The Food Safety Modernization Act is the largest overhaul of the U.S. food processing system in more than 80 years. Thought it impacts domestic and foreign producers, there are quite a few changes in the new law important for Importers & foreign food manufacturers. Here is a highlight on how FSMA impacts Imported foods.

1. THE FOOD SAFETYTHE FOOD SAFETY
MODERNIZATION ACTMODERNIZATION ACT
For importing productsFor importing products
Brian ToddBrian Todd
President/CEOPresident/CEO
The Food InstituteThe Food Institute

2. Since 1928,
we’ve covered
the
intersection of
government
and business.

3. We still do so
today.

4. Major Food RecallsMajor Food Recalls
 E. coliE. coli, packaged spinach – August 2006, packaged spinach – August 2006
 SalmonellaSalmonella, peanut butter – February 2007, peanut butter – February 2007
 ListeriaListeria, chicken – February 2007, chicken – February 2007
 E. coliE. coli, ground beef – June 2007, ground beef – June 2007
 Clostridium botulinumClostridium botulinum, canned meat – July 2007, canned meat – July 2007
 22 E. coliE. coli, ground beef – October 2007, ground beef – October 2007
 SalmonellaSalmonella, frozen pot pies – October 2007, frozen pot pies – October 2007
 E. coliE. coli, frozen pizza – November 2007, frozen pizza – November 2007
 Animal handling, beef processing – February 2008Animal handling, beef processing – February 2008
 SalmonellaSalmonella, tomatoes(?), peppers – June/July 2008, tomatoes(?), peppers – June/July 2008
 SalmonellaSalmonella, processed peanuts – January 2009, processed peanuts – January 2009
 SalmonellaSalmonella, eggs – August 2010, eggs – August 2010

5. Food Safety Modernization ActFood Safety Modernization Act
PL 111-353, 124 Stat. 3885PL 111-353, 124 Stat. 3885
 Enacted January 4, 2011Enacted January 4, 2011
 Most expansive changes since 1938 ActMost expansive changes since 1938 Act
 Sweeping new enforcement authoritiesSweeping new enforcement authorities
 Exacting new food import requirementsExacting new food import requirements
 Major new program activities for FDAMajor new program activities for FDA
 Ambitious schedule for increasedAmbitious schedule for increased
inspectionsinspections

6. Effective ImmediatelyEffective Immediately
 Increased inspection frequencyIncreased inspection frequency
 Expanded records accessExpanded records access
 Import certification authorityImport certification authority
 Mandatory recall authorityMandatory recall authority
 FeesFees
 Whistleblower protectionWhistleblower protection

7. Increased Inspection FrequencyIncreased Inspection Frequency
 Domestic high-risk facilities -- every 3Domestic high-risk facilities -- every 3
yearsyears
 Other domestic facilities -- every 5 yearsOther domestic facilities -- every 5 years
 When: effective immediately, but subjectWhen: effective immediately, but subject
to appropriationsto appropriations

8. 88
Mandatory Inspection FrequencyMandatory Inspection Frequency
 High-risk facility designation based on:High-risk facility designation based on:
 Safety risks of the food --Safety risks of the food -- e.ge.g., pathogens, allergens,., pathogens, allergens,
foreign objects?foreign objects?
 Facility’s compliance history --Facility’s compliance history -- e.ge.g., Class I recall,., Class I recall,
Form 483?Form 483?
 Rigor of hazard analysis and preventive controlsRigor of hazard analysis and preventive controls
 Whether certified by accredited third party auditorWhether certified by accredited third party auditor
 Any other factors FDA considers appropriateAny other factors FDA considers appropriate

9. 99
Foreign Facility Inspections
100 600 1,200
2,400
4,800
9,600
19,200
0
5,000
10,000
15,000
20,000
2010 2011 2012 2013 2014 2015 2016

10. Inspection of Foreign FacilitiesInspection of Foreign Facilities
 If foreign facility, or government of aIf foreign facility, or government of a
foreign country, refuses to permit entry offoreign country, refuses to permit entry of
U.S. inspectors or designees within 24U.S. inspectors or designees within 24
hours of official request, food from thathours of official request, food from that
facility will be refused admissionfacility will be refused admission

11. New Fees for RegisteredNew Fees for Registered
FacilitiesFacilities
 No registration feeNo registration fee
 Fee for each facility subject to re-Fee for each facility subject to re-
inspectioninspection
 Fee for failure to comply with a recall orderFee for failure to comply with a recall order
 Fee for accredited third-party auditorsFee for accredited third-party auditors
 Fee for export certificatesFee for export certificates

