 Federal, state and local agencies share responsibility for ensuring that food processors follow food safety laws. The goal of all of these laws is to protect the public by ensuring that food processors produce safe food. There are a number of tools available to help fresh cut processors comply with the law and help minimize hazards associated with processing fresh cut fruits and vegetables. These tools include regulations and government guidance, as well as voluntary programs developed by the fresh cut industry. In this segment, we will discuss requirements and voluntary guidelines. We will clarify and define many of the terms and definitions of these laws and regulations. Each tool is identified in this table as a law or regulation, a guideline or a voluntary program. Laws and regulations are legal requirements that must be followed. Government guidelines are recommendations often suggesting the best way to comply with laws and regulations. Voluntary programs, as the name implies, are completely voluntary. In many cases, voluntary programs are developed by food industry associations to provide guidance for their members. While government guidelines and voluntary programs are not requirements, they should be carefully considered as they are excellent sources of information on how to implement food safety programs and they often provide reliable direction on how to comply with legal requirements. Federal, state and federal public health agencies may inspect fresh cut processing facilities. Federal agencies such as the FDA have jurisdiction over products in interstate commerce, that is, products that move or have moved across state lines. State agencies have jurisdiction over produce, produced, distributed and consumed in the states. State regulators may adopt federal requirements as their own state laws. Some states may adopt requirements that must be met in addition to federal requirements. Fresh cut produce operations must comply with all existing state and federal laws and regulations that apply to food establishments. The first of these laws is the Federal Food, Drug and Cosmetic Act, which is sometimes referred to as the FD&C Act or simply the Act. The Act fits into the table under laws and regulations. The Act is one of the main legal authorities for food inspection in the United States. The Act was enacted to protect public health. The Act prohibits the interstate shipment of adulterated food, which includes any food containing a pathogen, an organism that can cause disease, such as Salmonella, E. coli 0157H7 or any other harmful substance. Foods that are spoiled or that are prepared using spoiled food or foods that are contaminated by insects, rodents or other types of filth are also considered to be adulterated. High quality food prepared or stored under insanitary conditions, such as a dirty environment or handled by workers with poor personal hygiene, is also adulterated. When food is adulterated, regulatory agencies have procedures that they follow. In some cases, they may ask the firm to voluntarily correct the problem. Sometimes the agency may send a warning letter to the firm. In other cases, the adulterated food may be removed from commerce through the courts. Similarly, in serious cases, the regulators may file an injunction to stop the firm from producing adulterated food, or they may initiate a criminal prosecution of the responsible persons, typically the manager and owner of the firm. Good manufacturing practices, or GMPs, are regulations that describe how food processing plants should be designed and run to ensure food safety. They will be placed in the table in the Laws and Regulations section. GMP regulations for food production and storage facilities can be found in the Code of Federal Regulations, Title 21, Part 110, Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food. The GMPs were designed to ensure that processed food is produced under conditions that meet minimum food safety standards. The standards were developed with input from the public, including the food industry. A copy of the Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food Regulation can be obtained by ordering from the U.S. FACSWATCH at 1-202-512-1716, or downloading from the FDA website at www.fda.gov. One section of the GMPs describes the requirements for the education and training of personnel. This section emphasizes the need for adequate employee training in proper food handling and food protection. It states that the responsibility for ensuring adequate training of employees should be assigned to competent supervisory personnel. Supervisors and managers are also responsible for ensuring that employees adhere to all of the requirements of the good manufacturing practices. Another section of the GMPs, entitled Plant and Grounds, covers facility construction and design. The Plant and Grounds section includes specific requirements for the layout of the facility. These requirements describe the measures necessary to provide adequate separation of raw materials from finished product. The design and layout of the facility is important to help prevent cross-contamination of food and food contact surfaces or packaging material. General maintenance and pest control is discussed in the Sanitary Operations section of the GMPs. This section outlines proper sanitation of food contact surfaces and proper storage of cleaning materials, cleaned equipment and utensils. Air supply, plumbing, sewage disposal, toilet facilities, rubbish disposal and hand-washing facilities are discussed in the Sanitary Facilities and Controls section. The Equipment and Utensils section states that all equipment should be designed and constructed so it is durable and easily cleanable. Food contact