ALERT: EPA PROPOSES TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDREN

[nosmokes]

original

ALERT: EPA PROPOSES TESTING CHEMICALS AND PESTICIDES ON ORPHANS & MENTALLY HANDICAPPED CHILDREN

Send a letter to EPA here!

Forward this alert to friends and colleagues

Tuesday, November 15, 2005

Public Comment Period Closes
December 12, 2005

Public comments are now being accepted by the Environmental Protection Agency (EPA) on its newly proposed federal regulation regarding the testing of chemicals and pesticides on human subjects. On August 2, 2005, Congress had mandated the EPA create a rule that permanently bans chemical testing on pregnant women and children. But the EPA's newly proposed rule, misleadingly titled "Protections for Subjects in Human Research," puts industry profits ahead of children's welfare. The rule allows for government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations:

1. Children who "cannot be reasonably consulted," such as those that are mentally handicapped or orphaned newborns may be tested on. With permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
2. Parental consent forms are not necessary for testing on children who have been neglected or abused.
3. Chemical studies on any children outside of the U.S. are acceptable.


Send a letter to EPA here!

OCA's focal concerns with this proposed rule specifically involve the following portions of text within the EPA document (Read the full EPA proposed rule here: PDF --- HTML):

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..."

(OCA NOTE: Under this clause, a mentally handicapped child or infant orphan could be tested on without assent. This violates the Nuremberg Code, an international treaty that mandates assent of test subjects is "absolutely essential," and that the test subject must have "legal capacity to give consent" and must be "so situated as to exercise free power of choice." This loophole in the rule must be completely removed.)

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..."

(OCA NOTE: Under the general rule, the EPA is saying it's okay to test chemicals on children if their parents or institutional guardians consent to it. This clause says that neglected or abused children have unfit guardians, so no consent would be required to test on those children. This loophole in the rule must be completely removed.)

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..."

(OCA NOTE: 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. This will allow chemical companies to do human testing in other countries where these types of laws are less strict. This loophole in the rule must be completely removed.)

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..."


(OCA NOTE: This clause allows the EPA to accept or conduct "ethically deficient" studies of chemical tests on humans if the agency deems it necessary to fulfull its mission. Unfortunately, the EPA report sets up no criteria for making such an exception with any particular study. This ambiguity leaves a gaping loophole in the rule. Without specific and detailed criteria, it could be argued that any and every study of chemical testing on humans is "necessary." This loophole in the rule must be removed, based on this inadequacy of criteria and definition.)

Send an email to EPA here!

Forward this alert to friends and colleagues

By mail: Send two copies of your comments to:
Public Information and Records Integrity Branch (PIRIB)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Mail Code: 7502C
1200 Pennsylvania Ave., NW
Washington, DC, 20460-0001
Attention: Docket ID Number OPP-2003-0132

[Algorem]

1. sounds very 3rd Reich-ish

[converted_democrat]

4. That is the first thing that crossed my mind too. This isn't the first

time they have tried this though, they tried to get poor families here in FL to let them test pesticides/chemicals on their children for a monthly check. I don't know what I did with the article, but this was within the last 6-8 months.


on edit- I left a word out.

[Lindsay]

8. I remember that.

Nelson and Boxer got them to back off.

But we just had to know they weren't going to give up the idea, just bring it back under some other disguise.

[truebrit71]

2. What kind of testing are we talking about here??

Holy shit! This is soooooooooooooo Nazi germany as to be almost unbelievable...

[Media_Lies_Daily]

3. Eugenics, pure and simple. A favorite subject of the Busch Family.

[Arugula Latte]

5. What the Hell?

I thought this was going to be a joke. :wtf:

[driver8]

9. So did I. Is this true??? WTF???

That first paragraph, alone, was enough to send shivers up my spine. What's next? Medical experiments on twins?

I swear this whole country is absolutely fucking crazy.

[The Backlash Cometh]

35. We should deport every person that was in favor of this.

Because they are definitely not upholding American ideals.

[SoCalDem]

6. They never let go of a bone, do they?

This shit came up LAST year, and they werte forced to step away from it. Last year, they were planning to PAY poor mothers to enroll their kids in a :study"..Seems to me they were planning to pay them $900 a child..

