The purpose of this rulemaking is to establish definitions, incorporate by reference current versions of federal regulations, update permitting requirements, consolidate the requirements of Chapter 5K-9, F.A.C., for vended water machines into ...  

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    DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

    Division of Food Safety

    RULE NOS.:RULE TITLES:

    5K-4.0010Definitions

    5K-4.002Adoption of Federal Regulations and Other Standards

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

    5K-4.0041Mobile Food Establishments and Commissaries

    5K-4.0050Special Process Approvals

    5K-4.020Food Permits; Requirements and Fees

    5K-4.021Food Manager Certification

    5K-4.023Packaged Ice

    5K-4.033Limited Poultry and Egg Farm Operation

    5K-4.035Guidelines for Imposing Administrative Penalties

    PURPOSE AND EFFECT: The purpose of this rulemaking is to establish definitions, incorporate by reference current versions of federal regulations, update permitting requirements, consolidate the requirements of Chapter 5K-9, F.A.C., for vended water machines into Chapter 5K-4, F.A.C., adopt rules for special process approvals and mobile food establishments, and adopt guidelines for administrative penalties.

    SUMMARY: This proposed rule chapter establishes definitions and administrative penalties, and updates requirements for food establishments, special process approvals, and vended water.

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

    The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

    The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The department’s proposed rules do not increase fees or otherwise impose any other costs, directly or indirectly, on the regulated industry. Based on this information, the department determined there will be no adverse impact to small businesses and the potential regulatory costs of the proposed rule chapter does not exceed any of the criteria established in Section 120.541(2)(a), F.S. Additionally, no interested party submitted additional information regarding the economic impact. Any person who wishes to provide information regarding the statement of estimated regulatory costs or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

    Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

    RULEMAKING AUTHORITY: 500.09, 500.12, 500.459, 570.07(23), FS.

    LAW IMPLEMENTED: 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.147, 500.148, 500.165, 500.169, 500.171, 500.172, 500.173, 500.174, 500.179, 500.459, 500.511, 500.70, 500.80, 570.07(23), FS.

    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Matthew Colson by email at Matthew.Colson@FreshFromFlorida.com.

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    5K-4.0010 Definitions.

    For the purpose of this rule chapter, the definitions in Section 500.03, F.S., and the following shall apply.

    (1) Candy is a type of confectionery that does not require refrigeration. Candy includes hard candies such as lollipops, chocolates, chocolate or sugar covered fruits or nuts, caramels, toffees or similar sugar-based foods customarily eaten as snack foods.

    (2) Confectionery mean sweet foods such as candy, chewing gum, or similar foods made primarily of sugar or sugar substitutes. Confectionery does not include baked goods where flour is the main ingredient such as cakes, cookies, or frozen desserts.

    (3) Commissary means a support service location for a Mobile Food Establishment that meets all applicable requirements of Chapter 500, F.S., and Chapter 5K-4, F.A.C.

    (4) Distribution means the transfer of food from one business to another, or from one business location to another.

    (5) Ice means food that is formed from water by freezing to a solid state that is intended for human consumption or offered for other use by the consumer.

    (6) Ice Vending Machine means a Food Establishment that is a self-serving device that, upon insertion of a coin or token or upon receipt of payment by any means, dispenses a bag or a bulk service of ice to a customer.

    (7) Maximum Contaminant Level (MCL) means the maximum permissible level of a contaminant as set forth in Rule 64E-8.006, F.A.C. and Rule Chapter 62-550, F.A.C.

    (8) Mobile Food Establishments are Food Establishments that are self-propelled or otherwise moveable from place to place such as a truck, trailer, or similar self-propelled conveyance or non-permanent kiosk or table where pre-packaged food products are sold.

    (9) Potentially Hazardous Food /Time/Temperature Control for Safety Food (PHF/TCS) means food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.

    (10) Potable Water means water that meets the quality standards of Chapter 62-550, F.A.C., and is satisfactory for drinking, culinary, and domestic purposes.

    (11) Production Batch of Sprouts means all sprouts that are started at the same time in a single growing unit (e.g., a single drum or bin, or a single rack of trays that are connected to each other), whether the sprouts are grown from a single lot of seed (including, for example, when multiple types of seeds are grown in a single growing unit).

    (12) Retail Food Establishment means an establishment that sells food products directly to consumers as its primary function.

    (13) Water Vending Machine means a self-service device that, upon insertion of a coin or token or upon receipt of payment by any means, dispenses a serving of water into a container.

    (14) Wholesale Food Establishment means an establishment whose sales of food products directly to consumers is not its primary function.

    Rulemaking Authority 500.09, 570.07(23), F.S.  Law Implemented 500.03, F.S.  History-New______.

     

    5K-4.002 Adoption of Federal Regulations and Other Standards.

    (1) The following materials are hereby incorporated and adopted as rules under the Florida Food Act, Chapter 500, F.S. Copies of all referenced materials documents are available for examination at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, Bureau of Food and Meat Inspection, 3125 Conner Boulevard, Suite H, Tallahassee, Florida 32399-1650 or online as indicated.

    (a) Code of Federal Regulations Title 7 – Agriculture, Part 51, Sections 51.2-51.3, 51.300-51.3749, Part 52, Sections 52.2-52.3, 52.771-52.3764, Part 56, Sections 56.1-56.2, 56.35-56.37, 56.39-56.41, 56.75-56.77, Part 57, Sections 57.1, 57.35, 57.45, 57.800-57.860, 57.900-57.970, and Part 70, Sections 70.1-70.2, 70.50-70.55, 70.110, revised as of January 1, 2016 2014, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX. http://www.flrules.org/Gateway/reference.asp?No=Ref-04643.

    (b) Code of Federal Regulations Title 9 – Animal and Animal Products, Parts 301, 303, 316-317, Part 318, Sections 318.10, 318.16, 318.20, Part 319, Part 352, Sections 352.1 and 352.7, Part 354, Sections 354.1, 354.70-354.72, and Part 381, Sections 381.1-381.15, 381.125, revised as of January 1, 2016 2014, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX. http://www.flrules.org/Gateway/reference.asp?No=Ref-04644.

    (c) Code of Federal Regulations Title 19 – Custom Duties, Part 134, revised as of April 1, 20162014, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX. http://www.flrules.org/Gateway/reference.asp?No=Ref-04647.

    (d) Code of Federal Regulations Title 21 – Food and Drugs, Part 1 (excluding subparts L, and M) , Part 2, Sections 2.5, 2.25-2.125, Parts 7, 70, 73-74, 100, Part 101, (excluding section 101.8,  subsection 101.9(g)(2), and section 101.11), Parts 102-109, Part 110 (except for 110.80(b)(3)(i) is amended to required refrigerated foods to be maintained at a temperature of 41 degrees Fahrenheit (5 degrees Celsius) or below and 110.80(b)(3)(iii) is amended to require that hot foods to be maintained at a temperature of 135 degrees Fahrenheit (57 degrees Celsius) or above), Part 111 – 190 and Part 1240, revised as of April 1, 20162014, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

    http://www.flrules.org/Gateway/reference.asp?No=Ref-04645 and http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

    https://www.flrules.org/Gateway/reference.asp?No=Ref-07843.

    (e) Code of Federal Regulations Title 21 – Food and Drugs, Part 112, Sections 112.3, 112.12, 112.44(a)(1)-(4), 112.140, 112.49(a), Subparts C, and LM-O pertaining only to sprouts, Part 117 (except for 117.80(c)(3) is amended to require refrigerated foods to be maintained at a temperature of 41 degrees Fahrenheit (5 degrees Celsius) or below and require that hot foods be maintained at a temperature of 135 degrees Fahrenheit (57 degrees Celsius) or above revised as of April 1, 2016, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-08684.

    (f) Code of Federal Regulations Title 40 – Protection of Environment, Part 180, (excluding subsection 180.6(d) and Section 180.101), revised as of July 1, 20182013, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

    http://www.flrules.org/Gateway/reference.asp?No=Ref-04646.

    (2) The following materials are hereby incorporated and adopted as rules under the Florida Food Act, Chapter 500, F.S. Copies of all referenced materials documents are available for examination at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, Bureau of Food and Meat Inspection, 3125 Conner Boulevard, Suite H, Tallahassee, Florida 32399-1650 or online as indicated.

    (a) The action levels for food defects declared by the United States Food and Drug Administration and referenced in the FDA/CFSAN Defect Action Level Handbook, The Food Defect Action Levels, May 1995 (Revised May 1998), http://www.flrules.org/Gateway/reference.asp?No=Ref-04900.

    (b) Industry Activities Staff Booklet, Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (August 2000), http://www.flrules.org/Gateway/reference.asp?No=Ref-04901.

    (c) Fish and Fisheries Products Hazards and Controls Guidance, 4th Edition (April 2011), http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

    (d) Guidance for Industry: Juice HACCP Hazards and Controls Guidance First Edition (March 2004), http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

    (e) AWWA B604-74: American Waterworks Association (AWWA) Standard for Granular Activated Carbon (January 1974) http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

    (f) Guidance Document for Unattended Food Establishments (December 2017) http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

    (3) Food Salvage Operations.

    (a) The “Food Sorting Guidance and Model Consumer Commodity Salvage Code (September 2017November 2002),” jointly published by the Association of Food and Drug Officials, the U.S. Department of Health and Human Services and the U.S. Department of Agriculture is hereby adopted as sanitation criteria, standards, and requirements for food salvage operations in Florida and is incorporated by reference, http://www.flrules.org/Gateway/reference.asp?No=RefXXXX. https://www.flrules.org/Gateway/reference.asp?No=Ref-04902, with the following exclusions: Sections 1-102(B), 9-102(C), (F) and (G), 13-101-13-106, and 14-101-14-107. The Department has determined that posting the incorporated material on the Internet would constitute a violation of the federal copyright law. The incorporated material will be available for public inspection and examination at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, Bureau of Food and Meet Inspection, 3125 Conner Boulevard, Suite H, Tallahassee, Florida 32399-1650.

    (b) For the purposes of subsection (3), of this rule, “Consumer commodity” is defined as: “any food, beverage, dietary supplement, animal food (pet food), single service food containers or utensils, soda straws, paper napkins, or any other product of a similar nature. It also may include animal feed when handled at the same facility as other consumer commodities. This definition includes salvage caused by disasters which could include animal feeds which are handled differently than “animal food” which is destined for consumption by pets (e.g., cans of cat food, broken bags of dry dog food).”

