Part II -  EPA and Bayer striking deal on Guthion

Aug. 3, the third anniversary of the Food Quality Protection Act, was approaching. By that date, the EPA was supposed to finish reviewing 3,000 pesticide uses. In addition to finishing the reviews, maybe the EPA could announce a big decision. That would show progress. Inside the agency there was even talk of banning a pesticide. But in the EPA’s computers, as technicians continued to adjust the data, Guthion was starting to look less risky after all.

Part I: How politics shaped pesticide law
Part II: Weighing the risks of Guthion
Part III:  The history behind the pesticide law
Part IV: Why farmers favor Guthion

[ Pesticide Poisoning and Kids ] * [ Symptoms of Pesticide Poisoning ]
[ MEMORIAL TO VICTIM of PESTICIDE POISONING ]

Subject:   Why an apple a day may longer keep the Doctor away----
Date:        Sat, 12 Feb 2000 11:39:29 -0500
From:        Stephen Tvedten <steve@getipm.com>
Organization:     Get Set Inc. (www.getipm.com)

To:     Lyndon Hawkins <hawkins@empm.cdpr.ca.gov>
          State of California, Department of Pesticide Regulation
          Integrated Pest Management

Dear Lyndon, I thought you might like to read part two of the EnviroNews Service coverage of the Guthion "deal" entitled: Pesticide’s path of tests, acceptance - EPA, Bayer differed on strategies but finally struck a deal. Or, A staple of American diets, apples are farmed using pesticides, one of which has a controversial history. (Or, An apple a day may longer keep the Doctor away!) By Brent Walth and Alex Pulaski - NEWHOUSE NEWS SERVICE.

During their long tussle about how to regulate the pesticide Guthion, the Bayer Corp. and the U.S. Environmental Protection Agency had different ideas about the right method for determining just how much of the pesticide is actually dangerous for humans. Bayer favored tests with human subjects, instead of the EPA’s practice of relying on experiments with laboratory animals to find how pesticides act in the human body and measure health risks.

‘The results of this study will further confirm that the use of azinphos methyl does not pose an unreasonable risk to either workers or consumers." — FROM DOCUMENT GIVEN TO TEST VOLUNTEERS TO FIGURE the extra risks that might be faced by children, as the EPA was now required to do under the 1996 Food Quality Protection Act, the agency turned to still another method: a computer program that calculates the odds of children's (ignoring the elderly and sick people's) exposure to risky levels of pesticide (poisons) (fittingly, it’s named for a gambling mecca, Monte Carlo). On the company's side of the argument, Monty Eberhart, Bayer’s chief of product safety, has said for years that pesticides should be tested on (healthy, young) people, not just on laboratory rats.

"We must be prepared to argue," Eberhart told an Ottawa conference in 1993, "that human volunteer studies with pesticides are safe and humane and that they are required to protect the interests of society." After all, he reasoned, how can researchers expect to accurately measure how pesticides act in the human body if all their lab test subjects had four legs and a tail?

HUMAN TESTS - When the organophosphate pesticide azinphos methyl, better known by Bayer’s brand name of Guthion, became the first pesticide examined under the 1996 Food Quality Protection Act, Bayer turned to human tests to prove Guthion’s safety. (Lyndon, I thought that it was against the federal law to say even the labeled use of any "registered" POISON was "safe".) To Eberhart, it was just plain common sense. (To use a safer, more effective and less expensive alternative would be "illogical" in his opinion?) "All kinds of chemicals are tested on people all of the time," Eberhart said. "You add the word ‘pesticides’ and it becomes more sensitive and more of an emotional issue."

Normally, the EPA reaches its pesticide standards by calculating the dose (of only the active ingredient) that is found safe (does not acutely destroy) for lab rats. Then it reduces that amount by at least 100 times to account for the differences between animals and humans, and among individual people. The EPA calls this additional protection a "safety" or "uncertainty" factor.

Bayer and other pesticide companies say that human tests can eliminate the guesswork by showing that humans often react no differently to pesticides than do lab rats. Using human subjects has "value (if you simply ignore the dangers from all of the "inerts", synergism, etc.) to the public and to society," Eberhart said. "If you’re spraying pesticides or eating residues on your food, what would you rather have us relying on to keep you safe, rat data or human data?" Past human testing in the 1960s and ’70s had raised ethical doubts. In many cases, subjects had no idea they were being exposed to pesticides. But Eberhart felt strongly that human tests could be done ethically, particularly by spelling out the risks to volunteers and gaining their full consent.

