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EPA Issues SSURO against EcoShield LLC for Selling an Unregistered Product Claiming Effectiveness against SARS-CoV-2
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.
On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2.
In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance). EPA published this Guidance in August 2016, to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels. The Guidance allows product registrants to make limited off-label claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA that demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2.
Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2. List N currently includes 469 products and is updated weekly. In many cases, EPA states that it was able to approve claims in as little as 14 days.
The 13 products approved include 12 unique products from the manufacturer Lonza and one additional Lysol product from Reckitt Benckiser. The 13 products approved are:
Additional information is available here.
EPA Announces Release of Guidance to Expedite Review of Requests to Add Electrostatic Sprayer Application Directions to Disinfectant Product Labels
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product labels. The Guidance outlines information that EPA asks registrants to submit to obtain expedited review of their proposed addition of this application method to their labels.
EPA notes that electrostatic spraying has drawn increased interest through the current public health emergency posed by COVID-19 because of the need to disinfect large indoor spaces, such as schools, offices, businesses, and other large areas, or areas with many surfaces. Unlike conventional spraying methods, electrostatic sprayers apply a positive charge to liquid disinfectants as they pass through the nozzle. The positively charged disinfectant is attracted to negatively charged surfaces, which allows for efficient coating of hard, nonporous surfaces.
EPA’s Guidance addresses adding electrostatic spray application methods to both new and currently registered disinfectant products that are on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, or that would qualify for List N, and require review under the Pesticide Registration Improvement Extension Act (PRIA 4).
EPA states that it will expedite the following registration applications:
EPA’s Guidance builds on EPA’s previously announced expedited review of certain submissions for products intended for use against SARS-CoV-2.
This guidance is important for many disinfectant products. Affected registrants or potential registrants should review it carefully.
EPA Announces Research Studying the Potential Long-Lasting Effectiveness of Disinfectants against SARS-CoV-2
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19. This research is being conducted at EPA’s Office of Research and Development's Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the high touch points in mass transit trains and stations.
EPA states that it is working directly with New York’s Metropolitan Transportation Authority, North America’s largest transportation network, on evaluating EPA-registered antimicrobial products across New York City Transit to determine their ability to provide effective anti-virus protection over time.
Currently, EPA-registered products that claim long-lasting effectiveness are limited to those that control odor-causing bacteria on hard, non-porous surfaces. At this time, there are no EPA-registered products that claim long-lasting disinfection. EPA researchers hope to determine whether antimicrobial products can provide residual disinfection on surfaces over time and how durable the disinfection ability of the product is with normal use, including routine cleaning and natural weathering. According to EPA, data generated by EPA researchers will inform any regulatory decisions (including the approval and use of these products according to the label) made as part of the pesticide registration process through EPA’s Office of Pesticide Programs.
EPA researchers are also evaluating other possible high-efficiency alternative methods to disinfect, such as ultraviolet light (UV), ozone, and steam, that could be used on public transit systems to keep trains, buses, and facilities clean and safe for passengers. EPA is additionally studying disinfectant application methods, such as electrostatic sprayers or foggers, that EPA believes are promising.
As part of this effort, EPA has partnered with the Los Angeles County Metropolitan Transportation Authority, the third largest transit agency in the United States, to evaluate a number of new technologies, including UVC lighting and air filtration systems, to combat SARS-CoV-2 on public transit systems.
EPA states that it will make the results of this research available to help inform decisions on the use of longer-lasting disinfection products, including information on the frequency of use to maintain disinfection capabilities over time.
Additional information on EPA’s research on COVID-19 in the environment 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.
On July 6, 2020, the U.S. Environmental Protection Agency (EPA) announced that it approved amended labels for two products, Lysol Disinfectant Spray (EPA Reg. No. 777-99) and Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127), based on laboratory testing that shows the products are effective against SARS-CoV-2. These are the first products for which EPA has reviewed laboratory testing data and approved label claims against SARS-CoV-2.
