FOOD SAFETY MODERNIZATION ACT (FSMA)

1. FOOD SAFETY MODERNIZATION ACT (FSMA) AN OVERVIEW Beverley Miller Date: 25 October 2011

2. THE FOOD SAFETY MODERNIZATION ACT • The Food Safety Modernization Act, an amendment of the Federal Food, Drug and Cosmetic (FD&C) Act, was signed into law on January 4, 2011 by President Obama. • The Act provides a legislative mandate to require science-based preventive controls across the food supply chain rather than a reactive approach to food safety problems.

3. WHY the FSMA? • Foodborne illness a big problem in the U.S.A. • Recent data from the Centers for Disease Control & Prevention: • About 48 million (1 in 6) Americans get sick; 128,000 are hospitalized and 3,000 die each year • Foodborne diseases a largely preventable public health burden

4. FEATURES OF FSMATitles 1-3 • 1. Improving capacity to prevent food safety problems; • 2. Improving capacity to detect and respondto food safety problems; • 3. Improving the safety of importedfood.

5. 1. Improving capacity to preventfood safety problems • Registration • Biennial registration renewal as of October 1, 2012; • Suspension of registration • Hazard analysis and risk-based preventive control • Authority to collect fees for re-inspection; mandatory recalls; voluntary qualified importer programme (VQIP); • Unique Identification Number for each registered facility (study underway).

6. 2. Improving capacity to detect and respondto food safety problems • Identification and inspection of facilities; increased frequency of inspection. (In year 1- at least 600 foreign facilities to be inspected) • Identification and inspection at ports of entry;

7. 2. Improving capacity to detect and respondto food safety problems(cont’d) • Laboratory Accreditation for Analysis of Foods; (Foreign labs which satisfy accreditation standards shall be accredited); • Enhanced tracking/tracing of foods(starting with pilot projects) & recordkeeping; • Foodborne illness surveillance system; • Mandatory recall authority.

8. FSMA & Lab. Accreditation • Section 202 of the Act, directs the FDA to:- Establish a programme for the testing of foods by accredited laboratories by January 2013; • Establish a publicly available registry of accreditation bodies recognized by the Secretary and of laboratories accredited by a recognized accreditation body by January 2013; • Require that any changes that would affect the recognition/accreditation be reported to the Secretary.

9. 3. Improving the safety of Importedfood • Foreign Supplier Verification Programme (FSVP) • Voluntary Qualified Importer Programme (VQIP)

10. Foreign Supplier Verification Programme • Monitoring records for shipments • Lot-by-lot certification of compliance • Annual on-site inspections • Checking hazard analysis and risk-based preventive control plan of foreign supplier

11. Foreign Supplier Verification Programme (Cont’d) • Periodic testing and sampling shipments • Exemption : Seafood; Juice & LACF Facilities (microb. hazards only) in compliance with HACCP Guidance /Regulations due January 2012

12. Voluntary Qualified Importer Programme • Prior notice of imported food shipments • Inspection of foreign food facilities • Accreditation of third-party auditors (FDA can accept 3rd party’s verification that facilities comply with US requirements)

13. Voluntary Qualified Importer Programme cont’d • Authority to require import certification for high-risk foods; • FDA to establish Foreign Offices to provide assistance on food safety measures. Programme to begin no later than 18 months after enactment of FSMA (by July 2012)

14. Major Elements of FSMA • 1. Preventive Controls: FDA now has legislative mandate to require comprehensive prevention-based controls across the food supply. • 2.Inspection and Compliance: The legislation recognizes the importance of inspection as a means of holding industry accountable for its responsibility to produce safe food. The law specifies how often FDA should inspect food producers

15. Major Elements of FSMA cont’d • Imported Food Safety: New tools to ensure that imported foods meet US standards e.g. importer verification of adequacy of supplier’s preventive control; FDA’s ability to accredit qualified third party auditors to certify foreign facilities based on US food safety standards.

16. Major Elements of FSMA cont’d • Response: FDA has mandatory recall authority for all food products. • Enhanced Partnerships: The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies including foreign agencies.

17. SUMMARY • Biennial registration renewal: During period Oct. 1 – Dec. 31 of even numbered year. • Suspension of registration by FDA: No imports until informal hearing is held. • Re-inspection: No charge for initial inspection. FY 2011, re-inspection costs US$325.00/hour • Failure to comply with Recall orders: Fees to be determined.

18. SUMMARY • Proposed inspections during FY 2012 (Oct.1, 2011-Sept. 30, 2011 will measure industry’s compliance with current requirements NOT future FSMA regulations.

19. NATIONAL TASK FORCE • Role: To drive the process of ensuring Jamaica’s preparedness to satisfy USFDA requirements as elaborated in the Food safety Modernization Act. • Membership: Multi-sector & multi-stakeholder based. • Operations/Meetings: Meets fortnightly

20. NATIONAL TASK FORCE cont’d • Responsibilities: To provide guidance to Secretariat (established at BSJ) in coordinating activities of regulatory agencies and other stakeholders in preparing for USFDA inspections To determine the extent of Jamaica’s readiness to satisfy the requirements of the USFDA FSMA.

21. NATIONAL TASK FORCE cont’d • To identify needs of Jamaica’s regulatory machinery in order to fulfill its role and strengthen collaboration with US food safety agencies; • To assist in the sourcing of funds to enable both public and private sectors to upgrade to the required level

22. NATIONAL TASK FORCE cont’d • To keep stakeholders abreast of developments under the FSMA. • To encourage, through the establishment of a ‘corporate’ mentoring programme, big successful companies to mentor smaller companies in need of development.

23. JAMAICA’S PROGRESS • Pre-assessment visits being conducted by regulatory officials to determine the status of each facility (Priority to FDA list). • List of Food Safety Consultants prepared and available to stakeholders • Auditors have been identified and being prepared to start conducting gap audits.

24. JAMAICA’S PROGRESS cont’d • BSJ collaborating with Department of Chemistry (UWI) re the conduct of a Better Process Control School (BPCS) scheduled for January 9 -13, 2012. • FDA ‘s training of Processed food inspectors in HACCP scheduled for January 30, 2012 and joint inspections (FDA/BSJ) of Ackee firms to start on January 31, 2012.

25. JAMAICA’S PROGRESS cont’d • Jamaica National Agency for Accreditation (JANAAC) is currently accrediting a set of labs. to collectively cover the range of tests by January 2013.

26. CLOSING APPEAL • We all commit to the common goal of ensuring Jamaica’s agri/agro-processed exports into the USA by complying with the requirements of the USFDA FSMA.

27. Some Sources of Information • The FDA website @ http://www.fda.gov.FSMA • The FSM Secretariat at 619-1131 • BSJ Website @ www.bsj.org.jm