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

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

 

 

 

ALERT: EPA PROPOSES TESTING CHEMICALS AND PESTICIDES ON ORPHANS &

MENTALLY HANDICAPPED CHILDREN

 

 

Send a letter to EPA here!

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

 

 

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!

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© " 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!

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

 

 

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

 

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