In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance), This Guidance was developed in April 2016 to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels. The Guidance allows product registrants to make limited claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA and demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2.
Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2. List N currently includes 431 products and is updated weekly. In many cases, EPA states that it was able to approve claims in as little as 14 days.
This week, EPA updated the entries for the two Lysol products on List N to indicate they have now been tested directly against SARS-CoV-2. This is significant since they are the first List N products for which EPA has reviewed laboratory testing data specifically against SARS-CoV-2, and not listed based on EPA’s determination that a product can be used against SARS-CoV-2 because of the product’s effectiveness against a harder-to-kill virus.
EPA states that it expects to approve such claims for additional List N products in the coming weeks.
The U.S. Environmental Protection Agency (EPA) announced on July 2, 2020, that it has registered NSPW Nanosilver (a new nanosilver formulation) to suppress odor-causing bacteria and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles. Textiles that may be treated with NSPW Nanosilver include fabrics, sportswear, footwear, linens, and awnings. NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard). The NSPW Nanosilver in Polyguard will be embedded within beads or pellets of a polymeric material in a “master batch,” and these beads of pellets will then be incorporated into treated textiles through a closed-loop manufacturing process. EPA states that once the beads or pellets containing NSPW Nanosilver are introduced into this manufacturing process, no beads or pellets can escape into the environment. EPA also states that the available data indicate that the leach rate of nanosilver from NSPW Nanosilver-treated textiles is below the limit of detection.
The same type of nanosilver was the active ingredient in another product that EPA previously conditionally registered under FIFRA Section 3(c)(7)(C) in 2015. The U.S. Court of Appeals for the Ninth Circuit issued a decision vacating that conditional registration because the court concluded that the mandatory public interest finding by EPA was not adequately supported by the administrative record. According to EPA, the new registration for NSPW Nanosilver involves a modified use pattern that will limit exposures compared to the product that received the previously vacated conditional registration. Based on additional data that the applicant has submitted to support the use pattern as modified, EPA has prepared an updated risk assessment for NSPW Nanosilver and has determined based on that risk assessment that the product as modified meets the standard for an unconditional registration under FIFRA Section 3(c)(5). Materials supporting this action will be posted in Docket ID EPA-HQ-OPP-2020-0043.
Registering any new metallic silver product that satisfies the EPA criteria for classification as nanosilver for use as an antimicrobial pesticide presents special challenges, because EPA has adopted a policy that it will construe each new nanosilver product as a new pesticidal active ingredient. The predecessor to NSPW Nanosilver (Nanosilva) was granted a conditional registration, a procedure that EPA uses when there are data gaps that must be filled before EPA is ready to make the determinations that would support issuance of an unconditional registration. EPA may only issue a conditional registration for a product containing a new pesticidal active ingredient when EPA makes a determination that “use of the pesticide is in the public interest,” and the Ninth Circuit Court determined that EPA did not compile an administrative record adequate to support that finding.
Colloidal metallic silver products that meet the definition of nanosilver were first synthesized in the late 19th century. Some industry stakeholders question whether the differences between different pesticide products that satisfy the EPA definition of nanosilver are sufficiently great to treat each new product as a new active ingredient, but it is also clear that the size and shape of the particles in these products do vary. In this instance, EPA has determined that the supporting data for the application allow EPA to issue an unconditional registration. Accordingly, the legal issue on which the Ninth Circuit based its prior decision to vacate the conditional registration for Nanosilva is not pertinent to the current registration decision. Given the challenge to the prior registration decision, it will be important to monitor any opposition to the newly issued registration.
District Court Rules That Prop 65 Warning for Glyphosate Is Barred by the First Amendment and Grants Permanent Injunction against Enforcement
On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate. The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial speech and therefore is contrary to the First Amendment of the Constitution. The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect. (See our February 28, 2018, blog entitled “Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products.”) The U.S. Environmental Protection Agency (EPA) also has stated that it would not allow a Prop 65 warning to be added to the labeling for any registered glyphosate product because such a warning is misleading and would cause the product to be “misbranded” under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(q)(1)(A). (See our August 15, 2019, blog entitled “EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds.”)
