 Federal, state and local agencies share responsibility for ensuring that food processors follow food safety laws and regulations. The goal of all 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 juice processors comply with the law and help minimize hazards associated with processing juice. These tools include regulations and government guidance, as well as voluntary programs developed by the juice industry. In this module, we will discuss requirements and guidance. We will attempt to clarify many of the terms and definitions of laws and regulations. Each tool is identified in this table as a law or regulation, a guideline or a voluntary program. Laws or regulations are legal requirements that must be followed. Guidelines are government recommendations, often suggesting how regulatory agencies believe you can best comply with laws and regulations. Voluntary programs may also be developed by industry to provide guidance for their members. While government guidelines and voluntary programs do not set requirements, they should be carefully considered as they are excellent resources for the implementation of food safety programs and often provide reliable direction on how to comply with legal requirements. The first of these laws is the Federal Food, Drug and Cosmetic Act, also 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 principal legal authorities for food inspection in the United States. The Act prohibits the shipment of adulterated food, including food containing a pathogen such as salmonella, E. coli 0157H7, or any other harmful substance. Foods that are spoiled or prepared using spoiled foods, or foods that are contaminated by insects, rodents, or other filth, are also considered adulterated. Good quality foods prepared or stored under insanitary conditions, such as in a dirty warehouse or handled by workers with poor personal hygiene, are also adulterated. Good manufacturing practices, or GMPs, are regulations. 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, including juice, is produced under conditions that meet minimum food safety standards. One section of the GMPs describes the requirements for the education and training of personnel, emphasizing the need for adequate employee training in proper food handling and food protection. It includes identifying the dangers of insanitary practices and poor personal hygiene, and how these practices can lead to consumer and employee illnesses. The Plant and Ground section covers facility construction and design, and includes requirements for facility layout that provide adequate separation of raw materials from finished product. General maintenance and pest control are discussed in the Sanitary Operations section. The Equipment and Utensils section requires that all equipment be designed and constructed so it is durable and easily cleanable. Equipment and utensils should be constructed of food grade materials. If uncertain about whether an item is made of food grade materials, you can contact the manufacturer, or NSF International at www.nsf.org or 1-800-NSF-MARK. The Process 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 storage of food should be designed and implemented to prevent contamination and ensure a safe product. This is just a brief outline of the GMPs that are required for processed food. A copy of the current good manufacturing practice in manufacturing, packing, or holding human food can be obtained by downloading from the FDA website at www.cfsan.fda.gov under the heading Industry Assistance. On January 19, 2001, FDA published a juice regulation called HACCP, Procedures for the Safe and Sanitary Processing and Importing of Juice, Final Rule. We will put this regulation in the column labeled Laws and Regulations. This regulation is based on the seven principles of the Hazard Analysis and Critical Control Point System called HACCP, and has become known as the Juice HACCP Regulation. A copy of the Juice HACCP regulation can be downloaded from FDA's website at www.cfsan.fda.gov under the heading HACCP. The regulation is Part 120 of Title 21 of the Code of Federal Regulations, CFR. Part 120 is divided into two subparts. Subpart A covers the general provisions of the regulation, including who is covered by the regulation, how the regulation impacts GMPs and SSOPs, the requirements for a hazard analysis, and for the HACCP plan if one is needed. This section also sets out definitions used in the regulation and specific requirements such as training, record keeping, and verification and validation. Finally, subpart A describes how the regulation will be applied to juice imported into the United States. Subpart B sets out that processors of juice products shall include in their HACCP plans control measures that will consistently produce, at a minimum, a five log reduction of the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions. The pertinent microorganism is the most resistant microorganism of public health significance that is likely to occur in the juice. Subpart B additionally requires process verification for certain processors. Each juice processor that relies on treatments that do not come into direct contact with all parts of the juice to achieve five log reduction of the pertinent pathogen are required to analyze the finished product. Twenty-one important terms are used throughout the regulation and FDA's Hazards and Controls Guide. Let me emphasize a few of these definitions. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. Cleaned means washed with water of adequate sanitary quality. Cold means separation of damaged fruit from undamaged fruit. Fallen fruit, also called grounders, when fall fruit and drops, means fruit that has fallen naturally from the tree to the ground in an orchard. Retail establishment means an operation that provides juice directly to consumers and does not sell or distribute juice to other businesses. Processing means activities that are directly related to the production of juice products. Processing does not include harvesting, picking, or transporting raw agricultural ingredients of juice products. The juice hassep regulations cover both products that cross state lines and products sold within a state. Some products are exempt from the juice hassep regulation. These are juice produced and sold at a retail establishment. Beverage is other than juice. However, if the beverage contains juice, the juice ingredient is subject to the regulation. Juice ingredients for use in non-beverage foods such as fruit-flavored candy and ingredients from fruit other than juice, for example, citrus oil. On July 8, 1998, FDA published a regulation requiring warning labels on juice products that were not processed to achieve a five-log pathogen reduction. For most juice, the warning label was an interim measure until hassep regulations could be finalized. Juice processors subject to the juice hassep regulation must use a hassep system on the applicable effective date of the regulation. The warning label will no longer be an option for those processors. However, retail establishments must continue to use warning labels on packaged containers of fresh juice that have not been treated for the five-log pathogen reduction. Retail producers of juice are not covered by the regulation and would not be required to establish a hassep system, regardless of whether they pasteurize their products. FDA's food code provides guidance to retail producers for making safe products. More detail on implementing the requirements of the juice hassep regulation will be presented shortly. Now let's consider guidelines. One example of a guideline is the guide to minimize microbial food safety hazards for fresh fruits and vegetables, which was published in 1998. This guideline provides recommendations on good agricultural practices, GAPs, and good manufacturing practices, GMPs, to minimize microbial contamination during the production and packing of fresh fruits and vegetables. A juice processor should know as much as possible about the source of the fruits and vegetables he uses and verify that these foods have been grown and harvested using GAPs. For example, water used in crop production involves numerous field operations, including irrigation, application of pesticides and fertilizers, cooling, and frost control. Whenever water comes into contact with fresh produce, its quality dictates the potential for pathogen contamination. A copy of these guidelines can be downloaded from FDA's website at www.cfsan.fda.gov under the heading Industry Assistance. Another guideline is the Juice Hassep Hazards and Controls Guide. These guidelines were developed specifically to help juice processors accomplish the steps that will be described in just a moment. The Juice Hassep Hazards and Controls Guide and additional guidance documents are available at the FDA website at www.cfsan.fda.gov under the heading Hassep. Information on obtaining copies is also available in the attachments accompanying this video. The Juice Hassep Regulation requires that each processor develop a written hazard analysis. The regulation outlines two major steps in a hazard analysis. First, determine whether there are hazards that are reasonably likely to occur. Second, identify preventative measures to control the identified hazards. Specific preventative measures will be discussed in more detail in Module 6 of this video and are also covered in the Juice Hassep Hazards and Controls Guide. Hazards that are reasonably likely to occur are defined as those hazards for which a prudent processor would establish controls. This means a prudent processor would establish controls because there is reasonable possibility that a hazard will occur. To make this decision, examine, experience, illness data, scientific reports, and other information such as FDA's Juice Hassep Hazards and Controls Guide. An example of a hazard that may be reasonably likely to occur in apple juice is Patulin. Patulin is a mycotoxin that can occur in rotten, moldy, or damaged apples and may occur at hazardous levels if such apples are used to make juice. Chronic exposure over time to high levels of Patulin may pose a health hazard. For more information on Patulin, see FDA's Compliance Policy Guide, CPG, for Patulin at www.cfsan.fda.gov under pesticides and chemical contaminants in the subsection on natural toxins. Your hazard analysis must be documented in writing to allow for review by yourself and by regulators. A written hazard analysis will help you remember the thought process used to identify the hazards and develop the hazard plan. This will be useful when periodic plan reassessments are conducted and when the plan is reviewed by regulators. You will need to have and follow a written hazard plan wherever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing. Your hazard plan should be specific to each processing location and each type of juice. Content requirements for the written hazard plan are specified in section 120.8b of the regulation. These include food hazards that are reasonably likely to occur, critical control points, CCPs, critical limits, monitoring procedures, corrective action plans if predetermined, verification measures, and a system of monitoring records. Food hazards can include microbiological hazards such as bacteria or parasites, chemical hazards such as harmful pesticide residues, natural toxins, undeclared ingredients that may be allergens or residues of other foods from cross contact with inadequately clean shared processing equipment, and physical hazards such as metal or glass fragments. You should consider hazards that can be introduced inside the processing plan and hazards that can occur before, during, or after harvest. The frequencies of the monitoring and verification procedures must be included in the HACCP plan. Monitoring records must provide the actual values or observations noted during monitoring. The HACCP plan must be signed and dated by the most responsible individual at the processing facility or a higher level official of the processor upon initial acceptance, upon any change, and upon verification and validation of the plan, at least annually. If you process a shelf-stable juice or heat-concentrated juice, you don't have to include control measures for the pertinent