Pesticide Labeling Questions & Answers - Subject to FIFRA
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(Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product).
These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures. These answers are primarily based on federal law, regulations and policies implemented by EPA. States, tribes, territories, and other federal agencies may have additional requirements relevant to their jurisdictions.
- Advertising Claims
- Antimicrobial Claims
- Contract Manufacture
- Use Sites
- Definitions of Terms
- Distributor Product Labeling
- Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
- Existing Stocks
- General Labeling
- Labeling from Web Sites
- Multiple Products Packaged Together
- NAFTA Labeling
- Pesticide Exemption (FIFRA 25B)
- Pictures and Logos
- Repacked Products
- Service Containers
- Subject to FIFRA
- Superlative Terms
- Supplemental Labeling (NOT distributor products)
- Is there a policy on correcting labels by adding stickers? For example, adding "net amount" with stickers, correcting an incorrect EPA reg. no. with a sticker, etc. As a State Lead Agency contact, I sometimes get questions from registrants asking if it is okay to correct already-printed labels with stickers. Does EPA have a policy on this? Or do I need to send them to EPA for approval of the specific issue? If so, to EPA PM or to regional office that has oversight over the production establishment? LC13-0597; 03/05/13
A registrant may correct labels by adding stickers. Adding a sticker to the label is considered relabeling and therefore production. The sticker must be applied in a registered establishment, the relabeling must be reported, and the sticker may only obscure the information it is replacing. If information is being added by a sticker, the sticker must not contradict labeling already on the container, must be firmly attached to the label and may not obscure information required to be on the labeling. Generally changes to labeling must be made through an amendment to the registration. However, Pesticide Registration (PR) Notice 98-10 and some subsequent PR Notices provide types of changes that may be made simply by first notifying the Agency of the registrant’s intention and what changes may be made through non-notification.
- If a product meets the requirements of 40CFR 152.6(f) as a vitamin hormone product and is exempt from FIFRA registration, how is it "labeled accordingly"? Are there any requirements of how it is labeled with the statement: "This product is not intended for use on food crop sites." Is there a specific font size or location or other requirement that must be met? In other words, if the product is exempt from FIFRA does it have to meet labeling requirements for precautionary statements as stated 156.10 and/or 156.60? LC12-0581; 12/11/12
The Office of Pesticide Programs does not generally review labels of products that are exempt from FIFRA registration and has no specific requirements or guidance on how they should be formatted. For some exempt products, certain information must be included on the label to meet the exemption. For example, 40 CFR 152.6(f)(2) requires that exempt vitamin hormone product labels not be intended for use on food crop sites and that they be labeled accordingly. This might be accomplished by explicitly stating the product is not for use on food crop sites or by stating that it is only for use on listed non-food sites. There are no other requirements for what must be on an exempt vitamin hormone product label to meet the exemption and EPA's other labeling requirements for registered pesticides do not apply. Please note, however, that including label language that is inconsistent with the criteria for meeting an exemption may call into question whether the product is truly exempt from registration requirements. Further, false or misleading claims may be subject to enforcement by the Federal Trade Commission. This answer addresses labeling for vitamin hormone products, see 40 CFR 152.6(f) for the complete criteria that must be met for a vitamin hormone product to qualify for exclusion from FIFRA.
- Many times we need to send a sample of material that is a registered manufacturing use pesticide to a customer for analytical testing or to confirm product quality or for product development. A label with the required text is attached to the sample container. Do we need to amend the label if we want to apply the following language, particularly on small samples, 1) "Sample Only - Not to be Sold; For Laboratory Use Only." 2) Read Material Safety Data Sheet Before Using This Product." LC11-414; 7/7/11
A sample that is intended for nonpesticidal testing is not subject to the labeling provisions of FIFRA but is subject to any applicable DOT shipping requirements. The language proposed in your question may appear on the sample.
A sample that is intended for pesticidal testing (e.g. testing for pesticidal activity or efficacy) must be labeled in accordance with FIFRA and may not bear the language proposed in your question unless the registration is amended to reflect the new labeling for samples.
- What are the labeling requirements for insect pheromone traps and lures when used to monitor insect activity in Food and Drug Administration (FDA) regulated food processing plants and warehouses? Are the labeling requirements the same as traditional insecticides and rodenticides? LC10-0355; 05/26/10
Products, such as traps and lures, that (1) do not contain toxicants; (2) are intended only to attract pests for survey and detection purposes, and (3) are labeled accordingly (i.e., no pesticidal claims are made on labeling or in connection with sale or distribution of the product), are not considered to be pesticides by the Agency because they are not intended for a pesticidal purpose (see 40 CFR § 152.10(b)). Therefore, these products are not subject to any FIFRA requirements.
Further, pheromone traps and lures that are intended for a pesticidal purpose are exempt from the FIFRA registration requirement pursuant to 40 CFR § 152.25(b). However, such products remain subject to other FIFRA provisions, such as labeling requirements.