A Prop 65 warning is required when the California Office of Environmental Health Hazard Assessment (OEHHA) determines that a product contains a substance that has been classified as a human carcinogen by certain authoritative bodies, including the International Agency for Research on Cancer (IARC). Based on an IARC determination that glyphosate is “probably carcinogenic” in humans, OEHHA listed glyphosate in July 2017 as a chemical known to the State of California to cause cancer, thereby triggering Prop 65 warning requirements. Despite the IARC determination, every other authoritative body that has considered the matter (including EPA, the European Commission, and the World Health Organization) has reached a contrary determination that glyphosate is not likely to be carcinogenic in humans. California’s imposition of a Prop 65 warning for glyphosate was challenged in 2018 by the registrant Bayer and a coalition of farming groups and industry stakeholders, who obtained a preliminary injunction against enforcement of the warning.
Before entering the new permanent injunction, the District Court considered whether California’s regulation of commercial speech should be scrutinized under the lower standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission. The Zauderer standard only applies to mandatory disclosure of “purely factual and uncontroversial information,” and the Court found that the Prop 65 warning for glyphosate is “misleading” and therefore neither factual nor uncontroversial. Under the Central Hudson level of scrutiny, a governmental agency may only restrict commercial speech when the restriction directly advances an important governmental interest and where the restriction is not more extensive than necessary to serve that interest. The Court found that the Prop 65 warning for glyphosate is misleading, and therefore does not directly advance the interest of the state in informing consumers regarding potential cancer hazards, and that the asserted state interest could be effectively advanced by other measures that do not burden freedom of speech in the same manner.
California argued that no Prop 65 warning would actually be required for glyphosate in practice because OEHHA has set a quantitative “safe harbor” level for glyphosate exposure, but the court found that this would not prevent parties other than California from bringing separate enforcement actions to enforce the listing. Since a Prop 65 warning only needs to be “clear and reasonable,” California also proposed several alternative forms for a warning that would meet state requirements, but the court found these alternate warnings to all be misleading as well. Based on all of these factors, the court decided to enjoin permanently the enforcement of Prop 65 warning requirements for glyphosate as an unconstitutional burden on commercial speech.
Under FIFRA Section 24(b), no state may impose any labeling for a registered pesticide that differs from the labeling approved by EPA. Although EPA has sometimes been willing to accommodate state labeling requirements or preferences within the labeling approved under FIFRA, there are necessary limits to this practice. When label language sought by a state becomes misleading, approving it would also be expressly contrary to FIFRA. How much precedential effect this decision may have with respect to other state requirements for labeling in the future is an issue that registrants should monitor closely.
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.
EPA Issues Stop Sale, Use, or Removal Orders to Amazon and eBay for Unregistered and Misbranded Pesticides and Devices, Including Products with Claims Related to COVID-19
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:
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:
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.
EPA Issues Order Governing Existing Stocks of Dicamba Products with Registrations Vacated by the Ninth Circuit Decision, and the Petitioners Have Moved for Emergency Relief to Enforce the Vacatur and to Hold EPA in Contempt
On June 8, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of an existing stocks order under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1) governing further sale, distribution, and use of existing stocks of three reduced volatility dicamba products (XtendiMax®, EngeniaTM, and FeXapanTM) with conditional registrations that were vacated by the June 3, 2020, decision of the Ninth Circuit Court of Appeals in National Family Farm Coalition v. EPA. EPA explained its action by stating that the existing stocks order would provide “clarity to farmers” in light of the Court decision. Because EPA believes that vacatur made those stocks of the three dicamba products that were already in channels of trade unregistered pesticides, and the Court’s decision did not specifically address or establish any regimen to govern these unregistered existing stocks, EPA concluded that issuance of an existing stocks order was a practical necessity. The existing stocks order includes provisions that: (1) prohibit all sale and distribution of existing stocks of the three vacated dicamba products by the registrants, and by persons other than commercial applicators except for disposal of the products or returning the products to the registrants or their contract agents, (2) allow commercial applicators to use existing stocks of the vacated dicamba products in their possession in a manner consistent with existing labeling until July 31, 2020, and (3) prohibit end users from using existing stocks of the vacated dicamba products in their possession except in a manner consistent with existing labeling and from using such stocks in any manner after July 31, 2020.
