The Florida Department of Agriculture and Consumer Services' (FDACS) Division of Food Safety is directly responsible for assuring the public of a safe, wholesome and properly represented food supply. The Manufactured Food Program (Wholesale Establishments), under the authority of Chapter 500, Florida Statutes (F.S.), and Rule 5K-4, Florida Administrative Code (F.A.C.), is responsible for permitting and inspecting food establishments engaged in the manufacturing, processing, packing, holding or preparing of food for sale or distribution to other businesses. This food includes food products consisting of or containing hemp extract, which includes CBD and other cannabinoids.
Businesses that typically fall into the wholesale category include: wholesale bakeries, food storage warehouses, bottling plants, canning plants, seafood processors and other food processors.
Businesses whose primary function is to sell food products directly to the consumer are considered retail food establishments. Learn about the requirements for a retail food establishment.
Foods that contain meat might fall under the jurisdiction of the U.S. Department of Agriculture (USDA) and would not fall under the authority of FDACS. These foods would include: beef jerky, meat sandwiches, meat pies, prepackaged meals that include 3% or more meat, and pizzas with meat toppings. Businesses that intend to produce foods that contain meat should contact USDA for more information but should also speak with an FDACS representative to ensure full regulatory compliance.
Food Facility Registration With the FDA
All manufactured food establishments that manufacture, process, pack or hold food for human consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA) as a food facility. Registration is free of charge and may be completed prior to initial FDACS permitting and then renewed, with the FDA, on a biannual basis. Any questions regarding FDA registration requirements should be directed to the FDA. More information can be found on the FDA website.
Current Good Manufacturing Practices and Preventive Controls
Preventive controls are steps you, a manufactured food establishment, must take to reduce or eliminate food safety hazards. The rule on Preventive Controls for Human Food is mandated by the FDA Food Safety Modernization Act (FSMA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (Title 21, Part 117, Code of Federal Regulations [CFR]) and has been adopted by the state of Florida in Rule 5K-4.002, F.A.C.
The requirements apply to you if you manufacture, process, pack or hold human food for consumption in Florida, and possibly anywhere in the United States (contact FDA for determination of the latter). The rule allows for several exemptions or modified requirements that allow for some manufactured food establishments to be exempt from the preventive control requirement (subparts C and G). However, the requirements for training, Current Good Manufacturing Practices, and records (for training) have no exemptions and apply to everyone.
All manufactured food establishments are subject to the requirements in
21 CFR 117
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as follows:
Subpart A — General Provisions: This subpart lists definitions, exemptions and applicability for certain foods, activities and facilities. Subpart A also includes requirements for qualified individuals.
Learn about the qualifications for individuals who manufacture, process, pack or hold food (training requirements).
Learn more about food establishments that are exempt from the preventive control requirement (subparts C and G).
Subpart B — Current Good Manufacturing Practices: This subpart applies to all foods, activities and facilities subject to the regulation. These serve as the backbone for ensuring the production of safe foods. The following areas are covered under the Current Good Manufacturing Practices:
- Personnel roles and responsibilities
- Plant and grounds
- Sanitary operations
- Sanitary facilities and controls
- Equipment and utensils
- Process and controls
- Prevention of allergen cross-contact (incorporated into applicable sections)
- Warehouse and distribution
- Holding and distribution of human food by-products for use as animal food
- Defect action levels
Learn more about each area of the Current Good Manufacturing Practices.
Subpart C — Hazard Analysis and Risk-Based Preventive Controls. This subpart applies to most foods, activities and facilities unless specifically exempt by provisions in Subpart A. Facilities subject to Subpart C must have and implement a food safety plan. The food safety plan must include a written hazard analysis. If the hazard analysis reveals one or more hazards requiring a preventive control, then the facility must have and implement appropriate preventive controls. Most preventive control requirements are outlined in Subpart C, with the exception of supply-chain program, which is outlined in Subpart G. The hazard analysis determines which preventive control program the facility will need to include in its food safety plan.
Learn more about the requirements for preventive controls.
Subpart D — Modified Requirements: This subpart outlines modified requirements for a qualified facility and for a facility that is solely engaged in the storage of unexposed packaged foods when it holds refrigerated food that requires time/temperature controls to prevent pathogen growth/toxin formation. Subpart A exempts these facilities from the requirements in subparts C and G.
Learn more about the modified requirements for a qualified facility.
Learn more about the modified requirements for facilities solely engaged in the storage of unexposed packaged food that requires time/temperature control for food safety.
Subpart E — Withdrawal of a Qualified Facility Exemption: This subpart covers the circumstances and procedures regarding the withdrawal of a qualified facility exemption.
Learn more about the requirements for withdrawal of a qualified facility exemption.
Subpart F — Requirements Applying to Records That Must Be Established and Maintained: This subpart outlines additional requirements for records mandated in subparts A, C, D and G.
Learn more about records requirements.
Subpart G — Supply-Chain Program: This subpart outlines requirements for a supply-chain preventive control program. A facility that identifies a hazard requiring a supply-chain control must follow the requirements in Subpart G. However, it is important to realize that not all facilities will need to identify the supply-chain program as a preventive control in a food safety plan.
Refer to Chapter 15 of the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food to learn more about the supply-chain program requirements.
Additional Regulations
Additional regulations may apply depending on the nature of the product you are manufacturing:
Acid, Acidified and Low-Acid Canned Foods
Acid, acidified and low-acid canned foods are considered a shelf-stable if, when properly processed, the food product can be safely stored at room temperature in a sealed container. Acid, acidified and low-acid canned foods must be evaluated by a food processing authority for proper classification and identification of any critical factors that must be monitored, such as pH and cook time/temperature.
Learn more about the requirements for acid, acidified and low-acid canned foods.
Bottled Water
Bottlers of drinking water are subject to the requirements in 21 CFR 129 [ Adobe PDF Document ] and 21 CFR 165.110 [ Adobe PDF Document ].
Juice Hazard Analysis Critical Control Points (HACCP)
HACCP is a systematic approach to identify and control biological, physical and chemical hazards related to the production of juice sold as such or used as an ingredient in a beverage that can cause a food product to be unsafe. An effective HACCP system will eliminate or reduce the risks to an acceptable level. A HACCP system is required to be implemented by all juice processors that sell juice products to other businesses. Juice processors are subject to the requirements in 21 CFR 120.
Learn more about the requirements for juice production.
Seafood HACCP
HACCP is a systematic approach to identify and control biological, physical and chemical hazards related to procurement, storage, handling, production and distribution that can cause a food product to be unsafe. An effective HACCP system will eliminate or reduce the risks to an acceptable level. A HACCP system is required to be implemented by all wholesale processors and distributors of fish and fishery products. Processors and distributors of fish and fishery products are subject to the requirements in 21 CFR 123 [ Adobe PDF Document ].
Learn more about the requirements for seafood production.
Finished Product Labeling
All food products must meet the labeling requirements found in Chapter 500, F.S.; Rule 5K-4, F.A.C.; and the requirements of 21 CFR 101, Food Labeling.
Learn more about labeling requirements.
Manufactured Food Inspections Expectations
Under Chapter 500, F.S., FDACS is given authority to freely access, at all reasonable hours, any food establishment, any food records, or any vehicle being used to transport or hold food in commerce for the purpose of inspecting the establishment, records or vehicle to determine whether this chapter or any rule adopted under this chapter is being violated.
Learn more about FDACS food safety inspections.