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On March 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a Press Release to clarify its Temporary Policy released on March 26, 2020, regarding EPA’s enforcement of environmental legal obligations during the COVID-19 pandemic. A discussion of the Temporary Policy is available on our blog.
The impetus for the Press Release was based, according to EPA, on the “reckless propaganda” by certain news outlets that provided erroneous or exaggerated information about the Temporary Policy, particularly that the Temporary Policy is providing a blanket waiver of environmental requirements or is creating a presumption that the COVID-19 pandemic is the cause of noncompliance.
EPA’s Press Release outlines certain elements of the Temporary Policy that should not be overlooked:
EPA notes that it expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible, once the COVID-19 threat is over. EPA states that it plans to lift the measures of the Temporary Policy as soon as normal operations can resume, which may occur sooner in some locations than others.
EPA Announces Additional Action to Assure Availability of Disinfectant Products for Use Against the Novel Coronavirus
On March 31, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA. This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). EPA announced on March 26, 2020, similar action on certain inert ingredients.
EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient. Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA. Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change). EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.
The eligible active ingredients are:
EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary. EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.
After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.
EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:
Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.
EPA to Schedule FIFRA SAP Meeting on New Approaches to Human Health Risk Assessment for Organophosphates
In September 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) plans to convene a Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting to discuss New Approach Methodologies (NAM) for organophosphate (OP) pesticides. EPA states that these NAMs could reduce reliance on default uncertainty factors for human health risk assessment and also reduce animal testing.
Under Administrator Wheeler’s directive to prioritize efforts to reduce animal testing, EPA is developing NAMs based on in vitro techniques and computational approaches that will also provide the opportunity to incorporate information relevant to humans. OPP states that it is evaluating use of “in vitro data for 16 organophosphate compounds to reduce potentially reliance on default risk assessment uncertainty factors in favor of more refined data-derived factors.” Human health risk assessment for OP pesticides has recently been focused primarily on potential developmental neurotoxicity, and the Office of Research and Development (ORD) has been working to develop a NAM to evaluate developmental neurotoxicity. Initial analyses of data derived from neuron cell models have been completed for specific OP pesticides as a case study and, when possible, compared to in vivo results (an in vitro to in vivo extrapolation).
This case study of a NAM for developmental neurotoxicity using OP pesticides will be presented to the FIFRA SAP at the September meeting for its consideration and advice. EPA will request external review and public comment on this research before implementing NAMs in human health risk assessments. Additional details, including dates, times and agenda, will be forthcoming at www.epa.gov/sap.
EPA has for some time had a general policy that it will try to develop and to implement alternatives to in vivo animal testing. These alternatives to animal testing are typically based on new in vitro assays and modeling methodologies. It is interesting that OPP has selected an in vitro NAM to assess developmental neurotoxicity of OP pesticides as a case study, given the controversy surrounding EPA’s use of the default Food Quality Protection Act (FQPA) uncertainty factor for all OP pesticides, which was based primarily on epidemiology data that EPA claimed may suggest a link between chlorpyrifos exposure and developmental neurotoxicity. Prior to this determination, human health risk assessment for OP pesticides was generally based on expert judgments by EPA that neurotoxicity would not be expected below the established threshold for acetylcholinesterase (AChE) inhibition, and that infants and children are not likely to be more sensitive to neurotoxic effects than adults. OPP adopted the FQPA determination for all OP pesticides even though it could not determine or propose a mechanism for the presumed developmental neurotoxicity of chlorpyrifos below the threshold for AChE inhibition, or evaluate whether other OP pesticides might share a similar mechanism. Since the 2015 release of the Literature Review, additional epidemiology studies have become available and a number of concerns regarding the reliability of the epidemiology data have been raised. EPA has also expressed concerns with the availability and reliability of the epidemiology studies. These developments bring into question the accuracy and reliability of the Literature Review.
