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Ms. Kaufman is a partner at Holland & Knight LLP in Washington, D.C.
In 2010 the U.S. Environmental Protection Agency announced that four separate consumer product manufacturers would pay more than half a million dollars to resolve enforcement actions involving the retail sale of shoes, headphones, and bathroom fixtures. See Press Release, Envtl. Prot. Agency, “The North Face” Parent Company, “Saniguard” Marketers, and Califone Fined More Than $500,000 Over Antimicrobial Claims (May 6, 2010), available at yosemite.epa.gov/opa/admpress.nsf/e51aa292bac25b0b85257359003d925f/ac0c1af1625888608525771b00561e83!OpenDocument&Highlight=0,FIFRA. According to the press release, the manufacturer of North Face sports apparel agreed to pay $200,000 for making unsubstantiated public health claims that their athletic shoes provided “antimicrobial protection” and inhibited the growth of “disease-causing bacteria.” Califone International, Inc. agreed to pay $220,000 for making unproven health claims that its headphones “prevent[ed] the spread of bacteria, mold and mildew for student protection.” At the same time, two companies selling and distributing Saniguard faucets and food service hardware products to hospitals settled an action arising out of claims that the products contained an antimicrobial technology that controlled the growth of E. coli, salmonella, and staph on treated surfaces.
None of the companies’ marketing directors was likely aware that the claims made in connection with the sales, advertising, and distribution of these consumer products violated the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq. (2006) when they developed their marketing approach. Nor is it likely they knew their companies would be subject to penalties of up to $7,500 for each sale of one of these products. Even their lawyers were probably not aware of the fact that EPA regulates pesticide claims connected with the retail sale and distribution of consumer articles, particularly housewares, clothing, and linens, if the sales rely on public sanitizing and antimicrobial/antibacterial claims. However, as with many types of regulation, ignorance of the law is not an excuse.
During health scares such as flu epidemics and bedbug infestations, many companies see a marketing opportunity for special “antibacterial” coatings on kitchen and other houseware products, as well as bedbug, dust mite, and allergy protection products. Their marketing departments then develop elaborate marketing programs centered on these claims. Unfortunately, the FIFRA statutory scheme governing antibacterial and antiallergen claims is not clear and is generally misunderstood by the regulated community and the public. The goal of this article is to provide clear advice to assist manufacturers, distributors, wholesalers, and retailers in marketing consumer products in compliance with FIFRA. It includes a description of the regulatory scheme governing pesticides in consumer products, the specific EPA guidance on antimicrobial claims and cleaning products and the regulatory requirements for “pesticide devices” such as bedbug resistant mattress covers and HEPA vacuums. It also includes a description of certain exceptions to the rules regarding pesticide claims, which allow antimicrobial claims about certain coatings, additives, and pesticides that protect the product itself from deterioration, rather than claiming to protect public health.
The FIFRA regulatory scheme is complex, and many attorneys and members of the regulated community may not even be aware that FIFRA is applicable until after a violation has occurred. Most environmental practitioners are aware that FIFRA regulates pesticides to ensure that they are applied safely, cause no harm to the environment or human health, and are effective in destroying or mitigating insects and other pests as intended. The general public may also be vaguely familiar with Rachel Carson’s book, Silent Spring, which brought attention to the dangers of DDT and other pesticides in the environment and ultimately resulted in the ban of DDT and other high risk pesticides in the United States. Most environmental lawyers know the impact of pesticides on the environment and sensitive species, as well as the dangers of older pesticides such as diledrin and chlordane, sprayed on building foundations to prevent termite and other insect damage. However, many people are not aware that FIFRA also regulates public health claims about consumer products such as soap, fabric, coatings, and clothing that “help prevent the spread of bacteria and viruses,” “reduce allergies,” and “kill germs on contact.” Products that make these claims are considered “pesticides” under the statute and are required to be registered with EPA, which involves a very expensive, multiyear process of submitting efficacy and safety data for each aspect of a product, development and review of labels, pesticide application and disposal instructions, and a series of EPA approvals.
