What You Need to Know About Producing, Distributing or Selling Pesticide Devices

EPA Document # 305F22003

-------
EPA Document # 305F22003

promote FIFRA compliance for devices by highlighting the pesticide regulations applicable to
devices.

Is My Product a Device or a Pesticide?

A device is an instrument or contrivance that is intended to destroy, repel, trap, or mitigate any
pest, including but not limited to rodents, molds, viruses, and bacteria, FIFRA Section 2(h). EPA
has interpreted devices as working through physical or mechanical means (such as electricity,
light, or physical force). Examples of devices may include water or air filters, ultraviolet light
systems, ozone generators, and sound generators. If a device incorporates a substance or mixture
of substances to perform its intended pesticidal purpose, then it is considered a pesticide, not a
device, and would require registration under FIFRA Section 3.

What are the FIFRA Requirements Applicable to Devices?

Any person who distributes or sells any device in the U.S. is expected to know and comply with
applicable statutory and regulatory requirements that include, but are not limited to, the
following requirements, found at 40 C.F.R. § 152.500:

• Labeling - FIFRA Section 2(q)(l) and 40 C.F.R. Part 156;

• Establishment Registration and Reporting - FIFRA Section 7 and 40 C.F.R. Part 167;

• Books and Records - FIFRA Section 8 and 40 C.F.R. Part 169;

• Establishments - FIFRA Section 9;

• Violations, Enforcement and Penalties - FIFRA Sections 12, 13, and 14;

• Imports and Exports - FIFRA Section 17;

• Child-resistant packaging - FIFRA Section 25(c)(3); and

• EPA's authority to declare devices subject to certain provisions of FIFRA - FIFRA
Section 25(c)(4).

Imports

CBP regulations implement and outline requirements for submitting a completed Notice of
Arrival of Pesticides and Devices (NO A) to CBP for FIFRA-regulated pesticide and devices (see
Section 17(c) of FIFRA and 19 C.F.R. §§ 12.110 - 12.117). Importers must submit a separate
NOA for each unique FIFRA-regulated pesticide and device in each shipment. EPA coordinates
regularly with CBP to identify and refuse entry to violative pesticides and devices at ports of
entry. For information on filing an EPA NOA, importers or their authorized agents can refer to
the "ACE Tips for Filing EPA Pesticides," which can be found at the link below.

State Regulation of Devices

In addition to EPA, some states also regulate devices and may require registration. Compliance
with FIFRA's requirements does not ensure that a device can be legally sold in those
states. Please see the following for a list of state contacts:

https://www.epa.gov/pesticide-advisorv-committees-and-regulatorv-partners/state-and-territorial-
pesticide-agencies

-------
EPA Document # 305F22003

Distribution or Sale of a Misbranded Device is Unlawful

Devices may not be distributed or sold if they are misbranded. A product may be considered
misbranded:

1. If the label or labeling is missing the applicable elements detailed in FIFRA Section
2(g)(1) and 40 C.F.R. Part 156 (e.g., Directions for Use EPA, Establishment Number).

2. If its labeling bears any statement, design, or graphic representation relative to it or its
ingredients that are false or misleading in any particular. Labels and labeling are defined
in FIFRA Section 2(p) and may include internet content (e.g., websites). 40 C.F.R.

§ 156.10(a)(5) provides some examples of false/misleading statements, including (but not
limited to):

• A false/misleading statement concerning the composition of the product.

• A false/misleading statement concerning the effectiveness of the device.

• A false or misleading statement about the value of the device for a non-pesticidal
purpose.

• A false or misleading comparison with other pesticides or devices.

• Any statement directly or indirectly implying that the device is recommended or
endorsed by any federal agency.

• A true statement used in such a way as to give a false/misleading impression to the
purchaser.

• Label disclaimers which negate or detract from requirement label statements.

• Non-numerical and/or comparative statements on the safety of the product.

