Document ID: EPA-HQ-OPP-2009-0681-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-27T05:00Z

United States

Environmental Protection

Agency

	Office of Prevention, Pesticides

And Toxic Substances

(7510P)		EPA 712-C-07-091

 	Product Performance Test Guidelines

		

		OPPTS 810.2300:

Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations

Public Review Draft

NOTICE

          This guideline is one of a series of test guidelines
established by the Office of Prevention, Pesticides and Toxic Substances
(OPPTS), United States Environmental Protection Agency 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 (FFDCA) (21 U.S.C. 346a).

	The OPPTS 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.  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 OPPTS harmonized test guidelines and
to access the guidelines electronically, please go to   HYPERLINK
"http://www.epa.gov/oppts"  http://www.epa.gov/oppts  and select “Test
Methods & Guidelines” on the left side navigation menu.  You may also
access the guidelines in   HYPERLINK "http://www.regulations.gov" 
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.

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 Agency’s Information Quality Guidelines does not apply until
this document is formally disseminated by the EPA in its final form. 
This draft document should only be cited or quoted in the context of
providing comments. 



OPPTS 810.2300:  Sanitizers for use on hard surfaces - efficacy data
recommendations.  

(a) Scope

(1) Applicability.  This guideline is intended to meet testing
requirements of the Federal Insecticide, 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
effectiveness of products which are sanitizers.  

(2) Background.  The source materials used in developing this OPPTS test
guideline are OPP guidelines 91-2: Products for use on hard surfaces 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 on hard surfaces, namely
sanitizers in a variety of product types (water-soluble powders,
liquids, sprays, towelettes, etc.).    

(c) General considerations

(1)  This guideline recommends tests to be conducted and data to be
submitted which the Agency believes will generally satisfy the
requirements for pesticide registration.  Studies conducted under this
guideline should be completed under EPA’s Good Laboratory Practice
regulations (40 CFR Part 160).  Note:  The Association of Official
Analytical Chemists (AOAC) recommended tests are expected to be
conducted as written.  For deviations (e.g., cultures grown with shaking
instead of static, dilution of culture prior to drying on carriers)
proposed to be used in the conduct of these tests, obtain written
approval from the Agency and document such deviations in the study
reports submitted to the Agency.  The Agency may consult with the AOAC
prior to accepting modification to their standardized methods.  Refer to
OPPTS Test Guideline 810.2000 for general testing recommendations prior
to initiating tests.

(2)  Confirmatory testing.  In certain situations an applicant may rely
on previously submitted efficacy data to support an application or
amendment for registration of a product and submit only confirmatory
efficacy data on his own product to demonstrate his ability to produce
an effective formulation. These situations are as outlined in paragraphs
(c)(2)(i) and (c)(2)(ii) in this guideline.

(i)  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 (Master Record ID Numbers [MRIDs]) to the
supporting data developed for the original product are cited by the
applicant.

(ii)  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 (MRIDs) to the supporting data developed for the
original formulation are cited by the applicant.  The confirmatory data
should 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 should be produced under
similarly modified conditions.

(3)  Table 1 provides a quick reference guide to testing for basic
claims described in this guideline. Consult the text for detailed
testing descriptions.

Table 1. Tests for basic claims described in this guideline. 

Level of Efficacy	Test Methods	Test Organisms	No. of Batches/Carriers
Evaluation of Success

Non-food Contact Sanitizer	Water soluble powders/liquids

 Spray products	EPA Sanitizer Test or ASTM E-1153-03 	Staphylococcus
aureus (ATCC 6538) and Klebsiella pneumoniae (ATCC 4352) Enterobacter
aerogenes (ATCC 13048) may be substituted for K. pneumoniae.

	Three batches, one at least 60 days old.	99.9% reduction within 5
minutes. 

	Towelettes	Reserved

	Food Contact Surface Sanitizer

Halide Products	Water soluble powders/liquids	AOAC International
Chlorine (Available) in Disinfectants Germicidal Equivalent
Concentration	

Salmonella typhi (ATCC 6539) or S. aureus (ATCC 6538)	Three batches, one
at least 60 days old.	Test results should demonstrate product
concentrations equivalent in activity to 50, 100, and 200 ppm of
available chlorine.

