Tag Archive for: Enforcement

EPA Reissues FIFRA Guidance on Cleaning Products

/in ,

FIFRA:

On January 11, 2011, EPA issued revised guidance regarding the types of claims that would require registration of cleaning products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §136 et seq.  Readers may recall that, in early 2010, the Agency initially issued guidance that could have made claims such as “removes mold, mildew and algae stains” potentially subject to registration, differing from the established interpretation of the “cleaning agents” exemption set out at 40 CFR § 152.10.  EPA reasoned that, in certain contexts, such statements would constitute claims of pest mitigation.  At the same time, EPA Headquarters was also coordinating with the Agency’s regional offices to undertake an enforcement initiative based in part on that 2010 guidance.  However, a large-scale enforcement initiative did not occur.  Industry trade associations and others were successful in convincing EPA that its expanded application of FIFRA was unnecessary and potentially unlawful.  EPA responded by issuing revised guidance essentially reducing the number of scenarios in which pesticidal intent would be inferred.

Under FIFRA a “pesticide” is “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”  FIFRA § 2(u), 7 U.S.C. § 136(u) (emphasis added).  Unless otherwise exempted from registration under 40 CFR §§ 152.20, 152.25 or 152.30, pesticide products that are intended for a pesticidal purpose must be registered.  In general, a product is considered to be intended for a pesticidal purpose when the person who distributes or sells it claims, states, or implies that the product prevents, destroys, repels or mitigates a pest.  Therefore, once a product label (or other statement made in connection with the sale or distribution of the product) includes any claim of pest mitigation, under 40 CFR § 152.15, the product is one that is intended for a pesticidal purpose and becomes subject to registration.  For cleaning products, claims of pest mitigation are frequently what trigger the registration requirement. 

According to EPA, a product need not act directly on a pest in order for it to mitigate the pest and be considered a pesticide.  See IN THE MATTER OF AQUARIUM PRODUCTS, INC. (IF&R Docket No. 1 1 1 – 4-C) (1995).  However, certain products may have effects that mitigate pests without being intended for a pesticidal purpose.  As noted above, the regulation at 40 CFR § 152.10 sets out three groups of products that are not pesticides because they are not intended to prevent, destroy, repel or mitigate a pest.  One of these includes deodorizers, bleaches and cleaning agents.  However, the regulation provides that these products are not pesticides only if no pesticidal claim, express or implied, is made on their labeling or in connection with their sale and distribution (e.g., web sites, advertising, promotional or sales activities and testimonials, or even website links to research demonstrating pesticidal efficacy).  This includes claims about the use of a cleaning product alone or in combination with other substances.

Some cleaning products claim pest mitigation, noting their ability to affect the habitat or food source of a pest, but others merely claim the ability to remove dirt or other debris.  Although such distinctions may appear subtle, they’re important from a regulatory standpoint.  Moreover, many claims are not so easily categorized, so the context in which they occur must be evaluated.  Thus, with the range of claims occurring in the marketplace, EPA guidance distinguishing between claims subject to registration and those not subject is important. 

EPA offers many examples of claims that would require registration because of a linkage to mitigating a pest, its food, food source, or its habitat.  These include the following:

  • Cleans away, washes away or removes any pest, biofilm or scum, allergen or allergen associated with a pest.
  • Removes pests by suffocating or drowning.
  • Cleans or removes pest habitats or breeding sites.
  • Cleans, precipitates or removes contaminants, nutrients or matter that provide food or habitat for pests.
  • Cleans, reduces or removes scum or sludge where pests breed, feed or live.
  • Out-competes or displaces a pest for nutrition or habitat.
  • Cleans or removes the habitat where biofilm, germs, allergens or microorganisms can hide, thrive or grow.
  • Prevents, blocks, removes, neutralizes or controls bacteria or other pests that cause odors.
  • Sanitizes, disinfects or sterilizes.
  • Images of pests or pest habitats (e.g., nest, hive or web) that imply cleaning or removal of pest habitats, or of nutrition or sources of nutrition for pests.
  • A banner, logo, design, header or any claim on a label or labeling, or through other means such as web sites, advertising, etc. that specifically links the cleaning product to pest control, Integrated Pest Management (IPM), pests or a specific kind of pest. 

