Belarus | BCH-RA-BY-113167 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

Loading...
  |  
BCH-RA-BY-113167-3   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 09 Feb 2018
General Information
Expert conclusion based on the results of the safety assessment for human health and the environment of genetically engineered organism - Domestic goat modified to produce human lactoferrin
EN
19 Jan 2018
Risk assessment details
  • Domestic goat modified to produce human lactoferrin
    | Republican Unitary Enterprise "Scientific and Practical Center of the National Academy of Sciences of Belarus on Animal Husbandry" | Production of medical or pharmaceutical compounds (human or animal)
Methodology and points to consider
EN
EN
EN
1. Findings of the State Safety Expertise of non-pathogenic genetically engineered organisms – transgenic goats with the inserted gene coding recombinant human lactoferrin – show that risk during release of the goats that are producers of recombinant human lactoferrin kept in the territory of the Biotechnological Scientific and Experimental Production of Animalsꞌ Transgenesis into the environment is very low and, therefore, the goats that are producers of recombinant human lactoferrin can be allowed for introduction and registration and for the purposes of related target protein testing.
2. Biotechnological Scientific and Experimental Production of Animalsꞌ Transgenesis used for keeping of the goats that are producers of recombinant human lactoferrin corresponds to the safety requirements for the facilities destined for release of non-pathogenic genetically engineered organisms and their registration.
EN
Following the precautionary principle, further research on safety and biological activity of recombinant human lactoferrin should be carried out in accordance with legislative regulatory acts and the Instructions of the Republic of Belarus with a view of developing products of various directions to improve public health. 
EN
EN
EN
EN
Additional information
The risk assessment has been performed based on the Legislation of the Republic of Belarus and methodology of the National Guidlines:
"Instruction on a Procedure for Conducting Risk Assessment of Potential Adverse Impacts of Living Modified Organisms on Human Health" (Approved by the Ministry of Health of the Republic of Belarus, 25.08.2006);
"Risk assessment of GMO effects on conservation and sustainable use of biological diversity with due account of risks to human health: methodical guidelines" (Agreed with the Ministry of Natural Resources and Environmental Protection of the Republic of Belarus on 22.10.2014) and
"Guidance on Risk Assessment of Living Modified Organisms" ( Biosafety Clearing-House).

Following the results of the meeting of the Expert Council on Safety of Genetically Engineered Organisms of the Ministry of Natural Resources and Environmental Protection of the Republic of Belarus, the DECISION was made: 1. To adopt recommendations on the feasibility of transgenic goat line release for testing in natural climatic conditions into the specially equipped experimental field and to submit the given recommendations and the State Expertise conclusion to the Ministry of Natural Resources and Environmental Protection of the Republic of Belarus; 2. RUE “Scientific and Practical Center for Animal Breeding, NAS of Belarus” shall design and approve the experimental field certificate before the planned release of the transgenic goat line into it for testing.
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 2