Inspections, Compliance, Enforcement, and Criminal Investigations
Celtrock Holdings Limited 6/21/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20742
JUN 21, 2013
VIA EXPRESS DELIVERY
Celtrock Holdings Limited
P. O. Box 13968
Reference No. # 394238
Dear Mr. Zavir:
The U.S. Food and Drug Administration (FDA) obtained a copy of documents related to your seafood processing operation. We have reviewed the documentation and find that it does not comply with U.S. requirements. This letter describes our findings and next steps for you to take in response.
On February 1, 2013, FDA requested a copy of the HACCP plan from Sea Quest (Fiji) Limited (hereafter referred to as Sea Quest) for the processing of their scombroid species of fish to control scombrotoxin (histamine) formation. In response to our request, we received several documents via email on February 5, 2013, from a representative of Sea Quest. Additional descriptions of your processing practices, monitoring procedures, and completed monitoring records were provided in a follow-up email on February 8, 2013.
As part of the responses, Sea Quest and Celtrock Holdings Limited (hereafter referred to as Celtrock) representatives explained that Sea Quest is a fishing company and, since October 2012, is also the parent company of Celtrock. Sea Quest indicated that they use Celtrock's HACCP plan when processing fish. Sea Quest provided the following documents:
- A HACCP plan entitled “Fresh Fish HACCP plan:Celtrock Holdings Limited” intended to cover, according to a document entitled “Product Description,” the processing of “Fresh fish G&G, H&G (Yellowfin Tuna, Bigeye Tuna, Albacore Tuna, Mahimahi, Opah, Oil Fish, Marlin, Swordfish, Sailfish”
- Process Flow Chart
- Hazard Analysis Worksheet
- Brief Description of Processing Steps
- Evaluation Criteria Reference
- Production records
As noted in the explanation by Sea Quest, these documents reflect the processing of fish and fishery products by your firm.
Our review of your HACCP plan and supporting documentation revealed serious deviations from the requirements of the seafood HACCP regulation (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 scombroid species of fish 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 FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through FDA's home page at www.fda.gov.
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Our review of the documentation revealed the following deviations:
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(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 plan entitled “Fresh Fish HACCP plan:Celtrock Holdings Limited” does not list the following critical control points (CCPs):
a. Receiving CCP for controlling the food safety hazard of scombrotoxin (histamine) formation in your scombroid species of fish received directly from the harvest vessels (i.e., as a primary processor). Your document entitled “(b)(4)” describes your firm’s activities as both a primary processor (e.g., unloading the fish from the vessel) and as a secondary processor (i.e., receiving and processing fish at your facility). However, your HACCP plan only lists a CCP for receipt of the fish at your processing facility. Because you are acting as a primary processor, your HACCP plan should include appropriate CCPs related to receiving fish as they are unloaded from the vessels.
For example, FDA recommends that primary processors of scombrotoxin-forming fish measure the internal temperatures of fish at the time they are off-loaded from the harvest vessels as one indicator of temperature and handling controls on the vessel. Your firm’s HACCP program and plan lists a monitoring procedure to measure internal temperatures of the fish upon receipt at your processing facility. The internal temperatures of the fish at the time they are received at the plant may not reflect the internal temperatures of the fish when they are off-loaded from the vessels. Your documentation reports a (b)(4) from the harvest vessels to your processing facility; however, this time does not likely take into full account the time from off-loading the first fish of the vessel lot until the fish are fully off-loaded from the trucks at the plant. A primary processor control of internal temperatures needs to be implemented when the fish are off-loaded from the vessel.
b. Processing CCP to control scombrotoxin (histamine) formation during periods of unrefrigerated handling and processing. The description of your processing practices in the documents provided include a number of steps, such as loading the fish into iced trucks, transporting the fish to the processing plant, grading, butchering, washing, weighing, and packing. Unless this entire series of (b)(4) lot received, your HACCP plan should include CCPs for time and temperature exposures to prevent the hazard of scombrotoxin formation.
Your firm may want to consider controlling the temperatures of the environment in which fish are held throughout processing. For example, your firm could expand safe exposure times if the processing room temperatures were to be maintained at or below 21 °C for the duration of the processing operation.
c. Storage CCP for controling scombrotoxin (histamine) formation during holding/storage of unrefrigerated fish. Unless each individual fish is shipped the moment it is processed and placed in shipping cartons, your firm needs to address finished product holding or storage periods in your HACCP plan.
Your firm does include a CCP in your HACCP plan identified as “(b)(4) (CCP 2).” However, the purpose of the CCP is not clear and, if intended as a storage CCP, it would likely not be effective as a control strategy for scombrotoxin (histamine) formation. Specifically,
i. One of the elements of the CCP is “(b)(4).” This “(b)(4)” concept is also reflected in your firm’s Hazard Analysis Worksheet and as a “(b)(4)” element in processing (b)(4) in the document entitled “(b)(4).” However, none of these documents provides any indication, instruction, or control element related to “(b)(4)” would not be a reliable scombrotoxin control at this late point in the process.
ii. A second element of the CCP is “(b)(4).” For this element, your firm’s HACCP plan lists the visual monitoring of placement of a sufficient number of (b)(4) packs in the cartons, in relation to the weight of fish. This is associated with a critical limit of “(b)(4).” However, (b)(4) is not a reliable method to chill warm fish. (b)(4) is typically used to maintain chilled product in the chilled state, such as during transportation in insulated cartons. Further, the monitoring procedures to visually count the number of (b)(4) units placed in a carton is not an adequate measure to ensure that the critical limit of chilling product to 4.4 °C or less is met.
Your firm’s “(b)(4)” documents indicate that your firm uses an “(b)(4)” operation to chill fish during processing. However, the “(b)(4)” step appears to be initiated only if the fish temperatures exceed 4.4 °C. Moreover, neither the monitoring of fish temperatures during processing or monitoring conditions of the “(b)(4)” to chill the warmed fish are included in your firm’s HACCP plan as controls. The “(b)(4)” is included in your firm’s HACCP plan only as a corrective action when fish become warm. However, there’s no monitoring of fish temperatures in the HACCP plan to determine when this warming has occurred.
Your firm does reference “(b)(4)” in your “Hazard Analysis Worksheet.” Additionally, your firm submitted a “CCP 2 Form; (b)(4)” monitoring record that includes “Temperature of Fish Products.” The form instructs that “[r]ecords shall be taken on random basis” and entries are included, but with only one or two fish temperatures per entry. However, there is no assurance that the temperature of one or two fish represents the condition of all fish in a lot at any given point in time. In addition, with very large fish, microbial activity can occur on edible portions while the CBT of the fish suggests the fish is retaining colder temperatures. Consequently, monitoring CBT would not serve as an adequate control even if it were to be included in the HACCP plan, nor would monitoring CBT provide your firm with adequate information to determine when it would be necessary to place the fish back into a chilling ice slurry during the holding or storage period.
iii. The third element of the CCP is “(b)(4).” For this element, your firm’s HACCP plan lists monitoring procedures to visually track the time of “(b)(4)” for a marked batch of product “(b)(4)”. Concerns related to this element include:
o The listed monitoring controls (b)(4) will not identify that the critical limit was met (b)(4) unless the entire time of exposure is also recorded.
o Your firm’s HACCP plan does not identify refrigeration equipment or cold storage.
o Your firm’s fish are not processed in batches with respect to the listed control, i.e., an entire batch of fish is not exposed to refrigeration or non-refrigeration at any one time. Rather, individual fish are pulled from chilled environments to undergo processing steps and then replaced in a chilled environment, potentially multiple times each, over the course of time. Therefore, your firm would need to monitor each fish individually to observe when the fish was or was not in a “refrigerated environment” to implement this CCP.
2. 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 entitled “Fresh Fish HACCP plan:Celtrock Holdings Limited” does not list monitoring procedures at the “Receipt of FP at Processing Plant (CCP1)” CCP that are adequate to ensure your critical limit is met as part of your harvest vessel record control strategy.
Your HACCP plan lists the visual review of harvest vessel records for every lot received as part of your primary processor receiving control for scombrotoxin-forming fish. This is linked with your critical limit to ensure that the fish were placed on ice within six hours of death. However, your harvest vessel records do not provide adequate assurances that all of the fish delivered meet your designated critical limit.
Your documents indicate that the fish are caught using longlining. In some of the vessel records you provided, the harvester reported the estimated time of death as one to four hours after the recorded time of landing for all sets. However, the record also shows a number of fish landed dead within each set for which there is no accounting of the time of death to determine if these met your critical limit. Because longliners cannot reliably predict the time of death of each fish that is landed dead, there is typically no alternative than to assume the time of death is the same as the time of deployment of the first hook of the line.
3. 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 action plan for your scombroid species of fish is not adequate at the “Receipt of FP at Processing Plant (CCP1)”CCP.
