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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsSeptember 2013

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Statutory Authority: 3 Delaware Code, Sections 102 and 302 (3 Del.C. §102 and §302)
3 DE Admin. Code 101
Notice of a public comment period of thirty (30) days on this proposed amended regulation was published in the Delaware Register of Regulations for July 1, 2013. This is the Department of Agriculture's Decision and Order adopting the proposed amended regulations.
4.1 This regulatory foundation shall be construed and interpreted to ensure the maximum protection of the public health and to reduce the risk of foodborne illness, while exempting certain small food processors, who process and produce specified non-potentially hazardous products on-farm utilizing domestic kitchens, from the statutory requirements of Title 16 Del.C. §122 and §134, and from the regulatory requirements of State of Delaware Food Code; and the program will ensure protection of the public health through processor compliance with regulatory requirements of the On-farm Home Food Processing Program.
Acid foods” or “acidified foods means foods that have an equilibrium pH of 4.6 or below.
Approved means acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.
Certifiedmeans any on-farm home-based processor who has met the requirements of the Delaware Cooperative Extension Service’s eight (8) hours of training in sanitation, cross-contamination controls, and food security.
Consumer means a person who is a member of the public, takes possession of food, is not functioning as an operator of a food establishment or food processing plant, and does not offer the food for resale.
DDA means the Delaware Department of Agriculture
Drinking water means water that meets 40 CFR 141 National Primary Drinking Water Regulations; and is traditionally known as "potable water."
Dry storage area means a room or area designated for the storage of packaged or containerized bulk food that is not potentially hazardous and dry goods such as single-service items.
Easily cleanable means a characteristic of a surface that allows effective removal of soil by normal cleaning methods; and 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.
Easily movable means portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to safely tilt a unit of equipment for cleaning; and having no utility connection, a utility connection that disconnects quickly, or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.
Equipmentmeans an article that is used in a food processing operation 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 warewashing machine.
Exclude means to prevent a person from working as a food employee or entering a food establishment, except for those areas open to the general public.
Farm means a place where agricultural commodities are grown, raised, or harvested for commercial purposes. “Farm” includes a place where, for commercial purposes crops are grown and harvested; fruit, nuts, or other agricultural commodities are harvested from trees; or animals are raised, fed, and managed for meat or other agricultural commodities.
Farmers’ market means a physical location listed with the Delaware Department of Agriculture for the direct-to-consumer marketing of limited Delaware/Delmarva grown and produced food products.
Foodmeans a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption.
Food-contact surface means a surface of equipment or a utensil with which food normally comes in contact; or a surface of equipment or a utensil from which food may drain, dip, or splash into a food, or onto a surface normally in contact with food.
Hazardmeans a biological, chemical, or physical property that may cause an unacceptable consumer health risk.
Homemeans a primary residence occupied by the processor, that contains only two (2) ranges, ovens, or double-ovens, and no more than three (3) refrigerators used for cold storage. This equipment shall have been designed for home use and not for commercial use, and shall be operated in the kitchen within the residence
Home-based processor means a farmer who, in the farmer’s home, produces or processes whole fruit and vegetables, baked cakes, muffins, or cookies with a water activity of .85 or less, candy (non-chocolate), containerized fruit preparations consisting of jellies, jams, preserves, marmalades, and fruit butters, fruit pies with an equilibrated pH of 4.6 or less, herbs in vinegar with an equilibrated pH of 4.6 or less, honey and herb mixtures, dried fruit and vegetables, spices or herbs, maple syrup and sorghum, snack items such as popcorn, caramel corn, and peanut brittle, and roasted nuts.
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.
Labelmeans a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of 3 Del.C. §§101 and 302 that any word, statement, or other information appearing on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of the article, or is easily legible through the outside container or rapper;
Law means applicable local, state, and federal statutes, regulations, and ordinances.
On-farm home food processing operation means a person who, on the person’s farm, produces food items that are not potentially hazardous foods, which are limited to:
Baked breads, cakes, muffins, or cookies with a water activity of .85 or less
On-farm market”, also known as farm stands, means a site on the farm where the farmer sells agricultural and value added products from his farm directly to consumers at a stand or kiosk located on or near his farm or along a road near the farm.
Packaged means bottled, canned, cartoned, securely bagged, or securely wrapped, whether packaged in a food establishment or a food processing plant.
Permit means the document issued by the regulatory authority that authorizes a person to conduct an on-farm food processing operation.
Permit holder means the entity that is legally responsible for the processing operation such as the owner or other person; and possesses a valid permit to conduct on-farm food processing operation.
Personmeans an association, corporation, individual, partnership, or other legal entity.
pH means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution.
Plumbing fixture means a receptacle or device that is permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system; or discharges used water, waste materials, or sewage directly or indirectly to the drainage system of the premises.
Plumbing system means the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the premises; and water-treating equipment.
Potentially hazardous food (PHF)
“Potentially hazardous food" does not include an air-cooled hard-boiled egg with shell intact; a food with an aw value of 0.85 or less; a food with a pH level of 4.6 or below when measured at 24oC (75oF); a food, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution; a food for which laboratory evidence demonstrates that the rapid and progressive growth of combination of barriers that inhibit the growth of microorganisms; or a food that does not support the growth of microorganisms as specified above in this definition even though the food may contain an infectious or toxigenic microorganism or chemical or physical contaminant at a level sufficient to cause illness.
