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An Update on: FDA FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE & THE NATIONAL SEAFOOD HACCP ALLIANCE. Ken Gall, NY Sea Grant/Cornell University CASA Conference, Long Island, NY - 2010. Cross-cutting Changes. FDA-Hazards and Controls Guide – 4 th Edition.
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An Update on: FDA FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE & THE NATIONAL SEAFOOD HACCP ALLIANCE Ken Gall, NY Sea Grant/Cornell University CASA Conference, Long Island, NY - 2010
Cross-cutting Changes FDA-Hazards and Controls Guide – 4th Edition • All elements of a control strategy are consolidated and listed sequentially • Information on completing HACCP Plan and Hazard Analysis moved to Chapter 2 • Expanded information on how to conduct Hazard Analysis and how to prepare HACCP Plan
Cross-cutting Changes FDA-Hazards and Controls Guide – 4th Edition • More information regarding the symptoms associated with pathogenic organisms and toxins in Chapters 4 to 21. • Verification – standard language for calibration of temperature sensing devices – recommend “checking for accuracy” before use and daily • Bibliography moved to end of each chapter
FDA-Hazards and Controls Guide – 4th Edition Chapter 6-Natural Toxins • Molluscan Shellfish • Azaspiracid Poisoning (AZP) listed as a hazard for molluscan shellfish in Europe and the EC action level of 0.16mg/kg is provided • Pectenotoxins (PTX) & Yessotoxins (YTX) are described (Mouse toxicity but no recommendations for control) • Finfish • Based on new risk data, the northern gulf of Mexico is considered problematic for ciguatera • Action levels for both Caribbean &Pacific ciguatera toxin Note: In cases where unpublished literature was used to develop for controls, the guidance was subjected to peer review – action level for ciguatera
FDA-Hazards and Controls Guide – 4th Edition Chapter 7-Scombrotoxin (Histamine) Formation • Based on FDA studies conducted in Hawaii and Grenada, changes in harvest controls for scombrotoxin species are being considered • Greater detail about an appropriate sample for histamine testing Note: In cases where unpublished literature was used to develop for controls, the guidance was subjected to peer review – harvest controls for histamine
FDA-Hazards and Controls Guide – 4th Edition Chapter 7-Scombrotoxin (Histamine) Formation • Additional recommendations for primary processor at receiving: _ Sensory evaluation _ Receiving temperature _ Corrective actions • Additional information regarding the receiving by a secondary processor • Clarification regarding risks with salad products and need for HACCP controls
Chapter 9-Environmental Chemical Contaminants FDA-Hazards and Controls Guide – 4th Edition • Changes in the listing of guidance levels for heavy metals • Updated tolerance levels for heavy metals
FDA-Hazards and Controls Guide – 4th Edition Chapter 11-Aquaculture Drugs • The addition of new approved drugs • An explanation of “extra-label” use of drugs • A list of drugs prohibited for “extra-label” use
FDA-Hazards and Controls Guide – 4th Edition Chapter 12 – Pathogen Growth • Growth parameters modified according to new information • Maximum cumulative exposure time • Recommended time of exposure critical limits for CRE • Recommended time of exposure critical limits for non-CRE
FDA-Hazards and Controls Guide – 4th Edition Chapter 13-Clostridium botulinum • Describe performance and suitability of Time-Temperature Indicators (TTIs) • Conforms to Skinner-Larkin formula • Functions under conditions of use • TTI’s are not intended to replace usual controls for product receipt and storage • Provides control strategy for ROP, raw, refrigerated product with no secondary barrier to C. bot. growth using a TTI. • Provides control strategy for frozen product with no secondary barrier to growth (CCP for labeling)
FDA-Hazards and Controls Guide – 4th Edition Chapter 16 - Cooking and Pasteurization • Cooking and Pasteurization combined in one chapter. • Pasteurization defined as a heat treatment applied to eliminate the most resistant pathogen of public health concern that is reasonably like to be present in the food. • End-Point Internal Product Temperature (EPIPT) provided as an option to continuous time/temperature monitoring when processor has conducted a study to validate a 6D process for Lm (Listeria monocytogenes).