    (4) Food Code – Provisions Adopted and Exclusions. The following materials are hereby incorporated and adopted as rules under the Florida Food Act, Chapter 500, F.S. Copies of all referenced materials documents are available for examination at the Florida Department of Agriculture and Consumer Services, Division of Food Safety, Bureau of Food and Meat Inspection, 3125 Conner Boulevard, Suite H, Tallahassee, Florida 32399-1650 or online as indicated.

    (a) Chapters 1-7, Subpart 8-101, Subpart 8-103, Section 8-201.13, Section 8-201.14, Section 8-202.10 of the “2017 2009  Food Code,” (hereafter known as the Food Code), “Annexes 3 – 7 of the 2017 2009  Food Code,” and the “Supplement to the 2009 Food Code” (effective date September 29, 2011), published by the U.S. Public Health Service of the U.S. Department of Health and Human Services. Interested persons may obtain copies of these materials online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

    http://www.flrules.org/Gateway/reference.asp?No=Ref-04648, and http://www.flrules.org/Gateway/reference.asp?No=Ref-04649, respectively.

    (b) The following provisions of the Food Code are not adopted by reference and therefore are specifically excluded from rule:

    1. 1-201.10(B), definitions for terms “Food Establishment,” “Food Processing Plant,” and “Temporary Food Establishment”; and,

    2. 1-201.10(B), the word “unpackaged” only within the definition of “Food Employee”; and,

    3. 4-301.12(C)(5), 4-301.12(D), 4-301.12(E); and,

    4. 3-203.11(C); and,

    5. All subsequent parts of subsection 6-202.110 after the word “law”; and,

    6. 3-502.11; and,

    7. 2-102.12.

    Rulemaking Authority 500.09, 500.12(1)(f), 500.12(5)(d), 500.12(6), 500.459, 570.07(23), (24) FS. Law Implemented 500.02, 500.03, 500.032, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.147, 500.166, 500.169, 500.172, 500.459, 570.07(2), (6), (9), (16), (18), (24), 570.0725 FS. History–New 3-1-72, Amended 12-31-74, 1-18-83, 6-17-85, Formerly 5E-6.02, Amended 7-25-88, 4-13-92, Formerly 5E-6.002, Amended 8-8-95, 9-9-96, 12-10-96, 4-10-97, 9-8-97, 11-15-99, 2-5-04, 3-1-09, 2-25-15, 1-16-17, 10-31-17,_____.

     

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

    The provisions of subsections (1) through (6)(7) 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 Plant and grounds.

    (a) Grounds – the grounds about a Ffood Establishment plant under the control of the operator shall be free from conditions which may result in the contamination of food including, but not limited to, the following:

    1. Improperly stored equipment, litter, waste, refuse, and uncut weeds or grass within the immediate vicinity of the Food Establishment plant 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 plant grounds are bordered by grounds not under the operator’s control of the kind described in subparagraphs 1.-3. of this rule paragraph, care must be exercised in the Food Establishment plant 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 Plant buildings and structure shall:

    1. Be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food processing purposes. Food Establishments Plants that are engaged primarily in the processing of foods must have concrete or other impervious floors with proper slope to adequate floor drains as may be required to prevent pooling or accumulation of water and other liquids. None of the operations connected with a food processing Food Establishment plant shall be conducted in any room or area used as living or sleeping quarters. There shall be no direct opening between living quarters and any room or area where foods are manufactured or processed.

    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 plant shall be of such construction as to be adequately 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 plant 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 plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to, the following:

    (a) Water supply – The water supply shall be sufficient for the operations intended and shall be derived from an approved adequate source in accordance with paragraph 500.03(1)(c), F.S. Any water that contacts foods or food-contact surfaces shall be safe and from an approved source in accordance with applicable provisions of Chapter 403, F.S the state sanitary code. Running water, at a suitable 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, in accordance with applicable provisions of Chapter 403, F.S the state sanitary code.

    (c) Plumbing – Plumbing shall be sized, installed, and maintained in accordance with applicable provisions of the Florida Building state sanitary Ccode, and maintained to:

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

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

    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 plant shall provide its employees with adequate toilet and associated hand-washing facilities within the Food Establishment plant in accordance with applicable provisions of the state sanitary code. Fixtures shall be of readily cleanable sanitary design. Water closets shall be equipped with open-front type seats of smooth non-absorbent material. 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 – Adequate and Cconveniently located facilities for hand washing and, where appropriate, hand sanitizing shall be provided at each location in the Food Establishment plant where good sanitary practices require employees to wash or sanitize and dry their hands. Such facilities, where appropriate, shall be furnished with running water at a suitable temperature for hand washing, effective hand-cleaning and sanitizing preparations, sanitary towel service or suitable drying devices and, where appropriate, 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 plant 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 plant and equipment maintenance and operation, or in manufacturing or processing operations, shall be used or stored in the Food Establishment plant. 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 Ffood Establishment plant. 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 approved 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 Ffood Establishments plants 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 plant 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 using adequate methods for cleaning and sanitizing. 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 and provide adequate sanitizing treatment.

    (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 in accordance with adequate sanitation principles. Overall sanitation of the Food Establishment plant 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 as necessary 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 be of adequate quality, and water 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 in accordance with adequate standards and 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, Insofar as necessary 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 – part 121) incorporated in paragraph 5K-4.002(1)(d), F.A.C., and should provide adequate protection from contamination.

    (i) Meaningful coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity should be utilized 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, but are not limited to, 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 plant management shall take all reasonable 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 Ffood Establishment plant 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 a high degree of personal cleanliness, and conform to hygienic practices 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 an adequate 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 adequately 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, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicants.

    (c) Education and training – Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food-handling techniques and food-protection principles and be cognizant of the danger of poor personal hygiene and unsanitary practices.

    (d) Supervision – Responsibility for assuring compliance by all personnel with all requirements of this rule shall be clearly assigned to competent supervisory personnel.

    (7) Dietary supplements containing ephedrine alkaloids. Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury to health under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use. Therefore ephedrine alkaloids are deleterious substances, and dietary supplements containing ephedrine alkaloids are adulterated under Section 500.10, F.S.

    (7)(8) Exemptions. Exclusions The following operations are excluded from coverage under these general regulations, however, the department will issue special regulations when believed necessary to cover these excluded operations: 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.

    (8)(9) Review of plans by the Ddepartment.

    (a) An Applicant or holder of a food permit may request assistance from the Ddepartment 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. 11/18), the attachments, and fee to the Department as required in the form. The Plan Review Application, FDACS-14222 (Rev. 11/18) is incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

    (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 Ddepartment. 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 Ddepartment.

    (9) Laboratory testing. Where laboratory testing is required in this rule chapter, such testing shall be performed by an ISO (International Organizaiton 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 www.FoodInsp@FreshFromFlorida.com, 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, ______.

     

    5K-4.0041 Mobile Food Establishments and Commissaries.

    (1) Mobile Food Establishments.

    (a) Mobile Food Establishments shall meet all applicable requirements as specified in the Mobile Food Permit Requirements (Rev. 11/18) incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX and as indicated on the form.

    (b) Each Mobile Food Establishment not operating in conjunction with a permitted Food Establishment will require its own permit and is subject to all applicable fees.  A permitted Food Establishment may operate one Mobile Food Establishment without paying an additional permit fee.  Any additional Mobile Food Establishments will require a separate permit and are subject to all applicable fees. 

    (c) Mobile Food Establishments shall not operate independent of a Commissary approved by the Department unless otherwise specified in this rule chapter. Each Mobile Food Establishment shall submit to the Department a completed Commissary Letter of Agreement, FDACS-14223 (Rev. 11/18) hereby incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

    1. Commissary Letter of Agreement, FDACS-14223 (Rev. 11/18), shall be executed on an annual basis.

    2. The Mobile Food Establishment shall make this agreement available to the Department upon request.

    (d) Each Mobile Food Establishment shall report to a Commissary to store or replenish supplies, clean utensils, and equipment, or dispose of liquid and solid waste, with the exception of Mobile Food Establishments that sell only prepackaged foods and have all necessary support equipment located in the unit. 

    1. The Mobile Food Establishment shall visit the Commissary each day of operation unless exempt by this Rule Chapter.

    2. The Mobile Food Establishment shall have more than one approved Commissary for each time it operates in a location where it cannot visit its primary Commissary once a day during operation. A Commissary Letter of Agreement, FDACS-14223 (Rev. 11/18) is required for each additional Commissary used by the Mobile Food Establishment.

    (e) Mobile Food Establishments shall not process or prepare exposed potentially hazardous foods (PHFs) within the mobile food establishment without first obtaining a food permit. Processing/preparing food includes combining food ingredients, heating/cooking food, cutting/slicing of food, and repackaging of bulk foods or similar operations.

    (f) Exemptions. Mobile Food Establishments selling only fresh fruits or vegetables are exempted from this rule chapter. 

    (2) Commissaries. A Commissary must be permitted as a Food Establishment under Chapter 500, F.S., a Public Food Service Establishment licensed under Chapter 509, F.S., or a Food Service Establishment licensed under Chapter 381, F.S.

    Rulemaking Authority 500.09, 570.07(23) FS., Law Implemented 500.09, 500.12, FS. History–New____.

     

    5K-4.0050 Special Process Approvals.

    (1) A Retail Food Establishment shall obtain a special process approval from the Department before the following:

    (a) Smoking food as a method of food preservation rather than as a method of flavor enhancement;

    (b) Curing food;

     

    (c) Using food additives or adding components such as vinegar as a method of food preservation rather than as a method of flavor enhancement or to render a food so that it is not time/temperature control of safety food;

    (d) Packaging TCS foods using a reduced oxygen packaging method except where the growth of toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under 3-502.12 of the FDA Food Code;

    (e) Operating a molluscan shellfish life-support system display tank used to store or display shellfish that are offered for human consumption;

    (f) Custom processing animals that are for personal use as food and not for sale or service in a Food Establishment;

    (g) Sprouting seeds or beans; or

    (h) Preparing food by methods other than those specified in this rule chapter. 

