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Inter-ministerial panel, assns give comments on GM bill.
Nov 25, 2021

The FSSAI has recently put to public domain, the draft of a 'bill' to govern genetically-modified food in India based on the recommendations of an expert panel. There was an inter-ministerial consultation on the draft Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021, wherein the ministries have given their comments along with industry associations.
 
According to the Ministry of Agriculture and Farmers Welfare – Department of Agriculture, Cooperation and Farmers Welfare, import of Genetically Modified Organisms (GMO)/ Living Modified Organism (LMO) for agriculture research purposes is entrusted with the National Bureau of Plant Genetic Resources (NBPGR), New Delhi, and Genetically modified/ Genetically engineered food products are not regulated by the Agriculture ministry.
 
However, the Ministry of Environment, Forests and Climate Change – (Biosafety) Division says that according to the procedure for grant of prior approval, once a Genetically Modified Organism or Genetically Engineered Organism or Living Modified Organism having unique identification Code provided by Biosafety Clearing House, Organisation for Economic Co -operation and Development etc., is approved by FSSAI, approval for the same will not be required for any other food business operator. Approval will also not be required, if it is used as an ingredient in any product.
 
'This Ministry is of view that since Biosafety Clearing House is a database platform under Cartagena Protocol on Biosafety, indicates the list of approved GMOs of all the countries, therefore, FSSAI may be requested to follow the same procedure for dealing with approved GMOs listed on Biosafety Clearing House as per Form 1 of the regulations,' reads the comment made by the Union Environment Ministry.  
 
Meanwhile, industry bodies suggested that the definitions under these regulations may be aligned with global best practices for better implementation of the regulation and the rationale was that the definition of 'Genetically Modified or Engineered Food' is very broad, which may also cover food and food ingredients derived from advanced technologies like gene editing. This technology is different from GM organisms. There are several enzymes, vitamins and nutrients, which are produced using GMO processing aid wherein the ingredient i.e. enzymes or vitamin nutrients does not contain any GMO. Such ingredients are not considered GM as per global best practices.
 
The expert panel to this suggestion responded that the definitions were as per the provisions in the FSS Act (2006) as it exists today. However, with the revised definition proposed as part of revising the Act (i.e., in sub-section 2 of Section 22 of the Act, the definition of 'genetically engineered or modified food' shall be substituted with 'genetically engineered or modified food means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology'), the issue raised will be addressed.
 
The industry added that there was no provision to take into account the presence of adventitious traces of GMO in food products, which is technically unavoidable during farming, harvesting and distribution process, to which the expert panel responded that the adventitious presence and low level presence is only applicable for non- GMO certification which is not the mandate of the proposed regulation.
 
Further, the industry suggested aligning the definition with the global definitions viz. USDA that 'Bioengineered foods' wherein such a food does not contain modified genetic material if the genetic material is not detectable. The panel rejected the suggestion and stated that definitions are as per the provisions in the FSS Act. Definition of ‘Modern Biotechnology’ as in Codex may be included in the draft regulations.
    

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