July 2006 / Issue 11
Legal Briefs
What’s in a Claim: When is a Pet Product a Pesticide?
By John D. Conner, Jr.1
McKenna Long & Aldridge LLP, Advisor to APPMA
Most APPMA members understand and appreciate that the federal law regulating pesticides, the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”),2 requires a person before selling a pesticide to register the pesticide with the U.S. Environmental Protection Agency (“EPA”). State laws also require a person to register a pesticide before selling the product in the state, although in most cases state registration merely requires proof of federal registration and payment of the state registration fee. For many APPMA members, the more troublesome challenge is knowing how and when their pet products become regulated pesticides. If a pet products manufacturer concludes that its product is a pesticide, it faces two choices: remove the offending pesticidal claim or register the product with EPA.3
Opportunities abound for a manufacturer of pet care products to cross the line of FIFRA regulation. The most obvious example of a pet care pesticide is a flea and tick product, regardless of form. The status of other products, however, may be less apparent. For example, a hard surface cleaning wipe for use in kennels also makes “antibacterial,” “bactericidal,” or “germicidal” claims. The manufacturer of a food bowl for pets claims that the bowl’s plastic has been treated to control harmful microorganisms. An aquarium product says it will control “slime.” Or, a product claims that it repels pets from furniture or wildlife from backyard ornamentals. Moreover, a product may not be a pesticide but a device (an instrument or contrivance) that is intended to trap or destroy a pest. Although FIFRA does not require the registration of pesticide devices, it does impose other requirements on such devices. An example of a device is an ultraviolet aquarium light.
This article reviews for APPMA members what makes a product a pesticide and how EPA’s criteria for defining a pesticide apply to pet products. This article also reviews EPA’s exemption of minimum-risk pesticides and treated articles from FIFRA’s registration requirement.
Knowing whether your product is a pesticide is good business. EPA has imposed significant fines against both large and small manufacturers and retailers of pet products for selling unregistered pesticides. The Agency also may issue a stop sale order that prohibits the manufacturer from sending product to its distributors and retailers, until the manufacturer removes the offending pesticidal claim or registers the product. EPA may even request your company to recall unregistered products from the channels of trade. FIFRA is a strict liability law. Accordingly, even an innocent mistake is punishable.
Definition of “Pesticide”
FIFRA defines a “pesticide” as a substance or a mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.4 It does not include an animal drug or animal feed containing an animal drug. Id. “Pest” is broadly defined to include any (i) vertebrate, except man, (ii) invertebrate, including insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal human or animal parasite, (iii) any plant growing where it is not wanted, (iv) any 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 and cosmetics.5 Thus, a pesticide includes any product that claims to control microorganisms, whether bacteria, viruses, or fungi on inanimate objects and surfaces. Such products generally are referred to as antimicrobial pesticides and must be registered with the Antimicrobial Division of EPA’s Office of Pesticide Programs.
Fungi, viruses, bacteria, and other microorganisms on or in living animals are not “pests,'” and products that control such organisms are considered “animal drugs” regulated by the Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act.6 As a general rule, if it goes on an animal to control an insect, it is a pesticide; if it goes in an animal, it is an animal drug. Pets (yes, even those we consider as family members) may qualify as “pests”: In 2001, Region 5 of EPA brought an enforcement action against a pet products retailer for selling unregistered pesticide products that claimed to repel dogs and cats from objects on which the products were applied. A product intended to discourage a pet from licking or chewing its own skin or fur, however, is not considered a pesticide.
Also, not all pests are organisms. Thus, a product containing a substance that claims it removes dust is not a pesticide, but EPA likely will consider a product a pesticide, if it claims to control allergens through the inhibition or removal of microorganisms, such as mold or mildew.
Key to FIFRA’s definition of “pesticide” is the person’s intent in selling or distributing a product. Thus, if a person uses water from a bottle to drown an insect, this application of the water does not make the bottle and its water a pesticide product. Water sold in bottle, however, together with a label claim that its contents may be applied to kill an insect makes the water and its container a pesticide product subject to registration, because the claim expresses an intent that the water be used to control an insect pest. EPA will look to one or more of the following representations to decide whether the seller intends to offer a product for sale as a pesticide: the claims on a product’s label, a representation accompanying a product’s sale, and/or the product’s actual ingredients. Thus, even if a product does not make a pesticidal claim, if the product contains an ingredient whose only purpose would be use as a pesticide, the Agency may claim that the product is a pesticide. Furthermore, if a product’s label does not make a pesticidal claim but a salesperson makes a pesticidal claim as part of the pesticide’s sale, the product may thereby become a pesticide.
A pesticide does not have to directly control a pest. EPA will consider a product a pesticide if its seller makes even an indirect claim that the product will control a pest. For this reason, the Agency has brought enforcement actions against manufacturers of aquarium products with the following claims: “Eliminates green water,” “Producing conditions that prevent algae or bacteria,” “Removes nutrients that promote the growth of algae and bacteria,” or “Precipitates phosphate, a nutrient for algae.” In other words, it is not a defense to registration as a pesticide that a pet product acts only indirectly to control a pest by controlling its food source. If a product does not kill or control an organism, however, the Agency will not consider it a pesticide. For example, EPA has stated that the following claim for an aquarium product is not a pesticidal claim: “Clarifies tank by precipitating organic particles and reducing sludge.”7
In short, a pet product that is not intended to control a pest is not considered to be a pesticide, unless the product makes a pesticidal claim. Potential pesticides include deodorizers, bleaches, and cleaning agents. For example, EPA may consider a product to be a pesticide, if the product claims to control odors by controlling microorganisms. Similarly, if a bleach product makes an antimicrobial claim, the Agency will consider the claim pesticidal and look for a FIFRA product registration. A product that is intended to exclude pests by a physical barrier against pest access, and which contain no toxicants, is not a “pesticide,” because EPA does not consider such use to be for a pesticidal purpose. An instrument or contrivance that traps or repels a pest, however, is a device that, while not subject to FIFRA’s registration requirements, is subject to FIFRA’s misbranding and other provisions, including production reporting and inspection provisions.
Minimum-Risk Pesticides
If a product is intended to control a pest, its toxicity makes no difference. Accordingly, as noted above, if water is sold as a pesticide, it is a pesticide, although it is safe to most organisms under most circumstances. Thus, a product’s ingredients may be “natural” or “organic,” but it is still a pesticide, if it makes pesticidal claims. FIFRA § 25(b) (7 U.S.C. § 136w(b)) exempts pesticides containing certain minimum-risk active ingredients from registration, however, if the product meets certain additional requirements. First, the active ingredient must be listed in 40 C.F.R. § 152.25(f). Examples of EPA-approved minimum-risk active ingredients are castor oil, citronella, and linseed oil. Second, the product must include only permitted inert ingredients. Finally, the label must identify the name and amount of each active and inert ingredient, and the product must not make any public health or false or misleading claims. Thus, a product claiming to control ticks that carry Lyme Disease (a public health claim) would not qualify as a minimal risk pesticide. Although exempt from the registration requirements of FIFRA, minimum-risk pesticides are not necessarily exempt from state registration requirements.
Treated Article Exemption
EPA’s regulations exempt from FIFRA registration an article or substance treated with, or containing, a pesticide to protect the treated article or substance itself, if the pesticide used for treatment is registered for such use.8 Some articles are treated with pesticides to inhibit the growth of microorganisms that may cause odors or to inhibit the growth of mold or mildew. Thus, a pet product that claims treatment to inhibit the growth of microorganisms that may cause odors or harm the product itself are exempt from registration, if the pesticide used to treat the article is registered for such use, namely, to protect products of the same composition. EPA’s treated article exemption prohibits a manufacturer of a treated article from making public health claims for the treated article. Consequently, , it would be inappropriate for a pet product to claim that it is treated with a pesticide that will reduce or eliminate pathogenic organisms that may cause food poisoning or infectious diseases, unless the pet product manufacturer first registers the treated article and supports the public health claim. EPA has explained the treated article exemption in Pesticide Registration (“PR”) Notice 2000-1.9
Summary
There are many opportunities for the manufacturer of a pet care product to unknowingly made a pesticidal claim. As noted, the penalties and disruption of product distribution are significant for selling an unregistered pesticide. So, when it comes to selling pesticides, an ounce of prevention indeed is worth a pound of cure.
1. John D. Conner, Jr. is a partner in the Washington, D.C. office of McKenna Long & Aldridge LLP, where he has practiced pesticide and chemical regulatory law for 31 years. He can be reached by electronic mail at jconnerjr@mckennalong.com.
3. APPMA will offer a webcast seminar this autumn in which McKenna Long & Aldridge LLP and its consulting subsidiary, Technology Sciences Group, Inc., will review for APPMA members how to register a pesticide.
4. FIFRA § 2(u), 7 U.S.C. § 136(u).
5. FIFRA § 2(t)-(u); 7 U.S.C. § 136 (t)-(u).
7. Enforcement Alert: Aquarium and Pond Chemicals May Require Federal Registration, Labeling as Pesticides, EPA 300-N-99-006 April 1999
9. See http://www.epa.gov/opppmsd1/PR_Notices/pr2000-1.pdf.