Increased Use of Disinfectants Prompts Spike in Related Calls to Poison Control Centers; President Suggests Injecting or Ingesting Bleach or Using UV Light as COVID-19 Therapeutics; EPA Advice and Major International Disinfectant Producer Roundly Condemn Suggestion

Each blog entry addressing the new coronavirus SARS-CoV-2 brings news of the ever-widening scope of the COVID-19 pandemic. According to the Johns Hopkins Virus Tracker as of this writing on April 24, 2020, worldwide cases number more than 2,766,000 cases and deaths number more than 194,000. Spread across the U.S. continues, with more than 884,000 cases and 50,000 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., with 271,000 cases and 21,000 deaths. The New York cases accounts for approximately 30% of U.S. cases and 42% of U.S. deaths.

As the awareness of the need for disinfects and their use has grown, the misuse of such products and potential poisonings from their use has spiked. The U.S. Centers for Disease Control and Prevention (“CDC”) published an article in the Morbidity and Mortality Weekly Report (MMWR) of April 20, 2020 entitled Cleaning and Disinfectant Chemical Exposures and Temporal Associations with COVID-19.

The article draws on data from Poison Control Center calls. There are fifty-five poison control centers spread across the U.S., each of which provides 24 hour a day professional advice to callers regarding exposures to poisons. The data collected from the call are uploaded to the CDC’s National Poison Data System (NPDS) on a nearly real-time basis.

The article covers the first quarter of 2020. During that period, calls concerning disinfectants increased from 12,801in the same period for 2019 to 17,392 this year, an increase of over 35%. Calls concerning cleaning products increased from 25,021 to 28,158, an increase of slightly more than 7%. The categorization of products actually falls across regulatory jurisdictional lines, as the data groups bleaches with cleaning products and hand sanitizers with disinfectants. The former products, when used as disinfectants, are actually regulated by the U.S. Environmental Protection Agency (EPA) as pesticides, while hand sanitizers are actually over-the-counter drugs regulated by the U.S. Food and Drug Administration (FDA).  

The detailed data provide some interesting insights into the nature of the exposures. In 2020 for disinfectants, over 80% of the exposure routes were ingestion. Even if most of the ingestions were by individuals under 19, that would still leave thousands of adults reporting exposure by ingestion.  This group increased by over 30% and represents the largest portion of the increase in exposures. Ingestion was also the leading route of exposure for cleaning products. The pattern is similar to disinfectants in that even if the majority of exposures of individuals under the age of twenty were by ingestion, it would still leave thousands of adults exposed through ingestion.  

The potential for misuse of these products was potentially aggravated on April 23 when President Trump, referencing the contact times for hard surface disinfectants, suggested that bleach might be either ingested or injected as a therapeutic for COVID-19. In fact, bleach is corrosive; skin or eye contact can cause severe burns. Any ingestion would cause severe mouth, throat and stomach burns. While there may not medical data, any injection would cause burns and potentially fatal systemic poisoning.

Reckitt Benckiser, a major international producer of disinfectants including Lysol®, immediately issued a statement warning against any such use of bleach. See Reckitt Benckiser Statement on Disinfectant Misuse.   To understand the severity of exposure to bleach, here is the warning statement from a typical Lysol® product containing bleach:

WARNING: Causes eye and skin irritation. Do not get in eyes, on skin or on clothing. Vapors may irritate. Use only in well-ventilated areas. Avoid prolonged breathing of vapors. Not recommended for use by persons with heart conditions or chronic respiratory problems such as asthma, emphysema or obstructive lung disease. Harmful if swallowed. For sensitive skin or prolonged use, wear rubber gloves. Wash after handling and before eating, drinking, chewing gum, using tobacco or using the toilet.

On the same day as the President’s pronouncement, EPA issued guidance on the safe use of disinfectants, including the specific advice to not apply a disinfectant to the human body nor ingest one. See EPA Guidance on Safe Disinfectant Use. In addition, numerous medical experts, including the current and immediate past Commissioners of the FDA, have immediately spoken out against such suggestions. Similar warnings have been issued by  The Clorox Company, The American Cleaning Institute, The American Chemistry Counciland the Center for Biocide Chemistries

In fact, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), such use of a registered pesticide would not be authorized by the product label, and thus would be a violation of Federal law.  Violations of FIFRA are punishable by a penalty of up to $20,288 per offense.

The President also suggested using ultraviolet (UV) light as a therapeutic. UV light is grouped into three categories, denominated as UV-A, UV-B or UV-C, the latter presenting the greatest risk to humans. UV devices designed for sterilization of medical devices and instruments are regulated by the FDFA. UV light exposure, particularly UV-C, poses significant risks.  Overexposure to UV-C light can cause adverse health effects, including acute effects such as erythema (sunburn), photo conjunctivitis and photokeratitis (arc eye). The World Health Organization issued a warning against using UV-C light to disinfect the human body.

