5K-4.004. General Requirements for the Manufacturing, Processing, Packing, Holding and Retailing of Foods

The provisions of subsections (1) through (6) shall apply in determining whether the facilities, methods, practices and controls used in the manufacture, processing, packing, holding, retailing or offering for sale of foods are in conformance with or are operated or administered in conformity with this rule to assure that food for human consumption is safe.

(1) Food Establishment and grounds.

(a) Grounds – the grounds about a Food Establishment under the control of the operator shall be free from conditions which may result in the contamination of food including the following:

1. Improperly stored equipment, litter, waste, refuse, and uncut weeds or grass within the immediate vicinity of the Food Establishment building or structures that may constitute an attractant, breeding place, or harborage for rodents, insects, and other pests.

2. Excessively dusty roads, yards or parking lots that may constitute a source of contamination in areas where food is exposed.

3. Inadequately drained areas that may contribute contamination to food products through seepage or food-borne filth and by providing a breeding place for insects or microorganisms.

4. If the Food Establishment grounds are bordered by grounds not under the operator’s control of the kind described in subparagraphs 1.-3. of this rule, care must be exercised in the Food Establishment by inspection, extermination, removal, or other means to effect exclusion of pests, dirt, and other filth that may be a source of food contamination.

(b) Food Establishment shall:

1. Be operated and maintained as required in Rule 5K-4.002, F.A.C. None of the operations connected with a Food Establishment shall be conducted in any room or area used as living or sleeping quarters.

2. Provide sufficient space for such placement of equipment and storage of materials as is necessary for sanitary operations and production of safe food. Floors, walls, and ceilings in the Food Establishment shall be of such constriction as to be cleanable and shall be kept clean and in good repair. Fixtures, ducts, and pipes shall not be so suspended over working areas that drip or condensate may contaminate foods, raw materials, or food-contact surfaces. Aisles or working spaces between equipment and between equipment walls shall be unobstructed and of sufficient width to permit employees to perform their duties without contamination of food or food-contact surfaces with clothing or personal contact.

3. Provide separation by partition, location, or other effective means for those operations which may cause contamination of food products with undesirable microorganisms, chemicals, filth or other extraneous material.

4. Provide adequate lighting to handwashing areas, dressing and locker rooms, and toilet rooms and to all areas where food or food ingredients are examined, processed or stored and where equipment and utensils are cleaned. Light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or display shall be of the safety type or otherwise protected to prevent food contamination in case of breakage.

5. Provide adequate ventilation or control equipment to minimize odors and noxious fumes or vapors (including steam) in areas where they may contaminate food. Such ventilation or control equipment shall not create conditions that may contribute to food contamination by airborne contaminants.

6. Provide, where necessary, effective screening or other protection against birds, animals, and vermin (including, but not limited to, insects and rodents).

(2) Equipment and utensils. All Food Establishment equipment and utensils should be:

(a) Suitable for their intended use,

(b) So designed and of such material and workmanship as to be adequately cleanable, and,

(c) Properly maintained.

The design, construction and use of such equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.

(3) Sanitary facilities and controls. Each Food Establishment shall be equipped with adequate sanitary facilities and accommodations including the following:

(a) Water supply – The water supply shall be sufficient for the operations intended and shall be derived from an approved source in accordance with Section 500.03(1)(c), F.S. Any water that contacts foods or food-contact surfaces shall be safe and from an approved source as required by Sections 403.850-403.891, F.S. Running water, at a temperature suitable for its intended use and under pressure, as needed, shall be provided in all areas where the processing of food, the cleaning of equipment, utensils or containers, or employees’ sanitary facilities, require.

(b) Sewage disposal – Sewage disposal shall be made into an approved sewerage system or disposed of through other approved means, as required by Sections 403.085-403.087, F.S.

(c) Plumbing – Plumbing shall be sized, installed, and maintained as required by the plumbing provisions of the state sanitary code, and maintained to:

1. Carry sufficient quantities of water to required locations throughout the Food Establishment.

2. Properly convey sewage and liquid disposable waste from the Food Establishment.

3. Not constitute a source of contamination to foods, food products or ingredients, water supplies, equipment, or utensils or create an unsanitary condition.

4. Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.

(d) Toilet facilities – Each Food Establishment shall provide its employees with toilet and associated hand-washing facilities within the Food Establishment as required by the plumbing provisions of the Florida Building Code. Fixtures shall be of readily cleanable sanitary design. Toilet rooms shall be furnished with toilet tissue. Toilet rooms shall be maintained in a sanitary condition and kept in good repair at all times. Doors to toilet rooms shall be self-closing and shall not open directly into areas where food is exposed to airborne contamination, except where alternate means have been taken to prevent such contamination (such as double doors, positive air-flow systems, etc.). Signs shall be posted requiring employees to use cleaning soap or detergents after using toilet.