Food Contact Surface Sanitizer

Non-Halide Products	Water soluble powders/liquids	AOAC International
Germicidal and Detergent Sanitizing Action of Disinfectants	

Escherichia coli (ATCC 11229) and S. aureus (ATCC 6538)	Three batches,
one at least 60 days old.  	99.999% reduction in the number of each test
microorganism within 30 seconds.

	Towelettes	EPA Test

	Sanitizers for Urinal and Toilet Bowl Water and In-tank Sanitizers

	Water soluble powders/liquids/tablets	Simulated-use study	

Enterococcus faecalis or Salmonella enterica	Three batches.	99.9%
reduction over parallel control counts.

Residual Self-sanitizing – wet surfaces

Simulated-use study	Representative gram positive and gram negative
organisms	Three batches, one at least 60 days old.	99.9% reduction over
parallel control counts.

(d) Sanitizers for nonfood contact surfaces (water soluble powders,
liquids, and spray products).  These products, when used as directed,
should reduce the number of test microorganisms on a treated surface
over those of an untreated control surface.  The following testing
recommendations apply to products bearing label claims for effectiveness
as sanitizers for inanimate hard surfaces other than those which come in
contact with food or beverages (e.g., floors, walls, furnishings).

(1) Test Procedures.  

(i) The Agency recommends the test procedures in this paragraph:  The
Sanitizer Test for Inanimate Non-food Contact Surfaces (prepared by the
Registration Division, Office of Pesticide Programs, EPA, 1976) (Ref.
1).  The propagation of cultures and the use of subculture media and
other related equipment may be as specified in Official Methods of
Analysis of AOAC International, Chapter 6, Disinfectants (Ref. 3). 
Three product samples, representing three different batches, one of
which should be at least 60 days old, should be tested against each test
bacterium on each representative test surface depending on the uses
proposed on the label (for hard, porous surface label claims use
unglazed ceramic tile) (for hard, nonporous surface label claims use
stainless steel carriers or glass slides), using 5 test carriers and 3
control carriers.  The test microorganisms are: Staphylococcus aureus
(S. aureus) (ATCC 6538) and Klebsiella pneumoniae (K. pneumoniae) (ATCC
4352).  Enterobacter aerogenes (E. aerogenes) (ATCC 13048) may be
substituted for K. pneumoniae.  The test elements in paragraphs
(d)(1)(A) through (d)(1)(I) of this paragraph should be used.

(A) Determine the bacterial count in an 18-24 hour broth culture and add
a 0.01- 0.03 mL quantity of the broth culture by spreading on a l x l
inch square of test surface using a bacteriological loop.

(B) If the product is intended to be represented as a cleaner-sanitizer,
an organic soil load, such as 5 percent blood serum, should be added to
the bacterial inoculum.

(C) The square of test surface should be dried for 40 minutes in a
bacteriological incubator at 30- 37 (C.

(D) A zero-time bacterial numbers recovery test (dried carrier count)
should be performed to demonstrate the efficiency of the recovery
process and should be reported.  The "zero-time" test is intended to
show the loss in viability that occurred during carrier drying.

(E) Apply the product to the inoculated test surfaces as directed on the
product label.

(F) Run parallel tests on the formulation with the active ingredients
omitted in an identical manner to serve as the control.  If such a
control solution is not suitable, use sterile distilled water to which
may be added 0.01percent isooctylphenoxypolyethoxyethanol (9-10 moles
oxyethylene, e.g., Triton X-100).

(G) After the label recommended exposure time, recover the test
organisms by washing the squares with agitation in media or dilution
fluid containing neutralizers

(H) Make plate counts on nutrient agar containing the same neutralizers
by the pour or spread plate technique.

(I) Exposure time intervals between 0-time and 5 minutes should be
tested for the product as well as the untreated controls.    