    (2)  The Department shall not issue a special process approval until the Department receives from the Retail Food Establishment the following: 

    (a) A complete Application for Special Process Approval For Retail Food Establishments, FDACS-14095 (Rev. 11/18), submitted either online at www.FoodInsp@FreshFromFlorida.com or by mail as indicated on the form. This application is incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX;

    (b) A statement citing the relevant FDA Food Code section numbers pertaining to the special process approval request;

    (c) Procedures that address potential public health hazards and nuisances as required by applicable sections of the FDA Food Code incorporated by reference in Rule 5K-4.002, F.A.C; and

    (d) A Hazard Analysis and Critical Control Point (HACCP) plan if required as specified under Section 8-201.13(A) of the FDA Food Code that includes the information specified under 8-201.14 as it is relevant to the special process approval requested.

    (3) If a special process approval application is granted by the Department, or a HACCP plan is otherwise required as specified under 8-201.13 of the FDA Food Code, the Food Establishment shall:

    (a) Comply with the HACCP Plans and procedures that are submitted as specified under 8-201.14 and approved as a basis for the special process approval; and

    (b) Maintain and provide to the Department upon request, records specified under 8-201.14 (D) and (E)(3) of the FDA Food Code that demonstrate that the following are routinely employed;

    1. Procedures for monitoring the critical control points,

    2. Monitoring of the critical control points,

    3. Verification of the effectiveness of the operation or process, and

    4. Necessary corrective actions if there is failure at a critical control point.

    (c) Maintain a copy of the special process approval, and all associated documents required in this rule.

    (d) Special process approvals are granted by the department only for one Food Establishment location and are not transferable to new owners or new locations. Once granted, a special process approval does not expire as long as the applicant holds a valid food permit. A separate application is required for each process the Food Establishment intend to implement.

    (e) The Department may suspend or revoke a special process approval if the Food Establishment fails to comply with the conditions specified in this rule. 

    Rulemaking Authority 500.09, 570.07(23), FS. Law Implemented 500.09, 500.10, 500.11, 500.13, 500.169, FS. History–New____.

     

    5K-4.020 Food Permits; Requirements and Fees.

    (1) As used in this rule, the following definitions shall apply in determining food permit fees:

    (a) Bottling plant. A processor or packer or both of juices, drinks, carbonated beverages or non-carbonated beverages in hermetically sealed containers (excluding bottled drinking water).

    (b) Canning plant. A processor or packer or both of fruit, vegetables, seafoods or other foods in hermetically sealed containers.

    (c) Convenience store. A business that is engaged primarily in the retail sale of groceries or motor fuels or special fuels and may offer food services limited to coffee from urns, or iced or frozen drinks, with no retail food processing.

    (d) Convenience store with limited food service. A convenience store where food is prepared and intended for individual portion service but limited to the display of snack foods or pastries, and/or heating or cooking of hot dogs, sausages, prepackaged pizza or meat pastries, regardless of whether consumption is on or off the premises or whether there is a charge for the food, but without retail food processing.

    (e) Convenience store with significant food service. A convenience store that has retail food processing activities consisting of on-site cooking or other preparation of hot entrees, chicken (fried, roasted or grilled), sandwiches, salads, or desserts for consumption on or off the premises. The term also applies to such foods brought to a location for sale on individual customer order or by buffet-style display.

    (f) Food salvage center. A firm specializing in sorting, segregating and re-working damaged foods, primarily for wholesale distribution.

    (g) Food storage warehouse. A cold storage warehouse, a dry storage warehouse, or a commercial food distribution center.

    (h) Grocery store. A retail food store stocking a wide variety of foods and engaged in retail food processing which contains four or fewer check-out registers and less than 15,000 total square footage, including display, preparation and storage areas.

    (i) Health food store. A retail food store engaged primarily in the sale of prepackaged vitamins, minerals, nutritional supplements and foods intended for health-conscious persons but with no food service or retail food processing.

    (j) Health food store with food service. A health food store where food is prepared and intended for individual portion service, and includes the site at which individual portions are provided, regardless of whether consumption is on or off the premises, or whether there is a charge for the food, but with no retail food processing.

    (k) Limited poultry and egg farm operation. A farm-based Ffood Eestablishment which directly produces and offers dressed poultry or whole shell eggs for sale. No additional processing or food preparation of such poultry or shell eggs is allowed under this permit category. For purposes of this rule, “farm” has the same meaning as provided in Section 823.14, F.S.

    (l) Limited Sales. Any business fitting any of the definitions in this subsection with gross food sales less than $15,000.00 annually.

    (m) Meat market. A retail food store engaged primarily in the cutting, processing and selling of meats or poultry, or both. A limited number of other foods may be stocked, but inventory and sales are predominantly meat or poultry or both.

    (n) Minor food outlet. Any retail establishment that sells groceries and may offer food service to the public limited to coffee from urns, or iced or frozen drinks, but neither the grocery sales nor the food service is a major retail function based on allocated space or gross sales. No retail food processing may be performed.

    (o) Minor food outlet, only non-perishable foods. A minor food outlet which sells, stores or offers only commercially prepackaged, non-potentially hazardous, non-perishable foods and at which there is no food processing activity, no food service or any activity related to repackaging of foods. Commercially prepackaged ice, not bagged on the premises, may be sold.

    (p) Minor food outlet with limited food service. A minor food outlet where food is prepared and intended for individual portion service, but limited to the display of snack foods or pastries, and/or heating or cooking of hot dogs, sausages, prepackaged pizza or meat pastries, regardless of whether consumption is on or off the premises or whether there is a charge for the food, and without retail food processing.

    (q) Minor food outlet with significant food service. A minor food outlet that has retail food processing activities consisting of on-site cooking or other preparation of hot entrees, chicken (fried, roasted or grilled), sandwiches, salads, or desserts for consumption on or off the premises. The term also applies to such foods brought to a location for sale on individual customer order or by buffet-style display.

    (r) Mobile vendor. Persons selling foods other than fresh fruits or vegetables from trucks, trailers or similar self-propelled conveyances.

    (s) Processor, other non-perishable foods. A processor or packager of grain products, snack foods, candy, table syrup, honey, coffee, tea, spices or other non-perishable foods not defined elsewhere in this section.

    (t) Processor, other perishable foods. A processor of cheese, packaged sandwiches, bulk or packaged salads, or other perishable foods not defined elsewhere in this section.

    (u) Rabbit or game processor. A processor of rabbits, quail, deer, or other bird or animal species normally considered game, excepting any equine, bovine, goat, sheep, swine, or chickens, turkeys, ducks, geese, squab, ratites or guineas.

    (v) Retail bakery. A Ffood Eestablishment that bakes breads, pastries or other similar baked goods, primarily for retail sale on the premises.

    (w) Retail bakery with food service. A retail bakery where food other than breads, pastries or other similar baked goods is prepared and intended for individual portion service, and includes the site at which individual portions are provided, regardless of whether consumption is on or off the premises, or whether there is a charge for the food.

    (x) Retail food processing. The cutting, grinding, or slicing of meats or cheeses for bulk or packaged display; the preparation and wrapping or packaging of sandwiches, salads, or other foods for retail display; the smoking or cooking of meat, poultry, or fish for retail display or on customer request; the steaming, cracking, or cooking of crustaceans or shellfish for retail display or on customer request; the on-premises baking of breads or pastries; or the peeling, cutting, or trimming and packing of fruit or vegetables for retail display.

    (y) Salvage store. A retail food store specializing in salvage foods.

    (z) Seafood market. A retail food store engaged primarily in the sale of seafood. A limited number of other foods may be stocked, but inventory and sales are predominantly fish, crustaceans, or shellfish.

    (aa) Seafood processor. A processor of fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption, primarily for wholesale distribution.

    (bb) Semi-permanent vendor. Persons selling foods other than fresh fruits and vegetables from a pushcart, flea market stand, roadside stand, kiosk or similar structure and which may offer ancillary food service.

    (cc) Supermarket. A retail food store stocking a wide variety of foods and engaged in retail food processing which contains five or more check-out registers or 15,000 or greater total square footage, including display, preparation and storage areas.

    (dd) Tomato Packing House means any establishment that washes, packs, or otherwise treats tomatoes in their unpeeled, natural form before they are marketed.

    (ee) Wholesale bakery. A Ffood Eestablishment that bakes breads, pastries or other similar baked goods, primarily for wholesale distribution.

    (ff) Unattended Food Establishment (also known as micro markets). A Food Establishment that provides packaged foods or whole fruit using an automated payment system and has controlled entry not accessible by the general public.

    (2) Food permits. The Department shall not issue a food permit to a Food Establishment until the following conditions are met:

    (a) The Food Establishment submits a complete Food Permit Application, FDACS-14306 (Rev. 11/18) to the Department, either online or by mail as indicated on the form.  Food Permit Application, FDACS-14306 (Rev. 11/18) is incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX;

    (b) The Food Establishment submits the permit fee indicated in subsection (4) to the Department; and

    (c) The Department conducts an inspection of the Food Establishment, its equipment, and methods of operation, and verifies that provisions of the Florida Food Safety Act, this rule chapter, and the Food Establishment Minimum Construction Standards (Rev. 1/17) have been met, and the Food Establishment submits to the Department a complete Interagency Coordination Of Regulated Establishments - DOH/DACS/DBPR/DCF/AHCA/APD Evaluation Of Onsite Sewage (SEPTIC) And Water Supply Capacity (Rev. 3/12) (SEPTIC Form) or provide proof that water quality requirements have been met as required by this rule. The Food Establishment Minimum Construction Standards (Rev. 1/17) are hereby incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. The SEPTIC form is hereby incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

    (d) A permit number shall be issued to the Food Establishment by the Department after completion of Paragraphs (a) – (c) above and is not to be used on any label or in any advertisement of food. Permits shall be conspicuously displayed at locations for which issued and are not transferable. The provisions of this section do not apply to public food service establishments as defined in Chapter 509, F.S.

    (e) No food permit shall be issued until all applicable fees required in by rule chapter have been submitted to the Department.

