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04/11/23 #1 FDA’s Current Thinking: Proposed Produce Safety Regulation
FDA Food Safety Modernization Act
Michael Rogers, M.S.Director, Latin America OfficeFood and Drug Administration
FDA – Latin America Regional [email protected]
04/11/23 #2 FDA’s Current Thinking: Proposed Produce Safety Regulation
Agenda
• Why is the law needed?
• Provisions of the law; focus on imports
• Implementation
04/11/23 #3 FDA’s Current Thinking: Proposed Produce Safety Regulation
Food Safety Modernization Act
“I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action.”
Margaret A. Hamburg, M.D.,
Commissioner of Food and Drugs
04/11/23 #4 FDA’s Current Thinking: Proposed Produce Safety Regulation
New law updates authority and tools
2011 – Food Safety Modernization Act
1976 Medical Device Amendments
1938 – Food, Drug, and Cosmetic Act
1906 – Pure Food and Drug Act
04/11/23 #5 FDA’s Current Thinking: Proposed Produce Safety Regulation
Why is the law needed?Globalization
• 15 percent of U.S. food supply is imported
Food supply more high-tech & complex• More foods in the marketplace• New hazards in foods not previously seen
Shifting demographics• Growing population (about 30%) of individuals are
especially “at risk” for foodborne illness
04/11/23 #6 FDA’s Current Thinking: Proposed Produce Safety Regulation
The Public Health Imperative• Foodborne illness is a significant burden
– About 48 million (1 in 6 Americans) get sick each year
– 128,000 are hospitalized
– 3,000 die
• Immune-compromised individuals more susceptible
– Infants and children, pregnant women, older individuals, those on chemotherapy
• Foodborne illness is not just a stomach ache—it can cause life-long chronic disease
– Arthritis, kidney failure
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Main Themes of the LegislationPrevention
Inspections, Compliance, & Response
Import Safety
Enhanced Partnerships
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Prevention:The cornerstone of the legislation
• Comprehensive preventive controls for food facilities – Prevention is not new, but Congress gave FDA
explicit authority to use the tool more broadly– Strengthens accountability for prevention
• Produce safety standards• Intentional adulteration standards
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Inspection, Compliance & Response• Mandated inspection frequency
– Considering new ways to inspect
• New tools– Mandatory recall – Expanded records access– Expanded administrative detention– Suspension of registration– Enhanced product tracing– Third party laboratory testing
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Enhanced Partnerships:
Vital to Success• Reliance on inspections by other agencies that meet standards
• State/local & international capacity building• Improve foodborne illness surveillance • National agriculture & food defense strategy• Consortium of laboratory networks• Easier to find recall information
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Import Safety:Most Groundbreaking
Shift• Importers now responsible for ensuring their suppliers have adequate preventive controls in place
• Can rely on third parties to certify that foreign food facilities meet U.S. requirements
• Can require mandatory certification for high-risk foods• Voluntary qualified importer program--expedited review• Can deny entry if FDA access for inspection is denied• Requires food from abroad to be as safe as domestic
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Import Safety MandatesSec. 301. Foreign supplier verification program• Requires importers to verify their suppliers use risk-based
preventive controls that provide same level of protection as U.S. requirements and that product is not adulterated or misbranded.
