Seafood Hazards
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Questions and Answers

What does HACCP stand for?

  • Health and Analysis Critical Control Points
  • Hazard Analysis Critical Control Points (correct)
  • Hazard Assessment and Control Procedures
  • Health and Safety Control Program

    • Which step is important for establishing monitoring procedures?

  • Develop corrective action procedures
  • Set the frequency of monitoring (correct)
  • Identify the method of distribution
  • Determine the critical limits

    • What is the primary purpose of establishing critical limits in a HACCP plan?

  • To prevent bacterial growth (correct)
  • To track distribution methods
  • To ensure food is served at the correct temperature
  • To identify viral pathogens

    • What is one possible effect of failing to maintain proper temperature during food storage?

    <p>Growth of pathogenic bacteria</p> Signup and view all the answers

    What factor is critical for tracking viral pathogens in food distribution?

    <p>Maintaining refrigeration at all times</p> Signup and view all the answers

    Which of the following should be included in a recordkeeping system of a HACCP plan?

    <p>Monitoring results</p> Signup and view all the answers

    How does a flow diagram benefit the HACCP plan?

    <p>It simplifies the steps involved in food processing</p> Signup and view all the answers

    What is the implication of inadequate corrective action procedures in a HACCP plan?

    <p>Heightened public health risks</p> Signup and view all the answers

    What processes are now identified as methods to retain raw product characteristics and reduce certain bacteria in shellfish?

    <p>Hydrostatic pressure and IQF</p> Signup and view all the answers

    Which bacteria are specifically mentioned as being reducible to non-detectable levels through certain processing methods?

    <p>Vibrio vulnificus and Vibrio parahaemolyticus</p> Signup and view all the answers

    What is recognized as a potential hazard in freshwater fish regarding parasites?

    <p>Introduction of pathogenic larvae through skin</p> Signup and view all the answers

    What was removed from the description of Package Type for raw oysters, clams, and mussels?

    <p>Hot Fill and Steam Flush</p> Signup and view all the answers

    Which chapter was modified to clarify the hazard of parasitic infections?

    <p>Chapter 5: Parasites</p> Signup and view all the answers

    Which method is NOT mentioned as a means of monitoring bacterial pathogens in shellfish?

    <p>Hot water immersion</p> Signup and view all the answers

    What is the purpose of the information added in the footnotes of the document?

    <p>To organize information into categories</p> Signup and view all the answers

    What recent modification concerning natural toxins was made as of August 2019?

    <p>Natural Toxin Detection Section was removed</p> Signup and view all the answers

    Which appendix addresses bacterial and viral pathogens of greatest concern in seafood processing?

    <p>Appendix 7</p> Signup and view all the answers

    What is the purpose of Appendix 8 in the guidance for fish and fishery product processing?

    <p>To outline procedures for safe and sanitary processing and importing</p> Signup and view all the answers

    Which appendix provides information regarding the regulation of allergen cleaning and sanitation?

    <p>Appendix 10</p> Signup and view all the answers

    What key factor is assessed in monitoring bacterial pathogen growth in seafood?

    <p>Time and temperature history</p> Signup and view all the answers

    Which of the following appendices would you refer to for guidelines on unapproved aquaculture drugs?

    <p>Appendix 12</p> Signup and view all the answers

    What does FDA’s guidance on fish and fishery products not create for individuals or entities?

    <p>Mandatory compliance requirements</p> Signup and view all the answers

    Which appendix outlines safety levels as per FDA and EPA regulations?

    <p>Appendix 5</p> Signup and view all the answers

    What type of public health impacts are primarily focused on in the context of seafood processing?

    <p>Pathogen transmission via consumption</p> Signup and view all the answers

    What processes are now recognized to help reduce Vibrio vulnificus and Vibrio parahaemolyticus to non-detectable levels?

    <p>Individual quick freezing and irradiation</p> Signup and view all the answers

    Which hazard related to fish farming was added in the modifications concerning parasites?

    <p>The occurrence of parasitic larvae entering through skin</p> Signup and view all the answers

    What was removed from the package type description for raw oysters, clams, and mussels?

