Document ID: EPA-HQ-OPPT-2009-0150-0025
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-03-13T04:00Z

United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 730-C-11-003
December 21, 2012

Product Performance
Test Guidelines

OCSPP 810.2500:

Air Sanitizers  -  
Efficacy Data Recommendations

                                       
                                       
                                       
                                       
                                       

                                       
                                        
                                     NOTICE
  
  This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).  To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number.  Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in their title.
  
  	 The OCSPP test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public and the companies that are subject to data submission requirements under TSCA, FIFRA and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice.  At places in this guidance, the Agency uses the word "should."  In this guidance, the use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.  
  
  	For additional information about these test guidelines and to access these guidelines electronically, please go to http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.
  

OCSPP 810.2500:  Air Sanitizers  -  efficacy data recommendations.
 
				
      (a) Scope.
            
	(1) Applicability. This guideline describes test methods that EPA believes will generally satisfy testing requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). It addresses testing to demonstrate the effectiveness of antimicrobial pesticides bearing label claims for the treatment of air to temporarily reduce the number of airborne bacteria.

      (2) Background. The source materials used in developing this OCSPP test guideline are OPP guidelines 91-5 Air sanitizers and 91-30 Acceptable methods (Pesticide Assessment Guidelines, Subdivision G, Product Performance, EPA report 540/9-82-026, October 1982).

		(b) Purpose. This guideline addresses efficacy testing for antimicrobial pesticides intended to be used for the treatment of air to temporarily reduce the number of airborne bacteria. 

		(c) General considerations.  - (1)  This guideline recommends methods for use in tests to be conducted to address the data requirements for pesticide registration.  Good Laboratory Practice Standards (GLP) as defined in 40 CFR Part 160 apply to studies to support sanitization of air. According to 40 CFR §160.17: "EPA may refuse to consider reliable for purposes of supporting an application for a research or marketing permit any data from a study which was not conducted in accordance with this part." 40 CFR §160.12(b) requires with any submitted research data"[a] A statement that the study was conducted in accordance with this part; [b] A statement describing in detail all differences between the practices used in the study and those required by this part; or [c] A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part." Refer to OCSPP Test Guideline 810.2000 for general testing recommendations prior to initiating tests.

		(d) Air sanitizers. This section addresses efficacy testing for antimicrobial products intended to be used to temporarily reduce the number of airborne bacteria. 

	(1)  Test procedure. -- (A) There is no standard test method for evaluating the effectiveness of antimicrobial pesticides to temporarily reduce airborne bacteria.  A list of references containing information and guidance on the testing of products intended for sanitizing the air of enclosed spaces is provided at paragraph (f) of this guideline. Applicants should contact the Agency and schedule a pre-registration meeting to discuss protocol development. Prior to the meeting, the applicant should provide an agenda of items for discussion, a draft label with the claims to be supported by the proposed protocol, and any research and development product performance data the applicant may have generated in support of the application. 
	
	The test protocol should address the following areas:  description of aerosol generator and generation;  description of medium used for generation; description of aerosol sampler including air volume sampled; volume of the chamber; particle size; aerosol dispersion of test material (vapor or particle dispersion; method used to ensure sterility of the test enclosure prior to conducting the microbiological assays; the procedure for introducing microorganisms into the air of the chamber, as well as the sampling and recovery procedures employed; the environmental conditions in the room or chamber, such as temperature and relative humidity; and the concentration of chemical and contact time needed to demonstrate effectiveness.  The settle rates in the air of the test enclosure should be measured for each of the recommended test bacteria. Quantitative microbiological assays should be performed to demonstrate the level of reduction of viable microorganisms achieved with the product, used as directed, in a sealed enclosure or space at least the size of a typical room (e.g., 10ft x 10ft x 8ft). The primary test bacteria for products intended for use in residential, commercial and industrial settings should be Staphylococcus aureus (American Type Culture Collection (ATCC) 6538) and Klebsiella pneumoniae (ATCC 4352). If the product is intended for use in hospitals or medical environ - ments, the product should also be evaluated for efficacy against Pseudomonas aeruginosa (ATCC 15442). The study design should also include a parallel, untreated control. Raw data, as well as any statistical or graphical interpretation of the results, should be included in the study report.
	
	(ii) Evaluation of sanitizer success. The test results should demonstrate a viable bacterial count reduction of >=99.9 percent (a 3 log10 reduction) over the parallel untreated control, after correcting for settling rates, in the air of the test enclosure with each of the required test bacteria.

      (e)  Data collection and reporting -- (1) General. To assist in the proper review and evaluation of product performance, complete descriptions of the test employed and the results obtained should be submitted to the Agency. All test reports should include, at the least, the following information:
      
      (i) Study title;
      
      (ii)  Product Identity;
      
      (iii)  Guideline number/Data Requirement; 
      
      (iv)  Identification of the testing laboratory or organization;
      
      (v)  Location where the test was performed;
      
      (vi)  Name(s) of the person(s) responsible for the test;
      
      (vii)  Statement of Confidentiality Claims;
      
      (viii)  Statement of 40 CFR Part 160 Good Laboratory Practice compliance and Quality Assurance Statement;
      
      (ix)  Purpose of the study;
      
      (x)  Date and time of the start and end of the test;
      
      (xi)  Test employed and any modifications (e.g., organic soil, hard water, etc), when using standard tests (e.g., AOAC, ASTM, etc) all deviations to the test methods should be reported;
      
      (xii)  Test microorganisms employed, including identification of the specific strain (ATCC or other);
      
      (xiii)  Description of the test substance, including the percent of active ingredient;
      
      (xiv)  Concentration or dilution of the product tested and how prepared;
      
      (xv)  Number of samples, batches and replicates tested;
      
      (xvi)  Manufacture date of each product batch; 
      
      (xvii)  Identification of all material or procedural options employed, where such choice is provided for or recommended in the test method selected (e.g., growth media, drying time for inoculated carriers, neutralization confirmation and/or subculture media, secondary subculturing);
      
      (xviii)  Test exposure conditions (e.g., contact time, temperature, and relative humidity);
      
      (xix)  Complete reports of results obtained for each replication;
      
      (xx)  Any control data essential to establish the validity of the test.
      
