Welcome to our broadcast. I'm Don Kraemer, Acting Deputy Center Director of FDA's Center for Food Safety and Applied Nutrition. Today we're here to talk about some of the important changes you'll see in the 4th Edition of FDA's Fish and Fishery Products Hazards and Controls Guidance, referred to as the Hazards Guide or simply the Guide. It has been about 10 years since the guide was last updated and many of you have been anxiously awaiting this release.
We're taking a different approach in this broadcast. As many of you remember, previous broadcasts were live and we encouraged viewers to call or fax in questions during the broadcast. This time, we've prerecorded the broadcast and posted it on the internet so you may watch it at your convenience or download it for future reference. We've divided the presentation into segments so you can easily go back to a particular segment. Each segment is presented by one of the many people who have been involved with the changes in the 4th edition.
We're very interested in your questions and have arranged an e-mail address where you can send them. Questions may be sent to SeafoodHACCP@fda.gov which is also shown here on the screen.
The program consists of 7 segments, each covering different topic areas. The first segment covers general format changes along with changes in the tables in Chapter 3, and to the parasites and natural toxins chapters. The other segments cover shellfish, histamine, pathogens, Clostridium botulinum, allergens and additives and finally information from the Seafood HACCP Alliance on available training. With that said, let's get started.
Our first segment will discuss general format changes and the tables in Chapter 3, parasites and natural toxins. Remember to e-mail your questions to SeafoodHACCP@fda.gov.
With this edition of the guide, we made some overall format changes. In previous editions, the mechanics of completing a HACCP plan were repeated in each chapter; now the mechanics of completing a HACCP plan are only discussed in Chapter 2. Then, the individual chapters contain the elements of a control strategy using examples pertinent to the topic of that chapter, and usually followed by HACCP plan examples.
There've also been many revisions made to the species related hazards listed in Chapter 3. We've added a new table on species substitution and misbranding, which is now Table 3-1.
A summary of the changes to the vertebrate species table includes the addition of 30 new species; 61 scientific name changes; 11 potential hazard changes; 12 species that are new to aquaculture, 15 market name changes and 1 species with a special labeling statement in the footnote.
Changes to the invertebrate table include 10 new species; 8 scientific name changes; 2 potential hazard changes; and 2 species that are new to aquaculture. You'll see these as you update your HACCP plans.
Due to the increased consumption of raw seafood that's being identified by Japanese or Hawaiian names, we've developed two tables listing the Japanese and Hawaiian market names and the corresponding English market names. These tables will aid in identifying species so that their potential species related hazards may be controlled. These tables are found in the appendices.
There has been little change in the Parasite chapter itself; however, we want to point out that, while a parasite hazard for a particular species may not be listed in Tables 3-2 or 3-3, this only means that a hazard hasn't been positively documented. Virtually any species of fin-fish may have a parasite hazard depending on its growth environment. This is explained in detail in Chapter 5 for wild caught, as well as aquacultured species.
The most significant change relating to natural toxins, found in Chapter 6, is the recognition of Azaspiracid shellfish poisoning or AZP. The table on the screen shows the currently recognized fish poisoning syndromes. The associated action levels are listed in the chapter.
You'll find additional discussions in the chapter pertaining to species and geographic location of fish poisoning syndromes based on historic occurrences. You'll also find HACCP plan examples for controlling natural toxins in molluscan shellfish.
And finally, you'll notice throughout the Guide that FDA no longer recommends the use of high-temperature alarms as a sole monitoring device. High temperature alarms may be helpful, but when used, they should be used in conjunction with a thermometer, preferably a recording thermometer.
Remember to e-mail your questions to SeafoodHACCP@fda.gov
Next is Paul DiStefano from CFSAN's Division of Seafood Safety. Paul will discuss molluscan shellfish. Paul.
