SUSHI HACCP

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FIRST CATCH SEAFOOD

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FLORIDA HACCP

FDA CONSULTING SERVICES

DENVER FISH

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HACCP

Hazard Analysis and Critical Control Point Contents

HACCP REGULATION FOR FISH AND FISHERY PRODUCTS

QUESTIONS AND ANSWERS

On December 18, 1995, The Food and Drug Administration (FDA) published as a final rule 21 CFR 123, "Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products" that requires processors of fish and fishery products to develop and implement Hazard Analysis Critical Control Point (HACCP) systems for their operations. The regulation became effective December 18, 1997.

The agency also published the "Fish and Fishery Products Hazards and Controls Guide" ("the Guide") in September, 1996, to assist processors in the development of their HACCP plans, and to provide information to help them identify hazards that may be associated with their products and formulate control strategies for those hazards. The guide was developed to coincide with the issuance of the final regulation.

A large number of questions have been raised by the seafood industry, regulators, consumers, and others about interpretation of the regulation. Recognizing this, FDA has developed "HACCP Regulation for Fish and Fishery Products: Questions and Answers" to provide answers to some of the more common questions. Future issues will be printed as other questions are received.

Seafood processors that are in the process of developing or revising HACCP systems to be in compliance with the new regulation, should first review the regulation to determine its requirements. Secondly, they should review the Guide for help to identify hazards and formulate control strategies. After reviewing the regulation and the Guide, if processors have remaining questions on the development of a HACCP system, they should refer to "HACCP Regulation for Fish and Fishery Products: Questions and Answers" for guidance.

"HACCP Regulation for Fish and Fishery Products: Questions and Answers" is intended only to be guidance to facilitate compliance with the new regulation. It does not bind the agency nor does it create or confer any rights, privileges, or benefits for or on any person. While "HACCP Regulation for Fish and Fishery Products: Questions and Answers" represents the best advice of the agency, it does not have the force and effect of law. The interpretations presented herein are obviously subject to the requirements of law both in the statute and in the regulations.

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Question: If a firm owns a seafood product but is not involved in its processing, is the firm required to comply with the regulation?

Answer: No, but conversely the processor is required to comply with the regulation regardless of who owns the product.

 

Question: If a custom seafood processor, such as a contract manufacturer, processes fish owned by another entity is the custom processor required to comply with the regulation?

Answer: Yes, if the custom processor is performing activities defined in the regulation as "processing", the processor is required to have and implement a HACCP plan to control those hazards that are reasonably likely to occur in the product. The processor is required to comply with the regulation regardless of who owns the product.

 

Question: How does the Seafood HACCP Regulation affect food service distributors? How does the regulation affect food service providers, hospitals, restaurants, and supermarkets?

Answer: Food service distributors that store fish and fishery products meet the definition of "processing" contained in the regulation, and are, therefore, covered if they are engaged in interstate commerce. However, food service providers, including hospitals, restaurants, and supermarkets, are retail establishments, and are, therefore, exempt.

A food service distributor must perform a hazard analysis and develop and implement a HACCP plan if the analysis identifies a hazard that is reasonably likely to occur. If a distributor stores only frozen or canned fish and does not otherwise engage in processing, it is not likely that a HACCP plan would be required. In either case, the distributor would still be required to comply with the sanitation provisions of the regulations.

 

Question: Is a firm that manufactures tuna sandwiches from canned tuna and distributes (sells) the product to sandwich vendors covered by the Seafood HACCP Regulation?

Answer: Yes. The vendors themselves sell the product retail, and are, therefore, exempt. However, the manufacturer sells the product wholesale and is, therefore, covered. The manufacturer must also be engaged in interstate commerce in order to be covered by the regulation, but, with canned tuna, that is highly likely.

 

Question: Is a firm that distributes seafood sandwiches in its own vending machines subject to the regulation?

Answer: No, such a firm is a retail entity and is exempt from the regulation.

 

Question: If a firm sells their product intrastate to another processor, such as a warehouse which distributes interstate, is the original firm covered?

