The cold chain is one of the most important links in ensuring the integrity of food and reducing foodborne illness. Food safety stakeholders in the global food supply chain—industry, regulators, international standard-setting agencies and researchers—have responded to the need for improved food safety assurance to support international trade in a variety of ways. Industry stakeholders from the growing, processing and foodservice/retail sectors are using cold chain systems, Hazard Analysis and Critical Control Points (HACCP) and other food safety management systems (FSMSs) such as the newly established ISO 22000 as models to achieve food safety to enhance trade opportunities in international markets. Advanced knowledge of food hazards has resulted in new regulations, which includes mandatory HACCP system implementation in processing plants in several countries. Food laws aim to protect consumers’ interests, their well-being, and to a degree, facilitate fair trade. Food safety-related legislation is continually under review as it needs to reflect new knowledge, technical innovation and changes in the pattern of the distribution. As a result, national regulatory authorities throughout the world are in a constant catch-up mode. Similarly, international food safety standard-setting bodies look to address current issues and to develop guidelines on systems and methods that will help streamline food safety best practices within and between nations.

As such, it makes sense to examine the international compatibility of these food safety systems, while also considering that improper application can result in the loss of valuable markets. Increasingly, it is becoming helpful to gain political support for these systems. Nonetheless, this support may at times present an obstacle to the necessary transparency required for viable food safety programs. Some nations, such as Canada, strongly encourage HACCP-based systems throughout the food continuum, from farm gate to consumer plate. The latter is particularly evident through voluntary industry codes of practice/guidelines, which become industry-enforced standards. Such standards are the preferred method of self regulation in the refrigerated food sector because of its product diversity and the rate of production innovation.

The Big Picture
International food agreements provide a reasonably uniform level of protection in terms of public health and food standards. Constant efforts to harmonize them are being made in order to minimize, if not remove completely, technical barriers to trade across frontiers. Legislation differs from country to country. It is therefore paramount that food traders stay up-to-date with the vast array of legislation and standard-setting as it applies to their operations.[1]

Codex Alimentarius. Members of the World Trade Organization (WTO) recognize Codex Alimentarius standards as the basic standard upon which national measures will be judged. The “Recommended International Code of Practice. General Principles of Food Hygiene,” for example, sets out the approach to be followed in the production of foods from on-farm to final preparation.[2] A HACCP-based approach to enhance food safety is recommended as described in “Principles of HACCP” and “Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application.”[3] The prevention or reduction of food safety risk leaves a significant degree of flexibility to manufacturers/operators and regulatory bodies as long as they achieve the objectives. As described in the Time and Temperature Control section of the latter document, users of temperature control systems need to take into account various factors, such as the nature of the food, the intended shelf-life, the method of packaging and processing, and how the product is to be used. Such systems need also to specify tolerable limits for time and temperature variations.

The Codex Alimentarius “Code of Hygienic Practice for Refrigerated Packaged Foods with Extended Shelf Life” is especially relevant to refrigerated foods. The code states: “For refrigerated foods, an important safety hurdle to control microbial growth is refrigeration (for example, 4°C).[4] Any recommendation for specific temperatures should be considered as guidelines only. The actual temperatures used will depend upon the requirements for the product, and processes used in terms of safety.”

An example of temperature requirements of a food is found in the Codex “Proposed Draft Code of Hygienic Practice for Fresh Meat.”[5] It states: “Storage of meat at temperatures that achieve the safety and suitability requirements...meat should be transported at temperatures that achieve safety and suitability objectives.” For fish, however, the “Proposed Draft Code of Practice for Fish and Fishery Products” states: “Refrigerated processed products should be maintained at the temperature specified by the processor but generally should not exceed 4°C...frozen products should be maintained at -18°C or below (maximum fluctuation 3°C)...fresh fish, shellfish and their products should be kept at a temperature as close as possible to 0°C.”[6]

Shorter-shelf-life products fall within the scope of the Codex “Code of Hygienic Practice for Precooked and Cooked Foods in Mass Catering.”[7] However, this does not refer to chilled foods for retail sale. This code deals with the hygienic requirements for cooking raw foods and handling cooked and precooked foods intended for feeding large groups of people and is not intended for application to the industrial production of complete meals. Chilled foods are defined in this code as “product intended to be maintained at temperatures not exceeding 4°C in any part of the product and stored for no longer than five days.”

