PPB August 2020

from spreading respiratory droplets when talking, sneezing or coughing. OSHA has developed a classification of exposure for airborne pathogens that corresponds with specific requirements for mask types for use in mitigating infection: • Low Exposure Risk: Jobs that do not require contact with people known to be, or suspected of being, infected. Workers have minimal occupational contact with the public and other coworkers. • Medium Exposure Risk: Jobs that require frequent or close contact with people who may be infected, but who are not known to have or suspected of having COVID-19. • High Exposure Risk: Jobs with a high potential for exposure to known or suspected sources of SARS- CoV-2. (SARS-CoV-2 is the virus that causes COVID-19.) • Very High Exposure Risk: Jobs with a very high potential for exposure to known or suspected sources of SARS-CoV-2 during specific medical, postmortem or laboratory procedures. Job duties affect exposure risk. As workers’ job duties change or they perform different duties during the day, they may move from one exposure level to another. Meeting Compliance Standards As Companies Pivot to Manufacturing And Importing Face Masks The standards that apply depend on the aspect of manufacturing, product design and the market in which the product is to be distributed. For Masks Intended For Use In A Medical Setting All masks and respirators intended for use in a medical setting are subject to FDA regulations. Face masks are regulated as medical devices, under 21 C.F.R. Section 878.4040, when intended for medical purposes (non-surgical masks). Surgical masks are, likewise, regulated under 21 CFR 878.4040, but as class II devices requiring premarket notification. Contingent upon whether the masks are intended for use by a health-care professional, a patient or a visitor, the masks may also be subject to OSHA regulation. • For microbial claims, joint review by FDA and Environmental Protection Agency (EPA) is required. • In environments where the risk of infection in the workplace to an employee is deemed high, masks are required to demonstrate compliance to NIOSH filtration standards. The facility is also required to implement a comprehensive PPE control program covering risk High Exposure Risk Very High Exposure Risk Dmytro K / Topuria Design / Azwel / Yenko /Shutterstock.com | AUGUST 2020 | 79 THINK