Friday, January 18, 2019


“Non-related comments bound to be ignored”
Monday, 02 April, 2018, 08 : 00 AM [IST]

FSSAI (Food Safety and Standards Authority of India) in recent times has brought out a series of standards, norms and other directives that aim at consolidating the food safety scene in the country. However, the apex regulatory body seems to be drawing a lot of flak over the methods that are going into formulating the standards. One important charge being vital comments by industry experts are ignored and not included in the draft by the authority. Pawan Kumar Agarwal, CEO, FSSAI, in a conversation with Ashwani Maindola threw light on the issues and more. Excerpts:

Elaborate the timeline of formation of a regulation by FSSAI.
First discussion is held by Scientific Panel then they make recommendation which goes to Scientific Committee. Then it comes to the authority and a draft is made which is sent to ministry of health. Then it is approved by the minister himself. In course of approval in the ministry, legal vetting is also done internally. After approval, the draft is notified. For WTO, it takes 60 days, otherwise 30 days, is the notification period for comments.

After that we receive comments and suggestions which then goes back to Scientific Panel. The panel then gives its comments on the received comments, about which one are accepted or rejected and with reasoning. Subsequently, the process again follows the same route for final approval.

After the approval and legal vetting from ministry of health and law, the draft, finally, is published in the gazette.

Sometimes panel may want to have multiple discussions, sometimes the committee or the authority may not be able to meet at the desired time, so usually there isn’t any timeframe for the process. But if we take minimum of the time, 6-8 months is what it may take for a regulation to complete the process.

Chairperson FSSAI has said at a recent event that in next six months to a year’s time, the work related to regulations for standards would complete. Comment.
The work related to standards is almost complete, particularly with respect to horizontal standards, like pesticide residue, microbiological residues, antibiotic residue etc., all these related regulations are completed or are in final stages of the process.

So once the broad standards are available, time to time there will be requirement of suggestions, comments, inputs about any change or updation in the laid regulations. So only housekeeping work will remain. We’re not working on vertical standards much. There are around 500 vertical standards, however.

So the 90-95% related work to standards should be over in next six months. After that only housekeeping job shall be left which is an ongoing process.

The industry has questions about FSSAI’s ability in consolidating laws relating to food like Legal Metrology, Agmark, BIS, GM Foods, Organic Foods and so on. Comment.
If there is a clarity that what is the role an agency has to play in the ecosystem then there  will not be any problem. The confusion arises where everyone tries to do the same thing. If roles are defined I don’t see any problem there. Like in India there are multiple agencies involved in other countries as well. It is important that the agencies know their jurisdiction.  We, in India, have created a coordinating mechanism like the regulatory portal. We had already one meeting on the subject and we will have more. It will take some time before things get streamlined. As regards to BIS, it has no such regulatory role. We treat BIS as agency on certain references for certification purposes. We have also reviewed BIS and Agmark certification’s need. We have also decided to remove a few items like tea from Agmark. There is no decision on BIS as yet.

The industry finds it baffling why most of the standards prepared are adoptions from Codex or USFDA or the EU or other foreign organisations without any risk assessment studies and examination of their suitability to Indian circumstances, raw materials, field conditions, weather, climate, regional requirements, consumer preferences and so on. Comment.
We can either be without standards or have some kind of arrangement that will offer us safety for food. The basic idea of a Scientific Panel and Committee is exactly this, giving us safe food. Ideally, it should happen that way as circumstance in each country may differ. So precisely, the point is looked upon by the Scientific Panel during the discussions on standards. If we would have adopted the standards blindly, there was no need for the Scientific Panel.  The whole idea is that they (Scientific Panel) examine the Codex standards, USDA standards, EU standards etc. in the context of India for all those reason. And if they find good reason it should be different for Indian condition, it should be different but if there is no good reason, why it should be? Then what is the purpose of standards? The Scientific Panel looks into these questions. Now as regards to risk assessment, that is not an exercise that can be done in a matter of days or months but it takes a long time before we could establish a pattern.  What we are trying to do is to have a data based of surveillance, enforcement of samples across many years then we will know that what the issues with respect to different products are.

The industry also feels that FSSAI is not able to involve all stakeholders as well as experts in discussions. Further, it is alleged that agenda for meetings of food authority and Central Advisory Committee is issued only two to five days before the meeting whereas the topics involved require wider consultation with stakeholders for making value-added feedback/suggestions.
As regards to Central Advisory Committee meeting, our efforts are to give agenda in advance. But agenda is not so complex that requires rigorous preparation. It’s an Advisory Committee in which people can come and comment it’s a very informal discussion and decisions are advisory in nature and this is largely a coordination mechanism in nature with state authorities. The other representatives, part of the committee, they do participate and add value. Even we allow committee members to give comments even after the meeting is over.  We welcome all the experts in improving the functioning of the FSSAI and we have very open approach to include experts in our processes as well. If there is any expert who feels he/she can contribute in any way, we would welcome them.

There is another issue about comments received for draft of the regulations. The industry says that when any notification (draft or final) is issued for comments, it is important that the comments/suggestions received are shared with the stakeholders. However, this procedure is not followed and many critical suggestions are ignored without giving reason.
As regards to regulations, we go through a process, we take comments and for final regulation we have to take a view based on the scientific analysis of the comments received. If we receive 10 comments, for example, and all are about different scenarios, we can’t include comment which is not related to the regulation. Just for the sake of inclusion, we can’t include comments, nine out of 10, non-related comments are bound to be ignored.

Some industry representative charged that huge funds were collected under the 'Product Approval Scheme' but were not accounted for and utilised properly. What is your response?
This was also raised by CAG in its report as well. The authority has taken a view that in several cases we have gone through a process, as most of the cases under product approval are now covered under standards that have since been formed. Like for nutraceuticals, proprietary food etc., so I think less than 100 cases, of old product approval cases, NoC cases and those that were pending are now under product approval and those who have already paid fees, they do not require to pay fees. We’re charging fees only from the fresh applicants. And the entire money is deposited in the government’s exchequer. It’s completely accounted for. And this is a view that has been taken that FSSAI has done some work and refund is not justifiable.
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