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OCR for page 86
III
Organizalional Arrangements
for Risk Assessment
The different structures, procedures, and histories of
the agencies responsible for regulating toxic substances
have produced diversity in their approaches to risk
assessment, but common patterns can be discerned, and
they permit some broad generalizations about agency
organizational arrangements.
first, most agencies have exerted little effort to
maintain a sharp organizational separation between
employees engaged in assessing the risks associated with
substances and those responsible for identifying and
evaluating regulatory responses. This is not to suggest
that the same persons perform both functions; generally,
they do not, for agency organizations reflect consider-
able specialization, recognizing the distinctive training
and capabilities of staff members. However, the two func-
tions are often housed in one organizational unit that is
responsible for preparing integrated analyses that incor-
porate assessments both of risk and of recommended regule-
tory responses. Sometimes, risk assessment stat f are
employed in an office that is separate from the office of
those who formulate and analyze regulatory options, but,
with she notable exceptions, this organizational struck
ture does not lead to a rigid separation of the two
staffs.
Second, with the exception of a few experiments in
interagency r, sk assessment during the late 1970s and
continuing informal exchanges of information, each agency
has performed its own assessments of the risks posed by
substances that are candidates for regulation. This
operational autonomy does not reflect willful ignorance
of the activities of sister agencies or indifference to
the desirability of consistency in the evaluation of
common candidate substances. Rather, it is a product of
86
OCR for page 87
87
several factors, including the lack of obvious mechanisms
for formalized interagency collaboration, the desire of
agency po}'cy-makers to reserve authority for policy dis-
cretion in reaching conclusions based on risk assessment,
the perception that the diversity of types of exposure
for which each agency is responsible makes collaborative
r isk assessment impractical, and differences in regu~a-
tory priorities and schedules.
Third, although the four agencies have viewed them--
sei ves as ultimately response b, e for the risk assessments
that support their actions, they often extend their own
staff resources available for performing risk assessment
by relying on consultants and contractors who are closely
supervised by agency personnel. Some agencies--notably
the Occupational Safety and Health Administration (OSEA)
and the National Institute for Occupational Safety and
Health (NIOSE) - whose staffs are small or lack needed
expertise rely very heavily on nongovernment contractors
and outside scientists in the academic community and
government research institutions for performance of risk
assessments or specific tasks related to risk assessment
(such as literature reviews).
In addition, outside scientists are often called on to
review assessments produced by agency staff. Such consul-
tations sometimes take place informally, but of ten through
special advisory committees. These committees can be per-
manent, such as the Environmental Protection Agency (EPA)
Clean Air Science Advisory Committee, or can be created
to review particular risk assessments, as is done for many
of the Food and Drug Administration (FDA) Bureau of Foods
assessments. Some are established by statute, with
requirements that they review agency assessments befor e
regulations are proposed. Others are created voluntarily
by an agency itself. The members of all federal advisory
co~t~ees are appointed by the agencies, perhaps with
the approval of higher executive-branch authority. Can-
d~dates for committee membership usually are identified
by agency staff, although some agencies seek nominees from
professional organizations and other interested parties.
Nominations for some statutorily mandated committees are
supplied by an external body, such as the National Academy
of Sciences or the National Science Foundation. Advisory
panels generally exercise considerable influence and,
although legally they are only advisory, share to some
extent the agencies' authority to reach conclusions about
risk.
OCR for page 88
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89
TYPES OF ORGANTZATIO~ AWNS
The prominent proposals for reforms in organizational
structures and procedures for risk assessment have
featured three interrel ated principles:
.
Risk assessment activities should be strictly
separated from the analysis of risk management options
and selection of regulatory strategies.
· Risk assessment act ivities should be centralized
in a single body that serves all regulatory agencies.
· Expert panels composed of nonagency scientists
should be used either to perform risk assessments for an
agency or to review assessments developed by agency staff.
The Committee outlined four idealized models that
reflect various combinations of these three principles.
The models are integration, intra-agency separation (with
or without centralization), extra-agency separation (with
or without centralization), and use of scientific review
panels. Examples of agency organizations that roughly
approximate each model are identified below and in Table
III-I. Most of the exiles chosen have many distinctive
characteristics that obscure or at least outweigh the
three organizational principles. In addition, they are
not the only examples of a particular model; others could
have been reviewed.*
INT~:GRATION
In this type of arrangement, a single organizational unit
both performs risk assessments and develops regulations.