surfaces should be smooth, non-porous, non-toxic and should not contribute off odors or colors. Corrosion resistant materials should be used in construction because rust and pitted surfaces are difficult to clean and allow for growth of microorganisms. Seams should be smooth and free of cracks and crevices. All equipment should be properly cleaned and maintained. Examples of acceptable equipment materials include some types of stainless steel, various plastics and laminates. Some types of stainless steel can corrode. Stainless steel that can corrode is not acceptable for fresh cut facilities. It is very important that equipment and utensils be constructed of food grade materials so as not to create a health hazard to consumers. Not all items found in general hardware stores or variety stores are recognized food grade materials. If uncertain, contact the NSF International at 1-800-NSF-MARK to verify whether or not a material is considered food grade. Utensils used in food production should meet the same criteria used for equipment. All equipment and utensils should be cleaned and sanitized daily or more frequently as needed to avoid product contamination. Information on cleaning and sanitation techniques for food contact surfaces, equipment and utensils is provided later in this video. The processes and control section of the GMPs covers all operations in a food processing facility. This section specifies that all operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging and storing of food should be conducted in accordance with adequate sanitation principles. The company should use appropriate quality control to ensure that the food packaging materials they use are both suitable and safe, and that the food is suitable for human consumption. This is only a brief outline of the good manufacturing practices that are required for processed food. GMPs can be useful in helping fresh cut processors control their process and minimize microbial, chemical and physical hazards during all stages of the processing operation. In addition, some states, including California, have incorporated the GMP regulations into the state health and safety codes, making them requirements for all food produced in the state. Pre-requisite programs is the term used to describe a range of programs that enhance operational conditions and provide a foundation for food safety programs. Examples of such programs are good manufacturing practices and standard operating procedures, which will be discussed next. Why are prerequisite programs important? Pre-requisite programs, when properly followed, help keep many things from becoming serious problems that could eventually have an impact on food safety. They also make up the foundation from which to develop a hazard analysis critical control point or HACCP program. More about this program shortly. First, it's important to look at some prerequisite programs. Good manufacturing practices represent one important prerequisite program. For example, as part of the good manufacturing practices, it is advisable to have a written training plan for employees that includes procedures and documentation of training activities. It should cover topics on proper food handling, food protection and concepts on how insanitary practices and poor personal hygiene can lead to consumer and employee illnesses. Other examples of prerequisite programs are standard operating procedures, sanitation standard operating procedures, master sanitation schedules, operational actions such as raw material controls, product coding and labeling, product traceability and recall procedures, consumer complaint management and crisis management. There are several areas of concern in a fresh cut process where properly implemented and monitored GMPs with appropriate standard operating procedures can effectively control contamination of food or food contact surfaces. For example, inadequate cleaning of food contact surfaces, poor personnel practices, inadequate plant construction or design and inadequate pest control. At a minimum, fresh cut processors should consider developing standard operating procedures for receiving and storage procedures ensuring and maintaining water quality, washing, cutting and drying procedures, temperature control, microbiological controls, pest control, packaging procedures including methods and controls, storage, transportation, date coding and recall procedures. If employees fail to follow standard operating procedures, reasons for the deviation should be clearly identified. For example, when a piece of equipment breaks down, the specific location, time and reason for the equipment breakdown should be documented along with an explanation of what was done to correct the breakdown. Each employee should clearly understand every prerequisite program involving themselves and their work area. This can be achieved by implementing continuous training programs, another component of prerequisite programs. Important components of prerequisite programs are the sanitation standard operating procedures and master sanitation schedules. They are instructions or procedures for sanitary practices developed for each specific cleaning and sanitation operation. They identify what to clean, how to clean and sanitize, when to clean and who should clean. Why are they important? Proper sanitary controls and procedures identify problems such as microbial contamination of fresh produce and their sources such as inadequately cleaned equipment before they cause illnesses and injuries. Once problems are found, they can be corrected. Suitable cleaning and sanitizing prevents product contamination from unclean equipment, utensils and facilities, thus reducing liability. Now let's consider guidelines which