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The advocacy group Coalition for a GM-Free India in response to Food Safety and Standards Authority of India's FSSAI’s) “weak forms” for licensing of GM foods, has insisted on the need to have “strong regulations to ensure safe food for citizens”.
Stating that this form is different from the FSSAI GM draft regulation which had come out recently for which it had shared its response, the NGO network said in letter to Pushp Vanam, joint director, Science and Standards, FSSAI, it is problematic that these forms were not shared at the same time as the GM regulation draft as it would have enabled more people who read and respond to it.
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This is in regards to the notification from FSSAI asking for inputs on the forms. We find it problematic that these forms were not shared at the same time as the GM Regulation draft as it would have enabled more people who read and responded on the regulation draft to have been able to comment on the forms too. Our response to the draft regulation shared earlier is here.The Coalition for a GM-Free India is a loose, informal network of scores of organizations and individuals from across India, campaigning and advocating to keep India GM-Free, and to shift our farming towards a sustainable path. Consisting of farmers’, consumers’, environmental, women’s and other organizations, this network is opposed to the environmental release of Genetically Modified Organisms (GMOs) given the potential adverse health and environmental impacts, in addition to the fact that GMOs also are taking away valuable research and other resources from more lasting solutions.
Given that GMOs and associated IPRs are used by corporations to control and expand their monopolistic markets, we are opposed to GMOs on those grounds too. The Coalition also looks at GM technology as an illustrative case for the need to democratize Science & Technology policy/decision-making, empowering individual citizens to have their right to informed choices.
Our comments on the forms are here below:
Form 1A
a) Amend from “This form is applicable for food derived from genome edited plant off the SDN3 category.”TO
“This form is applicable for food derived from all genome edited plants”.
b) Delete “Where a host other than the transgenic host is used to produce sufficient quantities of the newly expressed protein for toxicological analyses” and “of the non-plant expressed protein with the plant expressed protein” from 2.5 “Where a host other than the transgenic host is used to produce sufficient quantities of the newly expressed protein for toxicological analyses, demonstrate the structural, functional and biochemical equivalence of the non-plant expressed protein with the plant expressed protein.”
No definition for sufficient quantities is provided, nor can it be done so with certainty. Also there are cases where newly expressed protein are generated/introduced in an unintentional manner. In addition to individual protein, carbohydrate, fat, and other nutrient and non-nutrient small molecule (metabolite) checks are also important. We elaborate on the ways to check these in subsequent sections. Hence these must be checked in all conditions rather than only in a subset of cases.
c) Delete “that do not have a history of safe consumption” from
2.5 Potential toxicity assessment “Describe the safety studies undertaken to demonstrate lack of potential toxicity of any newly expressed proteins in the GMO that do not have a history of safe consumption”
AND
2.6 Potential allergenicity assessment question “Describe the safety studies undertaken to demonstrate lack of potential allergenicity of any newly expressed proteins in the GMO that do not have a history of safe consumption”.
It has been often seen in situations around the world that impact of newly expressed proteins which supposedly show a history of safe consumption that these have not been tested thoroughly. In many cases, tests have been of variable and even sub-standard quality.
Hence such historical studies must not be allowed to determine FSSAI’s process.
d) The following studies need to be added to the list of studies in form (rationale mentioned too):
1) Skin Irritation Test on animals (it was done for Bt brinjal)
2) Mucous Member Irritation test on animals (as it was done for Bt brinjal)
3) Sub-chronic oral toxicity (Form in 2.5 only refers to acute toxicity where even for Bt brinjal case subchronic oral toxicity studies were done)
4) Sub-chronic feeding studies (were done even for Bt brinjal)
5) Alkaloid tests (these were done for Bt brinjal too)
6) Chronic toxicity and carcinogenicity studies (including for physiology impacts, hepatic, pancreatic, renal, reproductive effects, haematological, biochemical, immunologic, testosterone, testicular parameters, organ weights) - need for long-term, multi-generational studies exists as many impacts show only over multiple generations rather than over subchronic studies. With the shorter lifespan of animals involved in testing, this is not too much to ask for too.
7) Chronic feeding studies - Long-term animal feeding studies are needed as they can detect adverse health effects of GMO diet which can take time to show up and are less likely to show up in sub-chronic feeding studies such as organ damage and cancer.
8) Comparative assessment growing the GM crop and its non-GM isogenic comparator side-by-side under the same conditions - it ensures that variations found in the GM crop are because of genetic modification and not from environmental factors such as different growing conditions.
9) Gut microbiome (including bacteria) tests - Rats fed GM potatoes in a study have shown excessive growth of gut lining similar to a precancerous condition; in another study rats fed GM rice have shown higher levels of coliform bacteria in their gut.
