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[Letter posted to queries from OCA supporters 11/29/2005]


Thanks for sending a message to us regarding your concerns about the accuracy of our recent EPA alert.

We apologize for any confusion folks may be having regarding our alert on the EPA proposed rule that allows testing of chemicals on children.

There is a lot of confusion circulating on this issue, and much of it is due to the EPA making false claims about the proposed rule. We are providing a myriad of external links on our alert page so you can research this topic more thoroughly. /old_articles/epa6.cfm There, you will find links to dozens of resources, including highly reputable organizations (like Natural Resources Defense Council and Public Employees for Environmental Responsibility) who support our stance on this problem and have issued similar alerts. You'll also find links to the actual proposed EPA rule as well as a large number of newspaper articles on the topic.

The EPA is proposing a rule that they would like to have approved. Anytime you are marketing a poor product, you sell its best points and hope that people won't look too deeply and find its flaws. The EPA website and the introductory description of the rule are very long winded and flowery, claiming this rule abides by the congressional mandate to ban all testing of women and children, without exception. In fact, if you read the rule, which is 30 pages of fine print, there are multiple exceptions. We have noted those in our template letter to the EPA and on our action alert page (and below).

Also, the EPA claims the rule bans all intentional dosing, but nowhere in the text does it actually do so. In fact, it provides exceptions for allowing what they refer to as "ethically deficient human research."

Congress mandated there be "no exceptions" to the rule. We are demanding the following exceptions be removed (the following are actual excerpts from the rule):

70 FR 53865 26.408(a) "The IRB (Independent Review Board) shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent...If the IRB determines that the capability of some or all of the children 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 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..."

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 53857 "EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient human research is found to be crucial to EPA’s fulfilling its mission to protect public health. This procedure would also apply if a scientifically sound study covered by proposed § 26.221 or § 26.421--i.e., an intentional dosing study involving pregnant women or children as subjects..."

(Read the full EPA proposed rule (PDF --- HTML))

Some of the confusion on this issue is also due to a dated posting by Snopes/Urban Legends regarding the CHEERS study. The Snopes/Urban Legends posting is actually in regards to an EPA proposed study called CHEERS and an alert we had sent out regarding that in late 2004
(/old_articles/epa-alert.htm). It is not directly related to this alert. The Snopes posting did a great disservice to that issue in their inaccuracy and lack of research into this issue. We spend massive amounts of staff time researching these issues, confer with outside experts on the topic, and cite dozens of references. The Snopes website, while valuable with most of its information, is not always accurate, and that is the case here. In fact, you'll find they reference only a couple of newspaper articles to backup their stance on this issue. Fortunately, enough concerned citizens, several nonprofits, dozens of mainstream newspapers, and many congress members, actually did their research on the EPA study and found that study was, in fact, very problematic. In fact, in early 2005, the EPA CHEERS study was permanently dropped, thanks to pressure from Congress. In August of 2005 Congress went a step further and mandated the EPA pass a rule that bans all testing of chemicals on children and pregnant women, without exception. That is what this alert pertains to. Snopes hasn't posted any information about this particular alert, and we hope they do their research this time. We ask our readers to do your research, as well. No single alert or single website will provide you with all of the information you need. We provided dozens of links on our alerts to external resources that allow you to further research and reference all of the information we provide. If you have questions, we're always happy to help out.

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