FDA-Hazards and Controls Guide – 4th Edition Chapter 17 - Pathogens in Raw Molluscan ShellfishProcesses designed to retain raw product characteristics • New chapter • Covers pathogen survival through post harvest processing to retain raw product characteristics • Hydrostatic pressure • IQF with extended cold storage • Mild heat processing (Strategy listed in Ch 16) • Irradiation
FDA-Hazards and Controls Guide – 4th Edition Chapter 19 -Undeclared Food Allergens and Certain Intolerance Substances • Information provided on Food Allergen Protection Labeling & Consumer Protection Act (FALCPA).Food that contains allergenic proteins be labeled to clearly identify the potentially harmful food component (e.g., salmon and cod). • Hazard Analysis information updated for major food allergens, certain intolerance substances, and prohibited food additives. • New control strategies and example HACCP plans for undeclared major food allergens. • Recommend that finished product labels be checked at time of labeling – rather than at receipt of labels.
Appendix 4--Pathogen Tables FDA-Hazards and Controls Guide – 4th Edition • Changes in Table A-1 e.g., limiting conditions pH, wps, water activity • Changes in Table A-2 e.g., • Recommended Time of Exposure Critical Limits for CRE • Recommended Time of Exposure Critical Limits for Non-CRE
Appendix 6 – Fish names FDA-Hazards and Controls Guide – 4th Edition • Includes a table of Japanese and Hawaiian vernacular names and their corresponding U.S. market names.
National Seafood HACCP Alliance A 15 year collaborative effort consisting of: • Sea Grant/University Seafood Specialists • U.S. Food and Drug Administration • Association of Food and Drug Officials • NOAA Fisheries Service • USDA Extension Service • Interstate Shellfish Sanitation Conference • National Fisheries Institute • Seafood Products Association
Alliance Accomplishments • Basic HACCP training curriculum developed & recognized by FDA (1990s) • Approximately 26,000 people trained • Alternative (Internet based) training format developed in 2001 (~4,700 students to date) • Sanitation Control Procedures course developed in 2000 • Train-the-trainer courses conducted
New Initiatives for the Alliance 1.Conduct applied research to guide changes in Alliance training programs and materials • Conduct a seafood industry survey to assess barriers to the implementation of effective HACCP controls. • Conduct a survey of active Alliance trainers to assess knowledge gaps & identify resources that are needed. • Conduct a survey of federal & state inspectors to identify the HACCP implementation issues they are encountering. • Analyze FDA compliance data to identify specific problems or hurdles that industry is experiencing • Use data to guide the revision of existing training programs and the develop new programs or resources.
New Initiatives for the Alliance 2.Revise training curriculum manual to incorporate changes in new FDA Hazards Guide Training manual revisions include: • Better integration of FDA guidance • New teaching models • Content revisions New curriculum manual completed in 2010
New Initiatives for the Alliance 3.Update lnternet training course to format of new training manual Revisions will include: • New content • New update format • New models Revisions expected to be completed in 2010-11
New Initiatives for the Alliance 4.Conduct update courses for the seafood industry and regulators on the new FDA Guidance • Develop training materials for an update course. • Coordinate activities with FDA and AFDO and its regional affiliates • Make training materials available to all Alliance trainers to conduct additional training programs.
New Initiatives for the Alliance 5.Update and re-qualify all existing Alliance trainers • ~ 675 people have been qualified to be Alliance trainers. • Less than 100 were active from 1996-2006 and only 16 people taught more than 10 courses during this period. • The Alliance will contact all trainers and determine their intent to train. • Trainers will have a period of time to attend an update session or participate in a Webinar type of training session to be re-qualified to deliver the Alliance training program.
New Initiatives for the Alliance 6.Conduct new train-the-trainer sessions • Empower a new group of Alliance trainers. • Currently scheduled Train-The-Trainer sessions: • May 25-27, 2010 - Battle Creek, MI • June 28-30, 2010 - Miami, FL • July 27-29, 2010 - San Francisco, CA
New Initiatives for the Alliance 7.Develop new problem solving Applied Training Pods (ATPs) for the seafood industry • Identify key issues or food safety hazards for which industry is having trouble complying with FDA expectations. • Develop and test problem solving modules available on demand via the Internet or other delivery mechanisms to help firm’s develop effective HACCP controls and records. • Evaluate the ATPs and make appropriate changes.
Funding support for Alliance activities is from: • The Food and Drug Administration. • USDA National Institute of Food and Agriculture’s National Integrated Food Safety Initiative competitive grant’s program. • With ongoing support from various state Sea Grant and university based programs for seafood specialists.
FDA Hazards Guide and New Initiatives for the Alliance Questions ?