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Summary
SETTING
This report explores the intricate relations between
science and policy in a field that is the subject of much
debate--the assessment of the risk of cancer and other
adverse health effects associated with exposure of humans
to toxic substances. It is a report of a search for the
institutional mechanisms that best foster a constructive
partnership between science and government, mechanisms to
ensure that government regulation rests on the best avail-
able scientific knowledge and to preserve the integrity
of scientific data and judgments in the unavoidable col-
lision of the contending interests that accompany most
important regulatory decisions.
Many decisions of Federal agencies in regulating
chronic health hazards have been bitterly controversial.
The roots of the controversy }ie in Improvements in
scientific and technologic capability to detect poten-
tially hazardous chemicals, in changes in public expec-
tations and concerns about health protection, and in the
fact that the costs and benefits of regulatory policies
Fall unequally on different groups within American
society.
me decade of the 197Os was a period of heightened
public concern about the effects of technology on the
environment. Individuals and groups urged strict gov-
ernment regulation as scientific evidence emerged that
various chemical substances may induce cancers or other
chronic health effects in humans, and new government
mrmn~=mc care -~ahlished to control potential hazards.
The evidence of health effects of a few chemicals, such
as asbestos, has been clear; in many more cases the
evidence is meager and indirect. To aid decision-making ,
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agencies have developed procedures for identifying chronic
health hazards and estimating the risks to human health
posed by products and activities. However, rather than
alleviating the controversy attending regulatory deci-
sions, the procedures themselves have become a focus of
criticism by scientists, industry representatives, and
publi~interest groups.
STUDY OBJECTIVES AND SCOPE
The Committee on Tr~stitutional Means for Assessment of
Risks to Public Health was formed, in response to a
congressional directive, to fulfill three primary
objectives:
.
To assess the merits of separating the analytic
f unctions of developing r isk assessments f rom the
regulatory functions of making policy decisions.
· To consider the feasibility of designating a
single organization to do risk assessments for all
regulatory agencies.
To consider the feasibility of developing uniform
.
risk assessment guidelines for use by all regulatory
agencies.
The Committee considered the current practice of risk
assessment and its relation to the process of regulation
of hazards to human health, past efforts to develop and
use risk assessment guidelines, the experience of gov-
ernment regulatory agencies with different administrative
arrangements for risk assessment, and various proposals
to modify risk assessment procedures. Our study was
directed primarily, although not exclusively, to the
issue of increased risk of cancer resulting from exposure
to chemicals in the environment, an issue that has aroused
areas Public concern in recent years, as illustrated by
_
the controversies involving the control of saccharin.
asbestos, and formaldehyde. Despite this emphasis,
however, our conclusions and recommendations are appli-
cable in some degree across the broad field of environs
mental health.
Criticisms of risk assessment have ranged broadly from
details of the process to administrative management to
statutory authority. The mandate to this Committee did
not include examination of the scientific issues involved
in risk assessment or the broad social policy questions
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that have been raised. m e Committee's more limited
purpose was to examine whether altered institutional
arrangements or Procedures can improve regulatory
performance.
THE NATURE OF RI SO ASSESSMENT
.
Regulatory actions are based on two distinct elements,
risk assessment, the subject of this study, and risk
management. Risk assessment is the use of the factual
base to define the health effects of exposure of indi-
viduals or populations to hazardous materials and situ-
ations. Risk management is the process of weighing
pot icy alternatives and selecting the most appropriate
regulatory action, integrating the results of risk
assessment with engineering data and with social,
economic, and political concerns to reach a decision.
Risk assessments contain some or all of the following
four steps:
Hazard zdentif location: me determination of
whether a particular chemical is or is not causally
linked to particular health effects.
.
Dose-resuonse assessment: The determination of
the relation between the magnitude of exposure and the
probability of occurrence of the health effects in
question.
· Exposure assessment: Me determination of the
extent of human exposure before or after application of
regulatory controls.
· Risk characterization: m e description of the
nature and often the magnitude of human risk, including
attendant uncertainty.
