Introduction
With passage of the Food Quality Protection Act (FQPA) nearly three years ago, the EPA assumed the daunting responsibility of overhauling the federal regulatory mechanisms for non-occupational exposures to pesticides and their residues. Few issues of environmental concern resonate as deeply with the American public; since the publication of Rachel Carson's Silent Spring, the human health and environmental consequences of our dependence on pesticides have been continuously debated. The extensive scientific and popular attention paid to the issue, however, has produced minimal progress towards consensus on the safety of pesticides. Today, the American public is in the uncomfortable position of thoroughly depending upon toxic compounds for pest control while harboring deep reservations about their effects on human health. While attached to the benefits of pesticides, especially their efficacy and economy, a great many consumers remain unsettled by their risk.
Is the tension between our dependence upon and fear of pesticides an inevitable consequence of incomplete knowledge, or can advances in the understanding of risks and benefits produce regulatory structures which satisfy both production and safety requirements? The FQPA was crafted as, and remains, an effective mechanism for achieving the balanced compromise which decades of work on pesticide regulation has struggled to achieve. To address human health concerns, the FQPA incorporates peer reviewed breakthroughs in toxicology and epidemiology, a conservative safety margin, and commits the EPA to expanded consumer education. To prevent unwarranted cancellations of registrations, the statute directs EPA to incorporate, and where necessary gather, reliable data in lieu of using worst case assumptions. To offset disruption arising from justified cancellations, the FQPA prioritizes registration of reduced risk compounds and products applied to minor use crops. The law is designed to insure a high, consistent, and publically acceptable safety standard while supporting the agricultural community and other pesticide users in a transition towards lower risk pest protection strategies. The speed and unanimous support which propelled the law's passage signaled that many traditionally adversarial constituencies saw the statute as a reasonable compromise which advanced their interests.
How effectively are the EPA and its regulatory partners meeting the challenges of FQPA implementation? This paper answers that question from the perspective of the Henry A. Wallace Institute for Alternative Agriculture, a leading advocate for the economic, environmental, and cultural sustainability of farming in America. The Institute believes that the EPA's efforts to implement the new law are as yet inconclusive, and that the Agency has earned an incomplete rather than a letter grade. Three growing seasons after the law's passage, the FQPA has not been used to reduce pesticide exposures or accelerate the transition towards reduced risk compounds. Until these objectives are achieved, the intent of the law—to establish a more consistent, protective exposure standard with additional safeguards for infants, children, and other high risk populations—will remain unfulfilled. The EPA had valid toxicological and exposure data at its disposal in 1996 to begin acting on tolerances—to withdraw the highest risk drivers, and retain the low risk majority which are acceptably safe. Instead, the Agency went back to square one, re-opening debate on many issues which had been effectively resolved in the statute. Doubtless, the Agency needed time to adjust to the statutory changes the law mandated, and there are recent indications that its decision making capability is gaining speed. However, the path to the future which the FQPA carved out in 1996 is in serious danger of becoming overgrown with the weeds of uncertainty and delay.
Ironically, the FQPA could serve to perpetuate the pest management status quo rather than facilitate the transition to a new generation of reduced risk compounds. The old arguments of economic necessity, lack of alternatives, and insufficient data are being used to weaken the EPA's mandate to implement the FQPA's enhanced safety standard. There is always a tension between the need to act and the desire to have more complete information, as there is between accepted practice and potential innovation. The Wallace Institute believes that the FQPA should catalyze the transformation of American agriculture, and not be used to justify entrenched and outdated practices. Many of the pesticides which the registrant, grower, and other pest control interests are rallying to protect are highly toxic, broad spectrum compounds which pose significant worker and environmental risk in addition to the concerns raised by their residues on food. As such, these pesticides are clearly out of step with innovations in pest management, as well as with consumer expectations of a safe and wholesome food supply. Successful implementation of the FQPA will largely hinge upon the EPA, USDA, and all stakeholders in the pesticide debate coming together to identify production practices which reduce risk for consumers, farmworkers, and the environment. The natural consequence of this transition will be the elimination of current labels and registrations which drive risk most significantly.
