16 Del. Admin. Code § 4458-2.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4458-2.0 - Adoption of United States Public Health Service 2017 Food Code

2.1 The State of Delaware Food Code adopts, as if fully set forth herein, the United States Public Health Service 2017 Food Code, available at https://www.fda.gov/media/110822/download, as amended herein:

2.1.1 Amend Subpart 1-101.10 by inserting the words "State of Delaware" before the words "Food Code" and after the words "as the".

2.1.2 Amend Subpart 1-102.10 by deleting the subpart in its entirety and by inserting in lieu thereof the following: "The purpose of this Code is to safeguard public health, reduce the risk of foodborne illness and provide to consumers food that is safe, unadulterated and honestly presented. The purpose is also to regulate, within the State of Delaware, the production, transportation, storage, processing, handling, preparation and consumer service of human food; the inspections of food establishments; the issuing and revocation of permits to food establishments; and the application of compliance and enforcement procedures."

2.1.3 Amend Subpart 1-201.10(B) Terms Defined

2.1.3.1 Amend Subpart 1-201.10(B) by adding thereto-new defined terms:

"Alternative Food Establishment" means food establishments inclusive of alternative facilities to prepare food for public consumption. Specified under §8-305.

"Approval to Construct" or "ATC" means the record produced by the regulatory authority approving the construction of a food establishment in accordance with applicable laws and regulations.

"Caterer without a Premise" or "CWOP" means an alternative to traditional brick and mortar food establishments that results in a food establishment permit. This alternative operation is one whereby the permit holder conducts food establishment activities within another permit holder's permitted food establishment and the foods are relinquished directly to the consumer. The utilities, physical facilities, food equipment, capacity and access must meet the needs of the CWOP operation and comply with the Food Code.

"Commissary" - See "Servicing Area".

"Confirmed foodborne disease outbreak" means confirmed foodborne disease outbreak is defined as an incident in which two or more persons from separate households experience a similar illness after ingestion of a common food or meal and epidemiologic evaluation implicates the meal or food as the source of illness. Confirmed outbreaks may or may not be laboratory-confirmed.

"Conveniently located" means the ability to access the equipment and/or location without (A) risk of contamination; and (B) obstructions.

"Food Preparation" means a broad topic, involving all of the steps that occur between obtaining raw ingredients and consuming them as food.

"High Risk" means a food establishment that prepares food with multiple (3 or more) risk steps: handling, (combining-mixing), of raw ingredients; cooking; cooling; reheating; hot and cold holding for service; freezing and thawing; time as public health control and including:

(1) Non-compliance on the same non-critical items on multiple inspections (3 or more) without correction, or

(2) Non-compliance with the same CDC risk factors in two consecutive inspections no corrections; or

(3) Serves a highly susceptible population.

"Limited Frozen Dessert Stand" or "LFDS" means an alternative food establishment that dispenses Italian water ice, snow cones, bulk hard-pack ice cream or frozen yogurt; and other similar products. It does not include the sites at which these products are processed; facilities which mechanically dispense (soft-serve style machines) these products; nor, facilities which add toppings.

"Low Risk" means a food establishment that:

(1) Prepares TCS Foods with only one or two of the following steps: cooking; cooling; reheating; hot and cold holding for service; low volume of foods; or

(2) Is Medium Risk with Hazard Analysis Critical Control Point (HACCP) plan, or substantial compliance.

"Medium Risk" means a food establishment that:

(1) Prepares TCS Foods with multiple (3 or more) risk steps: handling (combining-mixing) of raw ingredients; cooking; cooling; reheating; hot and cold holding for service; freezing and Thawing; Time as Public Health control; or

(2) Is High Risk with HACCP plan or substantial compliance; or

(3) Is Low Risk with non-compliance on multiple inspections (3 or more)

"Mobile Food Establishment" or "MFE" means a mobile food establishment is a vehicle mounted alternative food establishment that is readily moveable. MFEs require an agreement with a servicing area/commissary to ensure that the MFE in conjunction with the servicing area/ commissary area meets the Food Code.

