To:                                                                                       January 14, 2022

The Chief Executive Officer,

Food Safety and Standards Authority of India (FSSAI),

FDA Bhawan, Kotla Road,

New Delhi – 110 002

Email: regulation@fssai.gov.in

Sub: Objections/Suggestions with regard to Notification issued on 15th November 2021, about Draft Regulations called the “Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021”

Ref: F. No. 1/Standards/GM Food regulation/FSSAI/2018

Dear Sir,

We write to you from the Coalition for a GM-Free India which is a large platform of organisations and individuals representing farmers, consumers, experts and activists, in the forefront of ensuring that without independent studies in public domain that establish safety of long term use of GMOs and GM foods, India does not fall into the trap of unsafe, unwanted and unneeded gene technologies being pushed into our food and farming systems, in the name of “solutions”. The Coalition for a GM-Free India is very well-aware of the risks and dangers that gene technologies pose in our food and farming systems. We are fully conversant with the scientific evidence that supports our stand, and we/our members have come up with several publications with regard to the same. We are also a platform that has field level experience of setting up lasting alternatives to address several issues of our food systems. We would like to point out that a majority of Indians in several surveys on the subject have already expressed their preference against GM foods. As you know, nearly all state governments have taken a policy stand in India against GMOs in our food and farming, especially when it comes to foods even if they have allowed Bt cotton to be grown. We therefore begin our feedback to your draft regulations by reiterating our complete rejection of modern biotechnology as applied in our food and farming systems, and can certainly argue our case based on science and from the point of view of sound public interest, on why we have adopted such a position. We believe any kind of  GM food in India is a threat to health of our people, to our environment and to the diverse food cultures of India. We would like the Government of India to prohibit production, import and sale of any GM foods. We can see that the only way the government can approve unsafe foods is by compromising on the robustness of the regulatory regime.

We are providing this feedback to you on the draft regulations put out by the FSSAI with regard to GM Foods (as asked for in the said notification dated 15th November 2021) in two parts of this letter with the approach described above, i.e., that an overwhelming majority of people, as well as state governments in India, are against modern biotechnology in our food and farming systems and, if it is to regulate such foods then, the FSSAI and its regulations must prevent the industry from imposing such food on an unwilling population without independent studies in the public domain that establish the safety of long term use of GMOs and GM foods. This letter of ours is in two parts mainly: (1) overall feedback with a number of critical regulatory aspects highlighted that are unfortunately missing in the current draft notification and (2) specific point by point feedback to the draft notification put out. The second section of our letter assumes that the first section of overall feedback will be given due importance, since we find that there are serious lacunae with the lackadaisical and irresponsible manner in which the draft regulations are proposed.

1. OVERALL FEEDBACK THAT INCLUDES OBJECTIONS & SUGGESTIONS

The draft regulations do not embed several critical aspects that are essential to policy-driven, science-based regulation of GM foods, that are conducive to India’s unique and diverse food systems, health and consumption conditions, and consumer/citizen preferences, in addition to state government policies.

It needs to be acknowledged upfront that GM foods are being regulated in the first instance because they are risky to human health (and environment) and that citizens need to be protected from the risks of such foods. There are of course other risks including trade security, farmers’ seed sovereignty and autonomy and so on. Also pertinent in the context of GM foods is the fact that citizens are entitled to the right to information about what is available for eating, and their right to eat what they want to eat (right to know, and right to informed choices). It is also important to note upfront that undernourished people are always at a greater risk to toxicities in our food, compared to healthy individuals. Therefore, the food safety authority should have an explicit policy position on this within the Authority’s remit under Sec.16 (1) of the Act of ensuring safe and wholesome food and should pro-actively protect the health of the poor and malnourished in terms of food safety. It is also important to note that solutions like labeling do not readily lend themselves to the Indian conditions of food consumption where most of our food is not packed or labeled. The FSSAI’s affidavit in the Supreme Court of India, of May 2017 also acknowledges the issues with labeling.

Our response here is also based on our 20 years of continuous engagement with Genetic Engineering Appraisal Committee (GEAC) on issues related to GM regulation, and how regulation needs to include independent, long term, multi generational, comprehensive and rigorous biosafety assessment. We have highlighted, and engaged with the utter failure of FSSAI itself in ensuring that illegal GM foods do not enter our food chain, over many years now. Unfortunately, our concerns are compounded by the conflict of interest we have observed in the institutional mechanisms in FSSAI and we have written to you in the past about the same.

