CHAPTER-2
REGULATORY STANDARDS FOR FOODS IN INDIA AND INTERNATIONAL CONTEXT: A SOCIO-HISTORICAL OVERVIEW
This chapter attempts to examine how standards and regulations on foods have evolved, especially with reference to food safety in India. The chapter also draws upon interview material and correspondence with government officials located in Food Safety & Standards Authority of India, Bureau of Indian Standards, National Institute of Training for Standardization and other concerned departments, in addition to available secondary literature, in order to provide a glimpse into the perspectives, structure and functioning of regulatory bodies, their activities in relation to standards-setting at the national and international levels and the significant of such efforts for food safety in India.
The initial part of the chapter briefly describes various levels of standardization: national, international, voluntary/involuntary and intergovernmental standards. The next section deals with developments in relation to the need for food safety and traces the historical landscape of regulations pertaining to food safety over a period of time. It attempts to trace this history from the post-independence era to the contemporary period and also enumerates on the important changes in the new food laws.
The subsequent section attempts to compare Indian food safety standards in relation to international standards at CODEX and ISO level. It describes the focal areas of activity with regard to food standardization for these bodies. In this context, the section also attempts to provide a glimpse into the differences and lacunae with respect to such standards in India.
The following section of the chapter discusses some of the controversies related to foods & beverages, which have occurred in India in recent years. These controversies served to highlight that NGOs, consumer organizations and the media played a significant role in the discourse on standards related to food safety 23
issues. The concluding portion of the chapter provides a discussion and summary of the role of regulatory bodies in the standardization process in India.
2.1.1 United Nations Food Safety Resolutions and Other Actions
In 2002, the United Nations in cooperation with consumer organizations drafted and eventually adopted guidelines for consumer protection that urges governments to “give priority to areas of essential concern for the health of the consumer, such as food, water, and pharmaceuticals. . . . Governments should maintain, develop or improve food safety measures, including, inter alia, safety criteria, food standards and dietary requirements and effective monitoring, inspection and evaluation mechanisms.”
These international resolutions attest to the growing urgency of food safety. As food is increasingly traded globally, food safety has become a global public health issue. Dialogue between the United Nations’ specialized agencies and groups representing consumers’ interests is vital to improving national programs and protecting all consumers. Valuable contributions have been made by the long- standing involvement of international consumer organizations like Consumers International and the growing involvement of the International Association of Consumer Food Organizations in the work of the Codex Alimentarius Commission and its subsidiary bodies that deal with health and safety issues.
Looking closely on the above positions on international food standards governance, we find that there are mainly three sites of contestations; the first is the CODEX itself, wherein the international norms and guidelines are being formulated; the second one is the WTO, wherein CODEX non-conforming national regimes can be legally challenged through the dispute settlement process;
and the third one (and also perhaps the most dynamic and most interesting) has been the bilateral trade agreements between the two largest trade blocks (viz. the USA and the EU) and the developing countries(Chowdhury and Kumar,2008) .
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2.1.2 Intergovernmental Standards: Emergence of the Codex Alimentarius Standards
The intergovernmental body for the development of internationally recognized standards for food is the Codex Alimentarius Commission (CAC). The Codex Alimentarius Commission (Codex) was established in 1962 in Rome, Italy as an intergovernmental agency of the United Nations under the Food and Agriculture Organization and the World Health Organization (WHO). Currently the Codex Alimentarius Commission has 188 Codex Members - 187 Member Countries and 1 Member Organization (EU); 234 Codex Observers - 54 IGOs, 164 NGOs, 16 UN.
The voting members (one State, one vote) for the development of the Codex standards are the national agencies, departments or ministers that regulate the production of food, rather than the national standard organizations that vote for the development of ISO standards. Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO which are interested in international food standards. Regional economic integration organizations that are members of either FAO or WHO can also become members and special rules apply.6
The Codex Alimentarius Commission develops science-based standards taking into account the scientific advice provided by FAO/WHO expert bodies and ad hoc consultations and meetings. Codex committees, when developing standards, apply risk analysis and rely on the independent scientific advice from those FAO/WHO expert committees. Risk analysis is fundamental to the scientific basis of Codex food safety standards. Risk analysis within Codex is a structured, systematic process that examines the potential adverse health effect consequential to a hazard or condition of a food, and develops options for mitigating that risk. This also includes interactive communication among all interested parties involved in the process. Within Codex Alimentarius Commission and its procedures, the
6International food standards (Codex Alimentarius)
http://www.who.int/foodsafety/areas_work/food-standard/en/
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responsibility for providing advice on risk management lies with the Commission and its subsidiary bodies (risk managers), while the responsibility for risk assessment lies primarily with the joint FAO/WHO expert bodies and consultations (risk assessors). The three independent international risk assessment FAO/WHO expert committees are: Joint FAO/ WHO Expert Committee on Food Additives (JECFA): performs toxicological evaluation for food additives, contaminants, naturally occurring toxicants and residues of veterinary drugs in food.
India is a Codex member since 1964. The National Codex Contact point is the Food Safety Standards Authority of India7 with its head office at New Delhi. It coordinates and promotes Codex activities in India in association with the National Codex Committee and facilitates India's input to the work of Codex through an established consultation process. The FSSAI has appointed the Shadow Committees of the NCC on subject matters corresponding to the Codex Committees to assist the NCC in the study or consideration of technical matters.
Officers in the rank of Joint Secretary or above in the concerned Department/Ministry / Food Authority who handle the subject at the policy level and also serve as the members of the NCC may be nominated as the Chairpersons of these Shadow Committees. Specialized experts in the relevant field may be nominated as members of these Shadow Committees.
7 www.fssai.gov.in Accessed in March 2016
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2.2 Historical Background of Regulatory Framework for Foods in India
Till the advent of 21st century, a number of different laws governed the food processing sector in India. The prevailing laws/regulations adopted by the Government to verify the quality of food and drugs prescribe varied standards regarding food additives, contaminants, food colours, preservatives and labeling.
In order to rationalize the multiplicity of food laws, a Food Safety Standards Authority of India( FSSAI) was recently set up to suggest legislative and other changes to formulate a modern, integrated food law, which would be a single reference point in relation to the regulation of food products.