(ii) The American Society for Testing and Materials (ASTM) Test Method
for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact
Surfaces (E1153-03) may be used (Ref. 2).  Three product samples,
representing three different batches, one of which should be at least 60
days old, should be tested against each test bacterium on each
representative test surface depending on the uses proposed on the label.
(for hard, porous surface label claims use unglazed ceramic tile)  (for
hard, nonporous surface label claims use stainless steel carrier or
glass slide), using 5 test carriers and 3 control carriers.  The test
microorganisms are: (S. aureus) (ATCC 6538) and (K. pneumoniae) (ATCC
4352).  E. aerogenes (ATCC 13048) may be substituted for K. pneumoniae.
The ASTM method states that the inoculum employed should provide a count
of at least 7.5 x 105 colony forming units per carrier. 

(iii) Evaluation of sanitizing success for nonfood contact surface
sanitizers.  The results should demonstrate a reduction of at least
99.9% (a 3-log reduction) in the number of each test microorganism over
the parallel control count within 5 minutes.

(e)  Towelettes.  (Reserved.)

(f)  Sanitizers for Internal Toilet and Urinal Bowl Surfaces Above and
Below the Water Line

(1) Test Procedures. The Agency recommends the use of the Sanitizer Test
for Inanimate Non-food Contact Surfaces (prepared by the Registration
Division, Office of Pesticide Programs, EPA, 1976) (Ref. 1), or The
American Society for Testing and Materials (ASTM) Test Method for
Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact
Surfaces (E1153-03) may be used (Ref. 2).  The contained bowl water (96
fl oz) should used to calculate the appropriate use dilution for
testing.

(2) Evaluation of sanitizing success for toilet and urinal bowl surface
sanitizers.  The results should demonstrate a reduction of at least
99.9% (a 3-log reduction) in the number of each test microorganism over
the parallel control count within 5 minutes.

(g)  Sanitizing rinses (soluble powders and liquids) for previously
cleaned food-contact surfaces.  This section addresses efficacy testing
for products with a label recommendation for the treatment of previously
cleaned, nonporous, food contact surfaces (e.g., eating and drinking
utensils and food processing equipment) as a terminal sanitizing rinse. 

(1) Halide chemical products.  Sanitizing rinses formulated with
iodophors, mixed halides, and chlorine-bearing chemicals.

(i) Test procedure. The Agency recommends the AOAC International
Chlorine (Available) in Disinfectants Germicidal Equivalent
Concentration test (Ref. 3).  Three samples, representing three
different batches, one of which should be at least 60 days old, should
be evaluated for efficacy against Salmonella enterica (S. enterica)
(formerly Salmonella typhi) (ATCC 6539) or S. aureus (ATCC 6538).  When
claims are made for the effectiveness of the product in hard water, all
data should be developed at the hard water tolerance claimed. 

(ii) Evaluation of sanitizing success of halide formulations.  Test
results should demonstrate product concentrations equivalent in activity
to 50, 100, and 200 ppm of available chlorine.  The reference standard
is sodium hypochlorite.

(2) Confirmatory testing for halide chemical products

(i) Test procedure. The Agency recommends the AOAC International
Chlorine (Available) in Disinfectants Germicidal Equivalent
Concentration test (Ref. 3).  One sample should be evaluated for
efficacy against S. enterica (ATCC 6539) or S. aureus (ATCC 6538).  When
claims are made for the effectiveness of the product in hard water, all
data should be developed at the hard water tolerance claimed. 

(ii) Evaluation of sanitizing success of halide formulations.  Test
results should demonstrate product concentrations equivalent in activity
to 50, 100, and 200 ppm of available chlorine.  The reference standard
is sodium hypochlorite.

(3)  Non-halide chemical products.  Sanitizing rinses formulated with
quaternary ammonium compounds, chlorinated trisodium phosphate, and
anionic detergent-acid formulations.

