On December 12, 2012, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice the availability of a draft Pesticide Registration (PR) Notice entitled 'Guidance for Antimicrobial Pesticide Products with Mold-Related Label Claims (Draft PR Notice). 77 Fed. Reg. 74003. The Draft PR Notice has some potentially alarming implications regarding the continued use of certain claims under the treated articles exemption that any registrants of active ingredients used in treated articles subject to this Draft PR Notice or companies that rely upon the treated article exemption should be aware of and comment upon.
The Draft PR Notice is available online. Additional supporting documents are available at www.regulations.gov (search for Docket No. EPA-HQ-OPP-2010-0539). EPA is accepting comments through February 11, 2013.
Affected Pesticide Products
EPA guidance is intended to cover 'mold-related pesticides,' described as 'antimicrobial pesticides that bear a label claim to inhibit or destroy mold or mildew growth on hard, nonporous and porous surfaces in indoor environments.' EPA states that the Draft PR Notice is intended to provide guidance to the registrant concerning product performance (efficacy) data and labeling for mold-related pesticide products with indoor uses.
If a mold-related pesticide has both indoor and outdoor uses, the Draft PR Notice is intended only to cover the indoor uses. A pesticide product registered for use outdoors is outside the scope of the Draft PR Notice.
In the Draft PR Notice, EPA divides mold-related pesticides into two categories:
- Fungicides, a substance or mixture of substances that destroys fungi (including yeasts) and fungal spores pathogenic to man or other animals in the inanimate environment. EPA states: 'Because a fungicide destroys pathogenic fungi, its use is considered to be for public health-related purposes. EPA has historically considered a fungicide to be a public health related antimicrobial because it has killing or 'cidal' properties which must be demonstrated using a pathogenic fungus.'
- Fungistats, a substance or mixture of substances that inhibits the growth of fungi in the inanimate environment. EPA states: 'Because a fungistat is not potent enough to destroy fungi, its use is considered to be for aesthetic or cosmetic (non-public health) purposes only and not for public health related purposes.'
Under EPA's regulations regarding product performance data requirements, EPA has 'waived all requirements to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans.' 40 C.F.R. § 161.640, footnote 1. EPA further states that it 'reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.'
In the Draft PR Notice, EPA states that registrants are required to submit efficacy data for mold-related pesticides that are 'fungicides' because these products are 'intended to destroy microorganisms that pose a threat to public health.' EPA restates its long-standing policy to require the submission of efficacy data for fungicide products to support, for example, a product's residual activity and prevention claims. EPA goes on to state that it 'now considers most species of mold to be potentially public health related.' As such, EPA will require efficacy data to be submitted to support the listing of any specific species of fungus on a fungicide label. Examples provided by EPA of specific indoor mold species that may be added to a fungicide based on submitted efficacy data include Aspergillus versicolor, Aspergillus niger, Penicillium chrysogenum, Penicillium aurantiogriseum, Stachybotrys chartarum, Stachybotrys atra, and Chaetomium globulosum.
In contrast to fungicides, mold-related pesticides that are 'fungistats' would not require the submission of efficacy data because they are 'not intended for use against microorganisms that pose a threat to human health.' With EPA's new position that most species of mold are potentially public health related, EPA states that it does not consider fungistats acceptable for use against microorganisms pathogenic to humans and 'does not currently expect to approve the listing of any specific species of fungus on a fungistat label.' (emphasis in original).
Labeling and Efficacy Options
To assist in distinguishing between fungicides and fungistats and the label and efficacy data requirements for each, EPA sets forth in the Draft PR Notice illustrative options for applicants and registrants to consider.
- Fungistat Products: For products that are fungistats (i.e., intended for aesthetic or cosmetic purposes only), EPA states that such products should include the word 'fungistat' on the front panel of the label as well as a limitation statement (e.g., '[t]his product is intended to reduce, control or inhibit the growth of mold for aesthetic or cosmetic purposes only'). Registrants choosing to adopt these label changes can submit a notification according to PR Notice 98-10 for each product. The other option would be to delete all mold claims from the label, in which case registrants should submit an amendment to delete those claims.
- Fungicide Products: For products that are fungicides, EPA states that applicants should submit efficacy data. For currently registered products, EPA states that such data should already be submitted; if that is not the case and efficacy data were not submitted, EPA should be contacted. The other option would be to delete all fungicidal claims from the label.