    <p>Steam Flush process</p> Signup and view all the answers

    What is emphasized regarding the natural toxins in seafood as of August 2019?

    <p>The section for natural toxins was removed entirely</p> Signup and view all the answers

    In what manner was Chapter 4 modified regarding pathogenic hazards?

    <p>Divided into seafood types</p> Signup and view all the answers

    What critical control measures were indicated regarding the HACCP plan in context with hydrostatic pressure?

    <p>It was never intended as a required control measure</p> Signup and view all the answers

    What is included in the recommendations for handling raw oysters, clams, and mussels to prevent allergen issues?

    <p>The hazard of undeclared allergens has been removed</p> Signup and view all the answers

    Which chapter was updated to address the presence of parasites in fish raised in freshwater?

    <p>Chapter 5: Parasites</p> Signup and view all the answers

    What is the primary purpose of the flow diagram in a HACCP plan?

    <p>To provide a clear description of the steps involved in distribution and storage</p> Signup and view all the answers

    Which of the following is NOT a component that needs to be established in the HACCP plan?

    <p>Marketing strategies</p> Signup and view all the answers

    Which packaging type is used for foods that require long shelf life and protection from contamination?

    <p>Vacuum-packaged plastic bag</p> Signup and view all the answers

    What aspect of the HACCP plan addresses how products are handled after distribution?

    <p>Flow diagram</p> Signup and view all the answers

    What should be regularly recorded to ensure compliance with the HACCP plan?

    <p>Monitoring results of critical limits</p> Signup and view all the answers

    Which statement accurately describes the establishment of corrective action procedures in a HACCP plan?

    <p>They outline steps to rectify points where critical limits are not met</p> Signup and view all the answers

    What is a necessary component of the recordkeeping system in a HACCP plan?

    <p>Records of monitoring and verification activities</p> Signup and view all the answers

    Why is it important to understand the method of distribution and storage in a HACCP plan?

    <p>To prevent the occurrence of foodborne pathogens</p> Signup and view all the answers

    What is the main topic of Appendix 7?

    <p>Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing</p> Signup and view all the answers

    Which appendix provides information on allergen cleaning and sanitation?

    <p>Appendix 10</p> Signup and view all the answers

    What does the FDA guidance facilitate regarding alternative approaches?

    <p>It allows for deviations as long as legal requirements are met.</p> Signup and view all the answers

    What is addressed in Appendix 12?

    <p>Unapproved Aquaculture Drugs</p> Signup and view all the answers

    Which appendix would you refer to for procedures related to the import of fishery products?

    <p>Appendix 8</p> Signup and view all the answers

    Which appendix addresses FDA and EPA safety levels in regulations and guidance?

    <p>Appendix 5</p> Signup and view all the answers

    What is the focus of Appendix 4?

    <p>Bacterial Pathogen Growth and Inactivation</p> Signup and view all the answers

    What overall purpose does the guidance document serve?

    <p>To provide FDA's current thinking on fish and fishery products hazards.</p> Signup and view all the answers

    The hazard of undeclared allergen has been retained in the description for raw oysters, clams, and mussels.

    <p>False</p> Signup and view all the answers

    Hydrostatic pressure and individual quick freezing are recognized methods for reducing certain bacteria to non-detectable levels.

    <p>True</p> Signup and view all the answers

    Footnotes 5 and 6 were added to provide information categorized into two sections regarding risks in seafood processing.

    <p>True</p> Signup and view all the answers

    The natural toxin detection section was added in the modifications as of August 2019.

    <p>False</p> Signup and view all the answers

    The modifications made as of April 2011 recognize that parasites may enter fish through the food.

    <p>False</p> Signup and view all the answers

    All processes now identified are intended for processors to include in their HACCP plans as control measures.

    <p>False</p> Signup and view all the answers

    The chapter on pathogens from the harvest area was updated to include recommendations on molluscan shellfish.

    <p>True</p> Signup and view all the answers

    'Hot Fill' and 'Steam Flush' processes remain in the Package Type description for raw seafood.

    <p>False</p> Signup and view all the answers

    The HACCP plan includes the establishment of monitoring procedures such as What, How, Frequency, and Who.

