How Large will the Mask Market be in 2022 and Beyond?

OSHA Mask Standard has been Delayed

OSHA has the Power to Set and Enforce Mask Standards

OSHA Could Require Masks to Meet the  ASTM Standard

Mask Manufacturers Cite Present Production of One Billion High Efficiency Masks per Month

Italy Institutes Lockdown with Other EU Countries Also Pulling Back

Three EU Countries Suspend AstraZeneca Vaccine Use

Halo Life Mask Meets ASTM Standard

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How Large will the Mask Market be in 2022 and Beyond?

With high efficiency mask mandates likely in much of the world there will be a huge market for public masks over the next year. Mask suppliers are debating how much effort to place on this opportunity. The question is whether the market could shrink back to the $500 million market of 2019.

First of all it is likely that the COVID market will remain at some level for years to come. It will be several years before the world reaches herd immunity. Vaccines may be only effective for one year. New variants could cause trouble for 10 years according to some predictions.

So the COVID segment of the market could drop from $80 billion in 2021 to $40 billion in 2022 and $20 billion in 2023.

What about the traditional market which includes courtesy masks, air pollution protection, dust storms, wildfires, Red Tide, and other infectious diseases? WHO says eight million people are dying because of air pollution each year. The dangers of smoking were known for years before there was eventually guidance and regulation.

Courtesy masks alone could be a very big market. The average person has two colds per year.  So he might be infectious for 1/25 of the year. It is very likely that the Asian “courtesy” mask custom will become institutionalized. OSHA could alter the temporary mask policy to reduce the general requirement but leave it in place for anyone showing signs of a cold or flu.

If you are a restaurant owner and have to implement mask wearing for infectious servers that will provide a negative image. On the other hand if you require all servers to wear masks it creates a positive image.

To no small extent the future use of masks will be a function of CATER: Comfort, Attractiveness, Tight fit, Efficiency, Reusability or life

 

OSHA Mask Standard has been Delayed

The White House's self-imposed deadline to impose a nationwide face mask standard in workplaces won't be met, since deliberations are still underway. President Biden on January 21 directed the Labor Department's Occupational Safety and Health Administration to determine by Monday, March 15, if such a standard is needed.

An emergency temporary standard on face masks in the workplace is ultimately expected to be issued, but the analysis has not yet been completed, three people familiar with the process told CBS News. 

The nationwide temporary standard for face masks in the workplace would impact millions of workers and would last six months.

Public health and workplace safety experts told CBS News the emergency temporary standard could provide valuable social distancing advice for workers and safety guidance for face masks, since they vary in their protective abilities.  

OSHA workplace standards are enforceable and usually take years to implement, so an emergency temporary standard has occasionally been used to avoid normal rulemaking procedures so that "grave dangers" facing workers can be addressed. 

The last time the emergency temporary standards process was used was in 1983 to limit asbestos exposure in the workplace, according to the Congressional Research Service. The rule was eventually struck down in court. The nationwide temporary standard for face masks in the workplace would impact millions of workers and would last six months. In its absence, several states have enacted their own standards. 

Without a nationwide standard so far during the pandemic, several states have enacted their own standards.  

Dr. David Michaels, a former assistant secretary of labor for OSHA who served on Mr. Biden's presidential transition team, explained to CBS News the technical aspects of any emergency temporary standard must be balanced with the urgent need to protect workers from the spread of COVID-19.   

"OSHA lost a year because the Trump administration refused to prepare an emergency standard," Dr. Michaels said, "The longer the delay, the more exposures will occur."  

"OSHA has to show that the precautions required by the standard are effective in preventing exposure while at the same time being economically and technically feasible for employers," Dr. Michaels added.  

"The Occupational Safety and Health Administration has been working diligently, as appropriate, to consider what standards may be necessary, and is taking the time to get this right," a Labor Department spokesperson told CBS News on Monday. This official did not offer any timeline for their decision. 

"[The president's] objective is actually to protect workers and members of the workforce," White House Press Secretary Jen Psaki said on Monday when asked about the OSHA deliberations, "We are waiting for them to make a conclusion." 

Mr. Biden's deadlines for the Labor Department on this potential face mask standard landed on his 55th day in office, which is half the time he allotted for other 100-day goals, like vaccinating Americans and returning students to the classroom.  

