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et’s say you have a great product that not only serves as a wonderful shower curtain, but
also is impregnated with a chemical ingredient that seems to eliminate mold and mildew on the
curtain … or you develop a sheet that can be placed in a package and will keep any of the items
in that package from getting mold and mildew. These are some pretty nifty products, so you begin
thinking of how best to market your goods so that you can make a fortune.
Before your first infomercial airs, you had better wait a minute! Your product may be
subject to federal environmental laws – and state laws – that regulate pesticide products. While
you may believe the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) does not apply to
your product, here are some examples that may change your mind. Last year, the U.S. Environmental
Protection Agency (EPA) settled with Crocs Inc., Niwot, Colo., for $230,000 in penalties and an
agreement that Crocs would remove certain claims from its website, advertising and packaging for
its popular Crocs™ clogs. The EPA asserted that Crocs violated FIFRA by making unsubstantiated
antimicrobial health claims that its products killed or controlled growth of bacteria. Also last
year, the parent company of San Leandro, Calif.-based The North Face®, along with three other
companies, paid more than $500,000 in penalties to the EPA for antimicrobial claims made in
violation of FIFRA. The public health claims involved products including shoes, headphones and
bathroom fixtures; and advertised that the products prevented the spread of bacteria, mold and
mildew. In The North Face matter, the company was fined in connection with its marketing on more
than 60 products for allegedly making claims that the products inhibited the growth of
disease-causing bacteria. Normally, people would not consider a rubber clog or headphones as a
pesticide product; however, the item may become subject to FIFRA regulation if the company makes
certain antimicrobial claims.
Pesticide Regulation
Under FIFRA’s broad scope, mold and mildew are considered pests and are regulated as
such. The EPA’s definition of “pest” includes “any fungus, bacterium, virus, or other
microorganism, except for those on or in living man or other living animals and those on or in
processed food or processed animal feed, beverages, drugs.” A product that is meant to prevent,
destroy, repel or mitigate pests is considered a pesticide, and FIFRA makes it unlawful for any
person to distribute or sell any unregistered pesticide. Products that fall within FIFRA need to be
registered with the EPA and also must be registered in each state in which the product is
distributed. Since it is clear that unwanted mold and mildew fall within the meaning of “pest”
under FIFRA, what should you be aware of to avoid incurring penalties and a federal enforcement
action?
In most cases, a product would be regarded as a pesticide if it is intended to mitigate a
pest. A pesticide product is defined by the EPA as a pesticide in the particular form — including
composition, packaging and labeling — in which the pesticide is, or is intended to be, distributed
or sold. The term includes any physical apparatus used to deliver or apply the pesticide if
distributed or sold with the pesticide. Typically, substantial work is required to obtain a
registration for a pesticide product, including product chemistry, acute toxicity, and efficacy
data generation. If a company intends to advertise public health claims about the prevention of
disease-causing bacteria — such as “prevents bacterial and fungal growth” — the efficacy data must
also demonstrate a sufficient kill rate in order for the EPA to approve the claims. In fact, even
the labeling must be approved by the EPA.
Treated Articles Exemption
Referring to the antimicrobial shower curtain earlier in this article, it would be difficult
to obtain a registration for such a shower curtain with public health claims, because of the
difficulty in proving efficacy. Therefore, most distributors of such products have taken the path
of marketing these products under the EPA’s treated articles exemption.
The treated articles exemption is a creative method employed by the EPA to allow for the
distribution of products that may be useful, such as antimicrobial shower curtains, but also would
be hard to register because of the difficulty of demonstrating adequate efficacy. However, in order
to take advantage of the treated articles exemption, the antimicrobial product used within the
treated article must be registered for that use. By exempting these products, the agency has
allowed the use of minimal pesticide-related claims, such as “antimicrobial” and “kills
odor-causing bacteria,” on products that are not registered. Registration of pesticides for use in
treated articles is generally easier than registering new pesticidal products.
If there are claims that the product has an antimicrobial effect that goes beyond the
exemption, then a full EPA registration as a pesticide is needed to comply with FIFRA. This
distinction means that so long as the antimicrobial claim is only about the product itself, the
treated articles exemption applies, as for the mold-resistant shower curtain. However, the
exemption would not apply and a full FIFRA registration would be needed if you wanted to claim that
the shower curtain prevented mold and mildew in the shower/tub area.
