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NOAA for FDA QLN FSMA Workshop 22Sept2016

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NOAA presentation about seafood inspection program and the Food Safety Modernization Act (FSMA). Presentation was given at the FDA in Los Angeles Sept 22, 2016 by Laurice Churchill

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NOAA for FDA QLN FSMA Workshop 22Sept2016

  1. 1. FDA FSMA Compliance Workshop Office of International Affairs and Seafood Inspection NOAA Fisheries Seafood Inspection Program “We know that NOAA is involved in fisheries, but we really don’t know what NOAA Seafood Inspection does for the industry.”
  2. 2. US Department of Commerce/NOAA Fisheries Seafood Inspection Program NOAA Seafood Inspection ensures that fish and fishery processors and products meet: • Regulatory requirements and • Quality specifications So international and domestic buyers and consumers can have confidence in the seafood products that they purchase.
  3. 3. NOAA Seafood Inspection Program Federal Food Regulations in the United States USDA is responsible for the safety, wholesomeness and labeling of meat, poultry and processed egg products and FDA bears the same responsibility for all other foods, including seafood. EPA USDA H&HS USDC
  4. 4. NOAA Seafood Inspection Program NOAA Fisheries (formerly NMFS) Responsible for stewardship of living marine resources through science-based conservation and management and promotion of the health of their environment. • March 15, 2015 – Presidential Task Force Action Plan for combatting IUU Fisheries and seafood fraud. To leverage capabilities and to support a holistic “ocean to plate” approach to seafood safety, quality, sustainability and commercial integrity, NOAA merged two of its fisheries offices.
  5. 5. NOAA Seafood Inspection Program FDA / NOAA Authority & FDA/NOAA Cooperative Agreement FDA is the mandatory authority for seafood inspection in the United States • FD&C Act, PHS Act, FP&L Act • 21 CFR Part 110 (new 117) (GMPs) • 21 CFR Part 123 (SHR) • 21 CFR Part 101 (Labeling) • Performs periodic audits of processors of fish and fishery products to determine compliance with: • Food Safety • Wholesomeness • Proper Labeling NOAA Seafood Inspection Program Services were authorized by the: • Agricultural Marketing Act of 1946 • Empowered USDC to create regulatory requirements to carry out fee-based programs for the food industry per: • 50 CFR Part 260 • Inspecting and grading of raw and processed foods Memoranda of Understanding (MOU) with the FDA and USDA  NOAA Seafood Inspection Program Approved Establishments must meet all FDA requirements including:  21 CFR parts 110, 123 and 101
  6. 6. FSMA requirements that affect Processors of fish and fishery products subjected to 21 CFR Part 123 FSMA modifies 21 CFR 1.227 registration requirements and now requires that food processors renew their registration with the FDA every 2 years.
  7. 7. FSMA authorized the promulgation of seven regulations. 1. Preventive Controls for Human Food Final Rule 2. Preventive Controls for Food for Animals Final Rule 3. Standards for Produce Safety Final Rule 4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Final Rule 5. Accredited Third-Party Certification Final Rule 6. Sanitary Transportation of Human and Animal Food Proposed Rule 7. Focused Mitigation Strategies to Protect Food against Intentional Adulteration Proposed Rule
  8. 8. Three of the 7 will affect seafood processors subjected to 21 CFR Part 123. 1. Preventive Controls for Human Food Final Rule 2. Preventive Controls for Food for Animals Final Rule 3. Standards for Produce Safety Final Rule 4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Final Rule 5. Accredited Third-Party Certification Final Rule 6. Sanitary Transportation of Human and Animal Food Proposed Rule 7. Focused Mitigation Strategies to Protect Food against Intentional Adulteration Proposed Rule
  9. 9. 21 CFR Part 117 goes into effect (staggered implementation dates) beginning September 2016. Today, we’ll talk about the “Preventive Controls Rule for Human Food. • 21 CFR Part 117 Regulations on Sanitary transportation and focused mitigation strategies will be implemented at later dates.
