Food Safety Modernization Act
(FSMA) Key Themes/Concepts
Jeannie Perron, JD, DVM
Covington & Burling LLP
Food Safety Modernization Act
(FSMA) Key Themes/Concepts
• Focus on prevention, not inspection/
testing
• Risk-based approach
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Food Safety Modernization Act
(FSMA) Key Themes/Concepts
• Supply chain traceability/
transparency
– Know your supplier, particularly for
imports
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Food Safety Modernization Act
(FSMA) Key Themes/Concepts
• Enable food safety crises rapid
response, containment
• Enhance FDA’s inspection/
enforcement authority
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Hazard Analysis
• Must identify/evaluate known or
reasonably foreseeable hazards:
– biological, chemical, physical, radiological
hazards; natural toxins; pesticide and drug
residues; unapproved food/color additives;
allergens
– hazards naturally occurring or intentionally
introduced
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Hazard Analysis
• Reanalyze every 3 years or whenever a
significant change is made affecting risk
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Preventive Controls
• Identify and implement preventive
controls
– to significantly minimize or prevent identified
hazards and
– so undeclared allergens will not adulterate
or misbrand food
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Preventive Controls
• Must monitor and verify that preventive controls
are effective, and take corrective action when
needed
– Verification activities include environmental and
product testing programs
– Must keep records of these activities for 2 years,
including test results
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Preventive Controls
• Preventive controls are:
– Risk-based procedures, practices, and
processes
– That a knowledgeable person would
employ
– Consistent with current scientific
understanding of safe food manufacturing/
handling
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Preventive Controls
• Examples include:
– Sanitation procedures and practices
– Process pathogen controls
– Allergen control program
– Recall plan
– Current good manufacturing practices
(cGMPs)
– Verification procedures for suppliers and
incoming
ingredients
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Preventive Controls – FDA
Regulatory Implementation
• Hazard analysis/preventive controls
requirements effective July 2012
– Statute says FDA must promulgate
regulations by then that
– establish science-based minimum standards
for:
• analyzing and documenting hazards
• implementing and documenting preventive
controls
– work for all sizes and types of facilities
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Preventive Controls – FDA
Regulatory Implementation
• FDA may exempt from hazard
analysis/preventive control requirements
facilities solely engaged in the storage of
packaged foods that are not exposed to the
environment
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Traceability
• By Jan. 2013, FDA must require additional
recordkeeping for “high risk” foods
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Foreign Supplier Verification
Program
• U.S. importers must have a program by
January 2013 to verify that imported food is
produced in accordance with U.S.
requirements
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Foreign Supplier Verification
Program
• FDA must promulgate guidance and regulations
within 1 year, and may require:
–
–
–
–
monitoring records for shipments
lot-by-lot certification of compliance
annual on-site inspections
checking the hazard analysis and preventative
controls of the foreign supplier, and
– periodically testing and sampling shipments
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Expanded FDA Records Access
• FDA records access authority expanded to foods
FDA believes “likely to be affected in a similar
manner”
• FDA will have access to all newly-required
records (including test results)
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Facility Registration Changes
• Biennial registration
• No registration fee
– Bill does contain fees for reinspection and
reimbursement of FDA’s recall-related
expenses
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Facility Registration Changes
• Suspension of registration
– If FDA determines that a food manufactured,
processed, received, or held by a registered
facility has a reasonable probability of causing
serious adverse health consequences or
death, may suspend
– If suspended, food from facility may not be
introduced into commerce
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FDA Inspection/Enforcement
• Increased inspection schedule
– Hi-risk facilities
• Once during first 5 years after enactment
• Every 3 years thereafter
– Other facilities
• Once during first 7 years after enactment
• Every 5 years thereafter
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FDA Inspection/Enforcement
• FDA mandatory recall authority for Class I
recalls
• Relaxed standards for administrative
– detention
– “reason to believe” food is adulterated or
misbranded
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