DFID Policy/SOP Template



Table of Contents TOC \o "1-2" \n \h \z \u 1.PURPOSE2.SCOPE3.BACKGROUND4.RESPONSIBILITY5.DEFINITIONS6.PROCEDURES7.RELATED DOCUMENTS (includes References, Attachments)8.EQUIPMENT/MATERIALS NEEDED9.SAFETY10.CIRCULATIONPURPOSEThis document describes the procedures for uniformly determining the primary risk category and inspection frequency for retail food firms that are currently regulated by the Minnesota Department of Agriculture Food and Feed Safety Division’s (MDA-FFSD) Retail Food Program.SCOPEThis procedure applies to licensed MDA-FFSD food handler firms that are considered food establishments as defined in the Minnesota Food Code, Minnesota Rules Chapter 4626, and that are not a retail food vehicle, portable structure or cart, a special event food stand, or a temporary food establishment as defined in 4626.0020 Subp. 90. BACKGROUND1n 2000, a risk-based inspection approach was developed which included prioritizing inspections based on the risk category that was assigned to all food establishments (retail and wholesale). The risk category (High, Medium, Low) was based on the retail establishment operation as it related to the risk to food safety practices in causing foodborne illness. In 2020, the MDA-FFSD Retail Food Program revised the risk category criteria and developed five risk categories. Inspection frequency was determined based on the new risk category of the food establishment. This was developed in part by utilizing the FDA Retail Food Code Annex 5 “Conducting Risk-based Inspections”, the Minnesota Food Code, and input from other state and county inspection programs. There is a separate Manufacturer and Distributor Risk SOP (FOOD.30.08) that addresses manufacturing and wholesale distributing operations and that also details and encompasses criteria developed by FDA in the Manufactured Food Regulatory Program Standards (MFRPS).Retail food vehicles, portable structures, carts, temporary food establishments, and special event food stands are assigned a risk category based on the food preparation processes. However, these types of food establishments are not subject to inspection frequency and so are not assigned a pre-determined inspection frequency in the electronic inspection system USA Food Safety (USAFS). The risk category of these establishments will be used by the Retail Food Program for allocation of resources for inspections. RESPONSIBILITYRetail Food Program Manager – The Retail Food Program Manager will assist in the determination of an increased inspection frequency as needed.Retail Food Supervisor - The Retail Food Supervisor will assist in the determination of an increased inspection frequency as needed and update the inspection frequency in the electronic inspection system.Retail Food Inspector – The Retail Food Inspector will determine and select appropriate risk classifications and overall risk category for a facility during each inspection and determine need for an increased inspection frequency in consultation with the supervisor and compliance officer as pliance Officer – The Compliance Officer will assist in determining the need for an increased inspection frequency in consultation with the inspector and supervisor.DEFINITIONSChronic Violator: A chronic violator is a legal entity that has an approved enforcement action equal to or greater than a Warning Letter and that has had a prior enforcement action equal to or greater than a Warning Letter issued in the last three (3) years.Custom Processor: A person who slaughters animals or processes non-inspected meat for the owner of the animals and returns the meat products derived from the slaughter or processing to the owner. "Custom?processor" does not include a person who slaughters animals or poultry or processes meat for the owner of the animals or poultry on the farm or premises of the owner of the animals, meat, or poultry (MN Statute 28A.038). Retail Custom Processing includes animals and meat that are not for sale or service in a food establishment and not under USDA, state Equal To inspection, or that are required to have a MN Custom Processing Permit (for beef, hogs, etc). For the purpose of this SOP, custom processing includes game animals that are for personal use as food and not for sale or service in a food establishment and not under USDA or “state equal to” inspections, as stated in MN Rule 4626.0415D. Distributor: Any individual, firm, corporation, company, association, cooperative, or partnership who sells food to others for re-sale, stores or handles food for another, including buildings, trucks, trailers or other portable structures.Enforcement Actions: Enforcement actions are informal (non-appealable) or formal (appealable) actions taken outside of an inspection to achieve compliance with regulations. These actions include, but are not limited to Notice of Repeat Violation, Warning Letters, Corrective Action Orders, Administrative Meetings, issuance of penalties (civil or administrative), Criminal Prosecution, License Limitation or Revocation, Injunction, or other court actions. These actions are initiated by a firm’s non-compliance with regulatory requirements as evidenced by an inspection report, violative sample results, or other collected documentation of conditions.Field Compliance Actions: Field compliance actions are actions performed during an inspection to achieve compliance with regulations. These actions include, but are not limited to, re-inspections, cease and desist orders, and embargos. These