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FIFRA
and the
REAR
Process
LEGISLATIVE FRAMEWORK
INTRODUCTION
The stakes are high in pesticide regulation. The increased yield and
subsequent economic return to U.S. agriculture from pesticide technolo-
gy and the return to the chemical industry have encouraged many to rely
on pesticides as a primary means of pest control. Farmers spend more
than $2.2 billion a year on chemical pest control, thereby increasing the
value of their output by an estimated $8.7 billion, that is, by about 9
percent (Pimentel et al. 1978~. However, the possibility of substantial
risks to human health and to ecosystems from wide-scale use and,
sometimes, misuse of chemicals may entail costs beyond those that
society is willing to accept. On the other hand, depriving agriculture of
an important tool for which there is no substitute may involve risks and
economic costs both to the industry and to society that are - also
unacceptable.
Pesticides, depending upon the dose or exposure level, may produce
acute or chronic toxic effects in nontarget organisms, including humans.
There is increasing evidence that some chemical pesticides pose long-
term cancer and other risks to humans exposed to them through dermal
contact, inhalation, or the food chain. Society thus must decide how
much, what kinds, and what uses of chemical pesticides to allow.
In recent years, the historical presumption that unrestrained technolo-
gy is beneficial (the protechnical attitude) has been questioned. Evidence
18
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FIFRA and the RPAR Process
19
is accumulating, largely from the sciences of public health, ecology, and
economics, that technologies may have hidden impacts that produce
unacceptable side ejects. Consequently, society has increasingly come to
accept the proposition that technologies that affect the environment
should be rigorously assessed before they are applied.
The case for evaluating technologies by some form of benefit-cost
analysis (the analytical attitude) is a strong one, in the abstract. In
practice, however, because of the great uncertainties involved in
pesticide assessment, rigorous benefit-cost analysis is almost impossible.
The most rational comparison of the benefits of using a pesticide with
the risks it entails is fraught with uncertainty. Beyond that, stating the
question as one of comparing risks against benefits runs the danger of
weighting the answer on the side of risks, for there is a general reluctance
to balance risks to human health against mere economic gains. Calabresi
and Bobbitt (1978) in their book, Tragic Choices, explain why society is
reluctant to attempt rational trade-o~s:
When tragic choices are made through the pure market within an ex~st~g
distribution of wealth, costs arise which are external to the immediate decision
makers and are borne instead by the rest of us. These external costs may limit our
willingness to permit a market: The social costs of Indentured labor, for example,
surely include one's outrage at inducing the poor to sell themselves, and this cost
must be considered before the society allows peonage. The willingness of a poor
man, confronting a tragic situation, to choose money rather than the tragically
scarce resource always represents an oblique indictment of society's distribution
of wealth. That willingness, when it follows a first-order determination which has
been made collectively, is a yet more insistent accusation; it presents the
wrenching spectacle of a rich man and a poor man bidding against each other for
it. Yet the degree of redistribution of wealth necessary to avoid such external
costs would itself be too costly. It might require a virtual equivalence of wealth
such that incentives to produce would not survive.
The tragedy of the choice is the basis for adoption of a conservative
attitude that urges society to avoid the risks of introducing untried
technologies. The conservative attitude has both a substantive and a
procedural dimension. Substantively, it asserts categorically that it is
wrong to subject persons to certain risks. Procedurally, it places the
burden of proof on advocates of technological innovation and requires
that change be held in abeyance pending the production of information
necessary to a rational assessment of the innovation's net value to
society.
Distinctions among the protechnical, analytical, and conservative
attitudes as discussed above are essential to understanding the role of the
legal system in setting rules for pesticide regulation. But it must be
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20
REGULATING PESTICIDES
realized that the political process is too dynamic and flexible to fix
consistently on one attitude to the exclusion of others. Because the stakes
are high in pesticide regulation, the decision-making process can
accommodate diverse interests only through compromise. For this
reason, laws regulating the entry of pesticides into the market and their
subsequent use reflect simultaneously all three of the above attitudes.
The task of implementing the compromise legislation is then delegated to
an administrative agency EPA. The legislation tells the Agency that
pesticides are to be assessed rationally, that some risk is acceptable, but
that in any given case the Agency may be conservative in deciding to
prefer risk avoidance over economic benefits: in short, that EPA has great
but not unlimited discretion to regulate pesticides.
Knowledge of the background and structure of the laws regulating
pesticides is essential to understanding the problem with which this
report is concerned: How can EPA improve its procedures for rational
evaluation and regulation of pesticides? The problem is at one level a
technical one; at another level it is a question of consensus about issues.
But the consensus does not exist.
EARLY LEGISLATION: CONSUMER PROTECTION
Pesticide regulation developed in an atmosphere that presumed that the
application of technology was beneficial. Subsequent legislation has
challenged, but not supplanted, the earlier legislation based on this
assumption, although the first two statutes regulating pesticide manufac-
ture and use were classic examples of consumer protection legislation.
Chemical pesticides came into widespread use toward the end of the
nineteenth century. The formulas were simple and the compounds were
sold by many small, often itinerant dealers, or mixed by farmers
themselves with products ordered by mail. The fragmented market made
it easy to pass on adulterated goods, and this state of affairs alarmed
Congress in 1910. In response to pressure from the U.S. Department of
Agriculture (USDA) and farm organizations, a simple statute was passed
in 1910 specifying the percentage of certain ingredients for Paris green
and lead arsenate (arsenical pesticides) and setting general standards for
other insecticides or fungicides. Enforcement was ad hoc, as the evidence
necessary to prove a violation of the statute was collected only by
random plant inspections or through user complaints. The Insecticide
Act of 1910, therefore, had a limited purpose-the protection of
consumers from fraudulent goods-but the purpose was seen as an
adequate response to the problem until 1947.
