Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 1
1 Summary and
1 Major
Recommendations
INTRODUCTION
This report is an outgrowth of the work of the NRc'S Committee on
Environmental Decision Making (CEDM). The first recommendation in
that Committee's report reads as follows (NRC 1977c: 10~:
EPA'S decisions on standards and regulations should be supported by analyses
that explicitly state the objectives of the decisions, identify feasible alternatives,
evaluate (quantitatively, to the extent possible) the consequences of each
alternative decision, explore potential problems In implementation, and indicate
and examine the degree of uncertainty about the effects of EPA actions. He
analyses should be available to the public.
The authors of that recommendation knew they were setting forth an
ideal that many branches of EPA were already striving to attain, and that
there was much doubt within EPA that it was feasible to come noticeably
closer to attaining that ideal than already was the case, in view of the
limited resources and information available to the Agency. The CEDM,
however, did not share those doubts. On the contrary, it felt that by
intelligent use of the available information and resources EPA could
implement the recommendations far more consistently than it had been
doing. The CEDM made extensive suggestions to this eject (NRC
1977c:25-36~.
With this background, EPA entered into a contract in late 1977 under
which the National Academy of Sciences would study the feasibility of
1
OCR for page 2
2
REGULATING PESTICIDES
implementing routinely the quoted recommendation. This was to be
accomplished by the most practical test of actually undertaking to assess
the risks and benefits of three pesticides. The Committee on Prototype
Explicit Analyses for Pesticides (PEAP), appointed to undertake these
three assessments, soon requested that its charge be revised to provide
for a closer direct involvement with EPA'S Office of Pesticide Programs
(oPP). The new~charge to the PEAP Committee was to observe oPP's
assessment of three pesticides and to provide advice and consultation
directly to oPP on how to make its analytical assessment methodology
more explicit. The methodological recommendations developed from
this experience would be written up as the Committee's report and
illustrated, to the extent that oPP's three assessments did not follow the
recommendations, using the three pesticides oPP was assessing. The
focus of the Committee's study was to be oPP's mechanism for
conducting benefit-risk analyses, the Rebuttable Presumption Against
Registration (RPAR) process.
Shortly after beginning to work with oPP, the Committee recognized
the overwhelming problem that confronted oPP and its attendant delays.
Chapter 3 describes how oPP is charged with issuing literally thousands
of legally defensible regulations each year concerning the use of
pesticides in U.S. agriculture and elsewhere. The critical need that
preoccupies oPP is for procedures and methods that will enable it to
process as rapidly as possible the thousands of decisions it is required to
make. As soon as PEAP became aware of this urgent need, it tried to meet
it.
This report is the Committee's attempt. The Committee has not
ignored its charge to develop and implement more explicit analytical
methods for risk and benefit assessments, but it has embedded that
charge in the larger and more immediate problem. In order to expedite
its work, the Committee has concentrated on a single pesticide,
chlorobenzilate, instead of three.
Chapter 2 reviews the legislative and legal status of the Federal
Insecticide, Fungicide, and Rodenticide Act of 1947 (FIFING) as amended,
which is the legal foundation of oPP's activities. The chapter also
describes the administrative procedures that oPP has devised to carry out
its responsibilities under the Act.
The subsequent chapters discuss in more detail the procedures used by
oPP, together with recommended changes the Committee believes will
enable oPP to perform analyses in accordance with the recommendation
of the CEDM and to do so expeditiously and within the severe constraints
of resources and information available to oPP.
Chapter 3 deals with a problem of broad strategy: the determination
OCR for page 3
Summary and Major Recommendations
3
of the order in which pesticides are to be considered for further analyses
and possible regulation. As the Committee sees it, the judicious ordering
of tasks is the key to the fulfillment of oPP's responsibilities.
Chapters 4 and 5 deal with a pair of parallel tasks that have to be
performed for each pesticide considered. Chapter 4 is concerned with
assessing the risks to public health and to the environment that result
from the use of a pesticide and with the erects of alternative regulations
on those risks. Chapter 5 deals with the parallel assessment of the social
and economic benefits of the use of a pesticide and, again, of the changes
in those benefits that result from various regulatory alternatives.