Radio stations went ballistic, and they backed away from it..

I guess republicans ARE into recycling:cry:

Only now orphaned kids will not have Mom & Dad there to watch out for them..and handicapped kids are not able to speak up for themselves to complain about it.

[tigereye]

7. um tested for what?

for exposure to toxic agents? Then it might make some sense.

There are incredibly high ethical standards for most studies...this doesn't sound right. How about a bit more info.

[MrMonk]

12. Agreed

How about a link to the entire rule?
You managed to keep the link to demaction.



Found the link:

http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm

[nosmokes]

25. i managed the link to OCA where i copied this from

but in complying withDU's copyright rules i edit it to 4 paras.

and if you clicked on the link that said original you found the complete text of the proposals, which also includes provisions for doind some of this testing overseas, where i'm sure the standards will also be scrupulously upheld. just like the no torture provisions in the prisons that don't exist...

[MrMonk]

27. As I noted in my post

made long before your post immediately above (and to which you long ago replied), I found the complete EPA rule. (HINT: it's linked from your source.) The OCA article does not present the complete rule, only selected paragraphs. The rule does not include any provision allowing the EPA to conduct or support overseas studies that involve intentionally dosing children with chemicals or pesticides. EPA has no jurisdiction overseas. The rule does allow the use of data generated by such studies, under narrow circumstances.

You seem concerned that the U.S. Gov't will somehow try to circumvent the proposed rules, if they are adopted. That's a completely different issue than concerns over what the rules would allow. The issue that you raised in the OP involves the scope of the proposed rules and that is what I have been addressing.

[nosmokes]

28. you're spot on, mr monk. i don't trust this admin as far

as i could toss 'em. and i have real problems with the proposed rules and how they'll be enforced. first off congress mandated that the EPA draft a rule that banned testing of chemicals on pregnant women and children, secondly, this proposal is named * protections for human research subjects* or something similiar. now if history proves to be any sort of guide, if this protects research participants as well as the clear skies initiative has kept our skies clear, or the healthy forests act has protected the forests, or the clean water bill has cleaned up rivers and streams and bays, then i wouldn't allow my mother-in-law to be a research participant...

[marylanddem]

10. This is horrific - I will write them. nt

[nadinbrzezinski]

11. Ah the Third Reich ... but don't call them Nazis....

[Igel]

13. You don't give enough information for me to form an opinion.

If I had an autistic kid and they were doing clinical trials for some drug, they'd be asking my permission to test a chemical on a child that was unable to give consent. If that were never allowed, no such research could ever be performed.

In fact, there's a huge problem with precisely *not* knowing the effects of numerous approved chemicals on kids--insecticides, preservatives, drugs, chemicals in the environment. Their exposure is different, and their physiology is different. Like it or not, drug and other chemical testing on kids is pretty much required. If some company asked me to include my kid in testing--and if the kid was already exposed to the chemical in the manner and to the extent needed in the protocols--I'd probably say OK.

We also know that children in their first year respond differently than older kids: and these can *never* give their consent. Meaning, I suppose, that we should never let our kids near any chemicals. Unfortunately, infant formula's made of chemicals. So either we need a wet nurse industry, infant testing, or we have to say we're fine with not knowing the effect of the various chemicals (lic. supplements) in formula on infants. Personally, having had to use formula, I want to know that after doing animal studies they did some sort of infant studies.

On edit: The quotations are rather selective, actually, and are far from constituting the entirety of the regulations; the regulations, moreover, incorporate all Federal, State, and local laws. As for unethical research, there's a reasonable discussion of it, showing the various concerns and benefits. No serious objections. Unless I rely on the OCA's quotes, and assume massive ill-will on the part of the EPA.

[earth mom]

14. You have got to be FUCKING KIDDING ME!

Your answer is about the most disgusting thing I've read next to the EPAs disgusting plan upthread. :puke:

Do you even have kids of your own???!!! :grr:

[Igel]

55. Yes. I have one kid, currently.

And I like to know that the chemicals that he's exposed to, the drugs that he takes, and the materials that are used in the carpet and for fire-retardance have been tested on people that will have the same kind of physiology that he has.

