Genetically Modified (GM) foods are dealt with in Section 22 of the Food Safety and Standards Act, 2006. The section states that no person shall manufacture, distribute, sell or import any GM food article except as otherwise provided under the Act and regulations made thereunder.
In order to ensure food safety, the FSSAI has initiated work on framing regulations on GM Food. The intended regulations would essentially lay down procedures for safety assessment and approval of foods including imported foods that have been derived from genetic modification processes and based on the internationally well established and accepted scientific principles, as also procedures and best practices before being approved for food purposes.
Prior to the approval of such foods, FSSAI assessment would be based on
- the food safety of GM foods
- their environmental impacts
These aspects would be duly assessed by the GEAC prior to their approval as food by the FSSAI. Further, without prejudice to the requirement of prior approval of GM foods manufactured, sold or imported into the country as envisaged in the above-mentioned regulations in accordance with the Section 22 of the FSSAct, 2006; the FSSAI has also framed draft Food Safety and Standards (Labelling and Display) Regulations that specify threshold levels for labelling requirements of GM foods.
By way of explanation, it may be noted that the threshold level for labeling of GM foods refers to the maximum permissible level (in percentage) of unintentional and technically unavoidable GMO content in food but which does not call for labeling. A large number of countries including Japan, Canada, Thailand and Indonesia prescribe a threshold value of 5% by weight. EU prescribes thresholds of 0.9 %. However, it may be pointed out that the cost of demonstrating/verifying compliance with the specified threshold increases as the threshold level decreases. It may also be kept in mind that irrespective of the threshold level, the safety of all GM products need to be well established and proven to be as safe as non-GM food products. The proposed labeling of GM food in India falls within the range of internationally followed threshold levels and seems to be practical and cost-effective.
These draft regulations will, after formal approval of FSSAIās Scientific Panel, Scientific Committee, and the Authority, be notified in the Gazette to elicit comments of various stakeholders which will be duly considered after which the regulations will be finalized with the approval of the Government. The proposed regulations will bind food businesses to provide appropriate information to the consumers so as to enable them to make informed choices when purchasing GM foods, should any such foods be approved for manufacture or import in India. These draft regulations will also be notified in the Gazette for public comments which will be duly considered before the regulations are finalized.
Richard E Goodman says
Dear FSSAI,
Are you working with GEAC & RCGM?
I was involved in discussion with the committees before and had some contact a few years ago with FSSAI.
I hope that you will be working with the guideline of the CODEX Alimentarius Commission (2003 and 2009), and are considering what other countries including the US, Australia New Zealand and Japan do for safety evaluation.
They are pretty consistent. It is an evaluation process based on known risks of allergy (don’t transfer an allergen from one source to another; don’t transfer a likely cross-reactive protein), that are evaluated primarily with bioinformatics (sequence searches) against known allergens. Risks of toxicity, again, primarily based on source of the transferred gene, and sequence similarity to toxins. For most proteins the risks are minimal. Stability of the protein in pepsin and consideration of abundance are important. Stability in heat is only important if it binds IgE or is a toxin, but in foods that are always thoroughly cooked.
If I can help in discussions, I would certainly be happy to do so.
Please see Goodman RE in PubMed for publications related to GM safety and allergenicity.
Regards,
Rick Goodman, PhD, Research Professor at the Univ. of Nebraska