EPA to allow pesticide testing on orphans & mentally handicapped children

5. Should EPA adopt the sections of the HHS subpart D regulation it
has proposed to reserve, including 45 CFR 46.406, addressing ``research
involving greater than minimal risk and no prospect of direct benefit
to individual subjects, but likely to yield generalizable knowledge
about the subject's disorder or condition''; 45 CFR 46.407, addressing
``research not otherwise approvable which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the
health or welfare of children''; and 45 CFR 46.409, addressing
inclusion of wards in research approved under 45 CFR 46.406 or 46.407?
6. Under what circumstances, if any, should EPA be permitted to
rely in its decision-making under the pesticide laws on research
involving intentional dosing of children?

(replace "EPA" with "certain medical research facilities". sorry.)

Q&A Section

1) Question: I read on Snopes that this alert is false. Is that true?

Answer: 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 (http://www.organicconsumers.org/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 c****@org****consu****.org

...

However, I think the verdict, or at least the verdict on the degree of alarm thereof, is still out on this particular item, though.

Here's an early paragraph from the EPA rule: "With respect to human research conducted by EPA (``first-party research''), or by others with EPA's support (``second-party research''), this proposed rule would: (1) Categorically prohibit any intentional dosing studies involving pregnant women or children as subjects; and (2) adopt the Department of Health and Human Services (HHS) regulations that provide additional protections to pregnant women and children as subjects of other than intentional dosing studies."

Also interesting: "Although the Agency has never required or encouraged anyone to perform such tests, pesticide companies have sometimes chosen to conduct them and submit them to the Agency. For some two decades before passage of the Food Quality Protection Act (FQPA) in 1996, such studies were rare, but when they were submitted EPA considered them, and factored relevant information into its human health risk assessments. After passage of FQPA, submission of this kind of study to the Office of Pesticide Programs increased; the Agency has received some twenty studies of this kind since 1996."

So, pesticide companies are the ones conducting these studies on their own - they are not required by the EPA. The EPA rule would ban testing on any and all children as well as any and all pregnant women - no such restrictions are currently in place. The EPA is also attempting to decide if it will even accept data from intentional dose human studies inflicted on men and non-pregnant women.

The 45 CFR standards of testing the EPA wants to reserve addressing (i.e. not include) are from HHS, not the EPA. The EPA is stating it will not accept those sections of HHS subpart D.