FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 4, Equipment, Utensils, and Linens

Public Health Reasons / Administrative Guidelines for:


4-101.11 Characteristics.



4-101.12 Cast Iron, Use Limitation.

Equipment and utensils constructed of cast iron meet the requirement of durability as intended in section 4-101.11. However, the surface characteristics of cast iron tend to be somewhat porous which renders the material difficult to clean. On the other hand, when cast iron use is limited to cooking surfaces the residues in the porous surface are not of significant concern as heat destroys potential pathogens that may be present.

4-101.13 Lead, Use Limitation.

Historically, lead has been used in the formulation or decoration of these types of utensils. Specifically, lead-based paints that were used to decorate the utensils such as color glazes have caused high concentrations of lead to leach into the food they contain.


FDA has established maximum levels (see FDA Compliance Policy Guide Section 545.450 Pottery (Ceramics); Imported and Domestic - Lead Contamination (CPG 7117.07) for leachable lead in ceramicware, and pieces that exceed these levels are subject to recall or other agency enforcement action. The levels are based on how frequently a piece of ceramicware is used, the type and temperature of the food it holds, and how long the food stays in contact with the piece. For example, cups, mugs, and pitchers have the most stringent action level, 0.5 parts per million, because they can be expected to hold food longer, allowing more time for lead to leach. Also, a pitcher may be used to hold fruit juice. And a coffee mug is generally used every day to hold a hot acidic beverage, often several times a day.

The FDA allows use of lead glazes because they're the most durable, but regulates them tightly to ensure their safety. Commercial manufacturers employ extremely strict and effective manufacturing controls that keep the lead from leaching during use. Small potters often can't control the firing of lead glazes as well so their ceramics are more likely to leach illegal lead levels, although many do use lead-free glazes.

In 21 CFR 109.16, FDA requires high-lead-leaching decorative ceramicware to be permanently labeled that it's not for food use and may poison food. Such items bought outside the United States may not be so labeled, potentially posing serious risk if used for food.



4-101.14 Copper, Use Limitation.






4-101.15 Galvanized Metal, Use Limitation.


4-101.16 Sponges, Use Limitation.


4-101.17 Wood, Use Limitation.


4-101.18 Nonstick Coatings, Use Limitation.


4-101.19 Nonfood-Contact Surfaces.


Single-Service and Single-Use

4-102.11 Characteristics.


Durability and Strength

4-201.11 Equipment and Utensils.


4-201.12 Food Temperature Measuring Devices.



4-202.11 Food-Contact Surfaces.


4-202.12 CIP Equipment.



4-202.13 "V" Threads, Use Limitation.


4-202.14 Hot Oil Filtering Equipment.


4-202.15 Can Openers.


4-202.16 Nonfood-Contact Surfaces.


4-202.17 Kick Plates, Removable.



4-203.11 Temperature Measuring Devices, Food.

The Metric Conversion Act of 1975 (amended 1988, 1996, and 2004, 15 USC 205a et seq) requires that all Federal government regulations use the Celsius scale for temperature measurement. The Fahrenheit scale is included in the Code for those jurisdictions using the Fahrenheit scale for temperature measurement.


4-203.12 Temperature Measuring Devices, Ambient Air and Water.





4-203.13 Pressure Measuring Devices, Mechanical Warewashing Equipment.



4-204.11 Ventilation Hood Systems, Drip Prevention.


4-204.12 Equipment Openings, Closures and Deflectors.




4-204.13 Dispensing Equipment, Protection of Equipment and Food.



NSF/ANSI 18-Manual Food and Beverage Dispensing Equipment is the standard for manual food and beverage dispensing equipment which has been designed to maintain the safety of aseptically packaged fluid foods without refrigeration even after the hermetic seal is broken.

