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The Failure of US Law to Address the Ecological Considerations of Pesticide Use

Chapter 11
The Failure of US Law to Address the Ecological Considerations of Pesticide Use1


Although the basic regulatory framework of FIFRA dates back to 1972 some of its provisions, such as the misbranding prohibition, date back to the early consumer-protection statutes of the early twentieth century. Despite the fact that a statute containing the word “rodenticide” would hardly be expected to be cutting-edge, FIFRA surprisingly provides EPA with considerable legal authority to consider ecological concerns when registering pesticides. Certainly there is much that can be done to mold FIFRA into a more sophisticated ecologically based law. Nevertheless, ecologically based themes such as adaptive management and an ecological integrity baseline run throughout the existing statute.


FIFRA’s Strengths


An Ecological Baseline

The concept of an ecological baseline can be found in a number of places in FIFRA. Specifically, the standard for registration under FIFRA is designed to address a large array of ecological, as well as human health, concerns. FIFRA’s regulatory standard is aimed at preventing “unreasonable adverse effects on the environment.”2 The word “environment” is defined very broadly by FIFRA to include “water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these.”3 Thus, FIFRA not only broadly includes land, water, air, and plant and animal resources within the definition of “environment,” but also includes the “interrelationships,” an important ecological consideration, among these resources within the definition.


Moreover, FIFRA contemplates an ecological baseline in its premarket evaluation. Under FIFRA, a registration is required prior to the sale, distribution, or commercialization of any pesticide product. Moreover, except for in limited circumstances qualifying for an exemption, some level of regulatory review is required prior to the release of any pesticide into the environment, even if only for experimentation purposes. Unlike some other environmental regulatory programs, such as the Toxic Substance Control Act (TSCA),4 FIFRA imposes a some what precautionary approach in that pesticides, which are by definition intended to kill or disrupt living organisms, are presumed to pose unreasonable risks, and therefore cannot be sold or distributed without a premarket environmental review.5 In contrast, under TSCA, new non-pesticide chemicals entering the marketplace do not require a premarket environmental review.6 Instead, prior to manufacturing these new non-pesticide chemical substances under TSCA, all that is required is a 90-day notification to EPA.7 During the premarket notification period, EPA conducts a cursory review of the proposed new chemical, but unless a determination is made that generation of new data are required for a particular chemical, EPA typically does not require environmental testing.8 If a non-pesticide substance is later found to pose unforeseen risks, EPA can, by regulation, require additional testing to be conducted or impose regulations to reduce the risk from such a substance under sections 4 and 6 of TSCA, respectively.9


Moreover, FIFRA’s precautionary approach is manifest in its allocation of the burden of proof. While this is not expressly stated in the language of FIFRA, pursuant to a series of administrative and judicial decisions, the burden of proof that a pesticide does not pose an unreasonable adverse effect of the environment remains at all times on the proponent of registration or continued registration.10 Thus, a proponent of registration is required to demonstrate that it meets this burden prior to a pesticide being registered. Further, if EPA proposes cancellation of a pesticide or use of the pesticide, the burden of proof rests on the proponent of continued registration during any cancellation or suspension hearing that may ensue.


Adaptive Management: Flexibility and the Consideration of New Information

FIFRA also contains provisions that are compatible with the ecological concept of adaptive management. Many of FIFRA’s provisions are specifically designed to seek or adapt to new information, or to tailor the level of regulation to the level of certainty of risks based on the sufficiency of available data. For example, FIFRA establishes two different levels of registration—full registration and conditional registration.11 EPA may conditionally register a pesticide under certain circumstances despite the fact that sufficient data have not been generated to support full registration.12 As described above, such circumstances may occur when a new use is proposed for a pesticide that is already registered for another use.13 In such a situation, sufficient data exists to support the existing use but additional data may be required to support full registration of the newly proposed use. Under such circumstances, EPA may conditionally register the pesticide for the new use if EPA determines that the conditional registration would not significantly increase the risk of any unreasonable adverse effects on the environment.14 Accordingly, through the conditional registration process a degree of flexibility is built into FIFRA, allowing products to be used in new ways prior to full data generation. Of course, should the new data demonstrate that the new use does not meet the standards for full registration, full registration will not be granted.