Chapter 6 seeks to bring those two assessments together. This is,
perhaps, the most difficult part of the task and the part where careful
scientific stab work is of least avail. The risks of pesticide use include
increases in mortality and morbidity and impairment of environmental
vitality and amenities of all kinds. The benefits are largely, but not
entirely, an increase in the availability of foods and natural fibers and a
reduction in the amounts of resources needed to produce them. It is the
responsibility of EPA'S Administrator to select the regulatory alternatives
for each pesticide that, in his or her judgment, permit the freest possible
use of the pesticide that does not impose additional risks that are
excessive in relation to the additional benefits they afford. No one can
relieve the Administrator of this responsibility. The benefits, for the most
part, are the monetary equivalent of economic resources; the risks
concern depends partly on the Administrator's personal scale of values
and partly on his or her perception of the values held by the society in
whose behalf he or she acts. That is to say, it is partly a moral and partly
a political judgment. In these circumstances the most that staff and
consultants can do is prepare for the Administrator their best reasoned
judgment of the material consequences, in terms of all likely benefits and
risks, that are apt to follow from any of the alternatives.
The difficulties are magnified by the circumstance that no one knows,
or should pretend to know, precisely what risks and benefits will flow
from any of the alternatives. The stab has to present to the Administra-
tor its reasoned judgment of the limits within which the risks and benefits
of the various alternatives are likely to lie. Frequently these will be very
broad limits, in spite of the best efforts of the stab to narrow them. The
Administrator's task is then more difficult, but it would be misleading for
the stab to convey an impression of more certainty than its knowledge
affords. The final chapter, Chapter 7, is a sample application of the
methods recommended by the Committee in the chapters that precede it.
Although the entire study was conducted within the context of oPP,
the Committee did not lose sight of its broader objective: to study
OCR for page 4
4
REGULATING PESTICIDES
empirically the feasibility of implementing CEDM'S recommendation that
the benefits and costs of environmental regulations be assessed by
explicit and quantitative (insofar as possible) evaluation. The Committee
concluded that a policy of maximum explicitness and quantification
would facilitate the work of oPP by enforcing systematization and
standardization and by increasing the clarity of communication among
the various specialists and levels of authority involved. The Committee
believes that this conclusion, as well as many of the detailed recommen-
dations listed below, is applicable with equal force to other branches of
EPA, and it hopes that its recommendations win be accepted in that lift.
In one important respect, however, the Committee found that oPP was
already carrying quantification to an unwarranted extreme. In many of
its evaluations oPP attempts to estimate the effects of various potential
regulations on human morbidity and mortality. As set forth in detail in
Chapter 4, this effort generally places more weight on our understanding
of the pathological effects of pesticides than it will bear.
It should be stated before setting forth our recommendations that this
Committee, like oPP' labored under severe constraints of resources, time,
and talent. There are many issues we have not been able to pursue or to
probe as deeply as we should have. We are painfully aware of many
deficiencies and gaps in the report. For example, the Committee did not
have the time to consider the question of getting much more reliable data
(as would be highly desirable) or other questions such as the consider-
ation of biological alternatives to pesticide control. Further discussion of
how the scope of this report was limited appears at the end of this
chapter. Like oPP, we have done the best we could with the limited
resources available.
SUMMARY AND MAJOR RECOMMENDATIONS
Principal recommendations are summarized and discussed briefly below.
CHAPTER 3
With responsibility for regulating some 35,000 pesticides and an analytic
staff that, though large in absolute terms, is a small fraction of what is
required for the task, oPP is in urgent need of a plan of operation that
will direct its attention at the earliest possible time to the pesticides
whose uses present the gravest threats to public health and the
environment. This plan should be adapted to the fragmentary informa-
tion now available, should not impose additional burdens on the already
overburdened staff, should provide for acquiring all the information that
OCR for page 5
Summary and Major Recommendations
s
is likely to be available in time to be used in reaching the decisions that
require it, and should be flexible enough to be amended as new data
emerge. The Comm~ttee's recommendations, outlined below, are de-
signed to meet these criteria. The recommendations are closely allied to
the concept of generic chemical reviews (U.S. EPA 1978), and like that
concept take advantage of the fact that the enormous variety of pesticide
formulations makes use of a much smaller number- approximately
500 of active ingredients.
The Comm~ttee's first recommendation concerns the all-important
matter of deciding on the order in which pesticides should be considered
for possible RPAR proceedings. We recommend the following procedure:
· oPP should review the 500-odd active ingredients used in registered
pesticides and identify the ones that appear to be significantly toxic and in
widespread use, on the basis of readily available information. Priorities
should be assigned to these active ingredients, determined by relative toxicity
and extent of use, and oPP should consider registered pesticides for Span
proceedings in the order of the priorities that have been assigned to their
~ Cal J ~
active ingredients. Pesticide formulations that have the same active
ingredients (or ingredients of equal toxicity) should be considered for REAR
in an order that rejects the extent to which each formulation is used. The
review and preliminary ordering of the SOO-odd active ingredients could be
done by a committee of consultants.