FIFRA was originally enacted in 1947 to evaluate the efficacy of agricultural pesticides. It has been amended several times to ensure that EPA has broad regulatory authority to protect the public, consumers, and the environment from the adverse effects of pesticide use. FIFRA regulates all “pesticides” that are distributed into commerce or imported into the United States. A “pesticide” is: “(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest,” or (2) “any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant.” 7 U.S.C. § 136(u). Pesticides that are traditionally regulated under FIFRA include insect repellants, rat poison, crop pesticides, and consumer bug spray. However, FIFRA’s scope extends to all products intended to repel or mitigate any “pest.” FIFRA’s definition of “pest” includes not only “any insect, rodent, nematode, fungus, weed” but also extends to “ any other form of . . . plant or animal life or virus, bacteria, or other micro-organism which [EPA] declares to be a pest . . . ” 7 U.S.C. § 136(t).
To further expand the definition of “pest,” EPA promulgated the rule now codified at 40 CFR § 152.5, which declares “any microorganism” to be a pest under circumstances that make it deleterious to man or the environment (other than those on or in living man or other living animals). Such pests are further defined to include “[a]ny fungus, bacterium, virus, or other microorganisms, 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. . . .” Thus, by regulatory fiat, microorganisms such as bacteria, viruses, and “germs” are considered “pests,” and products that claim to prevent, destroy, or repel bacteria and germs are regulated as pesticides or pesticide devices.
Section 3 of FIFRA prohibits any person from distributing or selling a pesticide that is not registered with EPA. 7 U.S.C. § 136a(a). However, sometimes it is not clear whether it is a “pesticide” that is being sold, particularly in the case of certain chemicals that have other legitimate purposes, such as bleach and boric acid. For example, chlorine bleach is commonly used to kill fungus and mold, but it is not considered a fungicide unless the seller makes fungicidal claims. Most bleach products do not make those claims; instead, they simply claim that the bleach gets clothes cleaner, which is generally an acceptable claim under FIFRA. According to the FIFRA regulations, a substance is only considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if the seller or distributor intends it to be used as a pesticide. See 40 C.F.R. § 152.15. The following circumstances are examples of when EPA believes a seller intends to sell a substance for use as a pesticide:
Perhaps the best example of the “intended” rule is Avon’s Skin-So-Soft product, which was originally marketed by Avon solely as a body lotion and skin softener. The product was also effective as a mosquito repellant and did contain a common natural repellant. Based solely on word of mouth, many consumers purchased Skin-So-Soft to use as a mosquito repellant. Avon never made marketing claims that Skin-So-Soft was effective as a mosquito repellant and did not sell the product on that basis. As a result, Avon was not required to register the product with EPA. If the product could not be used for any purpose other than as a mosquito repellant, however, EPA may have brought an enforcement action. Ultimately, Avon did register the product as a pesticide and now sells it as a mosquito repellant as well as a skin conditioner.
There are substantial penalties for violations of FIFRA. EPA Regional Offices often bring enforcement actions, frequently on the basis of improper Internet advertising of consumer products. EPA has statutory authority to impose civil penalties of up to $7,500 per violation under FIFRA, with each shipment, sale, or application considered a separate violation. Criminal penalties of up to $50,000 per violation can be imposed for knowing violations. 7 U.S.C. § 136l. EPA also has the authority to issue stop sale orders and/or seize unregistered products. Historically, very large penalties have been imposed. For example, in 2008, EPA filed a complaint against 99-cent Only Stores in California for penalties of almost $1 million for the alleged sale and distribution of unregistered and misbranded consumer pesticides in multiple retail stores. See Press Release, Envtl. Prot. Agency, EPA Judge Levies Nation’s Largest Pesticide Fine on “99-cent Only Stores” (Sept. 15, 2010), available at http://yosemite.epa.gov/opa/admpress.nsf/e51aa292bac25b0b85257359003d925f/3b92cb417ca584ba8525779900747a34!OpenDocument&Highlight=0,FIFRA. The products were imported from Mexico and were not registered with EPA. But, they made claims in Spanish that they disinfected and sanitized surfaces, such as “inhibits mold, fungus and bacteria including E coli.”
