analyses (as they
presently do for water-quality  based effluent limitations) with technical
support  from EPA.

      Study  Issues  for FY 81:

      o    To the  extent possible,  define  the most  efficient allocation
          of responsibiliteis  for  this task  among  the federal agencies,
          states,  end local  governments.
      o .,  Assess  the adeqaucy  of existing techniques and  data bases to
           perform- such desk-top analyses,  identify deficiencies  and rem-
          edial  measures,  and  their costs.
      o    What are the costs of the studies  to  EPA and  the  states?
      o    What are appropriate sources  of funding  to support these
           activities?


      STEP- C

      It is  likely that in many cases,  existing  data are insufficient  to
 adequately  assess and define local problems..  Presumably,  the table-top
 analyses will  show  up these deficiencies and also provide information on
 areas/media requiring more study and/or data.

      This step should produce, through a cooperative effort between federal,
 state, -and local entities, a field sampling program designed to fill  data
 caps revealed in the  previous  step.  Methodological questions will  include
 examination of appropriate divisions of effort between participating parties,
 estimates of  unit costs for various types of studies conducted, establishment
 of  standard sampling  protocols in  various media,  and so forth.   Political
 questions may arise as to public  involvement in this phase, particularly if
 media to.be sampled are publically conspicuous and may arose public interest
 or  anxiety.

      As  is discussed  below  under  Step F,  this step may be  iterated repeatedly
 in  order to arrive  at conclusive  evidence.  Either in the  first or in sub-
 seouent  iterations, health  studies may be indicated, including direct
 sampling of tissues (hair,  blood,  urine,  adipose), or  other types of epi-
 demiological  work.   Due to  the costs  and legal  issues  involved, and the  int-
 erests  of  other  agencies  (CDC),  analysis of the health study Tssue should
 be  a special  sub-element  of this  part  of the study.

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    Study Issues  for  FY  81:

    o    Define types of survey or field  sampling  techniques that may
         be useful,  including standard unit  costs.
    o    Tackle the  health issue directly, determining  criteria for
         undertaking  such studies and for not  undertaking them.
    0    Establish formal relationships with health  organizations and other
         with  special authority or expertise in  relation to any of the
         study activities affected.
    o    Examine  relative roles of EPA,.states,  and  localities.
    o    Define protocols for inserting obtained data  into existing
         EPA  systems  (TOXET, STORET, etc.)


    STEP D

    Once a  plan has been developed to obtain further environmental or health
data,  protocols for analysis must then be defined.   At  this point we  assume"
that this  step is  a minor issue, since most tests will  have to  have national
uniformity,  and thus EPA  is expected to have  sole authority in  defining these
protocols  or in reviewing the protocols of other federal  agencies with
jurisdiction (CDC,'OSHA,  etc.).

     Study  Issues for FY  31:

     o    Review availability of existing protocols for categories of
          tests described  in Step C.
     o    Commission  development of  protocols where gaps or technical
          problems exist.
     o    Coordinate  as  necessary with  other agencies involved.


     Step E

    "At this step, analysis  of  samples  and interpretation of  results  will  begin
to-yield indications  of  the  true  extent of problems tentatively identified in
Step 3.  It is  important that the  interpretation of«test results be made  in
relation to uniform risk assessment  protocols, using, for example, consistent
assumptions about  population sizes  and  distributions, consumer habits,  and
other factors  affecting  exposure.   (See also work pi an for Activity 2  of this
project.)  Establishment of  these protocols  should presumably be solely an
EPA function,  since they should be  uniform across the country and based on
the most- advanced  risk  assessment  methodologies.

     Other methodological questions of importance here include who pays for
lab work  using what  funds:   certain costs may be  assumed by states  or localities,
others may be  reimbursed through federal  grants  (including those from non-EPA
sources).  How much  should these responsibilities  be formalized across studies,
to what extent should they be ad hoc?

     FY 81 Study  Issues:

     o    Identify uniform risk assessment protocols
     o    Analyze costs of basvc analysis methods  for  reference use  in regions

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    o    Determine requirements of quality assurance program
    o   - Determine approaches to equitable distribution of buirden between
         participating groups
    o    Identify appropriate sources of grant funding (EPA, mon-EPA)


    Step F

    At  this step, EPA and participating state and local groups would decide
whether  the  data gathered offer conclusive evidence one way or another about
the nature  and extent of'potential toxics problems.  Improved data could, if
necessary,  be fed into the models used in Step B.  If data are-found to be
to any extent inconclusive, the methodology would at this poirnt cycle back to
Step C,  where new sampling or  study techniques would be commissioned, such as
body burden or other epidemiological work on selected individuals or subpop-
ulations.

     To the extent that  national  health  standards or other external criteria
do not guide decisions to conduct more studies,  how should these decisions
be made.  In the  absence of consensus, should EPA have the dec-ceding role, or
"the states?  What  weight should  the opinion of other federal Agencies  (e.g.
CDC) be given?  How formal  should this process be?  What tradeoffs should be
nade between costs of  additional  data gathering  and conclusiveniess of existing
study results?  Finally, once conclusions  are  reached, what criteria should
be used to  rank the problems  identified  in  order importance? im order of
treatment?

     FY 81  Study  Issues:
          •
     o    All  above issues  will  be  addressed  empirically withiin the pilot
          studies.  Experience there  will  guide  the  strategy recommendations.


     STEP G

      Once the identity of problems is known to the desired decsree of  accuracy,
 control "options for correcting then can be developed-   Some ccartrol  options
 could  operate through the regular EPA problems,  but we expect  tthat degrees  of
 control  above and beyond customary levels will be needed in certain cases.*
 Alternative control  techniques, especially those that could be imposed by
 states  or  localities, must be considered.  Generically, responses could -
 include technical controls on sources,  modifications of sources/receptor
 relationships (from relocating sources to relocating populations, and steps
 in between)  and modifying receptor characteristics (treating drinking water
 rather than'controlling industrial effluent into streams).  Each option should
 be costed  out, and its  benefits estimated.

      At this point it may be  desirable  to  involve the public in listing options.
 It will almost certainly be  necessary to consult directly with industrial
 representatives where industries are identified as problem pollution sources.