This recommendation is discussed in more detail and suggestions for
implementing it are made in Chapter 3.
In one important respect, however, it will frequently be necessary to
diverge from the priority order established by the procedure recommend-
ed above. Particularly during the early stages of the process, some of the
information needed to evaluate regulatory alternatives will not be at
hand when needed by the RPAR assessment team unless special efforts are
made to obtain it. The data in question relate to the public health,
environmental, and economic ejects of the alternative pesticides that
will be brought into use by a regulation that restricts the use of a
pesticide high on the priority list. When the alternatives to a pesticide for
a particular use are significantly toxic and have not yet been evaluated,
assessment of potential regulation requires that their effects be known, in
order to estimate the changes in risks and benefits that would result from
adopting the regulation. The following recommendation is intended to
assure that this information will be at hand at the time that the
regulator decision has to be made.
· At an early stage of the work of reviewing a pesticide for possible
regulation, the pesticides that are alternatives to it in its major uses should be
identified. If any of them are presumed a potential toxic hazard and have not
OCR for page 6
6
REGULATING PESTICIDES
yet already been reviewed, they should be promoted from their assigned
places in the queue and reviewed as promptly as possible.
One consequence of this recommendation will be that the several
pesticides that are alternatives for the same use will be reviewed
simultaneously. This will make it possible, and advisable, to issue or
deny reregistrations for that use for that group of pesticides, without
waiting for decisions on the other uses of many of those formulations.
The application of this recommendation also is discussed in detail in
Chapter 3.
CHAPTER 4
The use of a pesticide may entail manifold risks. Risks to public health
are currently EPA'S predominant concern. These include the risks of
inducing cancers, mutations, spontaneous abortions, or abnormal
offspring. A wide variety of other chronic and acute toxic effects may
also be induced. In addition to impairing public health, a pesticide may
have adverse ejects on nontarget animals and plants, including crops,
livestock, and important wild species. Since the purpose of any
regulation is to reduce some or all of these risks, estimates have to be
made of the severity of the risks under the regulatory options that are
considered.
Since risks to public health are currently EPA'S primary focus, the
Committee concentrated its attention on them, and among these risks
paid particular attention to assessing the risks of inducing cancers. It
should be pointed out, however, that long-term effects of pesticides on
the environment per se and eventual indirect ejects on humans may, in
the long run, be more important than evaluations of risks and benefits
based solely on toxicity to animal or human. This report admittedly does
not address this important topic.
The Committee scrutinized carefully the methods used by oPP and
EPA'S Carcinogen Assessment Group. As a result of this scrutiny it came
to the conclusion, very much in line with the position of the Director of
the NC! (Carter 1979), that our present understanding of the mechanisms
of cancer.development does not permit us to draw reliable numerical
inferences from the kind of laboratory data normally available about the
ejects of pesticides and other compounds on the development of cancers
in humans. The bases for this conclusion are already well known and are
set forth at some length in Chapter 4 and Appendix A. On the basis of
this conclusion and the fact that, once outside CAG, numerical estimates
of human cancer incidences are often misued in EPA'S decision making,
the Committee makes the following recommendation:
OCR for page 7
Summary and Major Recommendations
7
· oPP should abandon its attempts to produce numerical estimates of the
elects of the use of pesticides on human mortality and morbidity except
when reliable human epidemiological data are available. In the usual case, in
which major reliance has to be placed on the results of bioassays, those
results should be used to construct indicators of the relative pathological
activity of the pesticide under review in comparison with other pesticides and
compounds. The elect on public health of alternative regulations should be
presented in the form of estimates of the doses of that pesticide to which
pertinent segments of the population will be exposed under those regulations.
The doses received should be evaluated according to the pesticide's virulence
relative to other pesticides and compounds.
The Committee recognizes that this recommendation is inconsistent
with the practice and methodological recommendations of some previ-
OUS NRC reports that have, in fact, recommended and used extrapolation
techniques to derive numerical estimates of human cancer incidence
from animal data (NRC 1972; 1976; 1977a, b, d; 1978a, by. But, for the
reasons discussed in this report, the Committee feels that the change
suggested here will improve the decision-making process.
