Procedures for Preparatior
of
ORD Scientific and
Technical Assessment Reports (STAR)
Office of Research and Development
U.S Environmental Protection Agency
Washington, DC 20460
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ATTACHMENT
WORKING GUIDELINES
FOR
•' PREPARATION OF ORD
SCIENTIFIC AND TECHNICAL ASSESSMENT REPORTS
(STAR)
OFFICE OF PROGRAM INTEGRATION
OFFICE OF RESEARCH AND DEVELOPMENT
ENVIRONMENTAL PROTECTION AGENCY
OCTOBER 1974
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1. INTRODUCTION AND OBJECTIVES
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The assessment of known available data on major pollutants of concern
to EPA is one of the major functions of the Office of Research and
Development. Whether the data are generated by EPA through in-house
efforts or through grants or contracts, or by other research
institutions, ORD has a responsibility, as the Agency's technical arm,
for assessing the information available to determine its validity and
significance. The purpose of Scientific and Technical Assessment
Reports (STARs) is to assist the Agency in complying with the
statutory directives for which it is responsible, in accordance with
the Assistant Administrator's memorandum of August 15, 1974. This is
a two-fold requirement on the part of ORD, which involves the close
interaction between our professional staff and: 1) the Program
Offices in developing various standards, guidelines, regulations, and
technical reports, and 2) the Office of General Counsel in defending,
as a result of possible litigation, those same standards, guidelines,
regulations and technical reports. The importance of the Reports,
therefore, cannot be overestimated.
Although the key characteristics desired for STARs are explained in
the Assistant Administrator's memorandum, it may be useful to briefly
summarize them here:
o Assessment, not just summarization of knowledge on each
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pollutant.
o Multi-media, not single media in scope.
o Objective assessment without recommendations.
o Dose-response relationships, not effects thresholds.
The objectives of these Working Guidelines and Procedures are to
establish a uniform set of procedures and a standardized outline, to
the extent practical, for the preparation of ORD STARs. These
guidelines and procedures supercede all previous ones and with the
exceptions noted in the next paragraph will be used in the preparation
of ORD assessment-type documents.
It is recognized that there are likely to be many cases where special
circumstances will make the standardized outline impractical and where
it will create more difficulties than it will resolve. In those cases
where it is possible to anticipate this, special detailed outlines
will be prepared. This is likely to be the case when specific
legislative requirements must be met (as in the case of criteria
documents) or when the documents report on terminated research. In
still other circumstances, the inappropriateness of the outline will
become evident only during the actual preparation of a section of a
document. In that case those responsible for the section should
proceed with a more useful structure of their section and notify the
OPI Coordinator if the change is sufficiently major so as to make the
revised section incompatible with sections being prepared by other
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laboratories. It is hoped that in this way the outline will prove to
be more of a guide, and hopefully an aid, to those preparing
assessment documents rather than a set of restrictions on their
activities.
In writing STARs, it is important to keep the English as simple and
straightforward as possible consistent with maintaining the precision
necessary. Professional jargon should be avoided whenever possible. .,
Where possible, the English should be understandable to a decision
maker in a program office who may not have technical training in the
particular specialized field being discussed.
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2. STANDARDIZED DOCUMENT OUTLINE
As discussed in the introduction, the standardized document outline to
be presented in this section is intended to be more a guide and an aid
to those preparing assessment documents than a set of restrictions on
their activities. The outline has been annotated in an attempt to
indicate the type of information or questions which should be
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considered in preparing each module. Additional sub-headings may be
used as appropriate.
DOCUMENT_OyjL_INE_
ABSTRACT
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Required by EPA regulations. 200 words or less. Will be prepared by
the report assembly organization.
PREFACE
The preface should state the objective of the document and acknowledge
contributions by the principal authors. It should also explain why
the report has been prepared and the relation of the document to other
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similar documents. The preface should be brief and prepared by the
report assembly organization.
TABLE OF CONTENTS
Will be prepared by the report assembly organization and carry the
. heading CONTENTS. First order headings should be listed in upper
case; second order headings should be listed using upper and lower
case style with the first letter of the first word capitalized. Third
order headings (also in upper and lower case style) may be included if
done uniformly throughout the report and if they are numbered in the
report. Section and subsection numbers should precede the title. The
first line of all titles should have a uniform indentation from the
left margin. Extra space should be left between sections.
