The US Department of Labor’s Occupational Safety and Health Administration said Tuesday it will be withdrawing the vaccination and testing emergency temporary standard for businesses with 100 or more employees, according to a statement on the agency’s website.

“Although OSHA is withdrawing the vaccination and testing ETS as an enforceable emergency temporary standard, the agency is not withdrawing the ETS as a proposed rule. The agency is prioritizing its resources to focus on finalizing a permanent COVID-19 Healthcare Standard,” the statement read.

The withdrawal of the emergency temporary standard “does not affect the ETS’s continuing status as a proposed rule,” a US Department of Labor spokesperson told CNN in a statement.

“OSHA is evaluating the record and the evolving course of the pandemic. OSHA has made no determinations at this time about when or if it will finalize a Vaccination and Testing rule. The agency intends to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards,” the spokesperson added.

The decision comes less than two weeks after the Supreme Court blocked the rule, dealing a major blow to President Joe Biden’s attempts to use the power of the federal government to combat the COVID-19 pandemic. OSHA’s regulation required businesses with 100 or more employees to ensure their workers are fully vaccinated or undergo regular testing and wear face coverings at work.

“After evaluating the Court’s decision, OSHA is withdrawing the Vaccination and Testing ETS as an enforceable emergency temporary standard,” OSHA wrote in a document set to be published in the Federal Register.

“OSHA strongly encourages vaccination of workers against the continuing dangers posed by COVID-19 in the workplace,” the agency also noted in its statement Tuesday.

The withdrawal will be effective Wednesday, according to OSHA’s statement.

The President has emphasized the necessity of getting vaccinated against the virus for months and eventually decided to use the mandate on large employers as his main vehicle for convincing hesitant Americans to get their shots.

In freezing a lower court opinion that allowed the regulation to go into effect nationwide, the Supreme Court majority sent a clear message that OSHA, charged with protecting workplace safety, had overstepped its authority. In contrast, the justices said that a separate agency could issue a rule to protect the health and safety of Medicare and Medicaid patients.

The rule would have affected some 80 million individuals. There would have been exceptions for those with religious objections.

The court allowed the vaccine policy rolled out in November by the US Department of Health and Human Services’ Centers for Medicare & Medicaid Services to take effect. It sought to require the COVID-19 vaccine for certain health care workers at hospitals, nursing homes and other facilities that participate in Medicare and Medicaid programs.

This story has been updated with additional reporting.

Source: https://www.cnn.com/2022/01/25/politics/vaccine-mandate-osha-withdrawn/index.html

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Biden voiced disappointment with the conservative-majority court’s decision to halt his administration’s rule requiring vaccines or weekly COVID-19 tests for employees at businesses with at least 100 employees. Biden said it now is up to states and employers to decide whether to require workers “to take the simple and effective step of getting vaccinated.”

The court was divided in both cases, centering on pandemic-related federal regulations at a time of escalating coronavirus infections driven by the Omicron variant in a nation that leads the world with more than 845,000 COVID-19 deaths.

It ruled 6-3, with the six conservative justices in the majority and three liberal justices dissenting, in blocking the rule involving large businesses – a policy that applied to more than 80 million employees. The court’s majority downplayed the risk COVID-19 specifically poses in the workplace, comparing it instead to “day-to-day” crime and pollution hazards that individuals face everywhere.

The vote was 5-4 to allow the healthcare worker rule, which requires vaccination for about 10.3 million workers at 76,000 healthcare facilities including hospitals and nursing homes that accept money from the Medicare and Medicaid government health insurance programs for elderly, disabled and low-income Americans. Two conservatives, Chief Justice John Roberts and Justice Brett Kavanaugh, joined the liberals in the majority in that case.

In a statement, Biden said the court’s decision allowing the healthcare worker mandate “will save lives” and his administration will enforce it. Workers must be vaccinated by the end of February.

The court heard arguments last Friday in the legal fight over temporary mandates issued in November by two federal agencies aimed at increasing U.S. vaccination rates and making workplaces and healthcare settings safer. The cases tested presidential powers to address a swelling public health crisis.

In an unsigned ruling, the court said the rule affecting large businesses, issued by the Occupational Safety and Health Administration (OSHA), was not an ordinary use of federal power.