In its announcement, OPP states that the new NAM is intended “to reduce potentially reliance on default risk assessment uncertainty factors,” although it does not state which uncertainty factors may be supplanted or modified. Standard uncertainty factors which may be implicated include the factor for extrapolating from animal data to human effects (“interspecies variation”), the factor for human variability (“intraspecies variation”), and the default uncertainty factor for potential increased sensitivity of infants and children (“FQPA uncertainty factor”). The issues may spark additional controversy. Additionally, even if OPP and the FIFRA SAP conclude that the proposed NAM for developmental neurotoxicity is a viable approach to human health risk assessment for OP pesticides, there are likely to be many related policy issues. For example, it is unclear whether OPP would be sufficiently confident in the reliability of such an assay to propose cancellation or suspension of affected pesticide products based on a resultant human health risk assessment.
The U.S. Environmental Protection Agency (EPA) announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak. The policy addresses different categories of noncompliance differently. For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.” The policy describes the steps that regulated facilities should take to qualify for enforcement discretion. To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic.
EPA notes that its policy does not provide leniency for intentional criminal violations of law and that it does not apply to activities that are carried out under Superfund and Resource Conservation and Recovery Act (RCRA) Corrective Action enforcement instruments. EPA states that it will address these matters in separate communications. The policy states that it does not apply to imports. According to the policy, EPA is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts.” EPA “expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”
The policy will apply retroactively beginning on March 13, 2020. EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary. To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy.
EPA Announces Continued Efforts to Help Increase Availability of Disinfectant Products for Use Against COVID-19
On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is allowing flexibility to manufacturers of disinfectants and other pesticides to increase the availability of products for use against SARS-CoV-2, the coronavirus that causes COVID-19. EPA announced that it is allowing manufacturers to obtain certain inert ingredients from different suppliers without EPA approval after manufacturers voiced concern with EPA about challenges they face obtaining inert ingredients with the disruption of the supply chain.
EPA stated it is allowing applicants submitting registrations or registration amendments to obtain commodity inert ingredients, approximately 280 total as of today, from various sources without having to provide the supplier name and address on its Confidential Statement of Formula (CSF). EPA, however, notes that only ingredients designated as commodity inert ingredients on its list will be eligible for this reduced CSF reporting.
EPA also announced it is continuing to expedite review of submissions from applicants requesting to add emerging viral pathogen claims to existing registered disinfectant labels. Claims currently are being approved within 14 days, as resources allow, compared to the typical 90-day review. EPA has added 70 new surface disinfectants to its List N: Disinfectants for Use Against SARS-CoV-2, which brings the total number of products listed to 351.
Additional information on EPA’s list of commodity inert ingredients is available here.
Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.
EPA Issues Revised Method for Conducting Biological Evaluations of Pesticides under the Endangered Species Act
On March 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the publication of its Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (Revised Method), a method for conducting Biological Evaluations under the Endangered Species Act (ESA).
The Revised Method will be used by EPA to evaluate potential risks from pesticides to federally listed endangered and threatened species and to make effects determinations during initial registration and as part of periodic registration review. The Revised Method allows EPA to include historical usage data that reflects where and how certain pesticides have been applied to make predictions about the future.
The Revised Method includes a three-step process to identify and evaluate the potential risk to endangered species by the assessed pesticide:
1 Although Step 2 is conducted at an individual level, consideration is given to the likelihood that an exposure and effect will occur. This step considers the proportion exposed across the landscape/watershed and the distribution of exposure among individuals.
2 This is the determination for listed species. The determination for designated critical habitats is “No Adverse Modification/Adverse Modification.”
EPA Administrator Andrew Wheeler stated: “EPA’s improved methodology will better protect and promote the recovery of endangered species while ensuring pesticide registration review decisions are conducted in a timely, transparent manner and are based on the best available science.”
EPA has also released for public comment draft Biological Evaluations for carbaryl and methomyl, which were conducted using the final Revised Method. If EPA determines a pesticide may affect a listed species or its critical habitat, it must consult with the Fish and Wildlife Service and the National Marine Fisheries Service (the Services). The Services will then issue a Biological Opinion to determine if the population of a species would be adversely impacted and, if so, propose ways to reduce risks.
