By Lisa M. Campbell and Lisa R. Burchi
On June 7, 2021, Health Canada’s Pest Management Regulatory Agency (PMRA) announced the issuance of its Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act (Interim Order), setting forth new requirements for certain devices claiming to control, destroy, make inactive, or reduce the level of bacteria, viruses, and other micro-organisms that are human pathogens. PMRA also issued an “Explanatory Note” and a Questions and Answers document regarding the Interim Order.
PMRA states that it issued the Interim Order following the increased sale of ultraviolet (UV) radiation-emitting and ozone-generating devices such as lights and wands in Canada since the COVID-19 pandemic. These devices are marketed to kill bacteria and viruses, including SARS-CoV-2, the virus that causes COVID-19. According to PMRA, it has not received enough evidence to confirm that UV radiation-emitting and ozone-generating devices are safe for users and the public, or that they are effective.
Thus, PMRA is now requiring that companies register certain UV radiation-emitting devices and ozone-generating devices before they may be sold or used in Canada. In its Explanatory Note, PMRA states:
By bringing certain UV and ozone-generating devices under the [Pest Control Products Act (PCPA)], they need to be registered or otherwise authorized in order to be on the Canadian market. An application to register a pest control product must be submitted to Health Canada in the form and manner directed by the Minister and must include any information and other material that is required by the Pest Control Products Regulations to accompany the application. Applications to register devices consist of a number of information and data requirements, including a cover letter stating the purpose of the application, an application and fee estimate forms, the proposed English and French product labels, as well as data to support the safety and efficacy of the device. A registration will be granted under the PCPA if the Minister considers that the health and environmental risks and the value of the device are acceptable after any required assessments.
The Interim Order clarifies that certain UV radiation-emitting devices and ozone-generating devices claiming to kill bacteria and viruses are not subject to the regulatory requirements of the PCPA and its Regulations. These include:
- Devices that are manufactured, represented, distributed, or used to control, destroy, or inactivate viruses, bacteria, or other micro-organisms that are human pathogens for use in swimming pools, spas, or wastewater treatment systems;
- Devices that meet the definition of “device” in Section 2 of the Food and Drugs Act and are classified as a Class II, III, or IV medical device under the Medical Devices Regulations; and
- UV radiation-emitting devices that satisfy the following conditions:
- The device is certified by a standards development organization accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements;
- The certification mark of the standards development organization appears on the label of the device;
- Any efficacy claim that is made in respect of the device is only a claim of supplemental sanitization;
- No express or implied reference to prevention, treatment, or mitigation of disease is made in respect of the device;
- The device has at least one of the following mechanisms:
- A mechanism that locks the device during operation, or
- A mechanism that automatically shuts off the device if it is opened during operation; and
- The UV lamp is fully shielded or enclosed in the device in a manner that prevents access to it by users of the device and prevents exposure to UV radiation.
For UV radiation-emitting devices that satisfy these conditions, there are additional labeling requirements for the display panels and operating manual.
This Interim Order changes significantly the requirements applicable to these types of devices that did not previously require registration. PMRA is providing a 30-day transition period after the Interim Order is issued before companies must comply with these requirements. PMRA also is advising Canadians to “stop using UV lights and wands that claim to disinfect against the virus that causes COVID-19 especially if the product is for use on the skin.”
Companies that produce devices that may be subject to this Interim Order should review the new requirements and exemptions carefully. PMRA states that unregistered or unauthorized devices are prohibited and may be subject to compliance and enforcement action.
By Lisa M. Campbell and Lisa R. Burchi
In January 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a revised compliance advisory (Advisory) on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA first issued this guidance on June 1, 2020, and it is discussed in our blog here.
The Advisory has been revised significantly, reflecting new developments and experience since the Advisory was first issued.
The first section of the Advisory addresses “Products claiming to be effective against the coronavirus causing COVID-19.” That title has changed, as well as the language throughout the Advisory, to refer now to products that are “effective against” the coronavirus, instead of products that “kill” the coronavirus.
EPA has added a new section entitled “What is the difference between an EPA registration number and an EPA establishment number?” Presumably, this is intended to address confusion among some with regard to this important difference. The Advisory now states:
An EPA establishment number is not the same as an EPA registration number. An EPA registration number signifies that the pesticide and its claims have been reviewed and approved by EPA. An establishment number identifies the EPA-registered location where the product was produced. EPA provides a National List of Active EPA-Registered Foreign and Domestic Pesticide and/or Device-Producing Establishments at: https://www.epa.gov/compliance/national-list-active-epa-registered-foreign-and-domestic-pesticide-andor-device-producing.
The section entitled “Devices that claim to kill the coronavirus” has been significantly modified. In particular, EPA has now deleted from the Advisory language that “ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.” Instead, the Advisory states legal requirements applicable to devices, namely that the labels “include adequate warning and caution statements and directions for use” and have an EPA establishment number. EPA further adds the following: “Additionally, making false or misleading labeling claims about the safety or efficacy of a pesticidal device is prohibited and could result in the issuance of a Stop Sale, Use, or Removal Order and penalties under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).”
In its “Compliance Concerns” section, EPA states it continues to pursue enforcement against products making false and misleading claims regarding their efficacy against the coronavirus, adding that it is “particularly concerned with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective.”
EPA has added new language to address a particular issue with regard to “residual” claims:
In the United States, it is unlawful to distribute or sell a pesticide which includes claims that it will kill a particular pathogen, unless that pesticide is registered by EPA and that particular claim has been deemed acceptable by the agency. In some instances, companies have unlawfully added additional claims to the labels of their registered pesticide products that have not been approved by EPA. For example, a claim for persisting or long-lasting effect against viruses, referred to as “residual claims” (i.e., claims that a product provides an ongoing antimicrobial effect beyond the initial time of application, ranging from days to weeks to months), may be accepted by EPA only when supported by acceptable studies demonstrating satisfactory residual efficacy. Until EPA approves a residual claim, it cannot lawfully be included on a registered product as part of distribution or sale. For more information on residual claims, see: https://www.epa.gov/coronavirus/there-anything-i-can-do-make-surfaces-resistant-sars-cov-2. For more information on registering products with residual claims, see EPA’s Interim Guidance: https://www.epa.gov/pesticide-registration/interim-guidance-expedited-review-products-adding-residual-efficacy-claims.
Of interest among the changes to the Advisory is the removal of the language stating that pesticide devices could not make claims against the coronavirus unless they had been specifically “tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.” While any such testing may be necessary to demonstrate efficacy or appropriate directions for use, EPA had not previously stated what particular testing was required for devices or against what testing standard it would determine whether a device claim is “false or misleading.” It remains important for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.
By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson
On October 30, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria.
EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as pesticide devices when sold or distributed with claims to kill or be otherwise effective against viruses and/or bacteria, unless an exception applies, and must comply with certain statutory and regulatory requirements. This is the second Compliance Advisory issued by EPA relating to UV light devices, as an Advisory issued in May 2020 entitled “What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19” also addressed in part whether UV light devices could make claims against the coronavirus.
The Advisory reiterates that UV lights sold or distributed with claims that the lights can be used for preventing, destroying, repelling, trapping, or mitigating any pests, which include plants, animals, viruses, bacteria, or other micro-organisms, are regulated by EPA under FIFRA as a device. UV lights without such claims would not be subject to FIFRA. According to the Advisory, pesticidal devices are subject to certain regulatory requirements under FIFRA, one of which is a prohibition of false or misleading labeling claims.
The Advisory answers the following questions:
How do I comply with FIFRA if I am selling or distributing a UV light with pesticidal claims?
- Devices do not need to be registered by EPA and, therefore, are not subject to a pre-market review by EPA (although some states require devices to be registered). However, federal regulations require devices to be produced in an EPA-registered pesticide producing establishment and there are production reporting requirements; see 40 C.F.R Part 167.
- Devices must be labeled per federal regulations at 40 C.F.R Part 156. Generally, device labels must include warning and caution statements, directions for use and the EPA establishment number, amongst other label requirements. A description of device label requirements can be found at https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices#labeling.
