1. (a) Seafood products that are processed for or placed into domestic commerce for human consumption may not be adulterated as described in 18 AAC 34.115 and must meet the following standards:

   1. (1) for fresh or frozen seafood products other than shellfish for

      1. (A) organoleptic: no contamination or decomposition detected; and
      2. (B) histamine in scombroid fish: less than or equal to 50 ppm;

   2. (2) for refrigerated or frozen ready-to-eat seafood product for

      1. (A) Listeria monocytogenes: none detected;
      2. (B) Salmonella species: none detected;
      3. (C) Escherichia coli: less than or equal to 1,000 MPN per gram, or the equivilant;
      4. (D) Staphylococcus aureus: less than or equal to 10,000 MPN per gram, or the equivilant; and
      5. (E) organoleptic: no contamination or decomposition detected;

   3. (3) for smoked salmon or sablefish for

      1. (A) sodium nitrite: less than or equal to 200 ppm; and
      2. (B) sodium nitrate: less than or equal to 500 ppm;
   4. (4) for smoked tuna, sodium nitrite: less than or equal to 10 ppm;
   5. (5) for cod roe, potassium nitrate: less than or equal to 200 ppm;

   6. (6) for shelf-stable seafood product,

      1. (A) the product must be capable of being stored at room temperature for extended periods without production of pathogenic or toxigenic microorganisms or product deterioration; and

      2. (B) the product must meet one of the following standards:

         1. (i) (the product has been thermally processed;
         2. (ii) the product has a water activity below 0.85 or a water phase salt of 20 percent or greater;
         3. (iii) the product is acidified below a pH of 4.6; or
         4. (iv) the product complies with 21 C.F.R. 172.385, adopted by reference in 18 AAC 34.010, for whole fish protein concentrate;

   7. (7) for shellfish,

      1. (A) either in the shell or shucked, but not eviscerated:

         1. (i) a fecal coliform density less than or equal to 230 MPN per 100 grams; and
         2. (ii) an aerobic or standard plate count of less than or equal to 500,000 colony-forming units (CFU) per gram; or

      2. (B) shucked and eviscerated, fresh or frozen:

         1. (i) a fecal coliform density of less than or equal to 100 MPN per 100 grams; and
         2. (ii) an aerobic or standard plate count of less than or equal to 100,000 colony-forming units (CFU) per gram;

   8. (8) for live, fresh, or frozen snails and shellfish, including uneviscerated shellstock:

      1. (A) PSP: less than 80 mug per 100 grams tissue; and
      2. (B) domoic acid: less than 20 ppm; and

   9. (9) for live, fresh, cooked, or frozen whole crab product for

      1. (A) PSP: less than 80 µg per 100 grams tissue; and
      2. (B) domoic acid: less than 30 ppm.

2. (b) A substance, color additive, indirect food additive, or direct food additive may be added to food if the substance, color additive, indirect food additive, or direct food additive is not prohibited, has been approved for use in human food, is used for its intended use, is used at appropriate use rates, and is considered by FDA to be generally recognized as safe under the following requirements, adopted by reference in 18 AAC 34.010:

   1. (1) 21 C.F.R. 73.1 - 73.615;
   2. (2) 21 C.F.R. 74.101 - 74.706;
   3. (3) 21 C.F.R. 170.3 - 170.285;
   4. (4) 21 C.F.R. 172.5 - 172.898;
   5. (5) 21 C.F.R. 173.5 - 173.405;
   6. (6) 21 C.F.R. 175.105 - 175.390;
   7. (7) 21 C.F.R. 176.110 - 176.350;
   8. (8) 21 C.F.R. 177.1010 - 177.2910;
   9. (9) 21 C.F.R. 178.1005 - 178.3950;
   10. (10) 21 C.F.R. 180.1 - 180.37;
   11. (11) 21 C.F.R. 181.22 - 181.34;
   12. (12) 21 C.F.R. 182.1 - 182.8997;
   13. (13) 21 C.F.R. 184.1 - 184.1985;
   14. (14) 21 C.F.R. 186.1 - 186.1839; and
   15. (15) 21 C.F.R. 189.1 - 189.300.

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

Authority: AS 17.20.005, AS 17.20.030, AS 17.20.290, AS 17.20.010, AS 17.20.072, AS 44.46.020, AS 17.20.020, AS 17.20.180