In each step, a number of decision points (components)
occur where risk to human health can only be inferred
from the available evidence. Both scientif lo judgments
and policy choices may be involved in selecting from
among possible inferential bridges, and we have used the
term risk assessment Pol ICY to differentiate those judg-
ments and choices from the broader social and economic
policy issues that are inherent in risk management deci-
sions. At least some of the controversy surrounding
regulatory actions has resulted from a blurring of the
distinction between risk assessment policy and risk
management policy.
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UNIFORM GUIDEI'INES
RI SK ASSESSORS
An inference guideline is an explicit statement of a pre-
determ~ned choice among alternative methods (inference
options) that might be used to infer human risk from data
that are not fully adequate or are not drawn directly from
human experience. For example, a guideline might specify
the majestical model to be used to estimate the effects
of exposure at low doses on the basis of the effects of
exposure at high doses.
Over the last 2 decades, most f ederal regulatory
agencies and other institutions responsible for risk
assessment of toxic chemicals have sought to develop such
guidelines. Their efforts have met with varied success.
Agencies have cited several reasons for writing guides
lines: to provide a systematic way to meet statutory
requirements, to inform the public and regulated indus-
tries of agency policies, to stimulate public comment on
those policies, to avoid arguing generic questions anew
In each specific case, and to foster consistency and
continuity of approach. Interagency guidelines for
carcinogens, although short-lived, were developed by the
agencies of the Interagency Regulatory Liaison Group
(IRLG) and adopted by the President ' s Regulatory Counci 1
in 1979. me stated objective of that effort was to
reduce inconsistency, duplication of effort, and lack of
coordination among the federal agencies.
The form of guidelines varies widely. Some guidelines
are comprehensive and detailed, addressing most of the
components of risk assessment and describing underlying
scientific concepts; others address only a few broad
principles. Guidelines differ greatly In their degree of
flexibility, We., the degree to which they permit
assessors to consider scientific evidence that may jus-
t if y departures f ram Me prescr ibed inference opt ions.
And they vary in the legal authority vested in them:
some are adopted as formal regulations and others by less
formal means.
The Committee concludes that guidelines are feasible
and, if properly designed, desirable; that clear state-
ments of the inferences to be made in each step would be
of advantage to the regulatory agencies, to the industries
concerned, and to the general public; and that guidelines
should be used uniformly by the governmental agenc ies .
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INSTITUTIONAL ARRANGEMENTS FOR RISE ASSESSMENT
.
Dissatisfaction with government regulatory actions has
led to proposals to restructure the institutional
arrangements for risk assessment by:
.
Organizational separation of risk assessment from
risk management.
· Centralization of risk assessment activities in a
single organization to serve all the regulatory agencies.
Four federal agencies--the Environmental Protection
Agency (EPA), Food and Drug Administration (FDA), Occupa-
tzonal Safety and Health Administration (OSAKA), and
Consumer Product Safety Commission (CPSC) have been given
primary authority to regulate activities and substances
that pose chronic health risks, and these four agencies '
past actions have inspired many of the proposals for
institutional change. The Committee reviewed a number of
agency structures and procedures in an attempt to deter-
mine the merits of institutional separation and centra}-
ization. Examples were selected to illustrate different
degrees of separation and centralization in the four
agencies. Independent scientific review panels have been
used to obtain some of the advantages proposed for
organizational separation, and some of their experiences
were examined.
Cross-agency compar isons are dif ficult, because the
regulatory agencies and their various programs differ
markedly in structure, procedures, personnel character-
istics, administrative history, and statutory direction.
In addition, agencies and programs change, and practices
adhered to for several years may be altered substantially.
These practical limitations to the evaluation of agency
structures and practices led the Committee to conclude
that predicting the likely effects of organizational
rearrangements on agency performance of risk assessment
is unavoidably judgmental. However, the available
evidence shows no clear advantage of one administrative
structure over another.
CONCLUSIONS ~ FOR ~CO~=ATIONS
Dissatisfaction with the actions of federal regulatory
agencies is often expressed as criticism of the conduct
and administration of the risk assessment process. The
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Committee believes that the basic problem in risk assess-
ment is the sparseness and uncertainty of the scientific
knowledge of the health hazards addressed, and this prob-
lem has no ready solution. The field has been developing
rapidly, and the greatest improvements in risk assessment
result from the acquisition of more and better data, which
decreases the need to rely on inference and informed j~dg-
ment to bridge gaps in knowledge.
