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Senate considers 'biopharm' crops ban / EPA pulls plug on unethical study (9/4/2005)

1.Senate considers 'biopharm' crops ban
2.EPA pulls plug on unethical study

Item 2 relates to an Environmental Protection Agency (EPA) study, GM Watch subscribers petitioned against, in which infants in participating low income families were to be monitored for health impacts as they underwent exposure to known toxic chemicals over the course of two years. The study entitled Children's Environmental Exposure Research Study (CHEERS) was to look at how chemicals can be ingested, inhaled or absorbed by children ranging from babies to 3 years old. For taking part in these studies, each family will receive $970, a free video camera, a T-shirt, and a framed certificate of appreciation. (Of course, low income American families are getting no rewards for feeding their kids unlabelled GMOs, nor is anyone bothering to monitor either the short or the long-term effects of ingesting them.)

Behind the study were the American Chemistry Council whose members include Bayer, Dow, DuPont and Monsanto.

excerpt: "The reason Stephen Johnson [the Acting Administrator for the U.S. Environmental Protection Agency] clung so stubbornly to this creepy CHEERS effort is that it served as the beacon to industry that EPA would welcome similar experiments. Stephen Johnson has become the pesticide industry’s 'go-to-guy' at EPA." (from item 2)
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1.Senate considers 'biopharm' crops ban
Lawmakers mull temporary halt to growing biologically engineered foodstuffs
By NIKI SULLIVAN
Associated Press
http://www.gazettetimes.com/articles/2005/04/09/news/oregon/sat03.txt

SALEM - Lawmakers are considering a temporary ban on growing food crops in Oregon that are biologically engineered to produce drugs or chemicals, such as vaccines.

Supporters of the bill say it would protect Oregon farmers from potentially harmful crop contamination. Opponents say the bill is an attempt to ban biologically engineered crops in general.

Oregon would become the first state to ban the crops, called biopharmaceuticals or biopharms, under a bill that was brought up for its first hearing Friday in the Senate Environment and Land Use Committee.

Currently in Oregon, genetically modified bentgrass is grown in Central Oregon and several varieties of insect-resistant corn are commercially available for farmers to grow.

But biopharm crops are a different type of genetically modified organism that represent a small percentage of U.S.-grown biologically engineered plants.

To create the crops, genes from other organisms are spliced into the plant - usually corn - that prompt it to produce the desired chemical compound, such as an anticoagulant or vaccine.

None are currently grown in Oregon, but the ban would prevent pharmaceutical companies from looking to put fields here.

"Plant species grown for use as food for humans or animals should not be grown to produce drugs and industrial chemicals," said Chris Schreiner, quality control director for Oregon Tilth, Inc., a nonprofit organization that certifies organic farms.

Schreiner compared biopharm crops to DDT, a chemical used more than 30 years ago because it was found to be toxic to humans and animals. Schreiner said the effects of DDT could have been avoided if the chemical wasn't "widely promoted and used prior to our full understanding of their toxic effects."

The bill would not ban growing other genetically modified organisms, but some warned that biopharm crops could contaminate food crops and have other unforeseen biological consequences that would tarnish the image of Oregon-grown foods.

"There is too much potential for leakage of these genes into the human food supply," said Bitty Roy, a biology professor from Eugene.

Roy said the risks and benefits of such crops needs to be more carefully studied before they are grown in the open air.

But others said the bill could cut off future economic benefits for Oregon's farms and research facilities, and that the federal government should create policy instead of a patchwork of state laws.

"This is a science discussion and these crops need to be grown under the best management practices," said Katie Fast of the Oregon Farm Bureau, but she said there's no reason to ban the crops altogether.

She said the bill could negatively affect Oregon's research facilities by prohibiting them from growing experimental crops that could be medically beneficial.

Katie Coba, director of the Oregon Department of Agriculture, said the agency has no official position on the bill, but that "it's important to remember that biopharming is regulated in the U.S. by the federal government," and that new guidelines are expected in one to two years.

She also said biopharm crops are "not the scary stories that we've heard," and said an example could be genetically enhancing a tomato to provide more health benefits.
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2.EPA GRUDGINGLY PULLS PLUG ON QUESTIONABLE "CHEERS" STUDY
Other Human Pesticide Dosing Studies Without Safeguards Can Continue
News Releases
For Immediate Release: April 8, 2005
Contact: Chas Offutt (202) 265-7337

Washington, DC — In a defensively worded statement, Stephen Johnson, Acting Administrator for the U.S. Environmental Protection Agency announced the end of the CHEERS study in which parents were paid to spray pesticides in the rooms occupied by their infant children under age 3. Johnson did not admit any ethical problems with the study but concluded without explanation that the study could not "go forward
in an atmosphere absent of gross misrepresentation and controversy." U.S. Senators Barbara Boxer (D-CA) and Bill Nelson (D-FL) had previously announced that they would hold Johnson’s confirmation as EPA Administrator unless he cancelled CHEERS.

While CHEERS (which stands for Children's Environmental Exposure Research Study) will no go forward with EPA funding, the exact same study can proceed with private sponsors, according to Public Employees for Environmental Responsibility (PEER). In fact, the American Chemistry Council, which represents 135 companies including pesticide manufacturers, had already pledged $2 million toward the study’s $9 million overall cost.

In February, EPA published a draft policy that opens the door for accepting any experiments conducted by pesticide companies and chemical manufacturers using human subjects without establishing safeguards to ensure that the studies are conducted ethically and without harm to the subjects. Under this policy, EPA indefinitely delays ethical rules and, instead, relies on its political appointees to flag immoral or unsafe practices on a "case-by-case" basis.

"The reason Stephen Johnson clung so stubbornly to this creepy CHEERS effort is that it served as the beacon to industry that EPA would welcome similar experiments," stated PEER Executive Director Jeff Ruch, noting that the pesticide industry wants to use human testing to trump animal studies so as to justify relaxed exposure limits. "Stephen Johnson has become the pesticide industry’s 'go-to-guy' at EPA."

Under the overall human dosing policy advocated by Johnson, EPA will have no protections for –

*Infants, neonates, pregnant women, and prisoners. By contrast, all medical and drug testing overseen by the Department of Health and Human Services has such safeguards; and
*Ensuring that companies have obtained informed consent or have not paid undue inducements.

As evidenced by the CHEERS fiasco, EPA lacks any independent safety or ethical review mechanism. In January, after the study had drawn controversy, EPA published a special Federal Register notice looking for experts in "ethical standards of research protocols and bioethics" because the agency lacked expertise in those areas.

To mask its lack of standards, during his confirmation hearing, Johnson claimed that the Centers for Disease Control had approved CHEERS. But, according to a January 18, 2005 letter from EPA to Representative Bart Gordon (D-TN), CDC had not reviewed it.

"EPA should adopt the basic safeguards required by common decency before they start using human dosing experiments," Ruch added. "Canceling CHEERS does not end the argument about the need for ethical standards in human testing; it merely opens another round in that debate."
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Find out about EPA’s open door policy on human dosing experiments
http://www.peer.org/news/news_id.php?row_id=470

For more information about CHEERS and human testing
http://www.peer.org/campaigns/testing/index.php

Read the statement from Acting EPA Administrator Stephen Johnson
http://yosemite.epa.gov/opa/admpress.nsf/b1ab9f485b098972852562e7004dc686/083d681b57e750dd85256fdd00639bc5!OpenDocument

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