    No food permit shall be issued until an inspection has been made of the establishment and its equipment and methods of operation, and these found to comply with the provisions of the Florida Food Safety Act and rules adopted thereunder. A permit number will be assigned by the department following receipt of the Annual Food Permit Application, DACS-14306, (Rev. 06/03), herein incorporated by reference, a copy of which can be obtained from the Florida Department of Agriculture and Consumer Services, Bureau of Food and Meat Inspection, 3125 Conner Boulevard, Tallahassee, Florida 32399-1650. The above application shall bear the signature of the applicant or applicant’s agent, a satisfactory report of inspection, and a fee in the amount specified in subsection 5K-4.020(4), F.A.C. Said permit number shall not be used on any label or in any advertisement of food. Permits shall be conspicuously displayed at locations for which issued and are not transferable. The provisions of this section do not apply to public food service establishments as defined in Chapter 509, F.S.

    (3) Any person violating this rule shall be subject to the injunction procedures of Section 500.171, F.S., and to the penalties provided in Section 500.177, F.S., and Rule 5K-4.035, F.A.C.

    (4) Food Permit Fees.

    (a) One food permit shall be issued to and one fee shall be charged to a person the Food Establishment for all food operations at a single location, regardless of whether the location may qualify under the definitions of this subsection for two or more permits. If a location qualifies for two or more permits, only the largest applicable fee shall be charged to that location, except that any location qualifying for a Limited Sales permit shall only be charged the fee applicable to a Limited Sales permit. If the ownership or physical location of a firm Food Establishment changes during a calendar year, a new food permit application, satisfactory report of inspection an inspection meeting requirements, and a fee in the amount specified in subsection 5K-4.020(4), F.A.C., is are required before a food permit shall be issued. Other license or permit fees may apply to a business, however, are not voided by payment of the food permit fee. Fees charged to new food Food Establishment permit applicants shall be the entire applicable fee if the completed application is submitted January 1 through June 30, and shall be fifty sixty percent (5060%) of the applicable permit fee if the completed application is submitted July 1 through December 31.

    (b) The following schedule of fees is established for each food permit.

    Bottling Plant   385

    Bottled Water Plant500

    Canning Plant490

    Convenience Store330

    Convenience Store with Limited Food Service430

    Convenience Store with Significant Food Service475

    Food Salvage Center470

    Food Storage Warehouse355

    Grocery Store540

    Health Food Store300

    Health Food Store with Food Service415

    Limited Poultry and Egg Farm Operation100

    Limited Sales130

    Meat Market455

    Minor Food Outlet300

    Minor Food Outlet, Only Non-perishable Foods190

    Minor Food Outlet with Limited Food Service415

    Minor Food Outlet with Significant Food Service470

    Mobile Vendor300

    Packaged Ice Plant250

    Processor, Other Non-perishable Foods335

    Processor, Other Perishable Foods490

    Rabbit or Game Processor390

    Retail Bakery355

    Retail Bakery with Food Service490

    Salvage Store470

    Seafood Market410

    Seafood Processor520

    Semi-permanent Vendor195

    Supermarket650

    Tomato Packing House100

    Wholesale Bakery530

    Unattended Food Establishment175

    Water Vending Machine  35

    (5) Late Fees.

    (a) The renewal fee for all food permits shall be the same as the food permit fee required by subsection 5K-4.020(4), F.A.C., and shall be due annually on by January 1. If the A Food Establishment will be assessed renewal fee is not received by the department within thirty days after its due date, a late fee in accordance with Chapter 500 F.S., if its renewal fee is received by the Department after December 31 must be paid. This fee is iIn addition to the food permit fee required by subsection 5K-4.020(4), F.A.C. before the Ddepartment will issue the food permit.

    (b) If a renewal fee is not paid in full by February 1, a late fee of $100 shall be assessed against the establishment.

    (b)(c) No Food Establishment establishment shall be issued a food permit until all applicable fees, including late fees, are received by the Ddepartment.

    (6) Recovery of Cost for Reinspections.

    (a) A Ffood Eestablishment shall pay a fee of $135 to the Ddepartment for recovery of the cost incurred to provide each reinspection of the Ffood Eestablishment. For the purposes of this section, a reinspection refers to any inspection conducted for the purpose of verifying compliance with Chapter 500, F.S., or the rules promulgated thereunder, following a previous unsatisfactory inspection not meeting requirements. Such unsatisfactory inspection not meeting requirements shall be indicated by issuance of an inspection report listing conditions which are not in compliance and which, when viewed as a whole, are more likely to contribute to food contamination, illnesses, or environmental health hazards.

    (b) Nothing in this section shall prohibit the Ddepartment from imposing additional sanctions for violations of Chapter 500, F.S., or the rules promulgated thereunder. The costs of reinspection will be billed by invoice of the Ddepartment and the reinspection fee shall be paid within 21 days receipt thereof. Failure to timely pay a reinspection fee is a violation of this chapter and shall be grounds for suspension of the Food Establishment’s establishment’s food permit.

    (c) The fee established for a reinspection shall include the average cost per inspection for inspectors’ salary, benefits, travel, training, equipment, supervision, and other costs or charges directly related to administration of the Ffood Eestablishment inspection program.

    (d) The fee shall be applicable for each reinspection regardless of whether the reinspection met requirements is satisfactory or did not meet requirements unsatisfactory. Provided however, a fee for reinspection shall not be required when both of the following conditions are met:

    1. The conditions Conditions which were deemed unsatisfactory in the prior inspection are in compliance and the overall finding of the reinspection is satisfactory, and.

    2. No previous reinspection of the establishment has been conducted during the same calendar year.

    (7) Food Establishments permitted pursuant to section 500.12 F.S., shall notify the department within 30 days after closure or dissolution of the business.

    Rulemaking Authority 500.09, 500.12(1)(b), 500.12(1)(f), 570.07(23) FS. Law Implemented 500.04, 500.09, 500.10, 500.12(1)(a), (b), (c), (d), (f), 500.12(2), 500.12(7), 500.121, 500.171, 500.172, 500.177, 570.15 FS. History–New 1-10-93, Formerly 5E-6.020, Amended 8-8-95, 3-11-98, 3-6-01, 10-30-01, 1-1-03, 11-1-04, 11-5-07, 10-28-08, 3-1-09, 3-24-14,_______.

     

    5K-4.021 Food Manager Training and Certification.

    (1) Food Manager Certification. All Retail Food Establishments shall have a certified food protection manager in accordance with section 2-102.20 of the 2017 Food Code as incorporated by reference in subsection 5K-4.002(4), F.A.C., except for the following:  Definitions. As used in this rule the definitions in Chapter 500, F.S., and the following shall apply:

    (a) “Food service” means the preparation of food for individual portion service at a food establishment regulated by the department under Chapter 500, F.S., regardless of whether it is intended for consumption on or off the premises.

    (b) “Food establishment operation” means the manufacturing, processing, packing, holding or preparing of food or selling food at wholesale or retail at a food establishment regulated by the department under Chapter 500, F.S. For purposes of this section, “food establishment operation” includes food service activities, where applicable, and in accordance with Section 500.12(5)(a), F.S. This term does not include specialized activities within a food establishment such as operation of eye care, pharmacy or film processing centers, nor does it include cashier, clerical, stocking or management functions which do not involve the stocking, holding or serving of food.

    (c) “Food manager” means a person responsible for all aspects of food establishment operation at a food establishment regulated by the department under Chapter 500, F.S.

    (d) “Qualified psychometrician” means a person with at least one year of professional experience in examination development or testing research and at least a bachelor’s degree, which includes two courses each in testing (measurement) theory and statistics, from a college or university accredited by an accrediting agency recognized by the United States Department of Education.

    (2) Each food manager shall possess knowledge of food protection and food safety principles and practices as demonstrated by passing a written examination acceptable to the department. Each food manager passing an acceptable examination shall receive a certificate valid for a period of five years from the date of issuance.

    (3) Food establishments shall designate in writing its food manager or managers. The designation shall be posted in a conspicuous place within the food establishment. The following types of food establishments are not required to designate a certified food manager:

    (a) Food Eestablishments that are not required to obtain a food permit in accordance with subparagraphs 500.12(1)(a)1.-4., F.S. Sections 500.12(1)(a)1.-3., F.S.;

    (b) Food Eestablishments that store, sell, or store and sell and/or sell only pre-packaged, non-potentially hazardous foods that arrive at the Ffood Eestablishment in a pre-packaged state and that are not opened or otherwise further processed by the Ffood Eestablishment;

    (c) Food establishments that only process seafood and that are in full compliance with the mandatory HACCP provisions in paragraph 5K-4.002(1)(a), F.A.C.

    (c)(d) Tomato packing houses.

    (d)(c) Limited poultry and egg farm operation.

    (4) All food establishments that are required to designate a certified food manager and that have four or more employees present at the same time engaged in food establishment operations, shall have at least one certified food manager present in the food establishment during all phases of food establishment operation. The food manager shall be responsible for and shall actively oversee all food establishment operations. Food establishments with fewer than four employees engaged in food establishment operation, present at the same time, shall have a certified food manager responsible for all phases of food establishment operation who shall actively oversee all food establishment operations; however, the certified food manager need not be on the premises at all times.

    (5) A food establishment shall have 90 days from the effective date of this rule amendment to have a certified food manager responsible for all food establishment operations in accordance with the provisions of this chapter. In the event the certified food manager leaves the employment of the food establishment or is relieved of food management responsibilities, the food establishment shall have 90 days from the date of the employment change to have a certified food manager.

    (6) Persons holding a food service manager certificate issued by the Florida Department of Health and Rehabilitative Services or the Florida Department of Business and Professional Regulation shall be considered certified as a food manager under this rule until such certificate expires.

    (7) The food manager certification examination shall be designed to assess the food manager’s knowledge of basic food protection and food safety requirements as set forth in this chapter.

    (8) Persons licensed as Dieticians or Nutritionists pursuant to the Dietetics and Nutrition Practices Act, Sections 468.501-.518, (Part X, Chapter 468), F.S., shall be considered certified as food managers under this rule.

    (9) Any test for certifying food managers must be established as set forth in this subsection. A written evaluation must be submitted to the department by a qualified psychometrician utilizing the following criteria: administrative independence, fairness, adherence to technical standards for test construction and evaluation, validity, reliability, measurement errors, test development and revision, scaling, norming, and score comparability and equating. Additional factors and criteria to be considered are: test publication, test administration, scoring and reporting of scores, information made available to the public, protection of the rights of persons taking the test, adherence to professional standards for test use for employment testing and professional and occupational certification, and adherence to related standards for testing linguistic minorities and handicapped persons.