2.3 The Food Safety and Standards Authority of India (FSSAI)
The FSSAI has been established under Food Safety and Standards Act, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has been created for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.8
Amongst the Government agencies, the Food Safety and Standards Authority of India (FSSAI) is the regulatory body responsible for food safety and quality issues across the country. Food Safety and Standards Act, 2006 consolidates various acts and orders that have hitherto handled food related issues in various Ministries and it is in turn implemented through the food control authorities in respective states. Thus, in Gujarat state, it is the Food and Drug Control Administration, Gandhinagar.
8Food Safety and Standards Authority of India (FSSAI) Source: http://www.fssai.gov.in/AboutFSSAI/introduction.aspx
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With the mandate of laying down science based standards for food, FSSAI proposes to support research projects and related innovative R&D proposals pertaining to food safety and quality control by extending financial assistance to various institutions/Universities and recognized R&D laboratories.
The Head Office of FSSAI is in New Delhi and it falls under the purview of Ministry of Health & Family Welfare. The Regional offices are located in four major zones, i.e., Northern, Western, Southern and Eastern.
A former Senior official9, based in Delhi, informed that “the Food Safety and Standards Act was enacted in the year 2006, to consolidate the multiple laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage distribution, sale and import, to ensure availability of safe and wholesome food for consumers. It provides for legal powers and specifies offences in relation to public health and consumers’ interest; and allows shifting from regulatory regime to self-compliance through Food Safety Management system.”
He further stated that “the Food Safety & Standards Authority of India is the principal Government Authority responsible for preparing specific regulations under the Act”.
Ministry of Health & Family Welfare, Government of India is the Administrative Ministry for the implementation of FSSAI. The Chairperson and Chief Executive Officer of Food Safety and Standards Authority of India (FSSAI) are appointed by Government of India. The Chairperson is in the rank of Secretary to Government of India.
9From 2009 to March 2012 the respondent worked with Food safety and Standards Authority of India, Ministry of Health & Family Welfare to draft various Meat, Milk and Food safety regulations. He is currently working with Ministry of Food Processing Industries, GOI.
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2.4 IMPLEMENTATION OF FOOD SAFETY LAWS
The existing levels of implementation of food laws vary from state to state, depending on the priorities attached to them, the resources made available and the leadership provided. The contribution of the State Governments and the local bodies will be critical to the effective implementation of the food laws in the country. The primary role assigned to local bodies is licensing as well as monitoring of foods as per the FSSAI regulations.
A very senior official10 informed that “FSSAI is mandated to streamline the procedures for licensing and registration. Currently each state has its own procedure for licensing and registration, and this prevents comparison and coordination between states.” However he desired that a common platform and format for such licensing and registration should be developed by FSSAI. Such a portal should be IT enabled so that it can be easily accessed by the regulator for prompt response.
In this regard, the researcher requested for interviews with the Food Safety Commissioner, Gujarat State. The request was directed to two senior Food Safety Officers based at Food and Drug Control Authority (FDCA), Gandhinagar. In depth interview was conducted on 26th February 2015. The queries were based on the Interview schedule (Annexure -3). The responses received were basically sourced from within the FSSAI Act and Regulations, 2011. The food safety officers were forthcoming about the shortage of staff and extreme work load and other such limitations. They informed about the annual schedule of sampling and testing of food products accordingly in the respective jurisdictions. One of them revealed that “a number of complaints received by us are actually found to be cases of personal rivalries or other such petty issues. Genuine complaints are far less in number than such false ones”. Thus, interestingly though, they need to take extra precaution with respect to sampling and enquiry for that matter.
10 The first Chairperson of FSSAI (2006), Interviewed in March 2016.
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Another interview was conducted with the Deputy Controller, Food and Drug Control Administration (FDCA), Gujarat. He also informed about the role and functioning of the Department. With respect to construction and formulation of standards for foods, it was learnt that they were only the enforcement agency and that the central head office was in charge.11
In this regard, the Deputy Director, Ministry of Consumer Affairs, Gujarat, emphasizing the need for effective implementation of food safety standards, highlighted the need for such awareness at grassroots levels. He also showed keen interest in playing a major role through various consumer organizations, consumer clubs and other govt. schemes.12
The Public Analyst and In-charge of Public Health Laboratory, Ahmedabad Municipal Corporation was interviewed to find out about the impact of Food Safety Standards vis a vis the earlier Prevention of Food Adulteration (PFA) that was repealed since 2006. He opined that the current laws were stronger and more meaningful in the present context, when food safety concerns went beyond adulteration. He also informed that “the Gujarat Government’s laboratory was the state of the art and equipped to perform all sorts of analyses required for ascertaining quality and safety of foodstuffs”.13However, he also mentioned that to overcome the workload of the entire region, staff strength was to be increased and that training and capacity building of food testing laboratory in terms of number and technical expertise was absolutely essential.
The state level authorities are represented in the FSSAI board through the respective Food Safety Commissioners, Dr. H.G.Koshia, for Gujarat state. The respondents included in the study reported to him with respect to the progress in implementation and also the problems associated therewith. The state level issues are conveyed by the concerned officials and representation to the authority for
11Interview conducted on 15th July 2015 at Ahmedabad
12Interview conducted on 15th July 2015 at Ahmedabad
13 Interview conducted on 7th May 2015 at Ahmedabad
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standards, procedures and new subjects were made in this manner. However, it was deduced from these interviews that their role was more or less restricted to following the FSSA regulations as enforcement agencies. The scope for contribution to the standardization process as such was negligible though they seemed to be knowledgeable about the deficiencies in current system and also international developments in the field of product safety and standards.
Some of the Delhi based FSSAI officials as listed in Annexure-3 were also contacted and requested to respond to the questionnaire through e-mail. However no response was received even after repeated reminders. The first Chairperson of the Food Safety Standards Authority of India was contacted for his views on related issues. Many relevant insights were obtained from his interview14 . He commented that “FSSAI has completed five eventful years of its existence and it is time for the Government to take stock of its performance, in relation to the objectives originally laid down by Parliament. It is also necessary to outline a road map for the next five years so that the food safety regulator comes up to the expectations of the Parliament which passed the Food Safety and Standards Act in 2006. As one of the main stakeholders, Government now has opportunity and responsibility to review the regulator’s performance and lay down the operative framework, short and medium term deliverables and timelines as well as priorities which it expects the regulator to follow in the area of food safety. The test of a good law is the way it is implemented. We have any number of excellent laws which remain in the statute book without being implemented.”
