Tag Archives: public health emergency

FDA

FDA Offers Help to Companies with Supply Chain Disruptions

By Food Safety Tech Staff
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FDA

FDA has given an update on its resources to provide the industry with continued assistance as it struggles through the challenges presented by the ongoing pandemic.

Coronavirus

Pandemic Forced Food Companies to Assess Agility, Focus on Data

By Maria Fontanazza
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Coronavirus

COVID-19 was an eye-opening public health emergency that brought a renewed focus on hygiene and safety across all industries. For McDonald’s Corp., this change prompted a deeper focus on science, including the use of analytical data, and consumer perception, according to the company’s Director of Global Food Safety Gary van Breda. “There are certain things that are important to our supplier base and for us moving forward, [including] harvesting information from different sources— information from audits, social media and being able to know whether we have the right inputs and algorithms in place to generate information to help us make decisions,” said van Breda in a panel discussion during the final episode of the Food Safety Consortium’s Spring Virtual Conference Series in May. These data-driven insights also helped the company take a closer look at attributes such as air quality and how to clean and sanitize high-touch areas in its restaurants.

Many organizations in the food industry were forced to completely change their strategic approach to doing business. “COVID was a once-in-a-generation disruption,” said Jorge Hernandez, vice president, quality assurance at The Wendy’s Company. “Many of the businesses didn’t survive, and many thrived. What’s the difference? In the leadership and approach: To be able to pivot, be flexible, and adapt to the changing circumstances—talk about flying a plane while you were building it.”

One of the key lessons learned from the pandemic was in the ability to remain flexible and make decisions based on the best information available at that time—and using the latest information to continuously improve processes, said Hernandez. For example, many food service and retail establishments took a giant leap forward in providing contactless ordering and delivery to customers—something that became an expectation versus a nice-to-have advantage. From an internal perspective, Wendy’s developed a much stronger connectivity between different job functions (i.e., operations, human resources, management) that helped them strengthen practices, guidance and procedures necessary to thrive during the pandemic.

During the pandemic, food safety fundamentals were brought to the forefront. “Handwashing became so critical. It would be silly not to take advantage of that moving forward,” said Hernandez. “Before the pandemic this was one of the biggest reasons for foodborne illness [outbreaks]. Now it’s up to us: With this pandemic, to use that momentum to move [these practices] forward and make it part of our routine. We have a unique opportunity to make that change to make safer food.”

Melanie Neumann, Neumann Risk Services
FST Soapbox

The COVID-19 Record Retention Conundrum

By Melanie Neumann, JD, MS
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Melanie Neumann, Neumann Risk Services

During this global pandemic, the U.S. Equal Employment Opportunity Commission (EEOC) green-lighted employers to take temperatures checks of employees and to administer COVID-19 testing for workers prior to returning to work without running afoul of the Americans with Disabilities Act (ADA). This appears straight-forward upon first reading, however, several practical uncertainties about implementation, including confidentiality, discrimination, and how long to retain records remain.

As such, deciding whether to take temperatures and/or require COVID- 19 testing as a return to work strategy is more complicated than it may seem.

Temperature Screening & Testing Considerations

Temperature screening and COVID-19 mandatory testing are both permitted medical examinations during this pandemic but are otherwise prohibited during non-pandemic times. Before adopting, employers should understand the requirements impacting the records these tests generate, including the need to protect confidentiality and to retain records for longer than one may expect.

Temperature Screens
Under normal circumstances, temperature checks are considered a prohibited medical examination under the ADA. During a pandemic, however, the Equal Employment Opportunity Commission (“EEOC”) makes an exception, allowing employers to take temperatures/use temperature checks and exclude employees from the workplace should temperatures exceed public health recommendations. If employers keep records of temperatures, they must retain these records per applicable regulations. This is important because an “employee medical record” would likely result if employers take employees’ temperatures or collect temperature related records. As we will see below, there are regulatory requirements that require how we conduct these screens, and where and for how long we must retain them.

COVID-19 Testing

COVID-19 testing also constitutes a permissible medical exam under ADA during this pandemic, per the EEOC-issued guidance regarding mandatory employee testing.

For medical examinations to be allowed under the ADA, the test must be “job related and consistent with business necessity,” and employers must treat information as a confidential medical exam.

The initial guidance acknowledged that the spread of COVID-19 is a “direct threat,” hence meeting the requirement that a medical exam be “job related and consistent with business necessity” and that temperature screenings were therefore appropriate. For the same reasons, in updated guidance released at the end of April 2020, the EEOC expanded that guidance to clarify that employers may choose to administer COVID-19 testing to employees before they enter the workplace to determine if they have the virus for the same reasons.