    (10)(a) Training and testing programs sponsored by persons, corporations or industry associations which meet the provisions of this chapter, and which are approved by the department, may be used to meet certification requirements of this rule.

    (b) Persons, corporations or industry associations desiring department recognition of a privately sponsored training and testing program must provide to the department for review and approval the documentation required by subsection (9) above.

    (2)(11) Training and certification of Ddepartment personnel. Any person performing required inspections of permitted Ffood Eestablishments for the Ddepartment or its agent must:

    (a) Be standardized in accordance with the procedures of the federal Food and Drug Administration stated in Interim Document 10/1/96-9/30/97 – Procedure for the Confirmation and Standardization and for the Certification of Retail Food Protection Program Personnel, published by the Food and Drug Administration;

    (b) Pass the department’s food manager certification examination; and

    (a)(c) Pass a written examination to demonstrate knowledge of Chapter 500, F.S., and Chapter Part 5K-4, F.A.C., which regulate Food Establishments food establishments.

    (b) Pass the basic food inspection training certification requirements as specified in the Manufactured Food Regulatory Program Standards revised as of September 2016, hereby incorporated by referenced and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX; or

    (c) Pass the basic food inspection training certification requirements as specified in Standard 2 of the Voluntary National Retail Food Regulatory Program Standards revised as of January 2017, and the Conference for Food Protection Regulatory Retail Food Safety Inspection Officers Field Training Manual revised as of May 2013 hereby incorporated by referenced and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX; and

    (d) Pass a certified food protection manager examination accredited in accordance with the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification.

    Rulemaking Authority 500.12(6), 570.07(23) FS. Law Implemented 500.12(6) FS. History–New 1-11-94, Formerly 5E-6.021, Amended 1-23-97, 5-25-98, 3-1-09, 3-24-14,____.

     

    5K-4.023 Packaged Ice, Ice Vending Machines, and Water Vending Machines.

    (1) In addition to the requirements in the general food products statute, Chapter 500, F.S. Florida Food Safety Act, and all applicable rules in Chapter 5K-4, F.A.C., packaged ice plant operators, water vending machines, and ice vending machines and packaged ice dealers shall comply with this rule.

    (2) Definitions:

    (a) Ice means food intended for human consumption that is formed from drinking water by freezing to a solid state.

    (b) Imported means manufactured, processed, packaged, stored or distributed from a point outside of the state of Florida.

    (c) Maximum contaminant level (MCL) means the maximum permissible level of a contaminant as set forth in Chapter 403, F.S., and Chapter 64E-8, F.A.C. (1/93), titled “Drinking Water Systems”, and Chapter 62-550, F.A.C. (5/94), titled “Drinking Water Standards, Monitoring and Reporting”.

    (3) Requirements:

    (a) Each person or public body that establishes, maintains, or operates a packaged ice plant must obtain a Packaged Ice Plant Operating/Food Permit from the department each year. Each packaged ice plant location must have a permit.

    (b) Each packaged ice dealer must obtain a Packaged Ice Dealer/Food Permit from the department each year. Ice transported into the state and packaged either before or after importation into the state must meet all of the requirements of this section and must be packaged, labeled, handled, and otherwise processed and sold according to the provisions of this section.

    (c) Any packaged ice plant operator who is also a packaged ice dealer shall be issued a combined Packaged Ice Plant Operating-Dealer/Food Permit by the department. Such permit shall be issued each year upon compliance with all statutory and rule requirements for the issuance of a Packaged Ice Plant Operating Permit and a Packaged Ice Dealer Permit. Each location must have a permit.

    (d) Each packaged ice plant operator or packaged ice dealer who is engaged in the sale or distribution of any other food product and whose operation qualifies as a food establishment under Chapter 500, F.S., shall be issued a combined Food/Packaged Ice Permit by the department. Such permit shall be issued each year upon compliance with all statutory and rule requirements for the issuance of a Food Permit, a Packaged Ice Plant Operating Permit, a Packaged Ice Dealer Permit, or a combination thereof. Each location must have a permit as per Section 500.12(1)(a), F.S. and subsection 5K-4.020(2), F.A.C.

    (e) All permits shall expire on December 31 of each year.

    (f) Application for permits must be made in writing to the department on form IN-63, an Annual Food Permit Application, (Revised 10/94).

    (4) Permit fees:

    (a) Each packaged ice plant operator must pay the department an annual non-refundable fee of $250.00 for each permit.

    (b) Each packaged ice dealer must pay the department an annual non-refundable fee of $100.00 for each permit.

    (c) Each packaged ice plant operator who is also a packaged ice dealer must pay the department an annual, non-refundable fee for each permit. Such fee shall be the greater of the Packaged Ice Plant Operating or the Packaged Ice Dealer permit fee required in this subsection.

    (d) Each packaged ice plant operator or packaged ice dealer who is engaged in the sale or distribution of any other food product and whose operation qualifies as a food establishment under Chapter 500, F.S., must pay the department an annual, non-refundable fee for each permit. Such fee shall be the greater of the Food Permit fee required by Rule 5K-4.020, F.A.C., or the applicable permit fee required by this subsection.

    (e) Fees charged to applicants for new permits shall be prorated with the applicant paying 1/12th of the applicable fee for each month remaining in the calendar year, including the month of application.

    (5) Source water and finished product quality:

    (a) All water used for the manufacture of ice intended for human consumption and in preparation of brine solutions must be from an approved drinking water supply as described in Chapters 64E-8 or 62-550, F.A.C.

    (b) Imported packaged ice product must be manufactured from source water that has been approved as a drinking water supply by the agency with jurisdiction in the state where the ice is manufactured and packaged.

    (c) Packaged ice dealers importing product must submit to the department a copy of the current source certification or a letter from the agency with jurisdiction for approval of drinking water supplies. This information must be submitted to the department with each annual permit application.

    (d) Packaged ice must be in conformance with maximum contaminant levels that have been established for drinking water supplies in Chapters 64E-8 and 62-550, F.A.C.

    (e) All packaged ice plants shall submit to an approved laboratory, once every three months, a sample of each type of finished product for microbiological analysis. A copy of the quarterly analytical results shall be forwarded to the department by out-of-state packaged ice dealers. In-state packaged ice plants shall maintain these records as required by Section 500.509, F.S., and make them available to the department upon request.

    (f) The quarterly laboratory analysis must include testing for fecal and total coliform organisms and Heterotrophic Plate Count (HPC). Total coliforms shall not be greater than 2.2 organisms/100 ml. using the Most Probable Number (MPN) method or not greater than 1 organism/100 ml. using the Membrane Filtration (MF) method. The HPC shall not exceed 500 colonies/ml. Packaged ice shall have no fecal coliform-positive samples.

    (g) Should finished product samples exceed the standards outlined in paragraph (f) of this subsection, the plant shall submit samples to an approved laboratory, on a weekly basis, until two (2) consecutive acceptable samples are obtained. Copies of weekly sample analyses shall be submitted to the department upon receipt by the packaged ice plant or packaged ice dealer.

    (h) The department shall collect and analyze samples of source water and finished product when necessary to determine if the source water and/or finished product meet quality standards established in this rule. When indicated by reason of complaint or illness, the department may obtain and analyze or require the ice plant to obtain and have analyzed, by an approved laboratory, samples of source water and/or finished product.

    (i) All records of sampling and analyses of source water and finished product shall be maintained by the plant for a period of not less than 2 years and shall be made available to the department upon request.

    (6) Processing and packaging:

    (a) Ice shall be processed and packaged using methods that preclude contamination of the product.

    (b) Air used for water agitation shall be filtered or otherwise treated to render it free of oil, dust, dirt, insects and extraneous material.

    (c) Manual packaging of product shall be performed in a manner that will preclude contamination of the packaging material and the product.

    (d) Any spillage created during manufacture, packaging, transportation or storage shall be disposed of and shall not be packaged or re-packaged for sale for human consumption.

    (e) Ice packaging material shall be of foodgrade quality and closures shall be designed to adequately protect its contents. Only pin holes or a butterfly vent that does not exceed ¼’’ inch in diameter shall be used in ice packaging material. Pin holes or butterfly vents must be located in the upper 1/3 portion of the bag.

    (f) Packaging material shall be protected from contamination during storage and handling.

    (7) Storage and transportation:

    (a) Packaged ice plants producing product that is not to be used for human consumption shall store this product in a designated area that is clearly identified and separated from other packaged ice products.

    (b) Packaged ice shall be stored above the floor protected from splash and shall not be located in areas susceptible to overhead dripping.

    (c) Wooden platforms or pallets shall not be used for the purpose of transporting ice or storing ice above the floor unless platforms or pallets have been designed or covered with surfaces that protect the product from splintering. Such surfaces shall be easily cleaned and sanitized or shall be replaced between uses.

    (d) Product shall be transported in an enclosed facility designed and equipped to protect the product from contamination and shall be maintained in a clean condition.

    (e) Packaged ice shall be handled in such a manner to preclude contamination during transportation and delivery. At no time during transport or delivery shall the packaged ice product come into contact with the floor or ground.

    (8) Labeling: Packaged ice plants producing product that is not to be sold for human consumption shall designate “Not for human consumption” on the package. This designation shall be clearly visible to the consumer.

    (9) Notification to the department: The operator or manager of a packaged ice plant or dealer who knows or should know that a primary maximum contaminant level has been exceeded or believes or has reason to believe that circumstances exist such as source contamination, spills, accidents, natural disasters, breakdowns in the sanitary processing of ice or other similar problems that may adversely affect the safety of the packaged ice, shall immediately notify the department of the incident.

    (10) Product recall procedures:

    (a) If the department determines, based upon results of representative sample tests and risk analysis that an immediate hazard to the health, safety and welfare of the public is present in any packaged ice product, the department shall order the packaged ice plant or dealer to initiate a product recall to effectively avoid or significantly minimize the threat to the public’s health and if appropriate, issue a notification to customers. The plant or dealer shall be responsible for disseminating the notice in a manner designed to inform customers who may be affected by the problem.