Pesticide compounds ceased to be simple by the end of World War II
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FIFRA and the RPAR Process
21
as synthetic organic pesticides came into widespread domestic use. The
new chemicals were more toxic, and valuable nontarget species were
vulnerable to damage if the pesticide was not used with care. Congress,
therefore, felt that there was a need to provide users with the advance
information necessary to make informed choices. The Federal Insecti-
cide, Fungicide, and Rodenticide Act of 1947 (FIFED) required for the
first time that all pesticides be registered before they could be marketed
and that the label specify the content. This law is an extension of classic
consumer protection objectives. A rational user is assumed and the
problem is defined as the disclosure of sufficient information for the user
to make an informed choice.
The crucial assumption underlying FIFRA was that the major problem
associated with the use of pesticides was their efficacy. The major basis
for denying registration was that the label contained claims that differed
from those made to the USDA. The only protection against undesirable
erects of the pesticide on nontarget species and plants was afforded by
the requirement that the label identify the pesticide as a poison. The
USDA administered FIFED on the assumption that efficacy was the major
problem and, as a consequence, the bulk of the USDA'S regulatory activity
was concerned with ensuring that pesticides were labeled accurately.
Few chemicals were barred from the market.
SHIFT TO HEALTH AND ENVIRONMENTAL PROTECTION
The assumption that efficacy was the principal problem was challenged
in the 1960s, first by Rachel Carson's Silent Spring (1962) and then by a
series of presidential commissions. These challenges led to the current
laws.
The basic argument raised by critics of pesticide use is that the major
problem is safety, not efficacy: pesticides are potentially unsafe because
they have unanticipated erects on nontarget species, and thereby pose
risks to ecosystem stability and to human health. The problem can be
solved only partially by the disclosure of impact information. A full
solution requires that some pesticides be barred from the market or have
limits placed on the circumstances in which they can be used.
Theoretically, this solution was possible under FIFRA because the statute
had established three review points for a pesticide: (1) registration, where
the chemical was screened prior to market entry; (2) suspension, a quasi-
summary removal from the market; and (3) cancellation of a registra-
tion, which resulted in permanent removal from the market. However, as
administered by the USDA, there was no substantial safety review at any
of these three stages. In part, the lack of adequate safety review was
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22
REGULATING PESTICIDES
caused by 1947 legislation that allowed a registrant whose chemical was
challenged to obtain a protest registration, thereby shifting the burden of
proving a pesticide ineffective or unsafe to the government and allowing
the challenged chemical on the market.
In the 1960s, a two-pronged attack was made against USDA'S
interpretation of FIFRA and on the adequacy of the legislation itself. Fit
was attacked by both the courts and Congress. Each branch of
government produced a reform of pesticide law, but the reforms were not
identical. The divergence between the approaches of the Congress and
the courts accounts for the tension in EPA'S current regulatory policy and
the continuing controversy that surrounds the scope of pesticide
regulation.
The courts adopted a conservative strategy by giving the USDA and,
subsequently, EPA the discretion to ban pesticides on the basis of a
comparison of benefits and risks that took a very conservative view of
socially acceptable risk. Congress accepted the necessity of basing
decisions upon risk as opposed to proof of harm, but attempted to ensure
that risk would be only one of the relevant factors considered by EPA. To
this end, Congress imposed a process that based all decisions on a
balanced benefit-cost analysis derived from neoclassical welfare econom-
ics. These two strains of reform the courts' and Congress's form the
basis of EPA'S current regulatory policy. An appreciation of the related
but distinct nature of each is essential to understanding the problems
that EPA iS now facing in subjecting pesticides to a rational benefit-risk
analysis.
The Role of Congress
Congress reformed FIFRA in two stages. In 1964, protest registrations
were eliminated and the definition of a misbranded pesticide was
expanded to include pesticides that would injure invertebrate animals, as
well as vertebrates and plants valuable to man. The 1964 amendments
expressly directed the USDA'S attention to safety considerations for the
first time. Eight years later, FIFRA was supplemented by the Federal
Environmental Pesticide Control Act of 1972 (FEPCA).
FEPCA did not eliminate the consumer protection objectives of the
earlier statute, but supplemented them with the recognition that the
public generally needed to be protected from potentially harmful erects
of pesticide use. The heart of EPA'S expanded mandate is Section 3(c)~5),
which requires the Agency to refuse to register a pesticide unless it is
determined that "when used in accordance with widespread and
commonly accepted practice it will not cause unreasonable adverse
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FIERY and the RPAR Process
23
ejects on the environment." The phrase "unreasonable adverse ejects
on the environment" is defined in Section 2(bb) as "any unreasonable
risk to man or the environment, taking into account the economic, social,
and environmental costs and benefits of the use of any pesticide" (emphasis
added). The standard, "unreasonable adverse ejects on the environ-
ment," controls the Agency's determinations about the acceptability of a
proposed use of a pesticide. A reading of the legislative history supports
the Agency's position that FIFE, as amended by FEPCA, requires the
Agency to subject all pesticide uses to benefit-cost (or benefit-risk)
analysis. The legislative history is equally clear that in all stages of
decision making the analysis should be a balanced one, that is, that equal
weight be given to benefits and risks. Congress recognized that some
risks are inherent and unavoidable in pesticide decision making, but
wanted risks to be weighed against benefits in every decision. Some
environmentalists have questioned this reading of the legislative history.
They argue, on the basis of drafts and explanations by the environmen-
tally oriented Senate Commerce Committee, that a substantial showing
of benefits would be required if a finding of risk were made. However, a
close reading of the legislative history indicates that the analysis was to
be a balanced one. The "spirit" of the section was summed up by the
report of the House Committee on Agriculture, whose version became
the final bill: "As the committee labored through the months of hearings
and discussions, one central legislative philosophy developed . . . the
theme of the 'search of balance!"' (U.S. Congress, House 1971:5~.
Any doubts that Congress intended a balanced assessment of benefits
and risks were dispelled in 1975 and 1978 amendments to the legislation.
A constant theme in the 1975 hearings was that EPA was not giving
adequate attention to agricultural development (i.e., benefits of pesticide
use) in its decisions. Congress redressed the imbalance indirectly by
strengthening the role of the USDA in the decision-making process and by
creating a new Scientific Advisory Panel, composed of seven persons
appointed from a list of six nominated by the National Institutes of
Health and six nominated by the National Science Foundation.
