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Pesticides: Science and PolicyRecent Additions | Contact Us You are here: EPA Home

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Antimicrobial Science Policies

Pesticides Home Science & Policy Home Advisory Committees Policy & Guidance Test Guidelines Models & Databases Laboratories Analytical Methods Procedures

Antimicrobial Science PoliciesDisinfectant Technical Science Section (DIS/TSS)Each of the "DIS/TSS" guidance documents listed below provides a summary of current efficacyrelated requirements and/or policy for a category of antimicrobial pesticide products, claims, or patterns of use. If more detailed guidance is needed, the Antimicrobials Division should be consulted ("DIS/TSS" is the acronym for Disinfectant Technical Science Section, the Antimicrobials Division's former Efficacy Evaluation Team). If any of the product's use patterns is classified as human health related (see DIS/TSS-16), efficacy data must be submitted for review in order to support the inclusion of that use pattern in the product registration. Regardless of the use pattern, however, product efficacy data is required to be maintained in the registrant's files. The documents may be grouped as follows: I. Initial review and label evaluation: DIS/TSS-15, 16 II. Efficacy data requirements: DIS/TSS-1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 13, 14 III. Confirmatory efficacy requirements: DIS/TSS-5 The first group helps define the intended pattern of use for a product (for those intended for use on hard surfaces) and helps determine if efficacy testing is required to be submitted. These are in large part dependent on the efficacy claims and directions for use on the product label. It is necessary for these facts to be established before further discussion of efficacy data requirements can be meaningful. The second group of documents contains efficacy data requirements to support efficacy claims (e.g., levels of antimicrobial activity, types of microorganisms) and specific types of products or patterns of use (e.g., one-step' disinfectant/cleaner, food-contact surface sanitizer). Before these requirements can be applied to a product, the intended claims and use patterns must be known (at least in a general way). Standard test methods are intended to support standard' claims or use patterns; for other claims and uses, modified methodology may be necessary. Therefore, adequate use directions on the proposed product label are necessary for a specific determination of efficacy testing requirements. In addition, the efficacy testing and reporting must include all elements necessary for evaluating the methodology employed and the results obtained (see DIS/TSS-2 and 3). The third group of documents contains confirmatory data requirements. These documents should be used only after the Agency has determined that minimal, confirmatory data is applicable and appropriate for the product in question. Such a determination involves comparison of formulations and manufacturing procedures, adequacy of referenced basic efficacy data, and conformity of claims and directions for use with current labeling requirements. Once confirmatory' data is determined appropriate for the product in question, it may be submitted as a supplement to the referenced basic' data. Number Title Date Jan. 22, 1982 Jan. 25, 1979 Jan. 29, 1979 Jan. 30, 1979 Sept. 22,

DIS-TSS 01 Disinfectants for Use on Hard Surfaces DIS-TSS 02 Supplemental Recommendations DIS-TSS 03 Reporting of Data DIS-TSS 04 Sanitizing Rinses for Previously Cleaned Food-contacted surfaces

DIS-TSS 05 Confirmatory Efficacy Data Requirements DIS-TSS 06 Supplemental Efficacy DIS-TSS 07 Virucides ( Test Results Table) DIS-TSS 08 Carpet Sanitizers DIS-TSS 09 Sterilizers DIS-TSS 10 Sanitizer Test for Inanimate Surfaces DIS-TSS 11 Air Sanitizers DIS-TSS 12 Swimming Pool Water Disinfectants DIS-TSS 13 Laundry Additives - Disinfection and Sanitization DIS-TSS 14 Laundry Additives - Residual Self-Sanitization DIS-TSS 15 Label Requirements for Antimicrobial Pesticides Used On Hard Surfaces

1982

Nov. 12, 1981 Apr. 18, 1981

Sept. 3, 1980 Apr. 23, 1979 Apr. 4, 1980 July 29, 1981 Mar. 24, 1981 Jun. 26, 1979 Dec. 2, 1979 Jan. 17, 1989 Jan. 17, 1980

DIS-TSS 16 Determination of Health- Related and Non-Health-Related Uses DIS-TSS 17 Label Requirements for Pesticides Used for Sanitation of Food Contact Surfaces

DIS-TSS 18 Label Requirements for Farm Premise Disinfectants DIS-TSS 19 Label Requirements for Poultry House Disinfectants

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Disinfectants for Use on Hard SurfacesDIS/TSS-1 Jan 22, 1982 EFFICACY DATA REQUIREMENTS Disinfectants for Use on Hard Surfacesa. Limited efficacy claims. The label of a disinfectant which is effective against a specific major group of microorganisms only (e.g., Grampositive or Gram-negative) must specify the major group against which it is effective. 1. Test requirements. The AOAC Use-Dilution Method (for water soluble powders and liquid products) or the AOAC Germicidal Spray Products Test (for spray products) is required. Sixty carriers must be tested with each of 3 samples, representing 3 different batches, one of which is at least 60 days old, against Salmonella choleraesuis ATCC 10708 (for effectiveness against Gram-negative bacteria) or Staphylococcus aureus ATCC 6538 (for effectiveness against Gram-positive bacteria). (Sixty carriers per sample; a total of 180 carriers.) 2. Performance requirements. To support products represented in labeling as "disinfectants", killing on 59 out of each set of 60 carriers is required to provide effectiveness at the 95% confidence level. b. General or broad-spectrum efficacy claims. Label claims of effectiveness as a "general disinfectant" or representations that the product is effective against a broad spectrum of microorganisms are acceptable if the product is effective against both Gram-positive and Gram-negative bacteria. 1. Test requirements. Use the AOAC Use-Dilution Method or the AOAC Germicidal Spray Product Test as in (a)(l). Sixty carriers must be tested against each of both S. choleraesuis and S. aureus with each of 3 samples, representing 3 different batches, one of which is at least 60 days old. (120 carriers per sample; a total of 360 carriers.) 2. Performance requirements. Same as in (a)(2) above. c. Hospital or medical environment efficacy claims. Label claims for use of disinfectants in Hospital or medical environments are acceptable only for those products that are effective for general or broad-spectrum disinfection and additionally against the nosocomial bacterial pathogen Pseudomonas aeruginosa. 1. Test requirements. Employ the AOAC Use-Dilution Method or the AOAC Germicidal Spray Products Test as in (a)(l). Sixty carriers must be tested against each of S. choleraesuis, S. aureus, and Pseudomonas aeruginosa ATCC 15442 with each of 3 samples, representing, one of which is at least 60 days old. (180 carriers per sample; a total of 540 carriers.) 2. Performance requirements. Same as in (A)(2) above.

d. Other microorganisms. Substantiated label claims of effectiveness of a disinfectant against specific microorganisms other than the designated test microorganism(s) are permitted, but not required, provided that the target pest is likely to be present in or on the recommended use areas and surfaces and thus may present a potential problem. 1. Test requirements. Effectiveness of disinfectants against specific microorganisms other than those named in the AOAC Use Dilution Method, AOAC Germicidal Spray Products Test, AOAC Fungicidal Test, and AOAC Tuberculocidal Activity Method (II. Confirmative In-Vitro Test), but not including viruses, must be determined by either

the AOAC Use-Dilution Method or the AOAC Germicidal Spray Products Test as in (a)(l). Ten carriers must be tested against each specific microorganism with each of 2 samples, representing 2 different batches. (10 carriers per sample, a total of 20 carriers.) 2. Performance requirements. Killing of the test microorganism on all carriers is required. Plate count data, on appropriate culture media, must be submitted on each test microorganism to disclose that a concentration of at least 104 microorganisms survive the carrier-drying step in order to provide meaningful results.

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Supplemental RecommendationsDIS/TSS-2 Jan 25, 1979 EFFICACY DATA REQUIREMENTS Supplemental RecommendationsWhen an antimicrobial Agent is intended for a use pattern that is not reflected by the test conditions specified in the Recommended Methods, one or more test conditions specified in the method must be modified and/or supplementary data developed in order to provide meaningful results relative to the conditions of use. The following basic information is critical to the development and submission of appropriate data.