      Key methodological questions will  revolve  around the type and degree  of
 quidance needed  in defining  technical and  non-technical control options, and
 in estimating the efficacy of each.  Should EPA be  the final arbiter  of

 »	TKP n-ilot studies, for  instance, will be conducted  in  metropolitan  areas
 where unusual toxics  problems will probably exist  after  imposition of  all  normal

 controls.

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efficacy (enforceability as well  as  technical effectiveness)?  To what
extent to the existing acts influence the  permissable range of control options,
especially those which are alternatives to customary program controls?
     Study Issues  for  FY  81:

     o    Compile  a  catalog  of alternative control measures
     o    Review current  legal  constraints on  their use  (especially
          in terms of  laws EPA administers—see  Activity 1)
     o    Evaluate EPA/state/local  roles  empirically through the pilot studies


     STEP H

     In  the  final  step, a control strategy or  strategies for identified problems
 will be  developed  jointly between EPA and the  affected state and locality.
 At  this  point,  cost/benefit assessments must be  made, and must  be balanced against
 ell  other  relevant considerations:  political acceptability; distribution of
 costs  among  different levels of government, industry, and the public; enforce-
 ability, potential adverse intermedia effects, end so forth.  It will probably
 not be.possible to develop detailed guidance on  most  of  these issues; rather
 the intent' will be to devise a methodology for making issues and tradeoffs
 explicit,  and for structuring judgments for decision.  As before, we must attempt
 to define  appropriate relationships between the  various  parties affected:
 who has  the last  word? what is the relationship between  this process and the
 regular  administration of EPA programs?

      In order to  approach the issues here, we  must study the  relationships be-
 tween EPA and state/local authorities in  some  detail.   Where controls  applicable
 to toxics  are concerned,  are there any gaps where no authority  exists  to  reg-
 ulate a class of  problem?   _Are  there overlaps between  authority, where one
 would have to choose  the  level of government, at which control  is exerted?
 Are there instances of actual interference  between state and  federal  authorities
 over a  certain class  of  problem?

      Also included  in the strategy must  be  explicit assignments of  responsibility
 for monitoring and  enforcement.  We  must  include consideration  of accountability
 mechanisms between  EPA and  the states  and local governments:  these  could
 build on present  SEAs, but  could also  include other devices (MOUs,  contracts,
 new state legislation or planning  programs, commitment of local police powers).
 These accountability  mechanisms  must be  carefully examined to determine the
 degree  to which their use is  consistent  with  EPA's legislative mandates.

      Study  Issues for FY 81:

      o     If  possible, create guidelines for  cost/benefit evaluations
      o     Investiaate types of possible  accountability  mechanisms, and
           their  legal status  in  relation to EPA legislative mandates

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    Analytical  Studies

    Steps B through F involve complex analytical examinations of local
 nbient environmental conditions in relation to toxics exposures and risks.
in the_past, EPA has attempted various approaches to geographic analysis of
this kind, generally in areas where under the existing programs it is unlikely
that observed or suspected toxics problems can be adequately corrected: in
such  areas, local concentrations of industry and population can be expected
to lead to_undesirable levels of toxics-related health and environmental
risk,  despite the application of nationally appropriate environmental
standards and controls. .  In  various ways, the projects previously sponsored
have  sought to answers to the following questions:

          (a)  What  are ambient  levels of toxics now, and what apparent health
               and environmental risks do they impose?

          (b)  What  are the  sources of these toxics?

           (c)  What  ere the  potential  pathways between sources and
               receptors?

           (d)  Wi.ll  the  normal  application  of EPA programs reduce-ambient
               toxics  levels to  acceptable  levels  (are we regulating the
               key  toxics pathways stringently enough)?

 Building  on past experience  with projects  of  this  sort will directly aid the
 development of  a geographic  strategy.

      We know fro-; past experience, however,  that trying  to analyze  geographic
 areas to  answer  such questions is  time consuming,  expensive,  and  usually
 inconclusive.   Our limited aim for the first  year is therefore  to test the
 general feasibility of existing tools and existing  data.  How far do these
 carry us  toward  the requirements of Steps B'through F?   What  are  the costs
 involved? How can we overcome data gaps and- methodological  problems? How
 expensive will  it be to gather conclusive evidence?  What  innovative altern-
 ative techniques are available to fill gaps in our current  knowledge?

    'We propose to focus our first year efforts  as* follows:

      1)   Evaluate past  geographic studies

           Past attempts  at  geographic analysis offer technical  and procedural
           lessons, especially on identifying avoidable problems.   We will
         '  document these in brief case studies.   (Task 5.0)

      2)   Commission two pilot  case studies

           Proposed  sites are north" Philadelphia PA, and the Kanawha Valley
            in West Virginia.  Principal elements will be:

            a.    To  assess sources  and  ambient toxics quality  in the  case
                 study  areas  (Task  1.0);
            b.    To  forecast  (if  possible) the future effects  of current.programs
                 in the  study area  (Tasks  2.0  and  3.0); and

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         c.    To  research innovative methods for controlling  discovered
               toxics problems (Task 4.0).

    3)    Integrate the findings of these activities into the  general
         meinodoTogy
II.   Structure of this Workplan

     This workplan 'incorporates all the elements of the general  toxics int-
egration project workplan, but has not yet ennuroerated more general  tasks
related to dealing with all the methodological questions raised above.  In
some cases the schedule has been changed: at this point it appears that the
detailed pilot study design (which now will involve considerable contractor
input) will not be complete until March 14, although the general pilot study
design will probably be approved ahead of schedule; the catalog of alternative
controls is now scheduled  to  be. complete two months earlier than originally
pi anned.

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TASKS

1.0 Pilot Studies

1.1 Workplan develop.
i.Z Pilots
    (Status reports)
1.3 Recommendations

2.0 Air Forecast Methods

2.1 Develop methodology
2.2 Apply to sites

3.0 Hater Forecast Methods

3.1 Improve methodology
3.2 Apply to sites

4.0 Catalog of Controlj

4.1 Research and Report

5.0 Case Studies

5.1 Selection of subjects
5.2 Research
5.3 Final reports

6.0 Project Management

6.1 Budget outputs
    (Status briefings)

6.2 Strategy
—X
                   (draft)
                 	fl
(final)
                               (MTGs)
                                 X
                              (ARC)
                                X
                             (draft)
                            	X	
                                                                          (fin
                                          X  = briefing, informal  report
                                          B ° formal written report

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                        ACTION
                                                        METHODOLOGICAL QUESTIONS
                      Select Site.
         Conduct "table top" studies, based on
        secondary data and various modeling and
          forecasting techniques, to determine
         sources/pathways/exposures of probable
                        concern.
                                                        o.  technical basis?
                                                        o   administrative/political-
                                                            basis?
                                                        o   relationships with
                                                            states?