Other proposed Codex Alimentarius codes of relevance to chilled and frozen food production include the “Code of Hygienic Practice for Primary Production, Harvesting and Packaging of Fresh Produce/Fruits and Vegetables,” “Code of Hygienic Practice for Pre-Cut Raw Fruits and Vegetables,” and the “Code of Practice for the Processing and Handling of Quick Frozen Foods.”[8-10]

ATP Agreement. There is an agreement, adopted by no less than 20 countries, entitled “Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be Used for Such Carriage” (ATP). Its purpose is to direct participants to follow common standards for the temperature-controlled equipment (road vehicles, railway wagons, containers etc.) within Europe, thereby facilitating international traffic in certain perishable foodstuffs.[11-12] The target foods are quick (deep) frozen, frozen and foodstuffs that need to be transported at refrigerated temperatures. Chilled foods would include, dairy products (pasteurized, industrial or raw milk, butter, yogurt, kefir, cream, fresh cheese), meat products, poultry, offal, game, fish and seafood.

Refrigerated and frozen foods are subject to detailed regulatory controls, and as such, serve as a good foundation for a discussion of global harmonization of food safety laws and standards. For example, in Canada, controls are in place at the national level and fit hand-in-glove with the international community requirements where HACCP-based approaches to hygiene have been established. The trend, worldwide, is to develop and implement HACCP-based food safety systems including food hygiene legislation. These plans are being developed at all levels of food production and handling, led by Codex Alimentarius. Given the highly dynamic and innovative nature of the cold chain sector, the practical implementation of HACCP relies on the ease with which “best practice guidelines” can be updated. In order to make HACCP a reality, irrespective of the operation in question, it is a fundamental requirement that operators and enforcers have a clear understanding of food safety and technology.[12]

The new International Standards Organization (ISO) 22000:2005 international standard integrates the principles of the HACCP system and application steps developed by Codex, and provides a framework of internationally harmonized requirements for a global approach. This international standard is designed to allow all types of organizations within the food supply chain to implement a food safety management system (e.g., HACCP). As the cold chain is part of the food continuum, ISO 22000 operates in close alliance with all food sectors including feed producers, primary producers, food manufacturers, transport and storage operators and subcontractors to retail and food service outlets, together with related organizations such as producers of equipment, packaging material, cleaning agents, additives and ingredients.[13]

In a previous article, our emphasis was on inconsistencies and conflicting recommendations provided by regulatory communities with regard to length of time potentially hazardous foods that may be kept within the “danger zone” (less than 60°C or 140°F or above 4°C or 40°F) prior to disposal.[14] Temperature control is not the only factor which influences the safety of foods throughout its journey along the continuum. Each sector, from manufacturer, warehouser, distributor, transporter and retailer is charged with the responsibility of adhering to, and utilizing, proper handling techniques. These programs are comprised of codes of practice, good manufacturing practices, codes of hygiene and acceptable industry practices for which no legislation exists. Responsibility is not waived at the checkout counter of the local grocery store. Government programs are being structured to encourage the consumer to take responsibility for handling products in a manner that contributes to quality and safety.

However, the lack of appreciation by industry and government with regard to international food laws and agreements still presents a challenge to maintaining food safety and quality. This discussion will attempt to deliver some insight into the status of international food codes and standards.

Canada
Canada is a nation with a population of approximately 32 million. It is considered a world leader in ensuring that food safety and quality in agricultural food products are maintained throughout the food continuum. Responsibility is shared by primary producers, processors, transporters, distributors, retailers, restaurants, and even manufacturers of packaging materials and ice.[15] Refrigerated and frozen foods are also subject to detailed regulatory controls. In Canada these regulatory measures are in place at the national level, and fit hand-in-glove with international community requirements where HACCP-based approaches to hygiene have been established. Canadian legislation affecting the cold chain includes the Canadian Food Inspection Agency Act, Food and Drugs Act, Meat Inspection Act, Canada Agricultural Products Act and the Fish Inspection Act and their respective regulations.

Industry within Canada’s borders has embraced voluntary national food safety standards in partnership with Agriculture and Agri-Food Canada (AAFC) and other government organizations. These standards manifest themselves within the Food Safety Enhancement Program (FSEP) developed by the Canadian Food Inspection Agency (CFIA), which was designed to encourage the establishment and maintenance of HACCP-based food safety systems in federally registered agricultural food processing establishments.[16] The controls exercised by the cold chain within FSEP, such as GMPs and temperature management, are part and parcel of the prerequisite programs, and/or critical control points (CCPs) developed and maintained by each producing member in the food chain. The generic models, including dairy products, egg and processed eggs, meat and poultry meat, and processed products, were developed to cover as many processes and products as possible to facilitate the development of plant-specific HACCP plans.[17]

