I’m going to talk about the Food Quality Protection Act. When I’ve done that in the past, I preferred to talk about agricultural uses of pesticides: why do farmers use herbicides? why do farmers use insecticides? What would happen if they were canceled? I talk about the benefits, if you will, of using pesticides. I always stayed away from discussing the risk issues. I thought they were too complicated for me. There’s a lot of science in risk assessments, you have to be a Ph.D. in toxicology to understand these things. I work in Washington, D.C .I have a B.A. in Public Affairs from George Washington University. I’m from East Peoria, Illinois. That’s about five strikes against me in terms of understanding any of these risk issues, but I tried to understand the risk issues last year. I found out that it’s easy to understand how EPA makes risk assessments. EPA makes them up. EPA makes up the risk assessments for pesticides out of thin air.

For other risk issues real world data are used to quantify the problem. We know how many people aren’t wearing seat belts and are dying in car accidents. We know how many people get sick from bacteria contamination when they eat their food.

Let’s contrast pesticide policy with air pollution policy. EPA has quantified the amount of reduced illness that resulted from cleaning up the air, quantified the number of days of lost work that were prevented by cleaning up the air, quantified the amount of laundry that did not have to be done as a result of cleaning up the air. EPA estimates that the benefits of cleaning up the air totaled $18 trillion over the last 20 years. And EPA calculates the cost of cleaning up the air over this same period at $500 billion. Now that’s something even the kid here from East Peoria can understand. The benefits are $18 trillion; the costs are $500 billion. That’s a policy that I can understand. It makes sense to go forward with cleaning up the air under the Clean Air Act. With regard to pesticides, there isn’t a single study showing that anybody has gotten sick from eating pesticide residues in food or water as part of a normal lifetime of eating and drinking.

The risk issue that has been studied the last several years because of the organophosphates is cholinesterase inhibition. There’s no evidence that anyone in the population is suffering from having their cholinesterase inhibited. If I could go back to East Peoria and tell people how this is a serious problem because 100,000 people had cholinesterase inhibition last year because of organophosphates, it really would make a difference in understanding the problem. But we don’t have any evidence that anyone’s cholinesterase was inhibited because of organophosphates. Some of the symptoms of cholinesterase inhibition are excessive sweating, nausea, and vomiting. We don’t have any estimates of the number of people who vomited last year because their cholinesterase was inhibited because they ate organophosphate residues. EPA doesn’t have any real world data at all to quantify any health problems due to pesticide residues in food.

So, what does EPA do? How does EPA make up these risk assessments? EPA uses mathematical models that contain lots of equations. There are default values, there are safety factors, there are various end point values. They extrapolate from rat tests. And basically there are two numbers; when all is said and done, there are two numbers of importance for each pesticide. The EPA says, "Well, here’s a number that tells you what the safe level is, and here’s a number that tells you what the exposure is. If this number, the exposure number, is higher than the safe level number then something’s got to be done. And basically what has to be done is to do something about the calculations because the problem isn’t out in the real world, it’s all in the calculations. EPA can change the assumptions; EPA can change the end-point values, The exposure can go from 10,000 down to 10. Change a few assumptions, change a little data, and that’s what I mean by "They can make it up out of thin air." For example, for supracide, EPA ran its preliminary assessment and reported that the dietary exposure was 600% higher than the safe level. In its revised assessment, EPA reported that the exposure was 95% below the safe level.

Let’s talk about one of these numbers in the risk assessments – the 99.9 percent rule. There are two data sets: one of food consumption, one of pesticide residues and they’re both for a particular crop. A distribution of the values of residues of a particular pesticide on grapes, and a distribution of the consumption of grapes. A random combination of the two data sets and all of a sudden EPA has calculated random estimates of the population’s intake of a particular pesticide on grapes. EPA distributes those values and says that these are estimates of the milligrams of that pesticide that the population is ingesting when they eat grapes, based upon the amount of grapes that they eat and the amount of residues in the grapes.

At 25 percent of the population, someone’s eating 5 grapes with 5ppm, at 50 percent someone’s eating 30 grapes with 2ppm, and out here at 99.9 percent there’s my best friend from third grade who ate 150 grapes at a single sitting (I do admit that he did get pretty sick) – and that extreme consumption value is combined with a residue value. That’s the person that EPA says it has to protect. That’s the basis of exposure values used in the calculation. The residue consumption value at 99.9 percent is the result of using outliers in the food consumption and residue data.

