****!!!!****!!!!**** {Excellent precautions and instructions for sodium chlorite safety practices} Sodium chlorite solutions in contact with acids, bases, organic materials, reducing agents or chlorine donors will produce chlorine dioxide gas. Therefore, sodium chlorite solutions need to be stored away from these materials, secondary sealing systems are used to prevent splashing on these materials, clear labeling and marking, and training to adopt the correct unloading process. Special protective measures should be taken during loading and unloading to ensure that non-sodium chlorite substances are not loaded into sodium chlorite storage equipment. Precautions include clear labeling and color-distinguished connectors, connector locking of connectors connecting storage tanks, so operators or suppliers of sodium chlorite must be present during the filling process and be vigilant. Dry sodium chlorite is a strong oxidant that can easily catch fire when heated or rubbed. Special care should be taken to these containers, which are not allowed to evaporate and dry containers with sodium chlorite residues. The treatment of sodium chlorite leakage should be equally careful, and it is not allowed to use absorbent clogging or drying treatment. If sodium chlorite and sodium chlorate are dried on cloth, wood or other flammable materials, a fire may occur. There was an accident in which a small amount of sodium chlorite was contaminated by workers wearing cotton gloves for sodium chlorite, which later ignited. Sodium chlorite and sodium chlorate should be stored away from flammable materials, ppE should be used in hazardous locations where sodium chlorite is present, and workers should be trained. On the other hand, the risk of personnel being exposed to chlorine dioxide gas should be taken seriously. Chlorine dioxide should not be used in confined places where careful monitoring and control is not carried out"

****!!!!****

****!!!!****!!!!**** "In implementing this mandate, EPA is not limiting its review to new claims that product manufacturers have made directly in response to the pandemic. Rather, EPA is considering the totality"

FDA is providing recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts.

****!!!!**** "Notice to permanently exempt or proposing to permanently exempt certain class I and class II medical devices from the premarket notification requirement in section 510(k) of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360(k). Under this notice, the Department is immediately making permanent the exemption of 7 class I device classes from the section 510(k) requirement and proposes to exempt an additional 84 class II and unclassified device classes from the same requirement on a permanent basis. These 91 devices were all subject a 510(k) waiving during the PHE."

2020

Jan 2021

{Includes recommendations for disinfection of transportation vehicles} "surface of environment objects can be wiped, sprayed or soaked with chlorine-containing disinfectants, chlorine dioxide and other disinfectants... Indoor air can be disinfected by peroxyacetic acid, chlorine dioxide, hydrogen peroxide and other disinfectants by spraying." "Floor and Wall--Visible pollutants should be completely removed before disinfection while invisible pollutants can be wiped or sprayed with 1,000 mg/L chlorine-containing disinfectant or 500 mg/L chlorine dioxide disinfectant. " "For invisible pollutants, spraying, wiping or soaking with 1,000 mg/L chlorine-containing disinfectant or 500 mg/L chlorine dioxide disinfectant for 30 minutes are recommended."

{Includes extensive recommendations for use of chlorine dioxide disinfectant.} {Note: 1,000 ppm is for "a chlorine releasing agent's" recommended concentration--NOT chlorine dioxide's (which varies per manufacturer instructions}

2020 April

****** "A product should be approved by EPA to inactivate at least one large or one small non-enveloped virus to be eligible for use against an enveloped emerging viral pathogen." "viral families in the ***small non-enveloped subgroup: (1) Picornaviridae, (2) Parvoviridae, (3) Caliciviridae, (4) Astroviridae, and (5) Polyomaviridae.... ***large non-enveloped subgroup: (1) Adenoviridae, (2) Reoviridae, and (3) Papillomaviridae... ***enveloped subgroup: (1) Arenaviridae, (2)Bornaviridae, (3) Bunyaviridae, (4) Coronaviridae, (5) Filoviridae, (6) Flaviviridae, (7) Hepadnaviridae, (8) Herpesviridae, (9) Orthomyxoviridae, (10) Paramyxoviridae, (11) Poxviridae, (12) Retroviridae, (13) Rhabdoviridae, and (14) Togaviriedae."

There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

***Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, many scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, the user must follow all applicable label instructions on EPA-registered products. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.

Ensure that the detergents or enzymatic cleaners selected are compatible with the metals and other materials used in medical instruments. Ensure that the rinse step is adequate for removing cleaning residues to levels that will not interfere with subsequent disinfection/sterilization processes. ***Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, multiple scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.***

Non-binding recommendations

Find information about how to disinfect a public space like a store or school to combat the novel coronavirus (COVID-19).

Aug 2020

MCM facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness.

The U.S. government is providing a portal for the 2019 novel coronavirus (COVID-19) medical countermeasures task force as a single point of entry for the submission of market research packages and meeting requests from interested stakeholders.

FDA is helping to accelerate the development of COVID-19 prevention and treatment options through new guidance for innovators and researchers.

Guidance for Industry and Investigators

Aug 2020

****!!!!****!!!!**** {510(k) exemptions for COVID.} "FDA considers chemical/physical disinfectant devices to encompass chemical disinfectant solutions used to disinfect medical devices." "Medical devices disinfectors... exempt from premarket review." "during the declared public health emergency, FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization, without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) [and some other requirements]. FDA believes such devices will not create such an undue risk where the performance and labeling elements... are met." "If the device generates ozone, FDA recommends that the manufacturer evaluate whether the product is within the maximum acceptable level of ozone given in 21 CFR 801.415." [****It sounds like chlorine dioxide could be used if stays below regulated air levels. FDA has endorsed ClO2 standards for air related to food processing [ but need to check FDA's approved air concentrations for around people]. EPA has approved safety of air concentrations at specific levels around people.****]