Other provisions of FIFRA that allow unique circumstances and changing information to be taken into consideration include the emergency exemption provisions,15 the state registration provisions,16 and the experimental use permit provisions.17 The emergency exemption provision of section 18 of FIFRA authorizes EPA to grant an emergency exemption to any state or federal agency under emergency conditions—i.e., urgent non-routine conditions for which no economically or environmentally feasible alternative practices that provide adequate control are available.18 Thus, section 18 provides flexibility to adapt to changing circumstances, which could include the outbreak and spread of a new pest or the spread of a public health disease. In such circumstances, EPA is authorized to act quickly to control the problem before the pest or disease vector is widely disseminated and to minimize the harm, without waiting for a full data set to be produced to support registration.19


The state registration provision in section 24(c) authorizes states to issue registration to meet special local needs.20 Accordingly, this provision allows states to take into consideration local circumstances that may warrant the use of pesticide products or uses that are not generally approved under FIFRA for nationwide use. Thus, in a state where a particular pest causes more severe harm than in other states, the cost/benefit analysis for the use of the pesticide in that state may have a different result from the nationwide cost/benefit analysis for that use, and accordingly, a special local needs registration may be granted for that state only. In this way, FIFRA’s flexibility allows registrations to be tailored to the special agricultural, environmental, economic, or other needs of a state.


Finally, the experimental use permit provision contained in FIFRA section 5 is another example of the flexibility afforded by FIFRA in tailoring the amount of data necessary to the level of risk resulting from a particular use. FIFRA section 5 authorizes EPA to issue permits for the field testing of pesticides necessary to generate data to support full registration.21 Thus, as the risk from exposure to a pesticide increases (i.e., as it moves from lab testing, to small-scale field testing, to full-scale use), progressively greater data requirements attach to ensure that sufficient data are available to make an unreasonable adverse effects determination for each level of use.22 Similarly, the ability for EPA to classify a pesticide as either general or restricted use23 allows EPA to adapt the amount of regulation required to the risks associated with the particular pesticide. By classifying a pesticide as restricted use, EPA ensures that users of the pesticide will have at least some level of training and supervision to reduce the risks associated with the use of that pesticide.


The ability to obtain and consider new information and to change course in response to new information is a cornerstone of adaptive management. FIFRA contains several provisions that authorize EPA to obtain, consider, and take action on new information. FIFRA contains some relatively forward-looking provisions that allow EPA to take advantage of new information as it develops, as well as to require new information as new testing methodologies become available or new risk scenarios are understood. Because hundreds of pesticides on the market were registered prior to the current registration data requirements being in place, FIFRA section 4 contains a detailed “reregistration” process designed to ensure that older pesticides are reexamined in light of more stringent regulatory standards and more sophisticated testing methodologies that have come into existence since the times of the early registrations of many pesticides.24 The current reregistration provisions include a multi-phased process with a number of deadlines, which must be met to avoid suspension or cancellation.25 This reregistration approach has been an extremely time-consuming, burdensome, and expensive process, but has also been important in evaluating pesticides that were registered under less stringent standards using outdated risk-assessment methodologies. Similarly, EPA’s current “registration review” process provides a process for continual re-evaluation of pesticidal risk as new information and analytical methods become available.