Answer: Yes, firms that sell their product intrastate to another processor with knowledge that the product will then be introduced into interstate commerce, or with good reason to believe that the product will be introduced into interstate commerce, are subject to the requirements of the seafood HACCP regulation.

However, a processor that distributes only to intrastate retailers or distributors with full expectation that the product will be ultimately distributed within that state, is not subject to the regulation. Situations such as these require careful consideration on a case-by-case basis.

 

Question: If a firm receives raw materials from outside the state and distributes the finished seafood product inside the state, is the firm subject to the HACCP regulation provisions for this product?

Answer: Yes, this scenario constitutes interstate commerce, and subjects the product to the provisions of the regulation.

 

Question: How is interstate commerce defined?

Answer: Interstate commerce is defined in the Food, Drug, and Cosmetic Act (FD&C) section 201(b) as "(1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body". A product is in interstate commerce if a component originated from another state, territory, or country, or if the finished product itself moves to another state, territory, or country.

 

Question: Are domestic firms that produce seafood for export considered to be "processors" under ¤123?

Answer: Yes, exportation is a form of "interstate commerce", and therefore those who process (manufacture) seafood products for export meet the definition of "processor" and must comply with the seafood HACCP regulation. However, the Import/Export section (Section 801(e)(1)) of the Federal Food, Drug and Cosmetic Act (the Act) exempts export products, including food, from the adulteration provisions of the Act if they meet the following criteria:-

(A) accords to specifications of the foreign purchaser

(B) is not in conflict with the laws of the country to which it is intended for export,

(C) is labeled on the outside of the shipping package that it is intended for export, and

(D) is not sold or offered for sale in domestic commerce.

Thus, seafood products to be exported that meet these criteria would be exempt from the seafood HACCP regulation provisions.

 

Question: Is a firm that stores imported frozen fish and distributes it to local fast food restaurants subject to the Seafood HACCP Regulation?

Answer: Yes. Storage meets the definition of "processing" in the regulation. The fact that the firm handles imported product indicates than they are engaged in interstate commerce. If the firm is also the importer of the product, as defined by the regulation, it would also be responsible for meeting the importer verification requirements of the regulation.

 

Question: Are public cold storage facilities exempt from the Seafood HACCP Regulation?

Answer: No, they are covered by the regulation. They are defined as "processors" for purposes of the regulation. See 21 CFR 123.3(l).

 

Question: Are cash and carry distributors covered by the Seafood HACCP Regulation?

Answer: Cash and carry distributors often sell both retail and wholesale. To the extent that they sell wholesale, they are covered by the regulation.

 

Question: Are central kitchens covered by the Seafood HACCP Regulation?

Answer: Central kitchens are processing centers that ship only to their own outlets, usually grocery stores or retail chains. They are considered a retail entity and are, therefore, exempt from the regulation even if they ship in interstate commerce, provided they ship only to their own retail outlets. However, if they ship to another company's outlet, they are considered processors, as defined by 21 CFR 123.3, and therefore subject to the regulation.

 

Question: Are central warehouses for grocery store chains required to comply with the Seafood HACCP Regulation?

Answer: Yes, central warehouses are subject to the seafood HACCP regulation. They store and handle fish and fishery products, and, as such, meet the definition of "processor" in 21 CFR 123.3. FDA has not sought to redefine "retail" for purposes of this regulation, but rather has relied upon the historical definition provided in its retail food protection program. The retail food program has not traditionally encompassed warehouses.

 

Question: Does the seafood HACCP regulation apply to food salvage firms that distribute reclaimed seafood to soup kitchens, shelters, and food banks?

Answer: Yes, a food salvage firm that stores, handles, repacks and relabels the product meets the definition of a "processor" in the seafood HACCP regulation. Such food salvage firms are not considered to be retail operations.

 

Question: Are airline caterers considered to be retail operations?

Answers: Yes, airline caterers are retail operations, under FDA's Interstate Travel Sanitation (I.T.S.) program, and therefore are exempt from the regulation.

 

Question: Since the regulation excludes retail, is a retail seafood market that processes some products (e.g. smoked fish) for the wholesale market covered?