In contrast, claims lacking a linkage to mitigation would not require registration.  Examples of such claims include:

  • Cleans or removes stains.
  • Cleans or removes stains from algae, mold, mildew or other non-public health organisms.
  • Cleans or removes dirt, soil, dust, debris, inanimate scum, inanimate nutrients, inanimate organic particulates, or inanimate contaminants.
  • Cleans a site (e.g., ponds, aquariums, etc.).
  • Prevents, blocks, neutralizes, reduces, eliminates, encapsulates or removes odors; deodorizes.
  • Cleans, reduces or removes sludge.
  • Cleans or removes inanimate scum such as “soap scum.”
  • Cleans, washes or prepares the surface for application of a registered disinfectant intended to kill biofilm.
  • Combines suspended inanimate particulates for easy removal by a filtration system.
  • Cleans away or removes inanimate dust-mite matter, non-living matter, or  allergens from non-living sources (e.g., pet dander allergens, cockroach matter allergens, dust mite matter allergens) (emphasis added).

Despite the numerous examples, there are scenarios for which EPA cautions companies to undertake a careful evaluation of the entire context.  These include the following types of scenarios:

  • Catalogs or web sites that list both cleaning products and pesticidal products in close proximity since these could imply that the cleaning products are pesticidal.   
  • Use of references to IPM on a cleaning product’s label.  (Although EPA considers IPM an effective and environmentally sensitive approach to pest management that relies on a combination of common-sense practices, references to IPM could imply by association that a clean product may control or mitigate a pest.)

The Agency’s guidance appears generally consistent with the longstanding practice of many companies.  However, FIFRA’s registration requirement has proven to be a source of confusion for others, so there are undoubtedly companies out there currently evaluating the guidance and adjusting their practices accordingly.

Crocs Shoe Company Settles FIFRA Enforcement Action with EPA

/in

FIFRA:

On December 30, 2010, EPA announced a settlement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with Crocs, Inc., the company famous for its ubiquitous, colorful foam clogs.   EPA alleged that Crocs violated FIFRA by making unsubstantiated antimicrobial health claims on its website, in advertising, and on packaging for several styles of the Company’s shoes.   Pursuant to the settlement agreement, Crocs will remove the offending language and pay a $230,000 penalty.  The Company will undoubtedly incur significant additional expense to revise its advertising materials, field questions from distributors and worried customers, and take other steps necessary to ensure future compliance and help protect the Crocs brand.  A copy of the settlement agreement is available here.

This case is another unfortunate example of the relative ignorance of many consumer products companies about the application of FIFRA to consumer products treated with antimicrobials or other pesticides.  One would not normally consider shoes to be a pesticide product, but under FIFRA, they can be.  Making an antimicrobial public health claim about a product (usually because of a chemical applied to the product) is one of the easiest ways to make a cutting board, computer keyboard, etc., subject to FIFRA.  Many companies simply don’t understand this, or they mistakenly think their products qualify for the “treated articles” exemption and therefore they don’t need to worry about FIFRA.   (More on the “treated articles” exemption in a minute.)  EPA’s enforcement docket is littered with past examples of such mistakes.

Simply stated, products that claim to kill or repel bacteria or germs are considered pesticides under FIFRA.   FIFRA requires companies to register pesticide products with EPA before selling, distributing, or making public claims about their ability to control germs or pathogens.   The registration process can be time-consuming and expensive because EPA will not register a pesticide until it has been shown, through testing, not to pose an unreasonable risk when used according to the label’s directions. 

Companies often aren’t aware of the scope of the registration requirement.  Others are aware of it, but  believe (mistakenly) that their products qualify for the “treated articles” exemption in 40 CFR 152.25(a).  Eligibility for this exemption is not as straightforward as it might seem.  In a nutshell, the exemption requires: (1) the incorporated pesticide to be registered for use in or on the article and (2) the sole purpose of the treatment to be protection of the article itself.  Implied or explicit public health claims for protection against bacteria, fungi, viruses, or other pathogens (e.g., “antibacterial”) are prohibited since they show that treatment was not solely for protection of the article itself.  Companies commonly make claims broader than those allowed or they fail to confirm that the registration covers treatment of their specific type of product.  The result is a violation of FIFRA with all the pain and expense that entails.

Where does this leave a consumer products company wanting to capitalize on society’s germ phobia?  Well, before succumbing to the sirens’ song from Marketing or Sales about the new marketing opportunities, usually an in-house counsel, product steward, or other EH&S professional inquires about FIFRA compliance.   If shrugs or blank stares are returned, that person will arrest the momentum and probe the issue further.  (Disclaimer:  This is a practical observation and not legal advice.)  EPA has helpful guidance , and other information is available on its website, here and here.