SEPA
Unnw SI«IM
Environment*! P'O««ction
Solid WMI«
DIRECTIVE NUMBER: 9285.4-06
TITLE: ATSDR Health Consultations Under CERCLA
APPROVAL DATE: November 21, 1991
EFFECTIVE DATE: November 21, 1991
ORIGINATING OFFICE: OERR
121 FINAL
D DRAFT
STATUS:
REFERENCE (other document!)
[ ] A- Pending OMB approval
[ ] B- Pending AA-OSWER approval
[ ] C- For review &/or comment
[ ] D- In development or circular i-.-*
headquarters
DIRECTIVE DIRECTIVE
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ted Slates ;rv/ironmer:ai Protection Agency
Washington. DC 20460
OSWER Directive Initiation Request
1. birective Numoer
9285.4-06
2. Originator Information
Ma HO.
lame or uontact nenon Man c
SF Document Center Coordinator OS-
Office
OERR
Telephone Code
202-260-9760
3. Title
ATSDR Health Consultations Under CERCLA
4. Summary ol Directive (include Onef statement of purpose)
The purpose of this memo is to clarify issues related to Agency for Toxic Subtances
and Disease Registry (ATSDR) health consultations under CERCLA. These clarifications
apply to ATSDR health consultations requested by the Superfund removal remedial and
site assessment programs.
5. Keywords
Removal and Site Assessment
6a. Does This Directive Supersede Previous Qirective(s)?
b. Does it Supplement Previous Oirective(s)?
; I No
V ! No
Yes What directive (number, title)
Yes What directive (number, title)
7 Draft .evel
I A - Signed 3y AADAA
8 - Signed by Office Director
C •• For Review & Comment
D - ;n Development
8.
Document
to
be
distributed
to
States
by Headquarters?
Yes , so
This Request Maata OSWEflyOlfectlvaa System Format Standards.
•,0. Name and Title of Approving Official
9. Signature oM.ead Office Directives Coordinator
jDate
i\j iiuc wi r^^^i \^v 11 iu wuMviQi
Henry L. Longest II, Director
Office of Emergency and Remedial Response
i Date
November 2i, 1991
EPA Form 1315-17 (R«v. 5-87) Previous editions are obsolete.
OSWER Of'VER OSWER O
VE DIRECTIVE DIRECTIVE DIRECTIVE
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
NOV 2
1001
OFFICE OF
SOLID WASTE AND EMERGENCY RESPONSE
MEMORANDUM
SUBJECT: ATSDR Health Consultations Under
FROM:
Directive 19285.4-06
Henry L. Longest II, Director
Office of Emergency and Remedi
ponse
TO:
Director, Waste Management Division,
Regions I, IV, V, and VII
Director, Emergency and Remedial Response Division,
Region II
Director, Hazardous Waste Management Division,
Regions III, VI, VIII and IX
Director, Hazardous Waste Division
Region X
Director, Environmental Services Division
Regions I, VI, and VII
PURPOSE AND SUMMARY
The purpose of this memorandum is to clarify issues related
to Agency for Toxic Substances and Disease Registry (ATSDR)
health consultations under CERCLA. These clarifications apply to
ATSDR health consultations requested by the Superfund removal,
remedial, and site assessment programs.
(1) EPA Regions should consult with Headquarters prior to
using an ATSDR health consultation as the basis for
selecting a residential soil cleanup level for lead,
for CERCLA removal and/or remedial sites, that is
greater or less than EPA's recommended interim range of
500-1,000 ppm.
(2) Regions also should consult with Headquarters before
taking actions based on other ATSDR health
consultations that raise similar nationally significant
or precedent-setting issues for the Superfund program.
(3) Findings and conclusions of ATSDR health consultations
are strictly site-specific and do not establish
national EPA policy. ATSDR health consultations should
not be applied to situations beyond the specific site
for which they were developed.
Printed on Recycled Paper
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BACKGROUND
CERCLA section 104(i)(4) directs ATSDR to "provide
consultations upon request on health issues relating to exposure
to hazardous or toxic substances, on the basis of available
information, to the Administrator of EPA, State officials, and
local officials." ATSDR defines a health consultation as a
response from ATSDR to a specific question or specific request
for information pertaining to a hazardous substance or site
(e.g., Does a given level of mercury in water pose a threat to
human health?). Health consultations, because they often are
time-critical and require rapid response, are a more limited
response than an ATSDR health assessment. EPA Regional staff
frequently have found ATSDR health consultations to be very
useful sources of information.
