16 Del. Admin. Code § 4457-17.0
Current through Register Vol. 28, No. 7, January 1, 2025
Section 4457-17.0 - General17.1 No person shall operate an ice plant who does not possess a valid permit issued to him by the Division of Public Health in accordance with Section 6.0 of these Regulations. Only a person who complies with the requirements of these Regulations shall be entitled to receive or retain such a permit.17.2 A valid Delaware Division of Public Health permit shall be posted in a conspicuous location, in every ice plant.17.3 The Division of Public Health, or its designated authority, for just reasons of non-compliance with the requirements of these Regulations, may: Refuse to issue a permit, deny the reissuance of a permit; or suspend/revoke a permit.17.4 Enforcement authority for the assurance of a safe source of water supply and the microbiological, chemical and physical standards of both the water and the ice product shall be vested concomitantly in these Regulations and in State of Delaware Regulations Governing Drinking Water Supplies.17.5 Change of Ownership, Management Firm or Lessee 17.5.1 A valid permit is not transferable from person to person or location to location. Therefore, it is the responsibility of the new owner/operator to apply for an operating permit prior to commencing operations.17.5.2 If any renovation(s) of the physical structure of the transferred facility is(are) required, based on previous inspection reports of the regulatory authority, the new owner/operator will be held responsible for this(these) renovation(s).17.5.3 Compliance with these Regulations shall be achieved prior to the start of business unless the new owner/operator is either granted a variance in accordance with Section 17.18.2, or is granted a provisional permit in accordance with Section 6.3.2 of these Regulations. Upon compliance with these Regulations, a permanent permit shall be issued to the operator as described in Section 6.3.1.17.6 Inspections 17.6.1 Inspection Frequency. 17.6.1.1 An inspection of an ice plant shall be performed at least once every twelve (12) months. Additional inspections of the ice plant shall be performed as often as necessary for the enforcement of these Regulations.17.7 Official Access. 17.7.1 Representatives of the regulatory authority, after proper identification, shall be permitted to enter any ice plant or gain access to product stored in vending machines at any reasonable time for the purpose of making inspections to determine compliance with these Regulations. These inspections may include any room, area or vehicle associated with the ice plant operation. In addition, the representatives shall be permitted to examine the records of any ice plant to obtain information pertaining to required water and ice product analysis, bulk ice product purchase receipts and supplies used. The Director, Division of Public Health, or his/her designee may, after providing the opportunity for a hearing, suspend for a period not to exceed ninety (90) days, the permit to operate an ice plant for refusing access to representatives of the regulatory authority.17.8 Inspection Report Form 17.8.1 A co-signed copy of the completed inspection report form adopted by the regulatory authority shall be furnished to the person in charge of the ice plant at the conclusion of the inspection. Inspectional remarks on the completed inspection form shall refer to the item(s) violated, give the time period for correcting the violation(s), and shall state the corrections to be made. The inspection report form shall summarize the requirements of these Regulations and shall set forth a weighted point value for each requirement.17.8.2 The post-construction/pre-permitting inspection report form shall be used to record the post-construction inspections of ice plants as specified in Section 17.9 below. This form shall contain the statement: "Items whose number and weight value are circled have not been completed." The Regulations Governing the Manufacture and Sale of Ice require that compliance with approved plans and specifications be obtained prior to a pre-opening inspection.17.8.3 The completed inspection report form is a public document that shall be made available for public disclosure to any person who requests it, in accordance with the Freedom of Information Act.17.9 Types of Inspections 17.9.1 Inspections of ice plants are performed for a wide range of purposes. All inspections shall be categorized by type, classified by purpose and shall include, but not be limited to, the following: 17.9.1.1 Regular Inspections. 17.9.1.1.1 Regular inspections are performed on a routine basis in permanent, operating, permitted facilities. These inspections shall address all items on the inspection report form. Items in violation shall be recorded by item number and the weighted point value given to that item. The rating score of the ice plant shall be the total of the weighted point values for all violations subtracted from 100.17.9.1.2 Follow-up Inspections. 