Regarding implementation by the food business operators he strongly felt that FSSAI should also draw up a simplified set of guidelines in plain English and other languages for easy undertaking of stakeholders without the need for obtaining the services of a consultant.
14Interviewed in March 2016 via telephone
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2.5 Procedure for Selection of Scientists on the Panel and Committee
The Scientific Panels and Scientific Committee are constituted as per the approved internal procedure for selection of members of the Scientific Committee, Scientific Panels and that includes experts for Working Groups of the Scientific Committee and Scientific Panels as per the provisions of the FSS Act, 2006.
Selection of scientists is a continuous process based on the availability of specific skills and new developments in science and technology.
Ex-Chairperson of FSSAI15 in his interview mentioned that a roadmap for FSSAI is necessary to bring in greater accountability. He suggested that FSSAI in consultation with relevant academic and research institutions, Scientific Panels and Committee, must develop a research agenda which addresses the scientific requirement of food safety policy and emerging areas of concern.
2.5.1 Scientific Committees [Table-2(iii)]
There are fifteen scientists/ experts empanelled on the Scientific Committee of FSSAI. In the eight Scientific Panels and the Scientific Committee constituted by the Authority, at present there are 27 scientists from the private sector out of a total of 123 scientists (21%).
2.5.2 Scientific Panel [Table-2(iv)]
There are nine panels under this depending upon the work entailed.
[See Appendix for Tables-2(iii) and 9iv)]
15The first Chairperson FSSAI ( 2006- 2011)
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2.6 NETWORK OF LABORATORIES
The FSSAI has notified 82 NABL16 accredited laboratories ( as on 7thJuly 2015) for the purpose of carrying out the analysis of food samples taken under the FSSAct,2006 Rules & Regulations made there under. There are two such laboratories in Gujarat region—one in Vadodara and the other one at Gandhidham.
The FSSAI official17 stressed upon the need for Food Testing Laboratories. He mentioned that without a network of reliable food testing laboratories, it is impossible to implement the provisions of the food law, initiate prosecution where warranted and evaluate the effectiveness of programmes. He said that “FSSAI has to work with state authorities, and central government agencies to build such a network and put in place a mechanism for continuously upgrading the capability of these laboratories and provide training to the staff to operate them.”
He cautioned that unless regular monitoring of the safety parameters, health indicators and consumer feedback is build into the standard setting process, it will not be possible to ensure the food safety measures are in line with the realities on the ground. Many such sources of information are already available with various agencies inside and outside the government and need to be accessed by FSSAI. It would also be necessary to track the safety development in other countries because any safety hazard can spread in real time with the open border and millions of transiting passengers. He suggested that institutions may be identified which can carry out such surveillance in different states.
16 National Accreditation Board for Laboratories (NABL) www.nabl-india.org
17 First Chairperson of FSSAI (2006-2011)Interviewed in March 2016
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2.7 REGIONAL OFFICES OF FSSAI
The FSSAI operates through its eight regional offices located in five zones across the country:
1. NORTHERN REGION—New Delhi, Lucknow and Chandigarh 2. EASTERN REGION- Kolkata
3. NORTH EASTERN REGION-Assam 4. WESTERN REGION- Mumbai
5. SOUTHERN REGION- Chennai and Cochin
The former Chairperson ofFSSAI 18 expressed the need for Training of staff so that FSSAI will develop and put in place a training programme for upgrading the skills of regulatory staff, state regulators and provide training in such critical areas as risk assessment, food testing, regulatory action, consumer education and emergency response management.
2.8 Regulatory structure in the States/ Union Territories
There are thirty six Food safety Commissioners/ Officers In charge all over the country designated for monitoring and implementation of the Food Safety and Standards Act, Rules & Regulations made there under. For Gujarat, Dr. H.G.
Koshia is the Commissioner of Food Safety & Commissioner Food and Drugs Control Administration officiating through Gandhi Nagar.
According to the FSSAI, there are altogether 731 designated officers, 633 Adjucating officers and 2442 Food Safety Officers in the country. In addition there are 113 notified Food Analysts (Public Analysts).
As per the official data, there are maximum number of designated officers, 78- in the state of Himachal Pradesh, maximum of 75 Adjucating officers in the state
18 Ex Chairperson FSSAI ( 2006- 2011)
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of Uttar Pradesh, maximum of 519 Food safety officers in the state of Tamil Nadu and maximum number of Food Analysts- 37, in the state of Maharashtra.
For Gujarat region divided into 43 districts, there are 35 designated officers, 2 Adjucating officers, 238 Food safety officers and 10 Food Analysts. The Referral Food Laboratory for the state is Food Research and Standardization Laboratory situated at Ghaziabad. There are 12 such referral laboratories across the country apart from the Public Health laboratories.
Former Chairman of the FSSAI19 stressed on the need for building in house capabilities. He explained that it was necessary to build FSSAI’s capacity to implement the provisions of the Act and access skills whenever required. “The technology levels in industry are far above the current skills within FSSAI and need to be brought at par. Otherwise, effective and responsible regulation will not be possible. It needs to be emphasized that all these tasks cannot be performed by FSSAI single handed. FSSAI has to acquire the capability to work with a multitude of other organizations which have the expertise and capability in various fields.
That is where the mark of an effective regulator lies.”
2.9 FOOD SAFETY AND STANDARDS REGULATIONS
The Food Safety and Standards Regulations, 2011 were notified in the Gazette of India dated 1st Aug 2011 and came in force after 5th Aug 2011. The important regulations are regarding --food product standards and food additives; prohibition and restriction on sales; contaminants, toxins and residues; laboratory and sampling analysis.
19Ex Chairperson FSSAI( 2006-2011), Interviewed in March 2016
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The Food Safety and Standards Authority of India has specified — Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. These regulations specify the requirements for various food articles.
Ex-Chairperson20warned that product approval by a team of officers is no guarantee of food safety. The food item has to be manufactured safely in line with the standards and this can only be ensured by insisting that industry follow verifiable process standards on a day to day basis get certified by accredited agencies and be subject to risk-based inspections. Even an advanced country like the US is able to inspect only 1% of the total food produced in the country. What other countries have done is to lay down easily understood safety standards and guidance documents for ensuring compliance. They intervened only when malfeasance was detected.
