IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES UNDER THE FOOD ACT B.E. 2522
BY
MISS NILUBON RAKNGAM
A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF LAWS IN BUSINESS LAWS (ENGLISH PROGRAM) FACULTY OF LAW THAMMASAT UNIVERSITY ACADEMIC YEAR 2014 COPYRIGHT OF THAMMASAT UNIVERSITY IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES UNDER THE FOOD ACT B.E. 2522
BY
MISS NILUBON RAKNGAM
A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF LAWS IN BUSINESS LAWS (ENGLISH PROGRAM) FACULTY OF LAW THAMMASAT UNIVERSITY ACADEMIC YEAR 2014 COPYRIGHT OF THAMMASAT UNIVERSITY
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Thesis Title IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES UNDER THE FOOD ACT B.E. 2522 Author MS. NILUBON RAKNGAM Degree Master of Laws Major Field/Faculty/University Business Laws Faculty of Law Thammasat University Thesis Advisor Professor Amnat Wongbandit, Ph.D. Thesis Co-Advisor (If any) Academic Years 2014
ABSTRACT
As commonly known that food is one of the basic bodily needs, consumers have the right to expect that food they purchase and consume will be safe and of high quality. The government agencies, in turn, should take measure to ensure that all food, whether locally produced or imported, freely sold on markets, is safe and consistent with national food safety standard.
For domestic consumption, Food and Drug Administration (FDA) has authorized by the Food Act B.E. 2522 to protect and prevent consumers from food hazards. However, the Act has failed to serve the Thai FDA officers with appropriate tool to detect and control of the food hazards in every part of Thailand. Detecting and controlling food safety problems largely depend upon whether it can follow a food product’s movement through the food supply chain. In this case, appropriate tool to access all relevant information associated with the food should be implemented in support of the Thai FDA’s operations. Notwithstanding, section 43 of the Act provides inappropriate control powers to acquire food information held by the food operators. At the same time, the Act lacks of record-keeping requirement to identify a food product’s movement across the food supply chain. (2)
Nowadays, food identification and control can be achieved most effectively by the principle of prevention throughout the food supply chain. As guided by the CODEX, the introduction of preventive measures at all stages of the food production and distribution chain, rather than only inspection and rejection at the final stage, making better economic sense. This is because suitable strategy is to entrust food producer and operator with primary responsibility for food safety. The preventive measure includes the application of risk analysis, the application of HACCP and GMP, and the surveillance system and response plan and traceability concept.
Several countries are now developing their own control system to promptly detect and control the food hazards. Instead of using a traditional approach as usual, they turn into a new preventive approach applied in line with the integrated approach 'From the Farm to the Fork' specifically including transparency, risk analysis, prevention, the protection of consumer interests as well as traceability concept. With the publication of the General Food Law, the European Union has made a new legal framework laying down the principles to ensure a coherent approach and to fix the principles, obligations and definitions that apply in the field of food safety. As a member states, traceability requirement becomes effective for all food business operators throughout UK. Article 18 establishes a clear record-keeping requirement that demonstrates who has responsibility to maintain record, what information should be enabled and how to deal with the ono-compliance. Based on risk analysis approach, the Food Standards Act 1999 also provides the procedure in place to allow for competent officer to have access to food-related information held by food operators.
Similar to the UK, the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the USFDA to better protect public health and focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The FD&C Act provides important new tools for inspection and compliance so that USFDA can trace the food product backward and toward through the entire food supply chain. The Act designates an obligation on food operators to maintain the record on food suppliers from who and to whom a product has been supplied. (3)
Moreover, according to section 414, the USFDA is enabled with the ability to access the record which includes all the records related to food adulteration and its widespread use.
After studying the principles of modern food control system and all relevant laws in both the UK and the US, the problems of identification and control of food hazards under the Food Act B.E. 2522 should be responded by expanding the competent officer’s control powers covering in most areas of the Thai FDA’s operations. The inspectional authority under section 43 of the Act should include the power to request the food-related information or other assistances from food business operators. At the same time, by the virtue of section 5 and section 6(7) of the Act, the Act should set the provision to establish a new food business operators’ responsibility for maintaining information that can identify food product’s movement throughout the food supply chain. As the final, food-borne diseases will be fully detected and controlled.
Keywords: Food Safety, Food Law, The Food Act B.E. 2522, Identification and Control of Food Hazards, Modern Food Safety System
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ACKNOWLEDGEMENTS
The thesis becomes a reality with the kind support of many individuals. I would like to extend my sincere thanks to all of them.
Foremost, I am deeply indebted to my thesis advisor, Professor Dr. Amnat Wongbandit. Without his thoughtful encouragement and careful supervision, this thesis would never have taken shape.
I would like to thank my committee members, Judge Nopporn Bhotirungsiyakorn, Dr. Nilubol Lertnuwat and Dr. Munin Pongsapan for their time and valuable information.
My thanks also go out to the fellow classmates and people who have willingly helped me out with their abilities. Ratagarn Sookthare who is always by my side when times I needed him most and helped me a lot in making this study.
Finally, I would like to express my graduate towards my family for the encouragement which helped me in completion of this thesis, most particularly, my beloved and supportive parents, who served as my inspiration to pursue this undertaking.
Miss Nilubon Rakngam Thammasat University Year 2014
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TABLE OF CONTENTS
Page ABSTRACT (1)
ACKNOWLEDGEMENTS (4)
LIST OF TABLES (9)
LIST OF FIGURES (10)
LIST OF ABBREVIATIONS (11)
CHAPTER 1 INTRODUCTION 1
1.1 Background 1 1.2 Hypothesis 9 1.3 Objective of Study 10 1.4 Scope of Study 10 1.5 Methodology 11 1.6 Expected Results 11
CHAPTER 2 CONCEPTUAL FRAMEWORK OF FOOD SAFETY AND ITS CONTROL SYSTEM 12
2.1 Definitions and Principles of Food Safety 12 2.1.1 Definitions of Food and Food Safety 12 2.1.2 Principles of Food Safety Protection 15 2.1.2.1 Food Safety and Food Security 15 2.1.2.2 The Rights for Food Safety 17 2.1.3 Role and Responsibility of Food-Safety Stakeholders 20 (6)
2.1.3.1 Government Sector 21 2.1.3.2 Consumers 21 2.1.3.3 Food Industry Sector 21 2.2 Conceptual Framework of Food Control System 22 2.2.1 Core Concept of Food Control System 22 2.2.2 The Principles of Modern Food Control System 23 2.2.2.1 The Farm-to-Table Concept 23 2.2.2.2 The Application of Risk Analysis 24 2.2.2.3 The Surveillance System and Response Plan 26 2.2.2.4 The Application of Hazard Analysis and Critical Control Points 29 2.2.2.5 Traceability Concept 32 2.3 Conceptual Framework of Food Control System in Thailand 36 2.3.1 Food Safety Relted Organizations and Regulations 37 2.3.2 Current Situations of Food Incidents in Thailand 39 2.3.2.1 Situations of Diarrheal Diseases 39 2.3.2.2 Situations of Food Contaminants 41 2.3.3 Strategic Plan for Food Safety 41 2.3.3.1 Road Map of Food Safety 42 2.3.3.2 Strategies of the National Food Safety Program 42
CHAPTER 3 LEGAL MEASURES SUPPORTING IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES IN FOREIGN COUNTRIES 46
3.1 Legal Measures Supporting Identification and Control of Food-Borne Illnesses in the United Kingdom 47 (7)
3.1.1 Government Agencies Responsible for Food Control Activities 47 3.1.2 Legal Basis for Food Indentification and Control under the UK Law 49 3.1.2.1 The Food Authorities' Official Control Powers under 50 the Food Safety Act 1990 (1) The Inspection Powers 50 (2) Food Sampling 52 3.1.2.2 The Food Standrads Agency' Official Control Powers under the Food Standards Act 1999 54 3.1.2.3 Food Business Operators’ Responsibility on Mandatory of Record-keeping 58 3.2 Legal Measures Supporting Identification and Control of Food-Borne Illnesses in the United States 62 3.2.1 Government Agencies Responsible for Food Control Activities 64 3.2.2 Legal Basis for Food Identification and Control under the US Law 66 3.2.2.1 The USFDA’s Official Control Powers under the Federal Food, Drug, and Cosmetic Act 66 (1) The Inspection Powers 67 (2) Food Sampling 69 (3) Record Access Authority 69 3.2.2.2 Food Business Operators’ Requirement on Mandatory of Record-keeping 73
CHAPTER 4 LEGAL FRAMEWORK SUPPORTING IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES UNDER THE THAI LAW 80
4.1 Government Agencies Responsible for Food Control Activities 80 4.2 Legal Basis for Food Identification and Control under the Food Act B.E. 2522 83 (8)
4.2.1 The Thai FDA’s Official Control Powers 83 4.2.1.1 The Inspection Powers 83 4.2.1.2 Food Sampling 86 4.2.1.3 Record Access Authority 87 4.2.2 Food Business Operators’ Requirement on Mandatory of Record-keeping 88 4.3 The Problems of Identification and Control of Food-Borne Illnesses under the Food Act B.E. 2522 92 4.3.1 Inappropriate Control Powers to Access Food-related Information92 4.3.1.1 Preventing the Abuse of Power 98 4.3.1.2 Protection of Sensitive Information 101 4.3.1.3 Liability for Non-compliance 102 4.3.2 Lack of Mandatory Requiring Food Business Operators to Keep Record Related to the Movement of Food 104 4.3.2.1 Analyzing the Possible Approach to Implement Record-keeping Requirement 109 4.3.2.2 Analyzing Appropriate Function Lies under the Food Act B.E. 2522 121 4.3.2.3 Analyzing the Essence of Record-keeping Requirement 124
CHAPTER 5 CONCLUSIONS AND RECOMMENDATIONS 127
5.1 Conclusions 127 5.2 Recommendations 129
REFERENCES 130
BIOGRAPHY 138
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LIST OF TABLE
Table Page 1.1 Examples of Food Safety Outbreaks (1971–2008) 1
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LIST OF FIGURES
Figures Page 2.1 Components of Risk Analysis 25 2.2 Food Control in Thailand Along the Food Chain 38 2.3 Morbidity Rate of Diarrheal Diseases in Thailand, 2001-2010 40
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LIST OF ABBREVIATIONS
Symbols/Abbreviations Terms
BMA Bangkok Metropolitan Administration CDC Centers for Disease Control and Prevention CESCR Committee on Economic, Social and Cultural Rights CFR Code of Federal Regulations Codex Codex Alimentarius Commission DHHS Department of Health and Human Services DMSc Department of Medical Sciences DOA Department of Agriculture DOF Department of Fisheries DOL Department of Livestock Development EHOs Environmental Health Practitioners EOC Emergency Operations Center FAO Food and Agriculture Organization of the United Nations FAST Food Alert System of Thailand FDA Food and Drug Administration FSA Food Standard Agency FSMA Food Safety Modernization Act GAP Good Agricultural Practice GHP Good Hygienic Practice GMP Good Manufacturing Practice HACCP Hazard analysis and Critical Control Point HRFs High-Risk Foods (12)
IMG Incident Management Group MOAC Ministry of Agriculture and Cooperatives MOC Ministry of Commerce MOI Ministry of Industry MOPH Ministry of Public Health PPHO Provincial Public Health Offices RASFF Rapid Alert System SPS Sanitary and Phyto-sanitary Standards TAS Thai Agricultural Standard TSOs Trading Standards Officers USDA U.S. Department of Agriculture USFDA US Food and Drug Administration WHO World Health Organization 1
CHAPTER 1 INTRODUCTION
1.1 Backgrounds
Generally, every human being has to be fulfilled by food to maintain life processes such as growth, repair, and maintenance of a normal environment inside the body. As a basic human right, food must be nutritious, safe, and culturally appropriate enough to provide health and longevity. However, due to several global changes in the 21st century including population growth, poverty, international trade in food etc., the food itself is likely to become the main route of transmission of microbial agents and chemical contaminants causing health problems. Over the past decade, numerous devastations of food-borne illness have occurred in both industrialized and developing countries. The consequences of food-borne diseases, due to microbial pathogens, biotoxins, and chemical contaminants in food, represent serious threats to the health of thousands of millions of people. Chemical contaminants in the food supply, for example the safety of colors and various types of additives added to the food supply, have gained attention from consumers throughout the world. At the same time, biological contamination has surfaced as one of the most important concerns of consumers, particularly in developed countries, in light of major food-borne disease outbreaks stemming from imported and domestically produced products in the United States (US), the United Kingdom (UK), and in Europe.1
Table 1.1: Examples of Food Safety Outbreaks (1971–2008)
YEAR CASE
2008 294,000 children affected by adulterated tainted with melamine. More than 50,000 were hospitalized and 6 died. (China)
1 The United Nation, Food and Agriculture Organization, Multilateral Trade Negotiations On Agriculture: A Resource Manual III; Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and Agreement on Technical Barriers to Trade (TBT), (FAO, 2000), available at http://www.fao.org/docrep/003/x7354e/x7354e07.htm. (last visited Mar. 20, 2013). 2
2004-2005 Aflatoxin contamination of maize caused more than 150 deaths. (Kenya)
2001 Cases of variant Creutzfeldt – Jakob disease (vCJD), which is caused by the same agent as bovine spongiform encephalopathy (BSE), stood at 117 worldwide. A number of animal studies suggest a theoretical vCJD risk from human blood donors in countries associated with the use of BSE-contaminated meat and bone meal and recycling of animals into the animal feed chain. The BSE (“mad cow”) outbreak was highly publicized by the media. It remains etched in consumer consciousness as an example of an acute breakdown in food safety and quality in the developed world. E. coli O157:H7, various animal foods, 20,000 cases, 177 deaths in Jiangsu and Anhui provinces. (China) 2000s Contaminated olive oil. (Spain) Staphylococcus in milk. (Japan) E. coli in spinach, carrot juice. (US) Listeria in ready-to-eat meat. (Canada) Salmonella in peanut butter. (US) 2000 WHO noted the presence of antimicrobial-resistant Salmonella bacteria in food animals in Europe, Asia, and North America, which have caused diarrhea, sepsis, and death in humans, as well as Enterococci infections, which present severe treatment problems in immunocompromised patients. 1990s E. coli in hamburgers. (US) BSE. (UK) Cyclospora in raspberries. (US/Canada) Avian influenza. (Southeast Asia) Dioxin in animal feed. (Belgium) 1999 Salmonella typhimurium, more than 1,000 cases, meat products, Ningxia. (China)
1998 Statistics from the Ministry of Health showed a marked increase in food poisoning attributed to Vibrio parahaemolyticus, from 292 incidents (5,241cases) in 1996 to 850 incidents (12,346 cases) in 1998. One large outbreak of 691 cases was caused by boiled crabs in 1996; another involved 1,167 cases traced to catered meals in 1998 (Japan). Outbreaks were also documented in Bangladesh, India, Thailand, and the United States 1980s Beef hormones. (EU) Salmonella in eggs and chicken. (UK) Alar in apples. (US) Hepatitis A in raw oysters, 300,000 cases, Shanghai. (China) 1971-82 Safe Food International, a global consumer organization, cited cases of foodborne illness arising from accidental or intentional adulteration: “During the winter of 1971– 1972, wheat seeds intended for crop planting and treated with methylmercury were 3
accidentally distributed in rural areas of Iraq. An estimated 50,000 people were exposed to the contaminated bread, of which 6,530 were hospitalized and 459 died. In Spain in 1981–1982, contaminated rapeseed oil killed more than 2,000 people and caused disabling injuries to another 20,000 many permanently.”
Source: Compiled by Tina George Karippacheril and Luz Diaz Rios; data on specific cases from (a) Ingelfinger 2008, (b) WHO 2001, (c) WHO 2000, (d) WHO 1999, and (e) Safe Food International (2005).
Likewise, food-borne illnesses have gained attention in Thailand as well. Diarrheal diseases have been a major public health problem in Thailand for many years. Food is considered as a main route of transmission of microorganisms causing diarrheal diseases. In fact, there are approximately a million cases of acute diarrhea reported each year, and the reported cases of food poisoning are more than 120,000 per year.2 Apart from diarrheal diseases, foods available to the market are often contaminated with exceedingly high level of chemicals. More than 5 percent of 400 meats sampled were contaminated with antibiotic resistance, and 50 percent of the meat sampled contained improper chemical additives including Synthetic Dyes.3 In term of major food incidents, the ongoing outbreaks of highly pathogenic H5N1 avian influenza in poultry have raised concerns about the source of infection and the risk to humans from various exposures throughout Thailand. From January 28, 2004, to February 2, 2005, Cambodia, Thailand, and Vietnam reported 55 human cases, including 42 deaths.4
2 FAO&WHO Regional Conference on Food Safety for Asia and the Pacific, Malaysia, May 24-27, 2004, Foodborne Diseases: Situation of Diarrheal Diseases in Thailand, U.N. Doc. A/CONF.9/10, available at http://www.fao.org/docrep/meeting/006/ad703e/ad703e00.htm. (last visited Mar. 21, 2013). 3 คณะกรรมการอาหารแห่งชาติ, กรอบยุทธศาสตร์ การจัดการด้านอาหารของประเทศไทย 43- 44 (ส านักงานกองทุนสนับสนุนการสร้างเสริมสุขภาพ, 2554). (The National Food Commission, Strategies of Food Management program 47-49 (Thai Health Promotion Foundation 2011).) 4 Sonja J. Olsen et al., Poultry-handling Practices during Avian Influenza Outbreak, Thailand, Emerging infectious Diseases, in Emerging Infectious Diseases 11 (2005), available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3366731/ (last visited Mar. 21, 2015). 4
These increased numbers of food-borne illnesses raise the question to national food control system around the world in detecting and controlling the widespread contaminations and the diseases thereof. One of the reasons is that many food products available on the market are unbranded. When food products from many suppliers are mixed in many stages of food supply chain, the government agency is unable to know who supplies a particular food. This problem becomes even worse than ever in case where food incidents or outbreaks occurred. Because the rapid movement of food contamination can have widespread throughout the entire stages of food chain in short period of time ,cause a serious ,and yet uncontrolled food-borne risk to public health such as food incidents, require urgent action to control the ongoing of food-borne disease. Inability to detect and control the disease thereof can have important consequences for protecting public health as well as economic loss. As seen in the North American E. coli outbreaks, the finding of E.coli tainted spinach in September 2006 can illustrate this problem clearly. Soon after spinach was identified as the vector of E.coli, the contaminated spinach was traced to Natural Selection Foods as the packer. However, because the US Food and Drug Administration (USFDA) were unable to rapidly identify the farm source of the outbreak and to isolate the contaminated spinach, it advised consumers on September 14 not to eat bagged spinach. Stores did not limit their response to the bagged product and pulled all fresh spinach from shelves. The farm of origin was only identified with further extensive investigation. However, the precise means by which spinach was contaminated could not be identified, so that the delivery of tainted spinach by one grower caused the largest recall ever for leafy-green products in the US.5
In light of global movement, the best traditions of the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) simultaneously agreed to lift the world community’s awareness of food safety and related issues to unprecedented heights by establishing the Codex Alimentarius Commission. Many of guidelines with increased surveillance and more rapid response to foodborne outbreaks and contamination incidents have been issued
5 Sebastien Pouliot & Daniel A. Sumner, Traceability, Product Recalls, Industry Reputation and Food Safety (2010), available at http://aic.ucdavis.edu/publications/traceability2.pdf. (last visited Mar. 15, 2015). 5 for the national governments in order to strengthen their food control system. Among achieved missions of Codex, traceability concept has also been recognized as a key of enhancing food safety and preventing food-borne disease. As appropriate to the objectives of the food inspection and certification system, it enables the government agencies to identify at any specified stage of the food chain (from production to distribution) from where the food came (one step back) and to where the food went (one step forward). With this function, it will provide accurate food-related information to determine what the exact problem of food safety is. In the same time, it enables targeted control measures such as product recalls or withdrawals more effectively and efficiently. As the case mentioned earlier, delays in traceability can have important consequences for protecting public health. Traceability concept is useful in the point that the origin of the contaminated spinach could have been identified quickly, a much smaller quantity of spinach could have been removed from the market, a smaller share of the industry could have been affected, and consumers could have been provided with the information much sooner.
Several countries are now developing their own control system to promptly detect and control the complex features of the food-borne illness ae well as food incidents. Instead of using a traditional approach as usual, they turn into a new preventive approach applied in line with the integrated approach 'From the Farm to the Fork' specifically including transparency, risk analysis, prevention, the protection of consumer interests as well as traceability concept. With the publication of the General Food Law, the European Union has made a new legal framework laying down the principles to ensure a coherent approach and to fix the principles, obligations, and definitions that apply in the field of food safety. Similarly, the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the USFDA to better protect public health and focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The FD&C Act provides important new tools for inspection and compliance so that USFDA can trace the food product backward and toward through the entire food supply chain.
In Thailand, a million cases of acute diarrhea or the ongoing outbreaks of highly pathogenic H5N1 avian influenza in poultry can also define the failure of our 6 national control system and its policies in detecting widespread food-borne diseases. After the crisis of such an avian flu outbreak had passed, the Ministry of Agriculture and Cooperatives (MOAC), which is one of responsible government bodies to inspect and control food supply chain, makes the move ahead in legislation for traceability. As seen in the notification of Thai Agricultural Standard (TAS) 9028-2014, under the Agricultural Standards Act B.E 2551, this is for the first time that principle for traceability has been recommended by a government body to assist the authority concerned in utilizing product tracing within their agricultural commodities and food inspection and certification system. However, it is designated to present as voluntary standards to comply with the request for importing countries requirements, rather than to protect consumers from food-borne diseases.
For domestic consumption, the ability to trace food products across the entire food supply chain is subjected to the Food Act B.E. 2522, but legal basis to facilitate traceability has hardly been seen in provision of the Act thereof. Nowadays, the competent officers are performing their duties to detect and control food-borne diseases mainly in reliance on official control power under section 43. On carrying out an inspection and sampling, the competent officers shall have power to enter a place of production including storage area, place of sale or office of the producer, storekeeper, distributor, and the importer office to ensure regulatory compliance or to gather evidence necessary to sustain legal action against food operator. Those official control powers are mostly based on observing actions which the information will be acquired merely on the physical checking food establishment. With these powers, it is impossible for the competent officer to gather all the pieces of evidence and to identify the source of the problems. Especially in case of the diarrheal diseases, food- borne pathogens, such as Shigella spp., Salmonella spp., and Escherichia coli., which are found in raw meat products, can link to all stages of the food supply chain. The Thai FDA’s officers are unable to know who supplies a particular food that may lead to serious health problems. Or even in case of identifying the pesticide residues in food crops, the officer also finds it difficult to trace back and forward through the food distribution chain because the information/record about food distribution have 7 not yet been kept by the wholesalers.6 For this reason, the investigation of food hazards is beyond only verifying food operators’ compliance in any food establishment under section 43 of the Food Act B.E. 2522.
Although food labeling regulation is in effect to help the officer in identifying whether who produces such food, such investigations frequently require the review of detailed information on dates, quantities, sources and conditions of foods receives, collection of original transporting containers and labels or other documentations, and information on lot numbers, facilities involved, production dates and the likes. In this case, it requires sensible measure to trace back to the source of contaminated foods. Food business operators which normally hold all relevant information on food production should be highlighted as one of the important mechanisms contributing a strong data collecting function that emphasizes prevention of harmful to consumers. Based on purchasing and sale system, food business operators hold the information that can assist the competent officer to trace back where the disease did come and trace forward to where the disease has spread for example, manufacturing records, raw materials (ingredients and packaging), receipt records, product distribution records, product inventory records, test records, recall records, reportable food records, complaint and adverse event records or customer distribution lists. However, only purchasing and sale system cannot be able to produce accurate and comprehensive information and records in a short period of time at the demand of the competent officers. It is true that the purchasing and sale system will utilize the ability to track and trace where the disease has spread, but in small food business operators, such system is rarely able to meet the objective without modification. Customization will be needed because traceability requires tracking and tracing the physical flow of the food rather than the commercial flow of the food,
6 ส านักส่งเสริมและสนับสนุนอาหารปลอดภัย, “สถานการณ์ปัญหาด้านความปลอดภัยอาหาร ปีงบประมาณ 2555-2556”, (The Bureau of Food Safety Extension and Support, Current Food Safety Issues in 2012-2013, available at http://www.fda.moph.go.th/food_safety/frontend/theme_1/show_detail_2.php?Table= food_safety_v2&Value_Name=ID_Food_Safety_V2&ID_Value=00000153 (last visited Jun. 1, 2015.)). 8 which in some cases, can be different.7 As one of the important mechanisms contributing a strong data collecting function that emphasizes prevention of harmful to consumers, food business operators should be responsible for their food products. The responsibility should be comprehensive enough including the obligation to at least establish a system that can identify their suppliers of food and any other substance intended or expected to be incorporated into food; identify the businesses to which they have supplied products; and can provide this information to the competent authorities on demand. Unfortunately, there is no legal obligation served on food business operators in supporting the system thereof. Regarding to the Food Act B.E. 2522, food licensing and registration system under section 14 and 35, and the existing record retention stipulated under the Notifications on Good Manufacturing Practice (GMP)8 are the two systems that enable food-related information to trace food through the production and distribution chain. Notwithstanding, these two systems only attempt to provide the preliminary information, such as name and type of food; name and address of food operator; equipment list which are used to produce food; location map indicating plant layout of the production building, so that such information cannot be able to identify a common source of problems associated with the control and prevention of food-borne diseases, especially in major problems associated with the control and prevention of food-borne diseases that effective strategies require an urgent action to solve the problems.