Read carefully, if that's possible: I'm not saying take previously untested chemicals and expose only mentally challenged kids to them that would otherwise never be exposed. I'm saying that if you never test a chemical--whether it's used in clothing or food or medicine--you don't know what you're exposing a toddler or infant to. I don't like blind ignorance performed in the name of "If we don't test, it must be safe."

We could just do all our testing on yeast cells in a beaker, and, well, if human's react differently from single-cell organisms, too bad. We'll know only when there are die-offs and cancer rates. We see that as it is, *with* testing, but the problems tend to be at the margins or with conflicting results. That solves that problem: no unambiguous or conflicting testing results for kids; no results at all. Welcome to your world, in which thalidomide-type events become much more common, but only among the most vulnerable segments of the population. But since they can't speak for themselves, we can. Oh ... wait ... that's the opposite of what you imply. We can't speak for them.

You want to use tylenol on your kid, you'd better hope that some EPA wonk authorized child safety testing on it, otherwise you're hoping to some unnamed deity that they didn't have their collective heads up their asses when they declared it safe.

I also don't assume that the EPA is a horrible monster out to perform Frankensteinish experiments on kids, and that anybody that goes to work for it is a moral and ethical midget. If so, we should immediately disband it: Surely that's not a call for abolishing the EPA I read in your posting.

[earth mom]

58. If you think this testing is so great-Let YOUR kid be the guinea pig!

Oh, that's right, it's YOUR kid-can't have that now can you? :sarcasm:

[sinkingfeeling]

15. Done. Wonder what they didn't understand about the Congressional

mandate.

[MrMonk]

16. It's an outright lie.

Not criticizing the OP, but rather his source.

The proposed rules contain the following two provisions (emphasis mine):

Sec. 26.420 Prohibition of research involving intentional dosing of
children.

Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.

Sec. 26.421 Prohibition of EPA reliance on research involving
intentional dosing of children.

In its regulatory decision-making under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall
not rely on any research involving intentional dosing of any child,
except when such research is deemed scientifically sound and crucial to
the protection of public health, under the procedure defined in Sec.
26.603.

In view of 26.420, and in accordance with the background information provided in the federal notice, 26.421 must refer to third-party investigations not under the jurisdiction of the EPA. The background information also clearly states that EPA's intent is to institute a categorical ban on intentional dosing of children. This is so clearly stated in the background and the proposed reg. that there is no excuse whatsoever for the OP's source to declare that EPA proposes testing pesticides on orphans and disabled children. I consider the source's statement to be an outright lie.

[nosmokes]

18. an outright lie huh? you trust the gov't that much?

then why is this clause in there at all?

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..."


why are are there memos defining torture if we don't torture?

[MrMonk]

19. Subpart A

of which 26.408(a) is only one paragraph, addresses "Basic Federal Policy for Protection of Human Research Subjects". The regulations under Subpart A pertain to *all* human test subjects. 26.405 requires both permission from parents/guardians *and* assent from children. 26.408(a), among other things, identifies exceptions.

However, without regard to what 26.405, 26.408 or any other paragraph of Subpart A says, intentionally dosing children with pesticides or other chemicals is categorically prohibited under 26.420 and the use of third-party data from studies in which children were dosed is provisionally prohibited by 26.421.

What part of "prohibited" don't you understand?

On edit: corrected paragraph numbers.

[converted_democrat]

20. You do know that they tried to use poor children in FL as test subjects

in the past?? It was 6-8 months ago, and Nelson and Boxer led the way to stop it from happening. They wanted poor parents to sacrifice their children for testing, in return for a check. You do know that did happen, right? I'm not the only one on the board that remembers it.

[MrMonk]

21. Show me.

Anyhow, the focus of the OP is on the proposed regulations, and that is what I have been discussing.

[converted_democrat]

22. There ya go!

http://www.organicconsumers.org/school/cheersvictory041105.cfm

on edit--more at link
http://www.theothernews.com/article.asp?dept=1&category=137&article=519

snip-
They call it CHEERS. The "Children’s Environmental Exposure Research Study" is a cooperative agreement between the Environmental Protection Agency and the American Chemical Council. The Chemical Council will provide $2.1 million of the $9 million dollar study—the rest coming from our federal government.

