By Dr. Vivencio Mamaril
Member of the Biotechnology Core Team of the Bureau of Plant Industry, Dept. of Agriculture, The Philippines

Source: BioLife via SEAMEO SEARCA
BioLife is a bi-monthly magazine published by the Biotechnology Coalition of the Philippines in cooperation with the J. Burgos Media Services Inc.
http://www.bic.searca.org/bmarc/biolife_sep_oct06.pdf

My previous viewpoints zeroed in on the technical aspects of biosafety. It specifically tackled risk assessment of transformation events applied for propagation. In simple words, risk assessment of genetically modified crops. My first column introduced us to corn varieties conferring resistance to Asiatic corn borer, and these varieties are registered as accredited varieties of the National Seed Industry Council (NSIC).

Variety Registration

Under Philippine laws, plant breeders can register their new varieties and such varieties are automatically accredited by the National Seed Industry Council. This framework is regulatory in nature and it is provided for by Republic Act 7308 otherwise known as the Seed Industry Act of 1992. This law paved the way for plant breeders- private and public to commercialize their new crop varieties getting a government seal of accreditation.

Question, what do we mean variety registration? It works like this, for example, a private seed company develops a new corn variety, can he market his new variety? The answer is yes. However, such variety is not accredited by the government. Does the government require that new varieties be registered before they are introduced in the market? No. Then, why do public and private seed companies register their new varieties? It is because if the Department of Agriculture would procure seeds, those that have been accredited by the NSIC would be prioritized to be bought. Also, farmers can avail cropping loans from government lending agencies if the variety they are going to plant is accredited by NSIC and crop insurance only covers NSIC-accredited varieties.

As a standard rule, before new varieties are accredited, such varieties are entered in the National Cooperative Test or commonly known as NCT. This NCT is a variety performance test in two wet and two dry season trials. Therefore, only those varieties that are as good as or better than check varieties shall be registered and accredited.

Rice and Corn

At present, rice and corn are the crops that have the most number of registered and accredited varieties. Although, other crops had been registered in the council, among others, these are rootcrops, plantation, fruit, vegetable, fiber, sugarcane, and others had been given government accreditation.

Biosafety Guidelines

There are two government issuances that regulate the development and propagation of transgenic crops. It is required that before transgenic crops are made available to the public, the crops have to undergo three biosafety protocols, and these are greenhouse, field, and propagation. These protocols are to be undertaken phase by phase, meaning a genetically modified crop has to be tested first under a controlled or greenhouse, field, and then evaluated for propagation.

Possible Harmony

Given the three successive biosafety protocols, we can see that there is the possibility of harmonizing the biosafety and variety registration guidelines. However, such harmony may only be applied to the field test of a genetically modified crop. Why do we have this opinion, an NCT and field test are both conducted in an open field, and it is only a matter of adding check varieties, the isoline or the untransformed variety, and replicate plants during the field tests.

Bt Corn Experience

At present, the NSIC has registered and accredited more than twenty Bt corn varieties. This Bt corm contains the MON 810 transformation event. Does this mean the Bt corn varieties were subjected to the NCT? Yes, it was. In the case of the first varieties that have been registered and accredited, a coordinated NCT and biosafety field tests were undertaken. This means that during the field test of MON 810 event, the transformed variety was an NSIC-registered and approved variety. The NCT protocol requirement of number of replicates, population sample, and number of trials were complied with then by the applicant. And, the members of the Corn and Sorghum Technical Working Group (CSTWG)of NSIC were invited to visit the sited of the biosafety field tests.

At the end of each biosafety field tests, two sets of data were gathered, organized, and evaluated. First was the biosafety, second was NCT data requirements. The first and second set of data was sent to the Biosafety authority and NSIC, respectively. Of course, the CSTWG of NSIC analyzed and evaluated the second set of data.

Let it be known however, that the MON 810 technology owner only submitted the second set of data when they had gotten a biosafety permit for propagation.

Existing NSIC Guideline

To date, only the CSTWG has an existing guideline in the registration and accreditation of transformed crop varieties. The NSIC policy is that, it can only accept and evaluate NCT data of genetically modified crops only when the transformation event had been approved for propagation by the Bureau of Plant Industry.

In addition, if the transformed variety is NSIC-registered and accredited, the CSTWG can accept NCT data generated from biosafety field tests. Otherwise, the variety undergoes a full-blown NCT that requires 2 dry and 2 wet seasons trial across more than ten testing cites in the Philippines.

Positive Implications

With the existing guidelines of NSIC, the technology developer is encouraged to use NSIC-registered and accredited varieties. Doing so, and if the techno developer has an intention to register his variety, he saves some cost intended for NCT.

The NSIC shall also formulate other relevant policies concerning variety registration and accreditation of genetically modified crops, especially now that the public research institutions are now transforming papaya, rice, eggplant, and tomato.

The take home message is that, the two distinct policies can be harmonized making the government more responsive to the needs of the seed companies, without of course sacrificing safety of human, animals, and the environment.