Against this backdrop, we urge that the following principles and elements be embedded into the proposed regulations of GM foods by FSSAI:

A. Embed the Precautionary Principle in the regulations: The precautionary principle is at the core of the Cartagena Protocol on Biosafety which India ratified. Based on that, FSSAI should explicitly mention that GM foods will not be allowed into India by way of production or imports, based on sound reasoning drawn from a variety of important reasons –  we have enumerated several above, including other important considerations like potential interference with Indian Systems of Medicine etc. GM foods have negative preference among the public and are not unavoidable. It is fraught with potential biosafety risks during production and health risks during consumption. Also, as stated in the earlier section Indian public should avoid the ingestion of such foods, especially for vulnerable sections of the public such as infants, children, pregnant and lactating mothers, the elderly and people with health issues. Plant, animal and human health are deeply connected and it is important that FSSAI adopt this “One Health” concept. In short, the mandate should be to adopt the precautionary approach and the regulatory framework should be evolved basically to fulfill this.

In view of the above:

i. Need Assessment and establishing lack of alternative: The final approval for an GMO/GEO/LMO ingredient / food should be based on assessment of needs and alternatives of safer ingredients / foods that can serve the same purpose as the GM ingredient/ food under consideration. This should happen at the GEAC end and thereafter also at the FSSAI end whenever applications are received.

ii. Public opinion: The final approval for an application should be based on obtaining public opinion. Just like these regulations have been put in the public domain to invite feedback, similarly each and every application made to the FSSAI for approval of such foods must also be put in the public domain to invite feedback.

B. Federal polity should be upheld with state government’s views and policies taken on board: FSSAI in these regulations should explicitly mandate that no GM foods will be sold or imported into any state unless the concerned state government gives an NOC for the same, given that this is a matter of public health. A majority of states in India have adopted policies that are against GMOs in our food and farming systems as of now, on the basis of public interest. Therefore, every application should be processed after obtaining inputs and recommendations from state governments. The processing of and decision on an application for approval of a GM ingredient should also ensure that the “No GM Foods Policy” of any state government is completely and inviolably protected and upheld. Therefore, the regulatory mechanisms that will be adopted by the FSSAI should take into account the federal polity and the rights of the states. This also means that there should be fool proof mechanisms put into place to ensure that there is no sale or import of these into states which do not want GM foods.

C. Harmonising regulation under FSSAI with various other regulations/regulatory bodies, and making it sequential regulation: In view of the complexity with regard to GM foods and its ramifications with regard to environment and animal well-being in addition to human health, it is important and imperative that the regulation of GM foods developed by FSSAI is harmonised with the regulations of GEAC under Ministry of Environment, Forest & Climate Change and of DGFT, in addition to working in coordination with other bodies like PPQS and NBPGR under Ministry of Agriculture & Farmers’ Welfare. All these agencies do have a regulatory role in particular cases, while GEAC and FSSAI have an explicit responsibility for all GM foods. The EPA 1989 Rules have a mandate imposed on GEAC to regulate all GM foods.

i. All GM food applications (including of non-LMO foods) should reach FSSAI only after GEAC processes such applications first. This applies to GM foods without Living Modified Organisms in them also, and with only GM ingredients. This is because FSSAI alone is not competent to deal with even processed GM foods (let us say, through the import route as an illustration), given that environmental implications exist for even such GM foods, in a full food chain analysis. GEAC also has regulatory history and institutional memory of at least 25 years. Further, FSSAI itself in its affidavit in the Supreme Court in May 2017 has explicitly said, “it is submitted that GEAC is responsible for risk assessment and approval of GM organism and products into the environment. As and when any GM food is approved by the GEAC, as per the provision in Sec.22 of Food Safety and Standards Act 2006, FSSAI has the responsibility to regulate it. FSSAI has the responsibility to regulate its manufacture, distribution, sale and import”.

ii. This harmonisation will require that the same definitions are used between all regulators for gene technologies, GMOs/LMOs and GM foods and feed are used. It goes unsaid that this should also include genome edited organisms and products thereof, which are an integral part of “modern biotechnology”.

iii. Importantly, this will also require a sequence to be adopted by different regulators when it comes to domestic production or import related regulatory decisions, where GEAC becomes the first point of appraisal, followed by FSSAI and only then decisions by DGFT and any others.

iv. It will also require inter-ministerial coordination mechanisms to be set up which are missing right now. In the Food Authority, there are no representatives of the Environment Ministry, for instance.

