IDAPA 02.05.01.012
Variance
01. Submission of Variance. The petitioner must submit the petition and all attached documents to the Department via the Department’s food safety email at fsma@isda.idaho.gov or mailed or hand delivered to the Department. (7-1-25) a. Within thirty (30) days of receiving a petition, the Department will complete a review of a petition. If the Department determines the petition meets all relevant requirements, the Department will submit the petition to the FDA within ten (10) days of that determination. (7-1-25) b. If the Department determines that the initial petition or any subsequent version is deficient, the Department will notify the petitioner and return the petition for correction. After correcting the deficiencies, the petitioner must resubmit the petition to the Department for evaluation pursuant to subsection 2 of this section. (7-1-25) 02. Support and Withdrawal of Petitions. (3-31-22) a. When the Department submits a petition to the FDA, the petitioner who prepared the petition, or an individual, business, group, association, or entity that supports the petition, shall assist the Department in responding to inquiries or directions from the FDA regarding the petition. If neither the petitioner nor an individual, business, group, association, or entity that supports the petition provides this assistance to the Department within thirty (30) days, the Department may withdraw the petition. (3-31-22) b. If the FDA takes action to modify or revoke a variance previously granted to the Department, the Department may waive the opportunity for a hearing unless a petitioner or an interested person adequately supports the Department in defending the variance in whole or in part from modification or revocation by FDA. (3-31-22) 013. – 999. (RESERVED)