The only legally permissible way for products to include a claim that they mitigate and control pests and protect human health is for the products to be registered with EPA. As part of the registration process, testing data have to be submitted to show that the product can protect humans from germs, microorganisms, or viruses, as applicable to the claims. The registration process requires the submittal of both adverse health effect studies and efficacy studies and requires several years to complete. Registered pesticides are assigned unique EPA registration numbers, which are required to be shown on the product label, enabling EPA to track the exact product involved in the event of a complaint or other incident. As part of the registration process, EPA also imposes very specific labeling requirements for each product, including statements of active ingredients, instructions for proper use, and safety instructions and warnings. The products cannot be legally sold in commerce until the registration is complete and the labels contain the assigned registration number.
Given the risk of high penalties and the sometimes obscure and confusing regulatory scheme, EPA has provided guidance to the regulatory community on many aspects of FIFRA requirements via guidance documents, FAQs, and EPA website summaries and references. FIFRA regulations also helpfully set out those groups of products that are not pesticides if no pesticidal claim is made in connection with their sale or distribution. These include deodorizers, bleaches, and cleaning agents, as well as products that are intended to exclude pests only by providing a physical barrier against pest access, such as a mattress cover or tree tar.
In the consumer product area there are two helpful EPA guidance documents pertaining to cleaning products and antimicrobial claims. Sometimes questions arise with respect to cleaning products, such as bleach and detergents, which are effective in cleaning and treating mold or other products that claim to clean “scum,” or the environments where insects or pests live. According to EPA, a claim that a product affects the habitat or food source of a pest is a “mitigation” claim that will bring the product under FIFRA’s regulatory umbrella. Such claims are in contrast with statements about a product’s use that merely claim to remove dirt or other debris without any linkage to mitigating a pest, its food source, or its habitat. See EPA Factsheet, available at http://www.epa.gov/pesticides/factsheets/pest-habitat-claims.html. In addition, according to this EPA publication, the following types of claims do not trigger registration requirements: “cleans or removes stains from algae, mold, mildew,” “cleans or removes ‘soap scum,’” and “cleans or removes inanimate dust-mite matter, pet dander allergens, or other non-living matter.” In contrast, certain types of claims, including “prevents, blocks, removes, neutralizes or controls bacteria or other pests that cause odors” or “sanitizes, disinfects or sterilizes” are all pesticidal claims because “the claims imply or express that the product mitigates a pest, directly or indirectly, either by itself or by removing the pest’s food, food source or its habitat.”
EPA has also treated products bearing claims for sanitizing or disinfecting properties as pesticides requiring registration. For example, a bleach will require registration if the label states that bacteria will be killed at certain doses. Conversely, if a bleach label only claims to whiten, bleach, or clean laundry, and it does not contain an explicit or implicit antimicrobial claim, the bleach is not required to be registered. See EPA Label Guidance available at http://www.epa.gov/oppfead1/labeling/lrm/chap-02.pdf . In this regard, EPA reached a $270,000 settlement with Unified Western Grocers, a Los Angeles grocery distributor, for the sale and distribution of “Western Family Cleanser with Bleach,” an unregistered product that stated on the label that it wiped out most household germs, including Staph, Salmonella, and Pseudomonas.” See EPA Press Release available at http://yosemite.epa.gov/opa/admpress.nsf/e51aa292bac25b0b85257359003d925f/cffbe283eb4e5ae7852574320069ae9b!OpenDocument&Highlight=0,FIFRA.