(i) Test procedure.  The Agency recommends the AOAC International
Germicidal and Detergent Sanitizing Action of Disinfectants test (Ref.
4).  Three samples, representing three different batches, one of which
should be at least 60 days old, should be evaluated for efficacy against
both Escherichia coli (E.coli) (ATCC 11229) and S. aureus (ATCC 6538). 
When claims are made for the effectiveness of the product in hard water,
all data should be developed at the hard water tolerance claimed. 

(ii) Evaluation of sanitizing success of non-halide formulations. 
Acceptable results should demonstrate a 99.999% reduction in the number
of each test microorganism within 30 seconds.  The results should be
reported according to the actual count and percentage reduction over the
control. 

(4) Confirmatory testing for non-halide products—(i) Test procedure. 
The Agency recommends the AOAC International Germicidal and Detergent
Sanitizing Action of Disinfectants test (Ref. 4).  One sample should be
evaluated for efficacy against both E. coli (ATCC 11229) and S. aureus
(ATCC 6538).  When claims are made for the effectiveness of the product
in hard water, all data should be developed at the hard water tolerance
claimed. 

(ii) Evaluation of sanitizing success of non-halide formulations. 
Acceptable results should demonstrate a 99.999% reduction in the number
of each test microorganism within 30 seconds.  The results should be
reported according to the actual count and percentage reduction over the
control.

(h)  Towelette Sanitizers for Food Contact Surfaces.  This section
addresses efficacy testing for products with a label recommendation for
the treatment of hard, non-porous surfaces which may come into contact
with food.  Food Contact Surface (FCS) towelettes are intended to be
used to sanitize the following surfaces: hard non-porous tables,
countertops (stainless steel, laminated, sealed ceramic,) stove tops,
interior and exterior surfaces of microwaves and refrigerators.   FCS
towelettes may not be used to sanitize the following food contact
surfaces: utensils, glasses, food containers, dishes, cutting boards,
cutting blocks, drain boards, and food processing equipment.  This list
is not meant to be all-inclusive, but to serve as general guidance for
the appropriate use of this type of antimicrobial pesticide.  The Agency
reserves the right to accept or deny use sites for food contact surface
towelettes on a case-by-case basis.

(1) Test Procedure.  The Agency recommends the use of the Interim
Guidance for Non-Residual Sanitization of Hard Inanimate Food Contact
Surfaces Using Pre-Saturated Towelettes.  This guidance may be found at:
 http://www.epa.gov/oppad001/towelette.htm

Three samples, representing three different batches, one of which is at
least 60 days old, should be evaluated for efficacy against E. coli
(ATCC 11229) and S. aureus (ATCC 6538).

(2) Evaluation of towelette sanitizing success.  The product should
demonstrate at least a 99.999% reduction in the number of test
microorganisms (bacteria) within 30 seconds. The result should be
reported according to the actual count and percentage reduction over the
control.

(i) Sanitizers for Toilet and Urinal Bowl Water. This section addresses
efficacy testing for products with claims as sanitizers for toilet and
urinal bowl water.

(1) Test Procedure. A simulated-use study should be designed which
incorporates all of the elements listed in paragraphs (i)(1)(i) through
(i)(1)(iv) in this guideline.

(i)  The product should be added to samples of the bowl water from three
toilets or urinals at the use concentration employing the recommended
method of dispensing.  Untreated control samples from the three toilets
or urinals should also be included.

(ii)  Whether the product is automatically metered, or dispensed in some
other fashion, into the bowl water (or urinal trap), the consistent
accuracy of the concentration dispensed and maintained should be
documented.

(iii)  Inocula containing representative Gram-positive or Gram-negative
test bacteria should be added to the treated and control samples of the
bowl water from each of the toilets or urinals to provide a
concentration of at least 104 colony-forming units per milliliter.

(iv)  Microbial counts of the treated bowl water and the control bowl
water should be conducted at a minimum of three exposure intervals, in
addition to a 0-time control.

(2) Evaluation of Sanitizing Success.  The reduction of each test
microorganism should be at least 99.9% over the 0-time control and the
parallel untreated inoculated control.

