Former FDA Chief Medical Officer David Acheson, MD, updates us on the food industry on the next phase of COVID-19. Joining Dr. Acheson is Ben Miller, Ph.D., renowned epidemiologist and Senior Director of Regulatory and Scientific Affairs at the Acheson Group, for an all-facts, no-spin, 30-minute Coronavirus update
FSMA Friday - The Next Phase with Dr. David Acheson and Ben Miller, Ph.D.
1. FSMA FRIDAYS
The Latest Industry News, Updates & Trends
Covid-19: The Next Phase
with Dr. David Acheson, MD and Dr. Ben Miller, Ph.D., MPH
April 24, 2020
2. MONTHLY INDUSTRY UPDATE
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
FSMA FRIDAYS
What is FSMA Fridays?
FSMA
Fridays
3. FSMA FRIDAYS
Agenda
AUDIENCE PARTICIPATION ENCOURAGED
✔Ask Questions (Q&A at end)
✔Only panelists are displayed
✔Recording link will be shared
✔Audio issues: use call-in number
WHAT WE WILL COVER
✔Covid-19 – The Next Phase
✔Audience Q&A
4. FSMA FRIDAYS
Presenters & Host
Aaron Bolshaw
VP Marketing
Ben Miller, PhD
Senior Director – Food Safety
● 20+ years industry experience in public health, food
regulation and food safety management
● Division Director of the Food and Feed Safety Division
at the Minnesota Department of Agriculture
● Epidemiologist at the Minnesota Department of Health
Dr. David Acheson
CEO & President, The Acheson Group
● 30+ years of industry experience including Former
Associate Commissioner for Foods at FDA and Chief
Medical Officer at the USDA Food Safety and
Inspection Service
6. FSMA FRIDAYS
Overview
● Mitigation to Suppression
● Continuing the Basics
● Moving into Suppression Phase
● The Role of Testing
● Challenges
● The Long-Term
9. • Dependent on testing capacity:
• Adequate testing
• Need 152 test per day per 100K people
• Currently at 46 tests per day
• Isolation
• Contact Tracing
• Goal is drive Rt to less than 1
• Current Rt in US is 1.57 (1.44-1.63)
https://www.nytimes.com/interactive/2020/04/17/us/coronavirus-testing-states.html
FSMA FRIDAYS
Moving from Mitigation to Suppression
https://mrc-ide.github.io/covid19-short-term-
forecasts/index.html#estimates-of-the-
current-effective-reproduction-number
10. • Essential industries have been running continuously since the
beginning of the outbreak
• Will need to rely on foundational measures for the foreseeable future
• “Reopening” will happen in phases depending on local, state, and
regional jurisdictions
• In US Federal Government recommending “gating” criteria:
• Reduction in Covid-like symptoms over 14 days
• Reduction in Covid-cases over 14 days
• Enough hospital capacity to treat all patients and test healthcare workers
FSMA FRIDAYS
Moving from Mitigation to Suppression
13. • Expanding list of conditions, including anosmia
• Fever
• Cough
• Shortness of breath or difficulty breathing
• Chills
• Repeated shaking with chills
• Muscle pain
• Headache
• Sore throat
• New loss of taste or smell
• Starting to look at O2 levels as indicator (O2 < 90%)
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Employee Wellness Checks
15. • As offices reopen, similar strategies used in food industry will still apply:
• Continue teleworking – preferred
• Return to work in phases
• Close common areas
• Split shifts in the office settings – 50% of employee at a time
• Minimize non-essential travel
• Continue:
• Employee wellness screenings
• Social/physical distancing
• Cleaning and disinfection
• Mask usage
FSMA FRIDAYS
Bringing the “Basics” to Other Settings
16. • Restaurants:
• Seating 6 feet or more apart
• Mask usage difficult while eating
• Will people come back or continue to order for pick-up or delivery?
• Customer health screening?
• Continue:
• Employee wellness screenings
• Social/physical distancing
• Cleaning and disinfection
• Mask usage
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Bringing the “Basics” to Other Settings
17. • First question should always be: “What will I do with this data?”
• FDA “Approved”
• Emergency Use Authorization Process (EUA) from FDA
• Expedited process
• Test sensitivity (false negatives) and specificity (false positives) may not be well evaluated
• Molecular (RT-PCR) Tests
• Used to determined active infection
• Looks for viral RNA (genetic material)
• Serological (antibody)
• Used to determine past infection
• Looks for IgM or IgG response
FSMA FRIDAYS
The Role of Testing
18. • Uneven public health response nationally
• Creates risk of resurgence of outbreak
• State or regional border closings?
• CDC Interim Guidance for Essential Workers
• Allows those with close-contact exposure to continue to work
• Not “science-based”
• Can create additional risks
• Doesn’t account for asymptomatic/pre-symptomatic transmission
FSMA FRIDAYS
Challenges
19. • Exposures extend beyond the workplace
• Employees can be infected outside of work
• Who lives with whom?
• Who carpools or rides to work together?
• Do employees know to practice social distancing outside of work?
• Food facilities receiving increasing attention from public health authorities
• Food facility is a “hot-spot”
• May negatively impact an entire state’s ability to “reopen” based on White House
“gating” criteria (sustained decrease in the number of cases)
FSMA FRIDAYS
Challenges
20. • Testing
• “What will I do with this data?”
• RT-PCR – could be useful as part of Employee Wellness Screening
• Needs to be timely – can’t be days to results
• Needs to be done frequently (every few days)
• Ideally done onsite
• Sample collection – currently nasal swab – possibility of saliva
• Serology
• What does it mean to show an antibody response?
• How long does immunity last – unknown!
• Create two “classes” of workers?
• Incentive to become infected?
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Challenges
21. • Fighting fake news
• Consider your information sources
• Avoid sharing misinformation
• Be mindful of pictures taken out of context
• Have access to reliable and credible information
• Communicate and educate your workforce
• Have a plan in place and react to misinformation
FSMA FRIDAYS
Misinformation
22. • Different regions may move in and out of stay-at-home orders
• Serological testing – what % of population has been infected
• Better understanding of immunity
• Vaccine development and herd immunity
• “New” normal?
FSMA FRIDAYS
Long-Term