2.10 COMPARISON AGAINST CODEX ALIMENTARIUS
When we compared these FSSA standards against the International Codex Standards, it is observed that in case of Codex, Standards belonging to a common subject group have been grouped and are available in separate editions of the Codex Alimentarius.21
The complete list of standards (including text) adopted by Codex Alimentarius Commission is also available on line. The standards may include Guidelines (GL), Maximum Residue Limit (MRL), Standards (STAN), Recommended Code of Practice (RCP) and/ or General Principles. Codex has made available online database -Codex General Standard for Food Additives (CGSFA), Veterinary Drug Residue in Foods and Pesticide Residues in Food and Feed. Codex has also published a list of information documents pertaining to:
20 ‘Eat, pray you don’t fall sick: Science-driven standards and making industry accountable will
tone up our food safety regime’, July 7, 2015, TOI,PI Suvrathan.
21Codex Alimentarius Commission
Source: www.fao.org/fao-who-codexalimentarius ( Accessed March 2015)
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• CCCF
Guidance for Risk Management Options in Light of Different Risk Assessment Outcomes
• CCFH
Process by which the Codex Committee on Food Hygiene (CCFH) will undertake its work
• CCPR
Information Document on the Application of the Guidance to Facilitate the Establishment of MRLs for Pesticides for Minor Crops
The Codex Alimentarius or "Food Code" was established by FAO and the World Health Organization in 1963 to develop harmonized international food standards, which protect consumer health and promote fair practices in food trade. Thus most of the standards here serve as guidelines or baselines for working up the national standards for domestic and/ or trade purposes. Indian regulations on foods have been devised with the approach and objectives that suit the nation’s interests and ideology.
Thus when compared both Codex and FSSAI are principally committed to formulate Science based standards. Codex International, as previously discussed (Section 2.1) is an intergovernmental body and India is a member. Codex Alimentarius establishes guidelines for quality, safety, nutrition and other important aspects of foods. It can act as a blue print, to be suitably modified to a country’s needs and conditions. Many of the Indian regulations are modeled on the fundamental guidelines given by the Codex. This is perceived as an act of avoiding duplication of research activities over already established standards and saves on time technical, human & financial resources. When compared 37
individually there may be differences between limits assigned for various contaminants and toxins in the Codex versus Indian standards. Though whenever a new subject is taken up for standardization at national level, it is almost essential to look at the Codex guidelines for the same along with the international counterparts.
Another significant difference between the two is that as seen from the Codex list above, is that there are certain special categories such as-- food-borne anti-microbial resistance, foods derived from biotechnology- genetically modified foods, organically produced foods. However, the FSSAI standards for these categories are still in the rudimentary stages and are either awaiting requisite consultations /finalization for various reasons including policy-level commitments. The issues mentioned here are serious in the context of citizen’s health and safety and require attention from Indian regulators at the earliest.
Some other instances of differences between international regulations are the permissible limits for use of various food additives that have been categorized as safe for use. Many of these artificial flavours, colours &
preservatives etc. that have been discontinued for usage are still used in India.
Maggi controversy is a case in point where flavour enhancer-Monosodium glutamate was detected beyond safe limits!22Thus revision or up gradation of Indian standards in such areas is sought with the help of Codex.
The FSSAI regulations form part of the Food Law prescribing the minimum mandatory standards for food safety in our country. Apart from this, the Bureau of Indian Standards is also an extremely important National Standard Body that works not only in the area of foods but also various other sectors.
The BIS specifies quality and safety standards for foods and beverages which are mostly voluntary in nature. The BIS specifications are all inclusive of the FSSAI regulations and hence their standards/limits can be better/stricter than
22 Discussed in Section 2.20 of Chapter-2 and also in Chapter-3.
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the mandatory ones. The following section traces the historical backdrop and present scenario vis-à-vis standardization activities led by this premier institution.
2.11 Significance and Role of Bureau of Indian Standards as National Standards Body
The Indian Standards Institution (ISI), now the Bureau of Indian Standards (BIS) came into being 1947. Initially, the organization concentrated on standardization activity. To provide the advantages of standardization to common consumers, the Indian Standards Institution started operating the Certification Marks Scheme under the Indian Standards Institution (Certification Marks) Act, 1952. The Scheme, which was formally launched by ISI in 1955-56, enabled it to grant licenses to manufacturers producing goods in conformity with Indian Standards and to apply ISI Mark on their products. To meet the requirements of the Certification Marks Scheme, the nucleus of a laboratory was started in 1963. While the product certification was being operated under the Indian Standards Institution (Certification Marks) Act, 1952, the formulation of standards and other related work were not governed by any legislation.
In this regard a senior BIS official,23 Head of the Food and Agriculture Department (FAD) of the Bureau of Indian Standards (BIS), observed that,
“Food Safety is the condition that ensures that food will not cause any harm to the consumer when it is prepared and/or eaten according to its intended use.” It implies absence or acceptable and safe levels of contaminants, adulterants, naturally occurring toxins or any other substance that may make food injurious to health. Emphasizing on the role of standards, he explained that “Food safety is the non-negotiable basic requirement of food quality. Standardization
23Interviewed on 16th December 2012
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provides benefits to manufacturers, consumers and service providers alike in various ways such as sustainable development, safety of products and services delivered. The current legislative requirements put tremendous emphasis on food hygiene, Good Manufacturing Practices, Hazard Analysis and Critical Control Points (HACCP), Food Safety Management Systems (FSMS) and nutritional labeling. Standardization results in harmonization of working procedures.”
He further expressed concern over the fact that majority of food businesses in India are small and cottage scale units which could be the grey area for food safety management regime. However since Food Safety is a complex process it requires involvement of all stakeholders. He concluded with remarks that,
“Standards have immense potential to safeguard public health and also promote the confidence of the consumer on entire gamut of food industry, if implemented efficiently. Implementation of these standards can give rise to exceptional improvements in food safety performance, but requires high level of commitment and full functional involvement of all stakeholders, particularly the industry.”
“The Bureau of Indian Standards (BIS) is a national standards body engaged in the preparation and implementation of standards, operation of certification schemes both for products and systems, organization and management of testing laboratories, creating consumer awareness and maintaining close liaison with international standards bodies”24.
BIS certification system has adopted the self-certification model of ISO Guide 28-1987, which has served the purpose of ensuring compliance to the standards as against a 100% inspection and testing scheme25. BIS is a certifying agency of these products. Its responsibility is to check the quality of
24www.bis.org.in ( Accessed on 3rd March 2016)
25www.bis.org.in accessed on 25thDecember 2011.
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the product at the manufacturing stage, before it is marketed. FSSA authorities are the implementing authority in the country that checks the product from the market in such cases. BIS has stated that its standards are dynamic. However, beyond a provision for reaffirmation or review after five years, no means of evaluating the validity of standards in a rapidly changing scenario have been explicitly laid down.
Another important schedule was carried out during 27-28 January 2015, including the Bureau of Indian Standards (BIS) Officials. The BIS is the National Standards body functioning under the aegis of Ministry of Consumer Affairs, Food and Public Distribution, Govt. of India. Presently, BIS has 14 Division Councils which are formulating Indian Standards covering various areas such as foods, electrical appliances, chemicals, plastics and so on.
There was interaction with BIS Officers empanelled on different committees involved in the formulation, revision and modification of product standards. They explained in details about how the standards are conceived, developed and finalized for end users. The entire process of standardization was discussed and an overview of working of the BIS was laid out. Based on the presentation by one of the senior official of the BIS26, the process of standardization has been depicted (Figure-2.1) below:
26 Head, Electronics & IT, BIS, NITS, NOIDA.
( Training programme on 27-28 January 2015)
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Figure-2.1. Process of Standardization (Source: NITS, NOIDA, January 2015)
Another session was held regarding functioning of international standardization and how BIS participates in such activities. This has been explained in latter part of the chapter.
It was understood that these standards are to be considered as priced artifacts with utility and economic value. Thus necessity of a particular standard is the usually the origin or starting point of an often long drawn standardization process.
Further, Government/ regulatory bodies have dual responsibilities ---one, of seeing to best interest of common consumers and at the same time developing quality /safety standards that work out for the industry as well. Thus playing a role of facilitator and moderator in the process of standardization.
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2.11.1COMPOSITION OF BIS COMMITTEES INVOLVED IN SETTING STANDARDS
The Head of the National Institute of Training and Standardization 27 in his training schedule (27-28 January 2015) explained the standardization structure of BIS as depicted in the diagram given below. He also elaborated on the composition and scope of work & functions of the respective members of the Divisional Councils as well as Technical Committees.
Figure- 2.2. Standardization Structure at BIS
Panels/
Subcommittees Sectional Committees
Division Council Standards
Advisory Committee Bureau
1
1
14 322 508
Standardization Structure at BIS
15/02/2016 National Institute of Training for Standardization 14
Source: National Institute of Training and Standardization, BIS, NOIDA (As on 15TH February 2016)
As depicted above (Figure-2.2) the Bureau has a Standards Advisory Committee which is divided into 14 Divisional Councils based on the field of work. These Divisional Councils are in turn split into a total of about 322 Sectional Committees depending on the area of specialization. The Sectional Committees function via various panels of experts and/or Sub-committees as and when
27 Scientist ‘F’ and Head of National Institute for Training and Standardization( NITS), BIS
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required. They mostly comprise of members from the respective Sectional Committees and sometimes from outside.
Divisional Council is the distinct committee, set up by the Bureau in defined areas of industries and technologies for formulation of standards. Its title and scope is as approved by the Bureau. The strength of Divisional Council is restricted to 40 and it is reconstituted once every three years. The Head of concerned Department of BIS is the Member Secretary of the DC. The Chairmen of Sectional Committees under Division Council may be invited to its meetings. Its role and responsibilities include:
• To set up Sectional Committees(SC), define their scopes, recommend appointment or removal of their Chairmen and approve appointment of members of SCs
• To approve subject areas for standards formulation
• To receive and deal with activity reports of Sectional Committees and to resolve technical issues concerning two or more SCs
• To decide on matters where there is sustained difference in opinion on technical issues in the SC
• To advise on R&D matters needed for establishment or revision of standards
• To study work of international organizations and their committees in related areas and recommend on extent and manner of participation in standardization activities at International level
• To advise on implementation of established standards
The respondent from BIS28 informed that the Sectional Committee is set up by concerned Division Council for preparation of a particular standard or group of standards. It may also be set up by the Bureau to deal with a field not covered by any Division Council. The Scope of work of Sectional Committee is defined by Division Council. There could be adequate number of SCs in each DC to ensure that an SC is available for specific and well defined field of work. The composition
28 Interviewed on 27-28 January 2015 at NITS, NOIDA
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of SC is such as to be able to bring together the views of all who have substantial interest in the work area under the scope of the SC. It should include representatives of various interests such as consumers, regulatory and other government bodies, industry, scientists, technologists, and testing organizations and concerned officer of BIS and may also include consultants. It is supposed to be reconstituted once every three years. The Member Secretary (MS) is Technical Officer of Bureau and the strength is restricted to about 35members.
There may also be Sub- Committees set up by Sectional Committees with scope of work defined by parent Sectional Committee. These are created to deal with specific but well defined area of work covered under the scope of the parent Sectional Committee. The relevance/need for Subcommittees may be reviewed from time to time and its constitution is same as of SC. The Convener –is appointed by concerned SC having similar responsibility as of Chairman of DC/SC. They report to the parent Sectional Committee.
An important part of the standardization exercise is carried out by the Panel of experts. The Panel is set up by Sectional Committees/Subcommittee, to take up very specific and time bound tasks through a small group of experts. The Panel is Ad-hoc in nature, i.e., its tenure normally ends with completion of work. The scope of work of panel is clearly defined by the committee constituting the panel.
It reports to the parent Sectional Committee/Subcommittee. The Convener is appointed by the parent Sectional Committee/Subcommittee. It assumes responsibility of Secretariat of Panel and is responsible for all documentation related to its function.
The Character Composition of Technical Committees is as below:
Consumers (C): Categorized as Organized Buyers (OB), Consumer Organizations (CO) and Individual Buyers (IB).
Organized buyers include buyers/users, including Govt., PSUs and other large industries who buy products for their own use.
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Consumer Organizations -Consumer bodies working for the cause of common citizens.
Individual consumers - Consumers not covered in any of the above.