apply to fresh cut produce. One example is the guide to minimize microbial food safety hazards for fresh fruit and vegetables, which was published in 1998. This voluntary guideline provides recommendations on good agricultural practices, GAPs, and good manufacturing practices, GMPs. This guide also discusses microbial food safety hazards common to fruits and vegetables sold to consumers in raw form. This guideline incorporates many comments and suggestions from the agricultural community and industry associations. All fresh produce should be grown according to the GAPs. GAPs minimize the likelihood that produce will contain pathogenic microorganisms. A fresh cut processor should know as much as possible about the source of the fresh produce he uses and verify that the produce has been grown and harvested in a manner consistent with the GAPs. Let's look at the table under voluntary programs. As mentioned previously, once GMPs and prerequisite programs are in place, processors can develop additional food safety programs such as HACIP. HACIP is an acronym that stands for Hazard Analysis and Critical Control Point. Its concept is an important part of a food safety program because it builds upon use of strong GMPs and prerequisite programs and focuses on prevention of food safety problems. HACIP is a tool for managers and line workers to evaluate each of the firm's operations from receiving to distribution. In HACIP, the biological, chemical and physical hazards that are associated with each operation are identified. After identifying the hazards, critical control points or CCPs are identified. CCPs are those points in the processing where controls can be applied and where loss of control would lead to a food safety problem. For example, monitoring residual antimicrobial levels such as chlorine in wash water is a critical control step. When antimicrobial levels are too low, any pathogen present may survive and result in food that is unsafe for consumption. Another process is put in place for each CCP to make sure that food safety problems do not occur. The process is then monitored frequently to ensure that all aspects of the product process at the CCP are in control. HACIP programs are a mandatory part of meat, poultry, juice and seafood production. But HACIP is not currently required for fresh cut products. Just as one cannot sanitize without first cleaning, HACIP cannot be properly planned and implemented without a strong foundation of GMPs and prerequisite programs. Thus far we have discussed the Federal Food, Drug and Cosmetic Act, the Good Manufacturing Practices, Good Agricultural Practices, Pre-Requisite Programs and HACIP. In the event of a foodborne illness outbreak, it will also be important to have traceback and recall procedures in place. We know that tracebacks cannot prevent foodborne illnesses from occurring, but being able to review good records and quickly trace a food back to its source can limit the public health and economic impacts of an outbreak. Fresh cut processors should develop and implement systems to facilitate tracebacks and recalls in the event of a problem. Fresh cut processors should test their systems regularly by conducting unannounced mocked recalls. Traceback typically begins with the retail source of the fresh cut produce thought to cause illness or injury and works back to a processing facility and field. Information from a traceback can often be used to aid in prevention of future illness outbreaks. Recall procedures are developed and used by a fresh cut processor to withdraw product that is already in the marketplace. A processor should be able to track all products. Records such as the grower identification, production and distribution records for a specific lot of fresh cut product should be orderly, properly maintained and easily retrievable in less than one hour. It is good procedure to periodically test the firm's ability to retrieve information from the records by conducting mock recalls. Locked coding packages by date code or other coding may facilitate recovery of the product if a recall is needed. Production records and date codes help put the puzzle together to identify the source. What are the consequences of an outbreak that implicates a product? Without records the whole product line is suspect. All of the production procedures are suspect. More questions are raised than can be answered. Is the pathogen limited to only one day, one week or one month of production? Is the source of the problem incoming product or employee practices? Has dirty equipment contaminated the product? The production facility has accurate records of effective cleaning and sanitation of equipment, has well trained employees and pays consistent attention to GMPs. The facility will greatly reduce the likelihood of its products causing a foodborne illness outbreak. This segment has focused on understanding the legal requirements and voluntary programs for fresh cut processors. To review GMPs are the regulations that fresh cut processors should follow in producing food that is safe to consume. Once GMPs are firmly established, prerequisite programs can be used to ensure that manufacturing and sanitation procedures are performed consistently. Pre-requisite programs will reduce the chances of problems occurring and will assist both the fresh cut processor and the regulator in identifying and correcting problems if they do occur. HACIP is a voluntary system that treats the production, processing, storage, distribution and service of food as a continuous process. This process is broken down into its logical components and each step is evaluated. The premise is simple. If each step of the process is carried out correctly, the end product will be safe food.