The Food Safety And Standards Act, 2006 : A Paradigm Shift In Indian Regulatory Scenario

Abstract:

In India multiple regulations for food have been enacted at different points of time to supplement each other. This incremental approach has lead to incoherence and inconsistency in the food sector regulatory scenario. The Food Safety and Standards Act, 2006 is a new statute that integrates eight different existing food laws, and is a major transformation that ensures to bring paradigm shift in the food regulatory scenario of the country. The Indian food industry appreciates the benefits of the Act and look forward to its implementation at the earliest. This review will present the highlights of the Act, focusing on its legislative history along with a general discussion of the specific provisions. In this analysis, selected regulatory concepts are also discussed to promote a better understanding and implications of this statute.

Keywords: The Food Safety and Standards Act, Indian Food Laws, Multiple Food Laws, Food Safety and Standards Authority of India

Introduction:

The food processing industry is one of the largest sectors in India in terms of production, growth,consumption, and export.   Food processing industry is widely recognized as the 'sunrise industry' in India and is of enormous significance for India’s development because of the vital linkages and synergies that it promotes between the two pillars of the economy, namely Industry and Agriculture. As the country moves on the path of development, agricultural sector evolves from traditional level farming to commercial agriculture producing high value and processed products.

The Indian food regulations comprise various food laws that have been enacted at different points of time, and are under the ambit of various ministries of Government of India (GOI) as shown in table 1. Historically they were introduced to complement and supplement each other in achieving total food safety and quality. The result is that the food sector in India is governed by a number of different statutes rather than a single comprehensive enactment. Each ministry has prescribed its set of rules and standards under relevant acts and orders often creating a confusing and sometimes contradictory environment for the industry.

The multiplicity of ministries and administering authorities at both the central and state level has resulted in a complex regulatory system that is not well integrated adding an additional burden on the food industry. In general, this regulatory system resulted in a lack of comprehensive, integrated food law under single regulatory authority that ensures public health, safety, and also specifies quality norms for meeting the globally recognized standards.

The Food Safety and Standards Act, 2006:

Following pressure from the industry and stakeholders for a single regulatory body and an integrated modern food law, the then Prime Minister of India (POI) in 2002 constituted a task force to review India’s food and agro industries management policy. The task force made wide-ranging recommendations.   One of the major recommendations was the consolidation of the various food laws under one umbrella so that a single authority can supervise the effective implementation. The task force proposed setting up a food regulatory authority somewhat akin to U.S. Food and Drug Administration. The task force also suggested an urgent need to align Indian food standards to international standards, and that the government and industry should work together to ensure that India is well represented and fully heard in international forums like Codex Alimentarius Commission. The task force articulated that the existing central committee on food standards does not have an established objective system to evaluate new innovations or ingredients in the food industry based on the international scientific bodies, nor does it rely on the scientific opinion of food research labs and institutions in India.

The Ministry of Food Processing Industries (MOFPI) took a keen interest and initiative in the implementation of the task force recommendations, and drafted a new Food Bill in 2002. The primary focus was to integrate the existing food laws and to bring about a single statute under a single regulatory authority, and to provide regulatory system for the production, manufacture, processing,and sale of safe and suitable food. In order to rationalize the multiplicity of food laws, the GOI constituted a group of ministers to suggest legislative and other changes to formulate a modern, integrated food law, which will be a single reference point in relation to the regulation of food products. However, formulating a single legislation that would replace the existing multiple laws was rather difficult and slow,considering the number of stakeholders involved and the nature of India’s food processing industry, which is dominated by small-scale units. After extensive discussions and consultations, the Food Safety Standards Bill, 2005 (the Bill) was drafted, and on January 15, 2005 posted for public comments. The GOI notified the proposed legislation to the World Trade Organization on June 27, 2005.

The Bill was introduced in the Lok Sabha (Lower house of the Parliament of India) on August 25, 2005, and was referred to the Parliamentary Standing Committee (PSC) on Agriculture for further review and scrutiny. The PSC presented its report to the Parliament on February 21, 2006.   The Lok Sabha passed the Bill after incorporating the PSCs recommendations on July 26, 2006. The Bill, as passed by Lok Sabha was presented in the Rajya Sabha (Upper house of the Parliament of India) on the July 31, 2006.  The Bill was passed on the August 2, 2006. The President of India signed the Bill on August 23, 2006 and was finally enacted as, The Food Safety and Standards Act, 2006 (No. 34 of 2006). The GOI notified the enactment in the official gazette on August 24, 2006.