                                                        o .  EPA/State/local roles?
                                                        o   definition of data items?
                                                        o   role of health studies?
                                                        o   costs to EPA?
                                                        o   costs to States?
                                                        o   sources of funds?
                                                        o   modeling methods?
C.
0.
 Design  and conduct field sampling or other study
 techniques to acquire necessary additional  data:
 ambient,  effluent, effects data, health studies
 Define analysis protocols for samples collected
o   methods?  ~
o   costs? sources of funds?
o   EPA/State/local roles?
o   role of other federal
    groups?
    Can we assume sole EPA
    responsibility?
E.
Analyze samples and interpret results in relation
 to standardized risk assessment protocols for
              population exposure
      •Does  total  data conclusively define sources/   »
                pathways/exposures of concern.
G.
                            YES
     0
   Define  universe  of  possible  control  options:
   technical  controls,  modifications  of source/
  receptor relationships,  receptor  modification
H.
  Select  preferred option,  devise implementation
     strategy,  enforcement strategy,  monitoring
                      strategy
o   costs of analysis?
o   sources of funds?
o   consensus on risk
    assessment protocols?
                                                         o   EPA/State/local  roles?
                                                         o   relation to national
                                                             standards?
                                                         o   Who has last word?
 o   EPA/State/local  roles?
 o   catalog of  alternative
     control measures?
 o   role  of industry?
 o   role .of public?
 o   relationship of EPA/
     State/locals in strategy
     definition?
 o   cost/benefit guidelines':
 o   who enforces, who
     monitors? accountability

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TASK  l.Q   PILOT STUDIES

      The  pilot studies will  have limited goals.

      1.    To establish how far existing data and methods  can  take us  in
           analyzing geographic areas and prescribing solutions.

      2.    To describe deficiencies in existing data and methods.

      3.    To define (as far as possible) how these deficiencies might be
           remedied, and at what cost.

      4.    To catalog innovative and alternative approaches  to control
           applicable to these and other sites, especially in  relation to
           intermedia effects.

      Many problem areas are.already visible.  The following are among
 the major ones; others will undoubtedly arise.

      Actual "effects"  information is not part of the study:  it  is hard
      to document toxics-related health  and environmental  effects, esp-
      ecially  since  these  usually  have long latency periods.  We will
      therefore  have  to design the study primarily around  desired  ambient
      levels (e.g.,  water  quality  criteria) and estimated  exposure-related
      risk levels.   We  may be  able to link with such groups  as NIH for
      limited  reviews  of local health effects.

      It  is  impossible  to  analyze  all toxic compounds of interest:  even  the
      "short lists'1  of  toxics  IMESHAPS,  consent decree, TIP  list of 20,
    •  RCRA) may  exhaust all  available funds for analysis;  some protocol for
      defining substances  for  geographic consideration is  necessary.
                       ,»
      Toxics-related ambient standards.have many problems:  inconsistencies
      between  standards (e.g., water quality  criteria vs.  MCLs), poorly defined
      definitions  of compliance/non-compliance, uncertain numerical values.

      Ambient  toxics data  is generally poor:   the  Chesapeake Bay  study has
.  •    unusually good toxics  data on  water, bu,t most other ambient toxics
      data,  especially for air and groundwater,  is sketchy  at best.

    .  Effluent data on toxics is not much  better:   some estimates can  be
      made on  the basis of permit and process data, but this  is unlikely  to
      be  hard  enough use  for an  enforceable  control strategy.
   t                                      ,
      Model ing techniques  have serious  methodological  and definitional
      problems:the water dilution studies,  for instance,  tend to  over-
      estimate projected problems; methodological  improvements are  needed,
      but corroborating monitoring is also needed.

      Before committing to further work on a geographic approach  in FY 82,
  we must determine if problems such as the above invalidate the entire con-
  cept of a geographic approach to toxics analysis.  We hope that  the  first
  year's  experience will provide us with a practical methodology  that  can
 'be fully developed over the second project year.

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                                    - 4 -

     Design of the pilot studies

  -   Our preliminary plan for the pilots follows.  We will focus in parallel
on defining ambient quality in air, surface water, groundwater,. and soils, and
in characterizing all effluent sources contributing to these media.  :Solid
waste sites — including  regulated and unregulated  (abandoned) sites-wriTl! be
treated as sources to these media.  Once this data is explored, we will
attempt to predict changes in ambient quality due to the controls imposed by
the various environmental programs  using techniques refined in Tasks 3 and 4.

     Host of the technical work will be done under contract under tfes tech-
nical direction of Dr.  Alvin  Morris, Deputy Regional Administrator esf
Region  II.

  \
TASK 1.1  Develop workplan for conduct of  geographic pilots

     The  geographic  approach  is  to  be tested through one or two pilot studies
of  selected  areas.   These  areas  will be  selected  within Region III, a-nd will
be  selected  by  that  Region's  sta
                                ff
    Gocl s- of the. pi lots  are to:

         To determine the adequacy of  existing data and methods far definition
         of multi-media  toxics problems  in  given geographic areas,

         To describe deficiencies in existing data and methods,

         To define remedies to these deficiencies and the costs of
         correcting them, and

         To determine the magnitude and  nature of toxics problems K'-kely
         to persist following the implementation of most stingent regulatory
         controls (see also Tasks 2 and  3).

Major  elements  of the pilots studies will be:

          Determination of present ambient quality* for air, water, e:nd
          land/groundwater,

         ' Inventory of existing sources of pollution to  these media,

          Estimation  of of likely  emission rates  following  imposition of
          regulatory  controls,

          Effects  of  these continued emission on  future  ambient  quality, and

          Development of  remedial  control strategies,  including cost;
          estimates.

In this task  the  contractor will  be directed by the  EPA project officer in
development of  a  detailed workplan designed to complete each major element
listed above.    The workplan  will  include:

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                                    -  5  -


    1.   Specific  activities  (sub-elements)  needed to complete each element
       .  above  for the selected area(s).


    2.   Scheduled dates of completion  of each  activitiy.


    3.   Resources to be allocated to each element and  sub-element.


    4.   Identification of individuals/offices  responsible for each
         sub-element.
                                                                          •


    This_task  must be completed in consultation with  a  list of EPA staff
and  officials to be provided to the contractor upon commencesaent of work.
The  final workplan must be explicitly approved by the  Deputy Regional Admin-
istrator for Region III.


     Output:   Workplan document


     Period of Performance:   Three calendar weeks from  commencement of work


     Estimated level  contractor effort:    Five person  weeks
 FASK 1.2: Conduct Pilots
A.   AIR'ASSESSMENTS

     Produce those  air  assessment  outputs assigned to contractor in TASK  1.1.


     Under the  air  assessment  element of the workplan, not ell  sub-elements
will be  assigned  to the contractor.  Major activities under this task will
be directed  at  the  following:
     Ambient  Air Studies

     a."   Existing monitoring data from all  sources
           - ORD
           - SAROAD (NAMS,  SLAMS,  National  Air Survey Network (metals))
       '   - Research Triangle Institute


     b.    Link to health data              .
           - OHEA estimates of risk for chemicals  identified
      Air  Pollution Sources •

      a.    Inventory all sources
           - Maiors (program listings, check local  data  ror  non-filers).
           - Minors (program listings, presumed higher prob.  of  non-filers)

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    b.    Toxic effluent  profiles
         - Majors:  source  by  source  (based  on permit files, process assumptions,
              monitoring data as  available)                               .
         - Minors:  characterize by groups  if technically necessary

    c.   Contrast  (a)  and (b)  against  expectations--!.e., knowledge of
              Regional/State  permitting  personnel

    d.    Contributions  of  other sources
         - Area  (mobile source, small  retail establishments; etc.)
         - Hazardous  waste sites/sanitary  land  fills (may link to other contract)


    Forecasting  Program Effectiveness

    a.   Methodology  development: contractor may consult in development of
         methodology  under Task 2.

    b.   Application  to sites


    The number cf hours devoted to this  task  and the scheduled dates of
completio'n  of each output will be provided  in  the workplarc-
     WATER ASSESSMENTS

     Produce those outputs assigned to contractor in TASK 1,1.

     Major activities in this task will be directed at the following:
                           .«•
     Ambient Water Studies

     a.   Existing monitoring data from all sources
          - Chesapeake Bay study
          - STORET
          - Enforcement data files               »
          - others as available

     Water Pollution Sources

     a.   Inventory all sources
       <  - Majors (program listings,  check local data for non-filers)
          - Minors (program listings,  presumed higher prob.  of non-filers)

     b.   Toxic effluent profiles
          - Majors: source by  source  (based on permit files, process assumptions,
               monitoring  data  as  available)
          - Minors: characterize  by groups if technically necessary

     c.  Contrast  (a) and  (b)  against  expectations—i .e., knowledge of
               Regional/State  permitting  personnel

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                                    -  7  -

    d.    Contributions of other sources
          -  Area (urban runoff study for Baltimore, application of general
               soil  loss equation and runoff estimates for Kanawha)
          -  Hazardous waste sites/sanitary land  fills  (may link to other contract)


    Forecasting program effectiveness

    a.    Consult as required in Task 3.

    b.    Apply improved methodology to pilot study sites.


    The number of hours devoted to this task and the  scheduled dates  of
completion of each output will  be provided in the workplan.


C.   SOLID WASTE /GROUNDWATER  LINKAGES                                "   "

     Produce those outputs  assigned to  contractor in TASK 1.1.

     Major  activities  in  this task  will be directed st the following:

     a.   Source  assessment
          - '-'ap known  Superfund candidates
          - Map known  hazardous waste/sanitary  landfill  sites
          - Review  existing aerials, for other sites
          - Review  whatever technical data  exists on all located sites
                (site contents, depth  to groundwater, site integrity)
          - Estimate loadings to groundwater (in conjunction with next task)
                        *»
     b.   Groundwater quality assessment.
          - Review  monitoring data  on public (private?) water supplies
          - State geologic survey assessment—perhaps data on contributions
 - _            to local aquifer flow, degree to which contamination from
                outside local area is significant
                                               *
      c.    Drinkino water assessment
           - Statement on extent to which drinking water  is derived  locally
                (contrast ambient data to MCLs, if applicable;  some  linkage  to
                project 5 is possible)
           - Map against population for areas exposed
        0

      The nutnber of hours devoted to this task and the scheduled dates of
 completion of each output will be provided in 'the workplan.
 D.   INVESTIGATE  INTERMEDIA  CONTROL RESPONSES

      Produce those outputs assigned to  contractor in TASK 1.1.

      Major activities  in  this  task will  be  directed at the following:

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    a.   Develop  approach  for  using  assembled data to define potential
               intermedia effects.

    b.   Assemble catalog of models  for analyzing intermedia flows,
               especially after imposition  of alternative abatement assump-
               tions.

    c.'  Conduct analysis of intermedia flows under  alternative abatement
               assumptions.

     d.   Recommend  selected options with most beneficial environmental
               effects.

     The number of hours devoted to  this task and the scheduled  dates  of
completion of  each output will be provided in the workplan.

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TASK 2.0  AIR FORECASTING KETHOOS

     In this task, headquarters  staff in Washington and Durham (QAQPS) will
confer on the design  of  methods  for forecasting the effects of projected con-
trols on ambient  toxics  concentrations of particular localities, such as
the selected pilot  study sites.

     This work  will  build on work  already under way by OAQPS, partially under
a past  contract with SAI Incorporated.  A new contract may be let to trans-
late exposure  assessment techniques  applicable to national risk assessment
studies to  a local  context.