Critics of the new method for doing Biological Evaluations have alleged that the purpose of the changes in this method, and of other recent revisions in ESA procedures, is to reduce the number of formal consultations that must be conducted with the Services. Such allegations must be evaluated in the context of the severe bottlenecks in the current consultation process created by the limited resources and personnel that are available at the Services to conduct any required consultations and to prepare formal Biological Opinions. The EPA method for doing Biological Evaluations has always been intended to use worst case assumptions to quickly remove from consideration those pesticides that are unlikely to pose any potential risk to endangered and threatened species, so that the limited resources available for the more extensive assessment triggered by consultation are used efficiently to address the most significant potential hazards. Worst case assumptions, however, exaggerate the “reasonable worst case” and other more realistic scenarios. Given the reality of limited review resources, focus on more uncertain risks draws resources away from attention on more certain risks to species. Eventually the assessment system is expected to include other techniques (example: use of probabilistic models) to refine the analyses to concentrate further regulatory options on the most effective ways to protect species.
On March 13, 2020, the U.S. Environmental Protection Agency (EPA) released an expanded list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19. The list contains nearly 200 additional products, including 40 new products that went through EPA’s expedited review process. While disinfectant products on this list have not been tested specifically against SARS-CoV-2, EPA expects them to be effective against SARS-CoV-2 because they have: (1) demonstrated efficacy against a harder-to-kill virus; (2) qualified for the emerging viral pathogens claim; or (3) demonstrated efficacy against another human coronavirus similar to SARS-CoV-2.
EPA Administrator Andrew Wheeler stated: “During this pandemic, it’s important that people can easily find the information they’re looking for when choosing and using a surface disinfectant. With this expanded list, EPA is making sure Americans have greater access to as many effective and approved surface disinfectant products as possible and that they have the information at their fingertips to use them effectively.”
EPA also made enhancements to the web-based list to make it more user friendly. Specifically: (1) the product list has been updated to include the product’s active ingredient and the amount of time the surface should remain wet to be effective against the given pathogen; and (2) users may now sort, search, and print the information on the table and easily view it on a mobile device.
FTC and FDA Send Warning Letters to Seven Companies about Unsupported Claims that Products Can Treat or Prevent Coronavirus
On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus.
The agencies sent the letters to the following companies:
Each of the seven companies have advertised products as able to treat or prevent COVID-19/coronavirus. The unapproved products include teas, essential oils, and colloidal silver.
According to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent the virus. FDA Commissioner Stephen M. Hahn, M.D. stated: “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one. The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses.”
The letters state that one or more of the efficacy claims made by the marketers are unsubstantiated and therefore may violate the FTC Act. The letters advise the recipients to cease immediately making all claims that their products can treat or cure coronavirus.
FTC Chair Joe Simons stated: “There already is a high level of anxiety over the potential spread of coronavirus. What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
FTC and FDA have pledged to continue to monitor social media, online marketplaces, and incoming complaints to ensure these products do not continue to make such claims. The letters sent emphasize that, if the false claims do not cease, FTC may seek a federal court injunction and an order requiring money to be refunded to consumers and instructing the recipients to notify the FTC within 48 hours of the specific actions they have taken to address FTC’s concerns.
In addition, the FTC recently issued a new consumer blog post with information about how to identify and avoid coronavirus-related scams. Coronavirus: Scammers follow the headlines notes that scammers are creating websites to sell bogus products, and using fake emails, texts, and social media posts as a ruse to take consumers’ money and obtain personal information. It then warns consumers of the “red flags” to monitor when shopping for products related to the virus.
EPA also has been active in this area, announcing the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19 and also announcing its process for expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.
As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear. The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration. According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles. According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket. The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.” Comments are now due March 30, 2020.
On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that due to the outbreak of SARS-CoV-2, the coronavirus that causes COVID-19, it is expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.
EPA states that only claims that do not require review of new efficacy data are being expedited at this time. Companies can submit these claims as non-Pesticide Registration Improvement Extension Act (PRIA 4) fast-track amendments. Registrants are asked not to include other label changes typically covered under amendments and notifications as part of the submission to add Emerging Viral Pathogen claims.
EPA requests that registrants include the following information in a letter to ensure the efficient processing of submissions:
Registrants should also submit a revised master label with a separate section for emerging viral pathogen claims that includes the generic claim statements identified in Attachment I of the Emerging Viral Pathogens guidance document.
If approved, the product will be added to List N: Disinfectants for Use Against SARS-CoV-2, during the next update to the list, which is scheduled to be updated in the next two weeks.
Additional information is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.