The 1975 amendments have been described as a shotgun wedding
between EPA and the USDA. Specifically, FEPCA was amended to require
the Administrator of EPA to take into account the ejects of cancellation
and suspension of a pesticide's use upon the production and prices of the
relevant agricultural commodities when the Agency issues a notice of
intent to cancel. Further, in connection with final action, the Administra-
tor must prepare and publish an agricultural economic impact statement.
To ensure that the Administrator receives the views of the agricultural
community, proposed cancellation and suspension notices must be sent
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24
REGULATING PESTICIDES
to the Secretary of Agriculture at least 60 days before they are issued,
and if the Secretary comments in writing within 30 days, the comments
must be published in the Federal Register.
The Scientific Advisory Panel was created to review health and
environmental hazard assessments with the intent to provide unbiased
and objective opinion on the risk side. The thought was to put a check on
EPA'S use of a line of reasoning that held that lack of knowledge about
ejects is a valid basis for banning a chemical in order to err on the side
of safety. Proposed cancellation and suspension notices are sent to the
Scientific Advisory Panel, and the Panel's comments are published along
with those of the Secretary of Agriculture. Upon a finding of imminent
hazard to human health, however, the Administrator may waive the
notice and comment procedure for a suspension proceeding.
The conclusion that emerges from the legislative history is that
Congress recognized that a certain level of risk is inevitable in pesticide
use and that the presence of risk is not sufficient reason to deny or cancel
the registration of a pesticide.
The Role of the Courts
At the same time, however, the courts were developing the doctrine that
risk alone is sufficient grounds for denying or cancelling a registration.
The doctrine evolved in a series of decisions reviewing USDA and,
subsequently, EPA decisions to suspend and cancel registrations. What
these decisions did was to set a conservative risk standard to determine
what evidence would trigger a benefit-risk analysis and, then, to hold that
the trigger evidence would be a sufficient basis to support a final
conclusion that the risks exceeded the benefits. Only secondary attention
was required for benefits. This is the assumption behind the Rebuttable
Presumption Against Registration (RP~) process (described later in this
chapter). RPAR rules stem much more from the pesticide precedents in
the U.S. Court of Appeals for the District of Columbia Circuit than from
Congress, as the 1978 amendments to FEPCA illustrate.
The first issue the courts were required to decide was when the USDA
had a duty to suspend a chemical and institute cancellation proceedings
under FIFED. We issue arose in 1969, when the Environmental Defense
Fund (EDF) petitioned the USDA to cancel all DDT registrations and the
USDA refused. The 1964 legislation required the USDA to suspend a
pesticide and institute cancellation proceedings if suspension were
necessary to "prevent imminent hazard." In a major decision interpret-
ing the phrase, the court transformed FIFING from a consumer protection
to a regulatory statute by holding that once a substantial question of
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FIFRA and the RPAR Process
25
safety was raised, the burden of proof shifted to the manufacturer to
justify continued registration (EDF V. Ruckelshaus 1971~. This burden has
been described as "heavy" (EDF V. U.S. EPA 1971) in that it requires the
registrant to establish the safety of a pesticide. Similarly, another court
said that "once risk is shown, the responsibility to demonstrate that the
benefits (of continued use) outweigh the risks is a heavy one . . . " (EDF
V. U.S. EPA 1976~.
A risk analysis often hinges on important but abstruse debates among
scientists about the permissible inferences that can be drawn from
laboratory expenments. In such situations, the most the courts can do is
attempt to understand the issues, make sure that the Agency has
considered all relevant factors and that all parties have had adequate and
real participation in the decision process, insist that the Agency has
disclosed the basis of its reasoning sufficiently to pendant a court to
conclude that the decisionfollows from the evidence, and make sure that
there is some objective basis for the decision. However, in the end' as
long as EPA bases its cancellation or suspension decisions on a risk
analysis that has respectable scientific support, its discretion is practical-
ly unreviewable. In the heptachlor-chlordane suspension decision, the
U.S. Court of Appeals for the District of Columbia Circuit announced
the following standard:
An ultimate finding in a suspension proceeding that continued use of challenged
pesticides poses a "substantial likelihood of serious harm" must be supported by
substantial, but not conclusive, evidence. In evaluating laboratory animal studies
on heptachlor and chlordane there was sufficient "respectable scientific authori-
ty" upon which the Administration could rely in detennining that heptachlor and
chlordane were carcinogenic in laboratory animals.
Human epidemiology studies so far attempted on chlordane and heptachlor
gave no basis for concluding that the two pesticides are safe with respect to the
issue of cancer. To conclude that they pose a carcinogenic risk to humans on the
basis of such a finding of risk to laboratory animals, the Administrator must
show a causal connection between the uses of the pesticides challenged and
resultant exposure of humans to those pesticides. He made that link by showing
that widespread residues of heptachlor and chlordane are present in the human
diet and in human tissues. Their widespread occurrence in the environment and
accumulation in the food chain is explained by their chemical properties of
persistence, mobility and high solubility in lipids (the fats contained in all organic
substances). Residues of chlordane and heptachlor remain in soils and in air and
aquatic ecosystems for long periods of time. They are readily transported by
means of vaporization, aerial drift, and run-off of eroding soil particles. The
residues have been consistently found in meat, fish, poultry and dairy products
monitored in the FDA Market Basket Survey and are also frequent in components
of animal feeds. This evidence supports a finding that a major route of human
exposure is ingestion of contaminated food-stu~s. EPA'S National Human
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26
REGULATING PESTICIDES
Monitoring Survey data show that heptachlor epoxide and oxychlordane, the
principal metabolites of heptachlor and chlordane respectively, are present in the
adipose tissue of over 90% of the U.S. population. (EDF v. U.S. EPA 1976)
The other side of a benefit-risk analysis is an evaluation of the benefits
of a pesticide's use. Welfare economics has made some progress In
developing benefit-cost (or risky procedures that can be applied to
pesticide decisions. EPA has generally argued that its mission is to protect
the public from environmental harm, and thus it is entitled to devote
more attention to the risks of an activity than to its economic benefits.
EPA'S general policy has never been directly challenged in the courts, but
there are indications that the courts may define with some precision the
duty to consider benefits as the choices the EPA must make become
harder.
