Since the Food Quality Protection Act (FQPA) was signed into law in 1996, the U.S. Environmental Protection Agency (EPA) and other federal agencies have worked to implement a health-based safety standard for pesticide residues in food, to reregister pesticides to ensure they meet current standards, and to review exposure and toxicity data to set appropriate tolerances, especially with regard to infants and children. In December 2001, the agency released preliminary cumulative risk assessment figures for organophosphorous pesticides, noting that the “formidable scientific challenge” involved in this work impedes a speedy resolution to its scientific inquiries.

In this question-and- answer discussion, Rick Jarman, V.P., Food and Environmental Policy, and Henry Chin, Ph.D., V.P., Center for Technical Assistance with the National Food Processors Association (NFPA) discuss the current and emerging challenges to the food industry in terms of pesticide residue regulation, testing and analytical considerations, and offer some practical advice to food manufacturers on strategies and tools that will aid in monitoring pesticide residues on foodstuffs.

Food Safety Magazine: Can you provide some background on the FQPA, and update us on some of the significant aspects of its implementation?

Rick Jarman: One of the primary drivers that had the processed food industry’s attention as FQPA was being debated pre-1996 and through the final stages of passage was the existence of the Delaney Clause in the Federal Food, Drug & Cosmetic Act (FFDCA), which mandated a zero-tolerance standard for carcinogens in processed foods. While examining that particular provision of FFDCA--and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is the governing statue for pesticide registration--to find ways to update the federal food safety laws, this clause became a point of vigorous debate. The debate centered on the fact that since the inclusion of the zero-tolerance Delaney Clause in the FFDCA (at which time analytical capability was at part-per-million detection level), the scientific community had increased its capability to detect pesticide residues at decreasingly smaller levels, down to parts- per-billion. The statute fixed the Delaney Clause in place, codified it, and thus, set the stage for debate. As a result, it was decided that rather than establish a law solely based on the ability to analyze down to these low detection levels, the whole question of pesticide oversight regulation at the federal level should be based on a science-based public health standard that could adapt, adjust and accommodate such advances in science.

This opened the door to a variety of long-standing issues with EPA, certain members of Congress, and various interest groups. At the end of the day, the introduction of new provisions and ways of performing health analyses introduced new requirements that really had not been anticipated. Basically, the implementation of FQPA since 1996 has been based on these unintended consequences, both from a scientific and a policy standpoint. The removal of the Delaney Clause as a factor, for instance, has ensured that the tolerance established for a given commodity and a given pesticide will carry through to the processed food form. FQPA also established the requirement to reevaluate all of the existing tolerances under the new standard, which establishes tolerances as a very significant part of the pesticide regulatory picture. The time line that was established for reviewing and reregistering pesticides for use in foods has created quite a hit of controversy and consternation in industry, and sometimes, within the EPA. Roughly 10,000 tolerances for pesticide residues exist, and the schedule requires the evaluation of one-third of those every three years under the new standard.

With respect to the new FQPA standard, one of the elements introduced is the requirement to consider the special needs of infants and children. The reasoning behind this is that it may be necessary for EPA to determine whether or not a safety factor should be applied to take into account the special sensitivities of infants or children, which some call the “10x factor.” FQPA also requires an aggregate analysis of a pesticide’s exposure and risk profile, which means to take into account all of the uses for a given pesticide on all applicable crops, including other nonoccupational exposures such as residential and drinking water exposures, not just the exposure from a single crop or the way the pesticide is used on the crop.

FQPA also requires a scientific review of the cumulative effect and exposure by chemical compounds and pesticides that have a common mechanism of toxicity, such as the organophosphorous (OP) pesticides, which have been in the spotlight recently with the issuance by EPA of a preliminary cumulative risk assessment. Another factor introduced by FQPA in evaluating pesticide tolerances is endocrine disruptors, which has received some attention, but poses very complex questions for science and policy. However, in terms of the impact on pesticide residue analysis and industry concerns, the work being done with endocrine disruptors continues to raise looming scientific questions that have not yet been resolved.