But there’s nothing cheery about CHEERS. The acronym is deliberately misleading and, when examined, downright scary. This time, the government is protecting an unethical study that actually exposes children, including babies, to some of the chemical industry’s most noxious poisons. Who is the EPA protecting? The health of American children? Or the profits of American corporate interests?

Parents of children in the CHEERS study must agree to routinely spray or have pesticides sprayed inside their homes during the two-year study period, according to Chemical & Engineering News. Chemical concentrations will be measured in air, dust, and urine samples of the children, and by analyzing chemicals absorbed in clothing before and after pesticide applications.

[converted_democrat]

26. Have you read the links yet?? What do you think?n/t

[MrMonk]

29. Yes, I've read them. I also took the time to do a little research.

The links that you posted lead to two pages that include the same statement. I don't accept the OCA as a source, because they completely botched their presentation of the proposed reg's addressed in the OP.

I think that there is a misunderstanding as to the CHEERS test protocol, and it goes back to an unfortunate mis-statement in the cited article in C&E News (October 18, 2004?). I lost the link to the article, but it is online. In its description of the protocol, the article says something like this: "All participating families must spray or have pesticides sprayed inside their home on a routine basis."

Now, what the hell does that mean. Does it mean that the family must be one that already uses pesticides on a routine basis, or that the family must begin using pesticides on a routine basis? On the face of it, it seems implausible that the EPA would require a family to institute a routine practice of spraying poison in its home simply to collect exposure data. Unfortunately, the original CHEERS protocol is no longer online.

What I did find were a huge number of sites that made statements similar to that on the OCA site, and a smaller number of other sites that apparently contained some original writing. For example, the American Chemical Society (ACS)(http://www.chemistry.org/portal/a/c/s/1/feature_pol.html?DOC=policymakers%5Cpol_housechem.html) says:

"The research is a collaborative effort with Florida’s Duval County Health Department and the U.S. Centers for Disease Control and Prevention. It would follow 60 children, aged 3 and under, for 2 years. Families would keep records of their use of pesticides and household products, and children would be monitored in their homes, according to EPA. The agency’s National Exposure Research Laboratory would coordinate the project."

There's nothing in the article about instituting a pesticide spraying program.

The Environmental Working Group (http://www.ewg.org/issues/humantesting/20041029/letter_20041015.php) objected to the partnership between EPA and the chemical industry in conducting this study. If there had been a legitimate concern regarding the institution of spraying programs in homes, I don't think that the EWG would have missed it. The EWG does note ethical concerns regarding the protocol itself (http://www.ewg.org/issues/humantesting/20041029/release20041223.php), but, again, makes no reference to the institution of in-home spraying programs. I also recommend reading the Congressional letters to the EPA, which are linked from the above-cited web page. One of them cites the EPA's intent to cease the study at homes where pesticides were being improperly applied and to educate the parents at such homes in the proper way to apply insecticides.

The Main Organic Farmer’s and Gardener’s Association (http://www.mofga.org/mofgm05n.html) finds ethical problems with the protocol:

"The CHEERS project was criticized for its offers of cash rewards and camcorders to families that regularly spray pesticides in their home. Although the Web site for the study promised, "EPA will not ask parents to apply pesticides in their home to be a part of this study," offering prizes may encourage families unaccustomed to using pesticides in the home to change their habits to become eligible. Clinics and hospitals selected as recruitment sites in Duvall County predominantly serve low-income communities and a greater proportion of African Americans than the rest of the county, thus children from low income communities of color are likely to bear the greatest risks in this EPA-led study."

MOFGA also cites its concern that the EPA protocol does not properly educate parents as to risks of pesticide use. I think that issue is addressed in one of the Congressional letters.

(BTW, this appears to be the only site that actually quotes part of the protocol.)

I share some of the concerns expressed by EWG and MOFGA, but I don't believe that the EPA ever intended to increase hazards to young children beyond those that they were already experiencing.


