Review Process for the Registration and Use Directions for Floor Wipe Towelette Products
This guidance provides Antimicrobials Division (AD) staff with guidance related to the registration requirements and use directions for presaturated/impregnated floor wipe towelette products. This document will be used for new and existing wipe registrations.
Companies with towelettes registered for use on floors (floor use currently on the product label) have expressed interest in clarification of registration requirements and use directions. The floor use intended on these labels is "spot treatment," and there is a need for a broader set of use directions, which would apply when these towelettes are used on an entire floor surface.
AD Staff Responsibilities
When staff are reviewing new or existing registrations for towelette products, the following points should be considered:
- Floors do not represent a new use site for labels which already specify treatment on hard, non-porous surfaces
- The current test method, a modification of the Association of Official Analytical Chemicals (AOAC) Germicidal Spray Test, is acceptable for efficacy substantiation of disinfection and sanitization claims. If a soil load is required, serum remains an appropriate representative soil load type.
- Glass carriers are appropriate to simulate floor surfaces for towelette products.
- If the towelette product is currently registered as a sanitizer or disinfectant, no additional efficacy data are required to support this use site (i.e., floors).
- An additional exposure assessment will be required only if additional use sites are proposed to the product label that would significantly increase exposure.
When staff are reviewing labels, the following elements should be considered:
- Precleaning (e.g., sweep, vacuum, wipe to preclean floor).
- Wetness (e.g., thoroughly wet surface).
- Changing wipe (e.g., change wipes when soiled).
- Floor size (e.g., use enough wipes for floor to remain visibly wet for the specific contact time; for a larger area you may need to use more than one wipe).
- Coverage (e.g., an approximate area that a typical wipe will cover is ____ square feet).
Guidance first issued October 16, 2003
Antimicrobial Division Review Guidance
Approved by Alison Clune and Emily Mitchell. See Antimicrobial Policy and Guidance Documents.