Select Toxin Guidance:
Appendix A. Summary of Select Toxin Natural Environments, Methods of Production, Regulatory and Starting Points of Select Toxin in Select Toxin-containing Samples

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Appendix A. Summary of Select Toxin Natural Environments, Methods of Production, Regulatory and Starting Points of Select Toxin in Select Toxin-containing Samples
Select Toxin
Regulatory Amount
Natural Environment
Method of Production
Regulatory Point
(So long as the quantity is in excess of the regulatory threshold)
Abrin 1000 mg Seeds of the plant Abrus precatorius (rosary peas) including rosary pea mash. Solvent extraction from crushed rosary pea seeds When crushed Abrus precatorius (rosary pea) mash is further processed, resulting in the extraction or concentration of abrin, the abrin containing product of this procedure is regulated.
Botulinum neurotoxins (BoNT) 1 mg Original food and clinical samples for which no additional procedures have been done to collect or extract BoNT. BoNT is extracted and purified from food, stool, serum and liquid cultures of Botulinum neurotoxin-producing species of Clostridium Intentional BoNT collection or extraction. For licensed products that contain BoNT (e.g. BOTOX), once BoNT is vialled in its final formulation and to be used for medical purposes as stipulated by its license, it is no longer regulated.
Alpha-conotoxins 100 mg Cone snails (Conus spp.)
  1. Recombinant production systems.
  2. Chemical synthesis.
  3. Milking of snails.
 Soluble peptides of the appropriate amino acid sequence extracted from the venom bulb of cone snails that have been treated with proteases to properly fold and activate alpha-conotoxin.
DAS 10000 mg
  1. Fusarium sambucinum cultures that produce DAS, or
  2. Food (e.g. potatoes) that was naturally contaminated by the fungi.
 Liquid cultures of F. sambucinum grown on yeast extract, peptone, and glucose, or grown on cooked rice Extraction from culture supernatant or contaminated food in organic solvent.
Ricin 1000 mg Castor beans (Ricinus communis) including castor bean mash, which is the by-product of castor oil production that contains crushed plant material Solvent extraction from crushed castor beans. When castor bean mash is further processed, resulting in the extraction or concentration of ricin, the ricin-containing product of this procedure is regulated.
Saxitoxin (STX) 500 mg Species of cyanobacteria and marine dinoflagellates and filter feeding shellfish that have concentrated STX from these sources Algal cells are removed from their growing medium (through filtering or centrifugation), rinsed to remove salts, concentrated into a pellet, and sonicated in mildly acidified water, or, contaminated shellfish are extracted with mildly acidified water. Dinoflagellate or cyanobacterial pellet, or contaminated fish or shellfish, is sonicated or otherwise disrupted and acidified water is added to extract STX.
Staphylococcal enterotoxin (SE) A,B,C,D,E subtypes 100 mg
  1. Staphylococcus aureus strains that produce SE A,B,C,D,E subtypes, and
  2. Original food and clinical samples that contain SE A,B,C,D,E subtypes for which no additional procedures have been done to collect or extract SE A,B,C,D,E subtypes.
 SE A, B, C, D, E subtypes can be extracted from food, stool, serum, and liquid cultures of S. aureus. Intentional SE A, B, C, D, E subtype collection or extraction.
T-2 toxin 10000mg
  1. Fusarium sporotrichioides cultures that produce T-2 toxin, or
  2. Food (e.g., oats) that was naturally contaminated by the fungi
 Liquid cultures of Fusarium sporotrichioides grown on yeast extract, peptone, and glucose, or gown on cooked rice. Extraction from culture supernatant or contaminated food in organic solvent.
Tetrodotoxin (TTX) 500 mg Aquatic animals and amphibians and organs that contain TTX so long as no additional extraction of TTX occurs. Several Japanese companies produce TTX commercially from puffer fish liver and/or ovaries. Toxic organs are homogenized with water and a weak organic acid followed by filtering. Purified by raising the pH with a weak base followed by cation exchange chromatography. Separation from inorganic salts and alkaline amino acids using activated carbon. Crystalized by concentrating the solution at a pH of 8-10. Extraction from aquatic animals and amphibians and organs that contain TTX in acidified water or organic solvent.
Page last reviewed: September 9, 2020
Content source: Division of Regulatory Science and Compliance