In general, this arrangement is the most common for Begun
latory programs. For example, for the assessment of
chron' c hazards involved with chemicals f rom consumer
products, the Consumer Product Safety Commission (cpsc)
*The Committee considered the possible merits of reviewing
risk assessment procedures used by other countries as well
and decided not to pursue this line of investigation,
because of the great differences in political and institu-
tional structures between this country and other coun
tries. Such differences would make it very difficult, if
not impossible, to extrapolate findings on institutional
structures used in other countries to the United States.
OCR for page 90
so
Directorate for Health Sciences is the responsible unit.
Before 1977, the Directorate for Health Sciences had few
people involved in the risk assessment process, and risk
assessments as such were not generally used. Since then,
the Directorate has acquired the expertise needed to per-
f orm r isk assessments itself . The r isle assessment Is
performed within the Directorate, which is distinct from
the Commission's politically appointed policy decisions
makers. Two different examples of this model examined by
the Committee are the OSBA Directorate of Health Standards
Programs and the FDA Bureau of Foods (Table III-1). In
the former example, risk assessors and those responsible
for formulating and recommmending regulatory strategies
are in the same organizational unit. FDA's Bureau of
Foods has a separate office that performs risk assessment,
but this separation stems from a functional division of
scientific disciplines; it is not intended to and does
not result In formal separation.of the risk assessment
staff from the regulatory staff.
INTRA-AGENCY SEPARATION
In this model, risk assessment is performed by a group
that is ostensibly separate from and independent of the
office responsible for regulation in the same agency. An
into e-agency risk assessment unit could be programs
specific or agency-wide. There are examples of program
specific, organizationally separate risk assessment units
(notably the Environmental Criteria and Assessment Offices
In EPA), but the Committee did not examine them; instead,
it reviewed activities of the EPA Carcinogen Assessment
Group as an example of an internally separate, agency-
wide body.
EXTRA-AGENCY SEPARATION
l
In this model, an agency's risk assessment Is developed
outside the agency. The examples reviewed demonstrate
the wide variety of arrangements included in this model.
Full organizational separation can be achieved by having
one institution perform risk assessment and a separate
institution regulate exposure to hazardous substances.
The relation between NIOSE and OSLO was studied as an
example of a permanent, statutory arrangement of this
kind. A regulatory agency's use of expert panels to
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91
perform risk assessments can also result in extra-agency
separation of risk assessment and regulation. Committees
of the National Research Council and several groups of
panels used by FDA to review the safety and effectiveness
of drugs provide varied examples of such arrangements.
The National Toxicology Program Panel on Formaldehyde is
an example of an ad hoc assessment group that consisted
of government scientists, was organizationally separate
from the regulatory agencies (although not without agency
members), and served all four agencies (i.e., it was
centralized). Because the Interagency Regulatory Liaison
Group did not perform r isk assessments, it has not been
examined as an example of an extra-agency assessment body.
USE OF SCIENTIFIC REVIEW PANELS
.
Agencies may use independent scientific panels to perform
risk assessments or to review assessments prepared by the
agencies. This distinction has been used by the Committee
to facilitate separate discussion of panels that perform
assessments as examples of full organizational separation
(see preceding discussion) and panels that review agency
assessments as examples of independent review panels.
However, the dichotomy is somewhat artificial, in that
there may be difficulty in classifying a particular panel.
For example, if a panel responsible for performing risk
assessments comes to rely heavily on preliminary analyses
prepared by agency staff, it can be thought of as acting
in a review capacity. Conversely, panels assembled solely
for the purpose of reviewing agency assessments have often
displayed remarkable independence, sometimes preparing
long critiques of agency documents and suggesting sub-
stitute Findings and reasons. In such cases, to specify
which group had performed and which had reviewed the
agency's final assessment of risk is difficult.
The extent to which agencies have used independent
scientific panels has varied considerably. For example,
OSKA has available two types of advisory committees:
standing bodies, such as the National Advisory Committee
on Occupational Safety and Health, and ad hoc committees
that provide advice on specific standards. Members of
both types of committee are expected to be knowledgeable
about occupational safety and health and may include
persons mainly interested in law or regulatory policies.
In addition to their professional expertise, however,
members of OSHA committees are intended to be represen-
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92
tative of groups interested in occupational health and
safety. Several committees have reviewed risk assess-
ments prepared by OSLO or NIOSE. Bowever, because men
bers were intended to be representatives of interest
groups, reviews were usually forums for policy debates,
not scientific evaluations of risk assessments. In its
initial years, OSHA routinely appointed an advisory
committee for each regulatory proceeding.
CPSC has had the least experience with expert panels.
