| Public Health Service Food and Drug Administration |
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Department of Health and Human ServicesWARNING LETTER
Via UPS
Signature Required
November 25, 2011
Eugene A. Bugatto, President/Owner
Robert Bugatto Enterprises, Inc., dba The Tides Wharf
Corporate Headquarters
505 Beach Street
San Francisco, CA 94133
Dear Mr. Bugatto:
We inspected your fish and fishery product processing facility located at 835 Highway 1, Bodega Bay, CA from July 25 - 29, 2011. 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. 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). Consequently, your canned, refrigerated, reduced oxygen packaged Dungeness crab, and your hot and cold smoked fish are adulterated within the meaning of section 402(a) of the Act, 21 U.S.C. § 342(a), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find FDA’s Fish & Fisheries Products Hazards and Controls Guidance, Fourth Edition (the Guide) through links on FDA’s home page at www.fda.gov.
Additionally, we have reviewed the label for “THE TIDES WHARF” brand kippered salmon and have determined that the product is misbranded within the meaning of Section 403 of the Act [21 U.S.C. 343] in that the labeling fails to include the required nutritional labeling information. The Act and FDA regulations can be found through links on FDA's webpage at www.FDA.gov.
Your significant violations were as follows:
Seafood HACCP
1. You must conduct or have conducted for you a hazard analysis for each fish or fishery product 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 canned, refrigerated, reduced oxygen packaged Dungeness crab to control the food safety hazards pathogenic growth and toxin formation, which may include Clostridium botulinum.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for:
A. “Hot Smoked Fish”,
• Does not list the monitoring procedures and frequency at the Receiving critical control point to control histamine (i.e., for the scombroid species). Specifically, your firm acts as both a primary processor receiving fish directly from the harvest vessel and a secondary processor receiving fish from previous processors.
i. As a primary processor your HACCP plan indicates that your firm will obtain the harvest vessel log. However, your HACCP plan does not include adequate monitoring procedures associated with harvest vessel logs. For example the plan does not reference what you will be monitoring on the harvest vessel log and how you will be conducting monitoring at the time of receipt from the harvest vessel. Additionally, the plan does not include adequate temperature monitoring. FDA recommends that the vessel logs demonstrate various internal temperatures of fish that correspond to various time periods for cooling of the fish while on board the vessels and recommends including the date and time of off-loading.
ii. For product delivered to your firm from previous processors, your HACCP plan states that you will be monitoring temperature. However, you do not state what temperature you will be monitoring, i.e., the truck or the fish, and, you do not state you will include monitoring the date and time the fish were removed from a controlled temperature environment before shipment and the date and time delivered.
• Lists a monitoring procedure after receipt of product at the “storage” critical control point that is not adequate to control histamine formation. Specifically, your monitoring procedure under “How” states that you will be “Visually checking thermometer on each cooler and freezer”, and under “Frequency” states that the (b)(4).” FDA recommends the use of a continuous monitoring and recording device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, FDA recommends 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.
• Lists a monitoring procedure at the “Thawing/butchering(albacore)” critical control point that is not adequate to control histamine formation. Specifically, your plan states you will be monitoring thawing to ensure that temperatures of the fish do not exceed (b)(4) degrees for more than (b)(4) hours cumulatively, or (b)(4) hours for product that has undergone extended frozen storage > 24 weeks. FDA does not recommend monitoring internal product temperatures during thawing to control histamine. FDA recommends controlling the time of exposure to temperatures above 40°F(4.4°C) or monitoring ambient temperatures.
• Does not list the monitoring procedures and frequency at the “Brining” critical control point to control pathogen growth. Specifically, your HACCP plan has a critical limit for brining of not less than (b)(4) brine strength and a minimum (b)(4) hour soak time; however, your monitoring procedures under “What” states you will be monitoring the water phase salt, and under “How” states you state you will be monitoring the “Clock”. You do not state how you will monitor the brine strength, or what you are monitoring with the clock. These procedures do not correspond to your critical limits that involve brine strength and soak time. Monitoring water phase salt may be used as a verification procedure for your process.
