HAR §11-50-13. Variances

(a) variance by modifying or waiving chapter if in the opinion of the or nuisance will not result from 50-42 The department may grant a the requirements of this director a health hazard the variance. If a §11-50-13 variance is granted, the department shall retain the information specified in subsection (b) in its records for the food establishment. (b) 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 department's file on the food establishment includes: (1) A statement of the proposed variance of the chapter requirement citing relevant chapter section numbers; (2) 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 (3) A HACCP plan if required as specified in section 11-50-4(h) (1) that includes the information specified in section ll-50-4(h) (2) as it is relevant to the variance requested. (c) Every application for a variance shall be made on forms furnished by the department. (1) The department shall not act upon or consider any incomplete application for variance. An application shall be deemed complete only when all required and requested information, including the application form, plans, specifications, applicable fees, and other information have been timely submitted; (2) Every application shall be signed by the applicant and shall constitute an acknowledgment and agreement that the applicant will comply with all the terms and conditions of the variance and this chapter; (3) The department may require the submission of additional information, including challenge studies if applicable, after the application has been submitted, and may ensure that, if an application is incomplete or otherwise deficient, processing of the application shall not be completed until such time as the applicant has supplied all required information or otherwise corrected the deficiency. If the variance application requires a challenge study for pathogen inactivation or growth inhibition to determine if a food requires time/temperature control for safety, the study shall follow the guideline entitled "Parameters for Determining 50-43 §11-50-13 Inoculated Pack/Challenge Study Protocols" by the National Advisory Committee on Microbiological Criteria for Foods, adopted 20 March 2009, Washington D.C.; (4) The failure of the department to act on a completed application within thirty days of the receipt of such application shall be deemed an approval of such application provided that the applicant acts consistently with the application process and has submitted all required or requested information. (d) Any approved variance shall be granted for time periods and under conditions consistent with this chapter and within the following limitations: (1) The department may issue a variance for a period not exceeding two years; (2) The department may revoke the variance at any time if the variance becomes a threat to public health and safety. (e) Variance renewal. Any variance granted pursuant to this section may be renewed for periods not exceeding two years provided that: (1) All of the conditions specified in the immediately preceding variance are complied with; (2) Current food safety concerns and concerns addressed in the immediately preceding variance are addressed; (3) A renewal application is submitted at least one hundred eighty days prior to expiration of the preceding variance; and (4) A variance renewal fee of $200 is paid to the department. (f) The department shall afford a hearing in accordance with chapter 91, HRS, in relation to an application for the denial of a variance. (g) No variance shall be construed to prevent or limit the application of any emergency provisions and procedures provided by law. (h) A non-refundable application processing fee of $200 shall be made payable to the department for all new and renewal variance applications. (i) If the department grants a variance as specified in subsection (a), or a HACCP plan is otherwise required as specified in section ll-50-4(h) the owner or operator shall: 50-44 §11-50-15 (1) Maintain the approved variance at the food establishment; (2) Comply with the HACCP plans and procedures that are submitted as specified in section 11-50- 4 (h) (2) and approved as a basis for the modification or waiver; (3) Maintain and provide to the department, upon request, records specified in section 11-50- 4 (h) (2) (C) and (D) (iii) that demonstrate that the following are routinely employed: (A) Procedures for monitoring the critical control points; (B) Monitoring of the critical control points; (C) Verification of the effectiveness of the operation or process; (D) Necessary corrective actions if there is failure at a critical control point; and (4) Provide any additional information and analyses deemed necessary by the department to eliminate or control public health hazards or nuisance. [Eff 2/24/2014; am and comp AUG 2 4 2025 l (Auth: HRS §321-11) (Imp: HRS §321-11)