17.9.1.2.1 Follow-up inspections shall be performed when a regular inspection score of less than 85 and greater than 69 is received, or when one or more 4 or 5-point weighted items are in violation. When the regular inspection score is 85 or above, the follow-up inspection shall address only items of "C" value or 4 or 5-point weighted items in violation. A rating score shall not be determined for these inspections. When the regular inspection score is less than 85, a complete inspection shall be performed and a follow-up rating score shall be determined.17.9.1.2.2 Follow-up inspections may also be performed after complaint and investigation inspections, or after administrative hearings. Rating scores may or may not be determined for these inspections.17.9.1.3 Complaint Inspections. 17.9.1.3.1 Complaint inspections are performed in response to formal or informal complaints against permitted facilities. A complete inspection may be performed by the regulatory authority in the interest of the public's health.17.9.1.4 Investigation Inspections. 17.9.1.4.1 Investigation inspections are performed on non-permitted ice plants for determining compliance with these Regulations.17.9.1.5 Other Inspections. 17.9.1.5.1 These inspections include post-construction, pre-operational and other inspections not included above. (See Sections 6.6 and 6.7 of the Regulations).17.10 Rating Score. 17.10.1 Rating scores of ice plants are kept on file by the regulatory authority and may be used to determine inspection frequencies. The receipt of any "C" value items, an overall rating score below 70 (excluding the presence of any critical violative items) during a regular inspection, a follow-up rating score below 85, or two successive regular inspection scores below 85, shall indicate the need for action by the regulatory authority as specified in Section 17.12 of these Regulations.17.11 Response to Violations 17.11.1 Official and/or operator response to citing of violative items shall be in accordance with the below stated procedures: 17.11.1.1 Closure Items (denoted "17.11.1.3"). When an inspection results in the finding of any violative items denoted "17.11.1.3", the permit shall be immediately suspended in accordance with Section 17.12.17.11.1.2 Critical Items (4 or 5-point weighted items) 17.11.1.2.1 When the rating score of an ice plant is determined to be 85 or above by regular inspection, all violations of 4 or 5-point weighted items shall be corrected, or written proof of intention to correct shall be provided as soon as possible, but in any event, within 48 hours following inspection.17.11.1.2.2 When the rating score of an ice plant is determined to be less than 70 by regular inspection, the permit shall be suspended in accordance with Section 17.13. All violations of 4 or 5-point weighted items shall be corrected or written proof of intention to correct prior to resuming operations.17.11.1.2.3 Follow-up inspections shall be conducted at reasonable time intervals to assure corrections are completed according to schedule.17.11.1.3 Non-critical Items (1 or 2-point weighted items). All 1 or 2-point weighted items shall be corrected as soon as possible, but in any event, by the time of the next regular inspection.17.12 Procedure for Administrative Action 17.12.1 Administrative action is required if any of the following conditions are found to exist: 17.12.1.1 The inspection discloses any immediate health hazards (described below) constituted by violation of any "17.11.1.3" value items; or17.12.1.2 the Director, Division of Public Health, or his/her designee determines that an imminent health hazard (described below) exist(s) in an ice plant which represents a threat to life; or17.12.1.3 there exists a serious risk of damage to health or safety of the public; or17.12.1.4 critical or repeat violations; or17.12.1.5 general insanitary conditions are found to exist.17.12.2 Immediate Health Hazard 17.12.2.1 An immediate health hazard shall include, but is not limited to, any one of the following: 17.12.2.1.1 An unapproved source of water for product (ice) manufacture;17.12.2.1.2 Source water or ice product fails to meet microbiological, chemical and physical standards for drinking water; or17.12.2.1.3 Cross-connections are found between potable and non-potable water systems.17.12.3 Imminent Health Hazard(s) 17.12.3.1 An imminent health hazard shall include, but is not limited to, any one of the following: 17.12.3.1.1 An ongoing outbreak of an infectious, pathogenic or toxic agent capable of being transmitted to consumers; or17.12.3.1.2 The absence of potable water, supplied under pressure, in quantities capable of meeting the needs of the facility; or17.12.3.1.3 A sewage backup into the facility or into equipment containing ice; or17.12.3.1.4 An infestation of vermin to the extent that ice or ice-contact surfaces cannot be protected from contamination; or17.12.3.1.5 Receipt of an overall rating score