Proposals to separate the administrative responsibility
for risk assessment From risk management imply that the
change would lead to improved risk assessment and hence
better risk management decisions. Administrative relocate
tion will not, however, improve the knowledge base, and,
because risk assessment is only one element in the forms
ration of regulatory actions, even considerable improve-
ments in r isk assessment cannot be expected to eliminate
controversy over those actions.
Organizational separation may have the advantage of
establishing Firmly the distinction between risk assess-
ment and risk management, }'ut it also has some disadvan~
sages. The importance of distinguishing between risk
_~--c.~=m~n~ and wick manaa -'rent does not imply that they
should be isolated from each other; in practice they
interact, and communication in both directions is desir-
able and should not be disrupted. Institutional separa-
tion would surely reduce the res;,onsi~reness of the risk
asses-C.~'ent process to the needs of the regulatory agencies
for tamely reports in accord with their priorities. In
addition to the operational disadvantages, the disruption
of current patterns of activity would be great, and the
benefits uncertain. On balance, the Committee believes
that transfer of risk assessment functions to an organiza-
tion seuar ate from the regulatory agencies is not
—,~ ·. ~ ~ _
_
appropriate. mare
We believe that rise assessment con "= =~_ a___
surely and more effectively by adopting a program with
three major parts: (A) implementation of procedural
changes to ensure that individual assessments routinely
take full advantage of the available scientif ic knowledge,
while preserving the diversified approaches to the admin-
istration of risk assessment necessary to accommodate the
varied needs of federal regulatory programs; (B) stan-
dardization of analytic procedures among federal programs
through the development and use of uniform inference
guidelines; and (C) creation of a mechanism that will
ensure orderly and continuing review and modification of
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risk assessment procedures as the scientif ic knowledge
base expands.
(A) We recommend that regulatory agencies take steps
to establish and maintain a clear conceptual
-
distinction between assessment of r~sks and consid-
.
elation of risk management alternatives; that is, the
scientific findings and Policy inditements embodied in
risk asses-~.,,ents should be explicitly distinguished
from the political, economic, and technical
considerations that influence the design and choice of
requlatorv strategies.
We agree with proponents of such measures as the
American Industrial Health Council' s proposed science
pane' and B.~. 638 that efforts should be made by regal
labors and others to distinguish clearly between the
assessment of risk and the choice of regulatory options.
We advocate the adoption of specific procedural mee-
sures that can be introduced under current arrangements.
These measures include timely independent scientific
review of major agency risk assessments and, to facili-
tate both scientific and public review of risk assess-
ments, the routine preparation of written risk assess-
ments that explicitly state the basis of choice among
inference options.
(a) We recommend that uniform inference quide-
lines be developed for the use of federal requla-
torv agencies in the risk assessment
The Committee endorses the development and use of
guidelines for risk assessment. These guidelines, which
would structure the interpretation of scientific and tech-
naval information relevant to the assessment of health
risks, should be followed by all federal agencies. They
should address all elements of risk assessment, but allow
flexibility to consider unique scientific evidence in
particular instances.
The use of uniform guidelines would promote clarity,
completeness, and consistency in risk assessment; would
c larify the relative roles of scientific and other factors
in risk assessment policy; would help to ensure that
assessments reflect the latest scientific understanding;
and would enable regulated parties to anticipate govern-
ment decisions. In addition, adherence to inference
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guidelines will aid in maintaining the distinction between
risk assessment and risk management.
(C) We recommend to the Congress that a Board on
Risk Assessment Methods be established to Perform
the follow~ti~s:
tific basis of risk assessment and to make
explicit the underlying assumptions and policy
ramifications of the inference options an each
component of the risk assessment process.
(2) To draft and neriodicallv to revise
recommended inf erence guidelines ~
assessment for adoption and use by federal
regulatory agencies.
(3) To study agency experience with risk
assessment and evaluate the usefulness of the
Guidelines.
_ , .
(4) To identify research needs in the risk
assessment f ield and in rel event underlvinq
.
disciplines.
The Committee concludes that success in improving the
risk assessment process requires the establishment of an
independent board of scientific stature. Such a board
can serve as a continuing locus of discussion about ways
to improve scientific and procedural aspects of risk
assessment.
Representative terms from entire chapter:
regulatory actions
