Compliance And Enforcement

(1) Applicability. (a) Public Health Protection. In enforcing the provisions of this chapter, the commissioner shall assess existing facilities or equipment that were in use before the effective date of this chapter based on the following considerations: 1. Whether the facilities or equipment are in good repair and capable of being maintained in a sanitary condition; 2. Whether food-contact surfaces comply with 0080-04-09-.04(1)(a); 3. Whether the capacities of cooling, heating, and holding equipment are sufficient to comply with 0080-04-09-.04(3)(a)1.; and 4. The existence of a documented agreement with the permit holder that the facilities or equipment will be replaced as specified under 0080-04-09-.08(3)(i)6. (b) Preventing Health Hazards, Provision for Conditions Not Addressed. 1. If necessary to protect against public health hazards or nuisances, the commissioner may impose specific requirements in addition to the requirements contained in this chapter that are authorized by law. 2. The commissioner shall document the conditions that necessitate the imposition of additional requirements and the underlying public health rationale. The documentation shall be provided to the permit applicant or permit holder and a copy shall be maintained in the commissioner’s file for the food establishment. (c) Variances. 1. Modifications and Waivers. The commissioner may grant a variance by modifying or waiving the requirements of this chapter if in the opinion of the commissioner a health hazard or nuisance will not result from the variance. If a variance is granted, the commissioner shall retain the information specified under part 2. of this subparagraph in its records for the food establishment. Variance requests shall be submitted to a committee including a food scientist and representatives from industry and state and local public health agencies appointed by the department. 2. Documentation of Proposed Variance and Justification. Before a variance from a requirement of this chapter is approved, the information that shall be provided by the person requesting the variance and retained in the commissioner’s file on the food establishment includes: (i) A statement of the proposed variance of the chapter requirement citing relevant chapter section numbers; (ii) An analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant chapter sections will be alternatively addressed by the proposal; and RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 (iii) A HACCP plan if required as specified under 0080-04-09-.08(2)(c) that includes the information specified under 0080-04-09-.08(2)(d) as it is relevant to the variance requested. 3. Conformance with Approved Procedures. If the commissioner grants a variance as specified in 0080-04-09-.08(1)(c), or a HACCP plan is otherwise required as specified under 0080-04-09-.08(2)(c), the permit holder shall: (i) Comply with the HACCP plans and procedures that are submitted as specified under 0080-04-09-.08(2)(d) and approved as a basis for the modification or waiver; (P) and (ii) Maintain and provide to the commissioner, upon request, records specified under 0080-04-09-.08(2)(d)4. and 5. that demonstrate that the following are routinely employed; (I) Procedures for monitoring the critical control points, (II) Monitoring of the critical control points, (III) Verification of the effectiveness of the operation or process, and (IV) Necessary corrective actions if there is failure at a critical control point. (2) Plan Submission and Approval. (a) When Plans Are Required. Plans drawn to scale for food establishments shall be submitted for review and approval to the department. A permit applicant or permit holder shall submit to the commissioner properly prepared plans and specifications for review and approval before: 1. The construction of a food establishment; 2. The conversion of an existing structure for use as a food establishment; or 3. The remodeling of a food establishment or a change of type of food establishment or food operation as specified under 0080-04-09-.08(3)(e)3. if the commissioner determines that plans and specifications are necessary to ensure compliance with this chapter. (b) Contents of the Plans and Specifications. The plans and specifications for a food establishment, including a food establishment specified under 0080-04-09-.08(2)(c), shall include, as required by the commissioner based on the type of operation, type of food preparation, and foods prepared, the following information to demonstrate conformance with chapter provisions: 1. Intended menu and plans to be reviewed; 2. Anticipated volume of food to be stored, prepared, and sold or served; 3. Proposed layout, mechanical schematics, construction materials, and finish schedules; RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 4. Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities, and installation specifications; 5. Evidence that standard procedures that ensure compliance with the requirements of this chapter are developed or are being developed; and 6. Other information that may be required by the commissioner for the proper review of the proposed construction, conversion or modification, and procedures for operating a food establishment. (c) When a HACCP Plan is Required. 