NSF/ANSI 18 was revised in 2006 to specifically address dispensing equipment designed to hold potentially hazardous food or beverages in a homogeneous liquid form without temperature control. NSF/ANSI 18 requires that such equipment designs include a number of safeguards that prevent the contamination of specially packaged food stored within the dispensing equipment. The Standard also requires that the dispensing equipment have lockout mechanisms that preclude the dispensing of the product if such safeguards fail or if a prescribed duration of storage is exceeded. The American National Standards Institute (ANSI) recognizes NSF/ANSI 18 as the sole American National Standard for the sanitary design of manual food and beverage dispensers.

4-204.14 Vending Machine, Vending Stage Closure.


4-204.15 Bearings and Gear Boxes, Leakproof.


4-204.16 Beverage Tubing, Separation.



4-204.17 Ice Units, Separation of Drains.



4-204.18 Condenser Unit, Separation.


4-204.19 Can Openers on Vending Machines.


4-204.110 Molluscan Shellfish Tanks.



4-204.111 Vending Machines, Automatic Shutoff.

Failure to store potentially hazardous (time/temperature control for safety) food at safe temperatures in a vending machine could result in the growth of pathogenic microorganisms that may result in foodborne illness. The presence of an automatic control that prevents the vending of food if the temperature of the unit exceeds Code requirements precludes the vending of foods that may not be safe.

It is possible and indeed very likely that the temperature of the storage area of a vending machine may exceed Code requirements during the stocking and servicing of the machine. The automatic shut off, commonly referred to as the "public health control," provides a limited amount of time that the ambient temperature of a machine may exceed Code requirements. Strict adherence to the time requirements can limit the growth of pathogenic microorganisms.

4-204.112 Temperature Measuring Devices.

The placement of the temperature measuring device is important. If the device is placed in the coldest location in the storage unit, it may not be representative of the temperature of the unit. Food could be stored in areas of the unit that exceed Code requirements. Therefore, the temperature measuring device must be placed in a location that is representative of the actual storage temperature of the unit to ensure that all potentially hazardous (time/temperature control for safety) foods are stored at least at the minimum temperature required in Chapter 3.

Installing an air thermometer in some open display refrigerators can be difficult without physically impairing the usability of the case and interfering with cleaning and sanitation. Use of a temperature monitoring system that uses probe-like sensors that are placed in material resembling the density of food is an acceptable alternative. Thus, the direct temperature of the substitute product is measured by use of this product mimicking method.

A permanent temperature measuring device is required in any unit storing potentially hazardous (time/temperature control for safety) food because of the potential growth of pathogenic microorganisms should the temperature of the unit exceed Code requirements. In order to facilitate routine monitoring of the unit, the device must be clearly visible.


The importance of maintaining potentially hazardous (time/temperature control for safety) foods at the specified temperatures requires that temperature measuring devices be easily readable. The inability to accurately read a thermometer could result in food being held at unsafe temperatures.



4-204.113 Warewashing Machine, Data Plate Operating Specifications.


4-204.114 Warewashing Machines, Internal Baffles.


4-204.115 Warewashing Machines, Temperature Measuring Devices.


4-204.116 Manual Warewashing Equipment, Heaters and Baskets.



4-204.117 Warewashing Machines, Automatic Dispensing of Detergents and Sanitizers.

The presence of adequate detergents and sanitizers is necessary to effect clean and sanitized utensils and equipment. The automatic dispensing of these chemical agents, plus a method such as a flow indicator, flashing light, buzzer, or visible open air delivery system that alerts the operator that the chemicals are no longer being dispensed, ensures that utensils are subjected to an efficacious cleaning and sanitizing regimen.

4-204.118 Warewashing Machines, Flow Pressure Device.


4-204.121 Vending Machines, Liquid Waste Products.


4-204.122 Case Lot Handling Equipment, Moveability.


4-204.123 Vending Machine Doors and Openings.



4-205.10 Food Equipment, Certification and Classification.





4-301.11 Cooling, Heating, and Holding Capacities.

