By Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 6, 2021, that Bear River Supply Inc., based in Rio Oso, California, has agreed to pay a $50,578 penalty to resolve EPA’s findings that the Company produced pesticides in an unregistered establishment, distributed and sold misbranded pesticides, and failed to maintain equipment properly. According to EPA, the California Department of Pesticide Regulation (CDPR) and EPA discovered the violations during a series of inspections conducted at two separate facilities in Rio Oso. Inspectors found that “Vistaspray 440 Spray Oil” and “Roundup PowerMax” were being repackaged and distributed with improper labeling. In addition, EPA states, inspectors determined that Bear River Supply was producing pesticides in a facility that was not registered with EPA. While at the facilities, inspectors also found that a secondary containment unit and loading pad, both used to contain potential spills, were inadequate. The Company has since corrected the violations.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide manufacturers must register their facilities with EPA and annually report their pesticide production. EPA states that production records provide information on the quantities of pesticides produced and distributed. EPA notes that in addition, the number assigned to the establishment must appear on the label. FIFRA’s reporting and labeling requirements allow EPA and state agencies to track pesticide products back to the companies that produced them and “are necessary to ensure safe management and distribution” of pesticides.
By Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on April 19, 2021, that Univar Solutions USA, Inc. of Portland, Oregon, will pay a $165,000 penalty for violating the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when it failed to label properly its “Woodlife 111” pesticide, which is used as a wood preservative. EPA notes that under FIFRA, “a pesticide is misbranded if, ‘the labeling accompanying it does not contain directions for use which are necessary … to protect health and the environment’ and if ‘…the label does not contain a warning or caution statement which may be necessary … to protect health and the environment.’” According to the press release, EPA alleged that between approximately January 1, 2017, and December 31, 2018, Woodlife 111 labels “omitted several required sections important for the protection of the handler and for the environment, including user safety requirements, first aid directions, use of personal protective equipment, and portions of the storage and disposal section.” EPA states that it cited the company for 33 FIFRA violations when Univar sold and distributed the misbranded pesticide via bulk shipments. According to the press release, the case resulted from a March 5, 2019, inspection of the Univar facility by the Oregon Department of Agriculture’s EPA-credentialed inspectors.
By Lisa M. Campbell and Lisa R. Burchi
On March 31, 2021, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) to ViaClean Technologies (ViaClean), operating in Philadelphia, regarding the sales, distribution, and marketing of the pesticide BioProtect RTU with claims that it is effective against surfaces from public health-related pathogens such as SARS-CoV-2, the virus that causes COVID-19.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), products that claim to kill or repel bacteria or germs, including disinfectants, are considered pesticides and must be registered with EPA. Public health claims can only be made regarding products that have been properly tested and are registered with EPA.
In this case, BioProtect RTU is a registered pesticide, with label claims approved by EPA, in part, to use the product to inhibit the growth of odor causing bacteria that cause staining and discoloration, and algae. According to EPA, ViaClean provided two BioProtect RTU fact sheets containing public health claims to at least one customer, including the statement that the pesticide can be used to kill “germs.” EPA also alleged that some online distributors, cleaning services, and end-recipients of BioProtect RTU were also making claims that this product is effective against pathogens, germs, disease-causing bacteria, viruses, and/or SARS-CoV-2 for up to 90 days.
EPA’s issuance of the SSURO is thus based on EPA’s belief that ViaClean was selling, distributing, and marketing BioProtect RTU with public health claims that have not been substantiated or approved through the pesticide registration process. EPA states that it is concerned that customers may have used this product as protection from viruses -- SARS-CoV-2 -- in lieu of other EPA-approved disinfection methods.
This case is another example of EPA’s enforcement priorities and vigilance over the past year to identify products making claims to act against the coronavirus and taking action to prevent further sales when such products are not approved by EPA to make such claims.
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 and Lisa R. Burchi
On October 15, 2020, the U.S. Environmental Protection Agency (EPA) announced a settlement with Electrolux Home Products, Inc. (Electrolux) to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for importing air filter products that contain nanosilver. Specifically, the settlement resolves EPA’s claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notices of Arrival in violation of FIFRA Section 12(a)(2)(N). As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400. The Consent Agreement and Final Order (CAFO) is available here.
According to EPA, Electrolux imported approximately 420,000 Frigidaire brand dehumidifiers and air conditioners that contained filters incorporating an unregistered nanosilver and that were labeled and marketed with pesticidal claims. With regard to the incorporation of nanosilver, there currently are no nanosilver pesticide products registered with EPA for use in home appliances to disinfect the ambient air or protect the health of the user. The only nanosilver pesticides that are currently registered with EPA are approved solely for incorporation into textiles to protect those articles themselves from antimicrobial pests such as mold and bacteria that can cause deterioration, discoloration, or odors. In those cases, the products (textiles) incorporated with nanosilver can be exempt from FIFRA registration under the “treated article” exemption. With regard to the claims, EPA states that claims it considers pesticidal include “antibacterial filter,” and “helps eliminate bacteria in the air that can make breathing difficult.”
The penalty in this case is significant, and represents a potentially growing trend for penalty amounts substantially higher than past cases. This trend is due at least in part to the inflation adjustments to statutory civil penalty amounts, as discussed further here.
