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Exposure Reduction Guidance
Exposure Reduction Claims
Definition: A claim that usage of an antimicrobial product, registered to be efficacious in killing a specific pathogen on surfaces, can reduce exposure to the pathogen from the treated surface.
An exposure reduction claim requires the registrant to provide scientific studies substantiating the following components:
- Pathogen is found on relevant surfaces;
- Pathogen can survive on surfaces sufficiently long enough for exposure to occur;
- Pathogen can be transferred from one surface to another;
- Antimicrobial product is registered for use against the pathogen.
This claim is limited to registered disinfectants for use in Institutional and Industrial settings only. This claim is unacceptable for consumer household products.
Method of Support to Obtain an Exposure Reduction Claim
- At least 2 articles, published in a peer-reviewed journal, are required to support each category
- Surface studies
- Survival studies
- Transfer studies
- Only the most recent articles on each subject should be submitted (< or equal to 10 years);
- Letters and review articles are not acceptable;
- Study conduct is scientifically sound including appropriate controls, methodology, representative test organisms, valid statistical evaluation, and comprehensive bibliography;
- Only one article is acceptable from conflicting interest (i.e. funded by entity seeking exposure reduction claim);
- Articles that refute position, with rationale, are required as a component of the summary.
Efficacy Data Package must include (1) journal articles; (2) summary/rationale of articles for each category with refuting studies/with rationale; (3) GLP study demonstrating efficacy of product against microorganism of interest; (4) proposed label.
Acceptable Claim(s):
"Reduces exposure to (pathogen X) from treated surfaces"
"When used according to label directions, this product reduces exposure to pathogen X from contact with the treated surface"
The Agency reserves the right to request additional documentation/references on a case-by-case basis.
Point of Contact: Tajah Blackburn, Ph.D., (703)-308-0372