Inspections, Compliance, Enforcement, and Criminal Investigations
Fisherman's Market Ltd. 11/15/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
NOV 15 2012
VIA EXPRESS MAIL
Bill Langdon, Plant Manager
Fisherman's Market Ltd.
607 Bedford Hwy.
Halifax, Nova Scotia, B3M 2L6
Reference No.# 375479
Dear Mr. Langdon:
We inspected your seafood processing facility Fisherman's Market Ltd., located at 607 Bedford Hwy., Halifax, Nova Scotia, Canada on June 28 and 29, 2012. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm during the inspection. We acknowledge receipt of your response sent via email on July 30, 2012. This response included descriptions of your corrective actions and a revised copy of your HACCP plan for "Mackerel, Mahi Mahi, Marlin, Herring Shad, Tuna." Your response, however, did not include a revised copy of your HACCP plan for your vacuum packaged frozen cooked lobster, crab and shrimp. Our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor offish 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 mackerel, mahi mahi, marlin, herring, shad, tuna and your vacuum packaged frozen cooked lobster, crab and shrimp products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryinformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are 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 are not appropriate, as follows:
a. Your firm 's revised HACCP plan for "Mackerel, Mahi Mahi, Marlin, Herring Shad, Tuna" provided with your July 30th response and for "Cooked Lobster, Crab and Shrimp" collected during the inspection do not identify the food safety hazard of undeclared allergens. FDA recommends that firms include a critical control point in their plans to monitor each batch of labels for the declaration of all allergenic substances, including the appropriate fish species, on each product label. Additionally, for products such as shrimp that are often (b)(4), FDA recommends that firms also monitor for declaration of these chemicals on the labels, when these chemicals have been used on the products.
b. Your firm's HACCP plan for vacuum packaged frozen "Cooked Lobster, Crab and Shrimp" collected during the inspection does not identify the food safety hazard of Clostridium botulinum growth and toxin formation. FDA recommends that firms include a statement on each label to instruct the end user to "Keep Frozen" and "Important Keep Frozen and Thaw Under Refrigeration Immediately Before Use." FDA further recommends that firms include a critical control point in their plans to monitor each batch of labels for presence of the handling instructions on each individual product label.
2. 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, your firm's HACCP plans do not list the appropriate critical control points, as follows:
a. Your firm's revised HACCP plan for "Mackerel, Mahi Mahi, Marlin, Herring, Shad, Tuna" provided with your July 30th response does not list the critical control point of refrigerated storage following receipt for controlling the food safety hazard of histamine formation.
b. Your firm's HACCP plan for vacuum packaged frozen "Cooked Lobster, Crab and Shrimp" collected during the inspection does not list a critical control point for (b)(4) following the cook step. FDA recommends cooling the products to below 70°F (21 °C) within two hours and from 70°F (21 °C) to 40°F (4.4°C) within an additional four hours. Additionally, we recommend monitoring internal temperatures during the cooling step to ensure the time and temperature parameters are consistently met.
3. 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 vacuum packaged frozen "Cooked Lobster, Crab and Shrimp" collected during the inspection does not list critical limits at the (b)(4) critical control point adequate to control the identified hazard of "pathogen survival."
Your plan lists critical limits at the cooking process as (b)(4) However, these time and temperature parameters are not adequate for controlling Listeria monocytogenes, the target organism associated with ready-to-eat cooked products. FDA recommends for control of Listeria monocytogenes that firms achieve a 6 log reduction (6D) in the number of organism. For example, at an internal temperature of 80°C products would need to be held for 0.09 minutes (5.4 seconds) to achieve a 6D reduction in the number of Listeria monocytogenes organisms. However, your critical time limit is listed as only (b)(4). Moreover, the monitoring procedure listed in your plan relies on (b)(4) Therefore, your firm needs to have established the (b)(4) based on a validated scientific study. The scientific study is necessary to ensure that the (b)(4) provides an adequate reduction in the number of organisms in the slowest heating unit or portion of product under the worse set of heating conditions. For example, FDA recommends that your firm do the following: 1) conduct a temperature distribution study within the heating system to identify any cold spots; 2) conduct heat penetration studies on each product type to account for the slowest heating product under the worse case conditions; and 3) consider any other critical factors that affect the rate of heating of the products.
We note that your firm did provide our investigator with a document entitled "Safe Operating Procedures for Lobster/Crab Cooking." While this document provides scheduled cook times and temperatures based on pounds of product, it indicates that the recommended cooks will achieve an internal product temperature of (b)(4) for only (b)(4) seconds listed in your plan). Moreover, the document does not provide any scheduled cook processes for shrimp.
4. 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 HACCP plan for vacuum packaged frozen "Cooked lobster, crab and shrimp" lists monitoring procedures at the "(b)(4) critical control point that are not adequate to control the identified hazard of pathogen survival and growth.
Your monitoring procedures list (b)(4)." However, this is not adequate to ensure that your firm is meeting your critical limits listed at the critical control point as "(b)(4) Because the processing time is extensive (i.e., 24 hours) your firm needs to ensure that you perform monitoring and recording of time and temperature of either internal temperatures or ambient (i.e., room) temperatures at least every 2 hours to ensure that temperatures are maintained between 4° and 10°C for the duration of the 24 hour period.
5. Predetermined corrective action plans included in a firm's HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective actions plans are not adequate as follows:
a. Your corrective action plan for your Mackerel, Mahi Mahi, Marlin, Herring Shad, Tuna is not appropriate at the (b)(4)" critical control point to control histamine formation. Specifically, your firm does not list how many fish in each affected lot will be tested for histamine. FDA recommends a minimum of 60 fish representatively collected from throughout the lot, including any individual fish observed to have been exposed to inadequate cooling media or ice.
b. Your corrective action plan for your vacuum packaged frozen cooked lobster, crab and shrimp is not appropriate at the (b)(4) critical control point. Advising your quality control personnel does not prevent the distribution of potentially adulterated products. FDA recommends chilling the affected product and evaluating the total time and temperature exposures; or cooking the product, after evaluating the potential for the heat stable Staphylococcus aureus or Bacillus cereus toxins; or diverting the product to non-food use; or destroying the product.
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. Your response should include documentation, such as: a copy of any revised HACCP plan or plans; at least five (5) complete product days worth of monitoring records to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
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 and all applicable regulations, including the Seafood HACCP regulation and the 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.
Additionally, 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 re-inspection-related costs. Are inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin via email at Mildred.Benjamin@fda.hhs.gov
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition