(1) A Retail Food Establishment shall obtain a special process approval from the Department before the following:
    (a) Smoking food as a method of food preservation rather than as a method of flavor enhancement;
    (b) Curing food;
    (c) Using food additives or adding components such as vinegar as a method of food preservation rather than as a method of flavor enhancement or to render a food so that it is not time/temperature control of safety food;
    (d) Packaging TCS foods using a reduced oxygen packaging method except where the growth of toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under 3-502.12 of the FDA Food Code;
    (e) Operating a molluscan shellfish life-support system display tank used to store or display shellfish that are offered for human consumption;
    (f) Custom processing animals that are for personal use as food and not for sale or service in a Food Establishment;
    (g) Sprouting seeds or beans; or
    (h) Preparing food by methods other than those specified in this rule chapter.
    (2) The Department shall not issue a special process approval until the Department receives from the Retail Food Establishment the following:
    (a) A complete Application for Special Process Approval For Retail Food Establishments, FDACS-14095 (Rev. 7/19), submitted either online at foodinspection@fdacs.gov or by mail as indicated on the form. This application is incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-11717;
    (b) A statement citing the relevant FDA Food Code section numbers pertaining to the special process approval request;
    (c) Procedures that address potential public health hazards and nuisances as required by applicable sections of the FDA Food Code incorporated by reference in Fl. Admin. Code R. 5K-4.002; and
    (d) A Hazard Analysis and Critical Control Point (HACCP) plan if required as specified under Sections 3-401.11(D)(4), 3-502.11, or 4-204.110(B) of the 2017 FDA Food Code that includes the information specified under 8-201.14 as it is relevant to the special process approval requested.
    (e) Scientific documentation supporting the determination that food safety is not compromised by the proposal shall be submitted for the processes outlined in paragraphs 5K-4.0050(1)(a)-(h), F.A.C.
    (3) If a special process approval application is granted by the Department, or a HACCP plan is otherwise required as specified under 8-201.13 of the FDA Food Code, the Food Establishment shall:
    (a) Comply with the HACCP Plans and procedures that are submitted as specified under 8-201.14 and approved as a basis for the special process approval; and
    (b) Maintain and provide to the Department upon request, records specified under 8-201.14 (D) of the FDA Food Code that demonstrate that the following are routinely employed;
    1. Procedures for monitoring the critical control points,
    2. Monitoring of the critical control points,
    3. Verification of the effectiveness of the operation or process, and
    4. Necessary corrective actions if there is failure at a critical control point.
    (c) Maintain a copy of the special process approval, and all associated documents required in this rule.
    (d) Special process approvals are granted by the Department only for one Food Establishment location and are not transferable to new owners or new locations. Once granted, a special process approval does not expire as long as the applicant holds a valid food permit. A separate application is required for each process the Food Establishment intend to implement.
    (e) The Department may suspend or revoke a special process approval if the Food Establishment fails to comply with the conditions specified in this rule.
Rulemaking Authority 500.09, 570.07(23) FS. Law Implemented 500.09, 500.10, 500.11, 500.13, 500.169 FS. History-New 3-16-20.