    <p>True</p> Signup and view all the answers

    A flow diagram is developed in the last step of creating a HACCP plan.

    <p>False</p> Signup and view all the answers

    Corrective action procedures should be established in a HACCP plan to address any failures in critical limits.

    <p>True</p> Signup and view all the answers

    The packaging type described in a HACCP plan does not need to protect the food from contamination.

    <p>False</p> Signup and view all the answers

    The purpose of documenting distribution and storage methods is to provide a clear description of the steps involved after distribution.

    <p>True</p> Signup and view all the answers

    Verification procedures in a HACCP plan can only occur during the final stages of the plan development.

    <p>False</p> Signup and view all the answers

    Recordkeeping is an essential component of the HACCP plan to track monitoring and corrective actions.

    <p>True</p> Signup and view all the answers

    The HACCP plan Form requires that all food products, including those vacuum-packaged, be described in terms of their method of distribution and storage.

    <p>True</p> Signup and view all the answers

    Appendix 6 provides information on fish that are commonly eaten raw.

    <p>True</p> Signup and view all the answers

    Allergen Cleaning and Sanitation guidelines are found in Appendix 10.

    <p>True</p> Signup and view all the answers

    Appendix 5 outlines the FDA and EPA's safety levels strictly related to air quality.

    <p>False</p> Signup and view all the answers

    The guidance document does not allow for any alternative approaches to the stated requirements.

    <p>False</p> Signup and view all the answers

    Appendix 4 focuses on factors that affect the survival and growth of bacterial pathogens.

    <p>True</p> Signup and view all the answers

    FDA's guidance on fish and fishery products aims to bind the public to specific requirements.

    <p>False</p> Signup and view all the answers

    Appendix 12 is dedicated to approved aquaculture drugs.

    <p>False</p> Signup and view all the answers

    Conditions for safe processing and importing of fish are described in Appendix 8.

    <p>True</p> Signup and view all the answers

    What is the purpose of establishing monitoring procedures in a HACCP plan?

    <p>To track the temperature of products reliably</p> Signup and view all the answers

    Which component is NOT part of establishing a HACCP plan?

    <p>Defining consumer preferences</p> Signup and view all the answers

    What best describes the role of a flow diagram in the HACCP plan?

    <p>To outline the steps in food processing</p> Signup and view all the answers

    Which method should be included when developing the HACCP plan regarding corrective actions?

    <p>Documenting deviations from critical limits</p> Signup and view all the answers

    How often should monitoring procedures be conducted, according to HACCP guidelines?

    <p>Regularly, as defined in the HACCP plan</p> Signup and view all the answers

    What is a common packaging type listed in a HACCP plan for maintaining product integrity?

    <p>Vacuum-packaged plastic bag</p> Signup and view all the answers

    What function does recordkeeping serve in a HACCP plan?

    <p>To provide evidence of compliance with safety standards</p> Signup and view all the answers

    What step is crucial for identifying potential hazards in a HACCP plan?

    <p>Conducting a hazard analysis</p> Signup and view all the answers

    What recent change has been made regarding the processing qualifications for raw oysters, clams, and mussels?

    <p>The hazard of undeclared allergen has been removed.</p> Signup and view all the answers

    Which of the following methods is identified as not intended to be included in the HACCP plan as a control measure?

    <p>Regular temperature monitoring</p> Signup and view all the answers

    Which parasitic infections associated with fish are recognized as a hazard due to their transmission through freshwater?

    <p>Liver, lung, and intestinal flukes</p> Signup and view all the answers

    What organizational change was implemented in Chapter 6 regarding natural toxins?

    <p>Natural toxin detection information was reorganized into two categories.</p> Signup and view all the answers

    What aspect of products was emphasized in the modifications for Chapter 4 concerning pathogenic hazards?

    <p>The ability of certain processes to retain raw product characteristics.</p> Signup and view all the answers

    How has the understanding of parasite hazards in fish raised in freshwater evolved?

    <p>Parasites may enter the fish through the skin, posing a hazard.</p> Signup and view all the answers

    What is the main focus of the added footnotes in the document?