The situation with respect to other aspects of public health appears
much the same. Empirical data on the mutagenic, teratogenic, and toxic
ejects of pesticides on human populations are rarely available, and the
basis for inferring those effects from laboratory experiments with
animals is generally lacking. Consequently, for those hazards also, to the
extent that they have to be inferred from laboratory experiments with
animals, the Committee recommends that the laboratory data be used to
show how the pathological activity of the pesticide under review
compares with the activities of other pesticides and compounds in
producing ejects. The effect on public health can be indicated by
estimating the doses to which pertinent segments of the population
would be exposed under alternative regulations, taking relative patholog-
ical activity into account.
An important component of assessing the effects on public health of
using a pesticide is-the task of estimating the number of people who
would be exposed to it and the doses that major segments of the
population would be likely to receive. Empirical data are often deficient
or entirely lacking, so that estimates must be inferred from fragmentary
sources or by analogy with other pesticides or experiences. Making these
inferences requires close familiarity with the conditions under which the
pesticide is used and with its routes of transmission, a familiarity that the
oPP stab cannot be expected to have in all instances. In order to enhance
the quality and reliability of these estimates the Committee makes the
following recommendation:
OCR for page 8
8
REGULATING PESTICIDES
· It should be a routine practice for the members of the EPA staid team
reviewing a pesticide to visit sites where it is applied, facilities where it is
formulated and handled, and laboratories where it is studied, and on those
visits to hold informal discussions with the people in day-to-day contact with
the manufacture, handling, and use of the pesticide.
The risks attendant on the use of a pesticide, as well as the economic
benefits that it produces, depend on the length of time it is used.
Expenence indicates that the economic lives of most pesticides are
limited, both because target species frequently adapt to them and
because they are often superseded by improved compounds. Unfortu-
nately there is very little information about the economic lives of
pesticides or about the factors that influence them. Accordingly the
Committee recommends that:
· OPP should undertake or sponsor a study of the economic lives of
pesticides and the factors that inJquence the economic lifetimes. Estimates of
both lifetime exposures and economic benef is should be based on the periods
of use that are revealed to be reasonable by this study.
This discussion and the Comm~ttee's investigation generally have
revealed that every component of the appraisal of risks is subject to
substantial uncertainty. oPP' however, almost always presents its
exposure estimates as single figures without an accompanying indication
of the degree of uncertainty. Every reader of the estimates, undoubtedly,
is aware that the estimates are subject to error, but normally readers have
no grounds for judging how large the errors are likely to be. It is
important that this information be provided. The format preferred by the
Committee is to present two estimates of every component of risk and
the data used in deriving those estimates. One of these figures should
convey the analyst's best judgment of the level that actually would be
realized under the assumed conditions. The other figure should present
an estimate of the maximum risk likely to be experienced (barring an
extremely implausible chain of unfavorable circumstances). These two
estimates are referred to in the text as the "most-probable" and
"maximum-plausible" estimates of risk. In the Committee's own work
the most-probable estimates correspond generally to the mode in
statistical terminology, and the max~mum-plausible estimates to the
upper limit of a 90 percent confidence interval.
These considerations lead to the following recommendation:
· The methods now used by oPp for estimating the exposures associated
with various regulatory options are sensible and, with the modifications
discussed above, are as sound and reliable as the available data permit. The
resultant estimates, however, are subject to substantial ranges of uncertainty
that should always be kept in mind. To this end, estimates that are subject to
OCR for page 9
Summary and Major Recommendations
9
uncertainty should always be presented as a pair of numbers, one showing the
exposure or other aspects of risk deemed most probable, and the other
showing the maximum exposure or comportment of risk likely to be
experienced (in the absence of an implausible array of untoward circum-
stances).
These conclusions, particularly the rec~i~hat unless there are
adequate epidemiologic n~ical estimate should be made of
the eject of various regulatory options on human morbidity and
mortality, have profound implications for the assessment of regulatory
alternatives. They imply, in particular, that regulatory decisions have to
be made on the basis of data that do not show explicitly the effect of
alternative regulations on the attainment of the purposes being pursued.
Put differently, it would be far easier to choose among regulations about
which the ejects on mortality rates or on the rate of incidences of
cancers are known than among regulations about which the only
available information concerning risks is the estimated doses of
chemicals having roughly estimated pathological activities to which
populations will be exposed. Yet these are the only data that can be
provided to the regulatory authorities in most instances. Chapter 6
discusses at some length the problem of reaching regulatory decisions
under these circumstances.