- All claims in connection with the sale or distribution of a device must be true and not misleading. FIFRA Section 12(a)(1)(F) specifically prohibits false or misleading labeling (known as misbranding); this includes claims made in marketing materials and on websites. Examples of misbranding are provided at 40 C.F.R 156.10(a)(5) and include, but are not limited to, false or misleading statements concerning product effectiveness (known as efficacy), claims about product safety, false or misleading comparisons with other pesticides or devices, or any statement directly or indirectly implying that the device is recommended or endorsed by any agency of the Federal Government. Companies are advised to maintain records, with information and data, to substantiate that claims made in regard to devices are not false or misleading.
In addition to FIFRA requirements, importers of all FIFRA-regulated devices must comply with the U.S. Customs and Border Protection (CBP) regulations set forth at 19 C.F.R. §§ 12.110 -12.117. Regulated entities that are importing UV pesticide devices are advised that the products being imported must be in compliance with FIFRA prior to entry into the United States. The EPA regularly coordinates with CBP to identify and reject violative UV pesticide devices at the port of entry.
Can a UV light be a pesticide requiring EPA registration?
Yes. If the UV light product incorporates a substance or mixture of substances to perform its intended pesticidal purpose, then it is considered a pesticide product, not a device, and must be registered with EPA in accordance with FIFRA Section 3 before it can be lawfully sold or distributed in the United States.
Are UV lights safe and effective?
Unlike chemical pesticides, EPA does not routinely review the safety or efficacy of UV light devices and, therefore, EPA has not conducted a human health risk assessment to determine the safety of these products. For the same reason, EPA cannot confirm whether, or under what circumstances, UV light devices might be effective against any pest, including viruses and bacteria. The effectiveness of any UV light device will depend on a variety of factors including, but not limited to, the device’s duration of use, distance of the light from the surface intended to be treated, the UV wavelength, the specific pest being targeted, the strength or wattage of the UV light bulb, the age of the UV light bulb, shadow areas or other factors.
Consumers are advised to use all pesticidal devices ONLY in accordance with the Directions for Use, which are required to appear on the product label. EPA recommends that consumers contact the manufacturer or seller of the pesticidal device directly if they have any questions about how to use the product, the product’s safety, or the product’s efficacy.
What are the compliance concerns related to UV lights?
There may be members of the UV light industry who are unfamiliar with FIFRA and may not be aware of statutory and regulatory requirements. For example, they may be unaware that it is a violation of FIFRA to sell or distribute pesticidal UV light devices that are misbranded or that have not been produced in an EPA-registered establishment. EPA has been receiving complaints that UV light devices may be in violation of FIFRA. These complaints are being reviewed and EPA intends to pursue enforcement, as appropriate. See EPA’s May 2020 compliance advisory on products making claims to kill the coronavirus that causes COVID 19 at https://www.epa.gov/sites/production/files/2020-05/documents/cornavirus-compliance-advisory.pdf and any subsequent updates.
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 the EPA’s violation disclosure policies, including conditions for eligibility, please review EPA’s Audit Policy website at https://www.epa.gov/compliance/epas-audit-policy. 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.
Are you unsure if your product is a device under FIFRA?
EPA has developed a guide concerning pesticide devices that explains what a pesticide device is and how it differs from a pesticide product which requires registration. This guide may be helpful to UV light manufacturers who need to determine if their product is regulated by FIFRA.See https://www.epa.gov/safepestcontrol/pesticide-devices-guide-consumers. If you are still uncertain about whether your UV light 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.
UV light devices are a heightened focus of EPA, whose import and enforcement officials have been reviewing materials (e.g., import documents, websites) related to devices and increasingly bringing enforcement actions against companies for FIFRA violations. These actions can address circumstances when a pesticide device is not produced in a registered establishment or when the label does not include certain requirement elements, but more recently EPA seems particularly interested in the claims that are being made with regard to these devices and whether those claims are “false and misleading” under EPA’s regulations.
