Inspections, Compliance, Enforcement, and Criminal Investigations
Superfish S.A. 10/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
October 16, 2012
VIA EXPRESS DELIVERY
Ms. Anna Rogowska
78-111 Ustronie Morskie, Poland
Reference No. 358838
Dear Ms. Rogowska:
In response to a request on July 9, 2012, by the U.S. Food and Drug Administration (FDA) for documentation associated with your firm’s various herring products, your firm provided copies of your firm’s seven (7) HACCP plans for ready to eat herring products. These plans were sent via email on July 16, 2012. Our evaluation of the HACCP plans for your ready to eat herring products revealed that your firm has serious deviations from the Seafood HACCP Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). This letter describes the deviations found during FDA’s evaluation of your HACCP plans and next steps for you to take.
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 otherwise operate in accordance with the requirements of 21 CFR part 123, 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, your firm’s marinated (pickled) and salted herring products are adulterated in that the products have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We are using the following grouping of products, as identified in your July 16th documents:
We note the following serious deviations from the requirements of the Seafood HACCP regulation:
1. 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(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 appropriate critical control points (CCPs).
a. The following HACCP plans to do not include a critical control point for the marinade process step to control histamine and pathogen growth:
Your herring is marinated for (b)(4) under refrigerated storage and there is a potential hazard for pathogen growth and scombrotoxin (histamine) formation; therefore, this step should be monitored as a CCP. FDA recommends a CCP that includes both critical limits of time and temperature of the process and parameters for the marinade strength to ensure control of these hazards.
b. (b)(4) do not include a critical control point for finished product storage to control pathogens, including the hazard of Clostridium botulinum growth and toxin formation. Your products are intended to be held refrigerated (i.e., are not shelf stable). Consequently, your plans should address adequate control of the hazard of pathogen and toxin formation including Clostridium botulinum in the finished products. FDA recommends a secondary barrier be used to minimize the hazard of Clostridium botulinum.
We acknowledge that your plans include references to a pH level of (b)(4) in the semi-finished products. However, FDA recommends that firms achieve a pH level of 5.0 or below in the finished product if using pH as a secondary barrier for Clostridium botulinum. This means your firm should ensure that a pH level of 5.0 is achieved following addition of the vegetable components because addition of the fresh vegetables to the previously acidified fish may raise the pH.
2. 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 “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 plans for your marinated (pickled) and salted herring products do not list critical limits that are adequate to control the food safety hazards as described below.
a. (b)(4) list critical limits at CCP 11 - (b)(4) that are not adequate to control the hazard of scombrotoxin formation. Your firm is a primary processor receiving the fish directly from the harvest vessels. Your firm has listed scombrotoxin (histamine) as a hazard; however, you did not include histamine analysis or obtaining harvest vessel records as part of the critical limit parameters. FDA recommends that, in addition to product temperature and organoleptic parameters, your firm include either histamine analysis to ensure the raw materials have not exceeded 50 ppm; or harvest vessel records to demonstrate the fish were properly handled onboard the vessels.
b. (b)(4), that includes your (b)(4) lists time and temperature critical limits for the (b)(4) the CCP 13 - (b)(4) that are not adequate to control pathogen growth, specifically the identified hazard of Staphylococcus aureus. Your firm’s critical limits list (b)(4). (b)(4) which are not adequate parameters to control toxin formation. FDA recommends holding hydrated (i.e., wet) batter for no more than 3 hours cumulative at temperatures above 21°C to control Staphylococcus aureus growth and toxin formation.
c. (b)(4), that includes your (b)(4), lists critical limits at CCP 14 - (b)(4) that are not adequate to control pathogenic bacteria. The HACCP plan lists temperature critical limits (b)(4). However, your plan does not list any corresponding critical limits for time for product that is cooked (fried).
d. (b)(4), that includes your (b)(4), lists cooling as a sub-CCP at CCP 14. The plan lists critical limits that are not adequate to control the identified hazards of scombrotoxin formation and C. botulinum toxin formation. The plan lists that the product (b)(4). FDA recommends the product be cooled to 70°F (21.1°C) within 2 hours and further cooled to 40°F (4.4°C) within an additional 4 hours or equivalent parameters. In addition, the plan lists that product (b)(4). FDA recommends product and cooler temperatures be maintained at ≤40°F (4.4°C).
3. 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 plans for marinated (pickled) and salted herring do not list adequate monitoring procedures.
a. (b)(4), CCP 11 – (b)(4) critical control point
i. Your plans list that you are monitoring internal temperatures and conducting organoleptic exams of the product. However, your firm’s plans do not list the number of fish to be examined. FDA recommends performing sensory examination on at least 118 fish collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish) and measuring the internal temperature of a representative number of the largest fish in each lot, concentrating on any that show signs of having been mishandled.
ii. Your firm’s plans do not identify the number of fish that will be used for your acceptance or rejection criteria when the critical limits are not met at internal temperature or organoleptic exam.
iii. Your plans do not state that trained personnel will perform the organoleptic analysis during (b)(4) of the raw materials.
b. All groups: CCP 4 – Time/temperature exposure through the entire processing cycle
The CCP includes numerous processing steps, including (b)(4). Each of these steps has different time and temperature exposures; however, most of the cycles list the monitoring procedures (b)(4) of temperature, but doesn’t provide a clear frequency of evaluating the temperature. FDA recommends that each the process cycles be monitored at least every 2 hours throughout process cycle.
c. (b)(4), CCP 1 – (b)(4) CCP:
Your firm’s plans list histamine analysis as a critical limit; however, the plans do not list the specific details regarding the histamine testing protocol, such as the test method, the minimum number of fish to be analyzed, and the acceptance or rejection criteria.
4. 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, the corrective actions listed in your HACCP plans for marinated (pickled) and salted herring products are not appropriate.
a. (b)(4), CCP 11 – (b)(4) CCP
Your corrective actions are inadequate in that, in addition to rapid cooling of the product to control pathogens, other controls should be in place for histamine. FDA recommends histamine analysis for raw materials where the temperature and sensory examination exceeds the critical limit and discontinuing use of the supplier until evidence is obtained that the harvesting and onboard practices and controls have been improved.
b. (b)(4), CCP 12 – (b)(4) CCP
Your corrective actions do not list a final product disposition of affected products to prevent distribution of potentially adulterated products. FDA recommends all affected product be destroyed or diverted to non-food use. In addition, your corrective actions do list how your firm intends to address the root cause to ensure measures are taken to prevent future occurrences.
c. All groups, CCP 04 – Time/temperature exposure through entire Processing CCP
Your corrective actions do not list a minimum number of fish to be sampled for histamine analysis. FDA recommends histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot. In addition, your corrective actions did not list how your firm intends to regain control of the product/process.
d. (b)(4), CCP 01 – (b)(4) CCP
Your corrective actions do not include actions taken regarding the supplier to prevent future occurrences. FDA recommends discontinuing use of the supplier until evidence is obtained that the harvesting and onboard practices and controls have been improved.
e. (b)(4), CCP 02 – (b)(4)
Your corrective actions do not include addressing the root cause of the critical limit deviation to ensure measures are taken to prevent future occurrences. In addition, the corrective actions do not list a specific final product disposition. FDA recommends steps be taken to ensure violative product is not distributed into commerce.
f. All groups, CCP 03 – (b)(4) CCP
Your corrective action does not list a minimal number of fish to be sampled for histamine analysis. FDA recommends histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot. In addition, your corrective actions do not list addressing the root cause of the critical limit deviation. FDA recommends your firm address the root cause of the deviation to ensure measures are taken to prevent future recurrences.
g. (b)(4), that includes your (b)(4), CCP 13 – (b)(4) wet CCP
Your firm currently lists rinsing the (b)(4) and increasing the frequency of (b)(4) as your corrective actions. FDA recommends corrective actions that address disposition of affected products to prevent distribution of potentially adulterated products. FDA recommends destroying the product and (b)(4); diverting to non-food use; or holding and evaluating the product and batter based on total time/temperature exposure. In addition, FDA recommends corrective actions to regain control of your process such as icing the (b)(4) and recirculation tanks; and repairing or adjusting the process or equipment to prevent recurrences of the deviation.
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 of your corrections, such as a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Providing your documentation in English will assist in our review.
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 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. This alert can be found on FDA’s web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html
In addition we note the following additional concerns:
1. Verification procedures/frequencies are not listed in (b)(4) associated plans. Specifically, your firm’s HACCP plan does not list daily verification of the thermometers at CCP 01, 02, 03,04, 05 10, 11, 12, 13 and 14.
2. CCP 13 (b)(4) CCP (b)(4). Your firm’s HACCP plan indicates that records are reviewed monthly; however, FDA recommends records be reviewed within one week of creation.
3. Your firm’s HACCP plan does not list a frequency for thermometer calibration. FDA recommends thermometers be calibrated once a year.
Please send your reply to Standra Purnell, Consumer Safety Officer, Food and Drug Administration, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may send any information related to this case and/or any questions you may have regarding this letter to Standra Purnell via email at: email@example.com.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition