S.J. Gualardo President, National Safety Consultants Inc.
Meeting testimony 10/22/21
The White House - Office of Management and Budget (OMB) - Office of Information and Regulatory Affairs (OIRA)
Meeting testimony 10/22/21
The White House - Office of Management and Budget (OMB) - Office of Information and Regulatory Affairs (OIRA)
My name is Samuel J Gualardo and I am President of National Safety Consultants, Inc.
Thank you for the opportunity to provide comments on the COVID-19 Vaccination and Testing Emergency Temporary Standard Rulemaking
I am an expert in the field of Occupational Safety and Health serving in the manufacturing, insurance, power and gas utility, academia, government, consulting, …and legal arenas over the past 41 years.
I recently retired as the Director of OSHA Consultation program for the state of Pennsylvania… under federal OSHA.
I hold a B.S. in Safety Management …and an M.A. Degree in Labor/Industrial Relations. I am also CSP…which is a certified safety professional… the most recognized credential in the occupational safety and health management field.
Over the years I've served as the president of the American Society of Safety Engineers, …the president of the Board of Certified Safety Professionals …and have been recognized as a Fellow by the American Society of Safety Engineers.
My comments regarding the Emergency Temporary Rulemaking are as follows:
The stated purpose of the Occupational Safety and Health Act of 1970 is to: to assure safe and healthful working conditions for working men and women in US workplaces.
Specifically, Section 5(a)(1) of the Occupational Safety and Health Act, stipulates that : Each employer --shall furnish to each of his employees… employment and a place of employment …which are free from recognized hazards that are causing… or are likely to cause death or serious physical harm… to his employees. … However, the Emergency Temporary Standard cannot possibly accomplish that requirement for the following reasons:
1) Never in its …history …since 1970 …has OSHA created a standard or regulation to deal with a “serious hazard” …which was applicable to workers in establishments with over 100 workers.
Employers of small businesses under 100 workers employ well over 40 million workers in the US …according to the US Small Business Administration. Those workers will be exposed to the same… “serious hazard” and will not be required to meet the vaccine mandate requirements.
Let me be clear…I am not advocating an extension of this emergency temporary standard to employers with less than 100 employees… I'm merely stating that it is illogical and totally inconsistent with any previous OSHA rulemakings.
2)The CDC has confirmed that existing vaccines wane in their effectiveness over time …and will expose fellow vaccinated workers to death or serious physical harm. This is contrary to the Occupational Safety and Health Act …employer General Duty requirement.
3) Booster vaccines have already proven to wane in their effectiveness in other countries …and will expose vaccinated workers to death or serious physical harm in the US. This is contrary to the Occupational Safety and Health Act …employer General Duty requirement.
4) The CDC and WHO have confirmed that vaccinated persons experience significant breakthrough potential of the COVID-19 virus …and this will expose vaccinated workers to death or serious physical harm. This is contrary to the Occupational Safety and Health Act …employer General Duty requirement.
5) The CDC and WHO have confirmed that vaccinated workers can carry a high viral load of the COVID-19 virus …and this will expose vaccinated workers to death or serious physical harm. This is contrary to the Occupational Safety and Health Act … employer General Duty requirement.
6) Even if vaccinated, workers will continue to be exposed to unvaccinated customers and visitors, as well as family members and others infected while off duty…which can potentially cause death or serious physical harm of workers. This is contrary to the Occupational Safety and Health Act …employer General Duty requirement.
7) VAERS and similar global vaccine injury data have clearly confirmed that COVID-19 vaccines can cause substantial injuries and deaths. This is contrary to the Occupational Safety and Health Act … employer General Duty requirement.
8) Persons with natural immunity antibodies as a result of previous COVID-19 exposure will be forced to take vaccinations ….which can cause death or serious physical harm. This too is contrary to the Occupational Safety and Health Act … employer General Duty requirement.
Any OSHA standard or regulation must be based on sound science and on clear evidence.
Current data reveals …that more persons have been infected and have died after vaccines began in the US on December 14, 2020, …than from the beginning of the COVID-19 pandemic.
Emerging US and global data, as confirmed by the CDC has proven beyond a reasonable doubt that… COVID-19 breakthrough cases are increasing significantly …among vaccinated persons.
