Inspections, Compliance, Enforcement, and Criminal Investigations
Sunrise Meats, Inc. 4/9/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
April 9, 2014
In reply refer to Warning Letter SEA 14-09
Stephen R. Fink, President
Sunrise Meats, Inc.
1325 E 1st St.
Port Angeles, Washington 98362-4602
Dear Mr. Fink:
We inspected your seafood processing facility, located at 1325 E 1st St., Port Angeles, Washington, on December 3, 2013 through December 4, 2013. 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 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). Accordingly, your hot-smoked and cold-smoked fishery productsare adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Additionally, we have reviewed the bulk case labels for your frozen, vacuum-packaged, hot-smoked, and cold-smoked fishery products and have determined the products are misbranded within the meaning of section 403 of the Act, 21 U.S.C § 343. You may find the Act, the seafood HACCP regulation, regulations on food labeling requirements, 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 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 Hot-Smoked Fish and Cold-Smoked Salmon (Lox) do not list the food safety hazard of allergens.
2. You must implement the monitoring, record keeping, and verification system that you listed in your HACCP plans, 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 (CCP), the Smoking/Cooking CCP, and the Cooler Storage CCP to control growth of proteolytic Clostridium botulinum and bacterial pathogens listed in your HACCP plans for Hot-Smoked Fish and Cold-Smoked Salmon (Lox) as follows:
a. Monitoring records for the Brining CCP and the Smoking/Cooking CCP were not kept from June 11, 2013 through December 3, 2013.
b. Recording thermometers and recording devices were not calibrated (b)(4) as required for your Cold Storage CCP and Smoking/Cooking CCP in your Hot-Smoked Fish and Cold-Smoked Salmon (Lox) HACCP Plans.
c. Finished products have not been monitored (b)(4) since March 22, 2011, for water phase salt as required for your Brining CCP in your Hot-Smoked Fish and Cold-Smoked Salmon (Lox) HACCP Plans.
You do not control your process to prevent growth of proteolytic Clostridium botulinum as evidenced by your failure to implement the water phase salt monitoring and other record keeping and verification systems that you listed in your HACCP plans. Additionally, you do not apply an alternative control to prevent growth of proteolytic Clostridium botulinum in vacuum packed seafood as demonstrated by your failure to label the product to “Keep Frozen”. Without these controls, your products are considered “Raw Ready to Eat” seafood which requires temperature to be controlled until it is received by the consumer to prevent growth of proteolytic Clostridium botulinum. The only known method for assuring temperature control is by including time temperature indicators (TTIs) with each product shipment.
3. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm did not verify the adequacy of the following critical limits for the CCPs in your Hot-Smoked Fish and Cold-Smoked Salmon (Lox) HACCP plans:
a. The critical limit for maximum cooler temperature is 38oF at the Cooler Storage CCP to control Clostridium botulinum (proteolytic) toxin formation. Temperature recording charts were not signed and dated to indicate that they had been reviewed for Cooler B, which is used to store in-process, unpackaged, seafood products, on the following occasions:
i. The October 7, 2013 through October 14, 2013, temperature recording chart indicates that for approximately 56 hours Cooler B exceeded 38oF, twelve hours of which were above 50oF.
ii. The September 23, 2013 through September 30, 2013, temperature recording chart indicates that for approximately 44 hours Cooler B exceeded 38oF, reaching a maximum temperature of 43oF.
iii. The February 25, 2013 through March 4, 2013, temperature recording chart did not indicate any temperatures recorded.
b. The critical limit for time-in-brine is a minimum of (b)(4) soaking time (for Cold-Smoked Fish) and a minimum soaking time of (b)(4) for small pieces of fish and (b)(4) for large pieces of fish (for hot-smoked fish) at the Brining CCP to control growth of Clostridium botulinum. The critical limit for salt content of the brine is (b)(4) of cure to (b)(4) of water at the Brining CCP to control growth of Clostridium botulinum. Brining CCP Production Logs were not signed and dated to indicate they had been reviewed for January 28, 2013 through June 11, 2013.
c. The critical limit for minimum internal temperature of fish is 145oFfor a minimum of 30 minutes at the Smoking/Cooking CCP to control growth of bacterial pathogens. Cooking Time/Temperature records for the Smoking/Cooking CCPs were not signed and dated to indicate they had been reviewed for January 28, 2013 through January 31, 2013.
4. 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 smoked oyster products to control the food safety hazards of pathogenic bacteria growth and allergens.
You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for any of the areas of sanitation required for the processing of hot-smoked fish and cold-smoked salmon (lox) products on January 29, 2013, January 31, 2013, March 12, 2013, and March 14, 2013.
1. Your frozen vacuum-packaged, hot-smoked and cold-smoked fishery products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels fail to declare the major food allergen, namely the species of the fish, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321 (qq), defines as “major food allergens” milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
a. The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A), or
b. The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, (e.g., “flour (wheat)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).
2. Your frozen, vacuum-packaged, hot-smoked and cold-smoked fishery products are misbranded within the meaning of section 403(i)(1) of the Act, 21 U.S.C. § 343(i)(1), in that the labels fail to bear the common or usual name of the food in accordance with 21 CFR 101.3. Specifically, “C.R. King” and “White King” are not appropriate common or usual names of food; seafood must be declared by the common name or an acceptable market name for any fish including salmon in the United States. These names do not identify the species of the fish. You may find information regarding acceptable market names for seafood sold in interstate commerce at the following FDA web page: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm113260.htm.
3. Your frozen, vacuum-packaged, hot-smoked and cold-smoked fishery products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Specifically, you use brine pre-mixtures to manufacture your products; however, you fail to list the brine ingredients on your finished bulk case label or inner package.
In addition, you informed our investigator that you interchange the brine mixtures used to manufacture your products. The ingredient statement must accurately reflect the ingredients used in the product. Only ingredients that are actually used to manufacture the product are permitted to be declared on the product labels.
4. Your frozen, vacuum-packaged, hot-smoked and cold-smoked fishery products are misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1), in that the labels do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
We also have the following comments about your products:
1. Your Hot-Smoked Fish and Cold-Smoked Salmon HACCP plans describe “Cooler Storage” as a critical control point and define corrective actions to be taken in response to deviations. Our investigator was unable to verify that corrective actions were taken per the HACCP plans because there were no written records of the corrective actions taken on the two above mentioned occasions when Cooler B showed temperatures exceeding 38oF.
2. Your frozen, vacuum-packaged seafood product labels declare the weight; however, they do not declare the units of measure [21 CFR 101.105(b)(1)].
Further, section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
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. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand,Compliance Officer,at 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issues in this letter, please contact Lisa Elrand at 425-302-0415.
Ann M. Adams, Ph.D.
Acting District Director
cc: Timothy E. Hansen
Director, Seafood Inspection Program
National Marine Fisheries Service
1315 East-West Highway
Silver Spring, Maryland 20910
cc: Washington State Department of Agriculture with disclosure statement
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560