Hence, ignoring legislation indicating primary responsibility for food business operators above can have important consequences for protecting public health in the point that it may obstruct a complete and accurate identification and control of food safety problems in a timely manner. Besides, due to this lack of legal obligation on maintaining tracking and tracing information, the Act has potential to
7 Food Safety Authority of Ireland (FSAI), Guidance Note No. 10: Product Recall and Traceability 7 (3 rev. ed., Dublin: FSAI, 2013), (2010) available at http://www.lenus.ie/hse/bitstream/10147/109594/1/GN%2010%20Revision%202%20 FINAL.pdf. (last visited Nov. 18, 2014). 8 By the virtue of the Food Act B.E. 2522, the Ministry of Public Health stipulates subsequent law to protect the consumer most of production. GMP regulations impose exceedingly food business operators’ responsibility on food record-keeping; however, those regulations are specified for some types of food productions. 9 create bad incentives for food businesses operators. According to section 43, inspectional authority has been provided comprehensively for the competent officers. This power also encompasses the authority to inspect records or documents connected with food. However, the Act does not set any mandatory record-keeping requirements on food business operators. Thus, if food business operators know they could be criminally or civilly liable based on records or documents that may be inspected by the officers, they may be less likely to keep documents or records that are completely accurate and some may not keep documents or records at all in order to avoid their liability.
In conclusion, for protecting public health and preventing food-borne illness, effective food control system should have a statutory basis and be mandatory in nature. Lacking a coherent approach to the development of food legislation may keep Thailand far from success. The weaknesses of the competent officers’ control powers as well as the absence of provision indicating food business operators’ primary responsibility under the Food Act B.E. 2522 can have negative impact on the ability to trace the source of food-borne hazards. It also indicates the Thai FDA’s failure in conducting their duty to protect consumers’ health. In the same time, it raises the question to our national food safety program and its control system in protecting consumer from hazardous foods. Finally, it may destroy consumer confidence in the safety of food. Therefore, the sphere of these legal problems should be studied thoroughly and in succession.
1.2 Hypothesis
The Food Act B.E. 2522 is the major law aimed at protecting and preventing consumers from health hazards occurring from food consumption. However, the Act has failed to serve the officer with appropriate tool to detect and control food-borne hazards which become a major public health problem at present time in Thailand. The weaknesses of the competent officers’ control powers in section 43 as well as the absence of provision indicating food business operators’ primary responsibility brings the difficulty to the competent officers in the point that they are 10 unable to trace back where the disease did come and trace forward to where the disease has spread in a timely manner. For all these reasons, the author suggests that section 43 of the Act should be revised by expanding the competent officer’s control powers covering in most areas of the Thai FDA’s operation. In the same time, by the virtue of section 5 and section 6(7) of the Act, the Act should set the provision to establish a new food business operators’ responsibility for maintaining information that can identify the movement of the food through the food chain. As the final, food- borne diseases will be fully detected and controlled.
1.3 Objectives of Study
1. To study the principles of food safety and significant principles of food control system; 2. To study the problems of identification and control of food-borne illnesses under the Food Act B.E. 2522; 3. To compare legal basis for food identification and control under the Food Act B.E. 2522 with foreign countries; 3.1 To study legal measures supporting identification and control of food-borne illnesses in foreign countries and Thailand; 3.2 To compare legal measures supporting identification and control of food-borne illnesses under the Food Act B.E. 2522 with the United Kingdom, and the United States; and 4. To seek appropriate legal measures supporting identification and control of food-borne illnesses for the Food Act B.E. 2522.
1.4 Scope of Study
This thesis aims to study food identification and control under the Food Act B.E. 2522. Firstly, it will introduce the significant principle of food safety and its control system. Then, conceptual framework of food control in Thailand will be 11 extracted briefly. After that the thesis will deal with laws and regulations concerning food identification and control in foreign countries. Due to the influence of EU's General Food Law, the UK becomes a progressive country enabling a comprehensive legal basis in support of food identification and control. Hence, the UK food laws and regulations will be studied along together with the US food laws and regulations, which the passage of the U.S. Food Safety Modernization Act (FSMA) in 2011 brings significant changes to build a new system of food safety oversight. The thesis will also provide information about the problems of the Thai Food Act B.E. 2522 in relation to identification and control of food-borne illnesses as well as analysis food safety laws and regulations in foreign countries to seek appropriate solutions for improving the ability to identify and control of food-borne illnesses.
1.5 Methodology
The method used in this thesis is based on documentary research by searching and analyzing Thai and foreign textbooks, articles, journals, statutory laws, government publications, newspapers, scholars' opinions, information on the internet, and other relevant documents.
1.6 Expected Results
1. To thoroughly understand the principles of food safety and significant principles of food control system; 2. To thoroughly understand the problems of identification and control of food-borne illnesses under the Food Act B.E. 2522; 3. To thoroughly understand legal basis for food identification and control in foreign countries and Thailand; and 4. To provide appropriate legal measures supporting identification and control of food-borne illnesses for the Food Act B.E. 2522. CHAPTER 2 CONCEPTUAL FRAMEWORK OF FOOD SAFETY AND ITS CONTROL SYSTEM
This chapter is designed to present the principles and concepts of food safety including the functions of national food control system and its principles related in order to improve the ability to detect and control a number of food-borne diseases.
2.1 Definitions and Principles of Food Safety
In the first part of this chapter, the thesis deals with the general principles and concepts underpinning food safety. It provides the meaning of food safety and the individual’s right basically based on food safety aspects. Then, the thesis will explain deeply in detailed account of the networking of all stakeholders involved in food supply chain.
2.1.1 Definitions of Food and Food Safety
In its most commonly accepted sense, food is any substance, solid or liquid, that may be ingested and digested by a living organism.9 This definition, however simple, is too board and imprecise compared to definition addressed by the Codex Alimentarius. For the purposes of Codex, food is referred as “any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of food.”10
Under EU Regulation (EC) No 178/2002, the meaning of food is defined similarly that food means any substance or product, whether processed,
9 Alain Gérard, An Outline of Food Law (Structure, Principles, Main Provisions) 7, (2nd ed. FAO, 1975). 10 FAO/WHO Food Standards Programme, the Codex Alimentarius Commission: Procedure Manual 41, (12th ed., 2001). 13 partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Food includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment.11
Likewise, Thai national food law also defines the meaning of food in section 4 of the Food Act B.E. 2522 as follow:
“Food” means edible items and those, which sustain life: (1) Substance can be eaten drunk, sucked or gotten into the body either by mouth or by other means, no matter in what form, but not including medicine, psychotropic substances, narcotic under the law as the case may be, (2) Substance intended for use or to be used as ingredients in the production of food including food additive, coloring matter and flavoring.
In sum, food is briefly divided into two parts based on its intended function. First, food refers to any substance that is intended for human consumption. Secondary, food refers to any substance that is intended for use or to be used as ingredients in the production of food. Nevertheless, cosmetics or tobacco, or substances used only as drugs are not considered as food within the purpose of this thesis. As part of the protection, the safety of food is defined by FAO as:12 “the assurance that the food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
To a large extent, food safety will assure that the food is safe enough for consumption, and must not be contaminated with food hazards that particularly would cause an adverse effect on the health or safety of consumers. The food hazards, in this case, may be introduced into the food supply chain any time
11 EU Regulation (EC) No. 178/2002 Art. 2. 12 Recommended International Code Of Practice General Principles Of Food Hygiene, § 2. 14 during harvesting, processing, transporting, preparing or storing. Microbiological hazards are a significant source of food-borne illness. The risk of milk-borne transmission of tuberculosis and salmonellosis was recognized early in the twentieth century, and being controlled by pasteurization was an early intervention. Similarly, problem with botulism were managed by controlling the application of heat to low acid foods in hermetically sealed containers. Despite remarkable advances in food science and technology, food-borne illness is a raising cause of morbidity in all countries and the list potential food-borne microbial pathogens keeps increasing.13 Due to providing inadequate food production and storage, the risks of microbiological hazards have been identically occurring in Thailand as well. Raw meat products and frozen processed seafood products available in the market can be often found with the contaminations of Escherichia coli, Staphylococcus aureus, Clostridium perfrigens, and Salmonella spp..14 Apart from those microbiological hazards, the contamination of food by chemical hazards is a worldwide public health as the route of food-borne illness. People worldwide have also suffered from chemical hazards no less than suffering from food-borne pathogenic microorganisms, although the effect may occur long after consumption. Indeed, there have been long-standing concerns about chemical safety of food due to misuse of pesticides, resulting in the occurrence of undesirable residues that could lead to acute or chronic illness.15 Moreover, misuse and illegal use of food additives create food safety problems and also have highlighted public concern. Under the same situation, foods sold to the public in Thailand often use the chemicals exceedingly the standards of food safety. There has been reported that food producers often misuse food additives such as antibiotic resistance to ensure that processed food remains in good condition. Apparently, more than 5 percent of 400 meats sampled were contaminated exceedingly with antibiotic resistance, and 50 percent of the meat sampled contained improper chemical additives
13 FAO, Assuring Food Safety and Quality: Guidelines for Strengthening National Food Control Systems, in FAO Food and Nutrition Paper 76 at 26 (Food and Agriculture Organization of the United Nation 1977). 14 คณะกรรมการอาหารแห่งชาติ, อ้างแล้ว เชิงอรรถที่ 3, น. 47-49. (The National Food Commission, Supra note 3, at 47-49.) 15 FAO, supra note 13, at 27-28. 15 such as Synthetic Dyes.16 According to the Public Health Ministry, the number of farmers and consumers who have dangerous levels of pesticide in their bloodstream is also on the rise.
In legislation, the assurance that protects people from food injurious to health has been addressed through food laws and regulations. In most the countries, the safety of food is imposed broadly as the general requirement that the food must be acceptable for human consumption. For example, the Regulation (EC) 178/2002 prohibits food being placed on the market, if it is unsafe by stipulating that the food to be in placed on the market must be suitable for human consumption.17 In Thailand, food operators are not allowed to produce or distribute the food that is the impure food, adulterated food, and substandard food.18 Therefore, the food safety assurance also involves instruments of food control including, if any, the reduction of risks which may occur in the food. Implementation of food control measure is crucial to minimize the risks associated with harmful foods as well.
2.1.2 Principles of Food Safety Protection
This chapter will start with a foundation of food safety rights, then, focus on the food safety system for more understanding about food safety protection.
2.1.2.1 Food Safety and Food Security
According to the 1996 World Food Summit, food security exists when all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active
16 คณะกรรมการอาหารแห่งชาติ, อ้างแล้ว เชิงอรรถที่ 3, น. 47. (The National Food Commission, Supra note 3, at 47.) 17 EU Regulation (EC) No. 178/2002 Art. 14. 18 The Food Act B.E. 2522 § 25. 16 and healthy life. The four pillars of food security are availability, stability of supply, access and utilization.19
(a) Food availability
The availability of sufficient quantities of food of appropriate quality, supplied through domestic production or imports (including food aid).
(b) Food access
Food access is concerned with access by individuals to adequate resources (entitlements) for acquiring appropriate foods for a nutritious diet. Entitlements are defined as the set of all commodity bundles over which a person can establish command given the legal, political, economic and social arrangements of the community in which they live (including traditional rights such as access to common resources).
(c) Utilization
Utilization of food confirms that adequate diet, clean water, sanitation and health care to reach a state of nutritional well-being where all physiological needs are met. This brings out the importance of non-food inputs in food security.
(d) Stability
To be food secure, a population, household or individual must have access to adequate food at all times. They should not risk losing access to food as a consequence of sudden shocks (e.g. an economic or climatic crisis) or cyclical events (e.g. seasonal food insecurity). The concept of stability can therefore refer to both the availability and access dimensions of food security.
19 FAO, Voluntary Guidelines to Support the Progressive Realization of the Right to Adequate Food in the Context Of National Food Security 5 (Food and Agriculture Organization of the United Nation 2005). 17
Ensuring safe and healthy food is an important precondition of food security. In the sense of utilization of food, the people should have adequate and safety of food to fulfill bodily needs. Due to serious events of food incident across the globe, food safety has become a matter of ever increasing international concern and the World Health Organization has defined food-borne diseases as a global public health challenge. Enhanced food safety is a key to improvements in health and nutrition, which, after all, is the ultimate goal of enhanced food security.
2.1.2.2 The Rights for Food Safety
In term of international law, human rights standard requires states to fulfill their relevant human rights obligations under international law.20 These obligations include the right to food.
Under the General Comment No. 12 on the Right to Adequate Food adopted by the UN Committee on Economic, Social and Cultural Rights (CESCR) affirms that the right to adequate food is indivisibly linked to the inherent dignity of a human being and indispensable for the fulfillment of other human rights. The General Comment also asserts that such food should be safe (“free from adverse substances”) and acceptable within a given cultural context. The right to food implies the right to produce or procure the food one needs, and it demands that those who for reasons beyond their control are unable to do so be provided for. The right to adequate food is thus relevant to all consumers and farmers, as well as to those who are unable
20 Food and Agriculture Organization of the United Nations, VOLUNTARY GUIDELINES to support the progressive realization of the right to adequate food in the context of national food security, guideline 8.1 provides that “States should facilitate sustainable, non-discriminatory and secure access and utilization of resources consistent with their national law and with international law and protect the assets that are important for people's livelihoods. States should respect and protect the rights of individuals with respect to resources such as land, water, forests, fisheries and livestock without any discrimination. Where necessary and appropriate, States should carry out land reforms and other policy reforms consistent with their human rights obligations and in accordance with the rule of law in order to secure efficient and equitable access to land and to strengthen proper growth. Special attention may be given to groups such as pastoralists and indigenous people and their relation to natural resources.” 18 to produce or procure their own food. In this last instance, international law recognizes that everyone, at the very least, must be given enough food to ensure their freedom from hunger.21
Due to the obligation, states are required the fulfillment of the right to food by providing all people with sufficient access to production resources, income or support so that they may feed and sustain themselves in a dignified manner.22 The states must not to take any measures that arbitrarily deprive people of their right to food. Contrary, the government must protect people from the actions that might violate the right to food.23
To comply with this obligation, the FAO’ voluntary guidelines recommend that states should institute a rights based approach to food. Resources can be used to build and maintain sustainable food systems, and policies and standards can be designed to ensure safe food and to enable healthy eating habits. In addition the guidelines emphasize that states should empower citizens with the necessary knowledge and skills to secure their right to food. States must be held accountable for measures taken to meet their obligations to respect, protect and fulfil the right to food.24
In the context of consumer protection, maintaining the right for food safety has been directing in the same way of the right to food. The Consumer
21 FAO, FAO Expert Consultation on Food Safety: Science and Ethics 30-32 (Food and Agriculture Organization of the United Nation 2003). 22 Kerstin Mechlem, Ellen Muehlhoff and Franz Simmersbach, Brief 5: Nutrition, Food Safetyand Consumer Protection available at http://www.fao.org/ag/agn/nutrition/docs/brief%2005_nutrition_en.pdf (last visited Apr. 2, 2013). 23 Jean Ziegler, What is the Right to Food?, in Right to Food available at http://www.righttofood.org/work-of-jean-ziegler-at-the-un/what-is-the-right-to-food (last visited Apr. 2, 2013). 24 Kerstin Mechlem ET AL., supra note 22. 19
International (CI) has delivered consumer protection guidelines at the international level.25 The guidelines have been defined into clear consumer rights as follows:26
the right to the satisfaction of basic needs; the right to safety; the right to be informed; the right to choose; the right to be heard; the right to redress; the right to consumer education; and the right to a healthy environment.
As commonly known that food is one of the basic bodily needs, the government should take measures to ensure that all food, whether locally produced or imported, freely available or sold on markets, is safe and consistent with national food safety standards. The measures may include establishing comprehensive and rational food-control and inspection systems, taking action to streamline institutional procedures for food control and food safety at national level and eliminating gaps and overlaps in inspection systems and in the legislative and regulatory framework for food, and also adopting scientifically based food safety standards.27
In Thailand, section 4 of Consumer protection Act, B.E. 2522 affirms the right to food safety by stipulating that:
“the consumer has the following right of protection:
25 The United Nations Guidelines for Consumer Protection (UNGCP) Act were adopted by the UN in 1985 after 10 years of campaigning by CI. They gave important legitimacy to the principles of consumer rights and practical support and guidance for developing national consumer protection legislation. 26 The Consumers International, Guidelines on Consumer Protection available at http://www.consumersinternational.org/who-we-are/un-guidelines-on-consumer- protection (last visited Mar. 16, 2013). 27 FAO, Voluntary Guidelines to Support the Progressive Realization of the Right to Adequate Food in the Context of National Food Security 19 (Food and Agriculture Organization of the United Nation 2005). 20
(1) the right to receive correct and sufficient information and description as to the quality of goods or services;
(2) the right to enjoy freedom in the choice of goods or service
(3) the right to expect safety in the use of goods or services;
(4) the right to have the injury considered and compensated in accordance with the laws on such matters or with the provision of this Act.”
Consequently, either human right or consumer right indicates similarly that the government has the responsibilities to assure the safety of food throughout the entire supply chain. Providing measures that arbitrarily deprive people of their rights, the government must take into account of food safety requirements and also its control system to assure and protect their populations from unsafe foods. With the growing of the complexity of production and processing techniques, it is necessary to provide a proper food control infrastructure and regulatory framework along with technical assistances against anything that may affect public’s health and abuse people’ s trust.
2.1.3 Role and Responsibility of Food-Safety Stakeholders
Previously, the thesis mentioned about the government’s duty to assure the safety of food in order to serve the purpose of human right requirement as well as consumer protection. However, ensuring that consumer’s health is protected requires the input of many organizations and individuals, both within regulatory agencies and the food industry.28 In this topic, the author, therefore, will explain the role of government agencies and other participants that have to be jointly responsible for protecting public health.
28 Principles and Guidelines for National Food Control Systems Cac/Gl 82-2013 § 3. 21
2.1.3.1 Government Sector
The role of national governments in protecting public health is paramount. At the center, government has the responsibility of a number of center government organizations, such as the ministries or department of agriculture, health, trade or commerce. At local level, such responsibilities are delegated to local authorities, municipalities, or local governments.29 The government also has a duty to establish a framework that provides food safety education and information to consumers and the food industry. The information includes factual information to consumers, information packages and educational programs for key officials and workers in the food industry.
2.1.3.2 Consumers
While consumers are entitled to safe and wholesome food, they in fact have responsibilities regarding food safety: observing good hygienic practices when handling food, storing food properly and following manufacturers’ recommendations on labels; however they cannot be expected to be the sole providers of food safety. Many consumers, through no fault of their own, lack adequate education concerning appropriate food handling practices in the home and may have only limited or no access to information on these practices.30
2.1.3.3 Food Industry Sector
Ultimate responsibility for food safety lies not with the regulator nor with the consumer but with food producers, processors, retailers, preparers, and servers. Whereas any individual or firm has the right to produce, process, prepare, serve, import and export food, this right comes with the inseparable responsibility to ensure that such food is wholesome and safe and that the conduct of
29 Alan Reilly, Raymond Ellard and Judith O’ connor, Food Safety at the National Level: the Role of Governments available at http://www.eolss.net/sample- chapters/c03/E6-59-15-06.pdf (last visited Mar. 26, 2014). 30 FAO, Risk-based Food Inspection Manual, in FAO Food and Nutrition Paper 89 at 7 (Food and Agriculture Organization of the United Nation 2008). 22 their business is within all applicable laws, including those regarding fraud. The capacity of producers and processors – and also of retailers and food preparers – to fulfill their roles adequately depends on their ability to understand, establish, and follow effective food control systems.31
2.2 Conceptual Framework of Food Control System
Food control is the key of success in protecting public health and reducing the risk of food-borne diseases. A well-organized food control system should prevent the food supply chain comprehensively along all the stages of the production of food.
2.2.1 Core Concept of Food Control System
Although food control has been described in many different ways, the FAO adopted a definition that appears to be most suitable. It is defined as: 32
“Food control can be defined as the mandatory regulatory activity of the enforcement of food laws and regulations by national or local authorities to provide consumer protection and ensure that all foods during production, handling, storage, processing and distribution are safe, wholesome and fit for human consumption; conform to safety and quality requirements; and are honestly and accurately labeled as prescribed by law.”
This definition was published by FAO in the Food and Nutrition Paper series on Food Quality Control - Manual 14/11 entitled "Management of Food Control Programs" by aiming to:33
31 Id. 32Food and Agriculture and World Health Organization Regional Conference on Regional Conference on Food Safety for the Americas and the Caribbean, San José, Costa Rica, 6-9 December 2005, Capacity Building for Food Quality and Food Safety: Selected Activities in the Americas and the Caribbean of the Food and Agriculture Organization (FAO), U.N. Doc. CONF.32, available at ftp://ftp.fao.org/docrep/fao/Meeting/010/af267e.pdf. 23
Protect public health by reducing the risk of foodborne illness; Protect consumers from unsanitary, unwholesome, mislabeled or adulterated food; and Contribute to economic development by maintaining consumer confidence in the food system and providing a sound regulatory foundation for domestic and international trade in food.
Because confidence in the safety and integrity of the food supply is an important requirement for consumers, food control should be proposed to cover all food produced, processed, and marketed within the country, including imported food. Such systems should have a statutory basis and be mandatory in nature.34 Apart from legislation and complementary regulations, food control cannot be carried out successfully without well-established policies, efficient food inspection services, adequate laboratory services, and the development of information, education communication and training.35
2.2.2 The Principles of Modern Food Control System
The objective of food control system can be achieved most effectively by the principle of prevention throughout the production, processing, and marketing chain. All following principles have been applied for strengthening the capacity of the food control system.
2.2.2.1 The Farm-to-Table Concept
To achieve maximum consumer protection, it is essential that safety be built into food products from production through to consumption. This calls for a comprehensive and integrated farm-to-table approach in which the producer,
33 FAO, supra note 13, at 6. 34 Id. 35 Id. at 6-9. 24 processor, transporter, vendor, and consumer all play a vital role in ensuring food safety and quality.
It is impossible to provide adequate protection to the consumer by merely sampling and analyzing the final product. The introduction of preventive measures at all stages of the food production and distribution chain, rather than only inspection and rejection at the final stage, makes better economic sense, because unsuitable products can be identified earlier along the chain. The more economic and effective strategy is to entrust food producers and operators with primary responsibility for food safety and quality. Government regulators are then responsible for auditing performance of the food system through monitoring and surveillance activities and for enforcing legal and regulatory requirements.36
2.2.2.2. The Application of Risk Analysis
To protect the interest of public health, governments have to provide an enabling institutional and regulatory environment for food control. Most developing countries already have some sort of food control system in place, usually based on hygiene and adulteration/fraud inspection. Since food control system is unable to detect and resolve many current problems, a number of developing country governments are already taking steps to improve and strengthen their systems for food safety management. Food safety regulators in many countries are already implementing different types of science-based actions and decision-making in their day-to-day work. To meet current challenges and improve the availability of safe food for consumers, a science-based approach can be used as reasonable option to minimize the occurrence of food-borne hazards, to reduce and manage risk, and to improve the outcomes of decision-making.37
These science-based approaches are an important and integral part of Risk Analysis to improve food safety systems. A risk analysis framework provides a process to systematically and transparently collect, analyze ,and evaluate
36 Id. at 10 37 FAO & WHO, Food Safety Risk Analysis: PART I: An Overview and Framework Manual 3-7, (Provisional ed., FAO 2005). 25 relevant scientific and non-scientific information about a chemical, biological ,or physical hazard possibly associated with food in order to select the best option to manage that risk based on the various alternatives identified. As a structured decision- making process, risk analysis is comprised of three components: risk management, risk assessment, and risk communication.38
Figure 2.1: Components of Risk Analysis
Figure 2.1 FAO and WHO, “Food Safety Risk Analysis: PART I; An Overview and Framework Manual,” Provisional Edition (Rome: FAO, 2005), 9. http://www.fsc.go.jp/sonota/foodsafety_riskanalysis.pdf (accessed January 20, 2013.)
In the course of a typical food safety risk analysis, almost constant interactions occur between risk managers and risk assessors within an environment characterized by risk communication. The process normally begins with risk management step to define the problem, articulate the goals of the risk analysis and identify the questions to be answered by the risk assessment. The science-based tasks of ‘measuring’ and ‘describing’ the nature of the risk being analyzed are performed during the risk assessment. Risk management and assessment are performed within an open and transparent environment based on communication and dialogue. Risk communication encompasses an interactive exchange of information and opinions among risk managers, risk assessors, the risk analysis team, consumers, and other stakeholders. The process often culminates with the implementation and continuous monitoring of a course of action by risk managers. In addition, this
38 Id. at 8-11 26 process is undertaken in an open and transparent manner and is facilitated by a continuous process of two-way communication among all the interested stakeholders about all aspects of the risk under consideration.39
In addition, the risk analysis approaches are not only applicable for monitoring outbreak detection, monitoring trends of food-borne disease in the manner of surveillance itself, but also applicable for the evaluating interventions in emergency situations in which such approaches will be used in order to assist and direct the competent officers in selecting appropriate control measures.
2.2.2.3 The Surveillance System and Response Plan
As amended by FAO/WHO, to prevent and when necessary to respond to food safety incidents, a national food control system should encompass the core elements of prevention, intervention, and response.40 Therefore, it is imperative to have knowledge on the current situation and trends with regard to the occurrence and spread of food-borne diseases in the food production chain. This knowledge needs to be updated continuously so that appropriate responses can be prepared. Activities involved in such a system are gathered under the terms monitoring and surveillance.