The ability of equipment to cool, heat, and maintain potentially hazardous (time/temperature control for safety) foods at Code-required temperatures is critical to food safety. Improper holding and cooking temperatures continue to be major contributing factors to foodborne illness. Therefore, it is very important to have adequate hot or cold holding equipment with enough capacity to meet the heating and cooling demands of the operation.

4-301.12 Manual Warewashing, Sink Compartment Requirements.



  1. Application of cleaners and the removal of soil;
  3. Sanitization.


4-301.13 Drainboards.



4-301.14 Ventilation Hood Systems, Adequacy.



4-301.15 Clothes Washers and Dryers.



Utensils, Temperature Measuring Devices, and Testing Devices

4-302.11 Utensils, Consumer Self-Service.


4-302.12 Food Temperature Measuring Devices.


When determining the temperature of thin foods, those having a thickness less than 13 mm (1/2 inch), it is particularly important to use a temperature sensing probe designed for that purpose. Bimetal, bayonet style thermometers are not suitable for accurately measuring the temperature of thin foods such as hamburger patties because of the large diameter of the probe and the inability to accurately sense the temperature at the tip of the probe. However, temperature measurements in thin foods can be accurately determined using a small-diameter probe 1.5 mm (0.059 inch), or less, connected to a device such as thermocouple thermometer.

4-302.13 Temperature Measuring Devices, Manual Warewashing.


4-302.14 Sanitizing Solutions, Testing Devices.








4-402.11 Fixed Equipment, Spacing or Sealing.


  3. Prevents the harborage of insects and rodents; and
  4. Provides accessibility for the monitoring of pests.

4-402.12 Fixed Equipment, Elevation or Sealing.





4-501.11 Good Repair and Proper Adjustment.

Proper maintenance of equipment to manufacturer specifications helps ensure that it will continue to operate as designed. Failure to properly maintain equipment could lead to violations of the associated requirements of the Code that place the health of the consumer at risk. For example, refrigeration units in disrepair may no longer be capable of properly cooling or holding potentially hazardous (time/temperature control for safety) foods at safe temperatures.



4-501.12 Cutting Surfaces.


4-501.13 Microwave Ovens.


4-501.14 Warewashing Equipment, Cleaning Frequency.


4-501.15 Warewashing Machines, Manufacturers' Operating Instructions.


4-501.16 Warewashing Sinks, Use Limitation.


4-501.17 Warewashing Equipment, Cleaning Agents.



4-501.18 Warewashing Equipment, Clean Solutions.


4-501.19 Manual Warewashing Equipment, Wash Solution Temperature.


4-501.110 Mechanical Warewashing Equipment, Wash Solution Temperature.


4-501.111 Manual Warewashing Equipment, Hot Water Sanitization Temperatures.


4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization Temperatures.

The temperature of hot water delivered from a warewasher sanitizing rinse manifold must be maintained according to the equipment manufacturer's specifications and temperature limits specified in this section to ensure surfaces of multiuse utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning.

The surface temperature must reach at least 71°C (160°F) as measured by an irreversible registering temperature measuring device to affect sanitization. When the sanitizing rinse temperature exceeds 90°C (194°F) at the manifold, the water becomes volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil surfaces. The lower temperature limits of 74°C (165°F) for a stationary rack, single temperature machine, and 82°C (180°F) for other machines are based on the sanitizing rinse contact time required to achieve the 71°C (160°F) utensil surface temperature.

4-501.113 Mechanical Warewashing Equipment, Sanitization Pressure.



With the passage of the Food Quality Protection Act of 1996 and the related Antimicrobial Regulation Technical Correction Act of 1998, Federal regulatory responsibility for chemical hard surface sanitizers was moved from FDA (CFSAN/OFAS) to EPA (Office of Pesticides Programs, Antimicrobial Division). As a result, the relevant Federal regulation has moved from 21 CFR 178.1010 to 40 CFR 180.940. The Food Code contains provisions that were not captured in either 21 CFR 178.1010 or 40 CFR 180.940, such as pH, temperature, and water hardness. There is need to retain these provisions in the Code.

