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“Assessment of Food and Environmental Safety (AFES)” On The Proposal for Authorisation Of Environmental Release of Genetically Engineered Mustard (BrassicaJuncea) Hybrid DMH-11 and use of Parental Events (Varuna Bn3.6 And EH2 Modbs2.99) For Development of New Generation Hybrids
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Full name*: RajinderChaudhary
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Affiliation* State Govts.(Deptt)/ Local elected bodies /Farmer /Student /NGO /academy /faculty/association/researchers/scientists/environmentalists/educational institutions/citizens/industry/research institution/others
Former Professor, Department of Economics, MD University, Rohtak, Haryana
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2. Brief Comments on AFES on GE Mustard
Ch / Section / Comments- / General comments / As per recent Supreme Court orders, regulators are to engage in dialogue with all stake holders and this process is still on. Hence this feedback is being sent.
Without full access to full bio-safety dossier, it is not possible to give comprehensive feedback. Pending availability of the same, following may be considered as partial comments.
2 / Biology of Indian Mustard / It is noted that eastern India is part of (secondary) “centres of
Diversification” (p 11). While as per international protocols GE crops are not to be allowed in centers of diversity, if for whatever reasons, it is being considered, then BRL trials should also have been conducted in these centers of diversity. However, no BRL trials have been conducted in Eastern India (p 7). Before, allowing for environmental release of DMH11, trials should be conducted in Eastern India, admitted center of diversity, albeit secondary.
3 / INDIAN BIOSAFETY REGULATORY FRAMEWORK / On p 31 it is noted that ‘Risk communication … involves an interactive dialogue between the Regulatory Agencies and stakeholders to build trust in the Regulatory system by discussing issues and addressing concerns. The Regulatory Agencies undertake extensive consultation with a diverse range of expert groups and authorities and key stakeholders, including the public, before deciding whether to authorize the release of a GE plant into the environment. The Risk Analysis Framework is part of the Indian government’s commitment to clarity, transparency and accountability for decision-making processes’. It is also pointed out that ‘The final dossier, incorporating comments of the GEAC and a sub-committee of experts, was submitted by the applicant to GEAC in February, 2016’(pp 24-25).
One fails to understand that if GEAC gives so much importance to risk communication as noted above, why the final dossier received by it in February 2016 could not be ‘communicated’ to all the stakeholders immediately to ‘build trust’. And even now, 7-8 months later, when it is no longer confidential and is open to public scrutiny, why this has not be done in a manner to actually facilitate ‘extensive consultation with a diverse range of …stakeholders’? Whole dossier should be immediately put on the website to enable diverse stakeholders to access it and stakeholders be given enough time to examine it.
5 / FOOD AND FEED SAFETY STUDIES / P 60 table 5.3 column 3 combines data from GE parents and non-gm varieties to compare it with gm hybrid and to argue that two sets are similar in composition; this is indefensible. Data from Varunabarnese and EH -2 barstar cannot be combined with observations from non-GE varieties to compare with observations from DMH11 and then argue that there is no difference in composition. Moreover, how can these GE parents of DMH11 be listed as “commercially cultivated varieties’ when these are still awaiting clearance!
In this very chapter in some tables (e.g., table 5.1) location specific data is reported and in others (e.g., table 5.2 and table 5.3) average of various locations is reported? Why this difference?
As per p 62 only acute and sub-chronic studies have been done and chronic, i.e., long term effects have not been studied. This may be justified in terms of regulatory protocols adopted, but to a consumer of gm mustard products, it is not reassuring at all. Further, food safety certificate given to these GE products in the report looses its significance as it is admitted that no livestock feeding studies have been done (p 67)
6 / ENVIRONMENTAL SAFETY ASSESSMENT STUDIES / This whole chapter is based on data submitted by applicant as already pointed out on p 7 and repeatedly pointed out in various sections of this chapter (e.g., pp 75, 78, 91, 92, 96). This is a serious lacuna in assessing the environmental safety assessment dealing with very important issues like weediness, contamination of existing germplasm and impact on soil microbial community, pest, diseases and beneficial organisms.
Moreover, at number of places there are statements like ‘The quality of data generated was sufficiently detailed and satisfied the criteria for successful risk assessment’ (p 90); (with regard to effect on soil microorganism it is noted that) ‘Minor variations were recorded in bacterial count taken from rhizosphere of DMH-11 at two locations (out of 6 locations tested) in BRL I trial season. Based on the weight of evidence approach in combination with earlier observations, the regulatory agency has concluded that these differences are not significant.’ (p 92). In absence of primary data there is no way to independently assess this. If we have to just put blind faith in the regulators, where is the need for public consultation!
