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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.
The Science Advisory Board (SAB) of the U.S. Environmental Protection Agency (EPA) announced that it will convene the Chartered SAB meeting on May 20, 2020, to review and discuss the draft report prepared by the SAB COVID-19 Review Panel. The draft report, SAB Technical Review of EPA’s Identification of Research Needs to Address the Environmental and Human Health Impacts of COVID-19, was funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. This research was conducted to assist EPA in its understanding of the environmental and human health impacts from COVID-19 and to identify EPA research already underway as well as new EPA research that has been proposed. The research included an evaluation of the efficacy of available disinfectants in killing SARS-CoV-2, the virus that causes COVID-19, on different types of surfaces that may be frequently touched by multiple people, such as in subway cars, door handles, and railings. Areas of particular interest include the efficacy of disinfection methods in controlling the virus on porous materials and soft surfaces, and the efficacy of products that claim to offer residual or long-term control of the virus.
EPA issued detailed charge questions for consideration by the SAB on April 21, 2020, and the SAB hosted a public teleconference and audio webcast of the presentation by EPA and the review by SAB on April 30, 2020.
Additional information on the forthcoming Chartered SAB meeting is available here.
EPA Announces Additional Procedures to Add New Disinfectant Products to List N and Creates New Web-Based Application Tool for Consumers to Find Disinfectant Products to Use Against SARS-CoV-2
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19.
EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2. These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2. This process does not replace the review process of all other submitted antimicrobial products.
EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces).
The following submissions may qualify for expedited review:
Amendments for Currently Registered Products
New Products – formulated with currently registered AIs that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.
Additional information on EPA’s requirements and process for submissions to be considered for expedited review is available here.
EPA also announced the availability of its new List N Tool: COVID -19 Disinfectants, a new web-based application (app) that allows smart phone users and others to access List N to identify disinfectant products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.
For several months, EPA has provided the public with List N, which currently lists 410 surface disinfectant products that meet EPA’s criteria for use against SARS-CoV-2. EPA is now making available the data from the List N webpage on a browser-based web app that allows users to identify the disinfectant products best suited for their needs. Users can search by use site (e.g., home, business, health care, etc.), surface type (e.g., hard, non-porous surfaces like countertops; porous surfaces like fabrics), contact time (i.e., the time the product needs to be visibly wet), EPA registration number, AI(s), or product name.
U.S. District Court Issues Temporary Restraining Order for Silver Products Fraudulently Promoted as a Treatment for COVID-19
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.
EPA Approves Experimental Use Permit for Field Testing of Genetically Modified Aedes aegypti Mosquitoes
On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases including Zika virus. The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring and sampling of the resultant mosquito populations. These field tests will proceed only after state and local approval, and they are intended as a first step toward potential wider use of genetically modified mosquitoes in the U.S.
Oxitec’s field tests will be conducted, if approved by state and local authorities, over a two-year period in Monroe County, Florida, beginning in summer 2020, and in Harris County, Texas, beginning in 2021. During these field tests, Oxitec will release into the environment male mosquitoes that have been genetically modified to carry a protein that will inhibit the survival of female offspring. After males carrying this protein mate with wild female mosquitoes, it is anticipated that only the male offspring will survive to become fully functional adults and that these male offspring will retain the same genetic modification. This should provide multi-generational effectiveness in reducing the number of adult females in Aedes aegypti mosquito populations in the release areas.
Female mosquitoes are the ones who bite humans and that serve as the vector for blood-borne illnesses. Since only male mosquitoes will be released into the environment and their female offspring are not expected to survive, EPA does not believe they will pose a health risk to the human population. EPA anticipates that these modified mosquitoes could be an effective tool in combatting the spread of certain diseases like the Zika virus in light of the growing resistance of mosquito populations to current insecticides. It is also anticipated that there will be no adverse effects to animals such as bats and fish who consume the genetically modified mosquitoes.
Oxitec is required to monitor and sample the mosquito population weekly in the treatment areas to determine how well the product works for mosquito control and to confirm that the modified genetic traits disappear from the male Aedes aegypti mosquito population over time. EPA has also maintained the right to cancel the EUP at any point during the 24-month period if unforeseen outcomes occur.