Producers and sellers of devices are responsible for ensuring that the device performs as claimed,
and that such performance claims are not false or misleading. EPA recommends that companies
maintain records, with information and data, to substantiate such claims.

Devices will be considered misbranded where the labeling states or implies that the EPA
establishment number, the EPA company number, or the fact that the device was produced in a
registered establishment, is an EPA recommendation or endorsement. The purpose of the EPA
establishment number is to identify the location where the product was manufactured or labeled,
and it is required on the device label.

Although device labels are not subject to pre-market review or approval by EPA, it may be
helpful to review the EPA Label Review Manual— in particular, the Labeling Claims chapter
(Chapter 12) and Graphics and Symbols chapter (Chapter 16)—for claims, graphics, and
symbols that EPA may consider false or misleading (See link below).

Additional Information and EPA Interpretations Impacting Devices

For instructions on requesting an EPA regulatory determination as to whether a product is
a device, pesticide, or not regulated under FIFRA:

If you are uncertain about whether your product is a device, you may submit a request for a
Device Determination from EPA. Instructions for submitting a request can be found at:
https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-
devices#obtain

-------
EPA Document # 305F22003

For text of FIFRA:

https://uscode. house. gov/view.xhtml?path=/prelim@title7/chapter6&edition=prelim

For text of the pesticide regulations, Title 40 of the Code of Federal Regulations, Parts 150
to 189:

https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E

For EPA's Pesticide Device Guide for Consumers:

https://www.epa.gov/safepestcontrol/pesticide-devices-guide-consumers.

For EPA's Compliance Advisory "EPA Regulations About UV Lights that Claim to Kill or
Be Effective Against Viruses and Bacteria":

https://www.epa.gov/sites/default/files/2020-10/documents/uvlight-complianceadvisory.pdf
For more information on applicable device requirements:

https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices
https://www.epa.gov/pesticide-registration/pest-control-devices-and-device-producers-1976-
federal -re gi ster-noti ce

For more information on labeling requirements:

https://www.epa.gov/pesticide-registration/label-review-manual
https://www.epa.gov/pesticide-labels/pesticide-labeling-questions-answers

For more information on the filing requirements for importing and exporting devices:

Overview of import and exports requirements at https://www.epa.gov/compliance/importing-
and-exporting-pesticides-and-devices

ACE Tips for Filing EPA Pesticides at https://www.cbp.gov/document/publications/ace-tips-
filing-epa-pesticides

For more information on registering an EPA Pesticide Producing Establishment:

https://www.epa.gov/compliance/pesticide-establishment-registration-and-reporting

For submitting tips and complaints related to devices that may be in violation of FIFRA:

https://echo.epa.gov/report-environmental-violations

For a List of Pesticide Regulatory Consultants:

https://www.epa.gov/pesticide-registration/list-pesticide-regulatory-consultants

Note that the inclusion of any business in this listing does not constitute a recommendation or

endorsement by EPA.

For more information on EPA's violation disclosure policies:

Regulated entities of any size who voluntarily discover, promptly disclose, expeditiously correct,
and take steps to prevent recurrence of potential violations may be eligible for a reduction or
elimination of any civil penalties that otherwise might apply. To learn more about EPA's
violation disclosure policies, including conditions for eligibility, please review EPA's Audit
Policy website at https://www.epa.gov/compliance/epas-audit-policv. Most violations can be
disclosed and processed via EPA's automated online "eDisclosure" system:
https://www.epa.gov/compliance/epas-edisclosure. Many states also offer incentives for self-
policing; please check with the appropriate state agency for more information.

-------
EPA Document # 305F22003

DISCLAIMER

Nothing in this Compliance Advisory is meant to replace or revise any EPA regulatory
provisions of any other part of the Code of Federal Regulations, the Federal Register, or FIFRA.
The regulated community is independently responsible for determining whether they have any
FIFRA obligations.

-------