    <p>To clarify and reorganize existing information in the chapters.</p> Signup and view all the answers

    What is the significance of individual quick freezing (IQF) in seafood processing?

    <p>It retains raw product characteristics and reduces certain bacteria to non-detectable levels.</p> Signup and view all the answers

    Which appendix provides guidelines on procedures for safe and sanitary processing of fish?

    <p>Appendix 8</p> Signup and view all the answers

    What is the focus of Appendix 4 of the guidance document?

    <p>Bacterial pathogen growth and inactivation</p> Signup and view all the answers

    Which appendix details the prevention procedures for allergen cross-contact?

    <p>Appendix 9</p> Signup and view all the answers

    In the context of the FDA guidance, how are alternative approaches treated?

    <p>They are encouraged under specific conditions.</p> Signup and view all the answers

    Which appendix addresses approved aquaculture drugs?

    <p>Appendix 11</p> Signup and view all the answers

    What topic does Appendix 3 cover?

    <p>Critical control point decision tree</p> Signup and view all the answers

    What significant aspect does the guidance document clarify regarding FDA's authority?

    <p>It does not create any binding rights.</p> Signup and view all the answers

    Which appendix is dedicated to allergen cleaning and sanitation procedures?

    <p>Appendix 10</p> Signup and view all the answers

    What are the key components that must be established in a HACCP plan?

    <p>Critical limits, monitoring procedures, corrective actions, recordkeeping, and verification procedures.</p> Signup and view all the answers

    How does the flow diagram contribute to a HACCP plan?

    <p>It provides a clear, simple visualization of the food handling steps and helps identify potential hazards.</p> Signup and view all the answers

    What is the purpose of establishing critical limits in a HACCP plan?

    <p>To define the maximum and minimum values for safety measures that must be maintained to prevent food safety hazards.</p> Signup and view all the answers

    Why is monitoring frequency important in a HACCP plan?

    <p>It ensures consistent oversight of critical limits and helps quickly identify any deviations from these limits.</p> Signup and view all the answers

    What types of packaging are recommended for food products required to maintain high safety standards?

    <p>Vacuum-packaged plastic bags and aluminum cans are noted to enhance shelf life and protect from contamination.</p> Signup and view all the answers

    What role do corrective action procedures play in a HACCP plan?

    <p>They outline the steps to take when monitoring indicates that critical limits are not being met.</p> Signup and view all the answers

    How should the method of distribution and storage be described in a HACCP plan?

    <p>It should detail the processes and conditions under which the product is distributed and stored after processing.</p> Signup and view all the answers

    What information should be included in the recordkeeping system of a HACCP plan?

    <p>Records should include monitoring data, corrective actions taken, and verification activities.</p> Signup and view all the answers

    What is the primary function of the Critical Control Point Decision Tree found in Appendix 3?

    <p>The primary function is to assist in identifying critical points in the food processing where controls must be applied to prevent hazards.</p> Signup and view all the answers

    Describe the significance of monitoring bacterial pathogen growth as outlined in Appendix 4.

    <p>Monitoring is crucial to ensure food safety by tracking pathogen levels and implementing control measures to prevent foodborne illnesses.</p> Signup and view all the answers

    What role do allergen cleaning and sanitation procedures, mentioned in Appendices 9 and 10, play in seafood processing?

    <p>These procedures are vital for preventing cross-contact and ensuring the safety of allergenic consumers.</p> Signup and view all the answers

    What information is included in Appendix 11 regarding aquaculture drugs?

    <p>Appendix 11 lists approved aquaculture drugs that can be used safely in food fish production.</p> Signup and view all the answers

    How does the guidance document facilitate alternative approaches to food safety?

    <p>The document allows for alternative methods as long as they meet the established statutory and regulatory requirements.</p> Signup and view all the answers

    What kind of health impacts are addressed in the guidance on seafood processing?

    <p>The guidance focuses on public health impacts related to bacterial and viral pathogens in seafood.</p> Signup and view all the answers

    In what way is the current Good Manufacturing Practices (cGMPs) relevant to seafood safety?

