Regulation of genetic engineering

**Regulation of Genetic Engineering**

– Many countries regulate GMO cultivation on a case-by-case basis
– Countries like Russia, Norway, and Israel allow GM food import but not cultivation
– Labeling of GMO products is required in 64 countries
– Legal status of GM foods varies worldwide
– Categories of Regulation: Transmission, Preventive measures, Treatments, Differences in definitions, Biosafety levels
– Biosafety Levels: Four levels ranging from 1 to 4, Based on virulence, Different nomenclature, Varying requirements
– European Regulation: Living GMOs regulated by European Directive, Contained use of GMMs, Risk assessments required, Minimal standards provided
– World Health Organisation (WHO): Includes animals and environment, Highest virulence classification, Dangers assessment, Different from countries, Varied level descriptions
– Regulatory Assessments: Before GMO use, Correct controls, Risk assessments, Assurance requirements, Standardization efforts

**History of Genetic Engineering**

– Regulatory framework for genetic engineering began in 1975 at Asilomar, California
– US established regulatory offices for rDNA research in 1976
– OECD released report on potential hazards of GMOs in 1982
– International consensus on safety assessment of GM food reached in 1993
– Cartagena Protocol on Biosafety adopted in 2000

**In the Laboratory**

– Institutions conducting genetic engineering research need permission from authorities
– No major accidents with GMOs in labs as of 2008
– Legislation for GMOs often adapted from existing regulations
– Regulations diverge among countries, even with similar risks
– Universal system for assessing risks associated with GMOs in labs

**Safety Assessment**

– Each GM food needs to be tested on a case-by-case basis
– Public perception of GM foods differs from scientific consensus
– Some advocacy groups call for more rigorous testing of GM food
– OECD, WHO, and FAO collaborate on safety assessment standards
– Codex Alimentarius Commission sets guidelines for GM food regulation

**Labeling of GM Products**

– Labeling of GM food varies globally
– Mandatory labeling up to a threshold GM content level in some countries
– Voluntary labeling may not always be accurate
– Europe mandates labeling for food with >0.9% approved GMOs
– Canada and USA have voluntary GM food labeling