We have heard conflicting reports about the potential spread of COVID-19 to and from people and animals, and between animals. Many government and industry officials have stated that there is no evidence that dogs and cats can transmit the virus to humans. Yet, as discussed by veterinary pathologists in a recent paper, the “absence of evidence [of zoonotic, reverse zoonotic, or inter/intra species COVID transmission] is not the same thing as evidence of absence.” See “A Critical Needs Assessment for Research in Companion Animals and Livestock Following the Pandemic of COVID-19 in Humans.”

As stated in the abstract,

this article presents in chronological order data that both individually (as received independently from multiple countries) and collectively urge studies that elucidate the following questions.

  1. What animal species can be infected with SARS-CoV-2, the likely sources of infection, the period of infectivity, and transmissibility between these animals and to other animal species and humans?

  2. What are the best diagnostic tests currently available for companion animals and livestock?

  3. What expressions of illness in companion and other animal species can serve as disease markers?

The article discusses the “critical need for pathogenesis, pathology and diagnostic research in companion animals,” particularly domestic pet and feral cats and working dogs. In light of the increasing number cases diagnosed in cats who exhibited clinical signs of disease in addition to testing positive, it is critical to prevent mass abandonment of pets, as reported in China, after officials announced the potential of disease spread.

In light of the above, it was disconcerting to see the letter to USDA from the American Association of Zoo Veterinarians (AAZV) in support of a petition filed by PETA to ban the practice of “cub petting” – think Tiger King—in USDA licensed exhibitor facilities. See AZA and AAZV Letter to USDA on Emergency “Cub Petting” Petition.

The letter states that both associations,

would like to express our collective support for the recent petition from PETA to USDA seeking an emergency ban on the practice of ‘cub petting’ at USDA-licensed facilities due to transmissions concerns of COVID-19 to big cats.

While protecting exotic cats from exposure to COVID-19 is important, when an association as prestigious as AAZV warns against human-animal contact because of disease transmission concerns, this could create panic to pet cat owners, animal shelter staff and those managing feral cat populations.

Until there are robust, peer-reviewed studies of COVID-19 transmission to and through animal populations, we should avoid statements that could result in mass euthanasia or abandonment of pets perpetuated by fear.

For more comprehensive information about coronavirus in animals see a factsheet titled “SCIENCE-BASED FACTS & KNOWLEDGE ABOUT WILD ANIMALS, ZOOS AND SARS-COV-2 VIRUS” published by the European Association of Zoo and Wildlife Veterinarians providing facts “collected from reliable sources such as OIE, European National references laboratories, WHO, and pre COVID-19 scientific literature about coronavirus.”

In Part 1 of this blog, we discussed the new interim guidance for meat processing plants.  To combat concerns of a devastating reduction in our food supply chain, President Trump issued an Executive Order requiring processing plants to stay open.  Despite that order, some employees at these processing plants have expressed an intent not to return to work.  So, what options do employers have if their workers refuse to work?

First, as the interim guidelines suggest, employers should follow the guidance that has been issued for meat processing plants both by their state and by the CDC and OSHA.  Those guidelines will help protect employees from exposure to the virus and prepare employers to maintain critical operations with a reduced workforce.  Additionally, there is pre-existing guidance on this issue from prior outbreaks.  In response to the 2009 H1N1 Influenza (“swine flu”) outbreak, the Occupational Safety and Health Administration (“OSHA”) developed guidance addressing employee protections. These guidelines clarify when an employee may refuse to come to work or perform work due to a concern about their health and safety in the workplace. Generally speaking, this older guidance states that an employer cannot discriminate against employees who:

(1) Refuse, in good faith, to expose themselves to a dangerous job condition; and

(2) Believe they have no reasonable alternative but to avoid the workplace.

Critical to this guidance is that the “reasonable person” standard applies: the employee’s fear must be one that a reasonable person in similar circumstances would conclude poses a real danger of death or serious injury. Further, there must be insufficient time to eliminate the danger through regularly statutory enforcement channels. If these factors are met, an employer cannot discipline or discharge said employee.  On the other hand, if these factors are not met, employees are expected to come to work and perform their job functions.