The CDC fully admitted that COVID-19 vaccines do not prevent disease transmission…do not prevent serious illness and hospitalization…and do not prevent death.
The CDC’s own website states that …Vaccine breakthrough cases are expected…no vaccine is 100% effective at preventing illness. Some fully vaccinated people will get sick, and some will even be hospitalized or die from COVID-19. (https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.htm)
As confirmed by the CDC, the science and evidence proves that vaccinated and unvaccinated persons can easily spread COVID-19. As a result…an employer vaccine mandate cannot possibly stop transmission of COVID-19 to workers.
Unless workers, customers and visitors at workplaces are tested pre-entry with reliable (rapid) COVID-19 tests, …workers will be exposed to the COVID-19 virus …and a vaccine mandate will not prevent that exposure.
If this proposed ETS is truly about prevention of injuries and deaths of workers…Pre-entry testing is the only method available… that will detect the presence of the virus and prevent exposure to workers.
The proposed ETS is unworkable from numerous perspectives. Just one example… is on multiemployer worksites and at similar workplaces employing temporary workers …where some workers are employed by firms with less than 100 workers and others are employed by firms with over 100 workers. Those employers with more than 100 employees would be required to have vaccinated workers …and those with less than 100 would not… Again, this is not logical …and very unworkable…
Similarly, how will an employer with over 100 workers deal with vendors or contractors at their workplace… if the vendor or contractor works for an employer with less than 100 workers?
The employer costs to manage compliance with this proposed ETS …and the labor strife it will cause will be substantial…but most important…the terminations and resignations of experienced workers …will harm businesses and the US economy beyond calculation…
I also firmly believe …that if this emergency temporary standard is enacted…future workplace safety standards and regulations promulgated by OSHA, …The Occupational Safety and Health Administration itself … and the broader safety and health management profession….will be immeasurably harmed…and their future effectiveness and respect will be severely diminished….
Assuming this Emergency Temporary Standard is promulgated… and vaccines are mandated….Employers will not be able to answer one simple question from their workers.
That question is this… Am I protected from the Covid virus while working here?
…There is no employer …who will be able to answer that question affirmatively…if they rely on mandatory vaccines to assure that protection…
Thank you for the opportunity to submit my comments on this important matter.
Do you have any question for me?
Formal Comments submitted to OSHA (11/10/21)
Re: Covid 19 Vaccination and Testing Emergency Temporary Standard
Samuel J. Gualardo, President, National Safety Consultants Inc.
The Occupational Safety and Health Administration recently released an Emergency Temporary Standard (ETS) for COVID-19 vaccination and testing. This ETS and numerous other related Executive Orders including 12196, 13991,14042, and 14043 from the Biden Administration applicable to employers will create undue hardships on U.S. employers. Most important, the vaccination provisions of the ETS and other related Executive Orders will not prevent transmission, infection, serious illness and death of COVID-19 to vaccinated or unvaccinated workers, which is the primary purpose of these initiatives. The following will analyze the OSHA ETS.
The Occupational Safety and Health Administration (OSHA) is issuing an ETS to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination. Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.
There are several inconsistencies and conflicts between the OSHA ETS and the above noted Executive Orders including the issuance of differing rules for government contractors and healthcare organizations, imposing vaccine and testing mandates for workplaces over 100 workers, and excluding members of Congress and their staff members.
Among other outcomes, these inconsistencies will produce confusion among employers such as: unnecessary worker terminations and resignations, the inability to create worker equity in organizations required to comply with conflicting rules and lawsuits by those treated unfairly or in an inequitable manner. However, most important, it is highly illogical and beyond reason for the Occupational Safety and Health Administration to exclude such a significant population of workers and permit exposure to this OSHA defined “grave” danger. Never in the history of OSHA has such exclusions been granted. Although vaccines as a proven method to eliminate worker exposure to COVID-19 will be disputed in the following information, employers with less than 100 employees will not be required to enforce frequent worker testing, which is arguably the most appropriate control measure to eliminate worker exposure to infected coworkers.