In the face of contradictory suggestions EPA continues to combat the sales of products making fraudulent disinfectant claims asserting the ability to control the SARS-CoV-2 virus. On April 23 EPA advised eight internet retail platforms that illegal products were being sold on their platforms. The platforms notified are Facebook, eBay, Alibaba, Shopify, Qoo10, JoyBuy.com, Wish.com and banggood.com.  See EPA Notifies 8 Retail Platforms of Illegal Disinfectant Sales. EPA urges the public to report illegal products at the EPA Violation Reporting Portal  

For more information about EPA’s action addressed to SARS-CoV-2 and disinfectants used to control the virus, see EPA Information for Registrants Regarding Disinfectants for the Control of SARS-CoV-2

EPA Continues Efforts to Facilitate Greater Availability of Disinfectants Registered for Use Against Novel Coronavirus SARS-CoV-2

The new coronavirus SARS-CoV-2 continues its onslaught across the globe. According to the Johns Hopkins Virus Tracker as of this writing on April 20, 2020, worldwide cases number more than 2,424,000 cases and deaths number more than 167,000. Growth in cases and deaths continues across the U.S., with more than 762,000 cases and 40,700 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for approximately 32% of U.S. cases and 45% of deaths.

Last week the U.S. Environmental Protection Agency (EPA) announced further temporary regulatory actions to increase the availability of disinfectants labeled for the control of SARS-CoV-2 virus. These products are identified on EPA’s List N. These changes apply only to products on List N.

The new changes revise the notification process, and are reflected in EPA’s Revised Temporary Amendment to Pesticide  Registration Notice 98-10 [April 14, 2020].  Most of the changes are to the scope of changes allowed by the original PR Notice 98-10.  In addition to broadening the scope of changes allowed by notification, EPA has now waived the waiting period normally required before changes by notification can be implemented by the registrant. If the substitution meets the eligibility criteria, the product may be released for sale and distribution once EPA receives the notification.

To facilitate registrants’ ability to implement these changes, EPA has established a process for submission of such notifications through the Agency’s Central Data Exchange (CDX) portal.  See EPA CDX Portal .

  1. Substitute Sources for Commodity Active Ingredients with Similar Purity

EPA is temporarily allowing registrants of eligible pesticide disinfectant products containing the following active ingredients to substitute any source of the active ingredient, whether registered or not, to produce their registered disinfectant products:

Ethanol                        64-17-5

Hydrochloric acid       7647-01-0

Sodium Hypochlorite 7681-52-9

Hydrogen Peroxide     7722-84-1

Hypochlorous Acid     7790-92-3

Citric Acid                  77-92-9

L-lactic Acid               79-33-4

Glycolic Acid             79-14-1

The purity of substitute product from the alternate source must fall within the certified limits of the currently registered formulation. Note that this authorization overrides the statement in Chapter 2 of the Registration Manual that an unregistered source will not be considered an “identical/substantially similar” product.”

  1. Substitute Sources of Commodity Active Ingredients with Purities That Are Not Similar

EPA is also authorizing substituting commodity sources of the identified commodity active ingredients with products with a purity that differs from the original source. The nominal concentration of the active ingredient in the product may not change; in order to achieve the same certified limits, adjustments in inert ingredient concentrations are limited to water only. Self-certification is allowed, and confirmatory efficacy data are not required.

2. Substitute Sources of Similar Registered Non-Commodity Active Ingredients

As has been the standard process, a registrant may substitute similar registered sources of active ingredients.

3. Substitute Sources of Registered Non-Commodity Active Ingredients That Are Not Similar

EPA is also authorizing substituting registered sources of non-commodity active ingredients with alternate sources with a purity that differs from the original source. The nominal concentration of the active ingredient in the product must not change; in order to achieve the same certified limits, adjustment in inert ingredient concentrations are limited to water only. Self-certification is allowed, and confirmatory efficacy data are not required.

4. Substituting Similar Inert Ingredients

Under existing arrangements, the Confidential Statement of Formula must identify the source of non-commodity inert ingredients, and registrants can substitute a similar inert ingredient source via notification. Composition information from the individual inert supplier must be provided to EPA. For commodity inert ingredients no notification is required, and a substitution may be made at any time. For the identification of commodity inert ingredients see EPA List of Commodity Inert Ingredients

5. Adding New Registered Pesticide Producing Establishments

Registrants with formulations that have a registered source of active ingredient may add already-registered producing establishments. This change is in addition to EPA’s already announced policy of expediting the registration of new producing establishments for disinfectants that fall within the designated list.

Other Measures

EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but despite the measures described above, the expedited service is available only for products that already have approved claims for other emerging pathogens. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2. Registrants who wish to add claims for emerging pathogens for the first time still must go through the standard amendment process.

 

 

EPA Announces Enforcement Efforts Addressing Fraudulent SARS-CoV-2 Disinfectant Claims

Each blog entry addressing the new coronavirus SARS-CoV-2 reflects the continuing onslaught of the pandemic. According to the Johns Hopkins Virus Tracker as of this writing on April 11, 2020, worldwide cases number more than 1,760,000 cases and deaths number more than 107,000. Spread across the U.S. continues, with more than 519,000 cases and 20,000 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for a significant portion of each.

