Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20742
March 27, 2013
VIA EXPRESS DELIVERY
Mr. Sebastian Greco, President
B7603GGD- Mar del Plata
Buenos Aires, Argentina
Reference No. # 394321
Dear Mr. Greco:
This letter is in follow-up to FDA’s letter issued to you regarding your seafood processing facility, Pranas S.A., dated September 19, 2012. That letter described several 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 association with the processing of your “Anchovies in Salt Brine.” In that letter, we advised your firm to provide written responses to the deviations and to include with that response a copy of your revised HACCP plan, copies of monitoring records to verify implementation of the revised plan and any additional information that would assist us in reviewing your corrections. We have not, as of this time, received any substantial response from your firm with any documentation to demonstrate that corrections have been made to those deviations.
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 anchovies in salt brine 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 Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
As noted in FDA’s September 19, 2012, letter, the same significant deviations remain:
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 plan for anchovies in salt brine does not identify the food safety hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus and undeclared allergenic substances.
a) Staphylococcus aureus is a pathogen likely to be introduced during the salting process because this process is conducted for an extended time period (i.e., listed as (b)(4) hours) and Staphylococcus is a salt tolerant organism; therefore, FDA recommends that temperatures be controlled at or below 40° F to prevent toxin formation for the duration of the salting process. Alternatively, your firm may choose to monitor time to ensure that the product exposure to temperatures above 40 °F is consistently less than 3 hours.
b) With regard to the hazard of undeclared allergens, your firm should implement a critical control point to ensure that the appropriate fish species is declared in the ingredient statement or in a “contains” statement on all the labels.
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 Part 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 for anchovies in salt brine does not list critical control points necessary for controlling the reasonably likely hazards of Clostridium botulinum growth and toxin formation, and histamine formation. Specifically, your firm needs to assess the following during your hazard analysis:
a) A critical control point for receipt of the anchovies at the dock, when being off-loaded from the harvest vessels. Your firm appears to be a primary processor receiving the fish directly from the harvest vessel, but also receives fish transported by trucks to your processing facility. As the primary processor receiving the fish directly from the harvest vessels, your firm needs to ensure that the fish were properly handled onboard the boats. This should include not only your listed strategies for histamine testing and sensory evaluation, but also a third strategy for monitoring temperatures of the fish at the time they are off-loaded at the dock. FDA recommends temperatures of 40°F (4.4°C) or below at off-loading from the harvest vessels to demonstrate adequate chilling onboard the vessels.
For receipt of the fish in transit from the wharf to your facility, your firm should include additional controls at receipt to ensure that the fish were held at proper temperatures or with adequate ice surrounding the products during the transit period to your facility to control histamine formation.
b) A critical control for heading, gutting, and filleting of the anchovies following receipt, prior to the brining operation to prevent pre-formed Clostridium botulinum toxin from developing (i.e., before the fresh fish have reached an adequate salt concentration during the salting step) because of the extended time period for the salting process.
c) A critical control point for salting. Your plan lists “(b)(4)” as critical control points in your plan. However your plan does not list a (b)(4) critical control point to ensure that a minimum salinity is achieved as either an adequate water activity (Aw) or water phase salt (WPS) level. Because your products undergo a (b)(4) process that appears to be conducted under ambient temperatures (i.e., not conducted under refrigerated conditions), your products should achieve a safe Aw or WPS during the (b)(4) process (i.e., Aw (b)(4), WPS (b)(4)). Since the product undergoes a subsequent (b)(4) process, the product must reach a “shelf stable” Aw or WPS to prevent the germination of Clostridium botulinum spores.
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, the (b)(4) critical control point of your HACCP plan for anchovies in salt brine listed a (b)(4) hours that is inadequate to control the food safety hazard of histamine formation, in the absence of a critical limit for temperature.
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 firm’s revised HACCP plan for your anchovies in salt brine does not list adequate monitoring procedures and frequencies at the following critical control points to control histamine formation.
a) At the “(b)(4)” critical control point, your plan indicates that you will test histamine content in (b)(4) samples of (b)(4) fish flesh to control histamine. This is not an adequate control at this step because it does not ensure that the entire batch of fish was properly controlled to prevent histamine formation for the duration of the ripening step. Your firm should implement controls that prevent the formation of histamine.
b) At the “(b)(4)” critical control point, your plan does not identify an adequate sampling frequency for testing histamine. The monitoring frequency lists that your firm will sample un-iced or inadequately iced products and test fish samples where the internal temperatures (b)(4). This does not assure that representative samples will be collected throughout the (b)(4) if all of the products come in iced and with internal temperatures below 4.4°C. FDA recommends collecting a (b)(4) routinely throughout the lot or shipment, including those products that appear to have been adequately chilled.
Further, the collection of representative samples for testing decomposition and internal temperature is unclear. The asterisk footnote under the (b)(4) critical control point implies that only (b)(4) are collected from each truck for decomposition. This is inadequate. Although those samples may include more than (b)(4), they should be more representative of the sub-lot or lot. A lot depends on how the fish are loaded on the trucks. If the fish are in large vessels or smaller totes, the samples should be collected throughout the shipment, not just from (b)(4). Since the fish are small, a sample should be determined by weight, not by the number of fish. FDA recommends collecting samples of approximately 1-2 lbs.
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 action plans for your anchovies with salt brine are not appropriate at the following critical control points to control histamine and Clostridium botulinum growth and toxin formation:
a) At the “(b)(4)” critical control point for histamine testing, your plan lists rejection of the lot but does not identify how your firm will correct the cause of the critical limit deviation. Your firm should address both in your corrective action plan.
b) At the “(b)(4)” critical control point, your firm’s plan does not identify the disposition of potentially adulterated products and does not identify how your firm will correct the cause of the critical limit deviation.
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. 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
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.
Please send your reply to Food and Drug Administration, Attention: Maria Corpuz, 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. Corpuz via email at Maria.Corpuz@fda.hhs.gov.
Office of Compliance
Center for Food Safety
and Applied Nutrition