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.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
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.
Additional information on submission information for registrants is available at Temporary Amendment to PR Notice 98-10 and on our blog.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
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.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
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
- A request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data);
- A request to add a new unregistered source of a non-commodity active ingredient (active ingredient not listed in the May 11, 2020, Temporary Amendment to PR Notice 98-10) to a product’s Confidential Statement of Formula; and
- A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data. Confirmatory efficacy data are a reduced set of data used to support certain changes in formulation to a registered product.
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.
- A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with a registered source of active ingredient(s); and
- A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with an unregistered source of the active ingredient(s).
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.
By Lisa M. Campbell, Timothy D. Backstrom and Kelly N. Garson
On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment. The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19.
DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor Suggests LLC and GP Silver LLC. The complaint alleges that defendants began fraudulently promoting and selling various silver products in early 2020 with claims that the silver products would treat and prevent COVID-19. Some of the alleged false and misleading claims made by defendants include that having silver particles in the bloodstream would block the virus from attaching to cells, that silver would “usher” the virus out of the body, and that silver would destroy all forms of viruses and protect against COVID-19.
The U.S. Food and Drug Administration (FDA) issued a statement on the Utah case that “FDA will continue to help ensure those who place profits above the public health during the COVID-19 pandemic are stopped” and that FDA is “fully committed to working with the Department of Justice to take appropriate action against those jeopardizing the health of Americans by offering and distributing products with unproven claims to prevent or treat COVID-19.”
The enforcement action will be prosecuted in a coordinated action by the U.S. Attorney’s Office for the District of Utah and the DOJ Civil Division Consumer Protection Branch, with the assistance of the FDA’s Office of Criminal Investigations and Office of the Chief Counsel. In addition to the TRO, prosecutors obtained a separate court order temporarily freezing the defendants’ assets in order to preserve the court’s ability to grant effective final relief and to maintain the status quo. A hearing on the DOJ’s request for a preliminary injunction is set for May 12, 2020. If the case proceeds to trial, the government will need to prove its allegations to obtain a permanent injunction against the defendants.
In another case, DOJ announced on April 17, 2020, that the United States District Court for the Southern District of Florida issued a TRO to halt the sale of an unapproved and potentially dangerous industrial bleach product being marketed as a “miracle” treatment for COVID-19. The FDA and the U.S. Federal Trade Commission (FTC) had issued a warning letter to the defendant, Genesis II Church of Health and Healing, on April 8, 2020. According to the FDA, oral ingestion of the defendant's product called the Miracle Mineral Solution can cause nausea, vomiting, diarrhea, and severe dehydration. The FDA and the FTC have issued nearly 40 separate warning letters in 2020 to companies selling unapproved or misbranded products with claims to prevent or to treat COVID-19.
Particulate elemental silver and silver salts can be effective antimicrobial agents, and numerous products containing these active ingredients are currently registered for various antimicrobial uses. The U.S. Environmental Protection Agency, along with other federal agencies, are working to ensure that necessary reviews and approvals of legitimate products intended to address COVID 19 are as expeditious as possible. Products that need these regulatory reviews and approval, but that are marketed without them, are and will likely continue to be a current enforcement focus.
By Lisa M. Campbell, Timothy D. Backstrom and Barbara A. Christianson
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.
By Heather F. Collins, M.S. and Barbara A. Christianson
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:
- Develop a plan
- Determine what needs to be cleaned;
- Determine how areas will be disinfected; and
- Consider the resources and equipment needed.
- Implement the plan
- Clean visibly dirty surfaces with soap and water;
- Use the appropriate cleaning or disinfectant product; and
- Always follow the directions on the label.
- Maintain and revise the plan
- Continue routine cleaning and disinfection;
- Maintain safe practices; and
- Continue practices that reduce the potential for exposure.
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.
- Clean: Use soap and water to remove germs, dirt, and impurities from surfaces. It lowers the risk of spreading infection.
- Disinfect: Use disinfectant products to kill germs on surfaces. By killing germs on a surface after cleaning, it can further lower the risk of spreading infection.
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.
By Kelly N. Garson and Barbara A. Christianson
On April 24, 2020, the U.S. Environmental Protection Agency (EPA) and U.S. Customs and Border Protection (CBP) announced that the agencies prevented a significant number of shipments of illegal health products from entering the Los Angeles International Airport (LAX) and the San Francisco International Airport (SFO).
The products at issue were not registered with EPA, including Virus Shut Out products. EPA previously announced on March 25, 2020, that EPA and CBP had prevented several shipments of Virus Shut Out from entering U.S. Pacific Ports. The announcement noted that because the product is not registered, EPA had not evaluated its safety and efficacy against viruses. Additionally, its label does not contain directions for its use in English as required by law, and on-line advertisements for the product contain misleading claims about its safety and effectiveness. The Department of Justice charged a Georgia resident with federal criminal charges relating to the illegal importation, sales, and distribution of Virus Shut Out, or Toamit Virus Shutout, on April 9, 2020, discussed in our earlier blog item.
Following the shipment denial on March 25th, EPA notified Amazon, and Amazon removed the product from its marketplace. EPA has been in communication with several retailers to ensure that these products are removed from their online marketplaces and asking for monitoring for products with illegal pesticidal claims.
In an effort to curb illegal pesticide products during the pandemic crisis, EPA has been working with CBP to identify and seize illegal products imported from Japan and Hong Kong through International Mail Facilities (IMF) in Los Angeles and San Francisco, and CBP has as a result of this effort seized a large number of products.
EPA Administrator Andrew Wheeler states “EPA is increasing the number of approved disinfectants on the market while taking action to prevent dishonest actors from selling fraudulent and illegal items that do nothing to protect Americans from the coronavirus.” This has included EPA’s expedited review of submissions for companies to add Emerging Viral Pathogen claims to registered surface disinfectants.
EPA has released an expanded list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the novel coronavirus that causes COVID-19. List N contains nearly 400 products that have qualified to be effective against SARS-CoV-2.
Additional information on EPA’s efforts to discover and protect against fraudulent products is available on our blog.
By Timothy D. Backstrom, James V. Aidala, and Kelly N. Garson
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:
(1) transit time, (2) distance traveled, (3) the nature of the material through which the pollutant travels, (4) the extent to which the pollutant is diluted or chemically changed as it travels, (5) the amount of pollutant entering the navigable waters relative to the amount of the pollutant that leaves the point source, (6) the manner by or area in which the pollutant enters the navigable waters, (7) the degree to which the pollution (at that point) has maintained its specific identity. Slip op. at 16.
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.
By Lisa M. Campbell and Timothy D. Backstrom
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.