Title: FDA
1FDA 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
2Agenda
- Why is the law needed?
- Provisions of the law focus on imports
- Implementation
3Food 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
4New 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
5Why 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
6The 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
7Main Themes of the Legislation
8PreventionThe 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
9Inspection, 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
10Enhanced 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
11Import 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
12Import 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
13Import 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
14Import 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
15Role 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)
16Accreditation 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
17Implementation 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
18Regulatory 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
19Rulemaking Process It Doesnt Happen Overnight
- FDA proposes rule and requests comments
- FDA considers comments and issues final rule
- FDA sets dates for companies to comply
20Strategic Communications Outreach Team
Sharon Natanblut
21Implementation 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
22Additional 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
23For more information
- Web site at www.fda.gov/fsma
- Subscription feature available
- www.regulations.gov
To Submit Comments
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25Thank 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