     Tasks  for the development of this methodology have not been described
 as  yet.  Feasibility of this effort will be  studied in parallel with  the
 development of the workplan, with suitable  input  from the Task 1 contractor.
 Proposed tasks sub-elements are:

 Task 2.1  Develop Methodology

 Task 2.2  Apply  to Pilot Sites

            In conjunction with Task 1 contractor.

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TASK 3.0   WATER FORECASTING METHODS

     At-least one method now exists for predicting the effect  of future  •
controls  on ambient environmental toxics levels.   Developed by OWWM for
surface water studies, this method first estimates current emissions of
toxics  from known sources in a given river network, using permit and
process data available in-house.  It then estimates the abatement expected
for  each  source under BAT controls.  The resulting new values  for toxics
emissions are then assumed to be diluted in the known 10-year, seven day
low  flow  of the river system.  The ambient values for toxics'thus obtained
are  compared to present water quality criteria; OWWM is thereby able to
screen  for stream reaches that are likely to exceed water quality criteria
values  after imposition of BAT.

      This task will build on work completed in the Monitoring  and Data
Systems Division.  It will use past "dilution study" efforts as a basis for
 developing a refined method of modeling the effects of improved point-source
 treatment technology on ambient  toxics concentrations in receiving waters of
 the  pilot study  sites.

      Produce those outputs  assigned to contractor  in TASK 1.1.

      Mc'jcr  activities  in  this  task will be directed at the following:


 Task 3.1   Irnsrove  Methodology

      a.    Identify deficiencies  and inaccuracies  in methodology.
            -  Does methodology  attempt  to account for all sources and sinks
                 of pollutants?
            -  What simplifying  assumptions  h'ave  been used—what effect are
                 these  assumptions likely to have on accuracy of the results?
            -  Can some,  all,  or any of  these assumptions be eliminated without
                 overcomplication of the methodology, thus improving accuracy?
            - Are data, available to replace assumptions with  reliable estimates?

      b.    Develop improved methodology.
            - Examine  identified deficiencies  insisting methodology, assess the
                 magnitude of error likely  to  be induced by each deficiency,
                 and attempt to correct or  minimize it.
            - Determine appropriate applications of the method.
            - Based on findings of preceding steps, formulate new  methodology
                 designed to maximize accuracy while minimizing data  needs.
                  (Likely to involve use of EXAMS model.)
            - Describe data needs for'the new  methodology.
              Describe simplifying assumptions used in  new methodology
                 and the likely sources of error.
            - Focus new methodology on new applications.

  Task 3.2 . Apply to Sites

            In conjunction with Task 1 contractor.

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TASK 4.0:   EVALUATION OF PAST GEOGRAPHIC STUDIES

     The  agency has  undertaken several  "geographic"  studies  over the past
several years,  all  of which will  offer significant lessons both in  relation
to the  pilot  studies and to the more general  evaluation  of the potential of
the giographic  approach as a whole.  This task will  compile  uniformly formatted
case studies  of at  least three such instances, and will  review others as
they come to  light.

     The  most important case studies (especially Memphis, perhaps also  Beau-
mont)  will be done in cooperation with the contractor working on the pilot
studies,  since the approach  and methods used will be important to the design
of the pilots.   Other cases  will be addressed by in-house staff; we estimate
that  approximately one  person week will be necesary for  each. Staff exists
to compile approximately  12  case studies; if more are needed or if  compilation
time  exceeds one person week per site, additional staff  will be required.

Task  4.1    Identify candidate sites for examination   (February 19 - 25) -

      a.    Call Regions  for names of sites, names for interviews.

            Regions divided into groups.  Will call S&A lab directors and
            consult HQ personnel as  necessary to  identify  sites.

            Site selection  to be final by 24 Febraury.
            Presume  inclusion of Memphis, Beaumont, Great  Lakes,
            Louisville,  Birmingham,  Love  Canal.


 Task 4.2' Develop  uniform data  requirements,  finalreport outline
            (already  complete in  draft)

       a.    Uniform data plan attached  (draft' 19  February).
            Includes  provision for primary  (interview)  and secondary data
            (existing reports, in-house documents,  etc.). Assume no travel
            required.  Exception may be Memphis,  for  general   study purposes.

   .   •{>.'   Final report outline due 25 February   *


       4.3" Conduct studies   (February 25 through April 15)

       a    Preparations (review of KQ data, phone calls): identify  respondents,
        "'  necessary reports.  Estimate 1 person-day per case.

       b    Conduct interviews and review secondary sources
                  (one person  per case, average 2 person-days  per
                  case)

       c.    Draft report (10-20 pp. max.; keep short; 2 person-days  per case)

       d.    Regional  review,  redraft in final

            Prepare  executive summary,  general conclusions,   as necessary.

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JASK 5.0   CATALOG OF ALTERNATIVE CONTROLS'

     A  geographic approach to toxics integration is  intended to discover pro-
blems that the ordinary operation of programs may have missed,  or will  be
unable  to correct.  It follows that controls to correct these problems  raav
have to rely, at least in part, on methods  unavailable to the Federal
regulatory programs, specifically regional, state, or local  methods that
do  not  require national regulation.

     Much work has been done in the area of innovative and alternative  controls
for environmental pollutants.  This task will compile and evaluate tools that
have already been researched and.developed in some detail.

      The task will be completed in-house, using staff on the toxics integration
project.


TASK 5.1  Research Available Methods and Complile Report   __

      a.   Research  avai-lable Federal-developed tools for toxics controls
           -   Controlled  trading
           -   Bubble/banking
•-   ,       ,-   other  innovative  controls as available

      b.   Research  available  State/local tools for toxics controls
                 (especially  those  applicable  for Maryland and West Virginia)
           -   Non-point source  runoff controls
                 (sedimentation  and  erosion control ordinances, subdivision
                 ordinances,  zoning,  performance standards)
            -   Emergency powers
            -   State  pollution  control legislation
                 (assess degree that it  offers more stringent control
                 of water pollution,  air pollution, etc.)
            -   Locally enforceable special purpose controls
                 (subdivision ordinances,  special  purpose zoning (e.g.,
                 emission density zoning), performance  standards, etc.)

       c.    (If possible) Link selected  control  possibilities to recommended
                 abatement recommendations ft-om  previous  task.


           t report will be complete by  April  15,  final  report one  month later.
  This is a considerable acceleration of the original  schedule,  which called
  for completion of this task effort by  July 1.