Specifically, at this CCP your firm’s HACCP plan includes corrective actions listed as “sensory evaluation of all FP in the lot…” and “any individual FP found to be decomposed…should be destroyed or diverted to a non-food use” instead of rejection of the lot. Scombrotoxin cannot be reliably detected by sensory means; therefore, the corrective action measure in your firm’s HACCP plan to simply cull out the decomposed fish from a lot is inappropriate and will not prevent distribution of potentially unsafe fish.
Additionally, the sensory evaluation component of your firm’s corrective action at this CCP fails to ensure that the cause of the critical limit deviation is corrected.
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.
In addition to the deviations noted above, we have the following additional questions and comments:
1. With regard to the “(b)(4)” in the “Receipt of FP at Processing Plant (CCP 1)” CCP in your firm’s HACCP plan, your firm lists the examination of at least (b)(4) representative of each lot received for decomposition, or the entire lot if there are fewer than (b)(4). While your procedure is consistent with that recommended by FDA, there are a few elements of concern. For example:
a. FDA recommends that the minimum of 118 fish be applied to each species of scombrotoxin-forming fish from each harvest vessel lot received. This is not reflected in your firm’s listed monitoring procedures.
b. Your firm’s sensory “Evaluation Criteria Reference” provides criteria for several attributes of your fish and gives gradations of (b)(4). The descriptors included for each element are very limited; however, as a whole, the descriptors associated with both the “(b)(4)” are characteristic of fish that have undergone time and temperature abuse. For purposes of this HACCP control, fish characterized by the descriptors in the “(b)(4)” category should be included in the monitoring for the (b)(4) critical limit criteria.
Additionally, we note that your firm’s “(b)(4)” provides “(b)(4)” of an accepted fish that are inconsistent with the “Evaluation Criteria Reference” document.
2. With regard to processing escolar, in your firm’s “(b)(4)” document there is a footnote under the section on “Potential Species with Identification Hazard” that states: “Escolar is not exported to the USA because of the ban.” While FDA does not explicitly ban escolar, the Agency advises against distributing this fish. However, despite your firm’s declaration not to export these fish to the U.S., our import records show that your firm exports escolar to the U.S.
3. With regard to your verification procedures at the receiving CCP, your firm submitted four reports from an outside lab in which (b)(4) each were tested for histamine. The June 13, 2012, report noted one of the subsamples in (b)(4) histamine limit. Your firm attached a Corrective Action Form that suggested that the harvest vessel operators associated with the sampled fish were interviewed, temperature records onboard were checked, and checks for any consumer complaints related to the product were made.
While it was appropriate to follow up with the specific vessel from which the deviating fish originated, your firm should have also reevaluated your receiving controls. Your firm relies on harvest vessel records as one of the components to ensure that fish you accept from harvest vessels are safe to process and deliver into commerce. Periodic histamine testing is a verification procedure related to this control, and is intended to ensure that the control application of harvest vessel records used by your firm is effective and reliable. The fish sent for the verification testing had been accepted by your firm; therefore, the elevated histamine finding should have been a signal to your firm that your control measure of harvest vessel records was not effective and reliable to control the hazard.
In addition, your corrective action form included resampling for histamines. However, it is not clear (1) what was resampled, (2) the results of the sampling, and (3) what follow-up took place.
Also, your firm’s verification procedures for the harvest vessel record component of your receiving control list histamine analysis on (b)(4) samples every (b)(4) months. In your February 8, 2013, email, your firm stated that collecting (b)(4) samples on a (b)(4) basis to meet EU requirements is equivalent to collecting the (b)(4) samples (b)(4) in your HACCP plan. (b)(4) sampling would equate to (b)(4)samples a year. In contrast, (b)(4) samples quarterly equates to (b)(4) samples per (b)(4). The two procedures are not equivalent.
Additionally, we advise that, instead of random sampling, it may be more appropriate to collect samples for histamine testing for verification purposes from a vessel that has had a history of problems or when a lot received is considered borderline acceptable by your firm.
4. The February 8 email references use of a histamine rapid test kit to monitor the “scombroid levels on suspected products.” In addition, your HACCP plan includes references to histamine testing as part of your corrective actions. Please provide additional information about the rapid test kit your firm is using and your testing and sampling protocol. Specifically, please provide the name of the rapid test kit and the written protocol your firm is using that describes your firm’s methods for sample collection and preparation of the samples for histamine testing.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. 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.
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
Please send your reply to the 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.
Office of Compliance
Center for Food Safety
and Applied Nutrition
Mr. Mandy Haywood
Sea Quest (Fiji) Limited
Shed 12, Rona St
Walu Bay, Suva