vvEPA
United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
DIRECTIVE NUMBER: 9295.1-01
TITLE: MOU BETWEEN THE ATSDR AND EPA
APPROVAL DATE: 04/25/85
EFFECTIVE DATE: 04/25/85
ORIGINATING OFFICE:
0 FINAL
D DRAFT
STATUS:
of Solid Waste
REFERENCE (other documents):
OSWER OSWER OSWER
fE DIRECTIVE DIRECTIVE
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03/19/87 United States Environmental Protection Agency
Washington, D.C. 20460
EPA OSWER Directive Initiation Request
1. Directive Number
9295.1-0:
2. Originator Information
Name of Contact Parson
ZAMUDA
Mail Code
Office
OERR/PAS
Telephone Number
382-2201
3. Title
MOU BETWEEN THE ATSDR AND EPA
4. Summary of Directive (Include brief statement of purpose)
Establishes policies and procedures for conducting
response and non-response health activities
related to releases of hazardous substances.
(4/85, 10 pp)
5. Keywords
SUPERFUND, CERCLA, PUBLIC HEALTH, REMEDY SELECTION, INTERAGENCY
.. AGREEMENT
6a. Does this Directive Supercede Previous Directives)?) yes [ X] No What directive (number, title)
b. Does it Supplement Previous Directives^)?
yes
No What directive (number, title)
7. Draft Level
A • Signed by AA/DAA
B • Signed by Office Director
C • For Review & Comment
In Developmen
This Request Meets OSWER Directives System Format
3. Signature of Lead Office Directives Coordinator
Date
9. Name and Title of Approving Official
J. MCGRAW
Date
04/25/85
OSWER OSWER OSWER
DIRECTIVE DIRECTIVE
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OSWER Directive 9295.1-1
MEMORANDUM OF UNDERSTANDING
BETWEEN
THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY
AND
THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
April 2, 1985
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MEMORANDUM OF UNDERSTANDING
BETWEEN
THE AGENCY FOR TOXIC .SUBSTANCES AND DISEASE REGISTRY
AND
THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
1. PURPOSE
The Agency for Toxic Substances and Disease Registry
(ATSDR) and the Environmental Protection Agency (EPA) agree
that guidance is required to define and coordinate joint and
respective responsibilities under the Comprehensive Environ-
mental Response, Compensation, and Liability Act (Public Law
96-510, 94 Stat. 2796, 42 USC 9601 et seq; CERCLA), Executive
Order 12316 (Responses to Environmental Damage), and the
National Oil and Hazardous Substances Contingency Plan (NCP;
40.CFR Part 300). This Memorandum of Understanding (MOU)
establishes policies and procedures for conducting response
and non-response health activities related to releases of
hazardous substances.
2. .AUTHORITY
CERCLA section 104 authorizes the President to respond
to releases or substantial threats of releases into the
environment of hazardous substances and certain releases of
pollutants or contaminants. CERCLA also establishes the
Hazardous Substance Response Trust Fund. CERCLA section 104(i)
authorizes ATSDR (part of the Department of Health and Human
Services (HHS)) to effectuate and implement specific health-
related activities with the cooperation of EPA and other agencies
Executive Order 12316 further delegates to the Secretary of
HHS certain investigatory authorities vested in the President
under CERCLA section 104 for conducting activities with the
cooperation of other agencies, relating to illness, disease or
complaints thereof. Executive Order 12316 delegates to EPA
the primary resoonse authority under CERCLA section 104
relating to release or extent of release of hazardous sub-
stances, pollutants, or contaminants, and determination of
the presence of an imminent and substantial danger to the
public health or welfare or the environment. Exceptions to
this authority include responses to releases from Department
of Defense (DOD) facilities or vessels (delegated to DOD) and
releases involving the coastal zone, Great Lakes waters,
ports, and harbors (delegated to the U.S. Coast Guard).