Need for an Existing Stocks Order
To understand EPA’s position concerning the need for an existing stocks order for the three dicamba products with registrations vacated by the Ninth Circuit decision, it is important to review the legal status of those existing stocks after issuance of the decision. In the absence of further EPA action, all stocks of the three dicamba products subject to the vacatur order that were already in channels of trade became unregistered pesticides. Under FIFRA, as unregistered pesticides, these products could not be distributed or sold, which would prohibit stock of the unregistered products from being returned to the registrants or disposed, absent further EPA action. Stocks of the three products that were labeled for uses other than soybeans and cotton (the uses extended by the conditional registration decision vacated by the Court) also became unregistered and thus also could not be distributed or sold absent further action by EPA. Without further action by EPA, stocks of the three products already in the hands of end users could be lawfully used without any kind of restriction because although FIFRA Section 3(a) prohibits sale or distribution of unregistered pesticides, FIFRA does not include any provision prohibiting or limiting use of unregistered pesticides. Thus, the Court’s vacatur action created a situation in which EPA needed to act expeditiously to establish a rational regimen governing existing stocks of the three dicamba products. EPA was able to issue an order creating such a regimen because EPA construes the vacatur of the product registrations by Court action as a type of cancellation, which is how EPA has construed vacatur orders in the past. FIFRA Section 6(a)(1) expressly authorizes EPA to issue orders governing sale, distribution, and use of canceled pesticides.
EPA Policy for Existing Stocks Orders
EPA adopted a policy in 1991 (56 Fed. Reg. 29362) outlining six factors it generally considers in adopting existing stocks orders for canceled pesticides under FIFRA Section 6(a)(1): (1) the quantity of existing stocks at each level in channels of trade, (2) the risks resulting from use of existing stocks, (3) the benefits resulting from use of existing stocks, (4) financial expenditures users and others have already spent on existing stocks, (5) the risks and costs of disposal or alternative disposition of existing stocks, and (6) the practicality of implementing restrictions on the distribution, sale, or use of existing stocks. EPA applied this policy to the current situation and determined that “[e]ach of the six factors weighs heavily in support of allowing end users to use existing stocks of these dicamba products that are in their possession.” Since use of these unregistered pesticides is not otherwise prohibited by FIFRA as discussed above, EPA adopted prohibitions of use of the products not in accordance with the current labeling and of any use after July 31, 2020. The only action taken by EPA to authorize further use of the three products involved stocks held by commercial applicators, which EPA allowed the commercial applicators to use according to the current labeling until July 31, 2020.
EPA Administrator Wheeler stated, “At the height of the growing season, the Court’s decision has threatened the livelihood of our nation’s farmers and the global food supply. Today’s cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation, and is designed to advance compliance, ensure regulatory certainty and to prevent the misuse of existing stocks.”