The Food Safety and Standards Act, 2006 (the Act) has 12 chapters containing 101 sections and two schedules. The Act incorporates the salient provisions of the Prevention of Food Adulteration Act 1954, and is based on international legislations, instrumentalities and Codex Alimentarius Commission. This Act with its three tier structure (an apex food safety and standards authority, a central advisory committee and various scientific panels and committees) is expected to lay more emphasis on science based and participatory decisions while adopting the contemporary approach in both standard setting and implementation.

Salient features of the Act:

This article provides a brief overview of the salient features of the Act. This overview is not intended to be complete or all-inclusive, but does provide some key points.

• The Act integrates eight different food related statutes. The Act also aims to establish a single reference point for all matters relating to food safety and standards, by moving from multi-level, multi-departmental control to a single line of command.
• The Act establishes the Food Safety and Standards Authority of India (FSSAI) as an apex regulatory authority consisting of a Chairperson and 22 members.
• The Act prescribes general provisions for the following articles of food:

oFood additives / processing aids are to be added only in accordance with provisions / regulations under the Act;

o Foods are not to contain any insecticides or pesticides residues, veterinary drugs residues, antibiotic residues, solvent residues, pharmacological active substances and micro-biological contaminants in excess of limits prescribed under the regulation;

o Regulations to be made for the manufacture, distribution or trade of any novel foods, genetically modified foods,irradiated foods, organic foods, foods for special dietary uses, functional foods, nutraceuticals, health supplements, proprietary foods, etc.

• The Act provides the general administrative principles to be followed by the Central Government, State Governments, and FSSAI while implementing the provisions of this Act.
• The Act prohibits advertisements which are misleading or deceiving or contravenes the provisions of this Act, and prohibits unfair trade practices.
• All imports of articles of food are subject to this Act.  No person shall import any unsafe or misbranded or sub-standard food or food containing extraneous matter.
• The Act impose the responsibility on the food business operator to ensure that the articles of food satisfy the requirements of this Act at all stages of production, processing, import, distribution and sale within the businesses under his control.
• The Act also imposes certain liabilities on the manufacturers, packers, wholesalers, distributors and sellers if an article of food fails to meet the requirements of this Act.
• The Act compels the establishment of food recall procedures.
• The FSSAI and the State Food Safety Authorities are responsible for the enforcement of this Act. The Act establishes a general authority line for the efficient enforcement of the Act.
• The Act compel licensing and registration of food business. Small business operators and temporary stall holders are exempted from the license but need to get their businesses registered with the local municipality.
• The Act provides general provisions relating to offences and penalties for failure to comply with the requirements of this Act. The Act makes provision for graded penalties where offenses like manufacturing, storing or selling misbranded or sub-standard food is punished with a fine, and more serious offences with imprisonment.

FSSAI Constitution

The FSSAI has been established under the Act as a statutory body for laying down science based standards for articles of food and regulating manufacturing, processing, distribution, sale and import of food so as to ensure safe and wholesome food for human consumption.

The FSSAI consists of a chairperson and 22 members, of which one-third shall be women. In their endeavor to carry out provisions of the Act, the FSSAI shall be assisted by Central Advisory Committee (CAC), Scientific Panels (SPs) and Scientific Committee (SC) each with specific responsibilities.

The FSSAI shall establish a CAC, which shall advise the FSSAI in drawing up proposals for the FSSAI’s work program, prioritization of work, identifying potential risks, pooling of knowledge, ensuring co-operation between the FSSAI and the enforcement agencies, and other functions as specified by the regulations. The CAC of FSSAI consist of  two members each representing from food industry, agriculture, consumers, relevant research bodies and food laboratories, commissioners of food safety, and the chairperson of the SC. The Chief Executive Officer (CEO) of the FSSAI shall be the Chairperson of the CAC. The CEO shall be the legal representative of the FSSAI, and shall be responsible for the day-to-day administration activities.

The FSSAI shall establish SPs, which shall consist of independent scientific experts. The FSSAI may establish as many SPs as it considers necessary in addition to the panels on food additives, pesticides and antibiotics residues, genetically modified organisms and foods, functional foods and other similar products, biological hazards, contaminants in the food chain, labeling and method of sampling and analysis. The FSSAI shall constitute a Scientific Committee (SC) which shall consist of the chairpersons of the SPs and six independent scientific experts not affiliated to SPs.

