Focal Point Information

The main law in GMO biosafety area is the Law “On Safety in Genetic Engineering Activity” (hereafter referred to as “the Law”) of 9 January 2006, No. 96 (as amended by the Laws of the Republic of Belarus dated 24.12.2007 N 299-З, dated 10.11.2008 N 444-З, dated 02.07.2009 N 31-З, dated 04.01.2010 N 109-З, dated 04.01.2014 N 130- Z, dated 12/18/2018 No. 154-3). Link to the Law https://biosafety.igc.by/wp-content/uploads/2021/01/04O-bezopasnosti-genno-inzhenernoj-deyatelnosti.pdf. A number of by-laws to ensure safety in genetic engineering activity were elaborated in addition to this Law. The by-laws describe all necessary procedures, departments/institutions authorized and responsible for each activity and interdepartmental coordination mechanisms. Both the Law and by-laws cover the following areas of GMO biosafety:

• specially authorized bodies responsible for each sphere of genetic engineering activity (GEA);
• work in self-contained systems;
• import into the Republic of Belarus, export from the Republic of Belarus and transit through its territory of GMOs;
• risk assessment of possible adverse effects of GMOs on the environment and human health before field trials and placement to the market;
• release of GMOs into the environment;
• use of GMOs for economic purposes;
• control in the field of safety in GEA;
• responsibility for violation of legislation on safety in GEA;
• GMO detection and identification.
• information exchange and the Biosafety Clearing-House;
• public awareness and its participation in decision-making with regard to safety in GEA;

Risk assessment of GM-products based on the "Procedures for Risk Assessment of Possible Harmful Effects of Genetically Engineered Organisms on Human Health. Instructions for use” approved by the Resolution of the Chief Sanitary Doctor of the Republic of Belarus of August 25, 2006 No. 076-086

Following the entry into the Eurasian Economic Union, a list of standards that includes principles and methods of GM-products` risk assessment, measurements for a GM-component in food products and food supplements, methodology guidelines “Food Products and Food Supplements. Biomedical Safety Assessment of Genetically Engineered Modified Organisms of Plant Origin. Methodical Guidelines” has been determined.

More information can be found on the website of the National Coordination Biosafety Centre on the link https://biosafety.igc.by/zakon-respubliki-belarus-o-bezopas/ and the Biosafety Clearing House on the link https://bch.cbd.int/en/countries/BY.

The Ministry of Natural Resources and Environmental Protection, the Ministry of Health and the Ministry of Agriculture and Food have been nominated as National Competent Authorities on biosafety issues by the Resolution of the Council of Ministers of the Republic of Belarus of June 5, 2002 N. 734. The Law “On Safety of Genetic Engineering Activities” of 6 January, 2006 No.96-3 regulates such areas of that activity as GMO development, its transporting, handling and processing and field trial testing under the first release of GMO into the environment.

GMO import and export is under the control of the State Customs Committee of the Republic of Belarus in accordance with the Resolution of the Committee “On the Procedure of Information Submission to the State Scientific Institution “Institute of Genetics and Cytology at the National Academy of Sciences of Belarus” of February 16, 2009, N. 7 (as amended by the decree of the State Customs Committee of 07.13.2010 N 27). The National Biosafety System (NBS) has been established in Belarus after the country accession to the Cartagena Protocol on Biosafety to the Convention on Biodiversity in 2002. This system ensures the safe biotechnology activities and protection of biodiversity and human health against possible adverse effect of GMO on them.

NBS includes the following elements:

(1) legislation;

(2) administrative system (system of the state expert examination for GMO, risk assessment, decision making, administrative system, system of gaining, keeping and disseminating information);

(3) system of law enforcement, inspection and monitoring;

(4) system of the public education and awareness, guarantee of the access to the actual biosafety information and its participation in decision making on biosafety issues.

The important role in improving the national biosafety system plays the National Coordination Biosafety Centre (NCBC) established in accordance with the Resolution of the Council of Ministers of the Republic of Belarus “On Establishment of the National Co-ordination Biosafety Centre” of June 19, 1998, N. 963 (as amended by Resolution of the Council of Ministers of 19.06.2019 N 404).