EPA’s decision and the approved permit are available here.
On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the three-phased approach, based on the advice of public health experts, to help state and local officials when reopening its economies, getting people back to work, and continuing to protect American lives.
The comprehensive plan was developed in consultation with EPA’s expertise on the safe and effective use of disinfectants against the SARS-CoV-2, the virus that causes COVID-19. The guidance offers a three-step process for preparing spaces for reopening:
EPA states that cleaning and disinfecting surfaces is an important, two-step process essential to any effort to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
EPA has compiled a list of disinfectants for use against SARS-CoV-2, List N: Disinfectants for Use Against SARS-CoV-2, which include ready-to-use sprays, concentrates, and wipes. EPA emphasizes to follow the product label instructions and safety information, including leaving the product on the surface long enough to kill germs, rinsing off the product to avoid ingesting it, and putting the product out of reach of children right away.
EPA also states that it is important to avoid over-using or stockpiling disinfectants or personal protective equipment, which can result in shortages of critical products needed for emergencies. In the event that disinfectant products on the EPA list are not available, the guidance provides other techniques for disinfecting surfaces that are as effective in reducing the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
EPA’s guidance documents are available here.
EPA and CBP Announce the Prevention of Shipments of Unregistered “Virus Shut Out” Product Imported into California
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.
On April 23, 2020, the Supreme Court ruled that pollution traveling indirectly to rivers and streams through groundwater can be covered by the Clean Water Act’s (CWA) permitting requirements. The case, County of Maui, Hawaii v. Hawaii Wildlife Fund, et al, 590 U.S. (2020), concerned whether pollutants discharged from a point source into groundwater, a non-point source, and then conveyed into navigable waters fall within permitting requirements of the CWA. In a 6-3 Opinion delivered by Justice Breyer, the Court held that the CWA “requires a permit when there is a direct discharge from a point source into navigable waters or when there is the functional equivalent of a direct discharge.” Slip op. at 15.
Under the CWA, a point source is a discernable conveyance such as a pipeline and other conduit, including wells (the Court notes that wells ordinarily result in discharge of pollutants through groundwater). Slip op. at 13. The case at issue concerned the County of Maui’s (Maui) operation of a wastewater reclamation facility that collected and partially treated sewage before pumping the treated water into four underground injection wells. From the wells, the treated water traveled half a mile through groundwater into the Pacific Ocean, a navigable water. Maui had not obtained a permit for the discharge, and in 2012, several environmental groups brought a citizens’ CWA lawsuit against the county.
The legal question of whether the CWA’s permitting program covers pollution that travels from a point source, like a factory discharge pipe or a containment pond, through groundwater before reaching a downstream water has major implications for industries ranging from agriculture to oil and gas. The Court’s “functional equivalent” standard for the reach of federal regulation is an interpretation that is narrower than the one sought by environmentalists and endorsed by the Ninth U.S. Circuit Court of Appeals, but the Court declined to defer to the U.S. Environmental Protection Agency’s (EPA) 2019 Interpretative Statement. 84 Fed. Reg. 16810, 16824 (April 2019).
EPA’s Interpretive Statement supported the argument of Maui and the U.S. Solicitor General that if any non-point source lies between the point source and the navigable water, a permit is not required for the release. Groundwater and non-point pollution that is generated, for instance, by rainwater runoff is not covered by the CWA and is regulated by the states. The Court rejected this interpretation, posing the question: “If that is the correct interpretation of the statute, then why could not the pipe’s owner, seeking to avoid the permit requirement, simply move the pipe back, perhaps only a few yards, so that the pollution must travel through at least some groundwater before reaching the sea?” Slip op. at 10. The Court held that “to follow EPA’s reading would open a loophole allowing easy evasion of the statutory provision’s basic purposes. Such an interpretation is neither persuasive nor reasonable.” Slip op. at 12.
The Court did not adopt the “fairly traceable” standard supported by the environmental groups and the Ninth Circuit either, as its scope would be too broad, and would interfere too seriously with states’ traditional and intended regulatory authority over groundwater and non-source pollution. Slip op. at 7-8.