1. Before engaging in an activity that requires a HACCP plan, a permit applicant or permit holder shall submit to the commissioner for approval a properly prepared HACCP plan as specified under 0080-04-09-.08(2)(d) and the relevant provisions of this chapter if: (i) Submission of a HACCP plan is required according to law; (ii) A variance is required as specified under 0080-04-09-.03(4)(a)1.(iv)(IV), 0080-04-09-.03(5)(b)1., or 0080-04-09-.04(2)(d)8.(ii); (iii) The commissioner determines that a food preparation or processing method requires a variance based on a plan submittal specified under 0080-04-09-.08(2)(b), an inspectional finding, or a variance request. 2. A permit applicant or permit holder shall have a properly prepared HACCP plan as specified under 0080-04-09-.03(5)(b)2. (d) Contents of a HACCP Plan. For a food establishment that is required under 0080-04- 09-.08(2)(c) to have a HACCP plan, the plan and specifications shall indicate: 1. A categorization of the types of time/temperature control for safety foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the commissioner; 2. A flow diagram by specific or category type identifying critical control points and providing information on the following: (i) Ingredients, materials, and equipment used in the preparation of that food, and (ii) Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved; 3. Food employee and supervisory training plan that addresses the food safety issues of concern; 4. A statement of standard operating procedures for the plan under consideration including clearly identifying: (i) Each critical control point, (ii) The critical limits for each critical control point, RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 (iii) The method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge, (iv) The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points, (v) Action to be taken by the person in charge if the critical limits for each critical control point are not met, and (vi) Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed; and 5. Additional scientific data or other information, as required by the commissioner, supporting the determination that food safety is not compromised by the proposal. (e) Preoperational Inspections. The commissioner may conduct one or more preoperational inspections to verify that the food establishment is constructed and equipped in accordance with the approved plans and approved modifications of those plans, has established standard operating procedures as specified under 0080-04-09- .08(2)(b)5., and is in compliance with law and this chapter. (3) Permit to Operate. (a) Prerequisite for Operation. A person shall not operate a food establishment without a valid permit to operate issued by the commissioner. (b) Submission 30 Calendar Days Before Proposed Opening. An applicant shall submit an application for a permit at least 30 calendar days before the date planned for opening a food establishment or the expiration date of the current permit for an existing facility. An applicant for licensure under this chapter shall remit its application and annual license fee to the department on or before July 1 of each year. All licenses issued under this chapter shall expire on June 30 following their issuance. If an applicant for renewal fails to remit payment of the license fee on or before July 16 of the licensure year for which renewal is sought, the applicant shall also be required to pay a late charge assessed under T.C.A. § 43-1-703 prior to renewal of the applicant’s license. (c) Form of Submission. A person desiring to operate a food establishment shall submit to the commissioner a written application for a permit on a form provided by the commissioner, which shall be completed in full. The department may deny any application for licensure that is not completed in accordance with this rule. (d) To qualify for a permit, an applicant shall: 1. Be an owner of the food establishment or an officer of the legal ownership; 2. Comply with the requirements of this chapter; 3. As specified under 0080-04-09-.08(4)(b)1., agree to allow access to the food establishment and to provide required information; and 4. Include with their application payment of an annual license fee as appropriate for the following categories of licenses. Food establishment license fees are determined in accordance with the degree of risk the establishment poses for outbreak of food borne illness. This determination is made by the department RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 based on the nature of the establishment’s operations. Fees designated under this rule shall be assessed as follows and in accordance with T.C.A. § 43-1- 703(f) as it may be amended from time to time: (i) Food Establishment License, Risk Level 1: Tier 7 license fee; (ii) Food Establishment License, Risk Level 2: Tier 4 license fee; (iii) Food Establishment License, Risk Level 3: Tier 2 license fee. (e) Contents of the Application. The application shall include: 1. Name of the applicant; 2. Proof of the applicant’s registration in its state of incorporation, registration with the Tennessee Department of Revenue, or business license issued by a local governmental authority; 3. Contact information for applicant, to include name of person legally responsible for applicant’s operations, telephone number, email address, address of the principal place of business, and address of the establishment to be licensed; 4. Name and address of applicant’s registered agent for service of process, if any; 5. A statement specifying whether the food establishment: (i) Is mobile or stationary and temporary or permanent, and (ii) Is an operation that includes one or more of the following: (I) Prepares, offers for sale, or serves time/temperature control for safety food: I. Only to order upon a consumer’s request, II. In advance in quantities based on projected consumer demand and discards food that is not sold or served at an approved frequency, or III. Using time as the public health control as specified under 0080-04-09-.03(5)(a)9., (II) Prepares time/temperature control for safety food in advance using a food preparation method that involves two or more steps, which may include combining time/temperature control for safety food ingredients; cooking; cooling; reheating; hot or cold holding; freezing; or thawing, (III) Prepares food as specified under item 5.(ii)(II) of this subparagraph for delivery to and consumption at a location off the premises of the food establishment where it is prepared, (IV) Prepares only food that is not time/temperature control for safety food, or RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 (V) Does not prepare, but offers for sale only prepackaged food that is not time/temperature control for safety food; 6. A statement signed by the applicant that attests to the accuracy of the information provided in the application; 7. Licensees shall notify the department in writing of any changes to the information or contents of an application within 30 days after the change takes place; 8. Other information required by the commissioner. (f) New, Converted, or Remodeled Establishments. For food establishments that are required to submit plans as specified under 0080-04-09-.08(2)(a), the commissioner shall issue a permit to the applicant after: 1. A properly completed application is submitted; 2. The required fee is submitted; 3. The required plans, specifications, and information are reviewed and approved; and 4. A preoperational inspection as specified in 0080-04-09-.08(2)(e) shows that the establishment is built or remodeled in accordance with the approved plans and specifications and that the establishment is in compliance with this chapter. (g) Existing Establishments and Change of Ownership. As applicable, the commissioner may issue a permit to a new owner of an existing food establishment after an application is submitted, reviewed, and approved, and an inspection shows that the establishment is in compliance with this chapter. Persons licensed under this chapter shall be responsible for permitted facilities until: the applicable license expires, the department receives written notification from the licensee of a change in ownership for the licensed establishment, or the department receives written notification from the licensee desiring to terminate the license. The department shall not refund license fees for early termination of any license under this chapter. (h) Responsibilities of the Permit Holder. Upon acceptance of the permit issued by the commissioner, the permit holder in order to retain the permit shall: 1. Comply with the provisions of this chapter including the conditions of a granted variance as specified under 0080-04-09-.08(1)(c)3., and approved plans as specified under 0080-04-09-.08(2)(b); 2. If a food establishment is required under 0080-04-09-.08(2)(c) to operate under a HACCP plan, comply with the plan as specified under 0080-04-09-.08(1)(c)3.; 3. Immediately contact the commissioner to report an illness of a food employee or conditional employee as specified under 0080-04-09-.02(2)(a)2.; 4. Immediately discontinue operations and notify the commissioner if an imminent health hazard may exist as specified under 0080-04-09-.08(4)(d)1.; 5. Allow representatives of the commissioner access to the food establishment as specified under 0080-04-09-.08(4)(b)1.; RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 6. Replace existing facilities and equipment specified in 0080-04-09-.08(1)(a) with facilities and equipment that comply with this chapter if: (i) The commissioner directs the replacement because the facilities and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the facilities and equipment were accepted, (ii) The commissioner directs the replacement of the facilities and equipment because of a change of ownership, or (iii) The facilities and equipment are replaced in the normal course of operation; 7. Comply with directives of the commissioner including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives issued by the commissioner in regard to the permit holder’s food establishment or in response to community emergencies; 8. Accept notices issued and served by the commissioner according to law; and 9. Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with this chapter or a directive of the commissioner, including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives. (4) Inspection and Correction of Violations. (a) Frequency. 1. Establishing Inspection Interval. Except as specified in parts 2. and 3. of this subparagraph, the commissioner may inspect a food establishment at least once every six months. 2. The commissioner may increase the interval between inspections beyond six months if: (i) The food establishment is fully operating under an approved and validated HACCP plan as specified under 0080-04-09-.08(2)(d) and 0080-04-09- .08(1)(c)3.(i) and (ii); (ii) The food establishment is assigned a less frequent inspection frequency based on a written risk-based inspection schedule that is being uniformly applied throughout the jurisdiction and at least once every six months the establishment is contacted by telephone or other means by the commissioner to ensure that the establishment manager and the nature of food operation are not changed, or (iii) The establishment’s operation involves only coffee service and other unpackaged or prepackaged food that is not time/temperature control for safety food such as carbonated beverages and snack food such as chips, nuts, popcorn, and pretzels. 3. The commissioner may periodically inspect throughout its permit period a temporary food establishment that prepares, sells, or services unpackaged time/temperature control for safety food and that: RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 (i) Has improvised rather than permanent facilities or equipment for accomplishing functions such as handwashing, food preparation and protection, food temperature control, warewashing, providing drinking water, waste retention and disposal, and insect and rodent control; or (ii) Has inexperienced food employees. 4. Performance and Risk-Based. Within the parameters specified in subparagraph (a) of this paragraph, the commissioner shall prioritize and conduct more frequent inspections based upon its assessment of a food establishment’s history of compliance with this chapter and the establishment’s potential as a vector of foodborne illness by evaluating: (i) Past performance, for nonconformance with this chapter or HACCP plan requirements that are priority items or priority foundation items; (ii) Past performance, for numerous or repeat violations of this chapter or HACCP plan requirements that are core items; (iii) Past performance, for complaints investigated and found to be valid; (iv) The hazards associated with the particular foods that are prepared, stored, or served; (v) The type of operation including the methods and extent of food storage, preparation, and service; (vi) The number of people served; and (vii) Whether the population served is a highly susceptible population. (b) Access. 1. Allowed at Reasonable Times after Due Notice. After the commissioner presents official credentials and provides notice of the purpose of, and an intent to conduct, an inspection, the person in charge shall allow the commissioner to determine if the food establishment is in compliance with this chapter by allowing access to the establishment, allowing inspection, and providing information and records specified in this chapter and to which the commissioner is entitled according to law, during the food establishment’s hours of operation and other reasonable times. 2. Refusal, Notification of Right to Access, and Final Request for Access. If a person denies access to the commissioner, the commissioner shall inform the person that: (i) The permit holder shall allow access to the commissioner as specified under 0080-04-09-.08(4)(b)1.; (ii) Access is a condition of the acceptance and retention of a food establishment permit to operate as specified under 0080-04-09-.08(3)(i)5.; (iii) If access is denied, an administrative warrant may be obtained according to law; and RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 (iv) A final request for access will be made. 3. Refusal, Reporting. If after the commissioner presents credentials and provides notice as specified under 0080-04-09-.08(4)(c)1., explains the authority upon which access is requested, and makes a final request for access as specified in 0080-04-09-.08(4)(b)2., the person in charge continues to refuse access, the commissioner shall provide details of the denial of access on an inspection report form. (c) Report of Findings. 