Supplemental Efficacy
DIS/TSS-6
EFFICACY DATA REQUIREMENTS
Supplemental Efficacy
(A) Pathogenic fungi.
(1) 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.
(2) Performance standard. The highest dilution that kills all fungal
spores is the minimum effective concentration.
(3) 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.
(4) Alternative performance standard. Killing
of the test microorganism on all carriers is required.
(5) 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.
(B) Mycobacterium tuberculosis.
(1) 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.
(2) Performance standard. Killing of the test microorganism
on all carriers, and no growth in any of the inoculated tubes of two
additional media.
(3) 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.
(C) Phenol coefficient(s).
(1) 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.
(2) 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.
(3) Permitted labeling claims.
(a) 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.
(b) "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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