vv EPA
United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
DIRECTIVE NUMBER:
Q ' - /
TITLE:
ENDANGERMENT ASSESSMENT GUIDANCE
OSWER DIRECTIVE 9850.-1
APPROVAL DATE:
EFFECTIVE DATE:
ORIGINATING OFFICE
0 FINAL
D DRAFT
STATUS:
REFERENCE (other documents):
OSWER OSWER OSWER
fE DIRECTIVE DIRECTIVE Di
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s>EPA
United States Environmental Protection Agency
Washington. DC 20460
OSWER Directive Initiation Request
Interim Directive Number
Originator Information
Name of Contact Person
Chuck Morgan
Mail Code
WH-527
Telephone Number
202-475-6690
Lead Office
D OERR
D OSW
D OUST
H OWPE
LJ AA-OSWER
Approved for Review
Signature of Office Director'
-See Attachment
Date
Title
ENDANGERMENT ASSESSMENT GUIDANCE .
OSWER DIRECTIVE 9850.-1
Summary of Directive
-""'• An EA is a determination that an imminent and substantial endangermer
it evaluates the cooective demographic, geographic, physical, chemical,
and biological factors which describe the extent of impacts of a
potential or actual release of a hazardous substance and/or hazardous
waste.' It is a Legal Prerequisite to issuing orders or filing actions
under S106 of CERCLA or S7003 of RCRA.
Type of Directive (Manual. Policy Directive, Announcement, etc.)
Guidance
Status
Draft
Final
t_J New
I I Revision
Does this Directive Supersede Previous Directive(s)? | | Yes | -^ No Doe's It Supplement Previous Directive(s)? ( | Yes
If "Yes" to Either Question. What Directive (number, title)
No
Review Plan
LJ AA-OSWER [J OUST
LJ OERR D OWPE
D OSW D Regions
OECM
D OGC
CH OPPE
D
Other (Specify)
This Request Meets OSWER Directives System Format
Signature of Lead Office Directives Officer
See Attachment
Date
Signature of.OSWER Directives Officer
See Attachment
Date
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
MOW O
NUV C. 2 i^B^ SOLID WASTE AND EMERGENCY RESPONSt
MEMORANDUM
SUBJECT: Endangerment Assessment Guidance
FROM: J. Winston Portfer
Assistant Administrator
TO: Addressees
PURPOSE
This memorandum clarifies the requirement that an
endangerment assessment be developed to support all administra-
tive and judicial enforcement actions unde.r Section 106 of the
Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA) and Section 7003 of the Resource Conservation and
Recovery Act (RCRA). Before taking enforcement action under
these provisions to abate the hazards .or potential hazards at a
site, the Environmental Protection Agency (EPA) must be able to
properly document and justify its assertion that an imminent and
substantial endangerment to public health or welfare or the
environment may exist. The endangerment assessment provides this
documentation and justification. The endangerment assessment is
not necessary to support Section 104 actions.
This memorandum also provides guidance on the content,
timing, level of detail, format, and resources required for the
preparation of endangerment assessments.
t
WHAT IS AN ENDANGERMENT ASSESSMENT
An endangerment assessment is a determination of the
magnitude and probability of actual or potential harm to public
health or welfare or the environment by the threatened or actual
release of a hazardous substance (for a CERCLA action) or a
hazardous waste (for a RCRA action).
An endangerment assessment evaluates the collective
demographic, geographic, physical, chemical, and biological
factors which describe the extent of the impacts of a potential
or actual release of a hazardous substance and/or hazardous
waste.
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In general, the endangerment assessment should identify and
characterize:
(a) Hazardous substances and/or hazardous-wastes present
in all relevant environmental media (e.g., air, water,
soil, sediment, biota);
(b) Environmental fate and transport mechanisms within
specified environmental media, such as physical, chemical
and biological degradation processes and hydrogeological
evaluations and assessments;
(c) Intrinsic toxicological properties or human health
standards and criteria of specified hazardous substances
or hazardous wastes;
(d) Exposure pathways and extent of expected or potential
exposure;
(e) Populations at risk; and,
(f) Extent of expected harm and the likelihood of such harm
occurring (i.e., risk characterization).
