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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsSeptember 2016

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On May 1, 2016 (Volume 19, Issue 11), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Del.C. §10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by June 9, 2016, or be presented at a public hearing on May 25, 2016, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
In accordance with Delaware Law, public notices regarding proposed Department of Health and Social Services (DHSS) Regulations Cottage Food Industries were published in the Delaware State News, the News Journal and the Delaware Register of Regulations. Written comments were received on the proposed regulations during the public comment period (May 1, 2016 through June 9, 2016).
I have reviewed the Proposed Cottage Food Regulations, established Department of Health and Department of Agriculture regulations pertaining to food industry regulations. I believe current regulations for commercial and farm kitchens are sufficient and do protect the public The proposed Cottage Food Regulations will create more adverse effects on established commercial and On-Farm Home Food Process Program and will increase risk to the public. There are established avenues within these regulations for the entry of a new business, a real new business that can hire employees and with no cap on gross annual sales.
First, I believe the proposed regulation should not be passed.
Second, if the proposed regulation is passed, current licensees with an On-Farm Home Food Process License should be grandfathered under current Department of Agriculture Regulations, with regards to the established licensed kitchen facility requirements and annual gross sales $40,000.00, and labeling requirements and registration fees.
Third, problems with the Proposed Cottage Food Regulation and suggested changes.
Response: DPH has included the $25,000.00 limit in the final regulations. This can be revised in the future if it is determined that many of the permitted businesses are hitting this ceiling, but DPH is using this as a limit as the proposed program is meant to small start-up businesses. Established businesses whose growth may be hampered by the limits are encouraged to look at other available permits relevant to larger operations.
Response: The labeling requirement is similar to surrounding jurisdictions and has not been changed in response to this comment.
Response: DPH is proceeding with the planned $30 per facility fee, which is reasonable in comparison with other jurisdictions. If it is determined that this fee is a burden to producers it can be revised in the future.
Comments from Katherine Hall
Response: These are intended for people who want to operate a small business making foods out of their home. This would allow them to make certain products for sale at farmers markets and other venues in their home kitchen which is currently not allowed. As far as bake sales, there is still an exemption for bake sales that is not affected by these regulations.
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.
7.1.4 [Solid, self-closing exterior doors shall be installed.] If doors are kept open for ventilation, self-closing screened doors with 16 mesh screening will be used.
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:
[9.3.1.1 9.3.2] Take action to correct the unsafe and unsanitary practices identified during the survey.
[9.3.1.1.1 9.3.2.1] The facility may submit evidence through a written plan of correction showing that the deficient practices, identified during the investigation, have been addressed and corrected.
[9.3.1.1.1.1 9.3.2.1.1] A change of location for the facility does not nullify an order to close and an acceptable plan of correction must still be submitted.
[9.3.1.1.2 9.3.2.2] The Department shall determine if the plan of correction is acceptable.
[9.3.1.1.3 9.3.2.3] Once accepted, the Department shall schedule a revisit as soon as possible.
[9.3.2 9.3.3] Request, in writing, an administrative hearing with the Secretary of the Department to contest the order to close.
[9.3.2.1 9.3.3.1] Such request must be received within 20 calendar days from the date on which the order to close was issued.
[9.3.2.1.1 9.3.3.1.1] As soon as possible, but in no event later than 60 calendar days after the issuance of the closure order, the Department shall convene a hearing on the reasons for closure.
[9.3.2.1.2 9.3.3.1.2] The Department shall make a determination based upon the evidence presented.
[9.3.2.1.2.1 9.3.3.1.2.1] A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.
[9.3.2.1.3 9.3.3.1.3] A facility may request an expedited hearing.
[9.3.2.1.3.1 9.3.3.1.3.1] The Department shall schedule the hearing on an expedited basis provided that the Department receives the facility's written request for an expedited hearing within five (5) calendar days from the date on which the facility received notification of the Department's decision to close the facility.
[9.3.2.1.3.2 9.3.3.1.3.2] The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.
[9.3.2.1.3.3 9.3.3.1.3.3] The Department shall make a determination based upon the evidence presented.
[9.3.2.1.3.4 9.3.3.1.3.4] A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.
[9.3.2.2 9.3.3.2] During an administrative hearing:
[9.3.2.2.1 9.3.3.2.1] The facility has the right to be represented by counsel.
[9.3.2.2.2 9.3.3.2.2] All statements made shall be under oath.
[9.3.2.2.3 9.3.3.2.3] The facility has the right to examine and cross-examine witnesses.
[9.3.2.2.4 9.3.3.2.4] A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.
[9.3.2.2.5 9.3.3.2.5] The decision of the Department shall be based upon sufficient legal evidence. If the charges are supported by such evidence, the Department may continue, modify or revoke the closure order.
[9.3.2.3 9.3.3.3] Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with §10128 of Title 29.
[9.3.2.4 9.3.3.4] All decisions of the Department shall be final and conclusive. Where the facility is in disagreement with the action of the Department, the facility may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the facility. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.
[9.3.3 9.3.4] Examination of Food
[9.3.3.1 9.3.4.1] Food may be examined or sampled by the Division as often as necessary for enforcement of this regulation.
[9.3.3.2 9.3.4.2] 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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