(j) In-Tank Sanitizers.  This section addresses efficacy testing for
products which bear label claims for use as an automatically dispensed
in-tank sanitizer.

(1) Test Procedures. In-tank sanitizer products should be evaluated by a
preliminary simulated-use test followed by a laboratory efficacy test. 
These tests should incorporate the elements in paragraphs (j)(1)(i)
through (j)(1)(i)(B).

(i) Preliminary simulated-use test.  The use-life of the in-tank product
should be documented for three product samples, each in a separate
toilet under the conditions in paragraphs (j)(1)(i)(A) and (j)(1)(i)(B)
of this guideline simulating actual usage.  Testing conducted with a 6
gallons/flush toilet may be used to generate data for low flush toilets
(3.5 gallons/flush).

(A) Number of flushes (dispensation of the dosage) per day per X weeks
(duration of effectiveness) with a non-chlorinated water supply at 25-30
(C (the warm water temperature extreme in summer).

(B) The bowl water should be analyzed at periodic intervals during the
testing indicated in paragraph (j)(1)(i)(A) in this guideline to
demonstrate the pH and concentration of the active ingredients.

(ii) Laboratory efficacy tests.  Bacteriologic assays should be
conducted on neutralized treated and untreated samples by standard
plating procedures employing:

(A) Samples of the residual bowl water from three toilets (at the
minimal use concentration) and corresponding untreated control samples
from three toilets at 10-.15 (C (the most stringent water temperature
for demonstrating efficacy).

(B)  Representative Gram-positive and Gram-negative bacteria (e.g.,
Enterococcus faecalis, Salmonella enterica) with an inoculum of at least
104CFU/mL.

(C)  A minimum of three exposure intervals, in addition to a 0-time
control.

(iii) Evaluation of in-tank sanitizing success.  The reduction of each
test microorganism should be at least 99.9% over the 0-time control and
the parallel untreated inoculated control.

(k) Residual self-sanitizing activity of dried chemical residues on
hard-inanimate surfaces - wet surfaces. This section addresses efficacy
testing for products which bear label claims to provide residual
self-sanitizing activity (e.g., significant reduction in numbers of
infectious microorganisms which may be present or subsequently
deposited) on treated surfaces that are likely to become and remain wet
under normal conditions of use.

(1) Test procedure.  Residual self-sanitizing products for use on hard,
inanimate surfaces should be evaluated for efficacy using a controlled
in-use study or simulated in-use study. The design of the study should
be done in consultation with the Agency and should include the basic
elements: in paragraphs (k)(1)(i) through (k)(1)(vii) of this guideline.

(i) The test microorganisms employed in the study should be pathogens
that are likely to be encountered in the environment in which the
product is to be used.

(ii) The starting inocula of the test microorganisms for both initial
and subsequent challenges should be of sufficient concentration to
provide at least 104 survivors on the parallel control surface.

(iii) Subsequent challenges should be of sufficient frequency to
accurately represent normal conditions of use. 

(iv) Quantitative bacteriological sampling should be conducted at
frequent and regular intervals for the length of time the residual
activity can be expected to exist under the expected use conditions.

(v) The same types of surfaces without the treatment should be employed
in the test and inoculated in a manner and over an exposure period
identical to the use pattern for which the product is intended.

(vi) The environmental conditions (e.g., relative humidity and
temperature) should be the same as those likely to be encountered under
normal conditions of product use.  Tests should also include those
environmental conditions that would act to reduce the effective
concentration of the product on the inanimate surface (e.g., rinsing,
abrasion, organic load, repeated challenges by microorganisms, etc.).

(vii) The length of time the residual activity can be expected to exist
under the expected use conditions should be documented.

(2) Evaluation of success of residual self-sanitizing action.  For
residual self-sanitizing claims, it should be demonstrated that a
product is capable of reducing the number of test microorganisms on the
test surface by 99.9% over that of the parallel control surfaces.

(l) Residual self-sanitizing activity of dried chemical residues on
hard-inanimate surfaces - dry surfaces.  This section addresses efficacy
testing for products which bear label claims to provide residual
self-sanitizing activity (e.g., significant reduction in numbers of
infectious microorganisms which may be present or subsequently
deposited) on treated dry surfaces.