While reregistration applies to all pesticides registered prior to 1984, there are a number of FIFRA data requirements that apply to previously registered pesticides in a more targeted manner. For example, FIFRA section 3(c)(2)(B) authorizes EPA to require holders of existing registrations to provide additional data to support the continued registration of a pesticide whenever EPA finds that “additional data are required to maintain in effect an existing registration of a pesticide.”26 Under FIFRA section 6(a)(2), if at any time after the registration of a pesticide the registrant obtains in any way factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant is required to submit such information to EPA. Unreasonable adverse effects information submitted to EPA may lead to EPA requesting additional data under section 3(c)(2)(B), EPA initiating a cancellation or suspension action, EPA reclassifying a general-use pesticide as a restricted-use pesticide, or some other form of regulation to ensure that the pesticide will not cause unreasonable adverse effects on the environment. Thus, FIFRA contemplates a process of ongoing evaluations of pesticide risks as new information becomes available. With regard to pesticidal GMOs, EPA has taken the section 6(a)(2) approach a step further to require ongoing reporting of adverse environmental effects data, not only for registered pesticides, but also for pesticides that qualify for a plant-incorporated protectant exemption.27 In its plant-incorporated protectant rule, EPA requires that any person who produces, for sale or distribution, a plant-incorporated protectant exempt under the rule, and obtains any information regarding adverse effects on human health or the environment alleged to have been caused by the plant-incorporated protectant, must submit such information to EPA.28


Ecological Risk Assessment

Some what ironically, given the state of pesticide regulation today, the earliest applications of FIFRA were relatively adept at addressing ecological considerations. Even by today’s standards, the 1972 DDT cancellation decision represents a fairly sophisticated ecological analysis focused on the tendency of DDT and its metabolites to persist in the soil and aquasphere, the tendency of DDT to be readily transported by leaching, erosion, runoff and volatilization, DDT’s fat-soluble characteristic, which enables it to collect and concentrate in animal fat tissue, the fact that DDT can bioaccumulate as it moves up the food chain, and the fact that once accumulated, DDT is toxic to animals and humans, and inhibits the ability of fish and other wildlife species to regenerate.29 EPA did not shy away from tackling the difficult issue of how to take into account the risks that may occur in the future due to the persistent nature of the pesticide. EPA also was not paralyzed by a lack of certainty in data. For example, even though EPA recognized that the degree of transportability of DDT was unknown, it utilized data showing that DDT was found in remote areas of the world and in ocean species, such as whales, as providing enough evidence from which a logical reference could be drawn that DDT is readily transported in the environment.30 Moreover, EPA concluded that persistence and biomagnification themselves were a “cause of concern, given the unknown and possibly forever undeterminable long-range effects of DDT in man and the environment.”31 Thus, even in 1972, EPA recognized the uncertainty surrounding ecological effects data, while at the same time employing a precautionary approach to prevent uncertain, possibly devastating effects that may occur in the long term.



Bridge Document 11.1 The 1972 EPA DDT Cancellation Hearing Final Order


[EPA has] established that DDT is toxic to non-target insects and animals, persistent in the environment, mobile and transferable and that it builds up in the food chain. No label directions for use can completely prevent these hazards. In short, [EPA has] established at the very least the risk of the unknown. That risk is compounded where, as in the case with DDT, man and animals tend to accumulate and store the chemical.


The risk-benefit equation is a dynamic one. Timing is a variable in that equation. What may, in the long run, be necessary to protect the environment could be a short-term threat to human health. This is exactly the case before me now. The benefits of using organophosphates are a long-range benefit and the risks of DDT result from continued long-term use. In the very short run, however, the equation balances out very differently.


Source: In the Matter of Stevens Industries, Inc, et al., I.F.& R. Docket Nos. 63, et al. (Consolidated DDT hearings, June 2, 1972).



When the group petitioners who opposed cancellation argued that DDT was only one toxic substance in a polluted environment and that therefore whatever its laboratory effects, it could not be shown as the causative agent of injury to wildlife, EPA responded that this argument “does not redeem DDT, but only underscores the magnitude of effect that will be necessary for cleaning up the environment.”32 Persuaded by evidence showing that metabolites of DDT cause eggshell thinning in certain bird species despite some contradictory evidence, EPA found it sufficient that there was “laboratory data and observation data, and in addition, a scientific hypothesis, which might explain the phenomenon.”33 EPA further found that there were no label restrictions that could completely prevent effects on non-target organisms, persistence and transport in the environment, or biomagnification. Accordingly, cancellation was the only available risk-reduction measure.