WHY PERFORM AN ENDANGERMENT ASSESSMENT
Under Section 106(a) of CERCLA, if the President determines
that there may be an imminent and substantial endangerment to
public health or welfare or the environment from an actual or
threatened release of a hazardous substance, the President may
secure such relief as may be necessary to abate such danger or
threat. Such relief may be in the form of a judicial action or
an administrative order to compel, responsible parties to respond
to hazardous conditions.
Before an order can be issued or an action filed under §106
of CERCLA, EPA must be able to document and justify its assertion
that an imminent and substantial endangerment to public health
or welfare or the environment may exist. The endangerment assess-
ment provides this documentation and justification. It is the
basis for the findings of fact in administrative orders, consent
decrees, and complaints.
In situations dealing with hazardous wastes or solid wastes
under RCRA, rather than hazardous substances under CERCLA, Section
7003 of RCRA may be used as the authority under which EPA may
issue orders or file civil actions I/. Section 7003 of RCRA
requires a similar finding of imminent and substantial endanger-
ment and, therefore, EPA must also document and justify such an
assertion with an endangerment assessment before taking enforce-
ment action.
I/ "Final Revised Guidance Memorandum on the Use and Issuance of
Administrative Orders Under Section 7003 of the Resource Conserva-
tion and Recovery Act", September 26, 1984 signed by Courtney Price
and Lee Thomas.
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It is important to note that "imminent" does not mean immediate
harm. Rather, it means an impending risk of harm. Sufficient
justification for a determination of an imminent endangerment may
exist if harm is threatened; no actual injury need have occurred
or be occurring. Similarly, "endangerment" means something less
than actual harm.
WHEN TO PERFORM AN ENDANGERMENT ASSESSMENT
At remedial sites subsequently targeted for CERCLA §106 or
RCRA §7003 enforcement action, all of the elements of an endanger-
ment assessment will be provided by completing the contamination
assessment, public health evaluation, and environmental assessment
during the RI/FS process. As such, these assessments are equivalent
to the endangerment assessment for enforcement sites. The informa-
tion from the contamination assessment, public health evaluation,
and environmental assessment will be considered sufficient to
issue an order although additional work may be needed prior to
litigation (See Attachment 1 and the RI/FS guidance documents
referenced on Page 6 of this guidance).
Where an RI/FS has not been initiated or completed, an
endangerment assessment must be prepared to justify an adminis-
trative order or judicial action under CERCLA §106 or RCRA §7003.
For example, orders issued to govern responsible party conduct of
an RI/FS or to compel responsible party performance of immediate
response actions will require an endangerment assessment prior to
issuance. In both cases,' the endangerment assessments will demon-
strate that there may be an imminent and substantial endangerment
which justifies either further investigative action to determine
the appropriate, remedy for a. site or an immediate response action.
In isolated cases, EPA has negotiated with potentially
responsible parties for the site remedy before it has developed
the RI/F.S. In these .few cases, an endangerment assessment must be
developed independently of the RI/FS and completed prior to issuance
of the order or decree for remedial action.
An endangerment assessment is required for all future RCRA
§7003 actions, as well as older RCRA §7003 cases to which CERCLA
§106 authority has been or will be added. An endangerment assess-
ment is not required for older RCRA §7003 cases already filed by
the Department of Justice without an endangerment assessment. The
litigation team, however, may determine on a case-by-case basis
that the preparation of an endangerment assessment or its equivalent
would substantially strengthen the government's case.
Endangerment assessments must be prepared for all RCRA §7003
or CERCLA §106 orders issued to another Federal agency for cleanup
of a Federally-owned facility. Normally, EPA. will seek response
action at a Federal facility through a site-specific compliance
agreement with the appropriate Federal agency or other responsible
parties. If, however, a compliance agreement is not complied with
by Federal owners or responsible parties, EPA may issue an order.
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WHAT LEVEL OF DETAIL
The determination that an imminent and substantial endanger-
ment to public health or welfare or the environment may exist is a
legal prerequisite that must be met before an order can be issued '
or an action filed. It is EPA policy that endangerment assessments
should be undertaken only to the extent "necessary and sufficient"
to fulfill the requirements of legal enforcement proceedings. At
any site, there is the potential for conducting studies beyond the
level of detail needed for enforcement actions. The level of
detail of the endangerment assessment should be limited to the
amount of information needed to sufficiently demonstrate an actual
or potential imminent and substantial endangerment. The level of
detail to sufficiently demonstrate endangerment will vary from case
to case based on the following factors:
0 the type of enforcement action (e.g., AO for removal
vs litigation);
0 the type of response action (e.g., removal vs remedial);
and
0 the stage of response action (e.g., RI/FS workplan vs
RI/FS completed).
The level of detail required to support a particular enforce-
ment action will ultimately be determined on a case-by-case
basis by Regional program personnel in consultation with Regional
Counsel. As a.general guide, the matrix on page 5 defines these
levels of detail based on the^..factors listed above. The matrix
should help the Regions to both (1) determine what constitutes an
adequate endangerment assessment for a particular enforcement
action, and (2). plan their intramural and extramural resources
accordingly.
When endangerment assessments are developed to support
administrative orders for private party RI/FS or removal actions,
information already available about the site will generally be
sufficient. Where sites are targeted for enforcement action
after completion of an RI/FS, the endangerment assessments
developed as part of the RI/FS will be more detailed and generally
more quantitative as they will be based on information obtained
from the remedial investigation. Such endangerment assessments
will be used to support any subsequent CERCLA §106 orders or
judicial actions seeking.design and construction of site remedies.
The information gathered in an RI/FS is generally similar
to the type of information needed for an endanqerment assessment.
However, RI/FS and endangerment assessments are developed for
different purposes. RI/FS are used to determine appropriate
response actions under CERCLA §104, while endangerment assessments
are used for enforcement actions under CERCLA §106 or RCRA §7003.
For sites with CERCLA §106 or RCRA §7003 enforcement potential,
Regions should review the RI/FS workplan to determine whether
information developed as part of the RI/FS will be sufficient
for an endangerment assessment. In certain complex cases,
additional information may be needed and a separate endangerment
assessment workplan may be required.
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The endangerment assessment should evaluate the adequacy,
accuracy, precision, comprehensiveness, reliability, and overall
quality of identified information and data.
Emergency actions do not require the same depth of assess-
ment as planned or remedial activities. By definition, an
immediate and significant risk of harm to human life or health
or the environment will be present in an emergency, making
the assessment of endangerment easier to prepare. Further,
EPA is justifying only the need for immediate action, not the
long-term remedial solution. Thus, the endangerment assessment
may be much briefer, although the Regions should attempt to
use as much available information as feasible. The Action
Memorandum supporting the emergency action will normally be
considered adequate to serve as an endangerment assessment in
'support of an enforcement action under §106 of CERCLA for an
immediate response.
Attachment 2 is an abstract of a detailed paper on "Endan-
germent Assessments for Superfund Enforcement Actions", prepared
by Technical Support Branch, CERCLA Enforcement Division, the
Office of Waste Programs Enforcement (OWPE). This paper,
previously distributed to the Regions, will provide technical
assistance in preparing qualitative and quantitative assessments.
OWPE is also preparing a handbook on preparation of endangerment
assessments.
Methodologies used for performance of such aspects of the
endangerment assessment as exposure and risk assessment should.
be consistent with the concepts and methods currently in use by
the EPA- Off ice of Research and Development (ORD).
Attachment 3 shows how the various toxicity, exposure, and
risk evaluations are used to define- the overall problems and
hazards (endangerment) at a site. Although the use of these
evaluations is possible at every site, the need for a detailed
analysis, as outlined, is likely to be appropriate at only a
limited number of sites to sufficiently demonstrate an actual
or potential imminent and substantial endangerment.
The Office of Emergency and Remedial Response (OERR) has
developed guidance manuals covering the 'performance of remedial
investigations and feasibility studies. The chapters listed
below from these documents and the OWPE handbook will provide
guidance in preparing endangerment assessments:
Guidance on Remedial Investigations Under CERCLA (OERR, May 1985)
Chapter 7 - Site Characterization
Chapter 9 - Remedial Investigation Report Format
Guidance on Feasibility Studies Under CERCLA (OERR, April 1985)
Chapter 5 - Evaluate Protection of Public Health Requirements
Handbook on Preparation of Endangerment Assessments (OWPE -
Technical Support Branch, Summer 1985)
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Attachment 4 is a list of references .that can be used in
preparation of the endangerment assessment*
FORMAT
The endangerment assessment generally should follow a
standard framework as provided in Attachment 5 and use qualitative
and/or quantitative terms as appropriate.