(e) Hand-washing facilities – Convenient facilities for hand washing and, where appropriate, hand sanitizing shall be provided at each location in the Food Establishment in areas where food preparation, food dispensing, and warewashing occurs, and in toilet rooms. Such facilities, shall be furnished with running water at a temperature for hand washing, effective hand-cleaning and sanitizing preparations, sanitary towel service or drying devices and easily cleanable waste receptacles. The use of a “common” towel is forbidden.

(f) Rubbish and offal disposal – Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, prevent waste from becoming an attractant and harborage or breeding place for vermin, and prevent contamination of food, food-contact surfaces, ground surfaces, and water supplies.

(4) Sanitary operations.

(a) General maintenance – Building, fixtures, and other physical facilities of the Food Establishment shall be kept in good repair and shall be maintained in a sanitary condition. Cleaning operations shall be conducted in such a manner as to minimize the danger of contamination of food and food-contact surfaces. Detergents, sanitizers, and other supplies employed in cleaning and sanitizing procedures shall be free of significant microbiological contamination and shall be safe and effective for their intended uses. Only such toxic materials as are required to maintain sanitary conditions, for use in laboratory testing procedures, for Food Establishment and equipment maintenance and operation, or in manufacturing or processing operations, shall be used or stored in the Food Establishment. These materials shall be identified and used only in such manner and under conditions as will be safe for their intended uses.

(b) Animal and vermin control – No animals or birds, other than those essential as raw material, shall be allowed in any area of a Food Establishment. Effective measures shall be taken to exclude pests from the processing areas and to protect against contamination of foods in or on the premises by animals, birds, and vermin (including, but not limited to, rodents and insects). The use of insecticides or rodenticides permitted and approved pursuant to Chapter 487, F.S., and Rule 5E-2.031, F.A.C., is permitted only under such precautions and restrictions as will prevent the contamination of food or packaging materials with illegal residues.

(c) Sanitation of equipment and utensils – All utensils and product-contact surfaces of equipment shall be cleaned as frequently as necessary to prevent contamination of food and food products. Nonproduct-contact surfaces or equipment used in the operation of Food Establishments should be cleaned as frequently as necessary to minimize accumulation of dust, dirt, food particles, and other debris. Single-service articles (such as utensils intended for one-time use, paper cups, paper towels, etc.) should be stored in appropriate containers and handled, dispensed, used, and disposed of in a manner that prevents contamination of food or food-contact surfaces. Where necessary to prevent the introduction of undesirable microorganisms into food products, all utensils and product-contact surfaces of equipment used in the Food Establishment shall be cleaned and sanitized prior to such use and following any interruption during which such utensils and contact surfaces may have become contaminated. Where such equipment and utensils are used in a continuous production operation, the contact surfaces of such equipment and utensils shall be cleaned and sanitized on a predetermined schedule. Sanitizing agents shall be effective and safe under conditions of use. Any facility, procedure, machine, or device may be acceptable for cleaning and sanitizing equipment and utensils if it is established that such facility, procedure, machine, or device will routinely render equipment and utensils clean.

(d) Storage and handling of cleaned portable equipment and utensils – Cleaned and sanitized portable equipment and utensils with product-contact surfaces should be stored in such a location and manner that product-contact surfaces are protected from splash, dust, and other contamination.

(5) Processes and controls. All operations in the receiving, inspecting, transporting, packaging, segregating, preparing, processing, and storing of food shall be conducted under conditions that protect against contamination of food. Overall sanitation of the Food Establishment shall be under the supervision of an individual assigned responsibility for this function. All reasonable precautions, including the following, shall be taken to assure that production procedures do not contribute contamination such as filth, harmful chemicals, undesirable microorganisms, or any other objectionable material to the processed product:

(a) Raw material and ingredients shall be inspected and segregated to assure that they are clean, wholesome, and fit for processing into human food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as required to remove soil or other contamination. Water used for washing, rinsing, or conveying of food products shall not be reused for washing, rinsing or conveying products in a manner that may result in contamination of food products.

(b) Containers and carriers of raw ingredients should be inspected on receipt to assure that their condition has not contributed to the contamination or deterioration of the products.

(c) When ice is used in contact with food products, it shall be made from potable water and shall be used only if it has been manufactured, stored, transported and handled in a sanitary manner.

(d) Food-processing areas and equipment used for processing human food should not be used to process nonhuman food-grade animal feed or inedible products unless there is no reasonable possibility for the contamination of the human food.

(e) Processing equipment shall be maintained in a sanitary condition through frequent cleaning, including sanitization where indicated. Where possible, equipment shall be taken apart for thorough cleaning.

(f) All food processing, including packaging and storage, should be conducted under such conditions and controls as are necessary to minimize the potential for undesirable bacterial or other microbiological growth, toxin formation or deterioration or contamination of the processed product or ingredients. This may require careful monitoring of such physical factors as time, temperature, humidity, pressure, flow-rate and such processing operations as freezing, dehydration, heat processing and refrigeration to assure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of the processed products.

(g) Chemical, microbiological, or extraneous material testing procedures shall be utilized where necessary to identify sanitation failures or food contamination, and all foods and ingredients that have become contaminated shall be rejected or treated or processed to eliminate the contamination where this may be properly accomplished.