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3. SCOPE OF RESPONSIBILITIES
This MOU covers the coordination of health-related
activities by ATSDR and EPA as authorized bv CERCLA and
delegated by Executive Order 12"U6. ATSDR has statutory
responsibilities under CERCLA and Executive Order 12316 for
activities related to illness, disease, or complaints thereof,
for disease registries and other responsibilities related to
response actions. EPA has statutory authority under CERCLA
and Executive Order 12316 for activities related to release
or threat of release of hazardous substances, pollutants or
contaminants, and for determination of the extent of .danger
to public health, welfare or the environment, as well as,
other responsibilities related to response actions.
ATSDR and EPA will carry out their responsibilities
according to CERCLA, Executive Order 12316, the NCP/ and
this MOU. ATSDR's major responsibility will be the
evaluation of populations with current or potential exposure
to waste sites, development of health advisories, and the
follow up on populations for the evaluation of future health
effects. EPA's major responsibility in the health area will
be risk assessment and risk management as defined herein.
Health advisories will be based on ATSDR's evaluations of
current health effects and will adapt EPA's risk assessments
at a site or sites. ATSDR will not perform risk assessments
as defined herein, using the funds made available from the
Hazardous Substances Response Trust Fund. If risk assessments
are not available ATSDR will consult EPA on a case-by-case
basis. ATSDR will conduct some of. its activities through
interagency agreements with other participating agencies of
the Public Health Service through cooperative agreements with
State health departments, and through contractual arrangements
whenever appropriate. Such interagency agreements include
those with the Centers for Disease Control to conduct health
studies and conduct research and provide assistance on worker
health and safety issues; with the Library of Medicine to
establish and maintain the needed data bases on health effects
of toxic substances; and with the National Toxicology Program
to conduct standard toxicological assays.
Definitions for the key terms used in this section follow
0 Health Consultation; Immediate or short-term
consultation by ATSDR to provide health advice and/or
health effects information regarding a soecific site.
0 Health Assessment: Initial multi-disciplinary reviews
by ATSDR of all readily available data to evaluate
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the nature and magnitude of any threat to huran
health at a site. These evaluations will adapt
EPA's risk assessment tor the characterization of
potential health threats at' a site or sites, and may
include literature searches,' information summari-
zation and evaluation of existing environmental data,
pilot samples, testing for food chain contamination,
and similar activities.
0 Public Health Advisory! An advisory issued by ATSDR
based on the results of its health assessment.
0 Epidemiologic Studies: Long-term epidemiologic study
by ATSDR involving a comprehensive protocol designed
to add knowledge of the health effects of a specific
substance or substances at a site or sites.
«»
0 Health Registry: A site-specific or adverse health
effects-specific registry established and maintained
to track specific diseases and illnesses and long-
term health effects to persons exposed to toxic
substances.
0 Pilot Study; A preliminary or short term medical,
laboratory, or epidemiologic study on a limited human
population to decide if additional, large scale
studies are warranted. The study populations can
include those living at, or near, a site and those
not residing at, or near, a.site (control or reference
population).
0 Risk Assessment; A qualitative/quantitative process
conducted by EPA to characterize the nature and
magnitude of potential risks to public health from
exposure to hazardous substances, pollutants or
contaminants released from specific sites. This
process consists of hazard identification, dose-
response assessment, exposure assessment, and risk
characterization and supports EPA's risk management
process.
0 Risk Management; The process conducted by EPA to
determine the nature and extent of remedy for a site,
including alternative selection.
A. Removal Actions
Removal actions are Superfund response activities
involving the short-term cleanup or removal of released
hazardous substances that pose an immediate hazard. These
actions generally are limited by CERCLA to $1 million in cost
and six months in duration.
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ATSDR activities in support of soecific removal
actions involve health consultations and health advisories.
In addition, ATSDR may monitor the health of residents who
have been exposed to the hazardous substances or who live
near the release site. ATSDR may also provide technical
assistance to EPA on matters of worker health and safety
durinq the removal and may provide community relations
assistance to EPA. ATSDR may become involved in removal
actions through a variety of mechanisms and at various stages
of a removal action. The On-Scene Coordinator (OSC) shall
recommend that ATSDR be called in at any time during the
removal action, at the time that the criteria under Section
B.3 are met, unless in the OSC's opinion there is no need for
further public health input into the removal action. Altern-
atively, the recommendation for ATSDR involvement may be
initiated by ATSDR itself, the State, or the EPA Regional
Admin istrator.