Answer: Any products that are sold wholesale must be processed in accordance with the regulation, provided that the product is in interstate commerce. This is true even if the firm's primary business is retail.

 

Question: Must a retailer who imports products comply with the Seafood HACCP Regulation?

Answer: Retailers are exempt from processor provisions of the regulation. However, if a retailer is also an importer, as defined in the regulation, the retailer must perform the importer verification functions described by the regulations. There is no retail exemption from the importer provisions of the regulations.

 

Question: Is the "Importer of Record" the same as the "importer", i.e., the individual responsible for verifying that a foreign processor has processed the seafood product in compliance with the seafood HACCP regulation?

Answer: No, the terms refer to separate responsibilities, under different regulations. The "Importer of Record" is a term used under U.S. Customs regulations to mean the holder of a redelivery bond at the time an entry is presented. For U.S. Customs purposes, someone (company or individual) is required to post a bond for a formal entry before the entry is allowed to move from Customs control. before the entry is allowed to move from Customs control.

Under the seafood HACCP regulation however, the "importer" is defined as either the U.S. owner or the U.S. consignee at the time of entry. If there is no U.S. consignee at the time of entry, then the "importer" is the U.S. agent of the foreign owner or consignee. The "importer" is responsible for ensuring that the goods are in compliance with the requirements of the seafood HACCP regulation.

Therefore, if an individual or company is solely acting in the capacity of the "importer of record" for Customs purposes, the requirements of the HACCP regulation would not necessarily apply to them. However, if the holder of the Custom's redelivery bond is also the "importer" as defined by the HACCP regulation, then both Customs and seafood HACCP requirements would apply to that person or company.

 

Question: Does the definition of "importer" apply to a warehouse that stores imported product and is not the "Importer of Record"? In this case both the owner and consignee are foreign. The product is stored in the warehouse under the foreign owner's account.

Answer: Yes, the regulation defines the "importer" as the U.S. owner at the time of entry. If there is no U.S. owner, which appears to be the case here, then the U.S. consignee is considered to be the "importer". However, if the consignee is a foreign firm, which also appears to be the case here, then the importer is the U.S. agent or representative of the foreign owner or consignee.

It is the responsibility of the foreign owner or consignee to designate a U.S. agent which may or may not be the warehouse. A U.S. agent is necessary to fulfill the importer requirements of the regulations before the product can be entered.

 

Question: Is an aquaculture producer a "processor" under the Seafood HACCP Regulation?

Answer: No, aquaculture producers are exempt from coverage. Treatment with carbon dioxide, bleeding, washing, and icing of otherwise unprocessed fish by the aquaculture producer is an integral part of the process of harvesting and getting the fish to market, and is, therefore, not considered to be processing. However, heading, gutting, or packaging of fish (e.g. retail or wholesale packages or cartons) performed by the aquaculture producer is considered processing, and would subject the producer to coverage under the regulations.

 

Question: Does holding lobsters in a lobster pound constitute "holding" as defined in the HACCP regulation?

Answer: Yes, the practice of holding live lobsters until they are marketed is a form of processing, as defined by the regulations. Consequently, lobster pounds are subject to the sanitation and HACCP requirements of the regulation. At a minimum, safety concerns to consider in the development of a HACCP plan for these operations include water quality and use of animal drugs.

 

Question: Which activities of a molluscan shellfish harvester are exempt from the requirements of the seafood HACCP regulation (21 CFR ¤123)?

Answer: A person is exempt from all provisions of 21 CFR, ¤123 if they engage in the activity of harvesting molluscan shellfish without otherwise processing the shellfish. The following harvesting activities are not considered to be "processing":

temporarily holding shellstock in bulk, or in containers, in a part of the same natural shellfish growing waters where harvested, where such holding is an integral part of the operation of getting the harvested product to market

 

placing shellstock in containers as they are harvested

 

placing shellfish shipping tags on containers of shellstock

 

sorting or washing shellstock in the harvest area

 

transporting by the harvester of shellstock in a boat or truck to a processing facility

 

Question: Are molluscan shellfish wet storage facilities covered by the Seafood HACCP Regulation?