    <p>cGMPs provide a framework for maintaining quality and safety in the processing of seafood products.</p> Signup and view all the answers

    What modifications regarding natural toxins were made in the August 2019 updates within the guidelines?

    <p>The updates emphasize the need for monitoring and controlling natural toxins present in seafood products.</p> Signup and view all the answers

    What are the implications of removing 'Hot Fill' and 'Steam Flush' from the Package Type description for raw shellfish?

    <p>Removing these methods indicates a shift in processing standards which may affect safety and preservation practices for raw shellfish.</p> Signup and view all the answers

    How do hydrostatic pressure and individual quick freezing contribute to shellfish safety?

    <p>These methods help retain raw product characteristics while reducing levels of harmful bacteria like Vibrio vulnificus and Vibrio parahaemolyticus to non-detectable levels.</p> Signup and view all the answers

    Why is it significant that undeclared allergen hazards have been removed for raw oysters, clams, and mussels?

    <p>This change may suggest improved clarity in product labeling, but it also raises concerns about potential allergic reactions in consumers.</p> Signup and view all the answers

    What modifications were made regarding the recognition of parasitic hazards in freshwater fish?

    <p>It is now recognized that parasites can likely enter fish raised in freshwater, highlighting the need for appropriate safety measures.</p> Signup and view all the answers

    What specific recommendations were updated in Chapter 5 regarding parasites as of April 2011?

    <p>Recommendations now include recognizing the likelihood of parasitic hazards in fish raised in freshwater that contain pathogens.</p> Signup and view all the answers

    What was the reason for reorganization in Chapter 4 about pathogens from the harvest area?

    <p>The reorganization aims to provide clearer distinctions between hazards related to different types of seafood, such as 'Fish other than molluscan shellfish' and 'Molluscan Shellfish.'</p> Signup and view all the answers

    What critical information was removed from the Natural Toxin Detection Section?

    <p>The Natural Toxin Detection Section was removed to streamline the guidance and focus on actionable safety measures for seafood processing.</p> Signup and view all the answers

    Why are the processes aimed at maintaining raw product characteristics important in seafood processing?

    <p>These processes help ensure food safety and maintain quality, thus reducing the risk of foodborne illnesses.</p> Signup and view all the answers

    Study Notes

    HACCP Plan Essentials

    • HACCP (Hazard Analysis Critical Control Points) is a systematic preventive approach focusing on food safety.
    • Key components include setting up a HACCP Plan Form, critical limits, monitoring procedures, corrective action procedures, recordkeeping systems, and verification procedures.

    Seafood Types Listed

    • Fresh tuna steaks
    • Frozen surimi-based imitation king crab legs
    • Fresh raw drum, in-the-round
    • Raw shrimp, in-shell
    • Raw, shucked clams
    • Fresh seafood salad with shrimp and blue crabmeat
    • Frozen breaded pollock sticks
    • Frozen crab cakes

    Monitoring Procedures

    • Identify the "what", "how", "frequency", and "who" for each monitoring procedure.

    Packaging Types

    • Common packaging includes vacuum-packaged plastic bags, aluminum cans, bulk in wax-coated paperboard boxes, and plastic containers with snap lids.

    Distribution and Storage

    • Establish methods for distribution and storage after product distribution to ensure safety.

    Modifications to Recommendations

    • "Hot Fill" and "Steam Flush" packaging types have been removed.
    • The hazard of undeclared allergens has been eliminated from specific product descriptions.

    Parasite Hazards

    • Recognition of parasites in fish raised in freshwater due to larval entry through skin has been acknowledged since April 2011.

    Toxin and Pathogen Management

    • Updates to management guidelines for natural toxins and bacterial pathogens as of August 2019 include reorganizing information into clear categories.
    • Hydrostatic pressure, individual quick freezing (IQF), and irradiation are noted as processes to maintain raw product characteristics and reduce harmful microorganisms.

    Appendices Overview

    • Appendices cover various topics like bacterial pathogen growth, allergen cleaning procedures, approved aquaculture drugs, and guidance for safe processing of fishery products.

    FDA and Industry Guidelines

    • The guidance provided by the FDA offers insights into fish and fishery product hazards and control measures, supporting flexible approaches compliant with regulations.