When the court reviewed the aldr~n-dieldrin suspension hearing, it was
the first time that the court considered EPA'S duty to assess benefits, and
out of this case a rather casual attitude toward benefits developed: a
suspension was analogized to a preliminary injunction (a decision before
a court decides the merits). The duty to consider a suspension arises
when any substantial question about a pesticide's safety is posed. When
this occurs, EPA is obliged to suspend whenever there are no offsetting
benefits to the public. Therefore, the Administrator has not exercised his
or her discretion properly unless he or she has given adequate
consideration to benefits. The court's standard makes it clear, however,
that the court is interested primarily in a discussion of benefits that is
basically adequate to support a suspension decision, but it does not
expect a rigorous analysis:
The Administrator's mere mention of these products' major uses, emphasized by
the EPA, cannot suffice as a discussion of benefits, even though "the data before
him . . . reflected the view that aldrin-dieldrin pesticides are the only control
presently available for some twenty insects which attack corn and for one pest
which poses a real danger to citrus orchards. . . . " (Brief for EPA: 19)
The interests at stake here are too important to permit the decision to be
sustained on the basis of speculative inference as to what the Administrator's
findings and conclusions might have been regarding benefits. Sound principle
sustains the practice of vesting choice of policy with the Administrator. Its
corollary is that the specific decision must be explained, not merely explainable,
in terms of the ingredients announced by the Administrator as compromising the
Agency's policies and standards. This is the case even though the variables of the
policy approach selected by the Administrator are not necessarily required by the
underlying statute.
Our conclusion that a mere recitation of a pesticide's uses does not suffice as
an analysis of benefits is fortified where, as here, there was a submission, by EDF,
that alternative pest control mechanisms are available for such use. The analysis
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FIFRA and the RPAR Process
27
of benefit requires some consideration of whether such proposed alternatives are
available or feasible, or whether such availability is in doubt. (EDF V. U.S. EPA
1972)
In subsequent cancellation and suspension cases, the adequacy of
benefit analyses has been given secondary emphasis, although the duty
to consider benefits is higher in the former than in the latter. This
secondary emphasis is given because (1) the benefit claims have often
been raised by manufacturers without adequate evidence, and (2)
alternative chemicals have been available. For example, in the hepta-
chlor-chlordane suspension hearing, the Administrator's benefit analysis
of use on corn was sustained on this ground:
Heptachlor and chlordane were used on an estimated 3.5% of the total corn
acreage in the United States in 1975, largely in an effort to control black
cutworm. Cutworms sporadically infest 2 to 8% of total U.S. corn farms, and
occur most often in lowland, river bottom areas. Chlordane and heptachlor are
used as preplan" treatments to insure against possible infestations. The Adminis-
trator found, with record support, that no macro-economic impact will occur as a
result of suspending those pesticides. He also found that crop surveillance or
"scouting" for infestations during the early weeks of plant growth, together with
application of post-emergence baits or sprays where necessary, provide an
effective alternative to the more indiscriminate prophylactic use of chlordane and
heptachlor. Velsicol urges that this approach is not as effective as the persistent
protection provided by chlordane. Especially in the absence of proof of a serious
threat to the nation's corn, there is no requirement that a pesticide can be
suspended only if alternatives to its use are absolutely equivalent in electiveness.
The Administrator reasonably took into account that a transition period would
be necessary to implement post-emergent techniques of control and concluded
that the challenged pesticides could continue in use for corn protection until
August 1, 1976. This evaluation of alternatives and the time required to
implement them is supported by substantial evidence, and we find no basis to
disturb the Adm~n~strator's balancing of costs and benefits. (EDF V. U.S. EPA
1976)
However, the attitude of giving secondary attention to benefits is
changing for institutional and legal reasons. As pesticide issues become
more difficult to resolve, and better benefit evidence is generated, the
hard-look doctrine, which courts follow with respect to judicial review,
may require EPA to present a more technically acceptable benefit
component of the benefit-risk analysis. A benefit advisory panel to
parallel the Scientific Advisory Panel might do much to strengthen EPA'S
benefits presentation (see Chapter 51.
A recent circuit court decision on an issue not involving pesticides
illustrates the possible procedural impact of such a panel. Seacoast Anti
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28
REGULATING PESTICIDES
Pollution League v. Costle (1978) held that the Administrator cannot use
a technical panel's recommendation as the basis for his or her decision
when the technical panel's assertions rest on scientific literature not
introduced into evidence in the hearing. Seacoast held, in erect, that if
an expert advisory panel is asked for a recommendation, the conclusions
on which the recommendation is based must be documented with
evidence consistent with the state of the art. Seacoast further suggested
that the use of advisory panels will require the Administrator to weigh a
panel recommendation carefully or run the risk that a decision will be
remanded for failure to justify departures from the recommendations.
Formally, of course, science advisory panels cannot bind the Adminis-
trator, since the issues at stake in a pesticide regulatory decision are ones
of policy. However, in subtle but significant ways, a technical panel
shapes the issues and the weighing of the evidence.
To summarize, from 1910 to the present, federal pesticide legislation
has evolved from largely a registration to primarily a regulatory statute
affording greater protection to both human health and the environment.
The legislation of 1910 and 1947 was basically concerned with consumer
protection. In the 1960s and early 1970s, the need was recognized to
evaluate a pesticide's safety and to remove unsafe pesticides from the
market. The 1972 legislation provided the framework for weighing the
benefits of using a pesticide (theretofore unquestioned) against the risks
it entails, and for cancelling unsafe pesticide uses. It required that all the
pesticides then registered, some 35,000, be reviewed under the newly
established standards of safety. In the mid-1970s judicial decisions
seemed to weigh risks more heavily than benefits. As a result, in 1975
and 1978 additional legislation was enacted in an attempt to restore the
balance between risk and benefit considerations. Recent court decisions
appear to be moving in that direction.
