Sunday, November 27, 2005

Back in April, this seemed like good news:

The Environmental Protection Agency on Friday canceled a controversial study using children to measure the effect of pesticides after Democrats said they would block Senate confirmation of the agency's new head.

Stephen Johnson, as EPA's acting administrator, ordered an end to the planned study, a reversal from the agency's position just a day earlier...

Over the study's two years, EPA had planned to give $970 plus a camcorder and children's clothes to each of the families of 60 children in Duval County, Florida, in what critics of the study noted was a low-income minority neighborhood....

Sen. Barbara Boxer, D-California, had joined with Sen. Bill Nelson, D-Florida, in demanding the study's cancellation as a condition for confirming Johnson's nomination by President Bush....


Johnson, who was acting head of the EPA at the time, was confirmed as the agency's head a couple of weeks after that, and everything seemed copacetic.

Well, now the EPA is proposing new regulations for the use of human subjects in pesticide research, and the Organic Consumers Association has picked out a few odd passages involving children as subjects of such experiments:

70 FR 53865 26.408(a) "...If the IRB [Independent Review Board] determines that the capability of some or all of the children [in a study] is so limited that they cannot reasonably be consulted, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement..."...

70 FR 53865 26.408(c) "If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements..." ...

70 FR 53864 26.401 (a)(2) "To What Do These Regulations Apply? It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under § 26.101(e), waive the applicability of some or all of the requirements of these regulations for research..."


On that last one, the OCA explains:

This clause is stating that the Administrator of the EPA has the power to completely waive regulations on human testing, if the testing is done outside of the U.S....

These passages are buried in a huge pile of bureaucratese, so it's possible I'm missing a nuance here or there, but it seems to me that the EPA is trying to sneak in unethical practices under the cover of a regulation seemingly written to keep research subjects safe. (The regulation is called "Protections for Subjects in Human Research.")

EPA is accepting public comments on this until December 12.

(Story via Human at Carbon Paper.)

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