EPA Registration of Disinfection Equipment and Sterilization Equipment

1. Which devices are regulated by the EPA?

FIFRA defines a device as any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than bacteria or virus on or in living humans or other living animals).

Common regulated devices include:

a) Certain ultraviolet systems, ozone generators, water filters, and air filters (excluding those containing substances), as well as ultrasonic devices, which are claimed to kill, inactivate, trap, or inhibit the growth of fungi, bacteria, or viruses in various settings;

b) Certain high-frequency sound emitters, carbide cannons, metallic foils, and rotating devices claimed to repel birds;

c) Black light traps, fly traps, electronic and thermal screens, fly ribbons, and fly papers claimed to kill or trap certain insects;

d) Mole thumpers, sonic repellents, foils, and rotating devices claimed to repel certain mammals;

e) Products claimed to control pests through electromagnetic and/or electrical radiation (e.g., handheld bug zappers, electric flea combs);

f) Products claimed to control burrowing animals through underground vibrations caused by the product; and

g) Products that act on a class of pests as directed by the principles outlined in the 1976 Federal Register notice but are claimed to control different types of pests (e.g., sticky traps for rodents without attractants, light or laser repellents for birds, etc.).

2. Devices Not Subject to Regulation

The Federal Register notice of November 19, 1976, on pest control devices and device manufacturers also provides examples of devices not regulated by FIFRA:

Devices whose effectiveness depends more on the performance of the person using the device than on the performance of the device itself; and devices for trapping vertebrate animals. Products typically falling into these two categories include mousetraps, fly traps, fly swatters, tillage equipment for weed control, and fish traps.

Production Requirements: Pesticidal devices must be produced at registered pesticide production establishments.

3. Labeling Requirements:

Devices must comply with the labeling requirements under 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 misbranded, and enforcement action may be taken if:

Its labeling bears any false or misleading statement, design, or graphic representation (see 40 CFR 156.10(a)(5));

Its packaging or wrapping does not conform to the standards established under FIFRA Section 25(c)(3) (as of 2010, no such standards have been established for devices);

It is an imitation of or sold under the name of another device;

Its labeling does not bear the establishment number where the product was produced;

Any required information is not prominently displayed on the label;

It lacks adequate instructions for use; or

It lacks sufficient warnings or caution statements.

4. Device Efficacy:

Unlike pesticide product registrants, FIFRA does not require device manufacturers to submit any data on the safety or efficacy of a device before distribution or sale. This is particularly significant for antimicrobial pesticidal devices that claim to disinfect, sanitize, and/or sterilize items or the surrounding air. Since microbial pests are not visible to the naked eye, users of such devices often cannot evaluate the actual performance of the device. If the device’s labeling, tags, and/or website (including general or specific efficacy claims) contain any statement, design, or graphic representation that is "false or misleading in any particular," the device may be "misbranded." FIFRA prohibits the distribution or sale of misbranded devices.