B. “Cold Smoked Aquacultured Salmon in Vacuum Packaging”
• Lists a monitoring procedure at the “Receiving” critical control point that is not adequate to control pathogen growth. Your monitoring procedure under “What” states that you will be monitoring temperature, and under “Frequency” you state “(b)(4)”. FDA recommends for products delivered refrigerated with a transit time of 4 hours or less that firms include the date and time product was removed from a controlled temperature environment before shipment and the date and time delivered; and the internal temperature of a representative number of product containers (e.g., cartons and totes) at the time of delivery for each lot of product at receipt.
• Lists a monitoring procedure after receiving at the “Storage” critical control point that is not adequate to control pathogen growth. Specifically, your monitoring procedure under “How” states that you will be monitoring the cooler temperature with a “Thermometer”, and under frequency (b)(4). FDA recommends the use of a continuous monitoring and recording device such as a continuous temperature data logger for monitoring refrigerated. 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.
• Lists a monitoring procedure at the “Brining” critical control point that is not adequate to control pathogen growth. Specifically, when monitoring water phase salt, under “Frequency” you list (b)(4). FDA recommends testing the brine strength level for each lot or batch. Quarterly testing is more appropriately as a verification procedure for your process, not a monitoring procedure. If you choose to include testing as a monitoring procedure, FDA recommends you monitor every lot.
3. 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 plan for:
A. “Hot Smoked Fish”,
• After receiving at the “storage” and “Thawing/butchering (albacore)” critical control points are not adequate to control histamine formation. Specifically, you do not address correcting the cause of the malfunction in the cooler.
• At the “Brining” critical control point to control pathogen growth. Specifically, while you list you will re-brine if still in the processing stages until the proper brining time is achieved, or hold and evaluate product. You do not address the cause of the brine strength deviation.
• At the “Smoking/cooking” critical control point to control pathogen growth. Specifically, while you list you will cook the product some more until (b)(4) degrees is achieved for greater than (b)(4) minutes,. You do not address the cause of the temperature deviation.
B. “Cold Smoked Aqua Cultured Salmon in Vacuum Packaging”,
• After receiving, at the “Storage” and ”Brining” critical control points to control pathogen growth. Specifically, you do not address correcting the cause of the malfunction in the cooler.
• At the “Finished Product Storage” critical control point for “(Vacuum Packed Sides)” to control pathogen growth. Specifically, you state you will evaluate how long the product is un-iced, but you are only performing a visual check of the presence of ice surrounding the product once daily.
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the “Brining” critical control point to control pathogen growth listed in your HACCP plans for hot smoked fish and cold smoked aqua cultured salmon. Specifically, you had no brining records from 2010 or 2011.
5. 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’s HACCP plan for “Hot Smoked Fish” does not list a critical limit at the Receiving critical control point adequate to control histamine (i.e., for the scombroid species). Specifically, your firm acts as a primary processor receiving fish directly from the harvest vessel. FDA recommends conducting a sensory examination of a representative sample of scombrotoxin-forming fish with an acceptance rate of less than 2.5% of the fish in the sample.
Your firm is slicing frozen cold smoked fish sides at ambient temperatures, which average 50-55°F. Your firm should assess whether this step would need to be included as a critical control point in your “Cold Smoked Aqua Cultured Salmon in Vacuum Packaging” HACCP plan to control scombrotoxin (histamine) formation and pathogens. Additionally, your firm should consider including the hazard of scombrotoxin (histamine) formation at additional critical control points in your “Hot Smoked Fish” HACCP plan where the hazard is not listed.
For additional information and guidance please refer to Chapters 7, 12, and 13 regarding Scombrotoxin (Histamine) Formation, Pathogenic Bacteria Growth and Toxin Formation (Other than Clostridium Botulinum) as a Result of Time and Temperature Abuse, and Clostridium Botulinum Toxin Formation respectively in the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
Labeling:
Your Kippered Seafood The Tides Wharf “Peppered Salmon” and “Teriyaki Salmon” products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that they fail to bear a nutrition facts panel as required by 21 CFR 101.9.
Your Kippered Seafood The Tides Wharf “Peppered Salmon” and “Teriyaki Salmon” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products appear to be fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. Specifically, both products consist of salmon and an added “peppered” or “teriyaki”, ingredient, respectively; however, the additional ingredients fail to be declared on the finished product labels.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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 Darlene B. Almogela, Director Compliance at 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Russell A. Campbell, Compliance Officer, at (510) 337-6861.
Sincerely,
/s/
Barbara J. Cassens
District Director
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