1. Documenting Information and Observations. The commissionershall document on an inspection report form: (i) Administrative information about the food establishment’s legal identity, street and mailing addresses, type of establishment and operation as specified under 0080-04-09-.08(3)(e)3., inspection date, and other information such as type of water supply and sewage disposal, status of the permit, and personnel certificates that may be required; and (ii) Specific factual observations of violative conditions or other deviations from this chapter that require correction by the permit holder including: (I) Failure of the person in charge to demonstrate the knowledge of foodborne illness prevention, application of HACCP principles, and the requirements of this chapter as specified under 0080-04-09- .02(1)(b), (II) Failure of food employees, conditional employees, and the person in charge to report a disease or medical condition as specified under 0080-04-09-.02(2)(a)2. and 4., (III) Nonconformance with priority items or priority foundation items of this chapter, (IV) Failure of the appropriate food employees to demonstrate their knowledge of, and ability to perform in accordance with, the procedural, monitoring, verification, and corrective action practices required by the commissioner as specified under 0080-04-09- .08(1)(c)3., (V) Failure of the person in charge to provide records required by the commissioner for determining conformance with a HACCP plan as specified under 0080-04-09-.08(2)(d)4.(vi), and (VI) Nonconformance with critical limits of a HACCP plan. 2. Specifying Time Frame for Corrections. The commissioner shall specify on the inspection report form the time frame for correction of the violations as specified under 0080-04-09-.08(4)(d) and 0080-04-09-.08(4)(e)1. 3. Issuing Report and Obtaining Acknowledgment of Receipt. At the conclusion of the inspection and according to law, the commissioner shall provide a copy of the completed inspection report and the notice to correct violations to the permit holder or to the person in charge, and request a signed acknowledgment of receipt. RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 4. Refusal to Sign Acknowledgment. The commissioner shall: (i) Inform a person who declines to sign an acknowledgment of receipt of inspectional findings as specified in 0080-04-09-.08(4)(c)3. that: (I) An acknowledgment of receipt is not an agreement with findings, (II) Refusal to sign an acknowledgment of receipt will not affect the permit holder’s obligation to correct the violations noted in the inspection report within the time frames specified, and (III) A refusal to sign an acknowledgment of receipt is noted in the inspection report and conveyed to the commissioner’s historical record for the food establishment; and (ii) Make a final request that the person in charge sign an acknowledgment receipt of inspectional findings. (d) Imminent Health Hazard. 1. Ceasing Operations and Reporting. (i) Except as specified in subpart (ii) of this part, a permit holder shall immediately discontinue operations and notify the regulatory authority if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross insanitary occurrence or condition, or other circumstance that may endanger public health. (ii) A permit holder need not discontinue operations in an area of an establishment that is unaffected by the imminent health hazard. 2. Resumption of Operations. If operations are discontinued as specified under part (d)1. of this paragraph or otherwise according to law, the permit holder shall obtain approval from the commissioner before resuming operations. (e) Violation of Priority Item or Priority Foundation Item. 1. Timely Correction. (i) Except as specified in subpart (ii) of this part, a permit holder shall at the time of inspection correct a violation of a priority item or priority foundation item of this chapter and implement corrective actions for a HACCP plan provision that is not in compliance with its critical limit. (ii) Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the commissioner may agree to or specify a longer time frame, not to exceed 10 calendar days after the inspection, for the permit holder to correct violations of a priority item or priority foundation item or HACCP plan deviations. 2. Verification and Documentation of Correction. RETAIL FOOD STORE SANITATION CHAPTER 0080-04-09 (i) After observing at the time of inspection a correction of a violation of a priority item or priority foundation item or a HACCP plan deviation, the commissioner shall enter the violation and information about the corrective action on the inspection report. (ii) As specified under 0080-04-09-.08(4)(e)1.(ii), after receiving notification that the permit holder has corrected a violation of a priority item or priority foundation item or HACCP plan deviation, or at the end of the specified period of time, the commissioner may verify correction of the violation. (f) Core Violation. 1. Except as specified in part 2. of this subparagraph, the permit holder shall correct core items by a date and time agreed to or specified by the commissioner but no later than 90 calendar days after the inspection. 2. The commissioner may approve a compliance schedule that extends beyond the time limits specified under part 1. of this subparagraph if a written schedule of compliance is submitted by the permit holder and no health hazard exists or will result from allowing an extended schedule for compliance.