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Every year nearly 1 in every 6 Americans become ill, 128,000 are hospitalized and 3,000 die from foodborne diseases according to the Centers for Disease Control and Prevention. Food safety and foodborne illness are matters of critical concern, requiring new regulatory tools for the U.S. Food and Drug Administration (FDA). In 2011, President Obama signed the FDA Food Safety and Modernization Act (FSMA) into law to help prevent foodborne illness.

This new food safety law creates new authority for the U.S. Food and Drug Administration (FDA), enabling it to institute food recalls rather than depend on voluntary measures by food producers and distributors. As part of the new Food Safety and Modernization Act (FSMA) legislation, the FDA will have the power for oversight to ensure compliance with new regulatory requirements and will be expected to respond effectively when problems arise.

Here are some of the new tools provided to the FDA by the Food Safety and Modernization Act for inspection and compliance:

      1. Mandated inspection frequency:
        As part of the effort to improve food safety, the FDA has the authority to inspect “high risk” food products annually and can initiate product recalls of suspected tainted food products. Previously, product recalls were conducted on a voluntary basis by individual food producers and distributors and were not mandated by the FDA.
      2. Access to records:
        The FDA will now have access to records, including documentation of food safety plans.
      3. Penalties:
        As part of the effort to increase compliance with food safety regulations, the FDA has been granted the power to levy heavy fines and may limit supplies to food companies that are uncooperative with FDA inspections and food product recalls.
      4. Food traceability:
        The U.S. Department of Health and Human Services has been tasked to create a food tracing system. This effort will streamline the discovery of contamination sources and aid in improving the response times during outbreaks of foodborne illness and food poisoning.
      5. Food safety plans:
        Food processors are now required to create comprehensive food safety plans, commonly referred to as Hazard Analysis and Critical Control Points (HACCP). These food safety plans must be readily accessible by governmental agencies in case of food safety emergencies. Hazard Analysis and Critical Control Points (HACCP) plans address the analysis and control of biological, chemical and physical hazards from raw material production, procurement and handling to manufacturing, distribution and consumption of the finished food product. This comprehensive effort is a science based system used to ensure that food safety hazards are addressed and controlled to prevent unsafe food from reaching consumers.

What is traceability?

Food product traceability involves documenting the production and distribution of food products at every stage of the process so that in case of an outbreak of foodborne illness or evidence of contaminated food, a food product can be traced back to a common source or forward through all distribution channels. Historically, food producers, processors and distributors have used paper based systems for product tracking. These systems are ineffective and do not provide information quickly in formats that can easily be accessed. Today, new technological tools can provide faster, more efficient ways to track & trace food products, facilitating food recalls.

An effective product tracing system enables governmental agencies, food producers, food distributors and food retailers to take the necessary action swiftly and effectively to keep the affected food products from endangering consumers.

At this point, many food producers, food distributors and food retailers have some elements or complete food track and trace systems either planned or implemented. There is a great variation in track and trace systems. Traceability systems vary widely in the information they collect as well as on the level of precision with which a product’s movement is recorded. Food track & trace systems may use barcodes, RFID tags or tracking media in order to monitor products. Full traceability includes the “ability to track any food, feed, food producing animal or substance that will be used for consumption, through stages of production, processing and distribution. “ Adherence to full traceability measures creates the ability to identify which products must be recalled, potentially reducing the expense of product recalls dramatically.

According to the International Organization for Standardization (ISO), the organization that develops voluntary international standards for products and services, traceability is the “ability to trace the history, application or location of that which is under consideration”. This definition is purposely very broad as food is a highly complex product, often composed of multiple ingredients. Companies define the precision, depth and breadth of their traceability systems based on their objectives and the parameters and characteristics of their production processes. In terms of traceability, the depth is the extent to which a traceability system can track relevant information; the breadth defines the amount of information that is collected and recorded and the precision is defined as the degree of assurance with which a tracing system can pinpoint a particular food product’s movement or characteristics.

Global standards for food traceability

In 2002, the European Union’s General Food Law became effective, making traceability compulsory for all food and feed businesses.
In accordance, European traceability systems require a unique piece of data via a barcode or RFID tag that can be traced through the entire production process. Because of the ease with which food and feed products traverse EU country boundaries, traceability can only be effective if common requirements are met across all Member States.

In accordance with food safety requirements in the EU General Food Law, all food and feed operators must implement special traceability systems to identify where their food products originated and are going to so that this information can be provided to the competent authorities. Records must detail the business operators to detail the names and addresses of suppliers, customers, nature of the product and date of delivery. Business operators are encouraged to maintain documentation on the volume or quantity of the product, batch number, if there is one and detailed product description including whether a product is raw or processed.

More specific requirements for food safety documentation of this regulation exist for specific types of food products such as fruits and vegetables, beef, fish, honey, and olive oil to enable consumers to identify their origin and authenticity. Special traceability rules for genetically modified organisms (GMOs) ensure that the genetically modified content of a product can be traced. Accurate labeling regarding genetic modification is required so allow consumers to make an informed choice.

With respect to animals, producers are required to “tag” every animal with details of their origin. When animals are taken for slaughter, they are stamped with the traceability code of the slaughterhouse. Vendors in different countries may use different traceability tools such as ear tags, passports or bar codes, but the information required for documentation remains consistent. In April 2004, the EU introduced the Trade Control and Expert System (TRACES) to provide a central database for tracking the movement of animals from within the EU and from third countries to enable immediate action to prevent products from potentially affected animals from reaching consumers.

RASFF (Rapid Alert System for Food and Feed) in place since 1979 was enhanced by the EU General Food Law in 2002. RASFF is a warning system that supports the traceability system by enabling rapid exchange of information whenever a risk to food or feed safety is identified. If a member of the network, (27 Member States, EU, European Food Safety Authority, Iceland, Liechtenstein and Norway) becomes aware of a potential risk to human health, it notifies the EU. They immediately transmit the information to all other members and beyond so that all necessary action can be taken immediately.

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