United State* Environmental Protection Agency Office of Solid Waste and Emergency Response &EPA by DIRECTIVE NUMBER: 9835.15 TITLE: Performance of Risk.Assessments in Remedial Investigation/Feasibility Studies (RI/FS) Conducted by Potential Responsible Parties (PRPs) i APPROVAL DATE: August 28, 1990 EFFECTIVE DATE: August 28, 1990 ORIGINATING OFFICE: OWPE/GEB Q FINAL D DRAFT LEVEL OF DRAFT EhA —Signed by AA or DAA OB — Signed by Office Director DC — Review & Comment REFERENCE (other documents): S WER OSWER OSWER DIRECTIVE DIRECTIVE Dl ------- - United SUlta Environmental Protection Agency ' Washington. DC 20440 QSWER Directive Initiation Request I.Directtve Number 9835.15 prtglniter Information Nam* ol ConUct Penon Arthur Weissman Mail Cod* OS-510 Office OWPE/GEB Telephone Cod* 202-475-6770 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 .No 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 jjtfur/OSWER Datt Oat* y August 28,. 1990 EPA Form 1315*17 (Rev. 5-17) Previous editions arc obsolete.- OSWER OSWER! OSWER 0 VE DIRECTIVE DIRECTIVE DIRECTIVE ------- "* 3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY >T WASHINGTON. D.C. 20460 *'«< 28 1990 SOLID WASTE AND EMEBGENCv R6SPCXSE OSWER Directive No. 9835.15 MEMORANDUM 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. Background 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 ------- -2- 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 assessment. 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. ------- -3- 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 consulted. 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. ------- -4- 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 ------- |