As the emergency standard remains under review at the Labor Department, dozens of public health officials and powerful unions like the AFL-CIO, National Nurses United and the American Federation of Teachers have pushed the Centers for Disease Control and Prevention to update their scientific guidance on the aerosol spread of COVID-19.  

 

OSHA has the Power to Set and Enforce Mask Standards

OSHA, a large regulatory agency within the US Department of Labor, has federal power to set and enforce standards to ensure safe working conditions that cover most working Americans in all 50 states. It can enforce requirements anywhere from local shops to factory floors to large corporations. Failure by a business to comply with any OSHA requirement can result in fines, jail time and legal liability.

Federally mandating masks in all workplaces is unprecedented. There were previous regulations on respiratory protection for workers in hazardous environments or healthcare roles, but not for the majority of the American workforce.

Earlier this year, OSHA issued guidance encouraging employers to implement measures to prevent the spread of Covid-19 in the workplace but did not mandate them to act. That may soon change.

A federal OSHA workplace mask regulation would apply even in states that are no longer requiring face coverings or have loosened Covid-19 restrictions.

A US Department of Labor spokesperson told CNN that OSHA is considering the need for an emergency temporary standard, or any new rules and regulations, to better protect workers during the pandemic. That includes considering rules for face masks, and OSHA is exploring using the first efficiency standard for consumer masks that can guarantee quality and effectiveness, which were recently published by ASTM International -- an international standards organization.

"As OSHA studies this potential action, it will consider the recent ASTM standard on barrier face coverings and its potential to provide the most effective personal protective benefits," a US Department of Labor spokesperson told CNN Wednesday

Four Democratic House committee chairs recently implored the CDC and the White House COVID Response team to do the same, declaring the government's current science on aerosol spread was "outmoded."  

 

OSHA Could Require Masks to Meet the ASTM Standard

ASTM International recently published the first national mask standard for consumers that outlines minimum fit, design, performance and testing requirements and would require user instructions, package labeling and a permanent tag on the product. To meet ASTM standards, manufacturers are required to test their facial coverings in accredited labs to certify performance, register their products and use an outlined ASTM labeling system on their products.

Previously there were no standards for consumer masks, even though masks are highly recommended by US health officials to help prevent the spread of the coronavirus.

While many Americans have been going to work throughout the pandemic, some Americans have yet to return to their workplace in a Covid-19 environment. To ensure workers are safe, OSHA is working to expand the ability to report workplace safety complaints in relation to Covid-19 protection.

"We are preparing to implement a national emphasis program that focuses our efforts on violations that put the largest number of workers at risk of contracting coronavirus or are contrary to anti-retaliation principles," a Department of Labor spokesperson told CNN Wednesday. "OSHA is reviewing its enforcement efforts related to Covid-19 and identifying changes to better protect workers and ensure the safety of its compliance officers," the spokesperson continued.

Pressure has been mounting on OSHA to adopt the new ASTM mask standards.

In a letter to Biden's top coronavirus advisers last month, a dozen health and safety experts -- including four members of Biden's former advisory board -- called on the CDC and OSHA to adopt the ASTM standard for better protection for workers and the general public.

The letter asks OSHA to create a higher benchmark for workers -- masks with 80% protection - using the design and testing criteria outlined by the ASTM standard.

 

Mask Manufacturers Cite Present Production of One Billion High Efficiency Masks per Month

Mask manufacturers are also encouraging OSHA to adopt the new ASTM mask standard. In two recent letters to the Biden administration, the Association of the Nonwoven Fabrics Industry, known as INDA, and the newly formed American Mask Manufacturers Association, or AMMA, tell the Biden administration that American mask and material manufacturers can adequately supply the country with high-quality masks and encourage the implementation of a national mask standard.

INDA represents more than 200 US suppliers of raw materials and equipment manufacturers and AMMA, is made up of more than 40 American mask manufacturing companies.

"Based on INDA's activities working with US government entities and its membership, it is INDA's opinion that the raw material shortage for the production of US face masks and respirators has been addressed for the time being," INDA President Dave Rousse said in the letter, which was sent to President Joe Biden.