EPA’s analysis of the benefits of DDT in formulating its decision to cancel was also fairly sophisticated, and in some ways was a better job of considering benefits than many more recent EPA decisions regarding cancellation or suspension of pesticides. The benefits analysis focused on the availability of alternatives including non-chemical pest management programs and the fact that the crops protected by DDT were not in short supply. EPA found that DDT was not necessary to ensure an adequate supply of cotton at a reasonable cost, given that only 35 percent of the cotton-producing acreage at the time was treated by DDT.34 In contrast to many recent EPA decisions, where non-chemical pest control alternatives and emphasis on availability of crops are conspicuously absent, or at least play a very minimal role in the decision-making process, EPA’s 1972 DDT cancellation decision takes a broader look at the cost/benefit analysis rather than merely counting up dollars and cents on each side of the equation. In fact, EPA’s 1972 DDT cancellation decision has other indicia of a sophisticated ecological approach. For example, in the final order, EPA’s statement that “the risk/benefit equation is a dynamic one” can be viewed as a foreshadowing of the arguments for flexibility and adaptive management that are at the center of natural resources and environmental policy scholarship today.


FIFRA’s Weaknesses


Notwithstanding all of these promising elements, FIFRA has not lived up to its early promise with regard to addressing ecological considerations. As described more fully below, a combination of statutory shortcomings, unfortunate interpretations, and problems with implementation and enforcement have resulted in FIFRA’s lack of success as an environmental protection statute. Accordingly, there is considerable room for improvement.


The Cost/Benefit Standard: General Concerns with Cost/Benefit Balancing

One of FIFRA’s most significant shortcomings that contributes to its failure to adequately protect ecological resources is its cost/benefit approach to registration and cancellation. The past 20 years of environmental law scholarship is characterized by a struggle between two opposite extremes—those who believe environmental values are paramount and those who believe economic interests are paramount.35 Environmental regulation in the US is frequently criticized for being unrealistic, because it is based on protecting the public or environment from risks without considering the costs associated with such protection.36 Of course it would be absurd to attempt to eliminate all environmental risks at all costs.37 Opponents of pure risk-based approaches contend that environmental regulations seek to attain zero risk regardless of the costs of attaining such a goal. For the most part these criticisms are unfounded.38 Despite the outcry of the opponents of risk-based regulation, the vast majority of federal environmental laws are not purely risk-based and few, if any, are zero-risk statutes.39 Instead, most environmental laws allow or require the consideration of other factors such as the costs of regulation or the economic feasibility of regulation. Even where zero-risk or absolutist risk-based environmental laws have been tried, the recognition of the potential illogical outcomes of these approaches have frequently led to either the interpretation of the laws to take other factors into account, or the amendment of the laws imposing these strict risk-based requirements.40


At the opposite end of the spectrum from the pure risk-based approaches to environmental regulation are those approaches that elevate economic efficiency above all other considerations. Cost/benefit analyses involve balancing the “social benefit” of a regulation against the cost to society to comply with the regulation.41 Cost/benefit standards are based on the premise that maximum economic efficiency is the goal of any regulatory system.42 Proponents of cost/benefit analysis often build their arguments in favor of economic efficiency by using examples of environmental regulations that achieved minimum risk reduction for enormous costs.43


The cost/benefit analysis measure of value is the consumer’s willingness to pay for goods or services.44 The concept of willingness to pay does not necessarily translate well to ecological values.45 Moreover, relying on willingness to pay may skew cost/benefit analyses away from protecting environmental values because embedded within the willingness to pay concept is an assumption that industry has the right to utilize resources, and that if environmentalists want to protect those resources, they have to be willing to pay for such protection.46



Bridge Document 11.2 Incorporating Emergy Synthesis into Environmental Law: An Integration of Ecology, Economics, and Law


Virtually all areas of environmental law are concerned in some way with both the ecological and the economic impacts of environmental decision-making. Unfortunately, existing environmental law statutes tend to incorporate ecological and economic considerations in a simplistic, piece-meal, and awkward fashion.