Before 1981, the Commission was not required to have any
assessment of carcinogenic hazard reviewed by an outside
panel, although it did make occasional use of such panels
(most notably CPSC's request for the National Toxicology
Program to form a panel on formaldehyde?. CPSC's ~eautho~
rization in 1961 included a pro:. A ~~---~
regulatory action could be proposed on a substance poten
tially presenting a carcinogenic, teratogenic, or muta-
genic hazard, a chronic hazard advisory panel (CHAP) must
be established, with the cooperation of the National
Academy of Sciences, to review the toxicity of the sub-
stance. The first CHAP has recently been convened to
review the toxicity of asbestos. Thus, CPSC relies on
two methods of peer review for any proposed action.
First, independent peer review by outside experts, as
well as by a scientific review panel, is performed before
- Second, the
Commission relies on a public rule-mak~ng proceeding in
accordance with the Administrative Procedure Act during
which comment is invited through a Federal Resister notice
on all aspects of the proposed action. Extensive written
comments have been received in the past by this procedure,
from industry, consumer groups, mothers of the academic
~ __ _ __—~^ ~ nab_ O—TON— t~IlV
a notice of proposed rule-mak~ng as issues.
and scientific communities, and others. Add~tzona~'y,
open, informal public hearings may be held in which inter-
ested groups present their views orally; in the past,
several such hearings were held during the consideration
of a single substance (formaldehyde).
EDA has often used independent scientific panels both
-^ perform and to review agency assessments. The Bureau
of Drugs has used standing committees to review and eval-
- ~ or——~—~
uate data on the safety and effectiveness of drug products
and to make appropriate recommendations to the Co"~ls-
sioner (see preceding discussion). The use of indecent
dent panels by the Bureau of Foods, however, has been on
an ad hoc basis, usually at the agency's discretion.
However, there are exceptions; for example, the Food,
Drug, and Cosmetic Act requires that carcinogenicity
OCR for page 93
93
issues related to color additives be referred to a come
settee of experts selected by the National Academy of
Sciences.
EPA, in contrast, has had less choice in its relations
with its advisory committees. Several statutes require
I: PA to consult such committees for scientific review of
agency risk assessments or regulations. Examples of
mandated advisory committees with a primarily scientific
role include the Agency-wide Science Advisory Board; the
Clean Air Scientific Advisory Committee, a part of this
Board, which reviews criteria documents for air-qual~ty
standards; and the Scientific Advisory Panel, which
focuses on scientific issues in the Agency Office of
Pesticide Programs. The Committee has examined this pane'
and a subcommittee of the Science Advisory Board as
examples of scientific review panels.
Agency actions, including risk assessments, have been
reviewed in the Executive Office of the President; how-
ever, because these reviews have, with a few notable
exceptions, focused primarily on risk management con-
cerns, the Committee has not examined them.
LEVIS OF Al PROS FOR USE AS=SS~
This section describes the practices used for risk
assessment in each of the organizational examples
reviewed by the Committee. The descriptions that follow
reveal some strengths and weaknesses of particular
approaches and permit some tentative generalizations to
be made. Such generalizations, augmented by the experi-
ence and judgment of Committee members, lead in turn to
recommendations applicable to organizational arrangements
for the performance of risk assessment.
The Committee's necessarily retrospective review of
agency performance has focused on events and practices of
the 1970s, which triggered the current proposals for
reform. Changes have been implemented, or at least are
contemplated, in the procedures of several of the agen-
cies studied, and the Committee recognized that such
changes could alter the performance of risk assessment.
Some of the descriptions of agency practices presented
here may be dated. However, our purpose is not to des-
cribe the current organizational structure of agencies,
but rather to discern in the historical record any gent
eral relationships between organizational design and
procedures and the quality of risk assessments. The
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94
paucity of experience with recent organizational changes
and the tendency of any new administration to disclaim
the approaches of predecessors while proclaiming the
effectiveness of reforms make very recent history less
germane to the Committee Is purpose.
OSLO ~ S DI=C=~= OF ~= STEMS PR=~ (DESP)
OSEA's health standards were expected by Congress to be
based on criteria and recommended standards provided by
NIOSE. Bowever, improvements in OSLO s scientific copay
bility and a court directive that OSHA itself review all
studies included in the risk assessment supporting a
proposed standard prompted Me agency to rely less heavily
on NIOSE and to begin performing its own risk assessments.
Until 1976, OSHA had only a few personnel in the health
sciences; however, DESP has since become an organization
staffed primarily by health professionals, including
industrialhygienists, responsible for performing risk
assessments and for preparing standards, relying on
economic and technical analyses supplied by the Office of
Regulatory Analysis In a separate directorate (Figure
III-1). In addition, the Directorate normally has used a
number of consultants who assist with risk assessment or
other aspects of standard development, contributing
considerable specialized expertise to the organization.