of less than 70 following an inspection by a representative of the regulatory authority.17.13 Suspension of Permit 17.13.1 If some condition(s) isre determined to exist in an ice plant which present(s) an imminent health hazard to the public, the Director, Division of Public Health, or his/her designee in the county in which the ice plant operates, may suspend the operating permit of the ice plant without a hearing or written notice for a period not to exceed ten (10) days. Further enforcement action shall be taken in accordance with Section 17.19.17.13.2 The suspension shall be effective upon receipt of written notice by the person in charge of the ice plant. A suspension statement recorded on the inspection report by the inspecting regulatory representative constitutes a written notice. The Director, Division of Public Health, or his/her designee, shall be notified of the suspension by the close of the following business day. Service of written notice of suspension by the Director, Division of Public Health, or his/her designee stating the reason(s) for the suspension shall be made by the close of the following business day. The person in charge shall be requested to yield the permit to the representative of the regulatory authority. The permit shall not be suspended for a period longer than ten (10) days without a hearing.17.14 Reinstatement of Permit 17.14.1 If a follow-up inspection by a representative of the regulatory authority shows that the immediate health hazard(s) or the imminent health hazard(s) no longer exist(s), the suspension shall be lifted immediately and the permit returned. If there is no evidence that the immediate health hazard(s) and/or the imminent health hazard(s) has/have been corrected by the end of the ten (10) day suspension, the Director, Division of Public Health, or his/her designee must schedule a hearing to determine if the suspension should be extended. Failure to hold a hearing within the ten (10) day period shall automatically terminate the suspension.17.14.2 The owner/operator of the ice plant may request, in writing, a hearing before the Director, Division of Public Health, or his/her designee at any time during the period of suspension, for the purpose of demonstrating that the immediate health hazard(s) and/or imminent health hazard(s) no longer exist(s). The request for hearing shall not stay the suspension.17.15 Administrative Hearings. 17.15.1 Whenever conditions in an ice plant warrant, the Director, Division of Public Health, or his/her designee shall schedule an administrative hearing to consider suspension or recommend revocation of a permit. The Director, Division of Public Health, or his/her designee shall neither suspend nor recommend revocation of a permit of an ice plant for serious or repeated violations, which do not present an imminent health hazard, without having first held a hearing to determine whether the permit should be suspended or revoked. The holder of the permit or the person in charge of the ice plant must be informed at least ten (10) days prior to the hearing, of the date, time, and place of the hearing and the specific charges against the ice plant. The notification of the hearing shall be sent by certified mail or by hand delivery. The Director, Division of Public Health, or his/her designee, after providing the opportunity for a hearing, may suspend for a period not to exceed ninety (90) days, or may recommend revocation of a permit to operate an ice plant for serious or repeated violations of any of the requirements of these Regulations.17.16 Records of Administrative Proceedings. 17.16.1 (Number needed) Written minutes shall be made of all hearing proceedings and shall become documents of record. A written report of the hearing decision shall be furnished to the Division of Public Health, the Bureau of Environmental Health and the owner/operator by the Director, Division of Public Health, or his/her designee within ten (10) days following the hearing.17.17 Right of Appeal to the Division of Public Health. 17.17.1 The owner/operator of the ice plant may appeal to the Secretary, Delaware Health and Social Services for reconsideration of the decision of the Director, Division of Public Health or his/her designee. In order to appeal for reconsideration, written notice of appeal must be received by the Secretary, Delaware Health and Social Services within forty-eight (48) hours after announcement of the decision of the Director, Division of Public Health, or his/her designee. The notice of appeal may be sent via certified mail or hand delivered to the Secretary, Delaware Health and Social Services. If a notice of appeal is timely filed, the decision of the Director, Division of Public Health or his/her designee in regard to ice plant suspension or revocation for serious or repeat violations, or for general insanitary conditions will be stayed until that decision is confirmed by the Secretary, Delaware Health and Social Services. If a notice