"Outdoor Spaces" means a porch, patio, deck or other structure with less than two contiguous walls that does not require travel through any indoor areas, including for entrance and exit.

"Peak Water Demand" is the quantity of water that the food establishment must have in order to meet all water needs in the food establishment.

"Peak Hot Water Demand" is the quantity of hot water that the food establishment must have in order to meet all hot water needs in the food establishment.

"Private" means a use or function that is intended for a particular individual or group, such as a celebration of a birthday, wedding, anniversary or funeral, and that is not intended for consumers as members of the general public.

"Probable foodborne disease outbreak" means a probable foodborne disease outbreak is defined as an incident in which two or more persons from separate households experience a similar illness after ingestion of a common food or meal, and a specific food or meal is suspected, but person-to-person transmission or other exposures cannot be ruled out.

"Request for Information" or "RFI" means a record produced by the regulatory authority requesting information related to the application for a permit to operate a food establishment in accordance with applicable laws and regulations.

"Very Low Risk" means a food establishment that:

(1) Serves food to the public on 52 occasions or less per year and does not serve a highly susceptible population; or

(2) Serves no Time/Temperature Control for Safety (TCS) foods and does not serve a highly susceptible population.

2.1.3.2 Amend Subpart 1-201.10(B) by amending defined terms:

Amend "Food Establishment" by adding thereto after (1)(b) the following: "(c) meets the physical facilities requirements of this Code."

Amend "Food Establishment" by deleting the words "that are not TIME/TEMPERATURE CONTROL FOR SAFETY FOODS".

Amend "Food Establishment" by adding thereto after (3)(g) the following: "(h) A private catered event." and "(i) A Cottage Food Establishment."

Amend "Food Processing Plant" by deleting the existing text after (1) "Food processing plant" and by inserting in lieu thereof the following: "means a type of food service establishment that is a commercial operation that processes food for human consumption, and provides processed food for sale and distribution to other business entities such as other food establishments."

Amend "Person in Charge" by deleting the existing definition and replacing it to read as follows: "means the individual present at a food establishment who is responsible for the operation during all hours of food operations."

Amend "Public Water System" to read as follows: "has the meaning stated in 40 CFR 141 National Primary Drinking Water Regulations and is also applicable to those private wells designated by the Division of Public Health as a Miscellaneous Public Well."

Amend "Regulatory authority" by deleting the existing definition and replacing it to read as follows: "means the Secretary, Delaware Department of Health and Social Services, or his/her authorized representative."

Amend "Service Animal" by deleting the existing definition and replacing it to read as follows: "as defined under 28 CFR § 35.136 and by the Americans with Disabilities Act."

Amend "Servicing Area" by adding the following after the last sentence: "The servicing area must be within our jurisdiction and reviewed during risk-based inspections. The servicing area must complement any caterer or mobile food establishment to allow the establishment to meet the physical facilities requirements of this Code."

Amend "Temporary Food Establishment" by deleting the existing definition and replacing it to read as follows: "or "TFE" means an alternative food establishment that results in a TFE permit and prepares food for the public, free or for a cost. Events sanctioned to operate by a local or state jurisdiction may operate for up to fourteen (14) consecutive days in conjunction with that single event or celebration. All other non-sanctioned vendors may operate, with each day counting as one event. Vendors are limited to fourteen (14) event permits per calendar year."

2.2 Amend Subpart 2-201.13 to revise paragraph (A)(1)(a) by deleting the phrase "24 hours" and replacing it with the words "48 hours".

2.3 Amend Subpart 2-401.11(A) by adding thereto after the words "any form of tobacco" the following: "and/or devices that people use to inhale an aerosol".

2.4 Amend Subpart 3-305.12(I) by deleting the existing text and by inserting in lieu thereof the following: "Under or in contact with sources of contamination."