As for the timing of my reply, please note that I don't hang around online to see if anyone replies to my posts. Research also takes some time.

[converted_democrat]

30. I'm sorry, but I don't buy it....

-I share some of the concerns expressed by EWG and MOFGA, but I don't believe that the EPA ever intended to increase hazards to young children beyond those that they were already experiencing.-

http://www.ewg.org/issues/humantesting/20041029/letter_20050124.php

http://www.fluoridealert.org/pesticides/cheers/cheers.duval.htm

On Friday, April 8, in the midst of Senate hearings on his nomination to head the U.S. Environmental Protection Agency, Stephen Johnson issued a defensively worded statement announcing the cancellation of the CHEERS study in which parents would be paid to spray pesticides in the rooms occupied by their infant children under age 3. Johnson did not admit any ethical problems with the study but nonetheless concluded the study could not go forward due to an atmosphere “of gross misrepresentation and controversy.”

http://www.fluoridealert.org/pesticides/cheers/media.documents.html
(link shows chemicals to be monitored half way down the page)

http://www.house.gov/corrinebrown/ccorner109/cc_050408_cheersstudy.htm
-snip-
Senator Bill Nelson acted quickly putting a hold on Johnson’s nomination process pending the investigation of the CHEERS program. The program had undertones reminiscent of Natzi Germany trading $970, a camcorder and a t-shirt for the health and well being of Duval County’s future, our children. The study would “monitor” the effects of indoor pesticides on babies 0-3 years of age, yet there was no reason to believe that the participants would be informed about incorrect use of pesticides that would abnormally affect the children. As a standard practice EPA recommends that all children are kept away from all pesticides because the ingredients pose some health risks. However, participants in this study would actually be encouraged to continue use of these harmful chemicals. This is in direct contradiction to these principals.

http://www.panna.org/resources/panups/panup_20041201.dv.html
-snip-
The CHEERS project was criticized for its offers of cash rewards and camcorders to families that regularly spray pesticides in their home. Although the website for the study promises, “EPA will not ask parents to apply pesticides in their home to be a part of this study” the offering of prizes may encourage families unaccustomed to using pesticides in the home to change their habits to become eligible. The clinics and hospitals selected as recruitment sites in Duval County predominantly serve low-income communities and serve a greater proportion of African Americans than the rest of the county, thus the children from low income communities of color are likely to bear the greatest risks in this EPA-led study.

[MrMonk]

31. In brief ...

http://www.ewg.org/issues/humantesting/20041029/letter_...

Expresses concern about ethics of study because EPA would be in position of standing around and watching while children were exposed to pesticides. I agree. But there is nothing about paying parents to start spraying pesticides.

http://www.fluoridealert.org/pesticides/cheers/cheers.d...

"announcing the cancellation of the CHEERS study in which parents would be paid to spray pesticides in the rooms occupied by their infant children under age 3." This is misleading. There is a big difference between paying someone to participate in a study in which they continue to do what they have been doing, and encouraging them to spray pesticides in their children's rooms.

http://www.house.gov/corrinebrown/ccorner109/cc_050408_...
-snip-
"reminiscent of Natzi Germany" a rhetorical trick, and incendiary to boot
"there was no reason to believe that the participants would be informed about incorrect use of pesticides that would abnormally affect the children." Incorrect. EPA said that they would inform parents, if they observed improper application (see one of the Congressional letters). There is still an ethical concern, because the parents should be so instructed at the start of the study, and such information should be made available to any parent without regard to their participation.

http://www.panna.org/resources/panups/panup_20041201.dv...

I addressed this in my earlier post. These are legitimate concerns, but they do not demonstrate bad faith on EPA's part.

And this is from me:
The study is not ethically sound (it may also not be scientifically sound, but I won't discuss that). However, there is no legitimate reason for implying that the study protocol was intended to do anything more than monitor exposures and outcomes as a family went about its normal, everyday business.

On edit: This finishes me for the day. Me go off-line now? Bye-bye.

[chalky]

47. Well, when ever you get on-line again, please attend to nosmokes

unanswered question: "why are are there memos defining torture if we don't torture?"

I believe I rephrased that question when I asked about the need of an IRB.