The interpretations of ecological realities on which existing statutes are based are outdated and in need of serious reexamination. Although many existing environmental laws pay lip-service to ecological science, they do not incorporate scientific understanding of the ecological world in any meaningful way.



One controversial issue in the cost/benefit debate is whether environmental values are significant only to the extent that consumers are willing to pay to preserve them. Many ecological goods and services are not assigned any value by neo-classical economic analysis despite the fact that they are integral for making economically valuable products and may even be essential for life on earth, leading to criticisms of economics as “pricing everything and valuing nothing.” The value of many ecological goods and services is not readily quantified, and thus is rarely included in any meaningful way in traditional cost/benefit analysis. Consequently, human disruptions to ecological systems are rarely part of cost/benefit analyses. The values inherent in ecological integrity or biodiversity are particularly ill-suited to be reduced to a dollar value under neo-classical economics. Although, many ecological products and services have instrumental value as food, medication, fiber, etc., that can be valued in a market system, many goods and services provided by nature do not have direct instrumental value and are not traded in a market system. Moreover, most consumers do not have the information available to them, or the technical understanding of the value that many ecological goods and services have in sustaining life. For example, many species serve important roles as producers, consumers, decomposers, competitors, dispersers, or pollinators. Each of these roles provides value to other members of the ecosystem, including humans. However, due to a lack of information and technical understanding, a typical consumer’s willingness to pay for these services probably has no relation to the true value that the good or service provides.


Source: Mary Jane Angelo & Mark T. Brown, Incorporating Emergy Synthesis into Environmental Law: An Integration of Ecology, Economics and Law, 37 ENVIRONMENTAL LAW 963 (2007).



Proponents of cost/benefit analysis believe that sound decision making is based on market indicators, whereas, environmentalists believe that a sound decision should be based on political indicators (Farber refers to this as “willingness to pay” versus “willingness to vote”).47 This distinction has been described as follows: “social regulation expresses what we believe, what we are, what we stand for as a nation, not simply what we wish to buy as individuals.”48 Moreover, relying solely on consumer choices leaves out the possibility of decision making based on community analysis, deliberation and vetting of ideas.49 Critics of cost/benefit analysis focus their arguments on the distinction between private consumer choices and public choices based on public values.50 In the pesticides arena, an economic argument could be made that the fact that most consumers purchase food that is treated with chemical pesticides means that consumers are making a conscious choice to do so, based on economic and other factors. While it is true that consumers may purchase such foods because they are generally significantly less expensive than foods that are grown without chemical inputs, to assume that this consumer choice means that consumers have consciously determined that the health and environmental risks of pesticides in food are outweighed by the increased cost of organically produced food is overly simplistic.


First, consumers may not be fully informed of the environmental and health risks associated with pesticide use. The time and thought that go into sorting out technical risk-assessment information may be more than the average consumer can, or desires to, commit. As described at length in this chapter, many of the risks of pesticides use are not well understood, even by the experts. Thus, it would be unreasonable for consumers to be able to make decisions based on preliminary or confusing data that experts are having difficulty grappling with. Moreover, the price of food treated with pesticides does not reflect the true cost of growing the food because of a failure to internalize what economists refer to as negative externalities. For example, the price of purchasing food treated with pesticides does not reflect the price that society may have to pay later to clean up pesticide contaminated sites, the long-term costs to society of the loss of insect pollinators, or the long-term costs to society of the development of pest resistance due to overuse of pesticides. Moreover, the price of the food is artificially low due to numerous government programs that encourage the use of chemical inputs in agriculture.51 As described in detail in Chapter 4, government programs, such as commodity crop subsidy programs, provide economic incentives for growing high yield commodity crops that depend on chemical pesticides and no corresponding incentives for growing crops without chemical pesticides. This results in artificially low food prices, which in turn, results in consumers perhaps purchasing more food grown with pesticides than they would in a pure market.52 Accordingly, in the agricultural pesticide arena as well as many others, a cost/benefit analysis that relies on market costs and benefits does not reflect consumers’ true preferences. Moreover, the assumptions upon which cost/benefit analyses are based, including perfect information, no externalities, and a truly free market, deviate so far from reality that cost/benefit analyses, standing alone, are an unreliable guide.


