United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
«-EPA
Publication 9285.7-01 DPS
EPA/540/F-97/036
PB97-963311
January 1998
Frequently Asked Questions:
RAGS Part D
Office of Emergency and Remedial Response
Quick Reference Fact Sheet
This fact sheet summarizes frequently asked questions regarding the U.S. Environmental Protection Agency's (EPA) Risk
Assessment Guidance for Superfund Volume I - Human Health Evaluation Manual (Part D, Standardized Planning,
Reporting, and Review of Superfund Risk Assessments) Interim (RAGS Part D). The March 21, 1995 memorandum on
Risk Characterization Policy and Guidance from EPA Administrator Browner directed improvement in the transparency,
clarity, consistency, and reasonableness of risk assessments at EPA. EPA, over the years, has identified opportunities for
improvement in presentation of Superfund risk assessments. Furthermore, the General Accounting Office, members of
Congress, and others have called for the betterment of Superfund risk assessments. The October 1995 Superfund
Administrative Reform #6A directed EPA to: Establish National Criteria to Plan, Report, and Review Superfund Risk
Assessments. EPA has developed an approach to respond to these challenges, which is presented in RAGS Part D.
RAGS Part D was developed by a Workgroup of EPA Headquarters and regional risk assessors (the RAGS Part D
Workgroup) in concert with the CERCLIS 3 database development team to help standardize and improve the risk assessment
process. The following frequently asked questions have been developed to clarify how and when RAGS Part D should be
applied to a risk assessment.
APPLICABILITY
1. To what sites will RAGS Part D apply?
RAGS Part D will apply to all Superfund risk assess-
ments starting after January 1, 1998. In addition, the
use of RAGS Part D is encouraged to the extent it can be
efficiently incorporated into ongoing risk assessments
started before that time. RAGS Part D is applicable to
Remedial, Post-Remedial and SACM sites. The use of
RAGS Part D is also encouraged for Removal and
RCRA Corrective Action sites. The RAGS Part D
Workgroup suggests that RAGS Part D could also be a
useful tool for quantitative risk assessment at non-NPL,
BRAC, and Brownfields sites, and encourages its use.
2. At what phase of investigation should the Standard
Tables be used at sites?
RAGS Part D describes the value that interim Deliver-
ables, which include the Standard Tables, add to the
CERCLA remedial process, beginning with scoping and
extending through the completion of the Baseline Risk
Assessment.
3. Has DOD accepted RAGS Part D? Who will be
responsible for ensuring that all of the services
receive and use the Standard Tables?
We are working with DOD Headquarters as well as our
EPA Federal Facilities office to introduce the elements
of RAGS Part D. So far, we have received positive
feedback from the management at DOD. The individual
services will be responsible for implementation of
RAGS Part D. We are briefing various levels of Federal
Facilities (DOD and others) about RAGS Part D and are
highlighting the advantages of using it.
Some Federal department staff were involved in the
development of RAGS Part D. The Air Force, Navy,
and Army were asked to comment on the draft Standard
Table package and many of their comments were incor-
porated into RAGS Part D.
4. Should every EPA region use RAGS Part D?
Yes
5. Does this guidance apply to non-NPL sites?
While the guidance is specifically targeted for NPL sites,
the use of RAGS Part D is also encouraged for Removal
and RCRA Corrective Action risk assessments. The
principles of continuous involvement of the EPA risk
assessor and the use of Standard Tools to plan, report,
and review risk assessments would be helpful at any site.
6. Is RAGS Part D applicable to state agencies?
RAGS Part D is applicable to Superfund risk assess-
ments performed under state oversight. The use of
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RAGS Part D is also encouraged for Removal and
RCRA Corrective Action sites.
7. Have state agencies been involved in the development
of RAGS Part D?
Several regions have shared drafts of RAGS Part D with
states in their region, and the Workgroup considered the
state comments when preparing RAGS Part D.