The effectiveness of chemical sanitizers can be directly affected by the temperature, pH, concentration of the sanitizer solution used, and hardness of the water. Provisions for pH, temperature, and water hardness in section 4-501.114 have been validated to achieve sanitization; however, these parameters are not always included on EPA-registered labels. Therefore, it is critical to sanitization that the sanitizers are used consistently with the EPA-registered label, and if pH, temperature, and water hardness (for quat) are not included on the label, that the solutions meet the standards required in the Code.

With respect to chemical sanitization, section 4-501.114 addresses the proper use conditions for the sanitizing solution, i.e., chemical concentration range, pH, and temperature minimum levels and, with respect to quaternary ammonium compounds (quats), the maximum hardness level. If these parameters are not as specified in the Code or on the EPA-registered label, then this provision is violated.

By contrast, paragraph 4-703.11(C) addresses contact time in seconds. For chemical sanitization, this paragraph is only violated when the specified contact time is not met.

Section 7-204.11 addresses whether or not the chemical agent being applied as a sanitizer is approved and listed for that use under 40 CFR 180.940.

EPA sanitizer registration assesses compliance with 40 CFR 180.940, therefore if the product is used at the appropriate concentration for the application on the EPA-registered label, it is not necessary to consult 40 CFR 180.940 for further compliance verification. If a sanitarian determined that a solution exceeded the concentration for the application on the EPA-registered label or is used for an application that is not on the EPA-registered label, section 7-204.11 would be violated.

To summarize, a sanitizing solution that is too weak would be a violation of section 4-501.114. A solution that is too strong would be a violation of section 7-204.11. Section 7-202.12 would not be violated due to the existence of section 7-204.11 that specifically addresses the use chemical sanitizers.



4-501.116 Warewashing Equipment, Determining Chemical Sanitizer Concentration.


Utensils and Temperature and Pressure Measuring Devices

4-502.11 Good Repair and Calibration.

A utensil or food temperature measuring device can act as a source of contamination to the food it contacts if it is not maintained in good repair. Also, if temperature or pressure measuring devices are not maintained in good repair, the accuracy of the readings is questionable. Consequently, a temperature problem may not be detected, or conversely, a corrective action may be needlessly taken.





4-502.14 Shells, Use Limitation.

The reuse of mollusk and crustacean shells as multiuse utensils is not allowed in food establishments. This prohibition does not apply to the removal of the oyster or other species from the shell for preparation, then returning the same animal to the same shell for service.

The shell itself may be potentially unsafe for use as a food utensil because of residues from natural and environmental contamination occurring after the mollusk or crustacean is removed. In addition, natural shells are not durable or easily cleanable as specified under section 4-502.13. When mollusk or crustacean shells (from commercial sources) are re-used by filling them with shucked shellfish, the food is considered misleading and not honestly presented.





4-602.11 Equipment Food-Contact Surfaces and Utensils.

Microorganisms may be transmitted from a food to other foods by utensils, cutting boards, thermometers, or other food-contact surfaces. Food-contact surfaces and equipment used for potentially hazardous (time/temperature control for safety) foods should be cleaned as needed throughout the day but must be cleaned no less than every 4 hours to prevent the growth of microorganisms on those surfaces.



Regarding the possible adulteration from one species of meat to another between cleaning of food-contact surfaces, USDA/FSIS does not automatically consider species adulteration as a health hazard. FSIS stated in an Advance Notice of Proposed Rulemaking that species adulteration falls into a gray area between safety and economic adulteration (65 FR 14486, March 17, 2000, Other Consumer Protection Activities). FSIS will review public comments received on the species adulteration issue and further review the scientific literature and risk assessment mechanisms before declaring species adulteration a health hazard. Meanwhile, species adulteration is generally considered by FSIS as an economic issue. However, investigations by FSIS of species adulteration incidents may include a determination regarding the impact of species adulteration as a health hazard on a case-by-case basis.

4-602.12 Cooking and Baking Equipment.