The basic tasks of the National Co-ordination Biosafety Centre have been formulated as follows:

– Collection, analysis and systematization of legislation and scientific information on biosafety problems, field trials of genetically engineered objects, import (export), commercial use of genetically engineered organisms and products derived on their basis in Belarus as well as the mentioned biosafety information retrieved from the database of international informational networks, and development of the national biosafety database;

– Submission of biosafety information to ministries and other Republican governmental bodies and mass media concerned;

– Exchange of information with co-ordination biosafety centres of other countries and international organizations;

– Organization of safety scientific examination of genetically engineered organisms and products derived on their basis when their use is assumed in the Republic of Belarus;

– Rendering of consultative services to ministries and other Republican governmental bodies in working out draft legislative documents concerning import (export) and safe use of genetically engineered organisms and products derived on their basis, guidance for assessment and prevention of their risk for the environment and human health and instructions for ensuring safe genetic engineering activities in molecular genetics laboratories;

– Rendering of consultative service to ministries and other Republican governmental bodies in preparing proposals for concluding bilateral and regional agreements, developing international agreements for biosafety issues.

 There are 17 laboratories for GMO detection (LDGMOs) in foodstuffs, food raw materials and seeds in Belarus. They are under subordination of the Ministry of Health, the Ministry of Agriculture and Food of the Republic of Belarus and the National Academy of Sciences of Belarus. All laboratories are accredited by the Belarusian State Centre for Accreditation, are included in the list of laboratories approved for the analysis of GMOs on the territory of the EAEU Customs Union. The list of the LDGMOs on the website of the National Coordination Biosafety Centre: https://biosafety.igc.by/spisok-akkreditovannyh-laboratorij/.

In the Republic of Belarus, a risk assessment for GMOs intended for release into the environment is carried out twice, before the first release of GMOs on experimental fields that meet safety requirements and before the State registration of a new breed of animal breed and plant variety. Risk assessment of GMOs intended for contained systems is carried out before the State registration, for example, new strain of microorganism. As of 2022, 5 risk assessments of  GMOs plant origin were carried out in Belarus, 3 of them were approved for testing on experimental fields that meet biosafety requirements. 1 GMO of animal origin (GM-goats for the production of medicines, release in a limited area of ​​the experimental farm) and 3 GMOs of microbial origin intended for amino-acids production (no release, contained system conditions) have passed a full cycle of risk assessment and were registered by the Ministry of Health of the Republic of Belarys for use for commercial purposes. Information on risk assessments on the website of the National Coordination Biosafety Centre: https://biosafety.igc.by/oczenki-riskov/.

Risk assessment Guidliness:

1. The Procedure for Risk Assessment of Possible Harmful Effects of Genetically Engineered Organisms on Human Health. Instructions for use. - Ministry of Health of the Republic of Belarus, August 25, 2006 No. 076-0806. (in Russian). NCBC website: https://biosafety.igc.by//wp-content/uploads/2021/01/20res-2006-MinZdr-instr.pdf.

2. Methodological Guidliness. Gmo Risk Assessment for Conservation and Sustainable use of Biological Diversity Taking into Consideration Risks for Human Health/ G.V. Mozgova // Institute of Genetics and Cytology of the National Academy of Sciences of Belarus. Agreed with the Ministry of Natural Resources and Environmental Protection of the Republic of Belarus (10/22/2014 No. 3-2-11 / 1124 - int.). - Minsk: Pravo I Economika, 2014. - 58 p. (in Russian) NCBC website: https://biosafety.igc.by/wp-content/uploads/2021/11/risc_assessment_guidelines.pdf.

Books:

A.P. Ermishin, V.E. Podlissky, E.V. Voronkova, B.Yu. Anoshenko, V.M. Zarkov. Biotechnology. Biosafety. Bioethics. - Minsk, Tekhnalogiya, 2005 .- 430p. (in Russian).

On-line training modules for Laboratories for GMO Detection and Customs Officers. (in Russian) NCBC website: https://biosafety.igc.by//wp-content/uploads/2021/01/modul-dlya-LDGMO-Tamozhennyh-organov.pdf.

Materials of the three training workshops on the BCHIII Project: https://biosafety.igc.by/unep-2018-2019/

Materials of the CEE Round Table “Enhancing the CEE Collaboration and Know-How Transfer in Biotechnology and Biosecurity” , Minsk,  September 18-20, 2019 (in English). NCBC website: https://biosafety.igc.by/kruglyj-stol-ukreplenie-sotrudniche/.

Materials of the CEE Regional Ceminar on GMO Risk Assessment, Minsk, September 24-28, 2018 (in English). NCBC website: https://biosafety.igc.by/regionalnyj-seminar-po-oczenke-risko/.