The Action Memorandum will normally be considered adequate
to serve as the endangerment assessment document in support of an
order under §106 for an emergency action.
The endangerment assessment document may be the order itself
(where the order contains all of the elements of an endangerment
assessment) or a separate document. In deciding whether to
develop a separate document or to include the elements of the
endangerment assessment in the order, Regions should consider the
following factors:
1. Are the responsible parties more likely to consent to
an order if the endangerment assessment is part of the body of -
the order, or a separate document?
2. Is the order likely to be issued unilaterally or on
consent? A separate document will, of course, be more important
in adversarial settings.
We strongly urge that the endangerment assessment in support
of an administrative order for private party cleanup be a -separate
document. Where all of the elements of an endangerment assessment
are in the RI/FS documents, a separate document may consist simply
of a brief statement cross-referencing the appropriate elements
of the RI/FS.
WHO SHOULD PERFORM AN ENDANGERMENT ASSESSMENT
The Regions have the responsibility to assure that endanger-
ment assessments are performed. The "Regions can draw on technical
expertise available in their Regional offices, OWPE - Technical
Support Branch, ORD, the Agency for Toxic Substances and Disease
Registry (see MOU between ATSDR and EPA), and/or contractor
personnel available through the Technical Enforcement Support
(TES) or REM/FIT and TAT contracts.
Endangerment assessments used to justify administrative
orders or judicial actions issued or filed before development
of the RI/FS should normally be drafted by Regional personnel
with the assistance of the TES contractor. The Regions and TES
contractor also have the lead in preparation of endangerment
assessments for older cases where an RI/FS has not been completed.
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If responsible parties elect to perform the RI/FS, they will,
in effect, perform an ^ndangerment assessment because they will
develop many or all of the elements of an endangerment assessment
as part of the RI/FS. Regions should review the RI/FS workplan to
determine whether information developed as part of the RI/FS will
be sufficient to show that an imminent and substantial endangerment
may exist. Because subsequent enforcement actions will rely on
the endangerment assessment developed as part of the RI/FS, close
Regional oversight should be given to this responsible party work.
The authority for determinations of imminent and substantial
endangerment relating to emergency response actions costing up to
one million dollars has been delegated to the Regions, subject to
the directives issued by the Office of Solid Waste and Emergency
Response. (See Delegation 14-1-A, Selection and Performance of
Removal Actions Costing Up to $1,000,000 and the Memorandum
"Waiver of Advance Concurrence Requirements for Certain Consent
Administrative Orders, Gene A. Lucero, January 3, 1985).
When exercising the authority to determine that an imminent
and substantial endangerment exists for the purposes of taking
enforcement action, the Region must consult with OWPE as outlinjed
in the November 30, 1984 Regional Assignment Memo (also see th«
Memorandum "Superfund Delegations of Authority - ACTION MEMORANDUM",
Howard Messner, April 4, 1984). In contacting OWPE, Regional
staff should be prepared to discuss the details of the endangerment
assessment for each determination. In certain cases involving
complex health and environmental endangerment- issues,.OWPE may ~-
request a copy of the draft endangerment assessment for review.
OWPE will complete a review of this document within 14 days of
receipt, to ensure consistent, timely response.
USE OF THIS GUIDANCE
The policy and procedures set forth here, and internal
office procedures adopted in conjunction with this document,
are intended for the guidance of sta-ff personnel, attorneys,
and other employees of the U.S. Environmental Protection Agency.
They do not constitute rulemaking by ,the Agency, and may not be
relied upon to crea-te a right or benefit, substantive or
procedural, enforceable at law or in equity, by any person.
The Agency may take any action at variance with the policies or
procedures contained in this memorandum or which are not in
compliance with internal office procedures- that may be adopted . .
pursuant to those materials.
If you have any questions or concerns regarding this guidance,
please have your staff contact Chuck Morgan (FTS-475-6690), Chief
of the Environmental Health Sciences Section of OWPE or Linda
Southerland (FTS-382-2035) of the Guidance and Oversight Branch.
