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FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Navigating COVID Complexity in 2021
to Stay Resilient
with David Acheson, MD
December 18, 2020
Monthly Industry Update:
✔ FSMA Related News
✔ Regulation Changes & Updates
✔ Industry Trends
✔ Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS
Casual but Professional Format
✔ Ask questions! (Q&A at end)
✔ Only panelists are displayed
✔ Recording link will be shared
✔ Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS
Featured Panelists & Host
FSMA FRIDAYS
Aaron Bolshaw
VP Marketing
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 FRIDAYS
The Latest FSMA Updates
Product Tracking Rule
FSVP
FSMA FRIDAYS
Overview
•Light at the end of the Tunnel
• And yet we’re still in the tunnel…
•Bridging between now and vaccinations
• Quarantine guidance from CDC
• Testing
• Use-cases
• Vaccination
• When will vaccines come to the Food and
Ag Sector?
• Communication strategies
FSMA FRIDAYS
Resources
• Rapidly changing situation
• Recommendations change daily
• https://www.achesongroup.com/covid-19
FSMA FRIDAYS
https://www.worldometers.info/coronavirus/country/us/
Cases and Deaths in the US
CDC Quarantine Guidance
FSMA FRIDAYS
CDC Quarantine Guidance
TAG’s Thoughts and Recommendations:
• CDC guidance allows “testing” out using
• After day 10 without testing
• After day 7 after receiving a negative test result (test must
occur on day 5 or later)
• Balance between risk and operational need
• States and local health departments may stay with more
stringent requirements and have enforcement authority
• Consider the nature of the “close-contact” exposure
• Lower risk incidental exposures (several episodes totaling more
than 15 minutes in a 24 hour period) while wearing a mask
• Higher risk exposures – close contact is a household member
with repeated and ongoing exposures
• Quarantine doesn’t start until the household member can be
released from isolation – total time in quarantine could be 17-20
days
• “Testing Out” of quarantine
• Better to wait to take test on Day 7
• Use PCR vs Rapid Antigen Test
FSMA FRIDAYS
When to Test?
• Use cases
• Individual Testing
• If someone is a close-contact
• Based on new CDC Quarantine Guidance to “Test Out of
Quarantine”
• Group Testing
• Regulatory Requirement (Cal-OSHA)
• Surveillance testing
• Testing a portion of the population at regular
intervals
• Goal - detect small clusters before they become big
outbreaks
• Full population testing
• Want to determine the “infection status” of a population
at a point in time
• Useful when restarting a facility or office
FSMA FRIDAYS
Vaccines
•What we know
• Pfizer received its EUA from FDA on 12/11/2020
• Vaccine is 95% effective after two doses (21 days apart)
• For use in 16 and older
• Moderna will likely receive its EUA on 12/18
• Also 95% effective
• Both mRNA vaccines that use the body’s cells to produce part
of the SARS-CoV-2 surface protein to stimulate an immune
response
• CanSino and Gameleya vaccines are in use in China and
Russia
• Currently in Phase 3 trials
• Russian vaccine 91.4% effective
• Adenoviruses
FSMA FRIDAYS
Vaccines
•What we know
• People will still need to practice risk reduction
measures such as mask wearing and physical
distancing after vaccination until we know more
• Those who are vaccinated may not carry as much of
the virus, but could still potentially transmit until we
have more scientific data suggesting otherwise
• Based on other coronavirus vaccines and viruses,
immunity should last at least a year (with two dose)
and likely longer
• More and longer studies are needed
FSMA FRIDAYS
Vaccines
•What we’d like to know
• How long will it take to get Group 1a vaccinated in the US?
• What will ACIP recommend for prioritization for Group 1b
(87M people)?
• This includes the Food and Ag Sector
• What contraindications for the vaccines may emerge as part
of Group 1a vaccination?
• UK found that those with a history of allergic reactions should
not be vaccinated in the first round
• When will other vaccines be ready for approval and will they
be as effective?
• How might individual states vary from the CDC and ACIP
recommendations for vaccine allocation?
FSMA FRIDAYS
Vaccines
•Employers have an important role in the
vaccination effort
• Companies are in a unique position, having
become a trusted source of information for
their employees throughout the pandemic
• Mandate vaccination?
• New FAQ from the EEOC says employers can
mandate vaccination.
• Workplaces are important places for
vaccination
• Offer clinics 2 or 3 times a year instead of
“now or never”
FSMA FRIDAYS
Vaccines
Communication and Trust
• Messaging needs to create “demand” for
vaccination
• Strategies that rely on “Prosocial” behavior
• People are much more likely to do things if they
think others are doing and value that activity
• Make vaccination efforts visible
• Find trusted and respected members of the
workforce
• Repeatedly share information (good and bad)
and be ready to answer questions
• Misinformation on vaccines has spread since
the beginning of the pandemic
Q & A
FSMA FRIDAY
✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
Resources & Future Events
FSMA FRIDAYS
January 21, 2021:
What’s New in SQF Ed. 9 & Tips for Your Conversion Plan
Leann Chuboff - VP Technical Affairs SQFI

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FSMA Friday: Navigating COVID Complexity in 2021

  • 1. FSMA Fridays Webinar Series Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers Navigating COVID Complexity in 2021 to Stay Resilient with David Acheson, MD December 18, 2020
  • 2. Monthly Industry Update: ✔ FSMA Related News ✔ Regulation Changes & Updates ✔ Industry Trends ✔ Q&A with TAG What is FSMA Fridays? FSMA FRIDAYS
  • 3. Casual but Professional Format ✔ Ask questions! (Q&A at end) ✔ Only panelists are displayed ✔ Recording link will be shared ✔ Audio issues: use call-in number Watch prior FSMA Friday recordings at safetychain.com > Resources > FSMA Fridays Before We Get Started FSMA FRIDAYS
  • 4. Featured Panelists & Host FSMA FRIDAYS Aaron Bolshaw VP Marketing 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
  • 5. FSMA FRIDAYS The Latest FSMA Updates Product Tracking Rule FSVP
  • 6. FSMA FRIDAYS Overview •Light at the end of the Tunnel • And yet we’re still in the tunnel… •Bridging between now and vaccinations • Quarantine guidance from CDC • Testing • Use-cases • Vaccination • When will vaccines come to the Food and Ag Sector? • Communication strategies
  • 7. FSMA FRIDAYS Resources • Rapidly changing situation • Recommendations change daily • https://www.achesongroup.com/covid-19
  • 9.
  • 11. FSMA FRIDAYS CDC Quarantine Guidance TAG’s Thoughts and Recommendations: • CDC guidance allows “testing” out using • After day 10 without testing • After day 7 after receiving a negative test result (test must occur on day 5 or later) • Balance between risk and operational need • States and local health departments may stay with more stringent requirements and have enforcement authority • Consider the nature of the “close-contact” exposure • Lower risk incidental exposures (several episodes totaling more than 15 minutes in a 24 hour period) while wearing a mask • Higher risk exposures – close contact is a household member with repeated and ongoing exposures • Quarantine doesn’t start until the household member can be released from isolation – total time in quarantine could be 17-20 days • “Testing Out” of quarantine • Better to wait to take test on Day 7 • Use PCR vs Rapid Antigen Test
  • 12. FSMA FRIDAYS When to Test? • Use cases • Individual Testing • If someone is a close-contact • Based on new CDC Quarantine Guidance to “Test Out of Quarantine” • Group Testing • Regulatory Requirement (Cal-OSHA) • Surveillance testing • Testing a portion of the population at regular intervals • Goal - detect small clusters before they become big outbreaks • Full population testing • Want to determine the “infection status” of a population at a point in time • Useful when restarting a facility or office
  • 13. FSMA FRIDAYS Vaccines •What we know • Pfizer received its EUA from FDA on 12/11/2020 • Vaccine is 95% effective after two doses (21 days apart) • For use in 16 and older • Moderna will likely receive its EUA on 12/18 • Also 95% effective • Both mRNA vaccines that use the body’s cells to produce part of the SARS-CoV-2 surface protein to stimulate an immune response • CanSino and Gameleya vaccines are in use in China and Russia • Currently in Phase 3 trials • Russian vaccine 91.4% effective • Adenoviruses
  • 14. FSMA FRIDAYS Vaccines •What we know • People will still need to practice risk reduction measures such as mask wearing and physical distancing after vaccination until we know more • Those who are vaccinated may not carry as much of the virus, but could still potentially transmit until we have more scientific data suggesting otherwise • Based on other coronavirus vaccines and viruses, immunity should last at least a year (with two dose) and likely longer • More and longer studies are needed
  • 15. FSMA FRIDAYS Vaccines •What we’d like to know • How long will it take to get Group 1a vaccinated in the US? • What will ACIP recommend for prioritization for Group 1b (87M people)? • This includes the Food and Ag Sector • What contraindications for the vaccines may emerge as part of Group 1a vaccination? • UK found that those with a history of allergic reactions should not be vaccinated in the first round • When will other vaccines be ready for approval and will they be as effective? • How might individual states vary from the CDC and ACIP recommendations for vaccine allocation?
  • 16. FSMA FRIDAYS Vaccines •Employers have an important role in the vaccination effort • Companies are in a unique position, having become a trusted source of information for their employees throughout the pandemic • Mandate vaccination? • New FAQ from the EEOC says employers can mandate vaccination. • Workplaces are important places for vaccination • Offer clinics 2 or 3 times a year instead of “now or never”
  • 17. FSMA FRIDAYS Vaccines Communication and Trust • Messaging needs to create “demand” for vaccination • Strategies that rely on “Prosocial” behavior • People are much more likely to do things if they think others are doing and value that activity • Make vaccination efforts visible • Find trusted and respected members of the workforce • Repeatedly share information (good and bad) and be ready to answer questions • Misinformation on vaccines has spread since the beginning of the pandemic
  • 18. Q & A FSMA FRIDAY
  • 19. ✔ FSMA Friday Session Recordings & Content Library ✔ TAG Newsletter ✔ Global Food Safety Consultants AchesonGroup.com ✔ FSMA Friday LinkedIn Group ✔ Q&A, Articles & Updates … Join FSMA FRIDAYS! Resources & Future Events FSMA FRIDAYS January 21, 2021: What’s New in SQF Ed. 9 & Tips for Your Conversion Plan Leann Chuboff - VP Technical Affairs SQFI