CHAPTER 10 - DEVICES - WHAT ARE THE REQUIREMENTS? A. GENERAL INFORMATION Section 25(c)(4) of FIFRA provides that the Administrator may specify devices which are subject to any provision of FIFRA section 2(q)(1) or section 7. Devices are defined in FIFRA Section 2(h). The Agency's policy concerning its authority and activities with respect to devices was published in the Federal Register of November 19, 1976 (41 FR 51065). B. DEFINITION OF DEVICES 40 CFR Section 153.240 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 bacterium, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom". 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 at 40 CFR 152.5, it is considered to be a device, and not subject to registration under FIFRA section 3. However, if the article incorporates a substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest, it is considered to be a pesticide and as such is subject to registration under FIFRA section 3. C. DEVICES SUBJECT TO THE ACT The Agency, in the November 19, 1976 Federal Register Notice, stated that devices subject to FIFRA section 2(q)(1) and section 7 include but are not limited to: 1. Certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances which 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, 2. Certain high frequency sound generators, carbide cannons, foils, and rotating devices, for which claims are made to repel birds, 3. 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 4. Mole thumpers, sound repellents, foils and rotating devices, for which claims are made to repel certain mammals. IMPORTANT NOTE: Although not specifically mentioned in the November 19, 1976 Federal Register Notice, the Agency has determined that electromagnetic devices are also subject to FIFRA section 2(q)(1) and section 7. D. DEVICES NOT SUBJECT TO THE ACT The November 19, 1976 Federal Register Notice provided the following examples of those types of devices that are not subject to FIFRA: 1. Devices which depend for their effectiveness more upon the performance of the person using the device than on the performance of the device itself, and 2. Devices which operate to entrap vertebrate animals. Products generally falling within these two categories include rat and mouse traps, fly swatters, tillage equipment for weed control and fish traps. E. REQUIREMENTS FOR DEVICES 1. Registration Not Required A device is not required to be registered under FIFRA section 3. However, devices are subject to certain other requirements of FIFRA as indicated below. 2. Labeling Requirements Devices are subject to the labeling requirements of FIFRA section 2(q)(1) and 40 CFR Part 156. These requirements are summarized below. a. Under FIFRA section 2(q)(1) a device is considered to be misbranded and subject to enforcement action if: 1) Its labeling bears any statements, designs, or graphic representations, which are false or misleading (see 2.b. below for examples of false or misleading statements), 2) Its packaging or wrapping must conform to standards established pursuant to FIFRA section 25(c)(3) (as of this date, such standards have yet to be established for devices), 3) It is an imitation of, or is offered for sale under the name of another device, 4) It's label fails to bear the establishment number, 5) Required information is not prominently displayed on the label, 6) It lacks adequate directions for use, or 7) It lacks an adequate warning or caution statement. b. 40 CFR section 156.10 (a)(5) provides the following examples of labeling statements or representations which constitute misbranding: 1) A false or misleading statement concerning the composition of the product, 2) A false or misleading statement concerning the effectiveness of the product as a pesticide or device, 3) A false or misleading statement about the value of the product for purposes other than as a pesticide or device, 4) A false or misleading comparison with other pesticides or devices, 5) Any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Government, 6) A true statement used in such a way as to give a false or misleading impression to the purchaser, 7) Label disclaimers which negate or detract from labeling statements required under the Act and regulations, and 8) Non-numerical and/or comparative statements on the safety of the product. 3. Establishment Registration and Reporting, Books and Records Devices are subject to the establishment registration and reporting requirements FIFRA section 7 and Part 40 CFR Part 167. All establishments in which devices subject to the Act are produced must be registered with the Agency as producing establishments. This includes foreign establishments in which devices shipped to the U.S. are produced, as well as establishments located in the U.S. which produce devices for export. Refer to Chapter 11 for information on how to obtain an EPA establishment number. FIFRA section 8 and 40 CFR 169 provide information on such records that are required to be maintained by producers of devices. 4. Inspection of Establishments Refer to FIFRA section 9 for information concerning inspection of establishments. 5. Violations, Enforcement Activities, and Penalties Refer to FIFRA sections 12, 13, and 14 for information concerning violations, enforcement activities and penalties. 6. Importation and Exportation of Devices Refer to FIFRA section 17 for information concerning the importation and exportation requirement for devices. Regulations (19 CFR Part 12.1) for the implementation of section 17 were published in the Federal Register (40 FR 32321) August 1, 1975. These regulations 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 sections 2(p), 2(q)(1)(A),(C),(D),(E),(G) and (H), 2(q)(2)(A),(B),(C)(i)and (iii), and (D). In addition, devices are subject to the record keeping and inspection requirements in accordance with section 8 of FIFRA. 7. Child-resistant Packaging Refer to FIFRA section 25(c)(3) and 40 CFR section 157.20 for information concerning child-resistant packaging requirements. F. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions concerning devices, whether they are subject to the Act, or establishment registration, please contact the Office of Compliance Monitoring, Compliance Division (EN-342), Environmental Protection Agency, 401 M St., S.W., Washington, DC, 20460. Telephone (202) 260-7835. G. REFERENCES CITED IN CHAPTER 10 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 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 2. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988 Section 2 - Definitions Section 3 - Registration of pesticides Section 7 - Registration of establishments Section 8 - Books and records 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 3. Federal Register Notice (40 FR 32321), August 1, 1975. 4. Federal Register Notice, Pest Control Devices and Device Producers, (41 FR 51065), Nov. 19, 1976.