D. Independent, long term, comprehensive, rigorous and transparent testing and biosafety assessment as the basis of decision-making: We note with concern and a sense of disbelief that FSSAI is not proposing any mechanisms for independent, long-term, multigenerational, comprehensive, rigorous and transparent biosafety testing as the basis for decision-making on applications received for GM foods of any kind. This flies in the face of the need for utmost scientific rigour to be applied while adopting a technology or food, which will have far-reaching consequences on human and animal health. This unscientific approach is unacceptable from the apex food regulator of the country, which is mandated to ensure food safety for all.

i. For every application that is submitted to FSSAI, biosafety data should be submitted as results of conducting third-party testing of the GM food, as per a set of prescribed tests (conducted by independent and accredited laboratories) as per prescribed rigorous test protocols, to prove long term and comprehensive safety of that GM food product. FSSAI has to evolve such a comprehensive testing regime to begin with, and the same should be applied as guidelines to be followed without exception for all applicants. Applications that do not provide data generated in India should not be accepted. FSSAI choosing to accept data generated and submitted to regulators elsewhere outside India, and going by the regulators’ decisions elsewhere is simply unacceptable and a clear abdication of the responsibility of the Indian regulator. If FSSAI is to simply adopt this kind of a procedure, it may as well clear all those foods that have already been approved elsewhere! Why does it even have to specify these regulations?

ii. There should be independent testing and scrutiny of biosafety data provided by the applicant.

iii. The entire biosafety dossier should be uploaded and comments sought from the public and specifically various independent biosafety experts. These inputs should form part of the assessment that is done by a newly-constituted GM Foods & Feed Safety Appraisal Committee (GMFFSAC). In Point E below, we have elaborated some more about this GMFFSAC.

iv. Biosafety assessment should be long term and multigenerational, with appropriate testing for at least three years if not more, for chronic impacts. Acute and so-called sub-chronic testing is not enough. Such a testing regime should be mandatory on all applicants and FSSAI should begin processing an application only after such a testing regime is followed.

E. Explicitly specify and constitute GMFFSAC as the safety assessment body, and Authority as the decision-maker in FSSAI: The draft regulations only refer to the “Authority” deciding on applications. This is something that is not possible, given that the Authority is not even properly constituted as per Sec.5 of the Food Safety & Standards Act 2006 right now, and importantly, does not meet often enough, nor has biosafety experts. The Authority also does not have Environment Ministry representatives, and coordination with GEAC will be difficult in this situation. The Authority, as per FSS Act 2006 is also not mandated to give routine regulatory approvals etc. The regulations have to specify which body in FSSAI would be taking decisions on applications received. This is why a GM Foods and Feed Safety Appraisal Committee (GMFFSAC) would have to be set up in FSSAI consisting of independent biosafety experts. This Appraisal Committee will peruse all applications on GM foods after clearance by GEAC in the MoEFCC, and run processes of biosafety assessment, based on which decision-making by the Authority can take place.

F. Including GM Feed into regulation, since GM animal/poultry feed affects human food chain too: The draft regulations have ignored GM feed, even though GM feed also affects safety of human food chain. FSSAI in the past has not hesitated to issue regulations with regard to some aspects of animal feed, and there is no reason why GM feed should be left out of the current regulations.

G. Preventing Conflict of Interest in regulation: The current mechanisms of preventing conflict of interest in regulatory decision-making in FSSAI are inadequate and unacceptable. The appraisal and decision-making bodies within FSSAI which will scrutinise and decide on each application should be completely devoid of any conflict of interest (GMFFSAC and the Authority). Conflict of interest can’t be defined narrowly only as one related to any particular application under discussion, since regulators end up influencing the entire regulatory regime in the course of their work. No GMO developer and no one with any immediate family member involved in GMO development, or imports of GM foods can be a regulator deciding on applications. There should be strict norms around cooling-off period of at least five years both before and after any post related to GMO development, for any regulator.

H. Approval and Post-Approval Norms and Mechanisms:

i. Any approval should be for a specified time period of one year initially and certainly not more than three years, as regulatory science is constantly co-evolving and all applications need to be reviewed automatically in the light of evolution of scientific methods and evidence.

ii. Post approval market surveillance mechanisms should be part of the regulations. The surveillance needs to be taken up along prescribed protocols by FSSAI as well as the applicant. Such a post-marketing response should also include a citizen complaint channel, upon which also, a response should be made mandatory.

iii. The regulations should specify grievance redressal mechanisms if citizen complaints are not responded to.