microorganism in your HACCP plan. However, you must provide a copy of the thermal process used to achieve shelf stability or concentration in your written hazard analysis. If your hazard analysis shows other hazards, such as glass, are reasonably likely to occur, these hazards must be controlled in your HACCP plan. The juice HACCP regulation provides that processors may determine whether sanitation controls are included in their HACCP plan, and if so, which ones. Some sanitation controls, for example cleaning shared equipment to prevent cross-contamination with allergens, are of sufficient importance that their control may benefit from being included within a HACCP plan. On the other hand, some sanitation controls may be troublesome to manage in a HACCP plan. In addition, it may be difficult to determine critical limits and corrective actions for some sanitation controls, particularly those relating to personnel hygiene, for example, hand-washing. Sanitation controls that are not in the HACCP plan must still be monitored. Sanitation is discussed in section 120.6 of the regulation and in a later module of this video. Corrective actions 120.10 requires that a corrective action take place whenever a critical limit is not met at a critical control point, a CCP. A proper corrective action plan describes the steps that are to be taken and assigns responsibility for taking those steps. The corrective action plan should be designed to ensure that no product enters commerce that is either injurious to health or is adulterated as a result of the deviation from the critical limit and the cause of the deviation is corrected. Developing a plan in advance allows faster action and less need to justify to management the appropriateness of the corrective action after it has been taken. However, some situations may arise that were not anticipated or you may choose not to plan corrective actions in advance. In these cases, the alternate corrective action procedure must be followed. The alternate corrective action procedure involves segregating and holding the affected product until it is determined that the product is safe for distribution. This determination must be made by someone who has adequate training or experience to understand the public health consequences of the deviation and to ensure no unsafe product enters commerce. You should take any action necessary to fix the problem that caused the deviation. You should also determine whether the asset plan needs to be modified to reduce the risk that the deviation will recur. Again, this determination must be done by someone that meets the training requirements set out in 120.13. All corrective actions must be fully documented in records. Verification and validation, 120.11, contains certain requirements to ensure that the asset plan is adequate and that it is followed effectively. For example, the asset plan must be validated at least once per year and whenever any changes occur that could affect the hazard analysis or the asset plan in any way. This could include changes in raw materials or source of raw materials, product formulation, processing methods or systems, packaging, finished product distribution systems, or the intended use or consumers of the finished product. Validation is an essential component of verification and requires substantiation that the asset plan, if implemented effectively, is sufficient to control the food safety hazards that are likely to occur. Initial validation occurs before implementation of the plan. Revalidation occurs when there are significant changes to the plan. The purpose of validation is to show that all essential elements of the plan have a scientific basis and represent a proven approach to controlling the food safety hazards associated with the specific product and process. There are several approaches to validating the asset plan. Among them are incorporation of fundamental scientific principles, use of scientific data, reliance on expert opinion or conducting in-plant observations or tests. Validation must be performed by an individual who meets the training requirements described in section 120.13. If a processor has no asset plan because no significant hazards were identified, then the hazard analysis must be reassessed whenever any changes occur that could affect the hazard analysis. In addition to periodic validation or reassessment of the asset plan, the regulation requires ongoing verification activities to ensure that the asset plan is being followed on a day-to-day basis. Hazard plans must include verification procedures for individual CCPs and for the overall plan. Verification includes keeping records of activities such as calibration procedures and end product or in-process testing that is performed as part of your asset activities and reviewing these records. Ongoing verification procedures must be in the hazard plan. Consumer complaints must also be reviewed to determine whether they relate to problems at a critical control point. The regulation does not give regulators access to consumer complaints but does give them access to corrective action records that relate to problems identified by consumer complaints. To assist in verification and validation, the regulation requires that certain records be kept. Records required by the regulation include records of SSOP implementation, a copy of the written hazard analysis and, if appropriate, the written asset plan, records of ongoing implementation of the plan such as monitoring records and corrective action records, and verification and validation records. The regulation also has certain requirements for these records. They must bear the name of the processor or importer, be completed at the time of the activity and, in most cases, indicate the time and date of the activity, be signed or initialed by the operator or creator where appropriate identify the product and production code, be retained for specific periods of time at the processing facility or at the importer's place of business, and be available for review and copying by regulatory authorities. The regulation also requires that you review certain records as part