Duties and functions of the FSSAI

• Framing of regulations to lay down the standards and guidelines in relation to the articles of food, and specifying appropriate system of enforcing various standards thus notified.
• Laying down mechanisms and guidelines for accreditation of certification bodies engaged in certification of food safety management system for food businesses.
• Laying down procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories.
• Provide scientific advice and technical support to central government and state governments in the matters of framing the policy and rules in areas which have a direct or indirect bearing of food safety and nutrition.
• Prescribe the food-labeling standards including claims on health, nutrition, special dietary uses and food category systems for foods.
• Prescribe the procedure subject to which risk analysis, risk assessment, risk communication and risk management shall be undertaken.
• Creating an information network across the country to disseminate rapid, reliable and objective information about food safety and issues of concern.
• Provide training programs for persons who are involved or intend to get involved in food businesses.
• Contribute to the development of international technical standards for food, sanitary and phyto-sanitary standards.
• Promote general awareness about food safety and food standards.
• Promote co-ordination of work on food standards undertaken by international governmental and non-governmental organizations.
• Promote consistency between international technical standards and domestic food standards while ensuring that the level of protection adopted in the country is not reduced.

The FSSAI while framing regulations or specifying standards under this Act shall consider the prevalentpractices and conditions in the country including agricultural practices and handling, storage and transport conditions, and as well take into account the international standards or practices that are pre-existing or in the process of being formulated.  

Status on enforcement of the Act:

The administrative control of the Act is assigned to the Ministry of Health and Family Welfare.   On September 5, 2008, the GOI notified the establishment of FSSAI consisting of a chairman and members who in turn will initiate the rule making process.   Certain provisions of the Act are enforced steadily and are notified by the GOI. FSSAI constituted the SC and SPs, and established its administrative process.

An amendment to the Act, called the Food Safety and Standards (Amendment) Act, 2008 (No. 13 of 2008) was recently enacted. This is an amendment providing an exemption to the members of FSSAI from the purview of office of profits and the age restriction to a maximum of 62 years. FSSAI is steadily drafting the draft guidelines and regulations for public consultation.

Formulating Rules and regulations under the Act of is a mammoth task and is anticipated to begin shortly. It will be a monumental task to integrate under one single authority the eight food laws that are currently being implemented by several Ministries, and it is anticipated to take one to three years to complete the rule making process. Until then the rules and regulations framed under the existing acts, which would be repealed, will continue to be in force. The implementation of the Act is reportedly in progress although it is unclear exactly when it would come in to force.

Key benefits of the Act:

One of the major benefits of implementation of the Act will be the consolidation of the existing eight laws relating to food and establishment of the FSSAI.

In one study conducted by the Federation of Indian Chamber of Commerce and Industry,95% of the respondents from food industry appreciate the benefits of the Act,and look forward to its implementation at the earliest. The prominent benefits of implementation of the Act as anticipated by industry are unification of existing eight food laws, stronger implementation and removal of existing anomalies during rule framing. As part of the process of consolidation, the first eight laws listed in the table 1 would stand repealed on commencement of this Act. This Act does not repeal all existing food-related legislations, such as the Standards of Weights and Measures Act and Packaged Commodity Rules.

Foods for special dietary uses or nutraceuticals or functional foods or health supplements is a category that has been specifically defined in the Act, a feature which was not there in existing food laws. The implementation of the Act is anticipated to facilitate and promote the development of new products thus enabling the growth of the industry and innovation.

Key issues, and anticipated implementation problems:

The key problem that industry anticipates from implementation of the Act is the initial phase of disorder that will be introduced. The small and medium scale industries that do not very vigorously keep track of the regulatory changes will find it difficult to identify the procedural and compliance changes brought by the Act. Industry is also apprehensive that during the transition phase, uncertainty will prevail till the food processing industries and the regulators can come to a common platform.

A comprehensive study report prepared for MOFPI reported that majority of the laboratories in India do not have accreditation, and only few laboratories are fully equipped to cater the domestic and export regulatory testing needs of the food industry. This report emphasizes a greater need of manpower development and up gradation of the laboratories in terms of infrastructure and sophisticated equipments. With the advent of the Act that will levy heavy penalties for non-conformances, a need for accredited laboratories is of paramount importance. GOI may need to look into this requirement as a priority to encourage accreditation to international standards. Industry anticipate that shortage of testing laboratories and equipment might hamper the implementation of the Act, and GOI may also find it difficult to identify, recruit and then continually train people for the accredited laboratories. The immediate adoption of international standards, without preparing the domestic food industry will pose challenges for the effective implementation of the Act.

The Act also mentions certain terms like 'Food Safety Management System' whose definition calls for adoption of 'Good Manufacturing Practices', 'Good Hygienic Practices' and n'Hazard Analysis and Critical Control Point'. However, it is not clear from the Act what these terms imply and whether the CODEX definition of such terms is to be followed.

