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Internal Guidance for the Review Process for the Registration and Use
Directions for Floor Wipe Towelette Products
October 16, 2003
Purpose:
To provide Antimicrobials Division (AD) staff with guidance related to
the registration requirements, as well as the use directions, for presaturated/impregnated
floor wipe towelette products. This document will be used for new and
existing wipe registrations.
Background:
There has been interest in clarification of registration requirements
and use directions by a number of companies which have towelettes registered
for use on floors (floor use currently on the product label). 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:
Registration Requirements:
When staff are reviewing new or existing registrations for towelette
products, the following points should be considered:
1. Floors do not represent a new use site for labels which already
specify treatment on hard, non-porous surfaces.
2. 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.
3. Glass carriers are appropriate to simulate floor surfaces for towelette
products.
4. 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).
5. An additional exposure assessment will be required only if additional
use sites are proposed to the product label that would significantly
increase exposure.
Use Directions:
When staff are reviewing labels, the following elements should be
considered:
1. Precleaning (e.g., sweep, vacuum, wipe to preclean floor).
2. Wetness (e.g., thoroughly wet surface).
3. Changing wipe (e.g., change wipes when soiled).
4. 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).
5. Coverage (e.g., an approximate area that a typical wipe will cover
is ____ square feet).
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