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Addressees:
Regional Administrators, Regions I-X
Directors, Environmental Services Division, Regions I-X
Regional Counsels, Regions I-X
Directors, Waste Management Divisions, Regions I, IV, V,
VII, VTII
Director, Emergency and Remedial Response Division,
Region II
Director, Hazardous Waste Management Division, Region III
Directors, Air & Waste Management Divisions, Regions II, VI
Director, Toxics & Waste Management Division, Region IX
Director, Hazardous Waste Division, Region X
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Attachment 1
!
RI/FS Process
REMEDIAL INVESTIGATION
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• E.lani ol Problem . . Community Hiia»om Plan
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lata, »l Datci«M«n of Cwnm Situation
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bat #5 Latmalwy b Banch Scale Sludin
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CH 4 Evaluai* Imtilulioiul RuqiMoii twits
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Attachment 2
ENDANGERMENT ASSESSMENTS FOR SUPERFUND ENFORCEMENT ACTIONS^
R. Charles Morgari2
Robert Clemens
Thomas T. Evans
Jerald A. Fagliano
Joseph A. LiVolsi, Jr.
Abraham L. Mittelman
J. Roy Murphy
Jean C..Parker
Kenneth Partymiller
Support Branch, Office of Waste Programs Enforcement, U.S. EPA
ABSTRACT
The Comprehensive Environmental Response, Compensation and
Liablity Act of 1980 (CERCLA) gave the Environmental Protection Agency
(EPA) new responsibilities and powers to take actions in response
to releases of hazardous substances into the environment which may
present an imminent and substantial endangerment to- the environment,
or the public health or welfare. —
In an action to abate an endangerment, an assessment is made
of the hazards or potential hazards at a site according to methods
outlined in the National Contingency Plan. Information needed
to perform an endangerment assessment includes the site history
and management practices, identification and quantification of
hazardous substances at a site, and their likely transport and
fate. Estimates of actual or potential human and environmental
exposures are compared to toxicological data to describe the kind
and degree of endangerment.
:-. This paper discusses the many factors that should be considered.
in an endangerment assessment and streses the need for strict
quality assurance and sound scientific judgment.
The information presented in the paper is based on the technical
enforcement case development experiences of the authors.
Contact to whom comments should be addressed:
(WH-527), 401 M. Street, S.W. Washington, D.C. 20460
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Attachment 3
Data Collection/Problem Characterization
Data Collection/Problem Characterization
I. Site Characterization
A. physical description of the site
B. geographical location
C. demographic surroundings
D. type of facility (landfill, incinerator, impoundment)
E. management practices
II. Contaminants Found at the Site
A. identity/type
. B. quantity
C. form
D. manner of disposal
E. ambient levels
III. Factors Affecting Migration
A. topography
B. soil parameters"
C. geological parameters
D. hydrological characteristics
E. climate
IV. Environmental Fate of Contaminants
A. physical and chemical degradation characteristics
B. movement between environmental media
C. hydrogeological/geochemical characteristics
D. evidence migration
V. Hazard Identification (site/populatibn specific)
A. Toxicological evaluation, e.g.
- organ toxicity, carcinogenic
- mutagenic, teratogenic
- neurotoxic, etc.
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B. Impact Evaluation (actual)
1. Environmental impacts
a. determination of need
b. literature searches
c. lab tests
d. food chain studies
e) environmental effect observation
- stressed vegetation
- wildlife or aquatic life morbidity/mortality
- domestic animal morbidity/mortalilty
f) natural resource damages
2. Public Health Impacts (actual)
a) health assessment/advisory (short-term)
1. determination of need?
2. literature searches
3. lab tests, pilot biological testing
4. testing of food chain contamination
5. health assessment document
6. health advisories
b) human health studies (long-term)
- epidemiological studies
" clinical studies __
- registries
•c) human health standards and criteria
Data Interpretation
I. Dose-Response Assessment (predictive)
A. quantitative component of cancer mathematical
modeling- probability
"B. ADI calculations for non-carcinogens
II. Exposure Assessment
A. locate potential populations at risk o.f exposure
B. determine routes and pathways of exposure
for each in various environmental media,
and environmental transport and fate data
'C. calculate maximum short-term dose and average
dose expected over a lifetime
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III. Risk Characterization (predictive)
A. combining exposure, hazard and dose-response
assessments for a specific site
B. estimation of the magnitude of the public health
problem at a particular site including Medical
Panel concerns.