The U.S. Environmental Protection Agency (EPA”) has recently announced actions to prevent the sales of products making fraudulent disinfectant claims asserting the ability to control the SARS-CoV-2 virus. In the U.S., disinfectants are regulated as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”). Each individual product must be registered with EPA as well as every state in which it is offered for sale. A violation of FIFRA, such as selling an unregistered disinfectant, carries a penalty of up to $20,288 for each offense.

EPA actions include educational efforts with major retailers and retail trade associations, as well as enforcement actions directed at specific products for which fraudulent claims are being made. EPA is coordinating with major online retailers to assist them in identifying unlawful products. Amazon has stated that it has removed from its listings more than 6 million products making illegal claims and has created algorithms to screen listings for such products.

While urging the public to report illegal products, EPA does not reveal any information regarding pending investigations or enforcement actions. Only when a matter is resolved does information become public. Nonetheless EPA has identified four products and their associated claims as examples of unlawful claims and presumably the subject of enforcement actions. They are:

  • Lanyards that claim to protect wearers from coronavirus
  • Unregistered disinfectant tablets
    • “Epidemic prevention Chlorinating Tablets Disinfectant Chlorine Tablets Swimming Pool Instant Disinfection Tablets Chlorine Dioxide Effervescent Tablet Chlorine Disinfectant 100g Cozy apposite Fun Suit”
    • “The Flu Virus Buster, CLO2 Disinfection Sticker, Removable sterilize air purifier, Anti COVID-19, Stop Coronavirus disease infection /Influenza Buster Disinfectant 1 Box / 10 Tablets”
  • Unregistered disinfectant sprays
    • “Fullerene silver antibacterial solution/24 Hour Defense Hand Sanitizer Disinfectant Spray Against Corona Virus COVID- 19 Kills 99.99% Of Germs Bacteria 24 Hours of Lasting Protection Alcohol Free 50ml (1.7 fl. oz)”
  • Unregistered disinfectant wipes
    • “99.9% Sterilization Wipes/16/32/48/64/96pcs Sterilization Rate of 99% Disinfection Wet Wipes and Paper Napkin Prevention of Coronavirus”

For more information about EPA’s action addressed to SARS-CoV-2 and disinfectants used to control the virus, see EPA Information for Registrants Regarding Disinfectants for the Control of SARS-CoV-2

EPA Broadens Efforts to Increase Availability of Disinfectants Registered for Use Against Novel Coronavirus SARS-CoV-2

Each blog entry addressing the new coronavirus SARS-CoV-2 reflects the continuing onslaught across the globe. According to theJohns Hopkins Virus Tracker as of this writing on April 5, 2020, worldwide cases number more than 1,260,000 cases and deaths number more than 68,000. Rapid spread across the U.S. continues, with more than 331,000 cases and 9,400 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for a significant portion of each.

In response to enormous public demand and supply chain problems being encountered by disinfectant registrants, the U. S. Environmental Protection Agency (EPA) has now taken the following additional steps:

EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but despite the measures described above the expedited service is only for products that already have approved claims for other emerging pathogens. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2. Registrants who wish to add claims for emerging pathogens for the first time still must go through the standard amendment process.

EPA Responds to Coronavirus; Reminds Registrants of Ability to Add Coronavirus to Disinfectant Product Target Pests on Expedited Basis

In response to the spreading coronavirus epidemic, the U.S. Environmental Protection Agency (“EPA”) issued a reminder to the registrant community that an expedited process is available to add the 2019-nCoV coronavirus as a target pest on appropriate hard surface disinfectant products.

 

Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) pesticide products may be used only for the control of pests identified on the product label. On August 19, 2016 EPA issued a guidance document entitled Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels.  (“Guidance”). The Guidance outlines a two-stage process for disinfectant registrants to position themselves so that emerging viral pathogens can be identified as target pests without having to pursue a formal label amendment or supply efficacy data on the specific emerging pathogen.  EPA has now announced that the process is available to add the 2019-nCoV virus as a target pest.

 

In order to take advantage of this option, a disinfectant registrant must have first pursued a formal amendment adding a specific emerging pathogen to its label. Once so positioned, the registrant may communicate through off-label channels that the product may be used for a similar, previously unidentified emerging pathogen. Coronaviruses are enveloped viruses, which are among the more easily viruses controlled on hard surfaces. To utilize this mechanism in this instance registrants must have previously added a different enveloped virus to the label.

 

To qualify for being promoted for a new emerging pathogen, the organism must either be appearing in a human or animal population for the first time or be rapidly increasing in scale or geographic range. EPA requires that the U.S. Centers for Disease Control (“CDC”) must have so identified the organism in question, and that the virus presents a survival risk on hard surfaces. CDC has done so for 2019-nCoV. See Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV)

 

Once qualified, registrants are allowed to communicate to target users the ability to employ their disinfectants for the control of 2019-nCoV. These off-label mechanisms can include technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, as well as consumer information sources, social media and websites under the control of the registrant. The Guidance prescribes statements that may be used to convey the availability of the product for emerging pathogen control. The availability of the product for control of the emerging virus may not be added to the product label without a formal amendment.