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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
MONTHLY INDUSTRY UPDATE
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
FSMA FRIDAYS
What is FSMA Fridays?
FSMA
Fridays
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
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
FSMA FRIDAY
FOCUS
Covid-19:
The Next Phase
FSMA FRIDAYS
Overview
● Mitigation to Suppression
● Continuing the Basics
● Moving into Suppression Phase
● The Role of Testing
● Challenges
● The Long-Term
• Rapidly changing situation
• Recommendations change daily
https://www.achesongroup.com/covid-19
FSMA FRIDAYS
Resources
https://preventepidemics.org/coronavirus/playbook/
FSMA FRIDAYS
• 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
• 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
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3561560
• 1918 Influenza outbreak
• Cities in the US that had stricter non-
pharmaceutical interventions (NPIs)
fared better economically after the
outbreak
• Mortality causes significant economic
disruption
FSMA FRIDAYS
Public Health and the Economy
FSMA FRIDAYS
Understanding the Role of Pre-Symptomatic Transmission
https://www.cdc.gov/mmwr/volumes/69/wr/mm6914e1.htm
• 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%)
FSMA FRIDAYS
Employee Wellness Checks
FSMA FRIDAYS
Maintaining the “Basics”
• 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
• 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
FSMA FRIDAYS
Bringing the “Basics” to Other Settings
• 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
• 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
• 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
• 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?
FSMA FRIDAYS
Challenges
• 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
• 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
Q & A
✔ FSMA Friday Session Recordings & Content Library
✔ info.safetychain.com/covid-19-readiness-kit
✔ COVID resilience and recovery solutions: ChangeOver Manager, Remote Supplier
Auditor, Personnel Screener
✔ email non-disease related questions to covid19questions@safetychain.com or
info@safetychain.com
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com/covid-19
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
FSMA FRIDAYS
Resources & Future Events
Join us next month on May 29, 2020

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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
  • 7. • Rapidly changing situation • Recommendations change daily https://www.achesongroup.com/covid-19 FSMA FRIDAYS Resources
  • 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
  • 11. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3561560 • 1918 Influenza outbreak • Cities in the US that had stricter non- pharmaceutical interventions (NPIs) fared better economically after the outbreak • Mortality causes significant economic disruption FSMA FRIDAYS Public Health and the Economy
  • 12. FSMA FRIDAYS Understanding the Role of Pre-Symptomatic Transmission https://www.cdc.gov/mmwr/volumes/69/wr/mm6914e1.htm
  • 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%) FSMA FRIDAYS 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 FSMA FRIDAYS 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? FSMA FRIDAYS 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
  • 23. Q & A
  • 24. ✔ FSMA Friday Session Recordings & Content Library ✔ info.safetychain.com/covid-19-readiness-kit ✔ COVID resilience and recovery solutions: ChangeOver Manager, Remote Supplier Auditor, Personnel Screener ✔ email non-disease related questions to covid19questions@safetychain.com or info@safetychain.com ✔ TAG Newsletter ✔ Global Food Safety Consultants AchesonGroup.com/covid-19 ✔ FSMA Friday LinkedIn Group ✔ Q&A, Articles & Updates … Join FSMA FRIDAYS! FSMA FRIDAYS Resources & Future Events Join us next month on May 29, 2020