3 Del. Admin. Code § 101
This regulation is written under the authority of Title 3, Chapters 1 and 3, and Sections 101 and 302 of theDelaware Code.
This regulatory foundation establishes standards of practice for on-farm home food processing operations that safeguard public health and provide consumers with food that is safe, unadulterated, and honestly presented.
This regulatory foundation sets forth definitions, describes operator qualifications, establishes operational food safety and physical facility requirements, and provides the regulatory authority with procedures to ensure compliance with this foundation.
The following words and terms when used in these regulations mean:
“ 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.
“ Certified ”means 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.
“ Equipment ”means 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.
“ Food ”means 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.
“ Hazard ”means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.
“ Home ”means 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.
“ Label ”means 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 |
| • | Candy (non-chocolate) |
| • | Containerized fruit preparations consisting of jellies, jams, preserves, marmalades, and fruit butters with an equilibrated pH of 4.6 or less or a water activity of 0.85 or less; |
| • | 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; and |
| • | Dried fruit and vegetables; |
| • | Spices or herbs |
| • | Maple syrup and sorghum |
| • | Snack items such as popcorn, caramel corn, and peanut brittle |
| • | Roasted nuts |
“ 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.
“ Person ”means 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) ”
| • | PHF means a food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic microorganisms; or the growth and toxin production of Clostridium botulinum; or in raw shell eggs, the growth of Salmonella Enteritidis. |
| • | "Potentially hazardous food" includes an animal food (a food of animal origin) that is raw or heat-treated; a food of plant origin that is heat-treated or consists of raw seed sprouts; cut melons; and garlic-in-oil mixtures. |
| • | Also included as potentially hazardous foods are low acid canned foods (vegetable, fish, meat, etc.) and acidified foods (pickled vegetables, fish, meat, eggs, etc.) |
| • | “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-added ”means 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 system ”means 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.
6.2 The registration form, available from DDA, shall include at a minimum the following information:
The below framework provides for the operator to possess the knowledge and demonstrate the abilities needed to safely perform production under the on-farm home food processing program.
8.1 Education and training.
8.1.2 An individual who wishes to process non-potentially hazardous foods in a domestic kitchen shall have adequate knowledge of safe food handling practices and shall have successfully completed a course offered through the Cooperative Extension Program prior to applying for a permit. The course shall be approved by DDA and provide a minimum of 8 hours of training in:
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:
| • | Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials; |
| • | Maintaining adequate personal cleanliness; |
| • | Washing hands thoroughly (and sanitizing if necessary to protect against contamination with 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. |
| • | Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials; |
| • | Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material; |
| • | Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints; |
| • | Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed; |
| • | Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco. |
| • | Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. |
| • | No animals or fowls shall be kept in or permitted to enter the premises of any on-farm food operations. |
8.4 While operating with a license issued in accordance with this regulation, the person-in-charge shall manufacture and process only non-potentially hazardous foods such as:
| • | Baked breads,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 with an equilibrated pH of 4.6 or less or a water activity of 0.85 or less; |
| • | Fruit pies with an equilibrated pH of 4.6 or less or a water activity of 0.85 or less; |
| • | Herbs in vinegar with an equilibrated pH of 4.6 or less; |
| • | Honey and herb mixtures; and |
| • | Dried fruit and vegetables; |
| • | Spices or herbs |
| • | Maple syrup and sorghum |
| • | Snack items such as popcorn, caramel corn, and peanut brittle |
| • | Roasted nuts |
8.5 While operating with a license issued in accordance with this regulation, the person-in-charge shallnotprocess potentially hazardous foods for commercial sale such as:
| • | Low-acid canned foods, such as home-canned or jarred fruits, vegetables, pickled products, sauces, relishes. |
| • | Cream, custard, pumpkin, meat, or other single-crust pies or cream or cheese-filled baked goods |
| • | Cured or fermented foods; |
| • | Seafood; |
| • | Apple cider or other juices; |
8.6 While operating with a license issued in accordance with this regulation, the person-in-charge shall limit processed food production to:
8.9 While operating with a license issued in accordance with this regulation while processing commercially, the person-in-charge shall:
9.1 Products must be properly labeled as follows:
11.1 Employees engaged in food preparation, service, and warewashing operations shall thoroughly wash their hands and the exposed portions of their arms with soap or detergent and warm water before starting work, after smoking, eating, or using the toilet, and as often as is necessary during work to keep them clean. All persons shall keep their fingernails trimmed and clean.
11.1.1 Handwashing facilities
The following requirements are the minimum acceptable standards for food processing areas:
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.
12.6.1 Mechanical cleaning and sanitizing shall be conducted as follows: A domestic or home-style dishwasher may be used if the following performance criteria are met: