Source: Ag-West Bio Inc. Bio-Bulletin Volume 1, Issue 3
Bio-Bulletin in PDF format: http://www.agwest.sk.ca/publications/Bio-Bulletin/BBNov06.pdf

by Janice Tranberg
Regulatory Affairs Director, Ag-West Bio Inc.

Adventitious presence has always been a part of export and trade, but with the influx of new traits being introduced into crops around the world, this issue is becoming front and centre. A perfect example can be found in the currently incidental release of Bayer’s herbicide resistant rice – LLRICE601.

On August 18, 2006, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Agency (APHIS) announced trace amounts of a genetically engineered variety of rice had been detected in long grain rice. Bayer CropScience disclosed full information on this rice line to the USDA, as well as the Canadian Food Inspection Agency (CFIA), but each government chose a very different path to deal with this unapproved event.
The glufosinate tolerance trait in this case involves the same gene (bar gene) used by Bayer in its other Liberty Link crop species, and in fact is the same gene used in two other rice varieties – LLRICE06 and LLRICE62 – both of which are approved for human consumption in the U.S., with the latter approved for use in Canada.

There are small variations in these three lines. Both the approved varieties were transformed using direct gene transfer, while the variety in question was transformed using agrobacterium-mediated transfer. Another difference lies in the promoter used to drive the expression of the bar gene. The 35SCaM promoter is slightly longer in the unapproved line as compared to the two approved lines. Finally, both approved lines were engineered into a medium grain rice variety, while LLRICE601 was placed into a long grain variety.

The USDA’s regulatory system has built in some flexibility to deal with these kinds of issues, which allowed for an extension of the non-regulated status of this variety based on the previous deregulated LLRICE06 and LLRICE62 rice lines.

After performing an environmental assessment, the USDA found no human health, food, feed or environmental concern with this variety. The analysis of their assessment concluded both methods of transformation are standard practices for introducing genetic material into plant genomes, the size difference of the commonly used 35SCaM promoter is not significantly different, and the host rice varieties are not significantly different (Department of Agriculture, Animal and Plant Inspection Service, Docket No. APHIS-2006-0140, Federal Register Vol. 71, No. 174, Friday, September 8, 2006). Therefore, the USDA reached a preliminary decision to extend the non-regulated status for the rice line LLRICE601 and placed it open for public comment until October 10, 2006. No final decision has yet been announced.

Canada, on the other hand, has no allowance to extend a product registration and so had to take a different approach. Again, through a preliminary scientific assessment, the CFIA found LLRICE601 at low levels is unlikely to pose a risk to human health, food, feed or the environment, especially as regular rice is not grown in Canada.
In order to be compliant with the Food and Drugs Act along with the Feeds Act, the CFIA introduced a strategy to detect the presence of this rice variety in import long grain rice shipments. This strategy involves audits of importer documentation indicating their shipments do not contain LLRICE601 and random testing by the CFIA of rice imports. A detection threshold of 0.5 percent of the unapproved event has been set initially, with a re-evaluation of the effectiveness of this strategy in two months (Canadian Food Inspection Agency, Technical Update – Genetically Engineered Rice Unintentionally Released in the U.S., September 29, 2006).

So, by taking a good look at this incident, it allows for some interesting comparisons. Both Canada and the U.S. came to the same conclusion on the safety and environmental aspects involved with this particular rice. The U.S. approach, though, has been to efficiently deal with this variety giving it non-regulated status. Therefore at the end of this procedure, there will be no additional management required for rice LLRICE601.

Canada, while being very efficient in their analysis of the unapproved event, will now have to deal with the on-going cost and time of monitoring shipments and conducting spot checks.

I find this a very interesting case because in terms of decisions, this should have been fairly simple. A very similar variety has already been found safe for human and animal consumption in Canada, and in terms of the environment, it is a non-issue as we cannot grow rice here due to our climate. And yet, our already extremely busy colleagues at the CFIA will be required to monitor and sample import shipments, and additional demands will be placed on our importers to assure their rice shipments are free of this ‘safe’ rice.

If this level of extra management is being placed on this fairly straight forward event, I wonder how the CFIA will manage if an unapproved event is detected which is not so clear cut?

Janice Tranberg
Regulatory Affairs Director, Ag-West Bio Inc.