In addition, employers should check their state COVID-19 orders. Some states, such as Michigan, have ordered that employers may not terminate or discipline employees for staying home from work if they or someone close to them tests positive for COVID-19 or exhibits its symptoms.

Keep in mind that employers must still follow pre-existing OSHA and federal and state anti-discrimination laws. For example, taking an employee’s temperature has been considered a “medical examination” under the ADA and is generally prohibited. However, the EEOC recently issued guidance temporarily relaxing this standard and permitting an employer during the COVID-19 pandemic to take the temperature of its employees in certain circumstances.  Helpfully, the interim guidelines expressly permit meat processing facilities to check their employees’ temperature.  However, other employers in the agricultural industry should check their state and any applicable CDC or OSHA guidance for their industry to determine if monitoring their employees’ temperature is warranted and/or permitted.

As indicated in Part 1 of this blog, the administration is developing what it refers to as liability guidelines that processing plants can implement.  Presumably, these liability guidelines will address how employers can protect themselves from liability in the event an employee or employees contract the virus.  In the meantime, employers should follow the current guidance below.

If an employee is diagnosed with COVID-19 in your workplace, employers should:

  • Notify potentially exposed employees, clients, vendors, or other guests;
  • If required by your state or local government, notify the local or state health authorities;
  • Protect the employee’s privacy and do not disclose the identity of the employee, or any health information gathered related to their condition;
  • Keep any health care documentation and any documents gathered during the investigation in a private health folder;
  • Do not allow the diagnosed employee to return to work before symptom-free for 72 hours or cleared by a physician or tested negative;
  • Require employees to monitor themselves for symptoms and stay home if sick;
  • Send home any sick employees, whether or not they have been diagnosed with COVID-19;
  • Clean and disinfect the workplace used by the diagnosed employee (the CDC has issued guidance on how to clean and disinfect your facility).

Visit Fox Rothschild’s COVID-19 Resource Center for more guidance on how to navigate employment decisions related to COVID-19 or contact us directly for assistance.

Workers in essential industries are increasingly concerned about their health and safety in the workplace. This is most clearly evidenced by the recent strikes, or threats of strikes, by employees at large manufacturing and distribution centers. Further, meat processing plants are reporting an increasing number of employees contracting COVID-19, requiring these plants to shut down or consider shutting down. Agricultural workers have been deemed essential by every state. These employees are essential to maintaining the health and welfare of the animals, continuing crops, and the production and processing of food items for the public. Therefore it is critical that these industries keep functioning.

Guidance for Meat Processing Plants

Meat processing plants appear to be particularly susceptible to employee exposure to COVID-19. This is largely due in part to the close proximity with each other in which processing workers work, the duration of shifts, and shared workspaces.  Further, workers in this industry commonly travel to work together.  In North Carolina alone, at least five hog and poultry processing plants have reported positive COVID-19 cases. As a result, on April 20, 2020, North Carolina state and agricultural officials issued Interim Guidelines in order to prevent exposure and contain the spread of the virus in processing plants. The guidelines list three key components to the prevention plan: 1) minimizing the risk for exposure to the virus; 2) early detection of people with symptoms of COVID-19; and 3) isolating suspected or positive cases from others until they are no longer infectious.

The guidelines further dictate that processing facilities should:

  • Create a COVID-19 Infection Control Plan;
  • Conduct worksite assessments to identify COVID-19 risks and prevention strategies;
  • Follow CDC interim guidance to implement safety practices for essential workers that may have been exposed to the virus;
  • Conduct contract tracing;
  • Follow the hierarchy of controls (engineering controls à cleaning/disinfection/sanitation à administrative controls à PPE and source control) when implementing infection control practices, and
  • Provide infection control information and training for all workers.

The specific details for each of these guidelines are clearly laid out in the Interim Guidelines. But the takeaway is that processing facilities need to identify and address the risk areas at the facilities (including transportation to the facilities), plan ahead for how to operate with a reduced workforce, adapt workspaces to allow for social distancing, pre-scan employees for fevers (>100.4 F) and other symptoms prior to entry into the facility, and require sick employees to stay home. These interim guidelines will be updated as more research and information is gathered.