CHAPTER 5
Pesticides confer many kinds of benefits. They are an essential ingredient
of modern commercial agriculture and forestry. They contribute to
public health by controlling insect vectors of disease. They protect
ornamental trees, lawns, and shrubs. They reduce the numbers of insects
in residences and other structures. Since, however, the Committee's
resources were limited and according to the 1978 estimates (U.S. EPA
1979) about three fourths of all pesticides by volume are used in
agriculture, the Committee devoted its review of benefit estimation
entirely to agricultural use. In the course of its review, the Committee
studied numerous directives and memoranda that prescribe the methods
used for benefit evaluation in oPP and evaluated in detail the benefit
analyses of six pesticides.
oPP's analyses of the benefits of pesticide use in agriculture are all
based on a procedure called "partial farm budgeting." This procedure
amounts to estimating the ejects of alternative regulations of the use of a
pesticide on the net farm incomes of growers of the crop that the
pesticide is used to protect. It therefore implicitly defines the economic
eject of regulating a pesticide to be its eject on net farm income. But
OCR for page 10
10
REGULATING PESTICIDES
this can be misleading. If a regulation increases the cost of producing a
certain crop, the total output of that crop will be reduced and its price
will generally rise. This rise in price will offset the increase in farm
production costs and the decrease in farm revenues caused by the
reduction in the size of the crop. The offset can be substantial; in fact, in
several of the analyses the Committee studied, it was so great that net
farm income was increased as a result of restrictions on the use of a
pesticide. But of course national income is not increased. The rise in
price that cushions the ejects on the incomes of farmers is borne by the
consumer, and in a more complete accounting of the effects of the
regulation, the loss on the part of consumers would offset completely the
cushioning effect of the price rise on the incomes of farmers. The
Committee therefore recommends:
~ In applying the partial farm budgeting approach to estimating the
benefits of pesticide use, oPP should exclude the effects on net farm income
of changes in crop prices induced by the regulations.
A budgeting procedure that implements this recommendation is
described in Chapter 5. The estimates obtained by following the
corrected farm budgeting approach will be tolerable approximations to
the effects of regulations on national income, but they will not reveal the
differential ejects on farmers, on consumers, and on other population
groups whose welfare may be of interest. Those differential effects are
often significant. oPP should therefore continue to use its present
methods for estimating ejects on farm income and should supplement
those estimates with estimates of the effects of regulations on the
incomes of other population groups. A format for incorporating all these
consequences of regulation is also suggested in Chapter 5.
One of the serious problems inherent in estimating the economic
ejects of regulating pesticides is the difficulty of foreseeing how farmers
will respond to regulations, in particular of foreseeing what alternative
methods of pest control they will employ. The analytical methods
currently used by oPP do not allow for farmers' responses to the differing
costs of various methods of pest control nor do they take into account
the extent of farmers' experience with different methods. It appears that
the mechanical method currently used has a tendency to overstate the
loss in benefits that would result from restricting the use of pesticides.
Though any forecast of changes in pesticide control methods must be
conjectural, the Committee recommends that a more realistic and less
biased method be used; one such method is suggested in Chapter 5. In
making forecasts it is essential to assemble and evaluate all possible
information. The site visits recommended in Chapter 4 Drill be useful for
this purpose.
OCR for page 11
Summary and Major Recommendations
11
Under the best of circumstances the estimation of the economic effects
of regulating a pesticide is a difficult task. It must employ data from
many sources, often unpublished and sometimes very informal. It
requires the exercise of considerable judgment in choosing underlying
assumptions and in making approximations where data are deficient. For
these reasons the resultant estimates require very careful review with
respect both to the quality and reliability of the data employed and to
the appropriateness and adequacy of the methods used. The current
procedures in oPP provide for a highly qualified review of risk
assessments (by the Science Advisory Panel) but not for a comparable
review of benefit assessments. The Committee therefore places particular
emphasis on the following recommendation:
· oPP should establish an external Benefits Review Panel, similar in
organization to the Scientific Advisory Panel, consisting of entomologists,
plant pathologists, weed specialists, economists, and others with expertise in
assessing the benefits of pesticide use. This panel should have the
responsibility of providing external scientific reviews of the benefits data and
analyses. For each RPAR compound, a review team (consisting, for example,
of one entomologist and one economist) should be selected from the panel.
