United States

Environmental Protection Agency Office of Chemical Safety

and Pollution Prevention (7510P) EPA 712-C-07-074 Draft: May 11, 2011



# Product Performance

Test Guidelines

OCSPP 810.2500: Air Sanitizers—Efficacy

Data Recommendations2 NOTICE

This guideline is one of a series of test gui delines established by the Office of Chemical Safety and Pollution Prevention (OCS PP) (formerly the Offi ce of Prevention,

Pesticides and Toxic Subst ances (OPPTS) prior to Ap ril 22, 2010), United States Environmental Protection Agency for us e 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 (FFDCA) (21 U.S.C. 346a), referred to hereinafter as the harmonized test guidelines.

The harmonized test guidelines serve as a compendium of accepted scientific methodologies and protocols that are int ended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA. This document provides guidance for conducting appropriate tests, and is also us ed by EPA, the public, and the companies that are subject to data submission r equirements under TSCA, FIFRA and/or the FFDCA. . At places in this guidance, t he Agency uses the word “should.” In this guidance, use of “should” with regard to an action m eans that the action is recommended rather than mandatory. 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 circumstanc es warrant and without prio r notice. The methods contained in this guideline are strongly re commended 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 al ternatives to the methods recommended in these guidelines, with your supporting ra tionale. The Agency will assess such proposals on a case-by-case basis.

For additional information about OCSPP harmonized test guidelines and to access the guidelines electronically, please go to http://www.epa.gov/ocspp and select

“Test Methods & Guidelines” on the left si de 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-OPPT2009-0576.

DRAFT DOCUMENT DISCLAIMER: This draft document is distributed solely for the purpose of external review. It has not been formally disseminated by the EPA and should not be construed to represent any Agency determination or policy. The information correction process under the A gency’s Information Quality Guidelines does not apply until this document is forma lly disseminated by the EPA in its final form. This draft document should only be cited or quoted in the context of providing comments.3 OCSPP 810.2500: Air Sanitizers – efficacy data recommendations.

(a) Scope. (1) Applicability

. This guideline describes test methods that EPA believes will generally satisfy testing requi rements of the Federal In secticide, Fungicide, and Rodenticide Act (FIFRA) (7U.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 beari ng 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, Subdivi sion G, Product Performance, EPA report 540/9-82-026, October 1982).

(b) Purpose . This guideline addresses effi cacy testing for antimicrobial pesticides intended to be used for the treatm ent of air to temporarily reduce the

number of airbor ne 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 disinfection and sanitiza tion of textiles. According to 40 CFR §160.17: “EPA may refuse to consider reliable for purposes of supporting an application for a research or marketing pe rmit any data from a study which was not conducted in accordance with this par t.” 40 CFR §160.12(b) requires with any submitted research data“[a] statement describing in deta il all differences between the practices used in the study and those require d by this part.” Refer to OCSPP Test Guideline 810.2000 for general testing recomm endations 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 gu idance 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 t he 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 dev elopment product performance data the4 applicant may have generated in support of the application. Quantitative microbiological assays should be performed to demonstrate the level of reduction of viable microorganisms achieved with the pr oduct, used as directed, in a sealed enclosure 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 environments, the pr oduct should also be evaluated for efficacy against Pseudomonas aeruginosa (ATCC 15442).

In addition, the test protocol should address the following areas: method used to ensure sterility of the test enclosure prio r to conducting the microbiological assays; the procedure for introducing microorganisms into the air of the chamber, as well as the sampling and recovery procedures employ ed; the environmental conditions in the room or chamber, such as temperature and relative humidity; and the concentration of

chemical and contact time needed to demonstr ate effectiveness. The settle rates in

the air of the test enclosure should be measured for each of the recommended test bacteria. The study design should also in clude a parallel, untr eated control. Raw data, as well as any statistical or graphica l 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 3log 10 reduction) over the parallel untreated control, after correcti ng for settling rates, in the ai r of the test enclosure with each of the required test bacteria within 5 minutes.

(e) Data collection a nd reporting—(1) General. To assist in the proper review and evaluation of product performanc e, complete descriptions of the test employed and the results obtain ed should be submitted to the Agency. All test reports

should include, at the leas t, the following information:

(i) Study title;

(ii) Product Identity;

(iii) Guideline number/Data Requirement;

(iv) Identification of the test ing laboratory or organization;

(v) Location where the test was performed;

(vi) Name(s) of the person(s) responsible for the test;

(vii) Statement of Co nfidentiality Claims;5 (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, incl uding 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 ma terial or procedural options employed, where such choice is provided for or recommended in the test method selected (e.g., growth media, drying time for inocul ated carriers, neutralization conf irmation and/or subculture media, secondary subculturing);

(xviii) Test exposure conditions (e.g., contac t time, temperature, and relative humidity);

(xix) Complete reports of result s obtained for each replication;

(xx) Any control data essential to es tablish the validit y of the test.

(xxi) Carrier counts;

(xxii) Statistical treat ment of the data;

(xxiii) Conclusions;

(xxiv) References;

(xxv) Appendices, including st udy protocol and all ra w data reports associated with the conduct of the study;6 The applicant is encouraged to use the EPA’s standard efficacy report format, which may be found at http://www.epa.gov/oppad001/e fficacystudystandards.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 pr otocol, identifying and describing each modification (e.g., organic load, hard water), should be pr ovided 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 procedur es employed in testing should be described in a manner consistent with orig inal research reports publish ed in technical or scientific journals. Where references to published reports or papers are made, copies or reprints of such references should be pr ovided with the test reports. The applicant should submit the proposed testing protocols fo r 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 additional background information.

(1) Brockmann, J.E. 1993. Samplin g 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 Environm ental 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. Disin fection of Microbial Aerosols. Chap

7. In: Modeling Disease Transmission and it s 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 Experimental Aerobiology. Wiley-In terscience, NY (1969).

(6) Greene, V.W. et al. Microbiological contami nation of hospital air.

I. Quantitative studies. Applied Microbiology 10:561-566 (1962).7 (7) Gregory, P.H. and J. L. Monteith (Eds.). Ai rborne Microbes. Cambridge Univ. Press, London (1967).

(8) Hirch, A., Lidwell, O.M., and Williams, R.E. 1956. The bacte rial flora of the air of occupied rooms. J Hgg (Lond) Dec. 54 (4): 512 – 523.

(9) Lester, W., Jr. et al. Factors of im portance 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. Bacteric idal 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 M anufacturers Association pp.106-111 (1970).

(12) McWall, R.E. 1975. Pr actical methods of reducing airborne contaminants in interior spaces. Arch Environ Health 30 (11): 552 – 558.

(13) Puck, T.T., et al. The bacterici dal action of propylene glycol vapor on microorganisms suspended in air. II. T he 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 aeria l disinfection by glycols and other chemical agents. II. An analysis of t he factors governing the efficiency of

chemical disinfection of the air. Journal of Experimental Medicine 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 Fann in, 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. Fr iedl. Testing aerosol products for germicidal and sanitizing activity. Processing Chemical Specialtie s Manufacturing Association, pp.93-97 (1955).

(18) Wolf, H.W., et al. Sampling micr obiological aerosols. Public Health Service Publication No. 686, Washington, DC (1959).