USDA approves rice producing human proteins

This is not the first time that a food crop designed to produce future drugs is approved by the United States Department of Agriculture (USDA), but it's one of the first food crops containing genes that produce human proteins according to Nature. The USDA justified its decision by saying that the future rice farm, located in Kansas, will be too far from other rice farms to contaminate rice grown for human consumption. It also said that this genetically-modified (GM) rice will exclusively be used to produce pharmaceuticals. As you can guess, not everyone agrees...

This is not the first time that a food crop designed to produce future drugs is approved by the United States Department of Agriculture (USDA), but it's one of the first food crops containing genes that produce human proteins according to Nature. The USDA justified its decision by saying that the future rice farm, located in Kansas, will be too far from other rice farms to contaminate rice grown for human consumption. It also said that this genetically-modified (GM) rice will exclusively be used to produce pharmaceuticals. As you can guess, not everyone agrees...

Where rice is grown in the U.S.

As you can see on the map above, rice is only grown two areas of the U.S., in Northern California and in a South-East region following the Mississipi river from Missouri to Louisiana (Credit: USDA). And Junction City, Kansas, "is more than 480 kilometres away from any commercial rice farms."

But why grow this very special GM rice? Here is the answer from Nature.

The rice strains, made by Ventria Bioscience in Sacramento, California, produce lysozyme, lactoferrin and human serum albumin in their seeds. All three are commonly found in breast milk. Lysozyme and lactoferrin are proteins with antibacterial, viral and fungal properties, according to the company.

Ventria says that they aim to use the rice to create drinks that can combat diarrhoea, and dietary supplements to help reverse anaemia. Diarrhoea, which often stems from gastrointestinal infection, is a major killer of children worldwide.

And it's interesting to note that Junction City agreed a while ago to be the host of a bioprocessing facility for plant-made pharmaceuticals (September 29, 2006).

Now, let's look at why the USDA approved this bioprocessing plant in the middle of Kansas. The official stamp of approval was given on May 16, 2007 and is named "Availability of an Environmental Assessment and Finding of No Significant Impact for a Proposed Field Release of Rice Genetically Engineered To Express Lactoferrin, Lysozyme, or Serum Albumin." Here is a link to this document (Federal Register, Vol. 72, No. 94, pages 27539-27540, PDF format, 2 pages, 52 KB). Here is the summary.

We are advising the public that the Animal and Plant HealthInspection Service has prepared an environmental assessment for confined field release of rice plants genetically engineered to express the human proteins lactoferrin, lysozyme, or serum albumin. After assessment of the application, review of pertinent scientific information, and consideration of comments provided by the public, we have concluded that these field releases will not present a risk of introducing or disseminating a plant pest. We have completed the environmental assessment and concluded that this field release will not have a significant impact on the quality of the human environment.

Before approving this GM rice farm, the agency received 20,034 comments, of which 20,005 were opposed to this plant. But the agency also noted that "one public interest group submitted 13,289 nearly identical comments, and 5,621 nearly identical comments were submitted by another public interest group."

Anyway, the environmental assessment (EA), finding of no significant impact(FONSI) and responses to comments are also available online (PDF format, 57 pages, 669 KB). The map shown above has been extracted from this document.

As you can infer from the number of comments mentioned above, several organizations disagree with the USDA. This is the case of the Center for Food Safety and of the Kansas Rural Center who have published a common news release saying that the USDA approval of drug-producing rice in Kansas poses threat to food safety (May 17, 2007).

It's more interesting to read another document published by the Center for Food Safety than their press release, "A Grain of Caution: A Critical Assessment of Pharmaceutical Rice" (PDF format, 36 pages, 243 KB).

Here are some of the conclusions of this document published in April 2007.

Genetically engineered, pharmaceutical rice is not the answer to diarrhea. The bioactive proteins in Ventria’s pharma rice may exacerbate infections or cause allergies or autoimmune disorders. They have apparently not been adequately tested on animals. A Ventria sponsored experiment on sick Peruvian infants was marked by lack of informed consent, incomplete presentation of data, and reports of adverse reactions in several study participants.

And the author adds, "Ventria's rice-grown drugs are not only unproven, they are not needed. Effective and inexpensive measures to prevent and treat diarrhea have already saved millions of lives, and could save millions more with adequate funding."

The decision has been made to start this bioprocessing factory, but is it a good one? Time will tell.

Sources: Emma Marris, Nature, May 18, 2007; and various websites

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