x>EPA
United States
Environmental Protection
Agency
i
0/dce of
Solid Waste and
Emergtncy Response
DIRECTIVE NUMBER: 9835.I5a
TITLE: "Supplemental Guidance on "Performing" Risk -j.-
Assessments in'Remedial Investigation/Feasibilit
Studies (RI/FSs) Conductedby Potentially " .--
Responsible Parties (PRPs)
APPROVAL DATE:-
EFFECTIVE DATE:
ORIGINATING OFFICE: OWPE
B FINAL
D DRAFT
LEVEL OF DRAFT
D~A — Signed by AA or OAA
D B — Signed by Office Director
DC — Review & Comment
REFERENCE (other documents):
s WER QSWER OSWER
DIRECTIVE ^DIRECTIVE Dl
7-f-'1 •
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x>EPA
United States
Environmental Protection
Agency
i
0/fice of
Solid Waste and
Emergtncy Response
DIRECTIVE NUMBER: 9835.I5a
"TITLE: "Supplemental Guidance on "Performing'Risk .i-•••-••
• Assessments in'Remedial Investigation/Feasibilit
Studies (RI/FSs).-Conductedby Potentially " •.--
. Responsible Parties (PRPs)
APPROVAL DATE:-
EFFECTIVE DATE:
ORIGINATING OFFICE: OWPE
E FINAL . • -
D DRAFT -
LEVEL OF DRAFT
D"A — Signed by AA or OAA
D B — Signed by Office Director
DC — Review & Comment
REFERENCE (other documents):
SWER
OSWER
DIREmiUEmDIRECTlVE Dl
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d St
es environmental Protection Agency
Washington. DC 20460
OSWER Directive Initiation Request
1. Directive Numoef
9835.15a
2. Originator Information
Name of Contact Person
Steve Ells
Mail Code
OS-510
Office
OWPE
I Telephone Code
475-9803
3.Title. Supplement Guidance on Performing Risk Assessments in Remedial Investigation/
Feasibility Studies (RI/FSs) Conducted by Potentially Responsible Parties (PRPs)
4. Summary ol Directive (include brief statement ol purpose) The purpose of their memorandum is to provide
additional guidance on implementing the policy that EPA will not enter into settlement
agreements under which PRPs perform the risk assessment components of the RI/FS, as
discussed by the Agency in OSWER Directive No. 9835.15 (August 28, 1990). This memorandu
provides guidance on coordinating the site characterization tasks and feasibility study
prepared by the PRP with the baseline risk assessment performed by EPA.
5. Keywords Remedial Investigation/Feasibility Study (Ri/FSs)
Potentially Responsible Parties (PRPs)
ia. Does This Directive Supersede Previous Directive(S)?
b. Does It Supplement Previous Directive(s)?
No
No
n
Yes
What directive (number, title)
Performance of Risk Assessments in RI/FSs by PHI'S
Yes What directive (number, title) 9835.15
, Dated 8-28-90
JDraft Level
A - Signed by AA/DAA
B - Signed by Office Director
C - For Review & Comment
D - In Development
8. Document to be distributed to States by Headquarters?
Yes
X
No
This Request Meets OSWER Directives System Format Standards.
9. Signature of Lead Office Directives "Coordinator
Q^jbJUx uOoJO^ry^
10. Name and Title of Approving Official
Date .
7/*/i(
Date
EPA Form 1315-17 (Rev. 5-87) Previous editions are obsolete.
OSWER
VE DIRECTIVE
V/ER
OSWER O
DIRECTIVE DIRECTIVE
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JUL 2 199!
OFFICE OF
SOLID WASTE AND EMERGENCY RESPONSE
OSWER Directive No.
9835.15a
MEMORANDUM
SUBJECT: Supplemental Guidance on Performing/iRisk Assessments in
Remedial InvestdgAtion/Feas/bilityVstudies (RI/FSs)
Conducted by P/bjtfe/tiaJyfyy} Rejeponsib^te Parties (PRPs)
FROM:
TO:
/Jjt/Don R. Clay
Assistant Administrate,
Regional Administrators, Regions I - X
Purpose
The purpose of this memorandum is to provide additional
guidance on implementing the policy that EPA will not enter into
settlement agreements under which PRPs perform the risk
assessment components of the RI/FS, as discussed by the Agency in
OSWER Directive No. 9835.15 (August 28, 1990). This memorandum
provides guidance on coordinating the site characterization tasks
and feasibility study prepared by the PRP with the baseline risk
assessment performed by EPA.
Included with this directive are revised and annotated
versions of the Model Administrative Order on Consent for
Remedial Investigation Feasibility Study (Model AOC, Directive
No. 9835.3-1A issued on February 5, 1990) and the Model Statement
of Work for a Remedial Investigation and Feasibility Study
Conducted by Potentially Responsible Parties (Model SOW,
Directive No. 9835.8 issued on June 2, 1989). Changes were made
only in those sections dealing with risk assessment. Regions
should use these Models as guides when drafting site-specific
AOCs and SOWs.
