Antimicrobial efficacy (microbiology/virology) – North America

The Environmental Protection Agency (EPA) and Health Canada require that all antimicrobials intended to kill or minimize microorganisms must provide efficacy data to support product label claims. Antimicrobial efficacy is inclusive of disinfection, sanitization, and preservation among other product claims.

Antimicrobial product performance data is required to demonstrate the product effectively targets the pest(s), which the product was made to control. Product performance data provides regulatory agencies with the conditions needed for the product to achieve the desired label claims.

EPA and Health Canada requirements

EPA and Health Canada have similar product performance test guidelines, but there are differences. Planning for these differences and similarities can save companies time and money.

TSG’s efficacy experts can provide guidance on antimicrobial efficacy testing and preservation testing required for registration, new protocol and test method strategies, lab training, and study monitoring. TSG has strong working relationships with contract testing laboratories and can guide your company throughout the testing and research process to ensure your product meets the appropriate registration requirements. Beyond the US Federal requirements, TSG is also equipped to support your company with individual State efficacy requirements.

TSG can support antimicrobial products across the following categories

  • Food-handling/storage
  • Commercial, institutional, and industrial
  • Residential
  • Medical premises and equipment
  • Drinking water systems
  • Materials preservatives
  • Industrial processes
  • Antifoulant paints and coatings
  • Wood preservatives
  • Swimming pools and spas
  • Aquatic areas
  • Pesticide devices
  • Hand sanitizers

We can also support efficacy development for the following claims

  • Air sanitizers
  • Disinfectants
  • Sanitizers
  • Virucides
  • Fungicides
  • Towelettes
  • Tuberculocides
  • Mildewstats
  • Biofilms

We have experience with various antimicrobial test methods including the following

  • AOAC Use Dilution Method for Testing Disinfectant (AOAC 955.14; 955.15; 964.02)
  • AOAC Germicidal Spray Products as Disinfectants Test
  • EPA Disinfectant Towelette Test
  • Quantitative Method for Evaluating Bactericidal and Mycobactericidal Activity of Microbicides Used on Hard, Non-Porous Surfaces
  • AOAC Tuberculocidal Activity of Disinfectants
  • AOAC Germicidal and Detergent Sanitizing Action of Disinfectants (AOAC 960.09 FCS)
  • Standard Test Method for Quantitative Method for Testing Antimicrobial Agents against Spores of C. difficile on Hard, Nonporous Surfaces
  • ASTM E1153 – EPA Non-Food Contact Sanitizer Test
  • Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings
  • ASTM E1053-20 Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
  • WK73519 ASTM Quantitative Method for Determining the Efficacy of Antimicrobial Towelettes

TSG can help with antimicrobial efficacy testing project planning

  • Identify efficacy requirements i.e., data bridging opportunities
  • Assist with interpreting guidelines and regulations (Series 810 Guidelines)
  • Develop new protocol and test method strategies:
    • Novel application
    • New technology
    • Device claim support
    • Non-guideline claim support i.e., non-public health
  • Draft and review the study design
  • Provide protocol reviews for efficacy studies

With antimicrobial efficacy data development

  • Conduct lab training and testing support
  • Troubleshoot and problem solve
  • Test method interpretation, implementation, and validation
  • Conduct study monitoring

With antimicrobial efficacy pre-submission support

  • Conduct data analysis and interpretation
  • Perform label development, preparation, and review

Need help navigating antimicrobial efficacy data requirements?


TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

Our professionals

Our efficacy team is led by microbiologist Milady Brutofsky. With 30+ combined years of regulatory and clinical work, Milady is an industry expert on antimicrobial efficacy strategy.

Antimicrobial efficacy - frequently asked questions

Yes, all antimicrobial end-use registrations must be supported by efficacy data. However, not all data is required to be submitted to the EPA. Not sure what data requirements are needed to satisfy your antimicrobial product registration? TSG’s team of experts can help you navigate product performance guidelines and support your company with any test method interpretation, implementation, and validation needs.

Yes! Generating efficacy data can be expensive. It’s best to have guidance on the appropriate requirements before initiating product development. Proper planning can save your company time and money. Additionally, novel antimicrobial claims are difficult to substantiate. Such products may require a creative efficacy strategy. Get in touch at [email protected] to find out how we can support you.

Generally, no. However, California does require efficacy data be submitted for review for any products making antimicrobial claims.

There are many overlapping data requirements between Canada and the US, but there are also some slight differences. For example, nonpublic health claims still require GLP efficacy data in Canada, unlike the US. Planning for these differences can expedite registration in both countries.

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