FDA

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FDA Food Safety Modernization ActMichael
Rogers, M.S.Director, Latin America OfficeFood
and Drug Administration
FDA Latin America Regional Office US-FDA-LAO_at_fda
.hhs.gov
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Agenda

• Why is the law needed?
• Provisions of the law focus on imports
• Implementation

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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

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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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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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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 acheit
  can cause life-long chronic disease
• Arthritis, kidney failure

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Main Themes of the Legislation
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PreventionThe 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 SafetyMost 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 Mandates

• Sec. 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
  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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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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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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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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Accreditation Body (or FDA) Accredits 3rd
parties Sec. 307
FDA Recognizes Accreditation Bodies
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
High-risk Food Certification When required by
FDA Sec. 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

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Regulatory Process(Rulemaking)

• Triggers
• Legislation
• Petition
• Court Decision
• Accident/Incident
• Technology

Proposed Rule (Step 1)
FinalRule (Step 2)
Effective Date (Step 3)
Triggering Event FSMA

• Initial Research
• Identify problem
• Substantiate problem
• Determine solution

Additional Tools
WE ARE HERE
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Rulemaking Process It Doesnt 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

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Strategic Communications Outreach Team
Sharon Natanblut
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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

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Additional Resources

• FDA FSMA page
• http//www.fda.gov/Food/FoodSafety/FSMA/default.h
  tm
• Produce Safety Alliance
• http//producesafetyalliance.cornell.edu/psa.html
  
• FDA Produce Safety Activities
• http//www.fda.gov/Food/FoodSafety/Product-Specif
  icInformation/FruitsVegetablesJuices/FDAProduceSa
  fetyActivities/default.htm

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For more information

• Web site at www.fda.gov/fsma
• Subscription feature available
• www.regulations.gov

To Submit Comments
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Thank you!

• Questions?
• us-fda-lao_at_fda.hhs.gov
• San José, CR (506) 2519-2224
• México DF (52) (55) 1997-1506
• Santiago, Chile [phone]