B. Remedial Response
Remedial actions are those response .actions consistent
with a permanent remedy at a site. Remedial action is
preceded by detailed planning. This section discusses
coordination of ATSDR and EPA efforts during the remedial
response process, which involves five major stages:
0 Site discovery, preliminary
assessment, and site inspection;
0 Site ranking and NPL listing;
0 Remedial investigation (RI);
0 Feasibility study (FS); and
0 Remedial design and construction.
The roles of ATSDR and EPA during these stages are
discussed in the subsections below.
B.I Site Discovery, Preliminary Assessment, and Site
Inspection
There are different methods for identifying sites for
potential remedial response under the Superfund program.
CERCLA section 103 requires certain parties to notify the
National Response Center when they have knowledge of a
release of a hazardous substance equal to or in excess of the
reportable quantity for that substance. Notification is
forwarded to EPA and the affected State. In addition to this
formal notification process, EPA may receive notification of
a potential or actual release from a local, State, or Federal
agency that discovers the release in the performance of its
responsibilities. Following notification of a potential or
actual release, EPA conducts a preliminary assessment of the
site to determine whether further investigation and Hazard
Ranking System (HRS) scoring is warranted.
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Site discovery, preliminary assessment, and site
inspection are primarily the responsibility of EPA. If
ATSDR discovers a potential or actual release daring the
performance of its responsibilities, ATSDR will notify EPA
of this release. EPA may perform preliminary assessments and
site inspections of such releases, as warranted, and will::
determine whether further investigation is necessary.
B.2 Site .Ranking and NPL Listing "...'••
CERCLA section 105(8) requires the President to develop
criteria for determining priorities among releases or
threatened're leases of hazardous substances and, based upon
those criteria, publish and amend the NPL. Executive Order
12316., section l(c) delegates to EPA "(t]he responsibility
for. . .all of the. . .functions vested in section 105" of
CERCLA.
Decisions regarding snecific site scoring and listing of
sites on the NPL are the responsibility of EPA. If ATSDR
discovers any information about potential candidates for the
NPL during the performance of its responsibilities, AT'SDR
will submit that information to ^PA. To facilitate this, EPA
Headquarters will notify ATSDR prior to each amendment of the
NPL to allow ATSDR to recommend sites to be considered for
the NPL, and EPA will consider such recommendations, based upon
the data used by ATSDR to make the recommendation,, before
publishing the amended NPL. EPA may decide to rank sites
identified by ATSDR, retain the site information on EPA files
for future reference, or seek further information about such
sites, and will notify ATSDR of its decision.
B.3 Remedial Investigation
CERCLA section 104(b) authorizes the President to under-
take "such investigations, monitoring, surveys, testing, and
other information gathering" necessary to "identify the
existence and extent of the release or threat thereof, the
source and nature of hazardous substances, pollutants or
contaminants involved, and the extent of danger to public
health or welfare or the environment." Section 2(a) of
Executive Order 12316 delegates to the Secretary of HHS in
cooperation with other agencies, those functions of Section
104(b) "relating to illness, disease, or complaints thereof."
HHS's responsibilities are performed by ATSDR. Section 2(e)
delegates to EPA most of the remaining authorities under
section 104, including those-.functions under section 104(b)
listed above as they relate"to the occurrence or potential
occurrence of a release.
The EPA Regional Administrator, or his designee, will
determine as early as possible in the RI/FS process for a
site whether concurrent ATSDR involvement in the RI/FS is
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necessary. In deciding whether to recuest concurrent ATSDR
involvement, the Regional Administrator, or his designee,
will consider the following criteria:
0 Whether the presence of toxic substances has been
confirmed at the site;
0 Whether pathways of huma.? exposure to toxic substances
have been demonstrated to exist at the site, especially
if such pathways involve direct contact with toxic
substances; and
*
. .• ° Whether a human population has been exposed to toxic
substances via the identified pathways., and whether
there exists a threat of current or future health
effects to the population being so exposed, after
considering EPA's risk assessments or health
effects information from other sources.