BATTLE BEGINS - When word of human testing plans reached the Environmental Working Group in Washington, one of the advocacy organizations that track pesticide issues and have called for bans or cuts in organophosphate use, its president, Ken Cook, suspected that pesticide companies could use the results of such tests to get around the Food Quality Protection Act. "We’ve got to make a stink out of this," Cook declared at a meeting with other environmentalists. They had a sympathizer in Lynn Goldman, the assistant EPA administrator overseeing pesticide programs. Inside the EPA, Goldman had been fighting a battle over human testing. She believed companies such as Bayer were planning to use the human tests to undermine the extra protection for children that the new law afforded.

On July 27, 1998, the Environmental Working Group issued a report raising ethical questions about new pesticide trials in Britain. The same day, EPA officials released a statement saying the agency "is deeply concerned that some pesticide (POISON) manufacturers seem to be engaging in health-effects studies on human subjects as a way to avoid more protective results from animal tests under the new Food Quality Protection Act."

Yet Bayer was forging ahead, looking for (healthy, young) volunteers who would be willing to swallow (only the active ingredient in) pesticides for pay.

FIRST VOLUNTEERS - The company retained Inveresk Clinical Research Ltd. in Scotland, which selected 50 suitable test subjects. The disclosure documents it gave the volunteers before the tests predicted the outcome: "The results of this study will further confirm that the use of azinphos methyl does not pose an unreasonable risk to either workers or consumers." Inveresk also disclosed potential problems: "vomiting, diarrhea, abdominal pain, blurred vision, weakness, constricted pupils, excess saliva production, slow pulse and involuntary muscle twitching." "It is highly unlikely that any of these effects will occur," the disclosure form added.

Volunteers underwent physicals and blood tests, and their personal physicians were consulted. Any pregnant female volunteers were excluded. (Lyndon, every time I sprayed a "registered" organophosphate POISON, I watched the gravid {pregnant female} roaches abort! I used to ask ladies who had just miscarried if they had just been exposed to pest/termite "treatments" - virtually ever one of these dear ladies told me yes, they were exposed to some of your "registered" POISONS - just before they lost their child!)

On Sept. 14, 1998, the first two volunteers, both men, checked into Inveresk and awoke the next day for breakfast. One ate a placebo; the other washed down a Guthion (Did it contain all of the "inerts"?) capsule with 5 ounces of water. The clinic set the dose below the level that affected lab rats in past tests, but high enough to show that the EPA’s estimates of how much people can withstand are too conservative.

The volunteers stayed for three days, and researchers drew their blood eight times to see whether their cholinesterase levels had changed. Inveresk clinicians said they didn’t see an effect. (Lyndon, as you well know acute exposure has nothing to do with chronic exposure.) One week later, a second group of seven men took a higher dose. Again, Inveresk saw no effect. With the third, fourth and fifth groups, the doses went higher and higher and higher.

Finally, on Nov. 24, seven men were given the biggest dose yet — 1 milligram of Guthion for every 2.2 pounds they weighed. The dose equaled the amount Bayer believed was the "no effect" threshold reached in lab rats. If the subjects showed no ill effects, Bayer felt it would prove that Guthion affected people no differently than it did rats. The subjects swallowed the pills, and waited. A few days later, Bayer had its answer from Scotland. No matter how high a dose the Inveresk subjects received, Guthion didn’t affect them (healthy, young men). Bayer paired these results with another human trial the company conducted in the Netherlands, one intended to see how quickly the human skin absorbs Guthion. The Netherlands test confirmed results from a California test on prisoners 24 years earlier.

When Bayer presented its testing results to California officials early in 1999, the state agency agreed to drop extra worker protection requirements it had imposed the previous growing season. (No sense in protecting the pregnant women in California!) Bayer then proposed a compromise to the EPA: The company would support raising the waiting period for going into an orchard sprayed with Guthion to 14 days, the same amount of time California now required after rolling back its emergency restrictions. The EPA agreed, and the new rules went into effect in January 1999. Unlike the California authorities, however, EPA officials did not explicitly agree that Bayer’s human-subject testing could be considered.

RISK SIMULATION - Meanwhile, under the new law, the federal agency also had to measure the risk that children might be exposed to dangerous levels of Guthion. To meet that requirement, EPA officials began working last February with a computer simulation that mimics what kids eat in the real world and then, after the virtual kids have eaten the virtual apples, sets odds on how many of them may be exposed to risky levels of pesticides in their diets.

This type of program — named Monte Carlo, after the European gambling resort — is designed to determine the probabilities of random events, such as the chances that a child will bite into an apple that has risky levels of pesticides on it. The particular program EPA used was the Dietary Exposure Evaluation Model, or Deem, developed by a Washington, D.C.-based company named Novigen Sciences Inc. that has been a longtime consultant to pesticide makers. (It is always a "good" policy to let the foxes "guard" the chicken coop.)

To run the test, the agency had to establish a definition of acceptable risk.

