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By Kevin Thorpe
In October of 1986, the United States Environmental Protection Agency (E PA) banned all uses of the nitrophenolic herbicide dinoseb, which can cause birth defects, sterility, cancer, damage to the immune system, and adverse ecological effects, and which has contaminated groundwater in several stages. Six months later, dinoseb was again legally available for application to a variety of crops in northwestern United States.
What new information surfaced to cause the reversal of this important decision? Had the human health and environmental risks been shown to have been overstated? No, the risk analysis had not been challenged. Instead, new estimates of the benefits attributed to dinoseb were produced.
This case illustrates the importance of the benefits portion of the risk/benefit analysis that determine what pesticides will be used in our nation.
To understand how EPA, after determining that a chemical poses a serious threat to health and the environment, could arrive at a decision to permit its continued use, it is necessary to review the legislation that governs the pesticide regulation process.
Under the auspices of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is charged with the task of registering all pesticide products, regulating their use through labeling, and establishing 'acceptable' levers of public and environmental exposure to pesticides. According to FIFRA, new pesticides can be registered only if they do not pose
"... 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.)
As an environmental statute, FIFRA is somewhat unique in that the potential benefits of toxic, polluting substances must be considered against their potential hazards (see Journal of Pesticide Reform 7(4):20). To evaluate risks, EPA technically requires the registrant to provide extensive data on acute and chronic toxicity, potential for skin and eye irritation, ability to cause tumors, birth defects, reproductive impairment, and, sometimes, nervous system damage, as well as data on predicted levers of exposure to the chemical. Some environmental risks are evaluated through data on the behavior of the pesticide in the environment, persistence in soil and water, ability to contaminate groundwater, residues in and on food, and hazards to non-target organisms. Estimated benefits of a pesticide are based on far less rigorous data requirements [than estimates of environmental and health risks.]"
On the other hand, estimated benefits of a pesticide are based on far less rigorous data requirements. EPA does not require efficacy data for most pesticides, and assumes that the marketplace will ensure product performance. Furthermore, the need for a product is not a criterion for registration of a pesticide, despite any hazardous potential.
Once registered, if EPA receives new evidence of health or environmental concerns, a pesticide can be called into a special review. A new risk/benefits analysis is conducted to determine whether to take regulatory action. Possible actions include cancelling or restricting some or all uses of a pesticide and requiring labeling changes. When EPA decides to cancer or change a pesticide registration, any adversely affected party may request an administrative hearing to challenge the decision. Furthermore, if not satisfied with the results of this hearing, parties may appeal through the federal court system. Throughout all of this, the pesticide remains on the market and in use as before.
If EPA determines that the pesticide presents an "imminent hazard during the time required for cancellation or change in classification," an emergency suspension order may be issued to prohibit its distribution, sale, or use during the cancellation proceedings. Again, FIFRA defines "imminent hazard" as "unreasonable adverse effects on the environment," which occur when the risks posed by the continued use of the product during the cancellation proceedings outweigh the benefits of that use.
In the case of dinoseb, new health risk information concerning its ability to cause birth defects at exposure levers that are likely to occur among farm workers prompted a cancellation notification on October 7, 1986. At the same time, an emergency suspension order was issued on the judgment that dinoseb's health risks, which include adverse reproductive effects, acute toxicity, cataract formation, cancer, and immune system damage, as well as birth defects, outweighed the benefits of dinoseb use.
In January of 1987, the American Dry Pea and Lentil Association (ADPLA) submitted new information in support of a decision to allow the use of dinoseb on dry peas, lentils, and chickpeas in Washington and Idaho.
This new information consisted of data from pesticide trials at Washington State University, which demonstrated differences in yield of these crops when grown with and without dinoseb. The new information did not challenge EPA's assessment of dinoseb risks, i.e., its toxicity or levels of exposure. Rather, the ADPLA claimed that yield losses that would result from the suspension of dinoseb would be greater than previously thought. Therefore, based on these new data, EPA concluded that the benefits of continued use of dinoseb on these crops outweighed the risks to health and environment, and granted an exemption.
Obviously, this approach to analyzing benefits is realistic only if no other methods of reducing commodity losses are available. "
There are many kinds of benefits that may be attributed to pesticides. The most obvious and easiest to calculate are economic benefits derived from the protection of commodity yield and quality, and the reduction of other costly inputs such as labor and fuel. These benefits can accrue to a variety of different recipients., such as farmers and other users of pesticides, the marketplace, consumers, and society.