If these criteria are met, the EPA Regional Administrator, or
his designee, shall request concurrent ATSDR involvement,
unless in his opinion there is no need for further public
health input into the RI/FS. Alternatively, the recommendation
for ATSDR involvement may be initated by ATSDR itself, or the
State.
Elements of the remedial investigation in which ATSDR
participates may include review of site sampling plans and
analysis protocols, site sampling, data analysis and interpre-
tation, worker health and safety, community relations, and the
remedial investigation report. The division of responsibilities
and coordination between EPA and ATSDR in conducting these
activities is described in the following paragraphs. EPA and
ATSDR will agree to strict time schedules on a site-specific
basis for all activities to be performed by ATSDR, to ensure
that the response process is not delayed. Any changes in the
time schedule will be mutually agreed upon by EPA and ATSDR.
Site Sampling. Where EPA has requested concurrent ATSDR
involvement/ ATSDR will advise EPA during the preparation of
sampling and analysis protocols to ensure collection of data
useful to ATSDR for health assessments and epidemiological
studies. EPA will be responsible for the development and
conduct of any environmental and biological (other than
human) sampling, and developing the tests therefor. ATSDR
will consult with appropriate health agencies and will summarize
recommendations regarding the necessity for testina of human
subjects. If human'subject testing is determined to be
necessary, ATSDR will be responsible for any such testing.
EPA shall review the protocols or sampling plans for such
testing to ensure collection of data useful to EPA in perform-
ing subsequent risk assessment and risk management.
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Samplinq Protocol. Where EPA has requested concurrent
ATSDR involvement, *?.A arid ATSDR will .submit a draft of all
protocols to each other for review prior to institution of
any site sampling or monitoring. Any changes in the sampling
protocols will also be provided to ATSDR for review. With
regard to the review of non-site specific protocols, (e.g.,
protocols for standard Contract Laboratory Program analysis)
EPA will provide these to ATSDR for review as early as possible
to avoid the necessity of ATSDR review of these protocols on
a site specific basis.
Data Analysis and Interpretation. At sites where EPA
has requested concurrent ATSDR involvement, EPA will-provide
its data from environmental, toxicological and other biolog-
ical sampling and testing to ATSDR. ATSDR will review all
available data for a site, including EPA's hazard identifi-
cation, dose-response assessment, exposure assessment, and
risk characterization information, drawing conclusions about
any threats to public health associated with the site. Based
on its interpretation of the site data, ATSDR will characterize
the health threats based on it's evaluation of current health
effects and in consultation with EPA concerning the magnitude
and timing of potential .future health effects. ATSDR will
communicate all health concerns to regional EPA staff and
will provide copies of health assessments and advisories to
EPA.
Worker Health and Safety. EPA may request assistance
from ATSDP on worker health and safety issues during a
remedial investigation, including consultation on the.design
of worker health and safety plans and monitoring of plan
implementation. ATSDR will make arrangements for laboratory
and field testing related to worker health and safety and
worker surveillance.
Community Relations. ATSDR may provide, at EPA's request,
assistance in conducting community relations activities during
the remedial investigation. Such assistance may include:
0 Preparation of technical and non-technical information
material for the public describing human health threats
posed by substances at a site;
0 Reviewing and commenting on human health-related
documents prepared and submitted by citizens
(e.g., citizen-generated health survey protocols);
0 Participation in public meetings, small group
meetings, and workshops; and
0 Preparing responses to specific public inquiries
regarding human health impacts of site problems.
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Remedial Investigation Report. At the conclusion of the
remedial investigation at sites where ATSDR is involved, F!P^
will send a copy of the re-nedial investigation report to ATSDR.
ATSDR will review health-related data and interpretations of
such data in the report and provide comments to EPA within a
mutually agreed upon time frame.
If EPA and ATSDR agree that ATSDR involvement is not
required at a site, ATSDR will not participate in the remedial
planning process at that site. ATSDR may undertake other
statutory activities, such as epidemiological studies or
disease.registries , at a site or sites. ATSDR will Coordinate
all such activities with EPA and will advise EPA of imminent
threats to human health at any site and at any time during
EPA's remedial process. In addition, EPA may request ATSDR
assistance in disseminating health information to the public
and in responding to health concerns of local citizens.