It is important to note that any product that is intended to control fungi, bacteria, viruses, or other microorganisms in or on living humans or animals is exempt from FIFRA. 40 CRF 152.5(d). These products include athlete’s foot remedies, dandruff medications, aquarium additives for treatment of fish diseases, and dermal disinfectants, and are instead typically regulated by the Food and Drug Administration (FDA). However, insecticides (pesticides that kill insects as opposed to microbes) are not included in the “living body” exception. Thus, products such as mosquito repellents, flea and tick remedies for pets, and other insecticides used directly on the living body of humans, pets, and livestock are considered to be pesticides and are required to be registered. Examples of exempt products include contact lens solutions that disinfect the lens in the contact lens holder, which are exempt from registration under FIFRA through an agreement with the FDA. Cedar products, such as cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles that are solely made of cedar wood or natural cedar are also exempt. Embalming fluids are exempt, as well as any food that is used to attract a pest (such as the cheese in a mousetrap). Finally, certain minimum-risk pesticides, such as citronella, mint oil, sesame, cinnamon, and putrescent whole egg solids (used as deer repellant) are exempt from FIFRA requirements. See 40 CFR 152.25(f) for a complete list of minimum-risk pesticides. Under certain circumstances, products such as wood that have been treated with a preservative to prevent plant growth, and other products that are treated with a pesticide to protect deterioration of the product itself are also exempt.
FIFRA regulations also provide a specific exemption for registration of products that fall within the “treated article” exemption in 40 CFR 152.25(a). Many marketers of consumer products try to take advantage of this exemption but run into trouble with EPA if they make public health claims about their products. The treated article exemption provides that an article treated with, or containing a pesticide to protect the treated article itself, does not require pesticide registration. Examples of treated articles are fabric that is treated with a pesticide to prevent mold growth on the fabric or fabric treated with an insect repellant to prevent moth holes. Labels on treated bedding products, outdoor cushions and fabrics, shower curtains, and certain kitchen products frequently include language along the following lines: “This item has been treated to prevent growth of mold and bacteria which causes fabric deterioration and odors.” One important requirement of the treated article exception is that the pesticide used to treat the article is registered and bears appropriate directions for use of the article. See 40 CFR 152.25(a) and PR Notice 2000-1; http://www.epa.gov/PR_Notices/pr2000-1.pdf.
The other important requirement is that no public health claims are made in connection with the sale or distribution of the product. For example, EPA has issued penalties and stop sale orders to manufacturers and distributors that claim that their products have coatings to protect customers against germs and bacteria. EPA recently brought an enforcement action against Samsung when the company claimed in advertising material that its computer keyboards, notebooks, and computer laptops were antimicrobial and inhibited germs and bacteria. Samsung ultimately paid a $205,000 fine and had to provide certification to EPA that it had complied with FIFRA by removing all pesticidal claims made in connection with the sales and distribution of these products. It also had to notify retailers and distributors to remove any pesticidal claims from labels, promotional brochures, and Internet/web-based content for the products. See EPA Press Release, available at http://yosemite.epa.gov/opa/admpress.nsf/e51aa292bac25b0b85257359003d925f/201d62b730b8262985257656005af84c!OpenDocument&Highlight=0,FIFRA.
Removal of products from shelves and relabeling can cost several million dollars. In addition, most contracts between distributors of products and retailers contain covenants by the manufacturer or distributor that the products comply with all laws, including environmental laws. A breach of those covenants requires the manufacturer and distributor to indemnify the retailer for all damages arising from the breach, including expenses, penalties, and even lost profits.
With so much riding on these claims, it is unfortunate that the treated article exemption is difficult to interpret. For example, EPA makes several distinctions under the treated article exemption about paints that make mildew protection claims. According to EPA, paints that have been treated with antimicrobial pesticides and bear claims that the dried paint film will be resistant to mold or mildew are acceptable. In contrast, EPA warns that paints with express or implied claims made for protection of the surface beneath the paint film or for preventing or destroying mold or mildew on the surface of the paint, are not within the treated article exemption. See EPA Label Review Manual, July 2011, available at http://www.epa.gov/oppfead1/labeling/lrm/chap-02.pdf.