4-602.13 Nonfood-Contact Surfaces.



4-603.11 Dry Cleaning.

Dry cleaning methods are indicated in only a few operations, which are limited to dry foods that are not potentially hazardous (time/temperature control for safety foods). Under some circumstances, attempts at wet cleaning may create microbiological concerns.

4-603.12 Precleaning.


4-603.13 Loading of Soiled Items, Warewashing Machines.


4-603.14 Wet Cleaning.


4-603.15 Washing, Procedures for Alternative Manual Warewashing Equipment.

Some pieces of equipment are fixed or too large to be cleaned in a sink. Nonetheless, cleaning of such equipment requires the application of cleaners for the removal of soil and rinsing for the removal of abrasive and cleaning chemicals, followed by sanitization.

4-603.16 Rinsing Procedures.


4-603.17 Returnables, Cleaning for Refilling.

The refilling of consumer-owned beverage containers introduces the possibility of contamination of the filling equipment or product by improperly cleaned containers or the improper operation of the equipment. To prevent this contamination and possible health hazards to the consumer, the refilling of consumer-owned containers is limited to beverages that are not potentially hazardous (time/temperature control for safety) foods. Equipment must be designed to prevent the contamination of the equipment and means must be provided to clean the containers at the facility.


4-701.10 Food-Contact Surfaces and Utensils.



4-702.11 Before Use After Cleaning.



4-703.11 Hot Water and Chemical.

Efficacious sanitization depends on warewashing being conducted within certain parameters. Time is a parameter applicable to both chemical and hot water sanitization. The time hot water or chemicals contact utensils or food-contact surfaces must be sufficient to destroy pathogens that may remain on surfaces after cleaning. Other parameters, such as rinse pressure, temperature, and chemical concentration are used in combination with time to achieve sanitization.

When surface temperatures of utensils passing through warewashing machines using hot water for sanitizing do not reach the required 71°C (160°F), it is important to understand the factors affecting the decreased surface temperature. A comparison should be made between the machine manufacturer's operating instructions and the machine's actual wash and rinse temperatures and final rinse pressure. The actual temperatures and rinse pressure should be consistent with the machine manufacturer's operating instructions and within limits specified in §§ 4-501.112 and 4-501.113.

If either the temperature or pressure of the final rinse spray is higher than the specified upper limit, spray droplets may disperse and begin to vaporize resulting in less heat delivery to utensil surfaces. Temperatures below the specified limit will not convey the needed heat to surfaces. Pressures below the specified limit will result in incomplete coverage of the heat-conveying sanitizing rinse across utensil surfaces.


4-801.11 Clean Linens.



4-802.11 Specifications.



4-803.11 Storage of Soiled Linens.


4-803.12 Mechanical Washing.


4-803.13 Use of Laundry Facilities.



4-901.11 Equipment and Utensils, Air-Drying Required.


4-901.12 Wiping Cloths, Air-Drying Locations.


Lubricating and Reassembling

4-902.11 Food-Contact Surfaces.


4-902.12 Equipment.





4-903.12 Prohibitions.


Preventing Contamination

4-904.11 Kitchenware and Tableware.
4-904.12 Soiled and Clean Tableware.
4-904.13 Preset Tableware.


4-904.14 Rinsing Equipment and Utensils after Cleaning and Sanitizing.

The rinsing of cleaned and sanitized utensils and equipment in a manner that may contaminate the surfaces before they are used, such as running them under a faucet or by dipping them in a vessel of water, is prohibited. The application of a post-sanitizing rinse is restricted to warewashing machines because there will be little opportunity for contamination of the potable water rinse if applied within the confines of a compliant warewashing machine. Provided the sanitization is achieved before the rinse is applied and as long as any chemical sanitizers are used in accordance with an EPA-registered label, the sanitary state of utensils and equipment should not be altered by applying a potable water rinse after the required final sanitizing rinse within a warewashing machine.

Page Last Updated: 09/30/2015