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FDA

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

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Title: FDA


1
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
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

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

7
Main Themes of the Legislation
8
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

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 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

12
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

13
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

14
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

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) 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
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)
FinalRule (Step 2)
Effective Date (Step 3)
Triggering Event FSMA
  • Initial Research
  • Identify problem
  • Substantiate problem
  • Determine solution

Additional Tools
WE ARE HERE
19
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

20
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
  • 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

23
For more information
  • Web site at www.fda.gov/fsma
  • Subscription feature available
  • www.regulations.gov

To Submit Comments
24
(No Transcript)
25
Thank you!
  • Questions?
  • us-fda-lao_at_fda.hhs.gov
  • San José, CR (506) 2519-2224
  • México DF (52) (55) 1997-1506
  • Santiago, Chile (562) 330 3035
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