 Federal, state and local agencies all share responsibility for ensuring that food processors follow food safety laws and regulations. The goal of these laws and regulations is to protect the public by ensuring that food processors produce safe food. There are a number of tools available to help sprouters comply with the law and produce safer sprouts. These tools include regulations and government guidance, as well as voluntary programs developed by sprouters themselves. In this module, we will discuss in depth the requirements and guidance for sprouters and clarify and define many of the terms and definitions surrounding existing laws and regulations. At times, the abbreviations for these tools may sound a little like alphabet soup. For clarification, each tool is identified in this table as a law or regulation, a guideline or a voluntary program. Laws or regulations are the legal requirements that should be followed. Guidelines are government recommendations, often suggesting how the government believes you can best comply with laws and regulations. As the name implies, voluntary programs are completely voluntary. In many cases, voluntary programs developed by food industry or grower associations have served as guidance for their members. While government guidelines and voluntary programs are not mandatory, they should be carefully considered as they are excellent resources for the implementation of food safety programs and sometimes on ways to comply with legal requirements. Local, state, and or federal government public health agencies may inspect a sprout facility. Federal regulators have jurisdiction over products that move across state lines, otherwise known as interstate commerce. State regulators may adopt federal requirements in their own state laws. Some states have adopted requirements that should be met in addition to federal requirements. Sprouters should comply with all existing state and federal laws and regulations that apply to food establishments. The first of these is the Federal Food, Drug, and Cosmetic Act, which is sometimes referred to as the FDNC Act or simply the Act. The Act fits into the table under laws and regulations. The Act is the legal authority for food inspection in the United States. The Act was introduced nearly a century ago to protect public health. It also creates a level playing field for the food industry. Sprouts are food. The Act prohibits the sale of adulterated food. In the words of the Act, food is considered adulterated if it contains any poisonous or deleterious substance which may render it injurious to health, section 402A. If it consists of any filthy, putrid, or decomposed substance or is unfit for food, section 402A. Or if it has been prepared, packed, or held under in sanitary conditions whereby it may have become contaminated with filth or rendered injurious to health, section 402A. In other words, the sale of adulterated food is illegal. Adulterated food is defined as any food containing a pathogen 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 with insects, rodents, or other types of filth are considered to be adulterated. High quality food prepared or stored in a dirty environment or handled by workers with poor personal hygiene is also adulterated because these conditions greatly increase the likelihood that the food may become contaminated with harmful substances. When food is adulterated, regulators have tools that they use to address the problem. In some cases, they may ask the firm to voluntarily make the appropriate corrections. Sometimes the regulator will send a warning letter to the firm. In other cases, the product may be seized. A seized product cannot be sold unless the court releases it. Finally, in serious cases, the regulators may file an injunction to stop the firm from producing food or they may prosecute the responsible persons, typically the facility manager or owners. GMPs are also regulations. GMPs are short for good manufacturing practice in manufacturing, packing, or holding human food. These regulations can be found in Part 110 of Title 21 of the Code of Federal Regulations. The GMPs were developed with input from the food industry to ensure that processed food is produced under conditions that meet minimum food safety standards. A copy of the current good manufacturing practices in manufacturing, packing, or holding human food is provided in your materials. A complete copy can be obtained by ordering at 1-202-512-1716 or downloading from the FDA website at www.fda.gov. The GMPs for food Part 110 are comprised of several subparts, which include general provisions, buildings and facilities, equipment, production and process controls, and defect action levels. Section 110.10 of the GMP describes the requirements for personnel education and training. This section emphasizes the need for adequate employee training in proper food handling and food protection. It includes identifying the dangers of insanitary practices and poor personal cleanliness and how these practices can lead to consumer and employee illnesses. 