By Lynn L. Bergeson and Carla N. Hutton
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.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
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.
By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson
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.
List N, EPA’s list of registered disinfectant products is available here. EPA’s Frequently Asked Questions about List N is available here.
By Lisa R. Burchi and Barbara A. Christianson
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:
- Vital Silver;
- Quinessence Aromatherapy Ltd.;
- GuruNanda, LLC;
- Vivify Holistic Clinic;
- Herbal Amy LLC; and
- The Jim Bakker Show.
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.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
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:
- A subject line that clearly indicates “Emerging Viral Pathogen Claim for SARS-CoV-2”;
- A request to make emerging viral pathogen claims;
- A description of how the product meets the eligibility criteria for use against one or more categories of viral pathogens consistent with the guidance;
- The identification of the virus(es) from the product label that the registrant is using to support the emerging viral pathogen claims and the study ID number (MRID) that supports the claim;
- Note: EPA recommends using the minimum number of supporting viruses needed for the emerging pathogen claim in order to expedite EPA’s review
- An up-to-date matrix (Form 8570-35); and
- A request to add the Terms of Registration outlined in Attachment I of the Emerging Viral Pathogens Guidance.
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.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced 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. Products on EPA’s “List N: Disinfectants for Use Against SARS-CoV-2” are registered disinfectants qualified for use against SARS-CoV-2 approved through EPA’s Emerging Viral Pathogen Program (Program). Currently there are 85 products listed that are qualified for use against SARS-CoV-2. Of note, EPA states that if the directions for use for viruses/virucidal activity of the listed products provide different contact times or dilutions, the longest contact time or most concentrated solution should be used.
EPA issued guidance for the Program in 2016; the guidance was intended to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens. In the event of an outbreak, companies with pre-approved products can make off-label claims (e.g., technical literature distributed exclusively to healthcare facilities, physicians, nurses, and public health officials; 1-800 consumer information services; company websites (non-label related); social media) for use against the outbreak virus. These emerging pathogen statements will not appear on marketed (final print) product labels. Additional information on EPA’s activation of its Emerging Viral Pathogen Program is available on our blog.
- Ensure that the product has a previously approved emerging viral pathogen claim.
- Provide the product name and EPA Registration number.
It is important to note that in releasing today’s list of products, EPA states in red bold font: “Note: There may be additional disinfectants that meet the criteria for use against SARS-CoV-2. EPA will update this list with additional products as needed.”
In addition, EPA has updated other lists of antimicrobial products registered with EPA for claims against common pathogens:
- List B: EPA Registered Tuberculocide Products Effective Against Mycobacterium tuberculosis;
- List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 Virus;
- List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus;
- List E: EPA’s Registered Antimicrobial Products Effective Against Mycobacterium tuberculosis Human HIV-1 and Hepatitis B Virus;
- List F: EPA’s Registered Antimicrobial Products Effective Against Hepatitis C Virus;
- List G: EPA’s Registered Antimicrobial Products Effective Against Norovirus;
- List H: EPA’s Registered Antimicrobial Products Effective Against Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococcus faecalis or faecium (VRE);
- List K: EPA’s Registered Antimicrobial Products Effective Against Clostridium Difficile Spores; and
- List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants.
Additional information on EPA’s List of Antimicrobial Products Registered with EPA for Claims Against Common Pathogens is available here.
By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson
On January 29, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has activated its Emerging Viral Pathogen Guidance for Antimicrobial Pesticides (Guidance) in response to the discovery of the novel coronavirus (2019-nCoV). According to the World Health Organization (WHO), coronaviruses cause numerous illnesses, from the common cold to Severe Acute Respiratory Syndrome (SARS). First identified in Wuhan, China, the 2019-nCoV coronavirus is a new strain that had not been previously seen in humans.
EPA developed its Guidance in 2016 to address emerging pathogens. Under this Guidance, EPA provides pesticide registrants with a voluntary “two-stage process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label.” These pathogens may not be identified on a label because the occurrence of emerging viral pathogens is less common and predictable than established pathogens and because the pathogens are often unavailable commercially and standard methods for laboratory testing may not exist. EPA’s intent is for the Guidance to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens associated with certain human or animal disease outbreaks. Registrants with a pre-qualified emerging viral pathogen designation can include an efficacy statement in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites. Additional information on the Guidance is available here and here.
