Transcript FSMA & PRS Update

FDA Food Safety
Modernization Act
Michael Rogers, M.S.
Director, Latin America Office
Food and Drug Administration
FDA – Latin America Regional Office
[email protected]
7/18/2015 #1
FDA’s Current Thinking: Proposed Produce Safety Regulation
Agenda
• Why is the law needed?
• Provisions of the law; focus on imports
• Implementation
7/18/2015 #2
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
7/18/2015 #3
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
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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
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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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FDA’s Current Thinking: Proposed Produce Safety Regulation
Main Themes of the Legislation
Prevention
Inspections, Compliance,
& Response
Enhanced Partnerships
Import Safety
7/18/2015 #7
FDA’s Current Thinking: Proposed Produce Safety Regulation
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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FDA’s Current Thinking: Proposed Produce Safety Regulation
Inspection, Compliance & Response
• Mandated inspection frequency
– Considering new ways to inspect
• New tools
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–
–
–
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Mandatory recall
Expanded records access
Expanded administrative detention
Suspension of registration
Enhanced product tracing
Third party laboratory testing
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FDA’s Current Thinking: Proposed Produce Safety Regulation
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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FDA’s Current Thinking: Proposed Produce Safety Regulation
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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FDA’s Current Thinking: Proposed Produce Safety Regulation
Import Safety Mandates
Sec. 301. Foreign supplier verification program
• Requires importers to verify their suppliers use riskbased 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
facilities
Sec. 303. Certification for high-risk food imports
• FDA has discretionary authority to require
assurances of compliance for high-risk foods
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FDA’s Current Thinking: Proposed Produce Safety Regulation
Import Safety Mandates
Sec. 304. Prior notice of imported food shipments
• Requires information on prior refusals to be added to
prior notice submission
Sec. 305. Capacity building
• FDA mandate to work with foreign governments to build
food safety capacity
Sec. 306. Inspection of foreign food facilities
• Can deny entry if FDA access for inspection is denied
Sec. 201. Targeting of inspection resources
• Increased inspection of foreign as well as domestic
facilities
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FDA’s Current Thinking: Proposed Produce Safety Regulation
Import Safety Mandates
Sec. 307. Accreditation of third-party auditors
• FDA can rely on accredited third parties to certify that
foreign food facilities meet U.S. requirements
Sec. 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
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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)
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FDA’s Current Thinking: Proposed Produce Safety Regulation
FDA
Recognizes
Accreditation Bodies
Accreditation Body (or FDA)
Accredits 3rd parties
Sec. 307
3rd Party Auditor
Certify high-risk
food imports
Voluntary Qualified
Importer Program
Importer inspection and
product certification enable
expedited product entry
Sec. 302
High-risk Food
Certification
When required by FDA
Sec. 303
Foreign supplier
verification program
Foreign firms may use
Certification as a tool
Sec. 301
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FDA’s Current Thinking: Proposed Produce Safety Regulation
Implementation Approach
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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
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FDA’s Current Thinking: Proposed Produce Safety Regulation
Triggers
•
•
•
•
•
Legislation
Petition
Court Decision
Accident/Incident
Technology
Triggering Event
FSMA
Regulatory Process
(Rulemaking)
Proposed
Rule
Final
Rule
Effective
Date
(Step 1)
(Step 2)
(Step 3)
Initial Research
• Identify problem
• Substantiate problem
• Determine solution
WE ARE HERE
Additional
Tools
7/18/2015 #18
FDA’s Current Thinking: Proposed Produce Safety Regulation
Rulemaking Process:
It Doesn’t Happen Overnight
1. FDA proposes rule and
requests comments
We are nearly here
2. FDA considers comments and
issues final rule
3. FDA sets dates for companies to comply
7/18/2015 #19
FDA’s Current Thinking: Proposed Produce Safety Regulation
Strategic Communications
& Outreach Team –
Implementation Executive
Implementation
Committee
Sharon Natanblut
Executive
Committee
Prevention
Standards
Don Kraemer
Inspection/
Compliance
Imports
David Elder
Barbara Cassens
Produce Safety
Regulation
Produce Safety
Guidance
Preventive
Controls
Regulation
Mandatory
Recall and Recall
Communications
Administrative
Enforcement
Tools
Registration
Federal/State
Integration
Fees
Joe Reardon
David Wardrop
Importer
Verification &
VQIP
Accredited
Third- Party
Certification
Lab
Accreditation &
Integrated
Consortium/
FERN
Frequency of
Inspection
Safe Food
Transport
Tracing
International
Capacity
Building
Manner of
Inspection/Food
Safety Plan
Review
Comparability
Contaminants
RFR
Improvements
Inspection &
Auditor Fees
David Dorsey
Reports to
Congress/
Studies
Import
Certification
Preventive
Controls
Guidance
Food Defense
Operational
Partnership
Reports/
Studies
Capacity
Building
Training
Task A:
Prior Notice
7/18/2015 #20
FDA’s Current Thinking: Proposed Produce Safety Regulation
Implementation & Compliance
Educate 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
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•
•
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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
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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
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FDA’s Current Thinking: Proposed Produce Safety Regulation
For more
information
• Web site at:
www.fda.gov/fsma
• Subscription
feature available
To Submit Comments:
• www.regulations.g
ov
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FDA’s Current Thinking: Proposed Produce Safety Regulation
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FDA’s Current Thinking: Proposed Produce Safety Regulation
Thank you!
Questions?
[email protected]
• San José, CR: (506) 2519-2224
• México DF : (52) (55) 1997-1506
• Santiago, Chile: (562) 330 3035
7/18/2015 #25
FDA’s Current Thinking: Proposed Produce Safety Regulation