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ALERT
UPDATE: The EPA has published a final human chemical testing rule
here.
Unfortunately, the agency did little to respond to the tens of thousands
of citizens opposed to the loopholes in the original proposed rule.
The EPA responds to the comments by moving the problematic sections
of the proposed document (see below) to other parts of the document.
One aspect of the final rule that is positive is that the EPA further
articulates that the rule bans all intentional dosing.
Still,
the rule has many loopholes (see below) regarding "observational
dosing." Observational dosing can have its benefits when conducted
via legitmate methods. But, historically, that has not been the
practice of chemical companies seeking to weaken regulations on
their products by testing on humans.
As
an example, the CHEERS study, which was finally dropped by the EPA
in early 2005, would have been an "observational study"
on low income minorities in Florida. Unfortunately, the study's
constructs were such that it could motivate study participants to
expose themselves and their children to higher levels of pesticides
and chemicals because of the study payout. The same holds true for
the current rule, wherein orphanages and institutions housing mentally
handicapped children could receive payout to increase everyday chemical
use, prior to applying for a payout study. Of course, the EPA does
not condone such behavior, but the new rule also does not disallow
it, nor does it set up any sort of detailed criteria that would
allow the agency or a review board to assess studies on this level.
At
this point, the rule is published and official. We, at the OCA,
are dissappointed in the EPA for not focusing more on creating stringent
standards for observational studies.
It
should be noted that this rule doesn't weaken current chemical testing
regulations. The problem here is that it does not strengthen regulations,
as mandated by Congress in 2005.
The
OCA will continue to assemble a body of supporting documentation,
as well as Congress and citizen supporters to create more stringent
human chemical testing regulations in the coming weeks and months.
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ALERT:
EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED
CHILDREN
(Tell
Congress to strengthen EPA's human chemical testing rules here!)
Despite
receiving over 50,000 letters from citizens, Congress, and EPA's
own scientists opposing the proposed rule, the EPA has published
a new federal regulation that will continue to allow observational
studies of chemical and pesticide exposure 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,
without exception. But the EPA's
newly proposed rule, is ridden with exceptions where observational
chemical studies may be performed on children in certain situations
like the following:
- Children
who "cannot be reasonably consulted," such as those
that are mentally handicapped or orphaned newborns, may be studied.
With permission from the institution or guardian in charge of
the individual, the child may be studied.
- Parental
consent forms are not necessary for studies with children who
have been neglected or abused.
- Chemical
studies on any children outside of the U.S. are acceptable.
"The
fact that EPA allows pesticide testing of any kind on the most vulnerable,
including abused and neglected children, is simply astonishing,"
said Sen. Barbara Boxer, D-Calif. Even EPA's own scientists are
speaking out against the agency's proposed rule. "I am somewhat
dismayed that this rule was presented in such a complex -- and I
would have to say, tricky -- way," said Suzanne Wuerthele,
a regional toxicologist for the EPA.
Tell
Congress to advise the EPA to strengthen this rule here!
OCA's
focal concerns with this proposed rule specifically involve the
following portions of text within the EPA document (Note:
This is in regards to the proposed rule: PDF
--- HTML).
The issues below are discussed by the EPA in their
final published rule but are not mitigated. See excerpts
here. EPA's full final rule is here..
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
The
OCA also needs your financial support to continue working on these
important issues. Please donate today!
Q&A
Section
1)
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.
2)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.
6)
Question: The EPA sent me a letter back that says "EPA's proposed
rule would ban EPA from conducting or supporting any intentional
dosing study of pregnant women or children with pesticides or any
other environmental substances. All children are included in this
ban. There are no exceptions." They seem to be saying this
rule is for studies that don't involve intentional dosing. Is that
correct?
Answer:
That is incorrect and is misleading PR from the EPA that contradicts
the text of their actual proposed rule. As you can see above, we
have outlined the specfic text in the rule that we have problems
with. Nowhere in the rule does the EPA say that all intentional
dosing studies are banned, yet that is exactly what congress had
asked them to do. In fact, the rule goes so far as to make make
allowances for what it refers to as"ethically
deficient human research."
(70 FR 53857). In short, the EPA is making public relations claims
that completely contradict what is clearly written in balck and
white in the actual proposed rule.
5)
Question: I can't get your email form to work. How can I send comments
to the EPA directly?
Answer:
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
By
email: send comments to opp-docket@epa.gov
The subject line should read: "Attention: Docket ID Number
OPP-2003-0132 "
If
you have questions, we're always happy to help out, but please read
all of the information provided on this alert page and follow the
links on the right hand side of this page to further information
prior to contacting us with questions.
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Other
Organizations Working on this alert (These organizations also have
further information about this alert on their websites)
Related
News Articles:
2005
Send
a letter to EPA here!
Forward
this alert to friends and colleagues
Related
Online Resources:
Related
Quotes from Congress and NGOs:
"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
------------------------
"I
am especially concered that the administration's proposed rule fails
to meet its congressional mandate and to provide the safety that
Americans desire and deserve. For example, the proposed rule, despite
its claims, allows intentional testing on pregnant women and children
in at least three circumstances."
Congresswoman
Hilda Solis (D-CA) article in Environmental
Law Institute
------------------------
"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
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