EPA will likely work closely with registrants as they take steps to use these procedures to make claims related to coronavirus. EPA notes that coronaviruses are enveloped viruses, meaning they are one of the easiest to kill with the appropriate disinfectant product, and thus using such products could help to limit the spread of these viruses. Registrants that do not meet the criteria set forth in this Guidance yet make claims related to the coronavirus could face enforcement action for selling or distributing misbranded pesticides. EPA states that it is working closely with the Centers for Disease Control and Prevention (CDC) to identify and address 2019-nCoV in a timely manner and will continue to monitor developments closely.
Information on the coronavirus is available on CDC’s website.
by James V. Aidala
The threat of the Zika Virus grows every day, and the need for clear information is especially pressing if you are pregnant. How do you prevent getting infected with the Zika Virus, and what insect repellents are best? The first question is easy to answer: public health experts agree that women who are pregnant or who might be pregnant should use insect repellents. The answer to the second question is not so simple.
I am a former senior official at the U.S. Environmental Protection Agency (EPA), and familiar with how the U.S. evaluates and approves pesticides, which include insect repellents. It is not easy for the average consumer to know what works and what does not work. Unfortunately, EPA policies have made this question much more complicated, having made important distinctions between some “natural”-type repellents and other products available in the marketplace.
Years ago, EPA de-regulated a number of natural, non-toxic materials from being subject to the registration requirements of the federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act). This made sense at the time since garlic, pepper, rotten eggs, vinegar, and other common chemicals are sometimes used as pesticides. Before de-regulation, these products were also subject to the same requirements as synthetic chemical pesticides with long unpronounceable names (e.g., diethyltoluamide, better known as DEET) which EPA requires to have volumes of efficacy and safety test data. Being natural does not mean a substance is non-toxic; some natural ingredients are fully evaluated and widely used. But in the interest of efficient use of resources EPA issued a list of products that could be sold as pesticides, but would not be subject to EPA data requirements and review (EPA calls them “minimum risk pesticides”).
This list of pesticides which are not subject to EPA evaluation, and which are not required to have data which proves they are effective, includes a number of botanical ingredients, such as oil of citronella, geranium, rosemary, peppermint, and many others. Many of these products can be used as pesticides -- some may work better than others -- and many work for the intended use (example: rotten eggs, or as EPA refers to them -- “putrescent whole egg solids” -- are used as a deer repellent).
Many of these ingredients have been marketed as “natural” insect repellents, and labeled as “safe” or “non-toxic” using words that will not appear on products where EPA reviews and approves the instructions on the product label.
Here is the bureaucratic distinction which matters greatly to EPA, but will not be understood by consumers:
- If the repellant label includes “public health claims” -- that it repels mosquitoes that may cause a disease (like Zika Virus or West Nile Virus) -- then the product has to have data showing that it works;
- If the product just says “repels mosquitoes,” it is not required to have data that shows it is effective, and may very well be ineffective.
Few, if any, humans outside of EPA label experts realize this important distinction: if there is no health claim on the label, then it is, in effect, a situation of “buyer beware.”
What remains: EPA’s deregulation of these products means it is legal to sell products which do not work, as long as the ingredients appear on the EPA minimum risk pesticides list.
Consumer Reports (CR) recently reported in May of this year on studies conducted on repellents. Their results:
- Using a “natural” mosquito repellent, with active ingredients such as citronella or clove, lemongrass, or rosemary oils, might seem like a good idea, especially if you’re pregnant or planning to be.
- But five of the six plant-based repellents we tested…lasted one hour or less against Aedes mosquitoes, the kind that can spread Zika.
Not all repellents with the same ingredient are equally effective, and they found that some formulations of the chemical repellents also do not work for very long in their tests. Some botanical pesticides are effective and have the public health claims on the label (example: lemon eucalyptus, a botanical ingredient not on the exempt product list, and CR testing did find it to be effective).
To reduce confusion about what works, EPA for years has struggled to correct the situation by trying to impose changes to the requirements for insect repellents.
Unfortunately, to end the confusion about the difference between “repels mosquitoes” and “repels mosquitoes that can cause the Zika Virus,” EPA has to conduct a rulemaking which requires a long and bureaucratic process to complete. The good news is that EPA is working on such a solution. The bad news is that they have been working on it for almost ten years and they still have more work to do. There are details and petitions and proposals and reasons why it has taken so long, but it is the kind of story that gives bureaucracy a bad name.
With the onset and fears about the Zika Virus, however, EPA should make the needed changes immediately to ensure that consumers are not misled into using products which are not proven effective in repelling mosquitoes.
From a consumer’s point of view, it really is that simple. Legally, it is more complicated. In the meantime, EPA should be loud and clear in its communication about the distinction, even if they cannot take immediate action to reduce the confusion.