Still waiting for a coherent answer for this seeming anomaly.

[MrMonk]

50. Bad analogy

In your analogy, a definition of torture would be needed so that one knows what is prohibited. But your premise is inaccurate. The key document that Gov't produced with regard to torture is not a definition, but rather methods suggestions on how to conduct torture. As I have explained, repeatedly and painfully, is that the exceptions to assent and permission in 408 apply to all tests having human subjects EXCEPT for dosing tests on children (or pregnant women, fetuses, etc.) which are categorically prohibited. Read the proposed rules and think about the context of each paragraph. Don't just mouth the words.


:banghead: :banghead: :banghead: :argh:

I'm outa this thread. It's been like trying to explain exposition to a pack of dogs.

[chalky]

46. So exactly WHY do we need the IRB to determine the child's ability to

consent, since dosing children is prohibited?

[MrMonk]

48. Because there is more to the regulation than the prohibition

against dosing children. The paragraphs that OCA is misleading you about deal with health studies in general. Dosing children is expressly forbidden, but the quoted paragraphs deal with other studies. I linked to the federal notice. Read it.

[chalky]

51. I DID READ IT. I think YOU may need to go back and read it.

Let us start with Section 26.401:

Sec. 26.401 To what do these regulations apply?

(a) This subpart applies to all research involving children as
subjects, conducted or supported by EPA. This subpart also applies to
all research involving children covered by Sec. 26.101(j).
(1) This includes research conducted by EPA employees, except that
each head of an Office of the Agency may adopt such nonsubstantive,
procedural modifications as may be appropriate from an administrative
standpoint.

Now have we cleared up who and what it covers? These are their words, after all.

Let's journey on down to section 26.420:
Sec. 26.420 Prohibition of research involving intentional dosing of
children.

Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.

Now, "notwithstanding any other provisions of this part...." usually means, "unless we've said anything to the contrary above." Section 26.405 is to the contrary. Now let us go back and read section 26.405, shall we?

Sec. 26.405 Research involving greater than minimal risk but
presenting the prospect of direct benefit to the individual subjects.

EPA will conduct or fund research in which the IRB finds that more
than minimal risk to children is presented by an intervention or
procedure that holds out the prospect of direct benefit for the
individual subject, or by a monitoring procedure that is likely to
contribute to the subject's well-being, only if the IRB finds and
documents that:
(a) The risk is justified by the anticipated benefit to the subjects.
(b) The relation of the anticipated benefit to the risk is at least
as favorable to the subjects as that presented by available alternative
approaches.
(c) Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians, as set forth in
Sec. 26.408.

Also, you keep referring to section 26.421 to negate our concerns but you ignore a specific portion in 26.421 (which I've made effort to bold for you below).

Sec. 26.421 Prohibition of EPA reliance on research involving
intentional dosing of children.

In its regulatory decision-making under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall
not rely on any research involving intentional dosing of any child,
except when such research is deemed scientifically sound and crucial to
the protection of public health, under the procedure defined in Sec.
26.603.


Your argument is comforting, but not particularly true.

edited to bold something else that seems to elude your notice.

[MrMonk]

52. "Notwithstanding" = "in spite of" (Webster's)

The categorical prohibition of 420 stands *in spite of* what other paragraphs may say.

Read in context, or with the help of the explanatory notes, 421 refers to data from studies that were conducted by third parties without support from EPA. It will require more than an EPA reg. to prohibit such third party tests.

[loyalsister]

57. You miss the point

It is not a matter of dosing them with anything.
The issue is that the fact that they are disabled or under guardianship automatically includes them in research. It's discrimination.
If ALL kids were given an incentive or opportunity to be tested. It would be different. This is making a selection based on a difference outside of the child's control.

[lovuian]

17. Good way to get rid of poor and helpless and benefit the

companies!!! I have seen true evil and the Republican party stands for it!!!

[Javaman]

23. yet another trisector for moron*...

torturing people, prisons for muslims and now experimenting on babies.

If this isn't nazism, I don't know what is...