“It is instead a significant encroachment on the lives – and health – of a vast number of employees,” the court said.

“Permitting OSHA to regulate the hazards of daily life – simply because most Americans have jobs and face those same risks while on the clock – would significantly expand OSHA’s regulatory authority without clear congressional authorization,” the court added.

Challengers led by the state of Ohio and the National Federation of Independent Business (NFIB), which represents employers, asked the justices to block OSHA’s rule after a lower court lifted an injunction against it. Companies were supposed to start showing they were in compliance starting this past Monday.

In dissent, Justice Stephen Breyer wrote on behalf of the liberal justices that the decision “stymies the federal government’s ability to counter the unparalleled threat that COVID-19 poses to our nation’s workers.”

‘Welcome relief’
“Today’s decision is welcome relief for America’s small businesses, who are still trying to get their business back on track since the beginning of the pandemic,” said Karen Harned, executive director of the NFIB’s legal arm.

The high court blocked a Dec. 17 decision by the Cincinnati-based 6th U.S. Circuit Court of Appeals that had allowed the mandate to go into effect.

In the healthcare facilities case, the court’s differently comprised majority concluded that the regulation “fits neatly” within the power Congress conferred on the government to impose conditions on Medicaid and Medicare funds, which includes policies that protect health and safety.

“After all, ensuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm,” the court said.

Four conservative justices dissented from the healthcare facility decision, concluding that Congress had not given the federal agency the authority to require vaccinations for millions of healthcare workers. In one dissent, Justice Samuel Alito doubted that the agency can “put more than 10 million healthcare workers to the choice of their jobs or an irreversible medical treatment.”

The justices lifted orders by federal judges in Missouri and Louisiana blocking the policy in 24 states, allowing the administration to enforce it nearly nationwide. Enforcement was blocked in Texas by a lower court in separate litigation not at issue before the Supreme Court.

Gerald Harmon, president of the American Medical Association physicians group, said that although he is pleased the court allowed the healthcare worker mandate, the broader workplace rule is also needed.

“Workplace transmission has been a major factor in the spread of COVID-19,” Harmon added. “Now more than ever, workers in all settings across the country need commonsense, evidence-based protections against COVID-19 infection, hospitalization and death.”

(REUTERS)

Source: https://www.france24.com/en/americas/20220113-us-supreme-court-blocks-biden-s-vaccine-or-test-mandate-for-businesses

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WASHINGTON (AP) — President Joe Biden’s sweeping new vaccine requirements have Republican governors threatening lawsuits. His unapologetic response: “Have at it.”

The administration is gearing up for another major clash between federal and state rule. But while many details about the rules remain unknown, Biden appears to be on firm legal ground to issue the directive in the name of protecting employee safety, according to several experts interviewed by The Associated Press.

“My bet is that with respect to that statutory authority, they’re on pretty strong footing given the evidence strongly suggesting … the degree of risk that (unvaccinated individuals) pose, not only to themselves but also unto others,” said University of Connecticut law professor Sachin Pandya.

Republicans swiftly denounced the mandate that could impact 100 million Americans as government overreach and vowed to sue, and private employers who resist the requirements may do so as well. Texas Gov. Greg Abbott called it an “assault on private businesses” while Gov. Henry McMaster promised to “fight them to the gates of hell to protect the liberty and livelihood of every South Carolinian.” The Republican National Committee has also said it will sue the administration “to protect Americans and their liberties.”

Such cases could present another clash between state and federal authority at a time when Biden’s Justice Department is already suing Texas over its new state law that bans most abortions, arguing that it was enacted “in open defiance of the Constitution.”

The White House is gearing up for legal challenges and believes that even if some of the mandates are tossed out, millions of Americans will get a shot because of the new requirements — saving lives and preventing the spread of the virus.

Biden is putting enforcement in the hands of the Occupational Safety and Health Administration, which is drafting a rule “over the coming weeks,” Jeffrey Zients, the White House coronavirus response coordinator, said Friday. He warned that “if a workplace refuses to follow the standard, the OSHA fines could be quite significant.”

Courts have upheld vaccination requirements as a condition of employment, both before the pandemic — in challenges brought by health care workers — and since the coronavirus outbreak, said Lindsay Wiley, director of the Health Law and Policy Program at American University Washington College of Law.