    HACCP Plan Essentials

    • HACCP (Hazard Analysis Critical Control Points) is a systematic preventive approach focusing on food safety.
    • Key components include setting up a HACCP Plan Form, critical limits, monitoring procedures, corrective action procedures, recordkeeping systems, and verification procedures.

    Seafood Types Listed

    • Fresh tuna steaks
    • Frozen surimi-based imitation king crab legs
    • Fresh raw drum, in-the-round
    • Raw shrimp, in-shell
    • Raw, shucked clams
    • Fresh seafood salad with shrimp and blue crabmeat
    • Frozen breaded pollock sticks
    • Frozen crab cakes

    Monitoring Procedures

    • Identify the "what", "how", "frequency", and "who" for each monitoring procedure.

    Packaging Types

    • Common packaging includes vacuum-packaged plastic bags, aluminum cans, bulk in wax-coated paperboard boxes, and plastic containers with snap lids.

    Distribution and Storage

    • Establish methods for distribution and storage after product distribution to ensure safety.

    Modifications to Recommendations

    • "Hot Fill" and "Steam Flush" packaging types have been removed.
    • The hazard of undeclared allergens has been eliminated from specific product descriptions.

    Parasite Hazards

    • Recognition of parasites in fish raised in freshwater due to larval entry through skin has been acknowledged since April 2011.

    Toxin and Pathogen Management

    • Updates to management guidelines for natural toxins and bacterial pathogens as of August 2019 include reorganizing information into clear categories.
    • Hydrostatic pressure, individual quick freezing (IQF), and irradiation are noted as processes to maintain raw product characteristics and reduce harmful microorganisms.

    Appendices Overview

    • Appendices cover various topics like bacterial pathogen growth, allergen cleaning procedures, approved aquaculture drugs, and guidance for safe processing of fishery products.

    FDA and Industry Guidelines

    • The guidance provided by the FDA offers insights into fish and fishery product hazards and control measures, supporting flexible approaches compliant with regulations.

    HACCP Plan Essentials

    • HACCP (Hazard Analysis Critical Control Points) is a systematic preventive approach focusing on food safety.
    • Key components include setting up a HACCP Plan Form, critical limits, monitoring procedures, corrective action procedures, recordkeeping systems, and verification procedures.

    Seafood Types Listed

    • Fresh tuna steaks
    • Frozen surimi-based imitation king crab legs
    • Fresh raw drum, in-the-round
    • Raw shrimp, in-shell
    • Raw, shucked clams
    • Fresh seafood salad with shrimp and blue crabmeat
    • Frozen breaded pollock sticks
    • Frozen crab cakes

    Monitoring Procedures

    • Identify the "what", "how", "frequency", and "who" for each monitoring procedure.

    Packaging Types

    • Common packaging includes vacuum-packaged plastic bags, aluminum cans, bulk in wax-coated paperboard boxes, and plastic containers with snap lids.

    Distribution and Storage

    • Establish methods for distribution and storage after product distribution to ensure safety.

    Modifications to Recommendations

    • "Hot Fill" and "Steam Flush" packaging types have been removed.
    • The hazard of undeclared allergens has been eliminated from specific product descriptions.

    Parasite Hazards

    • Recognition of parasites in fish raised in freshwater due to larval entry through skin has been acknowledged since April 2011.

    Toxin and Pathogen Management

    • Updates to management guidelines for natural toxins and bacterial pathogens as of August 2019 include reorganizing information into clear categories.
    • Hydrostatic pressure, individual quick freezing (IQF), and irradiation are noted as processes to maintain raw product characteristics and reduce harmful microorganisms.

    Appendices Overview

    • Appendices cover various topics like bacterial pathogen growth, allergen cleaning procedures, approved aquaculture drugs, and guidance for safe processing of fishery products.

    FDA and Industry Guidelines

    • The guidance provided by the FDA offers insights into fish and fishery product hazards and control measures, supporting flexible approaches compliant with regulations.