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 good manufacturing practices. Facility construction and design are discussed in the Plant and Ground section 110.20. Included in this section are specific requirements for facility layout that provide adequate separation of raw materials from finished product. This section identifies methods to avoid cross-contamination of food and its contact surfaces or packaging material. General maintenance and pest controls are discussed in the Sanitary Operations section 110.35. This section outlines proper sanitation of food contact surfaces and storage of cleaning materials, cleaned equipment and utensils. The Sanitary Facilities and Controls section 110.37 addresses water supply, plumbing, sewage disposal, toilet facilities, hand-washing facilities and rubbish disposal. The Equipment and Utensils section 110.40 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 is difficult to clean and allows for growth of microorganisms. Seams should be smooth and free of cracks or 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 sprout production. It is very important that equipment and utensils be constructed of food-grade materials. Not all items found in general hardware stores or variety stores are recognized food-grade materials. If uncertain, contact the NSF International 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. Cold storage compartments play an important role in keeping many types of foods safe but are also potential sources of contamination. All refrigerators used to store or hold food should be fitted with a thermometer that accurately indicates the temperature within the compartment. This indicator should have an automatic control for regulating temperature within the compartment or an alarm system to alert of equipment failure. Cold storage compartments should be of sufficient size to allow storage of food so that there is sufficient air flow for cooling, protection of the food from seepage, foodborne filth and overhead condensation from fixtures, ducts and pipes. Processes and controls section 110.80 covers all operations in a food processing facility from receiving through preparation, packaging and storage of food. This section stipulates 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 controls 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, although some food such as raw agricultural commodities are currently exempt from GMPs. GMPs can be useful in helping sprouters control their process during all stages of sprout production. In addition, some states including California have incorporated the GMP regulations into the state health and safety codes, making them requirements for all foods produced in the state. Once a facility has implemented GMPs, other tools can be considered to enhance operations and to supplement a food safety program. For example, standard operating procedures, or SOPs, and sanitary standard operating procedures, or SSOPs, are tools that can help the sprouter systematically evaluate and implement appropriate procedures and controls. Inspectional surveys of the sprouting industry have revealed significant areas of concern in some companies. Recurring problems included potential contamination due to inadequate cleaning of food contact surfaces and equipment, poor personnel practices, poor general maintenance, inadequate plant construction or design, lack of temperature controls, and inadequate pest control. All of these problems can be addressed by adopting GMPs and consistently following SOPs and SSOPs. SOPs and SSOPs are voluntary programs. SOPs are procedures developed by the sprouter, describing how things should be done in their own facility. Although an industry association or other party may develop SOPs, they need to be adapted for each specific facility. At a minimum, sprouter should consider developing SOPs for seed receiving and storage procedures, ensuring and maintaining water quality, sprouting procedures, temperature control, microbiological controls, pest control, packaging procedures including methods and controls, and recall procedures. When the standard procedure is not followed, reasons for the deviation should be clearly identified. An example might be equipment breakdown. Each employee should clearly understand every SOP involving them or their work area. This can be achieved by implementing continuous training programs. Why are SOPs important? SOPs help the entire firm operate consistently. This provides a recipe to follow for what should be done and what has been done. Time is saved in the long run when a firm follows its SOPs. Included in the handout materials is a self-inspection guidance document for sprout growers that was prepared by the California Department of Health Services Food and Drug Branch. Performing a self-inspection helps you identify problems and test proposed solutions. SSOPs are another ingredient in the alphabet soup. SSOPs are sanitary standard operating procedures. They are instructions or procedures for sanitary practices developed by the sprouter 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 SSOPs important? Proper sanitary controls and procedures identify problems and their sources 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. One example of a guideline is the guide to minimize microbial food safety hazards for fresh fruit and vegetables, which was published in 1998. This guideline provides recommendations on good agricultural practices, GAPs, and good manufacturing practices, GMPs. It addresses microbial food safety hazards and good agricultural and management practices common to fruits and vegetables sold to consumers in raw form. The voluntary guidance document was prepared in close cooperation with the agricultural community. GAPs apply in the area of seed production and conditioning. Seed for sprout production should be grown according to good agricultural practices that