Where Biden’s vaccine requirements could be more open to attack is over questions of whether the administration followed the proper process to implement them, she said.

“The argument that mandatory vaccination impermissibly infringes on bodily autonomy or medical decision making, those arguments have not been successful and I don’t expect that to change,” Wiley said. “I think the challenges that are harder to predict the outcome of are going to be the ones that are really sort of the boring challenges about whether they followed the right process.”

Emergency temporary standards — under which the rules are being implemented on a fast track — have been particularly vulnerable to challenges, Wiley said. But the risks presented by the coronavirus and the existence of a declared public health emergency could put this one “on stronger footing than any other ones past administrations have tried to impose that have been challenged in court,” she said.

Indeed, the question of whether the mandate is legally sound is separate from whether it will be upheld by judges, including by a conservative-majority Supreme Court which has trended toward generous interpretations of religious freedom and may be looking to ensure that any mandate sufficiently takes faith-based objections into account.

Vaccination “has become politicized and there are many Republican district judges who might be hostile to the regulation for political reasons,” said Michael Harper, a Boston University law professor.

“I could imagine an unfortunate opinion that attempted to justify this political stance by rejecting the use of OSHA against infectious disease rather than against hazards intrinsic to the workplace,” Harper wrote in an email.

The expansive rules mandate that all employers with more than 100 workers require them to be vaccinated or test for the virus weekly, affecting about 80 million Americans. And the roughly 17 million workers at health facilities that receive federal Medicare or Medicaid also will have to be fully vaccinated.

Biden is also requiring vaccination for employees of the executive branch and contractors who do business with the federal government — with no option to test out. That covers several million more workers.

Republican-dominated Montana stands alone in having a state law on the books that directly contradicts the new federal mandate. The state passed a law earlier this year making it illegal for private employers to require vaccines as a condition for employment.

But University of Montana constitutional law professor Anthony Johnstone said the federal rules would trump the state law. That means larger Montana businesses that previously couldn’t require their employees to get vaccinated will now likely be required to, including hospitals that are some of the largest employers in the sparsely populated state.

Given that the rules are still being drafted and haven’t been released, experts say the devil is in the details. It remains to be seen exactly what the rule will require employers to do or not do, and how it accounts for things such as other rights that unvaccinated employees may assert, such as the right to a disability accommodation, Pandya said.

For example — with the growing number of fully remote businesses and workers — if the rules are written to include people who don’t have workplace exposure, “there certainly is room for an issue there,” said Erika Todd, an employment attorney with Sullivan & Worcester in Boston.

Charles Craver, a labor and employment law professor at George Washington University, said the mandate presented a “close question” legally. But he said the Biden administration did have a legitimate argument that such a requirement was necessary for employers to protect the safety of workers, customers and members of the public.

The thornier question, though, is how employers — and courts — will sort through requests for accommodations for employees on religious or other grounds.

Though such accommodations may include having an employee work from home, “you can have a situation where someone has to be present and you can’t provide an accommodation because of the danger involved,” he added.

“I would not be a betting person if this went up before the Supreme Court,” Craver said. “I could even picture the court divided 5-4, and I wouldn’t bet which way it would go.”

____

Richer reported from Boston. Reporter Iris Samuels contributed to this report from Helena, Montana. Samuels is a corps member for The Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

Source: https://www.wnct.com/news/politics/bidens-vaccine-rules-to-set-off-barrage-of-legal-challenges-2/

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It is important to recognize that the optimal way to prevent airborne transmission is to use a combination of interventions from across the hierarchy of controls, not just PPE alone.

COVID-19 Resources on Face Masks and Surgical Masks

• Face Masks and Surgical Masks for COVID-19: Includes FAQs on manufacturing, purchasing, importing, and donating masks
• FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic
• Surgical Mask and Gown Conservation Strategies – Letter to Health Care Providers Includes conventional capacity strategies, contingency capacity strategies, and crisis or alternate strategies (if masks are running low and if no masks are available)

On this page:

• N95 Respirators Not for Use by the General Public
• CDC Recommends Cloth Face Coverings for Use by the General Public
• Surgical Masks
• N95 Respirators
• Comparing Surgical Masks and Surgical N95 Respirators
• General N95 Respirator Precautions
• Decontaminating Respirators
• N95 Respirators in Industrial and Health Care Settings

N95 Respirators Not for Use by the General Public

The Centers for Disease Control and Prevention (CDC) does not recommend that the general public wear N95 respirators to protect themselves from respiratory diseases, including coronavirus (COVID-19). Those are critical supplies that must continue to be reserved for health care workers and other medical first responders, as recommended by current CDC guidance.