Thank you Don. In recent years processing technologies directed at reducing Vibrio species to non-detectable levels have been developed and scientifically validated. Initially developed to control the risk of Vibrio illness associated with the consumption of raw molluscan shellfish, these processes reduce Vibrios to non-detectable levels while retaining the sensory characteristics of untreated raw product. In keeping with advances in food safety technologies, Chapter 4 of the Guide now recognizes the use of these processes to control naturally occurring pathogens associated with molluscan shellfish. Processes that are currently available for controlling Vibrio vulnificus and Vibrio parahaemolyticus in molluscan shellfish include individual quick freezing with extended frozen storage, mild heat, high hydrostatic pressure, and irradiation.
Better understanding of molluscan shellfish harvesting techniques has resulted in adoption of stricter time temperature controls under the U.S. National Shellfish Sanitation Program. As a result, the critical limit for controlling pathogen growth in molluscan shellfish prior to receipt by the primary processor is now linked to the time that the shellfish is first exposed to air. Because exposure to ambient air can affect product temperature and therefore bacterial growth, the new Guide recognizes that exposure to air can occur not only at harvest, when shellfish are removed from the water, but also by a receding tide in advance of actual harvest times. Acceptable time limits from exposure to air and placement under temperature control can be found in Chapter 4 under Control Strategy Examples for Shellstock Temperature Control.
In addition to State and foreign government authorities, the new Guide recognizes the role of Federal, Tribal and Territorial shellfish authorities in the identification of shellfish safety hazards and their control. And Chapter 17 has a new title and information that supplements Chapter 4. It contains guidance for the control of pathogen survival through processes designed to retain raw product characteristics. Don.
Thank you Paul. Remember to e-mail your questions to SeafoodHACCP@fda.gov.
Next is Robert Samuels from CFSAN's Division of Seafood Safety. Bob will discuss histamine. Bob.
Thank you Don. The most significant changes specific to FDA's recommended scombrotoxin controls that readers will find in Chapter 7 are associated with primary processor receiving controls. Much of this stems from additional research conducted by FDA on tuna and mahi mahi. Some of the study findings allowed FDA to relax the recommendations while others prompted us to recommend a more stringent control. The agency tried to get away from recommendations that invoked the need for onboard temperature measurements of fish in favor of recommendations that monitor only the time it takes to get dead fish into chilling media.
Onboard chilling controls for fish exposed to temperatures above 83 degrees Fahrenheit remain at a maximum of 6 hours after death of the fish. But fish exposed to sea or air temperatures of 83 degrees or less should be in chilling media no more than 9 hours after death, rather than the previously recommended 12 hours. On the plus side, we have seen significant advantages to proper and careful evisceration of fish prior to chilling and now recommend that these fish be chilled within 12 hours of death rather than 6 hours recommended previously.
FDA also studied an industry supposition that fish harvested in chilly waters will provide a natural delay in scombrotoxin formation. We found, and consequently recommended, that fish harvested under conditions that expose the dead fish to harvest waters of 65 degrees Fahrenheit or less could delay chilling requirements for up to 24 hours. Admittedly, this was studied using tropical caught fish that might have a natural microflora unaccustomed to the chilly test conditions, so processors in harvest areas where fish are taken from typically cold environments might want to test this limitation on their own fish. Also recognize, implementation of this recommendation obligates the processor to obtain set-by-set monitoring records from the fishermen that confirm the temperature measured at sea depths where the dead fish lie before retrieval
Another thing those studies taught us was that it is the lower anterior loin portion of the fish that gives the best possibility to detect histamine in an abused fish if histamine has formed. Taking samples elsewhere on the fish is very nearly a waste of resources and so we make the improved sample location recommendation in the new Guide.
We've also made a slight adjustment to primary processor receiving temperatures based on cooling curves of some of the large fish we studied. But processors would be best served by developing their own curves to generate meaningful expectations for their own particular fisheries. For example, in the new Guide, FDA's recommendation suggests that a processor off-loading fish 14 hours after their death should expect the fish temperatures to be down to 60 degrees Fahrenheit or below. However, this would not be a practical application for a processor that receives very small fish from a region where sea and air temperatures are 62 degrees Fahrenheit. It shouldn't take 14 hours to reduce the temperature of the little fish by 2 degrees if they were chilled properly. This processor will want to have cooling curve for the application that gives it better assurances that timely chilling took place on the vessel.