Three days after EPA issued the dicamba existing stocks order, on June 11, 2020, the Petitioners in the National Family Farm Coalition case submitted a motion requesting that the Court provide emergency relief “to enforce its vacatur” decision and that the Court hold EPA and Administrator Wheeler in contempt. According to the Petitioners, EPA’s entire rationale for issuing an existing stocks order is based on false premises. In the Petitioners’ view, existing stocks of the three dicamba products are not “unregistered” because the vacatur order only invalidated certain newly authorized uses, and the existing stocks should not be deemed to be “cancelled” either, although the conditional registration decision for the products has been vacated. In their motion, the Petitioners also assert that EPA is wrong because, “When read in context, FIFRA clearly prohibits the use of unregistered pesticides.” In addition to their request that the Court take emergency action to enforce its decision and hold EPA in contempt, the Petitioners also requested that the Court adjudicate their Endangered Species Act (ESA) claims, an action that would require that the Court recall the mandate and issue another decision on the ESA claims it previously declined to reach.
On June 12, 2020, the Court issued an order requiring EPA to file its response to the motion by 5:00 p.m. PDT on June 16, 2020, and the Petitioners to file any reply by 5:00 p.m. PDT on June 18, 2020.
In another development, BASF Corporation and E.I. DuPont de Nemours each filed separate “emergency motions” to intervene in the case on June 12, 2020. Each company asserts that it was not afforded notice that the Court might take adverse action concerning the registration for its dicamba product until after the decision vacating that registration was issued by the Court. At this juncture, the Court has not yet indicated whether it will consider these emergency intervention motions or whether it would be willing to allow any further briefing on the merits of the case.
Additional information on the Ninth Circuit Court of Appeals decision is available on our blog.
The Court’s June 3, 2020, decision stated, “We are aware of the practical effects of our decision,” but it is not clear from the discussion that follows whether the Court fully considered the chaotic effects of issuing a vacatur decision that did not specifically address the fate of existing stocks of the dicamba products with vacated registrations. On May 21, 2020, EPA asked for leave to file information on its plans to issue a cancellation order governing existing stocks of products with vacated registrations, but the Court declined to allow that filing. In any case, it should not have been surprising that EPA would construe its vacatur order as a form of cancellation, because that is what EPA did when the Ninth Circuit previously issued a vacatur order for sulfoxaflor products in 2015.
The Petitioners’ motion rejecting the basic legal premises underlying the EPA existing stocks order reflects a novel view of pesticide registration that is difficult to reconcile with the plain language and established constructions of FIFRA. Under FIFRA, EPA issues registrations for specific pesticide products, which may be labeled only for those uses that EPA has previously determined meet applicable requirements. Under FIFRA Section 6(b), EPA can decide that particular uses no longer meet the standard for registration and must be removed from an existing product label, but the only means by which EPA can effectuate that determination is by taking action to cancel any product for which the registrant does not agree to make the necessary changes. The Court vacated EPA’s conditional registration decision that authorized three registered dicamba products to be labeled for use on dicamba-tolerant soybeans and cotton but did not direct or establish any process for EPA to consider amending the product labeling or restoring the prior registrations. Under these facts, EPA has concluded that under FIFRA, existing stocks that are labeled for those uses became unregistered pesticide products because the labeling no longer conforms to the product registrations as they have been altered by the Court. In the absence of an existing stocks order, stocks of the affected products labeled for the disallowed uses could not be lawfully distributed for any purpose, including voluntary recall by the registrant, disposal, or relabeling to remove the disallowed uses.
Despite the assertions by the Petitioners that FIFRA prohibits use of unregistered pesticides, FIFRA has not been construed in this manner. While it a violation of FIFRA to distribute or sell any pesticide product with labeling that does not conform to a valid registration, FIFRA does not include any similar prohibition on use of an unregistered pesticide. Thus, in the absence of an existing stocks order, stocks of the three dicamba products with vacated registrations that are already in the hands of end users could be lawfully used without restriction. This notion is reflected in the provisions addressing end users in the order. No provision in the order authorizes end users who have the three dicamba products in their possession to do anything. Rather, the order prohibits end users from using the three products except in compliance with the existing labeling and from using the products at all after July 31, 2020.
