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Label Review Manual
Chapter 2: What is a Pesticide?

Table of Contents
Chapters:
  1. Purpose of Manual
  2. What is a Pesticide?
  3. General Labeling Requirements
  4. Types of Label Reviews
  5. Ingredient Statement
  6. Use Classification
  7. Precautionary Labeling
  8. Environmental Hazards
  9. Physical or Chemical Hazards
  10. Worker Protection Labeling
  11. Directions for Use
  12. Labeling Claims
  13. Storage and Disposal
  14. Identification Numbers
  15. Company Name and Address
  16. Graphic & Symbols on Labels
  17. Content/Net Weight Statement
  18. Unique Product Labeling
  19. The Consumer Labeling Initiative and Pesticide Labels


PDF Version (11 pp, 101 KB, about PDF)

Current as of December 2006

On this page

  • I. Introduction
  • II. Products that are not Pesticides
  • III. What makes a product a pesticide?
  • IV. Pesticides exempted from registration
  • V. Is the product a device and, therefore, not a pesticide?


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    I. Introduction

    This chapter discusses the statutory and regulatory criteria used to determine whether or not a product is a pesticide requiring registration under FIFRA. Relevant FIFRA definitions are found in section 2 of the statute and the applicable regulations are at 40 CFR Part 152, Subparts A and B. Exit EPA disclaimer Label reviewers should use the statute and regulations when evaluating the “pesticide” status of products or potential products.  It is acceptable to discuss whether hypothetical products are pesticides with anyone, including state enforcement personnel, registrants, applicants or the general public.  Whether or not a particular product that is the subject of an application is a pesticide under FIFRA must be treated confidentially through applicable CBI protections.  A final decision about the pesticide status of a particular product must be made in writing to the applicant or registrant and should be in response to a written request for an Agency determination, which includes proposed labeling and the composition of the product.

    As discussed in detail below, there are a number of types of products that the Agency has determined are not pesticides and others that the Agency has exempted from regulation even though they are pesticides.  If a label reviewer determines that a product is a pesticide, the label reviewer should consider whether the pesticide has been exempted from the FIFRA registration requirements.

    If the label reviewer determines that the product is not a pesticide, the label reviewer must consider whether the product is a device.  The last section of this chapter addresses this topic.

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    II. Products that are not pesticides

    Some substances and products may be excluded from FIFRA registration if they meet certain conditions or criteria.  40 CFR 152.6 Exit EPA disclaimer sets out the following types of products that fall into this category.

    1. Liquid chemical sterilants.

      A liquid chemical sterilant product is not a pesticide under section 2(u) of FIFRA if it meets all of the following criteria. See 40 CFR 152.6(a). Exit EPA disclaimer Excluded products are regulated by the Food and Drug Administration (FDA). Products excluded are those meeting all of the following criteria:

      1. Composition. The product must be in liquid form as sold or distributed. Pressurized gases or products in dry or semi-solid form are not excluded by this provision. Ethylene oxide products are not liquid products and are not excluded by this provision.

      2. Claims. The product must bear a sterilant claim, or a sterilant plus subordinate level disinfection claim. Products that bear antimicrobial claims solely at a level less than “sterilant” are not excluded and are jointly regulated by EPA and FDA.

      3. Use site

        • The product must be intended and labeled only for use on “critical or semi-critical devices.'' A “critical device'' is any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body. A semi-critical device is any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.

        • Liquid chemical sterilants that bear claims solely for use on non-critical medical devices are jointly regulated by EPA and FDA.

        • Liquid chemical sterilants that bear claims solely for use on sites that are not medical devices, such as veterinary equipment, are not excluded and are regulated solely by EPA.

    2. Nitrogen stabilizers.

      A nitrogen stabilizer is excluded from regulation under FIFRA if it is a substance (or mixture of substances), meeting all of the following criteria found in 40 CFR 152.6(b): Exit EPA disclaimer



      1. The substance prevents or hinders the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria and is distributed and sold solely for those purposes and no other pesticidal purposes.  For purposes of 40 CFR 152.6, Exit EPA disclaimer living organisms are not considered to be substances, and the actions of living organisms are not relevant to whether a substance is deemed to be a nitrogen stabilizer.

      2. The substance was in “commercial agronomic use” in the United States before January 1, 1992.  EPA considers a substance to be in commercial agronomic use if it is available for sale or distribution to users for direct agronomic benefit, as opposed to limited research, experimental or demonstration use.

      3. The substance was not registered under FIFRA before January 1, 1992.

      4. Since January 1, 1992, the distributor or seller has made no claim that the product prevents or hinders the process of nitrification, denitrification, ammonia volatilization or urease production.  See 40 CFR 152.6(b)(4) and (5) Exit EPA disclaimer to learn what EPA considers to be a claim that the product prevents or hinders nitrification, denitrification, ammonia volatilization or urease  production and for further information on this topic.

    3. Products Labeled Only For Use In Or On Living Man Or Animals

      Products excluded are those meeting one of the following criteria:

      1. Products intended for use only for the control of fungi, bacteria, viruses, or other microorganisms in or on living man or animals, and labeled accordingly.  See 40 CFR 152.6(c) and (d).  Such products include, for example: Athlete's foot remedies, dandruff medications, aquaculture and aquarium additives for treatment of fish diseases, and dermal disinfectants. Note: These exceptions apply only to antimicrobials (fungicides, disinfectants, viricides, etc.).  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 have historically been considered to be pesticides and are required to be registered.  Note that contact lens solutions that disinfect the lens in the contact lens holder are exempt from federal registration under FIFRA through an agreement with the Food and Drug Administration. An animal feed containing an animal drug is not a pesticide under section 2(u) of FIFRA. See also 40 CFR 152.6(e). Exit EPA disclaimer   An animal feed containing an animal drug is subject to regulation by the FDA under the FFDCA.

      2. Products intended for use only for control of internal invertebrate parasites or nematodes in living man or animals, and labeled accordingly.  See 40 CFR 152.5(b). Exit EPA disclaimer

    4. Vitamin Hormone Products

      See 40 CFR 152.6(f) Exit EPA disclaimer (previously 40 CFR 152.25(d)


    5. Products Intended Only To Aid In The Growth Of Desirable Plants

      As an initial matter, it is important to note that there is an important distinction between plant nutrients, which may be exempt from registration, and plant regulators, which require registration (and are defined in FIFRA at 2(v)).   Plant nutrients are described below.  Whether a product is considered to be a plant growth regulator basically turns on whether the plant response or mode of action being claimed would go beyond what would be expected from simple nutrition.  Claims such as increased blossom set, stimulation of root growth, prevention of sucker growth, delayed onset of sprouting of harvested root crops and abscission stimulation for fruit crops can be considered to be plant growth regulator claims.  In this area, the composition of the product may aid in making the determination.  Compounds such as auxins, cytokinins, and gibberellins have no other uses except as plant growth regulators.  Therefore, the presence of any of those compounds generally causes a product to be considered to be a plant growth regulator.  However, products containing auxins, cytokinins, and gibberellins may be exempt from registration if the labeling meets the criteria for vitamin-hormone horticultural products under 40 CFR 152.6(f) Exit EPA disclaimer


      6. Examples of products that aid in the growth of desirable plants, types of which are found in 40 CFR 152.6(g), Exit EPA disclaimer include:

      1. Plant or leaf coatings designed to protect against frost or to retard water loss through transpiration.  These types of products are usually glycerol-based.  Similar products are sometimes sold as cut-flower preservatives.  As long as plant disease or plant regulator claims are not made for the product and its composition is not such that pesticide benefits would be delivered, registration has historically not been required.

      2. Products sold as vase water additives for cut flowers, although such products bear special scrutiny.  If they are composed, as many are, of simple sugars intended to supply nourishment to the cut flower, they are likely not under the purview of FIFRA.  Historically, however, products with claims to prevent bacterial or fungal growth in the vase water, claims such as ”delays flower opening”, claims to control stem rot or decay or products with chemicals that only have pesticidal uses have been subject to FIFRA registration.

      3. Food washing products that do not claim to remove bacteria such as e-coli or salmonella.

      4. Fertilizer products not containing a pesticide, such as sphagnum moss used as plant growth media to retard damping-off.

      5. Plant inoculant products consisting of microorganisms applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system. See 40 CFR 152.6(g)(2). Exit EPA disclaimer

      6. Soil amendment (e.g., vermiculite, sand, lime) products containing a substance or substances added to the soil for the purpose of improving soil characteristics favorable for plant growth. See 40 CFR 152.6(g)(3) . Exit EPA disclaimer   Soil amendments are intended to increase porosity, retain moisture, adjust pH, and other uses intended to benefit crop production.  For example, although normally considered to be a fungicide or miticide, products containing sulfur when applied to soil to solely adjust the pH have historically not been subject to registration.  Sulfur may also have nonpesticidal uses as a foliar plant nutrient at low concentrations.