12. NEW REQUIREMENTS FOR
FOOD IMPORTS

13. Foreign Supplier Verification
Program
 Each U.S. food importer must
implement a written FSVP and conduct
risk-based foreign supplier verification
activities
 When: within 2 years
 Implementation: FDA to issue regulations
and guidance within 1 year

14. Foreign Supplier Verification
Program
 “Importer”
 U.S. owner or consignee of food at time of
entry into United States (If none, U.S.
agent of foreign owner or consignee)
 FDA is required to post on its website a
current list of importers in compliance with
law

15. Foreign Supplier Verification
Program
 Verification activities may include:
 Lot-by-lot certification
 Annual onsite inspection of foreign supplier
 Checking foreign supplier’s preventive
controls plan
 Periodic sampling and testing of shipments

16. Foreign Supplier Verification
Program
 Exemptions
 Foreign supplier subject to/in compliance with
HACCP or low acid canned food regulations
 FDA required to create exemptions for
product samples, foods imported for personal
consumption

17. Foreign Supplier Verification
Program
 Failure to comply
 Food offered for import will be refused
admission if it appears importer lacks FSVP
 Importing food, or offering food for import, if
importer lacks FSVP is a “prohibited act”

18. Import Certificates
 FDA has discretionary authority to require
food safety certification as a condition of
granting admission
 Certification by a foreign government
agency or an accredited third-party auditor
 Certification may be for a facility or
a particular shipment

19. Voluntary Qualified Importer
Program
 FDA required to establish Voluntary
Qualified Importer Program to expedite
imports for participating importers
 When: within 18 months
 To be eligible, importer must import from
facilities certified by accredited third-party
auditor (and meet other criteria)

20. Prior Notice – New Information
 Prior notice of food imports must include
“any country to which the article of food
has been refused entry”
 When: within 180 days
 Implementation: FDA interim final rule

21. Recordkeeping Requirements
 Foreign Supplier Verification ProgramForeign Supplier Verification Program
 Food importers must keep FSVP and relatedFood importers must keep FSVP and related
records for 2 yearsrecords for 2 years

22. New Import Fees
 No registration feeNo registration fee
 Fee for each importerFee for each importer
subject to re-inspectionsubject to re-inspection
 Fee for failure to comply with a recall orderFee for failure to comply with a recall order
 Fee for importers participating in VoluntaryFee for importers participating in Voluntary
Qualified Importer ProgramQualified Importer Program

23. FSMA Does Not Include
 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

24. “Hazarding” some guesses on
FSMA Implementation

25. FDA Implementation
 Some provisions effective upon enactmentSome provisions effective upon enactment
 More than a dozen rulemakingsMore than a dozen rulemakings
 Numerous guidance documentsNumerous guidance documents
 FDA series of public meetings beforeFDA series of public meetings before
publishing proposed rulespublishing proposed rules
 FDA talking with USDAFDA talking with USDA

26. FDA Implementation
 FDA has set up 6 Working Groups in
charge of implementation:
 Preventive Standards
 Inspection and Compliance
 Imports
 Federal-State Integration
 Fees
 Reports and Studies

27. FDA Implementation
 “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)

28. Companies Should Start Preparing
Now
 Improve documentation/recordkeepingImprove documentation/recordkeeping
 Hazard analysis and preventive controls planHazard analysis and preventive controls plan

SeeSee USDA National Agricultural Library, Food SafetyUSDA National Agricultural Library, Food Safety
Information CenterInformation Center::
http://fsrio.nal.usda.gov/nal_display/index.php?info_center=1&tax_levehttp://fsrio.nal.usda.gov/nal_display/index.php?info_center=1&tax_leve
 Universities with HACCP knowledge:Universities with HACCP knowledge:
http://www.fsis.usda.gov/Science/HACCP_Validation_Resources/indexhttp://www.fsis.usda.gov/Science/HACCP_Validation_Resources/index
 Foreign Supplier Verification ProgramForeign Supplier Verification Program
 Domestic facilities should also review supply chain managementDomestic facilities should also review supply chain management

29. HACCP & U.S. Food SafetyHACCP & U.S. Food Safety
GuideGuide
 Resource from The Food Institute’sResource from The Food Institute’s
catalogcatalog

31. Thank YouThank You
For questions about The Food Institute:For questions about The Food Institute:
Lina Khouri BushLina Khouri Bush
Account ExecutiveAccount Executive
201-791-5570 ext. 214201-791-5570 ext. 214
Lina.Khouri.Bush@FoodInstitute.comLina.Khouri.Bush@FoodInstitute.com