[MrMonk]

24. To the person who PM'd me.

Yes, I believe you that paragraph 26.420 has probably never been enforced. It is a proposed regulation. Proposed regulations are not enforceable. When it becomes an adopted regulation, then it becomes enforceable.

[HeeBGBz]

32. Is this fucking for real?

I am appalled at the paths my country is embarking upon. I can't believe this is even up for discussion.

[atfqn]

33. I am surprised.

I am surprised there are so many people who are in shock over this. Drug companies have been exploiting people and children for years. True, the newest cases revolves mainly around flouride but did everyone forget about "The House That Aids Built?" This story was printed January 2004 just twenty-three months ago - how fickle our memories are.

http://www.altheal.org/toxicity/house.htm

[The Backlash Cometh]

34. Fucking A. This country voted for Bush and it became Germany

in the 1940s.

[usregimechange]

36. WTF? Is this for real?

[chalky]

37. God, this is OBSCENE. DONE and forwarded to everyone I know.

n/t

[progressoid]

38. HOLD THE PHONE PEOPLE....

Let's take a deep breath.......OK?

This study was cancelled April 8, 2005.

Statement by Stephen L. Johnson, Acting Administrator of the Environmental Protection Agency

On April 8, 2005, I cancelled the Children's Health Environmental Exposure Research Study.

The Children's Health Environmental Exposure Research Study was designed to fill critical data gaps in our understanding of how children may be exposed to pesticides (such as bug spray) and chemicals currently used in households. Information from the study was intended to help EPA better protect children. EPA will continue to pursue the goal of protecting children's health.

Last fall, in light of questions about the study design, I directed that all work on the study stop immediately and requested an independent review. Since that time, many misrepresentations about the study have been made. EPA senior scientists have briefed me on the impact these misrepresentations have had on the ability to proceed with the study.

I have concluded that the study cannot go forward, regardless of the outcome of the independent review. EPA must conduct quality, credible research in an atmosphere absent of gross misrepresentation and controversy.

As a scientist and a 24-year employee of the EPA, I have a deep passion for the Agency's mission to protect human health and the environment. Continual review and reassessment is a fundamental aspect of scientific progress, and I am committed to ensuring that EPA's research is based on sound science with the highest ethical standards.


more: http://www.snopes.com/toxins/cheers.asp

[chalky]

40. Go to the U.S. Environmental Protection Agency Website. Note the date.

September 12, 2005
This IS NOT what Snopes has debunked.

http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm

DATES: Comments must be received on or before December 12, 2005. Under
the Paperwork Reduction Act, comments on the information collection
provisions must be received by OMB on or before October 12, 2005.



Now scroll waaaaay down to the bottom (long after most people have stopped reading):

Sec. 26.408 Requirements for permission by parents or guardians and
for assent by children.

(a) In addition to the determinations required under other
applicable sections of this subpart, the IRB 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. In determining whether children are capable of assenting, the
IRB shall take into account the ages, maturity, and psychological state
of the children involved. This judgment may be made for all children to
be involved in research under a particular protocol, or for each child,
as the IRB deems appropriate. If the IRB determines that the capability
of some or all of the children is so limited that they cannot
reasonably be consulted or that the intervention or procedure involved
in the research holds out a prospect of direct benefit that is
important to the health or well-being of the children and is available
only in the context of the research, 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 under circumstances in which consent
may be waived in accord with Sec. 26.116(d).
(b) In addition to the determinations required under other
applicable sections of this subpart, the IRB shall determine, in
accordance with and to the extent that consent is required by Sec.
26.116, that adequate provisions are made for soliciting the permission
of each child's parents or guardian. Where parental permission is to be
obtained, the IRB may find that the permission of one parent is
sufficient for research to be conducted under Sec. 26.404 or Sec. 26.405.
(c) In addition to the provisions for waiver contained in Sec.
26.116, 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 in subpart A of this part and paragraph (b) of this
section, provided an appropriate mechanism for protecting the children
who will participate as subjects in the research is substituted, and
provided further that the waiver is not inconsistent with Federal,
State or local law. The choice of an appropriate mechanism would depend
upon the nature and purpose of the activities described in the
protocol, the risk and anticipated benefit to the research subjects,
and their age, maturity, status, and condition.
(d) Permission by parents or guardians shall be documented in
accordance with and to the extent required by Sec. 26.117.
(e) When the IRB determines that assent is required, it shall also
determine whether and how assent must be documented.