      (xxi)  Bacterial titer;
      
      (xxii)  Statistical treatment of the data;
      
      (xxiii)  Conclusions;
      
      (xxiv)  References;
      
      (xxv)  Appendices, including study protocol and all raw data reports associated with the conduct of the study;
      
      The applicant is encouraged to use the EPA's standard efficacy report format, which may be found at http://www.epa.gov/oppad001/efficacystudystandards.htm.
      
      (2)  Data for modifications of recommended methods.  Where recommended methods are modified for testing conducted to support specific claims and/or use patterns for a product, the protocol, identifying and describing each modification (e.g., organic load, hard water), should be provided with the study report.  The applicant is encouraged to submit the proposed modification to the Agency for review and evaluation prior to initiation of the test.
      
      (3)  Data for other methods.  When recommended methods, or modifications thereto, are not employed to develop efficacy data (such as actual in-use or many kinds of simulated-use testing), complete testing protocols should be submitted with the test reports.  All materials and procedures employed in testing should 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.  The applicant should submit the proposed testing protocols for in-use or simulated-use studies (with a proposed label to show the claims to be supported by the protocol) to the Agency for review and evaluation prior to initiation of the test.
 
	(f) References.  The references in this paragraph may be consulted for addi - tional background information.

      (1)  Brockmann, J.E. 1993.  Sampling and Transport of Aerosols.  In: Aerosol Measurement: Principles, Techniques and Applications, pp. 77  -  111.  Eds. Willeke, K and Baron, P.A. Wiley New York, NY.
      
      (2)  Buttner, M. P., Willeke, K., Grinshpun S. A. 1997.  Sampling and Analysis of Airborne Microorganisms.  In: Manual of Environmental Microbiology, pp 629  -  640.  Eds. Hurst, C.J., Knudsen, G. R., McInerney, M.J., et al., American Society for Microbiology, Washington, D. C.
      
      (3)  Clark, S. and Scarpino, P. 1995.  Disinfection of Microbial Aerosols.  Chap 7.  In:  Modeling Disease Transmission and its Prevention by Disinfection, Hurst, C.M., Cambridge University Press.
      
      (4)  Cox, C.S. and Wathes, C.M. (Eds).  1995 Bioaerosols Handbook.  Lewis Publications, Boca Raton, Fl.
      
      (5)  Dimmick, R.L. and A.B. Akers (Eds.). An Introduction to Experi - mental Aerobiology.  Wiley-Interscience, NY (1969).
      
      (6)  Greene, V.W. et al.  Microbiological contamination of hospital air.
      I.  Quantitative studies.  Applied Microbiology 10:561-566 (1962).
      
      (7)  Gregory, P.H. and J.L. Monteith (Eds.). Airborne Microbes.  Cam - bridge Univ.  Press, London (1967).							
      
      (8)  Hirch, A., Lidwell, O.M., and Williams, R.E.  1956.  The bacterial flora of the air of occupied rooms.  J Hgg (Lond) Dec. 54 (4):  512  -  523.
      
      (9)  Lester, W., Jr. et al.  Factors of importance in the use of triethylene glycol vapor for aerial disinfection.  American Journal of Public Health 40:813-820 (1950).
      
      (10)  Lester, W., Jr. et al.  Bactericidal effects of propylene and triethylene glycol vapor on Escherichia coli.  Science 115:379-382 (1952).
      
      (11)  McGray, R.J. A test method for the evaluation of air sanitization. Processing Chemical Specialties Manufacturers Association pp.106-111 (1970).
      
      (12)  McWall, R.E. 1975.  Practical methods of reducing airborne contaminants in interior spaces.  Arch Environ Health  30 (11):  552  -  558.
      
      (13)  Puck, T.T., et al.  The bactericidal action of propylene glycol vapor on microorganisms suspended in air.  II. The influence of various factors on the activity of the vapor.  Journal of Experimental Medicine 78:387-406 (1943).
      
      (14)  Puck, T.T. The mechanisms of aerial disinfection by glycols and other chemical agents. II. An analysis of the factors governing the efficiency of chemical disinfection of the air.  Journal of Experimental Medi - cine 85:729-757 (1947).
      
      (15)  Reponen, T., Willeke, K., Ulevicius, V., et al.  1997.  Techniques for Dispersion of Microorganisms into air.  Aerosol Sci. Technol.  27:  405- 421
      
      (16)  Spendlove, J.C. and Fannin, K.F.  1983.  Source, Significance and Control of Indoor Microbial Aerosols:  Human Health Aspects.  Public Health Rep.  98 (3) May  -  June:  229  -  244.
      
      (17)  Stuart, L.S. and J.L. Friedl.  Testing aerosol products for germi - cidal and sanitizing activity.  Processing Chemical Specialties Manufactur - ing Association, pp.93-97 (1955).
      
      (18)  Wolf, H.W., et al.  Sampling microbiological aerosols.  Public Health Service Publication No. 686, Washington, DC (1959).