OSHA tried to achieve organizational separation of
risk assessment from the preparation of standards in the
case of carcinogens. One office in DSSP was supposed to
do risk assessment, another to draft standards. In prac-
t~ce, however, such separation was not achieved, largely
because personnel shortages required that individual
staff mothers perform both functions.
Agenda and Procedures
DH5P's regulatory and risk assessment agenda has been
determined largely by two external forces: petitions by
labor unions for action on particular hazards and dr='n=tic
discoveries of previously unidentified workplace hazards.
Court remands of several OSLO standards, such as the bend
zene standard, provided new work for Oslo, but none of
the mandated re~examinations has led to a final standard.
Criteria documents prepared by NIOSE also contributed to
O=A's agenda, in Mat DESP staff always read these docks
OCR for page 95
95
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96
meets when they were received and normally published a
Federal Resister notice soliciting further information.
DESP's risk assessments usually began with a NIOSH
criteria document or other NIOSE input, whatever informal
tion was submitted with a labor petition if there was
one, the data available from any precipitating discovery,
and assessments performed by others, such as the National
Academy of Sciences. A literature search and review were
conducted by DHSP personnel, often with the help of con-
sultants and NIOSE personnel; and sometimes environmental
data on the workplace were solicited or obtained by
contractors to contribute to the exposure assessment.
DESP has not prepared special assessment documents
before issuing notices of proposed rule making. Thus,
the first indication provided to the public of the results
of an OSHA risk assessment and of the conclusions it
intended to draw therefrom was In the Federal Resister
preamble to its proposed standard. Public comment was
invited on all aspects of the proposed standard, includ-
ing the risk assessment. Extensive written c ~ rents were
usually received from industry, labor, and others, such
as members of the academic scientific community. Cus-
tomarily a hearing was held at which oral presentations
were made and at which questioning of witnesses by OSlIA
personnel and other witnesses was permitted. The preamble
to the final rule, if one were issued, included OSEA's
f inal risk assessment, which incorporated a literature
review and 05EA's conclusions on the available scientific
data.
In 10 years, OSLO produced permanent health standards
for 23 substances or processes, 14 of which were regu-
lated together In a single rule-making. OKRA has also
proposed standards for eight substances for which final
standards have never been issued, and assessments were
conducted for several substances for which new or updated
standards are now being considered (Table III-2).
Methods and Use of Guidelines
For most of its history, OSHA has not had formal guides
lines for carcinogenic risk assessment. Instead, agency
staff have conducted their assessments by choosing options
for the components of risk assessment on a case-by-case
basis. However, the generic guidelines for identified
tion and classification of carcinogens proposed in 1977
and revised and promulgated in 1980 were intended to
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139
notice of proposed rule~malcing and any f inal rule. Appar-
ently, the agency is not bound by a panel's determination
of carcinogenicity or its estimation of the risk associ-
ated with exposure. Although it appears that each panel
is to perform its own risk assessment, the statute is
silent on The role to be played }by agency staff and on
the weight that a panel might legitimately accora to
analyses prepared by the agency ~ tself. These panels are
exempted from the Federal Advisory Committee Act; the
exemption pres'?Tnahly means that they are not required to
provide advance notice of their meetings or to deliberate
in public. A panel may seek information from third
parties, but only through CPSC.
CRITICISM OF PROPOS=S FOR S=~T7ON ~ ~~I=TION
The Four f ederal regulatory agencies have responded skew
tically to proposals to separate and centralize the func;
talon of assessing the risks of chemicals that are cane
didates for regulation (U. S. Congress, 19815) . Other
cheers have also found f laws in the proposals. A
central crit~ci=. made by those who argue against full
organizational separation between risk assessment and
regulatory policy-m~king is that simply separating risk
assessment from the regulatory agencies would not separate
science from policy.
, _ _
This argument is based on the fact
that the risk assessment process requires analytic choices
to be made that rest, at least in part, on the policy con-
sideration of whether to be more or less conservative when
determining possible publ~c-health risks. A second point
is that, although extra-agency separation of risk assess-
ment may help to minimize the influence of risk management
considerations on this process, the agency responsible for
deciding what exposure to permit or what costs to impose
must make what is ultimately a political judgment based
on the extent of risk determined in the risk assessment
and often on the benefits and costs of regulatory action
and its feasibility and political acceptability. For its
decision to be politically acceptable and the decisions
maker accountable, the agency must have responsibility
for each or these components of regulatory decisions
making. A third argument against institutional senar a-
Lion as related to the internal process by which agencies
It is claimed that this process is
unavoidably an iterative one. Different specialists are
called on repeatedly for analysis and advice as an agency
reach decisions.
