ALERT: EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDREN
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Public Comment Period Closes
December 12, 2005
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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:
- 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(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
The OCA also needs your financial support to continue working on these important issues. Please donate today!
Robin Stephens wrote:
Disabled worry lives not valued
Issue arises in context of making decisions about end-of-life care
Sunday, November 20, 2005
By Gary Rotstein, Pittsburgh Post-Gazette
A state task force working on thorny issues of decision-making and care for
dying patients will hear tomorrow from a group which feels all too ignored
on such matters: people with disabilities.
People with mental or physical impairments and those who advocate for them
say a history of feeling their lives were devalued by the medical community
made them all the more alarmed at a June symposium of the Task Force for
Quality at the End of Life in Pennsylvania.
The daylong session attended by government officials, health care
professionals and others analyzing end-of-life issues covered such matters
as living wills, health care decision-making, hospice and palliative care
without acknowledging special problems of people with disabilities,
representatives of the latter say. Those concerns include access to
equitable care, perceptions by others that disabled people's lives are less
valuable, and a lack of self-determination in planning their treatment.
Representatives of Arc of Pennsylvania, Centers for Independent Living and
other groups pressed for more involvement in the task force planning, and
they will present recommendations to the 56-member task force at its meeting
tomorrow. Underlying their concerns is a sense that physicians, relatives
and others would decide to end medical treatment of a disabled person more
hastily than that person truly would want due to some skewed judgment that
their life is lacking in quality.
"People don't see our lives as being as valuable as everybody else's,"
asserted Sandi Weber, a staff member of the Three Rivers Center for
Independent Living who has spina bifida. When ill in hospital beds, "we leak
and we drool and we're all those things and we just cost too much, so it's
just easier to let life supports go."
The concerns are being raised at a time when national reports and state
end-of-life reform advocates have focused on laws and practices enabling
terminally ill people to cease painful and intrusive life-preserving
treatment, if that's their wish. That issue is all the more visible in the
wake of the prolonged and controversial death of Terri Schiavo after family
members debated her artificial life support.
The task force report, due in January, and the disability movement's
concerns also come as state lawmakers, the Rendell administration and
interest groups revisit legislation dealing with end-of-life issues which
was vetoed by the governor a year ago.
The measure, sponsored by Sen. Stewart Greenleaf, R-Montgomery, was intended
as an overhaul of Pennsylvania's advanced directive statutes covering health
care decisions for incapacitated people. Medical groups convinced Gov. Ed
Rendell, however, that the bill could make it too hard for family members to
cease a dying relative's life support unless the patient specifically
authorized a surrogate to do so in a power of attorney document.
Most people neglect to fill out such paperwork, which could immobilize
hospitals and long-term-care institutions and require them to keep people
alive on ventilators indefinitely, said Dr. Chris Hughes, a St. Clair
Hospital intensive care doctor who is the Pennsylvania Medical Society's
spokesman on the topic. That would be worse than current practice, he said,
in which physicians are guided by families on late-life decisions, even if
no law specifically tells them how to do so.
Though they haven't weighed in specifically on any possible adjustments to
Mr. Greenleaf's new version of the legislation, which the Rendell
administration is expected to propose, activists for both the mentally and
physically disabled worry about how their lives' quality is viewed by
physicians and relatives.
Dr. Christopher Gorton, an Arc of Pennsylvania board member who was former
medical director of the state's Office of Mental Retardation, said he'd
heard reluctant physicians wonder aloud, "What are we saving here?" when
reviewing the conditions of critically ill patients with retardation.
"That's happened more than once," he said.
It has come up as well, disabled people say, in denial of transplant
operations to people with impairments, or more emphasis hospitals might give
to having them fill out do-not-resuscitate orders before undergoing medical
procedures, when other patients might not be asked.
Among the recommendations disabilities advocates plan to make to the task
force, based on a meeting they held three weeks ago, is that hospitals
provide a staff member to assist patients, families and physicians on
special issues related to disabilities and late-life care decisions. They
want better training of health professionals on disabilities issues, and
protection that keeps "quality-of-life" perceptions from entering into
life-and-death decisions about a disabled person's care.
On the other hand, they want disabled people to have the same rights to make
their own life-endangering decisions as other people to avoid certain care.
Dr. Alan Meisel, director of the University of Pittsburgh's Center for
Bioethics and Health Law, said the difficulty is recognizing that disabled
people must receive better treatment and protection than they sometimes have
in the past, while avoiding laws and policies which are detrimental to other
patients who want the leeway to end their own lives peacefully.
"Obviously, we don't want to take away treatment from people who want it,
but we also don't want to provide treatment to people who feel they lived a
full life and feel keeping themselves alive may be a sentence to severe
suffering for their remaining weeks or days," Dr. Meisel said. "How you
craft a law that accommodates both positions here can be pretty tricky."
________________________________________
(Gary Rotstein can be reached at grotstein@post-gazette.com or
412-263-1255.)
posted by MAYANKing @ 10:57 PM
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