1. FDA – Latin America Regional Office
FDA Food Safety Modernization Act Michael Rogers, M.S. Director, Latin America Office Food and Drug Administration
FDA – Latin America Regional Office

2. Agenda Why is the law needed? Provisions of the law; focus on imports
Implementation

3. 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
Congress passed the FSMA with overwhelming bi-partisan majorities in December 2010 and President Obama signed the legislation into law on January 4, 2011.

4. 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

5. 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

6. 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

7. Main Themes of the Legislation
Prevention
Inspections, Compliance,
& Response
Import Safety
Enhanced Partnerships

8. 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

9. 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

10. 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

11. 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

12. Import Safety Mandates
Sec 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 Voluntary qualified importer program
Allows for expedited review and entry of products from qualified importers received from certified facilities
Sec Certification for high-risk food imports
FDA has discretionary authority to require assurances of compliance for high-risk foods

13. Import Safety Mandates
Sec Prior notice of imported food shipments
Requires information on prior refusals to be added to prior notice submission
Sec Capacity building
FDA mandate to work with foreign governments to build food safety capacity
Sec Inspection of foreign food facilities
Can deny entry if FDA access for inspection is denied
Sec Targeting of inspection resources
Increased inspection of foreign as well as domestic facilities

14. Import Safety Mandates
Sec Accreditation of third-party auditors
FDA can rely on accredited third parties to certify that foreign food facilities meet U.S. requirements
Sec 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 Smuggled Food
In coordination with DHS, better identify and prevent entry of smuggled food

15. 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)

16. Accreditation Body (or FDA)
Recognizes
Accreditation Bodies
Accreditation Body (or FDA)
Accredits 3rd parties
Sec. 307
3rd Party Auditor
Certify high-risk
food imports
Foreign supplier
verification program
Foreign firms may use
Certification as a tool
Sec. 301
Voluntary Qualified
Importer Program
Importer inspection and
product certification enable
expedited product entry
Sec. 302
Sec 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 Voluntary qualified importer program
Allows for expedited review and entry of products from qualified importers received from certified facilities
Sec Certification for high-risk food imports
FDA has discretionary authority to require assurances of compliance for high-risk foods
High-risk Food
Certification
When required by FDA
Sec. 303

17. 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

18. Regulatory Process (Rulemaking)
Triggers
Legislation
Petition
Court Decision
Accident/Incident
Technology
Proposed Rule
(Step 1)
Final Rule
(Step 2)
Effective Date
(Step 3)
Triggering Event
FSMA
The regulatory process, also known as “rulemaking,” is triggered by an event such as a petition, court decision, accident or incident, technology or legislation. The enactment of the Food Safety Modernization Act directed FDA to issue several regulations.
After the triggering event, there are 3 primary steps in the process---Proposed Rule Making, Final Rule and Effective Date.
We could have other interim steps like issuing a modified proposed rule or an interim final rule. However, we’ll present the basic process that we typically follow.
Details of these 3 steps are on the NEXT SLIDE.
Initial Research
Identify problem
Substantiate problem
Determine solution
Additional Tools
WE ARE HERE

19. Rulemaking Process: It Doesn’t Happen Overnight
The proposed rule & final rule & supporting documents are filed in FDA’s official docket on: & also can be accessed at
FDA proposes rule and requests comments
FDA considers comments and issues final rule
FDA sets dates for companies to comply
We are nearly here

20. Implementation Executive Committee
Strategic Communications
& Outreach Team –
Sharon Natanblut

21. 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
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

22. Additional Resources FDA FSMA page: Produce Safety Alliance:
Produce Safety Alliance:
FDA Produce Safety Activities:
FruitsVegetablesJuices/FDAProduceSafetyActivities/default.htm
These additional resources are available for information and updates so check back frequently.

23. For more information Web site at: www.fda.gov/fsma
Subscription feature available
To Submit Comments:

24. Se puede suscribir haciendo click en “Get FSMA Updates by E mail”
You may Subscribe by clicking on “Get FSMA Updates by ”

25. Thank you! Questions? us-fda-lao@fda.hhs.gov
San José, CR: (506)
México DF : (52) (55)
Santiago, Chile: (562)
Muchas gracias por su atención de hoy. Nos puede contactar directamente al correo indicado o a los teléfonos siguientes.