Another glaring inconsistency is the fact that OSHA’s Bloodborne Pathogen standard permits workers to decline Hepatitis B vaccinations post exposure. It is well established that chronic Hepatitis B infection can lead to serious illnesses such as cirrhosis and liver cancer, obviously grave outcomes. However, employees can simply decline by signing a vaccine declination form post exposure. This significant inconsistency alone calls into question the ability of OSHA and employers to force vaccine mandates in the healthcare environment, and among various government workers and contractors.
OSHA shall issue an ETS if the agency determines that employees are subject to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and an ETS is necessary to protect employees from such danger.
It is virtually impossible for any employer and OSHA to accurately determine whether an infected employee contracted COVID-19 in the workplace or in an off the job setting. Arguably, most vaccinated and unvaccinated workers have substantially more exposure to COVID-19 while off the job in both community and home environments. It is equally impossible for any employer and OSHA to accurately determine whether an infected employee contracted COVID-19 from a vaccinated verses an unvaccinated person due to the high and substantially increasing prevalence of breakthrough COVID-19 cases among vaccinated persons.
Any data used by OSHA to discern that COVID-19 is a grave danger to workers based on workplace exposure is highly inaccurate for the above mentioned reasons. To conclude that COVID-19 workplace exposure singularly creates a “grave danger” has not been supported by scientific evidence. Moreover, of the known human diseases caused by coronavirus, SARS-CoV-2 has a cumulative case fatality rate of 1.6. SARS-CoV-1 has a case fatality rate of 10% and MERS has a case fatality rate of 34%. Admittedly, although SARS-CoV-2 has become more widespread, by comparison, SARS-CoV-2 (COVID-19) is much less grave than SARS-CoV-1 and MERS and no Emergency Temporary Standard was ever issued by OSHA for those highly contagious and deadly viruses. The fact that no ETS was issued by OSHA for those diseases affecting workers is not consistent with the need to issue an ETS for SARS-CoV-2 (COVID-19).
COVID-19 has killed over 725,000 people in the United States in less than two years, and infected millions more (CDC, October 18, 2021 – Cumulative US Deaths). Data suggesting that COVID has killed over 725,000 people in the United States and has infected millions more has not been supported by validated scientific evidence. Furthermore, it is not reflected of the working population.
It is well known that the data collection systems used for this information are not consistent throughout the U.S. The CDC has clearly and repeatedly admitted that the vast majority of deaths have resulted in persons with comorbidities and that roughly 75% of those deaths involved persons not of working age, 65 years old and older.
COVID-19 vaccines authorized or approved by the U.S. Food and Drug Administration (FDA) effectively protect vaccinated individuals against severe illness and death from COVID-19, unvaccinated individuals remain at much higher risk of severe health outcomes from COVID-19.
To suggest that COVID-19 vaccines authorized and approved by the U.S. Food and Drug Administration (FDA) effectively protect vaccinated individuals against severe illness and death from COVID-19 is inaccurate and misleading. The Agency’s own research demonstrates that the three vaccines approved or authorized for the prevention of COVID-19 in the U.S are not preventing COVID-19 and have substantially waned in their effectiveness in preventing infection post vaccination over time. Moreover, the studies relied upon by OSHA to conclude vaccine effectiveness did not incorporate very recent findings. OSHA totally relied upon aged studies not referencing the diminishing effectiveness of the current vaccines.
To illustrate the point of decreasing vaccine effectiveness and safety, recently researched state Department of Health website data for 26 states that list cumulative breakthrough infection data as of Oct. 29, 2021. Many of the remaining 24 states do not have data published, or it is difficult to discern.
This cumulative data revealed that there have been 804,676 vaccine reported breakthrough cases since these states began counting breakthrough cases. Note that some states began counting these cases 6-8 months ago, while others just started within the last couple of months. Of those 804,676 vaccine breakthrough cases, 38,038 resulted in hospitalization and 7387 resulted in the death of those infected. Again, this data only represents 26 states. Data from all 50 states would undoubtedly show a doubling of these numbers. Moreover, numerous breakthrough cases, hospitalizations and deaths have not been reported, as they are not counted as breakthrough cases unless symptoms occurred 14 days after the last vaccine inoculation. Additionally, many cases are also not counted as they are asymptomatic and no verification testing has occurred to validate COVID-19 infection.
