If your operations include bringing seafood into your facility, even if you do not open the product, you are subject to the Seafood HACCP Regulations.
What follows are excerpts from the Federal Register regarding facilities that are affected by the Seafood HACCP regulations. Of special interest is that Warehouse Facilities, even those that do not handle open product, fall under the regulation and need to conduct a Hazard Analysis to determine if a significant hazard exists and if so, what the critical control points would be. If significant hazards are identified then a full Seafood HACCP plan is required.
Federal Register 60 FR 65095 December 18, 1995
Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products; Final Rule
21 CFR 123 and 1240
Part I, Preamble, pp. 65095-65152
The entire document can be reviewed at the following linked site:
Excerpts beginning with Part I, Preamble, pp. 65095-65152,
II. The Comments
15. Processing and Processor
"b. Warehouses. In the preamble to the proposed regulations FDA stated that the definition of "processor" included warehouses. Warehouses store fish and fishery products, one of the operations included in the proposed definition of "processing." A "processor" is simply an entity that engages in processing.
There are food safety hazards that can be introduced while storing a product (e.g., in a warehouse). These hazards include, among other things, pathogen growth in cooked, ready-to-eat products and histamine development in scombroid toxin-forming species, as a result of improper storage temperatures. Nonetheless, the warehouse environment usually has few hazards compared to complex processing operations. Consequently, the preamble to the proposed regulations invited comment on whether warehouses should be exempted from the definition of "processor" and, by implication, whether "storing" should not be included in the definition of "processing," as one way of scaling the regulations back in terms of cost and burden.
37. The comments split about evenly on this subject. Those that gave a reason for including warehouses cited the need to monitor storage temperatures for species that are prone to safety hazards if they are temperature abused. Those that opposed and provided a reason tended to argue that storage alone should not subject an establishment to the requirements of the regulations. A related concern was the view that warehouse operators do not have a thorough knowledge of the products that they handle and only store products that are provided to them by others. This concern was expressed both by those who objected to the inclusion of warehouses and those who simply asked for clarification about the role of warehouses. Others who asked for clarification expressed the view that warehouses could be responsible for conditions during storage.
After consideration of these comments, FDA has decided to retain warehouses (e.g., public storage warehouses, foodservice distribution warehouses, and wholesale grocers) within the definition of "processor" and to retain "storing" within the definition of "processing." It is important to recognize that section 402(a)(4) of the act covers storage along with other forms of processing. It states that a product is adulterated if it is "prepared, packed, or held under unsanitary conditions * * * whereby it may have been rendered injurious to health." These regulations are being issued for the efficient enforcement of section 402(a)(4) of the act. Moreover, as described above, hazards can be introduced as well as controlled during storage. HACCP is an appropriate system for the control of these hazards.
FDA believes that the burden on warehouses will be minimal given the simplicity of the operation and the fact that, in most cases, a warehouseman's responsibility under HACCP will only extend to conditions within the warehouse that could cause a safety hazard to occur.
For the most part, hazards deriving from the environment (pesticides, etc.) will be controlled during the initial processing of the product (i.e., by the first processor to take possession). As a result, subsequent processors will receive products that are generally free of environmental hazards and thus will not need to establish HACCP controls for them. More often than not, storing will not be the first processing operation. Thus, a warehouse will not usually be responsible for environmental hazards. The same principle holds true for hazards arising during processing operations that occur before storage in a warehouse. Those hazards must be controlled during the prior processing and generally not during storage.
There may be occasions, however, when storage is the first processing operation (e.g., when a warehouse will be the first processor to receive raw material fish from a fisherman or aquacultural producer). Under these circumstances, the warehouse, rather than a distant owner of the product, may be in the best position to obtain information that may be needed about harvest site, fishing practices, and transportation to the dock that would be germane to safety. There should be some arrangement between the warehouse and the owner on this matter to ensure that environmental hazards are properly addressed.
38. One comment objected to the inclusion of storage within the definition of processing on the grounds that FDA should not dictate where CCP's should be. The agency is not attempting to do so. FDA acknowledges that whether storage is a CCP will depend on the circumstances. For example, refrigerated storage of a scombroid species will likely be designated as a CCP, whereas dry storage of canned fish will not likely be considered as such.
39. Another comment objected to including "airline warehousing" within these regulations.
If airlines hold product as part of their usual course of business as carriers, they are exempt from having HACCP plans in accordance with section 703 of the act."
Additional guidance can be found at the following link to the - Fish and Fisheries Product Hazards and Control Guidance: