Administration to Lean on Medical Supply Companies to Include Masks from Small Manufacturers

ASTM Standards are a Good Starting Point Toward More Effective Masks

President Biden Stresses Mask Use Until 2022

People have to be Viewed As Pollution Sources to be Controlled by a Central System

Bureau Veritas can Provide Safe Bubble Validation

CDC Releases Its School Guidance

Philadelphia Restaurants Open at 50% Capacity with MERV 11 Filters or Better

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Administration to Lean on Medical Supply Companies to Include Masks from Small Manufacturers

The White House on Thursday stepped into the fragmented market for disposable virus-filtering N95 masks, moving to connect medical supply companies with mask manufacturers who say they are loaded with inventory but can’t find buyers — even in the midst of a pandemic in which doctors and nurses are desperate for the protective gear.

President Biden’s coronavirus response coordinator, Jeffrey D. Zients, intervened after reading about the mask manufacturers’ dilemma on Thursday in an article in The New York Times.

“We will do all we can to get frontline workers the personal protective equipment they need, including breaking down barriers for N95 manufacturers,” Mr. Zients said in a statement, adding that he had “reached out to all of the major medical distributors to start connecting them with these new N95 mask manufacturers.”

A senior administration official said members of Mr. Zients’ team had talked with three top medical suppliers: AmerisourceBergen, Cardinal Health and McKesson Corporation.

Nearly two dozen small American companies have recently jumped into the business of making N95s but are sitting on extra supply, in part because of ingrained purchasing habits of hospital systems, competition from China and bans on mask advertising by companies like Facebook and Google, which were trying to thwart price gouging early in the pandemic.

Mr. Zients said the White House intended to work with “online retailers to ensure they are making more of these products available to their customers.”

One mask manufacturer, Luis Arguello Jr., said he had 30 million masks for sale. After the pandemic exposed a huge need for protective equipment and China closed its inventory to the world, his family-run business, DemeTech, began making masks in its factories in Miami. It invested tens of millions of dollars in new machinery and then navigated a nine-month federal approval process that allows the masks to be marketed.

“It’s insane that we can’t get these masks to the people who desperately need them,” he said.

The mask shortage has been one of the most visible failures of the federal response to the pandemic. One mask company executive, Mike Bowen of Prestige Ameritech, testified on Capitol Hill last year that he had been warning for years that the United States was too dependent on China for mask supply.

 

 

ASTM Standards are a Good Starting Point Toward More Effective Masks

The new standards are likely to be published early next week. The draft guidance includes both single use and reusable masks and outlines specific requirements for evaluating the performance of reusable masks. Dr. Donald Milton, a professor of environmental health at the University of Maryland who studies how viruses are transmitted, believes these standards will fill a major regulatory gap. "You've got all these knockoff masks coming in. They're not very good, claiming to be N95 and they're not. So having some benchmarks is a step in the right direction," he told CNN.

"This is desperately needed because people have no guidance at all right now," Linsey Marr, a professor of civil and environmental engineering at Virginia Tech with expertise in airborne transmission of viruses, air quality and nanotechnology, told CNN.

If the standards are adopted, each mask would come with a set of user instructions that describe proper sizing, fit and cleaning protocol. The standards strictly prohibit the use of vents, valves or any feature that allows people to blow out or breathe in unfiltered air.

The draft guidelines would also require manufacturers to test their facial coverings in accredited labs to certify performance, register their products and use the outlined labeling system to use the ASTM labeling designations.

Perhaps the most important change ASTM is proposing is a labeling system. Consumers in stores would be able to evaluate the quality of masks on store shelves from the labeling on the packaging. If a mask has ASTM labeling, it could ensure the customer that product has met the testing and quality requirements.

The drafted ASTM standard labeling requirements would indicate results of two testing criteria: breathability and filtration efficiency. Typically, when a mask has a higher filtration, it results in more resistance and can make it harder to breathe.

According to the ASTM draft guidelines, a lower performance, level one designation would require the product to filter 20% of particles -- something that would make the mask easy to breathe through, but that would provide less protection. A level two certification would designate high performance filtration of at least 50% of particles but would provide less breathability.