All that is really important from my perspective is that – if instead of picking the value at 99.9 percent, EPA steps back and says: we’re going to pick the value at 97 percent or 95 percent, the problem goes away because the 99.9 outliers are so dramatic that they drive the calculation of exposure way out of line. All EPA has to change is 99.9 percent rule to 95 or 97 percent. Again, the problem is there or not there depending on which number is used in the model.

In some of the assessments EPA has made, just for fun (to show you that they have a sense of humor), they have reported that they ran an extra calculation using 95 percentile and pointed out that there was no calculated problem for any population group. This was included in the assessment for phorate. This is just gratuitous fun, of course, designed to titillate us all. Since they are regulating at 99.9.

The EPA administrator could wake up tomorrow and say "Oh my gosh! Why don’t we change the rule to 95 percent?" The problem goes away with respect to the organophosphates. That doesn’t exactly inspire confidence with the folks in East Peoria that there was a problem to begin with. Arbitrary? You betcha.

Another number used in the risk assessments is the 1,000 fold safety factor. I don’t exactly know why it isn’t a billion fold or two fold. It could be any number really. EPA multiplies all the numbers of a pesticide by 1,000 if there is a missing piece of information or there is an inadequate rat test. Then the registrant comes around and says, "We’re doing a better lab study, we’ll be able to fill in the data gap, and EPA will be able to drop that thousand-fold safety factor." EPA gets the new study and revises the risk assessment, the default 1,000 fold safety factor gets removed and the risk calculations go down. It’s a game!

But then EPA says, "The calculations are in pretty good shape, but let’s negotiate some cancellations. We’d like you (the registrant) to make some changes with the label. Shorten some phi’s. Growers of some crops really don’t need the product. Let’s cancel it for those crops where it’s not used very much. There are some labeled uses that aren’t important. Let’s drop them." A lot of times the registrant will go along with this. EPA is willing to say the risk assessment is fine . The company doesn’t give up a very great market share, and EPA gets something: they get to say EPA has done something to mitigate risk for this active ingredient. So the process is a game!

The process isn’t "We have identified a serious human health problem in the United States; we can document that human health problem; it’s linked to this chemical; and here’s how many people are getting sick" It’s not like that at all. It’s a game. Instead of EPA saying, "Here’s a serious problem and here’s what we’re going to do to fix it." EPA goes into these risk assessments saying, "What can we get when we’re sitting down with the registrant and we’re negotiating about the label?"

What are some of the problems with this game? The first problem is sometimes the registrant may not play the game. This came up recently with Carzol. The EPA did it’s preliminary risk assessment with Carzol, and it had to use a thousand-fold safety factor because it didn’t have all the metabolism studies that it needed. The registrant was called in and said, "Well, we don’t have any better metabolism studies, and we don’t have any funds for doing a metabolism study. Let’s go right to some negotiations, let’s drop some big uses, and reduce this calculated risk." EPA said, "They’re not playing the game." So EPA called in commodity groups and said, "Well, the registrant’s not playing the game. Some important uses may be dropped right away." So the commodity groups are helping the registrants figure out what to do. Registrants have bottom lines, and not everybody will put up the amount of money to fill the data gaps. How much is UCB Chemical going to put on the table to defend ferbam, thiram, and ziram? Does anybody care? Is anybody looking down the road to see what is likely to be canceled voluntarily?

Environmentalists sometimes don’t play the game. Environmentalists have caught on to the fact that EPA plays a shell game. EPA says, "We’ve canceled 1,000 tolerances, and we’ve mitigated risk." Some environmentalists are saying, "Wait a minute we can document that these tolerances were never important. Nobody ever used the chemical associated with that tolerance; there are no detected residues associated with that tolerance." So, environmentalist are saying, "EPA is playing a game; it’s not serious; it’s not real risk reduction."

Of course, the environmentalists get to play the game a little bit further. If EPA were to change the 99.9 percent rule to 95 percent, then environmentalists could jump up and down saying, "EPA is caving in to the industry; they’re weakening the process." That’s the next step in the game. Every time EPA revises the risk assessment for an active ingredient, environmentalists get to say, "They’re caving in to industry." That’s part of the game.

