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In the Wake.
11th-Aug-2006 02:28 pm - locked

Monday, November 28, 2005

Public Comment Period for this rule 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:

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.)

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
3rd-Sep-2005 03:34 pm - :stands up:

I am Amanda.
I am beautiful, ugly, stunning, faded, gorgeous, overrun, and shimmering.
I am magnificient and also deviant.
I am good, bad, holy, and evil.
I am trustworthy and also manipulative.
I am the Light and also the Dark.
I can also be a Shadow.
I am a lily, a rose, and also a tulip. The trine flowers.

... just as much as

I am the virgin, the mother, and the crone.
I am Mary, Diana, and Lilith.
I am Fate, to whom is my Devine Mother & Father.


I am both a male and female spirit.
I am a faery, an elf, and a old maid.
I am yesterday, today, and also tomorrow.
I can also be still.
I am never, ever, and after.
I am the holder of the key and the mystery to Love.
I am worth more than all the greatest gifts in the world.
I am worth nothing.
I am the longest story ever written in a book with no pages.
I am Life.
I am Death.
I am Alpha and Omega.
I am Sin but
I am also Salvation.

Who are you that I should let you in... ?
26th-Feb-2004 08:30 am(no subject)
You think a spork is evil.... you have no idea the abyss of insanity and madness that boils in me to create a worse effect. I .... am..... so ...... fucking pissed right now.
27th-Dec-2003 11:49 pm(no subject)
You know what is great? The fact that Cody is out on vacation at Mel's for the weekend and I'm going out for drinks with John, Sarah, and Alex.... Juju here I come!
27th-Dec-2003 11:25 pm - Belated discussion with myself.
Nick said I should talk to people more and stop being so boxed up. I don't think anyone understands me when I'm 'talking'. It's as though if I sit here and I think about each word and I let it just flow across the paper and/or page people can get it. Not to say that I cannot talk to people that are just staring at me and not talking back. I can't stand them for some reason. I like people who 'listen' but if they aren't saying anything I feel like I'm pouring out myself and they are sitting there with their secret silent objections or what not and I have no idea who THEY are because they don't even talk. They just sit there and stare at you. It's a peeve I have. It's like sitting there slaving over cleaning a house while everyone is just sitting there on their ass staring at you. If you can understand how that feels you can understand how I feel when I'm talking to people.

So here begins, "The reasons why Manda is the way she is." And since most of all my issues surround around "The Picket Fence" theory then we will begin there.

Behind the Picket FenceCollapse )
27th-Dec-2003 10:59 pm(no subject)
Oh ... and I'm in serious debate about whether or not to make public my entire long post about my Theory of the Picket Fence People.

So vote now! Not that you have any idea what I'm talking about. But if you want to read the ramblings of my thoughts on why I have some issues with people... then you have to say so... cause otherwise I'm just not going to.
27th-Dec-2003 10:53 pm(no subject)
And these size 2 pants are hanging on me. I have to wear a fucking BELT ... with a size 2!

Okay yea... I'm setting up another appointment with a nutritionist ... cause it's not like I'm not eating.

I've come to the conclusion I hate my hair and it must be dyed.
31st-Jul-2003 04:13 pm(no subject)
So anyways... ::breaths::

My FAFSA papers are in at SCCC ... and now I get to go take some tests, then orientation, and then register for classes and then start going to school.

For some odd reason, I am deathly afraid... heh. I'm going. But my god I haven't been in a school since 1997.
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