1. EXPOSURE PERIODAll products tested by the recommended methods may be tested at the exposure periods prescribed in those methods. However, if the product is intended for use at exposure periods shorter or longer than those specified in the method, the method must be modified, in a manner acceptable to the Agency, to reflect the deviation in exposure intended. A modification to provide a shorter exposure period is restricted by the manipulative limitations inherent in the method, while a modification to provide a longer exposure period is restricted by the conditions applicable to the use pattern. If a ten-minute exposure period is necessary for the antimicrobial agent to be effective against the test microorganism the product cannot be represented as an "instantly active" product, or cannot be represented as being "effective in 30 seconds, "one minute," or at any time period shorter than 10 minutes. Also, the product cannot be recommended for use in a manner which is inconsistent with the exposure period necessary for effectiveness (as, for example, "Spray on surface, and immediately wipe with clean cloth") unless the standard method has been modified and reflects efficacy under such conditions of use. In any case, the exposure period or manner of use necessary to provide efficacy must be featured prominently on the product label.

2. TYPE OF SURFACEWhen an antimicrobial agent is intended to be effective in treating a hard porous surface, some of the Recommended Methods may be modified to simulate this more stringent condition by substitution of a porous surface carrier (such as a porcelain penicylinder or unglazed ceramic tile) for the non-porous surface carrier (stainless steel cylinder or glass slide) specified in the method. In addition, control data, described below in Supplemental Recommendation No. 6, must be developed to assure the validity of the test results when this modification of the method is employed. In no case may a surface carrier which represents a less stringent condition be substituted for a surface carrier which is specified in the Recommended Method.

3. HARD WATERThe Recommended Methods may be modified to demonstrate the effectiveness of an antimicrobial agent in hard water. The hard water tolerance level may differ with level of antimicrobial activity claimed. To establish disinfectant efficacy in hard water, all microorganisms (bacteria, fungi, viruses) claimed to be controlled must be tested by the appropriate Recommended Method at the same hard water tolerance level.

4. ORGANIC SOILAn antimicrobial agent identified as a "one-step" cleaner-disinfectant, cleaner-sanitizer, or

one intended to be effective in the presence of organic soil must be tested for efficacy by the appropriate method(s) which have been modified to include a representative organic soil such as 5% blood serum. A suggested procedure to simulate in-use conditions where the antimicrobial agent is intended to treat dry inanimate surfaces with an organic soil load involves contamination of the appropriate carrier surface with each test microorganism culture containing 5% v/v blood serum (e.g., 19 ml test microorganism culture $ 1 ml blood serum) prior to the specified carrier-drying step in the method. Control data, described below in Supplemental Recommendation No. 6, must also be developed to assure the validity of the test results when this modification is incorporated into the method. The organic soil level suggested is considered appropriate for simulating lightly or moderately soiled surface conditions. When the surface to be treated has heavy soil deposits, a cleaning step must be recommended prior to application of the antimicrobial agent. The effectiveness of antimicrobial agents must be demonstrated in the presence of a specific organic soil at an appropriate concentration level when specifically claimed and/or indicated by the pattern of use. A suggested procedure for incorporating organic soil load where the antimicrobial agent is not tested against a dry inanimate surface, such as the AOAC Fungicidal Test involves adding 5% v/v blood serum directly to the test solution (e.g., 4.75 ml test solution + 0.25 ml blood serum) before adding 0.5 ml of the required level (5 X 106 /ml) of conidia.

5. RE-USEThe Recommended Methods are designed to demonstrate efficacy of a freshly prepared antimicrobial solution intended for a single application. When the same use solution is intended for repeated applications, testing must be conducted in accordance with a test protocol specially designed to demonstrate retention of the claimed level(s) of antimicrobial activity in the use solution after repeated microbial and other appropriate challenges (such as supplemental recommendations indicated above) and stress conditions (such as an inadvertent or incidental dilution inherent in the use pattern) over the period of time or number of times specified in the directions for use.

6. MICROORGANISM SURVIVAL AFTER DRYING ON A HARD SURFACEQuantitative determinations of the viable microbial concentration on the untreated control carrier after drying are required in order to determine the validity of the test results obtained with treated carriers when the Recommended Methods are modified to include such elements as: i. test microorganisms not specified in the method, ii. substitution of a porous surface (e.g., porcelain penicylinder, unglazed ceramic tile) for the specified nonporous surface (stainless steel cylinder, glass slide), and/or iii. an organic soil load.

The detailed protocol for this testing must include: i. preparation of inoculum, ii. application of inoculum to the carrier, iii. the time/temperature and relative humidity conditions for drying the microorganisms on the carrier, iv. the technique for removal of the microorganisms from the carrier, and v. the specific assay procedure indicating such details as replication, subculture media/diluents, and the incubation time/temperature conditions for the enumeration procedure employed.

The test results must include the individual counts obtained by the method.

7. NEUTRALIZATIONFor each antimicrobial product, procedures must be employed that will preclude residual effects of the active ingredient(s) in the subculture medium. A specific medium capable of neutralizing the antimicrobial effects of a product (whenever one is known) should be employed prior to the microbiological assay. Some of the Recommended Methods rely solely upon the selection of an appropriate subculture medium to neutralize the antimicrobial

effects of certain general types of chemical compounds (active ingredients). However, to document absence of residual effects of the active ingredient(s) in the subculture medium, the following testing is necessary: i. secondary subcultures must be performed to demonstrate that antimicrobial effects were overcome, or ii. at the conclusion of the incubation period specified or employed in the method, the primary culture medium with test carrier must be inoculated with approximately 10 microorganisms/ml of the specific culture under test (documented by actual plate counts) and re-incubated for the specified period to demonstrate that the subculture medium was capable of supporting bacterial growth.

8. BATCH REPLICATION FOR MODIFIED TESTSWhere the required batch replication has already been performed and accepted for a product registration with unmodified tests by the Recommended Methods, additional testing at the same use concentration under modified conditions (e.g., different exposure period, presence of organic soil or hard water, porous surface carrier, etc.) may be conducted with reduced batch replication, as follows: i. for basic efficacy claims (e.g., sterilizers, disinfectants, or sanitizers), 2 samples, representing 2 different batches, instead of 3, and ii. for supplemental efficacy claims (e.g., fungicides, virucides, or tuberculocides), one sample instead of 2.

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Reporting of DataDIS/TSS-3 Jan 29, 1979 EFFICACY DATA REQUIREMENTS Reporting of DataSystematic and complete descriptions of the tests employed and the results obtained are essential for proper review and evaluation of product performance by the Agency. All test reports must include identification of the testing laboratory or organization, when and where the tests were conducted, and the name of the person(s) responsible for the conduct of the tests. 1. Recommended Methods. When the Recommended Methods (such as standard AOAC tests) are employed to develop efficacy data, certain minimal information must be provided in the test report. The report must include, but is not limited to, the following: a. Test employed, and any modifications thereto; b. Test microorganisms employed, including identification of the specific strain (ATCC or other); c. Concentration or dilution of product tested and how prepared; d. Number of samples, batches, and replicates tested; e. Preparation date of each product batch (individually formulated preparation of the product; f. Phenol resistance of test microorganisms (actual test results); g. Identification of all material or procedural options employed, where such choice is permitted or recommended in the test method selected (for example, growth media, drying time for inoculated carriers, neutralizer and/or subculture media, secondary subculturing); h. Complete report of results obtained for each individual replication; i. Any control data essential to establish the validity of the test. 2. Modification of Recommended Methods. Where Recommended Methods are significantly modified to support specific claims and/or use patterns for a product, the protocol employed for modifying the test must be provided in specific detail with the test report. The applicant may submit the proposed modification for review and evaluation prior to initiation of the test. 3. Other Methods. When Recommended Methods, or modification thereto, are not employed to develop efficacy data (such as actual in-use or many kinds of simulated-use testing), complete testing protocols must be submitted with the test reports. All materials and procedures employed in testing must be described in a manner consistent with original research reports published in technical or scientific journals. Where references to published reports or papers are made, copies or reprints of such references should be provided with the test reports. Proposed testing protocols for in-use or simulated-use studies of this kind may be submitted for review and evaluation by the Agency prior to initiation of the tests.

