With law in place, FSSAI must now re-invent itself
P. I. Suvrathan
First Chairperson, FSSAI
The enactment of a law is no guarantee that it will be effectively implemented. As food safety regulation gets implemented, unforeseen developments call for creative interpretation of the provisions keeping in view the spirit of the law. It is natural in a sector characterised by fast pace of technological change for the regulator to find himself without clear tools to manage and respond to events. This calls for development of new ideas and options, some of which may even require amendment of the law. Therefore, it may be useful to periodically reiterate the original intentions of the law and review the emerging scenario so as to rededicate the organization to its basic objectives.
Background of the Integrated Food Law
The statement of Objects and Reasons appended to the Food Safety and Standards Bill 2006 refers to a multiplicity of food laws, standard setting and enforcement agencies, and the need for modernisation of laws which are non-responsive to technological developments, all of which hinder the growth of a modern food processing sector and fixation of safety standards. It was in 1998 that the Prime Minister’s Council on Trade and Industry recommended comprehensive legislation on food, with a regulatory authority as a means to modernise the food sector and ensure safety of food.
In 2004, the Joint Parliamentary Committee on Pesticide Residues emphasised the need to converge all present food laws and to have a single regulatory body. The high level committee under the chairmanship of former Supreme Court Chief Justice Venkatachaliah recommended the introduction of an integrated food law based on risk assessment, principles of modern food technology and associating the stakeholders, rather than through an adversarial approach and criminal action in all cases. The Standing Committee of Parliament, in its 12th Report submitted in 2005, urged that the much needed legislation on Integrated Food Law should be expedited.
Apart from this, several policy statements by the President of India and the budget speeches of the Finance Minister promised such an integrated food law in a time bound manner as a means to modernise the food sector, increase employment and ensure consumer safety. Many international assurances were also given by the government regarding the integrated food law. The Member Secretary of the Law Commission was asked to make a comprehensive study of the food safety laws in various countries and he recommended replacing the Prevention of Food Adulteration Act 1954 (PFA) with an integrated food law incorporating modern science and technology, responsibility of manufacturers to ensure safety, scientific determination of standards and a risk-based approach to food safety. Finally, the Group of Ministers appointed by the Government of India recommended enactment of the FSSA bill 2005 after extensive discussions, consultations with stake holders and forging a consensus on various contentious issues.
Change in Approach to Food Safety
The main issue raised against the PFA was its adversarial approach to food safety, considering all cases through the prism of adulteration, when the technology and regulatory practices worldwide have moved on to risk-based determination of standards, holding the food manufacturer responsible for safety through documented safety practices rather than solely by taking samples from the market and prosecuting.
Modern food safety regulation recognises that safety can be compromised not only at the stage of manufacture but at any link in the food chain, starting from the farm, ingredients, processing, packaging, transport, storage and sale. Each link in the food chain has to be held responsible for following safety practices and this can only be done through a risk-based approach identifying the critical points where contamination can occur and specifying the parameters to be kept in mind to ensure safety. Neglect of this basic fact resulted in the number of PFA cases in courts going up to more than one lakh in number, most of which could not be proven beyond any reasonable doubt.
Modern legal principles advocate discrimination in the prosecution of food safety cases, rather than seeking the highest jail punishment. Decriminalisation is suggested by modern jurists while drafting laws as a means to achieve effective implementation. The consensus was that the potential of the food processing sector and Indian agriculture cannot be utilised fully within the framework of the PFA, which discouraged innovation and value addition.
In the new act, contamination is defined so as to differentiate between deliberate and unintentional acts or as part of the normal process of manufacture or migration from ingredients so that responsibility can be fixed accordingly. It incorporates a graded penalty depending on the severity of the crime and awards the highest penalty only where life is threatened. The emphasis is on monetary penalties in the majority of cases, to be quickly adjudicated and imposed. Jail sentences are to be awarded only when the crime results in death or severe injury to consumers.
When India is hoping to achieve the position of a food basket to the world, exporting a wide range of food products based on its widely diverse climatic conditions, the essential requirement is the modernisation of the food industry and assurance of safety and quality of food to the consumer, both within the country and abroad. Each food manufacturer has to be fully involved in the safety of his product rather than depending only on food inspectors to establish safety. When we are looking for means to expand the number of people employed in the food sector, only a safe, modern food industry in which safety is well established and entry and exit are easy can meet the requirements of a changing market. There is no other sector of industry, either organised or unorganised, that can bring such a large number of unskilled and semi-skilled population into gainful employment. These were some of the factors that weighed in favour of an integrated food law rather than cosmetic changes to the PFA as was suggested by some quarters.
Points of Departure from PFA Act
The following are the critical areas where the FSSA departs from the PFA Act:
• Food safety is primarily the responsibility of the Food Business Operator (FBO). He knows best how the food is manufactured and how safety can be compromised. The moment a manufacturer decides to place the product in the market, he should be held squarely responsible for its safety.
