(a) Before engaging in an activity that requires a HACCP plan. an establishment operator shall submit to the department, for review, a properly prepared HACCP plan as specified under section 271-9.6 of this Subpart and the relevant provisions of this Part if:

1. (1) submission of a HACCP plan is required according to law;
2. (2) a variance is required as specified under sections 271-2.23 and 271-2.24 of this Part; or
3. (3) the department determines that a food preparation or processing method requires a variance based on a plan submittal or an inspectional finding.