IMPLEMENTATION
8. Rather than save time and money, it seems that the
use of RAGS Part D will slow down the process. How
will use of the Standard Tables save time and money?
Adding another major review of Interim Deliverables
will cause major delays in projects.
Initially, implementation may take longer than tradi-
tional risk assessments; there is a learning curve associ-
ated with any new guidance. The road map for continu-
ous involvement of the EPA risk assessor, presented in
Chapters 2 through 5 of RAGS Part D, and the Standard
Tables, are standard tools to perform a risk assessment
that should ultimately make the process more efficient.
Specifically, review of Interim Deliverables will increase
the likelihood that deliverables will be right the first
time and will reduce rework because EPA's expectations
for the risk assessment are clear at project initiation to
both PRP and EPA contractors.
Preparation, review, and approval time will be shortened
when each risk assessment presents information in a
consistent manner using the Standard Table format.
Consistency of presentation between risk assessments
should also lead to better quality risk assessments.
Eliminating manual data entry into CERCLIS 3 will
greatly reduce time and resources spent on reporting risk
information. On the regional level, eliminating manual
data entry will save the regions from having to provide
hard copies of risk assessments to EPA Headquarters. In
addition, EPA should be able to respond more easily to
information requests, such as Congressional inquiries,
by accessing electronic databases.
Regarding Interim Deliverables, another review is not
being added; instead existing reviews are being phased
to occur at the most critical times. Early and continuous
involvement of the EPA risk assessor will lead to fewer
data gaps and less rework associated with the Draft
Baseline Risk Assessment.
9. The risk assessors in our region are so busy now, how
can they possibly be involved in every step of the RI,
FS, and other parts of the process? We are going to
need more risk assessors if this is the case.
EPA Headquarters has canvassed the regions and
requested resource requirements to implement the
elements of RAGS Part D. EPA Headquarters is attempt-
ing to supplement the staff in the regions to meet those
demands. In addition, the standard reporting formats
(Standard Tables) provided in this guidance will make
it easier for RPMs to identify risk assessment data
requirements if a regional risk assessor is not available
to review a risk assessment.
10. It seems that implementation of RAGS Part D will
cost more money, since most PRPs and contractors
already have their own standard formats for risk
assessments. Why are we reinventing the wheel?
How can we estimate the initial increase in cost of
this guidance for our contractors?
Initially, PRPs and contractors may have to amend their
spreadsheets to provide appropriate data for the Standard
Tables. Regional risk assessors should be able to
estimate the initial cost for amending spreadsheets.
After this initial effort, the cost should actually decrease
because of the standardization of requirements. EPA is
implementing RAGS Part D in response to concerns by
Congress (and the public) regarding the problems with
transparency, clarity, consistency, and reasonableness of
risk assessments. Without Standard Table formats, risk
assessment information would continue to vary in
completeness and clarity, and the data would have to be
entered into CERCLIS 3 manually.
11. Why are the Standard Tables so long and redundant?
Why not "nest" information within columns?
The Standard Table format promotes transparency in
data presentation and facilitates subsequent electronic
data transfer to CERCLIS 3. The electronic format will
enable risk assessors to copy columns rather than retype
information, so any repetition should not be burden-
some. In addition, because of the eventual link between
the Standard Tables and CERCLIS 3, it is necessary to
segregate distinct pieces of information in order to make
electronic transfer possible.
12. How will implementation of RAGS Part D add to
consistency in risk assessments when we say that risk
assessors should refer to regional guidance?
RAGS Part D adds to consistency of reporting of risk
information. Where there is not overarching National
guidance, regional differences exist. The risk assessor
should refer to the regional office for appropriate guid-
ance on topics such as variations in fish consumption
rates, models used for showering scenarios, and selec-
tion of default exposure parameters.
TRANSITION
13. If I am asking my contractors to implement the use of
Standard Tables, I will have to amend statements of
work for all my sites. This will be a lot of work.
