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December 21, 2012
Labeling for fungicides/fungistats

The variations of acceptable labeling language for fungicides and fungistats used to treat fungi or mold are discussed by EPA’s Office of Pesticide Programs (OPP) in a draft Pesticide Registration (PR) notice.  The OPP describes the draft notice as non-binding guidance.  Essentially this means that the labeling options discussed in the guidance are not the only avenues available to pesticide registrants.  Nonetheless, the OPP says it will “consider” the final PR notice when reviewing all applications for product registrations, for amendments to registered products, and for reregistration and registration review of registered products.

As defined by the OPP, a fungicide is a substance or mixture of substances that destroy fungi (including yeasts) and/or fungal spores pathogenic to man or other animals in the inanimate environment.  A fungistat is a substance or mixture of substances that inhibit the growth of fungi in the inanimate environment. 

Efficacy data

The PR notice covers the following:

  • When the OPP expects applicants or registrants to submit efficacy data in support of the registration of mold-related pesticide products.  All antimicrobial pesticide products must be supported by efficacy data generated by the registrant.  However, efficacy data must be submitted to the EPA only for fungicides, that is, products that bear claims to destroy mold.  For fungistats, the efficacy data must still be developed, but the registrant need only maintain the data as a record and must provide them to the EPA on request. 
  • Guidance on the appropriate labeling of mold-related pesticides more generally.  The OPP believes that mold claim products intended for aesthetic purposes (i.e., fungistats) should be clearly distinguishable from products that are intended for public health purposes (i.e., fungicides). Accordingly, the PR notice provides a range of labeling options that registrants may use.
  • Guidance addressing label language for fungicides; fungistats; products used for mold remediation; products used on nonporous and porous surfaces; products with residual activity; products used for mold prevention; and products used in heating, ventilation, air conditioning, and refrigeration (HVAC&R) systems.  This part of the PR notice includes recommendations for label language on cleaning hard, nonporous surfaces; directions on treating porous surfaces; use of products by homeowners; use of products in schools and commercial buildings; and cleaning HVAC&R systems before using a product. 

Notifications, applications, and fees

The draft PR notice notes that registrants who adopt label changes consistent with the guidance may generally do so through a notification sent to the OPP.  Registrants of existing products who want to use label language apart from what is included in the notice will need to do so through an application for an amended registration.

OPP-initiated amendments such as those included in the draft PR notice are not subject to registration service fees established by the Pesticide Registration Improvement Act of 2003 provided the labeling changes proposed are only those undertaken in response to the PR notice. 

Click here to read OPP’s draft PR notice.

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