- If a product is manufactured as a topical antiseptic on human skin, (regulated by FDA) and also as a hard surface disinfectant (regulated by EPA), can the uses be combined on a single label issued by both the EPA and FDA? (LC10-0344; 7/21/10)
EPA and FDA have never jointly approved such a product. Pesticides such as disinfectants are regulated under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) while drugs such as topical antiseptics are regulated under the authority of the Federal Food, Drug and Cosmetic Act (FFDCA). Both EPA and FDA each have their own regulations they use to regulate products subject to their respective jurisdictions. These regulations set out procedures, data and labeling requirements as well as criteria that are exclusive to specific claims and use patterns. Regulations for pesticide products are substantially different from those in place and used to regulate drugs. In general, the labeling requirements for a pesticide are significantly different from those required for a drug. Further, having directions for both pesticidal and drug use on the same product may create concerns over the proper use of the product that would not allow it to be registered by EPA. Given the difficulties involved with a joint approval, EPA encourages applicants to separate pesticide uses to a separate product.
If the substance being imported is a pesticide, a Notice of Arrival (NOA) must be submitted. See FIFRA § 17(c). More information on NOAs is available at http://www.epa.gov/oppfead1/international/trade/.
- When importing a substance for research and development that may sometimes be a pesticide, is it subject to the requirements of FIFRA? Must a Notice of Arrival be submitted? Must it be registered? What labeling requirements apply? (LC09-0288; 7/21/10)
Some substances can be both pesticides and non-pesticides. To determine whether a substance is a pesticide and therefore subject to FIFRA, one must determine if the substance is “intended for a pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest…” 40 CFR § 152.15. EPA considers a substance to be intended for a pesticidal purpose if:
- The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise)
- That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or
- That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or
- The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or
- The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose. 40 CFR § 152.15.
If the substance being imported is a pesticide, a Notice of Arrival (NOA) must be submitted. See FIFRA § 17(c). More information on NOAs is available at http://www.epa.gov/oppfead1/international/trade/.
A pesticide being imported for research and development may need to be registered depending on how it is being sold or distributed. If the pesticide is registered, an importer can sell and distribute it within the United States provided it meets all applicable FIFRA registration and labeling requirements.
Limited transfer, sale or distribution of an unregistered pesticide is possible under two scenarios: 1) if the transfer, sale, or distribution meets the applicable conditions set forth in 40 CFR 152.30 or 2) if the import of the unregistered pesticide is for the purpose of producing an unregistered pesticide intended solely for export and prepared or packed according to the specifications or directions of a foreign purchaser as explained in PR Notice 99-1.
What labeling is required on a pesticide being imported depends on whether the pesticide is registered or not. If registered, it must meet all labeling requirements of FIFRA and its implementing regulations. If not registered, the pesticide’s labeling must, based on the section 2(q) FIFRA definition of “misbranded,” include at least minimal directions for use, precautionary statements, an ingredient statement, the name and address of the producer, the name of the pesticide and net weight and if intended for export, a statement that the pesticide is not registered for use in the US.
My company manufactures a natural, organic drain cleaner containing bacterial spores that germinate and degrade organic material remaining in the drain and pipe. Recent IPM (integrated pest management) guidelines published by the industry and by universities call for cleaning the organic material out of drains as a method of eliminating drain flies. Manual cleaning of the drains is very expensive, and my product works very well at removing the organic material. As a drain cleaner, do we need an EPA registration? LC10-0310; 6/3/10
EPA's Office of Pesticide Programs has published a Web page that articulates and gives examples of some claims on cleaning products that require the products to be registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act. This Web page was prompted by several cases of non-compliance in the regulated community, especially among cleaners sold in Integrated Pest Management (IPM) product lines.
For more information, please see http://www.epa.gov/pesticides/factsheets/pest-habitat-claims.html
"What are the requirements for importing rodent glue board products?" LC09-0313; 3/11/10
Rodent glue board products are considered devices under FIFRA. In general, if an instrument or contrivance uses physical or mechanical means to trap, destroy, repel or mitigate any plant or animal life declared to be a pest (such as rodents), it is considered to be a device and is not subject to registration under the Federal Insecticide Fungicide and Rodenticide Act, Section 3 (FIFRA). While a Section 3 registration is not required for devices, they are subject to other requirements of FIFRA listed in 40 CFR Part 152 Subpart Z, including labeling regulations in 40 CFR Part 156. These requirements include but are not limited to: the device cannot bear false or misleading information, must bear the number of the registered EPA Establishment where the device was produced, and must bear adequate directions for use and warning or caution statements to prevent unreasonable adverse effects on the environment. Facilities that produce devices are also subject to the establishment registration and reporting requirements of FIFRA. These requirements are described in 40 CFR Parts 167 and 169. Devices produced by foreign manufacturers and imported in the United States must comply with all requirements applicable to domestic producers.
What characteristics must materials/ingredients/product have in order for companies to not have to register the products with EPA in terms of pesticides and disinfectants? LC09-0290; 11/4/09
A pesticide is defined as a substance or mixture of substances intended to destroy, prevent, repel, or mitigate a pest (FIFRA 2(u), 40 CFR 152.3). A product that makes a pesticidal claim must either be registered or exempt from registration. Certain categories of products have been determined not to be pesticides because they are not deemed to be used for a pesticidal effect and therefore need not be registered unless they contain a pesticidal claim. These categories, found in 40 CFR 152.10, are: 1) Deodorizers, bleaches, and cleaning agents; 2) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly; and 3) products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.