A couple of other things to highlight include our emphasis that retorted tuna can still present a scombrotoxin hazard once the cans or pouches are opened and the meat is recontaminated such as in the making of tuna salad products. This was overlooked by some processors in the past. Another important change was the elimination of the corrective action recommendation allowing sub-lotting and retesting of lots received with elevated histamine in the fish. The implementation of this approach was not found to provide adequate protection to consumers.
Thank you Bob. Remember to e-mail your questions to SeafoodHACCP@fda.gov. Next is Debra DeVlieger of ORA's Division of Field Investigations. Deb will discuss pathogens and time and temperature abuse. Deb.
Thanks Don. In the guides pathogen growth and toxin formation, Chapter 12, there are a couple of significant changes, much of those changes stem from new research on times and temperature of pathogen growth.
One of the more significant changes that should make it easier for you to develop a time temperature control strategy is that control of time and temperature abuse at receipt, during cooling and after cooking, during unrefrigerated processing and during refrigerated processing and storage are outlined in four separate control strategies with examples of HACCP plans for each one.
Now remember, however that it may be necessary to select more than one control strategy in order to fully control the hazard. For example, if you are receiving a refrigerated raw fish that will eventually be used in a refrigerated ready-to-eat product, you most likely will need to combine both the receiving and processing and storage controls in order to fully control pathogen growth.
Now, let's review the major changes in these control strategies:
For control of pathogen growth and toxin formation during transit of refrigerated cooked ready to eat or raw ready-to-eat fish or fishery products, it's now recommended that all lots of fish are accompanied by transport records that show either the ambient or the internal temperature of the fish during transit was at or below 40 degrees Fahrenheit.
Now, if chemical cooling media, such as gel packs are used, there must be adequate quantity of frozen cooling media to keep the internal temperature of the fish at 40 degrees or below and the internal temperature of the fish must also be taken at the time of delivery. In this instance, monitoring the quantity and frozen status of the cooling media is recommended in a representative number of containers.
And finally, if the transit time is 4 hours or less, you will need to ensure that the time of transit doesn't exceed 4 hours. Now this includes all the time the fish is outside a controlled environment – and not on ice. Also, the internal temperature of the fish at receipt is at or below 40 degrees Fahrenheit. It's also recommended that a secondary processor who is using only internal temperature of the fish because the transit time is less than 4 hours, that a temperature indicating device, or a thermometer be used to take the internal temperatures of product from at least 12 containers and all containers if there are less than 12 in the lot received.
For refrigerated storage and processing controls: It's now noted that critical limits that specify a cumulative time and temperature during storage or processing such as no more than 4 hours at 45 degrees Fahrenheit, aren't ordinarily suitable critical limits. Now, this is because of the difficulty in determining when specific products have entered and exited a cooler and the time and temperatures at which they are exposed to unrefrigerated conditions.
Chemical coolants, such as gel packs, are no longer recommended for control of temperatures during storage. Ice or continuous temperature monitoring are still recommended.
And, to avoid minor variations in cooler temperature measurements such as defrost cycles, it's now recommended that the temperature sensor be submerged in a liquid that mimics the characteristics of the product such as water, to avoid minor temperature fluctuations.