Claims, Labels And Language Choice
In an effort to assist the regulated community with compliance, the EPA has published a fact
sheet enumerating specific limitations applicable to the treated articles exemption. For example,
the fact sheet provides that claims for treated articles or substances are limited to the following
statement: “This product contains a preservative (for example, fungicide or insecticide) built-in
or applied as a coating only to protect the product.” An example of an acceptable label statement
would be:
- Antimicrobial properties are built-in to inhibit the growth of bacteria that may affect this
product. The antimicrobial properties do not protect users or others against bacteria, viruses,
germs, or other disease organisms. Always clean and wash this product thoroughly before and after
each use.
In addition, it should be noted that the treated articles exemption is available only for
the protection of the product and not for public health uses. The preservative claim and qualifying
statement on the product packaging must be given no greater prominence with regard to type, size or
color than other described product features.
The EPA’s description of what constitutes non-public health claims that may be acceptable
for treated articles is provided in the Pesticide Regulation Notice published by the EPA. Any of
the following must apply:
- A claim to inhibit the growth of mildew on the surface of a dried paint film or paint
coating. - A claim to inhibit microorganisms that may cause spoilage or fouling of the treated article or
substance. - A claim to inhibit offensive odors in the treated article or substance.
- EPA considers terms such as “antimicrobial,” “fungistatic,” “mildew-resistant,” and
“preservative,” as being acceptable for exempted treated articles or substances provided that they
are properly, and very clearly, qualified as to their intended non-public health use.
The EPA’s examples for acceptable mold- and mildew-resistant claims include, among others:
- This article has been treated with a fungistatic agent to protect the product from fungal
growth. - Mildew Resistant – Extends useful life of article by controlling deterioration caused by
mildew. - Article treated to resist deterioration by mold fungus.
- Article treated to resist deterioration from mildew.
- The fungistatic agent in this article makes it especially useful for resisting deterioration
caused by mildew. - Gives mildew-resistant coating.
The EPA’s examples for acceptable odor-resistant claims include:
- This product contains an antimicrobial agent to control odors.
- This product contains an antimicrobial agent to prevent microorganisms from degrading the
product. - Resists Odors – This product has been treated to resist bacterial odors.
- Inhibits the growth of bacterial odors.
- Resists microbial odor development.
- Retards the growth and action of bacterial odors.
- Guards against the growth of odors from microbial causes.
- Guards against degradation from microorganisms.
- Reduces odors from microorganisms.
- Odor-resistant.
- Acts to mitigate the development of odors.
Notwithstanding that the EPA offers the above examples as acceptable, statements regarding
public health claims for specific products should be reviewed by legal counsel to ensure that they
comply with the EPA guidelines. Further, the EPA also indicates that any specific attempt to try to
imply more than these sorts of effects by putting additional claims in the name of the product or
increasing the size of the claims relevant to other product descriptions is unacceptable.
Companies should be aware that FIFRA does not allow them to make public health pesticide
claims for any product unless the product falls within an exemption or has been registered by the
EPA. The EPA promises to continue to take action against companies that make certain antimicrobial
claims, as it did in the Crocs and The North Face enforcement matters. Therefore, manufacturing and
distributing companies should appreciate the marketing nuances relating to FIFRA compliance when
making antimicrobial claims involving mold and mildew. Costs to take steps to ensure compliance
with FIFRA pale in comparison to the costs of potential penalties and adverse business publicity
arising from EPA enforcement actions.
The devil is in the details when it is comes to mold and mildew prevention claims in your
product marketing and labeling. Because FIFRA is a claims-based regulatory scheme, the way you
phrase your claims may ultimately determine your company’s compliance status with FIFRA.
Editor’s note: Tricia Foley is a partner at Day Pitney LLP in New York City. Her practice
involves the business and regulatory aspects of environmental law, and she is a frequent author and
speaker on environmental topics.
Cindy J. Karlson is counsel in Day Pitney’s Hartford, Conn., office. Her practice is in
environmental and land use law; and involves counseling clients on permitting, compliance,
enforcement and transactional matters.
Robert Brennis, a former product manager for antimicrobial products at the U.S.
Environmental Protection Agency, is owner of Brennis Consulting Services LLC in Alexandria,
Va.
June 21, 2011