    HACCP Plan Form

    • The HACCP Plan Form involves setting critical limits, establishing monitoring procedures, establishing corrective action procedures, establishing a recordkeeping system, and establishing verification procedures.
    • The monitoring procedures involve identifying what is being monitored, how it is being monitored, the frequency of monitoring, and who is responsible for monitoring.
    • The HACCP Plan Form details how the product is distributed and stored, including the type of packaging used and relevant regulations.
    • Example packaging types include vacuum-packaged plastic bags, aluminum cans, bulk packaging in wax-coated paperboard boxes, and plastic containers with snap lids.

    Flow Diagram

    • A flow diagram is used to describe the steps involved in the food production process.

    Pathogens

    • Parasites can be a hazard in fish raised in freshwater environments.
    • In freshwater environments, parasites can enter the fish through their skin.
    • The parasite hazard could be reasonably likely to occur in freshwater fish.
    • Hydrostatic pressure with extended storage and irradiation are designed to reduce Vibrio vulnificus and Vibrio parahaemolyticus to non-detectable levels.
    • Natural Toxins section in the guidance has been reorganized into two categories "Fish other than molluscan shellfish" and "Molluscan Shellfish."

    Critical Control Point Decision Tree

    • The FDA provides a Critical Control Point Decision Tree to help processors develop HACCP plans.
    • The Decision Tree is utilized to make informed decisions regarding critical control points.

    Appendices

    • The guidance document features a series of appendices which offer additional information on relevant topics:
      • Appendix 3: Critical Control Point Decision Tree
      • Appendix 4: Bacterial Pathogen Growth and Inactivation
      • Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance
      • Appendix 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw
      • Appendix 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing-Public Health Impacts
      • Appendix 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products
      • Appendix 9: Allergen Cross-Contact Prevention
      • Appendix 10: Allergen Cleaning and Sanitation for the Control of Allergens
      • Appendix 11: Approved Aquaculture Drugs
      • Appendix 12: Unapproved Aquaculture Drugs
      • Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60)
      • Addendum 2: current Good Manufacturing Practices (cGMPs)

    Guidance for the Industry

    • The Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition provides information on FDA's current thinking on the subject.
    • The guidance document does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

    HACCP Plan Form

    • Set up the HACCP Plan Form, set critical limits, establish monitoring procedures, corrective action procedures, establish a recordkeeping system and verification procedures

    Packaging Types

    • Vacuum-packaged plastic bag
    • Aluminum can
    • Bulk, in wax-coated paperboard box
    • Plastic container with snap lid

    Distribution and Storage

    • Identify how the product is distributed and stored after distribution

    Flow Diagram

    • The purpose of this is to provide a clear representation of all steps involved in the process

    Parasites

    • The risk of parasites is reasonably likely to occur in fish raised in freshwater containing larvae of pathogenic liver, lung and intestinal flukes due to the fact that these parasites enter the fish through the skin

    Natural Toxins

    • Reorganized into two categories: "Fish other than molluscan shellfish" and "Molluscan Shellfish"

    Chapter Updates

    • Chapter 5: “Parasites” - It is now recognized that the parasite hazard may be reasonably likely to occur in fish raised in freshwater containing larvae of pathogenic liver, lung and intestinal flukes because these parasites enter the fish through the skin rather than in the food.
    • Chapter 6: “Natural Toxins” - The information in the Chapter has been reorganized into two categories in each section.
      • “Fish other than molluscan shellfish” and
      • “Molluscan Shellfish.”
      • Natural Toxin Detection Section was removed
    • Chapter 4: “Pathogens from the Harvest Area” - Hydrostatic pressure, individual quick freezing (IQF) with extended storage, and irradiation are now identified as processes that are designed to retain raw product characteristics and that can be used to reduce Vibrio vulnificus (V.vulnificus) and Vibrio parahaemolyticus (V.parahaemolyticus) to non-detectable levels.

    FDA Guidance

    • This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.
    • It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
    • You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
    • If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.
    • If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

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    Fish and Fishery Products Hazards and Controls Guidance PDF June 2022 Edition

    Description

    Test your knowledge on setting up a HACCP plan for seafood, including critical limits and monitoring procedures. This quiz covers various seafood items such as fresh tuna and imitation crab. Understand the essential practices to ensure food safety in handling seafood.

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