Answer: Yes, if the shellfish are harvested from the growing water and moved to another body of water (natural or artificial) in which they are then held awaiting marketing, the wet storage would be considered processing, as defined by the regulation, in that it constitutes "holding" or "storage." However, if, for example, aquacultured shellfish are harvested and then temporarily resuspended in a container in the same area during the remainder of the harvesting operation, the temporary storage would not be considered "holding," but rather a necessary part of the harvesting operation.

 

Question: Does the exemption for transportation include company trucks, contract haulers, drayage firms and middlemen i.e., firms that buy products from various harvesters at the dock, load product directly into their trucks, ice the product, and transport the product to market?

Answer: The Seafood HACCP Regulation specifically exempts common carriers from coverage. Furthermore, it is not FDA's intent to seek compliance with the regulation for any form of transportation, regardless of who is performing the transportation, who owns the product, or who owns the vehicle. Control of hazards that may be introduced during transport should be addressed through a receiving CCP by the firm receiving the product.

 

Question: Which activities of a harvest vessel are exempt from the regulation, under the definition of processing in 21 CFR 123.3(k), and which are not?

Answer: Specific examples of activities of fishing vessels that are exempt are:

 

A fishing vessel that simply catches the fish or that catches, heads, eviscerates, or freezes the fish onboard the vessel, and then delivers the product to market, whether retail or wholesale, is exempt from the regulation.

 

A fishing vessel that catches the fish and then processes the fish in any manner (e.g., cuts steaks and/or fillets or cooks), and then sells the product at retail (i.e., to the consumer or end user) is exempt from the regulation.

However, the following activities are not exempt from the regulation:

 

A fishing vessel that catches the fish and then processes the fish in a manner that is beyond the scope of "heading, eviscerating, or freezing intended solely to prepare Âit| for holding on board Âthe| harvest vessel" (e.g., steaking, filleting, cooking) and then sells the product, or a portion of the product at wholesale (i.e., with the intent that it will be resold to the consumer or end user), is subject to the requirements of the regulation.

Such an entity meets neither the fishing vessel exemption nor the retail exemption.

 

Question: Do vessels that process fish or fishery products on board (i.e. factory vessels) meet the definition of "processor" in the regulation?

Answer: Yes, a processing vessel meets the definition of "processor" in the regulation.

 

Question: Fish are frozen, bagged, and boxed on a harvest vessel, are sold upon docking, and are unloaded into the buyer's dockside storage. Is the vessel a "processor" and, therefore, covered by the regulations?

Answer: If the packaging is only what is minimally necessary in order to facilitate transport to the shore and subsequent unloading (e.g. totes or bulk bins), the operations onboard the harvest vessel would not subject it to the regulation. However, if the harvester places the product in packaging designed for marketing purposes (e.g. wholesale or retail packages or cases), then the operations onboard the vessel constitute "processing", and the vessel is covered by the seafood HACCP regulation.

 

Question: Since fishing vessels and carriers can have a marked influence on the safety of seafood products and yet are exempt from the Seafood HACCP Regulation, what can a processor do to minimize hazards that may be introduced at these points?

Answer: When a food safety hazard can be introduced or made worse by a harvester or carrier (e.g. histamine development in scombroid species of fish on the harvest vessel or pathogen growth in cooked, ready-to-eat fishery products during transportation) the processor should include controls in his HACCP plan that require, as a condition of receipt, demonstration that the hazard has been controlled by the harvester or carrier. For example, the processor may require documentation from the harvest vessel that shows that the scombroid species of fish were handled properly (e.g. cooling or icing log). Or, the processor may require documentation from the carrier that shows that the cooked, ready-to-eat fishery products were held at proper temperatures (e.g. temperature recorder chart). Such control options are covered in greater detail in FDA's "Fish and Fishery Products Hazards and Controls Guide."

 

Question: If scallopers treat scallops with sodium tripolyphosphate onboard the harvest vessels, are they still exempt from the regulation?