Surveillance refers to a specific extension of monitoring where obtained information is utilized and measures are taken if certain threshold values related to disease status have been passed. The main objectives of surveillance are outbreak detection, monitoring trends in endemic disease, evaluating interventions, and monitoring program performance and progress towards a predetermined control objective. However, surveillance is not merely a routine measure of the current situation, but a basis for giving qualified feed-back to
39 FAO, Food safety risk analysis: A guide for national food safety authorities, in FAO Food and Nutrition Paper 87 at 7 (Rome, 2007). 40 Principles and Guidelines for National Food Control Systems § 3 (CAC/GL 82- 2013). 27 producers, tracing back contamination to its origin, pin-pointing critical control points during production, and initializing targeted action.41
The surveillance should be considered at all levels of production. This requires a coordinated surveillance and response effort from all major stakeholders in food safety.
The food operator is responsible for the quality and the safety of its products and is therefore a major stakeholder in food safety. To effectively execute control measures, food producers, and processors generally implement complete food control systems using comprehensive approaches based on risk analysis such as GMP, GHP and HACCP system.42 Because food safety management systems should be documented and updated as necessary, written records should be kept for inspection by the competent officers.
The main stakeholders in food safety representing the government are the Ministries of Health and the Ministries of Agriculture. Under them are agencies that are responsible for the legislative, technical, and practical implementation of food safety programs and each agency often has a dedicated reference laboratory and epidemiological associated with it. The access to surveillance data often goes through these laboratories. These two organizational structures often run independently of each other. In order to get a comprehensive view of the national food safety status, the two Ministries and their respective agencies and reference laboratories should work closely together.43
41 FAO & WHO, Bangkok, Thailand, Oct. 12-14, 2004, Second FAO/WHO Global Forum of Food Safety Regulators: Building effective food safety system (2004) available at ftp://ftp.fao.org/docrep/fao/meeting/008/y5871e/y5871e00.pdf. (last visited Apr. 20, 2014). 42 FAO, supra note 39, at 33. 43 FAO, supra note 41. 28
In the context of institution, the governments are the main mechanism to veil the entire surveillance system. Actually, the food safety programs implemented by the government provide core functions of the system, namely:44
collecting the information recorded as well as factors that affect to food incidents; identifying cases and food incidents or outbreaks; reporting suspected and confirmed food incidents or outbreaks; providing preparedness; responding and controlling food incidents; implementing follow-up monitoring.
Finally, other stakeholders of food safety are the non- governmental organizations. They may represent consumers, food industry workers, or the environmentalists. Although these organizations seldom are directly involved in the generation of data, they can influence the launching of food safety initiatives and serve as a driving force behind initiation of surveillance efforts.45
The surveillance systems are only useful if they provide data for appropriate public health response and control. When food-borne disease that appears to be widespread, difficult to control ,and/or of serious health consequence has been reported, in responding incident, sensible preventive measures coupled with basic preparedness are needed to address threats posed by those intentional and unintentional food incidents.
In broad terms, the purpose of a food safety response plan is to set out a framework for the response to emergencies when they occur. Such plan provides guidance for those who have a role in food incident prevention or response. The greatest examples of surveillance system and response plan can be seen in EU where a Rapid Alert System (RASFF) has been established in order to monitor and
44 WHO, Communicable disease surveillance and response systems: Guide to monitoring and evaluating 11-13, (WHO 2006). 45 Id. 29 control possible risk of food-borne diseases. Identically, under supervising of Thai FDA, Food Alert System of Thailand (FAST) has been established to work along with Thailand FSER plan in monitoring and controlling emergency/crisis of food incidents.46
2.2.2.4 The Application of Hazard Analysis and Critical Control Points
The Hazard Analysis and Critical Control Points (HACCP) system is used internationally and has been adopted by the joint FAO/WHO Food Standards Program as the best approach to take to control food borne disease. The seven principles of HACCP, which encompass a systematic approach to the identification, prevention, and control of food safety hazards include:47
1) Conduct a hazard analysis
Plans determine the food safety hazards and identify the preventive measures the plan can apply to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
2) Identify critical control points
A critical control point is a point, step, or procedure in a food manufacturing process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.
3) Establish critical limits for each critical control point
46 Food and Agriculture Organization of the United Nations Regional Office for Asia and the Pacific, Bangkok, Thailand, Jun. 27-28, 2012, Report of the ASEAN Regional Meeting, Developing National Food Safety Emergency Response Plans – Sharing Experiences and Lessons Learnt 28 (Oct. 2012). 47 FAO, Manual on the application of the HACCP system in Mycotoxin prevention and control, in FAO Food and Nutrition Paper 73 at 29-30 (FAO 2001). 30
A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.
4) Establish critical control point monitoring requirements
Monitoring activities are necessary to ensure that the process is under control at each critical control point.
5) Establish corrective actions
These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injures to health or otherwise adulterated as a result of the deviation enters commerce.
6) Establish procedures for ensuring the HACCP system is working as intended
Validation ensures that the plants do what they were designed to do; that is, they are successful in ensuring the production of a safe product. Plants will be required to validate their own HACCP plans.
Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits, and microbial sampling and analysis.
Verification also includes 'validation' – the process of finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical limitations).
7) Establish record keeping procedures
The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and 31 records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations. Implementation involves monitoring, verifying, and validating of the daily work that is compliant with regulatory requirements in all stages all the time.
The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. However, for those sectors of the food chain that may not have capacity to reach all the application of HACCP system, they might put in place with prerequisite programs such as Good Agricultural Practice GAP), Good Manufacturing Practice (GMP), Good Hygienic Practice (GHP) prior to implementing a full effective HACCP program.
According to a Prerequisite Program, each component should contain expectations, procedures, and monitoring to ensure that employees prevent contamination and adulteration of products. Monitoring may occur daily, weekly, monthly, or other basis meeting the production need of the establishment. Corrective actions for deviations should be included and documented during monitoring of each component. Sample Components of a Prerequisite Program includes:48
Facilities(Design, construction ,and maintenance of the Facility); Supplier Control(List of suppliers and their food safety programs); Product Specifications (Specifications for ingredients, products ,and packaging); Production Equipment (Equipment operation/maintenance/installation); Cleaning and Sanitation (Cleaning and sanitizing procedures and master sanitation schedule);
48 N.p., Sample Components of a Prerequisite Program for HACCP Programs available at https://www.denvergov.org/Portals/771/documents/Sample%20Components%20of%2 0a%20Prerequisite%20Program%20for%20HACCP.pdf (last visited Aug. 20, 2013). 32
Personal Hygiene (Hygiene requirements for staff including hand washing, personal food/beverage, and bare hand contact); Training(Documented training on prerequisite programs and HACCP program); Chemical Control (Procedures for segregation and proper use of non-food/cleaning chemicals, pesticides, etc.); Receiving and Storage (Procedures for receiving goods and proper storage for dry goods and temperature control goods (shipping procedure is included for those that sell to others); Traceability and Recall (Method for tracking product in the event of recall); Pest Control (Pest prevention and control measures); and Record Retention for Regulatory Review (Record retention time based upon regulatory requirement and location for records storage).
2.2.2.5 Traceability Concept
Food production and distribution systems are becoming more interdependent, integrated, and globalized. At the same time, escalating and heavily publicized outbreaks of food-borne diseases have raised awareness of the need to ensure food quality and safety. This need drives much of the system to trace food consistently and efficiently from the point of origin to the point of consumption.
“Traceability” is a concept developed in industrial engineering and was originally seen as a tool to ensure the quality of production and products. Economic literature from supply-chain management defines traceability as the information system necessary to provide the history of a product or a process from origin to point of final sale. 33
In context of food sector, traceability systems allow supply chain operators and regulatory authorities to identify the source of a food safety or quality problem and initiate procedures to remedy it. Specific standards for food traceability have been mandated internationally; by law in the European Union (EU), Japan, and more recently the United States; and by private firms and associations.
In international level, traceability refers to full traceability along the supply chain, with the identification of products and historical monitoring, and not just the separation of products under specific criteria at one or more stages of the chain. The Codex Alimentarius Commission defines traceability as:49
“the ability to follow the movement of a food through specified stage(s) of production, processing and distribution. . . . The traceability/product tracing tool should be able to identify at any specified stage of the food chain (from production to distribution) from where the food came (one step back) and to where the food went (one step forward), as appropriate to the objectives of the food inspection and certification system”
Likewise, the EU General Food Law, Article 18 Regulation (EC) No 178/2002, defines traceability as “the ability to track food, feed, food- producing animal or substance intended to be, or expected to be used for these products at all of the stages of production, processing, and distribution.” In comparison to some international for traceability, the EU does not require internal traceability that it does not require all inputs to match all outputs. 50
A traceability system is an effective tool which food business operators can trace food throughout the food chain. The most common legal
49 Principles for Traceability/Product Tracing as a Tool Within a Food Inspection and Certification System, § 2. 50 World Bank, Module 12: Global Markets, Global Challenges; Improving Food Safety and Traceability While Empowering Smallholders Through ICT, in Information and Communications for Development 2012: Maximizing Mobile (2012) available at http://www.ictinagriculture.org/sites/ictinagriculture.org/files/final_Module12.pdf (last visited Jul. 9, 2013). 34 requirement is for food business operators to have, as a minimum, a documented one- step-back and one step forward traceability approach. Small food business operators with limited distribution may not be required to have a fully documented traceability system in place and may rely solely on their purchasing and sale records to act as their traceability records. Aspect of food recall system, the objectives of traceability are to:
1) uniquely a lot, batch, or consignment of food in a way that allows tracing of the physical flow of the food forwards through identify the food chain to the immediate customer and tracing of the physical flow of raw materials backwards to the immediate supplier;
2) create and maintain accurate traceability records that can be provided within a short time period when needed for recall or at the request of the competent authorities.
If there is no traceability system required within the country’s regulatory model, it is necessary to develop such a system. The system does not have to involve sophisticated information technology (IT)-orientated tools, but it needs to ensure effective record-keeping processes that follow the one-step-back and one-step- forward principle. The competent authority should establish a mechanism to collect food recall information. This information can be analyzed and exchanged with relevant parties. This mechanism can provide a platform for information sharing with other national and regional organizations and international networks (e.g. INFOSAN).51
In Thailand, traceability concept becomes effective as a guidance for authority concerned to utilize the design and application of traceability/product tracing, in cooperation, with safety and quality control system of agricultural commodities and food. The notification of Thai Agricultural Standard
51 FAO & WHO, FAO/WHO guide for developing and improving national food recall systems 26-27 (2012). 35
(TAS) 9028-2014, upon the Agricultural Standards Act B.E 2551, has been lunched in accordance with the FAO/WHO Food Standards (Codex). The TAS 9028-2014 suggests that product tracing tool should be designed according to harmonized needs, technical feasibility, practical for user and environment as well as the economic acceptability. Based on a case by case basis, the concerned factors include clear objectives, characteristics of products, the identification of the stage of the food chain, details of each production process and/or handling of product, documentation and record system and media, and so on. Nevertheless, the designed procedures to be used in the organization shall demonstrate production process, raw materials, and information on important control points. The procedures should be able to identify, at least:
Type of product; Identification of lot and batch of product; Records of production process and/ or product handling, from raw materials through final products as well as the identification of documentation and record system; and Information management and utilization.
The organization, thus, shall determine the required documents and information to achieve the objective of its traceability/product tracing that include:
1) Description of the relevant steps in the food chain 2) Description of the responsibilities for the management of data 3) Record forms and details of data to be recorded 4) Written or recorded information describing the activities, production lines as well as results of inspection, verification and audit 5) Records of corrective actions related to traceability/product tracing 36
6) Document retention time that shall correspond to product shelf life and relevant regulations.
If the organization participates in the traceability/product tracing of other organizations or is a part of the traceability/product tracing in the overall food chain, the coordination or information networking of the organization in the food chain shall be established as each organization identifies its immediate suppliers and the initial recipients.
The executive management of the organization shall fully support and demonstrate its commitment to the application of the traceability /product tracing by assigning management responsibility and providing necessary resources. In order to assure that the traceability/product tracing tool will achieve its objective , the effective application shall include traceability/product tracing plan, tasks and responsibilities, training plan, an appropriate monitoring scheme, internal audits ,and review.
However, this traceability guideline is designated to present as voluntary standards to comply with the request for importing countries requirements, rather than to protect consumers from food-borne diseases. It is not intended to be used as the basic principle for domestic consumption.
2.3 Conceptual Framework of Food Control in Thailand
Prior to understand deeply about Thai food safety strategies to solve the problems associated with food-borne disease, the thesis will explain about the government agencies operating food-related activities as well as the problems of food- borne disease in Thailand.
37
2.3.1 Food Safety Related Organizations and Regulations
Various ministries are working together for food safety control in the country. Different laws and regulations are enforced by different ministries, as shown below:
1) Ministry of Public Health (MOPH): a. Food Act B.E. 2522 (1979) b. Veterinary medicines and medicated premix are regulated by the Drug Act B.E. 2510 (1967) 2) Ministry of Agriculture and Cooperatives (MOAC): a. Agricultural Standard Act B.E. 2551 b. Fisheries Act B.E. 2490 (1947) c. Plant Variety Protection Act B.E. 2542 (1999) d. Ministerial Regulation Regarding Importation from and Transit through the Kingdom of Thailand of Animal Carcasses B.E. 2544 (2001) e. Hazardous Substances Act (concerning pesticides for agriculture) B.E. 2535 (1992) f. Feed Quality Control Act B.E. 2542 (1999) 3) Ministry of Industry (MOI): a. Industrial Product Standards Act B.E. 2511 (1968) 4) Ministry of Commerce (MOC): a. Controlling Importation and Exportation of Goods Act B.E. 2522 (1979)
In respect of food control operations, Ministry of Public Health (MOPH) and Ministry of Agriculture and Cooperatives (MOAC) are the two main ministries responsible for food safety control.
38
Figure 2.2: Food Control in Thailand Along the Food Chain
Figure 2.2 Srithamma S., Vithayarungruangsri J. and Posayanonda T., “Food Safety Programme: A Key Component for Health Promotion,” FDA, http://www.fda.moph.go.th/project/foodsafety/HealthPromotion2.pdf. (accessed October 13, 2014).
At the farm level, the system is controlled by the Ministry of Agriculture and Cooperatives (Department of Agriculture (DOA), Department of Fisheries (DOF) and Department of Livestock Development (DOL). For slaughterhouse control, the directly responsible organization is the Department of Livestock Development, Ministry of Agriculture and Cooperatives. Also, the Ministry of Interior is another organization playing a cooperative role with the Ministry of Agriculture and Cooperatives to perform the slaughterhouse control tasks at the farm level.
At the food importation and processing levels, the Thai Food and Drug Administration (FDA) and the Provincial Public Health Offices (PPHO) of the Ministry of Public Health, with the support of the food analytical services of the Department of Medical Sciences (DMSc), and of accredited laboratories, are both responsible for regulatory food control operations. In this case, these two government agencies are conducting all food control activities as competent authority under the 39 provisions of the Food Act B.E. 2522. Other than Thai FDA and the Provincial Public Health Offices, the Department of Health of the Ministry of Public Health is another responsible organization working cooperatively with the Bangkok Metropolitan Administration (BMA) at the food distribution level (fresh markets, supermarkets, street food vendors and restaurants) to strictly control food safety and operations in order to promote food quality, food hygiene, and food safety in the country.
2.3.2 Current Situations of Food Incidents in Thailand
Microbial agents and chemical contaminants, including other hazards that may make food injurious to health of the consumers, are among the public concerns and are involved with the global increase in the incidence of food borne diseases. In many developing countries, food borne disease outbreaks from bacteria, such as Escherichia coli and Salmonella spp., impose a substantial burden on health care systems and can markedly reduce the economic productivity of the countries. Similar to other developing countries, Thailand has been suffered from those food contaminants as well. Therefore, this chapter is designated to present the current situation of food-borne diseases that dramatically impact on Thai people’s health. It also reviews food contaminants occurred throughout Thailand.
2.3.2.1 Situations of Diarrheal Diseases
Diarrheal diseases have been a major public health problem in Thailand for many years. Food is considered as a main route of transmission of microorganisms causing diarrheal diseases.52 Commonly, microorganisms refer to bacteria such as Shigella spp., Salmonella spp., and Escherichia coli which can be found in raw meat, frozen seafood, frozen raw shrimp, and also frozen squid.
According to the report of Bureau of Epidemiology, there are approximately a million cases of acute diarrhea reported each year, and the reported cases of food poisoning are more than 120,000 per year. Only in 2010, there were 65
52 FAO&WHO, supra note 2, at 1. 40 deaths from diarrheal diseases. Resulting from this high number of food-borne illness cases, morbidity rate of diarrheal diseases is expected to increase or remain unchanged in the future.53
Figure 2.3: Morbidity rate of diarrheal diseases in Thailand, 2001-2010
Figure 2.3 คณะกรรมการอาหารแห่งชาติ. กรอบยุทธศาสตร์ การจัดการด้านอาหารของประเทศ
ไทย. พิมพ์ครั้งที่ 1. กรุงเทพฯ: ส านักงานกองทุนสนับสนุนการสร้างเสริมสุขภาพ. ม.ป.ป., 43-44.
(The National Food Commission. Strategies of Food Management Program. 1st. Bangkok: Thai Health Promotion Foundation, n.d., 43-44.)
In term of major food incidents, the ongoing outbreaks of highly pathogenic H5N1 avian influenza in poultry have raised concerns about the source of infection and the risk to humans from various exposures throughout Thailand. Since avian influenza was detected, 25 cases of human infection with H5N1 have been confirmed, and the deaths bring to 17 the total number of people killed by such influenza.54
53 คณะกรรมการอาหารแห่งชาติ, อ้างแล้ว เชิงอรรถที่ 3 น. 43-44. (The National Food Commission, supra note 3 at 43-44.) 54 CNN Library, Avian Flu Fast Facts, available at http://edition.cnn.com/2013/08/23/health/avian-flu-fast-facts. (last visited February 2, 2014). 41
2.3.2.2 Situations of Food Contaminants
Several factors may cause the incident of diarrheal diseases in the country, namely, contaminated food and drinking water, poor personal hygiene, and poor consumption behaviors.55 But the most important issue shaking consumer awareness is contaminants in food. Because consuming food is basically part of our life, it needs to be ensured that contamination of food and drinking water with pathogens leading to diarrheal diseases is minimized in every process involved with the food practice, including food production, food transportation, or food preparation.
Apart from diarrheal diseases, food contamination incidents also increase consumer awareness in Thailand. According to the report of Outbreak Verification Summary released by National Trustworthy and Competent Authority in Epidemiological Surveillance and Investigation, it found that foods available to the market are often contaminated with exceedingly high level of chemicals. More than 5 percent of 400 meats sampled were contaminated with antibiotic resistance, and 50 percent of the meat sampled contained improper chemical additives including Synthetic Dyes.56
2.3.3 Strategic Plan for Food Safety 57
A Cabinet resolution on 4 March 2004 approved the “Road Map of Food Safety” as a framework for the control of food and agricultural products at the operational level throughout the food chain. The framework clarifies distinct roles and responsibilities for each food control organization in Thailand. This reduces duplication of effort and overlapping actions among food control authorities. Close
55 FAO&WHO, supra note2, at 2. 56 คณะกรรมการอาหารแห่งชาติ, อ้างแล้ว เชิงอรรถที่ 3, น. 43-44. (The National Food Commission, supra note 3, at 43-44.) 57 Srithamma S. ET AL., Food Safety Programme: A Key Component for Health Promotion 1-20 available at http://www.fda.moph.go.th/project/foodsafety/HealthPromotion2.pdf. (last visited Aug. 20, 2014). 42 cooperation of activities at central and local governmental levels as a result of using this framework is expected to be an effective mechanism for ensuring good quality and safety of food in order to achieve the best possible level of health protection for consumers.
2.3.3.1 Road Map of Food Safety
The primary principles for the implementation of the Road Map of Food Safety are the following:
Equivalent food safety standards for domestic and international consumers; Standards placed on Thai food and agricultural products must be acceptable to the international community and conformable to international standards; Establishment of Sanitary and Phyto-sanitary Standards (SPS) of Thai food and agricultural products must be based on scientific evidence in order to attain the best level of health protection for consumers and the fair implementation of measures for producers of food and agricultural products;
The “from-farm-to-table” food control system, including plant and animal quarantine, in Thailand must be effective and equivalent to the systems in effect in other countries in order to ensure fair trading in food at both the domestic and international levels.
2.3.3.2 Strategies of the National Food Safety Program
Strategies for the food safety control system are categorized into five areas based on the concept of risk analysis, which is a proactive and appropriate approach used to control food safety across the entire food chain. In addition, controlling procedures of the quality assurance system is based on the 43
Hazard Critical Control Point (HACCP) and Good Manufacturing Practice (GMP) principles.
Five strategies of the National Food Safety Program have been implemented in Thailand as follows:
1) Development of regulatory measures to comply with international food standards
Laws and regulations related to food control have been revised and amended to comply with international food regulations in order to establish and improve national food standards on specifications, labeling, nutrition claims, hygienic practices and code of practices for certification and trading facilitation, and for promotion of compliance policies in marketplaces and for high- risk food products. It must be ensured that the enforcement of laws and regulations in Thailand provides equity in consumer protection for all food products (including all foods produced, imported and exported). From April 2003 to May 2005, Thailand has developed and amended 35 food and drug regulations.
2) Strengthening of food safety monitoring and risk management systems
Thailand’s Ministry of Public Health implements measures for strict and regular surveillance and monitoring of food contaminants focusing on six chemicals (borax, formaldehyde, sodium hydrosulfite, salicylic acid, salbutamol and pesticide residues), which are the major hazardous chemicals that contaminate some foods available in the Thai market. Since this measure has been implemented, it has been reported that the volume of food contaminated with the six chemicals has decreased tremendously.
In addition to controlling the six previously mentioned chemicals, Thailand also implements surveillance and monitoring program on food, focusing on contamination with microorganisms, heavy metals ,and aflatoxin, for example, as well as genetically modified organisms (GMOs). Moreover, all food 44 production sites, distribution sites and restaurants, will be regularly inspected to assure their adherence to good manufacturing practices (GMP) or Hazard Analysis and Critical Control Point (HACCP), hygiene and food sanitary systems.
3) Empowerment of consumers
Consumers have been empowered by providing public education through the media (e.g., television, radio, leaflets, pamphlets, newspapers, web sites, village information centers) in order to help consumers understand how to select and buy safe food for themselves and to increase consumer awareness about food consumption. In addition, organizations in both the central and local areas are being encouraged to set up responsible groups to increase consumer health protection with regard to food. These responsible groups also include youth volunteers at schools. They have been taught how to choose safe food for consumption. Consumer health protection and food safety-related activities at schools have also been promoted and developed by such responsible groups. For example, monitoring food inside and around the school areas by using test kits provided by the Ministry of Public Health so that the group can observe whether or not the food is contaminated with prohibited chemicals or microorganisms, etc. Currently, 10,256 schools and a million school children have joined the Ministry of Public Health’s Food Safety Program.
4) Capacity building and information networking
Training and education programs related to food safety have been provided for food safety personnel. Further, focus has been put on the information system linkage and the cooperation between relate organizations in order to develop and strengthen working capabilities, and to ensure that working processes are going in the same direction.
In addition, the Ministry of Public Health has a policy to provide rewards for health care and food personnel in order to increase their motivation to work. Further, since the National Food Safety Program was launched in 2003, the Food Safety Operation Centre was established under the Ministry of Public Health. This Centre is working as a cooperative unit for food safety monitoring and 45 follow-up as well as for collecting food-related information from food competent officers and all the other parties involved; sending food-safety reports to the Centre every month; and evaluating the results of implementing the National Food Safety Program.
5) Development of laboratory capability
Necessary equipment is provided to food-testing laboratories in both the public and private sectors for the development of their capability in food analysis and for increasing the number of accredited laboratories in the country. The aim is that central and local laboratories in Thailand will become well equipped to provide full food-testing services by 2009.
Mini-laboratories at ports of entry have been established to conduct strict surveillance and monitoring of imported processed food and raw materials used in food production in order to prevent the importation of unsafe or substandard food, as well as to prevent and reduce the importation of illegal or prohibited veterinary medicines, pharmaceutical products ,and chemicals into Thailand.
Food-testing mobile units are effective and important tools used in food monitoring and post-marketing surveillance of fresh food and ready-to- eat food in the country. Such mobile units have been well equipped with basic food testing tools for screening contaminants in food that is distributed in central and provincial areas of the country.
The risk analysis principle will be the main approach used in their regard. In doing so, traceability will be applied completely across the entire food chain in the national food safety control system. CHAPTER 3 LEGAL MEASURES SUPPORTING IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES IN FOREIGN COUNTRIES
Changes are taking place in relation to issues associated with general concerns for the safety of the food supply. Among the first of these changes are the efforts being made by most countries to up-date their food laws, rules, and regulations to serve the purpose of modern food control system.
Due to the influence of EU's General Food Law, the United Kingdom (UK) becomes a progressive country enabling a comprehensive legal basis in support of food identification and control. With an enhanced official control power and mandatory of the record-keeping process, all relevant information associated with the food throughout food supply chain will be made available for the officer to detect and control the possible hazards that might affect the people’s health. Shortly afterwards the importance of food identification and control had also been realized by the US food safety policies since national outbreaks of salmonella illnesses in foods were increased. Although these two countries may have food safety policies in common, there are some differences in detail which may point out the possible way to implement legal basis for food identification and control in Thailand.