[callady]

39. This is not surprising- but still appalling

Plutonium Files: How the U.S. Secretly Fed Radioactivity to Thousands of Americans

AMY GOODMAN: Eileen Welsome is our guest. Pulitzer Prize winning reporter, unearthed the names of 18 people injected with plutonium by the U.S. government. When we come back, we're going to talk about who these scientists were. We'll hear more of the stories. And then also the group studies, the studies of hundreds of people who were given -- well, a couple dozen disabled children in Massachusetts fed radioactive isotopes in their oatmeal, hundreds of pregnant women, also, served so-called vitamin cocktails containing radioactive iron -- how this all happened without anyone knowing about it until recently. Stay with us.

<snip>

AMY GOODMAN: So let's go through the experiments. The 18 people injected with Plutonium, none of them knew that that had happened to them. But moving on, in a Massachusetts school, 73 disabled children spoon fed oatmeal that had radio isotopes in them, radioactive isotopes. What happened?

EILEEN WELSOME: In that case, this was a nutrition study and they were given radioactive calcium and other radio isotopes.

AMY GOODMAN: Every morning?

EILEEN WELSOME: In their oatmeal, it was either mixed into the oatmeal or in the milk. And these boys did not know what was being given to them, nor did their parents. And in fact, they were told that this was really something nutritious and good for them. They were asked to give blood samples, urine samples, feces samples.

More:http://www.democracynow.org/article.pl?sid=04/05/05/1357230

[NMMNG]

41. Is this for real?

I thought they outlawed this sort of outrageous stuff years ago after they fed mentally retarded children irradiated oatmeal and the like. :mad: I can't believe they would try this sort of thing in the 21st century, but then again under Rethuglican rule maybe I shouldn't be so surprised if it does turn out to be true.

[chalky]

42. EPA link

http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm

You'll have to scroll down near the very bottom to get to the meat of the matter.

eta: do an "edit/find" for "53865" and start reading. Interesting stuff hidden under a huge pile of legalese.

[NMMNG]

43. Grrrrr

(c) In addition to the provisions for waiver contained in Sec.
26.116, 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 in subpart A of this part and paragraph (b) of this
section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

Appropriate mechanism for protecting the children? Like what, softer needles for injecting the deadly chemicals? :sarcasm:

[MrMonk]

49. Nuts

Reading one paragraph out of context does not give you any understanding of the proposed rule. I suggest reading the whole thing, including the prefatory material and considering how the paragraph fits into the overall context. Note that there is a categorical prohibition against dosing children. Paragraph 26.408 addresses other sorts of test subjects, e.g., children who are tested for the effects of environmental exposures.

[chalky]

53. Nuts my ASS. I posted several paragraphs in post #51 that

answer your willful ignorance of this subject. I made an effort to include all paragraphs, and even went to the trouble of bolding items that apparently fall well within your blind spot.

I request you go back and read that post.

eta: Oops. Sorry buffy. Was actually replying to monk.

[Rainscents]

44. This is so fucking sick! Our government truly us INSANE!

[NMMNG]

45. I just can't even tell you how much this pisses me off

I've spent the past 18 years working with adults who have developmental disabilities. I've read and heard of the horrors that these individuals have experienced over the centuries, including medical and psychological testing against their will. I honestly thought we as Americans had gotten past this sort of thing but obviously I was wrong, sadly wrong. I've sent my e-mail and I'm going to notify the Executive Director of my agency so he can decide if he wants to alert all of the staff in my agency of this travesty. :rant:

[mod mom]

54. this is what happens when you have War Criminals running the country!

DESPICABLE!

[mmonk]

56. The wording here

seems to be a problem area:
In its regulatory decision-making under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall
not rely on any research involving intentional dosing of any child,
except when such research is deemed scientifically sound and crucial to
the protection of public health, under the procedure defined in Sec.
26.603.

especially, "except", and combining "protection of public health". Sounds like a loophole whereby rationalization can be used.