    (b) When a laboratory report reveals a maximum contaminant level (MCL) has been exceeded, but when investigation indicates that the condition causing the MCL to be exceeded was promptly corrected and that previously distributed product will not cause illness nor present any significant health hazard, a company recall and media notification shall not be necessary. In circumstances where a recall or media notification is not necessary but consumer complaints indicate problems regarding product taste or odor, the department shall order the plant to communicate the exceedance of the MCL and the implementation of corrective measures by direct mailings to affected customers.

    (11) Department responsibilities and duties: Packaged ice plant operators and packaged ice dealers shall allow the department to examine records pertaining to the operation and maintenance of the plant or source water.

    (12) Forms: Form IN-63, an Annual Food Permit Application (Revised 10/94), is hereby incorporated by reference. Copies may be obtained from the Florida Department of Agriculture and Consumer Services, 3125 Conner Boulevard, Room 294, Tallahassee, Florida 32399-1650.

    (2) Water Source.

    (a) The source of the water supply used for packaged ice, vended ice, or vended water shall be an approved public water system as defined in Sections 403.850-403.864, F.S., Chapter 64E-8, F.A.C., and Chapter 62-550, F.A.C.

    (b) Packaged ice, vended ice, or vended water shall be in conformance with maximum contaminant levels that have been established for drinking water supplies in Chapters 64E-8 and 62-550, F.A.C.

    (3) Construction.

    (a) Water vending machines and ice vending machines shall be made of materials that are free of substances which may render the final product injurious to health or which may adversely affect the flavor, color, odor, radiological, microbial, or chemical quality of the water.

    1. Water vending machines and ice vending machines shall be designed and constructed to permit easy cleaning and maintenance of all exterior and interior surfaces and component parts in accordance with Chapter 6 of the FDA Food Code as incorporated by reference in subsection 5K-4.002(4), F.A.C.

    2. Water vending machines and ice vending machines shall have a guarded corrosion resistant dispensing spout.

    3. Water vending machines and ice vending machines shall have a backflow prevention device for all connections with the water supply.

    4. Water vending machines and ice vending machines shall be equipped with a self-closing, tight-fitting door on the vending compartment so the unit is not accessible to the public.

    (b) Water vending machines shall also comply with the following:

    1. Use methods for treatment including distillation, ion-exchange, filtration, ultra-violet light, mineral addition, or reverse osmosis.

    2. Be equipped with monitoring devices designed to shut down operation of the machine when the treatment or disinfectant unit fails to properly function.

    3. Granular activated carbon, if used in the treatment process of vended water, shall comply with the specifications provided by the American Water Works Association for that substance (AWWA B604-74) revised as of November 1974, as incorporated by reference in 5K-4.002, F.A.C.

    4. Water vending machines dispensing purified water shall meet the requirements for purified water as stated in 21 CFR 165 as adopted in 5K-4.002, F.A.C., and the requirements stated in Rule Chapter 62-550, F.AC.

    5. The vended water from each water vending machine utilizing silver-impregnated carbon filters in the treatment process shall be sampled once every six (6) months for silver and analyzed by an approved laboratory and the results made available for inspection by the Department.

    (4) Operating Requirements.

    (a) Packaged ice shall be made, packaged, and stored in a food facility in accordance with Chapter 6 of the FDA Food Code as adopted in subsection 5K-4.002(4), F.A.C.

    (b) Water vending machines and ice vending machines shall comply with the following:

    1. Have a written maintenance program available to the Department for inspection that includes:

    a. Visits for cleaning, sanitizing and servicing of machines every two weeks;

    b. Written servicing instructions;

    c. Technical manuals for the machines; and

    d. Technical manuals for the water treatment appurtenances involved.

    2. Have chemically treated towelettes for handwashing available and accessible when needed, as required by Section 5-203.11(c) of the FDA Food Code as incorporated by reference in subsection 5K-4.002(4), F.A.C.

    3. Have parts and surfaces of water vending machines and ice vending machines kept clean and maintained.

    4. Have the water or ice vending machine chamber and the vending nozzle cleaned and sanitized each time the machine is serviced.

    5. Be maintained in a clean and sanitary condition, free from dirt and vermin.

    6. Be located in an area that can be maintained in a clean condition and in a manner that avoids insect and rodent harborage.

    7. Have a record of cleaning and maintenance operations which shall be kept by the operator for each water or ice vending machine. These records shall be maintained in the unit and made available to the Department upon request.

    (5) Packaged ice and products dispensed from a water vending machine or ice vending machine shall be processed and packaged using methods that prevent contamination of the product.

    (a) Air used for water agitation shall be filtered or otherwise treated to render it free of oil, dust, dirt, insects and extraneous material.

    (b) Manual packaging of ice or water products shall be performed in a manner that will prevent contamination of the packaging material and the product.

    (6) Water vending machines and ice vending machines shall have the following information displayed in a conspicuous location on the machine as follows:

    (a) Name and address of the owner;

    (b) Source of water: either approved public water supply or licensed private water source;

    (c) Method of treatment to water, if applicable;

    (d) Method of post treatment to water, if applicable;

    (c) Local or toll-free telephone number that may be called for obtaining further information, reporting problems or making complaints; and

    (f) A valid decal furnished by the Department, which shall be affixed on each machine in a position clearly visible to the consumer. 

    (7) Packaged ice, water vending machine, and ice vending machine operators shall keep a record of all complaints received and shall make available upon request to the Department.

    (8) Finished Product Quality.

    (a) Operators of all packaged ice plants, water vending machines, and ice vending machines shall obtain and have analyzed by an Approved Laboratory, once every quarter of the calendar year, a sample of each type of finished product for microbiological analysis as specified in paragraph (b) below. A “quarter” is defined as one three-month period, four periods per year with at least 30 days between samples.  Therefore, unless subject to paragraph (c) below, four (4) samples are required for every full year of operation.     

    (b) The laboratory analysis shall include testing for fecal and total coliform organisms. Total coliforms shall not be greater than 2.2 organisms/100 ml. using the Most Probable Number (MPN) method or not greater than 1 organism/100 ml. using the Membrane Filtration (MF) method. Ice and/or water shall have no fecal coliform-positive samples.

    (c) Any vended water or vended ice sample that tests positive for total coliforms shall be considered unsatisfactory. If any sample collected from a machine is determined to be unsatisfactory by an Approved Laboratory, the machine shall be cleaned, sanitized, and resampled by the operator immediately. Prior to resuming operation, the machine shall be taken out of service until the source of contamination has been located and corrected.  When the finished product samples exceed the standards outlined in this rule, samples shall be taken and submitted to an Approved Laboratory, on a weekly basis, until two (2) consecutive samples testing negative for total coliforms are obtained. Copies of weekly sample analyses shall be submitted to the Department upon receipt online at www.FoodInsp@FreshFromFlorida.com.

    (d) For water vending machines and ice vending machines, when three consecutive quarterly samples are each found to contain zero coliform colonies per 100 milliliters of the finished product, microbiological sampling intervals shall be extended to a period not exceeding six months. Should a subsequent six-month sample test positive for total coliform, the required sampling frequency shall revert to the quarterly frequency until three consecutive samples again test negative for total coliform bacteria.

    (e) The Department shall collect and analyze samples of finished product when necessary to determine if the product meets quality standards established in this rule. When indicated by reason of complaint or illness, the Department may obtain and analyze or require the packaged ice plant, water vending machine, or ice vending machine owner to obtain and have analyzed, by an Approved Laboratory, samples of source water and/or finished product.

    (f) All records of sampling and analyses of source water and finished product shall be maintained for a period of not less than two (2) years after creation and shall be made available to the Department upon request.

    (9) Processing and Packaging.

    (a) Any spillage created during the manufacture, packaging, transportation, or storage of ice and water products shall be disposed of and shall not be packaged or re-packaged for sale for human consumption.

    (b) Ice packaging material shall be constructed of durable, smooth, easily cleanable and nonabsorbent material, and closures shall be designed to protect its contents. Only pin holes or a butterfly vent that does not exceed 1/4 inch in diameter shall be used in ice packaging material. Pin holes or butterfly vents must be located in the upper 1/3 portion of the bag.

    (c) Packaging material shall be protected from contamination during storage and handling.

    (d) Packaged ice and vended ice shall be properly labeled according to Title 21 Code of Federal Regulation, Part 101 as incorporated by reference in Rule 5K-4.002, F.A.C.

    (10)Storage and transportation of packaged ice.

    (a) Packaged ice shall be stored above the floor protected from splash and shall not be located in areas susceptible to overhead dripping.

    (b) Packaged ice products shall be transported in an enclosed facility designed and equipped to protect the product from contamination and shall be maintained in a clean condition.

    (c) Packaged ice shall be handled in such a manner to preclude contamination during transportation and delivery. At no time during transport or delivery shall the packaged ice product come into contact with the floor or ground.

    (11)Notification to the department. The owner or operator of a packaged ice plant, water vending machine, or ice vending machine who knows or has reason to believe that a primary maximum contaminant or microbiological level established in Rule Chapter 62-550, F.A.C., and/or paragraph 5K-4.023(2)(b), F.A.C., has been exceeded or believes or has reason to believe that circumstances exist such as source contamination, spills, accidents, natural disasters, breakdowns in the sanitary processing of ice or other similar problems that may adversely affect the safety of the finished product shall notify the Department.

    (12) Department responsibilities and duties.

    Packaged ice, water vending, and ice vending machine operators shall allow the Department to examine necessary records pertaining to the operation and maintenance of operations, and also provide access to the machines for inspection at reasonable hours.

    Rulemaking Authority 500.09, 500.509, 500.12(1)(d), 570.07(23) FS. Law Implemented 500.147, 500.459, 500.511 500.453, 500.509 FS. History–New 1-19-95, Formerly 5E-6.023, Amended 8-8-95,____.

     

    5K-4.033 Limited Poultry and Egg Farm Operation.

    (1) Purpose.