After the Food Safety Modernization Act (FSMA) was signed into law in 2011, there are significant changes in the US food laws and regulations. This new Act requires USFDA to designate high-risk foods (HRFs) for which additional record- keeping requirements to protect the public health. Different from EU's General Food Law, mandatory of record-keeping will be divided into two separate sets of records for high-risk food and also for non-high-risk foods. As part of the official control power, conducting food hazard investigation, in Thailand, is reliance on the inspection authority under the Food Act B.E. 2522. This inspectional authority is similar to the UK food laws that are quite board, and also encompass the ability to access the records in relation to food. Hence, studying the inspection authority in UK legislation 47 may be useful when considering enhancing the record access authority to better detect and control of food-borne illnesses in Thailand.
This chapter, therefore, will point out the significance of food safety provisions that have been reviewed and up-dated in both the UK and the US particularly for identification and control of food-borne illnesses.
3.1 Legal Measures Supporting Identification and Control of Food-Borne Illnesses in the United Kingdom
This part of the thesis deals with the function of government agencies in controlling food-borne diseases and food laws and regulations that enable the competent officers’ powers and also the food operators’ responsibility.
3.1.1 Government Agencies Responsible for Food Control Activities
Food Authority and the Food Standard Agency (FSA) are assigned as competent officers mainly to be responsible in dealing with food that fails to comply with food safety requirements in their areas.
Food Authorities are responsible to carry out the duties authorized under Section 5(6) of the Food Safety Act 1990 and Regulations made under it. The Act covers activities throughout the food distribution chain, from primary production to retail and catering. The Acts also gives the government powers to make regulations on matters of detail. In the local level, Environmental Health and Trading Standards Services are the main departments dealing much of the day-to-day work of regulatory enforcement.58 Trading Standards Officers (TSOs) have the principal responsibilities to ensure that food is correctly and accurately labelled, and contains legal ingredients
58 Food Standards Agency (FSA), Regulation (EC) No 882/2004 on official controls: guidance in Q&A format for enforcement authorities on the feed and food elements 13 (Revision 4 Feb. 2013) available at http://multimedia.food.gov.uk/multimedia/pdfs/offcqaguidancenotes.pdf (last visited Apr. 29, 2014). 48 and that any claims made are truthful. They also act on national food safety alerts and issue press releases to inform local businesses and consumers about product recalls or food alerts. While the TSOs are used to be known as Inspectors of Weights and Measures59, the Environmental Health Practitioners (EHOs) have to be responsible for any aspects relating to hygiene, cases of microbiological contamination, and chemical contamination in food. As for environmental health officers, the responsibilities include housing, pollution, pest control and, most importantly, aspect of food law enforcement. They are also responsible for monitoring the hygienic operation of food businesses and for the investigations and control of food poisoning outbreaks.60
Different from the day-to-day work of enforcement, the Food Standards Agency (FSA) enforces regulations made under the Food Safety Act 1990. Most of its regulatory duties are to enhance the ability of the food surveillance and response system in detecting and controlling food-borne diseases. As for a major food incident, the ad hoc incident group of the FSA will undertake a risk assessment which includes investigating food incidents, reviewing all relevant the information involved to be established the detailed nature of hazard, where and when the incident occurred, who is likely to be affected, size and complexity (UK, overseas), potential for wider implications (e.g. other parts of the food industry) and if food products are affected, their quantities, distribution and availability to consumers.61 Where there has been known distribution of potentially contaminated products, the FSA will contact the
59 FSA, The Food Safety Act 1990: A Guide for Food Businesses 16 (2009 ed., 2009) available at http://www.food.gov.uk/sites/default/files/multimedia/pdfs/fsactguide.pdf (last visited Apr. 29, 2014). 60 Domimique Lauterburg, Food Law: Policy and Ethics 101, (Cavendish Publishing Ltd., 2001). 61 FSA, Principles for Preventing and Responding to Food Incidents: A Guidance Document Produced by The Food Standards Agency’s Taskforce on Incidents at module 3-4, available at http://tna.europarchive.org/20110116113217/http://www.food.gov.uk/multimedia/pdf s/incidentsprinciples.pdf (last visited Apr. 22, 2012). 49 relevant Food Authority to trace this material and report back its findings to the FSA for managing those contaminated products.62
For the greatest effective identification and control of food-borne hazards, the FSA will arrange the issue of food alerts, allergy alerts, and product recall/withdrawal information notices to Food Authorities, other Government departments, etc. It should be noted that food alerts are regarded as the most appropriate way of communicating with the Food Authority officers, especially where action has led to withdrawal or recall of products. Hence, the FSA has to work closely with food authorities and provide advice and information to the food authorities, especially when the incident involves a serious localized food hazard or a non- localized food hazard or; when the Food Authority becomes aware that a food business operator within their area has withdrawn food from the market.63 At that time, food authorities should maintain facilities to receive food alerts and updated from the FSA, including those received outside normal hours. Moreover, food authorities have to ensure that any action issued by the FSA is undertaken promptly.64 According to its multitasking, the FSA also acts as a UK contact point for the Rapid Alert System for Food and Feed (RASFF) and is responsible for issuing RASFF notifications to the Commission.65
3.1.2 Legal Basis for Food Identification and Control under the UK Law
As aforementioned, the FSA works closely with food authorities to assess and manage food incidents, for example initiating food withdrawals or recalls. In assessing food incidents, the key questions may vary according to the class of hazard and the cause of the incident. To carry out their functions, information
62 FSA, Food Standards Agency Incident Response Protocol 6, (Revised 2012) available at http://www.food.gov.uk/sites/default/files/multimedia/pdfs/incident- response-protocol.pdf (last visited Apr. 25, 2012). 63 FSA, supra note 61, at Module 4-3. 64 Id. 65 FSA, supra note 62, at 6. 50 gathering is crucial to identify and trace the source, mode, and extent of the food contamination as well as to identify and implement adequate enforcement actions. Lacking information to trace food may jeopardize the functioning of the market in food.66
3.1.2.1 The Food Authorities’ Official Control Powers under the Food Safety Act 1990
Throughout the UK, the official controls are governed by the Food Safety Act 1990. Unless it concerns with relevant matters of food hygiene and health conditions, the Food Hygiene (England) Regulations 2013 will be active collaboratively. According to the laws, the official controls described below will be comprised of: the power of inspection; the power of entry; food sampling.
(1) The Inspection Powers
According to Article 2 of Regulation 882/2004, “inspection” means the examination of any aspect of food in order to verify that such aspect complies with the legal requirements in food law. Because of its meaning, the inspection becomes a primary tools enabled the Food Authorities to provide the information for instituting adequate corrective actions.
The Right to Enter
During an inspection, the authorized officers have the right to enter any premises unannounced to inspect and/or investigate all matters in relation to food. The word “premises” mentioned prior paragraph is intended to be used in the same meaning as food establishment. Notwithstanding, the definition of “premises” is very broad. Regarding to the Food Safety Act 1990, it includes the obvious buildings
66 EU, Guidance on the Implementation of Articles 11, 12, 14, 17, 18, 19 and 20 of Regulation (EC) N° 178/2002 on General Food law: Conclusions of the Standing Committee on the Food Chain and Animal Health 15 (2004) available at http://ec.europa.eu/food/food/foodlaw/guidance/guidance_rev_7_en.pdf (last visited Jun. 10, 2012). 51 where food is prepared, stored, or sold, such as food processing plants, supermarkets, or restaurants. It also covers farms and vehicles used for transporting or delivering food, ships, aircraft, road-side and market stalls, and also private dwellings if used by food businesses.67
In the regular course of inspection, authorized officers may enter any premises within their authority's area to carry out an inspection and to ensure that food legislation is not contravened. The officers must give at least 24 hours’ notice of their intention for entering any premises used as a private dwelling.68 Differently, for the purpose of entering to investigate any contravention, the officers may enter to premises, even without giving of such notice or at unreasonable time, if it appears that:
an application for admission or the giving of such a notice, would defeat the object of the entry or; the case is one of urgency; the case is one of urgency, or that the premises are unoccupied or the occupier temporarily absent,
The officers can apply to a justice of the peace for a warrant authorizing them to enter the premises.69
The Authority to Inspect
To support an inspection of any food, either section 9 of the Food Safety Act 1990 or section 29 of the Food Hygiene (England) Regulations 2013 designates the power for the authorized officer at all reasonable time to inspect any food intended for human consumption which: has been sold or is offered or exposed for sale; or is in the possession of, or has been deposited with or consigned to, any person for the purpose of sale or of preparation for sale.
67 FSA, supra note 59, at 17. 68 The Food Safety Act 1990, § 32 and the Food Hygiene (England) Regulations 2013, § 16. 69 Id. 52
Apart from inspecting the foods, after entering food processing establishment, an authorized officer may inspect such premises, processing, and any records in relation to a food. Where any such records are kept by means of a computer, he may have access to, and inspect and check the operation of, any computer and any associated apparatus or material which is or has been in use in connection with the records. In certain circumstance, an officer may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford him such assistance as he may reasonably require.70 The ability to access the records is beyond the ordinary power of inspection. The Food Safety Act 1990 and the Food Hygiene Regulations 2013 provides the ability to seize and detain any record if an authorized officer has reason to believe that it may be used as evidence in proceedings against violations of the provisions of the Act or of regulations.71
The power has always come with the obligation. This means authorized officers will commit an offence if they reveal commercially sensitive information acquired in the course of an official visit, unless the disclosure is made in the proper course of their duties.72
(2) Food Sampling
Effective sampling is an essential part of a well-balanced enforcement and compliance of food laws and regulations. When food samples are procured, the authorized officers should follow the procedures under section14 of the Food Hygiene (England) Regulations 2013 or section 29 of the Food Safety Act 1990, and the associated requirements of the Food Safety (Sampling and Qualifications) Regulations 2013.
70 The Food Safety Act 1990, § 32(5) and the Food Hygiene (England) Regulations 2013, § 16 71 The Food Safety Act 1990, § 32(6) and the Food Hygiene (England) Regulations 2013, § 16 72 The Food Safety Act 1990, § 32(7) and the Food Hygiene (England) Regulations 2013, § 16 53
The Food Hygiene Regulations 2013 and the Food Safety Act 1990 allow samples to be procured either by “purchasing” or “taking”. The choice is at the discretion of the authorized officer, having regard to the policy of the Food Authority. Where the quantity or frequency of sampling gives rise to significant financial consequences for the owner of the food, the Food Authority should offer an ex-gratia payment if samples are not purchased. The officer should give the owner a receipt for, or a record of, all samples the officer has taken. If enforcement action is anticipated following microbiological examination or chemical analysis the sampling officer should purchase the sample.73
By virtue of the provision of mentioned laws and regulations, an authorized officer may take sample any food or any such substance that is suspected to be hazardous to consumption if the food or any such substance:
a) appears to him to be intended for sale, or to have been sold, for human consumption; or b) is found by him on or in any premises which he is authorized to enter.
Apart from the food suspected, the officers may take a sample of food environment from any food source, or a sample of any contact material, which is found by them on or in any such premises. They also take a sample of any article or substance properly required as evidence in proceedings under any of the provisions of laws related.
In practice, food sampling in UK has been subdivided, according to whether chemical analysis, microbiological examination or both are carried out.
1) Samples for analysis
73 FSA, Food Law: Practice guidance (England) 101 available at http://www.food.gov.uk/sites/default/files/multimedia/pdfs/practiceguidanceeng.pdf (last visited Jan. 15, 2013). 54
Due to samples for analysis, section 53 of the Food Safety Act 1990 defines “analysis” as including microbiological assay and any technique to determine the composition of food. Similarly, all samples for analysis are taken under the Food Safety Act 1990. The nature and quantity of any sample procured should be such as to allow a satisfactory analysis to be made. The nature of the samples which are appropriate will depend on the purpose for which the analysis is being undertaken. The quantity will vary according to the product and type of analysis to be carried out. In any case of doubt, the public analyst should be consulted. In addition, the authorized officers have to submit all those samples to the public analyst at a laboratory accredited for the purposes of analysis and which appears on the list of official food control laboratories published on the FSA website.74
2) Samples for examination
Different from samples for analysis, samples for examination are taken in accordance with section 14 of the Food Hygiene Regulations 2013. The quantity of any sample procured should be such as to enable a satisfactory examination to be made. The quantity will vary according to circumstances but should normally be at least 100 grams. In any case of doubt, the food examiner should be consulted. After food samples were taken, the officers must submit all samples to the food examiner at a laboratory accredited for the purposes of examination and which appears on the list of official food control laboratories published on the FSA website.75
3.1.2.2 The Food Standards Agency’s Official Control Powers under the Food Standards Act 1999
Since the risk analysis was proposed by the General Food Law in 2002, information gathering and analysis are essential elements of food safety policy, and are particularly important for the identification of potential feed and food hazards. The member states in European are required to develop information
74 Id. at 103-104. 75 Id. at 104-106. 55 gathering systems into a risk-based analysis which will make the best use of available resources. According to the Regulation (EC) No 882/2004, general rules about arrangements for the monitoring and enforcement of feed and food law requirements have been launched to create a more comprehensive, integrated, risk-based, EU wide, farm to fork approach to official controls.76 The competent authorities shall carry out official controls in accordance with documented procedures. These procedures shall contain information and instructions for staff performing official controls. In this case, Member States are required to have legal procedures in place for ensuring that the competent authorities have access to premises of and documentation kept by feed and food business operators so as to be able to accomplish their tasks properly.77 In the UK, food laws and regulations about monitoring and enforcement arrangements were generally already consistent with most of the provisions of Regulation (EC) 882/2004. In support of information gathering and analysis, the Food Standards Act 1999 establishes the FSA and makes provision as to its functions; to amend the law relating to food safety and other interests of consumers in relation to food; to enable provision to be made in relation to the notification of tests for food-borne diseases; to enable provision to be made in relation to animal feeding stuffs; and for connected purposes.
Under the Food Standards Act 1999, the FSA has a self- sufficient of obtaining, compiling, and keeping under review information about matters connected with food safety and other interests of consumers in relation to food.78 This function aims broadly to ensure that the FSA has adequate information to enable it to take informed decisions effectively so that the FSA staffs are provided with the power to carry out observations as well as the power of entry for person carrying out observations stipulated in section 10 and section 11 respectively.
76 FSA, Regulation (EC) No 882/2004 on official controls: guidance in Q&A format for enforcement authorities on the feed and food elements 13 (Feb. 2013), available at http://www.food.gov.uk/sites/default/files/multimedia/pdfs/offcqaguidancenotes.pdf (last visited Jun. 3, 2015). 77 The Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on Official Controls Performed to Ensure the Verification of Compliance with Feed and Food Law, Animal Health and Animal Welfare Rule, Art. 8. 78 The Food Standards Act 1999, § 8 (1999). 56
Regarding to section 10 of the Act, the FSA may carry out observations with a view to obtain information about any aspect of the production or supply of food or food sources. The information that may be sought through such observations includes information, for examples, food premises, food businesses or commercial operations being carried out with respect to food, food sources, or contact materials.
For the purpose of carrying out any observations specified in section 10, the FSA has the power to authorize any individual whether a member of its staff or otherwise to obtain food-related information on behalf of its agency. However, such authorized person can exercise the power to carry out observations strictly through the power enabled in section 11(4) which stipulates that:
“An authorized person may, if it appears to him necessary to do so for the purpose of carrying out the observations specified in his authorization:
a) enter any premises at any reasonable hour; b) take samples of any articles or substances found on any premises; c) take samples from any food source found on any premises; d) inspect and copy any records found on any premises which relate to a business which is the subject of the observations (and, if they are kept in computerized form, require them to be made available in a legible form); e) require any person carrying on such a business to provide him with such facilities, such records or information and such other assistance as he may reasonably request;”
In contrast to the Food Authority that the official controls are governed by the Food Safety Act 1990, the FSA’s functions and powers are mostly contained in the Food Standards Act 1999. Other than the power to carry out observations specified in section 10, any person authorized by the FSA also carries out observations as well. Such individual person may properly refer to the Food 57
Authority. In practical terms, this day-to-day work of enforcements usually is undertaken by the food authority, while the FSA will provide the administrative lead and act as the first point of contact with others organizations.
Regarding to section 11(4) of the Act, the power of entry for person carrying out observations is based on the legal basis for food premise inspection; an authorized person will conduct an inspection practically in the same way as the Food Authorities. However, it is recognized that the ability to access records under the Food Standards Act 1999 is not only inspecting and copying records found on any food premises but also requiring any person to provide facilities, records, or information as he may reasonably request.
To prevent transmission of food-borne outbreaks, the word “records” in section 11(4) shall not be limited to any record in relation to food, in fact, the records also refer to any records which:79
(a) relate to the health of any person who is or has been employed in the business concerned; and (b) were created for the purpose of assessing, or are kept for the purpose of recording, matters affecting his suitability for working in the production or supply of food ,or food sources (including any risks to public health which may arise if he comes into contact with any food or food source).
A person who intentionally obstructs an authorized person exercising powers under section 11(4) or fails without reasonable excuse to comply with any requirement or in purported compliance with such a requirement furnishes information which he knows to be false or misleading in any material particular or recklessly furnishes information which is false or misleading in any material
79 The Food Standards Act 1999, § 11(6) (1999). 58 particular, is guilty of an offence and liable on summary conviction to a fine regarding to the Food Standards Act 1999.80
In addition, unless the disclosure is made in the performance of his duty, if an authorized person who enters any premises discloses to any person any information obtained on the premises with regard to any trade secret, he is guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.81
3.1.2.3 Food Business Operators Responsibility on Mandatory of Record-keeping
The profile of traceability has been raised widely at an EU level since food control system faced the difficulties in tracing where dioxin- contaminated animal feed had been used and the complex interactions and implications within the food chain of such contamination. The European Commission’s White Paper on Food Safety recommended that a successful food policy demands the traceability of feed and food and their ingredients. Adequate procedures to facilitate such traceability must be introduced. These include the obligation for feed and food businesses to ensure that adequate procedures are in place to withdraw food and feed from the market where a risk to the health of the consumer is posed. Operators should also keep records of suppliers of raw materials and ingredients so that the source of a problem can be identified. As a result, the EU General Food Law Regulation (178/2002) contains clear requirements for traceability, stating at Article 18.82
“(1)The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.
80 The Food Standards Act 1999, § 11(8) (1999). 81 The Food Standards Act 1999, § 11(7) (1999). 82 FSA, Traceability in the Food Chain: A preliminary study 11-12 (Mar. 2002), available at http://multimedia.food.gov.uk/multimedia/pdfs/traceabilityinthefoodchain.pdf (last visited Jan. 14, 2013). 59
(2) Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.
(3) Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.”
Article 18 is a general requirement which points out the necessary of gathering information as well as provides a comprehensive system of traceability within food businesses to assist in targeted and accurate withdrawals and to give information to control officials in the event of food safety incidents, thereby avoiding the potential for wider disruption. By this means, traceability requirement laid down in Article 18 is directly applicable in all member states and all areas of food law from 1 January 2005. Although this requirement becomes a general requirement applicable in all member states, liability of food business operators should flow in practice from the rules for civil or criminal liability which can be found in the national legal order of each Member state. The liability proceeding will not be based on Article 18, but on a legal basis to be found in the national legal order and in specific infringed legislation.
In UK, there is a need to introduce new enforcement powers and penalties in relation to the new obligations on food and feed businesses in Articles 18 of Regulation (EC) 178/2002. In doing so, the General Food Regulations 2004 have been launched to create offences and provide enforcement powers in respect of obligations applying from 1 January 2005 under Regulation (EC) 178/2002.83
83 FSA, Guidance Notes for Food Business Operators on Food Safety, Traceability, Product Withdrawal and Recall: A guide to compliance with Articles 14, 16, 18 and 60
By the virtue of the General Food Regulations 2004, traceability requirement applies to any operator throughout UK on trades in food at all stages of the food chain. This includes the activities of farmers, importers, manufacturers, wholesalers, retailers, transporters, distributors, those dealing in the purchase and sale of bulk commodities, caterers, and food brokers.84
Under traceability requirement laid down in Article 18, all those food business operators mentioned above are required to:85
identify their suppliers of food, food-producing animals ,and any other substance intended or expected to be incorporated into food; identify the businesses to which they have supplied products; and produce this information available to the competent authorities on demand.
As part of the information, Article 18 of Regulation (EC) 178/2002 does not include any requirement for records to be kept identifying how batches are split and combined within businesses to create particular products i.e. it does not require complete internal traceability. It will also not be possible to identify the bulking up of ingredients from a number of suppliers or the origin of the components of any batch.86 Because of its reliance on one step back – one step forward approach, the only information Article 18 requires food business operators to provide is the name of businesses who supply them and to whom they supply their products. However, EC law should be interpreted according to its purpose. Therefore, as a minimum, traceability records should include the address of the customer or supplier, nature and quantity of products, and the date of the transaction and delivery.
19 of General Food Law Regulation (EC) 178/2002 at 19 (Jul. 2007), available at http://multimedia.food.gov.uk/multimedia/pdfs/fsa1782002guidance.pdf (last visited Jan. 14, 2013). 84 Id. at 11. 85 Id. 86 FSA, supra note 82, at 12. 61
It is expected that the provision and retention of this type of information are already standard practice in basic accounting. It can also be helpful to record the batch number or durability indication where applicable.87 Additionally, this requirement does not mean that businesses necessarily need a dedicated traceability system. It is the need to produce information that is important, not the format in which it is kept. Article 18 does not foresee a minimum period of time for keeping records. The EC Committee on the food chain and animal health suggest that period of time may be considered on a broad basis which commercial documents are usually registered for taxation controls. 5 years period, where applied from date of manufacturing or delivery to traceability records, would be likely to meet the objective of Article 18.88
According to the General Food Regulations 2004, the FSA, Food Authority and port health authority are the competent officer operating for the purposes of the provisions of Regulation (EC) No. 178/2002.89 Indeed, these three bodies are the competent that can enforce food business operators to deliver all relevant information required by Article 18, and also can execute any food operator who refuses to comply with traceability requirement.90 However, the regulations thereof do not provide any details about the time of reaction for traceability data availability. Besides, Article 18 only provides that information must be made available to the competent authorities on demand. Under this circumstance, the EC Committee suggests that the interpretation should satisfy the objective of identification and control of food hazards which must be fast and accurate. A delay in the delivery of this relevant information would undermine a prompt reaction in case of crisis. The minimal information requested by the Article 18 shall be immediately available to the competent officer mentioned above. These minimal information includes name, address of supplier, and identification of products supplied; name, address of customer, and identification of products delivered; date and, where necessary, time of transaction and delivery; volume, where appropriate, or quantity. Additional information such as batch number which is highly recommended to be
87 FSA, supra note 83, at 11. 88 EU, supra note 66, at 14. 89 The General Food Regulations 2004, § 3 (2004). 90 The General Food Regulations 2004, § 6(3) (2004). 62 kept shall be available as soon as reasonably practicable, within deadlines appropriate to circumstances.91
Any food business operator who contravenes or fails to comply with Article 18 of Regulation (EC) No. 178/2002 shall be guilty of an offence under the General Food Regulations 2004.92 A person guilty of an offence shall be liable, on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both. On summary conviction, a person shall be liable to a fine not exceeding £20,000 or to imprisonment for a term not exceeding six months or to both.93
In addition, this record-keeping requirement can be defined as the general requirement for all food business operators at all stages of the food chain. However, there are more detailed requirements in separate legislation specific to particular food sectors.94 These separate legislation include, for example, mandatory of labelling requirements at the point of sale for fresh and frozen beef under the Regulation (EC) No. 1760/2000; the mandatory cattle identification under the Regulation (EU) No. 653/2014; and the rules relating to consumer information for fish and fish products under the Regulations (EC) 104/2000, 2065/2001, 1224/2009 and 404/2011.
3.2 Legal Measures Supporting Identification and Control of Food-Borne Illnesses in the United States
As global problems, food-borne disease has also been affected on American citizen. According to recent data from the Centers for Disease Control and Prevention, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. This is a significant public health burden that is largely preventable.