On Sunday, April 26, the CDC and OSHA also issued interim guidance for meat and poultry processing facilities.  Similar to the North Carolina guidance, the CDC and OSHA recommend changing processing lines and workplace setups to permit social distancing between employees.  Importantly, the CDC and OSHA guidance recommends that meat and poultry processing facilities work directly with the appropriate state and local public health officials and OSHA professional to develop their COVID-19 assessment and control plans.

The CDC and OSHA interim guidance is in addition to prior OSHA guidance on the responsibilities of employers to provide safe workplaces during the COVID-19 outbreak. This guidance provides that employers should review the risks their employees face and implement mitigation plans.  Given this guidance, employers should:

  • Develop an infectious disease preparedness and response plan;
  • Prepare to implement basic infection prevention measures;
  • Develop policies and procedures for efficient identification and isolation of sick individuals;
  • Develop, implement and inform workers of workplace flexibilities and protections
  • Implement workplace controls, including engineering controls, administrative controls, and use of personal protective equipment.

Details on how to implement this guidance are available here.

On Tuesday, April 28th, President Trump signed an executive order requiring meat processing plants to stay open under the Defense Production Act.  The order states that closures of meat and poultry processing facilities “threaten the continued functioning of the national meet and poultry supply chain, undermining critical infrastructure during the national emergency.  Given the high volume of meat and poultry processed by many facilities, any unnecessary closures can quickly have a large effect on the food supply chain.”  As such, President Trump finds that the meat and poultry in the food supply chain meet the criteria to invoke the Defense Production Act.  He therefore delegated to the Secretary of Agriculture the power to allocate materials, services, and facilities in such manner, upon such conditions, and to such extent as is deemed necessary or appropriate to promote the national defense.  In other words, the Secretary of Agriculture now has the authority to take all appropriate action to ensure that meat and poultry processors continue operations consistent with the recently issued interim guidelines from the CDC and OSHA.

This order comes as a result of reports that major processing facilities have already shut down large plants due to exposure to the virus and that these plant closures may result in a reduction of the country’s processing capacity by up to 80%.  In addition, the administration stated that it will issue guidance that will provide additional liability protections for the facilities.  Once this additional liability guidance is released, this blog post will be updated.

Part 2 of this blog series will discuss General Guidance for Employers and how to address employees right to refuse to work.

Two pet cats in New York have been infected with SARS-CoV-2 (the virus that causes COVID-19), as just announced by the U.S. Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture’s (USDA) National Veterinary Services Laboratories (NVSL).  See Confirmation of COVID-19 in Two Pet Cats in New York. 

The cats, who lived in different locations, not only tested positive, but exhibited clinical signs of respiratory illness, but are expected to recover, according to the agencies.  Exposure to infected people was reported in only one of the homes.

This result may change current recommendations not to conduct routine testing of pets.  But such testing is now available through at least one private veterinary laboratory-IDEXX-which announced that it can provide for testing for pets under the following conditions:

After consulting with a public health official IDEXX will test pets if,

  • Pet is living in a household with a human who has COVID-19 or has tested positive for the SARS-CoV-2 coronavirus
  • Pet has already been tested for more common infections, which a veterinarian has ruled out
  • Pet (especially cats and ferrets) is showing clinical signs consistent with COVID-19.

The veterinary school at Tufts University is also providing testing of pets that are patients at the Cummings Veterinary Medical Center upon receipt of an owner completed consent form (Patient Participation in Clinical Research Owner Consent Form)

Postdoctoral researcher Kate Sawatzki, the lead investigator for the study and professor and virologist Jonathan Runstadler, emphasize that there is no evidence of disease transmission from pets to humans, but believe that testing can provide proof that such transmission has not occurred.

The AVMA reminds the public that “routine testing of animals for COVID-19 is NOT recommended by the AVMA, CDC, USDA, American Association of Veterinary Laboratory Diagnosticians (AAVLD), or National Association of State Public Health Veterinarians (NASPHV).”