THE RPAR PROCESS: A DESCRIPTION
The preceding discussion of the legislative framework describes the
evolution of EPA'S current mandate to protect public health and the
environment from "unreasonable adverse effects" of pesticide use. The
mandate is interpreted to authorize an evaluation and weighing of costs
(or risks) and benefits to be used in determining whether a pesticide
should be registered, reregistered, or cancelled. The following discussion
describes EPA'S current procedures (as of mid-1979) for implementing
that mandate, namely, the Rebuttable Presumption Against Registration
(RPAR) process. The RPAR process was adopted in late 1975, and it is a
key part of EPA'S plan to review the approximately 35,000 pesticide
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FIFRA and the RPAR Process
~5
EPA erred in determining that the pesticide meets or exceeds the risk
criteria in 40 CFR 162.11; (2) any risk that exists can be reduced to such
an extent that significant adverse elects are unlikely to occur; or (3)
benefits of using the pesticide exceed the anticipated risks. By the time
180 days have elapsed, EPA iS supposed to have determined whether all
risks have been rebutted. A second Agency position document may be
issued at this point presenting EPA'S analysis of the rebuttals. If the risks
are rebutted, the RPAR iS cancelled, and PD 2 iS issued. More commonly,
however, if all risks have not been rebutted, PD 2 and PD 3 are issued
jointly in one document. PD 3 iS issued together with a notice of the
proposed determination concluding the RPAR ("notice of intent") and
presenting the benefit-risk analysis supporting the proposed action.
The collection of benefit data, like risk data, begins well before PD 1 iS
issued, even though the benefit assessment does not appear in a position
document until PD 3. The benefit assessment procedure is a joint effort
between USDA and EPA. Current USDA/EPA procedures provide for the
establishment of a joint assessment team as soon as oPP announces an-
intention to issue an RPAR. In practice, the procedure will usually allow
teams to be formed approximately 60 90 days prior to issuance of the
RPAR. The collection of benefit data is supposed to be completed within
180 days of issuance of the RPAR. An additional 60 days is then provided
for completion of the analysis, although extension of this deadline is
frequently necessary. The proposed determination and PD 3 (or PD 2/3)
are issued upon completion of the independent risk and benefit
assessments, supposedly 240 days after the initial RPAR notice.
Sixty days before the Agency plans to issue a final determination, the
proposed action and supporting position document (PD 3 or 2/3) are sent
to the independent FIFED Scientific Advisory Panel (SAP) and the USDA
for their review as required by the 1975 amendments to FIFING. Me
scientific review given to the risk and benefit assessments is described
later in this chapter.) If comments are received within 30 days, the
comments and EPA'S response are published in the Federal Register with
the proposed regulation. Thirty days after comments are received, EPA'S
Administrator is supposed to issue the final determination, supported by
PD 4.
Of the above deadlines, only the rebuttal period and the final external
(USDA and SAP) review period are Congressionally imposed, and even
there, some flexibility is allowed. In 1977, EPA estimated 4 1/2 months
(135 days) between rebuttals and PD 2/3, making the total time from PD
1 to PD 4 roughly 300 days (see Figure 2.3~. In fact, however, delays
occur at each step of the process, extending the deadline indefinitely.
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36
THE ANALYSIS
REGULATING PESTICIDES
The preceding sections have described the framework into which the
actual activity flows involved in conducting the risk and benefit
evaluations fit. In practice, the purpose of the RPAR process is to provide
a decision maker with information on the trade-o~s between risks and
benefits associated with regulatory options for each RPAR pesticide. This
section describes the sequence of steps and the organizational arrange-
ments involved in the development of an RPAR decision document.
Details of the methods used in the various analyses that ultimately
constitute the risk and benefit assessments are described in Chapters 4
and 5, respectively.
The major participants in an RPAR analysis are the project manager
and the RPAR team. The project manager coordinates and synthesizes the
benefit and risk assessment activities carried on by the members of the
RPAR team. In accordance with the Administrator's Health Risk and
Economic Impact Assessments of Suspected Carcinogens: Interim Proce-
dures and Guidelines (U.S. EPA 1976), benefit and risk assessments are
conducted separately. Thus, when the management, risk, and benefit
components are considered together, a tripartite flow of activities results.
The basic steps involved in these activity flows are presented in Figure
2.4 (see Figure 2.3 for the related time schedule). It should be
emphasized that there is continuous communication and interaction
among individuals from each activity stream.
Organizational Arrangements
Risk Assessment Lead organizational responsibility for conducting risk
assessments in oPP lies with the Hazard Evaluation Division (HED),
which is divided into four branches: Toxicology, Environmental Fate,
Residue Chemistry, and Ecological Erects. Table 2.1 shows the major
components of oPP's risk assessment and the lead organizational
responsibilities. The HED iS responsible for analyzing human exposure
and human health and ecological hazards associated with pesticide use.
Throughout the RPAR process, technical competence is provided both by
HED stab and outside consultants.
While HED iS responsible for assessing acute and chronic hazards,
investigation and analysis of cancer hazard is delegated to CAG, an
agency-wide group that focuses on predicted human risks from exposure
to suspected carcinogens. Cancer risk assessments made by CAG are
submitted to HED for further review and evaluation. In cases where
carcinogenicity is the only hazard, HED provides the exposure analysis
OCR for page 37
FIFRA and the RPAR Process
37
and retains review and evaluation responsibilities for the risk assess-
ments prepared by CAG. There is, however, a move within the Agency to
centralize risk assessment, and changes in the organizational arrange-
ments described above can be expected.
A close, informal working relationship is maintained between HED and
oPP's Benefit and Field Studies Division (BFSD). The primary aim of this
interaction is to enhance HED'S understanding of basic pesticide
formulation and to use concepts as they relate to areas of potential risk.
The interaction also provides insight into the feasibility of various
regulatory options being considered by HED. Such insight is important
when the issue of enforceability of proposed regulatory options is taken
into account.
Benefit Assessment Lead organizational responsibility for conducting
benefit analysis in oPP lies with BFSD, which is divided into three
branches that are organized along disciplinary lines: Animal Science and
Index, Plant Sciences, and Economic Analysis. Table 2.2 shows the
major components of oPP's pesticide benefit analysis and the lead
organizational responsibilities for analysis. The general guidelines for the
joint EPA and USDA benefit assessment effort are presented in a 1976
"Memorandum of Understanding between the U.S. Department of
Agriculture and the U.S. Environmental Protection Agency" and an
October 1977 supplement to that memorandum.
