A Lactnet friend sent me this very good information.  It does show the researchers tried to minimize known and proven levels of harm.  I have a great deal of sympathy for the researchers involved, in trying to design this study.  The grabber is that they were to instruct participants on use of the pesticides according to manufacturers' instructions.  This is enough different from fully informing them of the dangers of using pesticides, even according to manufacturers' instructions, that it leaves a wide avenue for a Human Subjects Review Board to drive their objections through.

For an analogy, consider instructing participants on the correct use of infant formula according to the manufacturers' instructions.  Would there still be significant risk of harm to the infant?  Clearly so.

Or, perhaps the thalidomide story is even closer.  While the manufacturer's instructions were carefully distributed along with the drug (in Europe), there was sufficient concern in the mind of one woman in the US FDA that it was not distributed here. These instructions are NOT proof against harm.  They are just what the market and the government will allow them to get away with.

There is a reason we have so little good information about timing and dosage of certain drugs on the development of humans.  As soon as we find a pregnant or breastfeeding woman is using, it is our ethical obligation to intervene and try to influence her usage pattern.

Is there a "safe level" of pesticide use in home of small children?  I don't think there is.  It would be helpful if I had some data, though.

As a scientist who wants more information, I do hope enough smart people get together to figure out a way to collect this important data with an acceptably low level of harm (whatever that may be).

Arly Helm, MS, IBCLC




Just as an FYI, this information is from the EPA study outline at:  http://www.epa.gov/cheers/images/fact_sheet.pdf

All personnel associated with this study are trained in the proper uses of pesticide products. If a member of the study team observes or collects questionnaire data that suggests the inappropriate use of pesticides, he/she will immediately discuss proper pesticide use practices with the participant. For example, during the screening phase for the pilot study, one of the field technicians was faced with just such a situation. Upon entering the potential participant’s home, the potential participant showed the field technician the pesticide products that had been applied in the home that morning. One of the products was clearly labeled only for outdoor use. The field technician spent a considerable amount of time educating the participant on the proper use of pesticides. The field technician also brought the matter to the attention of the field team supervisor who made the DCHD staff aware of the situation.

What will be done if we find high pesticide exposures based on metabolites found in the urine?

During the study, urine samples will be collected from participating children during each visit to their home. Within a week, these samples will be screened for pesticide metabolites. The metabolites are indicators of the children’s exposures to pesticides. The measured levels of the metabolites will be compared to the Dose Levels used for exposure risk assessments for the organophosphate and pyrethroid pesticides as reported by the Hazard Identification Assessment Review Committee of the Hazards Effects Divisions of the Office of Pesticide Programs of the

U.S. Environmental Protection Agency. Dose levels for chlorpyrifos and diazinon are published in the Hazard Assessment of the Organophosphates (July 7, 1998) available at http://www.epa.gov/pesticides/op/chlorpyrifos.htm. The dose levels for the pyrethroid pesticides, although not yet published by the EPA, have been developed and are available for use by the EPA principal investigators in this study. For the purposes of this study, a10X Safety Factor will be used in addition to the conventional Uncertainty Factor (UF) of 100. This is consistent with the Food Quality Protection Act Safety Factors which are intended to provide additional protection for children. These dose levels are used by the EPA to perform the exposure risk assessments during the pesticide registration/re-registration process. Because we will compare the urine levels collected in this study with the dose levels used by the EPA for pesticide registration, we will have the same safety factor. If the levels for any of
 the metabolites measured in the urine of a study participant exceed the dose levels, the parent/caregiver of the study participant and Dr. Aaron Hilliard (Duval County Health Department - DCHD) will be notified. Staff from DCHD will then conduct follow-up with the study participant parent/caregiver on integrated pest management practices. Furthermore, any participants found to have exposures or urine levels of concern, the EPA will immediately conduct further investigations and seek measures to mitigate such exposures. This intense monitoring of the participants will help ensure that this scientific investigation is being done in a way that also protects the health of the participants if concerns are identified.



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