The paper will assess the implementation framework established by the EPA, paying particular attention to the science policy issues which will largely determine how the statute is enforced. It will also identify deficiencies which jeopardize the ability of production agriculture to adapt to the changes which the FQPA will require. Finally, this paper will assess the role that a functional FQPA can play in resolving the chronic uncertainty which surrounds our dependence on toxic pesticides in the absence of a definitive understanding of their safety. The Wallace Institute recognizes that FQPA implementation is a work in progress, and commends the EPA for actively engaging stakeholders in these efforts. This analysis will hopefully contribute to a constructive approach to the FQPA which brings together new strategies, resources, and wisdom to overcome the doubt and divisiveness which have long shrouded our necessary pest management efforts.
From Statute to Regulation: The Science of the FQPA
While many have characterized the FQPA as a state of the art or landmark accomplishment, it might more accurately be described as an idea slightly ahead of its time. Derivative of the decade of progress on pesticide risk assessment spearheaded by the National Research Council's (NRC) Board on Agriculture, the FQPA synthesized many novel terms, principles, and models. To be practically applied, however, these methodological breakthroughs required further refinement and validation. Definitions for integral components of the statute, including common mechanism of toxicity, aggregate exposure, and cumulative risk assessment, while not unfamiliar to EPA, were far from standardized. The shortage of residue data, particularly for processed food and drinking water, was one significant impediment to implementation cited by the NRC. When the FQPA became law, the EPA found itself in the difficult position of enforcing a statute predicated on terminology much of which had no legal grounding beyond the authorizing legislation.
Regrettably, given the size of the task at hand, the EPA made extremely limited progress on FQPA implementation during the first two years after passage. Stakeholder participation was negligible, and few substantive policy developments emerged. The Agency's reduced productivity in 1997 reflected the difficulty it was having in adjusting to the new statute: Section 3 registrations declined, the turnaround time for Section 18 decisions increased, and tolerance awarded through the IR-4 program almost disappeared. In 1998, the Clinton Administration made the appropriate decision to maximize stakeholder participation and accelerate bringing the FQPA to life. This decision resulted in the formation of the joint EPA/USDA Tolerance Reassessment Advisory Committee (TRAC) to insure that the Agency's actions would be based on sound science, transparent to public and private stakeholders, and provide a reasonable period of transition for agriculture.
The initial TRAC meetings have provided the EPA, and increasingly the USDA, a public forum to provide stakeholders with an overview of the latest thinking on federal implementation strategies. By identifying technical components of the FQPA which required greater elaboration and validation, the TRAC meetings generated nine crucial science policy issues for notice and comment review. To date, the EPA has largely stuck to its schedule for publishing preliminary guidances on the science policy issues, and the comments it has received will hasten the development, and hopefully the acceptance, of the Agency's operating procedures. The notice and comment process has contributed significantly to an emerging consensus addressing important issues including defining a common mechanism of toxicity, the use of probabilistic (Monte Carlo) risk assessment modeling, and selection of appropriate toxicity endpoints for organophosphates. In each instance, the Wallace Institute submitted comments largely supporting the EPA's proposed guidelines, but also arguing to preserve the Agency's flexibility to take additional measures protective of human health. For example, while recognizing that evidence of cholinesterase inhibition in plasma and red blood cells does not inherently constitute an adverse health effect, the Institute believes that such data can be used as an appropriate toxicological endpoint. Such a provision would allow the EPA to err, if at all, on the side of reduced risk. Similarly, in supporting the transition from deterministic to probabilistic risk assessment models, the Institute urges the EPA to monitor carefully those few outlier data points that represent extreme exposures. We believe that these examples reflect the potential of the FQPA to codify significant procedural advances in risk assessment and management while still providing the EPA discretion to take additional measures needed to insure that the statutory "reasonable certainty of no harm" standard is satisfied.