actions are initiated by a firm’s non-compliance with regulatory requirements as evidenced by an inspection report, violative sample results, or other collected documentation of conditions.Juice: Juice means as defined in 4626.0020 Subp. 44a. Manufacturer: any individual, firm, corporation, company, association, cooperative, or partnership who processes or manufactures raw materials and other food ingredients into food items, or who reprocesses food items, or who packages food for sale to others for resale. This includes those who extract, ferment, distill, pickle, bake, freeze, dry, smoke, grind, mix, stuff, pack, bottle, recondition, or otherwise treat or preserve food for sale to others for resale and also to salvage food processors.Multi-department: For the purpose of this SOP, multi-department means a firm with more than one distinct or standalone food preparation facility AND each with a separate manager. For example, in a grocery store the deli, meat, bakery, and produce areas typically have separate managers with distinct food preparation facilities making it a multi-department firm. In contrast, a convenience store typically has a single manager for food safety with a food preparation facility (though may involve separate equipment areas in the store) and therefore is not multi-department.Packaged Food: Packaged Food means packaged as defined in 4626.0020 Subp. 53.Prepare: Prepare is defined in 4626.0020 Subp. 64a.Process: Process is the treatment of food substances in such a manner to change its properties with the intent to preserve it, improve its quality or make it functionally useful. This includes re-packaging of food.Ready To Eat (RTE): Ready-to-eat food means as defined in 4626.0020 Subp. 67. Retail Food Establishment: Retail Food Establishment means any individual, firm, corporation, company, association, cooperative, or partnership who sells food directly to a consumer (as defined in the MN Food Code). Risk Category (Level): Risk Category (risk level in USAFS) is the overall risk determination for a food establishment based on classification of food preparation processes and includes Type 1 and Type 2 (High Risk), Type 3 (Medium Risk), Type 4 and Type 5 (Low Risk).Risk Classification (Facility Classification): Risk classification (facility classification in USAFS) is the specific food preparation process conducted by the food establishment that helps define the overall risk category.Specialized Process: Foods produced as described under Minnesota Food Code 4626.0415 (Specialized Processing Variance Requirements).Surface Water: Water that is on the surface of the planet, such as rivers and lakes.Time as a Public Health Control: The concept of time only, rather than in conjunction with temperature control, is used as the public health control for a working supply of TCS food before cooking, or for ready-to-eat TCS food that is displayed or held for sale or service. (MN Food Code 4626.0408)Time/Temperature Control for Safety Food (TCS Food): Time/temperature control for safety food (TCS) means a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation as defined in MN Food Code 4626.0020 Subp. 90a.PROCEDURESDetermine the Risk Classifications (Facility Classifications) – Retail Food InspectorDuring every inspection, determine or review the risk classifications for the firm. risk classifications may change over time if the products or processes change at the facility. Select all appropriate risk classifications using the current version of Appendix A: Risk Categories – Retail based on the retail food establishment’s food business operations. Example: A firm sells food and is licensed as a Retail Food Handler. The firm is a grocery store which includes a Bakery, Deli, Meat, Produce, and has an operation that includes bulk food, prepackaged groceries, scratch-made bakery products, raw meats, sliced deli meats and cheese, and is making sushi using acidified rice for shelf stability. The firm would have the following specific product type codes:T102, T201, T202, T302, T307, T405, T501Utilize the “Not a risk classification” options to provide more information about the facility such as location, type, or setting of the operation, etc. If the firm conducts meat processing operations that are not regulated by the Retail Food Program; utilize the “Not a risk classification” options to describe the operation. Example: USDA Inspection, MN Equal-to Inspection or Custom Meat Processor. These options do not affect the overall risk level associated with the facility. Refer to Appendix A: Risk Categories – Retail for further information.Determine if the firm conducts only retail operations or if the firm also conducts manufacturing and distributing operations. If the firm does conduct manufacturing and distributing operations, notify the Retail Food Supervisor and the area Manufactured Food Inspector so that the appropriate risk classifications for the manufacturing operations can be entered by the Manufactured Food Program according to FOOD.30.08 – Manufacturer and Distributor Risk Category SOP.Risk Level Selection – Retail Food InspectorReview the specific risk classifications and identify the overall highest risk category High (Types 1or 2), Medium (Type 3), or Low (Types 4 or 5) for the facility.Inspection Frequency Retail Food InspectorUse the baseline frequencies listed below to identify the proper frequency for the retail food establishment (e.g.