LIST OF FIGURES
Should list all figures that appear in the report by figure number,
title, and page number. The title should be in upper and lower case
style, with the first letter capitalized. The first line of all
titles should have a uniform indentation from the left margin. Will
be prepared by report assembly organization.
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LIST OF TABLES
Should list all tables that appear in the report by table number,
title, and page number. The title should be upper and lower case
style, with the first letter capitalized. The first line of all
titles should have a uniform indentation from the left margin. Will
be prepared by report assembly organization.
LIST OF ABBREVIATIONS AND SYMBOLS
Will be prepared by report assembly organization. All abbreviations
used in the text should be listed alphabetically and the full word(s)
listed to the right using a uniform indentation.
LIST OF CHEMICAL FORMULAS
Will be prepared by report assembly organization. All chemical
formulas mentioned in the text should be listed alphabetically with
their full name listed to the right using a uniform indentation.
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1. SUMMARY AND CONCLUSIONS
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Each primary, module development organization will prepare a separate
sub-section on summary and conclusions to the specific module of the
outline for which it is responsible. The report assembly organization
will' use these contributions in preparing this section.
1.1 SUMMARY
An executive summary in which the most important points, from the
standpoint of decision-making, included in each major section are
presented in concise and simple language. The summary should contain
no information which is not supported in the rest of the document.
1.2 CONCLUSIONS
The conclusions should concisely assess the degree of knowledge of
various aspects of the problems posed by the pollutant, what critical
data gaps may exist, the extent of the problem posed by the pollutant,
and the range of possibilities available for doing- something about it.
There would be nothing in the conclusions that is not clearly based on
data in the report. Although significant gaps in knowledge should be
noted, no recommendations should be made as to whether future research
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should be carried out to fill them. There should also be no
recommendations as to what action, if any, the Agency should take with
respect to the pollutant.
2. POLLUTANT CHARACTERIZATION
2.1 CHEMICAL AND PHYSICAL PROPERTIES
A discussion of the chemical and physical properties of the pollutant
to be discussed in the report that may be significant with regard to
uses, sampling and analysis, transport and transformation, effects,
and control technology. This section should discuss why these
properties are important. Include the basic chemical formulae in the
case of compounds as well as a diagram of compound structure.
Emphasize compounds which may be of concern, whether or not they exist
naturally in the environment, their associations, stability,
solubility, etc.
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2.2 MEASUREMENT TECHNIQUES
This sub-section should discuss two questions: can the pollutant be
measured and how well? These questions should be addressed with
respect to ambient levels in air, water, and land materials (soil,
sediments, etc.), and concentrations in food receptors such as plants,
animals, and man, in food consumed by animals and man, and in effluent
emissions from pollution sources. In each case, these two questions
should be answered in terms of assessing the techniques available for
sampling and the preparation and analysis of samples for the more
promising techniques. Shortcomings of each technique should be
discussed. It is also appropriate to assess the availability of
instruments and of standard reference materials for instrument
calibration and to assess the quality assurance status -of the method
described. > flditionally, for the methods described, it is appropriate
to indicate the working range and recommended technique, and
equivalent techniques if no standard reference technique has been
established. Particular attention should be paid to the relationship
of what is measured by the analytical method to the form the pollutant
takes in the various media and on those techniques used to obtain data
presented in other modules of the same document. Where possible,
quantitative values for precision, accuracy, etc., should be stated.
Interference should be discussed specifically, as well as other
problems related to obtaining reliable data. Discussion of procedures
should not be repeated; simply reference previous paragraphs.
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3. ENVIRONMENTAL OCCURRENCE AND TRANSPORT
Where possible it would be useful to include somewhere in this section
a figure that conveys an idea as to the total cycle that the pollutant
goes through from source to receptor including approximate ranges of
concentrations in each medium and the exchange rates and mechanisms
between media and sub-media, where important.
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3.1 CONCENTRATIONS
An assessment of available data on observed concentrations in air,
water, land materials, plants, animals, man, and food for animals and
man should be presented. Characteristic patterns in space and time
for both short- and long-term changes should be emphasized. Dates of
data collection should be included, as well as confidence limits
(quantiative or subjective), measurement methods, and averaging times.
Significant gaps in the data and changes in measurement methods during
the period of record should be noted. If the term "trace" is used it
should be defined.