When reading the EEOC’s language closely, the permission granted by EEOC appears to be for diagnostic tests, as the guidance states testing is to determine if employees have the virus before allowing employees to return to work. It is unclear whether antibody testing is included in the above analysis because antibody tests do not determine if someone is currently infected.

In addition, there are other considerations employers should assess before adopting a testing protocol. EEOC reminds employers that they must review the accuracy and efficacy of the selected test per FDA and CDC recommendations. Moreover, pragmatic considerations, such as how to maintain social distancing and employee privacy, determining who will perform the testing and at what the frequency, not to mention evaluating whether there is enough test capacity to perform employee-wide testing at a meaningful cadence should be evaluated.

Records Management & Retention

There is another often over-looked question: What do employers do with documented test records? This question applies whether the employer conducts the test, requires tests from employee’s healthcare providers to be off work to self-isolate, or as a return to work requirement.

It was clearly outlined above that temperature records and COVID-19 test records constitute employee medical records. Why is this important? Because there are specific requirements relating to employee medical records, including what appears to be a surprisingly long retention requirement.

Where to retain: An employer should store all medical information related to COVID-19 in existing medical files, separate from the employee’s personnel file, per the ADA, limiting access to this employee confidential information. This includes an employee’s statement that he has COVID-19 or suspects he/she has the disease, or the employer’s notes or other documentation from questioning an employee about symptoms.

How long to retain: That is the 30-year question. The Department of Labor’s Occupational Safety and Health Agency (OSHA) provides retention requirements for employee medical records in certain situations for a period of an employee’s employment plus 30 years.

While COVID-19 test results and temperature screening documentation are deemed medical examinations under the applicable regulations, are the documented results deemed medical records? We turn to applicable EEOC OSHA regulations in section 1910.1020 for answers.

OSHA Requirements

The OSHA general duty clause, section 5(a)(1) requires employers to furnish to each of its employees a workplace free from recognized hazards that are causing or likely to cause death or serious physical harm. COVID-19 appears to rise to this threat level. But is that fact alone dispositive to falling under the applicable OSHA retention requirements?

OSHA regulation section 1910.1020 requires employers to retain employee exposure or employee medical records relating to employee exposure to certain hazards. This section applies to each general industry, maritime and construction employer who makes, maintains, contracts for, or has access to employee exposure or medical records, or analyses thereof, pertaining to employees exposed to toxic substances or harmful physical agents (Emphasis added).

Is SARS-CoV-2, the virus that causes COVID-19, considered a “toxic substance or harmful physical agent?”

Most would quickly assume the answer is ‘yes’. But it may not be as clear as the black and white letter of the law would hope. Let’s review some key definitions in the applicable regulation to help shed more light on this question.

What are Toxic Substances or Harmful Physical Agents?

The record retention requirement pivots on the last phrase of 1910.1020, that is “…pertaining to employees exposed to toxic substances or harmful physical agents.”

Toxic substances or harmful physical agents are defined as follows;

  • 1910.1020(c)(13) “Toxic substance or harmful physical agent” means any chemical substance, biological agent (bacteria, virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and non-ionizing radiation, hypo – or hyperbaric pressure, etc.) which:
    • 1910.1020(c)(13)(i) is listed in the latest printed edition of the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) which is incorporated by reference as specified in Sec. 1910.6; or
    • 1910.1020(c)(13)(ii) has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer; or
    • 1910.1020(c)(13)(iii) is the subject of a material safety data sheet kept by or known to the employer indicating that the material may pose a hazard to human health. (Emphasis added by author).

The use of “or” clarifies that only one of the criteria need to be met. Based on the above, while subsections (c)(13)(i) and (c)(13)(iii) do not appear relevant, subsection (c)(13)(ii) appears to apply as SARS-CoV-2 has shown to result in acute health hazard, resulting in the disease COVID-19. Whether there is a chronic health impact remains to be seen given the novelty of this virus. That said, acute health impact appears sufficient to determine SARS-CoV-2 as a “toxic substance or harmful physical agent” for purposes of this analysis.

This alone doesn’t automatically place an employer in a 30-plus year requirement to retain employee medical records. What constitutes an “employee medical record” and “employee exposure record” for purposes of this regulation must be further understood before determining appropriate retention.

What are Employee Medical Records and Employee Exposure Records?

