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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