-facilities with a Retail Food Handler license or secondary business program in USAFS):Type 1 High Risk Retail Food Establishment: Type 1 establishments are inspected at a baseline frequency of once every 9 months.Type 2 High Risk Retail Food Establishment: Type 2 establishments are inspected at a baseline frequency of once every 12 months.Type 3 Medium Retail Food Establishment: Type 3 establishments are inspected at a baseline frequency of once every 18 months.Type 4 Low Risk Retail Food Establishment: Type 4 establishments are inspected at a baseline frequency of once every 36 months.Type 5 Low Risk Retail Food Establishment: Type 5 establishments are inspected at a baseline frequency of once every 42 months.For establishments licensed as Retail Mobile Food Handlers, inspection schedule will be determined by the program based on resources available to conduct inspections at events where these establishments operate. Retail Food SupervisorDetermine the need to increase the routine inspection frequency to every six months for Type 1 and Type 2 High Risk Retail Food Establishments, to every 12 months for Type 3 Medium Risk Retail Food Establishments, and to every 18 months for Type 4 and 5 Low Risk Retail Food Establishments in coordination with the inspector, if the establishment: Had a sanitary notice issued during the current inspection; orHad a field compliance action occur during the previous inspection that was not complied with and was referred to the Compliance Unit; orIs referred to the Compliance Unit and further discussions between inspector, supervisor, program manager, and the Compliance Unit determines that increased inspection frequency is needed.Example: A firm is classified as overall Type 2 and is issued a Sanitary Notice on 1/2/2020. The firm was found in compliance on the reinspection conducted 1/6/2020. The supervisor and the inspector determine that an increase in inspection frequency is needed for this firm.a) Increase frequency to once every 6 months for one year. An inspection will need to take place by 7/2/2020. b) After this inspection, if no other compliance events occur, the firm can be moved back to a baseline once every 12 months inspection frequency.Determine the need to increase the inspection frequency according to paragraph 6.3.3 from the last routine inspection, in coordination with the Compliance Unit, for at least one inspection cycle if the establishment:Has had an enforcement action greater than a Warning Letter, with recommendation for increased frequency upon case closure, in the past twelve months; or6.3.4.2. Upon notification from the Compliance Officer, meets the definition of a chronic violator.6.3.5. Evaluate the need for an increased routine inspection frequency in situations where there is an extended enforcement case (i.e.-case is not closed by the mid-way point of the routine inspection frequency of the firm) in consultation with the Program Manager, Inspector, and the Compliance Unit to assess the firm’s overall compliance status. Example: A firm is classified as overall Type 3 and has an open enforcement case related to food adulteration orders issued during a routine inspection on 3/15/19. By 2/15/20, the case remains open due to non-compliance by the firm. A discussion is held between the program manager, inspector, supervisor, and the compliance unit and the routine inspection frequency is increased by 6 months, so an inspection will take place by 3/15/20. 6.3.6. Document this change by adding an internal note with the reason for the increased inspection frequency per the applicable USAFS Guidance/Work Instruction.RELATED DOCUMENTS (includes References, Attachments)Appendix A: Risk Categories – Retail Food HandlersFOOD.30.08 - Manufacturer Distributor Risk Category SOPEQUIPMENT/MATERIALS NEEDEDN/ASAFETYN/ACIRCULATIONThis document will be provided to the following: Retail Food Program Inspectors, Retail Food Supervisors, Retail and Manufactured Food Program Managers, and the Compliance Unit. The current version will be stored electronically on the FFSD document control site.Appendix A Risk Categories – Retail Food HandlersType 1 RETAILERSThe Type 1 high-risk retail food establishment category consists of retailers that prepare food with a method that requires a specialized process variance and HACCP plan as indicated in the MN Food Code. SPECIFIC PROCESS TYPE 1 RISK/FACILITY CLASSIFICATIONST1 01 – Conducts a process requiring a specialized process variance and HACCP plan – smoking for preservation/curing.T1 02 – Conducts a process requiring a specialized process variance and HACCP plan – using food additives such as vinegar for preservation.T1 03 – Conducts a process requiring a specialized process variance and HACCP plan – ROP requiring a variance.T1 04 – Conducts a process requiring a specialized process variance and HACCP plan – operating a molluscan shellfish tank.T1 05 – Conducts a process requiring a specialized process variance and HACCP plan – custom processing wild game animals.T1 06 – Conducts a process requiring a specialized process variance and HACCP plan – sprouting seeds or beans.T1 07 – Cooks raw animal food requiring a specialized process variance and HACCP plan.T1 08 – Conducts a process requiring a specialized process variance and HACCP plan – canning TCS foods.Type 2 RETAILERSThe Type 2 high-risk retail food establishment category consists of retailers that prepare TCS foods in multiple facilities within a multi-department firm; process TCS foods requiring multiple trips through the temperature danger zone; or conduct