Tests used by IDEXX and the Cummings Veterinary Medical Center do not use ingredients or reagents approved for use in humans and are not available for human testing.

On the other hand, at least a few animal health diagnostic laboratories have announced that they will begin testing human specimens for evidence of COVID-19 infection-Oregon State’s Veterinary Diagnostic Lab  and the Indiana Animal Disease Diagnostic Laboratory at Purdue’s College of Veterinary Medicine .  In both cases, the veterinary diagnostic labs have teamed up with local medical providers.

Whether testing pets or people, coordination with local, state and federal public and animal health regulators remains critical.

by Matthew R. Bailey Originally Published 6:30 a.m. ET April 17, 2020 | Updated 7:06 a.m. ET April 17, 2020

Scientists are working on dozens of potential treatments and vaccines for the novel coronavirus and the disease it causes, COVID-19. Virtually all of them have one thing in common — they’re the product of animal research.

Indeed, the race to beat COVID-19 shows just how critical animal research is to medical progress.

Consider how mRNA-1273, the potential vaccine furthest along in the development process, came to be. Scientists at Cambridge, Mass.-based Moderna originally developed it to inoculate against the coronavirus that causes Middle East Respiratory Syndrome. The vaccine has shown promise in mice and other animal models. The company hopes to launch phase 2 clinical trials in humans as early as this spring.

Or take the potential vaccine from Pennsylvania-based Inovio Pharmaceuticals. Mice and guinea pigs that have received it have produced both antibodies and T cells against the coronavirus. The research team is also investigating the vaccine’s impact in monkeys. Studies that test whether animals who have been inoculated are susceptible to infection by the coronavirus will follow.

Animal research is particularly crucial to the development of vaccines. As Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases (NIAID), said in a White House briefing last month, scientists can “get a good feel … in animal models” for whether a potential vaccine will protect someone from a dangerous pathogen or risk enhancing their infection.

Animal models are also helping scientists repurpose existing drugs to fight the novel coronavirus. Gilead Sciences’ antiviral remdesivir has “shown promise in animal models for treating Middle East respiratory syndrome,” according to the NIAID. This month, Chinese scientists are expected to release results from two separate trials of Gilead Sciences’ antiviral remdesivir in more than 750 patients with COVID-19.

New York-based Regeneron Pharmaceuticals is developing monoclonal antibodies with the help of humanized mice models. APEIRON Biologics is studying the effect of APN01, a recombinant human angiotensin-converting enzyme treatment, on laboratory mice.

Scientists are dusting off some decades-old vaccines against other germs to test if they could provide stopgap protection against COVID-19 until a more precise shot arrives.

Other scientists are investigating how the novel coronavirus works by observing it in animal models. Last month, Chinese researchers discovered that monkeys that had recovered from infection with the novel coronavirus showed no signs of reinfection when exposed a second time. This discovery could have vital implications for vaccine design.

People who have contracted COVID-19 are benefiting from several therapies and treatments that are the product of animal research. Take extracorporeal membrane oxygenation, or ECMO, a specialized medical treatment that uses an artificial lung to provide oxygenated blood to patients with critical respiratory issues — now including those with COVID-19. A University of Michigan researcher first developed the technique in sheep.

Animal research may also help solve the nation’s shortage of ventilators. This week, a research team at Auburn University successfully turned a continuous positive airway pressure machine, a relatively inexpensive device used to treat sleep apnea, into an emergency ventilator for a 200-pound goat. The lung capacity of goats this size is similar to that of humans.

Imagine a world where all this research came to a halt at the behest of animal rights activists. People hospitalized with COVID-19 would not receive the high-quality intensive care they need. And there would be no chance of developing a vaccine to protect against a resurgence of the virus in the future.

That’s as true today as it was in Sabin’s era. The COVID-19 pandemic is the most serious threat to public health in decades. We must make use of every tool at our disposal to beat it. Animal research is perhaps the most powerful of those tools.

Matthew R. Bailey is president of the Foundation for Biomedical Research.