Ensuring that claims related to the efficacy of the device are not considered by EPA to be “false and misleading” can be especially difficult based on the facts that EPA does not review and approve data that support the claims being made, and also that EPA has not historically provided guidance as to the type of data that it would require to support an efficacy claim for a pesticide device. This Advisory is interesting to the extent that EPA sets forth various factors to be considered when determining the effectiveness of a UV light device. These factors include, but are not limited to “the device’s duration of use, distance of the light from the surface intended to be treated, the UV wavelength, the specific pest being targeted, the strength or wattage of the UV light bulb, the age of the UV light bulb, shadow areas or other factors.” The May 2020 Advisory further states that “UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.” (Emphasis in original.) In light of the two advisories, it is critical for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.
By Lisa M. Campbell, Lisa R. Burchi and Kelly N. Garson
On June 11, 2020, the U.S. Environmental Protection Agency (EPA) announced in a press release that it issued stop sale, use, or removal orders (SSURO) to Amazon.com Services LLC (Amazon) and eBay, Inc. (eBay) for selling certain pesticide products that EPA claims are unregistered, misbranded, or restricted-use pesticides, and pesticide devices that EPA asserts make false or misleading claims. The SSUROs address over 30 products sold on Amazon and over 40 products sold on eBay, and include several products marketed with what EPA believes are false or misleading claims of efficacy against the novel coronavirus, SARS-CoV-2, the cause of COVID-19.
EPA notes that Amazon and eBay are two of the largest e-commerce marketplaces and that they oversee millions of product listings. EPA further notes that it has held discussions with the companies, and other e-marketplaces, to stop sales of products that falsely claim to be effective against COVID-19, as discussed on our blog. Prior SSUROs issued to Amazon are discussed on our blog.
Registration of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is required prior to selling or distributing pesticides in the United States and it is a violation of FIFRA Section 12(a)(1)(A) to sell or distribute an unregistered pesticide. The EPA-approved label for a FIFRA registered pesticide product contains directions for use, precautionary statements, and other provisions that reflect EPA’s evaluation of data to and determination of acceptable risk for the product at issue when used as directed on the label. Pesticide products and devices are considered “misbranded” and in violation of FIFRA if, among other potential facts, they contain false or misleading claims and/or if their labels are missing certain required information (e.g., ingredients, precautionary statements, and directions for use).
EPA included a list of the products and devices at issue in attachments to the SSUROs. In the Amazon SSURO, EPA states that none of the listed products is registered with EPA, and that the products were misbranded because EPA believes they contain one or more false or misleading statements on their labels. In the eBay SSURO, EPA provides three attachments listing products eBay offered for sale that EPA claims are unregistered, misbranded, or classified as restricted use in violation of FIFRA.
The SSUROs prohibit Amazon and eBay from distributing, selling, or offering these products for sale. EPA requires that Amazon submit a written accounting of all the violative products listed in the attachment to the SSURO, including providing the location, quantity, and container size for these products, every 30 days for the next 150 days following Amazon’s receipt of the SSURO, or until Amazon no longer has the violative products in its ownership, custody, or control. Amazon must obtain written approval from EPA before it moves or removes any of the products from its facilities. EPA requires eBay to notify EPA of the corrective actions eBay will take regarding the violative products in writing within ten days of receiving the SSURO.
EPA notes in its press release the following examples of what it believes are pesticidal claims made for the products at issue that would require their registration prior to sale or distribution:
- “Kills COVID-19”
- “Complete sterilization including the current pandemic virus”
- “Coronavirus disinfectant”
- “2020 Coronavirus Protection Coronavirus Protection Clearance Sale”
- “A Powerful, Green, Non-Toxic Solution Proven to Inactivate our current viral strain”
- “Epidemic Prevention”
- “Efficient disinfection to prevent the spread of disease”
- “Help keep your family and those you care for healthy”
- “Nontoxic causes no permanent injuries”
- “Ingredients are biodegradable and have no harmful impact on the environment”
- “There is no damage to the environment”
- “You can easily purify the living environment”
- “Safe for all people using”
- “Gentle to Child & Pets”
- “Chemical Free”
EPA claims as additional violations that the products it believes are pesticide devices sold by Amazon also lack required EPA establishment numbers (i.e., site-specific information for the facility where the pesticide or device was produced) that is a required element on all pesticide and device labels.