One controversial issue in the cost/benefit debate is whether environmental values are significant only to the extent that they can be translated into economic terms.53 Opponents of cost/benefit analysis maintain that economists “price everything and value nothing.”54 Cost/benefit analysts tend to limit their view of the benefits of environmental regulation to human lives saved or cancers averted.55 The true benefits of environmental protection extend far beyond counting the numbers of lives saved. For example, non-lethal human health effects, including subchronic neurological, behavioral, or reproductive effects are not well understood, not easily quantified, and rarely included in any meaningful way in cost/benefit analyses.56 Moreover, as described in detail below, ecological systems are not well understood by science and the value of such systems is not readily quantified. Consequently, human disruptions to ecological systems are rarely part of cost/benefit analyses. Further, ethical, religious, aesthetic, and other normative values of environmental protection are not typically included in cost/benefit analyses. Finally, even those components of the cost/benefit analysis that are more easily monetized, such as the cost of compliance with environmental regulations, are difficult to estimate. Frequently, regulatory agencies are asked to take industry at its word,57 and often in retrospect the true costs of compliance prove to be not as high as the pessimistic estimates of industry would suggest.58


Another concern often raised by opponents of strict cost/benefit analyses is that even when costs and benefits are balanced in an overall sense, what is left out of the equation is who pays the costs and who gets the benefits. In other words, if a disproportionate share of the costs are borne by segments of the population who do not share proportionally in the benefits, is there truly a balance of the costs and the benefits? Environmental risks tend to be disproportionately borne by vulnerable populations—frequently people of color, low income, and/or weak political power—who do not share in the benefits gained by industrial pursuits.59 The benefits of development and industry typically go to the advantaged segments of society who do not generally bear a great portion of the risks resulting from such activities. Environmental Justice60 proponents point out that cost/benefit analyses and other market-based systems can lead to the creation of risk “hot spots,” where the overall cost/benefit analysis may weigh in favor of an activity going forward, but within a given segment of society, typically economically and politically disadvantaged populations, the cost/benefit analysis weighs in the opposite direction—i.e., hot spots of risk with very little benefit. Accordingly, proponents of Environmental Justice reject strict cost/benefit analyses.61


A similar argument can be made with regard to ecological resources. Risk hot spots may emerge in situations where the overall cost/benefit analysis weighs in favor of allowing a pesticide to be used, but in a particular geographic area, or with a particular species or ecosystem, risk may be disproportionately high. This may occur with regard to sensitive species, including threatened or endangered species, or with ecosystems with low resistance and/or low resilience. One example of such a risk hot spot is the global amphibian crisis, in which pesticides are implicated.62 Although the cost/benefit analysis for a particular pesticide may reflect that the benefits outweigh the costs overall, this does nothing to protect the highly sensitive and highly vulnerable amphibian population.63


Finally, the values inherent in ecological integrity or biodiversity are particularly ill suited to be reduced to a dollar value.64 Of course many ecological products and services have instrumental value. Although, many species in nature can be eaten, made into medications, made into clothing or shelter, burned for fuel or otherwise used in a market-based economy,65 what is considerably more difficult to value are the aesthetic, inspirational, religious, or spiritual reasons that many people value ecosystems.66 And perhaps even more challenging, is attempting to reduce to dollars and cents the value that species have as members of ecosystems. For example, species in an ecosystem may serve important roles as producers, consumers, decomposers, competitors, dispersers, or pollinators.67 Each of these roles provides value to other members of the ecosystem, including humans.68 Another concern with the strict cost/benefit approach is that the lack of knowledge and uncertainty regarding biological systems, argues in favor of a cautious approach to the cost/benefits analysis. Our current, limited, understanding of ecological systems and inadequate methodologies for monetizing values, limit the ability of cost/benefit analyses to be sufficiently precise to control environmental decision making.69


