Pesticide Registration Manual:
Chapter 13 - Devices
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Current as of December 2010
In this Chapter;
- Devices - Introduction
- Devices Subject to Regulation
- Devices Not Subject to Regulation
- Requirements for a Device Subject to Regulation
- Import and Export of Devices
- Contacts for Additional information
- References Cited in Chapter 13
This chapter describes how EPA regulates pesticidal devices. This unit clarifies which types of devices are subject to regulatory oversight, and what requirements apply to them.
In 1976, EPA issued a policy statement (PDF) (3 pp, 478k) concerning the regulatory status of devices. In that notice, EPA also explained its interpretation of the distinction between a “pesticide” and a “device.”
FIFRA defines a device as any instrument or contrivance (other than a firearm) that 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. Refer to FIFRA section 2(h) (PDF) (109 pp, 288k).
In general, if an article is an instrument or contrivance that uses physical or mechanical means to trap, destroy, repel, or mitigate any plant or animal life declared to be a pest at 40 CFR 152.5 (PDF) (1 pp, 143.43 k About PDF) , it is considered to be a device and subject to regulation under FIFRA. However, devices are not subject to the registration requirements that apply to pesticides and pesticide products under FIFRA section 3. Further information can be found on EPA’s Pest Control Devices Web site.
If a product consists of an object or article that incorporates a substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest, the entire product is considered to be a pesticide and is subject to registration under FIFRA section 3.
If the product is an instrument or contrivance and is claimed to control pests through physical or mechanical means, the product is considered to be a device, unless it is a firearm.
Distinctions among devices, pesticides, and pesticide application equipment can be illustrated by comparing products that are outwardly similar but are treated differently under FIFRA. For example, a bait station that is sold by itself to be used in conjunction with other products in the control of insects or rodents is considered to be pesticide application equipment and is not directly regulated under FIFRA, although the labels for registered pesticide products may require them to be used in bait stations in some or all applications.
If the same design of bait station is sold with toxic bait in it (or packaged with it for use in it), the entire product is considered a “pesticide product” and is regulated and labeled as such. If the bait station is sold with a sticky trap inside it (or is packaged with sticky traps that are to be placed inside it), the entire product is a device, and is regulated under FIFRA because it achieves pest control by physical means.
- Pesticidal devices must be produced in a registered pesticide-producing establishment. See Chapter 14 for information on registering a site. Devices are also subject to certain labeling requirements. Refer to FIFRA section 2(q)(1) (PDF) (109 pp, 288k) and 40 CFR Part 156.
Questions about whether a product has been or should be registered should be resolved by consulting with EPA’s Office of Pesticide Programs on the matter before attempting to market the product. For products intended to control bacteria or other microorganisms, contact the Antimicrobials Division. For all other products, contact the Registration Division (see Contacts for Additional Information below). For products that are difficult to classify, EPA advises that questions on regulatory status be raised and resolved in writing.
In a Federal Register notice published on November 19, 1976 (Pest Control Devices and Device Produces) (PDF) (3 pp, 478k), EPA stated that devices subject to FIFRA section 2(q)(1) and section 7 include, but are not limited to:
- certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances that are pesticides), and ultrasonic devices for which claims are made to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites;
- certain high frequency sound generators, carbide cannons, foils, and rotating devices for which claims are made to repel birds;
- black light traps, fly traps, electronic and heat screens, fly ribbons, and fly paper for which claims are made to kill or entrap certain insects; and
- mole thumpers, sound repellents, foils, and rotating devices for which claims are made to repel certain mammals.
Since that notice was issued, EPA has determined that products of the following types also fall within the definition of device:
- products that are claimed to control pests via electromagnetic and/or electrical emissions;
- products that are claimed to control burrowing animals via product-caused subterranean explosions; and
- products that work via principles indicated in the 1976 document for one category of pest but are claimed to control pests of different types (e.g., sticky traps for rodents, light or laser repellents for birds, etc.).
Important Note: In applying the definition of "device" in FIFRA section 2(h), EPA examines each individual product on a case-by-case basis. For instance, the public should be aware that EPA has looked at a number of individual products that claim to provide pest control through the use of electromagnetic radiation and has found these products to be devices within the meaning of section 2(h). In addition, EPA has found that a silver ion generating washing machine marketed with claims that odor causing bacteria will be killed on laundry has to be registered as a pesticide.