Risk Management
process of evaluating and selecting options; environmental,
economic, social and political consequences may be considered
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Attachment 4
BIBLIOGRAPHY
Proposed Guidelines for Carcinogen Risk Assessment, EPA, 49
FR 84-30724 November 23, 1984.
Proposed Guidelines for Exposure Assessment, EPA, 49 FR 84-30723
November 23, 1984.
Proposed Guidelines for Mutagenicity Risk Assessment, EPA, 49
FR 84-30722 November 23, 1984.
Proposed Guidelines for the Health Assessment of Suspect Develop-
. mental Toxicants, EPA, 49 FR 84-30721 November 23, 1984.
Proposed Guidelines for the Health Risk Assessment of Chemical
Mixtures, EPA, 50 FR 85-589 January 9, 1985.
Remedial Investigations Guidance Document, February 1985.
Interim Procedures and Guidelines for Health Risk and Economic
Impact Assessments for Suspected Carcinogens, EPA, 41
FR 24102 May 25, 1976.
ScTerTtifi c7~B~a"s"e~s 'for Identification of Potential Carcinogens
and Estimation of Risks, Report by the Work Group on
Risk Assessment of the Interagency Regulatory Liaison
Group, 44 FR 39858 July 6, 1979.
Guidelines and Methodology Used in the Preparation of Health
Assessment Chapters of the Consent Decree Water Criteria
Documents, Appendix C of Water Quality Criteria Documents:
EPA, 45 FR 79347 November 28, 1980.
_Appendix E: Response to Comments on the Human Health Effects
Methodology for Deriving Ambient Water Quality Criteria,
45 FR 79368.
Endangerment Assessments for Superfund Enforcement Actions,
HMCRI Compendium of Papers, November, 1984.
Risk Assessment and Management: Framework for Decision Making
U.S. EPA, December 1984.
* Further references are forthcoming in the. Feasibility Study
Guidance Document, the Superfund Exposure Assessment Manual,
the Superfund Public Health Evaluation Process: Procedures
Manual, the Superfund Risk Evaluation Manual, and the Office
of Research and Development Handbook for Performing Exposure
Assessments.
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Attachment 5
1. Physical Description of the Site and Site History
a. geographic location
b. management practices/site use/site modifications
c. chronological survey
d. facility description/containment systems
e. substances brought on site (identity, quantity, form
manner of disposal)
2. Site Contamination/Off-Site Contamination
a. identity of substances detected
b. concentration of substances detected
c. analytical methodology and QA/QC
d. survey of environmental monitoring studies (detailed
discussion of environmental media and contamination
levels)
3. Environmental Fate and Transport
a. physical-chemical properties of specified chemicals/
substances (e.g., soil/sediment adsorption coefficients,
vapor pressures, solubility, etc.)
b. photodegradation rates, decomposition rates, hydrolysis rates,
chemical transformations,, etc.
c. local topography
_d. description., of the hydrological setting and flow system
e. soil analyses • .
f. climatic factors, other factors affecting fate and
transport
g. prediction of fate and transport (where necessary using
modeling methods)
/
4. Toxicological Properties (hazard identification)
a. metabolism
b. acute toxicity
c. subchronic toxicity
d. chronic toxicity
e. carcinogenicity
f. mutagenicity
g. teratogencity/reproductive effects
h. other health effects as relevant including neurotoxicity,
immuno-depressant activity, allergic reactions, etc.
i. epidemiological evidence (chemical specific or site
specific)
j. aquatic/non-human terrestrial species toxicity/
environmental quality impairment
k. human health standards and criteria
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5. Exposure Assessment
a. demographic profile of populations at risk including
subpopulation at special risk
b. background chemical exposures
c. life style and occupation histories
d. population macro-and micro-environments
e. exposure routes ..
f. magnitude, .source/ and probability of exposure
to specified substances
6. Risk Evaluation and Impact Evaluation
a. carcinogenic risk assessment
b. probability of non-carcinogenic human health
effects
c. non-human species risk assessment
d. environmental impacts/ecosystem alterations
7. Conclusions
8. Documentation (Appendices)
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