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You are here: EPA Home Pesticides Science and Policy Policy and Guidance Sanitizing Rinses (for previously cleaned food-contact surfaces)

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Sanitizing Rinses (for previously cleaned foodcontact surfaces)DIS/TSS-4 Jan 30, 1979 EFFICACY DATA REQUIREMENTS Sanitizing rinses (for previously cleaned food-contact surfaces)Sanitizers applied to food contact surfaces are defined as incidental food additives under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 201 et seq.), and require establishment of a food additive tolerance. Recommendation of a potable water rinse after treatment does not preclude this requirement. 1. Halide chemical products. Efficacy of sanitizing rinses formulated with iodophors, mixed halides, and chlorine bearing chemicals must be substantiated with data derived from the AOAC Available Chlorine Germicidal Equivalent Concentration Method. i. Test requirements. Data from one test on each of 3 samples, representing 3 different batches, one of which is at least 60 days old, against S. typhi are required. ii. Performance standard. Test results must show product concentrations equivalent in activity to 50, 100, and 200 ppm of available chlorine. (The reference standard is sodium hypochlorite.)

2. Other chemical products. Efficacy of sanitizing rinses formulated with quaternary ammonium compounds, chlorinated trisodium phosphate, and anionic detergent-acid formulations must be substantiated with data derived from the AOAC Germicidal and Detergent Sanitizers Method. i. Test requirements. Data from the test on one sample from each of 3 different batches, one of which is at least 60 days old, against both E. coli and S. aureus are required. When claims for the effectiveness of the product in hard water are made, all required data must be developed at the hard water tolerance claimed. ii. Performance standard. Acceptable results must demonstrate a 99.999% reduction in the number of microorganisms within 30 seconds. The results must be reported according to the actual count and percentage reduction over the control. The minimum concentration of the product which provides the results required above is the minimum effective concentration.

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Confirmatory Efficacy Data RequirementsDIS/TSS-5 Sept. 22, 1982 CONFIRMATORY EFFICACY DATA REQUIREMENTS1. When Applicable. In certain situations an applicant is permitted to rely on previously submitted efficacy data to support an application or amendment for registration of a product and to submit only minimal confirmatory efficacy data on his own product to demonstrate his ability to produce an effective formulation. These situations are as follows: a. Duplicated Product Formulations. In this situation, the applicant manufactures a formulation which duplicates a product that is already registered with complete supporting efficacy data. The chemical composition, manufacturing procedure, label claims, and directions for use are identical in substance to those of the original registration, and specific references to the supporting data developed for the original product are furnished by the applicant. b. Minor Formulation Change in a Registered Product. In this situation, the change in the formulation is relatively minor, e.g., a change of an inert ingredient. The label claims and directions for use are unchanged from those accepted for the registered formulation, and specific references to the supporting data developed for the original formulation are cited by the registrant.

2. Confirmatory Data Required. The following data must be developed on the applicant's own finished product. When the test methodology utilized in deriving the original supporting efficacy data were modified to include additional elements not specified in the recommended method, such as organic soil, hard water, longer or shorter contact time, etc., the confirmatory data must be produced under similarly modified conditions. The specified confirmatory data are required to be developed only at the dilution and condition which represents the highest level of efficacy and most stringent condition claimed on the label, e.g., as a hospital disinfectant in organic soil for a product which may be used at different dilutions for hospital or general disinfection or in the presence or absence of organic soil, or additionally as a sanitizing rinse for food contact surfaces. a. Disinfectants for Use in Hospital or Medical Environments. i. Test Requirements. Ten carriers on each of 2 samples representing 2 different batches are required against each of Salmonella choleraesuis ATCC 10708, Staphylococcus aureus ATCC 6538, and Pseudomonas aeruginosa ATCC 15442, employing the AOAC Use-Dilution Method for liquid products, or the AOAC Germicidal Spray Products Test for spray products. ii. Performance Standard. Killing on all carriers is required.

b. General Broad-Spectrum Disinfectants.

i. Test Requirements. Ten carriers on each of 2 samples representing 2 different batches are required against each of S. choleraesuis and S. aureus, employing the AOAC Use-Dilution Method for liquid products, or the AOAC Germicidal Spray Products Test for spray products. ii. Performance Standard. Killing on all carriers is required.

c. Disinfectants with Limited Efficacy. i. Test Requirements. Ten carriers on each of 2 samples representing 2 different batches are required against either S. choleraesuis or S. aureus, depending upon the microorganism against which the activity of the product is limited, employing the AOAC Use-Dilution Method for liquid products, or the AOAC Germicidal Spray Products Test for spray products. ii. Performance Standard. Killing on all carriers is required.

d. Sanitizing Rinses for Food-Contact Surfaces.

i. Test Requirements. One test on one sample, with or without hard water (depending on the label claim), is required using either: the AOAC Germicidal and Detergent Sanitizers Method against Escherichia coli ATCC 11229 for quaternary ammonium compounds, chlorinated trisodium phosphate, and anionic detergent-acid formulations; or the AOAC Available Chlorine Germicidal Equivalent Concentration Test against Salmonella typhi ATCC 6539 for iodophors, mixed halides, and chlorinebearing chemicals. ii. Performance Standard.

A. AOAC Germicidal Detergent Sanitizers Method. Acceptable results must show a 99.999% reduction in the number of microorganisms within 30 seconds. The results must be reported as the actual counts and the percentage reduction over the control. B. AOAC Available Chlorine Germicidal Equivalent Concentration Test. Test results must show product concentrations equivalent in activity to 50, 100, and 200 ppm of available chlorine. (The reference standard is sodium hypochlorite.) Note: For pressurized spray disinfectants, certification is required that all parts and materials used in the aerosol container are identical to those specified for the original product. 3. When Not Applicable. Products proposed for registration which are merely relabeled, repackaged, or simple dilutions of a product already registered and manufactured by another registrant require only documentation of this identity and specific references to the supporting data developed for the original product. Confirmatory test data are not required for these situations. For use patterns other than disinfectants and sanitizers as specified above, required bridging data will be determined (or waived) on a case-by-case basis.

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Supplemental EfficacyDIS/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 broadspectrum 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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EFFICACY DATA REQUIREMENTS: VIRUCIDESDIS/TSS-7 / Nov. 12, 1981 EFFICACY DATA REQUIREMENTS: VIRUCIDES(Proposed method prepared by Registration Division, Office of PesticidePrograms, EPA, 1976) The Agency will accept adequate data developed by any virological technique which is recognized as technically sound, and which simulates to the extent possible in the laboratory the conditions under which the product is intended for use. For virucides whose use-directions identify the product as one intended for use upon dry, inanimate, environmental surfaces (such as floors, tables, cleaned and dried medical instruments, etc.), carrier methods, which are modifications of either the AOAC Use-Dilution Method (for liquid surface disinfectants) or the AOAC Germicidal Spray Products Test (for surface spray disinfectants), must be used in the development of the virological data. To simulate in-use conditions, the specific virus to be treated must be inoculated onto hard surfaces, allowed to dry, and then treated with the product according to the directions for use on the product label. One surface for each of two different batches of disinfectant must be tested against a recoverable virus titer of at least 10 4 from the test surface (petri dish, glass slide, steel cylinder, etc.) for a specified exposure period at room temperature. The virus is then assayed by an appropriate virological technique. The protocol for the viral assay must provide the following information: i. The virus recovery from a minimum of 4 determinations per each dilution in the assay system (tissue culture, embryonated egg, animal infection, or whatever assay system is employed). ii. Cytotoxicity controls: The effect of the germicide on the assay system from a minimum of 4 determinations per each dilution. iii. The activity of the germicide against the test virus from a minimum of 4 determinations per each dilution in the assay system. iv. Any special methods which were used to increase the virus titer and to detoxify the residual germicide. v. The ID-50 values calculated for each assay. vi. The test results shall be reported as the reduction of the virus titer by the activity of the germicide (ID-50 of the virus control less the ID-50 of the test system), expressed as log 10 and calculated by a statistical method (Reed and Muench, 1938; Litchfield and Wilcoxon, 1949; as examples). vii. For virucidal data to be acceptable, the product must demonstrate complete inactivation of the virus at all dilutions. When cytotoxicity is evident (as in attached tables) at least a 3log reduction in titer must be demonstrated beyond the cytotoxic level. The calculated viral titers must be reported with the test results. A typical laboratory report of a single test with one virus (recovered from a treated surface) involving a tissue culture, therefore, would include the details of the methods employed and the information in the attached tables. Claims of virucidal activity for a product must be restricted to those viruses which have actually been tested. Separate studies on two batches of product are required for each virus.