In addition to the increasing breakthrough cases, a simple comparison of current and historical data from the UK and Germany, which are similar industrialized countries to the U.S., question the effectiveness of vaccines. In December 2020 when the vaccination rollout began in the U.S. and Europe, no persons were vaccinated. On December 11, 2020, the UK had a 7 day rolling average of 250 confirmed cases/million people. As of November 6, 2021, 67 percent of their population is fully vaccinated and the seven day rolling average has increased to 532 cases/million people. Similarly, Germany had a seven day rolling average of 266 cases at the time the vaccine was rolled out in the U.S. The current 7 day rolling average for Germany as of November 6, 2021, is 291 confirmed cases/million people. Germany has nearly 66% of its population fully vaccinated. Remarkably, both of these industrialized countries have lost ground since vaccinations began, despite having much higher vaccination rates than the US, which currently stands at 57% of its population fully vaccinated.
Although cases in the U.S. are currently leveling off, historical trends have demonstrated that the U.S. is only a few weeks behind Europe and will more than likely see another case spike shortly. It is also important to note that the U.S. has experienced more cases since vaccinations began than prior to them being administered beginning in December of 2020. Therefore, if vaccines were truly effective at combating COVID-19, the U.S. and other countries would not be experiencing these trends.
Unvaccinated workers are much more likely to contract and transmit COVID-19 in the workplace than vaccinated workers. At the present time, workers are becoming seriously ill and dying as a result of occupational exposures to COVID-19, when a simple measure, vaccination, can largely prevent those deaths and illnesses.
Although there is no dispute that some workers may contract COVID-19 from coworkers in an occupational setting, there is no conclusive evidence demonstrating that the majority of workers diagnosed with COVID-19 were actually infected in a workplace setting.
Importantly, as reported by the CDC in July 2021, the Delta infection has resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated persons. Accordingly, at that time, the CDC confirmed and stated that high viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus.
The ETS protects these workers through the most effective and efficient control available – vaccination – and further protects workers who remain unvaccinated through required regular testing, use of face coverings, and removal of all infected employees from the workplace.
Vaccinations have been determined by vaccine manufacturers and confirmed by the CDC to have varying degrees of initial and long term effectiveness. The vaccine manufacturers and the CDC also report that no vaccine is 100% effective. Thus, vaccinated persons can be infected with and easily transmit COVID-19. As stated earlier, this trend is increasing over time as breakthrough infections are now occurring exponentially among vaccinated persons. Moreover, vaccines have already proven to wane in their effectiveness over time causing breakthrough cases and the need to administer booster vaccines for those vaccinated. Additionally, many of these breakthrough cases are asymptomatic and a vaccinated person may expose both vaccinated and unvaccinated persons when working.
If reliable rapid testing is not performed daily for each employee, (vaccinated and unvaccinated) there is no possible way to determine whether any worker is free of the COVID-19 infection. Utilizing the Hierarchy of Controls, the only way to eliminate exposure to COVID-19 is to assure that it is not present in the workplace. Although it is not totally possible for all workplaces to prevent COVID-19 exposure to workers, (such as those where a public interface is necessary), reliable rapid daily testing will greatly identify and prohibit infected persons from remaining in the workplace and exposing fellow workers.
With respect to personal protective equipment, as OSHA should be well aware through NIOSH studies, the face coverings used by most workers in most workplaces do not meet the necessary filtering criteria to prevent COVID-19 aerosol droplet exposure. Furthermore, compounding this concern is that most workers are wearing masks incorrectly regardless of their filtering effectiveness. Thus, for OSHA and employers to rely on ineffective and improperly worn masks to protect vaccinated and unvaccinated workers from COVID-19 exposure is not an adequate control measure. With respect to the ETS intent of protecting workers, it cannot be denied that vaccines can also produce injuries and potentially deaths of workers, which is contrary to the stated purpose of the Occupational Safety and Health Act.
Recent data produced by the CDC showed that between Dec. 14, 2020, and Oct. 29, 2021, a total of 856,919 adverse events following COVID vaccines were reported to the Vaccine Adverse Event Reporting System (VAERS). Excluding “foreign reports” to VAERS, 634,609 adverse events, including 8,284 deaths and 52,685 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Oct. 29, 2021. Of the 8,284 U.S. deaths reported, 10% occurred within 24 hours of vaccination, 15% occurred within 48 hours of vaccination and 26% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
A study conducted for the U.S. Department of Health and Human Services and numerous reports have confirmed that data reported to VAERS only represents a small fraction of the total adverse vaccine events reported. Types of reported adverse events from vaccines include: anaphylaxis, myocarditis and pericarditis, reports of blood clotting disorders, cardiac disorders causing death, miscarriage or premature birth, Guillain-Barré syndrome and other neurological disorders.