B.4 Feasibility Study
EPA has the final authority for determining the extent
of remedy at a site and selecting a specific remedy during
the feasibility study. In conducting feasibility studies,
EPA will develop, evaluate, and select remedial options using
the approach described in its feasibility study guidance. For
those sites where there has been concurrent ATSDR involvement,
EPA staff will consult ATSDR for its assessment of any
human health data (e.g.r clinical, epidemiologic) and EPA's
risk assessment resulting from the remedial investigation.
EPA will be responsible for performing qualitative/quantitative
risk 'assessments evaluating long-term risks to the public that
may result from exposure to hazardous substances from Superfund
sites.
It is the responsibility of EPA (Office of Solid Waste
and Emergency Response) to incorporate the results of the
risk assessment process and of health assessments by ATSDR
into risk management determinations of the extent of remedy
for a site. The goal of this process is to ensure that the
remedial action is adequate with reqard to eliminating or
mitigating the existing and future public health threats.
EPA may consider and incorporate applicable information
provided by ATSDR on the current status of public health at
the site into the selection of the preferred remedy. At the
discretion of the appropriate Regional Administrator, EPA
staff may also consult with ATSDR staff for any interpre-
tation of human health data at sites where ATSDR is not
concurrently involved. In addition, EPA may request ATSDR
assistance at any site in disseminating health information to
the public and in responding to health concerns of local
citizens. In the course of performing its health activities,
should ATSDR discover any site which, in its opinion, poses
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an imminent: threat to public health, ATSDR wiLl imned iate ly.
notify the relevant EPA Regional Office and EPA Headquarters
of this finding.
For each remedial response site where ATSDR involvement
is requested , EPA will provide ATSDR with a copy of the
draft feasibility study, and where appropriate with rough.
draft sections of the feasibility study relating to human
health and interpretation, prior to the public comment period
if possible. ATSDR will review the interpretation of the
human health data in the draft feasibility study and provide
comments to EPA during the public comment period. ATSDR will
also provide to EPA any health information it possesses on
the site during the public comment period
B.5 Remedial Design and Construction
The design and construction of the selected remedy at
Superfund sites is EPA's responsibility. The Regional
Administrator may, at his discretion, request a health
assessment from ATSDR with regard to certain elements of the
remedial design. At the conclusion of the design stage,
EPA should provide advance copies of the Remedial Design and
Construction Plans to ATSDR whenever possible if: they wish
review and comment by ATSDR. ATSDR will notify EPA if the .
remedial design does not, in its opinion, eliminate or miti-
gate the public health threat.
C. Cost Recovery
Under CERCLA, EPA is authorized to recover from responsible
parties all government costs incurred during a response
action. ATSDR agrees to conform with all procedures and
requirements for documenting costs that are to be recovered.
D. Funding
All costs incurred by ATSDR in performing its CERCLA
responsibilities ace funded by ATSDR through funds provided
for this purpose. Funding for ATSDR activities performed
under CERCLA is from the Hazardous Substances Response Trust
Fund and is provided by EPA through the budget task force
required by Section 7 of Executive Order 12316 or through
separate interagency agreements for specific health studies.
ATSDR will comply with the financial and reporting requirements
putlined in the Interagency Agreements that transfer Fund
monies to ATSDR.
4. PERIOD OF AGREEMENT
This Memorandum of Understanding will continue in effect
until modified or amended by the assent of both parties or
terminated by either party uoon a thirty (30) day advance
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written notice of the other party. Nothing in the Memorandum
is intended to diminish or otherwise alter statutory authority
of the agencies involved.
5. AMENDMENTS
This'Memorandum may be amended at any time by the agree-
ment of both parties. Each amendment must be in writing and
signed by the appropriate ATSDR and EPA officials.
6.
EFFECTIVE DATE
This Memorandum will become effective at noon on the date
of the last signature below.
Date :
MAY ?
For the Agency for Toxic
Substances and Disease
Registry
For the United States
Environmental Protection
Agency
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