For unrefrigerated Processing Control, the recommended cumulative time and temperature exposures – or critical limits – have changed. They're intended to keep pathogenic bacteria of greatest concern in fish products from reaching the growth phase. The new recommendation gives alternate critical limits for each situation. So, it's important to know the times and at what temperatures the product is in unrefrigerated conditions in order for you to choose the critical limit that best fits your situation. Now here's some of the changes:
For Raw Ready-to-Eat products we outline 3 critical limits. First, during processing, if you hold product at temperatures below 135 degrees Fahrenheit but above 70, the time between those temperatures needs to be limited to 2 hours – or 3 hours if Staph aureus is the only pathogen of concern. Or, as an alternative, if you can get the product temperature below 70 degrees within those two hours, you have an additional two hours above 50 degrees as long as no more than the first two hours are above 70 degrees and below 135 degrees. The second critical limit during processing, where the internal temperatures are held above 50 degrees but never above 70 degrees, the exposure time to unrefrigerated conditions below 70 is now limited to 5 hours, which has been changed from 6 hours. Now, again, if you are only considering Staph aureus then the time limit is 12 hours. And finally, if the product is held at internal or ambient temperatures below 50 degrees throughout processing then there are no specific time limits.
The time temperature critical limits during processing of Cooked Ready-to-Eat products are similar except they add an upper internal temperature parameter of 80 degrees Fahrenheit. Now there are 4 new critical limit changes, and they are: If you hold product at internal temperatures below 135 degrees Fahrenheit but above 80, the time between those temperatures needs to be limited to 1 hour, or 3 hours if Staph aureus is the only pathogen of concern. Now, alternatively, if you hold the product above 80 degrees, but can get it cooled down to below 70 degrees within that first hour, then you have an additional three hours at temperatures between 50 and 70.
For processing situations where the internal product temperatures are between 70 and never higher than 80 degrees the cumulative exposure time above 50 should be limited to 2 hours – or, again, 3 if Staph aureus is the only pathogen of concern. Or, alternatively, if you can get internal temperatures of the products below 70 within 2 hours, then you have an additional 2 hours – for a total of 4 hours as long as no more than two of those hours are between 70 and 80 degrees Fahrenheit.
Third, if you hold product at internal temperatures above 50 but never above 70 degrees, exposure time to unrefrigerated conditions during processing should be limited to 5 hours. If you are only considering Staph aureus, you then have 12 hours
And, finally, if product is held at internal or ambient temperatures below 50 degrees throughout processing then there are no specific time limits.
Now, the goal here is to control pathogen growth and to keep it out of the rapid growth phase. So, if you can cool your product quickly, and before it is significantly handled, you have longer times during unrefrigerated processing.
Now, in addition to the changes for time and temperature controls in Chapter 12 there are also some changes in Chapter 16. The most significant is that the chapter now combines both cooking and pasteurization. Now, this is because both are considered heat treatments applied to eliminate the most resistant pathogen of public health concern.
Now, this alternate monitoring procedure is called End Point Internal Product Temperature or EPIPT and was added to the Guide based on scientific studies submitted to FDA from a seafood trade association.
Chapter 16 of the Guide also provides recommended pasteurization processes for reduced oxygen surimi based products, soups and sauces as well as Dungeness crabmeat that provide a 6D process for C bot type E and non-proteolytic B & F. So, that wraps up the significant changes in Chapters 12 and 16. Don.
Thank you Deb. Remember to e-mail your questions to SeafoodHACCP@fda.gov
Next is Mary Losikoff of CFSAN's Division of Seafood Safety. Mary will discuss Clostridium botulinum. Mary.
Thank you Don. One change in Chapter 13 on Clostridium botulinum that could affect many processors is a control strategy is now provided to ensure that frozen products are properly labeled when freezing is the sole barrier to prevent toxin formation.
In addition, it's now clarified that packaging material with the recommended oxygen transmission rate of 10,000 cc's per meter squared per 24 hours at 24 degrees C may not be suitable in products where the spoilage organisms have been eliminated or significantly reduced by heat or other processing and refrigeration is the sole barrier to toxin formation
A control strategy example is now included for secondary processors at receipt of refrigerated reduced oxygen packages.
A control strategy is now included on the use of Time Temperature Indicators or TTIs on reduced oxygen packages where maintaining the product below 38 degrees Fahrenheit is the only control to prevent nonproteolytic C. botulinum toxin formation. A TTI is a device that monitors the time and temperature of exposure of the package and visually alerts the consumer or end user if a safe exposure limit has been exceeded that may result in C. botulinum toxin formation. The TTI is applied to each one of the smallest package units, usually the consumer or end-user package. The TTI is for the consumer or end user and is not intended as a monitoring tool for the processor.
Information is provided on the need to determine the TTI's performance and suitability prior to use. The TTI should be validated to ensure that it is fit for its intended purpose and verified that it is functional at the time of use. Once triggered, the visual alert should remain visible and not revert to its original color regardless of environmental exposures.
The control strategy for TTIs includes receipt of the unactivated TTIs. Exposure to high temperatures or other environmental conditions during transport to the processor may affect TTI function, if this is the case, temperature records should be obtained. TTI functionality should also be confirmed. Storage of the unactivated TTIs may be critical as well to prevent a loss of performance and should be monitored. TTI application to each package and activation of the TTI are CCPs as well. The food product then needs to be maintained below 38 degrees Fahrenheit during storage and transportation which entails monitoring and recordkeeping by both the primary processor and secondary processor.
Other modifications to Chapter 13 relate to proper brining practices. Brining time should be monitored during processing and brine should be treated to minimize microbial contamination or be periodically replaced as a good manufacturing practice control. In addition, a water phase salt level of 20% is recommended for shelf-stable, reduced oxygen packaged products in which salt is the only barrier to pathogenic bacteria growth and toxin formation. Thank you. Don.
Thank you Mary. Remember to e-mail your questions to SeafoodHACCP@fda.gov
Next is Debra DeVlieger of ORA's Division of Field Investigations, discussing allergens. Deb.
Thank you Don. I want to start out by saying the Food Allergen Labeling and Consumer Protection Act of 2004 amended the FD&C Act. Now, as a result, all FDA regulated packaged foods containing a major food allergen require labeling clearly identifying the allergenic food source.
Now, the Act identifies 8 allergenic food sources – including fish - as seen here. Now, the recommendations in Chapter 19, which covers allergens and additives, have been updated to satisfy the requirements of the FD&C Act.
So, in short, to meet the requirements, the food label must declare the name of the food source either within the list of ingredients or in a separate “contains” statement. The updated labeling controls are intended to ensure that any major food allergen present in the food is declared on the label and the label is placed on the appropriate finished product container. For example, if the allergen is tree nuts, the label must be specific to type of tree nut, such as almonds. And, likewise, in the case of finish or crustacean shellfish, the market name, such as salmon or shrimp, must be identified on the label.
Now, in addition to the allergens, more information has also been provided on the regulatory requirements for labeling food and color additives. These can cause hypersensitivity reactions or food intolerances much like an allergic reaction.
Now, as a result of these changes in the regulations and labeling requirements, the steps for developing the HACCP plan to include label controls for allergens have been updated.
Thank you Deb. Remember to e-mail your questions to SeafoodHACCP@fda.gov
Our final presentation today comes from Steven Otwell, Chairman of the Seafood HACCP Alliance. Steve will discuss training opportunities. Steve.
Since 1986 the national Seafood HACCP Alliance has continued to provide current training programs and materials to assist compliance with the requirements outlined in the FDA Seafood HACCP Regulation. This educational support involves a core of academic expertise based in Extension Services and Sea Grant College programs working in collaboration with the FDA, Association of Food and Drug Officials, U.S. Department of Agriculture, National Marine Fisheries Service, and commercial trade associations. They maintain a team of qualified trainers to deliver courses in both domestic and international settings. All training is delivered in accordance with established protocols for uniformity and standards that include Certificates of Course Completion recorded and issued by the Association of Food and Drug Officials.
Special HACCP Alliance Update courses, will begin to be offered June of 2011 through Fall, will consist of a series of half day sessions to distribute and discuss changes introduced in FDA's new Fish and Fishery Products Hazards and Control Guides that was issued in 2011.