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Carpet SanitizersDIS/TSS-8 / April 18, 1981 EFFICACY DATA REQUIREMENTS Carpet SanitizersProducts bearing label claims for effectiveness as sanitizers for pre-cleaned carpeting must be tested by a protocol incorporating the basic elements of the attached recommended method. If the product is intended to be represented in labeling as a "one-step" cleaner-sanitizer, the method must be modified by including an appropriate soil with the bacterial inoculum.

a. Test requirements.1. Three product samples representing 3 separate batches, one of which is at least 60 days old, must be tested against Staphylococcusaureus ATCC 6538 and Enterobacteraerogenes ATCC 13048 with 2 different types of representative synthetic carpeting, such as acrylic and polypropylene tufted-loop types. If the application is intended for hospitals or medical institutions, the product must also be tested against Pseudomonasaeruginosa ATCC 15442. If the product is also intended for use on wool carpeting, an additional representative sample of wool carpet must be tested; otherwise, the label must bear a disclaimer for use on wool. All carpet samples tested must be fully identified by the pile fiber type, pile yarn weight of finished carpet, pile density, and tuft height. Adequate controls must demonstrate that bacteriostatic agents in the carpet pile or backing do not yield false-negative data which interfere with the test results. 2. The amount of solution applied to the sample carpeting in the tests must be determined and extrapolated to obtain the amount of the solution of product to be applied to carpeting (volume per unit area) as stated on the label.

b. Performance requirements.A 99.9% reduction of test bacteria over the scrubbed control count must be demonstrated. Note: If the product is intended for use in hospitals or medical institutions, a wet vacuum pickup must be specified in the label directions for use. In no case will the so-called "dry shampoo treatment" be considered for use in such areas. Sanitizers - Carpets (Proposed method prepared by Registration Division, Office of Pesticide Programs, EPA, 1976; revised 1981)

a. Special equipment and materials.1. Carpet mounting board. Mount a piece of l/8-in. (0.3 cm) tempered hardboard, tempered surface up, on a 16 x 16-in. (40.6 x 40.6 cm) base of 3/4-in. (1.8 cm) thick marine plywood, with 3/4-in. (1.8 cm) brads. 2. Cutting equipment. 2 x 2-in. (5.1 x 5.1 cm) squares of 1/4-in. (0.6 cm) acrylic plastic with 3/32-in. (0.24 cm) holes in the center as templates, and a sharp knife with replaceable blade. 3. Scrub brushes. 1 1/4 x 3 1/2-in. (4.2 x 8.9 cm) surgical hand brush with 5/8-in. (0.6 cm) nylon bristles.

4. 4. Extraction bottles. 8-oz. (236.6 ml), widemouth, round, polypropylene bottles with screw caps (Nalgene 2105 or equivalent) containing 10 stainless steel penicylinders and 100 ml of appropriate neutralizer broth. Similar style glass bottles may be used but care must be taken to prevent breakage during shaking. 5. Spray device. Adjustable spray atomizer modified to feed from a calibrated test tube or bottle. A Model 15 DeVilbiss atomizer on a 2-oz. (59.2 ml) bottle graduated with 10-ml marks may be used. 6. Carpet. If the product is intended for use on commercial grade carpeting, 2 representative carpets, such as acrylic and polypropylene tufted-loop type must be tested. No carpeting is available to serve as a standard. If the product is intended for use on wool carpeting, a representative wool sample must additionally be tested. All carpet samples tested must be fully identified, and the pile fiber type, pile yarn weight of finished carpet, pile density and tuft height must be reported. Adequate controls must demonstrate that bacteriostatic agents in the carpet pile or backing do not interfere with the test results.

b. Test cultures and media.1. Test bacteria. Use Staphylococcusaureus (ATCC 6538) and Enterobacteraerogenes (ATCC 13048). If the product is intended for use in hospitals, Pseudomonasaeruginosa PRD-10 (ATCC 15442) must additionally be tested. 2. NutrientagarB. AOAC Methods, sec. 4.023 (a) (2). 3. Phosphate buffer dilution water. AOAC Methods, sec. 4.023 (f). 4. Double strength neutralizer broth. For phenolic based products, Letheen broth [AOAC Methods, sec. 4.001 (d) (3)] plus an additional 0.7 g lecithin (Azolectin) and 5 g polysorbate 80 (Tween 80) per liter may be used; or a defoaming neutralizer consisting of nutrient broth [AOAC Methods, sec. 4.001 (a)] plus 1.0 % Pluronic 25R2 (Meroxapol 252) has been suggested. In the case of halogen or heavy metal based products, 0.1% sodium thioglycollate and 0.01% isooctylphenoxypolyethoxyethanol (Triton X-100) in phosphate buffer (pH 7.2) may be used. 5. Neutralizerplatecountagar. Tryptone glucose extract agar [AOAC Methods, sec. 4.037 (a)] plus 0.7 g lecithin (Azolectin) and 5 g polysorbate 80 (Tween 80) per liter.

c. Bacterial inoculumPrepare French square culture bottles with nutrient agar B and test bacteria (AOAC Methods, sec. 4.026). Prepare standardized bacterial stock suspensions by washing growth from bottles and adjust to a density of 10 x 10 bacteria per ml with phosphate buffer dilution water (AOAC Methods, sec. 4.026).

d. Procedure.1. Cut the carpet into 8 x 12-in. (20.3 x 30.5 cm) pieces. With the aid of the 2 x 2-in. (5.1 x 5.1 cm) template, cut six 2 x 2-in. squares (2 rows of 3 squares per row) from the backing side of the carpet, leaving at least 4 in. (10.2 cm) between the center of each square. The preferred method is to leave about 1/8 in. (0.32 cm) of backing intact at each corner of each cut square so that the entire piece of carpeting can be sterilized and inoculated without separation. Mark the pile surface in the center of each test square with a waterproof marking pen with the aid of the hole in the center of the template. Cover the pile surface of the carpeting with aluminum foil and fold over edges to secure. Steam sterilize and dry. Only carpet that has been determined to be free of residual bacteriostatic activity on the pile or backing, following autoclaving, shall be used. A seeded agar plate overlay technique should be used for this determination. 2. Dilute the standardized bacterial stock suspensions, prepared as in (c) above, with