Food Safety Magazine: What aspects of of FQPA implementation are having significant impact on the food industry?

Jarman: In terms of pesticide residues, the action of removing tolerances under FQPA has been the most contentious for both production agriculture and food processors. As the implementation of the various provisions and risk assessment analyses have proceeded, the registrants of some individual pesticides have chosen to voluntarily withdraw uses, or to reduce the number of commodities and crops to which a given pesticide is applied. That, in turn, has stimulated a look at each tolerance, and the general approach by EPA has been to remove tolerances as soon as possible, once a pesticide is no longer registered for a particular crop.

The bottom line is that while aggregate assessment has been performed one-by-one on all of the individual OPs, the cumulative risk assessment is still being worked through. At present, EPA is trying to address some of the major scientific, technical and policy questions on how to perform cumulative risk assessments on pesticides. In releasing its preliminary cumulative assessment results for the OPs, EPA is attempting to show how this has been studied and analyzed aggressively, and to show that there now is a protocol which combines a modeling approach with the availability of certain information that permits researchers to take a stab at it. I just returned from one of the many technical briefings that are being held on the cumulative risk assessment of the OPs, and I can state that this effort is definitely a work in progress. The preliminary report that was released in December already has been significantly changed, and the agency has indicated that we should be ready for more changes to the preliminary figures.

In considering the current status of FQPA implementation and its impact on the food industry, including what new or existing pesticides can be used or are currently registered for use, what residues remain on foods as a result of the use of a given pesticide, and what kind of oversight a food company or the industry collectively has to think about, three items are in play. First, the removal of tolerances, of course, affects the industry in the selection and use of appropriate and legal pesticides. Once a tolerance has been eliminated, particularly if some public health concern is related to use of the pesticide, a zero non-detectable standard now applies, which means the pesticide residues won’t be detectable in either fresh or processed foods. This affects the agricultural production and food processing industries’ abilities to effectively use and/or monitor pesticide residue levels.

Second, the introduction of new chemical compounds, particularly with respect to the OPs, that in some cases introduce a whole new set of chemistries is another area that can affect the food processor. The characteristics or kinds of residues these new compounds are likely to leave in both fresh and processed foods is also of concern, requiring the development of analytical methods to look for those in terms of being able to meet new tolerance requirements.

The third aspect of current concern to industry has to do with international trade. As new materials are registered, the profile of what is acceptable for sale with respect to meeting pesticide residue tolerances is changing very quickly. There are two sides to this concern. The first is from the standpoint of new materials being used in the U.S., which, as commodities treated with these chemicals enter into international commerce, raise export issues. Simply put, other countries aren’t necessarily keeping pace, which means that some of the new compounds may not have tolerances in foreign countries with which we trade. The question is raised over whether we are in sync with our trading partners and whether we are able to determine that given product meets the requirements of a foreign country. On the other hand, some of the compounds for which uses are being canceled in the U.S. are still allowed to be used in foreign countries. This raises the question of whether a food product from a foreign country that may have a standard and an approved use of a compound that now cannot be used in the U.S., can actually enter the U.S. The result is that we must make sure that foreign suppliers meet the requirements of the U.S.

Henry Chin: As Rick mentioned, FQPA has had some impact on analytical chemistry as applied to pesticide residues in foods, as well. If you look at the status of analytical methods for pesticide residues in foods, there has been a great deal of progress made not only in terms of detection limits but in terms of screening capabilities for the existing registered chemicals. As reevaluation and reregistration of pesticides under FQPA continues, new analytical challenges will come to the forefront, as new chemicals are introduced to replace the ones where the registration been canceled.

More significantly, the analytical challenge is also going be encountered in the determination of the methods for these new chemicals, as well as whether or not the new chemicals can fit into the established screening methodology. In the previous screening methodology, for example, you may have been able to do four tests and cover 100-200 pesticide residues; but newer chemicals that are introduced may or may not fit into those existing screens. So, the food industry will need to stay on top of these new challenges, as well.

