FDA – Latin America Regional Office US-FDA-LAO@fda.hhs

FDA Food Safety Modernization ActMichael Rogers, M.S.Director, Latin America OfficeFood and Drug Administration FDA – Latin America Regional Office US-FDA-LAO@fda.hhs.gov

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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 High-risk Food Certification When required by FDA Sec. 303

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

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

Rulemaking Process: It Doesn’t Happen Overnight • FDA proposes rule and requests comments • FDA considers comments and issues final rule • FDA sets dates for companies to comply We are nearly here

Implementation Executive Committee Strategic Communications & Outreach Team – Sharon Natanblut

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

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

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

Thank you! Questions? us-fda-lao@fda.hhs.gov San José, CR: (506) 2519-2224 México DF : (52) (55) 1997-1506 Santiago, Chile: (562) 330 3035

FDA – Latin America Regional Office US-FDA-LAO@fda.hhs