In sum, the shortcomings of cost/benefit analysis are numerous. First, current data and methodologies are not adequate for accurate and precise analyses. Second, cost/benefit analyses do not adequately address ecological values, community values, and other normative considerations. It is impossible to reduce such values to monetary terms. Finally, far from being value-neutral, cost/benefit analyses are laden with biases in favor of those who seek to use resources and away from those who seek to protect resources. Nevertheless, economic analyses are considered to be useful factors to inform environmental decision makers.70 In other words, cost/benefit analysis should assist rather than control environmental decision making.71


In a perfect world with perfect scientific data on ecological risks and perfect cost/benefit methodologies that adequately value all costs and benefits, a cost/benefit approach might be compelling. However, with the complexity pervasive in ecological systems, the dearth of good data, and the confused state of cost/benefit methodology, all coupled with the need to act now, strict cost/benefit balancing is simply inadequate and inappropriate when attempting to address ecological concerns. All but the most staunch proponents of cost/benefit analysis seem to recognize that cost/benefit analysis involves so many assumptions, judgment calls, values and unquantifiable factors, that it is overly simplistic to view cost/benefit analysis as a clear-cut quantifiable test, where all one has to do is plug the numbers in and the “right” answer comes out. For all of the reasons discussed above, eco-pragmatism rejects pure risk-based approaches and cost/benefit analysis in favor of a hybrid approach based on the concept of feasibility.72 Under the hybrid approach, environmental risks are reduced to the amount feasible, and cost/benefit analysis is used to assist, rather than control, decision making.73 This type of approach has been described as “doing the best that we can.”74 In other words, while the goal is environmental risk reduction, there is recognition that at some point the costs of further risk reduction become too high to justify. Pragmatic risk regulation attempts to reconcile conflicting values by “striving to achieve the maximum level of protection consistent with reasonable costs.”75


Although there has been extensive debate in the academic world over the appropriateness of utilizing cost/benefit analyses or pure risk-based approaches in environmental regulation, the truth is that for the most part, Congress has rejected both pure risk-based and cost/benefit standards and most of the substantial environmental regulatory programs involve “hybrid” standards—i.e., risk-based standards that take economic considerations into account but do not require strict cost/benefit balancing. Professors Shapiro and Glicksman have surveyed existing environmental regulatory statutes to determine which contain cost/benefit standards, which contain feasibility standards, and which are purely risk based. Their work demonstrates that the majority of existing statutes contain standards that require risk to be avoided to the extent feasible or to the extent that the best available technology can achieve. Accordingly, these statutes are referred to as technology-based statutes. The most common examples of environmental statutes that utilize technology-based standards include the Clean Water Act 76 and the Clean Air Act.77 While these standards take costs into account, they are not cost/benefit balancing standards.


Shapiro and Glicksman describe constrained balancing as regulation whereby the legislature establishes a level of environmental protection to be achieved by identifying regulatory objectives based on some model technology.78 In this way, costs are considered in choosing an appropriate technology as the model, but costs are not directly weighed against benefits.79 This approach is what is commonly referred to as “technology-based”80 standard setting and is also what Farber refers to as feasibility-based decision making. Under constrained balancing or feasibility approaches, risk reduction is sought to the point that additional reduction would result in extraordinary or disproportionate costs.81