CDC Recommends Cloth Face Coverings for Use by the General Public

The CDC recommends that members of the public use simple cloth face coverings when in a public setting to slow the spread of the virus since this will help people who may have the virus and do not know it from transmitting it to others. For more information, see the CDC’s Recommendation Regarding the Use of Cloth Face Coverings, Especially in Areas of Significant Community-Based Transmission.

The best way to prevent illness is to avoid being exposed to this virus. However, as a reminder, the CDC always recommends everyday preventive actions, such as hand washing and maintaining at least 6 feet of social distancing, to help prevent the spread of respiratory diseases.

Surgical Masks

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield. These are often referred to as face masks, although not all face masks are regulated as surgical masks.

Surgical masks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the face mask and how well the surgical mask protects you.

If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others.

While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.

Surgical masks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the face mask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag, and put it in the trash. Wash your hands after handling the used mask.

N95 Respirators

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.

The similarities among surgical masks and surgical N95s are:

• They are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), flammability, and biocompatibility.
• They should not be shared or reused.

Comparing Surgical Masks and Surgical N95 Respirators

The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Note that the edges of the mask are not designed to form a seal around the nose and mouth.

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.

The similarities among surgical masks and surgical N95s are:

• They are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), flammability, and biocompatibility.
• They should not be shared or reused.

General N95 Respirator Precautions

• People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should check with their health care provider before using an N95 respirator because the N95 respirator can make it more difficult for the wearer to breathe.
• Some models have exhalation valves that can make breathing out easier and help reduce heat build-up. Note that N95 respirators with exhalation valves should not be used when sterile conditions are needed.
• All FDA-cleared N95 respirators are labeled as “single-use,” disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator, discard it properly, and replace it with a new one. To safely discard your N95 respirator, place it in a plastic bag, and put it in the trash. Wash your hands after handling the used respirator.
• N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection.

Decontaminating Respirators

The FDA has issued Emergency Use Authorizations (EUAs) for the emergency use of decontamination systems for use in decontaminating certain respirators used by health care personnel when there are insufficient supplies of new respirators resulting from the COVID-19 pandemic. New FDA-cleared N95 respirators or NIOSH-approved N95 respirators or other FDA authorized respirators are always the first choice before a decontaminated respirator.

• If a used respirator that is FDA-cleared or NIOSH-approved is available and a new respirator covered under one of the FDA Emergency Use Authorizations for respirators is not available, you may consider decontaminating and reusing the used respirator with a decontamination system that has an FDA Emergency Use Authorization, if the used respirator is compatible with the decontamination system.
• If your facility is using respirators that have been subsequently removed from Appendix A, these respirators are no longer authorized by FDA for single use or for reuse by an FDA authorized decontamination system.
• Additionally, as of June 6, 2020, any respirator authorized by the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, or any respirators with exhalation valves are not authorized to be decontaminated by any of the authorized decontamination systems.
• If you have concerns about respirators or questions about the packaging, labeling, or quality of the respirators, consider replacing, discarding, or returning the respirators to the distributor.

Respirators that are NIOSH-approved before decontamination only retain their NIOSH approval status post-decontamination if the respirator manufacturer permits the use of the decontamination method with the specific system and cycle parameters. To determine the NIOSH approval status of a specific decontaminated NIOSH-approved respirator, please check with the respirator manufacturer.

N95 Respirators in Industrial and Health Care Settings

Most N95 respirators are manufactured for use in construction and other industrial-type jobs that expose workers to dust and small particles. They are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC).

However, some N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.

N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:

• The respirator is intended to prevent specific diseases or infections, or
• The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
• The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).

The FDA has a Memorandum of Understanding (MOU) with CDC NIOSH which outlines the framework for coordination and collaboration between the FDA and NIOSH for the regulation of this subset of N95 respirators.

For additional differences between surgical masks and N95 respirators, please see CDC’s infographic.

Source: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks

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