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140
identifies and considers new control options in attempting
to reach a decision. Although this description may over-
state the f luidity of internal agency deliberations,
captures something of their ad hoc character. Closely
coupled with this argument is Me necessity for agencies
to retain scientific capability so that they can under-
stand what a risk assessment means and how to use it in
developing risk management strategies. Thus, even if
risk assessment were performed outside the agency, a
scientific staff representing many different disciplines
would still be required, to ensure that an assessment
would be interpreted and used correctly.
Other criticisms of proposals for risk assessment by a
centralized panel stress the logistic difficulties of
meshing independent risk assessment activities with the
internal workings of different agencies. Experience
suggests that it will be difficult for any risk assess-
ment body to meet even generous time limits. Thus, agency
decisions will probably be delayed by ~ requirement to
consult, or refer issues to, such a body. A central
pane, also might become overburdened and cause additional
delays. Critics of I.. 638 and the AIEC proposal chal-
lenge the ass, - .tion that the regulatory agencies }rave
reached inconsistent conclusions in evaluating various
chemicals. The recent differences in Me regulation of
formaldehyde constitute a rare example of disparate
treatment of the same chemical, and even this disparity
may not betray basic disagreement over the interpretation
of scientific data, as distinct from the degree of risk
that justifies regulation. In the past, the agencies
have often selected different control options or imposed
different exposure limits for a given chemical, but these
disparities have typically reflected differences in expose
sure (and thus in risk characterization) or differences
in regulatory policy or statutory or administrative
requirements; none of the current proposals addresses
such differences.
CONCLUSIONS
The Committee was asked by the Congress to consider tithe
merits of an Institutional separation of scientific func-
tions of developing objective risk assessment from the
regulatory process of making public and social policy
decisions and the feasibility of unifying risk assessment
functions. " In this chapter, the Committee has addressed
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141
these two issues and a third, related issue: the value
of independent scientific review of agency risk
assessments.
In i ts review, the Committee was sensitive to a number
of considerations, including the scientific quality and
regulatory relevance of the assessments performed. It
also tried to ascertain how scientific and policy consid-
erations were handled in the performance of risk assess-
ment. To reach its conclusions, in the absence of
accepted criteria for evaluating agency practices and
proposals for change and in view of the sparseness of
relevant empirical data, the Committee has relied on
discussions with other persons knowledgeable and experi-
enced in risk assessment activities, the limited avail-
able literature, and especially its own knowledge and
experience in regulatory-agency risk assessments, as well
as its review and analysis of past agency practices.
VALUE OF INSTI'lu$ION~L SEPARATION
1. Although organizational separation mat help to ensure
that risk management considerations do not influence
the conduct of risk assessment, the degree of organi-
zational separation that is optimal for individual
agencies cannot be determined on the basis of the
Committee' s review.
Regulatory programs differ substantially In their
degree of organizational separation. In the cases of
NIOSE assessments that in the early 1970s were adopted by
OSEA and NRC assessments relied on by agencies, the
assessment function has been outside the regulatory
agencies. At EPA, the risk assessment units in the
Office of Health and Environmental Assessment of the
Office of Research and Development prepare assessments
for regulatory program offices that are organizationally
under different assistant administrators. Bowever, ache
Office of Toxic Substances does its own assessments, and
several other program offices are responsible for their
own exposure assessments. The risk assessments for the
FDA'S Bureau of Foods are produced within the Bureau, but
by an office distinct from offices responsible for fo~mu-
lating regulations and enforcement; since 1976, the D~rec-
torate of Health Standards Programs in OSLO has both
performed risk assessments and formulated all early risk
management options. Different agencies also have success-
OCR for page 142
142
fully used different organizational arrangements for risk
assessment. FDA, for example, has often called on NRC
and NTP for assessments, but in other cases relied on its
own staff. The Committee's review of different agency
structures and procedures did not demonstrate that one
particular structure produced risk assessments of superior
quality and integrity. In addition, the Committee notes
that, even if there were a clear finding that a particular
arrangement works For a given agency or program, it would
be extremely difficult (given the diversity in agency and
program mandates, personnel needs, and histories) to
justify a suggestion that that arrangement would best
serve all agencies or programs.
2. Organizational separation has several important
drawbacks that are likely to be intensified with
increasing degrees of separation.