A key element of the guidelines is a provision for establishing a joint
assessment team for gathering and analyzing benefits data. The assess-
ment teams (officially referred to as the usDA/state/EPA Benefit
Assessment Teams and hereafter abbreviated to USDA/EPA) consist of
representatives from USDA, state departments of agriculture and agricul-
tural colleges (extension service and experimental station personnel), and
EPA. The USDA, state, and college representatives including the team
leader are selected by the USDA (through the Pesticide Coordinator,
Office of Environmental Quality Activities, USDA). The EPA personnel are
appointed by the BFSD within oPP. The size of the team varies from about
three to fifteen, depending upon the complexity of the assessment.
An important function of the state and agricultural college people,
who are usually biologists, is to develop the basic biological information
(e.g., yield effects) and, to some extent, the economic data (e.g., price per
pound of active ingredient) necessary for conducting a benefit analysis.
In addition, the extension and experimental station experts frequently
provide information (e.g., method of application) useful in exposure
analyses. These data are gathered through a combination of literature
searches and personal communications with various agricultural experts
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38
~ Management
\ Flow
Risk
Analysis
Flow
\
REGULATING PESTICIDES
AWL
Assemble
Data Base
(ex isti ng
files, lit.
search )
Select Studies V d
for Risk - (Triggers) ~all ate
Assessment
Establish
Use Determine /
Profile _ Routes of
Data Exposure
l
at'
Form Risk
Analysis
Team
Form
Benefit _ Conditional _
Analysis _ Benefit _
Team ~
Review and
Request
Data Review
Val idations,
Guide Initial
Analysis
~ _
Determine
Uses to be
_ Analyzed
/ / /
_ Initial Statement / /
a. _ Risk _ of Data ~/
Analysis Needs /
Review and /
Evaluate _ Statement /
Assessment Needs
Plan
FIGURE 2.4 Tripartite activity flow (sequence of steps) in support of the RPAR process.
Source: Keaney (1977).
TABLE 2.1 Components of Pesticide Risk Assessment and Principal
Organizational Responsibilities in the Office of Pesticide Programs
Component
Background
Chemical and physical properties
Environmental fate and persistence
Human exposure analysis
Dermal
Respiratory
Dietary (food and water)
Inhalation, penetration and absorption rates
Human health risk
Cancer
Acute toxicity
Other chronic toxicity
Ecological hazard
a Not a branch of HED.
HED Branch
Residue Chemistry
Environmental Fate
Environmental Fate
Environmental Fate
Residue Chemistry
Toxicology
CAG,a Toxicology
Toxicology
Toxicology
Ecological Effects
OCR for page 39
FIFRA and the RPAR Process
Draft
Regulatory
notions
Distribute
Statement of
Data Needs
Validate, Document
and Modify Initial
Risk Assessment
Document
\
Validate, Document
and Modify
Conditional
Benefit Document
_
_
Prepare Potential
Adverse Effects
Document for
Chemical in
RPAR Process
_ _
Convey Document
on Substitutes to
Management
Representative
Risk Analysis
Team etc.
I Decisi on on
Review Rebuttals
Convey Relevant Triggers within
Information to _ Previously
Risk and Benefit Defined Structure
Teams
Prepare Conditional
Risk Argument
on Substitutes
_ _
Consideration
of Information
Generated from
Interaction with
USDA, Regions,
and States
_
Review Scientific and
Analytic Progress.
Final Statement of
Regulatory Options.
Fine Tune
Analytical Process
Where Appropriate.
Conditional Risk
Expanded to Include
Secondary Risk from
S',hstit''t~c
Develop Arguments
or Calculus of
Benefits by Option
39
. ~
Consolidation of
Risks and Benefits
Attendant to
Regulatory
Options.
77
If/
l
(reviewed in Chapter 5~. Finally, it appears commonplace for some of the
agricultural college (or perhaps USDA) people to have a background in
toxicology or allied fields, thereby allowing the joint assessment team to
comment on EPA'S risk assessment. The economic impact assessment is
usually a joint effort by economists from both USDA (Economics,
Statistics, and Cooperatives Service) and EPA (Economic Analysis
Branch, BFSD, OPP).
Before the official report of the assessment team is forwarded to oPP, it
must be approved by a variety of USDA officials, including the Secretary
of Agriculture. However, the terms of the Memorandum of Understand-
ing allow each agency to reach independent assessments if necessary;
consequently, oPP is not bound to rely only upon the findings of the
USDA/EPA assessment teams. The joint assessment team can be reactivat-
ed by USDA if further data collection or analysis becomes necessary.
Benefit-Risk Analysis The SPRD, in the person of the project manager,
has responsibility for coordinating the risk and benefit analyses and for
assembling appropriate decision-making (position) documents based on
contributions from various offices in oPP. SPRD is composed of five
chemical review branches and a Regulatory Analysis and Laboratory
Audit Branch. At the conclusion of the benefit and risk assessments, an
effort to weigh the benefits and risks is undertaken by the RPAR team
under the general supervision of SPRD'S Regulatory Analysis Branch. The
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40
REGULATING PESTICIDES
TABLE 2.2 Components of Pesticide Benefit Analysis (for a given site)
and Principal Organizational Responsibilities in the Office of Pesticide
Programs
BFSD Branch
Component
Insecticides/
Rodenticides
Herbicides/
Fungicides
Current use analysis
EPA registrations of RPARs and ASIBa PSBb
alternatives
Recommendations for use of RPAR and ASIB PSB
alternatives
Use of RPAR and alternatives EABC EAB
Performance evaluation of RPAR and
alternatives
Pest infestation and damage ASIB PSB
Comparative performance evaluation ASIB PSB
Use impact analysis EAB EAB
(projected change in use)
Economic impact analysis
Impact on production cost EAB EAB
Impact on volume produced EAB EAB
Impact on consumer prices EAB EAB
Aggregated economic impact EAB EAB
Limitations of analysis EAB EAB
a Animal Sciences and Index Branch.
b Plant Sciences Branch.
c Eiconorruc Analysis Branch.