"The use of the 'levels' defines a classification system intended to aid in understanding potential tradeoffs for higher levels of filtration efficiency with airflow (breathing) resistance," Jonathan Szalajda, deputy director at the National Personal Protective Technology Laboratory, told CNN in a statement.

Milton believes information on breathability would be an important consideration for consumers with chronic lung or heart disease and other conditions that might require easier breathability in a mask.

"It gives people information to make decisions on what they want, and what level of protection they feel they need," Milton told CNN.

ASTM's main test -- whether a mask can filter out particles measuring 0.3 microns. Why this size? It's a hard one to stop, and if a mask can handle a particle that size, it can stop droplets most likely to carry viruses and bacteria.

Marr understands why 20% and 50% protection benchmarks might seem low to the public but believes the actual performance against the virus could surpass 50%.

"That criteria is for a certain size particle that is really the hardest size to filter out," she told CNN. "It's very likely that the virus is mostly in particles that are larger than that critical size, the test size."

But while experts grow increasingly concerned at the growing spread of more transmissible coronavirus variants, some believe the draft mask guidelines need to require a higher level of protection to slow the spread and protect people.

"The first iteration may not be where you want it to be, but it's a step in the right direction to have some quality levels here," Milton told CNN. "I would like to see a level three on the higher end."

"If you would have asked me this in November last year, I would have said this is okay," Marr told CNN. "But now with, with the more transmissible variants. I'm more concerned. I think it's a higher level of certification...I would like to see another level of performance like 80%."

Several European countries have already required people wear masks with a minimum filtration efficacy of 80-90% against 0.3-micron particles. Germany, Austria and France have mandated the public to wear high filtration masks on public transport, shopping or in public areas.

While she hopes for the addition of a higher level of protection added to these guidelines, Marr believes that if approved, the standards will have an impact because consumers want and need guidance.

"I think if these standards are out, there will be a demand for the highest level of protection that ASTM is willing to have a level for," she told CNN. "The manufacturers, I think, will step up and provide that."

Currently, only medical-grade masks and respirators must meet standards. These include the N95 masks, which are regulated by the US Food and Drug Administration, National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) for fit, filtration efficiency, flammability and other qualities.

 

President Biden Stresses Mask Use Until 2022

President Biden on Thursday stressed the importance of wearing masks until at least 2022 to save lives — despite declaring the US will have enough supply of vaccines by the summer to inoculate 300 million Americans.

The president told reporters during a visit to the National Institutes of Health complex that he would not take his mask off even though he was standing more than 10 feet away from Dr. Anthony Fauci and NIH Director Dr. Francis Collins.

“You know that wearing this mask through the next year here can save lives — a significant number of lives,” Biden said. “And so I apologize if you don’t hear me as clearly as you, maybe you should.”

Biden warned that the country is still “in the teeth of this pandemic” with new, highly contagious variants spreading.

“January of 2021 was the deadliest month we’ve had. We lost over 100,000 — 100,000 of our fellow citizens. We’re on track to cross 500,000 dead Americans this next month,” he said. 

“The new strains emerging create immense challenges, and masking is still the easiest thing to do to save lives. But we need everyone to mask up.

“I know it’s a pain in the neck, but it’s a patriotic responsibility. We’re in the middle of a war with this virus. It’s a patriotic responsibility — not only if you care about your family, if you care about your fellow Americans.”

However, with more than 26 million jabs delivered in Biden’s first three weeks in office, the US is on pace to exceed his goal of administering 100 million doses in his first 100 days.

“Just this afternoon, we signed the final contracts for 100 million more Moderna and 100 million more Pfizer vaccines. And we’re also able to move up the delivery dates with an additional 200 million vaccines to the end of July — faster than we expected,” the president said Thursday.

 

People have to be Viewed As Pollution Sources to be Controlled by a Central System

People create 100% of the COVID contamination. So it is not surprising that tight fitting efficient masks are the solution to the problem. But masks also have to be considered in every  air cleanliness initiative.