“Employee medical records” are defined in section 1910.1020(c)(6), and means a record concerning the health status of an employee that is made or maintained by a physician, nurse or other healthcare personnel, or technician, including: Medical and employment questionnaires or histories, the results of medical exams, lab test results, medical opinions/doctor’s recommendations, first aid records, employee medical complaints, and descriptions of treatment or prescriptions.

Section 1910.1020(d)(1)(i) goes on to specifically prescribes a minimum of a 30-plus year retention period as follows: “The medical record for each employee shall be preserved and maintained for at least the duration of employment plus thirty (30) years.”

“Employee exposure records,” are defined in subsection 1910.1020(d)(1)(ii), as: “Each employee exposure record shall be preserved and maintained for at least thirty (30) years,…”. Some exceptions are listed in this subsection for records relating to health insurance claims, first aid records and records relating to employees working less than one year.

What Constitutes Employee Exposure?

One must also look at what “employee exposure” means in light of this regulatory requirement to determine applicability of the 30-plus year retention.

1910.1020(c)(8) defines “exposure” or “exposed” to mean that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations.

More Questions than Answers

This analysis may leave more questions than answers, as several questions remain after looking closely at the regulatory requirements. For example:

  • How can an employee prove that exposure to SARS-CoV-2 occurred in the course of employment?
  • Does the employee even have to? The regulation clearly states that it is the employer’s burden, in that the “employer demonstrate that a toxic substance or harmful physical agent was not present in the workplace in any manner different from typical, non-occupational situations”.
  • How can an “employer demonstrate” that the harmful physical agent was not present? In other words, how can employers demonstrate that its employees are at any greater exposure by coming to work than they are in their every day lives, like going to the grocery store?
  • How do employers prove absence? Is it even possible given several people are asymptomatic?
  • Does this analysis differ by food industry sectors? What about meat and poultry processors with known high rates of infection in their workplace? Would the analysis differ?

Conclusion

Short of additional guidance issued by Department of Labor’s OSHA, ultimately this will likely be decided by the courts when the first lawsuit on this topic arises, known as decision via case law. What do employers do in the interim while these shades of gray are not yet adjudicated? It is recommended to err on the side of caution. Find ways to adjust your company’s record retention procedures and systems to be able to accurately retain these records for the duration of your employee’s employment plus 30 years.

Resources

  1. OSHA Laws & Regulations. OSH Act of 1970. SEC 5. Duties. Retrieved from https://www.osha.gov/laws-regs/oshact/section5-duties
  2. OSHA Standards. Part 1910, Standard 1910.1020. Retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020
  3. OSHA. Access to Medical and Exposure Records. (2001). U.S. Department of Labor, OSHA. Retrieved from https://www.osha.gov/Publications/pub3110text.html
  4.  U.S. Equal Employment Opportunity Commission. “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws”. (Updated May 7, 2020). Retrieved from https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. See A. 6 and B.1.
FDA

FDA on How to Return Refrigerated Transport Vehicles and Storage Units to Food Use After Holding Human Remains

By Food Safety Tech Staff
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FDA

The increase in deaths during the COVID-19 pandemic has pushed funeral homes and morgues beyond capacity, and other measures have been taken to store the bodies of victims. As a result, refrigerated food transport vehicles and food storage units have been temporarily used for this purpose. Now, FDA has released the guidance document, “Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic” because when those additional storage units are no longer needed to store bodies, “industry may wish to return the trailers and storage units to use for food transport and storage”.

Returning these vehicles and storage units to use for food is possible—but only with thorough cleaning and disinfection. The agency recommends the use of EPA-registered disinfectants that are suitable for the material being disinfected. It also recommends these disinfectants be effective against SARS-CoV-2 and foodborne pathogens. When disinfecting, it is important to adhere to the instructions for use for guidance on how many times application is required, the contact time needed, and effectiveness at refrigeration temperatures. For instances in which the interior surfaces have been in direct contact with blood or bodily fluids, the FDA guidance provides the scenarios in which the vehicles and storage units should not be returned to use for transporting or storing food for humans or animals.

OSHA has also stated that compressed air or water sprays should not be used to clean contaminated surfaces due to the risk of aerosolizing infectious material.

Due to the public health emergency, the guidance has been issued without the agency’s usual 60-day comment period.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Ebola Virus and Body Fluids Clean-Up in Retail Food Operations

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

As the Ebola scare spreads in the United States and threatens the rest of the world, it is a race against time to find an effective vaccine or cure. Until then, the old reliable public health method of contact tracing, patient isolation and quarantine of suspected cases to disrupt transmission remains the only choice out there. The establishment of body temperature monitoring stations at the major airports will only capture elevated temperature symptomatic cases. This implies that infected individuals still within the incubation period of up to 21 days may not have high fever and thus may slip through the system. Examples include the index case from Liberia that arrived Dallas, Texas without elevated temperature or symptoms, and the recently infected Dallas Nurse that was cleared by CDC to fly to Cleveland, Ohio without elevated body temperature.

