Canadian Aviation Regulations — 700.225
700.225 (1) The air operator shall ensure that a safety case is established in respect of a flight subject to an exemption referred to in section 700.200 to demonstrate that the variance described in the notice of intent does not increase the level of fatigue or decrease the level of alertness of the flight crew members. (2) The safety case shall consist of (a) a description of the flight in respect of which an exemption set out in section 700.200 applies; (b) the provisions of these Regulations from which the air operator and flight crew members are exempt; (c) a description of the manner in which the flight is conducted results in a variance from the requirements of the provisions referred to in paragraph (b); (d) the data collection methodology and data used initially to establish, in respect of the flight, the baseline levels of fatigue and alertness of the flight crew members and to identify fatigue-related hazards and risks; (e) the data collection methods used to evaluate the safety case on an ongoing basis; (f) the scientific studies used to demonstrate that the variance referred to in paragraph (c) is not likely to have an adverse effect on the flight crew members’ levels of fatigue and alertness; (g) an analysis of the effect of the variance on the levels of fatigue and alertness of flight crew members that takes into account the flight crew members’ schedule before and after the flight in respect of which the exemption applies and the findings of the fatigue risk assessment; (h) the fatigue risk controls that are implemented to address the findings of the risk assessment; (i) procedures to measure the effect of the variance on the levels of fatigue and alertness of the flight crew members; (j) the preventive measures or corrective actions that are taken to remedy any adverse effect of the variance on the levels of fatigue and alertness of the flight crew members; and (k) the means that will be used to monitor the effectiveness of the fatigue risk management system in managing the safety case. (3) A safety case is validated when the following conditions are met: (a) fatigue and alertness data have been collected during a period of not less than one year and not more than two years starting on the day on which the flight is first conducted under an exemption referred to in section 700.200 , for not less than 20 consecutive flights identified in the notice of intent, and the data shows that not more than 5% of those flights have an adverse effect of more than 5% on the baseline levels of fatigue and alertness of the flight crew members determined by means of the methodology described in paragraph (2)(d); (b) the fatigue risk assessment has been conducted and the findings of the assessment have been analyzed; (c) mitigation measures have been implemented to manage the hazards and risks related to the variance to remedy increases in the level of fatigue and decreases in the level of alertness of flight crew members; (d) the mitigation measures have been monitored to determine their effect on the flight crew members’ levels of fatigue and alertness; (e) corrective actions have been taken if the mitigation measures monitored under paragraph (d) do not achieve the desired effect on the flight crew members’ levels of fatigue and alertness; and (f) the effectiveness of the mitigation measures and, if applicable, the corrective actions in maintaining the established levels of fatigue and alertness of the flight crew members is shown. SOR/2018-269, s. 13