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Risk Assessment
Record information and status
Record ID
113167
Status
Published
Date of creation
2018-02-09 08:12 UTC (g.mozgova@yandex.ru)
Date of last update
2018-02-09 08:18 UTC (g.mozgova@yandex.ru)
Date of publication
2018-02-09 08:18 UTC (g.mozgova@yandex.ru)

General Information
Country
  • Belarus
Title of risk assessment
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 
Date of the risk assessment
2018-01-19
Competent National Authority(ies) responsible for the risk assessment
Ministry of Natural Resources and Environmental Protection of the Republic of Belarus
10 Kollektornaya street
Minsk
Belarus, 220048
Phone:+375 17 200-5334
Fax:+375 17 200-5334
Email:minproos@mail.belpak.by
Url:Ministry of Natural Resources and Environmental Protection
Contact details of the main responsible risk assessor
Assoc. Prof. Minina
Grodno State Agrarian University
Grodno
Belarus
Phone:+375 152 77 09 09
Email:zifgen@ggau.by
Risk assessment details
Living modified organism
Domestic goat modified to produce human lactoferrin
Dr Alexander Ivanovich Budevich Production of medical or pharmaceutical compounds (human or animal)
Scope of the risk assessment
Risk assessment report / Summary
Methodology and points to consider
Estimation of the overall risk
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.
Recommendation(s)
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. 
Additional Information
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.
Other relevant website address or attached documents