I. Surveillance for, and action against illegal GM food sales: The regulations cannot be just about procedures for receiving and taking decisions on applications, and should have pro-active regulatory mechanisms spelt out about how to prevent and protect the public from illegal GM food sales/imports etc. At present, the draft regulations are completely silent about it.

i. We suggest that active surveillance through random testing of samples be taken up for those products which are imported from GMO-growing countries with those ingredients present in the food products, and also for those foods for which India has allowed GM crop field trials.

ii. Apart from lab-based testing, such a surveillance mechanism should also keep a watch out for supply chain points including import points that are likely to contaminate the food chain with GM material and domestic production units (for cotton seed oil that is part of the food chain in India, without FSSAI safety assessment and clearance, for example).

J. Laboratory testing:

i. All accredited labs should have event-specific testing protocols handed over to them, and any testing of samples should specify the event detected and the event developer should be made responsible for any illegal contamination detected.

ii. Further, SOPs for labs should be created and prescribed by the FSSAI itself, and it should not be left to the labs to create their own differential SOPs.

K. Labeling Requirements for GM foods should have 0.01% threshold: Labeling is not a matter of safety and cannot replace required biosafety assessment. However, labeling as a mechanism of providing a limited set of consumers their right to know and right to informed choices, should not be diluted in any way and should be mandatory. The labeling requirement should kick in by keeping the threshold at 0.01% when the detection mechanism is able to provide this at 0.01% threshold. Therefore, labeling should become mandatory if any food contains individual GM ingredient/ material at 0.01% threshold. This applies to genome editing also, since techniques for detection have been evolved for genome edited materials. However, as mentioned earlier, India’s unique consumption conditions and existing health/under- nourishment conditions should govern the fact that labeling is not an easy answer to even the issue of consumer’s right to know and right to informed choices.

L. Security Deposit for compensation to affected: Applicant should deposit one crore rupees (which should be inflation-indexed as years pass by) with FSSAI as a deposit for compensation to victims of possible health impacts of GM foods. This deposit is returnable after ten years after approval, depending on the health outcomes of the said GM food.

2. DETAILED COMMENTS ON DRAFT REGULATIONS:

• Chapter I General: ADD under 1. (2) (c) GM Animal and Poultry Feed

• ADD new definition under Regulation 2 (1) (b) (i) GM Foods & Feed Safety Appraisal Committee (GMFFSAC): A Committee of independent biosafety experts set up within FSSAI for appraisal of applications for comprehensive and long term biosafety

• Chapter I General: ADD under 2 (1) (d) definition of Genetic Engineering towards the very end: “and this includes genome editing techniques also”

• Chapter I General: ADD to 2 (1) (e) and (f) after ‘modern biotechnology’ the following: “including obtained through genome editing”

• ADD Definition of “GM (Animal/Poultry) Feed” means feed for animals and poultry, containing, consisting of or produced from GMOs.

• ADD 2A to specify the Constitution of the GM Foods & Feed Safety Appraisal Committee (GMFFSAC) to include INDEPENDENT (without any conflict of interest) biosafety experts including genetic toxicologists and veterinary experts.

• From Regulation 3 onwards, wherever Food Authority is mentioned, ADD the following: “Food Authority, based on the appraisal of GMFFSAC”.

• Regulation 4 (3) specifies mere scrutiny of documents along with application. This is completely inadequate. ADD: The documents submitted shall be put out in the public domain for independent public scrutiny and feedback obtained by GMFFSAC. Such public feedback will also be used by GMFFSAC for its appraisal of every application. GMFFSAC will also commission independent testing where required, at the cost of the applicant. GMFFSAC will also obtain feedback specifically from state governments where the GM food is intended to be sold.

• Regulation 4 (4) using words like ‘MAY’ and ‘IF REQUIRED’ are deeply problematic. The word SHALL replace MAY, and “IF REQUIRED” should be deleted. Further, the safety assessment protocols should be specified in the Regulations as a Schedule. This is the most critical part of regulation. The decision-making around approval should keep in mind India’s conditions of production, consumption and health, and should not be based on other countries’ decisions.

• Regulation 4(5) should say that approval is for an initial period of 1 year and then extend it incrementally, only if post-approval surveillance does not find any problems. Regulation 4(5) should also say/add that approval will be given only if state government provides an NOC.

• Regulation 4(8) should have provisions where any citizen can complain or present evidence about impacts of anything approved, and there should be procedures for recall laid down right here where approval is suspended or revoked.