The average person has two colds per year and is therefore infectious for 5% of the time.  In the average building 5% of the people are causing close to 100% of the infections if they are not wearing masks.

 

How would you rate a dust collection system which processes air from all the sources except the one which creates the pollution? An HVAC system where infectious people don’t wear masks is the equivalent.

When pick up of dust at the source is difficult, it is called fugitive dust and will need to be captured by an air cleaning system which is very large and costly.

This fugitive dust air cleaning system is similar to the filter cubes installed by Mann +Hummel at polluted  traffic intersections in Germany. These cubes reduce the pollutant load on the pedestrians. But you have to ask how inconvenient is it to wear masks  and does this inconvenience justify the cost of cleaning the outdoor air?

The filter cubes are a good solution for  a few busy intersections but prohibitively costly as a general cleanliness tool.

The cleanroom industry has already identified people as the largest contamination source and has gone to great lengths to minimize their impact.

Indoor and outdoor air cleanliness initiatives need to consider masks as one of the components in pollutant minimization.

Our thinking about masks is similar to that on seat belts and air bags decades ago. Unless there is a little inconvenience your car is not going to be a safe environment. This does not mean that there shouldn’t be large investments to see that the air is not polluted.  But in certain cities  ambient air pollution  under certain climatic conditions or due to wildfires, volcanoes or dust storms will be excessive and masks will be needed.
 

Bureau Veritas can Provide Safe Bubble Validation  

McIlvaine has recommended the safe bubble approach. It entails maintaining a low COVID risk environment. Bureau Veritas can provide the auditing.
It partners with clients to build a custom continuity program to mitigate COVID-19 risk and ensure safety.
 

CDC Releases Its School Guidance

The Centers for Disease Control and Prevention released its much-anticipated, updated guidance Friday to help school leaders decide how to safely bring students back into classrooms and/or keep them there. Rather than a political push to reopen schools, the update is a measured, data-driven effort to expand on old recommendations and advise school leaders on how to "layer" the most effective safety precautions: masking, physical distancing, handwashing and respiratory etiquette, ventilation and building cleaning, and contact tracing.

For politicians, parents and school leaders looking for a clear greenlight to reopen schools, this is not it.

"CDC is not mandating that schools reopen," CDC Director Dr. Rochelle Walensky said Friday on a phone briefing with reporters.

Instead, the CDC goes to great lengths to explain that proper mitigation can help keep kids and staff safe at school, even in hard-hit communities, though it also warns that schools lulled into a false sense of security because of low community transmission rates could still spread the virus if they don't enforce mask-wearing and socially distanced classrooms.

The updated guidance comes as President Biden tries to make good on his promise to help more K-8 schools reopen within his first 100 days in office. School reopening has become a potent political battle between parents and educators. In Washington, Republicans have used it to criticize the Biden administration for bowing to pressure from a powerful interest group, teachers unions, rather than listening to scientists and the concerns of parents.

The update offers a few key changes to earlier language, including a color-coded chart that divides schools' reopening options into four zones: blue, yellow, orange and red. Districts with low community spread of the coronavirus (blue, 0-9 new cases per 100,000 in past 7 days) or moderate transmission (yellow, 10-49 new cases) are encouraged to consider reopening for full, in-person learning.

Schools in areas with substantial transmission (orange, 50-99 new cases per 100,000) may still consider a limited reopening, as long as they can layer multiple safety strategies in the classroom. In hard-hit communities (red, more than 100 new cases per 100,000) elementary schools may consider limited reopening, with physical distancing required, but the CDC recommends middle and high schools be virtual-only unless mitigation strategies can be met.

The guidance also incorporates several recent, forceful statements by CDC scientists.

"School should be the last places closed and the first places open," Walensky said recently, a line that officially appears in Friday's guidance: "K-12 schools should be the last settings to close after all other mitigation measures in the community have been employed, and the first to reopen.

