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.
By Lisa R. Burchi and Kelly N. Garson
On June 17, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use, or Removal Order (SSURO) to OCCS, Inc. (OCCS) for the sale and distribution of unregistered antimicrobial disinfectants. EPA Region 9 states in a press release that OCCS, a chemical supply company located in Stanton, California, distributed and sold two unregistered products, Sanitizer/Quat Solution Ready to Use and Quat Solution Ready to Use Cleaner, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
It is a violation of FIFRA Section 12(a)(1)(A) to sell or distribute an unregistered pesticide. Additionally, antimicrobial disinfectant products may not contain public health claims that are not properly tested and supported by efficacy data submitted to EPA. EPA asserts that OCCS falsely labeled Sanitizer/Quat Solutions Ready to Use product as a registered disinfectant by including an EPA registration number that is assigned to another registered pesticide on its label. EPA further states that OCCS re-labeled the product from “Sanitizer/Quat Solutions Ready to Use” to “Quat Solution Ready to Use Cleaner.” OCCS also removed the EPA registration number from the new label, but stated that a registered pesticide (“MAQUAT® 10 E.P.A. Reg. No. 10324-63”) was the main cleaning agent of Quat Solution Ready to Use Cleaner. The SSURO requires OCCS to stop the sale and distribution of the products, which EPA notes were available for sale on different online marketplaces.
The SSURO does not affect lawful sales and distribution of “Maquat 10” an EPA-registered pesticide that is listed on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19), a list of products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.
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.
By Lisa M. Campbell, Timothy D. Backstrom and Kelly N. Garson
On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment. The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19.
DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor Suggests LLC and GP Silver LLC. The complaint alleges that defendants began fraudulently promoting and selling various silver products in early 2020 with claims that the silver products would treat and prevent COVID-19. Some of the alleged false and misleading claims made by defendants include that having silver particles in the bloodstream would block the virus from attaching to cells, that silver would “usher” the virus out of the body, and that silver would destroy all forms of viruses and protect against COVID-19.
The U.S. Food and Drug Administration (FDA) issued a statement on the Utah case that “FDA will continue to help ensure those who place profits above the public health during the COVID-19 pandemic are stopped” and that FDA is “fully committed to working with the Department of Justice to take appropriate action against those jeopardizing the health of Americans by offering and distributing products with unproven claims to prevent or treat COVID-19.”
The enforcement action will be prosecuted in a coordinated action by the U.S. Attorney’s Office for the District of Utah and the DOJ Civil Division Consumer Protection Branch, with the assistance of the FDA’s Office of Criminal Investigations and Office of the Chief Counsel. In addition to the TRO, prosecutors obtained a separate court order temporarily freezing the defendants’ assets in order to preserve the court’s ability to grant effective final relief and to maintain the status quo. A hearing on the DOJ’s request for a preliminary injunction is set for May 12, 2020. If the case proceeds to trial, the government will need to prove its allegations to obtain a permanent injunction against the defendants.
In another case, DOJ announced on April 17, 2020, that the United States District Court for the Southern District of Florida issued a TRO to halt the sale of an unapproved and potentially dangerous industrial bleach product being marketed as a “miracle” treatment for COVID-19. The FDA and the U.S. Federal Trade Commission (FTC) had issued a warning letter to the defendant, Genesis II Church of Health and Healing, on April 8, 2020. According to the FDA, oral ingestion of the defendant's product called the Miracle Mineral Solution can cause nausea, vomiting, diarrhea, and severe dehydration. The FDA and the FTC have issued nearly 40 separate warning letters in 2020 to companies selling unapproved or misbranded products with claims to prevent or to treat COVID-19.
Particulate elemental silver and silver salts can be effective antimicrobial agents, and numerous products containing these active ingredients are currently registered for various antimicrobial uses. The U.S. Environmental Protection Agency, along with other federal agencies, are working to ensure that necessary reviews and approvals of legitimate products intended to address COVID 19 are as expeditious as possible. Products that need these regulatory reviews and approval, but that are marketed without them, are and will likely continue to be a current enforcement focus.
By Kelly N. Garson and Barbara A. Christianson
On April 24, 2020, the U.S. Environmental Protection Agency (EPA) and U.S. Customs and Border Protection (CBP) announced that the agencies prevented a significant number of shipments of illegal health products from entering the Los Angeles International Airport (LAX) and the San Francisco International Airport (SFO).
The products at issue were not registered with EPA, including Virus Shut Out products. EPA previously announced on March 25, 2020, that EPA and CBP had prevented several shipments of Virus Shut Out from entering U.S. Pacific Ports. The announcement noted that because the product is not registered, EPA had not evaluated its safety and efficacy against viruses. Additionally, its label does not contain directions for its use in English as required by law, and on-line advertisements for the product contain misleading claims about its safety and effectiveness. The Department of Justice charged a Georgia resident with federal criminal charges relating to the illegal importation, sales, and distribution of Virus Shut Out, or Toamit Virus Shutout, on April 9, 2020, discussed in our earlier blog item.
Following the shipment denial on March 25th, EPA notified Amazon, and Amazon removed the product from its marketplace. EPA has been in communication with several retailers to ensure that these products are removed from their online marketplaces and asking for monitoring for products with illegal pesticidal claims.
In an effort to curb illegal pesticide products during the pandemic crisis, EPA has been working with CBP to identify and seize illegal products imported from Japan and Hong Kong through International Mail Facilities (IMF) in Los Angeles and San Francisco, and CBP has as a result of this effort seized a large number of products.
EPA Administrator Andrew Wheeler states “EPA is increasing the number of approved disinfectants on the market while taking action to prevent dishonest actors from selling fraudulent and illegal items that do nothing to protect Americans from the coronavirus.” This has included EPA’s expedited review of submissions for companies to add Emerging Viral Pathogen claims to registered surface disinfectants.
EPA has released an expanded list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the novel coronavirus that causes COVID-19. List N contains nearly 400 products that have qualified to be effective against SARS-CoV-2.
Additional information on EPA’s efforts to discover and protect against fraudulent products is available on our blog.
By Lisa R. Burchi
On April 9, 2020, the Department of Justice (DOJ) announced it had charged a Georgia resident, Rong Sun, a/k/a Vicky Sun with federal criminal charges relating to alleged illegal importation, sales, and mailing of an unregistered pesticide product. EPA also has taken steps to prevent further imports, sales, and distributions of this product within the United States, announcing in its press release that it prevented several shipments of this product from entering U.S. Pacific ports.
The product at issue, Toamit Virus Shut Out, was sold through eBay and made claims to protect individuals from bacteria and viruses and to reduce transmission risk by 90 percent. Claims regarding the product also included the following statement: “In extraordinary times, access to public places and confined spaces will be protected by one more layer and have one more layer of safety protection effect, thus reducing the risks and probability of infection and transmission.” The product was not registered by EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
DOJ’s Environment and Natural Resources Division is prosecuting the case. EPA’s Criminal Investigation Division, U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, and USPS are investigating this case. This type of collaborative investigative effort among federal agencies can be expected to continue to prevent defrauding victims during this coronavirus pandemic. In its press release announcing the arrest, DOJ stated that it “will take quick action through the Georgia COVID-19 Task Force to put a stop to criminals preying on the public with Coronavirus-related fraud schemes.” EPA Assistant Administrator for Enforcement and Compliance Assurance Susan Bodine stated further: “Reliance on fraudulent products may increase the spread of COVID-19 and exacerbate the current public health emergency.”