of appeal is not filed within the required time period, the permit suspension or revocation recommendation shall be upheld and other enforcement action taken in accordance with Section 17.19. If the notice of appeal is timely filed, the Secretary, Delaware Health and Social Services shall hold a hearing at the next scheduled Division of Public Health meeting.17.18 Division of Public Health Action 17.18.1 The Secretary, Delaware Health and Social Services, at its next scheduled meeting, shall consider the Director, Division of Public Health recommendation for permit revocation or hear an appeal by the owner/operator whose permit to operate an ice plant stands suspended. The Division of Public Health shall, at each scheduled meeting, release the name(s) of those ice plants not meeting the following criteria: 17.18.1.1 Permit revoked; or17.18.1.2 Permit suspended due to imminent health hazard; or17.18.1.3 Permit suspended due to repeat violation(s) of critical items; or17.18.1.4 Operating without a valid ice plant permit.17.18.2 Variance 17.18.2.1 The Division of Public Health may, from time to time, grant written permission to vary from particular provisions of these Regulations when the extent of the variation is clearly specified and such variation is: 17.18.2.1.1 In conformance with the variance requirements of the State of Delaware Regulations Governing Public Drinking Water Systems;17.18.2.1.2 Necessary to obtain a beneficial use of an existing facility; and17.18.2.1.3 Appropriate alternative measures have been taken to protect the health and safety of the public and to assure that the purpose of the provisions from which the variation is sought will be observed.17.18.3 Written applications for such variances shall be filed with the Director, Division of Public Health. No such variance shall be effective until granted by the Division of Public Health.17.19 Agency Emergency Actions 17.19.1 Condemnation/Embargo. 17.19.1.1 (Number needed) Ice and/or water may be sampled by the regulatory authority as often as necessary for enforcement of these Regulations. All product water and ice shall meet the quality standards set forth in quality standards of these Regulations. Ice failing to meet the quality standards shall not be kept on the premises. The established administrative procedures for the implementation and enforcement of the provisions of 16Del.C.,Ch. 33 (Volume 63, Chapter 148, Laws of Delaware), relating to the embargo of misbranded or adulterated food and penalties shall be applicable to this section.17.19.2 Procedure When Infection is Suspected 17.19.2.1 When the regulatory authority has reasonable cause to suspect possible disease transmission by an ice plant or an employee thereof, it may conduct an epidemiological investigation which can indicate morbidity histories of suspected employees or make any other investigations as indicated and shall take appropriate action. The regulatory authority may require any or all of the following: 17.19.2.1.1 The immediate exclusion of an employee from the ice plant;17.19.2.1.2 The immediate closing of the ice plant until, in the opinion of the regulatory authority, no further danger of disease outbreak exists;17.19.2.1.3 Restriction of an employee(s) services to some area of the ice plant where there is no danger of transmitting disease;17.19.2.1.4 Adequate medical and laboratory examination of the employee and of other employees and of his and their body discharges;17.19.2.1.5 Any other action deemed necessary and feasible by the Director, Division of Public Health or his/her designee or the State Epidemiologist to protect the health of the public and other employees of the ice plant.17.20 Recall Plan 17.20.1 The ice plant management must: 17.20.1.1 Prepare and maintain a current written contingency plan for use in initiating and affecting a recall;17.20.1.2 Use sufficient coding of regulated products to make possible positive identification and to facilitate effective recall of all violative lots; and17.20.1.3 Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the expected use of the product and is at least the length of time specified in other applicable regulations governing records retention.17.21 Penalties 17.21.1 Any person (or responsible officer of that person) who violates a provision of these Regulations and any responsible person (or responsible officer to that person) who is the holder of a permit or who otherwise operates an ice plant that does not comply with the requirements of these Regulations shall be subject to the provisions of 16Del.C.§ 107.17.21.2 The regulatory authority may seek to enjoin violations of these Regulations.17.21.3 A conspicuous, colored placard shall be prominently displayed at all entrances to ice plants meeting the following requirements: 17.21.3.1 Failure to obtain a valid permit; or17.21.3.2 whose permit stands suspended; or17.21.3.3 whose permit stands revoked.16 Del. Admin. Code § 4457-17.0
15 DE Reg. 527 (10/01/11)