  10. 10. How 21 CFR Part 117 will impact seafood processors subjected to 21 CFR Part 123 There are 7 subparts to 21 CFR Part 117. • Subparts A, B and F do apply to processors of fish and fishery products covered by 21 CFR Part 123. • Subparts C, D, E and G do not apply to processors of fish and fishery products covered by 21 CFR Part 123. Part 117 www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
  11. 11. How 21 CFR Part 117 will impact seafood processors subjected to 21 CFR Part 123 Subpart A - Training Requirement/Qualifications and Subpart F – Record keeping Requirements Individuals involved in processing food must be qualified to perform duties Have necessary training, education, or experience to perform job Trained in principles of food hygiene and food safety Records of training in food hygiene and food safety must be generated and maintained per 21 CFR Part 117 Subpart F.
  12. 12. How 21 CFR Part 117 will impact seafood processors subjected to 21 CFR Part 123 Subpart B – Current Good Manufacturing Practices • GMP requirements are all mandatory “must” statements • Explicitly incorporates control of allergen cross- contact. • 21 CFR Part 117 B will replace 21 CFR Part 110 per the FSMA implementation schedule. This course will teach the revised current Good Manufacturing Practices (GMPs) in Part 117 (b) instead of teaching the soon to be obsolete Part 110 GMPs.
  13. 13. How 21 CFR Part 117 will impact seafood processors subjected to 21 CFR Part 123 NOAA Approved Establishments will be required to meet applicable provisions of 21 CFR Part 117. NOAA SI will begin performing these expanded audits during Q4 of CY 2016.
  14. 14. NOAA Seafood Inspection Program-Industry Services Inspection • Mission: to provide inspection services for fish and fishery products and processors to: • Ensure safety and quality • Enhance marketability • Support sustainability • Inspection and Grading • Auditing • Export Certification • Consultative Services • Training and Education
  15. 15. NOAA Seafood Inspection Program-Industry Services Inspection • NOAA SIP provides lot inspection services for: • Domestic & International buyers and sellers of seafood products. • Lot inspections determine whether products meet approved buyer’s specifications for: • Net weight, counts other labeling claims • Quality attributes • Results are documented and certified. •
  16. 16. NOAA Seafood Inspection Program-Industry Services Grading • NOAA SIP Grading Services require that: • Processors meet all food processing regulations (50 CFR Part 260, GMPs, Seafood HACCP Regulation) NOAA SIP Ensures and provides: • The finished product quality characteristics meet published Grade Standard requirements. •
  17. 17. NOAA Seafood Inspection Program Auditing • NOAA SIP Auditing Services • Verify whether processors meet US Seafood Regulations. • Processors who have met these requirements may be listed on the USDC’s Approved Establishments list. • NOAA’s Approved Establishments (NOAA AE) include both U.S. and international processors who have meet FDA regulatory and NOAA approved establishments requirements by passing quarterly audits.
  18. 18. NOAA Seafood Inspection Program Export Certification – $6.5 billion export trade for seafood (2014) – To meet destination country’s import requirements • For safety and quality • For sustainability Certificate of Legal Origin from the U.S. • Currently 65 discrete export certificates – To meet aquatic health requirements
  19. 19. NOAA Office of International Affairs and Seafood Inspection In Conclusion Mission: to provide inspection services for fish and fishery products and processors to: • Ensure safety and quality • Enhance marketability • Support sustainability Primary services: • Inspection and Grading • Auditing • Export Certification • Consultative Services • Training and Education • Seafood – ready for FSMA • Approved Establishments have been HACCP compliant since 1992. • USDC can help industry be compliant!
  20. 20. NOAA Seafood Inspection Program Conclusion For More information: http://www.seafood.nmfs.noaa.gov/ Laurice.Churchill@noaa.gov (562) 388-7346 Thank you!

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