Source: U.S. EPA (1977b).
procedure involves determining trade-offs between risks and benefits
associated with each regulatory option and presenting them to the
Deputy Assistant Administrator for Pesticide Programs. The integrity of
the individual benefit and risk assessments is not compromised since
they have already been completed. Regulatory action recommended on
the basis of the benefit-risk analysis is presented.
Activity Flow
As shown in Figure 2.4, the first step in the RPAR activity flow is "core"
data collection and validation, and the development of a use profile for
the RPAR pesticide. The data gathered during this initial stage are
augmented and used during the entire scientific inquiry of the RPAR
*
OCR for page 41
FIERY and the RPAR Process
41
process. oPP's Program Support Division provides core data from
registrant files, other EPA files, and most importantly a worldwide
literature search that is done under contract and produces a list of
abstracts. The abstracts are reviewed by oPP often by the project
manager alone or with assistance from HED and complete studies are
obtained for selected abstracts. Studies that are relevant to the risk
assessment are subjected to a validation procedure (see the section on
Scientific Review in this chapter).
The next step is to determine routes of exposure. The project manager
engages appropriate individuals from BFSD, HED, USDA, or outside
contractors to determine routes of exposure on the basis of information
about the chemistry and use of the compound. The early involvement of
USDA, before the issuance of an RPAR notice, is important in order to
begin fine tuning the mechanism for evaluating high-risk uses as opposed
to low-risk uses.
While the project manager is coordinating the risk data validation
procedure and evaluating the status of existing and needed data, risk and
benefit assessment teams are formed and begin initial analyses. The risk
analysis involves linking uses of the RPAR pesticide with hazards
considered valid. The HED develops a preliminary exposure profile, i.e., a
rough estimate of the number of people exposed to different dose rates,
using the core data provided by the project manager (see Chapter 4,
section on Exposure Analysis). The early presence of an exposure
analysis enables a clear articulation of potential risk in the issuance of
the RPAR notice and PD 1. It also creates the framework for formulating
preliminary regulatory options to reduce exposure that can then be used
as background material for subsequent benefit and risk analyses. The
preliminary exposure profile and hazard data are used to provide the
initial risk analysis transmitted to the project manager for use in
developing PD 1.
The benefit analysis team begins the process of linking uses of the
RPAR pesticide with economic and agricultural impacts attendant on the
uses. This effort results in an initial examination of conditions that would
be likely to result from cancellation, including use of alternative
pesticides. The principal concern of a benefit analysis is assessment of
the economic impacts a regulatory action would have on the pesticide
users and on the consumers of the products of the users. The assessments
are explicitly prohibited from considering any of the potential economic
impacts a regulatory decision might have on pesticide manufacturers
(U.S. EPA 1976: Appendix II). From the initial analysis, a plan of work is
developed that will be shared with the risk analysis team and will be
critical in selecting uses for in-depth analysis.
The project manager, taking into consideration uses, potential expo
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42
REGULATING PESTICIDES
sure, and toxicity data, drafts PD 1 or the statement of presumptive risk.
If the risk criteria are reached or exceeded, an RPAR is issued. The RPAR
notice should specify the extent to which critical information regarding
exposure is unavailable, and requests should be made for this specific
information. At the same time, additional data required for more
definitive assessment of benefits and risks are identified and steps to
acquire them are initiated.
Following the RPAR notice, the RPAR team determines the uses of the
pesticide to be analyzed in depth and develops a range of draft
regulatory options. The determination of which uses to analyze in depth
depends significantly upon data supplied by the USDA/EPA benefit
assessment team.
The benefit assessment team elaborates upon its initial estimate of
alternative pesticides and the new use patterns that would result from the
regulatory options that have been analyzed. The estimation of new use
patterns is conveyed to the project manager and to the risk team. The
risk team continues to validate or modify its initial risk assessment
document and begins an assessment of the risks associated with
alternative pesticides that would be likely to be used if a particular
regulatory option regarding the RrAR pesticide were chosen. Meanwhile
the project manager asks HED to conduct an analysis of rebuttals using
HED staff and the CAG or contractors. Relevant information from this
process is fed into the risk assessment. The rebuttal analysis and the
decision as to whether the risk criteria have been rebutted are presented
inPD2.
The assessment of risks associated with current use of the RPAR
compound is expanded by HED to include a comparison with risks from
alternative pesticides that would be brought into use by the regulatory
options being considered. Concurrently, the benefits team completes its
assessment of economic impacts that would be expected to result from
the previously formulated regulatory options.
The project manager next reviews the risk and benefit analyses to
determine whether they can be used to describe the benefit-risk trade-
o~s associated with each regulatory option. A final group of regulatory
options is then chosen, on the basis of the ability of changes in use
patterns or use conditions to reduce the risks. The project manager, in
consultation with the RPAR team, writes PD 3, which is a synthesis of the
risk and benefit analyses. It describes and documents the risks and
benefits associated with each regulatory option, and demonstrates the
trade-offs between risks and benefits and the trade-o~s among risks
when alternative options are considered. When possible, the relevant
trade-o~s are displayed in a matrix, in which economic impacts of each
OCR for page 43
FIFRA and the RPAR Process
43
option are presented in dollar terms and risks are presented in terms of
numbers of anticipated morbidity or mortality incidences. For a more
detailed discussion of oPP's current methodology for comparing risks
and benefits see Chapter 6.
Once PD 3 iS developed and approved, the proposed regulatory
determination is drafted and sent to USDA and the SAP for external
review.
SCIENTIFIC REVIEW
i'
There is a consensus within EPA on the need for scientific review of the
data base and positions formulated at the various steps in the RPAR
process. There are several points in the process at which such review
occurs. These reviews can be internal or external. Some are required by
law, others have been created by EPA for the RPAR procedure, and still
others are imposed by outside interests.