There are severa} arguments against organizational
separation. Separation of the risk assessment function
from an agency's regulatory activities is likely to
inhibit the interaction between assessors and regulators
that is necessary for the proper interpretation of risk
estimates and the evaluation of risk management options.
Separation cat" lead to disjunction between assessment and
regulatory agendas and cause delays In regulatory proceed-
ings. Common sense suggests that increased separation
would aggravate these drawbacks. In its review, the Com-
mittee observed these disadvantages when assessors and
regulators were in different organizations (e.g., NIOSE
and N~C). Another perceived drawback in extra-agency
separation that was neither detected nor likely to --merge
in the Committee's review is the erosion of scientific
competence within agency staffs if risk assessments are
routinely performed outside the agency. Also, any major
organizational change may have a disruptive effect on
agency performance; thus, such organizational changes are
especially questionable when the benefits, if any, are
unclear.
3. Organizational arrangements that separate risk
assessment from risk management decisionrmakinq will
,
not necessarily ensure that the Policy basis of
-
choices made in the risk assessment Process is clearly
distinguished from the scientific basis of such
choices.
_
OCR for page 143
143
If risk assessment as practiced by the regulatory
agencies were pure science, perhaps an organizational
separation could effectively sharpen the distinction
between science and policy in risk assessment and regu-
latory decision-making. However, many of the analytic
choices made throughout the risk assessment process
require individual judgments that are based on both scien-
t,fic and policy considerations. The policy cons~dera-
tions In risk assessment are of a different character
from those involved in specific risk management decisions
and are generally common to all assessments for similar
health effects. Thus, even when one has drawn the rela-
t~vely obvious distinction between risk assessment and
risk management, there remains the more difficult task of
distinguishing between the science and policy dimensions
of risk assessment itself. We believe that the latter
distinction cannot be ensured or maintained through organ-
izational arrangements. Given the inherent mixture of
science and policy in risk assessment, organizational
separation would simply move risk assessment policy into
a different organization that would then have to become
politically accountable. The Committee believes that
other approaches are more likely to maintain the distinc-
tion between science and policy in risk assessment, most
notably the development of and adherence to guidelines.
VALUE OF CENTRALI ZATION
4. Common risk assessments performed primarily by scienr
fists from all interested agencies on an ad hoc basis
-
mav capture the major advantanes of centralization
without the drawbacks that accomoanv Permanent,
extraragencv centralization.
An argument often advanced for centralization is that
it might expedite and perhaps reduce the administrative
costs of decisionrmaking when two or more agencies contem-
plate regulation of the same substance. And if two or
more agencies are going to regulate the some substance,
there is much to be said for developing a system that
facilitates production of a single, common risk assess-
ment. This was one rationale for CPSC's decision to
empanel a group of scientists to evaluate the carcinoge-
nicity data on formaldehyde, and it argues in support of
the central panels suggested in E.R. 638 and the American
Industrial Health Counczl's proposal. Although the Come
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144
Settee endorses government-wide consistency in risk
assessment, it is less sanguine concerning the prospects
of a permanent arrangement for such centralized risk
assessment as contemplated by these proposals, in which
the idea of centralized assessment is inextricably linked
to extraragency separation. The Committee concluded that
extra~agency separation would have disadvantages that
would offset any advantages.
The Committee did find, however, that agency scientists
could collaborate to perform joint risk assessments on an
ad hoc basis. Because agency scientists would perform an
assessment, such an arrangement would avoid most of the
drawbacks of extra-agency separation. The Committee
looked at the Panel on Formaldehyde as an example of a
centralized assessment group. In the Committee's view,
the Panel functioned well and produced an assessment that
has been accepted by the scientific community. The
Panel's assessment has not produced parallel regulatory
action among the agencies, and the Committee observed
that similar r isk assessments should not necessarily lead
to similar regulatory decisions, which reflect consid-
erations that often justify different risk` management
responses.
USE OF SCIENTIFIC KEVTsW PANELS
l
5. Independent scientific review oŁ~
-
assessments improves the scientific ~ual i=.,r of the
assessments and strengthens them against later
challenge
Agencies and programs with mandated peer review panels,
such as EPA's Office of Pesticide Programs, which is
required to submit to a Scientific Advisory Panel propose
sals to cancel or restrict pesticide use, produce final
risk assessments in support of regulatory decisions that
are generally of high scientific quality and are accepted
by the pu}:'lic and the regulated parties. In contrast,
the Committee found several cases in which mechanisms for
peer review could be markedly improved: OSLO, which uses
public comments to ref ine its risk assessments, rather
than formal peer review; NIOSH, which has not had a mech-
an~sm to ensure that reviewers' comments are given appro-
priate consideration; and FDA's Bureau of Foods, which
uses ad hoc panels to review its assessments (a procedure
that unfortunately can be circumvented).