Seafood HACCP Alliance Trainer Re-qualification courses will be offered beginning in June 2011 through Fall. These special half day training sessions will be for existing Seafood HACCP Alliance trainers and will provide the necessary re-qualifications to teach HACCP and Sanitation courses, including the new FDA Fishery Products Hazards and Controls Guide.
We will continue to offer the regular Seafood HACCP Alliance courses, in either a classroom format or internet format. The classroom format lasts for 2 to 3 days depending on the audience, and the internet format is self-paced.
Course schedules and registration information is available at the University of California-Davis Website or the AFDO website posted on the screen.
Copies of the FDA Fish and Fishery Products Hazards and Control Guidance, the Seafood HACCP Alliance Course for basic training in HACCP and the Sanitation course manuals may be purchased through the University of Florida bookstore, or may be downloaded from the FDA website.
Thank you Steve.
Before we finish up, let me take a moment to tell you about two last things. FDA is producing several informational videos to supplement the information in the 4th edition of the Guide. The videos will be available in the near future through the FDA website and the Seafood HACCP Alliance website. Keep an eye out for these.
We'd also like to take a moment here to mention an active MOU between FDA and the National Marine Fisheries Service. National Marine Fisheries Service's Seafood Inspection Program assists the industry in improving the quality, wholesomeness, safety, proper labeling, and marketability of fish and fishery products for the benefit of the consumer. A Memorandum of Understanding between National Marine Fisheries Service and FDA went into effect in October 2009 and outlines the roles and responsibilities of each agency with regard to seafood safety. The MOU is 225-09-0008.
FDA and the National Marine Fisheries Service have certain common objectives that lend themselves to cooperation between the agencies. The National Marine Fisheries Services inspection services contribute to consumer protection by helping establishments fulfill their responsibility to ensure that fishery products are safe and meet applicable FDA requirements. While FDA is the recognized competent authority in the United States, the National Marine Fisheries Service is responsible for the development and advancement of commercial grade standards and provides certification services for interested parties. The MOU outlines several key items to encourage open communication between the agencies and lends itself to improve the overall quality of seafood products produced in the US.
There are three key points in the MOU that the National Marine Fisheries Service has agreed to. First, National Marine Fisheries Service agrees to ensure that as part of their inspection, approval and certification process that their Approved Establishments will comply with FDA's current GMPs and the Seafood HACCP regulation. Second, the National Marine Fisheries Service agrees to issue a notice of suspension or termination to any of their Approved Establishments when notified that FDA has issued a warning letter or intends to take regulatory action such as injunction or seizure. Third, the National Marine Fisheries Service agrees to maintain a complete list of Approved Establishments that have voluntarily contracted their inspection services and that have been deemed capable of producing safe, wholesome products in accordance with their specific quality regulations.
There are four key points in the MOU that FDA has agreed to. First, FDA has agreed to invite the National Marine Fisheries Service Inspector assigned to and present in the processing plant to accompany us during the inspection. Second, FDA has agreed to discuss inspectional observations with the National Marine Fisheries Service inspector assigned to the processing facility prior to closing the inspection with the plant management. Third, FDA has agreed to notify the National Marine Fisheries Service when FDA intends to take regulatory action, including issuing warning letters, to a fish or fishery product establishment currently inspected by the National Marine Fisheries Service. And fourth, FDA has offered to invite National Marine Fisheries Service personnel to attend training in FDA's Office of Regulatory Affairs Investigator Certification Program and related activities, as resources permit. Cooperation between our agencies will improve compliance with law and improve the quality of fish and fishery products produced in the US. Please refer to the MOU for a complete list of FDA and National Marine Fisheries Service roles.
For more information and to review the memorandum go to www.fda.gov.
Thank you all for joining us. Please remember to e-mail your questions about the new Guide to SeafoodHACCP@fda.gov.