The “functional equivalent of a direct discharge” standard will require a permit for discharge from any point source directly into navigable waters, and from point sources when the discharge “reaches the same result through roughly similar means.” The Court identified seven factors that may be relevant in determining whether the discharge comes “from” a point source:
The Court notes that time and distance will be important factors in many (though potentially not all) cases. For example, a distance of a few feet is concretely within the scope of the permitting requirement; a distance of 50 miles that may take a year for the water and perhaps mixing with other materials before reaching the navigable water is indeterminate.
The Court stated that the “functional equivalent” standard will essentially maintain EPA’s longstanding interpretation of the 1972 water law’s requirements prior to the 2019 Interpretive Statement that sought to narrow its reach. The Court further acknowledges that the new standard may expand the scope of the CWA as it applies to wells and septic systems, but does not expect an “unmanageable expansion” of the permitting program, and expects that EPA and the states will mitigate harms and initiate a best practices permitting policy, and that judges will exercise discretion mindful of the complexities of indirect discharges. Slip op. at 18.
The decision of the Supreme Court to construe National Pollutant Discharge Elimination System permitting requirements to extend to indirect discharges that originate at a point source but travel through groundwater before reaching navigable waters was not particularly surprising. Reviewing courts have generally been mindful that completely excluding all discharges to groundwater from permitting might encourage dischargers to use discharges to groundwater to evade otherwise applicable control requirements. Nonetheless, it was somewhat surprising when the Court created a new “functional equivalence” standard that was not specifically advocated by the litigants.
Although the Court clearly intended to adopt a construction that was less expansive than the “fairly traceable” standard adopted by the Ninth Circuit, EPA and the states will have to determine how the seven potentially relevant factors identified by the Court will be utilized in determining when a permit will be required for indirect discharges. EPA and the states will also have discretion to determine whether there are other “potentially relevant factors applicable to factually different cases” as anticipated by the Court. Slip op. at 16. This case involved deliberate discharges of municipal wastewater to underground injection wells, but future policy disputes and litigation are likely to focus on indirect discharges that are more inadvertent in character. Activities of particular interest include indirect discharges from agriculture, and indirect discharges from impoundments that have been used to collect coal ash, mining tailings, and other types of industrial waste.
In the absence of Congressional intervention to codify clearly what is required, the courts can only do so much. The Supreme Court has concluded that Congress could not have intended to create a loophole in the water permitting scheme so large as to encourage deliberate evasion, but it falls now to EPA and the states to determine what sort of indirect discharges are “functionally equivalent” to a direct discharge. Although the Court has afforded considerable latitude to permitting agencies in deciding how to effectuate the new standard, the decision will most likely lead to a new round of contentious litigation before a policy for permitting of indirect discharges can ultimately be adopted.
On April 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Wheeler has requested that the Science Advisory Board (SAB) provide feedback on research needs concerning SARS-CoV-2 (the virus that causes COVID-19). This research is intended to help EPA understand and mitigate the environmental and human health impacts from COVID-19, and identifies EPA research that is already underway as well as new EPA research that has been proposed. EPA issued detailed charge questions for consideration by the SAB on April 21, 2020. EPA has requested that any comments on the charge questions be submitted by April 26, 2020. The SAB will host a public teleconference and audio webcast of the presentation by EPA and the review by SAB on April 30, 2020, from 1:00 P.M. – 5:00 P.M. Eastern Daylight Time.
Some of the research to be reviewed will be funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. The research includes an evaluation of the efficacy of available disinfectants in killing the COVID-19 virus on different types of those surfaces that may be frequently touched by multiple people, such as in subway cars, door handles, railings. Areas of particular interest include the efficacy of disinfection methods in controlling the virus on porous materials and soft surfaces, and the efficacy of products that claim to offer residual or long-term control of the virus. EPA will collaborate with the Centers for Disease Control and Prevention (CDC) on research to evaluate the use of ultraviolet (UV) light, ozone, and steam as solutions for large-scale disinfection. EPA and CDC will also evaluate whether electrostatic sprayers and foggers used with List N EPA-approved disinfectants are efficacious in killing the virus.