According to EPA, other products that fall within the treated article exception include shower curtains treated with a fungicide to retard mildew growth; lumber treated with a wood preservative; bathroom caulks impregnated with a mildewcide; and fabrics and leather treated with preservative compounds (all of which uses are intended to protect the treated articles themselves). In contrast, shirts and other articles of clothing treated with an insecticide to repel mosquitoes and other insect pests are examples of products treated with insecticides that require registration of the article of clothing. Because the treatment would be for the benefit of the wearer rather than to protect the integrity of the clothing, the treated article exemption would not apply. Id.
In the past few years, a silver product that consists of a highly pulverized silver powder has become popular as an anti-microbial coating on metal surfaces, engine parts, and even fabric. Laboratory tests have shown that the silver coated surface discourages and provides a hostile environment that inhibits the growth of germs and bacteria. The coating is a registered EPA pesticide, but the registration and manufacturer information specifically warn that products that incorporate the coating may not make claims of antimicrobial activity other than protection of the article itself against growth of bacteria, mold, and mildew. Further, the manufacturer warns that the antimicrobial powder is for commercial and industrial use and is designed to be incorporated into various materials during varying stages of the manufacturing process to preserve the integrity of the manufactured materials.
EPA’s April 6, 2000, Pesticide Registration Notice regarding the “Applicability of the Treated Article Exemption to Antimicrobial Pesticides” also states that the term “antimicrobial” may be used if it refers to protection of the product, rather than protection of human health. It specifically permits claims such as “Antimicrobial properties built in to protect the product.” Thus, any marketing claims that the pesticide coating inhibits the growth of germs, bacteria, or viruses on the surface of the product, must specify that it for the purpose of protecting the product from deterioration. See PR Notice 2000-1, available at http://www.epa.gov/PR_Notices/pr2000-1.pdf.
Like treated articles, another confusing area of the FIFRA regulations is the requirement applicable to pesticide devices, which include such devices such as “bug zappers,” fly traps, and physical pest barriers.
For purposes of FIFRA, a “device” is defined as “any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life . . .” 7 U.S.C. § 136(h); 40 CFR 152.500(a). According to EPA’s Device Policy Statement, “If an article uses physical or mechanical means to trap, destroy, repel, or mitigate any plant or animal life declared to be a pest . . . it is considered to be a device.” 41 FR 51065 (Nov. 19, 1976). Pesticide devices includes black light traps, fly traps, fly paper, sound repellents, certain ultraviolet light systems, ultrasonic devices that claim to kill, inactivate and entrap, and certain high frequency sound generators. In addition, with the advent of bedbug epidemics in hotel and apartment buildings, mattress and pillow encasements have been used as pesticide devices. Several studies have shown that physically covering a mattress with an impenetrable cover can help control dust mites and bedbugs that feed on mattresses and pillows. Mattress covers that rely on the physical action of covering the mattress to protect against bedbugs are considered a “pesticide device.” In addition, fabrics with an extremely tight weave have been shown to prevent dust mites from passing through a mattress to the human being and are also considered to be devices because of this “blocking” action.
Any domestic or foreign establishment that engages in the production of pesticide devices must be registered with EPA. “Production” includes formulation, packaging, repackaging, labeling, and relabeling. 7 U.S.C. § 136(w). The product itself does not have to be registered, but the producing facility must register. To register a facility, relatively simple registration forms must be submitted to EPA and EPA then generates an establishment number, which must be placed on the label or package insert of each package sold. In addition, importers of devices must submit a Notice of Arrival of Pesticides and Devices to EPA for review and determination as to whether the shipment should be sampled and/or permitted to enter into the United States. 41 FR 51065, referring to 12 CFR § 12.1.
