1. (a) A person may not conduct an activity described in 18 AAC 34.005(b) unless the person has been issued a permit or provisional permit in accordance with this section.

2. (b) Except as described in (c) of this section, to apply for a permit, a person shall submit to the department a complete application that demonstrates compliance with this chapter and includes

   1. (1) an application form provided by the department;
   2. (2) each applicable fee required by 18 AAC 34.900;
   3. (3) a site plan that accurately depicts the location of all processing and storage buildings, roads, alleys, docks, and other areas that are part of the facility and that will be used to support the processing, storage, or transportation of seafood products;

   4. (4) a facility floor plan that accurately depicts the location or placement of

      1. (A) processing equipment; and
      2. (B) storage areas for seafood, food ingredients, and food packaging materials;

   5. (5) a plumbing schematic that shows

      1. (A) piping used for potable water, nonpotable water, and wastewater;
      2. (B) each plumbing fixture, including each floor drain and floor sink, located in a processing area; and
      3. (C) toilets and handwash sinks;
   6. (6) a written description of the surface finish of walls, floors, and ceilings in processing, packaging, and storage areas;
   7. (7) a written description of how garbage and refuse will be stored, handled, and disposed of;

   8. (8) documentation showing that required approvals have been granted or permit applications have been submitted to the department for

      1. (A) the facility's drinking water supply as required by 18 AAC 80;
      2. (B) the facility's wastewater disposal system as required by 18 AAC 72; and
      3. (C) the discharge of pollutants into waters of the United States as required by 18 AAC 83;
   9. (9) a list of ingredients to be used for seafood products that have two or more ingredients;
   10. (10) a written hazard analysis or hazard analysis critical control point (HACCP) plan, that meets the requirements of 18 AAC 34.045;
   11. (11) a recall plan that meets the requirements of 18 AAC 34.047;
   12. (12) sanitation standard operating procedures that meet the requirements of 18 AAC 34.050;

   13. (13) for any thermally processed product, a copy of

       1. (A) the food canning establishment registration (FDA form 2541) and the food canning establishment process filing form (FDA form 2541a) submitted to the United States Food and Drug Administration (FDA); and
       2. (B) the scheduled process as set out in 21 C.F.R. 113.83 (Establishing Scheduled Processes), adopted by reference in 18 AAC 34.010;
   14. (14) for a person who wishes to conduct an activity described in 18 AAC 34.005(b) within a permitted processor's facility, a written statement of consent from the permitted processor authorizing the person to utilize the facility and the agreed upon times or locations that each person will conduct processing activities;
   15. (15) an example label of the seafood products to be produced that meets the requirements of 18 AAC 34.110 and 21 C.F.R. 101.1 - 101.108, adopted by reference in 18 AAC 34.010; and
   16. (16) any other information the department determines is necessary to find the application complete.

3. (c) To renew a permit, a permittee shall submit to the department a complete renewal application that demonstrates compliance with this chapter and includes

   1. (1) the current year's application form;
   2. (2) each applicable fee required by 18 AAC 34.900; and
   3. (3) any plans and documents listed in (b)(3) - (16) of this section that have changed since the prior year, are not minor, and affect seafood processing.

4. (d) After receiving a complete application or complete renewal application, the department will review the application and will, to the extent possible, within 60 days

   1. (1) issue a permit;
   2. (2) issue a provisional permit that will state in writing the reasons for and the terms of the provisional approval; or
   3. (3) deny a permit.

5. (e) A permit or provisional permit issued under this section

   1. (1) will be assigned a permit number by the department;
   2. (2) must be maintained at the facility;
   3. (3) is not transferable; and
   4. (4) expires on December 31 of the year in which the permit is issued, or in accordance with the terms of the provisional permit.
6. (f) A permittee who extensively remodels an existing seafood processing facility or adds a new type of operation or process to an existing seafood processing facility must submit to the department for the department's approval any documentation described in (b)(3) - (16) of this section related to the activity, including updated plans or procedures; a permittee must allow the department at least 60 days to review and approve the documentation.
7. (g) A person seeking a permit or approval under this section may request informal review of the department's decision under 18 AAC 15.185.
8. (h) If the department denies a permit or issues a provisional permit, it will notify the applicant in writing of the reasons for denial or provisional permit. Not later than 30 days after issuance of the notice of denial or provisional permit, the applicant may request an adjudicatory hearing under AS 44.62 (Administrative Procedure Act) by submitting a request to the commissioner. Upon receipt of a timely request for an adjudicatory hearing, the commissioner will refer the matter to the office of administrative hearings (AS 44.64.010) for a hearing and recommended decision under 2 AAC 64.100 - 2 AAC 64.990 to the commissioner or to the commissioner's designee if the designee is a person other than the person who issued the contested decision.

(Eff. 12/18/97, Register 144; am/readopt 12/2/99, Register 152; am 8/6/2006, Register 179; am 11/5/2017, Register 224; am 8/21/2019, Register 231)

Authority: AS 17.20.005, AS 17.20.072, AS 44.46.020, AS 17.20.065, AS 17.20.180