Sec. 302. Voluntary qualified importer program• Allows for expedited review and entry of products from
qualified importers received from certified facilitiesSec. 303. Certification for high-risk food imports• FDA has discretionary authority to require assurances of
compliance for high-risk foods
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Import Safety MandatesSec. 304. Prior notice of imported food shipments• Requires information on prior refusals to be added to
prior notice submissionSec. 305. Capacity building• FDA mandate to work with foreign governments to build
food safety capacitySec. 306. Inspection of foreign food facilities• Can deny entry if FDA access for inspection is deniedSec. 201. Targeting of inspection resources • Increased inspection of foreign as well as domestic
facilities
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Import Safety MandatesSec. 307. Accreditation of third-party auditors• FDA can rely on accredited third parties to certify that foreign
food facilities meet U.S. requirementsSec. 308. Foreign Offices of the Food and Drug Administration. • Establish offices in foreign countries to provide assistance on
food safety measures for food exported to the U.S.Sec. 309. Smuggled Food• In coordination with DHS, better identify and prevent entry of
smuggled food
04/11/23 #15 FDA’s Current Thinking: Proposed Produce Safety Regulation
Role of Third-Party Certification Programs
• Tool for importers to obtain needed assurances to meet their obligations for the foreign supplier verification program (sec. 301)
• A way for importers to participate in the voluntary qualified importer program to expedite movement of food through the import process (sec. 302)
• Can be required by FDA to accompany high-risk foods (sec. 303)
04/11/23 #16 FDA’s Current Thinking: Proposed Produce Safety Regulation
Accreditation Body (or FDA)Accredits 3rd parties
Sec. 307
3rd Party AuditorCertify high-risk
food imports
Foreign supplier verification programForeign firms may use Certification as a tool
Sec. 301
Voluntary Qualified Importer Program
Importer inspection and product certification enable
expedited product entrySec. 302
FDARecognizes
Accreditation Bodies
High-risk Food Certification
When required by FDASec. 303
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Implementation Approach• Implementation already underway• Coalition needed• Transparency a priority• Focus on public health protection• Engage with stakeholders to help determine
reasonable and practical ways to implement provisions
04/11/23 #18 FDA’s Current Thinking: Proposed Produce Safety Regulation
Regulatory Process(Rulemaking)
Triggering Event
FSMA
Triggers• Legislation
• Petition
• Court Decision
• Accident/Incident
• Technology
Initial Research• Identify problem
• Substantiate problem
• Determine solution
Proposed Rule
(Step 1)
FinalRule
(Step 2)
Effective Date
(Step 3)
WE ARE HEREAdditional
Tools
04/11/23 #19 FDA’s Current Thinking: Proposed Produce Safety Regulation
Rulemaking Process: It Doesn’t Happen Overnight
1. FDA proposes rule and requests comments
2. FDA considers comments and issues final rule
3. FDA sets dates for companies to comply
We are nearly here
04/11/23 #20 FDA’s Current Thinking: Proposed Produce Safety Regulation
Implementation Executive
Committee
Prevention StandardsDon Kraemer
Inspection/ ComplianceBarbara Cassens
ImportsDavid Elder
Importer Verification &
VQIP
Accredited Third- Party Certification
Lab Accreditation &
Integrated Consortium/
FERN
Fees
David Wardrop
Federal/State Integration
Joe Reardon
Reports/ Studies
David Dorsey
Operational Partnership
Capacity Building
Produce SafetyRegulation
Produce Safety Guidance
Preventive Controls
Regulation
Preventive ControlsGuidance
Mandatory Recall and Recall Communications
Manner of Inspection/Food
Safety Plan Review
Inspection & Auditor Fees
Reports to Congress/
Studies
Comparability
Task A: Prior Notice
TrainingFrequency of Inspection
Administrative Enforcement
Tools
Safe Food Transport
Food Defense
Contaminants
Import Certification
Registration
RFR Improvements
Tracing
International Capacity Building
Implementation Executive Committee
Strategic Communications & Outreach Team –
Sharon Natanblut
04/11/23 #21 FDA’s Current Thinking: Proposed Produce Safety Regulation
Implementation & ComplianceEducate before we regulate• Partner with stakeholders to provide education & outreach
Non-traditional strategy:• Educate & outreach to enhance compliance
• Small entity compliance guide on how to comply with the regulations• Updated GAPs guidance
• Utilize existing & develop new partnerships with governments• Consider how existing efforts & information may be used• Develop appropriate review & oversight mechanism• Interface with trade associations, commodity groups, individuals
with diverse farming practices and operations
Flexibility built into regulation via Alternative approaches, Variances and Compliance dates
04/11/23 #22 FDA’s Current Thinking: Proposed Produce Safety Regulation
Additional Resources• FDA FSMA page:
http://www.fda.gov/Food/FoodSafety/FSMA/default.htm
• Produce Safety Alliance:http://producesafetyalliance.cornell.edu/psa.html
• FDA Produce Safety Activities:
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/FDAProduceSafetyActivities/default.htm
04/11/23 #23 FDA’s Current Thinking: Proposed Produce Safety Regulation
For more information
• Web site at: www.fda.gov/fsma• Subscription feature available
• www.regulations.gov
To Submit Comments:
04/11/23 #24 FDA’s Current Thinking: Proposed Produce Safety Regulation
04/11/23 #25 FDA’s Current Thinking: Proposed Produce Safety Regulation
Thank you!
• San José, CR: (506) 2519-2224
• México DF : (52) (55) 1997-1506
• Santiago, Chile: (562) 330 3035
