Guidance and Reference Materials

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

"Liquid chemical germicides intended for use in conjunction with a variety of articles that fit within the statutory definition of "device," such as operating instruments, medical examining tables, hospital scales, and other hospital equipment, also fall within the definition of "device" because they are considered accessories to these devices."

****!!!!**** "For promulgating health standards, the usual hourly, daily, weekly, and yearly components when calculating an employee's "working life" are 8 hours per day, 5 days per week, 48 weeks per year for 45 years."

{Safety standards for inhaled air} "TLV-TWA guidelines that are levels that should not be exceeded during any 8-hour workday of a 40- hour workweek" "TLV-STEL guidelines which are 15-minute exposure levels that should not be exceeded during a workday."

Search EPA’s list n legacy search page of registered disinfectants for use against SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19).

Explanation of requirements under FIFRA for importing and exporting pesticides.

Pesticides designed to control microbial pests such as viruses and bacteria must have data proving their ability to kill these pests (known as efficacy). The guidance documents on this page describe current efficacy-related requirements.

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product.

links to series 885 test guidelines in the docket

"EPA maintains the following list of cost estimates of studies required to support a pesticide’s registration. EPA uses these estimates when determining whether a pesticide use meets the economic incentive portion of the definition of a minor use. The estimates were obtained by EPA from independent laboratories and are adjusted for inflation annually, although they may also change when the Agency has new information on the cost of tests that satisfy data requirements. "

questions concerning Notice of Arrival EPA Form 3540-1

EPA News Release: EPA Takes Action to Protect Public from Coronavirus Protection Scams

{Draeger tubes are used by OSHA for on-site testing of chlorine dioxide, though OSHA specifies that ClO2 levels should be tested with Dräger CH24301 tubes, which are for checking chlorine levels from 0.2 to 30 ppm.} DrägerTubes® are glass vials filled with a chemical reagent that reacts to a specific chemical or family of chemicals. A calibrated 100 ml sample of air is drawn through the tube with the Dräger accuro® bellows pump. If the targeted chemical(s) is present the reagent in the tube changes color and the length of the color change typically indicates the measured concentration.

****!!!!****!!!!**** (1991) {Is this back-up method? Or actually fully validated?} "Collection devide: An air sample is collected using a calibrated sampling pump and a midget fritted glass bubbler. The bubbler contains a collection solution of 0.02% potassium iodide (KI) in a sodium carbonate/sodium bicarbonate buffer." "Analytical Procedure: In the weakly basic solution, chlorine dioxide reacts with KI to form chlorite (ClO2¯) which is then determined by an ion chromatograph equipped with a conductivity detector and gradient pump." "The stock standard should be standardized at least monthly. It was noted during testing that this standard solution decreases in concentration approximately 4% per month. No significant difference in results was noted when sampling at different humidities. As shown in the mixture study, Cl2 does not interfere with the sampling or ion chromatographic analysis of ClO2 at the concentrations tested. Although a resultant 10% decrease in ClO2 and 7% increase in Cl2 concentrations occurred, this could have been due to the difficulty in generating both gases simultaneously. A mixture of ClO2 and Cl2 can be collected and analyzed together; however,Cl2 measurements are considered for screening purposes only. Further work is necessary to validate the KI/buffer sampling and IC analysis for Cl2.Detection limits are adequate if samples are taken for 240 min at 0.5 L/min"

"Collection: 2% KI in an impinger... Analytical Procedure: Titration with 0.01 N sodium thiosulfate"

"An air sample is collected using a calibrated sampling pump and a midget fritted glass bubbler. The bubbler contains a collection solution of 0.02% potassium iodide (KI) in a sodium carbonate/sodium bicarbonate buffer."

****!!!!****!!!** {Includes Fast Track Approvals, etc} "reports on New Drug Application (NDA)"

"intended for use in water and ice at an at-use concentration between 13 and 26 ppm. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption."