[Fwd: Letters needed to the EPA]

[Guest guest]

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Letters needed to the EPA

 

 

 

Wed, 30 Nov 2005 19:16:03 -0800

 

 

 

Anne Fewell <rocketfewell

 

 

 

 

 

 

 

Dear Friends,

 

Please compose a letter OPPOSING allowing testing of chemicals and

pesticides on orphans and mentally handicapped children. This proposal is a

replay of Nazi Germany. Public comment period closes on Dec 12, so do it

now!

 

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

 

Full briefing on which clauses to oppose and why follows.

 

Love,

 

Cassandra

 

 

ALERT: EPA PROPOSES CHEMICAL AND PESTICIDE TESTING ON ORPHANS & MENTALLY

HANDICAPPED CHILDREN

 

ORGANIC BYTES #69 11/14/2005

OCA [Organic Consumers Association]

 

 

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 h uman 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.

 

OCA's focal concerns with this proposed rule specifically involve the

following

portions of text within the EPA document

 

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

ot her countries where these types of laws are less strict. This loophol e

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 Â

§ 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.)

 

 

Forward this alert to friends and colleagues