Contamination can occur at any point in the food chain starting from the quality of ingredients, processing, technology, storage, transport, sale, and even at the consumer end. Each stage is required to follow specific safety practices for which the concerned entity can be held accountable. Certification of safety processes thus becomes an essential part of manufacture so that the FBO can ensure that by following such practices which are certified, he can protect himself from prosecution. The law, in fact, makes a specific provision that the courts will take note of the fact that the FBO has undergone a safety audit and taken necessary steps to ensure safety of his product. This is in line with safety practices in advanced countries where it is only after the FBO defaults after warnings that prosecution is resorted to. This is also in recognition of the fact that no regulator can inspect 100 per cent of the industries being regulated.
The law also recognises that food safety can only be ensured in collaboration with the various agencies in the field such as panchayats, health departments, homes, industry, agriculture, protection of water sources, waste management etc, all of which contribute to food being rendered unsafe. The task of the regulator, then, would be to monitor safety levels in various sectors and identify critical bottlenecks and agencies responsible for meeting them.
Risk assessment is the internationally established methodology to address food safety issues. The issues affecting food safety are so numerous and difficult to monitor that the regulator has to prioritise the safety issues and identify those which require immediate attention. Many issues are best left to be handled by the agencies directly responsible by giving appropriate guidance to them. The resources and skills available to the regulator put a limit on the number of safety issues which can be successfully handled.
The food safety regulator is specifically required to monitor the latest scientific developments in the food sector, emerging safety issues across the world and anticipate safety risks before they actually hit the country. With large scale movement of people and goods across borders, the food safety crisis in one country can reach another country in no time.
Transparency becomes an essential requirement in the development of standards, with stakeholders being well apprised of proposed regulations and given reasonable time to give their suggestions. Hastily drafted and announced measures can equally quickly collapse, raising unexpected problems in execution and issues coming up which were not anticipated. Science itself can come up with discoveries and research findings which contradict current regulatory measures.
The FBO is now given a clear means to contest the findings of government food safety labs by appealing to certified labs that need to confirm the original findings. This provision was introduced on the basis of the widespread feeling that many laboratory results are unreliable, not based on scientific procedures and cannot be the basis of successful prosecution.
Determination of food safety standards will be initiated and finalised by FSSAI, the food safety regulator, so that there is no duplication of work or parallel determination of standards for the same items and there is some degree of harmonisation with international safety standards. The fate of Indian food exports is directly linked with such harmonisation across borders.
Uniform application of safety standards across the country is sought to be achieved by making FSSAI the sole agency to coordinate determination of such standards. The training and skilling of food safety employees will also be made uniform across the country to ensure professionalism, efficiency and predictability.
FSSA seeks to achieve a light-handed regulation of a fast changing sector in which technology plays an important role and the regulator does not need to second guess the FBO. A similar approach to the software industry has yielded intended results.
A Responsive Regulatory System
In a sector where technology moves at a pace that the regulator cannot hope to match, and which provides employment to millions without being tied down by bureaucracy, India has a lot to gain by adopting a light-handed regulatory system that holds the food manufacturer squarely responsible for food safety, and also provides the means to demonstrate compliance with such safety through simple, easily understood standards. The objective should be to build food safety as an integral part of how food is manufactured, processed, handled and sold as well as eaten, rather than being imposed by an external regulatory system.
It may be interesting to recall that during discussion in Parliament of the food bill, the view was strongly expressed that food manufacture in India is the only occupation where, for example, a widow with young children to support, without any means, can decide one day to start a business to sell idli or poha and launch the venture the next day without a license, inspection, payment of fees or any other formality. Which other regular employment can the state offer to a citizen struggling to make both ends meet?
The Way Forward
Keeping in view the original intentions of the FSSA and the experience till date, the most critical steps which FSSAI should put in place are:
• Build up its capability to undertake risk analysis and development of standards and professionalism among its cadres.
• Lay down and implement clear processes for utilising scientific advice while formulating regulations.
• Undertake regular food safety surveys to estimate and quantify the level of food safety across the country so that the impact of food regulation and its success or otherwise can be established.
• Train the food safety personnel in the states to high professional levels and establish networks with centres of excellence in various fields where FSSAI does not have specific expertise.
• Establish a wide network of accreditation and certification agencies to audit and certify food safety.
• Put in place a risk based mechanism for import of food.
• Upgrade the skills and reliability of food testing laboratories as the basis for estimating food safety levels.
Historically, regulatory systems have gone through phases of dormancy and activism, with the state, the consumer as well as science pushing for regulatory innovation to meet the emerging trends and crises in the sector. It is perhaps time for FSSAI to reinvent itself keeping in view the expectations of the nation.