    This rule establishes the regulatory parameters for a farm based Ffood Eestablishment, limited to the provision of whole shell eggs and dressed poultry products only. The basis for establishment of such parameters is the USDA Guidance for Determining Whether a Poultry Slaughter or Processing Operation is Exempt from Inspection Requirements of the Poultry Products Inspection Act (revision date April 1, 2006), derived from language in Title 9, Code of Federal Regulations, Chapter 3, subsections 381.10(a)(5) and (b)(1) and (2) as administered by the USDA Food Safety Inspection Service and adopted by reference in paragraph 5K-4.002(1)(b), F.A.C., and, the Regulations Governing the Inspection of Eggs (Egg Products Inspection Act) as provided in Title 7, Code of Federal Regulations, Part 57, as administered by the USDA Food Safety Inspection Service and adopted by reference in paragraph 5K-4.002(1)(a), F.A.C.

    (2) Definitions. Requirements – poultry.

    (a) Limited Poultry and Egg Farm Operation means a farm-based Food Establishment which directly produces and offers dressed poultry or whole shell eggs for sale. No additional processing or food preparation of such poultry or shell eggs is allowed.

    (b) For purposes of this rule, “farm” has the same meaning as provided in Section 823.14, F.S.

    (3)(2) Requirements – poultry.

    (a) For purposes of this rule, when the criteria for a Producer/Grower – 20,000 Limit Exemption as identified in the USDA Guidance for Determining Whether a Poultry Slaughter or Processing Operation is Exempt from Inspection Requirements of the Poultry Products Inspection Act (revision date April 1, 2006) is met as determined by the USDA Food Safety Inspection Service (FSIS), a poultry grower that slaughters and minimally processes no more than 20,000 birds in a calendar year, grown on his or her own farm in the State of Florida, shall be permitted as a limited poultry and egg farm operation. Qualification for this exemption, as identified in the above guidance document, must be met in accordance with the Poultry and Poultry Product Inspection Act, Title 21, U.S. Code Chapter 10, subsection 464(c)(1)(C) &(c)(3) and Title 9, Code of Federal Regulations, Chapter 3, subsection 381.10(a)(5) and (b)(1) and (2) as administered by the USDA Food Safety Inspection Service and as adopted by reference in paragraph 5K-4.002(1)(b), F.A.C.

    (b) Dressed poultry sold or offered for sale by a limited poultry and egg farm operation must also meet the applicable requirements of Chapter 583, F.S., and Chapter 5K-5, F.A.C. Sale of dressed poultry by a limited poultry and egg farm operator with a flock of 20,000 or less, shall be limited in accordance with the definition of a “Dealer” in Section 583.01(4), F.S. Poultry producers with flocks in excess of 20,000 poultry that seek to process poultry shall be permitted as a processer in accordance with Section 583.09, F.S. and paragraph 5K-4.020(1)(s), F.A.C.

    (4)(3) Requirements – shell eggs.

    (a) For purposes of this rule and in compliance with the Regulations Governing the Inspection of Eggs (Egg Products Inspection Act) as provided in Title 7, Code of Federal Regulations, Part 57, administered by the USDA Food Safety and Inspection Service, and adopted by reference in paragraph 5K-4.002(1)(a), F.A.C., a shell egg producer that maintains a flock of less than 1,000 poultry within any calendar year, on his or her own farm in the State of Florida, for the purpose of producing shell eggs for human consumption, is eligible to be permitted by this agency as a limited poultry and egg farm operation.

    (b) A limited poultry and egg farm operation that sells or offers for sale whole shell eggs must also meet the applicable requirements of Chapter 583, F.S., and Chapter 5K-6, F.A.C. Sale of shell eggs by a limited poultry and egg farm operator with a flock of less than 1,000 poultry shall be limited in accordance with the definition of a “Dealer” in Section 583.01(4), F.S. Shell egg producers with flocks in excess of 1,000 poultry shall be permitted as a shell egg processer in accordance with Section 583.09, F.S. and paragraph 5K-4.020(1)(s), F.A.C.

    (5)(4) Requirements – general.

    (a) Limited poultry and egg farm operation products shall only be sold within the State of Florida and must not be sold or offered for sale in interstate commerce.

    (b) For purposes of this rule, a whole shell egg product or dressed poultry product includes chicken, turkey, duck, goose, guinea, or quail.

    (c) A limited poultry and egg farm operation shall not sell poultry or egg farm products by mail order or at wholesale.

    (d) Inspection of the premises of a limited poultry and egg farm operation to determine compliance with this rule will be to provide information during the opening inspection and permitting process or upon receipt of a valid complaint.

    (e) No brokers or dealers in agricultural products as defined in Section 583.01(4) or 604.15(2), F.S., may be used to sell limited poultry and egg farm operation products. Only the permitted limited poultry and egg farm operator, family member or employee of the farm operation may sell limited poultry and egg farm operation products, deliver products, or serve as a sales representative for the permitted farm operation. A permitted limited poultry and egg farm operator may also use another permitted limited poultry and egg farm operator to facilitate delivery or sales of farm products at a roadside stand, farmer’s market or similar open-air market locations, or by direct delivery to the purchaser.

    (6)(5) Materials adopted by reference. All documents and materials referenced in this rule are hereby adopted and incorporated by reference and are available as follows:

    (a) The Poultry and Poultry Product Inspection Act, Title 21, U.S. Code Chapter 10, subsection 464(c)(1)(C) & (c)(3) revision date January 3, 2012, is accessible through the internet at: http://www.flrules.org/Gateway/reference.asp?No=Ref-03706.

    (b) Title 9, Volume 1, Parts 1 to 199, Code of Federal Regulations, revised as of January 1, 2000, is accessible through the internet at: http://www.flrules.org/Gateway/reference.asp?No=Ref-03709.

    (c) The USDA Guidance for Determining Whether a Poultry Slaughter or Processing Operation is Exempt from Inspection Requirements of the Poultry Products Inspection Act; revision date April 1, 2006, is available through the internet at: http://www.flrules.org/Gateway/reference.asp?No=Ref-03707.

    (d) Regulations Governing the Inspection of Eggs (Egg Products Inspection Act) as provided in Title 7 Code of Federal Regulations, Part 57, revision date April 12, 2006, is available through the internet at: http://www.flrules.org/Gateway/reference.asp?No=Ref-03708.

    Rulemaking Authority 500.09(3), (4), (8), 500.12(1)(a), (b), 570.07(23), 583.01, 583.04 FS. Law Implemented 500.09, 500.12, 583.09 FS. History‒New 3-24-14, Amended,           .

     

    5K-4.035 Guidelines for Imposing Administrative Penalties.

    (1) This rule sets forth the guidelines the Department will follow in imposing the penalties authorized under Chapter 500, F.S. The purpose of the guidelines is to give notice of the range of penalties that will be imposed for a single violation within a three-year period. The three-year period shall be based on the date of the last administrative enforcement action imposed against the violator. These guidelines list aggravating and mitigating factors that, if present, will reduce or increase penalties to be imposed. No aggravating factors will be applied to increase a fine imposed for a single violation above the statutory maximum for a Class II category of $5,000 for each violation as provided in Section 570.971, F.S., except for violations of Section 500.165, F.S., which have a statutory maximum for a Class III category of $10,000 as provided in Section 570.971, F.S. The guidelines in this rule chapter are based upon a single count violation of each provision listed. Multiple counts of the violated provision or a combination of the listed violations will be added together to determine an overall total penalty and will be grounds for enhancement of penalties.

    (2) The Department will enforce compliance with Chapters 500, F.S., and this rule chapter by issuing an administrative complaint, a stop-sale order, stop-use order,  release order, destruction order, notice of non-compliance, permit suspension or revocation, or an immediate final order for violations of Chapters 500, F.S., and this rule chapter.

    (3) Stop-Sale Stop-Use, Release or Destruction Orders. The Department shall issue a Stop-Sale,  Stop-Use Release and/or Destruction Order FDACS-14402, (Rev. 03/18), as provided in Section 500.172, F.S., whenever necessary to effectuate the statutory duties of the Department in the interest of public health, safety, and welfare and as necessary to promote the safety of any food product, food-processing equipment, or areas within an entity operating as a Food Establishment in Florida. A Stop-Sale, Stop-Use Release and/or Destruction Order 14402, (Rev. 03/18), will be used to give notice that such a product, processing equipment or area is, or is suspected of, failing to comply with the requirements of Chapter 500, F.S., or this rule chapter, and shall prohibit the removal, use, or disposal of such item. The Stop-Sale,  Stop-Use Release and/or Destruction Order FDACS-14402, (Rev. 03/18) is incorporated by reference and avilable online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

    (4) Nothing in this rule shall limit the ability of the Department to informally dispose of administrative actions by settlement agreement, consent order, or other lawful means.

    (5) Rule Not All-Inclusive. This rule contains illustrative violations. It does not, and is not intended to, encompass all possible violations of statute or Department rule that might be committed by any person. The absence of any violation from this rule shall in no way be construed to indicate that the violation does not cause harm to the public or is not subject to a penalty. In any instance where the violation is not listed in this rule, the penalty will be determined by consideration of:

    (a)The closest analogous violation, if any, that is listed in this rule; and

    (b)The mitigating or aggravating factors listed in this rule.

    (6) Aggravating and Mitigating Factors. The Department will consider aggravating and mitigating factors in determining penalties for violations of Chapters 500, F.S., and this rule chapter. The factors shall be applied against each single count of the listed violation.

    (a) Aggravating Factors:

    1. The violation caused, or has the potential to cause, harm to the public and the degree or extent of such harm.

    2. The violation endangered the public safety or welfare.

    3. Previous violations for the same or a similar offense that resulted in enforcement action, defined as follows:

    a. First Offense. A violation of any law subject to penalty under Chapters 500, F.S., when no disciplinary administrative complaints involving the same permitholder have been filed with the Agency Clerk within the three years preceding the date the current administrative complaint is issued.

    b. Second Offense. A violation of any law subject to penalty under Chapters 500, F.S., after one disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceeding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

    c. Third and Any Subsequent Offense. A violation of any law subject to penalty under Chapters 500, F.S., after two disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceeding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

    4. The length of time the business has been in operation and the violation history over the past three years.

    5. The violation was repeated within one year.

    6. The violator impeded, or otherwise failed to cooperate with, the Department’s inspection and/or investigation.

    7. Whether the violation resulted from negligence or an intentional act.

    8. The cost of enforcement action.

    9. The number of other violations proven in the same proceeding.

    10. The benefit to the violator.

    (b) Mitigating Factors:

    1. Any documented efforts by the violator at rehabilitation.

    2. Whether intentional actions of another party prevented the violator from complying with the applicable laws or rules.

    3. Acts of God or nature that impaired the ability of the violator to comply with Chapter 500, F.S., or this rule chapter.