91 EU, supra note 66, at 14. 92 The General Food Regulations 2004, § 4 (2004). 93 The General Food Regulations 2004, § 5 (2004). 94 FSA, supra note 83, at 11. 63
Prior to the enactment of the FSMA, the US Food and Drug Administration (USFDA)’s enforcement authority over food products was more limited. This is evidenced by the 2009 Peanut Corporation salmonella outbreak that infected 677 people in 45 states. USFDA could not readily shut down the facility or mandate a recall of products that were suspected to be contaminated and had to rely on Peanut Corporation’s voluntary recalls to remove the salmonella-impacted products. The recall eventually included over two years of processed peanut butter products. Peanut Corporation was filed for bankruptcy during the recalls, hampering USFDA’s efforts to remove the contaminated products from the market. In the aftermath of the 2009 outbreak, USFDA provided testimony to Congress requesting new authority over food products—specifically, the ability to require preventative controls, improved access to records, and increased food registration authority.95
As a result, the USFDA Food Safety Modernization Act (FSMA), signed into law in 2011, enables USFDA to better protect public health by strengthening the food safety system. It enables USFDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. For the first time, USFDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. The law provides mandatory preventive controls for food facilities that require food facilities to implement a written preventive controls plan. Moreover, to ensure compliance with requirements, FSMA provides the USFDA with a new tool for inspection and compliance so that USFDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans. The FSMA also recognizes that USFDA must have the tools to respond effectively when problems emerge despite preventive controls. New authorities include: mandatory recall; expanded administrative detention; suspension of
95 Alston & Bird LLP [Cathy L. Burgess and Guillermo E. Cuevas], FDA invokes FSMA suspension authority – beginning of new era in food safety enforcement actions?, available at http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm388921 .htm (last visited Dec. 12, 2012). 64 registration; enhanced product tracing abilities; additional recordkeeping for High Risk Foods.96
3.2.1 Government Agencies Responsible for Food Control Activities
The US Food and Drug Administration (USFDA) is an agency within the U.S. Department of Health and Human Services (DHHS). It is charged with protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. Most importantly, the USFDA is responsible for the safety and security of most of U.S. nation’s food supply.97 Only meat, poultry, and egg products are exempt from USFDA’s authorities. These types of food fall within the activities of the U.S. Department of Agriculture (USDA) in the part of the Food Safety Inspection Service (FSIS). As a result, USFDA’s agencies do not inspect premises, or that portion of a plant continuous inspection specified under USDA’s Meat Inspection Act, Poultry Inspection Act, or Egg Products Inspection Act. However, there may be certain situations, whether delegated by regulations or by agreement, that the USFDA’s agencies go beyond their normal authorities and crossover the USDA jurisdiction. For example, USDA and USFDA have an agreement in specific areas concerning ingredients or manufacturing processes common to both USDA and USFDA regulated products. The agreement puts the inspection activities on the USFDA. Or, by the provisions of the USDA Acts, USFDA has been delegated detention authorities to control over meat, poultry, and egg products.98
96 USFDA, FSMA Facts: Background on the FDA Food Safety Modernization Act (FSMA) 1-2 (Oct. 7, 2011), available at http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM263773.pdf (last visited Apr. 20, 2013). 97 USFDA, FDA Basics, available at http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm (last visited Jun. 14, 2013). 98 USFDA, The Investigations Operations Manual (IOM) 2014: Chapter 3 Federal and State Cooperation 79-80, available at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123506.pdf (last visited Aug. 21, 2014). 65
As protecting the most of the nation’s supply, USFDA must continue to meet its mission even during emergency situations, under adverse conditions, and/or from alternate locations as needed. In addition to day-to-day activities, USFDA activities may expand to include performance of specific, incident- related functions, such as:99
Conducting inspections and investigations, and assessing damage to USFDA-regulated industry in impacted areas Coordinating the tracing (forward and backward) of the distribution of any potentially contaminated USFDA- regulated products and initiating seizures or recalls, as appropriate Collecting and analyzing product samples Conducting assessments of food retail establishments in impacted areas Issuing safety alerts, health information advisories, warnings, and advice and guidance to consumers and industry Detaining or removing contaminated or unfit merchandise from the market and/or restricting those marketing it
To carry out USFDA’s activities, the district offices in which the event is occurring (e.g., the physical location where people have been affected) will obtain necessary information for USFDA to confirm the health hazard.100 Dependent on the nature and complexity of the agency’s response to an incident, an intra-agency approach may be used to coordinate resources and incident-related information and to support incident management and agency policies. The process of coordination will occur through the USFDA headquarters. Emergency Operations Center (EOC) serves
99 Department of Health and Human Services (DHHS), FDA Emergency Operations Plan 2, available at http://www.fda.gov/downloads/EmergencyPreparedness/EmergencyPreparedness/UC M230973.pdf (last visited Jan. 20, 2013). 100 Id. at 20. 66 as the agency-wide focal point for emergency operations coordination and dissemination of information. The EOC monitors ongoing events, processes complaints and alerts, issues mission assignments to USFDA organizational components, coordinates overall agency emergency management operations, and communicates with interagency partners to provide technical and material support. To put more advanced incident management, Incident Management Group. (IMG) may be typically established when an incident involves multiple USFDA organizational components or involves complex incident management or coordination.101
3.2.2 Legal Basis for Food Identification and Control under the US Law
Because of the passage of the FSMA in 2011, legal basis supporting identification and control of food-borne illnesses has been changed to better protect public health from the event of food-borne disease or outbreaks. This chapter will point out laws and regulations that have been improved in accordance with the FSMA.
3.2.2.1 The USFDA’s Official Control Powers under the Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the basic authority for most of USFDA operations.102 As part of food control activities, the basic authority falls under the statutory provisions of section 702(a) of the FD&C Act [21 USC 372(a)], which authorize examinations, investigations, and samples for the purpose of this Act. The following official control powers are entitled under the FD&C Act to support examination, investigations, and sample activities.
101 Id. at 20-21. 102 The FD&C Act generally specify the authority conferred on the Secretary of DHHS. This authority is delegated by regulations to the Commission of Food and Drugs, and certain authorities are delegated further by him. FDA has delegated enforcement activities at “food retail and food service establishments" to state and local jurisdiction utilizing the food code. 67
(1) The Inspection Powers
For gathering information, the USFDA’s officers may conduct investigation in reliance on search warrant to obtain information related to any aspects intended to be used against the food laws and regulations.103 However, there will be times when the officers are at the manufacturing site or doing work similar to inspections which are conducted to evaluate the methods, facilities and controls used in manufacturing, storage, and distribution of foods.104 In this instance, the officers shall deal with information gathering in the same manner as they conduct establishment inspection designated under section 704 of the FD&C Act [21 U.S.C. 374].
The Authority to Inspect Food Establishment
Under section 704, it authorizes the competent officers to enter and to inspect at reasonable times, within reasonable limits, and in a reasonable manner, establishments or vehicles being used to process, hold, or transport food. The statute does not define, in specific terms, the meaning of "reasonable". USFDA's establishment inspection procedures maintain this authority extends to what is reasonably necessary to achieve the objective of the inspection.105
Apart from the general inspectional authority, inspection shall extend to all records and other information related to the manufacture, processing, packing, distribution, receipt, holding, or importation of the article of food if the criteria for records access are met under section 414(a)(1) or 414(a)(2). Records inspection will be explained thoroughly below.
103 Jonathan W. Emord and Peter A. Arhangelsky, FDA Inspection Guide (For Food and Dietary Supplements) 1 (May 2013), available at http://www.emord.com/Emord%20&%20Associates%20FDA%20Inspection%20Gui de%20-%20May%202013.pdf (last visited Oct. 22, 2013). 104 USFDA, IOM 2014: Chapter 8 Investigations 317, available at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123515.pdf (last visited May 12, 2013). 105USFDA, IOM 2014: Chapter2 Regulatory 40, available at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123504.pdf (last visited May 12, 2013). 68
The Right to Enter
In concurrent use with the authority of inspection, the competent officer, upon presentation of the appropriate credentials and a written notice to the occupier, has the right to enter any food establishment in which food are manufactured, processed, packed, or held for the purpose of sale or of preparation for sale. And if necessary, the officer has the right to enter and inspect any vehicle being used to transport or hold such food.106
Prohibiting the officer from obtaining information in which USFDA is entitled under the law, whether a refusal of entry or a refusal to permit an inspection may invoke a criminal provision of section 301(f) of the FD&C Act [21 U.S.C. 331(f)]. Depending on the individual situation, these instances of refusal may be met by judicious use of inspection warrants. Because seeking an inspection warrant may violate individual’s right in private dwelling, the officer needs to ensure that:107
1) USFDA is entitled by statute or regulation to inspect the facility and to have access to the information which has been refused; and 2) there is a compelling USFDA need for that information, and 3) the occupiers/individuals have refused to allow inspection or access to information in spite of a clear demonstration or explanation of appropriate statutory authority.
The USFDA’s officer does not routinely request inspection warrants in conducting investigations or inspections of food establishment. Warrants have been used effectively to gather information that has been refused improperly.
106 Federal Food, Drug, and Cosmetics Act of 1938 § 704(a) (1) (A), 21 U.S.C. § 374(a) (1) (A) (2010). 107 USFDA, Regulatory Procedure Manual: Chapter 6 Judicial Actions 6-42, available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresMa nual/UCM074317.pdf (last visited Jul. 12, 2013). 69
Moreover, in case of urgency, for example there may be times when there is good reason to believe that required information will be refused and that information will then be destroyed before an inspection warrant can be obtained, there is no exception to entry and inspect the establishment without obtaining such warrants. To solve an inconvenience of this procedure, the USFDA will seek a preemptive inspection warrant prior to conduct investigations.108
(2) Food Sampling
Section 702(a) of the FD&C Act [21 U.S.C. 372 (a)] gives USFDA authority to conduct investigations and collect samples. While inspections and investigations may precede sample collection, a case under the law does not normally begin until a sample has been obtained. Therefore, proper sample collection is the keystone of effective enforcement action.109
Due to samples collecting, the USFDA’s officer is required by the FD&C Act, section 704(c) to issue a receipt describing any samples obtained during the course of an inspection. The receipt is to be given to the owner, operator, or agent in charge, upon completion of the inspection and prior to leaving the premises. Also, if analysis is made of any sample of such food for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, the USFDA is required to furnish a report of analysis to the owner, operator as well regarding to section 704(d) of the FD&C Act.
(3) Record Access Authority
The USFDA can invoke its authority to access and copy records when the statutory requirements in section 414(a)(1) or 414(a)(2) of the Act are satisfied, whether or not intentional adulteration is known or suspected. According to section 414, USFDA may exercise records inspection when:
108 Id. 109 USFDA, IOM 2014: Chapter 4 – Sampling 109, available at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123507.pdf (last visited May 13, 2013). 70
1) USFDA has a reasonable belief that an article of food, and any other article of food that USFDA reasonably believes is likely to be affected in a similar manner: (a) Is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (b) The records are needed to assist USFDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
2) USFDA believes that there is a reasonable probability that use of or exposure to an article of food, and any other article of food that the FDA reasonably believes is likely to be affected in a similar manner:
(a) Will cause serious adverse health consequences or death to humans or animals, and
(b) The records are needed to assist USFDA in determining whether there is a reasonable probability that the use of exposure to the food will cause serious adverse health consequences or death to human or animals.
This record access authority is affirmed, under section 101 of the FMSA, as a new tool to assist USFDA in achieving higher rates of compliance with food safety requirement and to better response to food incidents when they do occur. The law expands USFDA's former records access authority beyond records 71 related to the specific suspect article of food to records related to any other article of food that the USFDA reasonably believes is likely to be affected in a similar manner.110 For example, in case of Salmonella outbreak in which multiple foods are initially implicated as potential sources of the Salmonella, by the virtue of the provision thereof, the USFDA is able to access and copy the records of all those implicated foods. Or in the situation where articles of food are prepared or packed on an identical processing line as another article of food which may cause serious adverse health consequences or death to humans, USFDA access record authority may extend to not only the suspected food, but also the foods shared in the same processing line. As a result, the request to access and copy the record is particularly useful when USFDA becomes aware of food incidents such as food-borne illness, epidemiological evidence which implicates food causing illness or death, adverse event reports, or even product recalls.111
As currently written by the FD&C Act, the USFDA can access and copy all records related to the manufacture, processing, packing, distribution, receipt, holding, or importation of the article of food that are maintained by or on behalf of an entity in any format (including paper and electronic formats) and at any location. Records related to food include manufacturing records, product distribution records, product inventory records, test records, customer distribution lists, complaint, and adverse event records. Apart from those records, the USFDA can also request for the records that are kept by the food operators in accordance with regulation concerning record-keeping as follows:112
110 USFDA, Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act, available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257978.htm#new (last visited Mar. 14, 2014). 111 Id. 112 Robert B. Wallace and Maria Oria, Enhancing Food Safety: the Role of the Food and Drug Administration 298-299 (the National Academies Press 2010), available at https://books.google.co.th/books?id=vyve_oRM3B0C&printsec=frontcover&hl=th&s ource=gbs_ge_summary_r&cad=0#v=onepage&q&f=false (last visited Jun. 2, 2015). 72
The records showing the movement of food in interstate commerce kept by shipper/carriers and by recipients;113 The records kept by shipper/carriers regarding to sanitary transportation practices;114 The records relating to infant formula.115
This authority does not apply to records recipes for food, financial data, pricing data, personnel data, research data (except test marketing a food), or sales data (other than shipment data regarding sales), all of which are excluded under section 414(d).116 Additionally, there will be times that information obtained under the records access authority may include a company's non-public confidential commercial or trade secret information. Therefore, USFDA personnel will comply with all applicable protections, procedures, and legal requirements against the unauthorized disclosure of non-public information such as the Trade Secrets Act, the Freedom of Information Act ,and the agency's information disclosure regulations (21 CFR Parts 20 and 21). 117
Once the criteria for records access are met, written notice must be issued in order to inform food operator or agent in charge about the record requested. Furthermore, the USFDA’s officer may at a later time, request additional records related to the same article of food or other article of food that is likely to be affected in a similar manner, as long as the criteria in section 414(a)(1) and (a)(2)
113 Federal Food, Drug, and Cosmetic Act of 1938 § 703(a), 21 U.S.C. § 373(a) (2010). 114 Federal Food, Drug, and Cosmetic Act of 1938 § 703(b), 21 U.S.C. § 373(b) (2010). 115 Federal Food, Drug, and Cosmetic Act of 1938 § 704(a) (3), 21 U.S.C. § 374(a) (3) (2010). 116 USFDA, Regulatory Procedure Manual: Chapter 10 Other Procedures 10-11, available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresMa nual/UCM074292.pdf (last visited Jul. 12, 2013). 117 USFDA, supra note 110. 73 continued to be met. The request for additional records may be verbal or written as necessary to facilitates access to the records.118
The scope of an USFDA’s authority requesting for the records under section 414(a)(1) or 414(a)(2) applies to food operators who manufacture, process, pack, transport, distribute, receive, hold, or import food excepting farms and restaurants. The food operators mentioned have to ensure that records are readily available for inspection. Moreover, such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the request.119 A person’s refusal to permit USFDA to access and copy any records as required by this section is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)). The term “person” has the same meaning as defined in section 201(e) to include individual, partnership, cooperation, and association.
3.2.2.2 Food Business Operators’ Requirement on Mandatory of Record-keeping
The ability of food facilities to provide information about their sources, recipients, and transporters are essential to ensure the safety of the Nation’s food supply. Especially in the event of food-borne outbreak or incident, USFDA needs to be able to quickly identify the source of a contamination and remove unsafe products from retail shelves. Mandatory of record-keeping below has been proposed to enhance food facilities’ ability in providing relevant information associated with food.
Record-keeping Requirement
In support of inspection purpose, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)
118 USFDA, Investigations Operations Manual 2015: Chapter 5-Establishment Inspection 260 (2015), available at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf (last visited Jun. 2, 2015). 119 21 C.F.R. § 1.361 (2011). 74 direct the Secretary of Health and Human Services to issue regulations that require food business operators to keep the records about food production and distribution. The Bioterrorism Act also suggests that the records kept by these regulations should allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging. This, in turn, will help address credible threats of serious adverse health consequences or death to humans or animals.
Pursuant to the Bioterrorism Act, final regulations that establish requirements regarding the establishment and maintenance of records have been set forth in the Code of Federal Regulation, part 1.326-1.368 (21 CFR Part 1.326-1.368).
Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S. are required to establish and maintain the records regulated under the Code of Federal Regulation. But this regulation does not apply to farms; restaurants; non- profit operations that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing. Retail food operations also are exempted from maintaining records if foods are sold directly to consumers.120
Other than transporters, persons who own food or who hold, manufacture, process, pack, import, receive, or distribute food have to establish and maintain the records that can:121
1) Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including: the name of the firm and the responsible individual;
120 21 C.F.R. § 1.326 and § 1.327 (2011). 121 21 C.F.R. § 1.337 and § 1.345 (2011). 75
type of food, including brand name and specific variety; date received; lot number or other identifiers if available; quantity and type of packaging (e.g., 12 oz. bottles); and the name, address, telephone number of the transporter who brought it. 2) Identify the immediate non-transporter subsequent recipients of all foods released, including: the name of the firm and the responsible individual; type of food, including brand name and specific variety; date released; lot number or other identifiers if available; quantity and type of packaging; and the name, address, telephone number of the transporter who transported the food.
Differently, for transporters, the records for each food transported would have to include the name, address, telephone number of the firm who had the food before; the name, address, telephone number of the firm who had the food immediately after; and the date delivered it. The records also include the type of food, date released, number of packages, description of freight, route of movement during the time the food was transported, and transfer point(s) through which the shipment moved.122
According to the regulation, USFDA is specifying the information a covered entity must keep but not specifying the form in which the records must be maintained. The records may be kept in any format, paper or electronic, provided they contain all the required information. The records are also
122 21 C.F.R. § 1.352 (2011). 76 required to be created when food is received, released, or transported except to the extent the information is contained in existing records. However, the period for which the records must be retained depends on the perishability of the food, but not longer than two years.123
Failure to establish or maintain records as required by section 414 of the FD&C Act is a prohibited act under section 301 of the Act.124 Besides, a civil action or a criminal action may be taken against food operators who failed to establish or maintain records.125
Additional Record-keeping Requirement
Since outbreaks of food-borne illness prompted a number of high-profile food recalls during the past several years, they have raised serious questions about the USFDA’s ability to protect the Nation’s food supply. Traceability has become an important issue in US food management system.
In 2011, the FSMA provides measures to improve traceability within the U.S. supply chain. Because traceability refers to record-keeping process, enhanced record-keeping requirements are defined as strengthened traceability system. As a result, section 204 of the FMSA requires USFDA to designate High- Risk Foods (HRFs) for which additional recordkeeping requirements are appropriate and necessary and to establish recordkeeping requirements for these foods. The additional requirement is designed to enable foods to be more rapidly and effectively tracked and traced during a foodborne illness outbreak or other events.
To do so, the USFDA must define high-risk foods, considering such factors as the known risks of a food based on foodborne illness data, the likelihood that a particular food has a high potential risk for contamination, and the likely severity of an illness attributed to a particular food. After the passage singing of the FMSA into law, USFDA is still working on its mission to designate
123 21 C.F.R. § 1.360 (2011). 124 21 C.F.R. § 1.363 (2011). 125 21 C.F.R. § 1.284 (2011). 77 high-risk foods appropriately. Until February 4, 2014, USFDA’s Draft Methodological Approach to Identifying High-Risk Foods was published in the Federal Register. To create and publish the high-risk food list, FDA considers a comprehensive evaluation of a set of several factors as follows:126
the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC); the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food; the point in the manufacturing process of the food where contamination is most likely to occur; the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination; the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
Primarily, it means that if food operators process or use any of the foods on the high-risk list, they will have to adhere to increased recordkeeping
126 USFDA, FDA’s Draft Approach for Designating High-Risk Foods as Required by § 204 of FSMA Feb. 2014 at 1, available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM380212.pdf (last visited Mar. 14, 2014). 78 requirements (which are yet to be defined) for these foods, to increase tracking and tracing capabilities, to make it easier to rapidly and effectively identify recipients of a food, to prevent or mitigate a foodborne illness outbreak. Moreover, in case where food operator processes or uses both high-risk and non-high-risk foods, the operator will need to either maintain two separate sets of records, or simply follow the high- risk recordkeeping rules for all food products in order to avoid confusion.
After the Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law in 2011, a number of new powers are granted to the USFDA and its officers for ensuring the safety of U.S. food supply chain. For better response contaminations in food, the law renders very useful powers to assist the USFDA’s officer in identifying and controlling the source of food hazards more effectively and faster. Actually, traceability record-keeping requirement and authority to access records provide accurate information of food production and distribution linked across all the stage of food supply chain. In 2014, the multistate outbreak of E. Coli O121 infections was reported by the Centers for Disease Control and Prevention (CDC). A total of 19 persons infected with the outbreak strain of E. coli O121 from six states as follows: California (1), Idaho (3), Michigan (1), Montana (2), Utah (1), and Washington (11). Results from state and local epidemiologic investigations indicate a strong link to eating raw clover sprouts. Once such outbreak related to food was identified, the USFDA performed a traceback analysis which is evaluating and analyzing records to determine whether there is a common source of raw clover sprouts. With the FSMA’s legal reform efforts, this analysis used documents collected directly from the distributors and the grower, Evergreen Fresh Sprouts LLC, as well as documents collected by the states from the points of service. Finally, the USFDA found that Evergreen Sprouts LLC, in the time frame prior to the outbreak, supplied sprouts to seven restaurants at which 9 people who became ill during the outbreak reported eating before they became ill. Eight of the people who became ill recalled eating sprouts.127 Recently, there is another multistate outbreak caused by Salmonella
127 USFDA, FDA Investigates Multistate Outbreak of E. coli O121 Infections Linked to Consumption of Raw Clover Sprouts, available at 79
Paratyphi B variant L(+) tartrate(+) from raw tuna. Based on traceback investigation, the USFDA is now evaluating and analyzing records to determine whether there is a common source of tuna. The FDA then works with its investigational partners to identify clusters of people made ill in separate geographic areas and works to trace the path of food eaten by those made ill back to a common source. This is labor intensive and painstaking work, requiring the collection, review and analysis of hundreds and at times thousands of invoices and shipping documents. Such operation is still on process.128
In conclusion, investigating food hazard is depending on the ability to follow the food throughout supply chain. As appropriate tools rendering all relevant food-related information linked across supply chain, possibly, either mandatory of record-keeping the food’s movement or record access authority may be considered, in particular, to assist the government officer in determining the source of food-borne illnesses. Today, the impacts of food hazard are still a major public health concern. Enhanced food safety laws and regulations are a must to control or eliminate pathogens in domestic and imported food, reduce or prevent contamination of food during growing, harvesting, and processing. These include the improvement of legal basis for identification and control of food hazards, namely, mandatory of record- keeping the food’s movement as well as record access authority.
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm398536.htm (last visited Jun. 25, 2015). 128 USFDA, FDA Investigates Multistate Outbreak of Salmonella Paratyphi B Infections Linked to Frozen Raw Tuna, available at http://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm447742.htm (last visited Jun. 25, 2015). CHAPTER 4 LEGAL FRAMEWORK SUPPORTING IDENTIFICATION AND CONTROL OF FOOD-BORNE ILLNESSES UNDER THE THAI LAW
Similar to both UK and US, food injury to health of the consumers becomes a public concern in Thailand as well. Laws and regulations must provide the competent officers with adequate tools to prevent the food-borne illness and outbreaks in the present day. This chapter will start with the networking of government agencies responsible for food identification and control. Then legal basis under the Food Act B.E. 2522 will be extracted. Finally, the thesis will emphasizes legal problems of identification and control of food-borne illnesses originally under the Act in order to provide the possible approaches to detect and control the source of food hazard effectively.
4.1 Government Agencies Responsible for Food Control Activities
Although various food control activities are undertaken by several organizations in Thailand, the Minister of Public Health and Ministry of Agriculture and Cooperatives are the main organizations that have responsibility to assure the safety of food. Ministry of Agriculture and Cooperatives has played the role in protecting and controlling the safety of food at the farm level, in particularly the foods that are agricultural commodities such as fishery, livestock, or forestry.129 In term of exportation, the Agricultural Standards Act B.E. 2551 has been enacted in support of trading foods and agricultural commodities. The Act provides mechanism on the establishment of standard and inspection and certification on agricultural commodities
129 § 3 of the Agricultural Standards Act B.E. 2551 stipulates that “Agricultural commodity” means produce or a product derived from agriculture, fishery, livestock or forestry and by-product of such produce or product; 81 in order to meet standard for the sake of safety.130 Foods and agricultural commodities exported therefore shall be subjected to this Act as well.
Apart from agricultural commodities, Minister of Public Health has primary duty to ensure safety, quality, and efficacy of most food consumed in Thailand. The Minister thereof is designated to be in charge of the execution of the Food Act B.E.2522, and is empowered to appoint competent officers, promulgate regulations, and set other activities in order to carry out the provisions of this act. The Thai FDA and the Provincial Offices of Public Health are responsible for legal food control operations with the support of food analytical services of the Department of Medical Sciences.131 At the provincial level, Provincial Health Offices (76 Provinces) throughout the country are delegated by the Thai FDA to take responsibility for certain extents according to the Food Act. The Provincial Health Offices are in charge of food control in each provincial boundary. The Provincial Officers will coordinate their policies with the Central Institute, Thai FDA. Hence, their duties and responsibilities are similar to those of the Thai FDA.132
By virtue of Food Act B.E.2522, Thai FDA’s operations involve implementation and enforcement. The operations also include:
controlling the production and importation of food products; reviewing/granting approvals for the registrations of specially controlled foods; inspecting food manufacturing premises and sellers; conducting sampling and quality assessments of food products; taking legal actions, e.g. seizure, product recalls, prosecution.
130 The National Bureau of Agricultural Commodity and Food Standards (ACFS), Guidance to The Agricultural Standards Act B.E. 2551 (2008) available at http://www.acfs.go.th/news/docs/Guidance_agri_2008.pdf (last visited Jul. 24, 2014). 131 Thai Food and Drug Administration (Thai FDA), Food control in Thailand, available at http://www.fda.moph.go.th/eng/food/details/foodControl.stm (last visited Oct. 14, 2014). 132 Id. 82
To control hazardous and deteriorated food, its function includes pre- marketing approval and post-marketing activities. In regard of pre-marketing control, the activities may involve issuance of Manufacturing License and Importation License to manufacturer and importer respectively; registration of controlled food products before marketing; approval of food additives to be used in foods, labeling and advertising approvals. The objective of post-marketing control is to ensure that foods distributed to consumers are wholesome and have quality that complies with the national food standard. As a result, this measure deals primarily with the activities of enforcement. Inspection of all food factories and premises throughout the country is conducted regularly, together with sampling of food products for analysis and assaying to ensure compliance with legal requirements. In case of violations, actions like seizure, recall, and prosecution will be executed.133
For incidence of infection with pathogens transmitted commonly through food, Thai FDA will work together with the Bureau of Epidemiology. The investigations that concern with the distribution of food-borne disease particularly in human populations will be undertaken by National Trustworthy and Competent Authority in Epidemiological Surveillance and Investigation. Otherwise, Thai FDA is responsible for investigating any aspect of foods as well as food establishment and storage. As part of Thai FDA’s responsibility, Food Alert System of Thailand (FAST) has been put in place to provide Thai FDA officers with an effective tool to exchange information about measures taken responding to serious risks detected in relation to food.134 This exchange of information helps Thai FDA act more rapidly and in a coordinated manner in response to a health threat caused by food. Its core function will practically be based on risk analysis. Risk communication assists the Thai FDA officers in exchanging information during the occurrence of incident. All collected information also will be used for risk management for promptly taking action to prevent, control, or eliminate the potential incidents which can create adulteration of food with public health threats.