high-risk processes that require a HACCP plan or variance other than a specialized process in Type 1. MDA-FFSD considers these retailer facilities to be Type 2 high-risk because the food preparation process(es) presents a higher level of risk to food safety but does not include a method that requires a specialized process variance.SPECIFIC PROCESS TYPE 2 RISK/FACILITY CLASSIFICATIONST2 01 – Multiple (2 or more) TCS foods heated and cooled; or heated, cooled and reheated. (i.e., a deli that cooks, hot holds and cools fried chicken and rotisserie chicken)T2 02 – Raw or ready to eat TCS foods handled and prepared in multiple (2 or more) departments (i.e., slicing deli meats, cutting raw meat or poultry, assembling RTE sandwiches, cutting melon).T2 03 – Process requiring a HACCP plan but not a specialized process variance (i.e., ROP without a variance, processes unpasteurized juice requiring a 5-log reduction in pathogens, canning non-TCS food).T2 04 – Food process requiring a non-equipment, process variance from the MN food code (i.e., a TCS food item with a variance from cold holding and not a specialized process variance).T2 05 – Source water from a surface water supply. Type 3 RETAILERSThe Type 3 medium-risk retail food establishment category consists of retailers that prepare TCS food in only one facility of a multi-department firm or in a single department; process a single TCS food that requires multiple trips through the temperature danger zone; or that process TCS food with one trip or less through the temperature danger zone. MDA-FFSD considers these retailer facilities to be a Type 3 medium-risk because the food preparation process(es) presents some risk to food safety but not as high as or to the extent of Type 1 or 2 retailer facilities.SPECIFIC PROCESS TYPE MEDIUM RISK/FACILITYCLASSIFICATIONST3 01 – A single menu item heated, hot held and cooled. (i.e., convenience store that heats and cools soup/chili but no other TCS food)T3 02 – Unpackaged TCS food heated and hot held (one trip through the temperature danger zone).T3 03 – TCS food heated for immediate service (one trip through the temperature danger zone).T3 04 – Raw and ready-to-eat TCS food prepared and handled in a single department.T3 05 – Unpackaged, raw TCS food to be cooked by the consumer off-site (i.e., fresh meat or seafood).T3 06 – Ready-to-eat TCS food prepared and packaged or served (i.e., cutting and packaging melons; preparing salads/sandwiches/wraps, processing TCS juice using a warning label).T3 07 – Non-TCS food prepared and packaged or served (Bakeries: scratch baking or bake off food processes, blended drinks, popcorn, processing non-TCS juice using a warning label).T3 08 – Time as a public health control. Type 4 RETAILERSThe Type 4 low-risk retail food establishment category consists of retailers that complete one or more lower risk food process such as repacking ready-to-eat TCS food, making and bagging ice, and hot or cold holding pre-packaged TCS food. MDA-FFSD considers these types of facilities to be Type 4 and lower risk because the food product being processed is pre-packaged, requires little preparation, or is a non-TCS food. SPECIFIC PROCESS TYPE 4 RISK/FACILITY CLASSIFICATIONST4 01 – Repacking or sampling ready to eat TCS food. (Re-packaging bulk deli salads prepared by a food manufacturer).T4 02 – Ice cream – soft serve or dipped.T4 03 – On premises making and/or bagging of ice.T4 04 – Repacking or sampling non-TCS food.T4 05 – TCS and Non-TCS bulk food offered for self-service (self-service bulk bakery case, candy).T4 06 – Hot holding or cold holding pre-packaged TCS food. (i.e., convenience store that heats and hot holds pre-wrapped sandwiches).T4 07 – Beverage self-service machines (i.e., coffee and coffee vending, cappuccino, fountain soft drinks, self-service water vending).T4 08 – Brewery taproom, wine tasting room, distillery, bar service.T4 09 – The firm has a variance other than a process variance or specialized process variance (micro-market, variance for a mop sink).Type 5 RETAILERSThe Type 5 low-risk retail food establishment category consists of retailers that sell the lowest risk food products such as ambient pre-packaged food, raw agricultural products, and food vending machines.SPECIFIC PROCESS TYPE 5 RISK/FACILITY CLASSIFICATIONST5 01 – Commercially prepackaged ambient food.T5 02 – Intact raw agricultural products (i.e., oranges, apples, head lettuce, produce with minimal trimming).T5 03 – Food vending machine (Packaged TCS or non-TCS food).NOT A RISK CLASSIFICATION OPTIONSThe following list of options available under “Classification” provide further information about the facility (i.e.-location, type, setting of operation), but does not affect the overall risk level:Custom Meat Processor (These are the facilities which are inspected quarterly by a DMID meat inspector.) Farm Food Delivery/TransportPersonal Home (e.g. use when obtaining a home/unofficial food sample as part of an outbreak investigation)Plan Review Received (for use by Plan Review only)Renaissance Festival (booth is permanently located on the Renaissance Festival grounds)Retail Mobile Food Handler (use to identify a facility licensed as a Retail Mobile Food Handler)Shared Kitchen (use to identify when a facility is operating out of a kitchen utilized by other businesses)State Fair (booth is permanently or temporarily located on the State Fairgrounds)USDA InspectionMN Equal-to Inspection ................
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