    4. The violation has a low risk of, or did not result in, harm to the public health, safety, or welfare.

    5. The disciplinary history of the violator.

    6. The violator expeditiously took affirmative or corrective action after it received written notification of the violation to rectify any financial damage or harm to the public.

    7. If a repeat violation, whether three years has passed since the prior violation.

    (7) The provisions of this rule chapter shall not be construed so as to prohibit or limit any other civil action or criminal prosecution that may be brought.

    (8) In addition to the penalties established in this rule, the Department reserves the right to seek to recover any other costs, penalties, attorney’s fees, court costs, service fees, collection costs, and damages allowed by law. Additionally, the Department reserves the right to seek to recover any costs, penalties, attorney’s fees, court costs, service fees, collection costs, and costs resulting from a payment that is returned for insufficient funds to the Department.

    (9) Penalties.

    (a) Minor Violation. Any Department investigation or inspection which reveals violations of this Rule Chapter in which the Department determines that the violator was unaware of the rule or unclear as to how to comply with it will result in the issuance of a Notice of Non-Compliance as the Department’s first response to the violation. For the purposes of this rule, the following violations shall be considered minor and shall result in the issuance of a notice of noncompliance:

    1. Violations to subsection 5K-4.002(1), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    2. Violations to subsection 5K-4.002(2), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    3. Violations to subsection 5K-4.002(3), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    4. Violations to subsection 5K-4.002(4), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    5. Violations to Rule 5K-4.004, F.A.C, where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    6. Violations to subsection Rule 5K-4.0041, F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    7. Violations to Rule 5K-4.0050, F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    8. Violations to Rule 5K-4.023, F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

    (b) Major Violations. Any violation of Chapters 500, F.S., or this rule chapter that may result in economic or physical harm to a person or may adversely affect the public health, safety, or welfare or creates a significant threat of such harm shall be considered a major violation.

    1. Tier I. Tier I major violations shall result in the issuance of a stop-sale order, stop-use order, and/or destruction order.  For the purposes of this rule, the following violations shall be considered Tier I major violations:

    a. Operating a Food Establishment with no hot water available.

    b. Operating a Food Establishment while hot water is available, but the source is turned off.

    c. Failure to provide copies of required microbiological and/or chemical analysis for review.

    d. Failure to provide Water Vending Machine Relocation Form (WVMRF), FDACS-14809, (Rev. 11/18), in accordance with Section 500.459, F.S., when a water vending machine is relocated. The Water Vending Machine Relocation Form (WVMRF), FDACS-14809, (Rev. 11/18) is incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=RefXXXX.

    e. Operating a Food Establishment without the required service sink or curbed cleaning facility.

    f. Failure to have an adequate or accurately maintained process control system including Hazards Analysis and Critical Control Points (HACCP), scheduled process, food safety plan, or any such other requirement in provided in by Rule 5K-4.002, F.A.C.

    g. Failure to follow process control system such as, but not limited to, Hazards Analysis and Critical Control Points (HACCP), scheduled process, food safety plan, or any such other requirement provided in Rule 5K-4.002, F.A.C.

    h. The manufacture, sale or delivery, holding or offering for sale any food that is deemed adulterated, as outlined in Section 500.10, F.S.

    i. The manufacture, sale or delivery, holding or offering for sale any food that is misbranded as provided in Section 500.11, F.S, or in 21 CFR Part 101 as incorporated in Rule 5K-4.002.

    j. Transporting food under conditions which may render the food to be deemed adulterated, as provided in Section 500.10, F.S.

    k. Transporting food in a vessel contaminated by any substance that may pose a threat to human health as provided in Section 500.165, F.S.

    l. Packaged ice found in violation of Rule 5K-4.023(5), F.A.C.

    m. Vended water or ice sample found positive for coliforms or E. coli. 

    n. The presence of a pathogenic Escherichia Coli, Salmonella Enterica, or Listeria Monocytogenes found in the environment of a Food Establishment in a location where contamination of food is likely to occur from the presence of the organism(s). In case of such violation, a stop-use order(s) shall be issued and shall not be released by the Department until the Food Establishment has  cleaned and/or repaired the affected areas and  all  test results following  environmental sampling  are observed by the Department and reported as “negative”  from an ISO (International Organizaiton of Standardization) 17025 based accrediated laboratory certified to conduct testing for the microorganism of concern.  Any and all cleaning, repairs, environmental sampling and testing shall be at the expense of the facility.

    o. Violation of 21 CFR Part 117.20, as incorporated in Rule 5K - 4.002, F.A.C. Sewage is not conveyed to the point of disposal through an approved sanitary sewage system or another system constructed, maintained, and operated according to law, which may result in a way that a public health hazard or nuisance is created.

    p. Violation of 21 CFR Part 117.20, as incorporated in Rule 5K-4.002, F.A.C. Premises are not maintained free of roaches and rodents.

    2. Tier II. Tier II violations shall result in the issuance of a stop-sale, stop-use order, destruction order, and/or an administrative fine of $500 up to the statutory maximum. Aggravating factors, as defined in paragraph (6)(a). of this rule, shall warrant the adjustment of the fine upward per violation per aggravating factor and mitigating factors, as defined in paragraph(6)(b). of this rule, shall warrant the adjustment of the fine downward per violation per mitigating factor, but no fine shall exceed the statutory maximum as outlined in Section 570.971, F.S., as applicable. If, three years after the day of the last violation under Chapters 500, F.S., or this rule chapter, no new violation has occurred, all previous fines shall be disregarded when administering a fine for the next violation. For the purposes of this rule, the following violations shall be considered Tier II major violations:

    a. Violations that result in a second and any subsequent minor violation, or Tier I major violation for the same or similar offense, within a three-year period.

    b. The receipt of two or more consecutive inspection reports not meeting requirements.

    c. The receipt of an inspection report not meeting inspection requirements, followed by an inspection report meeting inspection requirements, followed by an inspection report not meeting inspection requirements, within a three-year period.

    d. The person-in-charge does not exclude or restrict a food employee from an establishment as required in section 2-201.12 of the Food Code incorporated by reference in Rule 5K-4.002, F.A.C.

    e. The misbranding of species identification.

    f. Refusal to permit entry or inspection during operating hours as required by Section 500.147, F.S.

    g. Operating as a Food Establishment without a valid food permit as provided in Section 500.12, F.S.

    h. Any violation requiring an Immediate Final Order, as authorized by Chapter 500, F.S.

    (10) Willfull Violations. Willful violations shall result in the imposition of an administrative fine of $5,000 per violation, permit suspension, or permit revocation or any combination thereof. The following shall constitute a willful violation:

    (a) The unauthorized breaking, cutting, or removal of any seal or tag applied by the Department.

    (b) The sale or distribution, or offering for sale or distribution, of any commodity under stop sale order unless done so within the parameters of a conditional release.

    (c) The use of any equipment under stop-use order unless done so within the parameters of a conditional release.

    (d) Failure to comply with conditions stipulated in a release of a stop-sale, and/or stop-use order.

    (e) The introduction of adulterated or misbranded products into commerce.

    (f) The failure to comply with either a Final Order, Immediate Final Order, or a Default Final Order of the Department.

    (h) Operating a Food Establishment that has been deemed an imminent threat to the public health, safety, and welfare by the Department for failure to comply with Chapter 500, F.S., this Rule, and/or Rule Chapter 5K-4, F.A.C.

    (i) The falsification of any records required under Chapter 500, F.S., this Rule, and/or Chapter 5K-4, F.A.C.

    (11) Resolution Of Violations, Settlement, And Additional Enforcement Remedies.

    (a) The Department and person(s) charged with a violation may agree to resolve violations prior to an administrative hearing or enter into settlement pursuant to Section 120.57(4), F.S. The penalties addressed in this rule chapter shall not be construed to limit the authority of the Department to resolve violations prior to or after initiation of any administrative action or to settle with any party. The Department shall utilize all available remedies to ensure compliance including administrative action, civil actions, settlements, and referrals for criminal prosecution. The Department shall enforce a failure to comply with an agreement to resolve violations or a settlement agreement with the penalties and remedies provided in the agreement and as authorized by Chapter 120 or Chapter 500, F.S.

    (b) Failure to respond to an administrative complaint shall result in the entry of a Default Final Order against the violator or entity responsible for the violation. The Department shall impose administrative fines in a Default Final Order equal to the maximum amount possible, not to exceed $5,000 per violation.

    (c) A violator’s failure to comply with either a Final Order or a Default Final Order of the Department shall result in additional enforcement actions as authorized by law.

    (d) Fines resulting from multiple violations or Final Orders shall be assessed cumulatively.

    Rulemaking Authority 500.09, 500.12, 570.07(23), FS. Law Implemented 500.04, 500.09, 500.121, 500.171, 500.172, 500.173, 500.174, 500.177, History–New,_____________.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Matt Colson, Chief of Food Inspection

    NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Nicole “Nikki” Fried, Commissioner of Agriculture

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 12, 2019

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 26, 2018

Document Information

Comments Open:
3/29/2019
Summary:
This proposed rule chapter establishes definitions and administrative penalties, and updates requirements for food establishments, special process approvals, and vended water.
Purpose:
The purpose of this rulemaking is to establish definitions, incorporate by reference current versions of federal regulations, update permitting requirements, consolidate the requirements of Chapter 5K-9, F.A.C., for vended water machines into Chapter 5K-4, F.A.C., adopt rules for special process approvals and mobile food establishments, and adopt guidelines for administrative penalties.
Rulemaking Authority:
500.09, 500.12, 500.459, 570.07(23), F.S.
Law:
500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.147, 500.148, 500.165, 500.169, 500.171, 500.172, 500.173, 500.174, 500.179, 500.459, 500.511, 500.70, 500.80, 570.07(23), F.S.
Contact:
Matthew Colson by email at Matthew.Colson@FreshFromFlorida.com.
Related Rules: (10)
5K-4.0010.
5K-4.002. Adoption of Federal Regulations and Other Standards
5K-4.004. General Requirements for the Manufacturing, Processing, Packing, Holding and Retailing of Foods
5K-4.0041.
5K-4.0050.
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