HACCP is now mandatory in federally inspected meat and poultry processing plants. Prior to the development of HACCP plans under FSEP, establishments are required to have developed, documented and implemented programs to control factors that may not be directly related to manufacturing controls but that support the HACCP plans. The CFIA and the food sector have developed generic models for many commodities including one specific to cold storage/freezer facilities and a mandatory Quality Management Program (QMP) for fish and seafood.[18,19]

Today, the Canadian approach to food safety is complemented by the Canadian Food Safety and Quality Program (CFSQP) headed up by AAFC under the Agricultural Policy Framework (APF). It is a partnership between the federal government, provinces and territories, the Federation of Agriculture, a multitude of food industry trade organizations and the CFIA. This approach requires the programs to be industry-led, national and accessible; commodity-specific; HACCP-based and auditable; consistent, affordable and recognized in Canada; and internationally acceptable.

The Canadian On-Farm Food Safety Recognition Program (COFFSRP) was developed by the agricultural community, with CFIA and AAFC, to address the requirements of primary producers. In most cases this has been built on existing practices.[20] This is resulting in technically sound programs that are founded on a rigorous “HACCP-based” approach, consistent with the Codex Alimentarius. It uses CFIA’s FSEP/HACCP toolkit to develop a generic model and program requirements. Extending food safety in the other direction, programs are also required for the off-farm sector. Many cold chain stakeholders, including the Canadian Trucking Alliance (CTA), Canadian Federation of Independent Grocers (CFIG) and Canadian Council of Grocery Distributors (CCGD) have, after developing their own specific models, collaborated in order to assist each with their operations’ models. This assures that there is no weak link in product integrity from farm to plate, while avoiding duplication of food safety related issues.

The Canadian Food Inspection System (CFIS) is a collaborative initiative of all levels of government.[21] The CFIS Implementation Group has, as one of its key responsibilities, the creation of harmonized national standards. These standards not only include regulations but point towards codes for guidance. For example, the Food Retail and Food Services Regulations and Code, National Dairy Regulations and Code, National Meat and Poultry Regulations and Code, Good Transportation Practices Code and the General Principles of Food Hygiene Code of Practice are specifically relevant to the cold chain. All these documents fit nicely with the HACCP-based systems that are presently under development.

In Canada, there are many smaller food plants that fall under provincial jurisdictions and rely on the cold chain sector. Provinces are working with the federal government to develop food codes that will apply to these smaller companies that trade within a given province. Ontario and Alberta, for example, have already developed their own “HACCP Advantage” programs. In the province of Nova Scotia, legislation covers food manufacturing, retail and food service operation.[22] They must however, comply with all relevant federal legislation.

United States
The population of this modern, food-producing nation is estimated at 298 million in 2006. U.S. federal and state governmental bodies regulate the manufacture, distribution and retailing of chilled (refrigerated) foods. The U.S. Food and Drug Administration (FDA) monitors the manufacture, import, storage and sale of foods that are required to be in compliance with the relevant U.S. Food Code. The 2005 Code provides guidelines on sanitation and the safe handling of refrigerated and frozen foods. The Code requires that the stored frozen foods be maintained frozen and that potentially hazardous foods shall be maintained at 5°C (41°F) or less; or 7°C (45°F) in existing refrigeration equipment that is not capable of maintaining the food at 5°C (51°F) or less.[23]

To complement this Code, the new 2005 Sanitary Food Transportation Act has transferred authority for regulating the safe transportation of food from the Department of Transportation to the Department of Health and Human Services. It requires shippers, motor vehicles, or rail vehicle carriers and other persons engaged in the transportation of food to use sanitary transportation practices.[24] Other documents speaking to the storage, handling and transportation of cold chain products include the U.S. “Transportation and Storage Requirements for Potentially Hazardous Foods” guidelines.[25-27]

In addition to government legislation, industry has developed voluntary recommended practices for the handling and merchandising of frozen foods.[28] This was necessary in order to ensure frozen food quality for the benefit of the consumer. Some important factors considered are maintaining a temperature of 0°F (-18°C) and rotation of inventory throughout the cold chain.