phosphate buffer dilution water containing 0.01% isooctylphenoxypolyethoxyethanol to a concentration 10 x 10 bacteria per ml. Inoculate the previously marked center of each cut square with 0.1 ml of the bacterial suspension. (Retain the bacterial suspensions for determination of inoculation numbers.) Dry inoculated carpet in an incubator at 35-37C for 60 min. with the foil wrap loosely in place. 3. Condition brushes by immersing the bristles in separate containers (15- cm glass petri dishes or equivalent) of diluted test solution and a control solution without the active antimicrobial ingredient(s) for 15 min. (If such a control solution is not available, use sterile distilled water containing 0.01% isooctylphenoxypolyethoxyethanol.) Fasten 2 pieces of inoculated carpet (each containing 6 test squares) onto the carpet mounting board by nailing each corner with upholstery tacks, and with the foil wrapping positioned so as to protect the controls during spraying and scrubbing with the test solution. Place the board in a biological hood or glove box. A simple safety chamber can be constructed from a large plastic bag. 4. Determine the amount of test solution intended to be applied to one piece of the carpeting containing 6 spots of dried bacterial inoculum [96 sq. in. or 2/3 sq. ft. (244 sq. cm)] and subtract approximately 15 ml which will be applied later in the brushing procedure. Apply the pre-determined amount of diluted test solution at room temperature uniformly by metered spray to one piece of the test carpet. Shake excess test solution from a conditioned brush and transfer to a fresh dish containing 100 ml of test solution at room temperature. Dip bristles of brush and transfer the retained test solution to an inoculated spot on the sprayed carpet. Scrub the spot for 30 sec. using 30 circular clockwise strokes and 30 circular counterclockwise strokes. A circular area of pile approximately 3 in. (7.6 cm) in diameter around each spot must be covered by this treatment. Moderate to heavy pressure should be applied downward on the brush to work the solution to the base of the pile. Repeat dipping of brush into test solution and scrubbing procedure until each of the 6 spots is treated. The brush dipped into the solution no more than 6 times will deliver about 15 ml of solution to the carpet. Do not exceed this amount. Record the total volume of solution applied by spray and brush. Allow the treated carpet piece to remain at room temperature for 60 min. for partial drying of the treated areas. 5. While the piece of carpet treated with the test solution is drying, spray the nonactive control solution at room temperature onto half of the other (control) piece of carpet so as to cover 3 of the 6 spots of dried inoculum. Position the aluminum foil over the remainder. Spray an amount equivalent to half of the amount of sprayed test solution. Scrub the 3 wet spots in the same manner as the test carpet. The remaining 3 spots are unscrubbed controls to determine the numbers of bacteria which survived drying of the inoculum. Care must be taken not to wet or scrub over the unscrubbed control area. Allow the scrubbed and unscrubbed controls to remain at room temperature for 60 min. as with the test piece. 6. Following the 60-min. drying periods, cut each 2 x 2-in. test square free with flamed forceps and knife. Transfer each square of carpet to a separate extraction bottle of neutralizer broth. Shake each extraction bottle vigorously for at least 1 min. to free the bacteria from the carpet fibers. Determine the number of viable bacteria in each sample bottle by plating duplicate dilutions in neutralizer plate count agar. Similarly determine the number of viable bacteria in 0.1 ml of the suspension used for inoculating the carpet. Also incubate all broth extraction bottles to determine whether neutralization of the test sample was achieved. 7. Determine the percent reduction of viable bacteria by the test solution by comparing the number of survivors from each treated test square against the average viable count from the scrubbed control squares. An average viable count of at least 1.0 x 106 bacteria from the extracted unscrubbed control squares is necessary for a valid test. Also see: Horowitz, William, ed. 1975. Official Methods of Analysis of the Association of Official Analytical

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Supplemental Efficacy: SterilizersDIS/TSS-9 EFFICACY DATA REQUIREMENTS Supplemental EfficacyA "sterilizer" is an antimicrobial pesticide that destroys or eliminates all forms of microbial life in the inanimate environment, including bacterial spores. The term "sporicide" is deemed to be synonymous with "sterilizer". Since sterilization includes eradication of all living microorganisms, such claims are intrinsically related to protection of human health. The following apply to all products represented in labeling as sterilizing or sporicidal agents.

1. Test requirements.The AOAC Sporicidal Test is required for substantiating sterilizing claims. Sixty carriersrepresenting each of two types of surfaces (porcelain penicylinders and silk suture loops) are required to be tested against spores of both Bacillus subtilis ATCC 19659 and Clostridium sporogenes ATCC 3584 on three product samples representing three different batches, one of which is at least 60 days old (240 carriers per sample; a total of 720 carriers). Any sterilizing agent (liquid, vapor, or gas) which is recommended for use in a specific device must be tested by the AOAC Sporicidal Test in that specific device and according to the directions for use.

2. Performance requirements.Killing on all of the 720 carriers is required. No failures are permitted. Data to support sterilizing claims must be confirmed by tests conducted by the Agency's Microbiology Laboratory before the data submitted for registration will be considered acceptable. *Note: Due to curtailment of laboratory operations at the EPA microbiology laboratory at Beltsville, MD, the required confirmatory validation data for a product as a sterilizer should be conducted by a second, independent laboratory of your choice (other than the laboratory which developed the original data). The following minimal confirmatory data must be developed on one sample of the product: Thirty carriers with each of the two types of surfaces (silk suture loops and porcelain penicylinders) against spores-of both Bacillus subtilis and Clostridium sporogenes (a total of 120 carriers) by the AOAC Sporicidal Test.

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Sanitizer Test for Inanimate SurfacesDIS/TSS-10 EFFICACY DATA REQUIREMENTS Supplemental EfficacySanitizer Test (for inanimate, non-food contact surfaces) (Proposed method prepared by Registration Division, Office of Pesticide Programs, EPA, 1976)

a. Test requirements.1. Three product samples, representing 3 different preparations, one of which is at least 60 days old, should be tested against each test bacterium on each test surface. The test bacteria are Staphylococcusaureus ATCC 6538 and Klebsiella pneumoniae, aberrant, ATCC 4352. Enterobacter aerogenes (ATCC 13048 or 15038) may be substituted for K. pneumoniae. The test surface(s) represent the type(s) of surfaces recommended for treatment on the label including, but not limited to, glass, metal, unglazed or glazed ceramic tile, porcelain, or vitreous china. The propagation of cultures and use of subculture media and other related equipment may be as specified in Sec. 4 (Disinfectants) of the Official Methods of Analysis of the A.O.A.C., 12th ed. (1975). 2. Determine the bacterial count in an 18- to 24-hr broth culture and add 0.01- to 0.03-ml of the broth culture by spreading on a 1 x l-in. square of the test surface using a bacteriological loop. If the product is to be represented as a "one-step" cleaner-sanitizer, an appropriate organic soil load, such as 5% blood serum, must be added to the bacterial inoculum. The square should be dried for 40 min. in a bacteriological incubator at 30-37C. A "zero time" bacterial numbers recovery determination should be performed and reported to show the number of viable bacteria on the test surface after drying. The product is applied to the inoculated test squares as directed on the label. Parallel tests are run on the formulation with the active ingredient(s) omitted in an identical manner to serve as controls. If such a control solution is impractical, use sterile distilled water to which may be added 0.01% isooctylphenoxypolyethoxyethanol (with 9-10 moles oxyethylene, e.g., Triton X-100). After a suitable time interval, recover the test bacteria by washing the square with adequate agitation in appropriate media or dilution fluid containing appropriate neutralizers. Make plate counts in appropriate nutrient agar containing the same neutralizers by the pour or spread plate technique. Exposure time intervals between zero time and five minutes must be tested for the product as well as for the untreated controls.

b. Performance requirements.The results must show a bacterial reduction of at least 99.9% over the parallel control count within 5 minutes.