       The level of effort for this task has not been assigned;  in order to
  comolete it  by  the date stated, additional  staff are likely to be necessary.
  No contract  support  is now contemplated, but could  conceivably be used if
  time constraints require it.

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TASK 6.0  PROJECT MANAGEMENT

     This general task  will  produce  two  main  products: (1) budget  reports
and briefings  (as necessary)  to  both the media  task groups and the Agency
Ranking Committee,  and  (2)  the strategy  itself.


Task 6.1  Budget Outputs

     In  coordination with TIP Activity 6, budget memos and briefings will
be  prepared as necessary to allow the Agency  to:

     a.   Assess current resources being expended on  activities  related
           to geographic assessments.

     b.    Cost out options being developed under this Activity.

      c.    Integrate (to the extent possible)  the developed strategy....
           into the FY  33 budget request.

      These materials will be  compiled by the  TI? staff in-house.   No level
 of effort has been  assigned.  MTG briefing materials  will be available by
 mid-May, ARC  materials  by the end of July.
 Task 5.2   STRATEGY

      The  final  strategy  document will  summarize the findings of all  tasks
 of this Activity,  and  include  at least the following elements in relation to
 the pilot studies:

      a.    Statement on link's between  sources and ambient quality

      b.    Identification of sources
            - Unregulated
            - Underregulated

      c.    Statement on further data  needs

      • d.    Statement on desired spot  monitoring/other desirable  analysis

       e.    Specify FY 32 workplan for two sites,  if  recommended:

            - Development of further analytic  tools,  potentially  including:

            (1)  Aerial surveys (use of Enviro-pods,  remote  scanning,  overflights)
                 "Purpose: dump site location,  remote  scanning for all  types  of
                 visible  and invisible plumes  in all  media,  etc.
                 Sources.of expertise: NEIC,  Las Vegas  lab and other  ORD sources,
                 Regions, contractors, other agencies,  States.

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         (2)  Existing monitoring networks  (air and water ambient monitors  on
              State and locallevels; effluent monitoring}
              Purpose: general data  review

         (3)  Existing data  bases (SAROAD, STORE!, TOXET, Toxics Inventory,  etc.}
              Purpose: detailed ambient quality and exposure estimates

       •  (4)  Original sampling and  monitoring (dumps, abandoned sites,  air
              and  water  quality,  groundwater, water supply, sludge quality,
              federal  facilities, human and animal tissues)
              Purpose: multiple

          (5)  Epidemiological  studies
              Purpose:  estimate  effects  of identified local exposures

          (6)  Mathematical models (SEAS,  air  diffusion oodels, etc.)
               Purpose: multiple

          - Development of cost estimates  for  all of above.


     Any other documents or  reports  required  under  Activity 6 will also
be-'prpduced.

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TASK 4 ATTACHMENTS
                     Evalution of Past Geographic Studies
 Background information for respondents
      EPA is investigating the possibility of using a geographic  approaoch to
 integrating its toxics programs: this would involve any number of  techniques
 .aimed at investigating localized problems with toxics in the ambient  environ-
 ment, rather then only applying^nationally appropriate regulations and  controls
 to "local problems.   Over  the past  several years, EPA has sponsored various
 studies of local toxics problems (often emergencies).  In our current
 investigation of the geographic approach to integration, we want to use as much
 experience from past studies as possible.

      If any version  of  a  geographic  approach to controlling toxics is to be-
 come institionalized,  it  is  important to be thorough in identifying the
 costs-and  benefits  of such  past studies.  The following questions  are in-
 tended  to  elicit information related to the costs of previous studies,  as well
 as to assess  the relative success  or failure of past efforts.

      In this  exercise of  looking into past studies we want to identify
 what led  to each  study—was  it a particular health problem, odor problem,
 citizens'  complaints, or  the Agency's independant concern about a potential
 problem?   What  were the actual  problems  found (if any), and could they be
 documented well?   What were the benefits of thg effort?  If problems
 were identified but not resolved,  what  prevented application of suitable
 controls:  was there insufficant data to  define  the problem, were  there
 questions about the interpretation of  the  data, were  there  institutional
 or cost problems related to cleaning up  the problem?  Or were there no
 standards, no criteria, or no  legislation  or  regulatory  support for  actions?

      Your assistance in providing  the  following information  is appreciated.
 Please  recommend the names of  others who might  assist us  in  obtaining  nec-
 essary  information.

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                            INFORMATION WORK SHEET
SITE
NAMES AND TITLES  OF  RESPONDENTS             (Phone)
    (1)
    (2)"
    (3)'
    etc.

SECONDARY  SOURCE MATERIAL

    (1)
     (3)                    •                        	
     etcT    ~    ~~  '


 A.   What was study area: town or city, county,  state?


 B.   When was study conducted?


 C;   What caused the study to take place?

     1. • Did a  specific,problem exist, if so what?


     2.  When was  the  first  indication that a problem existed?  '


     3.  Were local and  state agencies aware o£ potential problems and how early?


     4.  Were citizens aware that problems existed and how  was 'this expressed?


     ,5.  Why did EPA undertake  study?


 D.  What  activities  did the study  involve?


  '   1   What  actions  did local  agencies  take?  ( increased  monitoring,
          increased inspections,  described situation  to public,  other.)

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    2.   What actions could have been taken by local agencies but were not?


    3.   What actions did state agencies take? (increased monitoring  increased
        inspections, described situation to public, other)


    4.   What actions could have been taken by state agencies but were not?


    5.   What were EPA's actions?


    6.   Which offices  in EPA  became involved: Regions, ORD,  others?


£.  What were the technical/scientific issues?


    1.   What was  technical nature of problem?

  -  2.   Were,data adequate to define problems?

    3.  Did EPA  have adequate expertise to assess the significance of the
        problem  in  terns  of  risks or exposure?  Explain.

    4.  In  general, what  did the  environmental data show?

    5.  If  data  was*inadequate, what were the inadequacies?

        data  quality unknown?

        disagreement on the  interpretation of the data?

        insufficient n°umber  of stations?

        unsatisfactory distribution of monitoring  stations?
                                             *
        how was  adequacy or  inadequacy of data determined?

