United State*
            Environmental Protection
              Office of
              Solid Waste and
              Emergency Response

 TITLE:  Performance of Risk.Assessments in Remedial
  Investigation/Feasibility Studies (RI/FS) Conducted
  by Potential Responsible Parties (PRPs)
 APPROVAL DATE:   August 28, 1990

 EFFECTIVE DATE:   August 28, 1990





   EhA —Signed by AA or DAA
   OB — Signed by Office Director
   DC — Review & Comment

REFERENCE (other documents):
S WER       OSWER       OSWER

                        -    United SUlta Environmental Protection Agency
                       '           Washington. DC 20440
                  QSWER Directive Initiation Request
                                  I.Directtve Number

                                   prtglniter Information
      Nam* ol ConUct Penon
         Arthur Weissman
     Mail Cod*
Telephone Cod*
      3. TiUe
            Performance of Risk Assessements in Remedial Investigation/Feasibility.Studies
            (RI/FSs) Conducted by Potential Responsible Parties (PRPs)
      4. Summary o( Directive (indude brief statement of purpose)
        To provide initial guidance on • implementing my recent decision that  in the future
        EPA will develop all risk assessments for sites remediated under CERCLA.      /
      5. Keywords
               Risk Assessment; RI/FS; PRPs
       b. Does ft Supplement Previous OlricUve(s)?
                                           I No
                     YM   Whit diractrv* (number, tftfe)
                     Yts   Whet direct** (number. BC«)
      7. Oralt Level
          A' - Signed by AM3AA
B - Signed by Offlc* Director
       C - For Review & Comment
         D -
            8. Document to be distributed to States by Headquarters?  dlYtt
This Request Meets OSWER Directives System Format Standards.
9. Signature of Lead Office Directives Coordinator *
V^-^3— oL5i^vJ^_ CIN • t&-JUk-^*.-rr-D-^
10. Name and Title of Approving Official
Don R. Clay, Assistant Administra
Oat* y
August 28,. 1990
      EPA Form 1315*17 (Rev. 5-17) Previous editions arc obsolete.-
   OSWER           OSWER!               OSWER              0

      >T                  WASHINGTON. D.C. 20460
                             28 1990

                                             SOLID WASTE AND EMEBGENCv R6SPCXSE

                                          OSWER Directive No.
  SUBJECT:   Performance  of Risk Assessments  in Remedial
             Investigation/Feasibility .Studies  (RI/FSs) Conducted  by
             Potentially  Responsible Parties  (PRPs)
  FROM:     Don R. Clay
            Assistant Administx'a
  TO:       Regional Administrators, Regions  I-X

       The purpose of this memorandum  is to provide  initial
  guidance on implementing my  recent decision that in  the  future
  EPA will develop all risk assessments for sites remediated  under
  CERCLA.  This directive focuses on the applicability of  the
  decision to new and existing orders  or decrees for RI/FSs
  conducted by PRPs.  A companion memorandum  from the  Office  of
  Enforcement addresses the performance of risk assessments at
  Federal facilities.

       In. essence, EPA or a State (whose oversight of  the  PRP is
  Federally funded) will develop the risk assessment for all  new
  orders or decrees.  For existing orders or  decrees that  specify
  that the PRP prepares the risk assessment,  the PRP will  be  given
  an opportunity under the terms of the order or decree to complete
  an acceptable risk assessment under  stringent oversight  and
  without undue delay.  The term "risk assessment" in  this
  directive is meant to include environmental assessments  as  well
  as assessments of risks to human health.


       As you know,  OSWER recently completed  a study that, among
  other things,  compared remedies selected where the RI/FS was
  conducted by PRPs with those where the RI/FS was conducted  by EPA
  or a  State under cooperative agreement with EPA ("A  Comparative
  Analysis of Remedies Selected in the Superfund Program During FY
  87, FY  83,  and  FY  89,"  June 20,  1990, OSWER Directive 9835.13).
  The study revealed that PRP risk assessments tended  to need
  extensive modifications by the Regions.   For this  reason I
                                                         Printtd on Ktcycliet Peptr

 decided that in the future  EPA  alone  (or a State if its oversight
 of the PRP is Federally funded) would develop the risk
 assessment.   I announced this decision  in a hearing before the
 Senate Subcommittee on Superfund,  Ocean and Water Protection on
 June 21,  1990.

      I realize that there are many orders and decrees already in
 existence for PRP RI/FSs that stipulate that the PRP will develop
 the risk assessment.   Negotiations are  also underway for PRPs to
 conduct additional RI/FSs.   Therefore,  this memorandum explains
 how my decision applies to  new  and existing orders or decrees for
 RI/FSs to be conducted by PRPs  under CERCLA authority.