Further 40 CFR 152.20 describes certain pesticides or classes of pesticide that are exempt from any FIFRA requirements because EPA has deemed them to be adequately regulated by another Federal agency. These categories include certain biological control agents and non-liquid chemical sterilants.
In addition, there are a number of exemption provisions described in 40 CFR 152.25 that allow products to carry limited pesticidal claims without requiring registration, when such products are intended for use, and used, only in the manner specified:
- 152.25(a) allows an article or substance to make a pesticide claim if the article is treated with an EPA registered product that is registered for such use and the claim is limited to protection of the article,
- 152.25(b) exempts pheromones and identical or substantially similar compounds from registration if they are the sole active ingredient in a pheromone trap and they labeled for use only in pheromone traps,
- 152.25(c) exempts embalming fluids and other products used to preserve animals or animal organs in mortuaries, laboratories, hospitals, museums and institutions of learning. Also exempt are products used to preserve the integrity of urine, blood, milk or other body fluids for purposes of laboratory analysis,
- 152.25(d) exempts food products that contain no active ingredient that are used to attract pests,
- 152.25(e) exempts natural cedar when it meet all of the criteria specified in that section are met,
- 152.25(f) exempts products containing certain minimum risk active ingredients listed in this section provided all of the criteria of the section are met.
If a product makes a pesticidal claim and does not fit into one of the categories described above, then the product must be registered.
What is the EPA's position on a farmer buying Formaldehyde from a dealer for the use of treating dairy cattle hooves? Is an EPA product registration required? How should this product application be treated as an antimicrobial, pesticide, or cleaner (disinfectant) through EPA? (LC09-0246; 5.27.09)
Formaldehyde used to treat the hooves of dairy cattle for control of microorganisms is not considered a pesticide and does not need an EPA registration. FIFRA defines "pest" to exclude "viruses, bacteria, or other micro-organisms on or in living man or other living animals." FIFRA sec. 2(t). Only substances or mixtures intended for preventing, destroying repelling, or mitigating “pests” as defined by FIFRA or intended for use as a plant regulator, defoliant or desiccant are regulated as pesticides by EPA. Thus, products for use against microorganisms intended for use on or in living animals are not subject to EPA regulation. They instead are within the jurisdiction of FDA. For information on the FDA requirements regarding the use of formaldehyde on animals contact The Center for Veterinary Medicine (CVM) which regulates the manufacture and distribution of food additives and drugs that will be given to animals (http://www.fda.gov/cvm/).
What are the regulations, PR notices, guidance documents related to glue traps used for rats and mice? (LC09-0245; 3/25/09)
FIFRA section 2(h) defines "device" as any instrument or contrivance ... which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant of animal life..." with some exceptions. In general, if an article uses physical or mechanical means to trap, destroy, repel, or mitigate any plant or animal life declared to be a pest in 40 CFR 152.5, EPA considers it to be a device, and is not subject to registration under FIFRA section 3. See also 40 CFR 152.500. However, certain devices, while not required to be registered under FIFRA Section 3, are subject to the labeling requirements of FIFRA Section 2(q)(1) and 40 CFR Part 156. On November 19, 1976, EPA issued a policy statement in the Federal Register (41 FR 51065) providing guidance and clarification on pest control devices and declared some devices to be of a character unnecessary to be subject to FIFRA. According to that FR Notice "devices which operate to entrap vertebrate animals" are not subject to FIFRA. However, based on January 30, 1980 decision by EPA's Pesticide and Toxic Substances, Enforcement Division (currently the Office of Enforcement and Compliance), EPA clarified that when it excluded devices that "entrap" vertebrate animals from regulation under FIFRA, it intended the exclusion to apply only to mechanical devices such as mouse traps and did not intend to exclude glue boards, which are analogous to fly paper and fly ribbons. These devices were both specifically identified in the 1976 Notice as being subject to FIFRA's requirements for devices.
- Are military products exempt from Federal and State requirements such as antimicrobials? (LC09-0238; 2.26.09)
Military products that bear any pesticide claim are not exempt from the requirements of FIFRA. You will need to check with each individual state regarding how military products are regulated within that state.
- Are products labeled as anti-bacterial adult toy cleansers which fight bacteria with triclosan subject to EPA jurisdiction as a pesticide/antibacterial product? (LC08-0173)
“Pesticide” is defined in part as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigatingany pest.” FIFRA § 2(u)(1). Microorganisms (except for viruses, bacteria, or other microorganisms on or in living man or other living animals) are pests as defined by FIFRA sec. 2(t). Products labeled as anti-bacterial adult toy cleansers which fight bacteria with triclosan are considered to be pesticide products because they are mitigating a pest and thus subject to EPA jurisdiction under FIFRA. The term “anti-bacterial” is also considered to be a public health claim which would require efficacy data be submitted with any application for registration. These types of products are registered by the Antimicrobials Division.