(h) Packaging processes and materials shall not transmit contaminants or objectionable substances to the products, shall conform to any applicable food additive regulation in 21 CFR 121 incorporated in paragraph 5K-4.002(1)(d), F.A.C., and should provide protection from contamination.

(i) Coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity is recommended to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use. Records should be retained for a period of time that exceeds the shelf life of the product, except that they need not be retained more than 2 years.

(j) Storage and transportation of finished products shall be under such conditions as will prevent contamination and will protect against undesirable deterioration of the product and the container. Food that is being held for later sale or use shall be stored on pallets or equivalent with adequate separation between lots and walls to permit personnel to properly clean and protect such food. Sources of contamination that foods and food products shall be protected against include dust, flies, rodents and other vermin, toxic material, unclean equipment and utensils, unnecessary handling, flooding by sewage, overhead leaking, and development of pathogenic and toxigenic microorganisms.

(6) Personnel. The Food Establishment management shall take measures and precautions to assure the following:

(a) Disease control – No person affected by disease in a communicable form, or while a carrier of such disease, or while affected with boils, sores, infected wounds, or other abnormal sources of microbiological contamination, shall work in a Food Establishment in any capacity in which there is a reasonable possibility of food or food ingredients becoming contaminated by such person, or of disease being transmitted by such person to other individuals.

(b) Cleanliness – All persons, while working in direct contact with food preparation, food ingredients, or surfaces coming into contact therewith shall:

1. Wear clean outer garments, maintain personal cleanliness, while on duty, to the extent necessary to prevent contamination of food products.

2. Wash their hands thoroughly (and sanitize, if necessary to prevent contamination by undesirable microorganisms) in a hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.

3. Remove all insecure jewelry and, during periods where food is manipulated by hand, remove from hands jewelry that cannot be sanitized.

4. If gloves are used in food handling, maintain them in an intact, clean, and sanitary condition. Such gloves should be of an impermeable material except where their usage would be inappropriate or incompatible with the work involved.

5. Wear hair nets, caps or other effective hair restraints. Hair spray or the equivalent is not acceptable as a hair restraint.

6. Not store clothing or other personal belongings, eat food or drink beverages, or use tobacco in any form in areas where food or food ingredients are exposed or in areas used for washing equipment or utensils.

7. Take any other necessary precautions to prevent contamination of foods with microorganisms or foreign substances including perspiration, hair, cosmetics, tobacco, chemicals and medicants.

(c) Education and training – Wholesale Food Establishment personnel shall meet the training requirements set forth in 21 CFR 117.4(b) as adopted by reference in Rule 5K-4.002, F.A.C. Retail Food Establishment personnel shall meet the training requirements set forth in Rule 5K-4.021, F.A.C.

(d) Supervision – Responsibility for assuring compliance by all personnel with all requirements of this rule shall be clearly assigned to supervisory personnel who meet the training requirements specified in paragraph 5K-4.004(6)(c), F.A.C.

(7) Establishments engaged solely in the harvesting, storage, or distribution of one or more raw agricultural commodities which are ordinarily cleaned, prepared, treated or otherwise processed before being marketed to the consuming public are exempted from coverage under these general regulations. This exemption does not apply to persons selling Food consisting of or containing Hemp Extract. Tomato packing houses and repackers must comply with Rule 5K-4.029, F.A.C.

(8) Review of plans by the Department.

(a) An Applicant or holder of a food permit may request assistance from the Department in the review of construction or remodeling plans to evaluate conformance with requirements as established in this chapter by submitting a completed Plan Review Application, FDACS-14222 (Rev. 12/19), the attachments, and fee to the Department as required in the form. The Plan Review Application, FDACS-14222 (Rev. 12/19) is incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-11769.

(b) The fee for plan review assistance will be determined by multiplying the number of reviewer hours expended in reviewing plans and in consulting with the applicant, at the rate of $30.10 per hour. An additional flat fee of $25.00 per plan review will be charged for associated expense costs such as FAX, telephone, mailing, shipping or document duplication expenditures incurred by the Department. Time expended shall be recorded in quarter hour increments with a minimum charge of one hour per plan review. Payment for plan review assistance is due 15 days from the date of invoice from the Department.

(9) Laboratory testing. Where laboratory testing is required in this rule chapter, such testing shall be performed by an ISO (International Organization of Standardization) 17025 based accredited laboratory certified to conduct testing for the microorganism, or analyte of concern. The results of such testing shall be provided directly from the laboratory to the Department via email to [e-mail], and the testing shall be done at the expense of the Food Establishment.

Rulemaking Authority 570.07(23), 500.09, 500.12 FS. Law Implemented 500.04, 500.09, 500.10, 500.12(2)(b), 500.13, 500.172 FS. History–New 3-1-72, Repromulgated 12-31-74, Amended 1-18-83, Formerly 5E-6.04, 5E-6.004, Amended 9-30-96, 7-26-04, 3-16-20.