Impact of GM food is not only via the crops being genetically modified but also through the additional herbicides, a herbicide-tolerant crop is designed to use more herbicides. Studies have shown via analysis of organ histological structure and blood/urine biochemistry, the gene expression profile, severe liver damage resulting from long-term exposure to an ultra-low dose of Roundup. Hence the following must also be done:
10) Organ histological structure
11) Blood/urine biochemistry
12) Gene expression profile
To verify if plant’s biochemistry has been altered in unexpected ways ensuring that potentially dangerous functional and compositional changes have not taken place (including production of toxins or allergens, higher levels of existing toxins and allergens, or altered nutritional value) -
13) Transcriptomic analysis (gene expression patterns in the organs)
14) Metabolomics analysis (metabolites present in the organs)
15) Proteomic analysis (protein composition of organ)
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16) Genotoxicity
17) Human epidemiological studies
18) Nutritional impact tests compared to non-GM isolines in side-by-side growing conditions - Experimental GM rice varieties had major unintended nutritional disturbances compared with non-GM isolines in past studies.
These are also important to be done as there have been numerous studies which have shown off-target, unintended impacts of genetic modification (including new generation genome editing techniques too).
e) Question to be added: Why does this GM food need to be produced or imported into India, what are the alternatives and what would be the potential consequences if not produced or imported.
Needs and alternatives need to be established keeping Precautionary Principle in mind.
f) Question to be added: Details of earlier import, if any (if imported)
(i) Whether the proposed GMOs/ LMOs were imported earlier: Yes/No If yes, provide the copy of relevant permits issued previously and quantities imported.
g) Question to be added: Quantity per year of the product to be imported (if imported):
(f) and (g) are important questions to be asked as many GM foods are being illegally imported currently, and in case of impact of GM food if found to have taken place in future - can have corresponding impact measured.
h) For 3.1, add transport, disposal and contingency procedures.
In case of a health emergency/impact if detected later, if these have to be recalled/destroyed.
i) Question to be added: Whether approved in country of origin and if approved, uses of the GMO (if certificate is issued by the concerned authority of country of origin, the certificate should be endorsed/ authenticated by Indian Embassy/High Commission/Consulate in that country/Embassy of the country of origin in India)
As in some host countries, GM food is not allowed however there is export of GMO to other countries.
j) Question to be added:
(i) Port of Loading/Shipment.
(ii) Port of Discharge in India.
Form IB
a) Add enzymes and processing aids to scope too.b) In addition to Section 3, 2. List of countries where ingredient/additive derived from GMM is approved for food use ; should also add a question - List of countries where ingredient/additive derived from GMM has had permission denied.
c) Question to be added: Why does this GM food need to be produced or imported into India, what are the alternatives and what would be the potential consequence, if not produced or imported.
Needs and alternatives need to be established keeping Precautionary Principle in mind.
d) Question to be added: Details of earlier import, if imported and if any
(i) Whether the proposed GMOs/ LMOs were imported earlier: Yes No If yes, provide the copy of relevant permits issued previously and quantities imported.
(ii) Statement of utilisation on the earlier GMOs/LMOs and products thereof imported:
e) Question to be added: Quantity per year of the product to be imported (if imported):
(d) and (e) are important questions to be asked as many GM foods are being illegally imported currently, and in case of impact of GM food if found to have taken place in future - can have corresponding impact measured.
f) Add a Declaration: I declare that the information provided in the above format is correct and accurate to the best of my knowledge and that the above-mentioned food does not contain GMOs in the end product.
g) Question to be added: Why does this GM food need to be produced or imported into India, what are the alternatives and what would be the potential consequences, if not produced or imported.
Needs and alternatives need to be established keeping Precautionary Principle in mind.
h) Question to be added: Details of earlier import, if any (if imported)
(i) Whether the proposed food was imported earlier: Yes/No If yes, provide the copy of relevant permit issued previously and quantities imported.
i) Question to be added: Quantity per year of the product to be imported (if imported):
(h) and (i) are important questions to be asked as many GM foods are being illegally imported currently, and in case of impact of GM food if found to have taken place in future - can have corresponding impact measured.
j) Question to be added “Add transport, disposal and contingency procedures”.
In case of a health emergency/impact if detected later, if these have to be recalled/destroyed.
k) Question to be added: Whether approved in country of origin and if approved, uses of the GMO (if certificate is issued by the concerned authority of country of origin, the certificate should be endorsed/ authenticated by Indian Embassy/High Commission/Consulate in that country/Embassy of the country of origin in India)
As in some host countries, GM food is not allowed, however there is export of GMO to other countries.
l) Question to be added
(i) Port of Loading/Shipment:
(ii) Port of Discharge in India:
In all the forms, the applicant/importer must be mandated to share updated information in the forms as and when newer information is available with the applicant/importer.
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