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3.2 TRANSFORMATION AND TRANSPORT MECHANISMS
This sub-section should assess the state of knowledge of chemical,
physical, and biological processes in both natural and man-made (such
as those arising from disposal and recycling) systems including
removal mechanisms and rates when known, transport within and between
media, residence times, etc., in air, water (including running,
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standing, ground marine and estuarine), and soil environments.
Knowledge of mechanisms that influence visibility and climate should
be assessed. The biological discussion should include food chain
transfer as well as biological magnification. To the extent possible,
this section should be concerned with the total environmental cycle
and the principal mechanisms that have an impact upon environmental
loading, as well as the extent to which environmental observations
confirm the implications of process information. Knowledge of the
following biological processes in fresh surface and marine waters
should be assessed where relevant: degradation by algae, bacteria,
fungi, and other hetrotrophic populations; microbial transformation
(product formation); effects on growth; and incorporation and storage
(bioaccumulation). In the case of biological processes in
groundwater, degradation as a result of interaction with soil
microorganisms and transformation should be assessed. The following
chemical processes should be discussed in surface waters: fast
(equilibrium conditions) and slow (kinetics) reactions and
transformations foz both chemical and photochemical processes. The
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following physical processes should be assessed in the case of fresh
surface waters: mass transport and dispersion, adsorption,
sedimentation, solution, diffusion, and exchange (substrate-water-air-
water). The same physical processes should be assessed in the case of
marine environments except for the addition of density (salinity)
gradients and currents. In the case of physical processes in
groundwaters, infiltration and retention rates should be assessed.
Chemical processes in air and on surfaces (such as photo-degradation)
should be discussed. If relevant, assess the role that other
pollutants may have in the transformation of the subject pollutant in
the various media in which they come together.
4. ENVIRONMENTAL EXPOSURE AND UNDESIRABLE EEFECTS
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Although this section is organized in such a way that each species or
group of species would have to be discussed under four different
headings, each STAR Committee should carefully consider whether it may
prove more efficient and understandable to subdivide this section by
groups of species, such as plants, animals, and man or non-human and
human, and then to discuss consecutively each of the four subjects of
the subsections shown below for each group. If this is done, non-
human groups should, in general, be discussed prior to man, the
ultimate receptor.
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4.1 MECHANISMS OF EXPOSURE
This section is concerned with assessing the mechanisms operating at
anatomical and physiological interfaces. The discussion of animals
should include respiratory, body surface, and digestive tract routes.
Plants should include epidermal, root, and stomatal systems.
Materials should include mechanisms relating to undesirable effects,
such as corrosion. Mechanisms may be chemical, physical, or
biological.
4.2 MECHANISMS OF RESPONSE
In this sub-section, consider the receptor's normal handling of the
constituent being reviewed. Include uptake, distribution, metabolism,
and excretion. Include information on retention sites and times and
on response to various retention levels. Background information
necessary to make judgments concerning potential problems should be
included along with nutritional requirements if applicable.
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4.3 UNDESIRABLE EFFECTS
Identify and describe undesirable effects of the pollutant involved on
plants, animals, materials, man, weather and climate, visibility in
air, land materials, and water use (including aesthetic uses).
Effects on ecosystems as well as effects on individuals and
populations should be included when appropriate. This discussion
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should be_ structured in_ such a_ way that these undesirable effects can
be scaled against the level of environmental contamination. In the
case of the effects on plants, animals, materials, and man, the
discussion should include the results of both laboratory and field
studies. Detailed treatment of individual experiments or studies is
not necessary; results should be emphasized. Information regarding
experimental design should be included if appropriate.." A discussion
of reversibility or irreversibility should specifically be included.
Synergistic effects of the pollutant, if any, with other pollutants
commonly found with it should be assessed. The discussion should
include proved, suspected, and possible effects, but clearly
distinguish among them. The major gaps and uncertainties in our
ability to predict or measure the effects should be assessed.
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4.4 ENVIRONMENTAL EXPOSURE
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The purpose of the sub-section is to assess the possible exposure
levels (i.e., the accessability of the pollutant and the combined
exposure) of various receptors and the probability that the receptors
will, actually be subjected to these levels. These exposures may come
through a number of routes, all of which should be discussed where
relevant. These routes include air, water, food (in the case of man
and animals), land materials, occupational activities (in man) and
special routes (man) such as smoking, cosmetics, and Pharmaceuticals.