133 Id. 134 For a more effective Thailand’s food safety control system, the establishment of FAST was suggested under the cooperation of the EU-Thailand economic cooperation small projects facilities. 83
4.2 Legal Basis for Food Identification and Control under the Food Ac B.E. 2522
The officer's ability to access food-related information through the food supply is crucial to the success of food control system. This part will explain laws and regulations that support function of collecting information associated with food productions in Thailand.
4.2.1 Thai FDA’s Official Control Powers
This part of the thesis will explore the official control powers laid down on the Food Act B.E. 2522.
4.2.1.1 The Inspection Powers
The objective of food premise inspection generally aims to make sure that the food is safe enough for consumption. However, the inspection becomes even more important when food does represent potential risk to people’s health. In legislation, the inspection is recognized as a legal basis for the Thai FDA’s officer in identifying the sources of food contaminations. Under of the Food Act B.E. 2522, legal basis for food inspection is laid under section 43 which states that:
“In the performance of their duties, competent officer shall have the following powers:
1) to enter a place of production, storage area, place of sale or office of the producer, storekeeper, distributor, including the importer office for inspection in connection with enforcement of this act during normal working hours;
2) where it is suspected that there is a violation of this Act, the competent officers shall have the power to enter a place or vehicle to inspect the food and seize or attach the food or utensils connected with 84
the violation including the containers and packages of food and documents connected with the food;…”
Basically, the competent officer shall have power to enter a place of production including storage area, place of sale or office of the producer, storekeeper, distributor, including the importer office to carry out an inspection for ensuring regulatory compliance or gathering necessary evidence to sustain legal action against food operator. The Thai FDA’s officer can revoke the authority to inspect food premise only if statutory requirement described in section 43(1) or section 43(2) is satisfied.
In the regular course of inspection, section 43(1) allows the Thai FDA’s officers to enter and inspect food premises for the purpose of ascertaining the compliance with food requirements regulated by the Act. To serve its objective, inspection should be conducted at a reasonable time. A reasonable time, in this instance, refers specifically to normal working hours.
Differently, section 43(2) allows the officer to enter to food premises for gathering all the evidences against violations of the provisions of the Act. The violations include failure to comply with food safety requirement regarding to section 25 of the Act that requires food operators not to produce food that are impure; adulterated; substandard; or other condition which is specified by the minister. Legal actions may be taken against that food operator who contravenes food safety requirements. In gathering evidences for the legal action alleged, section 43(2) of the Food Act B.E. 2522 states that:
“where it is suspected that there is a violation of this Act, the competent officers shall have the power to enter a place or vehicle to inspect the food and seize or attach the food or utensils connected with the violation including the containers and packages of food and documents connected with the food”
Due to occurrence of food-borne diseases, food may properly contravene section 25 of the Act in the point that foods were impure, adulterated, or substandard. The officers, thus, have ability to enter and inspect food premise 85 suspected to be the source, mode, and extent of food contamination by using the authority provided in section 43(2) straightly. It should be noted that the entry and inspection of food premise under 43(2) are carried out to ascertain whether there is, on the premises, any evidence of any contravention. The officers have the right to enter and to inspect not only food premise, but also vehicle used in food processing. Moving on to more advanced powers, section 43(2) provides the officers with the authority to seize or attach the food or utensils connected with the violation including the containers and packages of food and documents connected with the food.
Whoever obstructs or does not give facility to competent officers to carry out their duties of inspection shall be liable to imprisonment or a fine specified in section 52 of the Act. Notably that any aspects of food that may be seized or attached by section 43(2), have been used for the purpose of inspection. Therefore, the use of seizure or detention has not been regarded as measures to condemn food operators in violating the Act.
One must beware of possible confusion between inspection and the power of search. An inspection practically concerns with multiple actions based on observation such as noticing, perceiving, or watching. The officers have no ability to discover any evidence in relation to food by themselves; food operator, instead, will give appropriate facility as the officer’s request. In contrast, the power of search aims to discover any evidence used for legal actions so that investigation and examination can be conducted directly by the officers.135 In case where an inspection food premise is impractical, the officers can employ those inspection activities
135 สุวิมล สายสุวรรณ, ความรู้เกี่ยวกับการสืบสวนประมวลหลักฐานทางด้านกฎหมายอาหารและยา: ตอนที่3บทบาทพนักงานเจ้าหน้าที่ตามกฎหมาย อย., (กรุงเทพฯ: กลุ่มนิติการ, 2538), น. 3. (Suvimon Saisuwan, The Introduction to Regulatory Inspection Procedure toward Food and Drugs: Chapter 3; Role of Competent Officers 3 (Legal FDA’s legal Officers, 1995).) 86 through administrative or police official in reliance on search warrants.136 The following examples are the situation that an inspection is impractical:
The officer reasonably believes that an inspection should progress into private dwelling/area; In case in one of urgency, for example, required information will be destroyed or removed before an inspection warrant can be obtained; Entering or inspecting has been refused improperly.
Search warrants, in Thailand, are subjected to Criminal Procedure Code under section 59 which stipulates that a search for a person or article in a private place may only be conducted upon a judicial order or warrant thereof.
4.2.1.2 Food Sampling
Food sampling is a process used to assess the safety and quality of food. According to its process, the Thai FDA’s officers undertake the former step of food sampling. It involves selection of a portion from the whole, which is then submitted to a laboratory for analysis. In Thailand, food analysis is undertaken by the Department of Medical Sciences for official food law enforcement or control purposes.
Section 43(3) of the Food Act B.E. 2522 contains the basic legal provisions related to the sampling of foods. It allows the officers to take reasonable quantity of food for inspection and analysis. To carry out food sampling, the Thai FDA must ensure that the sample represents the food as sold to the consumer. Where divided, all parts of the sample must individually be representative of the food and of each other. Besides, the sampling process must not alter the sample
136 สมใจ สุตันดี, การปรับกลยุทธ์การตรวจสอบและท าหลักฐานตามพระราชบัญญัติอาหารให้มี ประสิทธิภาพ, (กรุงเทพฯ: กองสารวัตร, ส านักงานคณะกรรมการอาหารและยา, 2544), น. 31. (Somjai Suthumdee, Improving Strategies for an Effective Inspection under the Food Act 31 (FDA, 2001).) 87 in any way that might affect the analysis. Likewise, storage and transportation of the sample must not alter it in any significant way, whether through contamination, loss, deterioration, or other means.137
4.2.1.3 Record Access Authority
The ability to access the records is not specified clearly. As such, the interpretation of existing legal basis in support of investigations should be taken into account. Considering the Food Act B.E. 2522, legal basis in support of Thai FDA’s operations to investigate food hazards is subjected to inspection powers as amended on section 43.
According to section 43(2), the Thai FDA’s officers have the power to enter and inspect food premises in case where they are suspected that there is a violation of the Food Act B.E. 2522. This section enables extended powers to seize or attach any aspects of foods including documents connected with the food. Based on its objective, the powers to seize or attach under section 43(2) can be invoked specifically for gathering information or finding records on food premises, and used such information and records as evidence in proceeding against the violations of the provisions of the Act. By this means, the information or records that can be seized or attached must be found during an inspection and such information or records are necessary enough to support the violation alleged. When compared to the objective of record access authority, the need of information is to identify the common source of food safety problem and control it properly. The information is about the details of food production and distribution, for examples manufacturing records, raw materials records, receipt records, product distribution records, product inventory records, and test records. All information and records are outside the intention of the power to seize or attach under section 43(2) in the point that they are not used as evidence in proceeding against the violations of the provisions of the Act, but used as accurate information to help the officer in identifying a common source of food safety problem properly. By the virtue of this subsection, the officers may attach
137 Id. at 18. 88 the records to use as an evidence for taking legal actions; however, the officers are not allowed to compel food operators to provide him with the relevant information associated with food production and its distribution. In the other words, this power cannot be implied to encompass the ability to access information and records in connection with the food.
4.2.2 Food Business Operators’ Requirement on Mandatory of Record-keeping
Today, the Food Act B.E. 2522 does not provide a direct support to impose food business operator’s responsibility that involves documenting the production and distribution chain of products. Most all of information about production and distribution will be obtained from food registration and manufacturing license, as well as record retention specified by Thai GMP law.
Registration and licensing
The application of Food Manufacturing License or Food Production License regarding to section14 of the Act will provide the officer with preliminary food-related information. In case of those licenses, applicant who intends to establish a food plant shall submit petition together with the information as follow:138
Name and type of food; Name and address of food operator; Equipment list used to produce food; Location map indicating plant layout of the production building; and Other related Registrations such as domestic registration, company registration, trade or commercial registration.
138 The applications form of food manufacturing license (Form Orr.1), the application form of food production license which premise is not recognized as factory (Form Sor Bor.1) 89
Notably, section 14 requires only food operator whose premise is recognized as factory to obtain a manufacturing license. Other than those registered operators, the operators are allowed to manufacture food for sale without the permission of Thai FDA.
Apart from the license, the officer can have access to the following information due to food registration as well. According to section 31 of the Act, any person who produces food in Thailand must consider about food registration. The Food Act classifies food into 3 main categories which are Specially Controlled Foods; Standardized Foods; and Other Foods. Specially controlled foods are the most strictly controlled based on the assumption that they can pose significant risk to consumer’s health. Whoever intends to produce specially controlled foods for sale, he must be subjected to food registration. The application for food registration must include the information, as follows:139
name of food; name and quantity of the ingredients in the food; size of packing; label; name of producer and place of production; result of analysis of the food by government laboratory or institutions specified by the Commission; and other materials in connection with the food recipes.
Thai GMP Laws
Another existing record-keeping process is spotted by the provision of the Act but it seems to be brought for the purpose of assuring food quality standard. By the virtue of section 5 and 6 (7) of the Food Act B.E. 2522, GMP has been adopted into Thai food laws as an appropriate food quality assurance measures for Thailand. The first General GMP has come into force by the Ministry Notification No. 193, B.E. 2543. It put an obligation on particular operators who manufacture and
139 The Food Act B.E. 2522, § 35. 90 store food that is described specifically under the notification. According to its principle, food operators are required to conduct their production processes, production equipment, and food storages in accordance with Thai GMP law. As part of record-keeping process, the information should be kept at least the following:
a) Products analysis reports. b) Types and quantities of production and production date
These types of information are the minimum requirement that compel food operators described in the Ministry Notification to keep the record and make it available, upon the request, to the Thai FDA’s officers. Apart from the General GMP, Specific GMP, stipulated in separate notification, may contain extra information concerning the production of food. For example, in case of the drinking water in sealed container, Notification of the Ministry of Public Health No. 220, B.E. 2544, obligates duty on food operators to record the conditions of equipment used in such production other than products analysis reports types and quantities of production and production date.140
Although the effect of this Thai GMP laws provide the record- keeping obligation on food business operator, the food-related information kept may not be particularly useful to a new preventive approach as hope. Due to different purposes of record retention, information, and records under Thai GMP laws are provided merely to review the compliance of food quality standard. The information cannot identify from whom and to whom a food has been supplied.
In recent years, because the Thai FDA recognizes the need for enhancing quality control of all processed foods in their jurisdiction, the Primary GMP has been introduced to Thai food law. Yet the record retention seems to be less important for this type of GMP. The food operators’ obligation on record retention actually has been excluded indeed so that food operators subjected to Primary GMP are not obligated to keep information or records regarding to Notification from the Ministry of Public Health No. 342, B.E. 2555.
140 The notification of Minister of Public Health (No. 220), B.E. 2544 91
Food labelling regulations
Although the Act does not provide a direct support to impose record-keeping process, food labelling regulations are in effect today for not only the consumers, but also for the officer in detecting and controlling the source of food hazards. Under section 5 and section 6(10) of the Food Act, the Notification of the Ministry of Public Health No. 194, B.E. 2543 has been launched in order to require food operators to have labels on foods produced in Thailand, which include all categories, namely, Specially Controlled Foods; Standardized Foods; and Other Foods. However, the level of restriction may vary depending on food categories. According to Notification No. 194, label must be expressed of the following information:
Name of food; Food serial number; Names and addresses of producers or re-packers of food which is produced within the country, names and addresses of importers and country of producers as the case may be; Food quantities expressed in the metric system; Main ingredients; Date, month, and year of manufacture and year of expiry for consumption; and Declaration of the specific words for any usage such as “Utilizing preservatives”, “Natural color” or “Artificial color”, “Natural flavor.”
As mentioned above that the level of restriction may vary depending on food categories, some of food products do not express all of information prescribed in the Notification.141 For example, Pre-packed processed foods, such as unprocessed meat from pork, poultry, or food crops, if these foods intend to sale to food manufacturers or food distributors but not to consumer, label must be expressed only
141 Notification of the Ministry of Public Health(No. 194) B.E. 2543 (2000), Clause 4 92 information about name of food; food serial number (if any); names and addresses of producers or re-packers of food which is produced within the country, names and addresses of importers and country of producers as the case may be; food quantities.142
4.3 The Problems of Identification and Control of Food-Borne Illnesses under the Food Act B.E. 2522
The Food Act B.E. 2522 has been used as the primary tool in support of the Thai FDA’s operations for almost 35 years after the Act was passed. Without any improvement, the old concept of food inspection and control is far from enough to ensure food safety. Actually, this drawback food law lacks appropriate tool for identification and control of food-borne illnesses which are among the most widespread public health problems.
4.3.1 Inappropriate Control Powers to Access Food-related Information
Owing the fact that food hazards posting the biggest threat today are microbiological or chemical contaminations, when combined with longer and more complex of the food chain, the rapid movement of food contamination can have widespread throughout the entire the stages of food production. Sometimes food may be contaminated before the food or ingredient arrived at food premise while some other times, the contaminations may have occurred at food premise. Appropriate tools to identify the source of the food contamination are required as a last resort for government agencies in order to reduce potentially serious consequences of food
142 ส านักงานคณะกรรมการอาหารและยา, ส านักอาหาร, คู่มือการขออนุญาตอาหารแปรรูปที่บรรจุใน ภาชนะพร้อมจ าหน่ายตามหลักเกณฑ์วิธีการที่ดีในการผลิตอาหาร (Primary GMP) (ส านักอาหาร, 2555), น. 23, available at http://iodinethailand.fda.moph.go.th/Primary_GMP/file/total_manual_primary_GMP. pdf (last visited June 6, 2015). (Thai FDA, Bureau of Food, Manual for an Application of Primary GMP in Pre-packaged Processed Foods 23 (Bureau of Food, 2012).) 93 hazards. Under the Food Act B.E. 2522, the Thai FDA has responsibility to ensure that contamination of food with pathogens leading to food-borne diseases is minimized in every process involved in food supply chain. Yet, only a small proportion of the control powers, upon the Food Act B.E. 2522, have been provided to find the source of the contamination in food. As for today, the Thai FDA’s competent officers are performing their duties to investigate food hazards in reliance on inspectional authority under section 43 of the Act. By means of this section, it intends to be used for physically checking all the area of food premise so that the authorities herewith are largely comprised of basic elements, namely the right to entry, the authority to inspect, and the authority to take sample. However, the Thai FDA’s competent officers too often find difficulty tracing suspected food backwards through its distribution and product channels to its place of origin. Especially in case of diarrheal diseases, food-borne pathogens, such as Shigella spp., Salmonella spp., and Escherichia coli., which are found in raw meat products, can link to all stages of the food supply chain. Therefore, investigating those food hazards is beyond physically checking all the area of food premise and food products.
Because detecting and controlling the source of the food safety problems largely depend upon whether they can follow a food product’s movement through food supply chain, appropriate tool to access all relevant information associated with food production should be implemented for the Thai FDA’s officers to identify and to reduce potentially serious consequences of food-borne illness in a timely manner. In this case, enough information should be available for the competent officer in order to trace back food distribution until the source of the food contamination is identified. The relevant information includes, but not limited to, manufacturing records, raw materials (ingredients and packaging), receipt records, product distribution records, product inventory records, test records, recall records, reportable food records, complaint and adverse event records or customer distribution lists.
Unfortunately, the Food Act B.E. 2522 does not exactly provide legal basis of how to acquire food-related information which mostly exists in the possession of food business operators. Nowadays, acquiring such information is 94 relying on official control powers under section 43(2) of the Act. According to this subsection, the competent officers have the power to inspect records or documents connected with the food. And if such record or document found can be used as evidence in proceeding against the violations of the provisions of the Act, the officer also has the power to seize or attach such record or document. However, it should be noted that the power to seize or attach documents connected with the food regarding to section 43(2) can be invoked merely for gathering documents that is found on food premises. It is not applicable when the information is required to identify and to reduce potentially serious consequences of food-borne illness, but such information cannot be found during performing an inspection, or such information is needed outside the time of inspection.
Because section 43(2) does not enable the officer with appropriate power to access any information kept by food business operators, the Thai FDA may not have enough information about food product and food distribution to identify and control food-borne hazards effectively. In the context of food incidents and outbreaks, this drawback authority becomes even worse. Due to a more complex system of food chain, the food chain extends from farm through the various stages that may include transportation, selection and packing, slaughter and dressing, processing for transformation into new, value-added products, distribution and retail, all the way to the home of the consumer. Opportunities for contamination of food throughout this chain are multiple. A mere traditional inspection approach which is carried out to identify regulatory violations in section 43(2) is impractical to cope with the complex, persistent pervasive and evolving areas of food safety issues exiting day. Instead of providing appropriate power to have access to the records or information kept by food operators, the Act contrarily does not allow the officer to request any information from food business operators when it is outside the time of inspection. If that so, once the food incident or outbreak occurred, the officer must enter and inspect food premise in every time when information is needed to magnitude the problems. With this inappropriate record access power, identification and control of food hazards would be time and resource consuming, especially in food-borne outbreak that requires large number of competent authorities in order to carry out their incident 95 investigation. As compared to rapidly increasing number of food operators, serious consequences of food-borne outbreaks cannot be identified and controlled in the timely manner.
Moreover, this traditional food inspection approach is also inadequate to serve the purpose of a new approach launched by the Thai FDA itself. Based on the principle of risk analysis, Food Alert System of Thailand (FAST) has been established under EU-Thailand Economic Co-operation Small Project Facility. It provides an effective information exchange among relevant agencies under the Ministry of Public Health. At the same time, it renders the best option to investigate and control food hazards in the timely manner. Information gathering and analysis, therefore, are essential elements of this food safety policy, and are particularly important for the identification of potential food hazards. As a result, inappropriate record access authority under section 43 may obstruct a process of risk analysis that systematically collects, analyzes, and evaluates information about a chemical, biological, or physical hazard possibly associated with food. Food hazards may not be identified and controlled appropriately. In the end, food alert may be issued to consumer ineffectively or was never issued at all.
Not only used for contributing a strong food control system in Thailand, the principle of risk analysis has been used to strengthen the ability of traditional food control system worldwide. The risk analysis framework offers a tool that national food safety authorities can use to make significant gains in food safety. Risk analysis encompasses three major components: risk assessment, risk management, and risk communication. Risk analysis provides a systematic approach to estimate the risks, in order to identify and implement appropriate measures to control the risks, and to communicate information about the risks and the control measures applied.
Since the General Food Law was released in 2002, risk analysis must form the foundation on which food safety policy is based. The UK’s regulatory is required to develop information gathering systems into a risk-based analysis which will make the best use of available resources. At the same time, the competent 96 authorities must also carry out official controls in accordance with documented procedures to create a more comprehensive risk-based approach. To do so, UK’s regulatory shall have legal procedures in place in order to ensure that the competent authorities have access to premises of and documentation kept by feed and food business operators so as to be able to accomplish their tasks properly. In support of information gathering and analysis, the Food Standards Act 1999 establishes the Food Standards Agency (FSA) with an appropriate function to gather and analyze information in relation to food for the identification of potential feed and food hazards. Under the Act, the FSA staffs are provided with the power to carry out observations as well as the power of entry for person carrying out observations stipulated in section 10 and section 11. Regarding to section 10 of the Act, the FSA may carry out observations with a view to obtain information about any aspect of the production or supply of food or food sources. Moreover, any person authorized by the FSA can exercise the power to carry out observations through the powers enabled in section 11(4). These powers not only include legal basis for an inspection, but also record access authority which the FSA has the right to require any person carrying on such a business to provide him with such facilities, such records or information and such other assistance as he may reasonably request. Differently, this enhanced power has not been provided to the Food Authorities who conduct an inspection based on the day-to-day work of regulatory enforcement under the Food Safety Act 1990. Based on traditional inspection approach, Food Authority may inspect and seize the record found on food premise if he has reason to believe that such record can be used as evidence in proceedings against violations of the provisions of the Act or of regulations. Food Authorities are not able to require any person carrying on such a business to provide him with such facilities, such records or information and such other assistance as he may reasonably request. However, it should be noted that there is no necessary authority provided for the Food Authorities. Even though they cannot exercise such enhanced authority directly through the Food Safety Act 1990, but as person authorized by the FSA, they can exercise record access authority through section 11(4) of the Food Standards Act 1999 instead. 97
In US, the Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, enables USFDA to better protect public health by helping to ensure the safety and security of the food supply chain. It enables USFDA to focus more preventing food safety problems rather than relying on reacting to problems after they occur. The law also provides USFDA with new enforcement authorities to help achieve higher rates of compliance with prevention and risk-based food safety standards. According to section 101 of the FSMA, the law expands USFDA’s access to records beyond records related to the specific suspect article of food to records related to any other article of food that the USFDA reasonably believes is likely to be affected in a similar manner. As currently written by the FD&C Act, upon the USFDA’s request, any records and other information must be made readily available for an inspection as soon as possible if:
(1) USFDA has a reasonable belief that an article of food, and any other article of food that USFDA reasonably believes is likely to be affected in a similar manner: a. Is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and b. The records are needed to assist USFDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. (2) USFDA believes that there is a reasonable probability that use of or exposure to an article of food, and any other article of food that the FDA reasonably believes is likely to be affected in a similar manner: a. Will cause serious adverse health consequences or death to humans or animals, and b. The records are needed to assist USFDA in determining whether there is a reasonable probability that the use of exposure to the food 98
will cause serious adverse health consequences or death to human or animals.
After considering the above laws, to facilitate preventive approaches based on risk analysis as well as to better detect and control food hazards, the author believes that the power to access food-related information regulated by section 43 of the Food Act B.E. 2522 should be clearer and have a comprehensive coverage in most areas of the Thai FDA’s operations. On carrying out an inspection, section 43(2) may be implied to encompass the ability to inspect and seize documents connected with the food. However, like in the UK’s Food Standard Act 1999 and the US’s FD& C Act, the Thai FDA’s officer should also be enabled, with specific power including the power to request information or other assistance in relation to food from food business operators. With this enhanced power, the competent officer will access to food-related information, even when the information has not been found in the normal inspection time or even acquiring information is outside the course of inspection.
The idea of expanding official control power for accessing records or information in relation to food has been affirmed by the new draft Food Act B.E. 2554 already. According to section 46(6) of this draft Act, the officers have the power to summon any person operating the business in relation to food for a testimony or submission of evidences or relevant information as he may reasonably request. However, the draft thereof has not yet specified relevant matters concerning how to prevent the officers from abusing their authority, or how to deal with food operator who refuses to comply with the officer’s request. These relevant matters will be explicated below.
4.3.1.1 Preventing the Abuse of Power
In general, any broad power can be abused by the officer. The use of record access authority under the US’s FD&C Act, therefore, is applied limitedly to particular circumstances regulated in section 414(a) and (b) which concerns about food adulteration and the widespread use of such adulterated food. 99
According to section 414, the USFDA’s officers cannot access records regarding to this section unless “there is a reasonable probability that such adulterated food or the widespread use of such adulterated food presents a threat of serious adverse health consequences or death to humans or animals and the records are needed to assist USFDA in determining the source of the problem.” Comparing with the USFDA’s record access authority under section 414 of the FD&C Act, the FSA is enabled with a broad power. According to section 11 of the UK’s Food Standard Act 1999, the competent officers are authorized broadly that they have the power to require any person carrying on food business to provide them with facilities, such record or information and such other assistance as they may reasonably request. Based on discretionary powers, the UK’s Food Standard Act does not impose an obligation on the FSA and its staffs to exercise such power in a particular manner, but appropriately in accordance to legal requirements. Even though FSA’s power is much more flexible, in turn, it can lead to the abuse of officer’s power either. Without specific criteria, there are possibilities that the power to request records may be used unfairly or improperly, for examples, in the case of unnecessary requesting of records or information from food operators or improper request for confidential business information. Under these circumstances, the abuse of power might cause severe damage to food business operators.
Identically, the power for accessing records or information in relation to food regarding to section 46(6) of the draft Food Act is also based on discretionary powers which are quite broad and may cause unnecessary disadvantage to food business operators. Other than imposing the power to request information held by food operators, the criteria for accessing records, therefore, should be considered in order to avoid the improper use of power. In the other words, the scope of this power should be proportionate to protect the public health safety, and does not affect the food operators too much. Actually, this power should be suitable, necessary, and reasonable enough to support the purpose of identification and control of food hazards. Hence, similar to the US FD&C Act, section 46(6) of the draft Food Act may allow the Thai FDA’s officer to exercise the power to summon any person operating 100 the business in relation to food for a testimony or submission of evidences or relevant information particularly when:
1. “there is a reasonable probability that any article of food presents a threat of serious adverse health consequences or death to humans; and 2. the records are needed to assist the competent officer in determining the source of the problem.”
