Idaho Administrative Code
Title IDAPA 02 - Agriculture, Department of
Rule 02.05.01 - RULES GOVERNING PRODUCE SAFETY
Section 02.05.01.012 - VARIANCE
Universal Citation: ID Admin Code 02.05.01.012
Current through August 31, 2023
01. Procedure for Seeking a Variance. Under the Produce Safety Rule, only a State, tribe, or a foreign country may request a variance from the Produce Safety Rule's requirements by submitting a petition to the FDA in accordance with Subpart P of the Produce Safety Rule and with 21 CFR 10.30. Pursuant to 22-5404, Idaho Code, the Idaho Legislature designated the Department to administer the Produce Safety Rule, which includes the authority to decide whether to submit petitions to the FDA. The Department will submit a petition to the FDA if the following procedures are followed: (3-31-22)
a. The
petitioner must prepare the petition in accordance with the requirements of
Subpart P of the Produce Safety Rule and
21 CFR
10.30. Additionally, the petitioner must
attach all required documentation and any other supporting documentation. 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 to the Department at the mailing address above or hand delivered to the
Department at the physical address above. (3-31-22)
b. Within thirty (30) days of receiving a
petition, the Department will complete a review of a petition to determine
whether it meets the requirements of Subpart P of the Produce Safety Rule and
21 CFR
10.30. (3-31-22)
i. If, after reviewing the petition, the
Department determines that the petition meets the requirements of Subpart P of
the Produce Safety Rule and 21 CFR 10.30, the Department will
submit the petition to the FDA within ten (10) days of that determination.
(3-31-22)
ii. If, after reviewing
the petition, the Department determines that the petition does not meet the
requirements of Subpart P of the Produce Safety Rule and
21 CFR
10.30, 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.
Within thirty (30) days, the Department will complete an additional review of
the petition to determine if the petition meets the requirements of Subpart P
of the Produce Safety Rule and
21 CFR
10.30. (3-31-22)
iii. If, after reviewing the petition, the
Department determines that the petition meets the requirements of Subpart P of
the Produce Safety Rule and 21 CFR 10.30, the Department will
submit the petition to the FDA within ten (10) days of that determination. If,
after reviewing the petition, the Department determines that the petition still
does not meet the requirements of Subpart P of the Produce Safety Rule and
21 CFR
10.30, the Department will follow the
procedure in Subparagraph 012.01.b.ii. (3-31-22)
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)
Disclaimer: These regulations may not be the most recent version. Idaho may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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