The TRAC meetings, notice, and comment on the science policy issues, and the expedited release and review of the organophosphate risk assessments have greatly contributed to increased public dialogue on FQPA implementation. The EPA and USDA have responded to this stakeholder feedback with an accelerated commitment to FQPA transition. The USDA in particular has made significant strides since the beginning of the TRAC process in generating critical data on how pesticides are used in the field and what risk reduction strategies are available. Despite this progress, however, by far the most difficult FQPA science policy issues remain unresolved. The Agency has failed to establish guidelines for determining how to apply the tenfold safety factor, aggregate exposure from all non-occupational sources, and conduct a cumulative risk assessment. The other science policy issues address either widely acknowledged data gaps (residential and drinking water exposures) or relatively narrow methodological concerns, such as toxicity endpoints and incorporating residue data which show no presence of the pesticide. By contrast, the tenfold safety factor, aggregate exposure, and cumulative risk assessment science policies are central to the FQPA's innovative approach: consideration of multiple compounds and multiple routes with added protection for high risk populations. They are the provisions within the statute which have the greatest potential to increase risk through both addition and multiplication to unacceptable levels. Satisfactorily resolving these three science policy issues represents an extremely challenging yet essential task if the FQPA is to achieve the widespread stakeholder approval needed to overcome the longstanding conflicts associated with pesticide regulation.
As the ultimate expression of how the FQPA was designed to regulate pesticide safety, conducting a cumulative risk assessment for pesticides with a common mechanism of toxicity remains the Holy Grail of the implementation process. While the consideration of effects from multiple pesticides did not begin with the FQPA (the original Federal Insecticide, Fungicide, and Rodenticide Act provides that authority) the methodological challenges of doing so pose significant obstacles. An overview of a cumulative risk assessment on organophosphates, the class of pesticides most widely cited as sharing a common mechanism of toxicity, is illustrative. The EPA will need to conduct an aggregate exposure analysis (dietary, water, and residential) for each active ingredient, determine the probability that an individual will be exposed to multiple compounds during the time frame of the assessment, and establish a common expression of potency affecting the shared toxicological endpoint. The Agency must review upwards of forty organophosphates, and also consider if additional materials, such as carbamates or other environmental toxins, share the mechanism of toxicity and need to be added to the risk cup. There are also likely to be variations in the pharmacokinetic and pharmacodynamic properties of similarly acting pesticides which will impact their relative contribution to the risk assessment.
The NRC study Pesticides in the Diets of Infants and Children (1993) included a preliminary attempt at a limited cumulative risk assessment which, while drawing no conclusions from the results, found it a "workable and useful mechanism for assessing exposure." Subsequently, the most visible and substantial cumulative risk assessment efforts have been conducted by researchers at Consumers Union (CU) and the Environmental Working Group (EWG). These organizations have published high profile reports (CU's Worst First: High-Risk Insecticide Uses, Children's Foods and Safer Alternatives (1998) and Do You Know What You're Eating? (1999) and EWG's Overexposed: Organophosphate Insecticides in Children's Food (1998) and How 'Bout Them Apples? (1999)) which use cumulative risk methodology to calculate daily dietary exposure to organophosphates in the diets of children. Their research concludes that residue levels on fruits and vegetables documented by the USDA result in children routinely receiving doses of neurotoxic organophosphates in excess of EPA reference doses (RfD). Extrapolating from their statistical measurement of exposure and census data, the EWG estimates that hundreds of thousands, potentially millions, of American children consume unsafe levels of organophosphates on a daily basis. Results from the preliminary CU and EWG cumulative risk assessments contain startling implications for public health in the United States, as well as for the future of production agriculture and pest management. Are the human health risks from exposure to pesticides as grave as CU and EWG estimate? The Wallace Institute shares the consensus of the toxicological and regulatory communities that cumulative risk assessment is a valid and appropriate technique for the protection of human health. However, these assessments will require significant methodological improvements before the Institute can place full confidence in their projections.