Another wild card in the game are decisions by food processors and packers that can deny the usage of the chemical to the growers. The food processors and the packers will say, "We know this product is still registered, but it’s getting a lot of bad press! There are risk assessments on the web about these chemicals exceeding safety factors. We know it’s all preliminary, but we don’t want any of the growers selling to us using any of these compounds." So even when EPA has made no final decision, there can be a de facto ban on certain pesticides because the food processors, the packers play their own game.

The dietary risk assessment is just the beginning. Other games start. There are more calculations: occupational exposure, environmental effects, drinking water exposure, household exposure. It’s the same basic game, starting with assumptions and default values that lead to exaggerated preliminary risk assessments. More studies are done, real world monitoring data are brought in, EPA revises the assessment, and the problem goes away after some further tinkering with the label and after millions of dollars have been spent on the additional studies.

Recently EPA has changed its cancer assessment process. If a pesticide is a "likely" carcinogen, it’s going to need a cancer risk assessment. So chemicals that pass the first FQPA tests are going to be queued up to go through the cancer assessment, and still waiting in the wings are other assessments for endocrine disrupters. Millions and millions of dollars for additional risk assessments are going to be spent over the next several decades sorting all these factors out. The expectation is that everyone is going to hang in there, see it through and spend the money and pay attention.

Why is FQPA and pesticide regulation in general playing out this way? Well, first of all EPA is a regulatory agency and regulators regulate. They’ve been given the authority. They wake up in the morning and say, "Let’s go draft some federal regulatory notices. Let’s look at these lab studies. Let’s discuss. We’re toxicologists. This is our science. We’re lawyers. Let’s go after the bad guys. What are the options? To wake up in the morning and say, "There’s no problem here. There’s nothing to do here. Let’s say everything is OK and go home." Regulators regulate. They have power, they have power over every agricultural interest in this country, they have power over the chemical industry. They can get these companies to come in, groveling, very solicitous, taking all their calculations very seriously.

Crop consultants get up in the morning, and they say, "Let’s go walk some fields." Regulators get up in the morning and want to regulate.

Secondly, the EPA is a political agency. The people at the top of EPA have to go out publicly every so often, as they did in August. We all knew what they were going to do. At the three year anniversary of the passing of FQPA, the Administrator came out and said, "We’ve met the goal, we’ve reviewed all these tolerances, and today we’re canceling a couple of nasty uses of organophosphates." The risk assessments were preliminary; they could have been refined further. The people down in the trenches at OPP have got to give their political bosses those kinds of opportunities. It’s a political agency.

I think another reason EPA behaves this way is because the game has always been played this way. Even in the old days, when there were special reviews. It’s always been the same game. EPA came out with a preliminary risk assessment, proposing all these cancellations, but by the time EPA got to a final rule, they often would only have to cancel a few uses because they changed the calculations.

EPA has canceled some pesticides over the years for which predictions were made that growers were going to suffer significant economic losses. For the most part, it appears that bad things haven’t happened. Crop production is at an all-time high; food is cheap. EPA has paid no significant political price at all for any of their previous actions. So it is a safe game for the Agency to play. They continue to go through this procedure, and everything comes out OK. Their budget hasn’t been cut.

Finally, EPA with agriculture is dealing with a very weak adversary. The Department of Agriculture is very weak on pesticide regulatory actions. It has gotten 10,000 percent better (or is it a billion times better) in the last several years because of the activities of USDA’s Office of Pest Management Policy. I’ve worked with Al Jennings and his little band of merry warriors in the Office of Pest Management Policy. It’s a pretty small office for the kind of responsibility they have. There are 800 employees in EPA’s Office of Pesticide Programs, and four in USDA’s Office of Pest Management Policy. They get to see EPA documents first, before they go up on the web. That’s pretty good. It’s better than in the old days when they got to see them with everyone else. Although they get to see them, USDA does not have the authority or clout to stop EPA from proposing actions that they disagree with. EPA does not have to get USDA agreement on its actions before proceeding.

Not every Agency in Washington works this way. When it comes to ocean regulations, for regulations affecting activities in the oceans, EPA doesn’t do anything until NOAA approves. The Department of Energy is the same way. EPA and DOE work together for years developing a regulation. These agencies like NOAA and DOE can do this because they themselves have the expertise. They have invested $10’s of millions in the studies and expertise they need in order to work with EPA in developing the regulations that affect their industries. That has not been done by the Department of Agriculture.

