Schneider's Fish & Seafood Corp.

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Avenue Jamaica, NY 11433

May 17, 2011
 

WARNING LETTER NYK 2011-21

VIA UNITED PARCEL SERVICE

Steven B. Perelstein, President/Co-Owner
Brian Perelstein, Vice-President/Co-Owner
Schneider's Fish & Seafood Corp.
2150 Old Union Road
Cheektowaga, NY 14227-2725
 

Dear Messrs. Perelstein:
 

We inspected your seafood processing facility, located at 2150 Old Union Road, Cheektowaga, NY, on December 6-15, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, also renders your fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your salted cod, vacuum packed tuna loins and S/B Mahi fillets, pasteurized crab, shellfish, and histamine and non histamine producing products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
 

Your significant violations were as follows:
 

1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards which are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR123.6(a) and (b). However, your firm does not have a HACCP plan for salted cod to control the potential food safety hazards of pathogen growth and toxin formation.
 

2. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological; chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plans for "Histamine PRODUCING [sic Fish] and "NON Histamine PRODUCING [sic Fish]" do not list the food safety hazards of pathogen growth and parasites. These plans indicate the intended use of the fish as "Cooked or raw consumption". Consequently, pathogen growth is a reasonably likely hazard for the fish intended for raw consumption by the consumer for all of the fish. Parasites will be a reasonably likely hazard for those species that pose the hazard, such as some species of Snapper and Tuna, as well as many of the non-histamine producing species.
 

3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However:
 

a. Your firm's HACCP plan for "Pasteurized CRAB" does not list the critical control point of "Receiving" for controlling the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum. Your critical limits and monitoring procedures at the "Stored in a Temperature Control Cooler" critical control point references activities and temperatures that are associated with receipt of the products, however, there does not appear to be a separate critical control point for receiving. FDA recommends these products be held at or below 40°F during transit and during any subsequent storage of the products. In addition, because these products are received following an extended transit time to your facility, FDA recommends you implement procedures that will provide continuous monitoring and recording of the temperatures during the entire transit period to your facility.
 

b. Your firm's HACCP plan for "VACUUM PACKED TUNA LOINS" does not list a separate critical control point for "Storage" of the fish following the defrosting step through to the time the fish are shipped, to control histamine development. Your plan combines defrosting and storage, however, your firm subsequently stores the loins following the defrosting step, and consequently you should include a separate critical control point to control histamine development during storage. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure it is operating properly.
 

c. Your firm's HACCP plan for "HISTAMINE PRODUCING [sic Fish]" does not list a separate critical control point for refrigerated "Storage" to control histamine. Your plan includes a critical control point "Receiving temperature control from to it's received to time it's shipped to end user" that appears to cover the time between receipt to final shipping. However, there is no clear indication that this is a "storage" critical control point. In addition, there is no indication your firm is adequately controlling the temperatures of the fish during this step. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan, and monitoring records should reflect this monitoring activity accordingly.
 

4. You must have a HACCP plan that, at a minimum, lists the critical limits which must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "VACUUM PACKED TUNA LOINS" does not list a critical limit for temperature at the "Storage & defrosted temperature control" critical control point to control pathogen growth and toxin formation, including Clostridium botulinum, and histamine formation. While your plan lists as the critical limit at the critical control point to "Make sure product is well iced to assure temperature control", your monitoring procedure lists "Product is kept under proper temperature control". Consequently, we would expect to have a specific "temperature" critical limit listed in the plan. In addition, we recommend defrosting these products under refrigerated conditions, with use of equipment capable of monitoring and recording the temperatures of the cooler on site at your facility, rather than defrosting under ice. This will ensure that proper temperatures are consistently maintained and will provide the necessary parameters for your firm to take an adequate corrective action, should one be necessary when there is a deviation from the temperature critical limit. This is particularly important because your firm defrosts these products overnight, when your 'firm is not in operation. Additionally, because you are opening each package prior to the start of the defrosting step, to allow for the introduction of air and therefore eliminating the potential for Clostridium botulinum toxin formation, we recommend a defrosting temperature of 40°F. However, in the absence of the step that allows for the introduction of air into each package, we recommend a defrosting temperature of 38°F (i.e., to control for toxin formation).
 

5. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c) (4). However,

a. your firm's HACCP plan for "PASTEURIZED CRAB" lists a monitoring procedure(s) / frequency at the "Stored in a Temperature Controlled cooler" critical control point that is not adequate to control pathogen growth and toxin formation, including Clostridium botulinum. Your HACCP plan lists a monitoring frequency of "once a day, where product is being stored. The temperature is checked daily Mon-Sat. The cooler is set to an alarm as a backup in case of malfunction", and your alarm system is set to trigger an alarm at 39 degrees F even though your critical limit calls for product to be stored at below 38 degrees F.
 

These procedures do not ensure compliance with the critical control limit at the storage critical control point.
 

FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly.
 

b. your firm's HACCP plan for "VACUUM PACKED TUNA LOINS" does not list Under the HOW for the monitoring procedure at the Storage & defrosted temperature control critical control point an examination method which assures each vacuum package of tuna loin has been cut open to control Clostridium botulinum growth and toxin formation.
 

6. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your
 

a. "VACUUM PACKED TUNA LOINS" at the "Storage & defrosted temperature control" critical control point to control pathogen growth and toxin formation, including Clostridium botulinum, and histamine formation is not appropriate. Your Corrective Action states: "Open all packages of tuna, re-bag with new clean poly bag w/twist tie, repack with ice." If your Monitoring procedure found that not all vacuum packages of tuna loins were thawed unopened, these bags might contain Clostridium botulinum toxin. If the product was not maintained at a proper temperature, then you could also have Histamine formation. Re-bagging would simply place the product with Clostridium botulinum and/or histamine toxin in a new sealed bag. In addition, your action does not correct the cause of the deviation.

b. "VACUUM PACKED S/B MAHl FILLETS" at the defrosting, packing and storage control critical control point to control pathogen growth and toxin formation, including Clostridium botulinum, and histamine formation is not appropriate. Your Corrective Action states: "If product exceeds 38°F the product is to be chilled down with ice until below 38°F." Re-chilling product that has been temperature abused will not remove the inherent hazards caused by the temperature abuse. Histamine formation may have occurred as well as the production of Clostridium botulinum toxin. In addition, your action does not correct the cause of the deviation.
 

c. "PASTEURIZED CRAB" at the "Stored in a Temperature Controlled cooler" critical control point to control pathogen growth and toxin formation, including Clostridium botulinum, and histamine formation is not appropriate. Your Corrective Action states: "Surface area temperature should not exceed 38°F or product will be moved to alternate storage area (ref truck)." Re-chilling product that has been temperature abused will not remove the inherent hazards caused by the temperature abuse. Pathogen growth may have occurred as well as the production of Clostridium botulinum toxin. In addition, your action does not correct the cause of the deviation.
 

d. "HISTAMINE PRODUCING [sic Fish]" at the "Receiving temperature control from to it's received to time it's shipped to end user" critical control point, that appears to be related to storage is not adequate to control histamine formation. Your Corrective Action lists "Product will be move to alternate storage area", however, moving product that has been temperature abused will not remove the inherent hazards caused by the temperature abuse. Histamine formation may have occurred during the temperature excursion. In addition, your action does not correct the cause of the deviation.
 

We may take further action if you do not promptly correct these violations. For instance, we may take farther action to seize your product(s) and/or enjoin your firm from operating.
 

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plan operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food. and Drug Administration, Attention: Patricia A. Clark, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Ms. Clark at 716-551-4461, ext. 3168.
 

Sincerely,

/S/
Ronald M. Pace
District Director
New York District

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