NEW DELHI: Barely two years ago, the Supreme Court raised a conflict of interest objection to the power assumed by the department of biotechnology (DBT) to regulate the environmental release of genetically modified organisms.
In a bid to reclaim that power from the environment ministry, DBT has now come up with a draft law to set up the national biotechnology regulatory authority (NBRA).
Since it is proposed as a statutory body that will provide "a single window mechanism for bio-safety clearance" of GM products and processes, NBRA is clearly meant to shift the regulatory power from the environment ministry to DBT, despite being a party dedicated to promoting biotechnology.
NBRA will be empowered to regulate, among other things, the "containment" and "environmental release" of GM organisms, which are functions currently performed by the genetic engineering approval committee in the environment ministry. The only concession to the conflict of interest issue is that NBRA is envisaged as "an independent, autonomous and professionally-led body". But the bill also makes it clear that NBRA will very much be, like some of the other statutory regulators, vulnerable to interference by the nodal department.
For, the draft bill expressly provides that NBRA shall be "bound by such directions on questions of policy" as DBT may give in writing to it from time to time. For good measure, the bill adds that if NBRA ever disagrees on whether a direction given to it fell under the category of policy or not, DBT's decision on the dispute shall be "final".
Inspired by science and technology minister Kapil Sibal, the bill will also trench on the domain of the health ministry, which is at an advanced stage of establishing its own regulatory body concerned with GM foods. In fact, the NBRA Bill was released for public consultation about a fortnight ago just when the health ministry announced that former food processing secretary P I Suvrathan would be the chairman of the food safety and standards authority (FSSA).
The NBRA Bill, which purportedly covers all GM related matters, seems to be undermining the 2006 law under which FSSA is specifically empowered to regulate the manufacture and sale of GM foods. The concept paper accompanying the bill seeks to reconcile this conflict by saying that NBRA could undertake "all or part of the safety assessment of GM foods on behalf of FSSA".
If DBT is allowed to have its way, NBRA will take over the more sensitive aspect of GM food safety, while FSSA will have to settle for "conventional safety provisions related to adulterants, extraneous matter and unhygienic processing or manufacturing of food". It remains to be seen whether the health ministry or FSSA will agree to such dilution of its jurisdiction.
Another arm of the government that is going to be affected is the department of chemicals and petrochemicals, which deals with the rules relating to pharmaceutical drugs. NBRA will regulate GM organisms with applications in human and veterinary health.
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