      7. Plant nutrient products consisting of one or more macronutrients or micronutrient trace elements necessary to normal growth of plants and in a form readily useable by plants.  See 40 CFR 152.6(g)(1). Exit EPA disclaimer

    6. Antimicrobial products used solely in processed foods or feeds, in beverages, or in pharmaceuticals.

      Cracking, milling, grinding and other processes that cause a physical change in the commodity are methods that meet the definition of "processed."  Substances used in these processes against microbes in or on the processed food are not pesticides under FIFRA and are regulated by FDA, not EPA.  Drying, husking and shelling do not meet the definition of “processed” so that products used during these processes are FIFRA pesticides and are regulated by EPA under FIFRA.  Cosmetics are pharmaceuticals regulated by FDA. See 40 CFR 152.5(d) . Exit EPA disclaimer

    7. Products With No Pesticidal Claims

      Products that are not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate, or regulate the growth of plants are not considered to be pesticides.  Some of these products may appear to be pesticides, but are not considered as such unless pesticidal claims are made on their labeling or in connection with their sale and distribution.  40 CFR 152.10 Exit EPA disclaimer lists products which fall under this category.

      1. Deodorizers, bleaches, and cleaning agents.  OPP has treated products bearing claims for sanitizing or disinfecting properties as pesticides requiring registration.  For example, a bleach which consists of 5.25% sodium hypochlorite would likely require registration if the label states that bacteria will be killed at certain doses.  An identical bleach would not likely need to be registered if the labeling only claims to whiten, bleach or clean laundry, and does not contain an explicit or implicit antimicrobial claim.

      2. Attractants. Products that are intended only to attract pests for survey or detection purpose, that are labeled accordingly, and which contain no toxicants.

      3. Physical barrier. Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants.  Examples might include: pruning for trees; latex or asphalt tree wound dressings that make claims of preventing the entrance of insects or fungi into fresh cut surfaces of plants; cocoa bark or pine bark mulches that claim suppression of weed growth; black plastic or tar-paper used to suppress weeds or prevent the entrance of insects.

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    III. What makes a product a pesticide?

    The term “pesticide” is defined at FIFRA 2(u).  One of the most important words in the FIFRA definition of “pesticide” is "intended."  One of the analytical steps to determining whether a product is a pesticide is to consider whether the product is “intended” to be used as a pesticide.  Products are generally considered to be pesticides if they are intended for preventing, destroying, repelling, or mitigating any pest or intended for use as a plant regulator, defoliant, or desiccant.  OPP determines intent by examining claims on the label, advertising, composition/use, and/or mode of action of the product as distributed or sold.  Section 40 CFR 152.15 Exit EPA disclaimer sets forth the criteria to help establish intent.  If the regulatory criteria are met the label reviewer can conclude that the product is a pesticide and must be registered.  The regulatory criteria are described below:

    1. Claims. If a person who distributes or sells the product claims, states or implies by labeling or otherwise (such as, advertising, collateral literature, or verbal statements), that the product can or should be used as a pesticide or that the product contains an active ingredient and that it can be used to manufacture a pesticide, then the product is a pesticide.  40 CFR 152.15(a). Exit EPA disclaimer

    2. Composition. If a product is composed of one or more active ingredients that have no other significant commercially valuable use other than for a pesticidal purpose or for use in manufacturing a pesticide then the product historically has been considered to be a pesticide.  40 CFR 152.15(b).  For example, a company markets a granular product that has labeling identifying the presence of 2,4-D, directions to apply it to lawns at a certain dosage rate, and warns the user about over-application, but does not claim that broad-leaved weeds will be killed, is the product a pesticide?  Most likely, the product is a pesticide because 2,4-D is a well-known herbicide and has no other significant commercially valuable use.

    3. Knowledge that the substances will be used as a pesticide. Even if pesticidal claims are not made for the product, if the person who distributes or sells the substance has actual or constructive knowledge that the substances will be used, or is intended to be used, for a pesticidal purpose, the product is a pesticide product required to be registered.  40 CFR 152.15(c).

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    IV. Pesticides exempted from registration

    The Agency has exempted certain pesticides from regulation under FIFRA under the authority of FIFRA 25(b) because the pesticides have been determined to be (1) adequately regulated by another Federal agency or (2) of a character which is unnecessary to be subject to FIFRA.  Just because a pesticide is exempted under FIFRA, however, does not mean that the Federal Food, Drug and Cosmetic Act (FFDCA) or state laws may not apply.  For example, even if a pesticide product meets the conditions for exemption from regulation under FIFRA, it might still be subject to FFDCA requirements requiring a tolerance or tolerance exemption if there is a pesticide chemical residue on food.  The following are examples of products exempted from FIFRA under 25(b):

    1. Pesticides Regulated by Another Federal Agency

      1. Certain Biological Control Agents.  Biological control agents are generally exempt from FIFRA regulation.  40 CFR 152.20(a).   However, the Agency has determined (40 CFR 152.20(a)(3)) Exit EPA disclaimer that the following biological control agents are not exempt and are subject to FIFRA.