    '•6   What other information was  used (could have been used) to  define
        problem (e.g., aerial photographs, ground  photos, site investigations,
         etc.)
    9
     7.  What were  the recommendations  for correcting  problems?



 f   what were the  political   issues?  (with  public, with local  government,
     •	with state  government)

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.  What were  the  administrative/institutional  issues?


   1.  Why  couldn't  local  agencies  respond?   (lack of expertise  funds
       authorization,  etc.)                                    '      '

   2.  Why  couldn't  state agencies  respond?  (lack of expertise  funds
       authorization,  etc.)            '                       '      '

   3.  Did  public accurately understand the  problem bei-ng addressed?
       If not,  how did they perceive it?

   4.  How  could communications with the public  have been improved?

   5.  Was  there adequate time to design the study?

       How  much time was there?

       What was the driving force behind the study?

   5.   Were adequate funds  available for the study?

     *        i                                              •
;-;..  What were the costs of the study?

    1.   Cost  to local agencies in work years?

    Z.   Cost  to state agencies in work years?

  •  3.   Cost  to EPA  in  terms of work years and contracts? (fill in table)
                              Work years"                 dollars_
                                                  in-house     contracts
    ORGANIZATION

       Regions

       ORD

     .  MEIC

       Other (list)

    'ACTIVITIES
       Planning
       Sampling
       Data analysis
       Quality assurance
       General analysis
       Source inspections
       Enforcement action

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    4.  if  funds were inadequate, what is the estimate of  how much an
        adequate study would cost?

    -5.  What type of work would be done with additional  funds?

    5.  What type of control actions could possibly  result from the
       .  additional effort?


 I.  What  were the results of the study?

    1.   Did problem actually exist?

    2.   Was there a concensus between agencies of exactly  what the problem
         or problems were?   Explain.

     3.   Were any  controls or remedial actions taken  to correct problems?

         What type of  actions or  controls?

         Who provided  the funding for  the corrective  action?

          If cgntrol  actions  were  taken by private industries -did they do it
          voluntarily?

         Was legal  action considered before action taken by industry?

          Was action  taken by industry  after legal action initiated?

     4.   Was problem actually corrected?


• J.  General Conclusions

     1.   What  recommendations would you make  to  someone conducting similar
          study?

     2    What   from your perspective,  were  the weaknesses of  this study?
 '   '   '   How would you would advise people  initiating similar studies in
          order to avoid these problems?

     '3    Even  if the problem was corrected  as a  result of this study, could a
       '   similar result have been obtained  through some other means,  such as
          the routine operation of existing  EPA or state control  programs?
    t
     4    Has the Region developed a general  plan or procedure to follow
          for future studies/responses?

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TOXICS INTEGRATION;   OUTLINE OF  THE  REPORT TO THE ADMINISTRATOR
     In addition  to an Executive Summary,  the  report will
contain .an  Introduction and sections or. Information Collection
and Analysis,  Control Strategies,  and Recommendations .  This
outline identifies major features in each of those  sections-
we cannot at  this point,  of course,  detail conclusions.

     The Introduction will discuss past and on-going efforts at
toxics integration, such as development of risk-assessment
methodologies and intra-agency work groups on  pollutants.
Also, we will identify the important assumptions  and goals of
the  current study:  the need to set collective agency  priorities
on the worst  threats to the environment; the need to focus better
EPA's  limited resources; the need to factor economic impacts
more directly into the regulatory development  process."-


A.   EPA  Must Make  Its Data Collection and Analysis  Procedures
    " Consistent for all Programs

      EPA can never achieve an integrated and efficient regulatory
 process  as long  as its programs have individualized
 procedures for identifying problems, acquiring information,
 and analyzing risk and economics data.  We need to  improve
 consistency  and  prevent duplication.  No matter what
 integration  strategy  — and what speed of implementation —
 is chosen, this  project will review with the expectation of
 standardizing such basic  procedures as:   • *-     "—

      o  more directed and coordina'ted priorities
         for  information collection on pollutants
         and  industries;

      o  an agency -wide cancer policy;   ^

      o  agency-wide risk  assessment  methodologies;

      b  review  procedures by  independent experts;

      o  as much as possible,  economic impact  and cost-
         effectiveness analytic  procedures.


      In trvina to establish these agency-wide procedures,
 EPA will be  making a number of difficult technical and
         choices.   A cancer policy,  for instance, will
         balancing of .economic criteria as well as  risk
         oai anc ^         .   apprOpriateness  and extent of
         ~   Si- *«ly \ny a9tn=y-vide poXicies .bout
       anS  costs imply iwXing judgments on the basis of   .

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Report Outline
Page Two
imperfect data and not fully tested analytic tools.   Methods
for applying the standardized tools developed under  this
section will be elaborated in Section C of the report.


3.   Toxics Integration Project'(TIP) Studied Three Strategic
     Approaches Which Could be Used to Guide Future Integration

      Common sense suggested that any eventual integration
 strategy will  consist of parts of all the approaches
 considered in  this  study:  regulation by pollutant,  by •
 industry, and  by  geographic area.  Given the great number
 of toxic chemicals,  it is likely that selected compounds--  "
 nay require  in-depth analysis  or intermedia review.- It is
 also likely  that  controlling such pollutants may be most
 ecorxsrnical.ly feasible  if approached  on an industry-wide
 basis.   Finally,  there  is an important potential role for
 Geographic  analyses to play  in stucturing responses to
 specialised intermedia toxics  problems.

      Nevertheless,  each of  these  three strategic approaches
 is being developed as  though  it were the  single, dominant
 integrative force upon which the  agency would,  in the
 future,  depend.  Each approach will be evaluated in isolation.

      What would be the strengths  and weaknesses of  that
 method of integration?  What is the catalogue of "issues
 with which that integrative methodology would need  to  deal?  -
 What are the  immediate problems — such as  availability  of
-""data — in testing  the usefulness of the  strategy?   What
  are the resource, organizational,  and legislative  impacts  of
•• using this approach?  This section of the report  will
  oresent findings of those kinds of questions for  each.  ..,
  strategy.

