Philippine Golden Rice research for Vitamin A at IRRI: ethical and approved

Written by: Bob Zeigler (IRRI, Philippines)

As the ethical and regulatory oversight of Golden Rice-related research conducted at other institutes has recently been questioned, some might wonder about how our Golden Rice research is conducted. I'd like to tell you a little about IRRI's commitment to the highest standards of ethics and regulatory compliance in our own research and development work on this potentially life-saving crop.

To research Golden Rice thoroughly and ensure its safety, we have to do all sorts of tests—in the laboratory, in the greenhouse, and out in the field. At IRRI, all of our research that involves genetic modification is overseen by an Institutional Biosafety Committee (IBC) that is responsible for ensuring that we comply with local and international regulations and guidelines in the conduct of our experiments.

IRRI's IBC is composed of three IRRI scientists, two scientists from the University of the Philippines Los Baños, and four representatives from the local Los Baños and Bay communities around the IRRI headquarters. It works under the Philippine regulatory framework, called the Biosafety Committee of the Department of Science and Technology (DOST-BC), which oversees IRRI's IBC and, through the IBC, all research on genetically modified rice at IRRI. No GM organisms can be used in IRRI's research without prior authorization from DOST-BC.

We're lucky to be working in the Philippines because it has such a thorough, transparent, and independent regulatory system for biotechnology.

In addition, all Golden Rice field trials in the Philippines are conducted under permits issued by the Bureau of Plant Industry of the Department of Agriculture (DA-BPI), the national regulatory authority in the Philippines for crop biotechnology research and development, after they established that the trials will pose no significant risks to human health and the environment. This assessment was based on a step-wise evaluation that included contained and confined field evaluations.

Thanks to this transparent and open system of regulation, anyone can go and see for themselves details of what is approved and when, via the DA-BPI online approval registry. If you care to look closer, you can see the Golden Rice field trial approvals: Golden Rice is on page 5 and 6 under the Philippine Rice Research Institute.

The same principles apply in the other countries where we are working on Golden Rice. We follow national regulations and adhere to internationally established guidelines and procedures for the safe use of genetically modified crops, including the Codex Alimentarius (Principles and Guidelines for Food Safety Assessment of Foods derived from Modern Biotechnology), OECD Consensus Documents, and the Cartagena Biosafety Protocol.

As you may have gathered, I strongly believe that all research should be conducted with appropriate checks and measures in place to ensure that it is done in not just an ethical way, but so that it is fully approved by all appropriate regulatory bodies. I insist that all GM rice research at IRRI is conducted with required approvals on hand, following well-established protocols for the safe use of biotechnology.

I cannot speak for what happened with the Golden Rice research in China, as IRRI and our partners working with us on Golden Rice were not involved. But it is important to note that the Tufts study wasn't a safety trial, because existing research was already available that showed that beta-carotene in Golden Rice was as safe as beta-carotene in other foods. As the statement from Tufts notes, their review found no concerns related to the safety of the research subjects. From all reports, it is very clear, perhaps more importantly, that no one was harmed in any way in the China trials. To the contrary, the studies showed unequivocally that Golden Rice is an effective way to improve the Vitamin A status of deficient children. This is great news, indeed!

I was disappointed, of course, to hear from Tufts that the research itself was found not to have been conducted in full compliance with the appropriate board policy or relevant regulations.

But I don't think that these lapses should be used as a cynical excuse to stop all Golden Rice research, or indeed to be used as an inflammatory attack point to suggest that everyone involved in Golden Rice research has misguided intentions or that the research should be stopped.

Golden Rice offers a very unique opportunity to improve the nutrition of people—particularly of women and children in Asia—who are not reached by current interventions to reduce Vitamin A deficiency.

Vitamin A deficiency is a major public health concern, and it has not been overcome yet. We need more solutions and we need solutions especially targeted to helping rice consumers. My job is to make sure our research is conducted properly, with the best interests of those rice consumers at heart. I hope our work shows that Golden Rice is safe and effective and that it is judged on its potential to help people, not on who has helped develop or research it along the way, or anything else, but simply on its value to humanity.

IRRI