Govt/Regulatory Bodies (G): Government departments/Ministries (excluding those departments covered under organized buyers/users & manufacturers), Regulators and Local Bodies.
Industry (I) :Manufacturers (including Govt. organizations and PSUs into manufacturing business), raw material manufacturers, consultancy organizations, industry/manufacturer associations, service industry, etc.
Technologists (T): Scientists, technologists, R&D organizations, academic and technical institutions, academic & technical institutions, professional bodies,/institutes, concerned officers of the Bureau.
Testing Organizations (L): Testing laboratories/organizations (but excluding R&D laboratories)
Individual Experts (E): All persons not included in any of the other categories.
To ensure balance of representation, total number of members in a committee may generally be distributed in the following manner:
Category Percent of the Committee Size
Consumer (C) 30 Industry (I) 30 Technologists (T), Testing Organizations (L)
& Individual Experts (E) 30 Govt. /Regulatory bodies (G) 10
Members of committees are appointed by the respective appointing authority (Bureau, Division Council, Sectional Committee, and Subcommittee). Members of committees are either- Organizations or 46
Individual members (Experts). Organization appointed as a member then nominates its representatives as:
(a)Principal Representative (b)Alternate representative
Chairman of a Technical Committee is by appointment by the appropriate committee so authorized i.e. Bureau, Division Council or Sectional Committee.
Chairman may be appointed by name or by designation. Convenership of a Sub-committee or Panel is assigned to one of the members by the Committee.
In another important interview session with BIS official the process of initiating standard formulation was understood. She informed that “The proposal or request for any standard formulation may come from29
• Government / Ministry
• Consumer Organization / User
• Industry / Industry Association
• Professional Bodies
• Technologists
• Members of Bureau
• Members of BIS Technical Committee
There is a well-established procedure and Proforma for sending any project / proposal for new standard. The general steps in development of a standard involve:
I. Receipt of proposal II. Establishment of need
III. Meeting of technical committee
IV. Preparation of working/preliminary draft standard V. Circulation of working / preliminary draft
VI. Meeting of technical committee VII. Approval of draft for wide circulation VIII. Wide circulation of the draft
29 Scientist ‘B, Food and Agri. Deptt , Bureau of Indian Standards ( On 27th January 2015)
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IX. Meeting of technical committee X. Finalization of the draft
The BIS has also published a Standard Formulation Manual apart from Indian Standard which is IS 12:2004 ‘Guide for Drafting and Presentation of Indian Standards’. These provide guidelines on drafting, revision, amendments, review, reaffirmation, withdrawal, declaration of obsolescence and grading of standards for various products and services. The frequency of review of a standard after publication is usually once in 5 years as per BIS Act/Rule. 30
2.12 PARTICIPATION IN STANDARDIZATION EFFORTS AT INTERNATIONAL LEVEL
A senior official form BIS31 explained in detail about the role and responsibilities of members in relation to international standardization activity.
This was during the two day training programme held at NITS, NOIDA on 27- 28 January 2015. He elaborated on how it was extremely important to be a part of standardization activity at international level. He explained with an example- “If we consider the example of internationally standardized freight containers that has enabled all the components of a transport system- railways, air and sea transport, highways, and packages to interface efficiently. The standardized documents accompanying the cargo identify sensitive or dangerous cargoes and makes international trade cheaper, faster, and safer.
Similarly, standardization of the format and size of banking cards, credit cards, and telephone cards, paper sizes, the same symbols for automobile controls in cars all over the world are some other examples of internationally accepted standards. Hence, the standards for similar technologies in different parts of the world contribute to the elimination of technical barriers to trade.”
30Information obtained as a part of training programme organized by the BIS (for members of standard-setting committees) on 27-28 January 2015
31 Scientist, International Relations Department, BIS.
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BIS as the National Standards Body of India participates in International Standardization activities and projects India’s interest during various stages of the development of International Standards.Developing International Standards for voluntary application is done with the aim of
• Facilitating exchange of goods and services among the people of all countries
• Improving communication and collaboration in all spheres of activity
• Supporting the smooth and equitable growth of trade for a safe and sustainable development
• Associating all stakeholders through transparent and democratic mechanisms based on national contribution and international networking
The respondent from BIS32 gave information on major leading international standards organizations:
1. International Organization for Standardization(ISO)
2. International Electrotechnical Commission for Electrotechnology(IEC)
3. International Union for Telecommunications (ITU)
Apart from these three there are about 50 other international standardization bodies working in several specific sectors.
The structure and functioning of the three leading international organizations has been discussed in brief in the upcoming sections as described by the BIS officials involved with the specific activities. 33
32 Scientist, International Relations Department, BIS
33Information obtained from BIS, NITS, NOIDA during Training Programme for technical committee members
( Held on 27-28 January 2015)
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2.13 FUNCTIONING OF ISO
ISO is an independent, non-governmental membership organization and the world's largest developer of International Standards. ISO is made up of 166 member countries who are the National Standards Bodies around the world, with a Central Secretariat that is based in Geneva.It has over 640 organizations in liaison with 166 national members. It comprises of 217 active Technical Committees, 3483 technical bodies and 100 000 experts worldwide. There are three categories of ISO membership – 1) Member bodies (full members ) who are entitled to participate in any policy or technical body, with voting rights ; 2)Correspondent members who are entitled to participate in any policy or technical body as observers, with no voting rights ; 3) Subscriber members who are in contact with international standardization through observer status at General Assemblies .Thus, there are 120 full members , 41 Correspondent members and 5 Subscriber members.
ISO Council works through three Policy Development Committees, i.e., CASCO – (Committee on Conformity Assessment) ; COPOLCO - (Committee on Consumer Policy); DEVCO - (Committee on Developing Country Matters).
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2.14 Food and Beverage Controversies in India in Recent Years:
Impact on Regulations & Standards
As discussed in the first chapter, the review of literature attempted to bring out some of the controversies occurring from time to time that have impacted standards and regulations all over the world.