Shapiro and Glicksman refer to the second category of balancing approaches as “open-ended balancing,” which they describe as a type of balancing whereby the legislature prescribes the factors that the agency must consider in making a decision, but does not dictate the weight the agency must give to any particular factor.82 Interestingly, Shapiro and Glicksman describe FIFRA as an open-ended balancing statute. And while it is true that an initial reading of the statutory standard of “unreasonable adverse effects” would lead one to believe that it is indeed an open-ended balancing statute, whereby the agency has been directed to consider a variety of risk and benefit factors but has not been directed as to how to weigh such factors, in practice, FIFRA has been interpreted and applied by EPA as a cost/benefit balancing statute such that for a pesticide to be registered, its benefits must outweigh its costs. This interpretation has been articulated in agency orders83 and upheld in many judicial decisions.84 Thus, despite the significance of pesticides in the development of environmental law, FIFRA virtually stands alone in its cost/benefit approach to environmental protection.85


The plain language of FIFRA, as it currently stands, does not mandate a strict cost/benefit balancing. Some scholars have noted that on its face, FIFRA could be read to contain what is known as an “open-ended balancing standard,” which allows consideration of a variety of factors but does not require weighing costs against benefits to determine which one outweighs the other.86 As described above, FIFRA’s definition of “unreasonable adverse effects on the environment” means any unreasonable risk to humans or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide. Congress’ only direction to EPA was to “take into account” economic and social as well as environmental considerations. Nevertheless, EPA has interpreted and implemented this standard as more of a strict cost/benefit balancing.87


Failure to Adopt the “Overriding Benefits Standard”

Subsequent to the DDT cancellation, EPA brought forth a number of cancellation and suspension actions, through which the agency’s interpretation of the statutory standard, “unreasonable effects on man and the environment,” was further developed.88 This series of FIFRA cancellation and suspension cases cemented the interpretation of FIFRA as containing a cost/benefit balancing standard, rather than the open-ended balancing standard that, at least arguably, it was intended to be.89 As Professor William Rodgers has described, in the legislative history of FIFRA, the “unreasonable adverse effects” language was intended to be an environmentally stringent standard for registration.90 The Senate Commerce Committee, which created the standard, described it as not tolerating any adverse effects, “unless there are overriding benefits from the use of a pesticide.”91 Accordingly, it appears that the standard contemplated by the Senate drafters of the 1972 FIFRA amendments intended that, although economic and social factors should be considered and balanced against environmental risks, the balancing would not be a simple accounting of dollars and cents on two sides of the equation with the pesticide winning the right to registration as long as the scale was tipped, no matter how slightly, in favor of the benefits provided by the pesticide. Instead, the Senate drafters appeared to intend that, where environmental risks exist, the analysis would favor registration only where the risks were outweighed by “overriding benefits.” An example of an overriding benefit might be where a particular pesticide is important to fighting a significant public health problem such as West Nile Disease, and where other less risky control alternatives are not available or are too costly. The importance that pesticides can play in preventing significant public health problems is specifically addressed by FIFRA. The definition of “unreasonable adverse effects on the environment” provides that:


[t]he Administrator shall consider the risks and benefits of public health pesticides separate from the risks and benefits of other pesticides. In weighing any regulatory action concerning a public health pesticide under this subchapter, the Administrator shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.92


Other overriding benefits might include situations where a particular pesticide is necessary to the maintenance of a segment of agriculture, where nonchemical or less risky alternatives are not available, and where growing a particular crop without the pesticide would result in severe economic losses or dramatically increased food prices. However, an overriding benefit would not be found in a situation where, if the pesticide were taken off the market, the evidence showed only that chemical companies would lose money or farmers would have to switch to other existing alternative pest control practices, which might involve some additional cost. If FIFRA were interpreted to mean that only overriding benefits could outweigh significant environmental risks, then potential registrants would face a more stringent standard and pesticides that posed significant risk would not routinely be registered. Unfortunately, EPA’s longstanding interpretation of FIFRA’s “unreasonable adverse effects” standard as a strict cost/benefit balancing standard has resulted in the registration of pesticides where all that is demonstrated is that the economic benefits outweigh risks despite the fact that lower risk alternatives may be widely available and may even be less costly.


Failure to Require Demonstration of Benefits