Section R. 285.569.15 - Documentation of proposed variance and justificationRule 15. Before a variance from these rules is approved by the director of the department, the information that is provided by the person requesting the variance shall include all of the following:
(a) A statement of the proposed variance from the rule requirements that cites the relevant rule numbers.(b) An analysis of the rationale for how the potential public health hazards addressed by the relevant rule will be alternatively addressed by the proposal. If not included in the analysis, the director may require, but shall not be limited to requiring, any of the following:(i) A letter from a process authority.(ii) Copies of relevant articles from scientific journals.(iii) Studies obtained or performed consisting of not less than 3 processing runs showing that under the requested parameters the desired result is reliably achieved.(iv) Laboratory analyses that demonstrate both of the following:(A) For Clostridium botulinum, zero toxin production in the fish product through a time period beyond the shelf life of the product of not less than 1/3 of the shelf life, demonstrated through inoculated pack studies under normal and moderate abuse conditions.(B) No detectable Listeria monocytogenes in the final fish product.(v) Actual federal, state, or local government regulations or advisories.(c) A HACCP plan that includes the information specified in R 285.569.17 as it is relevant to the variance requested.(d) If the person is a processor outside this state, verification of inspection or licensing by a regulatory agency as an approved source of smoked fish.Mich. Admin. Code R. 285.569.15