Of course, the U.S. is involved in food law harmonization efforts through its work with Codex Alimentarius, and several government representatives from FDA and USDA sit on the various food safety-related committees, including Food Hygiene. This committee has issued several proposed draft principles and guidelines related to improving cold chain management, including those for the conduct of microbiological risk management and the application of general principles of food hygiene to the control of Listeria monocytogenes in ready-to-eat foods. Similarly, the U.S. provides leadership in the Codex Committee on Food Import and Export Certification and Inspection Systems, which is charged with developing principles and guidelines for food import and export certification and inspection systems. In November 2006, this committee will consider draft appendices to the Codex “Guidelines for the Judgment of Equivalence of Sanitary Measures Associated with Food Import and Export Inspection and Certification Systems.”[29]

Australia/New Zealand
The Australia-New Zealand food standards development system is a cooperative arrangement between Australia, New Zealand and the Australian States and mainland territories. Its mandate is to develop and implement uniform food standards for a combined population of some 24 million. In Australia, Food Standards Australia-New Zealand (formerly Australia New Zealand Food Authority) is charged with the development of food standards that cover the entire food supply chain, from paddock to plate. This includes primary producers through to the manufacturing industry. This organization works in partnership with Australia’s Commonwealth, state and territory governments and the New Zealand government. Responsibility for enforcing and policing domestic food standards rests with the states and territories in Australia and the New Zealand governments.

When it comes to imported foods, the Commonwealth enforces the Code using the “Imported Food Control Act 1992” as its legal authority. Within each jurisdiction, there are one or more agencies responsible for food surveillance. Each is charged with the task of ensuring the requirements of the Code are met.[30] The Commonwealth uses Standard 3.2.2 (Food Safety Practices and General Requirements) as the basis of enforcement and policy. Its divisions and subdivisions specify process control requirements to be satisfied at each step of the food handling process.[31] The Australian and New Zealand authorities also refer to “The Temperature Control of Potentially Hazardous Foods” guide as it explains the temperature control requirements and provides some advice on how to comply with these requirements.[32]

Industry stakeholders include the Australian Food and Grocery Council, the Australian Supermarket Institute and the Refrigerated Warehouse and Transport Association. In order to exhibit their involvement and interest in delivering safe, top quality chilled and frozen foods to the consumer, they have combined efforts to contribute to this common industry/government goal. Their contribution is evidenced by two documents: “Australian Cold Chain Guidelines” and its companion volume “The Australian Cold Chain Food Safety Programs” for the safe handling of frozen and chilled foods. These food safety guidelines seek to strengthen the cold chain by recommending maximum product temperatures and appropriate practices for each link from manufacturer to consumer.[33,34]

European Union
The European Union (EU) has been active for many years in developing harmonized food laws to facilitate trade for a population of some 460 million within its member nation community. The EU agri-food sector generates approximately 670 billion. The ACP (Africa, Caribbean and Pacific) countries, with a population of some 600 million, have a trading agreement with the EU that now makes them responsible for establishing effective control systems for food and feed sector operators under the new food hygiene legislation.

The application of ISO 9000 series standards on quality assurance, generated food safety management systems, which resulted in the updated ISO 22000 series. EU member countries developed the responsibility for enforcement of food safety standards and the basic principles of food law were set down in Regulation 178/2002. This evolved into the present “good hygienic practices” under new controls, for food and feed production, which were adopted in 2004 and went into effect on Jan. 1, 2006. Food safety has also been coordinated for the transportation of food within the new hygiene code.

The harmonized food hygiene package now affects every point of the EU food chain. Food hygiene legislation applies compulsory, self-run, verification programs to industry and combines them with HACCP principles. The legislation is designed to result in good practice guides for the EU food industry, which, together with self-run verification programs, encourages food operators to be registered. Important features of the new regulation include microbiological standards, to reduce foodborne illness for food products, with set criteria for Salmonella and Listeria levels.

The European Food Safety Authority (EFSA) is expected to list criteria for additional pathogens in the future. This harmonized EU control system applies to all EU member countries and others that wish to export to the EU. It is worth noting that import controls for products destined for the EU require the presentation of EU standard conformance guarantees.

Russia
Food safety regulation in Russia involves a number of federal government bodies, each with their own area of specialization. These include the National Body of Sanitary Control, Ministry of Agriculture, Agency of Technical Regulation, State Trading Inspection, Ministry of Economic Development and State Grain Inspection. Each is involved in traceability, safety and hygiene for the food market in Russia. As a major food producer, it was necessary to set standards for food safety and quality for domestic and international requirements. Standard GOST R 51074-1997 provided the classification of some food products and also prohibited the use of ambiguous product descriptions. The new Russian food standard, GOST P 51074-2003, became law on Jan. 1, 2005. It is more fully developed and designed to integrate with international food safety standards.

