The first overhaul of the U.S. food manufacturing process in more than 80 years, the federal Food Safety Modernization Act (FSMA) law updates the role of the government in verifying the safety and availability of our food supply. FSMA, as it rolls out, has implications for both domestic manufacturers and those that distribute goods made abroad, in foreign facilities. The Food Institute analyzed the intersection of daily food production and regulatory compliance in this first in a series of 3 presentations on FSMA.

1. Brian Todd
President/CEO
The Food Institute
A Primer

2. The more things change…

3. The more they stay the same

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5. RECALLS…RECALLS….RECALLS

6. Enacted January 4, 2011
Most expansive changes since 1938 Act
Sweeping new enforcement authorities
Exacting new food import requirements
Major new program activities for FDA
Ambitious schedule for increased
inspections
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7. Increased inspection frequency
Expanded records access
Import certification authority
Mandatory recall authority
Fees
Whistleblower protection
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8. Must re-register every even-numbered year
(Oct. 1 – Dec. 31)
New registration information
Introducing food into commerce without
complying is a “prohibited act”
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9. Elements:
Hazard analysis
Preventive controls
Monitoring of preventive controls
Corrective actions
Verification
Performance Standards (if any)
Records
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10. FDA is required to conduct vulnerability
assessment of food system and determine
mitigation strategies to protect against
intentional adulteration
Implementation:
FDA regulations within 18 months
FDA guidance documents within 1 year
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11. Hazard analysis and preventive controls
plan
Registered food facilities must keep hazard
analysis and preventive controls plan and
related records for 2 years
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12. Domestic high-risk facilities: every 3 years
Other domestic facilities: every 5 years
When: effective immediately, but subject to
appropriations
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13. If foreign facility, or
government of a foreign
country, refuses to permit
entry of U.S. inspectors or
designees within 24 hours of
official request, food from
that facility will be refused
admission
*

14.  No registration fee
 Fee for each facility subject to re-inspection
 Fee for failure to comply with a recall order
 Fee for accredited third-party auditors
 Fee for export certificates
*

15. *

16. FDA has discretionary authority to require
consumer notification of “reportable foods”
If report made to the Reportable Food Registry,
FDA may require responsible party to submit
“consumer-oriented information” to FDA
FDA then will post 1-page summary on its
website
*

17. Any grocery store that sold
reportable food and is part of chain
with 15 or more locations must
provide notification to consumers
within 24 hours and maintain for 14
days
Manner and location of notification
to be determined by FDA within 1
year (e.g., notice where food is sold
in store, targeted information given
to consumer at cash register)
Question: What is a grocery store?
*

18. All testing of food for a
regulatory purpose must be done
by an accredited lab and results
sent directly to FDA
Regulatory testing:
for admission of imported food,
removal from Import Alert,
to comply with a specific testing
requirement, or
otherwise required by FDA
When: within 30 months
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19. *

20. FDA must first give company opportunity to
voluntarily recall product
If no voluntary recall, FDA may order
company to cease distribution
After opportunity for informal hearing
(within 2 days), FDA may order recall.
Failure to comply a is “prohibited act” and
subject to civil fine ($50,000 for
individuals, $250,000 for companies)
*

21. FDA may detain food if “reason
to believe” article of food is
adulterated or misbranded
Previously, FDA needed “credible
evidence” food posed “threat of
serious adverse health
consequences or death”
When: within 180 days
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22. If reasonable probability food from
a facility will cause serious adverse
health consequences or death to
humans or animals, FDA may
suspend registration of:
Facility responsible for causing hazard;
and
Any facility that packed, received, or
held the food if it knew, or had reason
to know, of hazard
When: within 180 days
Implementation: FDA to issue
regulations
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23. The FSMA greatly expands FDA
records access authority
Hazard analysis and preventive
controls plan and certain related
records (e.g., monitoring records,
verification records,
nonconformance and corrective
action records)
*

24. Reports of regulatory audits
by accredited third-party
auditors and documents used
to prepare such reports
*

25. Lab accreditation system
Third-party auditor
accreditation system
Product tracing system for food
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26. *

27.  Registration fees
 Civil fines (except for failure to comply
with recall order)
 Country of origin labeling
 Full pedigree traceability
 Reportable Food Registry reporting
requirement extended to all employees
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28. FDA has 6 Working Groups in charge of
implementation:
Preventive Standards
Inspection and Compliance
Imports
Federal-State Integration
Fees
Reports and Studies
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29. “We recognize that third-party
inspection programs need to be a
bigger part of the discussion because
we can’t do all the work ourselves.”
John Taylor, Acting Principal Deputy
Commissioner, FDA (quoted in
Bloomberg Businessweek)
*

30. Improve documentation/recordkeeping
Hazard analysis and preventive controls plan
USDA National Agricultural Library, Food
Safety Information Center:
http://fsrio.nal.usda.gov/nal_display/index.php?
info_center=1&tax_level=1&tax_subject=614
The Food Institute’s resource on HACCP
https://foodinstitute.com/catalog/product/haac
p-us-food-safety-2nd-ed
Foreign Supplier Verification Program
Domestic facilities should also review
supply chain management
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31. 31
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*FDA’s webpage on the FSMA:
http://www.fda.gov/Food/FoodSafety/FSMA/default.htm
*The Food Institute’s webinar series on FSMA
implementation for companies:
https://foodinstitute.com/catalog/product/Food-Safety-
Modernization-Act-series
*Washington Section of www.FoodInstitute.Com & Weekly
Report

32. Brian Todd
The Food Institute
201-791-5570
Brian.Todd@FoodInstitute.com
*THANK YOU
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