Perhaps the most contentious methodological issue currently under debate is the selection of an appropriate reference point for normalizing toxicity between active ingredients of varying potency. Both CU and EWG chose to normalize toxicity by equating each pesticide's RfD, or the amount of exposure that is believed to have no significant effects if consumed over a 70-year life span (chronic RfD) or in a single day (acute RfD). CU further modified its toxicity factor by incorporating data on a compound's carcinogenic and endocrine disrupting properties. While an innovative approach, using RfDs to normalize toxicity can misrepresent risk in several ways. The EPA calculates an RfD by first determining a no observable adverse effect level (NOAEL) in a dose and response study, then dividing this quantity by as many as three safety factors. The Agency applies a tenfold safety factor for intraspecies variability, a second tenfold for interspecies variability, and may elect (though most often it has not) to impose the additional three- to tenfold FQPA factor. Due to data gaps, uncertainty factors differ greatly between pesticides, and this variation makes them problematic for use as common denominators. This method is vulnerable to distortion due to the data and uncertainty factors associated with the pesticide to which toxicity is normalized. Additionally, to reflect a truly shared effect, the value used to normalize toxicity should be based on studies for each pesticide using a shared species, exposure route, exposure time, and end point. This approach represents significant obstacles for data collection. Despite these methodological shortcomings, the use of RfDs to normalize toxicities is a valuable "first tier" technique for identifying high risk combinations of residues. However, the Wallace Institute believes that significant refinement will be necessary before this methodology can be used to make critical regulatory decisions such as canceled tolerances or registrations.
Beyond methodological concerns, the availability and reliability of pesticide residue data are of critical importance to successful implementation of the FQPA. The emphasis on aggregate and cumulative exposure necessitates a comprehensive database; an accurate appraisal of risk will require understanding how much of each similarly acting material a person receives through dietary, drinking water, and residential sources. The EPA and USDA have made significant progress in developing data bases to accurately forecast anticipated exposures for various sub-populations. In particular, the USDA's Pesticide Data Program (PDP) and Continuing Survey of Food Intake by Individuals (CFSII 1994-1996) are integral components of the advances represented by Monte Carlo risk assessment techniques. Including the EPA's preliminary guidelines for estimating drinking water and residential exposures among the science policies submitted for notice and comment review was another constructive step towards refining predictive models and identifying data to replace assumptions. However, existing residue and exposure collection activities are incapable of providing as much data as the aggregate and cumulative risk assessment methods demand. Because the federal government cannot be expected to assume the entire expense of the additional testing required to make FQPA work, the EPA must aggressively employ its data call authority to generate the type of residue and exposure data most needed to support registrations. The EPA should coordinate its activities with registrants to insure that the information needed to make prompt, transparent, and credible decisions is made available.
The collection of data to support the establishment of tolerances on minor use commodities is one area where the federal government needs to expand its financial commitment. The FQPA has engendered concern that use of cumulative risk assessment methodology will create disincentives for registrants to maintain minor crop uses on their labels; economic sense dictates that the most profitable uses would be the first to fill the risk cup. While the loss of minor crop labels due to excessive risk remains a problem, we believe that many tolerances which would be allowed on the basis of risk will be dropped due to the excessive cost of the field trials and data collection needed to support them. The FQPA can be used to evaluate risk effectively, but it is a very data intensive, and thus expensive, undertaking. Many different forms of data including residue decline, bridging, and degradation studies, and processing factors can go into refining a risk assessment to identify more room in the risk cup. However, registrants are unlikely to expend resources to support pesticide uses on commodities for which the return on their investment appears to be unprofitable. Producers of minor crops could potentially lose safe, low cost pesticides, some of which have been incorporated into IPM programs for years, because no proprietary interest will come forward to fund the research needed to establish that their risk is acceptable.
