Pesticide Makers Attempt to Show EPA Their Products Are Harmless

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Misty

 

 

Pesticide Makers Attempt to Show EPA Their Products Are Harmless

 

Pesticide makers are hoping to persuade the EPA that if healthy

adults suffer no adverse effects after consuming a bit of pesticide,

then restrictions should be relaxed.

 

by Sharon Begley

The Wall Street Journal

 

The World Health Organization lists aldicarb, a pesticide, as

" extremely hazardous. " It calls the pesticide dichiorvos " highly

hazard-ous " ; the U.S. Environmental Protection Agency classifies it

as a " possible human carcinogen. " Yet, if you are healthy and up

for an adven-ture, pesticide makers will pay you $500, $800, even

$1,500 to imbibe in or the other, either once or daily

for 18 days with your morning OJ.

 

The controversy over the scientific value and ethics of testing

pesticides on people is approaching, full boil, spurred by intense

pressure from the pesticide industry to loosen federal pol-icies and

by a law suit that manufacturers filed against the EPA to make it

accept data from such experiments. At last count, 14 studies of 11

pesticides have been sub-mitted since 1996.

 

The push for human testing was triggered by the 1996 Food

Quality Pro-tection Act. In exchange for allowing traces of car-

cinogenic pesticides to re-main on food (previously illegal), the

act requires the EPA to use an additional " safety factor " in setting

allowed residue levels, to protect children and fetuses. Pesticide

makers have that safety factor in their cross hairs, hoping to

persuade the EPA that if healthy adults suffer no adverse

effects after consuming a bit of pesticide, then restrictions should

be relaxed.

 

 

THE RECENT EXPERIMENTS dosing people with pesticides haven’t

exactly covered themselves in glory, ethically speaking. In one

testing dichlorvos, in Scotland, many of the volunteers were cash-

strapped college students. The possibility of financial coercion

always is an ethical no-no. And in several places, the consent form

referred to dichlorvos as a " drug " and said it was used as a

medicine, misleading volunteers, as The Wall Street Journal

reported in 1998.

 

But leave aside ethics concerns for a mo-ment and focus on the

science, for unless an experiment on humans yields valuable data it

is by definition unethical. The argument in, favor is simple: " There

is no substitute for the knowledge gained from human volunteer

studies, " as Monty Eberhart of Bayer CropScience, a major pesticide

maker, puts it.

 

True ,but only in the abstract. The current round of studies have

used small numbers (10 to 50, typically) of healthy adults, raising

doubts about the studies statistical power. " If you see an effect,

you can be reasonably confident in that finding even if you used

only 10 or 15 people, " says toxicologist Michael Gallo of the

Environmen-tal and Occupational Health Sciences Institute in

Piscataway, N.J. " But to be confident that you have no

effect is much more difficult. You may just happen to have studied

10 people who are not sensitive to the compound. To prove a negative

you need many more people, " probably hundreds.

 

The existing studies border on junk science for another reason: You

can't volunteer for them unless you're a healthy adult. Given this

" voluntarism bias, " as epidemiologist Lynn Gold-man of Johns Hopkins

University, Baltimore, calls it, there are real doubts that a level

found to produce no adverse effects in such a group also is safe for

children, the ill and the elderly.

 

When you run a toxicology study, you don't ask, " So, what does this

chemical do, anyway? " You define an endpoint, such as, " How does

this chemical affect acetyl cholinesterase activity? " " This is the

basic fallacy of relying on these studies, " says Dr. Goldman, a

former EPA pesticide official. The critical effects are things like

developmental neurotoxicity in children and fetuses, and those might

reflect chemical pathways unrelated to whatever is causing toxicity

in adults. Organophosphate pesticides have been found to alter gene

expression in the brains of fetal rats, for instance, yet are tested

for how they inhibit enzyme activity in adult red blood cells.

 

 

BUT LET'S SAY the endpoints are chosen properly, and the tests have

enough subjects to offer statistical power. Let's say, too, that the

studies adhere to ethical standards. Are they OK now? You still

have an inherent ethical problem. When people volunteer to

test the safety of drugs, " those Phase 1 trials are for things in-

tended to make people better, " says bioethicist Jeffrey Kahn of the

University of Minnesota, Minneapolis. " If the purpose is to allow

industry to get higher levels of pesticides into the environment,

then it's very questionable. "

 

When an EPA Science Advisory Panel studied the acceptability of

experimenting with pesticides on people, it concluded in 2000 that

if the study is conducted with rigorous ethical controls, if there

is no other way to fill data gaps and if the goal is to protect

public health, then the EPA should consider it. " We felt that only

under the most extraordinary circumstances should human testing be

done, " says toxicolo-gist Ronald Kendall of Texas Tech University in

Lubbock, who chaired the panel.

 

Interestingly, very few experiments would likely meet those

guidelines. As Prof. Gall, who is viewed as sympathetic to industry,

asks, " For existing pesticides, where we have a great deal of human

data from epidemiology and biomonitoring of farmworkers exposed to

pesti-cides, why do we need these studies? "

 

Hoping for scientific and political cover, the EPA has asked a panel

of the National Academy of Sciences to answer that. Its report is

expected late this year.

 

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Does it concern anyone else that on top of everything else, the

study only lasts for 18 days? Can that really be representative of

a lifetime of ingesting pesticides?

 

Misty.