Although there are a number of registered disinfectant products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, that offer antiviral activity against COVID-19, research to identify and to recommend scalable technologies for disinfection of the COVID-19 virus on environmental surfaces is a critical part of a strategy for reducing infection rates in the ongoing pandemic. Technologies that can control the virus on porous or soft surfaces are important, as is the long-term durability of antiviral treatments and coatings on environmental surfaces. Nonetheless, while research on disinfection techniques is important, EPA also needs to consider whether there are procedural changes that would help promising antiviral agents and technologies to be brought to market more quickly.
Disinfectants that are sold with antiviral claims must be registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Although there are at present a number of promising new antiviral products in the pipeline, securing a new registration under FIFRA for an antiviral disinfectant would typically take from 18-24 months and it is uncertain how much EPA can accelerate this timetable. Despite the urgency of the current public health emergency, the only more expeditious alternative to allow distribution and sale of new antiviral products is an emergency exemption under FIFRA Section 18.
Securing an emergency exemption requires that the request be sponsored by a Federal or State agency. CDC in particular has been unwilling to submit or to sponsor any emergency exemption requests for COVID-19 because it wishes to avoid any perception that it is favoring any specific product or manufacturer. Although State agencies are likely to be more willing to request emergency exemptions, State-by-State relief is not very well suited to addressing an infection crisis of global proportions. In addition to conducting research on disinfectant products and technologies, EPA needs to consider whether the current process for obtaining emergency exemptions for antiviral agents could be modified or streamlined to reflect the urgency of the current crisis.
EPA Announces Its Continued Efforts to Provide Critical Information on Safe Disinfectant Use During COVID-19 Crisis
On April 23, 2020, the U.S. Environmental Protection Agency (EPA) announced it is continuing efforts to provide critical information on surface disinfectant products that can be used against SARS-CoV-2, which causes COVID-19. EPA states that it now has nearly 400 products that have qualified to be effective against SARS-CoV-2. EPA also published an overview of its actions and resources related to disinfection against the novel coronavirus.
EPA’s Office of Chemical Safety and Pollution Prevention’s Assistant Administrator Alexandra Dapolito Dunn stated that “EPA is dedicated to its mission of protecting human health and we want all Americans to have access to effective and approved surface disinfectant products,” and emphasized “[w]e also want everyone follow the directions on the product so that we can safely use registered disinfectants and provide critical protection to our families.”
EPA in its announcement stressed when using an EPA-registered surface disinfectant, always follow the product’s directions and:
Additional information on EPA’s disinfectant safety messages is available on EPA’s twitter feeds, @EPA and @ChemSafety. These channels will be updated with new materials throughout the COVID-19 crisis.
EPA states it is also continuing to add additional chemicals to its list of common inert ingredients. These actions are intended to help address supply chain issues for EPA-registered disinfectants and other pesticides. It allows manufacturers of already-registered EPA products to change the source of listed inert ingredients.
EPA Remarks That Requirements to Notify EPA of Certain Changes to Disinfectants During COVID-19 May Be Retained
On April 22, 2020, Assistant Administrator Alexandra Dapolito Dunn stated, on prerecorded remarks posted by the American Bar Association, that the U.S. Environmental Protection Agency (EPA), after the coronavirus crisis subsides, will review whether some of the current requirements to submit notifications or label amendments are necessary. Some of these requirements have been suspended as part of EPA’s efforts to hasten the process for disinfectants approved for use against SARS-CoV-2, which causes COVID-19.
EPA modified the requirements to submit a notification or label amendment to increase quickly the number of disinfectants available to fight the novel coronavirus that causes COVID-19. These steps include a temporary policy EPA updated on April 14, 2020, describing situations in which manufacturers producing disinfectants for use against SARS-CoV-2 can change certain ingredients or sources of those ingredients without the normal requirement to notify EPA.
On the prerecorded remarks, Assistant Administrator Dunn stated as an example, “if a baker is changing its source of flour, we don’t need to know where it’s coming from as long as it’s the same quality and the company maintains its records.” She also remarked “dropping such ‘administrative hoops’ has helped disinfectant manufacturers get their products to market without putting public health or the environment at risk.”
EPA will proceed with formal rulemaking or another process if EPA decides to modify the requirements to keep the flexibility currently used during the COVID-19 crisis.
Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.
Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies. Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.
All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space. All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music. Subscribe so you never miss an episode.