• Regulation 4(8) and 4(9) should specify post-marketing surveillance procedures by independent authority, and not by the applicant or FBOs.

• Regulation 4(10) (a) should specify regulatory mechanisms related to random sampling and testing-based surveillance, to prevent unauthorised sale, import, storage, production etc.

• A section on Post-Approval regulatory procedures is needed to be added after Section 4, for cases when there is evidence of adverse impacts or risk to health as detected either by the operator, or by the general public, when complaints are raised, or when the Food Safety Officers/ Designated Officers detect such issues. Presently this is very inadequately addressed in 4(9) and 4(10). Such a section should spell out all the actions that have to be taken by FBOs and the applicant, such as how to constitute an enquiry, alert consumers, call back products, address the risk and health issues, provide compensations if any, and so on.

• Regulation 4(11) is completely unacceptable and should be deleted fully. For instance, GMO corn elsewhere might be approved for bio-fuel – how can we accept that for food or feed here without in-country proper assessments.

• Regulation 4(12) about no GMO in infant foods should be a general policy. Except under exceptional circumstances (that too after NOC from a majority of states), No GM Food should be allowed in our food chain in a preventive and precautionary approach (since it is not practically possible to implement a special approach specific to vulnerable groups like under-nourished, infants etc. in the country).

• Under Regulation 5(2) – “(2) The laboratory shall have instruments for detection of DNA/ RNA by qRT-PCR, Protein by ELISA and Western blotting and GM organism by Fluorescent microscopy”, add “and such modern instruments as may be prescribed from time to time”.

• Section 5(4) – Amend to: “The GM food testing laboratory staff shall be well versed with these regulations and proficient with internationally recognised protocols related to biosafety and techniques related to molecular biology, protein biology and food testing.”

• Add Regulation 5(5) about all labs having to be equipped with event-specific testing protocols, so that liability can be fixed on particular event developers.

• Regulation 7 on “GM Food Labelling” should be 0.01% threshold clearly, especially given that the event-specific testing protocol being asked for is at 0.01% detection level. Mandatory Labelling requirement, therefore, can kick in at the same level.

2A. IN THE FORMS FOR APPLICANTS:

• In Form I, Point 7(2), it is completely unacceptable that the information submitted and approved in another country is accepted here. This needs to be deleted.

• Points 7(3) and (4) also cannot be the main determinants of safety – safety assessment has to happen within India in a transparent and independent fashion.

• Questions 13 and 14 are set up for a particular kind of answer. They need to be rephrased where the applicant has to be asked “what is the basis for claiming safety of the product being applied for” and for the entire data of testing in India to be shared.

• Question to be added: Why does this food need to be produced or imported into India, what are the alternatives and what would happen if not produced or imported.

• Add a Form III specifically for any GM feed application with all relevant details sought, related to biosafety data generated within India.

3. OUR SERIOUS OBJECTION TO THE INDUSTRY BEING ALLOWED TO GIVE ITS INPUTS ON THE DRAFT REGULATIONS BEFOREHAND:

We took note of the fact that the industry got to see and comment on the draft regulations beforehand. This is unacceptable and adds to our concerns about the regulation giving short shrift to citizen interests in favour of business interests. As a food safety regulator FSSAI has to stand with the citizens to ensure their right to safe food and information about what we eat.

IN CONCLUSION:

We end this letter by communicating yet again that Indian citizens have negative preference towards GM foods, for valid reasons. We also conclude that the draft regulations as put out by the FSSAI are unacceptable to us, and we reject the same. The proposed regulations reflect a lackadaisical and irresponsible approach towards devising a comprehensive regulatory regime even though the Food Authority is mandated with the responsibility of protecting citizens from the risks of GM foods. Proposed Regulations should be revised drastically to reflect all the important responsibilities and aspects that we described above and that is the only way FSSAI would be able to fulfill its statutory mandate. We hope that there will be constructive engagement going ahead on this matter and that citizen interests will be fully protected.

Our feedback in the format that FSSAI prescribes (which incidentally coerces citizens to respond within a narrow framework of reacting only to what has been proposed, and not raise more fundamental issues) is available here: https://docs.google.com/document/d/1BnmDLCHaoyZ_PnJH59M5iNdcoHLQCkGq/edit?usp=sharing&ouid=101253924326915607407&rtpof=true&sd=true

Sincerely,

Kavitha Kuruganti on behalf of

Coalition for a GM-Free India & 300+ citizens including experts who have signed on to this letter

Mob: 8880067772

—