Because the circumstances of each particular event vary, the scope of an officer request for record may vary in each situation as well. The officer may request any records that help identify and control potential hazards in food. However, the records which need to assist the competent officer in determining the source of the problem may not extend to recipe, financial data, pricing data research data, and sales data other than shipment data regarding sales.
Once the criteria are met, the power to summon food operators for a testimony or submission of relevant information must be conducted with written letter to inform food operators or agent in charge about the information requested. As the evidence against the officer, this written letter will also protect food operators from unnecessary or improper request of information abused by the officer.143 The written letter, thus, must give details of the name of food operators, the name of food premise, and, most importantly, the time limits which must be realistic, justifiable, and having regard to the extent and complexity of the request required. Moreover, it must be clear exactly what the recipient is required to do and why to be easily understood.
In case where the officer exercises their power without probable cause to access the records or information, the food operator who is injured
143 ประภาพร ขอไพบูลย์ และคณะ, โครงการศึกษาและยกร่างกฎหมายอาหารตามมาตรฐานสากล 165 (ส านักงานกองทุนสนับสนุนงานวิจัย, 2550). (Prapaporn Khopaibool ET AL., Project for the Review and Drafting of Food Act in Accordance to Universal Standards 165 (The Thailand Research Fund, 2007).) 101 by the wrongful act of the officer has the right to claim for compensation from the officer and its government agency, the Thai FDA.144 The injured operator may claim for compensation through the Administrative Court in order that the Thai FDA shall compensate him as required by section 5 of the Act on Liability for Wrongful Act of Officials, B.E. 2539. Instead of filing a lawsuit, the operator may choose to submit a petition for the damage which he received directly to the Thai FDA as well, regarding to section 11 of the Act. In this case, if the food operator is still not satisfied with the result of decision of the Thai FDA, an operator shall has the right to submit his petition within 90 days as from the date of receipt of the result of the decision to the Petition Committee, under the Council of State Act.
4.3.1.2 Protection of Sensitive Information
When suggesting an option to enhance the power to access the records, the confidentiality of any protected information in such records should be considered to balance between the protection of food operators’ privacy right and public health safety.
In UK, Food Authority who reveals commercially sensitive information acquired in the course of inspection will commit an offence specified in section 32(7) of the Food Safety Act 1990. While the FSA staff will be guilty of an offence and liable on summary to a fine if he discloses to any person any information with regard to any trade secret. In order to avoid an unauthorized disclosure of information, the USFDA’s officers must to comply with all applicable protections, procedures, and legal requirements such as the Trade Secret Act, the Freedom of Information Act and the agency’s information disclosure regulations under 21 CFR Part 20 and 21.
144 The Act on Liability for Wrongful Act of Officials B.E. 2539, § 5 “The State agency shall be liable for the result of the wrongful act of its official in the performance of duties to the aggrieved or injured individual. In this case, the aggrieved or injured individual may directly sue such a State agency but cannot sue the official. If a wrongful act is caused by an official who does not belong to any State agency, it shall be deemed that the Ministry of Finance shall be held the liable agency under paragraph one.” 102
Food-related information acquired from food operators sometimes may harm the food operators’ business itself; so that the Act shall take appropriate measure to ensure that it is in effective procedure to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the competent officer operating. Under the Food Act B.E. 2522, there shall be provisions to indicate the competent officers’ liability for disclosing information acquired from food business operators.
Apart from the provision lied under the Food Act B.E. 2522, the Thai FDA’s officers should note that there is another specific regulation governing the protection of sensitive information. Under the Trade Secret Act B.E 2545, the food operator has the ownership rights to their trade secret information.145 The act of disclosure, deprivation or usage of trade secrets without the consent of the food operator can be regarded as infringement.146 Even though, within the purpose of this thesis, the Thai FDA’s officers are allowed by the Food Act B.E. 2522 to have access to food operators’ records or information, it does not constitute an exception for the officer to infringe the food operators’ rights confirmed by the Trade Secret Act. Thus, the officers have to take reasonable steps to ensure that trade secret information will not be disclosed or being used in unfair trading activities.147 Otherwise, the food operator who is affected or imminently to be affected by the infringement of trade secrets may file an action in the court for a permanent injunction, permanently to stop the infringement of trade secrets and claim damages from the officer.148
4.3.1.3 Liability for Non-Compliance
The absence of the liability of food operator who refuses to comply with the officer’s request for a testimony or submission of evidences or
145 The Trade Secret Act B.E 2545, § 3. Under this Act: “Trade Secrets” means trade information not yet publicly known or not yet accessible by persons who are normally connected with the information. The commercial values of which derive from its secrecy and that the controller of the trade secrets has taken appropriate measures to maintain the secrecy. 146 The Trade Secret Act B.E 2545, § 6. 147 The Trade Secret Act B.E 2545, § 6. 148 The Trade Secret Act B.E 2545, § 8. 103 relevant information can create bad incentives. As known that food operators normally hold all relevant information about food production and its distribution, they may furnish information intentionally in order to avoid their liability, if they know that they could be criminally or civilly liable based on such records or documents.
In response, the UK’s Food Standards Act 1999 stipulates food operator liability for any person who intentionally obstructs an authorized person exercising power thereof. The liability includes the situation when the food operator fails without reasonable excuse to comply with the officer’s request or furnishes information which he knows to be false or misleading in any material particular or recklessly furnishes information which is false or misleading in any material particular. Similarly, a person’s refusal to permit USFDA to access and copy any records or the failure to establish or maintain any record, or make any report, required by the USFDA’s officer shall be imprisoned for not more than one year or fined not more than $1,000, or both.
Hence, the draft Act should impose the liability of food operators who intentionally obstruct the officer exercising powers under section 46(6) or fail without reasonable excuse to comply with any requirement or in purported compliance with such a requirement furnishes information which they know to be false or misleading in any material particular or recklessly furnishes information which is false or misleading in any material particular. Possibly, any food operator who fails to comply with the officer’s request without reasonable excuse will be guilty of an offence or a fine specified under the Food Act B.E. 2522.
As known that the MOAC makes the move ahead in legislation for traceability, the idea of expanding official control power to access food-related information has also been affirmed by the Agricultural Standards Act B.E 2551. Regarding to section 43(5), the competent officers have the power to summon a conformity assessment service provider, producer, exporter, importer, or any involved person for testimony, or submission of evidences or relevant information, or correction on deficiency or error found in the inspection. 104
In conclusion, the Food Act B.E. 2522 should be revised by expanding the inspectional powers to include the authority to request records or information from any person carrying on food business. However, there shall be provisions concerning protection of sensitive information, liability for non- compliance, and most importantly, criteria for access record that should be specified to prevent the food operators from the abusing power instead of discretion-based power specified under the draft Food Act B.E. 2554, section 46(6).
4.3.2 Lack of Mandatory Requiring Food Business Operators to Keep Record Related to the Movement of the Food
The need to identify the origin of contamination brings another set of legal basis for food identification and control under the Food Act B.E. 2522. Apart from those inappropriate control powers mentioned above, lacking a mandatory of record-keeping can obstruct a complete and accurate identification of the food safety problem in a timely manner as well.
In case where necessary information to trace the food hazards has not even been kept by the food operators, the officers will face a great challenge to fulfill their duty in finding the source of the contamination and helping remove unsafe food products from the food chain. Because of the outdated Food Act, there is no a direct support for food tracing that involves documenting the production and distribution chain of products. It is hard to the Thai FDA and its officers to trace back to a common source or forward through distribution channels. As seen in the report released by the bureau of Food Safety Extension and Support, it is found that the officer finds it difficult to trace back and forward through the food production and distribution chain, especially in case of identifying the pesticide residues in food crops because the information/record about food distribution have not yet been kept by the wholesalers. In fact, most of wholesalers cannot even remember the suppliers’ name who has supplied them. Although raw materials such as pork, poultry, or food crops are subjected to labelling regulations stipulating that the label must express, at least, information about name of food; food serial number (if any); names and addresses of 105 producers or re-packers; and food quantities, but this label cannot demonstrate the path of particular batch of products or ingredient from suppliers. As a result, the problem of inability to detect and control of food hazards still remains.
Apart from food labelling regulations, most of information about food-related hazards will be obtained from licensing registration as well as record retention specified in Thai GMP law. However, all those the information kept may not be particularly useful to food incident investigation as hope.
As part of licensing and registration under section 14 and section 35, the officer will be provided with preliminary food-related information, for examples, name and type of food; name and address of food operator; equipment list which are used to produce food; location map indicating plant layout of the production building; and other related Registrations such as domestic registration, company registration, trade or commercial registration. Yet, the said information cannot identify a common source or forward through distribution channels.
As part of Thai GMP laws under section 5 and 6(7) of the Act, the Ministry Notifications put an obligation on food operators who manufacture products to maintain records used in food manufacturing processes. The information includes products analysis reports; types and quantities of production; production date; or the conditions of equipment. However, due to different purpose of record retention, information and record retention thereunder are provided merely to review the compliance of food quality standard. The information itself is not able to identify from whom and to whom a food has been supplied either. To enhance the Thai FDA’s ability in investigating a larger variety of food hazards, the Food Act B.E. 2522 should have function or any feature that allows the Thai FDA’s officers to trace contamination to its source. To extent the possible, it should be broader enough to enable various type of food-related information. Moreover, it should expand to all sectors of food chain under the jurisdiction of the Food Act B.E. 2522.
Thailand is not the only country facing such problems. Effective food control system in many countries is undermined by complexity of food systems, 106 street foods and consumer habits, the existence of fragmented legislation, and weaknesses in surveillance, monitoring, and enforcement. To solve this problem, traceability concept has been widely recognized. Based on its principle, traceability is not an objective in itself, but rather a tool, which may assist countries demonstrating that foods manufactured meet food safety requirements. It facilitates identification of the source of the food safety problem, and also helps food operators as well as government authorities to identify, trace, and effectively and rapidly remove unsafe foods at any stage of the food production and distribution chain. Traceability, therefore, may apply to all or specified stages of the food chain (from production to distribution). Moreover, it should be able to identify at any specified stage of the food chain from where the food came (one step back) and to where the food went (one step forward).149
In legislation, traceability is known as legal requirement for food business operators to have, as a minimum, a documented one-step-back and one step forward traceability approach. In UK, traceability requirement can be recognized as a board system that provides various form of traceability to serve different objectives. In the context of the safety matters, it creates a self-sufficient function of traceability requirement, not only for animal identification, but also for the entire food supply chain. In legislation, a clear compulsory requirement of record-keeping is the essential component that optimizes legal support for identification of suppliers and consumers. Because traceability is critically reliant on the recording of information that shows the path of a particular unit or batch of product or ingredient from suppliers, the EU food laws and regulations, therefore, are necessary to have a clear record-keeping requirement that demonstrates who has responsibility to maintain the record about food-related information, what information should be available, and how to deal with the non-compliance against such requirement. As a result, Article 18 of Regulation (EC) No 178/2002 is stipulated explicitly as compulsory requirement of record- keeping applicable in all member states and all areas of food law, including throughout the UK. While, traceability legislation in US is set by section 1.361 under
149 FAO/WHO, Principles for Traceability/Product Tracing as a Tool within a Food Inspection and Certification System (CAC/GL 60-2006), Joint FAO/WHO Food Standards Programme, FAO, (2006). 107 title 21 of the Code of Federal Regulations (21 CFR 1.361) as part of its implementation of the amendments to the Federal Food, Drug, and Cosmetic Act made by the USFDA Food Safety Modernization Act as well as the Bioterrorism Act of 2002. Under the same legal basis, the effect of these compulsory requirements of record-keeping creates a new general obligation for food business operators at all stage of the food chain. The obligation includes, namely, a legal requirement to keep necessary information for identifying from whom and to whom a product has been supplied, and also the requirement to have system and procedures in place that allow for this information to be made available to the competent authorities upon their request.
Although simply knowing where a food product can be found in the food supply chain does not improve food safety directly, but when traceability is combined with food management system in Thailand, it may render the safety to food consumption. By providing information on suppliers involved in potential food safety problems, traceability will enhance government agencies’ ability in part reflect on identification of public health threats and a consequent need to take appropriate actions. Or simply say that traceability is particularly useful for the investigations in which it provides accurate information to determine what the exact problem of food safety is. In the same time, it enables targeted control measures such as product recalls or withdrawals more effectively and efficiently.
Because it provides an effort to investigate food incidents, traceability is not a new concept for strengthening food control system in Thailand. The MOAC, which is one of responsible government bodies to inspect and to control food supply chain, makes the move ahead in legislation for traceability. As seen in the notification of Thai Agricultural Standard (TAS) 9028-2014, upon the Agricultural Standards Act B.E 2551, this is for the first time that principle for traceability has been recommended by a government body to assist the authority concerned in utilizing product tracing within their agricultural commodities and food inspection and certification system. Like many other countries, establishment of standard on food tracing tool under the TAS 9028-2014 is in accordance with the FAO/WHO Food Standards (Codex). 108
The TAS 9028-2014 suggests that product tracing tool should be designed accordingly to harmonized needs, technical feasibility, practical for user, and environment as well as the economic acceptability. Based on a case by case basis, the concerned factors include clear objectives, characteristics of products, the identification of the stage of the food chain, details of each production process and/or handling of product, documentation and record system and media, and so on. Nevertheless, the designed procedures to be used in the organization shall demonstrate production process, raw materials, and information on important control points. The procedures should be able to identify, at least:
Type of product; Identification of lot and batch of product; Records of production process and/ or product handling, from raw materials through final products as well as the identification of documentation and record system; and Information Management and utilization.
Since the standard under the TAS 9028-2014 was released, there has been important progress in this endeavour in recent years. Currently, the Ministry of Agriculture and Cooperatives becomes a partner with IBM, FXA Group, and the Communications Authority of Thailand (CAT) to implement a global traceability program, allowing the country’s exports to be tracked from the retail level all the way back to the farm. Under this program, it uses smart sensor technology and traceability software to allow “all participants in the food chain” to access information on the products, including farm of origin, date of harvest, and temperature during shipping.
While the legal basis of food tracing in part reflect on farm-level productions has been improved by the provisions of the Agricultural Standards Act B.E 2551, food tracing tool in manufacturing process has hardly been seen in provision of the Food Act B.E. 2522. For all these reasons, the author believes that traceability requirement should be implemented under the Act thereof.
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4.3.2.1 Analyzing the Possible Approach to Implement Record- Keeping Requirement
Like in many developing countries, capacity to control the safety of the food supply in Thailand is limited by several factors. Many of which were originally from national government agencies, food operators, and consumers themselves. Poor management of legislation, surveillance system, and strategic direction bring difficulties to the government in strengthening our food control system. Identically, due to a large number of small food operators, they are ill equipped and lack of knowledge to deal with the maintenance of food safety and quality. The following factors should be considered prior to implementing record- keeping requirement.
1) Food Registration System
For those comprehensive traceability system used in UK and US, other than a clear requirement for traceability, there is another important component supporting traceability in legislation which is a well-established registration in food chain. Because implementing traceability system aims to require all of food business operators to initiate record-keeping process within their food production, manufacturing, distribution, the registration becomes one of the mechanism being implicitly used to veil traceability system in the point that the consequence of registration would provide the connectivity of information linked among food business operators. Most importantly, as a legal enforcement, registration can hold all food business operators to be in the same setting of traceability requirement. It, in fact, facilitates traceability regulation enforcement as well as compliance verification. By this mean, their food laws and regulations require all food business operators to register with the authorized officers concerned in order to have an accurate and far-reaching traceability system.
In contrast, licensing and registration under the Food Act B.E. 2522 may not serve the purpose of an accurate and far-reaching traceability system as compared to traceability legislation in UK and US. According to the Act, it 110 requires food operators to apply for approval in two portions namely approval of the premise and approval of the product. Nevertheless, neither approval of the premise nor approval of the product is intended to apply covering all food business activities. In fact, such approval is intended to use a certain type of products as well as for a limited condition of food premise.
2) Capability of food operators
While traceability requirement under UK ad US food laws and regulations has reached a high level of food safety, compelling all food business operators to maintain record-keeping process might put too much of a burden on food business operators to enhance their traceability. As developing country, Thailand is highly fragmented and dependent upon a large number of small food business operators which normally lack appropriate knowledge and expertise in dealing with the application of modern traceability requirement. Thus, capability of food operators should not be ignored to facilitate traceability requirement in legislation.
3) Cost
When food business operators are required to enhance their responsibility in food products, whether they are involved in any stage of food supply chain, the impact of rising food costs is unavoidable. The economic impact of traceability on the prevention of food safety hazards will depend on the type of system that is implemented. A deeper system will enable the establishment of links among more food operators further up or down a supply chain. Increased precision means that the origin of food hazard can be more exactly identified (e.g., at the level of a group of animals versus an individual animal). Clearly, economic and technical decisions on which type of traceability system should be designed involve tradeoffs between system features and their related benefits and costs.150 As a minimum standard set for all food business operators in the UK and US, the effect of high
150 Diogo M. Souza-Monteiro and Julie A. Caswell, The Economics of Implementing Traceability in Beef Supply Chains: Trends in Major Producing and Trading Countries, Department of Resource Economics 2, University of Massachusetts Amherst, (Jun. 2004). 111 traceability requirement as well as a complete registration is now extremely requiring those food operators to take a more advanced step in consumer protection. As a consequent, the full economic impact of traceability regulations is likely to be extensive.
As the first traceability regulations existed in Thailand, the Agricultural Standards Act B.E. 2551 is designed to present traceability specifically as voluntary standards to comply with the request for importing countries requirements, rather than to protect consumers from food-borne diseases. Although it has different goal and objective when compared to the Thai Food Act, nevertheless, its feature system may show a different point of view in legislation to enable the most appropriate traceability requirement under the Food Act B.E.2522.
Instead of establishing a comprehensive record-keeping responsibility on food business operators in the same way as the UK and the US food laws and regulations, the Thai Agricultural Standards Act tries to restrict such responsibility partially for certain types of agricultural commodities and foods. By the virtue of section 5, Section 15 and Section 16 of the Act, various notifications concerning Thai GAP standards are the existing record retention that already induces agricultural commodity producers to maintain and to record detailed production processes of agricultural commodities, including the information associated with the movement of the agricultural commodities and foods. Because the Thai GAP standards’ notifications have been released as a recommendation in support of agricultural commodities and foods that potentially impacts on consumer health or export competitiveness, hence, the standards thereof are not intended to apply for all of the producers. On the other hands, they are applied particularly to producers who are operating their business in connection with agricultural commodities and foods described in the notifications. In this case, traceability requirement, which is put in place on those standards, also applies specifically to whom the notifications on the GAP standards are mentioned strictly. For example, in support of evaluation and traceability, the notification of Thai GAP for food crop requires the procedures to record “tracking and tracing information” including sources of inputs, data of produce 112 traders, or locations that each lot of produce is sold.151 Apart from the notification of Thai GAP for food crop, the notification of Thai GAP standards such as for “Thai Hom Mali rice” also puts the requirements similarly that show where all products were distributed as well.152 Due to this limited form of traceability, information indicating the movement of the food has been simply added to Thai GAP Standards. This means that the agricultural commodity producers can easily acknowledge traceability requirements by keeping and maintaining tracking and tracing information. However, it should be noted that all those Thai GAP notifications are established as voluntary standard to promote agricultural commodity. As such, traceability requirement also deems as voluntary of record-keeping that only recommends the best practices for those food producers who need to enhance the safety to their products. No legal obligation serves on the producers.
At this point, in order to seek the possibility of implementing the appropriate record-keeping requirement under the Food Act B.E. 2522, the consideration should weight related benefits and cost between a comprehensive traceability used in the UK and US legislation and a limited form of traceability under the Thai Agricultural Standards Act.
Due to a limited form of traceability specified in the Agricultural Standards Act B.E 2551 that the ability to follow a product (or its ingredients) forward or backward through the food supply chain is restricted to certain types of agricultural commodities and foods, this requirement may finally not serve the objective for enhancing capacity to detect and control food hazardous. As known that food tracing depends on networking and records in each step related to food products, food compositions and packaging, a mere limited form of traceability may not be comprehensive enough to enable tracking of a larger variety of food hazards. When compared to legal basis for traceability in UK and US, it provides a broader record-keeping responsibility which compels all of the food business operators at least to make information or records accessible in the time requested by competent authority. Based on their system, traceability moreover combines with food
151 Thai Agricultural Standard, TAS 9001-2013. 152 Thai Agricultural Standard, TAS 4400-2009. 113 premise/establishment registration in order to create an advanced information system providing connectivity among all food business operators. As a consequence, procedures to facilitate traceability under UK and US legal framework enable a more sustainable and robust food protection and prevention.
However, traceability requirement for certain type of foods under the Agricultural Standards Act would benefit small and medium food business producers the most. Due to lack of infrastructure dealing with the safety and quality of food, most producers in Thailand do not have enough knowledge about appropriate production techniques. Implementing traceability requirement with limited record- keeping requirement as much as necessary, therefore, may not put too much of a burden on the producers as compared to traceability requirement procedure in the US and UK. On the other hand, food costs may not be increased as much as the full range of traceability system specified in both UK and US. Finally, it may benefit for the Thai government because extra funds and resources are also not necessary as much.
After considering both advantage and disadvantage of the above traceability requirements, the author believes that the possible way to facilitate record-keeping responsibility on food business operators should make it slow in the first run for contributing a comprehensive traceability in the long term. Based on same reason as the Agricultural Standards Act B.E 2551, compelling all food business operators to maintain record-keeping of suppliers might bring the difficulties to food business operators. For those food operators who have sufficient funds available in their account, establishing traceability requirement may not be beyond their capability that much. They have already enough appropriate knowledge and expertise in dealing with the application of modern traceability requirement. But for those small food business operators, which account for a large proportion of the total food operators in Thailand, mandatory of traceability requirement may put too much of a burden on them. Other than food operators’ capability, legal basis for food licensing and registration under the Food Act B.E. 2522 itself cannot serve the purpose of an accurate and far-reaching traceability system. By means of section 14, food business operators in general are not required to obtain food manufacturing license. Unless for those food operators who employ more than 7 workers or use equipment with more 114 than 5 horsepower, their premises have to be approved before an operation begins. With this incomprehensive licensing function as well as capability of food operators, it is impractical to initiate a board traceability system that requires all the food business operators to be responsible for record-keeping requirement, or whether it enables tracking of a large variety of food hazards throughout food supply chain at once. Instead, the Act should begin facilitating traceability with a limited form of record-keeping requirement applicable for only certain food business operators.
The idea underlying “Additional Recordkeeping Requirements for High Risk Foods” in the US food legislation can probably point out the possible approach to implement traceability in Thailand. The concept of additional requirement thereof aims to enable foods to be more rapidly and effectively tracked and traced during a foodborne illness outbreak or other events. The USFDA is required under section 204(d)(2) of FSMA to define and make a list of High Risk Foods. For the last result, the USFDA will use such list to obligate an increased record-keeping responsibility on food operators. Similar to the purpose of this thesis that aims to restrict record-keeping requirement applicable for certain food business operators, the Food Act may initiate the mandatory of record-keeping requirement for those food operators who produce, process, transport, or hold the High Risk Foods.
To make a list of High Risk Foods, we must turn to the basic principle existed under the Food Act B.E. 2522. In order to control food produced in Thailand, the Act classifies food into three main categories, which is normally comprised of:153
Category 1 Specially Controlled Foods; Category 2 Standardized Foods; and Category 3 General Foods.
In each category, there has different levels of protection depending on the scale and severity of the hazards. According to category 1, specially
153 Thai FDA, Law and Regulations, available at http://www.fda.moph.go.th/eng/food/laws.stm (last visited Dec. 12, 2014). 115 controlled foods are the most strictly controlled. Based on the assumption that they can pose the significant risk to consumers’ health, 18 types of food have been listed. Whoever intends to produce specially controlled foods for sale, he must be subjected to food registration, standard quality, specifications, packaging and labeling requirements, as well as other aspects of Good Manufacturing Practice (GMP). Meanwhile, the main objective of category 2 is to facilitate and encourage food producers on upgrading or at least maintaining hygienic quality of their products. Hence, standardized food does not require registration but its quality (GMP) and labeling have to meet the standard requirements as specified in the Notification of the Ministry of Public Health. At present, there are 28 types of food in this category. If the food produced is not listed under category 1 or 2, such food will be considered as general foods, for examples raw materials such as meat, poultry ,and pork, food ingredients such as sugar, or food crops. This category exposes a low risk of hazard to consumers’ health so that registrations are not required. However, general food products are controlled and monitored with regard to hygiene, safety, labeling, and advertisement. Foods in this category may be subdivided into (a) foods that must bear standard labels and (b) other general foods.154 There are 13 items of food required to bear standard labels.