Thus if we observe the Indian food marketing and consumption scene, we find numerous such instances that have shaped and in many cases completely remoulded or transformed the regulations to a significant extent. We discuss below some of the most controversial food and beverage products in the recent times:
2.14.1 The case of Maggi Noodles: Company – Nestle India34
Maggi Noodles, the two-minute noodles, which was marketed as easy to prepare, tasty and supposed to be filling and healthy. In May 2015, Food Safety Regulators from Uttar Pradesh, India reported that samples of Maggi noodles had high levels of monosodium glutamate (MSG). There was also lead content in Maggi much beyond the permissible limits. The FDA officials reported that the lead content in Maggi was 17.2 parts per million (ppm) while the acceptable limit of lead ranges between 0.01 ppm and 2.5 ppm. It withdrawn from the market immediately after the controversy erupted. Maggi is now back on retail shelves in select markets, six months after it was banned. Nestle India is rolling out once again Maggi Noodles with changed recipe and label information. They have responded to food regulators objections and the new products are armed with food safety certificate from accredited independent laboratory.
3434
How Safe is Our Food: Food and Beverage Controversies in India in Recent Years December 31, 2015by Rumani Saikia Phukan (Source: http://www.mapsofindia.com)
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2.14.2 The case of Dairy Milk chocolates: Company – Cadbury In 2004, Cadbury chocolates had to face the wrath of consumers when it was reported that there were worms in its Dairy Milk bars in Maharashtra. The Maharashtra Food and Drug Administration were quick to respond, and immediately seized the chocolate stocks manufactured at Cadbury’s Pune plant. Sales were also withdrawn on the grounds that they were produced under unhygienic conditions and improperly packaged.
Later, Cadbury spent a huge amount of money to get imported machinery to ensure better packaging and also roped in film star Amitabh Bachchan as the brand ambassador to earn the trust of its customers. Cadbury continues to lead the Indian chocolate market and this could be a perfect case study of a comeback from a crisis and controversy.
2.14.3 The case of Coke-Pepsi: Company – Coca Cola Pvt. Ltd. and PepsiCo
In 2003, the Centre for Science and Environment, a NGO in New Delhi, reported that carbonated drinks produced by soft drinks manufacturers in India like Pepsi and Coke contained pesticides that can cause cancer and deterioration of the immune system. The report mentioned that the pesticide content in these drinks was found to be much higher than the actual safety standards developed by the Bureau of Indian Standards. Similar allegations were also reported again in 2006. Both the companies were also criticized for having bottling plants in Kerala leading to water pollution, water depletion, thereby causing health issues and affecting agriculture production.
In spite of all allegations and controversies, the Coca-Cola Company and Pepsico, Inc. are dominant players in the soft drinks market in India and overseas. Coke and Pepsi still align themselves with brands, sports, celebrities, and lifestyles that Indians find very appealing. The standards in
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question regarding pesticide residues are still in draft stages due to want of proper methodology for analysis.
2.14.4The Case of Mother Dairy Milk: Company – Mother Dairy Another food product that has attracted controversy is Mother Dairy Milk.35 In June 2015, the UP Food and Drug Administration reported that detergent was found in the milk samples produced by Mother Dairy.
Mother Dairy subsequently denied any adulteration of its milk supplies.
Mother Dairy vehemently denied the allegations. In house tests and third party reports cleared the products and saved the repute from further damage.
In recent years, we find that McDonald’s, Kurkure, Lay’s potato chips and many such leading brands with their food products have been accused of poor quality, unsafe products, misleading labeling and tall claims.
2.14.5 Role of different interest groups in the above controversies:
A discussion
In spite of so many controversies and allegations, these food products and beverages are still ruling the lives of the Indian consumers. However, a positive outcome of these controversies has been that they have ensured dialogue between various interest groups and strengthened standardization efforts in the food sector.
If we try to probe further into the role played by various actors in the above-mentioned food controversies, one fact emerges that the bigger the company/brand the bigger would be its impact. For instance in the recent instance regarding Maggi, which was the leading brand of noodles until then, the product lost, its sales and repute within weeks of the controversy.
35Source: http://economictimes.indiatimes.com/industry/cons-products/food/uttar-pradesh-fda- finds-detergent-in-mother-dairy-milk-sample/articleshow/47693905.cms
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One viewpoint that was expressed was that the entire controversy was
‘created’ to tarnish its image by rivals or due to other similar reasons.
However the controversy was able to bring into focus the presence of hazardous metals and additives (viz. MSG) in our food supplies. This led to swift action from regulators and subsequently new standards were drafted for instant noodles.36 Due to the report from the government laboratory based at Lucknow (which was later rejected due to lack of NABL37 accreditation which is a mandatory requirement by law for food testing labs) it acted as a catalyst to initiate action against such a well-established brand. This issue has been discussed in details in the fourth chapter also.
In case of Cadburys chocolates worm infestation, the company tried to gather its act together through celebrity endorsements- Amitabh Bachchan vouching for the safety and quality of its chocolates. Thus again media played an integral role in brand rebuilding. However Cadburys line of defence that it was responsible for the products ‘quality till it leaves the factory premises was challenged. The counter argument was that a manufacturer needs to ensure that its food remains safe for the consumer till the time when purchased. A multinational brand such as Cadbury could well afford and ensure good transport and storage facilities for its products.
The draft regulations on this were accordingly discussed and now all such perishable goods are required to have safe packaging and storage facilities.
Coke/Pepsi controversy regarding pesticide residues in soft drinks was an eye-opener for India and was able to highlight the need for stringent standards comparable to international norms. Delhi based NGO, Centre for Science and Environment is credited with the ground breaking work on standardization thereby challenging the global leaders in the business.
Here again role of general public, the consumers and citizen experts has
36http://www.fssai.gov.in/Enforcement.aspx ( March 2016)
37 National Accreditation Board for Laboratories.www.nabl-india.org
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been central to drafting of regulations on highly toxic pesticide residues in food and beverages.
Mother Dairy milk issue got coverage in the wake of synthetic/adulterated milk problem rampant since early part of the last decade. It was reported from northern parts of India, mainly Uttar Pradesh and the regions around Delhi. It was a very serious health issue since milk is considered the basic necessity especially for infants and small children.
Various stories were being circulated through media of how and where such unscrupulous traders were getting this artificial milk laced with harmful chemicals. Test reports from UP-FDA Laboratory mentioned presence of detergent in milk. The involvement of a big name like Mother Dairy in the issue led to swift action by Government bodies and control over the issue was achieved to some extent. Subsequently, after repeated representations to regulators by consumer bodies as well as via media reports the draft standards were formulated for ensuring safety of milk.