2.5 Amend Part 3-305 by adding thereto a new subpart 3-305.15 to read as follows:

"3-305.15 Food Preparation Sink.

(A) A dedicated food preparation sink shall be installed in the food establishment.

(B) This section does not apply to certain types of food establishments deemed by the regulatory authority to pose minimal risk in the absence of a dedicated food preparation sink, such as establishments with non-TCS foods or those with commissaries that provide prewashed and prepared foods."

2.6 Amend Subpart 3-602.11(B)(4) by deleting the phrase "manufacturer, packer, or distributor" and replacing it with the words "location of food preparation and packaging".

2.7 Amend Subpart 4-205.10 by deleting the existing text and by inserting in lieu thereof the following:

(A) Food equipment that is certified or classified for sanitation by an American National Standards Institute (ANSI)-accredited certification program is deemed to comply with Parts 4-1 and 4-2 of this chapter; and

(B) Manufacturer's specifications are required as documentation to support compliance with Parts 4-1 and 4-2 of this chapter.

2.8 Amend Subpart 4-501.16(B) by deleting the existing text and by inserting in lieu thereof the following: "If a WAREWASHING sink is used to wash wiping cloths the sink shall be cleaned as specified under § 4-501.14 before and after each time it is used to wash wiping cloths."

2.9 Amend Subpart 5-104.12(E) by adding thereto before the words "Piping, tubing, or hoses connected to an adjacent APPROVED source." the following: "Safely connected and protected".

2.10 Amend Subpart 5-202.12(A) by adding thereto before the words "A HANDWASHING SINK" the following: "With the exception of facilities at a TEMPORARY FOOD ESTABLISHMENT,".

2.11 Amend Subpart 5-203.11 by adding paragraph (D) to read as follows: "If approved, an Alternative Food Establishment may use alternative handwashing equipment:

(1) Provided with clean, running and warm water; and

(2) Provided with a safe means to collect gray water."

2.12 AmendSubpart 6-101.11(B) by deleting the phrase "covered with mats, removable platforms, duckboards, or other APPROVED materials that are" in subparagraph (1) and by deleting the existing text in subparagraph (2) and inserting in lieu thereof the following: "Protection from weather and windblown dust and debris shall be provided."

2.13 AmendSubpart 6-202.13(B)(1) by adding thereto after the words "a food preparation" the following: "warewashing or food dispensing".

2.14 Amend Subpart 6-301.12 by deleting subparagraph (B) in its entirety.

2.15 Amend Subpart 6-501.115(B) by adding subparagraph (6) to read as follows: "Dogs in designated OUTDOOR SPACES that are not used for food storage or preparation, when a person controls the animal and if a health or safety hazard will not result from the presence or activities."

2.16 Amend Subpart 8-201.11(A) by adding thereto after the words "FOOD ESTABLISHMENT" the following: "or alternative food establishment".

2.17 Amend Subpart 8-201.11(C) by adding thereto after the words "remodeling of a FOOD ESTABLISHMENT," the following: "change of ownership".

2.18 Amend Subpart 8-302.11 by deleting the existing text and by inserting in lieu thereof the following: "An applicant shall submit an application sufficiently in advance of date of planned opening to allow for review and approval. The REGULATORY AUTHORITY will communicate with the applicant with REQUEST FOR INFORMATION and APPROVAL TO CONSTRUCT records."

2.19 Amend Subpart 8-302.14(A) by adding thereto before the words "telephone number," the following: "email address,"; and by adding thereto before the word "signature" the following: "electronic or print".

2.20 Amend Subpart 8-302.14(D) by adding thereto after the word "title," the following: "mailing"; and by adding thereto before the words "and telephone number" the following: "email address,".

2.21 Amend Subpart 8-302.14 by deleting subparagraph (E) in its entirety.

2.22 Amend 8-304.10(A)by deleting the phrase "a copy of" and replacing it with the words "access to".

16 Del. Admin. Code § 4458-2.0

24 DE Reg. 158( 8/1/2020) (final)