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Home , Cholera toxin, Ricin, Streptolysin, Taipoxin, Tetanospasmin

Environmental Protection Agency § 725.422

below in paragraphs (d)(2) through Sequence Source Name (d)(7) of this section, these comparable Bacillus anthracis factor (Factors I II); toxin sequences, regardless of the orga- Lethal factor (Factors II III) nism from which they are derived, Bacillus cereus (diarrheagenic must not be included in the introduced toxin, mouse lethal factor) genetic material. Adenylate cyclase (Heat-la- bile factor); Pertussigen (2) Sequences for synthesis in- (, islet acti- hibitor. vating factor, histamine sensitizing factor, Sequence Source Toxin Name lymphocytosis promoting factor) Corynebacterium diphtheriae botulinum C2 toxin & C. ulcerans Clostridium difficile Enterotoxin (toxin A) Pseudomonas aeruginosa A Beta-toxin; Delta-toxin Shigella dysenteriae Shigella toxin (, Shigella dysenteriae type I & other Heat-labile (LT); toxin, Vero cell toxin) Enterobacteriaceae spp. Heat-stable enterotoxins , (STa, ST1 subtypes ST1a communis, seeds ST1b; also STb, STII) Legionella pneumophila Cytolysin (3) Sequences for . cholerae & Vibrio toxin (choleragen) mimicus Sequence Source Toxin Name (6) Sequences that affect membrane Neurotoxins A, B, C1, D, E, integrity. F, G (Botulinum , botulinal toxins) Sequence Source Toxin Name toxin () Clostridium bifermentans & Lecithinase Proteus mirabilis other Clostridium spp aureus Alpha toxin (alpha lysin) Clostridium perfringens Alpha-toxin (phospholipase Yersinia pestis Murine toxin C, lecithinase); Enterotoxin Snake toxins Corynebacterium pyogenes & Cytolysin (phospholipase C), Bungarus caeruleus Caeruleotoxin other Corynebacterium spp. Ovis toxin Bungarus multicinctus Beta- (sphingomyelinase D) (phospholipase) Staphylococcus aureus Beta-lysin (beta toxin) Crotalus spp. Crotoxin (phospholipase) Dendroaspis viridis Neurotoxin (7) Sequences that are general Naja naja varieties Neurotoxin cytotoxins. Notechia scutatus Notexin (phospholipase) Oxyuranus scutellatus Sequence Source Toxin Name toxins Chironex fleckeri Neurotoxin Adenia digitata Modeccin Androctnus australis Neurotoxin Aeromonas hydrophila Aerolysin (beta-lysin, Centruroides sculpturatus Neurotoxin cytotoxic lysin) Clostridium difficile Cytotoxin (toxin B) (4) Sequences for oxygen labile Clostridium perfringens Beta-toxin; Epsilon-toxin; cytolysins. Kappa-toxin Escherichia coli & other Cytotoxin (Shiga-like toxin, Sequence Source Toxin Name Enterobacteriaceae spp. Vero cell toxin) Pseudomonas aeruginosa Bacillus alve Alveolysin Staphylococcus aureus Gamma lysin (Gamma toxin); Bacillus cereus Cereolysin Enterotoxins (SEA, SEB, Bacillus laterosporus Laterosporolysin SEC, SED SEE); Bacillus thuringiensis Thuringiolysin Pyrogenic A B; Clostridium bifermentans Lysin Toxic syndrome tox- Clostridium botulinum Lysin ins (TSST-1) Clostridium caproicum Lysin Staphylococcus aureus & Leucocidin (, Clostridium chauvoei Delta-toxin Pseudomonas aeruginosa cytotoxin) Clostridium histolyticum Epsilon-toxin pyogenes S (SLS); Clostridium novyi Gamma-toxin Erythrogenic toxins (scarlet Clostridium oedematiens Delta-toxin fever toxins, pyrogenic Clostridium perfringens Theta-toxin (Perfringolysin) exotoxins) Clostridium septicum Delta-toxin Yersinia enterocolitica Heat-stable enterotoxins (ST) Clostridium sordellii Lysin Clostridium tetani Listeria monocytogenes Listeriolysin (A B) § 725.422 Physical containment and Streptococcus pneumoniae Pneumolysin control technologies. Streptococcus pyogene Streptolysin O (SLO) The manufacturer must meet all of (5) Sequences for toxins affecting mem- the following criteria for physical con- brane function. tainment and control technologies for

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any facility in which the new micro- quirements of § 725.65 and maintains organism will be used for a Tier I ex- records for the initial and subsequent emption; these criteria also serve as uses of the new microorganism that guidance for a Tier II exemption. verify compliance with the following: (a) Use a structure that is designed (i) The certifications made in para- and operated to contain the new micro- graph (b) of this section. organism. (ii) All the eligibility criteria for the (b) Control access to the structure. Tier I exemption including the criteria (c) Provide written, published, and for the recipient microorganism, the implemented procedures for the safety introduced genetic material, the phys- of personnel and control of hygiene. ical containment and control tech- (d) Use inactivation procedures dem- nologies. onstrated and documented to be effec- (b) Certification. To be eligible for the tive against the new microorganism Tier I exemption under this subpart, contained in liquid and solid wastes the manufacturer or importer must prior to disposal of the wastes. The in- submit to EPA a document signed by a activation procedures must reduce via- responsible company official con- ble microbial populations by at least 6 taining the information listed in this logs in liquid and solid wastes. paragraph. (e) Use features known to be effective (1) Name and address of manufac- in minimizing viable microbial popu- turer or importer. lations in aerosols and exhaust gases (2) Date when manufacture or import released from the structure, and docu- is expected to begin. ment use of such features. (3) The identification (genus, species) (f) Use systems for controlling dis- of the recipient microorganism listed semination of the new microorganism in § 725.420 which is being used to create through other routes, and document the new microorganism which will be use of such features. used under the conditions of the Tier I (g) Have in place emergency clean-up exemption. procedures. (4) Certification of the following: (i) Compliance with the introduced § 725.424 Requirements for the Tier I genetic material criteria described in exemption. § 725.421. (a) Conditions of exemption. The manu- (ii) Compliance with the containment facture or import of a new microorga- requirements described in § 725.422, in- nism for commercial purposes is not cluding the provision in paragraph subject to review under this part if all (a)(3) of this section. of the following conditions are met for (5) The site of waste disposal and the all activities involving the new micro- type of permits for disposal, the permit organism: numbers and the institutions issuing (1) The recipient microorganism is the permits. listed in and meets any requirements (6) The certification statement re- specified in § 725.420. quired in § 725.25(b). Certification of (2) The introduced genetic material submission of test data is not required meets the criteria under § 725.421. for the Tier I exemption. (3) The physical containment and control technologies of any facility in § 725.426 Applicability of the Tier I ex- which the microorganism will be man- emption. ufactured, processed, or used meet the The Tier I exemption under § 725.424 criteria under § 725.422. applies only to a manufacturer or im- (4) The manufacturer or importer porter of a new microorganism that submits a certification described in certifies that the microorganism will paragraph (b) of this section to EPA at be used in all cases in compliance with least 10 days before commencing initial §§ 725.420, 725.421, and 725.422. manufacture or import of a new micro- organism derived from a recipient § 725.428 Requirements for the Tier II microorganism listed in § 725.420. exemption. (5) The manufacturer or importer The manufacturer or importer of a complies with the recordkeeping re- new microorganism for commercial

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