Early Public Involvement
Although EPA is preparing the baseline risk assessment, it
is important that all interested parties, including the public
and PRPs, be given an opportunity to have early input into the
direction of the risk assessment. This can best be achieved by
RPMs actively soliciting input from all interested parties during
Printed on Recycled Paper
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the RI/FS scoping process. At many sites, public scoping
meetings may be the appropriate means to accomplish this.
EPA Responsibilities
In order to complete the RI/FS and the baseline risk
assessment and select a remedy without undue delay, it is
imperative that there be a timely exchange of information between
the PRPS and EPA throughout the entire process. Timely
submission of high quality site characterization deliverables by
the -PRP will allow EPA to develop the baseline risk assessment,
but the PRP also needs information from EPA to develop an
acceptable FS.
In order to develop a list of potential remedial
alternatives, the PRP must know the chemicals of concern and the
media of concern that are to be treated (or contained where
appropriate) . As soon as EPA has evaluated the site
characterization data submitted by the PRP, EPA should develop
and release two or more risk assessment memoranda to all
interested parties. One should list the chemicals of concern for
human health and ecological effects and their toxicity values;
the other should list the potential exposure scenarios, exposure
assumptions,- and exposure point concentrations that EPA plans to
use in the baseline risk assessment. The purpose of releasing
this information is three-fold: 1) to keep the public informed
about progress at the site, 2) to allow public input at this
stage, and 3) to give the PRP sufficient information to continue
developing remedial alternatives that are appropriate for the
site.
After considering all submitted comments, EPA will prepare
the baseline risk assessment report. EPA should release this
report to the public at the same time it releases the final RI
report prepared by the PRP. The PRP needs this information to
continue work on the FS report and on treatability studies.
Although EPA will consider any comments submitted on the baseline
risk assessment memoranda in drafting the baseline risk
assessment, EPA is not obligated to respond to comments at that
point in the process. If, after the baseline risk assessment
report is released, any commenters feel that EPA did not address
their concerns in the baseline risk assessment report, they
should notify EPA of their continued concerns during the formal
public comment period, i.e., after the Proposed Plan is released.
This notification should clearly identify the previous comments
that were not addressed to ensure that EPA addresses all that are
considered significant in the responsiveness summary of the ROD.
Re-submission of the comments is not necessary.
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acceptable RI/FS. We will re-evaluate this process as we gain
more experience.
\If you have any questions about this policy, please contact
Stephen Ells, Chief, Technical Oversight Section, Office of Waste
Programs Enforcement, at FTS 475-9803.
cc: Waste Management Division Directors, Regions I-X
Regional Counsel, Regions I-X
Regional CERCLA Branch Chiefs, Regions I-X
Regional CERCLA Section Chiefs, Regions I-X
Attachments
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RI/FS Schedule
Implementing these new procedures should not lengthen the
time it takes to complete an RI/FS and select a remedy at most
sites. To minimize delays, frequent discussions should be held
with PRPs and the public to keep them informed of site progress
and current EPA guidances and policies.
EPA seeks to make clear that it will not repeatedly review
PRPs1 RI/FS deliverables. If PRPs do not revise their
deliverables and the draft RI and FS to reflect EPA comments in a
timely way, EPA should consider either taking over the RI and/or
FS or writing its own supplements to these documents.
Revisions to the Model AOC
All PRP risk assessment deliverables have been eliminated
from the AOC. A change has also been made in Task III: Site
Characterization. PRPs are now required to submit all sampling
results in a computerized format in order to allow EPA to rapidly
evaluate the collected data and develop the baseline risk
assessment.
A new section has also been added in the AOC in order to
emphasize EPA's oversight role in evaluating the PRPs1 estimates
of residual risks associated with various remedial alternatives
in the feasibility study.
The section on dispute resolution in the AOC has also been
modified by excluding the baseline risk assessment from dispute
resolution. The baseline risk assessment is not a PRP
deliverable required under an AOC but an EPA document. All
interested parties have an opportunity to review and comment on
two baseline risk assessment memoranda prepared by EPA during the
RI phase. EPA will respond to significant comments on the final
baseline risk assessment, the final RI, the final FS, and the
Proposed Plan during the formal comment period.
Model SOW
All PRP baseline risk assessment deliverables have been
removed. In addition, EPA will now review and approve the PRPs1
Technical Memorandum Documenting Revised Remedial Action
Objectives and the Technical Memorandum on Remedial Technologies,
Alternatives and Screening in order to ensure that the PRPs have
properly incorporated the findings from EPA's baseline risk
assessment. Language was also added recommending an additional
point of EPA management review before EPA finalizes the baseline
risk assessment.
After initial issues are worked out, EPA expects that this
revised process will help reduce the time it takes to complete an
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