This was just published by the Foundation for Biomedical Research.  The use of animal models for researching coronavirus and other fatal human and animal diseases and disorders bears repeating, again and again.

Animal research is at the front lines of the battle with the coronavirus and with the help of animal models, a vaccine and treatments for the coronavirus will be found.

In FBR’s latest video “The Importance of Animal Research for a COVID-19 Cure,” learn about three animal models being used in the research for the development of a potential coronavirus vaccine.

Watch the video and show your support for animal research by sharing it on social media and/or leaving a comment.

Subscribe to our YouTube Channel to be notified about PART 2 of this COVID-19 mini-series!

Despite activists’ rhetoric that animal models are not necessary for the advancement of biomedical research and development,  the criticality of the continued use of animal models in biomedical research is highlighted by Americans for Medical Progress and the Foundation for Biomedical Research (see respectively, AMP’s COVID-19 Resources The Critical Role of Animals in Developing COVID-19 Treatments and Vaccines and the Foundation for Biomedical Research and FBR’s COVID-19 Resources-We’re committed to improving health through education .

As stated on FBR’s website, “[n]early every medicine, medical device, surgical procedure and therapy we have today has depended on animal testing and research. Animal research is one of the first steps in medical discovery . . . Contrary to the claims of animal rights groups, animal models have been and will continue to be crucial to medical development and public health.”

AMP’s website includes links to multiple articles that describe the importance of animal models in COVID 19 research, including, e.g., Scientific American : New Coronavirus Drug Shows Promise in Animal Tests; WLBZ TV : Maine lab genetically modifies mice for COVID-19 research; ABC News : Louisiana researchers studying monkeys for a coronavirus vaccine face challenges as state cases spike; and The Mercury News: I know lab animals are crucial in finding a COVID-19 vaccine.

As we appear to be nearing the peak of COVID 19 infection, at least in the northeastern US, there is a continued need to research potential treatments and preventative measures for those not yet infected with the virus.

As we have recently learned, at least large cats appear to be susceptible to infection with COVID 19, according to colleagues at the Bronx Zoo and as confirmed by the United States Department of Agriculture (USDA) National Veterinary Services Laboratories (NVSL).

However, most animal health professionals believe that the potential for spread to humans from pets, or even most zoo animals, is unlikely.  The tiger and other felids with clinical signs of infection were likely infected by a zoo keeper.  While recommendations include limiting exposure of infected people to their pets, such practices can be difficult to implement if the pet is affectionate.  Best to keep other people away from pets exposed to COVID-19, at least while the owner is still symptomatic.

In the meantime, veterinarians have been designated essential personnel and are working diligently to provide needed medical care to their patients, while endeavoring to minimize exposure of staff and pet owners to the virus.  Veterinarians needing assistance during this difficult time can contact me at any time at nhalpern@foxrothschild.com.  Fox Rothschild has compiled a plethora of information for businesses, including veterinary practices at https://www.foxrothschild.com/coronavirus-resources/.

 

FDA has recently announced it is relaxing its enforcement of telemedicine for veterinarians under two federal provisions:  (1) when prescribing extralabel drug use; and (2) when prescribing medicate feed pursuant to the Veterinary Feed Directive.  Both generally require an initial physical examination of animals prior to such prescription.

FDA only enforces certain regulations governing a veterinarian’s relationship with its clients and patients.  As stated in a news release “Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic,”

The federal [veterinarian client patient relationship] VCPR definition requires that veterinarians physically examine animal patients and/or make medically appropriate and timely visits to the location where the animal(s) are kept. Therefore, the federal VCPR definition cannot be met solely through telemedicine.

Recognizing the importance of veterinary practice to animal and public health, FDA, provides the following examples of its proposed relaxed standards:

For example, the owner of a sick dog could share a video with a veterinarian. If necessary, the veterinarian could then prescribe a drug not approved for use in dogs or for that illness (extralabel use). As another example, a veterinarian could remotely examine and diagnose a group of food-producing animals with a skin disease, and then authorize the use of certain drugs in the animals’ feed.