The November 19, 1976, Federal Register Notice Pest Control Devices and Device Produces (PDF) (3 pp, 478k) also provided examples of those types of devices that are not subject to regulation under FIFRA:
- devices that depend for their effectiveness more upon the performance of the person using the device than on the performance of the device itself; and
- devices that operate to entrap vertebrate animals.
Products generally falling within these two categories include rat and mousetraps, fly swatters, tillage equipment for weed control, and fish traps.
Pesticidal devices must be produced in a registered pesticide-producing establishment. Refer to 40 CFR 152.500(b)(2)(PDF) (2 pp, 146.36 k About PDF) . See Chapter 14 for information on registering a site.
Devices are subject to the labeling requirements of FIFRA section 2(q)(1) and 40 CFR Part 156. These requirements are summarized below.
Misbranding - Under FIFRA section 2(q)(1) a device is considered to be misbranded and subject to enforcement action if:
- the labeling bears any statements, designs, or graphic representations that are false or misleading (see 40 CFR 156.10(a)(5) (PDF) (6 pp, 162.65 k About PDF) );
- its packaging or wrapping does not conform to standards established pursuant to FIFRA section 25(c)(3) (as of 2010, such standards have yet to be established for devices);
- it is an imitation of, or is offered for sale under the name of another device;
- the label fails to bear the establishment number of the establishment where it was produced;
- any required information is not prominently displayed on the label;
- it lacks adequate directions for use; or
- it lacks an adequate warning or caution statement.
Devices are subject to child-resistant packaging (CRP) requirements when they meet certain toxicity and use criteria. Please refer to 40 CFR 157.20 – 157.36(PDF) (1 pp, 146.06 k About PDF) for information concerning CRP requirements.
Child-resistant packaging is defined as packaging designed or constructed to be significantly difficult for children less than five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time, and that is not difficult for normal adults to use properly. 40 CFR 157.21(b)(PDF) (1 pp, 146.06 k About PDF) .
Please refer to FIFRA section 17 (PDF) (109 pp, 288k) for information concerning import and export requirements for devices. U.S. Customs regulations at 19 CFR 12.1(b) related to the implementation of FIFRA section 17 require, in part, that devices produced by foreign manufacturers and imported into the U.S. comply with all requirements applicable to domestic producers. In addition, the regulations require an importer to submit to EPA a Notice of Arrival of Pesticides and Devices (EPA Form 3540‑1) for review and determination as to whether the shipment should be sampled and/or permitted entry into the U.S.
FIFRA section 17 states that no device produced solely for export to any foreign country shall be deemed in violation of FIFRA when prepared or packaged to the specifications or directions of the foreign producer, except that producers of such devices are subject to labeling requirements and certain misbranding restrictions found in sections 2(p) and 2(q) of FIFRA.
In addition, producers of devices are subject to record keeping and inspection requirements in accordance with section 8 of FIFRA (PDF) (109 pp, 288k).
If you have any questions concerning regulatory requirements for devices that are not subject to registration, please contact:
U.S. Environmental Protection Agency
Office of Compliance, Agriculture and Ecosystem Division (2225A)
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Telephone (202) 564‑2355
Refer to Chapter 19 for information on the source of these documents.
- Part 152 - Pesticide registration and classification procedures
- Part 153 - Statement of policies and interpretations
- Part 156 - Labeling requirements for pesticides and devices
- Part 157 - Packaging requirements for pesticides and devices
- Part 167 - Registration of pesticide-producing establishments, submission of pesticide reports, and labeling
- Part 169 - Books and records of pesticide production and distribution
Federal Insecticide, Fungicide, and Rodenticide Act (PDF), as amended by the Food Quality Protection Act of August 3, 1996
- Section 2 - Definitions
- Section 3 - Registration of pesticides
- Section 7 - Registration of establishments
- Section 8 - Books and records
- Section 9 - Inspection of establishments, etc.
- Section 12 - Unlawful acts
- Section 13 - Stop sale, use, removal, and seizure
- Section 14 - Penalties
- Section 17 - Imports and exports
- Section 25 - Child-resistant packaging
Federal Register Notice, Pest Control Devices and Device Producers (PDF) (3 pp, 478k), (41 FR 51065), November 19, 1976