Health consultations typically are performed as joint
efforts by ATSDR Regional offices and appropriate ATSDR
Headquarters staff. The variety of topics encompassed can
include environmental health, environmental medicine,
epidemiology, toxicology, worker health and safety, acute release
events, and site operations. Physicians, toxicologists,
environmental engineers, environmental health scientists, and
emergency response coordinators are available on a 24-hour basis
for emergency response. ATSDR can deliver recommendations
verbally or in writing, whichever is deemed most appropriate.
Because of the importance of timely response to these types of
requests, written health consultations are not routinely released
for public review, but recommendations may be discussed with
relevant federal, state, or local agencies prior to release.
DISCUSSION
Recently, there have been some CERCLA sites for which EPA
has selected, based (at least in part) on ATSDR health
consultations, residential soil lead cleanup levels that have
been outside the range recommended by the Office of Solid Waste
and Remedial Response (OSWER). OSWER has issued a directive and
a memorandum providing guidance on cleanup levels for lead in
soil at CERCLA sites:
"Interim Guidance on Establishing Soil Lead Cleanup Levels
at Superfund Sites," OSWER Directive #9355.4-02, September
1989
"Update on OSWER Soil Lead Cleanup Guidance," Memorandum to
Regions from OSWER Assistant Administrator, August 29, 1991
The August 1991 memorandum, which provides a progress report
on OSWER's efforts to revise the September 1989 directive,
reaffirms the recommended interim soil cleanup level of 500-
1,000 ppm total lead for CERCLA sites established in that
directive. It also states that "OSWER believes that the best
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available approach is to use the EPA Uptake Biokinetic (UBK)
Model as a risk assessment tool to predict blood lead levels and
aid the risk management decision on soil lead cleanup levels at
CERCLA/RCRA sites which are characterized as residential."
However, before issuing a final directive recommending the UBK
Model as the preferred method for setting soil lead cleanup
levels at CERCLA/RCRA sites, OSWER has decided to seek additional
review of the model, beginning with the Science Advisory Board on
November 7, and to evaluate its use at several types of sites.
In the interim, the August 1991 memorandum directs that
Headquarters be consulted before a Region uses the UBK Model as
the basis for soil lead cleanup levels outside the 500-1,000 ppm
recommended interim range.
In parallel with this recent guidance on the use of the UBK
model, Regions should consult with Headquarters prior to using an
ATSDR health consultation as the basis for selecting a soil lead
cleanup level that falls outside EPA's recommended interim range
of 500-1.000 ppm. This request for consultation applies both to
removal and remedial sites. Headquarters consultation is needed
in these situations because of the potential precedents set by
using ATSDR findings as a basis for site-specific soil lead
cleanup levels that fall outside of OSWER's recommended range (as
published in Directive #9355.4-02) and because of the national
significance of lead cleanups. The consultation should be with
the OSWER Lead Technical Review Group. The Headquarters lead
staff persons are Dr. Susan Griffin (FTS 260-9493) and Karen
Tomimatsu (FTS 260-9861).
By definition, ATSDR health consultations are limited and
situation-specific. ATSDR's findings and conclusions are based
on review and analysis of individual circumstances specific to
the site in question. They also are frequently prepared in
response to time-critical situations, and therefore limited in
scope and depth of analysis. Finally, ATSDR health consultations
are not subject to EPA review and consensus-building and
therefore may not always be consistent with published EPA
policies and guidelines. For these reasons, the findings,
conclusions, and recommendations of an ATSDR health consultation
should not be considered national Superfund policy and should not
be assumed to apply to sites other than the one for which it was
developed.
DISCLAIMER
This document is intended solely as guidance. EPA decision-
makers may act at variance with any of the recommendations
contained in this document. These recommendations are not
intended and cannot be relied upon to create any rights,
substantive or procedural, enforceable by any party in litigation
with the United States. These recommendations may change at any
time without public notice.
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