Veterinarians, should be and are aware, that state law predominantly governs the practice of veterinarian medicine.  Therefore, a review of the current relevant state law statutes and regulations must also be considered when providing for animals in each particular state.  An easement on federal regulation does not preempt state veterinary practice laws.  That said, some states had previously introduced and adopted regulations permitting telemedicine as prescribed, and other states would likely take a reasonable approach to such care.

Practitioners should record the content of any telemedicine-provided examination and treatment, consistent with the standards of care in each state and practice area.

Despite myths perpetuated by animal activists, animal models remain critical to ensure that vaccines developed to prevent COVID 19 infections do not make those patients worse as a result of such treatment, as Dr. Fauci recently acknowledged during a briefing at the White House.

As also reported in Catching up to Coronavirus: Top 60 Treatments in Development,  “[m]ost of the therapy candidates for COVID-19 . . . were vaccines that are only in animal testing stages.”

Matthew R. Bailey, President, National Association for Biomedical Research, noting the criticality of animal research in halting the spread of coronavirus,  reported that “[two researchers at the University of Wisconsin-Madison just announced that they’ll ‘test medical countermeasures such as vaccines and therapeutics’ in nonhuman primates. They hope to discover how much of the coronavirus enters the body, where it infects the lungs, and how immune systems respond to it.”

Researchers and scientists throughout the United States are developing effective treatment models, first based on studies in genetically modified mice.  Such work is supported by the National Institutes of Health, and is a continuation of previous studies investigating the pathogenesis and treatment against other viruses, e.g., Nipah, Ebola and MERS, studied in rhesus macaques.

Such animal studies cannot be bypassed or replaced by computer simulation or organs on a chip.  COVID 19 causes multisystem infection that can only be adequately tested on entire organisms.  The current Phase I human vaccine trials underway in Seattle were preceded by testing in animal models:

The investigational vaccine was developed using a genetic platform called mRNA (messenger RNA). The investigational vaccine directs the body’s cells to express a virus protein that it is hoped will elicit a robust immune response. The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans.

There is no requirement for those opposed to the use of animal models in biomedical research to seek preventative or therapeutic treatment related to COVID 19 or other devastating human and animal illnesses, when such therapies were developed with animal heroes.   But such activists should not stand in the way of millions of others who accept the importance of the humane use of animal models and understand the rigors imposed on such researchers, who even without such mandates, would provide these animals with humane care while bred, raised and used throughout these critical life-saving endeavors.

As concerns about coronavirus continue to escalate, universities and colleges have taken advantage of spring break to protect students and staff from circulating virus, and many are planning on remote teaching for the rest of the semester.  For schools with students who remain at on campus residences and/or employees with service or emotional support animals, the following should be considered:

  1. People with service animals cannot be discriminated against, but they are required to provide for the care of their service animal, directly or through some other person.  If the disabled individual is infected and quarantined, s/he may be unable to care for that animal.  There should be plans for someone else to care for the service animal without exposure to the virus.  If the service animal can transmit the virus, even if only as a fomite, additional precautions must ensue.  The disabled person must be able to retain the services of that animal for the task(s) for which it has been trained, or an alternative must be considered.
  2. People with emotional support animals, that may not be afforded as significant protections as those with service animals, would likely benefit from the ability to keep that animal with them in the event they are quarantined, which can be a stressful situation.  The same concerns about disease spread to other people and the environment exist.
  3. The continuation of biomedical research with animal models may be disrupted by the inability to obtain adequate supplies, medications, feed, and/or bedding.  Since animals must be properly cared for, plans to provide alternate animal care staff should be considered in the event of infection in existing staff.

It is now increasingly evident that animals are critically important in testing of a potential vaccine against and treatment for COVID-19.  See, e.g., These Lab Animals Will Help Fight Coronavirus.  Continuing with this research is important for public health during this unprecedented pandemic.

There are many additional concerns about the potential transmission of the virus in a university setting.

As chair of the firm’s Animal Law Practice, I am available to answer any questions you have on this topic. Feel free to email me at Nhalpern@foxrothschild.com