The eBay SSURO also addresses claims that eBay sold restricted-use pesticides without limiting those sales to certified applicators as required by FIFRA Section 12(a)(2)(F). EPA states that EPA representatives purchased and received restricted-use products listed in Attachment C, Table 2 of the SSURO, but were not certified applicators at the time of the purchase, and were not required to submit proof that they were certified applicators prior to or during the sale. Restricted-use pesticides may only be distributed or sold to certified applicators or persons under their direct supervision. Certified applicators and persons they directly supervise are the only persons authorized to use restricted-use pesticides.
EPA’s press release highlights the following products:
- Described as a “particularly egregious” case are products found on Amazon containing Chlorine Dioxide sold with “unprovable claims of sanitizing and disinfecting hospitals, offices, and homes.” In addition, several versions of the product listed on the site have very little to no English-language instructions.
- Product listings on eBay.com include 55-gallon drums of Methylene Chloride marketed for use against SARS-CoV-2 as a disinfectant and paint stripper. Methylene Chloride is not approved for use against SARS-CoV-2. EPA notes also that EPA banned the retail sale of Methylene Chloride to consumers for paint removal purposes under the Toxic Substances Control Act “due to acute fatalities that resulted from exposure to the chemical.”
- Product listed on eBay called Virus Shut Out claiming to be a spatial disinfection card that would provide protection against SARS-CoV-2 to the wearer. Virus Shut Out was subject to previous EPA enforcement action, discussed in our earlier blog items.
- Product listed on eBay called Xtreme-Bio stating that it was exempt from EPA regulation and made entirely with “clean, green, safe, environmentally friendly ingredients” and that made claims to deactivate SARS-CoV-2.
EPA has been vigilant in reviewing and acting quickly to address products making claims against coronavirus, SARS-CoV-2, and COVID-19. The actions against Amazon and eBay are significant, as other actions have been largely targeted toward producers. The responses to the SSUROs will be of interest and should be monitored.
Additional information on EPA’s efforts to discover and protect against fraudulent products is available on our blog.
By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson
On June 1, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a compliance advisory on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19.
EPA states that the advisory was issued because it has received tips and complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. EPA says it is actively reviewing these claims and is working to identify others. EPA states that it intends to pursue enforcement for those products making false and misleading claims regarding SARS-CoV-2. EPA has made available a webpage where tips can be reported.
The advisory reiterates EPA’s message that disinfectant products that claim to kill viruses must be registered with EPA before they can be sold and that pesticide products cannot legally make claims that they kill a particular pathogen, such as SARS-CoV-2, unless EPA has authorized the claim during the registration process.
In the advisory, EPA emphasizes that it will not register a product claiming to be effective against SARS-CoV-2 until it has determined that the product will not pose an unreasonable risk and will be effective when used according to the label directions. EPA notes that it maintains List N, which is a list of disinfectants that meet EPA’s criteria for use against the virus that causes COVID-19. While surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, EPA expects them to kill the virus because they demonstrate efficacy against a harder-to-kill virus or another human coronavirus similar to the one causing COVID-19.
The advisory also discusses devices that claim to kill SARS-CoV-2. It states that a pesticidal device is an instrument or other machine that is used to destroy, repel, trap, or mitigate any pests, including viruses (i.e., ozone generators, UV lights). EPA notes that unlike registered pesticide products, the safety and efficacy of pesticidal devices are not routinely reviewed by EPA. EPA states that it therefore cannot confirm whether, or under what circumstances, such products might be effective against SARS-CoV-2. The advisory states that consumers should be aware that pesticidal devices making such claims have not been reviewed and accepted by EPA. It further states that while pesticidal device labels must have an EPA establishment number (which identifies where a product was produced), they will not have an EPA registration number because pesticidal devices are not subject to the same registration requirements as pesticides.
According to the advisory, pesticidal devices are subject to certain regulatory requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), one of which is a prohibition of false or misleading labeling claims. The advisory specifically states:
Making false or misleading labeling claims about the safety or efficacy of a pesticidal device may result in penalties under FIFRA. Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses. In addition, because EPA does not review these data as part of a registration review process, these claims are not supported by any government review.
Because EPA does not review or register pesticide devices, these products are not included on List N.
It is important for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.