The other letter, by AMMA, outlines the current US monthly production capacity of 902 million high-filtration masks and says there are 690 million unused high-filtration masks currently sitting in warehouses.

"We want to assure you that America's mask manufacturers have ample capacity to meet the entire needs of our nation during emergencies such as this pandemic," the AMMA letter says.

 

Italy Institutes Lockdown with Other EU Countries Also Pulling Back

A year after Italy became the first European country to impose a national lockdown to contain the spread of the coronavirus, the nation has fallen eerily quiet once again, with new restrictions imposed on Monday in an effort to stop a third wave of infections that is threatening to wash over Europe and overwhelm its halting mass inoculation program.

As he explained the measures on Friday, Prime Minister Mario Draghi warned that Italy was facing a “new wave of contagion,” driven by more infectious variants of the coronavirus.

Just as before, Italy was not alone.

“We have clear signs: The third wave in Germany has already begun,” Lothar Wieler, head of the Robert Koch Institute for Infectious Diseases, said during a news conference on Friday. Prime Minister Viktor Orban of Hungary predicted that this week would be the most difficult since the start of the pandemic in terms of allocating hospital beds and breathing machines, as well as mobilizing nurses and doctors. Hospitalizations in France are at their highest levels since November, prompting the authorities to consider a third national lockdown.

Officials in the United States are watching those developments with wary eyes. At a White House news briefing on Monday, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, pleaded with Americans not to let their guard down as case numbers have dropped from their peak. She pointed to images of young people crowded onto Florida beaches, though generally people are safer outside than inside, and to European nations as a warning.

“Each of these countries has had nadirs like we are having now, and each took an upward trend after they disregarded no mitigation strategies,” she said. “They simply took their eye off the ball. I’m pleading with you for the sake of our nation’s health. These should be warning signs for all of us.”

The U.S. death rate remains at nearly 1,400 people every day. That number still exceeds the summer peak, when patients filled Sun Belt hospitals and outbreaks in states that reopened early drove record numbers of cases, though daily deaths nationwide remained lower than the first surge last spring. The average number of new reported cases per day remains comparable to the figures reported in mid-October.

Across Europe, cases are spiking. Supply shortages and vaccine skepticism, as well as bureaucracy and logistical obstacles, have slowed the pace of inoculations. Governments are putting exhausted populations under lockdown. Street protests are turning violent. A year after the virus began spreading in Europe, things feel unnervingly the same.

In Rome, the empty streets, closed schools, shuttered restaurants and canceled Easter holidays came as a relief to some residents after months of climbing infections, choked hospitals and deaths.

“It’s a liberation to return to lockdown, because for months, after everything that happened, people of every age were going out acting like there was no problem,” said Annarita Santini, 57, as she rode her bike in front of the Trevi Fountain, a popular site that had no visitors except for three police officers. “At least like this,” she added, “the air can be cleared and people will be scared again.”

For months, Italy had relied on a color-coded system of restrictions that, unlike the blanket lockdown of last year, sought to surgically smother emerging outbreaks in order to keep much of the country open and running. It does not seem to have worked.

“History repeats itself,” Massimo Galli, one of Italy’s top virologists, told the daily

 

Three EU Countries Suspend AstraZeneca Vaccine Use

Germany, France, Italy and Spain became the latest countries Monday to suspend use of AstraZeneca’s COVID-19 vaccine over reports of dangerous blood clots in some recipients, though the company and European regulators have said there is no evidence the shot is to blame.

AstraZeneca’s is just one of three vaccines in use on the continent. But the cascading number of nations raising the alarm amounts to another setback for the European Union’s vaccination drive, which has been plagued by shortages and other hurdles and is lagging well behind the campaigns in Britain and the U.S.

The EU drug regulatory agency called a meeting for Thursday to review experts’ findings on the AstraZeneca vaccine and decide whether action needs to be taken.

The furor comes as much of Europe is tightening restrictions on schools and businesses amid surging cases of COVID-19.

Germany’s health minister said the decision to suspend AstraZeneca shots was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven cases of clots in the brains of people who had been vaccinated.

“Today’s decision is a purely precautionary measure,” Jens Spahn said.

