Source: Black Sea Biotechnology Association (BSBA)
by Igor Tchumikov and Alexander Golikov*

General situation - regulations potentially provide for GM growing

Belarus is the party to the Cartagena Protocol on Biosafety and had participated in all UNEP-GEF projects on the development and implementation of national biosafety frameworks. Thus it’s regulatory environment is pretty well developed when compared with the majority of CEE countries.

The country’s biosafety node is National Coordination Center of Biosafety (NCCB) established by the Government in 1998. NCCB coordinates the use of biotechnology in Belarus and national activities on biosafety. It also conducts risk assessment and studies of GMO’s using facilities of the Research Institute of Cytology and Genetics of the National Academy of Sciences. The other two organizations involved into field studies are Belarusian Research Institute of Potato Growing of Ministry of Agriculture and Belarusian Research Institute of Plant Protection of Ministry of Agriculture.

The Law “On Safety of Genetic Engineering Activity”  was enforced in July 2006. Together with preceding regulations still in force, and with a number of newer implementation acts it constitutes the basis for biosafety framework of Belarus (the Law and other relevant legal documents are available at http://biosafety.org.by, in Russian only).

The Law stipulates that only those varieties, hybrids, breeds and microbial strains  that are registered for use in Belarus can be used commercially. State registration is subsequent to approving verdict of the state biosafety expertise (list of biosafety experts) and positive results of environmental trial release. Registration procedure (including animal breeds and microbial strains) is given by Government’s Directive Nr. 1195 of 12.09.2006. However, no GM varieties have been registered so far, though NCCB even undertook attempts to negotiate collaboration on development of local GM plant varieties with major biotech companies like Bayer and Monsanto.
 

Importation of GMO’s into Belarus is regulated under Article 11 of the Cartagena Protocol on Biosafety and legal requirements of Belarus related to import of raw food materials, food products and feed. Food and feed approval systems are far from being developed, while existing regulations lack inter-harmonization and clarity which is typical situation for most former USSR republics.

Belarus imports minor quantities of food/feed plant products from US, which “may contain” GMO (mainly maize derivatives and soybean meal, not more that 1,500.00 metric tons altogether).
 

Food - no specific procedure for GMO; literally zero labeling threshold

According to Dr. Alexander Yermishin, Director of NCCB, Belarus does not have a special system of registration of GMO for food and feed use. Use for food purposes is allowed for GM crops approved for food use in USA, EC and Russia, provided they are properly labeled. Labeling is compulsory.

   However there are some regulatory acts adopted prior to Gene Law that require GM food registration, e. g., Directive of the Chief State Sanitary Inspector Nr 116 of 02.09.2003 requires that starting 01.01.2004 hygienic regulation and registration is applied to all raw food materials and food products as well as components (fragments) for their production, obtained from or with GM sources if content of the latter exceeds 2%. Later (25.08.2006) the Chief State Sanitary Inspector issued “The Order of Conducting Assessment of Risks of Possible Harmful Impact of Gene Engineering Organisms on Human Health”, which was prepared together with NCCB and generally based on internationally accepted common principles of GMO food safety assessment. It appears that these documents either do not work or imported food products contain less than 2% of GM components. There is no any official Registry of GM food approved for use in Belarus. Nevertheless any imported food product (including GM) has to be certified as hygienically safe and registered by the Ministry of Health Care and shall be accompanied by quality assurance documents. Hygienic registration of food products which “may contain” GM components (maize and soybeans products, rice expected soon) requires that protocols of event identification are supplied. The authorities say that hygienic registration of any food product is responsibility of a supplier.

Labeling of food containing GMO was introduced on 28.04.2005 by Governmental Directive Nr. 434 “On some issues of informing the consumers on raw food materials and food products”. The Directive requires mandatory labeling of each consumer package. No labeling threshold is specified therefore it is literally zero. The Directive bans production and sales of baby food produced from GM sources. It also bans sales of raw food materials and food products, obtained from GMO’s “without proper information and documentation”. The authorities claim PCR laboratories for GMO detection are available in each region of the country.

Feed - approval by both EU and Russia is enough

Though registration system for GM feed is also underdeveloped the practical situation is more clear than with food. Since the major share of locally produced meat and dairy products is exported to the Russian Federation Belarus may eventually harmonize its regulatory approach with the Russian system.

The authorities do control imports of feed (mainly soybean and maize derivatives) for presence of GM components. The National Veterinary Sanitary Rules for Safety of Feeds and Feed Additives, introduced by the Resolution of Ministry of Agriculture Nr.48 of 28.04.2008, do not allow use of feed products (forage grain and its products, oilcakes, milk substitutes and their concentrates, raw materials for combined feed production for pigs, poultry and fish) which contains more than 0.9% of GMO. But some GM crop events are exempted from the rule and are allowed for unlimited feed use (no threshold applied). The latest amendments to the Rules, introduced by the Resolution of the Ministry of Agriculture and Food of Belarus Nr94 of 23.12.2008 indicate the list of the feed use approved events in Belarus that includes RR Soybean (MON 40-3-2), Soybean A 2704-12, maize lines - Bt-11, T-25, MON-810, GA-21, NK-602, MON-863.

The authorities say that an event could be approved feed use in case only it is already approved in both EU and Russia. However it is unlikely that any written confirmation of this approach could be found.

* Igor Tchumikov - Consultant, Regulatory Affairs, Russia and CIS; igor.tchumikov@perseus.eu;
  Alexander Golikov - Executive secretary, BSBA; ag@bsba.ag