THIS IS REAL! EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDREN

[Guest guest]

For those that thought this was a joke! no this is NOT a joke! its for real! please let your voice be known! ____________- http://www.organicconsumers.org/epa6.cfm This is a very real issue! the law in question is: 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..."This is certainly NOT a joke! A place to sound off would be: http://www.demaction.org/dia/organizations/oca/campaign.jsp?campaign_KEY=1532 RE: Docket ID Number OPP-2003-0132 __ Organic Consumers AssociationCampaigning for Health, Justice, and SustainabilityNewsAbout OCAActionJoin/SubscribeCampaignsSearchFind Organics OCA HomeOCA Issues & News:OrganicsHealth, Food Safety & EnvironmentGeneticallyEngineeredFood & CropsGlobalization and PoliticsMad Cow Disease Buying Local, Organic & Fair MadeFarm Bill & Agricultural AppropriationsChildren's HealthFair TradeCloning & PatentingIrradiationrBGH (Bovine Growth Hormone)OCA Publications:Sign up for OCA's bi-weekly email news briefs: Organic BytesOCA's quarterly hard-copy newsletter:Organic ViewOCA Campaigns:Coming Clean: Working towards the development of strong organic standards for body care products.Safeguard Organic Standards:Protecting and strengthening organic standards and policies regarding organic farming and products.Appetite for a Change:A campaign focused on reducing children's pesticide exposure in schools and at home.Biodemocracy Alliance: Creating GMO-Free Zones Across the Americas.Mad Cow USAStop the Madness:Pressuring the USDA to adopt policies that stop factory farm practices that spread mad cow disease.Millions Against Monsanto:Building a massive alliance of consumers to bring positive change to the business practices of one of the planet's most powerful corporations. Clothes for a Change:Working with the clothing industry towards ecological and sweatshop free sourcing of textiles.Organics Watch:Countering industrial agriculture's attack on organics. ..... ALERT: EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDRENSend a letter to EPA here!Forward this alert to friends and colleaguesNote: Concerns about Snopes or other questions are answered hereFriday, November 25, 2005 Public Comment Period for this rule Closes December 12, 2005Public 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: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. Parental consent forms are not necessary for testing on children who have been neglected or abused. 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© "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 colleaguesBy mail: Send two copies of your comments to:Public Information and Records Integrity Branch (PIRIB)Office of Pesticide Programs U.S. Environmental Protection AgencyMail Code: 7502C1200 Pennsylvania Ave., NWWashington, DC, 20460-0001Attention: Docket ID Number OPP-2003-0132The OCA also needs your financial support to continue working on these important issues. Please donate today! Q & A Section1) 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 craig2)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.Related News Articles:10/15 - San Francisco Chronicle Covers EPA Testing Proposal 9/15 - Exceptions in new EPA rules would allow testing pesticides on children (Baltimore Sun) 9/8 - Washington Post Covers EPA Chemical Testing Proposal 7/1 - Senate Votes to Stop EPA from Allowing Testing of Toxic Pesticides on Humans 6/28 - Congress Questions EPA about Human Toxin Testing 6/28 - LA Times: EPA Criticized for Pesticide Testing Rules 6/28 - Congressional Flash Report on EPA's proposed rule changes 6/27 - Washington Post: EPA Proposal Would Allow Human Tests Of Pesticides 2/8 - EPA Avoids Regulation of Chemical Experiments on Humans Send a letter to EPA here!Forward this alert to friends and colleaguesRelated Online Resources: Read the full EPA proposed rule (PDF --- HTML) National Academy of Sciences report to EPA on human testing, advising the agency discontinue unethical practices Other Organizations Working on this Issue (These organizations also have further information about this alert on their websites)Center for Health and Environmental Justice Beyond Pesticides Physicians for Social Responsibility Related Quotes: "Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board."Congressional Mandate to EPA, requiring the agency create a rule banning testing of pregnant women and children. The law was passed on August 2, 2005 , as part of the Department of Interior, Environment, and Related Agencies Appropriations Act, 2006, Pub. L. No. 109-54 ------------------------"A proposed rule on human pesticide testing that fails to protect children and families should be shelved immediately. A protective rule must be issued in its place," Senator. Barbara Boxer (D-CA) in an interview with the Washington Post on this issue------------------------"For the first time in our nation's history, the EPA has proposed a program to allow for the systematic and everyday experimentation of pesticides on humans. Moreover, the proposed program is riddled with ethical loopholes." Rep. Henry A. Waxman (D-CA) in an interview with the Baltimore Sun ------------------------"EPA's proposal is the pesticide industry's dream, and the public's nightmare." Richard Wiles, senior vice president of Environmental Working Group------------------------"The exemptions are obviously driven by the pesticide industry's goal of relaxing pesticide safety standards. The rule says it's acceptable to test children if there is a direct benefit. How can any child possibly benefit from exposure to pesticides? What was EPA thinking about?" Aaron Colangelo, a senior staff lawyer with the Natural Resources Defense Fund------------------------