Of course, it is not surprising that EPA applied its established criteria for existing stocks orders in the manner that it did. Representatives of affected growers argued that prohibiting all use of the products in the middle of the 2020 growing season would lead to billions of dollars in damages, at a time when the entire agricultural economy has already been severely impacted by the Covid-19 pandemic.
In addition to arguing that an existing stocks order was necessary to establish a practical regimen governing distribution and use of those stocks of the three dicamba products in channels of trade when the Court’s decision was issued, EPA will likely argue that the Circuit Court lacks jurisdiction to review the existing stocks order.
Ninth Circuit Vacates EPA’s Renewal of Conditional Registrations for Lower Volatility Dicamba Formulations
On June 3, 2020, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in National Family Farm Coalition v. EPA, No. 19-70115, vacating the U.S. Environmental Protection Agency’s (EPA) 2018 decisions to extend the conditional registrations for three reduced volatility dicamba herbicides, Bayer’s XtendiMax, Corteva’s FeXapan, and BASF’s Engenia.
The manufacturers of these dicamba products designed them to facilitate control of glyphosate resistant weeds in strains of soybeans and cotton that have been genetically modified to be dicamba tolerant (DT). Although the manufacturers intended these dicamba products to be less volatile and less susceptible to drift into adjacent non-target areas than previous formulations of dicamba, there were nonetheless many complaints that the products cause damage to non-tolerant crops and other vulnerable vegetation. The Petitioners that challenged EPA’s decision to extend the conditional registrations for these reformulated dicamba products include a group representing small farmers who claim that the new dicamba products have damaged their crops (National Family Farm Coalition) and several non-governmental organizations that routinely oppose new pesticide registrations (the Center for Food Safety, the Center for Biological Diversity, and Pesticide Action Network North America).
Although the case included some allegations by the Petitioners that EPA did not comply with the requirements of the Endangered Species Act, the court did not reach those issues. The court found unanimously that EPA’s decision to extend the conditional registrations for the three dicamba herbicides did not satisfy the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Specifically, the court found that the administrative record compiled by EPA did not include “substantial evidence” supporting EPA’s determination that registering the new uses “would not significantly increase the risk of any unreasonable adverse effects on the environment.” EPA is required under FIFRA Section 3(c)(7)(B) to make this determination to grant a conditional registration of new uses of a currently registered pesticide. The court concluded that EPA could not make this required determination because, the court stated, the record shows that EPA “substantially understated the risks that it acknowledged” and also “entirely failed to acknowledge other risks.”
According to the court, EPA made six material errors in its analysis supporting the registrations. First, the court stated that EPA understated the amount of acreage planted with DT crops in 2018, and consequently also underestimated the amount of the new dicamba products that would be applied that year, even though the decision to extend the conditional registrations for the new dicamba products was not issued until the end of the 2018 growing season. Second, in the court’s view, EPA improperly found that the number of complaints concerning damage to non-target crops and vegetation by the new dicamba products might be over-reported when the record included overwhelming evidence that non-target damage was being under-reported. Third, the court stated that EPA refused even to estimate how much damage to non-target vegetation would be caused by the new dicamba products when the record contained sufficient information for EPA to make such an estimate. Fourth, according to the court, EPA refused to acknowledge the substantial risk of non-compliance with the large number of detailed restrictions set forth in the 40-page approved label, although the court found that “there was substantial evidence that even conscientious applicators had not been able to consistently adhere to the label requirements.” Fifth, the court believes EPA failed to acknowledge the anti-competitive effect of the new technology, which encourages other growers to use DT crops even if they do not use the new dicamba products, to avoid damage from nearby applications. Sixth, according to the court, EPA failed to acknowledge the social cost being caused in small communities where damage caused by use of the new dicamba products has turned formerly amicable neighbors against each other.