Since 1963, the USDA has operated the Interregional 4 (IR-4) program to conduct field trials and laboratory analysis on essential minor use registrations which would not be supported by private sector registrants. The program conducts the basic residue level testing (maximum label rate, minimum post-harvest interval) needed to submit petitions for tolerances on behalf of registrants. The IR-4 program has played an integral role in the reregistration mandate of the 1988 FIFRA reform by generating data to support more than 700 minor crop tolerances. Even before passage of the FQPA, the program was moving towards the next generation of reduced risk compounds which currently account for two-thirds of its projects. The program has been an extremely effective forum for EPA, USDA, growers, registrants, and the participating Land Grant Institutions to prioritize and conduct the research needed to support labels for minor use crops. Increased funding will be needed to expand work in the reduced risk chemistries and conduct mitigation efforts for registered compounds which require modified application procedures. The Wallace Institute strongly supports the $2,000,000 increase in funding which the Administration is seeking for FY 2000. The immediate potential of the IR-4 program to sustain the production of high value minor use crops makes the program well worth funding at the higher level.
Economic Impacts of FQPA Implementation
With its primary emphasis on the protection of human health, the FQPA pays minimal attention to the potential economic impacts which would result from a significant number of canceled registrations and withdrawn labels. By limiting acceptable risk levels and requiring more periodic reassessment, the statute actually diminishes the EPA's discretion to include economic considerations when establishing tolerances. The major economic implication of FQPA implementation is the potential loss of widely used pesticides which, either singularly or cumulatively, pose excessive risk. Agricultural groups and other pest control interests have raised concern that the risk assessment and management requirements of the statute will preclude their continued use of essential pesticides. The initial focus of these concerns have been the organophosphate and carbamate compounds which have well established neurotoxic properties, are the most frequently cited examples of compounds acting with a common mechanism of toxicity, and have been prioritized for tolerance reassessment. The EPA's list of potential carcinogens (the B2 compounds) are additional priorities for reassessment which potentially could encounter significant difficulty in satisfying the FQPA's enhanced safety standard. These three categories of compounds include many pesticides used in a wide variety of cropping and pest control systems which have long played a central role as low cost components in IPM operations. While the FQPA is clear in prioritizing human health above economic interest, it would be irresponsible of the EPA and the USDA not to consider the unintended consequences of the registration actions they are considering.
While the economic impact of canceling registrations for widely used pesticides is potentially enormous, few reliable estimates of the cost have emerged. A wealth of studies have addressed the subject in recent years with the conclusions largely dependent on the assumptions employed in the modeling. Some pesticide reduction studies have shown relatively modest impacts which could be offset by the new opportunities created by alternative pest management practices. Other studies project drastic drops in agricultural production and farm income accompanied by escalating food prices and decreased consumption of fresh fruits and vegetables. In 1997, Dr. Ted Jaenicke evaluated reduced use studies in a Wallace Institute report entitled The Myths and Realities of Pesticide Reduction. The report concluded that most such studies did not examine the benefits of pesticide reduction, failed to consider that farmers can cope with new regulations through innovative adaptation, or generally ignored the full range of policy options. In essence, these studies portray static scenarios in which important variables are dropped out of the pest management equation without giving consideration to the alternatives which could potentially replace them. While not a panacea for every producer currently dependent on restricted use pesticides, alternative production practices including organic and biointensive integrated pest management. It will be essential to examine carefully claims regarding the loss or reduction of pesticide applications to insure that they incorporate all the benefits and that they consider the full range of production alternatives which exist.
The FQPA related economic challenges confronting producers are but one part of the broader financial environment which is transforming production agriculture in America. The prevailing depressed markets for agricultural commodities are exacerbating the chronic cash flow and profit margin problems associated with farming. The drastic decline in the number of farmers and the irreversible loss of prime farm land over the past fifty years have initiated changes with deep social, economic, and environmental implications. Put simply, agriculture has been driven out of many communities in America, and is struggling to survive in most of those where it endures. The increasingly global market place is likely to perpetuate the erosion of agriculture's role within the domestic economy, and the increased competition is certain to exert downward pressure on food and fiber prices. The full consequences of agriculture's decline have been masked by the relative stability of key bottom line figures: yields are high, food prices low, and agricultural exports make a significant positive contribution to the balance of trade. However, the concentration of production, processing, and distribution resources which support this modern bottom line have eliminated hundreds of thousands of family farms. It is reasonable to conclude that even if the economic burden attendant to FQPA implementation was minimal, it could push many more into insolvency. Beyond economic considerations, the loss of essential pest management tools could make the production of some agricultural commodities impossible, even in regions where they have been grown for generations. While the design of the FQPA is not inherently biased against small and medium sized producers, they will certainly struggle to weather the economic and managerial dislocations associated with the transition to safer alternatives.