Other kinds of benefits include the maintenance of aesthetic quality, the protection of human health from disease-carrying organisms, the suppression of nuisance-causing pests, and the protection of other organisms, including endangered species, from pests.
When reliable commodity loss data are available, monetary benefits are relatively easy to calculate from current market statistics and economic theory. In this sort of analysis, benefits are equated with the potential value of the commodity that is lost because the pesticide is not used. Obviously, this approach to analyzing benefits is realistic only if no other methods of reducing commodity losses are available. While this is rarely the case for any pesticide, the analysis commonly employed in pesticide risk/benefits analyses does not consider other methods of reducing crop or other losses.
Non-monetary benefits are more difficult to calculate. Policy makers have long wrestled with how to put dollar-based values on such things as aesthetic quality, the survival of certain endangered species, and peace of mind. In practice, such non-market benefits are rarely considered by policy makers to be as important as benefits that can be measured in the marketplace, and hence they are generally simply ignored.
The calculation of pesticide benefits at EPA usually starts with the development of a profile of pesticide use. Pesticide use data are often difficult to obtain, and in some cases, especially for minor crops and non-agricultural uses, do not exist. Officials at EPA have identified the lack of a pesticide use data base as a major impediment to determining accurate estimates of the impact of changes in pesticide availability.
The development of realistic economic analyses are hindered by the lack of market data and economic models for minor crops and non-agricultural pesticides. Economic impacts are further complicated by the various governmental programs that subsidize pesticide users, such as price supports and deficiency payments. The economic benefits of greater yields are unclear for commodities such as corn and wheat, for which huge surpluses exist.
Additionally, the overall benefits of a pesticide are difficult to evaluate when they are distributed unevenly among various impacted groups such as pesticide users, non-users (e.g., organic growers), other market participants (e.g., shippers and retailers), residents of areas where the pesticides will be applied, consumers of products treated with the pesticide, formulators, marketers, and applicators. Obviously, the risks and benefits to these diverse groups will vary considerably, but all should be considered.
The assessment of pesticide benefits requires a determination of the effect of use of the pesticide on pest population reduction or commodity yield and quality. This step is technically the most difficult. To establish this pesticide-use/commodity-value relationship, EPA must wade through a diversity of studies conducted by industry, government, and universities.
Since EPA does not require efficacy data as a condition of pesticide registration, the Agency has no control over the quality, focus, or availability of these studies. A major, if not primary source of this information is pesticide trials of various sorts conducted or sponsored by the manufacturers who wish to register and self the pesticide. There are numerous opportunities for bias to be built into such studies to enhance the apparent effectiveness of the pesticide. For instance, the studies can be conducted under marginal growing conditions, non-optimal cultural practices can be used, pest-susceptible or herbicide-adapted varieties can be used, and rates of application can be employed when longer rates might be equally effective.
As an example, a recent preliminary benefits analysis of the herbicide alachlor identified seed company yield trial as a source of yield data.The stated objective of these trials was to determine the sensitivity of the company' varieties to the herbicide alachlor. Therefore, data on the effects of alachlor on yield were generated from a plant variety that had been specifically bred to realize its maximum yield when used along with alachlor. The economic benefits of greater yields are unclear for commodities such as corn and wheat, for which huge surpluses exist. "
Clearly, one would expect the beneficial effects of alachlor on yield to be exaggerated on this variety, compared to other, non-alachlor-adapted varieties that could have been tested. Therefore, while EPA claims that "maximum yield from [the seed company's] hybride is the motive, not herbicide endorsement," the data nevertheless supports conclusions biased toward those endorsing alachlor's continued registration and sales.
This example points out a crucial component of both pesticide risk and benefit calculations: The review, assessment, and interpretation by EPA of scientific studies used to calculate risks and benefits and, ultimately, to develop policies. There is an extraordinary lack of consistency in procedures, objectives, interpretations, and experimenter competency among the studies upon which EPA depends for benefits data.
Underlying all of the above considerations are uncertainties associated with all biological and economic data. Uncertainties can be minimized by using 'good scientific and economic procedures and assumptions, but they can never be eliminated.