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145
· ~~ d~B
.
mechanisms to maintain the independence of their
members appear to be the most useful review bodies.
Continuity and independence of review panels help to
ensure that such panels are sensitive to regulatory needs
while retaining the necessary scientific objectivity.
Examples of standing committees, such as the Scientific
Advisory Panel in EPA, support this perception. Con-
versely, the Committee observed that short-lived or ad
hoc groups, such as the Subcommittee on Airborne Carcinoma
gens, often do not have sufficient tome to develop a
working relationship among panel mashers and that much of
the time allotted to review is actually spent in clar~fy-
ing individual versus panel viewpoints and understandings.
Similarly, an ad hoc panel may not clearly understand its
role in relation to the regulatory process. Thus, stand-
~ng panels appear to be of greater value to the agency
than ad hoc committees. Furthermore, the existence of a
standing panel might encourage an agency to seek its
advice more frequently.
Because it is important for review committees to be
free to express their scientific judgments without
concern for regulatory implications, panels that are
formed in a manner that neither compromises nor appears
to compromise their independence are more likely to
improve ultimate risk assessments. The Committee observed
that several review panels used by EPA already have a
nomination process Mat places the responsibility for
developing a slate of possible panel members outside the
agency. Although the EPA Administrator maces the final
selections of panel members, Me fact that nominations
come from outside the agency emphasizes the intent that
EPA panels be independent and as free of agency influence
as possible. A related point is that membership on EPA
panels, and in fact on most review panels used by the
regulatory agencies, rotates; members are usually selected
for staggered, f iced terms "generally 3-4 years) . This
rotation itself reduces the likelihood that members will
develop an institutional b' as.
· Review Panels are best Qualified to Dive scien-
t~fic advice when they are composed of scientists who
are highly knowledgeable in the aPpronr iate
disciplines.
For carc~nogen~city r Ask assessments, for exhale,
some relevant disciplines would be toxicology, pathology,
biostatistics, chemistry, and epidemiology. The Com
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146
mittee believes that professional or organizational
affiliation should not be used as a primacy criterion in
the determination of the makeup of a particular panel.
That is, in contrast with the advisory panels used by
05aa, which are constituted to reflect balance among
different aff il iations and presumed biases, the Committee
believes that scientific competence must be the primary
factor determining panel membership If review panels are
to be asked to give their advice on the scientific aspects
of an agency's risk assessments. }however, the Committee
notes that panel meters who understand the policy in~pli-
cations of their scientific judgments are more likely to
be helpful to an agency's assessment process and that an
attest to balance viewpoints of scientif ically qualif fed
panel members may increase a panel's credibility.
· Review unreels will be ~,3=
the
_
announcement of the agenc~r's intended regulatory
actions, except in cases of emergenev.
The Committee believes that review panels serving
regulatory agencies should serve in an advisory capacity.
That is, the judgments of a panel should not be binding
on the agency. Nevertheless, the Committee also believes
that the authority of agency review panels should be such
that agencies must demonstrate that adequate consideration
has been given to reviewers' judgments, and prior consul-
tation with review panels helps to ensure this. Because
announcements of intended actions or proposed regulations
must be thoroughly developed and substantiated, review at
the time of announcement or later is likely to be too late
to influence an agency; although the regulation is only
proposed, the decision of whether to act has, for all
practical purposes, already been made. In the Comm~-
tee's judgment, exceptions to this idea of prior review
are appropriate in the case of emergency actions, such as
suspension of pesticide registration. Risk assessments
supporting such actions could be reviewed after the
announced action.
.
Independent panels with authority to review risk
assessments for all agency regulatory decisions,
including decisions not
_ =~
~rounds.
Panels with the authority to request the review of any
agency risk assessment supporting a particular regulatory
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147
decision will have a greater impact on agency decision-
making. For example, if a panel can review only assess-
ments referred to it by an agency, some agency decisions
might not benefit from independent review of their screw:
tific basis. This is especially likely if an agency has
decided not JO regulate. Such a decision may have con-
siderable impact and should receive the same careful
review as decisions to regulate. In addition, panels
with the authority to request reviews can respond to
suggestions for review from the public.
.
Although most requirements of the Federal
Advisorv Committee Act are salutary, others mav
inhibit agency use of review panels.