HACCP based food safety programs are being used more frequently by Russian industry to satisfy international and local market demands. Russia’s 2002 census revealed a population of 145 million, with most of the food consumers located in major urban centers. The cold chain is becoming more visible in the new regional refrigerated warehouses that are being built to maintain a safe food supply.

Proof of compliance with the new EU Hygiene Code for food products imported from Russia has made it necessary to modify food production techniques. Russian food exports to Commonwealth of Independent States countries must still present proof that Russian safety regulations are met.

China
China, with a growing population, now at 1.3 billion, also has an expanding food industry. Food safety is receiving its share of public concern and government scrutiny. The food industry in China has grown at a rate of 13% per year since the 1980s. This growth, together with foodborne illness frequency, has made food safety a major challenge. Increasing numbers of supermarkets, growing at a rate of 30-40% a year, have created a dramatic growth of infrastructure. Food distribution and transportation sectors have started to depend increasingly on a more reliable cold chain during this growth process.

Provisions of the “Food Hygiene Law of the Peoples Republic of China” contain food safety regulations and risk management measures. Its fifth provision stipulates that “the government encourages and protects the supervision of food safety by social bodies and individuals.”

Ministries of Agriculture and Health are responsible for food safety. Some 69 standards are under development to guide the safe production, storage and transport of food. These standards are expected to be active in 2006, meet the requirements of Codex Alimentarius and include HACCP standards.

India
The need to meet food safety challenges, and provide a population of almost 1.1 billion with safe food, has raised the awareness of international food safety systems in India. While many small food enterprises and street vendors supply local food needs in accordance with local standards, the assurance of safe food production for international markets has created an opportunity to harmonize domestic and Codex Alimentarius standards with a HACCP approach. The Food Safety and Standards Bill, 2005, aims to consolidate eight laws governing the food sector and seeks to establish the Food Safety and Standards Authority.

The Directorate General of Health Services in the Ministry of Health and Family Welfare is presently integrating Codex standards into domestic food laws. The national standards body, the Bureau of Indian Standards, has adopted Codex, HACCP and food hygiene standards. Food processors are being encouraged to adopt these standards voluntarily. The cold chain is expanding in accordance with international market demand and regional food distribution needs.

Export certification is mandatory, for a variety of foods, under India’s Export Inspection Act. Inspections are carried out under ISO standards.

Latin America
Refrigerated and frozen products are becoming an important part of the food processing and distribution sectors in Latin America and the Caribbean. It is a region of 20 independent nations with a population of 560 million people. The cold chain is being recognized here as a key element in maintaining food safety and quality for domestic and export purposes.

While these temperature requirements are identified as crucial to food safety, it was noted by the FAO and WHO that at least 6,000 outbreaks of foodborne diseases occurred between 1993 and 2002. A December 2005 meeting, of two hundred regional food safety experts and regulators, hosted by the government of Costa Rica, was given FAO and WHO figures of an estimated 57,000 deaths from food- and waterborne diarrhea, which occurred in the region in 2004. A comprehensive plan of harmonized food legislation and Codex Alimentarius standards is now being developed to improve the safety and quality of food. Both domestic health and international trade will benefit from these measures.

The region is expected to rapidly increase its food exports, presently some 66 billion USD worth, when costly rejections due to food safety problems are reduced.

Conclusion
The handling of refrigerated and frozen foods by all players within the international community is extremely important. This is confirmed by the fact that each government body and the industry player strives to develop unique yet similar controls. The world is becoming more interconnected. The need for harmonization of food safety regulations and practices, and for reaching international agreements to benefit a functional cold chain sector is vital. This will facilitate trade and instill confidence in food-related markets across the world. Such harmonization would give us security, adequate health protection and consumer acceptance.

Simon Jol is President of Foodpath Inc. and the director responsible for market development and client relations. He has been actively involved in applying HACCP principles to the food distribution sector and has extensive experience in the design and installation of environmental engineering systems and food processing facilities. Jol has been active on a variety of standards committees, including the Canadian General Standards Board, and recently contributed to the development and formation of the new Canadian Organic Food Standard. He also developed a special focus on the needs of food safety in the transportation and food distribution sectors.

In addition to Jol, this article was researched and prepared by a diverse group of individuals, including Alex Kassianenko, DVM. MSc, research/systems specialist; Kaz Wszol, FST, research/systems specialist; and Jan Oggel, BSc, associate director of research, Foodpath, Inc..

References
1. Smith, J., and P. Sewell. Legislation and food transport. In Food Transportation (eds. R. Heap, M. Kierstan, and G. Ford), Blackie Academic & Professional, pp. 215-228.
2. Codex Alimentarius. 2003. Recommended internatio