Answer: Yes. This is a customary practice associated with the onboard scallop eviscerating process, and is, therefore covered by the harvest vessel exemption of the regulation. It is similar in that respect to the onboard treatment of shrimp with sulfiting agents, which is also covered by the harvest vessel exemption.

 

Question: When does temporary storage by a fisherman become "processing" as defined in the HACCP regulation?

Answer: Holding or storage by a fisherman is not covered by the regulation when the temporary storage is a necessary component of harvesting and getting the product to market. However, such holding is covered if it is performed while a marketing decision is being made.

The following activities are temporary storage that are not covered by the regulation:

A fisherman holds his catch in port until he can deliver it to market, or until it can be picked up for delivery to market.

The following activities constitute "holding" and are covered by the regulation:

A crab fisherman unloads live crabs and stores them for several days until he has enough to sell.

 

A crab fisheman stores his and others' crabs in his cooler, until they are picked up by a truck or sold elsewhere.

 

A wholesale dealer buys crabs from fishermen and holds them for pick up by a common carrier.

 

Question: Are sea cucumbers considered "fish" under the Seafood HACCP Regulation?

Answer: Yes, sea cucumbers are included in the definition of "fish", 21 CFR part 123.3(d).

II. Current Good Manufacturing Practice ¤123.5 (21 CFR)

 

Question: Does the Seafood HACCP Regulation replace the Current Good Manufacturing Practice Regulations (21 CFR 110) for fish and fishery products?

Answer: No, the requirements of Part 123 are in addition to the requirements of other FDA regulations, including Part 110. Section 123.5(a) of the Seafood HACCP Regulation states that the GMPs continue to be applicable to seafood processors in determining whether their facilities, methods, practices, and controls are safe and whether those products have been processed under sanitary conditions.

III. Hazard Analysis ¤123.6(a) (21 CFR)

 

Question: Are all processors of raw fish species that have a parasite hazard required to control that hazard regardless of the intended use of the product (e.g., consumed raw, or cooked)?

Answer: No, a processor only needs to control the parasite hazard under the following conditions:

the processor has reason to know that the fish will be consumed raw, OR

the processor markets the fish for raw consumption, i.e., represents, labels, or promotes the product to be consumed raw

ÂNote: This question was previously q. 13 in Section IV of Qs and As, Issue 2|

 

Question: Is the hazard of parasites reasonably likely to occur in the processing of fish roe during which the eggs are removed from the scein and then processed in brine?

Answer: No, ordinarily under these circumstances, the brine would serve to separate the parasite larvae from the fish eggs, i.e., the parasite larvae would sink and the fish eggs would float.

 

Question: With respect to changes that require processors to reassess their hazard analyses and HACCP plans [¤123.8(a)(1) and (c)], what do the terms "sources of raw material" and "consumers of finished product" refer to?

Answer: "Sources of raw materials" refers to the harvester or supplier of the raw material. If, for example, a processor expands or changes the area from which he purchases a species of fish to include an area in which a harvest closure based on chemical contaminants exists, the processor should reassess whether it is necessary to change his plan to accommodate the new hazard.

"Consumers of product" refers to the ultimate consumer, who buys the product at a retail establishment or consumes it at a food service establishment. If, for example, a processor changes his marketing for a product to specifically target persons in hospitals and nursing homes, or other high risk populations, he should reassess whether it changes the significance of potential hazards in the product.

 

Question: What are the factors that make Clostridium botulinum a hazard that is reasonably likely to occur in a fishery product?

Answer: Some factors which contribute to the likelihood of a Clostridium botulinum hazard include packing the product under vacuum, in a modified atmosphere, in a hermetically sealed container or in oil, and/or applying a moderate heat treatment in combination with salt at less that 10%. For additional information consult FDAÕs "Fish and Fishery Products: Hazards and Controls Guide" (Guide), Edition Two, p. 154.

 

Question: Is Clostridium botulinum (C. bot.) a hazard in vacuum packaged raw seafood products that are stored and distributed refrigerated?

Answer: Yes, the Guide states that FDA is not aware of any suitable controls for C. bot. in vacuum packaged raw fish, i.e. such a product would not contain any known barriers to the growth of C. bot. Refrigeration alone is not a suitable barrier without adequate temperature control (monitoring) from processor to consumer. If a processor intends to pack raw fish in a vacuum package, he will need to establish adequate safety controls. The most likely procedure would be to carry out innoculated pack studies.

 

Question: Would a processor of a vacuum packaged salmon product made from smoked salmon and cream cheese need to control the percent water-phase salt (wps)?

Answer: In some cases, yes. The processor would need to exercise sufficient control to prevent the growth and toxin formation of Clostridium botulinum in the finished salmon and cream cheese product. Such controls could include the incorporation of barriers to its growth, such as water phase salt, water activity, pH, or a combination of these. If the barriers used do not match the levels presented in the Guide, the firm would be required to establish the safety of the product through trials, such as inocculated pack studies.

 

Question: Is the hazard of PSP reasonably likely to occur in lobster?

Answer: No, based on current information, its is not reasonably likely that lobster meat or lobster tomalley will contain a toxic quantity of PSP. This is in part because the amount of toxin in lobster meat and tomalley, even from lobsters caught in the same suspect location, is highly variable. This change in the current FDA recommendation will be reflected in the next edition of the Guide (Edition Three).

 

Question: A firm that obtains shellfish from federal waters performs a hazard analysis in which the potential for PSP in these waters is considered. The firm concludes that this hazard is not reasonably likely to occur. In its analysis, the firm recognizes that while no state or federal agency has conducted an actual study of the federal waters for the incidence of PSP, the agencies expressed opinions that the hazard is not reasonably likely to occur. Additionally, the firm notes that there is no notice from federal or state agencies that these waters are occasionally closed due to a PSP hazard. Is this information sufficient from which to draw a conclusion that the hazard is not reasonably likely to occur, or would the firm need to perform a study?

Answer: The scenario describes a responsible hazard analysis. FDA would not ask that the processor perform a study of the federal waters for the incidence of PSP in such a case.

 

Question: If a state regulatory authority has issued a "Consumption Advisory" for fish, including paddlefish roe, taken from a specified body of water, must a processor of the fish consider or address that advisory in his hazard analysis?

Answer: Yes, any fish processor should consider the consumption advisory. The processor should not accept fish from an area that is "closed" to harvest. However, consumption advisories are not closures. Thus, the processor should first ask the state if the consumption advisory is based on a state decision that fish coming from the area are reasonably likely to contain contaminants above the FDA/EPA action levels. If the advisory is based on those levels, the processor must test every lot of the fish before accepting it.

However, most consumption advisories are not based on such levels. The level of safety in most consumption advisories is usually stricter than the federal action levels, i.e. they are set at a smaller amount of the contaminant based on locally high consumption patterns. In this case, the processor can accept the fish with no further action.

 

Question: Is it true that no HACCP plans are required for raw shrimp and non-scombroid fresh fish?

Answer: All processors must conduct, or have conducted for them, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur in their product. This hazard analysis must be conducted for each location, each process and each kind of product processed. If no safety hazards are determined, then no HACCP plans are required.

Raw shrimp and non-scombroid fresh fish may not need a HACCP plan, but this must be determined in each individual processor's situation. For example, if the raw shrimp comes from aquaculture farms, then the use of animal drugs is a hazard that must be addressed by the primary processor. Also, parasites may be a hazard in some non-scombroid fresh fish that are marketed for raw consumption.

 

Question: Must sulfites be identified as a significant hazard in a HACCP plan for shrimp?

Answer: In all cases, sulfites should be considered in the hazard analysis for shrimp, and in most cases sulfites will be a hazard that must be controlled in a HACCP plan. However, in geographical areas where sulfites are not used in shrimp, the hazard may not be reasonably likely to occur. Another example in which the hazard may not be reasonably likely to occur is shrimp from a harvester that immediately freezes shrimp on board the harvest vessel without using sulfites.

IV. Hazard Analysis Critical Control Point (HACCP) Plan, ¤123.6(b-g) (21 CFR)