Tag Archives: FDA

FDA

FDA Unveils Blueprint for New Era of Smarter Food Safety

By Food Safety Tech Staff
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FDA

Today FDA released the New Era for Smarter Food Safety Blueprint. The much-anticipated document was originally scheduled for release in March but was delayed due to the agency’s response to COVID-19. Although the agency’s plan places a lot of focus on the use of new technology, FDA Commissioner Stephen Hahn, M.D., stressed that it is also about enabling more effective methods and processes.

FDA’s Blueprint for the Future breaks down the four core elements of the plan:

  • Tech-Enabled Traceability. A lesson learned during the coronavirus pandemic was that there is a need for greater traceability and visibility in the supply chain. “One of the challenges we’ve faced over the years is recurring outbreaks of illnesses associated with the consumption of certain foods,” said Hahn. “What this daunting problem underscores is the critical importance of the FDA working with industry so that we can rapidly trace a contaminated food to its source. And when I say rapidly, I mean minutes, not days, weeks, or even longer.
  • Smarter Tools and Approaches for Prevention and Outbreak Response. Here, the FDA is emphasizing the “power of data”. “The plans embraced by the blueprint include strengthening our procedures and protocols for conducting the root cause analyses that can identify how a food became contaminated and inform our understanding of how to help prevent that from happening again,” said Hahn.
  • New Business Models and Retail Modernization. This element address food production and delivery, as well as food safety in restaurants and the retail setting.
  • Food Safety Culture. “The pandemic has given us a new perspective on what we mean by food safety culture,” said Hahn. He stated that beyond influencing human behavior, food safety culture must also address worker safety and consumer education.

View the New Era of Smarter Food Safety: FDA’s Blueprint for the Future.

FDA

FDA Expects to Release Blueprint for New Era of Smarter Food Safety Soon

By Food Safety Tech Staff
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FDA

On October 1, Frank Yiannas will be the keynote speaker for the 2020 Food Safety Consortium Virtual Series || The series takes place during the weeks of September 3 through December 17Expect the much-anticipated blueprint for FDA’s New Era of Food Safetyto be released soon. The agency has not provided an exact date but in an update prior to the July 4th holiday, FDA stated it would be rolled it out “in the coming weeks”.

“The challenges we’ve faced during the pandemic have made it clear that the goals we set forth in the New Era blueprint are more important now than ever. Some of them, like enhanced traceability, are particularly meaningful in light of recent events,” Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, stated in an agency consumer update. “What we have learned from the pandemic is that we’re on the right track with the New Era of Smarter Food Safety. The steps that we’ll take will prepare us to protect the safety of our food supply, no matter what challenges we face.”

In addition to the focus on emerging digital technologies, traceability in the supply chain, ensuring safety in the home delivery of food (e-commerce), and food safety culture, FDA will be including the lessons learned from the COVID-19 pandemic as part of the blueprint structure.

Hyvee Garden Salad

FDA, CDC Investigating Multistate Cyclospora Outbreak Involving Bagged Salads

By Food Safety Tech Staff
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Hyvee Garden Salad

An outbreak of Cyclospora infections is being linked to bagged, garden salads sold at ALDI, Hy-Vee and Jewel-Osco grocery stores in six states across the Midwest (Iowa, Illinois, Kansas, Minnesota, Missouri and Nebraska). The FDA, CDC and other state and local agencies are investigating the multistate outbreak, which has sickened 76 people and resulted in 16 hospitalizations. No deaths have been reported.

The FDA and CDC are recommending that consumers should not eat the products, and restaurants and retailers should not serve or sell the products, which fall under the following brand names: ALDI Little Salad Bar Brand Garden Salad from ALDI grocery stores, Hy-Vee Brand Garden Salad from Hy-Vee grocery stores, and Signature Farms Brand Garden Salad from Jewel-Osco. The illness onset date range is currently May 11–June 14, 2020.

Recall

Undeclared Allergens, Bacterial Contamination Top Q1 2020 Recalls

By Food Safety Tech Staff
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Recall

The COVID-19 crisis has led to supply chain management challenges for food manufacturers and processors, ingredient suppliers and vendors, and regulators. In its Q1 2020 Recall Index, experts from Stericycle advise that companies use this time to take a closer look at their supply chain processes and reevaluate their recall plan.

Watch two complimentary on-demand webinars: COVID-19 in the Food Industry: Enterprise Risk Management and the Supply Chain |
COVID-19 in the Food Industry: Mitigating and Preparing for Supply Chain Disruptions
“Companies in the food industry have their work cut out for them during this outbreak and for months after,” the report states. “But the key is to focus intensely on the basics. It’s too easy to assume food safety protocols and quality controls are followed as strictly and uniformly as they always are. Use this time wisely to recheck your supply chain, review your food-safety processes and update your recall plan.”

