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
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- 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
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"*
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
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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.
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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.
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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
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