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Air SanitizersDIS/TSS-11 / Sep. 3, 1980 EFFICACY DATA AND LABELING REQUIREMENTS: Air SanitizersThese requirements apply to products with label claims for the treatment of air to reduce the numbers of airborne microorganisms.

a. General.There is considerable evidence that glycol vapors produce significant decreases i/n numbers of viable airborne bacteria under relatively wide conditions of relative humidity and temperature when properly and continuously dispensed by a vaporizing device so as to maintain suitable concentrations in the air of enclosed spaces. With dispensers for the intermittent treatment of air, such as pressurized aerosols, several investigators have shown that glycols (triethylene, dipropylene, or propylene glycol) at concentrations of 5% or more in such formulations will temporarily reduce numbers of airborne bacteria when adequate amounts are dispensed under relatively ideal conditions. For other types of products intended for the treatment of air, claims for reducing numbers of airborne microorganisms will be considered, providing supporting experimental data are submitted to justify such claims.

b. Test StandardNo standard method for evaluating air sanitizers has been adopted. Refer to the attached references for information on testing products intended for sanitizing the air of enclosed spaces. Proposed testing protocols for studies of this kind may be submitted for review and evaluation by the Agency prior to initiation of the tests. 1. Glycol Products. For products containing at least 5% glycols (triethylene, dipropylene, and/or propylene glycols), quantitative chemical determinations must be performed, using an air sampling device, to show the concentration of glycol vapor achieved with the product, used as directed, in an enclosed experimental room or chamber. (Note: Until the proposed Product Performance Guidelines are finalized, testing requirements are being deferred for products of this type. Currently, efficacy requirements are satisfied by the chemical formula statement showing appropriate glycol content.) DIS/TSS-11 3 Sept. 80 2. Other Products. For products other than those specified in (b)(l), quantitative microbiological assays must be performed, using an air sampling device, to show the level of reduction of viable microorganisms achieved with the product, used as directed, in an enclosed experimental room or chamber. The primary test bacteria are Staphylococcusaureus ATCC 6538 and Klebsiellapneumoniae ATCC 4352. If the product is intended for use in hospital or medical environments, tests with Pseudomonasaeruginosa ATCC 15442 are also required. 3. The methodology employed, such as spraying and sampling procedures, and the

environmental conditions in the room or chamber, such as temperature, relative humidity, etc., must be reported. Raw data, as well as any statistical or graphical interpretation of the results, must be included in the reports.

c. Performance Standard.For products containing at least 5% glycols, the results must show that adequate vapor concentrations (50% saturation or more) are achieved in the air of the test enclosure. [Note: See (b)(l) above for current policy in this regard.] For other products, the results must show a viable count reduction of at least 99.9% over the parallel untreated control, after correcting for settling rates, in the air of the test enclosure with each of the required test bacteria.

d. Claims.Adequate experimental data is available to show that air sanitizers do not sterilize, disinfect, act as a germicide, or protect experimental animals from infections by airborne bacteria or viruses. Thus, claims of value in preventing or treating diseases, or providing any other health protection, whether expressed or implied, are not acceptable. Claims must clearly indicate the mitigating nature of the activity, such as "Temporarily reduces the number of airborne bacteria."

e. Directions For Use.The label directions for use of air sanitizers must state: 1. That application be made in closed spaces ("Close all doors and windows; close air vents or turn off air conditioners."); 2. The duration and frequency of spraying; 3. How the spraying should be conducted; 4. The relative humidity necessary for maximum effectiveness. With glycols and glycol mixtures intended for use in continuous vaporizing devices, the vaporizers themselves do not require registration. However, since their use is an integral part of the directions for use of the pesticide product, the labeling used in connection with the sale of the vaporizer is collateral to the labeling of the pesticide and must be submitted as a part of the registration.

ReferencesBigg, E., B.H. Jennings, and F.C.W. Olsen. 1945. Epidemiological observations on the use of glycol vapors for air sterilization. Am. J. Public Health 35:788-798. Challinor, S.W. and J.P. Duguid. 1944. Propylene glycol as an air disinfectant. I. Edinburgh Med. J. 51:280-289. Dimmick, R.L. and A.B. Akers (Eds.). 1969. An Introduction to Experimental Aerobiology. WileyInterscience, New York. Greene, V.W., D. Vesley, R.G. Bond, and G.S. Michaelsen. 1962. Microbiological contamination of hospital air. I. Quantitative studies. Appl. Microbiol. 10:561-566. Gregory, P.H. and J.L. Monteith (Eds.). 1967. Airborne Microbes. Cambridge Univ. Press, London. Hall, L.B. 1962. Air sampling for hospitals. Hospital Topics 40:97-100. Hamburger, M.J., O.H. Robertson, and T.T. Puck. 1945. The present status of glycol vapors in air sterilization. Am. J. Med. Sci. 209:162-166.

Kerlan, I. 1950. Glycol vapors for air sanitation...the F.D.A. view. Soap Sanitary Chem. 26(2):122124. Lester, W.,Jr., O.H. Robertson, T.T. Puck, and H. Wise. 1949. The rate of bactericidal action of triethylene glycol vapor on microorganisms dispersed into the air in small droplets. Am. J. Hyg. 50:175-188. Lester, W.,Jr., S. Kaye, O.H. Robertson, and E.W. Dunklin. 1950. Factors of importance in the use of triethylene glycol vapor for aerial disinfection. Am. J. Public Health 40:813-820. Lester, W.,Jr., E. Dunklin, and O.H. Robertson. 1952. Bactericidal effects of propylene and triethylene glycol vapor on Escherichia coli. Science 115:379-382. McConnell, W.J. 1949. An experiment with triethylene glycol vapor for the control of colds among office workers. Ind. Med. 18:192-196. McGray, R.J. 1970. A test method for the evaluation of air sanitization. Proc. Chem. Specialties Manufact. Assoc., pp. 106-111. Puck, T.T., O.H. Robertson, and H.M. Lemon. 1943. The bactericidal action of propylene glycol vapor on microorganisms suspended in air. II. The influence of various factors on the activity of the vapor. J. Exper. Med. 78:387-406. Puck, T.T. 1947. The mechanism of aerial disinfection by glycols and other chemical agents. II. An analysis of the factors governing the efficiency of chemical disinfection of the air. J. Exper. Med. 85:729-757. Robertson, O.H., E. Bigg, B.F. Miller, Z. Baker, and T.T. Puck. 1941. Sterilization of air by certain glycols employed as aerosols and vapors. Trans. Assoc. Am. Physicians 56:353-358; Science 93: 213-14. Robertson, O.H. 1943. Sterilization of air with glycol vapors. Harvey Lect. 38:227-254. Robertson, O.H., B.F. Miller, and E. Bigg. 1943. Method of sterilizing air. U. S. Patent No. 2,333,124. Rosebury, T. 1947. Experimental Airborne Infection. Williams and Wilkens, Baltimore. Stuart, L.S. and J.L. Friedl. 1955. Testing aerosol products for germicidal and sanitizing activity. Proc. Chem. Specialties Manufact. Assoc., pp. 93-97. Wolf, H.W., et al. 1959. Sampling microbiological aerosols. Public Health Service Publication No. 686, Washington.

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Swimming Pool Water DisinfectantsDIS/TSS-12 / Apr. 23, 1979 EFFICACY DATA REQUIREMENTS Swimming Pool Water DisinfectantsNumerous factors influence the concentrations necessary for disinfection of swimming pool water in practical applications: numbers of swimmers in the pool; frequency of use; frequency with which water is changed; general weather conditions; and types and degree of organic contamination of the water by the swimmers themselves (e.g., suntan lotions and oils) and by various debris. Therefore, a two-phased study (presumptive laboratory testing and confirmatory field testing) is required.

1. Laboratory test requirements.Presumptive efficacy of swimming pool water disinfectants may be substantiated with data derived from the AOAC Method for Water Disinfectants for Swimming Pools or with slight modifications (e.g., pH) thereof, against both E.coli and S.faecalis.

2. Performance standard for laboratory test.The lowest concentration of the test germicide providing results equivalent to those of the sodium hypochlorite control is the lowest concentration of the product that can be considered effective.

