Inspections, Compliance, Enforcement, and Criminal Investigations
Newport Seafoods Inc. 07-Jul-05
Department of Health and Human Services
Public Health Service
July 7, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-25
John P. Kaney, President
Newport Seafoods Inc.
22613 76th Avenue South
Kent, WA 98032
Dear Mr. Kaney:
On March 24-25, 30-31, 2005, we inspected your seafood processing facility, located at 22613 76th Avenue South, Kent, Washington. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or to otherwise operate in accordance with the requirements of this part, renders the 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 the seafood products you produce in your facility are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act, the Seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001 (the Hazard Guide), through links in FDA's homepage at www.fda.gov.
The deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that 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 did not adequately address the critical limits in the HACCP plan for your refrigerated vacuum-packaged ready-to-eat hot smoked wild and farmed salmon as follows:
A. Your HACCP plan does not list the critical limit of maximum fish thickness at the brining critical control point to control Clostridium botulinum toxin formation. Your plan describes the brining critical control point as "Brining up to [redacted] thick portions and fillets." It is imperative that you include maximum fish thickness as a critical limit to ensure that you are consistently achieving an adequate process for every batch of finished product.
B. Your HACCP plan lists a critical limit of "Maximum cooler temperature of [redacted] degrees F" at the cooler storage critical control point that is not adequate to control pathogens, including, for example, Listeria monocytogenes and some strains of Clostridium botulinum growth and toxin formation. FDA recommends that to reduce the likelihood for pathogen growth and potential toxin formation during refrigerated storage that coolers be maintained at or below 40°F. For more information please refer to the Hazard Guide.
C. Your HACCP plan does not list a critical limit (i.e., value) for the salimeter reading at the brining critical control point to control Clostridium botulinum formation.
D. Your HACCP plan does not list a critical limit for temperature control during the [redacted] hour brine step control point to control pathogens. Because certain pathogenic organisms, such as Staphylococcus aureus, are salt tolerant, FDA recommends that brining be conducted under refrigerated conditions (i.e., 40°F or below).
2. 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, your firm's HACCP plan for refrigerated vacuum packaged ready-to-eat hot smoked wild and farmed salmon lists inadequate monitoring procedures at the following critical control points as follows:
A. The HACCP plan lists critical limits of 145°F for thirty (30) minutes to control Clostridium botulinum at the smoking critical control point. However, your monitoring frequency of checking the internal temperature at the [redacted] cycle and [redacted] cycle while smoking" is not adequate in that it is not capable of ensuring that the critical limits are met. Specifically, your monitoring procedure will only provide the temperature at two points during the cook process and will not ensure that the product is maintained at 145°F for the duration of the 30 minute cook, as listed in your plan. Consequently, FDA recommends that time and temperature critical limits be monitored continuously by the instrument itself, with a visual check of the monitoring instrument at least once per batch.
B. The HACCP plan identifies critical limits of "must cool from 140 degrees F to 70 degrees F or below within two hours and to 40 degrees F or below within four hours" at the cooling critical control point. The monitoring frequency of "every [redacted] hours for each batch" is not adequate in that it does not ensure that temperatures will achieve 70°F in 2 hours. You should monitor the time the batch is removed from the cooker, recording the internal temperature of the product after two hours to ensure the product has reached 70°F and again after four more hours to ensure the product has reached 40°F.
C. The HACCP plan lists a monitoring frequency of [redacted] per day" to monitor the cooler storage temperature. To reduce the likelihood for unobserved and thus undocumented fluctuations in temperatures that exceed the critical limits (i.e., above 40°F) for extended time periods during storage, FDA recommends using equipment that is capable of continuously monitoring and recording the cooler temperatures. We additionally recommend a visual check of the equipment daily.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the following critical control points as listed in your HACCP plans for:
A. Refrigerated, Vacuum-Packaged Ready-To-Eat, Hot Smoked Wild and Farmed Salmon:
1. Farm raised Atlantic salmon and/or steelhead were processed on 114/05; 1110105, 1/16/05; 1/17/05; 1/24/05, 1/25/05, 1/31/05; 2/2/05; 2/7/05; 2/9/05 ; 2/14/05 2/15/05; 2/28/05; 3/9/05, and 3/23/05. The critical limits of weight of the brine and brine to fish ratio were not recorded on the smoke house monitoring record.
2 . Farm raised Atlantic salmon and/or steelhead were processed on 1/4105; 1/10105, 1/16105; 1/17/05; 1/24/05, 1/25/05, 1/31/05; 2/2/05; 2/7/05 ; 2/9/05; 2/14/05 2115/05; 2/28105; 3/9/05, and 3/23I05. The critical limits of time and internal temperature at the cooling critical control point were not recorded on the smoke house monitoring record.
B. H&G and Fillet Scombroid Fish and Re-packed Cooked Ready-To-Eat Crab and Shrimp:
1. You are not recording the adequacy of the ice surrounding your products as written in your HACCP plans at the storage critical control point. Your HACCP plans for H&G and Fillted Scombroid Fish and Repacked Cooked Ready-To-Eat Crab and Shrimp list that adequate (i .e., sufficient) amount of ice on product will be monitored to ensure product ( or product core) temperature does not exceed 40°F", and that you will record this [redacted] a day by visual observation on your refrigerated storage temperature log. At this time, you are only recording temperatures, rather than the presence of ice.
4. Since you chose to include corrective actions in your HACCP plan, your corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, the corrective action plans listed at each of your critical control points for your refrigerated vacuum-packaged ready-to-eat hot smoked salmon are not appropriate because they do not correct the cause of the deviation. In addition, "recook and recool," which are listed as your corrective actions at the cooling critical control point when the critical limits are not met, are not appropriate because of a potential for heat stable toxins to have formed following an inadequate cook and cool cycle. Recooking and recooling will not likely deactivate these types of toxins.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as your revised HACCP plan or other useful information that would assist us in evaluating your corrections . If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal, Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Ms. Elrand at (425) 483-4913.
Charles M. Breen