However one still, stumbles upon such adulteration in milk issues in many parts of the country every once in a while. FSSAI is in the process of revising the standards for ensuring safety & purity of milk available at consumers’ doorstep. This also calls for stringent monitoring and surveillance activities for effective implementation of the law.
2.15 Standardization and the Role of Regulatory Bodies: Discussion and Key Arguments
If we attempt to examine standardization in relation to the role of regulatory bodies and their negotiations in relation to food safety regulations, we find that several experts and officials are part of this process. Organizations such as the Bureau of Indian Standards and the Regulatory body- FSSAI, in principle endeavor to include various groups 55
of stakeholders in the standards setting process. Also, the inherent structure of technical committees, their composition at national and international level gives us a glimpse into the different actors shaping this process. Here, food safety standards, as the technical artifacts in question, are constantly in a state of flux. Though the mechanism for formulation and periodic revisions/alterations do exist, we find that on several occasions, it is controversies and health scare issues, which trigger the process of standardization.
Though regulatory officials act as facilitators for this process of standardization, sometimes bureaucratic requirements hinder the outcome.
It could be attributed to problems ranging from transfers of member secretary of the committee, lack of effective communication between members, insufficient meetings/ attendance etc. The composition of committees is also a very important aspect, since maximum representation is given to government officials in these bodies. Many a times it is observed that there is very little response from some such members, who attend the meetings just to fulfill job requirements. Thus inputs from them hardly make any significant impact. There is a view that participation from industry representatives, on the other hand is much more enthusiastic owing to the direct impact on their business as far as product/standards are concerned. A few respondents also observed that consumer bodies and other NGOs need to focus more on the safety and quality parameters of items of mass consumption. So their participation is extremely important in terms of socio- technical aspects of the standards.
The meetings of the regulatory agency FSSAI are generally felt to be more closed door as discussed in the relevant sections. The membership from outside agencies- NGO’s/consumer and industry are limited. The updates on activities such as consultation on standards or expert group meetings are not as regular or as timely as desired. The minutes are often delayed and edited to a suitable extent. So the happenings are more of a 56
‘black-box’ that remains to be decoded! It is felt that there is a lot of further scope for transparency and open end discussions within the system.
The interviews with the respondents also brought out several other facets, which need improvement with respect to food safety regulations and standards. It was felt that India really needs a paradigm shift in its food safety regulation system – from relying solely on supply-side food safety, it should develop demand-supply systems for it. These systems work with consumers demanding quality and safety attributes in food and forcing the supply side to fall in line. Failing which, they would be made to face punitive market response and regulatory action. Keeping in view the large unorganized sector India’s food safety law requires the regulator to lay down simple standards, undertake extensive food safety education, and enable industry to achieve and demonstrate safety. Drafts of critical regulations such as food labeling, functional foods, limits for fat/salt/sugar in processed& packaged foods, standards for school meals, water quality and so on are still awaiting regulatory attention. It was also felt that public food testing laboratories needed to be upgraded urgently. Several food safety professionals need to be trained to man vacant posts in the states.
The regulator also needs to work with state governments to bring the use of chemicals in agriculture to safe limits.
The State Government that is the enforcement agency for the law is struggling with its own set of problems. Interaction with the respondents from Food and Drug Control Authority threw light on the precarious situation with respect to food safety in the states. In addition to the monitoring, surveillance of the safety mechanism they are also responsible for licensing and registration under the new Act. On conditions of anonymity, the officials informed that though their designations (‘Food Safety Officer’ in place of ‘Food Inspector’) have been changed there is little or no change in terms of emoluments even after years of seniority in 57
service. There appears to be discontent in relation to emoluments and levels of job satisfaction. Thus there are numerous problems within the state departments that need to be addressed and sorted in order to have an effective system.
With reference to the BIS related standardization activities, the tasks of Scientists/Officials assigned for the purpose appears more of an administrative nature. The member secretary of the technical committee/sectional committee was responsible for carrying out tasks like- organizing meetings of the stakeholders periodically; preparing agenda accordingly and ensuring smooth conduction of meetings; recording minutes and circulating them among members for finalization and reimbursement of travel dues, if any, to members attending from outside.
Usually their technical /scientific contribution was of a limited nature.
However, the Scientists from BIS Central Laboratory do need to give their inputs as and when required regarding workability of test methods, standard limits and other technical matters.
Negotiations between the different interest groups ranged from friendly banter to heated arguments. Nevertheless, the meetings are intended to be systematic with pre planned schedules and minutes being duly recorded for further action. For this, the agenda is circulated in advance so that minimal time is wasted and meetings can be held within the accorded period. The BIS thus, apparently functions in a very business-like manner, where Standards are meant to be a ‘consumable product’ that is prepared for selling and consumption by the buyers. The buyers are actually manufacturers who, go in for standardization of their products which in turn are sold to the end-users, i.e., consumers.
The member representatives from regulatory body, i.e., FSSAI, however are seen to give their opinions with respect to existing regulations.
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They are restricted in their comments and seem to be there to provide information regarding the legal requirements only. It may be noted that in case of foods, the BIS prescribes quality & safety standards which are expected to be over and above the minimum mandatory standards by the FSSAI. This means those manufacturers who wish to opt for BIS certification (ISI mark) still have to get their product registered by the FSSAI. Thus such a product will have dual standard markings- both FSSAI license number as well as BIS certification number.
It seems that after almost 10 years of the enactment on FSS Act and after 5 years of the FSSA regulations, there are several loose ends. The establishment still appears to be in its infancy stage. Though it is noteworthy that the process of standardization is a continuous one and with advancement in science & technology, there will be additional challenges that will have to be faced by the regulatory and enforcement divisions of the FSSA. Involvement of public and transparency in the system is appreciable as is reflected by the official communications through its website as well as media. Food being a commodity driven and affected by various Ministries—Health, Agriculture, Consumer Affairs, Commerce, Industry, Environment, Exports, and so on – cannot be easily dealt with respect to regulatory affairs. This is in addition to diverse interests of the stakeholders associated with the standardization process itself. Effective implementation of FSSA is fraught with several challenges. India thus presents a unique case of vastness and complexity. Besides these, other aspects revealed during the interviews was the limited number of food safety officers and the lack of funds with the state governments, coupled with shortage of quality laboratories lacking uniformity of standards.
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