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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMay 2016

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Regulatory Flexibility Act Form

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Copies of the proposed regulations are available for review in the May 1, 2016 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Division of Public Health at (302) 744-4951.
1.2 Purpose. Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122. These regulations establish registration procedures and standards of practice for conducting food processing operations in home-style kitchens that safeguard public health and provide to consumers food that is safe, unadulterated and honestly presented.
Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, §402.
Approved" means acceptable to the Regulatory Authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.
Beverage” means a liquid for drinking, including water.
Consumer” means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food establishment or food processing plant and does not offer the food for resale.
Cottage Food Establishment” (CFE) refers to facilities/locations where food items are made in a home-style kitchen for sale to and consumption by consumers.
Cottage Food Products” refers to a non-Time/Temperature controlled for safety food as specified in these Delaware Cottage Food Regulations that is offered for sale directly to consumers and only at a farmer's market or other approved venue.
Delaware Food Code” means the current State of Delaware Food Code.
Delaware State Registry of Cottage Food Establishments” means a list of establishments approved by the Division to sell approved products in cottage food establishments.
Direct Sales” means sales by the cottage food establishment that moves the products only within the State of Delaware directly to the consumer without the use of an independent retailer or other intermediary.
Division” means the Delaware Division of Public Health.
Drinking Water” means water that meets criteria as specified in 40 CFR 141 National Primary Drinking Water Regulations. "Drinking water" is traditionally known as "potable water." "Drinking water" includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking" water.
"Easily Cleanable" means a characteristic of a surface that: allows effective removal of soil by normal cleaning methods; is dependent on the material, design, construction, and installation of the surface; and varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface's approved placement, purpose, and use.
Employee” refers to an individual having supervisory or management duties; an individual on the payroll; a volunteer; an individual performing work under contractual agreement; or any other individual working in a cottage food establishment.
Equipment” means an article that is used in the operation of a food establishment such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or ware washing machine. "Equipment" does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids.
Food-Contact Surface” means a surface of equipment or a utensil with which food normally comes into contact; or a surface of equipment or a utensil from which food may drain, drip or splash into a food or onto; or a surface normally in contact with food.
Food Establishment” refers to a State of Delaware food establishment where food or drink is prepared for sale or service on the premises or elsewhere; or an operation where food is served to or provided for the public with or without charge.
Home-style Kitchen” refers to a residential style kitchen. A residential style kitchen shall be in the permanent, primary residence of the producer.
Imminent Health Hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on: the number of potential injuries, and the nature, severity, and duration of the anticipated injury.
Person” means an association, a corporation, individual, partnership, or other legal entity.
pH” refers to the symbol for the negative logarithm of the hydrogen ion concentration in gram equivalents per liter of solution where: pH values from 0 to 7 indicate acidity; pH values from 7 to 14 indicate alkalinity; and the pH value for pure distilled water, regarded as neutral, is 7.
Poisonous and Toxic Materials” means substances that are not intended for ingestion, including cleaners and sanitizers, pesticides, necessary maintenance substances, such as non-food grade lubricants, and personal care items, such as medicines, first aid supplies, cosmetics and toiletries.
Private Event” refers to an event restricted to organization members or another event that restricts the general public from attending.
Processing area” refers to the area of the Cottage Food Establishment where food prep and other food service activities occur.
Producer” refers to the person that manufactures cottage food products in a home-style kitchen.
Ready-to-eat Food” refers to food in a form that is edible without washing, cooking, or additional preparation by the food service facility or the consumer.
Registration Holder” means the entity that is legally responsible for the operation of the cottage food establishment such as the owner, the owner’s agent, or other person; and possesses a valid registration to operate a cottage food establishment.
Regulatory Authority” means the Secretary, Delaware Department of Health and Social Services (DHSS), or authorized designee such as the Division of Public Health (Division).
Sanitization” refers to a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999 percent reduction of the number of representative disease microorganisms of public health significance.
Single-service Articles” refers to an article designed, fabricated, and intended for one-time consumer use.
Single-use Articles” refers to an article intended by the manufacturer for one-time use by the preparer of the food.
Temperature Measuring Device” (TMD) means a thermometer, thermocouple, thermistor or other device that indicates the temperature of food, air or water.
Time/Temperature Control for Safety Food (TCS)” means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.
At least one employee during hours of operation shall be on location and have shown proficiency in food safety through passing a test that is part of a program approved by the Office of Food Protection.
7.8.3 TMD shall be accurate to ±1o Celsius or ±2o Fahrenheit to measure food temperatures.
9.3 In response to the order to close, the facility may:
9.3.3 Examination of Food
9.3.3.2 All food shall be wholesome and free from spoilage. Food that is spoiled or unfit for human consumption shall not be kept on the premises. The establishment administrative procedures for the implementation and enforcement of the provision of Chapter 33 of Title 16 of the Delaware Code, relating to the embargo of misbranded or adulterated food, and penalties shall be applicable to this section.
9.4 Penalties
9.5 Injunction. The Division may seek to enjoin violations of the Regulation.
Last Updated: December 31 1969 19:00:00.
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