Food Safety Magazine: Since pesticide residues do not currently appear to be high on the list of food safety hazards, why is it important that food companies address pesticide residues via testing and control programs?

Jarman: From a true human safety standpoint, the way FQPA has been implemented and the types of analyses that EPA has performed as required by the act have confirmed that pesticide residues in food are not a significant public health issue. However, as this information has been analyzed and issues raised during implementation of both FQPA and FIFRA, it has become clear that worker exposure to the OPs is a primary safety concern. Risks to human health posed by pesticide residues in foods has become even less of a concern as registrants have cancelled certain uses and/or retained registration for pesticides after confirming scientifically that the residues do or don’t pose a risk in foods. From the standpoint of any testing or monitoring of ingredients, FQPA essentially has raised a regulatory/legal compliance issue for the industry, more so than a food safety issue. Again, removal of tolerances from the books and the changing international trade issues are some of the real concerns for the food industry.

Chin: I would add that when we have talked to food companies about pesticide residues in foods, we’ve never predicated a need for testing on the basis of any concerns about health effects. If you look at the health risks of pesticides in foods, it comes in fairly low on the list of identified dietary health risks. Certainly, pesticide residue related health risks are far lower on the list than the potential health risks posed by pathogenic microorganisms and allergens, and even fall below nutritional issues on that scale. Thus, when we talk with food companies about pesticide residues in foods and testing, it is actually predicated on the basis of the regulatory, consumer and media issues involved.

Similarly, testing cannot be used as a control procedure; testing is only a validation process. The key is to have a good pesticide residue monitoring program in place, which involves several factors. In general, the food company needs to know its suppliers, to have a good rapport with growers and suppliers who are supplying the company with raw materials, so that everyone is on board with respect to the company’s goals involving pesticide residues.

In addition, not all companies want to accomplish the same thing. On one level, you want to make sure that you don’t have any illegal residues on your product, and perhaps the majority of companies will be satisfied with that standard. Then, on another level, there are companies that have their own individual standards to meet specific company objectives. So the first thing that a food company needs to establish is what it wants to accomplish from its residue control program. And second, there is a risk matrix decision that must be made by the food company when considering instituting a pesticide residue control program: Are you interested in avoiding regulatory problems? Or are you trying to make sure that 60 Minutes doesn’t come knocking at your door, saying, “Did you know that you’re using a chemical that has some experimental evidence for causing a certain adverse health affect?” The answers to these questions help guide the company in implementing a program that will help accomplish the stated goals.

Since pesticide residues won’t be identified as a hazard by most companies, it usually won’t be a part of a Hazard Analysis & Critical Control Points (HACCP) program. A lot of companies rely upon certification from suppliers and monitoring or checking occasional samples to make sure that those certifications are valid.

Jarman: Although instituting a pesticide residue control program is not something all food companies do in the same way, at some level, there is some attention paid by most companies. Some companies establish very stringent goals for themselves, and as a result, have fairly elaborate, multi-component pesticide residue control programs in place.

Chin: In fact, many food companies have field representatives, particularly companies that deal with agricultural commodities, and some companies
actually may give responsibility for the pesticide control program to the suppliers. The company receiving the raw product in many cases will check for pesticide residues on the incoming product, and the supplier will either provide a certificate of analysis (COA) or some other kind of certification to demonstrate that they are in compliance. Again, the purchaser will occasionally conduct periodic monitoring to ensure that all the certifications are as they should be. But, the bottom line is that no company can afford to do 100% testing for pesticide residues. There may be some companies that do very extensive pesticide residue monitoring, but it is going to be a very special situation.

Food Safety Magazine: Has FQPA had any positive impact on the food industry? How can industry work with regulators to ensure that we focus on the most sign if want challenges with regard to pesticide residues?