Agriculture has no plan of its own. It can only react. What is the plan for apple pest management? What is the big vision thing for corn weed control for the U.S. To put it the other way, if you’re from EPA, you go to USDA and say, "What do you want, what is your vision with regard to managing these pests?" There’s no answer

Al Jennings’ group is addressing this issue now with the development of what are being called Pest Management Business Plans. USDA is pulling together documents for individual crops and identifying the pest management needs for those crops. For which pests and regions are older pesticides critically important? What research is needed to help reduce dependence on older chemicals? What new pesticides should EPA register to lessen dependence on older chemicals? USDA is working with commodity groups, crop consultants, extension specialists and growers to identify these needs. Hopefully, these documents can be used proactively to warn everyone about which older chemical uses should be preserved indefinitely because of absence of alternatives.

I think that’s a good start. I think that’s a very productive thing to do, but I think USDA needs to develop a whole hallway full of experts for particular crops. There are no pest management specialists at the federal level at the Department of Agriculture for any crop. I can’t open a door at USDA and say, "You’re the corn weed control guy. You’ve been keeping up with all the literature. You know what all the alternatives are." That person doesn’t exist at the federal level. Such a person would bring expertise into the process. On the other hand, USDA is filled with hallways of specialists in the Rural Electrification Program.

Contrast that with other industries: The Department of Energy has plenty of specialists who know the electric power industry very well. There are people who know the petroleum refining industry very well. They are experts, they are in Washington, DC and they participate in the regulatory process with EPA.

Here’s an example of the way things work currently with EPA and agriculture. Recently, EPA completed some work on TPTH, a fungicide. EPA said, "We think TPTH’s use on potatoes could be canceled. There are plenty of other Late Blight fungicides." The potato industry heard about this, prepared a document and convinced the Agency that TPTH had an important role to play in controlling diseases in potatoes. We can all bemoan the fact that EPA did a lousy job in determining the need for TPTH in potatoes. At the same time, we can all bemoan the fact that there was no proactive document for EPA to look at. Why wasn’t there a document named "Potato Disease Management: The Important Role of Fungicides"? If you’re a decision maker at EPA, you could look at that and say, "TPTH has an important role. We shouldn’t cancel it. Why is it reactive? Why isn’t it proactive? Every crop, every use, every registration needs documents that explain the importance of existing chemicals and such documents need to be kept up to date.

Agriculture is really alone in Washington, DC and has not learned to play the regulatory policy game.

The Office of Management and Budget could be a natural ally. There are really nasty people at OMB, accountants who like to use cost/benefit analysis to assess regulatory policy. Some Ag folks have gone to OMB and said that FQPA is going to cost a lot of money and deliver very few benefits. The guy at OMB says, "Show me your study." And there are no studies. There has been no investment in developing any kind of pesticide regulatory simulation models for any crop. If you were at OMB, or even EPA, and you asked simple questions: What would the effects be if the REI was lengthened for the crop? What would be the effects if EPA canceled this use but registered this new compound? All that can be done now is to provide ad hoc testimony and anecdotes. There is no organized national regulatory simulation model for any crop. The model should include every crop, every use, every region, every pest.

I must apologize to the risk assessment office at EPA. I disparaged the squishy nature of the calculations and assumptions in the risk models. But at least risk models exist. Data can be changed. Assumptions can be changed. Simulations can be rerun with new results. A tremendous investment has been made in the risk models, and they can be used with different data and assumptions. In the pest management area there are no models or simulation tools for public policy analysis. EPA policy makers must be able to do some simulation analysis. Where are the opportunities to register new insecticides? For which crops should OP’s be kept? All 80? 40? Should some OP’s be kept for certain crops while others could be canceled? What would be the aggregate costs of the regulations? By how much would the alternatives increase cost of production? Ten times? Is it a billion dollars in regulatory costs or $10 billion?

Let’s look at chlorpyrifos, for example. Dow has spent hundreds of millions of dollars on the risk side of the equation, but hardly anything on the benefits side of the question. There are people in DC who be interested in solid economic benefit studies – the Office of Management and Budget and Capitol Hill staff, for example. Why shouldn’t chlorpyrifos be canceled? Why shouldn’t 30 crops be taken off the label? Where are the studies? What would the economic impact be?