This team, in contrast to current sAP procedures, should be involvedfrom the
earliest stages of the benefits assessment, and should have the primary
responsibility for presenting an evaluation of the benefits assessment to the
entire Benefits Review Panel.
CHAPTER 6
Chapter 6 deals with the assimilation of the results of the risk and benefit
analyses discussed in the preceding two chapters. It considers two
principal topics: the generation of alternative regulatory options and the
comparison of the ejects of the alternative options studied.
Actually, the generation of the regulatory options cannot wait until the
late stages of the study. At least a general preview of the possibilities that
eventually will be evaluated is needed from the very inception of the
analytic work in order to initiate the accumulation of relevant data and
to establish the assumptions to be used in preparing the estimates of risks
and benefits. Additional regulatory possibilities are likely to emerge,
however, as the work progresses. The plans for analysis should be revised
as such new possibilities come to light, so that the data necessary for
appraising them will be available when needed.
The options available for regulating a pesticide are generally fairly
well standardized. An agricultural pesticide being reviewed for reregis
OCR for page 12
12
REGULATING PESTICIDES
tration will normally be used on several crops (food and fiber production
accounts for almost 75 percent of pesticide use by volume), in several
sections of the country, and for contending with a number of different
pests. The regulatory options, then, are choices among which of these
uses (if any) are to be allowed and disallowed. Restrictions may also be
placed on the mode of application of the pesticide in any or all of the
uses and on precautions that may be required to reduce the exposures of
people and of nontarget species in general. Considerable familiarity with
the pesticide and its use, as well as some exercise of ingenuity, is required
to select ~ manageably small number of significant regulatory alterna-
tives that have good promise of reducing undesirable exposures without
imposing prohibitive or excessive costs on the users. It is generally not
feasible to analyze more than a half dozen or so alternative options with
any thoroughness. The development of alternative options is therefore an
important matter, and deserving of considerable deliberation and
attention, because it delimits the range of choice. The eventual decision
will be a choice of the best of the regulatory alternatives subjected to
analysis; regulatory possibilities that may be substantially superior are
forever ruled out if they are not included in the list of options subjected
to analysis. Thus, the development of the list of regulatory alternatives
amounts to a rejection of all possibilities not included in the list and as
such is a genuine regulatory decision. It should not be regarded as
merely a preliminary stage in the analysis.
The second stage in the decision process is the adoption of one of the
options that have been proposed and analyzed. The data pertinent to this
choice are the costs of the different options (discussed in Chapter 5 as
forgone benefits) and their erect on risks of various sorts (discussed in
Chapter 4), all of which are imperfectly known. Furthermore, these costs
and risks have to be known or estimated in some detail, since different
segments of the population will fare differently under the different
options. It cannot be expected that there will be any option that is
superior to all the rest from all points of view or from the standpoint of
all members of the population. Thus the choice inevitably amounts to
choosing among risks of various sorts, between risks and economic costs,
and among options that are favorable to different segments of the
population. These choices are difficult and cannot be made mechanical-
ly.
Choices of this sort are the subject of decision theory, which by now
has developed a substantial body of techniques for facilitating decisions.
Most of the techniques used in decision theory depend upon the decision
maker's "utility function," which is essentially a scale for measuring the
_. . ~.. . . ~.
OCR for page 13
Summary and Major Recommendations
13
relative desirability in his or her esteem of different combinations of
costs, risks, and other consequences that may be expected to result from
the selection of any one of the options. In the Committee's judgment
these utility functions cannot be ascertained in the circumstances in
which oPP operates. We therefore recommend procedures that do not
employ this concept, but rather consist of presenting in intelligible form
a menu or range of choices open to the decision maker. The recommend-
ed procedures are discussed in some detail in Chapter 6.
CHAPTER 7
The Committee's work had both a normative and a descriptive aspect.
The normative aspect was to make recommendations that would
facilitate the analytic and decision-making work of oPP and would
increase the cogency of their analyses. The descriptive or empirical
aspect was to test the feasibility of those recommendations in the light of
the limitations of data, time, and facilities that constrain oPP in reaching
its numerous decisions. In the nature of the case, we were not able to
formulate a test with any pretensions to scientific rigor. Our test
consisted of working through a single decision problem- the choice
among alternatives for regulating the pesticide chlorobenzilate using
only data and methods that are available to oPP. We were not able to do
even this task completely realistically, because our stab and other
resources were far smaller than those that oPP can bring to bear on a
similar problem and because we were restricted to using, with some
minor exceptions, only the data that oPP had generated in its analysis of
chlorobenzilate-although our recommendations called for acquiring
certain additional data at an early stage in the study of a pesticide.