Sites with risk assessments already underway will be
handled on a case-by-case basis and may not need
amended SOWs. EPA Headquarters has offered assis-
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tance to regions in amending SOWs for EPA contractors
performing risk assessments. For PRP lead sites, regions
will be responsible for amending consent decrees as
needed.
14. Will RPMs, contractors, etc. be trained in the use of
RAGS Part D?
There will be training in each region in FY 98 for
Federal and state risk assessors, RPMs, and contractors
regarding the elements of RAGS Part D.
15. How will the format of the Standard Tables change in
years ahead as new guidance is released?
The format of the Standard Tables is the result of an
extensive development effort, and we do not expect
major changes to the Standard Tables except for addi-
tions resulting from new guidance (e.g., lead guidance,
Monte Carlo/Probabilistic Analysis, and ecological
guidance).
16. If I have questions on how to complete one of the
Standard Tables, who do I contact?
The Instructions for the Standard Tables offer detailed
guidance for completion of these Tables. EPA is also
developing a website and telephone Helpline to assist
users in implementing RAGS Part D and as a source of
update information. In addition, the RAGS Part D
Workgroup member from your region (listed at the end
of this Fact Sheet) should be able to assist you and
answer questions about the Standard Tables.
PROCEDURES/APPLICATION
17. Are there comparable tables for ecological risk
assessment?
Standard Tables for ecological risk assessment are on a
different track than the human health Standard Tables.
EPA Headquarters representatives are working with
regional risk assessors on Standard Tables for ecological
risk assessment.
18. If ecological concerns are driving the site cleanup,
what Standard Tables should be used?
The Standard Tables for human health risk assessment
should be completed if a human health risk assessment
is being prepared. Ecological Standard Tables, once
finalized, should be used to present ecological risk
assessment information. Standard Tables for ecological
risk assessment are being developed under another
initiative.
19. EPA just released Monte Carlo guidance. How will
this be reflected in the Standard Tables?
The current version of the Standard Tables in RAGS
Part D does not address Monte Carlo Analysis; however,
Chapters 2 and 3 discuss probabilistic analysis. Once
the Superfund program completes guidance in these
areas, Standard Tables will be developed to implement
the guidance. In addition, there will be updates to these
tables periodically and a website and Helpline will be
available for guidance on changes.
20. What is the definition of EPA risk assessor?
This term refers to the risk assessor responsible for
reviewing the risk assessment on behalf of EPA. In
general, the EPA risk assessor is employed by EPA.
Many EPA regions may also receive contractor, inter-
agency, or state support in performing the role of the
EPA risk assessor. The designation is a region-specific
matter.
21. How is lead exposure addressed by the Standard
Tables?
A separate Standard Table documenting lead exposure,
based on the IEUBK model, is under development.
When completed, it will be made available through the
website (http ://www. epa. gov/superfund/oerr/techres/
ragsd/ragsd.html) and through the RAGS Part D Work-
group member from your EPA region.
22. Will Interim Deliverables be subject to enforceable
schedules?
Enforceable schedules of Interim Deliverables will be
handled on a site-specific basis in each region.
23. Can the Standard Tables be altered?
No. The Standard Table formats can not be altered (i.e.,
columns can not be added, deleted, or changed); how-
ever, rows and footnotes can be added as appropriate.
Standardization of the Standard Tables is needed to
achieve Superfund program-wide reporting consistency
and to accomplish electronic data transfer to CERCLIS
3.
24. When, in the risk assessment process, are Interim
Deliverables due?
The schedule for Interim Deliverables will be deter-
mined on region-specific and site-specific bases.
25. Does RAGS Part D contradict the format outlined in
RAGS Part A?
No. RAGS Part D supplements RAGS Parts A, B, and
C.
26. What happens if a chemical is not originally included
as a Chemical of Potential Concern, but is later
detected?
The Standard Tables should reflect the information used
in the Baseline Risk Assessment to make the remedy
decision. If necessary, the Standard Tables may require
modification to reflect new data. The use of electronic
spreadsheets makes this an easy task.