In contrast, for other industries such models exist. For example, there are about 10 big mathematical models for air pollution implementation. If Carol Browner wakes up tomorrow and says, "EPA is thinking about changing the NOX standards for power plants," these models will simulate impacts. The air pollution models include every industrial smokestack in America, and the models predict the effects on every plant if the rules are changed. These models exist because DOE and EPA have spent $100 million to develop them. They are public policy simulation models. Different models have different assumptions and produce different results. There are major conferences to sort out the differences.

I can already hear you people thinking, "Gee, apples orchards are 1,000 times (or is it 1,000,000,000 times) more complex than those clunky stationary power plants. Fields and orchards are dynamic: thousands of biological processes that change every year and that vary around the country. It would be impossible to build a realistic national simulation model for any crop. And they have to be kept up to date.

But it would be useful to start somewhere. The problem in a nutshell is that there is a regulator at EPA who is thinking, "What would happen if this REI were lengthened? What would happen if this use were canceled?" The objective should be to provide answers to those questions as early in the game as possible.

Let me mention some practical things that NAICC can do. I encourage you to keep working with the Office of Pest Management Policy, participate in the development of these transition strategy documents for individual crops. A lot of what we need information on, you people are the practitioners of. Maybe at the end of a season, if you could sit down and write a couple of pages on the season, in your state, in your crop, detailing what pests were present, what chemicals were used, and what the results were. I think the cotton industry does that real well with the Beltwide Proceedings. I can read that every year and get paragraph after paragraph for every state on what the insect situation was. We don’t have that for other crops. You could document what was used, what worked, what didn’t work, what was unusual. We need some documentation like that. Just jot down a couple of pages and send it in. Send it to EPA, send it to the Office of Pest Management Policy, put it in newsletters.

I think the other thing we need is organizing comparative product performance data. For those of you who are research consultants, EPA has hardly any organized way of getting at comparative product performance data. I was with one of the EPA entomologists last week. He had to come up with chlorfenapyr comparative performance data. He went to arthropod management tests and got the data from there. There is a whole bunch of data that he never saw. He had no data from anyone in Mississippi who had worked with chlorfenapyr. Why is that? Why can’t the comparative product performance data be organized? Maybe someone here wants to take three months off and come up with a plan or proposal. How do we get comparative product performance data to EPA?

How to summarize what is going on with respect to FQPA. There are a couple of take-home messages. One message is that everything is up for grabs. Every pesticide out there is subject to re-registration. EPA will be coming at each pesticide in a lot of different ways. It won’t just be dietary risk assessment. It’s worker exposure, it’s environmental, it’s cancer. There is no endpoint to this. This will never go away. It is not the Agency’s intention to say, "We are now closing the book on this pesticide. This pesticide is completely re-registered, and everything is fine with the registrations, and it can be used indefinitely." I don’t think it will ever get to that point for any chemical. Everything is up for grabs. Don’t take anything for granted.

My take on FQPA is that EPA inherited a lot of labels. These labels on older products, EPA didn’t set them up. These labels came from the old days at USDA. EPA is really interested in tightening up these labels. Over time, there will be fewer crops and fewer uses and more stringent requirements on older labels. New labels are under EPA’s purview right now, and they are being very cautious. New labels will not have these really long lists like for carbaryl or malathion or 2,4-D, where you can find a label somewhere that will allow you to do almost anything you want. EPA will not allow those kinds of labels any more. New labels will be very carefully drawn with maybe one use to begin with and others added if they’re really needed. It’s a different way of thinking. EPA inherited the old labels. EPA’s going to clean them up. New labels are under EPA’s control. EPA’s going to add to them very carefully. Agriculture’s need for pest control products needs to be articulated clearly and documented. Should the new labels be longer? What is agriculture’s plan?

What is the optimal strategy for pest management? Register every new pesticide for every crop? Is EPA simply going to dictate what the management strategies are through the labeling actions? How can that be optimal for pest management purposes? EPA is not responsible for making crops profitable to producers. There is no part of EPA’s mandate to help U.S. growers stay competitive with foreign producers.

It isn’t EPA’s job to design optimal pest management strategies for any crop. Gee – the design of optimal pest management strategies – that sounds like a job for independent crop consultants.

Stay interested and involved in the public policy process.