In addition to the civil penalty, the CAFO states that Electrolux has replaced the filters manufactured with nanosilver and removed the online and on-box pesticidal claims for the products it had imported, as well as some additional products already in the United States. The CAFO states:
The SSURO also provided for the movement of subject products for the purpose of consolidating the products for a rework project whereby Respondent, among other things, would replace the filter manufactured with nanosilver contained in each unit with a filter that was not manufactured with a pesticidal substance, affix a sticker with modified language over any pesticidal claims on the product packaging, and remove all pesticidal claims made for the subject products in Respondent’s online marketing
The CAFO further states that “Respondent offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver within its possession regardless of the date those products were imported.” To date, EPA states that Electrolux has brought over 500,000 air conditioners and dehumidifiers into compliance.
By Lynn L. Bergeson, Lisa M. Campbell, and Carla N. Hutton
Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, wrote to Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos on October 7, 2020, requesting that he launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices. The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.” According to the press release, many of these products were never recalled and continue to be sold.
In addition to their request that Bezos initiate an investigation into the safety of AmazonBasics products, Pallone and Schakowsky also seek answers to a series of questions, including:
- What Amazon-owned products are no longer for sale due at least in part to safety concerns?
- What products -- both Amazon-owned and third party -- have been officially recalled?
- What notification does Amazon provide to customers who have purchased products that are later recalled or found to be unsafe?
- In addition to direct notification, what other kinds of consumer or public outreach does Amazon conduct to ensure consumers properly dispose of, repair, or replace an unsafe product?
- How can consumers find information regarding recalled products? If information is not readily available, why not, and what plans exist to make it available?
- How can consumers report product safety issues to Amazon?
- How many staff does Amazon have devoted to ensuring that products sold on its platform follow all applicable laws and regulations, and that Amazon is in compliance with obligations to notify the U.S. Consumer Product Safety Commission (CPSC) when a product is suspected of being unsafe?
The letter requests a response no later than October 21, 2020.
The letter and request for answers to the questions noted above are another indication of the pressure certain Members in Congress are putting on Amazon to ensure the safety of the products the platform hosts. Amazon is under increasing scrutiny by the U.S. Environmental Protection Agency (EPA) in this regard, as reported in our February 16, 2018, and June 17, 2020, blog items, and this Congressional inquiry seems more of the same. These efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant.
Innovations in agricultural chemicals have revolutionized and enhanced food production, but with progress come new challenges. Agricultural chemicals can have widespread impacts on ecosystems and human health, and marginalized communities -- children and farmworkers in particular -- can be especially vulnerable. Manufacturers, regulatory agencies, public health experts, and nonprofit organizations are working to address these challenges head-on by developing new products and devising robust protective measures.
Recent changes in federal regulations include the Worker Protection Standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which expand the requirements for protecting agricultural workers from pesticide exposure. The Environmental Law Institute (ELI) presents "Pesticides, Farmworkers, Industry, and Environmental Justice," a webinar exploring the issues addressed in the new regulations and the implementation of these new obligations. James V. Aidala, Senior Government Affairs Consultant, Bergeson & Campbell, P.C. (B&C®), will moderate this discussion.
By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson
On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens. EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims. The SSURO against EcoShield is another in a series of enforcement actions EPA has taken against products that EPA believes are making claims in violation of FIFRA during the COVID-19 public health emergency. Some of these actions include the Amazon and eBay SSURO and the prevention of importation of the unregistered “Virus Shut Out” pesticide product. (See our blogs here and here for more information on these two actions.)
Under FIFRA, products that claim to kill or repel bacteria or germs, including disinfectants, are considered pesticides and must be registered with EPA. EPA will not register a disinfectant until it has been determined that it will not pose an unreasonable risk when used according to the label directions. In this case, Eco AirDoctor Portable was marketed as a “personal air sanitizer” that users hang from shirts or backpacks. The product claims to release chlorine dioxide gas to sanitize the air of pathogens. EcoShield also claimed on its website and social media that the product is a “safe and effective germ-killing agent” and, EPA claims, implies protection against SARS-CoV-2. EPA also expressed concerns regarding prolonged exposure to and inhalation of chlorine dioxide gas, which EPA states can adversely affect the health of users.
To find EPA-registered disinfectant products that are qualified for use against SARS-CoV-2, please search EPA’s List N, which currently contains 473 products, including products that went through the expedited review process for emerging viral pathogens.
Additional information on EPA enforcement actions on unregistered products is available here.
This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.
This week I sat down with James Aidala, B&C’s Senior Government Affairs Consultant, to catch up on what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is up to and to get a sense of what we might expect to develop over the remainder of the year. As a former Assistant Administrator of what is now the Office of Chemical Safety and Pollution Prevention, Jim’s thoughts and analyses are always spot on.
We discuss leadership within OPP, which is transitioning. Not surprisingly, who holds the position of Office Director is always of great interest to the agricultural and biocidal chemical communities.
We also touch upon a number of high-profile pesticide science policy debates about substances, some of which have been raging literally for years. These substances include dicamba, glyphosate, and chlorpyrifos. The legal and scientific administrative and judicial reviews under way in the United States and internationally are fascinating, precedent setting, and closely watched.
Our conversation also includes a bit about the commercial agricultural chemical community. Industry consolidation and international trade issues continue to challenge the commercial landscape, and they make keeping up with these issues all the more important.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.