Importantly, vaccine adverse events have been clearly acknowledged by vaccine manufacturers and the CDC. As a result, precautionary information including many of the abovementioned adverse reactions have been established and are listed for all vaccines by the CDC for each vaccine manufacturer. Thus, although vaccines may help in preventing some undesirable COVID-19 outcomes, it is indisputable that vaccine mandated by employers following OSHA’s ETS and the various Executive Orders will result in some workers being injured or perhaps worse.
Remarkably, there is no provision in the ETS for employers to consider natural immunity of workers who have already been infected with COVID-19. The CDC has promoted vaccines and has overwhelmingly discounted natural immunity of those already infected. However, it is clearly obvious from the emerging data that vaccines are not providing adequate long term protection. There is also emerging data, such as that reported by the National Institutes of Health that natural immunity may prove to offer greater long term protection than vaccines. For OSHA to ignore this data and mandate a solution that is waning in effectiveness, and fully proven as not being able to prevent COVID-19, transmission, infection, serious illness and death, is very concerning.
Based on its enforcement experience during the pandemic to date, that continued reliance on existing standards and regulations, the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1), and workplace guidance, in lieu of an ETS, is not adequate to protect unvaccinated employees from the grave danger of being infected by, and suffering death or serious health consequences from, COVID-19.
OSHA will continue to monitor trends in COVID-19 infections and death as more of the workforce and the general population become fully vaccinated against COVID-19 and the pandemic continues to evolve. Where OSHA finds a grave danger from the virus no longer exists for the covered workforce (or some portion thereof), or new information indicates a change in measures necessary to address the grave danger, OSHA will update this ETS, as appropriate.
It has been widely reported that COVID-19 will never be eradicated as similar viruses still exist and circulate in society. Thus, it is unclear how OSHA will determine how and when a grave danger for workers no longer exists.
COVID-19 exposure in the U.S. has been known since January 2020. If this issue was so grave, why did the Agency wait until October 2021 to issue an Emergency Temporary Standard? If this issue was so grave, why is the ETS implementation being delayed until January 4, 2022? If this issue is so grave, and since the vast majority of workers are allegedly exposed to non-compliant employers now required to implement a vaccine or testing mandate, why did OSHA only issue COVID-19 related citations (most of which dealt with respiratory protection and recordkeeping) in 669 inspections conducted since January 1, 2020? If the workplace exposure was as grave as OSHA portrays, daily testing of workers should have been deployed from the beginning of the pandemic.
Finally, OSHA was promulgated to regulate workplace safety and health in the United States. According to CDC data, 75% of COVID-19 deaths thus far have occurred in persons beyond 65 years of age, most of which undoubtedly were not employed. This data reveals that COVID-19 is clearly a public health issue and not a workplace safety issue within the regulatory enforcement arena of OSHA.
Following the implementation of the ETS, will OSHA or any employer be able to affirmatively answer the following questions?
1) Can it be proven with clear indisputable evidence that a COVID-19 infected employee contracted the infection in the workplace?
2) Can an employer or OSHA assure that workers are fully protected from COVID-19 exposure when all workers are vaccinated?
3) Will the reliance on weekly testing and masks prevent COVID-19 exposure to workers?
The answer to the each of the above questions is no and unfortunately the stated purpose of the ETS to protect the health and safety of workers will remain unfulfilled.
The only way to prevent COVID-19 exposure in the workplace is to perform reliable accurate rapid COVID-19 testing of workers on a daily basis. Vaccines, masks, barriers etc. have not been proven scientifically to be effective in preventing COVID-19 transmission, infection, serious illness and death. As a result, daily worker testing is the only viable way to assure COVID-19 infection is not present and able to be spread freely among workers.
Samuel J. Gualardo, MA, CSP, FASSP
President, National Safety Consultants Inc.
Fellow, American Society of Safety Engineers (Professionals)