The first scientific review, which occurs before the RPAR notice is
ssued, involves only the risk data. The data base that is collected from
the worldwide literature search to support PD 1 is subjected to a
validation procedure. Validation is coordinated through the project
manager and done either by contract, by in-house EPA scientists, or by a
combination of these. It involves an examination of the test methodology
or protocol, consideration of whether the results support the conclusions,
evaluation of the study's weaknesses and strengths, and a general review
of the value of the study to the RPAR process. Where cancer is an issue,
this review is performed by the CAG.
Once an RPAR is issued, a kind of de facto scientific review of the risk
data and EPA'S assessment of it can occur through the rebuttal process.
Often, major manufacturers will subject the scientific studies on which
EPA'S RPAR determination is based to a very thorough review and at the
same time will review EPA'S use of the studies in coming to its
conclusions. These rebuttals, in turn, must be analyzed and evaluated by
the project manager and the RPAR team. Again, if cancer is an issue, CAG
is involved in the review.
If the risk criteria are not rebutted, a draft position document (PD 2/3)
is prepared with an appropriate benefit-risk evaluation and presented to
the working group and the PCRC for their review (see the previous section
on Administrative Responsibility in this chapter).
The final scientific reviews are required by FIFED, as amended, and are
performed by external bodies. These reviews occur when a tentative
decision is made and a notice of regulatory intent is issued. The tentative
decision and the supporting benefit-risk evaluation are submitted to the
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44
REGULATING PESTICIDES
USDA and the SAP. The USDA iS expected to review the decision with
respect to agricultural economics; the SAP reviews it with respect to
human health and environmental factors.
NOTE
1. Acute Toxicity
(A) Hazard to Humans and Domestic Animals.
mist or spray;
(3) Has an inhalation LC50 of 0.04 mg/liter or less as formulated.
(B) Hazard to Wildlife
(1) Occurs as a residue immediately following application in or on the feed of a
mammalian species representative of the species likely to be exposed to such feed in
amounts equivalent to the average daily intake of such representative species, at levels
equal to or greater than the acute oral LD50 measured in mammalian test animals as
specified in the Registration Guidelines.
(2) Occurs as a residue immediately following application in or on avian feed of an
avian species, representative of the species likely to be exposed to such feed in amounts
equivalent to the average Gaily intake of such representative species, at levels equal to or
greater than the subacute dietary LC50 measured in avian test animals as specified in the
Registration Guidelines.
(3) Results in a maximum calculated concentration following direct application to
a 6-inch layer of water more than 1/2 the acute LC50 for aquatic organisms representative
of the organisms likely to be exposed as measured on test animals specified in the
Registration Guidelines.
(1) Has an acute dermal LD50 of 40 mg/kg or less as formulated; or
(2) Has an acute dermal LD50 of 6 g/kg or less as diluted for use in the form of a
Chronic Toxicity
(A) Induces oncogenic effects in experimental mammalian species or in man as a result
of oral inhalation or dermal exposure; or induces mutagenic ejects, as determined by
multitest evidence.
(B) Produces any other chronic or delayed toxic effect in test animals at any dosage up
to a level, as determined by the Administrator, which is substantially higher than that to
which humans can reasonably be anticipated to be exposed, taking into account ample
margins of safety; or
(C) Can reasonably be anticipated to result in significant local, regional, or national
population reductions in nontarget organisms, or fatality to members of endangered
species.
Lack of Emergency Treatments Has no known antidotal, palliative, or first aid treatments
for amelioration of toxic effects in man resulting from a single exposure.
REFERENCES
Calabresi, G. and P. Babbitt (1978) Tragic Choices. New York: W.W. Norton and
Company, Inc.
OCR for page 45
FIFRA and the RPAR Process
45
Carson, R.L. (1962) Silent Spring. Boston: Houghton Mifflin Co.
Environmental Defense Fund v. Ruckelshaus (1971) 439 F 2d 584 (D.C. Cir.).
Environmental Defense Fund v. U.S. Environmental Protection Agency (1971) 510 F 2d 1292
(D.C. Cir.).
Environmental Defense Fund v. U.S. Environmental Protection Agency (1972) 465 F 2d 528
(D.C. Cir.).
Environmental Defense Fund v. U.S. Environmental Protection Agency (1976) 548 F 2d 998
(D.C. Cir.).
Keaney, K. (1977) A Guide to the Management, the Risk and the Benefit Activity Flows in
Support of the RPAR Process. Office of Pesticide Programs, U.S. Environmental
Protection Agency, Washington, D.C. (Unpublished)
Pesticide and Toxic Chemical News (1979) Carter budget proposes $81.6 million for taxies
in fiscal year 1980. January 24, 1978, pages 1~15. Washington, D.C.: Food Chemical
News, Inc.
Pimentel, D., J. Krummel, D. Callahan, J. Hough, A. Merrill, I. Schreiner, P. Vittum, F.
Koziol, E. Back, D. Yen, and S. Fiance (1978) Benefits and costs of pesticide use in U.S.
food production. BioScience 28:772, 778-784.
Seacoast Anti-Pollution League v. Costle (1978) 572 F 2d 872 (1st Cir.).
U.S. Congress, House (1971) To Amend the Federal Insecticide, Fungicide, and
Rodenticide Act and for Other Purposes (Federal Environmental Pest Control Act of
1971). H.R. No. 92-511, Committee on Agriculture, 92nd Congress, 1st Session.
U.S. Environmental Protection Agency (1976) Health Risk and Economic Impact
Assessment of Suspected Carcinogens: Interim Procedures and Guidelines. 41 Federal
Register (102)21402-21405.
U.S. Environmental Protection Agency (1977a) Pesticide Benefit Analysis Seminar: Session
I, Overview of Benefit Analyses Under FIFRA. Briefing Materials. September 14, Office of
Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. (Un-
published. Available from A. Aspelin, Benefit and Field Studies Division, oPP.)
U.S. Environmental Protection Agency (1977b) Plan for Benefit Analysis in the Office of
Pesticide Programs, October 20, 1977. U.S. Environmental Protection Agency, Wash-
ington, D.C. (Unpublished. Available from A. Aspelin, Benefit and Field Studies
Division, oPP.)
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.
Representative terms from entire chapter:
regulating pesticides