Jarman: One of the positive things that has occurred as a result of FQPA’s passage is that it raised the flag of the importance of—and actually industry’s demand for—decisions and analyses based on solid, sound science-based information, rather than on assumptions and theoretical estimates. Because decisions are based on scientific evidence, and with all due credit to EPA and the U.S. Department of Agriculture (USDA), the considerable investment and focus on trying to obtain and use quantitative, verifiable information, particularly with respect to food, FQPA generated data has quieted some of the pointing at a given chemical and attacking it without foundation. The plus side of FQPA really shows in cases in which the use of a chemical or even a detectable or traceable level of a chemical is being targeted as a real health concern, but in reality, is not a health concern.

With regard to how the food industry can work with regulators, the best way is to comply with the act and keep up with any changes in tolerances or trade issues brought forth by the implementation of the act. NFPA has attempted in various ways to explore the idea that the processed food industry might assist regulators with data collection, monitoring, surveillance and compilation of information about pesticide residues that could somehow be used in the decision making, but that really doesn’t fly. The food industry cannot compete with a $10-$15 million program at USDA, for example, for the purpose of meeting the criteria for representative, verifiable data collection, and so on, nor is the food industry well- equipped to generate data to put into EPA’s decision making process.

Food Safety Magazine: Given the complexity of the scientific challenges involved with FQPA mandates and the flux of new data on exposure/toxicity levels of pesticide residues, the challenges posed to food processors to implement science-based controls in a real-world setting appear to be difficult. Can you provide some tips on establishing a practical pesticide residue control program?

Chin: When a food company approaches NFPA with questions about establishing a pesticide residue control program, we sit down and discuss with them all the different considerations involved. It is truly a program that must take into consideration what the company wants to achieve and, knowing that you can’t do 100% testing, determining the level of risk with which the company is willing to live. I would recommend that the company know what is going on in the regulatory area, and talk with people who are familiar with pesticide residue analytical methodology and who know about the supply. These are the types of information that must be considered in the planning stage, so that the company can get a clear picture of the potential cost of such a program. During these discussions, the company may find the program to be very costly to implement, or from an operational viewpoint, that it may not be possible to implement in the facility on a “real-time” basis.

In fact, many companies enter into pesticide residue control program planning and development with high hopes, but quickly realize the practical challenges of dealing with a perishable commodity, for example, requires a certain amount of time that may not work in a real-world setting. If the company begins by saying, “We want to test everything,” the reality that pesticide residue analysis may take days to complete and that perishable commodities may not give you time to wait on an analytical result, will make you rethink the plan.

Jarman: I agree. In making the overall assessment and decision about instituting a pesticide residue control or monitoring program, the company must first determine what level of certainty they want—whether it is to a level of certainty in terms of meeting regulatory and legal standards, or whether it is to a level of certainty in meeting the internal company objectives in terms of pesticide residues—and then balance that with what can be achieved from both a technical and economic standpoint. As the analytical chemistry and our ability to determine the whole character of pesticides and how they operate in foods becomes more sophisticated, food companies with pesticide residue monitoring programs also will have to consider the analytical side. As Henry noted, the landscape is changing with regard to our ability to perform multiresidue screens and/or individual metabolite or active ingredient analysis, and so on. I think there are real implications for the whole analytical industry and capability within food companies, as well.

Rick Jarman is Vice President, Food and Environmental Policy, with the NFPA, headquartered in Washington, DC, where he manages regulatory and policy staff and focuses on domestic and international food issues of importance to NFPA member companies. Backed by an extensive resume spanning both governmental and private agencies, Jarman is responsible for recommending and implementing appropriate programs and positions concerning federal legislation and regulations with specific relevance to the NFPA member companies and holds primary program responsibility for environmental issues.

Henry Chin, Ph.D., is Vice President of NFPA’s Center for Technical Assistance. An expert in the chemistry and composition of foods and analytical techniques for the analysis of foods, Chin has published many articles on product-package interactions, pesticide residues in foods, the nutrient content and composition of foods, food toxicology, and analytical methods for foods. As Vice President of NFPA’s Center for Technical Assistance, he manages the technical assistance provided to NFPA member companies.