In general, foods that can pose significant risk to consumers’ health always require the highest level of food safety protection in order to ensure that food hazards such as microbiological or chemical contamination has been fully detected and controlled. Similar to foods classified in category 1 and 2, they are classified as foods that cause a serious illness or injury to a person, and need to maintain hygienic quality of their products. One of the example events that can explain the meaning of a significant risk exploring public health impact clearly is the biggest botulism outbreak caused by home-canned bamboo shoots. Although Botulism outbreaks are rare, such outbreaks are public health emergencies affected a large number of people (209 people). Such Botulism outbreaks require rapid recognition to identify the disease source, distinguish outbreak types, prevent additional cases, and effectively administer treatment to affected patients. In response,
154 Id. 116 home-canned bamboo shoots are classified as Specially Controlled Foods which must be subjected to several food safety requirements, including registration, standard quality (GMP), packaging, and labeling requirement. As seen in the example, foods classified in category 1 and 2 can cause a serious illness or injury to a large number of people. Therefore, establishing traceability requirement is crucial to reduce risk exposure, limit impacts, and be better prepared to cope the diseases. In fact, it provides a quick and reliable identification of the hazards. It also enables appropriate control measures such as food recalls or withdrawals more effectively. For this reason, in my opinion, Specially Controlled Foods and Standardized Foods may be the first two categories that are required to have record-keeping procedure for identifying food production and distribution, based on their scale and severity.
Besides, whoever produces food in category 1 and 2 is always required to comply with the GMP standard stipulated under the Ministry Notification No. 193. According to its basic rules, food manufactures must maintain proper documentation and record to build up a detailed picture of what a manufacturing has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. By this mean, those manufactures produced foods in category 1 and 2 have documentation system to maintain the information about food production, food equipment, and its storages already. If that so, maintaining the information that can identify the movement of the food may not put too much burden on them.
Other than food classified in category 1 and 2, there are some types of foods that appear specifically in the Ministry Notification No. 193 in order to assure food quality standard, for examples husked rice flour, bread, chewing gum and candy, some meat products, frozen foods, foods packed together with material intended for qualities control purpose, bakery product, or noodles made from rice flour. Because food manufactures produced these kinds of food have the record retention existed in their food production, in my opinion, they should also be obligated the responsibility on maintaining traceability record as well. 117
For clearly defined, any operators who conduct their business involving the following types of food soon after the traceability requirement is released, have the responsibility to maintain traceability records.
1. Infant Foods and Follow-up Formula Food for Infant and Young Children. 2. Supplementary Foods for Infant and Young Children. 3. Modified Milk for Infants and Follow-up Formula Modified Milk for Infants and Young Children. 4. Ice. 5. Drinking Water in Sealed Containers. 6. Foods in Sealed Containers. 7. Cow’s Milk. 8. Cultured Milk. 9. Ice Cream. 10. Flavored Milk. 11. Other Milk Products. 12. Food Additives. 13. Sodium Cyclamate and Food containing Sodium Cyclamate. 14. Weight-control Foods. 15. Tea. 16. Coffee. 17. Fish Sauce. 18. Natural Mineral Water. 19. Vinegar. 20. Fat and Oil. 21. Peanut Oil. 22. Cream. 23. Butter Oil. 24. Butter. 118
25. Cheese. 26. Ghee. 27. Margarine. 28. Semi-processed Foods. 29. Some Particular Kinds of Sauces. 30. Palm Oil. 31. Coconut Oil. 32. Electrolyte Drinks. 33. Soybean Milk in Sealed Containers (Except manufacturers which are not recognized as factory conforming to the Factory Laws.). 34. Chocolates. 35. Jam, Jelly, and Marmalade in Sealed Containers. 36. Special Purposed Foods. 37. Alkaline-preserved Eggs. 38. Royal Jelly and Royal Jelly Products. 39. Food Seasonings derived from the Hydrolysis or Fermentation of Soy Bean Protein. 40. Honey (Except manufacturers which are not recognized as factory conforming to Factory Laws.). 41. Fortified Rice with Vitamins. 42. Husked Rice Flour. 43. Brine for Cooking. 44. Sauces in Sealed Containers. 45. Bread. 46. Chewing Gum and Candy. 47. Processed Gelatin and Jelly Desserts. 48. Some Meat Products. 49. Flavoring Agents. 50. Frozen Foods. 119
51. Foods Packed Together with Material Intended for Qualities Control Purpose. 52. Bakery product. 53. Noodles made from Rice Flour.
For those foods are not listed above, they are classified as General foods in Category 3 which include:
foods that have passed through processing procedures such as trimming, roasting, drying, fermenting; foods that have passed through processing procedures resulting in characteristic changes; or foods that have passed through manufacturing processes and been packed into pre‐packaged containers for sale to the consumer (excluding specific controlled foods, standardized foods).
Due to exposing a low risk of hazard, there are not many food safety requirements designated to food business operators compared to the first two categories. The Act only requires food manufacturers produced foods in category 3 to comply with a minimum standard regulated by the Ministry of Notification No. 342. Under this Notification, Primary GMP standard has been set up in order to encourage consumption of clean and safe food. The premises where the production process takes place must be clean, free of waste and water stagnation. They must also have appropriate control of production processes, materials, ingredients, and storage. Besides, equipment must be easily cleaned and free of oxidation. However, documentation and record have been excluded from their legal basic. It is probably because food manufacturers lack of a system or procedure for providing information on the food safety matters, and may need time to establish such appropriate system or procedure. Due to lacking appropriate procedure to keep record, food operators in this group need time to improve and change their current practices to facilitate traceability requirement. 120
Although this kind of foods may not pose a significant risk to public health, we have to admit that finding the point of contamination and source of food raw materials is the main food safety problems occurred in Thailand. Most of raw materials such as raw meat, poultry, or food crops are unbranded, and come from different sources to produce a single product. Sometimes they can undergo changing during manufacturing operations and other processing steps. As a result, the officer often faces the difficulty knowing who supplies such particular material. To enhance the ability to trace food products across the entire food supply chain, the author believes that establishing record-keeping requirement for any operators who produce foods in category 3 is also necessary as much as the food that can pose the significant risk to consumers’ health classified in category 1 and 2. However, because of lacking appropriate procedure to keep record, timeframe for establishing record-keeping procedure may be provided before such requirement becomes fully effective. Perhaps it may be even within three years after the date of this traceability requirement is enforced, similar to the Primary GMP standard, Ministry Notification No. 342.
In conclusion, the author believes that the Food Act. B.E. 2522 cannot compel all the food business operators to maintain the records that can identify the food’s movement at once. In the first place, the Act should begin to facilitate traceability with a limited form of record-keeping procedure for a High Risk Foods that some food operators, the manufactures, have appropriate record retention process available in theirs production already. Food operators who produce 53 types of foods mentioned above will be responsible probably soon after traceability requirement is released. On the other hand, for those operators who do not have enough appropriate knowledge and expertise in dealing with record-keeping process, they may need time to improve and change their current practices in order to meet traceability requirement. Timeframe for establishing record-keeping procedure may be provided before such requirement becomes fully effective. During that time, traceability requirement will be applied as voluntary standard.
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4.3.2.2 Analyzing Appropriate Function Lies under the Food Act B.E. 2522
After analyzing who will be responsible soon after such requirement is released and who will have time to improve and change his current practices. The next consideration is about what is the appropriate function lies under the Food Act B.E. 2522. According to the Act, there are two functions that can initiate traceability requirement which are:
1) The GMP record retention process under the Notification No. 193 of the Act
Apparently, all those 53 types of food mentioned above are described by the Ministry Notification No. 193, B.E. 2543, or called “the General GMP.” It requires whoever produces food described in such notification to have food quality assurance measures on production processes, production equipment, and foods storages. Such GMP standard also has record retention process that requires food manufacturers to keep information about detailed production processes. In this case, there is a possibility that this General GMP stipulated in the Food Act B.E. 2522 will be the most appropriate function supporting traceability requirement. As equivalent to the GAP standards stipulated in the Agricultural Standards Act B.E 2551, traceability requirement is implemented easily by merely adding information associated with food tracing to record retention existed under such GMP standard.
However, this existing record retention still has some weaknesses. Firstly, such record retention is practically unenforceable. In fact, it has been ignored from both food business operators and Thai FDA’s officers. Secondary, based on its purpose, this GMP standard aims to control “food producers” or “manufacturer” who produces foods which deem to pose serious health risks to consumers, including Specially Controlled Foods (category 1), Standardized Foods (Category 2). If that so, the word “food producers of sale” upon this standard refers in particular to any person who makes, mixes, transforms, or repacks such foods for 122 sale.155 The meaning of food producers mentioned would not reach so far to all participants involved in food supply chain. Although this GMP standard has the existing record retention supported traceability requirement, it is not meant to control wholesalers, retailers, transporters, distributors, but rather food manufacturers. As a result, the record retention thereof lacks of a function that provides the connectivity of information for identifying from whom and to whom a product has been supplied, at the same time, it lacks of appropriate enforcement to deal with the non-compliance.
2) The power to promulgate subsequent regulations under section 5 and 6 of the Act
In order to seek the appropriate function to support record- keeping responsibility, the idea underlying “establishment and maintenance of records under section 414 (21 U.S.C. 350c) of the Federal Food, Drug, and Cosmetic Act may be preferable. To facilitate traceability concept, the USFDA is authorized to promulgate subsequent regulations concerning record-keeping requirement. This section will establish mandatory of record-keeping on any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, receives, holds, or imports food. It also contains which records are needed for inspection to allow the USFDA to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. In general, the USFDA issues such regulations through subpart J of part 1 of title 21, the Code of Federal Regulations (CFR).
With the same based objective, legal basis for establishing record-keeping requirement under the FD& C Act may point out possible function of record-keeping requirement being initiated into the Food Act B.E. 2522. As compared to the US law, section 5 and section 6 of the Food Act B.E. 2522 are the similar source of power that enables the Thai FDA to promulgate subsequent regulations
155 § 4 of the Act stipulates that; “Produce” means to make, to mix, to transform, or repacking 123 concerning record-keeping requirement. By the virtue of these sections, the Thai FDA may issue the Ministry Notification in case of;
1. Prescribing controlled food; 2. Prescribing quality or standard of controlled food by reference to the name, class, kind, or nature if food produced for sale, import for sale or sale including principle, conditions ,and methods of production for sale; 3. Prescribing quality or standard of food other than controlled food with or without the principle, conditions ,and methods of production for sale, import for sale or sale; 4. Prescribing the proportion of ingredients used in the production of food by reference to the name, class, kind ,or nature of food produced for sale, imported for sale or sale, including the use of coloring matter and flavoring; 5. Prescribing the principle, conditions and methods of using preservative and methods of preserving, admixture of coloring or other matters in food produced for sale, imported for sale or sale; 6. Prescribing the quality or standard of container and use of container including the prohibition to use any packaging material as a container of food; 7. Prescribing the methods of production, tools and utensils used in the production and preservation of food in order to prevent the food produced for sale, imported for sale from becoming impure food under this Act; 8. Prescribing food, which is prohibited to be produced, import or sold; 124
9. Prescribing the principle conditions and methods of inspection, storage, seizure, and method of analysis of food including reference documents; 10. Prescribing the class and kind of food produced for sale, imported for sale or sale which required labels, the texts on the labels, conditions, and the display of the labels and also the principle and method of advertising on the labels.
To establish supported function of record-keeping requirement, the Food Act should be amended by adding the Thai FDA’s power to promulgate Ministry Notifications concerning on record-keeping requirement into section 6 of the Act along together with the above description.
4.3.2.3 Analyzing the Essence of Record-Keeping Requirement
After considering function to facilitate traceability, this part of thesis will analysis what should be contained in the Ministry notification mentioned above. In doing so, the notification is necessary to have a clear record-keeping requirement that demonstrates who has responsibility to maintain the record related to food, what information should be available, and how to deal with the non-compliance against such requirement.
1) Who has responsibility to maintain the record about the distribution of food
There is a difference between the agency governing control activities in the UK and the agency in the US. Throughout UK, the Food Authority and the FSA are integrated agencies that work closely together in dealing with food that fails to comply with the safety standards. The Food Authority’s officers have to perform much of the day-to-day work of regulatory enforcement. Meanwhile, most of the FSA’s regulatory duties are to enhance the ability of the food surveillance and response system in detecting and controlling food-borne diseases. Differently, 125 government agencies in the US are multiple. Among the agencies, they are solely responsible for food operated in their jurisdiction. The USFDA is responsible for the safety and security of most of U.S. nation’s food supply, excepting for those primary productions such as meat, poultry, and egg products, which are in the USDA jurisdiction. Due to the unlikeliness of such arrangement, defining who has responsibility to maintain the traceability record is also slightly different among these two countries. With an integrated food control arrangement, Article 18 of The EU General Food Law Regulation (178/2002) requires “any food business operator throughout UK that trades in food at all stages of the food chain to maintain traceability requirement.” Such operators include primary producers, manufacturers, wholesalers, retailers, transporters, distributors, those deals in the purchase and sale of bulk commodities, caterers and food brokers. Within the USFDA’s jurisdiction, the Code of Federal Regulations defines food business operators responsible for traceability requirement as persons who manufacture process, pack, and transport, distribute, receive, hold, or import food in the United States. Notably, farms, fishing vessels, and all kinds of restaurant are exempt from traceability requirement described in such regulations. However, this not means the US food supply has not been fully protected. Indeed, there is regulation that requires food primary producers to maintain the record associated with the distribution of agricultural commodities. But, such requirement is available upon laws and regulations imposed within the USDA’s jurisdiction.
For Thailand, food control activities are governed by the Thai FDA and the MOAC. Similar to the US agencies, traceability requirement on record- keeping must be implemented both in the Food Act B.E. 2522 and also the Agricultural Standards Act B.E. 2551 in order to enable the connectivity of information along food supply chain. If that so, like the US legislation, food business operators responsible for traceability requirement upon the proposed Ministry Notification should be defined narrowly as “person who produces, processes, packs, transports, distributes, receives, holds, or imports food specified in this notification for sale.” In this case, the meaning of food business operators does not include agricultural producers who are in the scope of MAOC’s jurisdiction. The agricultural 126 producers, in this case, refer to a producer in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling produce are considered part of harvesting. The producers include a person that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and a person that manufactures/processes food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
2) What information should be available
Due to limited food operators’ capabilities, the proposed notification, therefore, should be imposed broadly what information should be available in the same way as UK legislation. Because traceability is reliance on one step back – one step forward approach, the essential information that the notification should be required is the name of businesses who supply them and to whom they supply their products. Possibly, traceability records should include the address of the customer or supplier, nature and quantity of products, and the date of the transaction and delivery.
3) How to deal with the non-compliance
In general, when food operators performing their business contravene the Ministry Notifications promulgated under section 6 of the Act, they will be punished by the provisions under chapter 8 of the Act. So this means, if a proposed notification concerning on record-keeping requirement is issued upon the power provided in section 6 of the Act, in turn, food operators’ liability will also be enacted in the chapter 8 of the Ace as well. CHAPTER 5 CONCLUSIONS AND RECOMMENDATIONS
5.1 Conclusions
The Food Act B.E. 2522 is outdated and poorly designed to overcome the current food hazards in Thailand, especially in case of food-borne pathogens that lead to incident of diarrheal diseases. Lacking of a well-established legal basis for food identification and control defines inability to trace the source of food-borne hazards and indicates the Thai FDA’s failure in conducting its duty to protect consumers’ health.
However, Thailand is not the only country facing such problems. Effective food control system in many countries is undermined by complexity of food systems, street foods and consumer habits, the existence of fragmented legislation, and weaknesses in surveillance, monitoring and enforcement. This ineffective of food control system brings a number of foodborne disease outbreaks and incidents, including those arising from natural, accidental, and deliberate contamination of food documented in every part of the world. In response, national governments interact to improve the safety of the food supply. The current food safety policy is based on a series of principles applied in line with the integrated approach 'From the Farm to the Fork' specifically includes transparency, risk analysis, traceability and prevention, the protection of consumer interests.
Prior to the publication of the EU General Food Law, countries around the world had recognized traceability requirement as for animal identification. Its procedure helps the countries improve the effectiveness of their policies and activities relating to disease prevention and control, animal production food safety, and certification of exports. However, the significant movement towards traceability system becomes increasingly interested in recent years as a result of a rise in food- borne illness cases in every part of the world. Until nowadays, traceability plays the role as a record-keeping procedure obligated by the law to food operators at all stage of the food chain in order to identify the movement of food products or ingredients. 128
In developed countries such as the UK and the US, traceability concept has been adopted to their legal framework as record-keeping requirements. Under the full range of traceability requirements, all food-related information must be kept and must be accessible to help determine the source and scope/magnitude of a food safety problem. Therefore, adequate procedure underlying their food laws and regulations is comprise of two legal basis components, namely mandatory of record-keeping and official control powers to access food-related information. For mandatory of record- keeping, the food laws put legal obligation on food operators to keep records of suppliers of raw materials and ingredients so that the competent authority will use information available to trace the source of the problem. In the same time, the laws provide the extended official control powers to be used effectively together with mandatory of record-keeping. Under extended powers, the authority can now access all food related information associated with food hazard. Such information does not include only records which have to be kept by the provision of the laws, such as records of supplier information (traceability) and records of production process, but also other information related.
By means of various Notifications upon the Agricultural Standards Act B.E. 2551, Good Agricultural Practices (GAP)” implements the record-keeping process aiming to support the protection of consumers as well as to facilitate the trade on the basis of accurate product description.156 In the meantime, section 43 of the Act provides inspectional authority in order to access information associated with food hazards. Regarding to the section thereof, on carrying out an inspection, the competent officer may inspect any premises, warehouse, or vehicle of producer, exporter, importer, seller, or holder of agricultural commodity at any time whenever there is a reasonable ground to suspect of any violation or non-compliance under the Act. Moreover, the officer has the power to summon any involved person for
156 By virtue of the Cabinet Resolution on Appointment and Authorization of the National Committee on Agricultural Commodity and Food Standards dated 5 August B.E. 2551, the Notifies on Thai Agricultural Commodity and Food Standard entitled Principle for Traceability / Product Tracing as a Tool within an Agricultural Commodity and Food Inspection and Certification System is hereby issued as voluntary standard. 129 testimony, or submission of evidences or relevant information as he may request even if the request is outside the course of inspection.
To provide the ability to trace food products across the entire food supply chain, traceability requirement must be implemented both in the Agricultural Standards Act B.E. 2551 and the Food Act B.E. 2522. The problems of lacking of a well-established legal basis for food identification and control under the Food Act B.E. 2522 can pose significant risk to the consumers’ health. For all these reasons, the Food Act B.E. 2522 should be revised and amended in part reflecting on legal basis for food identification and control, so that ability to trace the source of food-borne hazards can be improved effectively.
5.2 Recommendations
Within the purpose of the Food Act B.E. 2522 that aims to protect consumers from food injurious health, the author believes that:
1. Under section 43 of the Food Act B.E. 2522, the competent officer’s power should be enabled with specific power including the power to request food operators to provide him with the records or other assistances, as he may reasonably request. 2. By means of section 5 and 6(7) of the Food Act B.E. 2522, the notifications concerning on record-keeping requirement should be promulgated in order to obligate a new food business operators’ responsibility for maintaining the necessary information that can identify the movement of the food across the entire food supply chain. 130
REFERENCES
1. Books and Book Articles
1.1 English books Alain Gérard. An Outline of Food Law (Structure, Principles, Main Provisions). 2nd ed. Rome: FAO, 1975. Domimique Lauterburg. Food Law: Policy and Ethics. United Kingdom: Cavendish Publishing Limited, 2001. FAO and WHO. FAO/WHO guide for developing and improving national food recall systems. Rome: n.p., 2012. FAO and WHO. Food Safety Risk Analysis: PART I; An Overview and Framework Manual. Provisional Edition. Rome: n.p., 2005. FAO. Assuring Food Safety And Quality: Guidelines For Strengthening National Food Control Systems. FAO Food and Nutrition Paper 76. Rome: FAO, 2003. FAO. FAO Expert Consultation on Food Safety: Science and Ethics. Rome: FAO, 2003. FAO. FAO/IAEA Training and Reference Centre for Food and Pesticide Control: Manual on the application of the HACCP system in Mycotoxin prevention and control. FAO Food and Nutrition Paper 73. Rome: FAO, 2001. FAO. Food safety risk analysis: A guide for national food safety authorities. FAO Food and Nutrition Paper 87. Rome: FAO, 2007. FAO. Risk-based Food Inspection Manual. FAO Food and Nutrition Paper 89. Rome: FAO, 2008. FAO. Voluntary Guidelines to Support the Progressive Realization of the Right to Adequate Food in the Context of National Food Security. Rome: FAO, 2005. FAO/WHO Food Standards Programme. The Codex Alimentarius Commission: procedure manual. 12th ed. Rome: n.p., 2001. 131
FAO/WHO. Principles for Traceability/Product Tracing as a Tool within a Food Inspection and Certification System (CAC/GL 60-2006). Joint FAO/WHO Food Standards Programme. FAO. Rome: n.p., 2006. Food and Agriculture Organization of the United Nations Regional Office for Asia and the Pacific, Report of the ASEAN Regional Meeting. Developing National Food Safety Emergency Response Plans – Sharing Experiences and Lessons Learnt. Bangkok: n.p., 2012. Souza-Monteiro, Diogo M., and Julie A. Caswell. The Economics of Implementing Traceability in Beef Supply Chains: Trends in Major Producing and Trading Countries. Department of Resource Economics. University of Massachusetts Amherst: n.p., 2004. The European Commission. Health & Consumer Protection Directorate General: Guidance document on Implementation of procedures based on the HACCP principles, and facilitation of the implementation of the HACCP principles in certain food businesses. Brussels: n.p., 2005. WHO. Communicable disease surveillance and response systems: Guide to monitoring and evaluating. n.p.: WHO, 2006.
1.2 Thai books คณะกรรมการอาหารแห่งชาติ. กรอบยุทธศาสตร์ การจัดการด้านอาหารของประเทศไทย. พิมพ์ครั้งที่
1. กรุงเทพฯ: ส านักงานกองทุนสนับสนุนการสร้างเสริมสุขภาพ. ม.ป.ป. (The National
Food Commission. Strategies of Food Management Program. 1st. Bangkok: Thai Health Promotion Foundation, n.d.) สมใจ สุตันดี. การปรับกลยุทธ์การตรวจสอบและท าหลักฐานตามพระราชบัญญัติอาหารให้มี
ประสิทธิภาพ. กรุงเทพฯ: กองสารวัตร. ส านักงานคณะกรรมการอาหารและยา, 2544.
(Somjai Suthundee. Improving Strategies for an Effective Inspection under the Food Act. Bangkok: FDA, 2001.)
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สุวิมล สายสุวรรณ. ความรู้เกี่ยวกับการสืบสวนประมวลหลักฐานทางด้านกฎหมายอาหารและยา: ตอนที่ 3 บทบาทพนักงานเจ้าหน้าที่ตามกฎหมาย อย. กรุงเทพฯ: กลุ่มนิติการ, 2538.
(Suvimon Saisuwan. The Introduction to Regulatory Inspection Procedure Toward Food and Drugs: Chapter 3; Role of competent officers. Bangkok: Legal officer, 1995.) ส านักงานคณะกรรมการอาหารและยา. ส านักอาหาร. คู่มือการขออนุญาตอาหารแปรรูปที่บรรจุใน ภาชนะพร้อมจ าหน่ายตามหลักเกณฑ์วิธีการที่ดีในการผลิตอาหาร (Primary GMP). กรุเทพ:
ส านักอาหาร, 2555. (Thai FDA. Bureau of Food. Manual for an Application of
Primary GMP in Pre-packag Processed Foods. Bangkok: Bureau of Food, 2012)
2. Articles
FAO. Building effective food safety system. in Second FAO/WHO Global Forum of Food Safety Regulators. Bangkok: n.p., 2004. FAO. Capacity Building for Food Quality and Food Safety: Selected Activities in the Americas and the Caribbean of the Food and Agriculture Organization (FAO). in FAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean. San José: n.p., 2005. FAO. Foodborne Diseases: Situation of Diarrheal Diseases in Thailand. in FAO/WHO Regional Conference on Food Safety for Asia and the Pacific. Malaysia: n.p., 2004.
3. Electronic Media
Alan Reilly, Raymond Ellard and Judith O’ connor. “Food Safety at The National Level: The Role of Governments.” Medical Sciences, no. 11 (n.d.)
Alston & Bird LLP [Cathy L. Burgess and Guillermo E. Cuevas]. “FDA invokes FSMA suspension authority – beginning of new era in food safety enforcement actions?,” Lexology (n.d.)
FSA. Food Law: Practice guidance (England). n.p.: FSA, 2012
Ministry of Public Health (MOPH). “Food Control in Thailand.” MOPH.
136
USFDA. “FDA Basics.” U.S. FDA.
137
Wallace, Robert B, and Maria Oria. Enhancing Food Safety: the Role of the Food and Drug Administration. Washington, D.C.: The National Academies Press, 2010.
4. Other Materials
Principles and Guidelines for National Food Control Systems Cac/Gl 82-2013. Principles for Traceability/Product Tracing as a Tool within a Food Inspection and Certification System. Recommended International Code Of Practice General Principles Of Food Hygiene. The Act on Liability for Wrongful Act of Officials B.E. 2539. The Agricultural Standard B.E. 2551. The Code of Federal Regulation. The Federal Food, Drug, and Cosmetic Act. The Food Act B.E. 2522. The Food Hygiene (England) Regulations 2013. The Food Safety Act 1990. The Food Standards Act 1999. The General Food Regulations 2004. The Regulation (Ec) No 178/2002 of the European Parliament and of The Council of 28 January2002 Laying Down the General Principles and Requirements of Food Law, Establishing the European Food. The Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on Official Controls Performed to Ensure the Verification of Compliance with Feed and Food Law, Animal Health and Animal Welfare Rule. The Trade Secret Act B.E 2545. 138
BIOGRAPHY
Name Miss Nilubon Rakngam Date of Birth October 8, 1986 Educational Attainment Academic Year2009: Bachelor of Laws, Naresuan University Academic Year2012: Barrister at Law, Thai Bar Association