The Act excludes plants prior to harvesting and animal feed from its purview. Any harmful input (such as pesticides in vegetables or antibiotics in animal feed) that could affect the safety standards of food products is not effectively covered. Industry sense that it will be difficult for processing industries to take the onus for ensuring that such standards are within the acceptable levels in processed food when raw material fails to meet these standards. Though standards are specified for water used as an input in manufacture/preparation of food, the Act does not require any specific standards for potable water. The Industry hopes that this concern will be addressed during the rule framing activity.

Section 90 under the Act provides the transfer of existing employees governing the existing food laws to the FSSAI. FSSAI has notified this transfer on February 19, 2009. Industry anticipates that changing the mindset of existing employees will pose a challenge for GOI in enabling the effective implementation of the Act.

Conclusions

The food sector in India has been governed by multiple laws enacted at different points of time to complement and supplement each other under different ministries. The Food Safety and Standards Act, 2006 is a major transformation that has happened after decades and ensures to bring a paradigm shift in the food regulatory scenario of the country. The Act aims to establish a single reference point for all matters relating to food safety and standards, by moving from multi-level, multi-departmental control to a single line of command. As part of the process of consolidation, the eight contradicting and overlapping food laws in the country would stand repealed on commencement of this Act. This unified Act will enable unidirectional compliance and address the need for a single regulatory body.

 Implementation of the Act is a mammoth task not only for the food processing industries but also for the GOI to incorporate the proposed changes in the existing structure and functioning of the government machinery. To fully realize the benefits of the Act, FSSAI needs to maintain total transparency in rule framing. Involvement of industry and other stakeholders at the earliest stages of rule framing and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law is essential for setting of sound scientific standards.

The Indian food industry appreciates the benefits of the Act and look forward to its implementation at the earliest. Food industry anticipates that effective implementation of the act will ensure alignment with international standards. At this juncture, the GOI needs to expeditiously move forward with the implementation of the Act.

The Indian food industry has been closely following the Act with a keen interest,since the formation of one single regulatory system will definitely bring synergy in technical and regulatory matters, and substantially reduce the transaction costs imposed on Industry. Global food investors and regulatory agencies are also tracking the development on this front.

The views expressed in this article are those of the authors and do not reflect the official policy or position of the Government or any other agency. Owing to the emergingregulatory situation and given the voluminous nature of the specific details,the reader is directed to the pertinent GOI and FSSAI publications for the current regulatory scenario. The authors and journal will not be responsible for the accuracy or legality of any statement made at this constantly changing regulatory environment.

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About Authors:

M.Prasad Palthur, S.S.Sajala,and Suresh Kumar Chitta

Mr.M.Prasad Palthur is a Certified US Regulatory Affairs Professional with core competencies in the areas of Pharma regulatory affairs, formulation design & development and quality. As of his academic accomplishments, he holds university gold medal for scholastic excellence both in his B.Pharmacy and M.Pharmacy. He has publications in the reputed journals. He has over 7 years of pharmaceutical industry experience in the areas of regulatory affairs, quality and product development. Presently, he holds the designation of Director of Regulatory Affairs and Quality, and is responsible for regulatory and quality operations.

Dr. S.S.Sajala Palthur is a food technologist by education and has core competencies in the areas of Pharma regulatory and compliance affairs. She has a Doctorate in Food Technology from Punjab Agricultural University, and has 6 publications in the reputed journals. She has immense experience in setting up quality system and its related documentation and processes. Presently, she is working in the areas of pharma regulatory and quality compliance, and is responsible to ensure compliance of pharmaceutical products and quality processes.

Dr. Chitta Suresh Kumar is the founder and Professor-In-Charge, College of Pharmacy at Sri Krishnadevaraya University, and has been recognized for his contributions in the field of Computer Aided Drug Design, Structural Bioinformatics, Molecular Modeling of Drug Targeted Proteins, Screening of Photochemical in regulation of Cancer and Apoptosis. Prof. Chitta Suresh Kumar has contributed in the establishment of research facilities in the area of Transgenic Plants, Bioinformatics, Structural Biology and Drug design. He has completed 5 Major Research Projects and presently operating 2 projects (UGC and DBT). He has developed the agro-cultivation practices for Medicinal Plants in Rayalaseema region. Dr. Suresh has organized 7 national workshops/seminars in the field of Bioinformatics sponsored by DBT, DST, ICMR, CSIR, APSCHE and UGC. He has published 16 papers in International journals. He is the recipient of DBT National Associateship, AICTE Career Award in Biotechnology, DST-SERC visiting fellowship and has been elected as Fellow of Association of Biotechnology & Pharmacy-2008. He has over 18 years of experience in the academic and research environment.