Based on all of these purported deficiencies, the court held that EPA’s rationale for determining that the risk of unreasonable adverse effects would not be significantly increased by the new dicamba uses, and that the registration for the new dicamba products could therefore be extended for two additional years, was not supported by “substantial evidence” in the administrative record taken as a whole. The court also held that remanding the matter to EPA for further action without vacatur would not be appropriate because EPA did not satisfy the requirement to extend the conditional registrations. Instead, the court simply vacated the registrations and invited EPA to try again. The court acknowledged that such a decision would cause disruption, especially for those growers that have already purchased DT seeds and dicamba herbicides for this year's growing season, but concluded that no remedy other than vacatur would be appropriate given the deficiencies in the administrative record.
When FIFRA was amended to allow new pesticide products to be “conditionally” registered even though the applicants had not submitted data to satisfy all applicable requirements, the focus was primarily on allowing registration of new products that are “substantially similar” to already registered products. FIFRA Section 3(c)(7) also allows conditional registrations to be issued for new uses of existing active ingredients and for new active ingredients without all required data if EPA has sufficient information to make certain findings while it waits for additional data, but requires that EPA be able to determine that certain requirements can be met even though not all of the supporting data that will ultimately be needed are yet available.
This court’s decision illustrates the type of problems that can occur when EPA issues a conditional registration for new products that are not “substantially similar” to registered products. The court’s view of the sufficiency of the record in this case sets a high bar for the determinations that must support other types of conditional registrations. This problem was previously illustrated when a reviewing court vacated a new registration for a new nanosilver product even though there were already registered nanosilver products. In that case, because EPA chose as a matter of policy to characterize the product as a new active ingredient, it was required to make a “public interest” determination under FIFRA Section 3(c)(7)(C). When the administrative record was deemed insufficient to support this mandatory determination, the reviewing court vacated the registration.
In the case of the new dicamba products, to grant conditional registrations for new uses of an existing active ingredient, EPA was required to determine that the new uses on DT soybeans and cotton would not “significantly increase the risk of unreasonable adverse effects on the environment” under FIFRA Section 3(c)(7)(B). The court found the record supporting this mandatory determination to be insufficient, resulting in the court’s vacatur of EPA’s decision. These two reviewing courts have taken a relatively deep dive into the administrative record supporting a conditional registration for a new use of an existing active ingredient or a new active ingredient in evaluating whether substantial evidence in the record supports the determinations required by FIFRA. Whether future decisions will maintain such a stringent evidentiary standard will be important to monitor.
EPA Announces the Issuance of an Advisory on Disinfectants Making False and Misleading Claims against COVID-19
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:
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.
From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf.
EPA Announces Third Temporary Modification to Pesticide Registration Notice 98-10 to Address Supply Chain Issues for Food-Contact Surface Sanitizer Products in Response to COVID-19
On May 15, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is issuing its third temporary modification to Pesticide Registration (PR) Notice 98-10 to include food-contact surface sanitizer products containing the active ingredient (AI) isopropyl alcohol. This new temporary amendment permits all the registration modifications outlined in the March and April modifications, while also expanding the criteria for the types of products that qualify for the provisions of this amendment.
EPA states that this temporary, time-limited amendment to PR Notice 98-10, dated May 11, 2020, will extend some of the supply chain flexibilities to products used in the food manufacture and preparation industries. Specifically, this temporary amendment expands these flexibilities to manufacturers of food-contact surface sanitizer products containing isopropyl alcohol and adds isopropyl alcohol to the list of AIs commodity chemicals allowed to be changed by notification in order to use any similar source to produce List N registered disinfectant products.
According to EPA, these isopropyl alcohol sanitizer products are not to be applied directly to food. Instead, they are used to sanitize equipment and surfaces used in food manufacturing and food preparation.
EPA intends for these flexibilities to increase the availability of products for use against the SARS-CoV-2. This third temporary modification to PR Notice 98-10, according to EPA, is in response to feedback from the food manufacture and preparation industries that are experiencing challenges acquiring sanitizers for use in production facilities processing low-moisture products like cereal, flour, and industrial baked goods.