Inspections, Compliance, Enforcement, and Criminal Investigations
High Tide Seafoods, Inc. 12/10/08
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
December 10, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-08
Earnest J. Vail, Owner
High Tide Seafoods, Inc.
808 Marine Drive
Port Angeles, Washington 98362
Dear Mr. Vail:
We inspected your food and seafood processing facility located at 808 Marine Drive, Port Angeles, Washington, on July 24-25, 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, CFR, Part 110 (21 CFR 123 & 110). 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 renders the 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 canned Dungeness crabmeat is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & 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 produce to determine whether there are food safety hazards that 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 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for cooked Dungeness crabmeat packed into five pound sealed metal cans to control the food safety hazards of pathogen growth, specifically Clostridium botulinum growth and toxin formation; natural toxin; environmental chemical contaminants; and pesticides.
Specifically related to the hazard of Clostridium botulinum growth and toxin formation, please note that when refrigeration is the sole barrier to outgrowth of the organism and spores have not been destroyed via pasteurization or some other control method, the temperature of the products must be strictly maintained at 38°F or below. Therefore, in order to ensure that the products are maintained at adequate temperatures throughout distribution, FDA recommends the use of time/temperature integrators on each consumer package. Effective use of TTIs is considered an appropriate means to alert the final consumer to any potential unsafe product. Alternatively, products of this type may be safely marketed frozen with appropriate labeling. For additional information on the hazard of Clostridium botulinum please refer to Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide). For more information on the hazard of natural toxins please refer to Chapter 6 of the Hazard Guide; for more information on the hazards of environmental chemical contaminants and pesticides, please refer to Chapter 9 the Hazard Guide.
2. You must conduct or have conducted for you, a hazard analysis for each kind of fish and fishery product that 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(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 plan for Dungeness crab does not list the food safety hazard of environmental chemical contaminants and pesticides.
The Dungeness crab you process at your plant is harvested from both deep and close to shore water, where chemical pollutants are present. As a primary processor, "Environmental chemical contaminants and pesticides" are considered a significant hazard at any processing step where a preventive measure is, or can be, used to prevent or eliminate the likelihood of unsafe levels to occur. For more information on the hazard of natural toxins and environmental chemical contaminants and pesticides, please refer to Chapters 6 and 9 of the Hazards Guide.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for Dungeness Crab lists monitoring procedures/frequencies at the "Store (fresh)"critical control point that are not adequate to control pathogen growth because they are not consistent with your listed critical limits. Specifically, your monitoring procedures/frequencies list that you will monitor both temperature and/or quantity of ice or cooling media (b)(4). However, your critical limits at this critical control point which list, "Exposure to temperatures between (b)(4) and (b)(4)°F does not exceed (b)(4) for the temperature monitoring portion of the critical limit; and "Exposure to temperatures above (b)(4)°F does not exceed (b)(4) for the portion of the critical limit associated with monitoring ice or cooling media require a more frequent monitoring procedure than (b)(4) (i.e., every 4 hours and every 2 hours). Consequently, your monitoring procedure/frequency of (b)(4) is not adequate because it does not provide the necessary information consistent with your critical limits, making it impossible for your firm to maintain your listed critical limits. In addition, your corrective action plans indicate that you will take actions based on (b)(4) intervals. Again, monitoring procedures/frequencies that are performed (b)(4) will not provide enough information on which to base the need to take a corrective action.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor safety of water, condition and cleanliness of food contact surfaces, prevention of cross-contamination, prevention from adulteration, proper use of toxic chemicals, and exclusion of pests from the food plant with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:
a. Probe thermometers used to take internal temperatures of cooked crab are not sanitized before each use.
b. An employee used his gloved hands to touch the bottom of his boots while he was sitting, and pulling up his pants. This employee was then packing frozen, cooked, ready-to-eat whole crab into a tote without washing hands.
c. One employee was drinking iced tea in the processing area.
d. Condensate was observed dripping off the hoist equipment and directly into the cages containing cooked, ready-to-eat Dungeness crab. Also, condensate was observed dripping from a water pipe on the ceiling onto any product beneath it, including crab staged for cooking.
e. A chemical (b)(4) is being used for food contact surfaces but not approved for that use.
f. Five flies were observed in the processing area and were flying near cooked ready-to-eat crab.
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.
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 plant 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 written reply to the Food and Drug Administration~ Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Elrand at (425) 483-4913.
Charles M. Breen
Copy of FDA 483
cc: WSDA, with disclosure statement