minimize the likelihood that they will contain pathogenic microorganisms. A sprouter should know as much as possible about the source of the seeds and verify that they have been grown and harvested in a manner consistent with the GAPs. The GMP section of this guide provides information on facility sanitation, employee hygiene, training, and pest control for the packing house operation. These basic principles can also be applied to the seed conditioning and storage facilities and the sprouting facility. Two related guidance documents are the reducing microbial food safety hazards for sprouted seeds and sampling and microbial testing of spent irrigation water during sprout production. These guidance documents are intended to provide recommendations to suppliers of seed for sprouting and sprout producers about how to reduce microbial food safety hazards and to ensure that sprouts comply with the food safety provisions of the Federal Food, Drug, and Cosmetic Act. The first guideline identifies the most important steps such as good agricultural practices, seed disinfection treatment, and microbial testing for reducing the likelihood of sprouts as a vehicle for foodborne illness. The second document is intended to assist sprouters in implementing one of the principal recommendations in the broader guide, such as microbial testing of spent irrigation water. Recommendations in the Sprout Guidance documents will be discussed at different points throughout this video, and the documents have been included in the materials that came with this video. Another food safety control measure is hazard analysis and critical control point, known as HACIP. It is a preventative program that focuses entirely on food safety and builds upon a strong GMP program. HACIP evaluates a processing operation and identifies the microbiological, chemical, and physical hazards with established critical control points and frequent monitoring and verification. HACIP programs are a mandatory part of meat, poultry, and seafood production, but HACIP is not currently required for other foods. Just as one cannot sanitize without first cleaning, HACIP cannot be properly implemented without a foundation of adherence to GMPs. Traceback cannot prevent foodborne illness from occurring. However, being able to trace a food back to its source quickly can limit the public health and economic impacts of an outbreak. Sprouters, seed producers, conditioners, and distributors should develop and implement systems to facilitate tracebacks and recalls in the event of a problem. All parties should test their systems in advance of a problem. Traceback typically begins with the sprouts and works back to a facility or a lot of seed. This information can often be used to aid in prevention of future illness outbreaks. Recall procedures are developed and used by a sprouter to withdraw product that is already in the marketplace. A sprouter should be able to track all activities and products. Records should be orderly, maintained, and easily retrievable. It is good procedure to periodically test the firm's ability to retrieve information from the records. Can the seed source, production, and distribution records for a specific lot of sprouts be recovered in less than one hour? Lot-coding sprout products by date code or other coding may facilitate recovery of the product if a recall is needed. Records help put the puzzle together to identify the seed source with related production records and date code. What are the consequences in the event of an outbreak that implicates the product? Without records, the entire outgoing product is suspect. All of the production procedures are suspect. More questions are raised than can be answered. Is the pathogen limit to only one day, one week, or one month of production? Is the source of the problem the seed or employee practices? Has dirty equipment caused product cross-contamination? With SSOPs and sanitation checklist records, the effect of a recall could be limited to a short time period if records show a thorough and complete cleaning and sanitation is done regularly. If a sprouter has accurate records of cleaning and sanitation, well-trained employees, consistent and appropriate use of seed disinfection treatments, and negative lab results on a lot-by-lot basis, they will greatly reduce the likelihood of being involved in an outbreak. You cannot build food safety without meeting the standards outlined in the good manufacturing practices. Understanding the requirements for sprouters has been the focus of this segment. The ingredients in the alphabet soup all play a role in food safety. GMPs are the standards that sprouters should follow in producing food. Once a sprouter has GMPs firmly established, SOPs and SSOPs can be used to ensure that manufacturing and sanitation procedures are performed consistently. These procedures will reduce the chances of problems occurring and will assist both the sprouter and regulator in identifying and correcting the situation if problems do occur. As previously mentioned, once GMPs are in place, additional food safety programs such as HACCP can be developed. HACCP is a technique and a thought process that treats the production, storage, distribution and service of food as a continuous system. This system is broken down into its logical components and each is evaluated by principles of failure analysis. The premise is simple. If each step of the process is carried out correctly, the end product will be safe food.