Devices are also subject to labeling requirements. In particular, labels for devices must meet certain requirements to ensure that they are not misbranded, including listing the pesticide establishment number of the device’s producer; the name and address of the producer, registrant, or person for whom it was produced; and directions for use which are necessary for affecting the purpose for which the product is intended. 7 U.S.C. § 136(q)(l). In addition, there are annual EPA reporting requirements that require submittal of information regarding any products produced, sold, or distributed during the past year and products estimated to be produced during the current year. 40 CFR 167.85.
EPA has jurisdiction of all pesticide devices, even though some devices are used in the medical setting as sterilizers and antimicrobials to clean air, sanitize surfaces, and treat allergens. The FDA has concurrent jurisdiction over medical devices, and EPA has expressed its policy to defer to FDA’s jurisdiction over medical devices that are also pesticides or pesticide devices. As a result, many products such as mattress covers, autoclaves, and encasements used for bedbug protection in hospitals may contain the text “FDA Class 1 Medical Device” on the product advertising or description. If a product can qualify as a medical device, it is exempt from FIFRA labeling and marketing requirements and can include claims that it protects against dust mites and other allergens.
It is clear that EPA is well aware of antimicrobial issues and is actively policing marketing claims of antimicrobial protection. Competitors are also very motivated to report mislabeling to EPA, which is then bound to investigate it. Internet searches of product advertising are simple and inexpensive for EPA staff, which can then verify product sales with in-store inspections as necessary. State agricultural agencies also perform inspections and report findings to EPA. The September 2011 EPA enforcement against Logitech, Inc. provides a good example. According to EPA’s press release, Logitech agreed to pay $261,000 to settle a case against it for making unsubstantiated public health claims about its computer keyboards. EPA Press Release available at http://yosemite.epa.gov/opa/admpress.nsf/eeffe922a687433c85257359003f5340/9ebca2e340e09ab3852579190068cb02!OpenDocument.
The company incorporated a silver compound designed to protect the keyboard against deterioration, then marketed the keyboard as protecting the user from bacteria and microbes. In its press release, EPA states that “[u]nverified public health claims can lead people to believe they are protected from disease-causing organisms when, in fact, they are not” and that “[t]he EPA takes very seriously its responsibility to enforce the law against companies that make such claims for their products.” Logitech had reportedly distributed some 1,300 cordless desktop laser keyboards to various retailers and customers throughout the United States. The keyboard and mouse combination incorporated an EPA registered pesticide, AgION silver compound. Evidence apparently found online and during an investigation of the distribution facility led the EPA to issue a complaint against Logitech. After being contacted by EPA, Logitech promptly stopped making claims that their product protects consumers against bacteria, mold, and mildew; removed claims from their website; and revised their product packaging. Similarly, Marukai Corporation reached a settlement with EPA of more than $200,000 for selling kitchen, bathroom and home care products at its retail outlets that were not registered. See EPA Press Release, available at http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a9efb85257359003fb69d/1a693e4215de143d8525783700647cc8!OpenDocument.
Removal of products from store shelves and new labeling is very expensive and can often cost much more than penalty payments. EPA enforcement actions can also provoke lawsuits by the plaintiffs’ lawyers. A class action could, for instance, seek nominal compensation for all consumers who used an improperly labeled or advertised product, a new marketing campaign to correct mislabeling and alleged misimpressions, and an award of attorney fees. Reputational loss can be a significant factor as well, as a company can be irreparably damaged by adverse publicity. It is important to note that retailers, as well as manufacturers, are equally liable under FIFRA for the sale of unregistered pesticides and pesticide products. While the manufacturer may indemnify the retailer, indemnification cannot change public perception that a retail establishment has sold a faulty or even dangerous item. Consumer manufacturers, distributors, and retailers have much to lose in the battle against bugs and bacteria, and they need to proceed with caution when they make any antibacterial, antimicrobial, or pesticidal claims. Labeling and marketing material for standard retail products such as linens, kitchen wares, clothing, and home care products must, therefore, be scrutinized to ensure they do not contain public health claims before they are placed on the shelves of any retail establishment.