Chapter 7 reports the results of this test application of our recom-
mended procedures. We studied five regulatory options and obtained
clear indications of their relative merits and demerits. We deliberately
refrained from choosing among those options, since the limitations under
which we worked made it presumptuous for us to over such a decision,
and since it was not part of our purpose or charge to second-guess oPP's
choice. Nevertheless, this small test persuades us that it is entirely
practicable for oPP to carry out analyses in accordance with the
procedures that we recommend. It is for the reader to judge whether the
information yielded by our recommended procedures is significantly
more helpful in arriving at decisions than the information provided by
oPP's current methods. The Committee thinks that it is.
OCR for page 14
14
CONCLUDING REMARKS
REGULATING PESTICIDES
The Committee's thinking evolved strikingly in the course of its work. In
the beginning, it perceived its task as testing the feasibility of employing
the established methods of benefit-risk analysis in decision-making
procedures of EPA, using the Office of Pesticide Programs as a test case.
Almost immediately it became embroiled in the overwhelming problems
that oPP confronts: the problem of processing the reregistrations of some
35,000 pesticides within the tight timetable prescribed by the legislation.
The Committee became increasingly impressed by the enormousness of
the task assigned to oPP. On the one hand, it was obvious that simple
expeditious procedures were required for processing the individual
pesticides. On the other hand, it was just as obvious that rough and ready
methods would not suffice. The implications of the decisions for public
health and environmental integrity were too great, and the stakes that
many people had in them were too high for decisions to be reached
lightly or without thorough analysis of their implications for consumers,
for farmers, for farm workers, and for everyone concerned with health
and with environmental conditions.
The recommendations summarized above show that the Committee
did not choose to sit on either horn of this dilemma. Life for oPP cannot
be made simple, and the Committee quickly abandoned the attempt to
make it so. Most of the recommendations are directed to increasing the
logical and scientific probity of oPP's analyses. The Committee believes
that by following standardized procedures of greater logical clarity, oPP
can save some time and effort in the performance of its tasks, but not
very much. More time can be saved, and electiveness can be increased,
by following a more systematic strategy for selecting pesticides for
review, as recommended in Chapter 3. These improvements can alleviate
oPP's predicament somewhat, but they can by no means enable oPP to
complete its assigned task within the time allotted. The Committee
cannot claim to be offering oPP a solution to its central problem, that of
arriving at considered judgments about the regulation of all the
pesticides used in this country in a short space of time.
So much for the quantity of decisions. Quality is also important, and
here the Committee feels more content with its work. The Committee
was impressed by the carefulness and thoughtfulness of oPP's work, but
it did observe a number of significant shortcomings. These have already
been summarized and there is no need to repeat them. Still it is worth
repeating that many of the deficiencies result from inadequacy of the
data available to oPP. Insufficiency of data is a frustrating and time
consuming obstacle to every phase of the analyses. Appraisals of risk to
OCR for page 15
Summary and Major Recommendations
15
human health are made complicated and uncertain by the lack of
information about human exposures. Estimates of the costs of restrictive
regulations are made vague and controversial by the paucity of
information about the electiveness of pesticides. There is little reliable
information about the elects of most pesticides on nontarget species of
animals or vegetation, wild or domestic. As exemplified in Chapter 7,
mucn or tne analytic effort of oPP Is devoted to attempting to bridge
these gaps in the data by interpolating, extrapolating, or inferring from
whatever tangentially relevant information can be found. Research
designed to remedy these deficiencies would expedite and strengthen
oPP's analyses greatly. Of course, much such research is in progress; it
should be pursued vigorously. More complete and systematic monitoring
of exposures of people and wildlife to pesticides and the ~nn~.~ll~nr
are of particular importance.
L . 1~ ~ _ ~ the . ~ · . . . . . .
., , ~ ~ _,__-,
The recommendations in Chapter 4 concerning the characterization of
the pathological potencies of different pesticides point to an area of
special concern. This report has already raised strong objections to the
methods currently in use. The proposed alternative, Carcinogenic
Activity Indicators, have more scientific justification, but they, too, rest
on assumptions that stand in need of verification. The CAN'S also are
somewhat difficult to interpret, though this difficulty may stem largely
from their unfamiliarity. Although the Committee recommends that
CA'S be employed as indicators of the relative hazardousness of different
chemicals, it does not feel that the measure recommended is the ultimate
word. Serious research should be undertaken into methods for measuring
and expressing the potencies of different chemicals in inducing, ~.~nrPr~
and other diseases.
