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Rocky Mountain Farmers Union disappointed at CDA approval of biopharm permit

(Thursday, June 5, 2003 -- CropChoice news) -- From a news release.

DENVER - Rocky Mountain Farmers Union expressed frustration at the Colorado Department of Agriculture’s (CDA) approval of an application to grow biopharmaceutical corn in Eastern Colorado this growing season.

On May 2 of this year, Rocky Mountain Farmers Union, along with 40 other groups representing farmers, rural communities, consumer groups and environmentalists, submitted a letter to Governor Owens and CDA, requesting that a moratorium be placed on growing biopharmaceutical crops in Colorado until the potential impacts to human health and the environment are studied and the technology is proven safe in an open, public process. Neither the Governor’s office, nor CDA responded to the letter, nor to repeated requests to meet with the groups.

“Since we first heard that biopharmaceutical crops may be grown in Colorado, we have had concerns,” said John Stencel, president of the Rocky Mountain Farmers Union. “The regulatory framework at both the states and federal levels does not appear to require research on issues such as potential water and soil contamination, health impacts or other types of genetic pollution. We want to see that scientific studies have been done, rather than just rely on the industry to tell us that the technology is safe.”

Once the United States Department of Agriculture approves a permit to grow a biopharmaceutical test crop, the application is sent to the Department of Agriculture in the state in which the crop is to be grown. Earlier this year, CDA stated that it was in the process of creating an application review process for approving biopharmaceutical crops, and that this review process would be open to public comment.

“It is disturbing that CDA would approve this permit application without first establishing some sort of review protocol,” said Stencel.

Today’s permit approval will allow Meristem Therapeutics, a French-based company, to grow 17 acres of genetically engineered corn in Phillips County, Colo. The corn is genetically altered to produce lipase, a digestive enzyme. A three-member panel of scientists, whom many believe are biased towards the industry, reviewed the permit for CDA.

This same panel will write the application review protocols for CDA. Many groups have asked that the panel be broadened to represent the concerns of farmers, consumer advocates, environmentalists, and ecologists, as well as representatives from other state agencies, such as the Department of Public Health and Environment or the Colorado Division of Wildlife.

“The bottom line is that we can’t support this technology until there is a process in place which requires that these concerns be studied,” said Stencel. “We are changing the rules of nature with this technology, and in return, we have to make sure that the rules that govern this technology will protect human health and the environment.”

If you have questions or comments, please feel free to contact me.

Jennifer Kemp
Director of Government Relations
Rocky Mountain Farmers Union
5655 S. Yosemite St., Suite 400
Greenwood Village, CO 80111
303-283-3540

The following two items are from the Colorado Department of Agriculture.

  • media release
    Colorado Department of Agriculture
    http://www.ag.state.co.us
    May 14, 2003
    Contact: Jim Miller
    303.239.4103 or
    Jim Rubingh
    303.239.4114

    State issues OK on pharmaceutical corn

    The Colorado Department of Agriculture today granted conditional concurrence to clear the production of a small plot of corn in Phillips County containing a pharmaceutical protein. The permit, submitted by Meristem Therapeutics of France, will allow the planting of up to 30 acres of corn that will produce an experimental pharmaceutical designed to aid sufferers of cystic fibrosis.

    The department's conditional concurrence with the permit proposed by the U.S. Department of Agriculture was based on the recommendation of a panel of experts that reviewed the application. The panel consisted of faculty of the University of Colorado and Colorado State University who held expertisein microbiology and plant science.

    "I am convinced that production of pharmaceuticals using biotechnology can be accomplished in Colorado safely and without threat to our agricultural markets or to the consumer of our food products," said Agriculture Commissioner Don Ament. "However," Ament cautioned, "any company that comes to Colorado to grow biotech pharmaceutical or industrial-use crops must be aware that our standards for performance are exceedingly high and as an agency, the Colorado Department of Agriculture intends to see to it that those standards are met."

    The application for a permit to grow the crop was submitted to Colorado on May 7, 2003 for the state's review and comment. Under USDA rules, states may take up to 30 days to review the applications and offer or withhold their concurrence with the terms of the permit. While states may not block the planting of pharmaceutical or other experimental biotech crops, USDA has indicated that state comments will be given highest consideration.

    The Agriculture Department offered its concurrence to the terms of the permit with three conditions. First, the department is insisting that state agriculture department inspectors be permitted to accompany USDA inspectors on each site visit to be sure permit conditions are being met. Secondly, the state ag department is insisting that the number of inspections be set at a minimum of five during specific times within the permit period. Third, the department is to be allowed to inspect the plots any time the agency deems necessary, provided prior notice has been given to the permittee.

    ###

  • Fact Sheet Regarding the Meristem Therapeutics Permit to Grow a Plant-Made Pharmaceutical in Phillips County, Colorado

    Applicant: Meristem Therapeutics, Cambridge, MA
    Pierre Dorfman, M.D., Medical and Regulatory Affairs Director

    Contact: Emmanuel Boures, Communication Director. Meristem Therapeutics, Clermont-Ferrand, France.
    eboures@meristem-therapeutics.com
    Fax: +33 473 98 68 19

    or Local contact: Jennifer McCallum, Ph.D., Esq., The McCallum Law Firm, LLC. Phone: 303.828.0655

    Pharmaceutical: Recombinant mammalian gastric lipase to aid in treatment of cystic fibrosis

    CDA Experts on Review Panel:

    Tom Holtzer, Ph.D., Professor and head, Department of Bioagricultural Sciences and Pest Management, and Interim Associate Dean of Reasearch for the College of Agricultural Sciences, Colorado State University. 970.491.5843

    Pat Byrne, Ph.D., Associate Professor/Extension Agronomy Specialist, Department of Soil and Crop Sciences, Colorado State University. 970.491.6985

    Andrew Staehelin, Ph.D., Professor, Department of Biology, Molecular, Cellular and Developmental Biology Instruction, University of Colorado, Boulder. 303.492.8843

    Summary of Permit: A plot not to exceed 30 acres in Phillips County will grow the biotech corn. Producers will use a planter and harvester dedicated exclusively to the production of Plant-Made Pharmaceutical corn. The planter and harvester will be thoroughly cleaned following its use under inspection by USDA and CDA. The corn will be exported to France after processing in specialized equipment to contain and re-load/off-load the product in the event of an accident.

    Precautions to Avoid Cross-Pollination:

    The plot where the lipase-producing corn will be grown under the USDA requirement of at least 1 mile from the nearest corn field. The plot will be surrounded by a 50 foot fallow zone. Furthermore, the lipase-producing plants will be de-tasseled (the pollen-generating portion of the plant will be removed and destroyed) so that the lipase-producing plants can be pollinated with the traditional, non-biotech corn. De-tasselling will be by hand using a local crew. Steps will be taken so that the de-tasselling crew does not come in contact with other corn fields until the crew has showered and the clothing laundered.

    Additional State Requirements:

    CDA has stipulated that the number of mandatory USDA inspections be increased to at least 5 to occur at specified periods during the tenure of the permit (e.g., inspection at the time of de-tasselling).

    CDA will be allowed to accompany the USDA inspectors at all inspections. And CDA will be permitted to inspect the plot at its discretion with or without USDA inspectors present.

    Follow-on Inspections:

    The plot will then be planted with a soil-conserving cover crop and later sprayed to kill all plants present within the plot in order to ensure that neither the cover crop nor any biotech "volunteer" corn enters the food or feed system.