ASTM E2946-21

Standard Test Method for Determining the Bacteria-Reducing Effectiveness of Food-Handler Handwash Formulations Using Hands of Adults

SIGNIFICANCE AND USE
5.1 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms and is critical for reducing the incidence of food-borne disease. Food-handling settings are unique in that moderate to heavy soil load present on hands often can influence the ability of a product to remove or kill microorganisms (3, 4). Test methods are needed for assessing the efficacy of hand hygiene products under conditions representative of those encountered in a food-handling environment.  
5.2 This test method is specifically designed to evaluate the effectiveness of food-handler products to kill and remove bacteria from experimentally-contaminated hands under conditions of moderate to heavy organic soil load. The inclusion of soils typical of food service setting makes this a methodology more appropriate than Test Method E1174, which was designed to evaluate healthcare personnel hand washes and does not include an option to include soil (4).
SCOPE
1.1 This test method is designed to determine the activity of food-handler handwashes against transient bacterial flora on the hands.  
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (1)2.  
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2 (2).  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements see 8.1.1.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Mar-2021
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2946 − 21
Standard Test Method for
Determining the Bacteria-Reducing Effectiveness of Food-
1
Handler Handwash Formulations Using Hands of Adults
This standard is issued under the fixed designation E2946; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E1174Test Method for Evaluation of the Effectiveness of
Health Care Personnel Handwash Formulations
1.1 Thistestmethodisdesignedtodeterminetheactivityof
E2756Terminology Relating toAntimicrobial andAntiviral
food-handler handwashes against transient bacterial flora on
Agents
the hands.
4
2.2 AATCC Standards:
1.2 Performance of this procedure requires the knowledge
Test Method 147Antibacterial Activity Assessment of Tex-
of regulations pertaining to the protection of human subjects
tile Materials: Parallel Streak Method
2
(1) .
3. Terminology
1.3 This test method should be performed by persons with
training in microbiology, in facilities designed and equipped
3.1 Definitions—See Terminology E2756.
for work with potentially infectious agents at biosafety level 2
3.2 food-handler handwash, n—a water or non-water-aided
(2).
formulationusedforhandwashingbypersonnelinfoodservice
1.4 Units—The values stated in SI units are to be regarded
settings intended to kill or remove transient bacteria, or both
asstandard.Nootherunitsofmeasurementareincludedinthis
from the hands.
standard.
3.3 non-medicated/non-antimicrobial soap, n—a soap or
1.5 This standard does not purport to address all of the
detergent that is mild to the skin and does not contain any
safety concerns, if any, associated with its use. It is the
germicidal chemicals.
responsibility of the user of this standard to establish appro-
3.4 test material, n—a product or formulation that incorpo-
priate safety, health, and environmental practices and deter-
rates one or more antimicrobial ingredients.
mine the applicability of regulatory limitations prior to use.
For more specific precautionary statements see 8.1.1.
4. Summary of Test Method
1.6 This international standard was developed in accor-
4.1 This test method is performed using adult subjects who
dance with internationally recognized principles on standard-
have provided written informed consent, and whose hands
ization established in the Decision on Principles for the
havebeendeterminedtobefreeofanyapparentdamageatthe
Development of International Standards, Guides and Recom-
time of participation in the study. Subjects are to refrain from
mendations issued by the World Trade Organization Technical
use of any antimicrobials for at least one week prior to the
Barriers to Trade (TBT) Committee.
initiation of test procedures (Section 11).
2. Referenced Documents
4.2 Subjects contaminate hands with E. coli incorporated
3
2.1 ASTM Standards:
into a medium or heavy organic soil (beef broth or hamburger,
E1054Test Practices for Evaluation of Inactivators ofAnti-
respectively), which then is distributed over all surfaces of the
microbial Agents
hands and fingers to result in a minimum baseline recovery
7
population of ≥10 colony forming units (CFU)/hand.
1
This test method is under the jurisdiction of ASTM Committee E35 on
4.3 Test material effectiveness is measured by comparing
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
thenumberofchallengebacteriarecoveredfromcontaminated
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2021. Published May 2021. Originally
hands after a single application of the test material to the
approved in 2013. Last previous edition approved in 2013 as E2946–13. DOI:
numberrecoveredfromcontaminatedhandsnotexposedtothe
10.1520/E2946–21
2 test material.
The boldface numbers in parentheses refer to a list of references at the end of
this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from American Association of Textile Chemists and Colorists
Standardsvolume information,referto thestandard’sDocumentSummary page on (AATCC), P.O. Box 12215, Research Triangle Park, NC 27709, http://
the ASTM website. www.aatcc.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2946 − 21
5
5. Significance and Use 7. Reagents and Materials
5.1 Hand hygiene
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2946 − 13 E2946 − 21
Standard Test Method for
Determining the Bacteria-Reducing Effectiveness of Food-
1
Handler Handwash Formulations Using Hands of Adults
This standard is issued under the fixed designation E2946; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This test method is designed to determine the activity of food-handler handwashes against transient bacterial flora on the
hands.
2
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (1) .
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work
with potentially infectious agents at biosafety level 2 (2).
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this
standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of
the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use. For more specific precautionary statements see 8.1.1.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use. For more specific precautionary statements see 8.1.1.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
3
2.1 ASTM Standards:
E1054 Test Practices for Evaluation of Inactivators of Antimicrobial Agents
E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
4
2.2 AATCC Standards:
Test Method 147 Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method
1
This test method is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 1, 2013April 1, 2021. Published November 2013May 2021. Originally approved in 2013. Last previous edition approved in 2013 as
E2946–13. DOI: 10.1520/E2946–1310.1520/E2946–21
2
The boldface numbers in parentheses refer to a list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
Available from American Association of Textile Chemists and Colorists (AATCC), P.O. Box 12215, Research Triangle Park, NC 27709, http://www.aatcc.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2946 − 21
3. Terminology
3.1 Definitions—See Terminology E2756.
3.2 food-handler handwash, n—a water or non-water-aided formulation for use used for handwashing by personnel in food service
settings intended to kill or remove transient bacteria, or both from the hands.
3.3 non-medicated/non-antimicrobial soap, n—a soap or detergent that is mild to the skin and does not contain any germicidal
chemicals.
3.4 test material, n—a product or formulation that incorporates one or more antimicrobial ingredients.
4. Summary of Test Method
4.1 This test method is performed using adult subjects who have provided written informed consent, and whose hands have been
determined to be free of any apparent damage at the time of participation in the study. Subjects are to refrain from use of any
antimicrobials for at least one week prior to the initiation of test procedures (Section 11).
4.2 Subjects contaminate hands with E. coli
...