For example, in EPA's preliminary benefits analysis for alachlor, seven "limitations" (elements of uncertainty) were identified.6 These included limited biological data, inadequate consideration of alternatives, and lack of consideration of reduction over time in the cost of alternative controls.
An extremely important shortcoming of most benefits analyses is the lack of consideration of alternative pest management strategies. All too often, the only alternatives considered are the use of other pesticides. If these alternative pesticides are more expansive, as is usually the case, the benefits analysis becomes little more than a simple arithmetic exercise.
Take, for example, the case of the insecticide diazinon, which entered the special review process in January 1986 because it had been implicated in approximately 60 bird kills involving migratory and non-migratory waterfowl, songbirds, shorebirds, wading birds, and other species. Twenty of these kills occurred on golf courses, including one incident in New York in which 700 Atlantic brant geese died, resulting in a significant population impact.
EPA initially cancelled diazinon use on golf courses and sod farms, but in January 1988 an administrative law judge voided the cancellation. Even though viable alternatives are available that would decrease risks with an increased cost of less than one half of one percent of total maintenance costs for both golf courses and sod farms, the judge decided the "benefits of diazinon are sufficient to justify the continued use of diazinon," if the material is reclassified as a restricted use pesticide* for these areas.
Chlordane provides another good example of a pesticide with enormous potential adverse health risks due to its acute and chronic toxicity and high levels of human exposure through applications to residential structures. Because of the high costs associated with termite infestations, a 1983 analysis found that the benefits of chlordane outweighed its massive risks.
Missing from this analysis was any consideration of non-chemical means of mediating the threat of termites, such as the removal of wood debris from around buildings, the reduction of excess moisture, and the use of termite barriers and routine inspections for early detection of infestations.
While EPA subsequently reached a settlement with chlordane's manufacturer, Velsicol, to temporarily stop chlordane production, it agreed to allow existing stocks to be sold and used, citing economic hardship that would be suffered by consumers and industry if chlordane use were banned."
The National Coalition Against the Misuse of Pesticides (NCAMP), NCAP, and ten other environmental organizations sued EPA over this decision. On February 23, 1988, Judge Oberdorfer of the D.C. District Court found that EPA's decision had been "arbitrary, capricious, and an abuse of discretion," and that the EPA-Velsicol agreement had been illegal.
In 1978, David Pimentel and associates at Cornell University estimated that non-chemical insect controls are used on 9% of crop acres while insecticides are used on only 6%. Similarly, non-chemical controls of disease are used on 9% of crop acres while insecticides are used on only 6%. Similarly, non-chemical controls of disease are used on 90% of crop lands, compared to 1% treated with fungicides, and nonchemical weed controls are used on 80% of crop acres, while 17% are treated with herbicides.
These data show that non-chemical pest management techniques exist for many crops and are currently in wide use. Of course, each pest situation must be evaluated separately, but these statistics suggest that the EPA should not, as it often does, assume a lack of alternatives or user acceptance of alternatives.
Furthermore, the practice of using yield data from plants grown with and without a pesticide to determine the economic impact of banning that pesticide is certainly not realistic. Farmers and other resource managers obviously will not simply stand by and do nothing if a specific pesticide is eliminated as an option. They are necessarily resourceful and will make adjustments to maximize their economic gain. Possible adjustments include adopting integrated pest management (IPM), altering cropping practices, shifting to resistant varieties or alternative crops, or utilizing new markets, such as those for organic produce (see JPR 7(4):16-17). All of these possibilities should be incorporated into various reasonable alternatives that can be objectively evaluated for both economic and non-market benefits.
Since EPA does not require efficacy data as a condition of pesticide registration, the Agency has no control over the quality, focus, or availability of these studies. "
Current law provides for no public participation in either the initial registration of a pesticide or its re-registration.
During a pesticide special review process, however, public notice of decisions and the availability of documents is given in the Federal Register, which is available at all major libraries. Periods for public comments on EPA decisions and documents are specified in these notices. All documents (other than those that are deemed "confidential business information"), including the minutes of meetings, are made available for inspection and copying during the process in public dockets, the availability of which is also announced in the Federal Register notices.
