Pesticide DevicesASSOCIATION OF AMERICAN PESTICIDE CONTROL OFFICIALS

EPA PresentationMarch 11, 2020

Office of Pesticide Programs Ed Messina

Deputy Office Director (Programs)

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Overview

• Review definition of pesticides and pesticide devices

• Process for requesting device determinations

• Common pesticide device concerns

Notable decisions and new devices

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Pesticides

• FIFRA defines a pesticide as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”• FIFRA defines a “pest” broadly to include:

• Any insect, rodent, nematode, fungus, weed, or • Any other form of terrestrial or aquatic plant or

animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other animals).”

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Pesticide Devices

• 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).

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Pesticide Devices

• A device must work only by physical means (such as electricity, light or mechanics) , e.g., antimicrobial UV lights, filters using only mechanical means, or the on-site generation of a pesticide (not sold with a substance), e.g., ozone generator.

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Pesticide Devices - Background

• Devices require no pre-market review. • Many devices being sold make public health claims. • Companies cannot make false or misleading claims on their labels and must be able to

substantiate any pesticidal claims.• Efficacy data are not submitted to, or reviewed by the Agency.• Labels are also only reviewed only when they are submitted with an M009 PRIA submission.

• Often, the Agency becomes aware of a device through the import Notice of Arrival process which is time-sensitive.• The Agency is discussing the unresolved issue of a tolerance or exemption for the

output of certain devices used on crops or food contact surfaces. (FDA’s Food Code requires a tolerance or exemption for sanitizers used in food service.)

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Process for Obtaining a Device Determination

• Prior to 2017, device determinations were ad hoc and provided by various groups within EPA.• PRIA 4 established a fee category for a 4-month review for voluntary

FIFRA “nonregulatory” determinations, e.g., device, 25(b) AI, barrier, pesticide determination under PRIA category M009.• Applicants provide product-specific documentation and claims

relevant to their product.• M009 applications are reviewed by the Device Determination Work

Group, product management team and then routed for signature through senior management.

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EPA Website UpdatesEPA is updating the webpages on pesticide devices

• Pesticide Registration Manual Ch.13• https://www.epa.gov/pesticide-registration/pesticide-registration-manual-

chapter-13-devices• Pesticide Devices: A Guide for Consumers

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

Recent updates include:- How to request a Device Determination (PRIA code M009)- Potential data to submit for a determination- Statement on device efficacy- Email address for questions about devices- Listing of new categories of devices e.g., hand-held electronic bug zapper

Future updates in the works:• Examples of device determinations• Photocatalytic device policy

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Notable Decisions and New Devices

• Devices used by water treatment facilities are not exempt from FIFRA. • Ozone generators used against zebra mussels are FIFRA regulated

devices. • Ion generators, Cu and Ag, must be registered as pesticides.

• Individual components of devices that bear pesticidal claims, are considered devices even when sold separately e.g., replacement UV bulbs. • New types of apparatus include plasma generators, gamma

irradiation units, and radio frequency (microwave) irradiators. All of these products are making public health claims.

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Plasma Generators

• AirPHX plasma generator technology. Falkenberg R, BAOJ Microbiology 2018, 4: 24: 036

• Solid, Liquid, Gas… and Plasma!• Highly charged gas cloud• Add chemicals (H2O2) or air• Chemicals split and recombine in

new ways- new ROS!• ROS formed more powerful

oxidizers, more unstable than UV-C• NO2, O•, •NO and other

unstable compounds- human health and facility risk

Threads of Plasmahttps://gph.is/2dnoXQz

Radio Frequency (RF)

• RF microwaves interact with water molecules in microbes• Water molecules twist and bend,

heating up• Cooks microbes from the inside• Moisture sensitive• Permitted wavelengths tightly

controlled by FCC• Used for nuts, seeds, plant material

(cannabis) https://pisces.bbystatic.com/image2/BestBuy_US/images/products/5712/5712110_sd.jpg;maxHeight=640;maxWidth=550

Gamma Radiation

• Very High Penetration• Can penetrate sealed packaging• Uses radioactive material (typically

cobalt-60)• Can not be “turned off”, requires

significant shielding• Forms ROS within cells, scrambling

DNA• Does not grant superpowers

https://www.oregonlive.com/environment/2011/03/research_nuclear_reactor_at_so.html

X-Ray

High penetration- through sealed packagingHighly directional- needs care in uniform application (efficacy concerns)Requires radiation shieldingCan interact/degrade materials, must choose with careForms ROS within cells, scrambles DNA

https://gph.is/H3yX1z

UV-C

• Low penetration• Creates Reactive Oxygen Species

(ROS):• Superoxide radical •O2

−

• Hydroxyl anion •OH−

• Hydrogen peroxide H2O2• Peroxyl ROO•−• And more!

• ROS destroy cell walls.• ROS can form in cell, scramble DNA• Regulatory perspective complex• Safety concerns include skin cancer,

permanent blindnesshttps://www.visualeffectsind.com/blacklights

Common Issues with Devices

• Although devices cannot make false and misleading claims, we are concerned about the following:• Immediately following the novel coronavirus outbreak, several companies made

claims against this emerging pathogen. It is unlikely that these claims are supported by data. Devices, like pesticides, cannot make disease prevention claims nor pandemic claims.

• Several devices make claims that they are faster acting than registered pesticides.• Hypochlorous acid-generating devices claim a 60 second contact time against C. diff (faster

than any registered disinfectant with 10 minute contact times).• Other products have dual jurisdictional with FDA.

• These products include CPAP mask/tubing processing devices, electric lice combs, & pharmaceutical manufacturing filters.

• There are a number of devices that make claims for Cannabis

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Appendix:

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• https://www.govinfo.gov/content/pkg/CFR-2011-title40-vol24/pdf/CFR-2011-title40-vol24-part152-subpartZ.pdf

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

• https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices

• https://www.epa.gov/sites/production/files/2015-06/documents/frn-devices.pdf

• https://www.federalregister.gov/documents/2007/09/21/E7-18591/pesticide-registration-clarification-for-ion-generating-equipment