(1) Test Procedure.  The Agency recommends the use of the Protocol for
Residual Self-Sanitizing Activity of Dried Chemical Residues on Hard
Non-Porous Surfaces.  This guidance may be found at: 
http://www.epa.gov/oppad001/regpolicy.htm.

(2) Evaluation of residual self-sanitizing success.  The product should
demonstrate that it is capable of reducing the number of test
microorganisms on the test surface by 99.9% over that of the parallel
control surfaces within 5 minutes for a 24 hour period.

(m)  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, what is in paragraphs (m)(1)(i) through
(m)(1)(xiv) of this guideline:

(i) Study title;

(ii) Product identity;

(iii) Guideline number; 

(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) Good Laboratory Practice compliance;

(viii) Purpose of the study;

(ix) Date and time of the start and end of the test;

(x) Statistical treatment of the data;

(xi) Conclusions;

(xii) References;

(xiii) Appendices;

(xiv) Certification.

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 recommended methods.  When recommended methods from the
Official Methods of Analysis of AOAC International; the Annual Book of
Standards of the American Society for Testing and Materials; or, EPA
methods are used to develop efficacy data, certain minimal information,
in addition to that described in this guideline, should be provided in
the test report.  The report should include, but is not limited to, the
material in paragraphs (m)(2)(i) through (m)(2)(xii) in this guideline:

(i) Test employed, and any modifications thereto (e.g., organic soil,
hard water, etc);

(ii) Test microorganisms employed, including identification of the
specific strain (ATCC or other);

(iii) Description of the test substance, including the percent of active
ingredient;

(iv) Concentration or dilution of the product tested and how prepared;

(v) Number of samples, batches and replicates tested;

(vi) Preparation dates of each product batch (individually formulated
preparation of the product);

(vii) Identification of all material or procedural options employed,
where such choice is permitted or recommended in the test method
selected (e.g., growth media, drying  time for inoculated carriers,
neutralization confirmation and/or subculture media, secondary
subculturing);

(viii) Test exposure conditions (e.g., contact time, temperature, and
relative humidity);

(ix) Complete reports of results obtained for each replication;

(x) Any control data essential to establish the validity of the test;

(xi) Carrier counts;

(xii) Any additional data pertinent for specific tests described in this
guideline.

(3) Data for modifications of recommended methods.  Where recommended
methods are modified to support specific claims and/or use patterns for
a product, the protocol, identifying and describing each modification,
should be provided in specific detail with the test report.  The
applicant is encouraged to submit the proposed modification to the
Agency for review and evaluation prior to initiation of the test.

(4) 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 to submit the proposed testing
protocols for in-use or simulated-use studies to the Agency for review
and evaluation prior to initiation of the test.

(n) References:  The following references may be consulted for
additional background information:

(1) Environmental Protection Agency, Sanitizer Test for Hard, Inanimate
Nonfood Contact Surfaces Modified to Include Organic Soil. (Registration
Division, Office of Pesticide Programs, 1976).  

(2) Annual Book of Standards, Test Method for Efficacy of Sanitizers
Recommended for Inanimate Non-Food Contact Surfaces, Designation
E1153-03.  American Society for Testing and Materials, 100 Barr Harbor
Drive, West Conshohocken, PA 19428.

(3) Official Methods of Analysis of the AOAC International, Chapter 6,
Disinfectants, Official Method 955.16 Chlorine (Available) in
Disinfectants, Germicidal Equivalent Concentration.  Eighteenth edition.
 AOAC International, Suite 500, 481 North Frederick Avenue,
Gaithersburg, MD 20877-2417.

(4) Official Methods of Analysis of the AOAC International, Official
Method 960.09 Germicidal and Detergent Sanitizing Action of
Disinfectants.  Eighteenth edition.  AOAC International, Suite 500, 481
North Frederick Avenue, Gaithersburg, MD 20877-2417.

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