       1.  Integration by Chemical Pollutant.

       This  approach  has been dominant historically in EPA
    r-lv  because of  legislative mandate and partly because
     lv is of health  and environmental risks must begin with.
  &n^iific pollutants.   Two overriding difficulties of the
  S?7i,- = r,-f  control  model have  been  1) the vast  numbers of
  P°i lutlnts to be controlled,  and  2}  the  difficulty in
    *^'na aoency-wide toxics  priorities given  the variety
  •^requirements of each program's  differing  legislation.

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Report Outline
Page Three
     o
     o
     The  current strategy proposes  to:

     o  strengthen the agency-wide  chemical priority rankina
        process;                                          ^

     o  standardize the methodology for  calculating pollution
        control costs and comparing control costs for each
        chemical across media;

        consider the effectiveness  of the  work group format
        for developing agency-wide  control strategies;

        develop support documents which  consolidate exposure,
        risk,  chemical characteristics,  regulatory action
         level, and cost-related information on selected
        priority pollutants;

      o   develop a strategy for analyzing and  taking
         regulatory, or non-regulatory, action for each
        priority chemical.


 2.   Integration by Industry.

      Toxics integration by industry would force  regulators
 to  consider assessment and control  technologies  front an
 intermedia perspective; and would increase the visibility of
 economic  considerations.  This strategy  will  describe the
 total pollution problem created by a specific industry,
 then assess the health and environmental risks of that
 pollution.  Traditional and innovative control options  -
'will be priced.  Finally, this approach  will  compare risk
 data- with control  costs for each option ^nd recommend a  :,
'regulatory decision tailored to that industry and to the
 population exposed.

     . Critical  factors  in  developing the strategy are:

      o  proposing  criteria for. industry selection,  such  as
         nature  of  intermedia pollution discharges,  technical
         feasibility of control options,  and economic
         condition  of  the  industry;

      o  modeling the  extent of a selected industry's  toxics
         emissions;

      o  estimating economic impacts;

      o  developing methods for intermedia risk assessment
         for a  given  industry  (based on other 71? work)   and
         a means for  selecting  regulatory priorities;

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Report Outline
Page Four


     o   developing industry analytic work  groups or other
        .organizational devices to implement this approach.


     The report to the Administrator will  summarize findings
of the  industry case studies which are  testing this approach.


3.   Integration by Geography.

     Toxic pollution problems vary in severity across -the
country.  A geographic approach will examine the feasibility
of applying intermedia analytic and control strategies
 (particularly non-regulatory devices) to the unique problems.
of particular geographic areas.'                   _

      This year the project will identify and develop tne
primary components of a geographic approach to toxics
 control.  This approach will include such  elements as
 site selection and planning procedures, development of
 analytic tools, and definition of control  strategies
 appropriate to the special problems of a particular area.

      Control strategies which are cost-effective and suitable
 for a given geographic area must be devised  on the basis  of
 defensible and fairly comprehensive descriptive  information.
 Analytic tools currently available  lackjihe  necessary
 sophistication to "provide  such information.   Therefore, in ' ..
 addition to describing basic  requirements of a geographic  -
 approach, this project will  focus on developing the requisite
 analytic  techniques,  using to the maximum degree data which is
'already available.   Testing  these analytic tools will be
. an  important  function of- several case  studies to be    •      :
 conducted in  sites  suspected of  having unusually severe
 toxic  problems.                           .    •    •'   - -

      The  final report will summarize the utility of the
 geographic  approach,  drawing from past geographic analyses
 and the two case studies  in addition to answering questions
 such as the following:

      -How adequate are available data  bases for routine
 geographic  analyses?

      -What are the appropriate roles of Federal, state
 and local Governments in targeting  analyses, in developing,
 and finally in implementing control options?

       -How feasible is implementation of such an approach
 within EPA?

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Report Outline
Page. Five


C.   TIP  Will Recommend Changes in a Kurrber  of  Areas

      1.   The Most Promising Strategic Approach

      The report will recommend criteria for when, based on
our current knowledge, each strategy can best  be used
 (e.g.  when a particular chemical is of compelling "health
 concern and to which there is wide exposure; when an industry
 emits many toxic pollutants whose regulation can most
 effectively and cheaply be accomplished collectively; where
 a localized pollution problem exists for which a national
 regulatory control would be inappropriate). If possible,
. the report will also  suggest idea's for combining parts of
 two or all three  strategies  (e.g., an industry based
 regulatory  strategy,  but with intermedia work groups on top
 priority pollutants on the assumption that all of  an
 industry's  waste  streams cannot be regulated cost-
 effectively;  and  with alternative control measures  for high
 priority geographic problems.)

 2.   Implications  of Strategy  Cnoice.

      This  section of  the  report  is perhaps  the most  important
 because it  will  articulate the management  decisions and
 orocedural  changes necessary to  implement  the preferred
 integration strategy.  This  portion  of  the report will
 define 'an  array of possible  changes  in  stairute, in
 organization, and in  "decision-making process.  It will
  suggest criteria for applying the tools and making  the policy
  judgments  raised in earlier  sections of the report,  including
  such considerations as:
                                                             V
       o  what rules to develop and when £hey should  be
    • ""   issued;

       o  what standards to use which consider  cost  or
          risk trade-offs and against which regulations
          should be evaluated;

       o  how  and when to evaluate intermedia effects and
          relationships.

       The organizational implications of changes such as these
  mioht range  from  expanding the number of pollutant-specific
  and industrial workgroups,  to creation of offices of specific
  industry regulation  empowered to  initiate  all controls
  affecting  that  industry.  The summary  of  legislative issues
  will  hiahlight  obstacles to  implementation of the  strategy.
m

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Report Outline
Page Six •
3.  -Time  Table

     The  report will present a timetable with options
related to  speed of implementation of  the  selected strategy
or  strategy elements.  Gaps in necessary information will
exist when  the final report is prepared, and we will need
more time before we understand 'the full implications of
each strategic approach:  that knowledge shortfall will
brake  immediate implementation.  The Administrator, however,
will be  presented choices for EPA resource allocation and
focus,  legislative initiatives, allocations of authority,
etc.,  which could determine the pace of integration activity.

D.   The  Report Will Present a Draft FY82 Toxics Integration'•
     Project Workplan.

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