Premises means the physical facility, its contents, and the contiguous land or property under the control of the permit holder; or the physical facility, its contents, and the land or property not described above in this definition, if its facilities and contents are under the control of the permit holder and may impact food operation, personnel, facilities, or operations, and a food operation is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.
Ready-to-eat food means food that is in a form that is edible without washing, cooking, or additional preparation by the food establishment or the consumer and that is reasonably expected to be consumed in that form. "Ready-to-eat food" includes potentially hazardous food that is unpackaged and cooked to the temperature and time required; and raw, washed, cut fruits and vegetables; whole, raw fruits and vegetables that are presented for consumption without the need for further washing, such as at a buffet; and other food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed.
Regulatory Authority means the local, state, or federal enforcement body or authorized representative having jurisdiction over the food operation.
Sanitization means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of 5 logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance; and to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
Sewage means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.
Utensil means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is multiuse, single-service, or single-use; gloves used in contact with food; food temperature measuring devices; and probe-type price or identification tags used in contact with food.
Value-addedmeans any activity or process that allows farmers to retain ownership and that alters the original agricultural product or commodity for the purpose of gaining a marketing advantage. Value- added may include bagging, packaging, bundling, pre-cutting, etc.
Waste water systemmeans that portion of a plumbing system that normally conveys liquid waste and sewage away from the fixtures and equipment of the premises of the food operation.
Water activity (AW)” means a measure of the free moisture in a food, is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
8.2 Disease control:
8.3 Cleanliness:
8.3.1 All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to:
Baked breads, cakes, muffins, or cookies with a water activity of .85 or less
8.6.2 $40,000 $50,000 of sales of on-farm home processed foods.
9.0 Labeling
10.0 Supervision
12.1 Food contact surfaces shall be smooth and easily cleanable. The use of wood or glass for food preparation is not approved;
12.2 Non-food contact surfaces in the facility, including floor, walls and ceilings, shall be smooth and cleanable. The use of carpeting in the processing area is not approved;
12.3 Refrigeration: All facilities shall have a sufficient number of mechanical refrigeration units capable of holding raw materials requiring refrigeration at a minimum of 41°F. Each such mechanical refrigerator shall be equipped with a thermometer located in the warmest portion of the refrigerator;
12.4 Water supply: All facilities shall have hot and cold running water under pressure, supplied to all sinks in the processing room. If a non-public water supply is used, the laboratory results of a satisfactory water quality test (bacteriological and chemical) shall be submitted to the regulatory authority at least once each year;
12.5 Waste water system: All wastewater and other liquid waste generated during processing operations shall be disposed of through an approved wastewater system designed and installed according to law. A non-public wastewater system shall be approved and permitted by the Delaware Department of Natural Resources and Environmental Control (DNREC);
12.6 Warewashing: For manual cleaning and sanitizing of cooking equipment, and utensils, a sink of three (3) compartments shall be provided and used. A two-compartment sink, with an additional portable tub is acceptable.
12.7 Handwashing: Adequate hand washing facilities separate from the utensil cleaning facilities, which includes hot and cold water, single service paper towels and hand soap are required. Properly supplied hand washing facilities provided in toilet facilities located within the structure containing the domestic kitchen may suffice for this provision.
12.8 Plumbing system- in the processing area shall be designed and installed according to law under a valid plumbing permit with a satisfactory plumbing inspection;
12.9 Refuse: recyclables and returnable waste generated during processing operations shall be stored in heavy duty, cleanable waste containers equipped with tight fitting lids;
12.10 Artificial lighting - (electrical lamps) in the processing area shall be protected from shattering by either shielding or an approved shatter-resistant coating;
12.11 Toilet facility: A completely enclosed toilet room equipped with a toilet and a hand washing sink shall be located on premises. The toilet room shall have a tight fitting door, and shall have either mechanical ventilation or an open-able window. The hand washing sink shall be supplied with hot and cold running water, under pressure and be supplied with liquid soap, paper towels and a wastebasket.
12.12 Exterior openings: All exterior doors and windows in the process area shall be tight fitting to prevent the entry of vermin. If these doors or windows are to be kept open for ventilation they shall be covered with screening, not less than 16 mesh to the inch. Exterior doors shall be self-closing;
12.13 Service sink - shall be provided separately for the disposal of mop water and other liquid waste;
12.14 Equipment and utensils - intended for use in food processing shall be separate from those used to cook domestic meals;
12.15 Storage areas - for both raw ingredients and finished product shall protect these items from contamination;
12.16 Ventilation - that is adequate to prevent an accumulation of excess steam, heat, and condensation on floors, walls and ceilings of the processing area shall be provided; and
12.17 Poisonous and toxic materials - shall be stored so they cannot contaminate raw ingredients, utensils, equipment, packaging materials and finished products. This requirement also applies to medicines and medical items intended for use by humans or on livestock.
Last Updated: December 31 1969 19:00:00.
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