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ALERT UPDATE: The EPA has published a final human chemical testing rule here. Unfortunately, the agency did little to respond to the tens of thousands of citizens opposed to the loopholes in the original proposed rule. The EPA responds to the comments by moving the problematic sections of the proposed document (see below) to other parts of the document. One aspect of the final rule that is positive is that the EPA further articulates that the rule bans all intentional dosing.

Still, the rule has many loopholes (see below) regarding "observational dosing." Observational dosing can have its benefits when conducted via legitmate methods. But, historically, that has not been the practice of chemical companies seeking to weaken regulations on their products by testing on humans.

As an example, the CHEERS study, which was finally dropped by the EPA in early 2005, would have been an "observational study" on low income minorities in Florida. Unfortunately, the study's constructs were such that it could motivate study participants to expose themselves and their children to higher levels of pesticides and chemicals because of the study payout. The same holds true for the current rule, wherein orphanages and institutions housing mentally handicapped children could receive payout to increase everyday chemical use, prior to applying for a payout study. Of course, the EPA does not condone such behavior, but the new rule also does not disallow it, nor does it set up any sort of detailed criteria that would allow the agency or a review board to assess studies on this level.

At this point, the rule is published and official. We, at the OCA, are dissappointed in the EPA for not focusing more on creating stringent standards for observational studies.

It should be noted that this rule doesn't weaken current chemical testing regulations. The problem here is that it does not strengthen regulations, as mandated by Congress in 2005.

The OCA will continue to assemble a body of supporting documentation, as well as Congress and citizen supporters to create more stringent human chemical testing regulations in the coming weeks and months.

Saturday, January 28, 2006

http://www.organicconsumers.org/epa6.cfm

The Environmental Protection Agency (EPA) is just days away from publishing a new federal regulation that will allow 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, without exception. But the EPA's newly proposed rule, is ridden with exceptions where chemical studies may be performed on children in certain situations like the following:

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.

Despite receiving over 50,000 letters from citizens, congress, and EPA's own scientists opposing the proposed rule, on January 24, the EPA notified the Associated Press, saying they are on the threshold of approving the proposal and allowing chemical testing on children.

"The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," said Sen. Barbara Boxer, D-Calif. Even EPA's own scientists are speaking out against the agency's proposed rule. "I am somewhat dismayed that this rule was presented in such a complex -- and I would have to say, tricky -- way," said Suzanne Wuerthele, a regional toxicologist for the EPA.

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.)

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

The OCA also needs your financial support to continue working on these important issues. Please donate today!

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 craig@organicconsumers.org

2)Question: I read the EPA website and part of the introduction of the rule, claims the rule is to prohibit all such testing and to establish sanctions. That sounds like a good thing. So what's the problem?

Answer: The EPA is proposing a rule that they would like to have approved. Anytime you are marketing a 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. This is a specific layout of the problematic text as taken directly from the actual EPA rule. In short, these are the loopholes in the document that need to be removed, as mandated by congress, which says the rule must have no exceptions.

3) Question: The rule says these waivers apply when the IRB sees a benefit of the test for the children involved, and also calls for supplementary protective measures when necessary. That sounds like a good thing. So what's the problem?

Answer: Actually, you are referencing a point made under subpart §26.405 of the rule. That subpart is designed to only address "research presenting the prospect of direct benefit to the individual subjects." In that subpart, it says that "more than minimal" risk to children subjects is acceptable if there is a chance it could benefit the child. Outside of that subpart, there are no stipulations requiring that the studies be beneficial to the test subjects. Anywhere else in the document where this type of situation is noted, it is under an "or" clause. In other words, the loopholes for this rule state that the rule can be disregarded if the study was done overseas, OR the test subject's guardian consents, OR if the study may be of benefit to society as a whole, OR if the study may be of benefit to the test subject, etc. The study also calls for supplementary protective measures when necessary but outlines no criteria for how this "necessity" is defined or determined. Without a clearly defined line of what is acceptable and what is not, it's at the whim of the IRB, EPA administrator or third party research organization to determine whether or not supplementary protective measures are necessary. In that sense, it could simply mean the IRB might determine, for example, a test subject should wear safety goggles when being doused with atrazine. In other words, without specific definition of what defines a situation that calls for further supplementary protective measures, this becomes a simple, flowery token statement with no meaning and no teeth.

6) Question: The EPA sent me a letter back that says "EPA's proposed rule would ban EPA from conducting or supporting any intentional dosing study of pregnant women or children with pesticides or any other environmental substances. All children are included in this ban. There are no exceptions." They seem to be saying this rule is for studies that don't involve intentional dosing. Is that correct?

Answer: That is incorrect and is misleading PR from the EPA that contradicts the text of their actual proposed rule. As you can see above, we have outlined the specfic text in the rule that we have problems with. Nowhere in the rule does the EPA say that all intentional dosing studies are banned, yet that is exactly what congress had asked them to do. In fact, the rule goes so far as to make make allowances for what it refers to as"ethically deficient human research." (70 FR 53857). In short, the EPA is making public relations claims that completely contradict what is clearly written in balck and white in the actual proposed rule.

5) Question: I can't get your email form to work. How can I send comments to the EPA directly?

Answer: 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

By email: send comments to opp-docket@epa.gov The subject line should read: "Attention: Docket ID Number OPP-2003-0132 "

If you have questions, we're always happy to help out, but please read all of the information provided on this alert page and follow the links on the right hand side of this page to further information prior to contacting us with questions. craig@organicconsumers.org

Public Comment Period Closes
December 12, 2005
http://www.organicconsumers.org/epa6.cfm

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 : http://www.demaction.org/dia/organizations/oca/campaign.jsp?campaign_KEY=1532

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.)