Apart from airports and hospitals, other public places, including retail food service outlets, have the risk of becoming potential sources of contact for fully bloom symptomatic cases that can indeed transmit the Ebola virus and infect several others. Recently a Doctor under voluntary Ebola quarantine after returning from Liberia broke the quarantine to visit her favorite restaurant.

Some of the Ebola transmission dynamics that should be a source of concern to the retail industry are as follows:

  • Ebola virus is transmitted through close contact with body fluids (blood, urine, saliva, sweat, feces, vomit, breast milk, semen, etc.) from a sick Ebola patient.
  • Ebola virus can spread through contact with objects likes clothes, bedding, syringes/sharps, medical equipment or contact surfaces contaminated by blood or body fluids of a patient.
  • Emergency body fluids incidents are regular occurrence from customers in retail food facilities.
  • According to CDC, Ebola virus dried on contact surfaces like door knobs and countertops can survive for several hours, while Ebola virus in body fluids can survive for several days on contact surfaces at room temperature.
  • Restrooms at retail outlets are accessible to both customers and the general public, and thus may constitute a hazard in Ebola virus transmission, if not properly cleaned and disinfected (not sanitized!).
  • Ebola patients can transmit the virus within the time frame of the first appearance of symptoms before hospital isolation. Patients may visit retail environments during this infectious period before the onset of severe symptoms that will trigger immediate hospitalization.

The foodservice and retail environment is among the vulnerable public places where infection may be possible if appropriate measures, protocols and employee training are not in place. What can retail management do differently to be ready and to proactively safeguard their facilities and protect their customers and the entire public health? The good news is that a lot of these measures are already contained in the Food Code and thus would only need to be reinforced to highlight their importance during these Ebola times.

Some of these proactive measures may include the following:

  1. Establish proper protocol for cleaning and disposal of body fluids (see previous blog on Combating Norovirus Hazards in Retail Foodservice). The pathogen kill-step is the most important step in any body fluid clean-up process and must be done with a disinfectant grade chemical. Adequate personal protective equipment (PPE) like gloves, disposable aprons, and protective eye goggles is mandatory.
  2. Compliance with use of gloves and no bare hands contact with ready-to-eat foods.
  3. Adequate and frequent washing of hands by food handlers while encouraging hand washing by customers through the provision of the necessary accessories in hand wash sinks. According to CDC, Ebola virus is readily killed by using soap and water, bleach or hospital grade disinfectants.
  4. Handle body fluids in the restroom, grocery store aisles, play areas, dining rooms, and kitchen areas as potential infectious materials.
  5. Establish and implement an appropriate Employee Health Policy without punitive measures; to encourage hourly paid employees to stay home when sick.
  6. Introduce a non-residual disinfectant grade chemical (instead of regular sanitizers) for disinfecting restrooms, play areas and high touch points like doors knobs and equipment handles. Note: Disinfectants cannot be used on food contact surfaces.
  7. Eliminate or put on-hold programs like Back Stage Tours that bring customers in close proximity with food and food preparation areas at the back of the house.
  8. Buffet style food services should develop a better strategy to completely protect food from self-service customers.
  9. Proper cleaning and sanitizing of food contact surfaces using best practices like the single use no-rinse cleaning and sanitizing wipes from Sani Professional (see previous blog on Clean Matters). Hand sanitizers should be made available to customers at strategic locations throughout the retail facility to encourage use.
  10. Training and re-training of employees on best practices cannot be over emphasized in this new era of Ebola scare and confusion.

Finally, retail and foodservice employees should be trained to recognize the obvious signs of sick customers especially if accompanied with vomiting and diarrhea. The affected incident area should be cordoned off and the facility may be closed down depending on the severity of the suspected case. The State and Local Public Health officials and the CDC should be notified immediately. In these Ebola times, it’s better to err on the side of caution than to regret actions on a potentially positive Ebola case.

It is indeed a good time also to rethink the level of food safety culture in your organization and what you can do to ensure that your organization is not in the news for the wrong reasons. Foodservice and retail operations must remain on alert until the US Public Health Service and other relevant US government agencies have a complete handle on this monumental public health emergency.