French President Emmanuel Macron said his country will likewise suspend shots until at least Tuesday afternoon. Italy’s drug regulator announced a temporary ban, less than 24 hours after saying the “alarm” over the vaccine “wasn’t justified.” And Spain said it will stop using the vaccine for two weeks while experts review its safety.

AstraZeneca said there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country European Union and Britain. The drug maker said there is no evidence the vaccine carries an increased risk of clots.

In fact, it said the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.

The World Health Organization and the EU’s European Medicines Agency have also said that the data does not suggest the vaccine caused the clots and that people should continue to be immunized.

“Many thousands of people develop blood clots annually in the EU for different reasons,” the European Medicines Agency said. The incidence in vaccinated people “seems not to be higher than that seen in the general population.”

The agency said that while the investigation is going on, “the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.”

Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 instances of pulmonary embolisms, or clots in the lungs.

The AstraZeneca shot has become a key tool in European countries’ efforts to boost their sluggish vaccine rollouts. It is also pillar of a U.N.-backed project known as COVAX that aims to get COVID-19 vaccines to poorer countries.

Pfizer’s and Moderna’s vaccines are also used on the European continent, and Johnson & Johnson’s one-shot vaccine has been authorized but not yet delivered.

In the U.S., which relies on the Pfizer, Moderna and J&J vaccines, AstraZeneca is expected to apply for authorization in the coming weeks.

Denmark last week became the first country to temporarily halt use of the AstraZeneca vaccine. It said one person developed clots and died 10 days after receiving at least one dose. The other countries include Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.

Britain and Canada are standing by AstraZeneca’s vaccine for now.

Dr. Michael Head, a senior research fellow in global health at the University of Southampton in England, said there is no data yet to justify suspending the AstraZeneca vaccine and called the decision “baffling.”

“Halting a vaccine rollout during a pandemic has consequences,” Head said. “This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned.”

Spahn, the German health minister, said of the decision to suspend the AstraZeneca shot: “The most important thing for confidence is transparency.” He said both first and second doses would be affected by the suspension.

German authorities have encouraged anyone who feels increasingly ill more than four days after receiving the shot — for example, with persistent headaches or dot-shaped bruises — to seek medical attention.

Germany has received slightly over 3 million doses of the AstraZeneca vaccine, and about half of those have so far been administered, compared with almost 7 million of the Pfizer shot and about 285,000 from Moderna.

The head of the Spanish Medicines Agency, Maria Jesús Lamas, said Spain detected its first case of clots last Saturday. She said the ban was “not an easy decision” because it further slows the national vaccination campaign, but it was the “most prudent” approach.

Almost 940,000 people in Spain have received the AstraZeneca shot.

Europe, meanwhile, is reimposing restrictions in a bid to beat back a resurgence in infections, many of them from variants of the original virus.

In Italy, 80% of children nationwide couldn’t attend classes after stricter rules in more regions took effect on Monday. In Poland, bolstered restrictions were applied to two more regions, including Warsaw. Paris could go into lockdown in a matter of days because intensive care units are getting swamped with COVID-19 patients.

 

Halo Life Mask Meets ASTM Standard

The Halo Life mask was also recently certified by public safety organization ASTM International. This is a big deal. The ASTM released much-needed standards for face masks—which are the first of its kind—in mid-February. 

In order to be certified by the ASTM, companies must show that their masks meet standards of breathability and fit and have the ability to filter out particles at least 0.3 microns, the typical size of aerosols that contain viruses and bacteria. The Halo Life face mask made the cut and was in the first group of masks to ever be awarded this certification.

The mask is crafted with two layers: A polyester outer layer with a honeycomb look and a lining made of bamboo. Why bamboo? It’s cooling and naturally antibacterial, so it can help get rid of germs and prevent the mask from getting smelly with time and repeat use. The mask also contains a nanotechnology filter that captures more than 99.8 percent of airborne particulates. So, technically, it’s a three-layer mask.

The mask itself is durable, its filter lasts for more than 200 hours before it should be replaced. The mask is usually $35. Extra filters are $4 each. So the cost is 2 cents per hour. If masks were worn 1000 hours per year the cost would be $20 per year.

The performance has been verified by Nelson Laboratories.