Guidance and Reference Materials

(1991)

(2021)

"their danger to health and what the National Food Crime Unit (NFCU) are doing to prevent them being sold and or consumed."

****!!!!****!!!!**** "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"

****!!!!****!!!! (2013)

****!!!!****!!!! {Registration test requirements for sanitizers, disinfectants, etc} "generally intended to meet testing requirements for the effectiveness of pesticide products under FIFRA"

****!!!!****!!!!**** (1980) "Requirements apply to products with label claims for the treatment of air to reduce the numbers of airborne microorganisms." "claims of value in preventing or treating diseases, or providing any other health protection, whether expressed or implied, are not acceptable. Claims must clearly indicate the mitigating nature of the activity, such as "Temporarily reduces the number of airborne bacteria."" "The label directions for use of air sanitizers must state: That application be made in closed spaces ("Close all doors and windows; close air vents or turn off air conditioners.")."

"A scientist or team of scientists, depending upon the size of the study, will be assigned to the project and begin to work directly with the study sponsor to define parameters or develop a protocol if necessary. Each device is unique and should be tested in a manner that best simulates actual use. At Microchem, the scientists strive to provide innovative strategies to accomplish any testing objective."

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Now is the time for infection preventionists to harness the current attention to biopreparedness and use the momentum to build the foundations for strong local programs that can be sustained through future waves of competing priorities.

2020

**** (2007)

Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)

The global market for sodium chlorite is projected to observe substantial growth over the forecast period, owing to the rising usage of sodium chlorite in...

**** {Revoked EUAs for medical devices} This page contains a listing of all the EUAs have been terminated [revoked] and this information is no longer current.

Information for Filing Personal Protective Equipment and Medical Devices During COVID-19

Answers to frequently asked questions about emergency use authorizations (EUAs) issued by the FDA during the COVID-19 pandemic.

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

{Examples of time periods for FDA reviews of drug approval applications}

****!!!!**** "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."

****!!!!**** {Summary with well-divided reference sections} View osha standards for chlorine dioxide in WISER. "Vacated 1989 OSHA PEL TWA 0.1 ppm (0.3 mg/cu m); STEL 0.3 ppm (0.9 mg/cu m) is still enforced in some states."

****!!!!****!!!*** "OSHA defines "commercial grade" as a typical maximum concentration of the chemical that is commercially available and shipped. The term "commercial grade" includes reagent grades, which, in some cases, will be in different concentrations from the typical commercial grades." "Chlorine Dioxide (ClO(2)), which is not commercially available and which is produced in a workplace process, the threshold quantity is determined not only by the free standing quantity of the HHC, for example, ClO(2) gas but also by the amount of HHC(s) in the mixture(s), for example, ClO(2) in a water solution. A process containing 150 pounds (68.00 kg) of ClO(2) gas and 900,000 pounds (408,231.00 kg) of ClO(2) water solution would be covered as follows. Assuming that the ClO(2) is 0.1 percent by weight of the water solution, there is 900 pounds (408.23 kg) of ClO(2) in the water solution. This process contains 150 + 900 or 1050 pounds (476.27 kg) of ClO(2) which is greater than the threshold quantity of 1000 pounds."

The OSHA permissible exposure limits (PELs), as found in Tables Z-1, Z-2, and Z-3 of the OSHA General Industry Air Contaminants Standard (29 CFR 1910.1000), that were effective on July 1, 1993* and which are currently enforced by OSHA are listed on the page for each chemical in the Pocket Guide.