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Home , Cholera toxin, Clostridium tetani, Leukocidin, Streptolysin, Taipoxin, Tetanolysin

Environmental Protection Agency § 725.422

Sequence Source Name Sequence Source Toxin Name

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

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(f) Use systems for controlling dis- (3) The identification (genus, species) semination of the new microorganism of the recipient microorganism listed through other routes, and document in § 725.420 which is being used to create use of such features. the new microorganism which will be (g) Have in place emergency clean-up used under the conditions of the Tier I procedures. exemption. (4) Certification of the following: § 725.424 Requirements for the Tier I (i) Compliance with the introduced exemption. genetic material criteria described in (a) Conditions of exemption. The manu- § 725.421. facture or import of a new microorga- (ii) Compliance with the containment nism for commercial purposes is not requirements described in § 725.422, in- subject to review under this part if all cluding the provision in paragraph of the following conditions are met for (a)(3) of this section. all activities involving the new micro- organism: (5) The site of waste disposal and the type of permits for disposal, the permit (1) The recipient microorganism is listed in and meets any requirements numbers and the institutions issuing specified in § 725.420. the permits. (2) The introduced genetic material (6) The certification statement re- meets the criteria under § 725.421. quired in § 725.25(b). Certification of (3) The physical containment and submission of test data is not required control technologies of any facility in for the Tier I exemption. which the microorganism will be man- ufactured, processed, or used meet the § 725.426 Applicability of the Tier I ex- emption. criteria under § 725.422. (4) The manufacturer or importer The Tier I exemption under § 725.424 submits a certification described in applies only to a manufacturer or im- paragraph (b) of this section to EPA at porter of a new microorganism that least 10 days before commencing initial certifies that the microorganism will manufacture or import of a new micro- be used in all cases in compliance with organism derived from a recipient §§ 725.420, 725.421, and 725.422. microorganism listed in § 725.420. (5) The manufacturer or importer § 725.428 Requirements for the Tier II complies with the recordkeeping re- exemption. quirements of § 725.65 and maintains The manufacturer or importer of a records for the initial and subsequent new microorganism for commercial uses of the new microorganism that purposes may submit to EPA a Tier II verify compliance with the following: exemption request in lieu of a MCAN (i) The certifications made in para- under subpart D of this part if all of graph (b) of this section. the following conditions are met: (ii) All the eligibility criteria for the (a) The recipient microorganism is Tier I exemption including the criteria listed in and meets any requirements for the recipient microorganism, the specified in § 725.420. introduced genetic material, the phys- (b) The introduced genetic material ical containment and control tech- nologies. meets the criteria under § 725.421. (b) Certification. To be eligible for the (c) Adequate physical containment Tier I exemption under this subpart, and control technologies are used. The the manufacturer or importer must criteria listed under § 725.422 for phys- submit to EPA a document signed by a ical containment and control tech- responsible company official con- nologies of facilities should be used as taining the information listed in this guidance to satisfy the Tier II exemp- paragraph. tion request data requirements listed (1) Name and address of manufac- at § 725.455(d). EPA will review proposed turer or importer. process and containment procedures as (2) Date when manufacture or import part of the submission for a Tier II ex- is expected to begin. emption under this section.

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