3. Field test requirements.In addition to the laboratory test requirements referred to above, confirmatory efficacy data shall be derived from in-use tests under an Experimental Use Permit in at least two swimming pools. The tests must be conducted for an entire swimming season (4 to 12 months). Reports must include (but are not limited to) the following information concerning the test pools: i. The design of the pool, the recirculation and filter system, and water capacity. ii. The daily bather load. iii. The amount and identification of all chemicals added daily to the swimming pool water (including the time, site, and method). iv. The range of chemical characteristics of the swimming pool water, such as: ph, nitrogenous substances, metals, and hardness. v. The physical characteristics of the swimming pool water, including temperature and clarity, determined at least daily. vi. Meteorological data, including air temperature, rainfall and number of hours of sunlight (determined daily) for outdoor pools. vii. Water samples for bacteriological analysis should be taken on opposite sides of the pool in the shallow area and as remote as possible from the inlets, preferably at the midpoints between inlets. A minimum of 144 samples should be collected during the test period. Samples should be taken just below the surface of the water and

preferably at such times when the number of persons using the pool during the preceding hour has been at least equal to 50% of the maximum bather load of the pool and the number of persons in the pool water at the time the samples are collected is at least equal to 25% of the maximum bather load of the pool. Pertinent chemical characteristics of the pool water at the sampling site should be determined at the time of sampling. viii. The concentration of the antimicrobial agent in the swimming pool water monitored daily at the same time-intervals that the bacteriological assay samples are obtained.

ix. The method that the product user will employ for monitoring the level (concentration in ppm) of antimicrobial agent contained in the pool water.

4. Performance standard for field test.The product, when used as recommended in swimming pool water, should demonstrate that not more than 15% of the samples collected shall fail to meet the following bacterial indices. i. The standard plate count at 35o shall not exceed 200 colonies per L0 ml. ii. The most probable number of coliform bacteria shall be less than 2.2 organisms per 100.0 milliliter. When the membrane filter test is used there shall be no more than 1.0 enterococcal organisms per 50 ml. iii. The most probable number of entercoccal organisms shall be less than 2.? organisms per 50 ml. * As defined in Suggested Ordinance and Regulations Covering Public Swimming Pools, APHA Joint Committee on Swimming Pools and Bathing Places.

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Laundry Additives - Disinfection and SanitizationDIS/TSS-13, April 4, 1980 EFFICACY DATA AND LABELING REQUIREMENTS Laundry Additives - Disinfection and SanitizationThe following requirements apply to antimicrobial products which bear label claims or recommendations for use in the treatment of laundry to provide disinfecting or sanitizing activity for fabrics and/or laundry water. Label claims must distinguish between products recommended as soaking treatments prior to laundering and products represented as additives in actual laundry operations.

a. Pre-soaking treatmentsProducts recommended for pre-soaking soiled fabrics prior to routine laundering must be shown to be effective by appropriate tests (e.g. AOAC Use Dilution Method for disinfectants; Sanitizer Test for inanimate non-food contact surfaces for sanitizers) in the presence of organic soil (e.g. 5% blood serum). The directions for use must specify rinsing of the items to remove gross filth prior to soaking, followed by complete immersion in an adequate volume of soaking solution (at least 5:1 w/w solution to fabric ratio, e.g. half a washload in a 3 - gallon pail) at the recommended use dilution for a specified contact time prior to the laundering operation.

b. Laundry operations.A clear distinction should be made on the label between products recommended for household and coin-operated laundering and products represented as commercial-industrialinstitutional laundry additives. The water to fabric ratio in home or coin-operated machines is about 10:1 (w/w), whereas in industrial laundering operations the ratio is about 5:1. The effectiveness of products may be significantly altered by these differences; thus, demonstrated eficacy in one system may not be able to be extrapolated to the other. In addition, directions for use of household laundering products may require different dosages for front-loading automatics (e.g. 8-10 gallon water capacity) and top-loading automatics and wringer-type washers (e.g. 12-15 gallon water capacity). Product dosages, in this instance, should be specified in household measurements. Dosage instructions for industrial laundering may be based on pounds of dry fabric. The directions for use of laundry additives should specify the machine cycle in which the product is to be added, water level, temperature range, and treatment time. Compatibility of the treatment with other common laundry additives (e.g. soaps, detergents, bleach, starch, bluing, sours, fabric softeners) should be determined in testing and addressed in labeling, when applicable. Efficacy data requirements for disinfectants and sanitizers intended for use as additives in laundry operations are as follows: 1. Disinfection

i. Test standard. A proposed simulated use procedure employed by Petrocci and Clarke

(Petrocci, A. M. and Clarke, P. 1969. Proposed Test Method for Antimicrobial Laundry Additives. J.A.O.A.C. 52: 836-42) is acceptable. Alternately, a simulated-use study utilizing washing machines may be employed. The following basic elements must be incorporated in either study: A. The test bacteria are Staphylococcus aureus(ATCC 6538) and Klebsiella pneumoniae(ATCC 4352). If the product is intended for use on hospital linens, it must also be tested against Pseudomonas aeruginosa(ATCC 15442). B. The basic bacteriological procedures must be the same as those specified in the Petrocci and Clarke protocol. C. Tests must be conducted with 3 product samples, representing 3 different batches, one of which is at least 60 days old. Each sample must be tested with 9 fabric swatches against each of the specified test bacteria. D. The method employed must be designed to include testing both the fabric and the laundry water (5ml from the automatic washer, or 0.5 ml from the simulated washing device in individual widemouth jars containing subculture media and neutralizers. The laundry water-tomedia volume ratio must not exceed 1:40. E. Growth or no-growth must be recorded and reported after a 48-hour incubation period.

ii. Performancestandard. There must be no growth in the fabric subcultures and no growth in the subcultures from the laundry water with all test bacteria. 2. Sanitization. i. TestStandard. The same type of studies referred to under "Disinfection" above must be employed for evaluating the efficacy of laundry additives intended to sanitize laundry, with the following exceptions:

A. Tests must be conducted with 3 samples representing 3 product batches, one of which is at least 60 days old. Each sample must be tested with 3 cloth swatches against each test microorganism required. B. Quantitative bacteriological assays must be conducted and the results reported.

ii. Performance standard. The data requirements outlined herein do not apply to sodium-calcium hypochlorites, sodiumpotassium dichloro-s-triazinetriones or trlchloro-s-triazinetrione.

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Laundry Additives - Residual Self-SanitizationDIS/TSS-14 July 29, 1981 Efficacy Data Requirements Laundry Additives Residual Self-Sanitization a. Laundry operations.A clear distinction should be made on the label between products recommended for household and coin-operated laundering and products represented as commercial-industrialinstitutional laundry additives. The water to fabric ratio in home or coin-operated machines is about 10:1 (w/w), whereas in industrial laundering operations the ratio is about 5:1. The effectiveness of products may be significantly altered by these differences; thus, demonstrated efficacy in one system may not be extrapolated to the other. In addition, directions for use of household laundering products may require different dosages for frontloading automatics (e.g., 8-10 gallon water capacity) and top-loading automatics and wringer-type washers (e.g., 12-15 gallon water capacity). Product dosages, in this instance, should be specified in household measurements. Dosage instructions for industrial laundering may be based on pounds of dry fabric. The directions for use of laundry additives should specify the machine cycle in which the product is to be added, water level, temperature range, and treatment time. Compatibility of the treatment with other common additives (e.g., soaps, detergents, bleach, starch, bluing, sours, fabric softeners) should be determined in testing an addressed in labeling, when applicable.

b. Test standard.A suggested protocol published by Petrocci and Clarke (J. AOAC 52:836-842) is acceptable for treating the fabric. The basic elements outlined in the protocol of the "Quantitative Procedure" of the American Association of Textile Chemists and Colorists (AATCC) Test Method 100-1974 employing Staphylococcus aureus (ATCC 6538) and Klebsiella pneumoniae (ATCC 4352) are acceptable for evaluating the residual antimicrobial activity. However, 3 samples, representing 3 different product batches must be tested, and the following modifications to the method must be incorporated: 1. Use a sufficient number of swatches placed exactly on top of each other so that they completely absorb 1 ml of inoculum which is prepared to contain at least 107 microorganisms/ml. 2. The number of swatches used per jar must be reported. 3. Incubation must be at 20-21 C (68-70 F). 4. Quantitative bacteriological assays should be performed at the following time intervals: 0, 30 min., 1-hr, 3-hr, 6-hr, and 24-hr. Consideration could be given to fewer or different time intervals, depending on the label claims, on a case-by-case basis.

c. Performance standard.For residual self-sanitizing claims against pathogenic microorganisms, the reduction of each test microorganism must be at least 99.9% over the "0-time" control and the parallel

