Infectious Agents/Pathogens and Biological Toxins Registration 2025

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Biological agents include bacteria, viruses, fungi, other microorganisms and their associated toxins. They have the ability to adversely affect human health in a variety of ways, ranging from relatively mild, allergic reactions to serious medical conditionseven death.
Select agents are biological agents and toxins that have the potential to pose a severe threat to both human and animal health, plant health, or to animal and plant products. These materials are regulated by the Federal Select Agent Program, under 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.
Infectious agents and toxins considered by the Department of Health and Human Services (HHS) or the Department of Agriculture (USDA) as having the potential to pose a severe threat to human, animal, or plant health are regulated as select agents.
Listen to pronunciation. (BY-oh-LAH-jih-kul AY-jent) A substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological agents include antibodies, interleukins, and vaccines.
Biological agents are widely found in the natural environment and as a result found in many work sectors. They include bacteria, viruses, fungi (including yeasts and moulds) and internal human parasites (endoparasites). The majority of these agents are harmless however some may have potential to cause ill health.

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Infectious diseases are caused by pathogens, which include bacteria, fungi, protozoa, worms, viruses, and even infectious proteins called prions. Pathogens of all classes must have mechanisms for entering their host and for evading immediate destruction by the host immune system.
Biological toxins are poisonous substances produced by certain microorganisms, animals, and plants. Examples of toxins of biological origin include Diphtheria Toxin, Tetrodotoxin, Pertussis Toxin, Botulinium Toxin, Snake Venom Toxins, Conotoxin and Ricin.

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