Coming to specifics, on p 86 it is noted that in some cases ‘the rate of outcrossing up to 11 to 17.5%’ is observed. But it is added that ‘In case of DMH-11, the crossing with neighbouringB.juncea would be similar with other non-GE hybrid/ varieties’. This means that threat of out crossing upto 17.5% is there. That it is no higher than ‘existing mustard varieties or conventional hybrids’ is no consolation, particularly for farmers undertaking organic farming as the world over including in India GE products are banned under organic farming, as well as for consumers not wishing to consume GE products. Thus while on the one hand risk of contamination is admitted, it is repeatedly underplayed (e.g., on p 88).11 to 17.5% out crossing cannot be treated to be ‘negligible to low’
Table 6.2 on p 97 implies that BLR 1 2nd year trial was conducted at Sriganganagar also. This is contradicted by p 99 where it is noted that ‘Field trial at Sriganganagar was discontinued prematurely (two weeksbefore harvest) in the BRL I, 2nd season’.
7 / EVALUATION OF AGRONOMIC PARAMETERS FOR GE HYBRID DMH-11 AND THE PARENTAL LINES / In chapter 6, at p 77, it is noted that the ‘data revealed significantly higher shoot and root weight in hand made non-GE hybrid (VEH2-F1) as compared to the GE hybrid DMH-11under field conditions. Hence, the transgenes presence does not lead to any enhancement in the growth of DMH-11 as compared to the hand-made hybrid VEH2-F’.
This clearly indicates that non-GE hybrids showed greater hybrid vigour than GE produce, but when it comes to evaluation of agronomic parameters,this chapter indicates that GE products were not compared with non GE hybrids at all.
Anyway this chapter concludes on p 103 that ‘The hybrid DMH-11 … is superior as compared to the parents’. That GE hybrid is better than its parents, is hardly of any agronomic interest, either for the farmer or for policy makers looking at food/oil security. Question of interest is: is DMH 11 better than other hybrids or best available varieties? Unfortunately, in spite of having noted (p 77) that ‘the transgenes presence does not lead to any enhancement in the growth of DMH-11 as compared to the hand-made hybrid VEH2-F’, when it comes to agronomic studies, DMH 11 is not compared with it or any other hybrids (as evident from p 100)
Oil content of GE products has not been compared with controls. For oilseed crops, only yield comparison is meaningless without comparing the oil content.
8 / CONCLUSION AND THE SUMMARY OF RISK ASSESSMENT / On p 107 under summary it is mentioned that ‘biosafety studies were carried out in various national institutes like National Institute ofNutrition (NIN) Hyderabad an ICMR institute; Institute of Microbial Technology (IMTECH) Chandigarh, a CSIR institute; Directorate of Rapeseed Mustard Research (DRMR) Bharatpur,an ICAR institute’.
This gives the impression that all regulatory studies have been done independently. This is at variance with facts. As pointed out on p 7 all ‘Environmental Safety Studies’ reported in chapter 6 have been done by applicant only and not by any independent body. So, summary given on p 107 is wrong and misleading.
On p 108 it is noted that ‘hence a pollination control mechanism is required to disallow self-pollination and facilitate cross-pollination for production of … hybrid’. If basic propose of this GE technique is to facilitate development of a hybrid, then this should have been compared with other hybrids. Without this comparison, this GE product should not be allowed.
While it is admitted that ‘GE mustard hybrid DMH-11 contains the bar gene, conferring resistance to herbicide Basta (Phosphinotricin)’ (p 79) implying that DMH11 is herbicide tolerant, table 8.1 on pp-105-106 (and the other chapters) clearly indicate that in all the studies reported under various chapters effect of use of herbicide has not been studied at all. This is particularly surprising because the authors of the report are aware of the possibility of increased usage of herbicide on this product. On p 112 while listing out ‘some post-release monitoring/stewardship … as a precautionary measure’ it is observed that “Additional measures should be taken not to include (sic.) any chemicals for weed control in the package of practices”. How is that going to be possible? Can usage of herbicide on herbicide tolerant crop be banned? Will herbicide Basta be sold on the condition that it will not be used on DMH11? How will this be effectively implemented? So, it is a foregone conclusion that DMH 11 is going to be doused with herbicide for which it has been made tolerant. Hence, all trials and safety studies should be repeated after incorporating increased herbicide usage in experiments/trials. Without this these GE products should not be released.
Other ‘post-release monitoring/stewardship’ measures suggested are ‘monitoring honey bee behavior particularly with respect to presence oftarget proteins in honey; impact on non-target organisms and intra and inter –specific interactions’(p 112). What happens if post-release adverse consequences are noted on all or some of these counts? Neither any remedial steps are suggested nor is responsibility regime identified. Without clearly articulated withdrawal plan in case things go wrong, no army moves into action, nor should Indian farming. Similarly, without putting in place an accountability regime, there should be no permissions. If we go ahead without these two mechanisms, retrieval and accountability regime, in place ‘post-release monitoring/stewardship’ measures only become just pious wishes (albeit these will serve to underline the fact that threats were foreseen and yet ignored).
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