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You are here: EPA Home Pesticides Science and Policy Policy and Guidance Label Requirements for Antimicrobial Pesticides Used On Hard Surfaces

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Label Requirements for Antimicrobial Pesticides Used On Hard SurfacesDIS/TSS-15 / March 24, 1981 LABEL REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES USED ON HARD SURFACES: Directions For UseLabeling must bear directions for each recommended use. The directions for use must include the following: 1. The major area(s) in which the product is recommended for use (e.g. homes, schools, hospitals). 2. Identification of the type of surfaces, objects, or items intended for treatment (e.g. floors, walls, bathroom fixtures, surgical instruments), in addition to any description of surface composition (e.g. stainless steel, chrome, glass, vinyl). 3. The necessity for removal of gross filth or heavy soil. In addition, instructions must be provided for thorough cleaning of surfaces prior to application of the product, unless the product has been shown to be effective in the presence of moderate amounts of representative soil. Cleaning instructions must be clearly separated from the directions for use of the product as an antimicrobial agent. 4. If the product is to be diluted, the recommended use dilution and instructions for preparing it. The units of measure (e.g. tablespoons, ounces, quarts, gallons) to be employed in diluting the product must be given, and must be understandable to the user. 5. The method(s) of application (e.g. "by sponge, mop, or spray" or "by immersion in the solution", followed by a statement such as "to wet all surfaces thoroughly"). 6. The contact time necessary for effectiveness. The directions must also indicate if, and how, the product should be removed from the surfaces after the recommended exposure period.

7. The number of times or duration of time a prepared use solution may be used for immersable items (e.g. whether a fresh solution should be prepared for each batch or for each day's use if the solution does not become diluted or soiled, or whether the solution may be re-used for a given number o batches or for a given number of days). 8. Additional instructions may be recommended by the applicant, or required by the Agency, as determined on a case-by-case basis.

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You are here: EPA Home Pesticides Science and Policy Policy and Guidance Determination of Health-Related and Non-Health-Related Uses

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Determination of Health-Related and NonHealth-Related UsesDIS/TSS-16 / June 26, 1979 REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES: Determination of Health-Related and Non-Health-Related UsesAccording to Section 3 (c) (5) of FIFRA, as amended by the Federal Pesticide Act of 1978, and the provisions of 40 CFR 162.18-2 of the Regulations for the Enforcement of FIFRA, products bearing claims for control of microorganisms which pose a threat to human health require specific efficacy data to support such claims and patterns of use; products bearing claims expressly for control of microorganisms not directly related to human health do not require supporting efficacy data. The following criteria will be utilized to determine whether or not the labeling of an antimicrobial pesticide bears uses of human health significance: 1. Products bearing claims for control of microorganisms infectious for man will be considered as directly related to human health and will require specific and complete efficacy data to support such claims and patterns of use. 2. Unqualified and non-specific claims for products as sterilizers, disinfectants, or sanitizers will be considered to include or imply effectiveness against microorganisms infectious for man. Antimicrobial products recommended for use in hospital or medical environments, including sickrooms in public or private dwellings, will be similarly considered as human health-related. Such claims or recommendations must be expressly qualified or deleted in order to remove implications of human health significance. 3. Algaecides, slimicides, preservatives, deodorizers, and other products expressly claiming control of microorganisms of economic or aesthetic significance not directly related to human health will not require efficacy data. However, adequate dosage recommendations and complete directions for use must be provided in labeling. 4. Since elimination or significant reduction in numbers of microorganisms (sterilization, disinfection, sanitization) must be demonstrated before a product is considered acceptable for claims against microorganisms infectious for man, or for use in medical or sickroom environments, products bearing claims for effectiveness at the bacteriostatic level (inhibition of growth) will not be accepted for such situations. Bacteriostatic claims will only be permitted for products expressly recommended for control of microorganisms of economic or aesthetic significance (e.g. slime-forming bacteria, odor-causing bacteria). 5. When no pesticidal purpose or function is known or shown to exist for a proposed claim or pattern of use for an antimicrobial product, registration will not be considered. 6. Hospital sterilizers and disinfectants, swimming pool water disinfectants, human drinking water disinfectants and purifiers, and food contact surface sanitizers are, by their very nature, human health-related and will require efficacy data whether or not control of specific infectious microorganisms are claimed. 7. Veterinary and animal premise disinfectants will require efficacy data to support claims against those microorganisms which are infectious for both man and animals. Efficacy data will not be required for those microorganisms which are solely pathogenic for animals.

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You are here: EPA Home Pesticides Science and Policy Policy and Guidance Label Requirements for Pesticides Used for Sanitation of Food Contact Surfaces

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Label Requirements for Pesticides Used for Sanitation of Food Contact SurfacesDIS/TSS-17 / Dec. 2, 1979 LABEL REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES USED FOR SANITATION OF FOOD - CONTACT SURFACES Directions For UseLabeling must bear directions for each recommended use. The directions for use must include, but are not limited to*, the following: 1. The major areas in which the product is recommended for use (e.g. restaurants, dairies, food processing plants). 2. The identification of the types of hard surfaces, or objects, intended for treatment. 3. The necessity for removal of gross food particles and soil by a pre-flush, or pre-scrape and, when necessary, pre-soak treatment. In addition, instructions must be provided for thoroughly washing the surfaces or objects with a good detergent or compatible cleaner, followed by a potable water rinse prior to application of the sanitizing solution. 4. The recommended use dilution and instructions for preparing it. The units of measure (e.g. tablespoons, ounces, quarts, gallons) to be employed in diluting the product must be given, and must be understandable to the user. The concentration (ppm) of principal active ingredient (e.g. titratable iodine, available chlorine, active quaternary) provided by the recommended use solution should also be given. 5. The method of application (e.g. immersion, flooding, spraying) to wet all surfaces thoroughly. Additional instructions for in-place sanitizing may be required (e.g. filling piping with the sanitizing solution). 6. The contact time of at least 1 minute required for sanitization. The directions must also indicate if, and how, the product is to be removed from the surfaces after the recommended contact time. Instructions to drain the use solution from the surface and air dry are appropriate for product cleared for use on food contact surfaces under the Federal Food, Drug and Cosmetic Act. A potable water rinse must be recommended for removal of the use solution from the food contact surface under any other circumstances. 7. For mechanical operations, the limitation that the prepared use solution may not be reused for sanitizing but may be re-used for other purposes such as cleaning. For manual operations, the recommendation that fresh sanitizing solution should be prepared at least daily or more often if the solution becomes diluted or soiled. *Additional instructions may be necessary for certain use patterns and/or categories of products to ensure safe and effective use of a product. Such additional instructions may be recommended by the applicant, or required by the Agency, as determined on a case basis.

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You are here: EPA Home Pesticides Science and Policy Label Requirements for Farm Premise Disinfectants

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Label Requirements for Farm Premise DisinfectantsDIS/TSS-18 / Jan. 17, 1989 LABEL REQUIREMENTS FOR FARM PREMISE DISINFECTANTS Directions For UseThe following label directions are required for farm premises disinfectants to permit their classification as non-food use products: 1. Do not use in milking stalls, milking parlors, or milk houses (for phenolics, cresylic acid, and pine oils). 2. Remove all animals and feed from premises, vehicles, and enclosures. 3. Remove all litter and manure from floors, walls and surfaces of barns, pens, stalls, chutes, and other facilities and fixtures occupied or traversed by animals. 4. Empty all troughs, racks, and other feeding and watering appliances. 5. Thoroughly clean all surfaces with soap or detergent and rinse with water. 6. Saturate all surfaces with the recommended disinfecting solution for a period of 10 minutes. 7. Immerse all halters, ropes, and other types of equipment used in handling and restraining animals, as well as forks, shovels, and scrapers used for removing litter and manure. 8. Ventilate buildings, cars, boats, and-other closed spaces. Do not house livestock or employ equipment until treatment has been absorbed, set, or dried. 9. Thoroughly