FDA Recalls: Notable Numbers (Q1 2020)

  • 141 recalls affecting more than 8.8 units
  • Undeclared allergens: 39.7% of recalls. The top cause of recalls for the 11th consecutive quarter
  • Bacterial contamination: 58.1% of recalls by number of impacted units
  • Nearly 20% of fresh and processed food recalls impacted products distributed nationwide

USDA Recalls: Notable Numbers (Q1 2020)

  • 6 recalls impacting 22,500 pounds of product
    • More than half of recalled pounds were a result of lack of inspection
  • Recalls dropped nearly 79%
  • Undeclared allergens: 4 recalls
Melanie Neumann, Neumann Risk Services
FST Soapbox

The COVID-19 Record Retention Conundrum

By Melanie J. Neumann
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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

COVID-19 Leads FDA to Extend VQIP Application Period to July 31

By Food Safety Tech Staff
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FDA

Last week FDA announced the extension of the application period for importers that want to participate in the Voluntary Qualified Importer Program for FY 2021. The COVID-19 pandemic has resulted in travel restrictions and advisories that have hampered efforts by accredited Certification Bodies (CBs) to both conduct the onsite regulatory audits and issue certifications to foreign entities, which are required by the VQIP application.

The application portal will stay open until July 31.

VQIP is a voluntary fee-based program that was established under FSMA. Approved applicants are granted an expedited review and import of human and animal foods into the United States if they prove they are achieving and maintaining a high level of control over their supply chains from a safety and security standpoint. Eligibility criteria includes ensuring facilities of foreign suppliers are certified by a CB that has been accredited via FDA’s Accredited Third-Party Certification Program.

FDA

FDA, USDA Reach MOU to Prevent Disruptions in FDA-Regulated Food Facilities

By Food Safety Tech Staff
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FDA

This week the USDA and FDA signed a Memorandum of Understanding (MOU) in an effort to prevent disruptions at FDA-regulated food facilities, including fruit and vegetable processing locations. The agencies are also trying to prepare for the peak harvesting seasons that involve freezing and canning fruits and vegetables. The MOU provides a process by which the agencies can determine the instances when USDA would exercise authorize under the Defense Production Act (DPA) related to food resource facilities that manufacture, process, pack or hold foods.

“While the FDA will continue to work with state and local regulators in a collaborative manner, further action under the DPA may be taken, should it be needed, to ensure the continuity of our food supply. As needed, the FDA will work in consultation with state, local, tribal and territorial regulatory and public health partners; industry or commodity sector; and other relevant stakeholders (e.g. Centers for Disease Control and Prevention, Occupational Safety and Health Administration) to chart a path toward resuming and/or maintaining operations while keeping employees safe,” stated FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in an agency press release. “We are working with our federal partners who have the authority and expertise over worker safety to develop information on protecting worker health. We are also working with other federal partners to assist the food and agriculture industry in addressing shortages of personal protective equipment (PPE), cloth face coverings, disinfectants and sanitation supplies.”

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.

FDA

As States Look to Reopen, FDA Releases Best Practices for Retail Food Establishments

By Food Safety Tech Staff
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FDA

Across the country, many restaurants have been closed for at least two months, while others have been partially closed and offering take-out or delivery to customers during the COVID-19 pandemic. As states begin their strategy to reopen the economy, many restaurants have already opened, and others are preparing for when this day comes. To better help food retail establishments during this uncertain time, the FDA has issued the checklist, “Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic”, along with a two-page infographic.

The checklist offers guidance in several key areas related to food safety practices, including:

  • Facility Operations
  • Water, Plumbing and Ice
  • Food Contact and Non-food Contact Surfaces (clean, disinfect, sanitize)
  • Food Temperature Control
  • Product Inspection, Rotation
  • Dishwashing Equipment
  • Handwashing Stations
  • Employee Health/Screening
  • Social Distancing

While the food safety checklist covers a lot of ground, the FDA has stated that the list is not comprehensive. “We encourage retail food establishments to partner with local regulatory/health authorities to discuss the specific requirements for their retail food establishment prior to re-opening,” the agency states.

food safety tech

Food Labs/Cannabis Labs Virtual Conference Includes FDA Comments on Proposed Lab Accreditation Rule

By Food Safety Tech Staff
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food safety tech

Next month join Food Safety Tech and Cannabis Industry Journal for the virtual conference, Food Labs / Cannabis Labs. The event is complimentary for attendees and will be held Tuesday, June 2 through Friday, June 5 (each day the event begins at 11 am ET). The event was originally planned as an in-person event but was converted to a virtual conference as a result of the COVID-19 pandemic.

The event kicks off with FDA’s comments on the proposed FSMA laboratory accreditation rule, which will be presented by FDA’s Timothy McGrath and Donald Burr. Other session highlights include FSMA’s impact on labs; navigating the regulatory pitfalls of cannabis lab testing; the evolution of the lab testing market; documentary standards and reference materials; and vulnerability assessment frameworks and food fraud mitigation strategies. Many of the educational sessions will be followed by Tech Talks, which will be provided by sponsors in the laboratory technology or service provider fields, who will educate attendees about solutions that can assist in the food lab and/or cannabis lab environment.

More than 500 people have already registered to attend! Don’t miss this unique opportunity and register now. Please note that only registrants who attend the live event will have access to the recording.

For companies interested in Tech Talk opportunities, Contact RJ Palermo (203-667-2212). Tuesday and Wednesday are sold out.