The assessment of receptor risks might be treated analogously to a
time and motion concept, that is, by considering the buildup of body
burden or effect from various environmental (and other), exposures and
what proportion is presented by each exposure. Include population
density aspect, location of source, receptor location and activities,
and chance of contact.
If possible, the exposure estimates presented, summarized, or cited in
this subsection should be sufficiently quantitative so as to make it
possible to calculate the benefit estimates in Section 6.1. If
insufficient data exist to present such calculations, then a
qualitative estimate should be prepared. Exposure estimates should be
determined for a range of potential control levels, ideally, the same
ones considered in Section 5.2, and including the case of no further
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control. In some cases, it may be more convenient to put this
discussion at the beginning of Section 6.
5. SOURCES AND CONTROLLABILITY
5.1 SOURCES
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This sub-section should include a discussion of both current and
projected sources of the pollutant from both natural and man-made
sources. In the case of natural sources, the section should discuss
what they are, how they are distributed geographically, and what their
expected contribution is to the total emissions and to the ambient
level. In the case of man-made sources, include in addition
production, uses, and emission factors and distinguish between
stationary and mobile sources. If available, process material balance
studies should be cited. At this point in our discussion, we should
be concerned with quantitative estimates of the man-made contribution
to ambient levels of the pollutant in air, water, biological, and land
materials. The discussion should include the processing of raw
materials as a source of the pollutant. In discussing the current and
projected sources of the pollutant, the impact of existing and planned
reductions resulting from current environmental regulations should be
identified.
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5.2 CONTROL TECHNOLOGY AND CONTROLLABILITY
For each major source listed in Section 5.1 assess the potential for
control by all methods; if it can be controlled, assess the
availability and effectiveness of technology and/or administrative
measures available to do so, the cost of achieving a range of reduced
ambient levels, such as those considered in Section 4.4, their
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applicability, and whether their use generates other pollution
problems in the same media. Distinguish between control measures
already in use as a result of existing environmental regulations,
those planned or expected to be used, and untried and unplanned
measures.
5.3 UNDESIRABLE INTERMEDIA EFFECTS OF PRINCIPAL CONTROL MEASURES
Some or all of the control measures discussed in Section 5.2 may
create other pollution problems in the same or other media. The
existence, extent, and possible solutions to such problems should be
discussed for a range of control alternatives:
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6. OVERVIEW, BENEFITS, AND INSTITUTIONAL PROBLEMS OF CONTROL
6.1 ECONOMIC BENEFITS FROM CONTROL
To the extent possible, this sub-section should describe the total
benefits to the nation, various regions, and income groups from a
variety of potential control levels, in that order of importance.
This information should be quantitative and expressed in dollars to
the extent warranted by the reliability of the data, although
quantitative statements expressed in other units (e.g., deaths
avoided, hospital days not required, etc.) or even qualitative
statements should be made if sufficiently reliable data are not
available. Emphasis should be placed on national economic benefits
over a range of potential control levels, such as those,considered in
Sections 4.4 and 5.2, and including the case of complete control.
6.2 SOCIETAL/INSTITUTIONAL CONSTRAINTS ON CONTROL
The intent of this section is to assess the major institutional and
societal constraints on the implementation of the potential control
measures discussed in Section 5 in order to reach the control levels
discussed in Section 6.1. Since the relative difficulty of applying
various control measures should be discussed in Section 6.3, this sub-
section should be devoted to an analysis of any difficulties likely to
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be encountered in implementing each of the various control measures
discussed in Section 5. For each administrative or physical control
measure described there, the analysis should ascertain whether there
exists any Federal legislative authority for carrying out the measure,
what the major difficulties of so doing would be, and whether there
would be any other (non-legislative) implementation problems of
carrying out the measure including administrative problems given
current EPA, state, and local policies.
6.3 OVERVIEW
This sub-section should provide an overview assessment of how serious
the health, ecological, and materials damage threats posed by the
pollutant are and how serious the technological, economic, and
institutional/societal problems of control may be. The discussion of
how serious the problem is should include both the current situation
and projections to the year 2000 if possible. The institutional
discussion, unlike that in Section 6.2, should describe the relative
difficulty of a range of reasonable control measures, including that
of the lowest cost measure. In making this overview assessment,
particular attention should be given to the quality and certainty of
key information and its relevance to regulatory decisions that the
Agency may face.
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