Trying to protect all but one in a million children could be too stringent; protecting one in 10 would be too few. (What an attitude!) The EPA decided that no more than one in 1,000 of the computerized people should eat excessive pesticide (POISON) residues in their food. Even at that rate, the agency's computer would estimate that as many as 50,000 kids a day would get a dose the EPA considered too risky.

Michael Metzger didn’t believe the first numbers the EPA’s computer spat out. The calculations told him that by eating fresh fruits, especially apples, a child could face Guthion exposures 10,000 times above those the agency considered safe. Metzger, a branch chief in EPA’s Pesticide Reregistration division, knew the results were way off.

Past EPA risk estimates were based on worst-case scenarios. A 1997 EPA analysis concluding that Guthion posed a "serious health concern" was based on an assumption that Guthion was sprayed on 100 percent of the crops where its use was legal, Now, in February 1999, the agency’s computer had done the same thing. The result: wildly exaggerated estimates of pesticide exposure among children.

After the implausible result of the first computer run, EPA reprogrammed the computer to reflect, for example, the fact that only 82 percent, not 100 percent, of apple crops nationwide were actually sprayed with azinphos methyl. After that and other adjustments, risk numbers were lower but the results could still cause the EPA to severely limit or even ban Guthion after 43 years of use. (Lyndon, these "adjustments" totally ignore misuse!)

BLENDED RESULT - Meanwhile, Aug. 3, the third anniversary of the Food Quality Protection Act, was approaching. By that date, the EPA was supposed to finish reviewing 3,000 pesticide uses. In addition to finishing the reviews, maybe the EPA could announce a big decision. That would show progress. Inside the agency there was even talk of banning a pesticide. But in the EPA’s computers, as technicians continued to adjust the data, Guthion was starting to look less risky after all.

Then they realized that the computer was scoring the pesticide residues on applesauce the same way as those found on a single apple. But applesauce is a blend of many apples. As a result, the computer should have looked for an average residue number, not one that could have spiked up because one apple in the program’s data banks might have had a big dose of Guthion on it. Bayer officials provided an estimate of how Guthion’s toxicity fades when cooked. EPA officials adjusted the estimates again. This time, in general, the virtual one-in-a-thousand child was right on the edge of the daily Guthion limit the EPA would allow. (If you simply ignore TOTAL pesticide exposure!)

The subset of children between 1 and 6, however, were still over the line. No matter how the EPA revised, after that, the numbers barely budged. The new law required the agency to weigh the total risks from similarly acting chemicals, especially organophosphates. Now, the EPA’s computer (even with all of the "adjustments") had shown that the food uses of one organophosphate, Guthion, represented all that risk by itself.

DEAL REACHED - In early July, EPA officials summoned executives of Bayer Corp. and the U.S. Apple Association to hear an unwelcome message: Bayer had to propose dramatic cuts in the use of Guthion. If the company couldn't find a way, the EPA might move to ban Guthion.

Bayer and apple industry officials were taken aback by the sudden urgency. But Bayer executives believed they could save Guthion if they could convince EPA officials that they were being far too conservative in how they measured the dose and drew the lines on risk.

The company thought its tests using human volunteers (none of which was between the ages of 1-6) in Scotland proved Guthion was safer than the EPA made it look.

But agency officials balked at accepting the test, citing ethical concerns about pesticide companies’ use of people in chemical trials.

Rather than resorting to time-consuming and expensive hearings, the EPA sought a deal with Bayer.

Though workers’ safety isn't addressed in the Food Quality Protection Act, the EPA opened the negotiations on that issue. Eventually, the agency agreed to the same rules for workers that had been adopted by California. Those standards were set after Bayer presented the evidence of its human-subject trials in Scotland, so, although officially ignored by EPA, the human testing did seem to influence the outcome after all.

Another issue was how long before harvest growers should stop spraying Guthion. The longer the wait, the less pesticide (POISON) would remain on picked fruit. After a fight, Bayer agreed to increase the existing 14-day pre-harvest spray limit (Label limit- but, as you well know, not everyone follows the label, Lyndon.) to 21 days — but only if growers were allowed to use heavier Guthion doses.

How about the total amount (of POISON) sprayed during the season? The existing rule capped the total use at 6 pounds per acre during the year. The EPA proposed cutting that to 4.5 pounds. Bayer agreed.

With only hours to go before an Aug. 2 news conference, the EPA and Bayer struck a deal. Guthion’s trial under the Food Quality Protection Act was effectively over.
Part I: How politics shaped pesticide law
Part II: Weighing the risks of Guthion
Part III:  The history behind the pesticide law
Part IV: Why farmers favor Guthion

Brent Walth and Alex Pulaski are staff writers with The Oregonian of Portland, Ore. © 2000 Newhouse News Service.

Well Lyndon, it appears that the Food Quality Protection Act should now be renamed to "LET'S MAKE A DEAL"!

Respectfully, Stephen L. Tvedten