The Committee believes that most provisions of the Act
are beneficial and endorses such provisions as the
requirement that advisory committees meet In public and
provide advance notice of their meetings. However, the
Act does Impose requirements, some burdensome, for agency-
created bodies that meet the definition of advisory
committee. Notably, the Act requires that an advisory
committee be formally chartered by an agency head and
approved by the General Services Administration. This
procedure has often proved cumbersome. Some agencies,
such as FDA, lack independent chartering authority and
thus require approval at the departmental level. In
addition, procedures used by the General Services Adminis-
tration for screening new committees have often imposed
long delays, sometimes inspired by political concerns
about committee membership or by resistance to the crea-
tion of new government "agencies. These legal require-
ments of the Act have caused some agencies to seek other
ways of obtaining the views of scientific experts,
especially when the issues involve single chemicals or
tests. In such cases, regulators often confine their
consultations to gov~r~ent scientists, who can be.
accessible immediately and, if necessary, for extended
per iods.
.
Written reviews help to ensure agency
consideration of scientific criticism.
A summary of a panells review that is transmitted in
written form and made available to the public will help
to avoid confusion and to ensure agency consideration of
the panel's comments. As mentioned earlier, in the
absence of adequate mechanisms to ensure agency cons~der-
ation of reviewers' comments, the comments might be
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148
ignored, or the public might perceive that they are
ignored. Putting its summary in writing should also
ensure that the panel states its findings clearly and
make it more likely that the agency will interpret its
comments correctly.
O~;R OBSERVATIONS
6. Preparation of fully documented written risk assess-
ments that exPl~citlv define the iudq~ents made and
attendant uncertatrti~.~.~y~f]d =~ _!~:Y_:
dec~s~onrmakinq process and aids the review Process
considerably.
When a fully documented written risk assessment is not
produced before an agency's decision to regulate or not
to regulate, it is difficult to understand the process by
which an agency made its assessment. The Committee
believes that the creation of such a document encourages
public understanding of and respect for agency procedures
and provides a basis for review by a scientific advisory
panel. Furthermore, a detailed risk assessment document
that clearly identifies the inference options chosen in
the assessment and explains the rationale for those
choices will help to maintain a sharper distinction
between science and policy in the assessment of risk and
will guard against the inappropriate intrusion of risk
management considerations.
REFERENCES
AIEC (American Industrial Health Council). 1979.
Recommended Framework for Identifying Carcinogens and
Regulating Thorn in Manufacturing Situations.
EPA (Enviror~ental Protection Agency). 1976. Health
risis and economic impact assessments of suspected
carcinogens: interim procedures and guidelines. Fed.
Reg. 41(102):21402-21405.
EPA (Environmental Protection Agency).
}979. Water
Quality Criteria, Request for Comments. Fed. Reg.
44(52):15926.
EPA (Envi~ormental Protection Agency). 1980. Water
Quality Criteria Documents; Availability. Fed. Reg.
4 5 (231): 79350-79353 ~
OCR for page 149
149
Food Safety Council. Social and Economic Committee.
1979. Principles and Processes for Making Food Safety
Decisions. 54 pp.
H~gginson, John. 1982. Report of the Scientif ~ c
Workshop on the Critical Evaluation of Proposals by
the American Industrial Health Council to Strengthen
the Scientific Base For Regulatory Decisions.
Rantrowitz, Arthur. 1975. Controlling technology
democratically. Am. Sci. 63:505-S09.
NRC "National Research Council). 1981. The Bandling of
Risk Assessments in ARC Reports. A Report to the
Governing Board, National Research Counci}, by the
Governing Board Committee on the Assessment of Risk.
19 pp.
Office of Science and Technology Policy. 1978.
Identification, Characterization, and Control of
Potential Human Carcinogens: A Framework for Federal
Deciszon-Making.
O.S. Congress. 1981a. Omnibus Budget Reconciliation
Act. {P.L. 97 - 35, August 13, 1981) 15 U.S.C. 2077.
O.S. Congress. 1981b. Bouse of Representatives,
Committee on Agriculture, Hearings on the National
Science Council Act, B.~. 638. Bearings Before the
Subcommittee on Department Operations, Research, and
Foreign Agriculture of the Committee on Agriculture,
June 23, 1981.
U.S. Congress. 1981c. Bouse of Representatives B.R.
638. National Science Council Act 97th Congress, 1st
Session, 1981.
O.S. Congress. 1981d. Senate. S. 1442. Food Safety
Amendments of 1981, 97th Congress, 1st Session, 1981
.
Representative terms from entire chapter:
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