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§ 725.422 40 CFR Ch. I (7–1–11 Edition)

Sequence Source Name (7) Sequences that are general cytotoxins. Crotalus spp. Crotoxin (phospholipase) Dendroaspis viridis Sequence Source Toxin Name Naja naja varieties Neurotoxin Notechia scutatus Notexin (phospholipase) Adenia digitata Modeccin Oxyuranus scutellatus Aeromonas hydrophila Aerolysin (beta-lysin, cytotoxic lysin) Chironex fleckeri Neurotoxin difficile Cytotoxin (toxin B) Androctnus australis Neurotoxin Centruroides sculpturatus Neurotoxin Beta-toxin; Epsilon-toxin; Kappa-toxin (4) Sequences for oxygen labile & other Cytotoxin (Shiga-like toxin, cytolysins. Enterobacteriaceae spp. Vero toxin) Pseudomonas aeruginosa Proteases Sequence Source Toxin Name aureus Gamma lysin (Gamma toxin); (SEA, SEB, alve Alveolysin SEC, SED SEE); Cereolysin Pyrogenic A B; Bacillus laterosporus Laterosporolysin Toxic syndrome tox- Bacillus thuringiensis Thuringiolysin ins (TSST-1) Clostridium bifermentans Lysin & Leucocidin (, Lysin Pseudomonas aeruginosa cytotoxin) Clostridium caproicum Lysin pyogenes S (SLS); Clostridium chauvoei Delta-toxin Erythrogenic toxins (scarlet Clostridium histolyticum Epsilon-toxin fever toxins, pyrogenic Clostridium novyi Gamma-toxin exotoxins) Clostridium oedematiens Delta-toxin Clostridium perfringens Theta-toxin (Perfringolysin) Yersinia enterocolitica Heat-stable enterotoxins (ST) Clostridium septicum Delta-toxin Clostridium sordellii Lysin § 725.422 Physical containment and control technologies. monocytogenes Listeriolysin (A B) Streptococcus pneumoniae Pneumolysin The manufacturer must meet all of Streptococcus pyogene Streptolysin O (SLO) the following criteria for physical con- (5) Sequences for toxins affecting mem- tainment and control technologies for brane function. any facility in which the new micro- organism will be used for a Tier I ex- Sequence Source Toxin Name emption; these criteria also serve as Edema factor (Factors I II); guidance for a Tier II exemption. Lethal factor (Factors II III) (a) Use a structure that is designed Bacillus cereus (diarrheagenic and operated to contain the new micro- toxin, mouse lethal factor) Adenylate cyclase (Heat-la- organism. bile factor); Pertussigen (b) Control access to the structure. (, islet acti- (c) Provide written, published, and vating factor, histamine sensitizing factor, implemented procedures for the safety lymphocytosis promoting of personnel and control of hygiene. factor) (d) Use inactivation procedures dem- Clostridium botulinum C2 toxin Clostridium difficile Enterotoxin (toxin A) onstrated and documented to be effec- Clostridium perfringens Beta-toxin; Delta-toxin tive against the new microorganism Escherichia coli & other Heat-labile enterotoxins (LT); contained in liquid and solid wastes Enterobacteriaceae spp. Heat-stable enterotoxins (STa, ST1 subtypes ST1a prior to disposal of the wastes. The in- ST1b; also STb, STII) activation procedures must reduce via- Legionella pneumophila Cytolysin ble microbial populations by at least 6 cholerae & Vibrio toxin (choleragen) logs in liquid and solid wastes. mimicus (e) Use features known to be effective (6) Sequences that affect membrane in minimizing viable microbial popu- integrity. lations in aerosols and exhaust gases Sequence Source Toxin Name released from the structure, and docu- ment use of such features. Clostridium bifermentans & Lecithinase (f) Use systems for controlling dis- other Clostridium spp Clostridium perfringens Alpha-toxin (phospholipase semination of the new microorganism C, lecithinase); Enterotoxin through other routes, and document Corynebacterium pyogenes & Cytolysin (phospholipase C), use of such features. other Corynebacterium spp. Ovis toxin (sphingomyelinase D) (g) Have in place emergency clean-up Staphylococcus aureus Beta-lysin (beta toxin) procedures.

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