of verification to ensure that the records are complete and that the activities recorded occurred in accordance with your written procedures. The records must be reviewed by someone who meets the training requirements described in section 120.13. Monitoring and corrective action records must be reviewed within one week of when the record was made. Calibration and in-process or in-product testing records must be reviewed in a timely manner. Examination of HACIP records enables an inspector to see how the processing facility operates over time, rather than just on the day of the inspection. Additionally, it enables a regulator to review the adequacy of the processor's preventative control system. HACIP plans and records, which come into FDA's possession, will be treated as either trade secrets or commercial confidential materials. Additional information on records and record retention is contained in the regulation. Section 120.13, training, requires that certain activities and functions be performed by an individual trained in HACIP. These activities include developing a hazard analysis, developing the HACIP plan, validating or reassessing and modifying the HACIP plan and hazard analysis, and review of HACIP records. You can use a trained employee or a trained third party to perform these functions. The jobs may be done by one person or by several as long as they have been properly trained. What kind of training would be required? Training in the application of HACIP principles to juice processing should be at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration. For example, course material developed by the National Juice HACIP Alliance has been recognized by FDA as adequate for use in training people to meet the requirements of the juice HACIP regulation. Alternatively, the individual may be qualified through job experience to perform these functions. Job experience will qualify if it has provided knowledge at least equivalent to that provided through a standardized curriculum. However, if you are considering using an alternate curriculum, you should evaluate its equivalency with that of the Juice HACIP Alliance standardized curriculum and ensure that it covers biological, chemical and physical hazards, applicability of current good manufacturing practices and sanitation standard operating procedures, the five preliminary steps of HACIP with application to juice processing, the seven principles of HACIP with application to juice processing, and FDA's Juice HACIP regulation, 21 CFR Part 120, and related FDA guidance documents. The standardized curriculum produced by the Juice HACIP Alliance is available for download at no charge through the National Center for Food Safety and Technology at www.iit.edu forward slash tilde NCFS. Sanitation is a prerequisite program that is necessary for effective implementation of HACIP. The regulation requires that you take certain actions to control sanitation conditions and practices. These actions must be taken even if you determine there is no need for a HACIP plan. The sanitation requirements of the regulation may be part of your HACIP plan or they may be managed separately. Current GMP regulations are the standard for proper sanitation conditions and practices. The regulation specifies eight key sanitation conditions and practices. These include safety of water, condition and cleanliness of food contact surfaces, prevention of cross contamination, maintenance of hand washing, hand sanitizing and toilet facilities, protection from adulterants, labeling, storage and use of toxic compounds, employee health conditions and exclusion of pests. The regulation also requires sanitation monitoring with record keeping, corrections with record keeping and sanitary standard operating procedures, SSOPs. You must have and implement a set of SSOPs that address sanitation conditions and practices before, during and after processing. Your SSOP should describe how you will ensure that key sanitation conditions and practices will be met and monitored. Monitoring frequencies should be sufficient to ensure that the current GMP requirements are met. When the conditions and practices contained in the current GMP regulations are not met, they must be corrected in a timely manner. Records of the SSOP monitoring and correction must be kept and may be reviewed by regulators. Under the Juice HACCP regulation, CFR 120.14, imported juice must be processed under a HACCP system similar to juice produced in the United States. Additionally, the regulation requires that importers take certain steps to verify that their foreign suppliers meet the requirements of the regulation. Importers may meet their obligation in one of two ways. They may import juice that is covered by a memorandum of understanding between the United States and a foreign country. In this case, they do not need to take any other action to meet the requirements of the regulation. There are currently no established MOUs for Juice HACCP. Normally, the process is started by a letter to FDA from a foreign government requesting initiation of the MOU process. Examples of FDA MOUs can be found at the Food and Drug Administration International Cooperative Agreements webpage at www.fda.gov forward slash oia. Without an MOU, the importer must have and follow written procedures for ensuring that the juice offered for import into the United States was processed according to the requirements of the Juice HACCP regulation. The written procedures for ensuring that the juice offered for import into the United States is processed in accordance with the requirements of the regulation, shall provide at a minimum certain product specifications and affirmative steps. The regulation provides several examples of affirmative steps that an importer may choose to ensure imported juice is not adulterated. An importer may hire a competent third party to perform verification activities. However, the importer remains responsible for demonstrating to FDA that the requirements have been met. The importer must maintain records in English that document the affirmative steps have been taken and the results of those steps.