_ ~
This report has commented several times on the vast scope of oPP's
task. The Committee's task was correspondingly large, so that we were
forced to concentrate on a few salient aspects of the work to the neglect
of many other important issues. For example, our review of the analysis
of the cost of pesticide regulation was confined to the costs of regulating
pesticide use in commercial agriculture. Other uses, for the control of
disease vectors, for noncommercial gardening, and many other purposes
are by no means negligible, and in fact account for over a third of total
pesticide use. Though the Committee could not review the costs of
regulating any application of pesticides other than in commercial
agriculture, those costs are undoubtedly substantial and the methods
used to estimate them should be audited carefully by some specialists
who are independent of EPA.
The Committee's review of the estimation of the risks of using
pesticides was similarly incomplete. It was limited almost entirely to the
OCR for page 16
16
REGULATING PESTICIDES
estimation of risks to public health, and within that area to the risks of
increasing the incidence of cancer and adverse mutations. The Commit-
tee feels that most of the risks to public health that result from prolonged
exposures to pesticides give rise to issues similar to the ones studied and
should be dealt with by similar methods. The estimation of the risks of
acute toxic ejects is an entirely different, but apparently less difficult,
task. The Committee did not consider it. Neither was it able to consider
the appraisal of the environmental and ecological consequences of
pesticide use beyond noticing that the data available for making such
estimates are particularly inadequate and untrustworthy. No attention
could be paid to the possibility of long-run climatolog~cal, ecological, or
evolutionary effects. In short, there are wide gaps in this study, long
though it is, gaps that may be serious and which ought to be filled.
Finally, while enumerating the inadequacies that the Committee is
painfully aware of, the length of the report has to be included. The report
is far too long, but to quote Sam Johnson, "there was no time to make it
shorter."
REFERENCES
Carter, L.J. (1979) How to assess cancer risks. Science 204:811-815.
National Research Council (1972) The Effects on Population of Exposure to Low Levels of
Ionizing Radiation. Assembly of Life Sciences. 1974-582412:45. Washington, D.C.:
U.S. Government Printing Office.
National Research Council (1976) Health Effects of Alpha-Emitting Particles (Hot
Particles) in the Respiratory Tract. Assembly of Life Sciences. BPA 520/4-7~013.
Washington, D.C.: U.S. Environmental Protection Agency.
National Research Council (1977a) A Review of the Use of Ionizing Radiation for the
Treatment of Benign Diseases. Assembly of Life Sciences. U.S. DHEW (PDA) 78-8043.
Washington, D.C.: U.S. Department of Health, Education and Welfare.
National Research Council (1977b) Considerations of Health Benefit-Cost Analysis for
Activities Involving Ionizing Radiation Exposure and Alternatives. Assembly of Life
Sciences. BPA 520/4 77-003. Washington, D.C.: U.S. Environmental Protection Agency.
National Research Council (1977c) Decision Making in the Environmental Protection
Agency. Volume II, Analytical Studies for the U.S. Environmental Protection Agency.
Committee on Environmental Decision Making, Environmental Studies Board, Com-
mission on Natural Resources. Washington, D.C.: National Academy of Sciences.
National Research Council (1977d) Drinking Water and Health. Assembly of Life
Sciences. Washington, D.C.: National Academy of Sciences.
National Research Council (1978a) Nitrates: An Environmental Assessment. Environmen-
tal Studies Board, Commission on Natural Resources. Washington, D.C.: National
Academy of Sciences.
National Research Council (1978b) Chloroform, Carbon Tetrachloride, and Over
Halomethanes: An Environmental Assessment. Environmental Studies Board, Commis-
sion on Natural Resources. Washington, D.C.: National Academy of Sciences.
OCR for page 17
Summary and Major Recommendations
U.S. Environmental Protection Agency (1978) Notice of Intent to Establish a Generic
Standards System for the Registration of Pesticide Products; Solicitation of Public
Views. Proposed Federal Register Document, Office of Pesticide Programs, Washington,
D.C.
U.S. Environmental Protection Agency (1979) Pesticide Industry Sales and Usage 1979
Market Estimates. Office of Pesticide Programs, EPA, Washington, D.C. 20460.
(Unpublished)
17
Representative terms from entire chapter:
regulating pesticides