 Policy for New Orders  or Decrees  for PRP RI/FSs

      Effective immediately,  EPA will not enter into any new
 orders or decrees for  PRP RI/FSs  in which risk assessments are to
 be  conducted by PRPs.   That is, new orders or decrees for PRP
 RI/FSs must  state that EPA  (or  a  State  whose oversight is
 Federally funded)  does the  risk assessment, and must not include
 risk assessment products or deliverables to be developed by the
 PRP.   Such risk assessment  products, including but not limited to
 identification of chemicals of  concern, current and future
 exposure  scenarios,  and toxicity  information, will be prepared by
 EPA.   The FS and remedy selection shall be based on EPA's risk
 assessment.   New orders or  decrees should explicitly state that
 PRPs will use EPA's risk assessment as  the basis of the FS.

      This new policy does not change any responsibilities PRPs
 may have.regarding the collection of site data relevant to the
 development  of the baseline risk  assessment.  It is not expected,
 nor is it generally necessary,  that EPA should independently
 collect data from the  field in  order to be able to develop the
 risk assessment.   Rather, these data should be provided by the
 PRP's normal activities in  conducting the RI under EPA oversight
 (of course,  as part of oversight  Regions should continue to
 conduct audits,  engage in split sampling, etc. to assure the
 accuracy  of  PRP-generated data).

      New  orders or decrees  should stipulate that the PRPs will
 pay the costs for EPA  (or a State)  to develop the risk

 Policy for Existing Orders  or Decrees for PRP RI/FSs

      For  existing orders or decrees where the PRP is to prepare
the  risk  assessment, procedures are to  be followed to allow PRPs
to complete  high  quality risk assessments, or alternatively, to
allow  EPA  to complete  risk  assessments  that PRPs do inadequately.

 In implementing this policy guidance, Regions should examine the
 specific terms of the order or decree in any given case.  If
 there appear to be problems in implementing the guidance under
 the terms of a particular order or  decree, Headquarters should be

      Within the terms of existing orders or decrees, EPA will
 give a PRP an opportunity to complete the risk assessment
 correctly.   I encourage  and expect  PRPs to consult with EPA early
 and throughout the risk  assessment  process so they can ensure
 that their work is in accordance with the NCP and Agency guidance
 and is of high quality.   If the risk assessment delivered by the
 PRP is unacceptable,  even after EPA has provided comments or
 after the parties have exhausted other procedural requirements
 (such as dispute resolution)  as may be provided for in the order
 or decree,  EPA will undertake its own risk assessment.

      Depending on the terms of the  order or decree, the Region
 may provide comments  on  drafts of an intermediate deliverable in
 those cases where orders require major intermediate deliverables
 for the risk assessment;  if,  after  providing comments as required
 and pursuing other recourses as may be required under the order
 or decree,  the intermediate deliverable from the PRP remains
 unacceptable,  the Region may decide at that point to prepare its
 own risk assessment.   These procedures will allow EPA to avoid
 numerous reviews throughout the development of the risk
 assessment,  which can be so costly  in time and resources.

      If the Region determines that  the final PRP risk assessment
 is  fully acceptable,  the Region should document this finding in
 writing and place the written certification in the Administrative
 Record  File.   Such an explicit certification by EPA of a PRP risk
 assessment  should help assure the public that EPA is providing
 the  necessary  oversight.

      If,  on the  other hand,  a risk  assessment is undertaken by
 EPA  because the  PRP's is  unacceptable, EPA may use any parts of
 the  PRP's work deemed to  be of high quality.  That is, it is not
 necessary to duplicate work that the PRP has already done well.

      I,feel that  this approach will eliminate unnecessary
duplication of resources  while ensuring that all risk assessments
on which  future remedy selections are based will be of the
highest quality.


Further Implementation Steps

     As you are probably aware, the PRP community has expressed
concern about my decision and its effect on their conduct of the
rest of the RI/FS.  I recognize that PRPs have some legitimate
issues regarding coordination, scheduling, and accountability.  I
have therefore agreed to discuss these particular problems with
PRP groups and other interested parties with the intent of
implementing my decision in the most efficient and least
disruptive way.  I will certainly include the Regions as we enter
into these discussions later in the year.

     If you have any questions about this policy, please contact
Arthur Weissman, Chief, Guidance and Evaluation Branch, Office of
Waste Programs Enforcement, at FTS 475-6770.

cc:  Director, Waste Management Division,
          Regions I, IV, V, VII
     Director, Emergency & Remedial Response Division,
          Region II
     Director, Hazardous Waste Management Division,
          Regions III, VI, VIII, & IX
     Director, Hazardous Waste Division,
          Region X
     Regional Counsel, Regions I-X
     Regional CERCLA Branch Chiefs, Regions I-X