- For products that are fungicides and are making a residual activity claim, EPA states that applicants and registrants should submit the appropriate efficacy data or delete the residual activity claim. EPA defines 'residual activity' as:
[A] claim that a fungicide is intended to destroy existing mold on a contaminated surface and leave a pesticidal residue that further inhibits subsequent fungal growth for more than seven days (as supported by efficacy data). Since fungicidal efficacy tests measure fungicidal activity for seven (7) days, residual activity is a claim that a product is effective for a period of more than seven (7) days and that is based on testing that demonstrates that the product is efficacious for such period. A residual activity claim should be made only for a fungicide because a fungicide will destroy existing mold, but a fungistat will not.
- For products that are fungicides and are making a prevention claim, EPA states that applicants and registrants should submit the appropriate efficacy data or delete the prevention claim. EPA defines 'prevention' as:
A claim that a fungicide is intended to inhibit the growth of mold on an uncontaminatedsurface with efficacy that continues for more than seven days (as supported by efficacy data).
- EPA further states: 'If a product claims prevention of mold growth on a fungicide label, then applicants or registrants should submit efficacy data for a designated period of time under conditions conducive to fungal contamination. The Agency believes the prevention claim should be limited to new articles or surfaces that are uncontaminated.'
Under any option for adding, revising, or deleting label statements for fungicide products, registrants of existing products must submit an application for amended registration. Applications for EPA-initiated amendments are not subject to the Pesticide Registration Improvement Act so any application to amend a registration in response to the Draft PR Notice will not be subject to a registration service fee.
The Draft PR Notice also includes specific label statements for fungicidal products used for mold remediation on hard, nonporous surfaces, fungicidal products used on porous surfaces, fungicidal products with residual activity or prevention claims, fungicidal products used by homeowners, fungicidal products used in schools and commercial buildings, and fungicidal products used in heating, ventilation, air conditioning, and refrigeration systems.
\Noticeably absent from the Draft PR Notice is any discussion of how EPA's new guidance will affect EPA's policy and practices for the treated article exemption for antimicrobial pesticides. EPA's regulations exempt treated articles from FIFRA Section 3 pesticide registration requirements provided the article is 'treated with, or containing, a pesticide to protect the article or substance itself' and provided the 'pesticide is registered for such use.' 40 C.F.R. § 152.25(a). PR Notice 2000-1 provides that the treated article exemption applies only if a number of conditions are satisfied, including, of particular importance here, that claims must be limited to protection of the article or substance itself and that the treated article exemption does not apply to articles or substances bearing implied or explicit public health claims against human pathogens. EPA has provided examples of mildew and mold resistant claims that it considers acceptable -- and thus not public health claims -- under the treated article exemption.
Products with indoor uses that currently rely upon the treated article exemption (e.g. interior paints, plastic and wood fiber products) with claims that are compliant with PR Notice 2000-1 may now be in conflict with the new guidance if EPA believes that the main purpose of the treatment for many treated article products is to protect the objects from deterioration by the mold and mildew and if EPA potentially determines that such article protection claims do not fit within the 'cosmetic or aesthetic purposes' category created by the Draft PR Notice. Since EPA already prohibits public health claims for products that claim the treated article exemption, it may be the case that EPA would, under the draft policy, consider all currently acceptable claims under the treated article exemption to be fungistatic and thus for 'cosmetic or aesthetic' purposes. It is possible, however, that the Draft PR Notice could potentially be interpreted to limit fungistatic claims to a subsection of non-public health claims that are for 'cosmetic or aesthetic' purposes only; under such an interpretation, limiting the claims for active ingredients under the Draft PR Notice could have a ripple effect on the claims allowed on a treated article.
Thus, registrants of the specific mold-related products subject to the Draft PR Notice (i.e., antimicrobial pesticides that bear a label claim to inhibit or destroy mold or mildew growth on hard, nonporous and porous surfaces in indoor environments) and those companies that treat their articles with such products may wish to comment on these issues.
EPA also is seeking specific comments from affected registrants that will need to make labeling changes and potentially submit efficacy data as to whether EPA should set a specific implementation date for these amendments when considering the costs of making label changes, level playing field issues, and other relevant issues. EPA also would 'be interested in knowing the life cycles of labels, how often registrants normally amend their labels, and to what extent the changes recommended in this notice could [be] implemented with minimal impacts.'
It may also be prudent to review currently registered products to determine whether any may -- despite EPA's statements to the contrary -- be labeled as fungicides yet otherwise have only non-public health claims. EPA states that for currently registered fungicide products, efficacy data should already be submitted, but that may not be the case for products that EPA has already approved and permitted the use of the term 'fungicide' without claims with killing or 'cidal' properties. Companies should review their labels and determine whether their products are fungicides or fungistats as EPA currently defines those terms in the Draft PR Notice, and how those definitions and EPA's new policy on efficacy data and labeling requirements will affect the ability of registrants to maintain current claims.