CERCLIS 3
27. How will information be entered into CERCLIS 3?
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The Standard Tables prepared in Lotus® and/or Excel®
formats will be electronically transferred to CERCLIS 3
using an upload function that is under development.
28. Who will enter information into CERCLIS 3?
Responsibility for entry of CERCLIS 3 risk data during
FY 98 has not yet been determined. Use of Standard
Tables by the risk assessor will minimize the burden of
manual entry of risk data into CERCLIS 3.
29. Who will have access to the risk data in CERCLIS 3
(e.g., public, DOD, EPA Program Managers, RPMs,
risk assessors)?
The CERCLIS 3 database managers will determine data
accessibility. It has been recommended that entities
contributing data to CERCLIS 3 be given access to it.
At the moment, it is planned for the public to have
access to non enforcement-sensitive data. The EPA
regional Information Management Coordinators will
have information on CERCLIS 3 data accessibility.
FOR FURTHER INFORMATION
The technical details (e.g., equations and assumptions)
necessary to complete a risk assessment are available in
RAGS. Additional information and guidance can be found
in the various OSWER directives that have been released on
risk assessment. For additional copies of this Frequently
Asked Questions Fact Sheet, or any of the aforementioned
risk assessment guidance documents, call the National
Technical Information Service (NTIS) at (703) 487-4650 or
1-800-553-NTIS (6847). Alternately, you can access infor-
mation on RAGS Part D via the Internet at the following
location:
http://www.epa.gov/superfund/oerr/techres/ragsd/
ragsd.html
The following members of the EPA RAGS Part D Workgroup
may also be contacted:
EPA Headquarters: Jim Konz
(konz.james@epamail. epa.gov)
Region I: Ann-Marie Burke
(burke.annmarie@epamail.epa.gov)
Region It: Marian Olsen
(olsen.marian@epamail.epa.gov)
Region HI: Jennifer Hubbard
(hubbard.jennifer@epamail.epa.gov)
Region IV: Glenn Adams
(adams.glenn@epamail. epa.gov)
Region V: Andrew Podowski
(podowski. andrew@epamail. epa.gov)
Region VI: Ghassan Khoury
(khoury.ghassan@epamail. epa.gov)
Region VII: Dave Crawford
(crawford. david@epamail. epa.gov)
Region VHI: Chris Weis
(weis. chris@epamail. epa.gov)
Region DC: Stan Smucker
(smucker.stan@epamail.epa.gov)
Region X: DanaDavoli
(davoli.dana@epamail.epa.gov)
REFERENCES
U.S. EPA. 1989. Risk Assessment Guidance for Superfund
(RAGS): Volume I: Human Health Evaluation Manual
(HHEM), Part A, Interim Final. Office of Emergency and
Remedial Response, Washington, DC. EPA/540/1-89/002.
NTIS PB90-155581.
U.S. EPA. 199 la. Risk Assessment Guidance for Super-
fund (RAGS): Volume I: Human Health Evaluation Manual
(HHEM), Part B, Development of Risk-Based Preliminary
Remediation Goals. Office of Emergency and Remedial
Response, Washington, DC. EPA/540/R-92/003 Publication
9285.7-01B. NTISPB92-963333.
U.S. EPA. 1991b. Risk Assessment Guidance for Superfund
(RAGS): Volume I: Human Health Evaluation Manual
(HHEM), Part C, Risk Evaluation of Remedial Alternatives,
Interim. Office of Emergency and Remedial Response,
Washington, DC. EPA/540/R-92/004. Publication 9285.7-
01C. NTIS PB92-963334.
U.S. EPA. 1998. Risk Assessment Guidance for Superfund
(RAGS): Volume I: Human Health Evaluation Manual
(HHEM), Part D, Standardized Planning, Reporting, and
Review of Superfund Risk Assessments. Office of Emergency
and Remedial Response, Washington, DC. EPA/540/R-
97/033. Publication 9285.7-01D. NTIS PB97-963305.
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