The macroeconomic structure of American agriculture is beyond the scope of this paper, but some consideration of the broader dilemma producers face is necessary. Farmers are caught between flat commodity prices, growing foreign competition, the threat of increased costs and/or reduced management options due to the FQPA, and significant public concern about the safety of their products. Farmers in America have consistently demonstrated their willingness to adopt innovative technology and comply with environmental regulations, yet they receive an ever decreasing portion of the proceeds generated by their efforts. Central to the economic problems confronting American farmers is the growing gap, both literal and figurative, between farmers and food consumers. In the figurative context, the gap corresponds to consumers' limited comprehension of the expertise and effort required to produce a safe, abundant, and affordable food supply. In its literal meaning, the gap refers to the increasing portion of the food dollar absorbed by the processing, distribution, and retailing sectors. This dislocation contributes to an undervalued food supply, depressed prices for raw commodities, and makes agriculture an increasingly unprofitable venture for too many dedicated and skilled farmers. Pesticide regulation, particularly the public perception of its costs and benefits, is an essential ingredient in reversing these trends and establishing a pricing structure which sustains diverse, regional food and fiber production systems in America.
The success enjoyed by certified organic producers is illustrative of the potential benefits which their conventional counterparts can reap from a fully functional FQPA. Capitalizing on public sentiment that abuse of synthetic pesticides created ecological and human health risks, organic producers adapted their management strategies to accommodate this niche market. They reduced the toxicity of their inputs, learned to work on appropriate scales, developed biologically based pest and disease control systems, and successfully communicated their approach to consumers. In essence, they turned their production practices into a value added process which distinguishes their products amidst a marketplace full of conventionally produced competitors. The opportunity exists for conventional producers to use the FQPA to transform their production practices in a similar manner: the high risk products and uses should be dropped, to be replaced by reduced risk and biological controls. Given the enormous investment of infrastructure, research, and human experience which American agriculture has made in synthetic pesticides, this transition will be difficult. However, it is in the best long term interests of farmers to use the best available science to bring the risk from pesticide exposure down to a safe level. If they can be successful in this effort, they deserve the full support of the USDA, EPA, and every stakeholder from the consumer and environmental community in communicating the message that the food supply is responsibly produced and safe to eat.
In addition supporting the full $2,000,000 increase proposed for the IR-4 program, the Wallace Institute believes that there are other federal research and marketing initiatives which could contribute significantly to the transition towards a more sustainable domestic agriculture. The Sustainable Agriculture Research and Education (SARE) program, the Federal-State Marketing Improvement (FSMIP) program, and the Conservation Farm Option (CFO) are cutting edge examples of a commitment to sustainability which bridge the gap between producers and consumers. However, Congressional and Administration support for these programs has been woefully inadequate; the SARE and FSMIP programs have been level funded at low levels for years, and the CFO has never received an appropriation. A substantial funding commitment to these and other federal programs oriented towards sustainability would constitute a meaningful down payment on a better future for American agriculture. However, resolving the economic and environmental dilemmas associated with our dependence on synthetic pesticides will require more than funding increases for isolated programs. Our investment, as a nation and a people, in the production of food and fiber to meet our future needs must be predicated upon systems based, reduced risk practices compatible with the well being of consumers, farmworkers, and the environment. By accurately assessing and mitigating risk, the FQPA can provide invaluable assistance in achieving that goal.
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