toxic levels in seafood (FDA, 2001a). Regulatory monitoring programs have been effective; but new toxins and plankton blooms are emerging worldwide, particularly in areas less subject to surveillance. Incidences of toxicity could increase without controls, although the likelihood for an outbreak is low. Appendix Table B-4 identifies tolerances and action levels set by federal agencies for potentially problematic products.


Most aquaculture operations depend on the use of various chemotherapeutants to control infectious diseases (FAO/NACA/WHO Study Group, 1999; FDA, 2001a). Aquaculture initially relied upon the same antimicrobials employed for production of beef and poultry and other land-based farming. The resultant food safety concerns, as for land-based agriculture, include possible toxic residue in the edible portions, contributions to potential antibiotic-resistant diseases (for both animals and consumers), and concomitant issues involving environmental contamination. Although the volume of chemotherapeutants used in aquaculture is far less than for other medical practices and agricultural production, international aquacultural use with less scrutiny may increase. Product seizures due to the presence of chemotherapeutants in some imported farm-raised seafood have occurred. (Allshouse, 2003;;

Compounds of concern have included chloramphenicol, nitrofurans, fluoroquinolone, malachite green, and others (Table 4-15). All of these antimicrobial/antifungal agents have been used at some time for aquacultural production in the United States, prior to the implemention of restrictions by federal agencies (FDA, 2005f). The established level of controls is zero toler-

TABLE 4-15 Antimicrobial/Antifungal Agents Used at Some Time for Aquaculture Production in the United States

Illegal Antibiotic or Chemotherapeutant

Action Level Based on Detection Limit


0.3 ppb


1.0 ppb

Malachite green

1.0 ppb


5.0 ppb

Quinolones (Oxolinic Acid, Flumequine)

10.0 ppb (oxolinic acid) and 20.0 ppb


10.0 ppb


2.0 ppm

NOTES: ppb = parts per billion; ppm = parts per million.

SOURCE: Personal communication, W. Jones, Food and Drug Administration, October 12, 2006.

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