W
hereas 2020 saw dramatic changes in
food manufacturing, retailing, and the
supply chain, the rules of the Food
Safety Modernization Act continue to impact food
manufacturers, their distributor and retail partners.
This activity was addressed at the Food Safety
Preventive Controls Alliance virtual conference,
which took place on December 8 and 9, 2020.
FSPCA is the government/industry alliance
funded by FDA to develop training programs to
assist the food industry to comply with FSMA
regulations. It has issued more than 128,000
certificates to industry professionals who have
completed the recommended training for the
Preventive Controls for Human Food, the Foreign
Supplier Verification Program, Intentional
Adulteration rule, and other regulations. It has
conducted conferences for the past four years
to update the industry and its instructors on
implementation of the FSMA rules.
Adopting a New Food Safety
Paradigm
The day led off with a presentation from the FDA's
Office of Regulatory Affairs' Deputy Director of
Human and Animal Food Program, Glenn Bass.
He noted that the pandemic had a major impact
on FDA inspections, with all foreign inspections
postponed as of March 10 and domestic inspections
as of March 18. He said, "Some inspections are
temporarily on hold, but the food industry is still
required to meet food safety requirements—that has
not changed," adding that FDA has continued to
perform "mission critical" inspections, online and
in person.
FDA utilizes a tool that describes regions,
states, and counties as red, yellow, or green
based on COVID activity. Only "mission critical"
inspections are done in red regions; and less critical
inspections took place in yellow and green regions
when the pandemic weakened in July. As of press
time, most regions were back in the red.
The following mission critical inspections
were conducted in FY 2020 (October 1, 2019 –
September 30, 2020):
• On-site: 211
• Remote: 98
• Priority Surveillance: 195
Overall, inspections fell dramatically in 2020,
as follows:
• Domestic Inspections:
8,579 in 2018 vs. 3,696 in 2020
• Foreign Inspections:
1,740 in 2019 vs. 640 in 2020
Along with ongoing inspections, there were 425
full scope domestic Preventive Controls inspections
and 98 full scope foreign Preventive Controls
inspections, plus one Intentional Adulteration
inspection.
In the Full Scope Preventive Controls
inspections, the most frequent reasons for a
citation were:
1. Lack of Hazard Analysis
2. Lack of Food Safety Plan
3. Lack of Preventive Controls
4. Lack of Sanitation Controls
Verification Procedures
5. Lack of Sanitation Controls
Monitoring Procedures
2020 FSMA Round Up
BY RON TANNER
SPECIALTY FOOD SPECIALTYFOOD.COM
SPECIALTY FOOD
MAKER