If you cannot come to Washington, DC, to access the docket, copies of its contents can be obtained via mail by writing to Freedom of Information (A-101); Environmental Protection Agency; 401 M Street, SW; Washington, DC 20460. You must specify the document number and the name of the pesticide the document concerns. Also, you can request receipt by mail of monthly docket indices.
Unfortunately, preparing and submitting comments does not guarantee a response, and in fact rarely even results in a reply. While it is important to- find logical or technical flaws in the special review documents, the final decisions are usually political.
To have any influence, then, political pressure must be applied. Focus in on economic issues, as these often hold the most political sway, but don't ignore the toxicological aspects of the chemicals involved, especially - when, as is usually the case, there are missing data and unanswered questions. Always point out the existence of less toxic alternatives.
Enlist the aid of professionals (physicians, lawyers, professors), especially those with expertise in areas related to the special review in question. Seek out anyone sympathetic to your position, especially those wielding political influence or representing popular support. Enlist the aid of sympathetic growers, growers' associations, and marketing cooperatives. Get these individuals to participate in an organized letter-writing campaign . Send copies of all letters and comments to everyone who might be interested, including elected officials, citizen groups, and the media. Another major environmental policy making process that results in decisions on pesticide use based on risk/benefits analyses is the Environmental Impact Statement (EIS). Federal agencies undertaking programs involving pesticides and other public agencies doing the same with federal funding, need to prepare an EIS indicating the adverse environmental and health impacts that may be caused by the proposed pro gram and all reasonable alternatives to the proposed program.* By law, public comment and suggestions are encourages both prior to and following the issuance of a draft EIS, which contains interpretive summaries of the risks and benefits associated with three or more proposed alternatives. A public comment period of either 30 or 45 days is usually provided, during which time comments are accepted from all interested parties.These comments must be acknowledged, addressed, and considered in the development of the final EIS.
There is an extraordinary lack of consistency in procedures, objectives, interpretations, and experimenter competency among the studies upon which EPA depends for benefits data."
If you prepare comments on special review decisions or documents, or on an EIS, pay particular attention to the benefits attributed to each of the proposed alternatives. They are probably based on questionable data, assumptions, and analyses, and they could have a decisive effect on the outcome.
1. Federal Insecticide, Fungicide, and Rodenticide Act, Section 2(bb).
2. U.S. General Accounting Office. 1986. Pesticides: EPA's formidable task to assess an regulate their risks.
3. Federal Insecticide, Fungicide, and Rodenticide Act, Section 3(c)(5).
4. U.S. Environmental Protection Agency February 18, 1987. Hearing concerning application to modify the final suspension ord for pesticide products containing dinoseb. Federal Register 52(32): 4963-4967.
5. Gregory, Robin. 1985. What's the value of butterfly? Figuring nonmonetary effects into the costs and benefits of pesticide programs J. Pesticide Reform 5(2): 16- 18.
6.Schneider, Bernard et al. 1986. Preliminary benefit analysis of pesticide uses of alachlor Washington, D.C.: U.S. Environmental Protection Agency.
7. O'Brien, Mary. 1984. On the bail of a pesticide. Eugene, OR: Northwest Coalition for Alternatives to Pesticides.
8. U.S. Environmental Protection Agency. December, 1985. Diazinon support document Washington, D.C.
9. Ciba-Geigy, et al. January 1988. FIFRA Docket No. 562, et al.
10. U.S. Environmental Protection Agency. November, 1983. Analysis of the risks and benefits of seven chemicals used for subterranean termite control. Washington, D.C.
11.NCAMP, et al v. U.S. EPA, et al Civil Action No. 87-2089-LFO. October, 1987.
12. NCAMP, et al u. US. EPA, et al Civil Action No. 87-2089-LFO. Judgment and Order. February 23, 1988.
13. Pimentel, David, et al. 1978. Benefits and costs of pesticide use in U.S. food production Bioscience 28:772-783.
14. D'Arbois, Findley. 1985. Commenting on ElS's. J. Pesticide Reform 5(2):29-33.
Citation for this article: Thorpe, Kevin 1988, "Pesticide risk/benefit analysis : Who is making the benefit portion?", Journal of Pesticide Reform, Vol 8, No. 1, Spring 1988, pp 13-16
Copyright © 1988 Northwest Coalition for Alternatives to Pesticides.
Reprinted with permission.
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