 

There is detailed guidance on masks Universal and correct use of masks

Core principle for masks:

Require consistent and correct use of face masks, by all students, teachers, and staff to prevent SARS-CoV-2 transmission through respiratory droplets. Masks should be worn at all times, by all persons in school facilities, with exceptions for certain persons who, because of a disability, cannot wear a mask or wear a mask safely, or for certain settings such as while eating or drinking. Masks should be required in all classroom and non-classroom settings, including hallways, school offices, restrooms, gyms, auditoriums, etc.

 • Mask policies for all students, teachers, and staff set the expectation that individuals will use masks throughout the school.

 • Most students, including those with disabilities, can tolerate and safely wear a mask. However, a narrow subset of students with disabilities may not be able to wear a mask or cannot safely wear a mask. Those who cannot safely wear a mask – for example, a person with a disability who, for reasons related to the disability, would be physically unable to remove a mask without assistance if breathing becomes obstructed – should not be required to wear one. For the remaining portion of the subset, schools should make individualized determinations as required by Federal disability laws in order to determine if an exception to the mask requirement is necessary and appropriate for a particular student. If a child with a disability cannot wear a mask, maintain physical distance, or adhere to other public health requirements, the student is still entitled to an appropriate education, which in some circumstances may need to be provided virtually.

 • If visitors are permitted in school, they should be required to wear masks at all times and should maintain at least 6 feet of distance from others.

• Schools should encourage modeling of correct and consistent mask use by school leaders, local leaders, and others respected in the community.

 • The most effective fabrics for cloth masks are tightly woven such as cotton and cotton blends, breathable, and in two or three fabric layers. Masks with exhalation valves or vents, those that use loosely woven fabrics, and ones that do not fit properly are not recommended

 

 

Philadelphia Restaurants Open at 50% Capacity with MERV 11 Filters or Better 

@PHLPublicHealth announced that restaurants are able to begin operating at up to 50% capacity for indoor dining as early as Friday, February 12 if they can certify they meet new ventilation standards.

The standards and application are available online: https://bit.ly/36XZ7S5

According to officials, if restaurants have an HVAC system or standalone ventilation unit in use, the following standards are required to open to 50% capacity:

- HVAC system is fully operational and ventilates the entire indoor dining area

- At least 20 percent outside is air circulated by the HVAC system

- Filtration MERV 11 or higher

- At least 15 air exchanges per hour are measured indoors

- Exhaust vent has a minimum six-foot clearance from tables, chairs, or other items

If restaurants use window fans instead of an HVAC system:

- At least 15 air exchanges per hour must be measured indoors

 

Philadelphia Health Commissioner Dr. Thomas Farley said businesses must submit documentation certifying their establishments to meet the standards from their HVAC maintenance company or the establishment proprietor.

"I should note here that we are breaking new ground, and we're not aware of other locations that have done this, but we do think this is a way to try to have restaurants get back on their feet, economically, to provide service to customers, but while also doing it safely," Farley said.

Several members of the Restaurant Advisory Committee released a statement earlier this week saying, "The regulations punish small, owner-operated restaurants that give Philadelphia its authentic character and support our communities of color and immigrant communities." 

Pennsylvania restaurants outside Philadelphia reopened indoor dining with limited capacity on Jan. 4.

Restaurants must go through a self-certification process to go to 50% capacity, otherwise, they are limited to 25%.

Indoor dining at Philadelphia restaurants was banned in November 2020, as coronavirus cases were rising in the city and officials were anticipating holiday gatherings. It resumed at 25% capacity on January 16.

According to the city's 'Enhanced Ventilation Standards for Indoor Dining and Application Form for Increased Dining Capacity,' "If restaurants demonstrate that they meet these ventilation standards, they can have indoor dining at 50% capacity. If they do not, they can have indoor dining at 25% capacity. As COVID-19 case rates change, these capacity limits may be revised."

Indoor dining was banned twice since the start of the pandemic. From March 16 to Sept. 8, 2020, there was no indoor dining. City officials then allowed restaurants to open at 25% capacity, then increased the limit to 50% on Oct. 2 before the second ban went into effect.