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EFFICACY DATA REQUIREMENTS
- Pathogenic fungi.
- Test requirements. Effectiveness of liquid disinfectants against specific pathogenic fungi must be supported by efficacy data derived from each of 2 samples representing 2 different batches using the AOAC Fungicidal Test.
- Performance standard. The highest dilution that kills all fungal spores is the minimum effective concentration.
- Alternative test requirements. Alternatively, the AOAC Use Dilution Method, modified to conform with appropriate elements in the AOAC Fungicidal Test, may be employed. If the product is intended for use as a spray, the AOAC Germicidal Spray Products Test must be employed. The inoculum in the above tests must be modified to provide a concentration of at least 106 conidia per carrier. Ten carriers on each of 2 samples representing 2 different batches must be employed in the test.
- Alternative performance standard. Killing of the test microorganism on all carriers is required.
- Permitted labeling claims. Acceptability of claims against pathogenic fungi on environmental surfaces is contingent upon correlation between the claim and the recommended use areas and surfaces to be treated where pathogenic fungi are likely to be a problem.
- Mycobacterium tuberculosis.
- Test requirements. Effectiveness against M. tuberculosis must be substantiated with data derived on 10 carriers by the AOAC Tuberculocidal Activity Method (II Confirmative In Vitro Test for Determining Tuberculocidal Activity) for each of 2 samples representing 2 different batches of a liquid product under test. If the product is a spray, the procedure must be modified to conform with the AOAC Germicidal Spray Products Test using the media, microorganisms, and other elements described in the AOAC Tuberculocidal Activity Method.
- Performance standard. Killing of the test microorganism on all carriers, and no growth in any of the inoculated tubes of two additional media.
- Permitted labeling claims. Labels of products claiming disinfection of inhalation therapy and/or pulmonary diagnostic equipment, or unidentified medical equipment and/or instruments, or all-inclusive hard non-porous surfaces in the medical environment but which have not been tested for effectiveness against Mycobacterium tuberculosis must bear the following statement: "This product had not been tested for effectiveness against Mycobacterium tuberculosis, and must not be relied upon when a tuberculocidal product is desired." In lieu of this statement, the label recommendations must clearly exclude the use of the product on inhalation therapy and/or pulmonary diagnostic equipment.
- Phenol coefficient(s).
- Test requirements. Phenol coefficients for Salmonella typhi (the only official test organism), and for any additional Gram-negative or Gram-positive asporogenous bacteria must be determined by the AOAC Phenol Coefficient Method on each of 2 samples representing 2 different batches against each bacterium.
- Performance standard. The Phenol Coefficient is a numerical value that compares the bactericidal concentration of a disinfectant to the bactericidal concentration of pure phenol. This numerical value is obtained by dividing the greatest dilution of disinfectant killing. S. typhi in 10 minutes, but not in 5 minutes, but the greatest dilution of phenol showing the same results.
- Permitted labeling claims.
- Phenol coefficient claims are permitted only on labels of those products when the value claimed can be considered meaningful and not misleading. Only when the phenol coefficient of a product, as claimed on the label, can be multiplied by the factor "20" to provide the effective use dilution of the product (as confirmed by the AOAC Use Dilution Method) will the phenol coefficient claim be permitted on the label.
- "Phenol Coefficient" tables which list phenol coefficient values for numerous bacteria are frequently included in collateral labeling, such as technical bulletins or brochures for formulated products, technical grad chemicals, and chemicals for manufacturing-use products only. These claims ("Phenol Coefficient" tables) must be prominently prefaced with a statement such as: "The following Phenol Coefficients are intended only to indicate the broad-spectrum activity of the product. This information must not be interpreted as having any relevance to the use patterns recommended, effective dosages, or activity against specific microorganism when used as directed."
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