        1. Eucaryotic microorganisms, including protozoa, algae, and fungi;
        2. Procaryotic microorganisms, including bacteria; and
        3. Viruses.

    2. Pesticide Not of a Character Requiring FIFRA Regulation

      1. Treated Articles or Substances.  The Agency has determined that the use of a pesticide to treat or be contained in an article or substance to protect the article or substance itself, so long as it is registered for such use, does not require regulation under FIFRA.  Generally speaking, claims about such products should be limited to the protection of the article itself and the pesticides used for those purposes must be registered and bear appropriate directions for such uses. See 40 CFR 152.25(a) Exit EPA disclaimer and PR Notice 2000-1.  Examples include:

        1. Paints that have been treated with an antimicrobial pesticide and bear claims that the dried paint film will be resistant to mildew.  Historically, OPP has not accepted, expressed or implied claims made for protection of the surface beneath the paint film or for prevention of mold spores that could infect foods or beverages.  Paints that are to be used in canneries, breweries, hospitals, or other areas where a crucial consideration is prevention of bacteria or mold that would pose a health risk are generally not subject to the treated articles exemption and, therefore, generally not exempt from FIFRA regulation.


        2. 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 are other examples of products that OPP has historically viewed as treated articles.


        3. Pheromones and Pheromone Traps. Pheromones and identical or substantially similar compounds labeled for use only in pheromone traps (or labeled for use in a manner which the Administrator determines poses no greater risk of adverse effects on the environment than use in pheromone traps), and pheromone traps in which those compounds are the sole active  ingredient are not subject to FIFRA regulation.  Refer to 40 CFR 152.25(b)(1), (b)(2), and (b)(3) to determine whether a substance is a pheromone for purposes of this exemption.  Refer to 40 CFR 152.25(b)(4) to determine whether the pheromone trap falls within the exemption.  Pheromones are chemicals used in intra-species communication.  A chemical used in inter-species communication (i.e., using fox urine to repel rabbits) is an "allomone" and would be subject to FIFRA. Exit EPA disclaimer

      2. Preservatives for Biological Specimens

        1. Embalming Fluids.  Mortuary supplies intended to prevent or mitigate mold and bacteria on or in human cadavers are exempt. 40 CFR 152.25 (c)(3). Exit EPA disclaimer The rationale for this exemption is that the use is limited to embalmers and morticians who are specially trained to handle such products and do not require the protection afforded by registration. The general public would not be exposed to such products.

        2. Animal and animal organ preservatives.  Products used to preserve animal or animal organ specimens in mortuaries, laboratories, hospitals, museums, and institutions of learning are exempt.  40 CFR 152.25(c)(2). Exit EPA disclaimer

        3. Preservatives for Laboratory Analysis.   Products used to preserve the integrity of milk, urine, blood, or other bodily fluids for laboratory analysis are exempt. 40 CFR 152.25(3). Exit EPA disclaimer


      3. Foods. Products consisting of foods and containing no active ingredients, which are used to attract pests, are exempt.  40 CFR. 152.25(d) . Exit EPA disclaimer


      4. Natural cedar. Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles that meet all of the following criteria:


        1. The product consists totally of cedarwood or natural cedar;

        2. The product is not treated, combined or impregnated with any additional substance(s); and

        3. The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific arthropods, or must exclude ticks if any general term such as "arthropods," "insects," "bugs," or any other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to repel ticks. The exemption does not apply to cedar oil, or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture. See 40 CFR 152.25(e). Exit EPA disclaimer

      5. Minimum Risk Pesticides. 40 CFR Section 152.25(f) exempts certain "minimum risk pesticides" from the requirements of FIFRA if they satisfy all the conditions described in that provision (i.e., 152.25(f)(1)-(3)).  Some of the conditions of exemption specifically relate to a product's labeling (see 152.25(f)(3)). For further information, see PRN 2000-6:  ”Minimum Risk Pesticides Exempted under FIFRA Section 25(b) Clarification of Issues.”  See also the notice published in the Federal Register, September 28, 1994 (59 Fed. Reg. 49400) for the list of minimum risk inerts (also known as the List 4A inerts). Exit EPA disclaimer

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    V. Is the product a device and, therefore, not a pesticide?


    FIFRA defines a device 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 (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom”  FIFRA 2(h).  FIFRA does not require the registration of pesticidal devices.  Devices, however, are subject to a number of FIFRA’s provisions including, labeling requirements and establishment numbers identifying the location where the device was produced.  See 40 CFR 152.500 Exit EPA disclaimer for more information on devices and additional FIFRA requirements.

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