Published online 18 May 2007 | Nature | doi:10.1038/news070514-17

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Pharmed food crop approved for growth despite controversy.

Rice modified to express proteins often found in breast milk will be planted in Kansas. Getty

Rice modified to express proteins often found in breast milk will be planted in Kansas. The go-ahead for the planting came on 16 May from the United States Department of Agriculture (USDA).

It's certainly not the first crop designed to produce pharmaceutical proteins given the go-ahead in the United States or elsewhere (see 'Turning plants into protein factories'). But this is among the first food crops containing genes that produce human proteins to gain approval for large-scale planting. Many other pharmaceutical genetically-modified (GM) crops are grown indoors or in inedible plants such as tobacco.

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 anaemia1. Diarrhoea, which often stems from gastrointestinal infection, is a major killer of children worldwide.

Many further regulatory hurdles involving other agencies would need to be passed before products made from this rice could be sold to consumers.

Public comment

The crop, which has been tested in Peru, was given preliminary approval in March, and the USDA then opened the proposal up for public comment. Of the more than 20,000 comments they received, only 29 were positive, although many of the negative comments consisted of form letters.

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In the end, the USDA thought that the fears of many that the rice would escape into the environment or the food supply were not warranted, thanks to the many cautious procedures proposed by Ventria - including the fact that they plan to plant the test field more than 480 kilometres away from any commercial rice farms.

The permit states that any seeds eaten by animals or birds would pose them no significant risk. It adds that the chance that a tornado or other extreme weather event might disperse the seed widely is low, but requires an emergency management plan to deal with this.

A 2005 report by the USDA's Office of the Inspector General criticized the agency's approval of GM crops as being too lax, but the agency says that it has improved the approval process since then and that it has always been more vigilant about crops that produce pharmaceuticals.

In 2006, a fairly typical year, according to USDA public affairs specialist Rachel Iadicicco, the USDA received 14 requests for outdoor plantings of GM crops expressing pharmaceuticals or industrial compounds. Of those fourteen, ten have been granted, three are pending and one was withdrawn. Some of these resulted in plantings in 2006, and some were planted this year. The agency requires a new permit each year.

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