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WARNING LETTER

Atum Do Brasil Captura Industria e Comercio


Recipient:
Atum Do Brasil Captura Industria e Comercio


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
MAR 18, 2016
 
 
VIA EXPRESS DELIVERY
 
Mr. Mauro Lucio Pecanha de Almeida
President
Atum Do Brasil Captura Industria e Comercio
Rua Sebastiao Alves de Almeida, No. 469
Praia de Itaoca
Itapemirim, Brazil
 
 
Reference No: 491504
 
Dear Mr. Pecanha de Almeida,
 
On October 16-19, 2015, a representative from the U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Atum Do Brasil Captura Industria e Comercio, located at Rua Sebastiao Alves de Almeida, No. 469, Praia de Itaoca, Itapemirim. 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, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.
 
We acknowledge receipt of your response to the FDA-483 sent via email on October 23, 2015 and December 14, 2015. Your response included descriptions of your corrective actions, letters from the Brazilian Ministry of Agriculture, monitoring records, and your revised HACCP plans for “Fresh Whole Fish,” “Fresh Gutted Fish Beheaded or Not,” and “Fresh Fish Filets.” Review of your responses and revised plans revealed serious deviations from the requirements of the seafood HACCP regulation, 21 CFR Part 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 fresh whole fish, fresh gutted fish, and fresh fish filets 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
 
Your significant deviations are as follows:
 
1)    You must conduct or have conducted for you 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 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 “Fresh Fish Filets” does not list the food safety hazard of Clostridium botulinum toxin formation. Your “Production Technological Report” which describes the process flow for your Fresh Fish Filets indicates at the (b)(4)
 
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 HACCP plans do not list all of the critical control points for controlling the food safety hazard of scombrotoxin (histamine) formation. Specifically,
 
a)    Your HACCP plans for “Fresh Whole Fish”, “Fresh Gutted Fish Beheaded or Not”, and “Fresh Fish Filets” do not list the “Waiting Room” (or “Wating Room”) critical control point. FDA recommends that one of the following critical limits be established at this critical control point:
 
i)    For refrigerated (not frozen) storage of raw material, in-process product, or finished product:
 
o    The product is held at cooler temperature of 40°F (4.4°C) or below.
 
OR
 
ii)    For raw material, in-process product, or finished product stored under ice:
 
o   The product is completely and continuously surrounded by ice throughout the storage time
 
b)     Your HACCP plans for “Fresh Gutted Fish Beheaded or Not” and “Fresh Fish Filets” do not list the unrefrigerated processing critical control points of “Washing”, “Gutting” (or “Gutting/Filleting”), and “Packing/Weighing.” FDA recommends that during processing (e.g., butchering, cleaning, brining, salting, smoking, drying, fermenting, pickling, mixing, fermenting, stuffing, packing, labeling, and staging) of scombrotoxin-forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:
 
i)      The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
 
OR
 
ii)    The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C)
 
Please Note: You may want to list a single “Processing” critical control point that includes all unrefrigerated processing steps from the time the first fish in a marked batch is removed from ice prior to the washing step until the last finished product from that marked batch is packed in ice at the packing/weighing step.
 
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 plans for “Fresh Whole Fish”, “Fresh Gutted Fish Beheaded or Not”, and “Fresh Fish Filets” list critical limits, at the following critical control points, that are not adequate to control the food safety hazard of scombrotoxin formation:
 
a)    At the “Receiving Fish at the Plant” critical control point, your HACCP plans for “Fresh Whole Fish”, “Fresh Gutted Fish Beheaded or Not”, and “Fresh Fish Filets”:
 
i)    List critical limits that do not include a maximum value(s) for the internal temperature of a representative number of the largest fish in the lot, at the time of off-loading from the harvest vessel by the processor, to ensure that appropriate harvesting and onboard practices were used onboard the harvest vessel. FDA recommends that:
 
o   For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death:
 
The internal temperature should be 40°F (4.4°C) or below;
 
OR
 
o   For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:
 
The internal temperature should be 50°F (10°C) or below;
 
OR
 
o   For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death:
 
The internal temperature should be 60°F (15.6°C) or below;
 
OR
 
o   For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death:
 
The internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel. Chilling of the fish should begin on the harvest vessel regardless of the time from death until off-loading from the vessel by the processor, unless the environmental conditions (e.g. air and water temperatures) are below 40°F (4.4°C) from the time of death until off-loading from the vessel by the processor;
 
OR
 
o   For fish held iced or refrigerated (not frozen) onboard the vessel:
 
Elapsed time from death and internal temperatures at the time of off-loading from the vessel by the processor should be consistent with cooling curves that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.
 
ii) List a critical limit of “Temperature/time: 4.4°C/15 minutes” that, does not ensure that appropriate transportation-handling practices were used during transit from the harvest vessel to the processing plant. FDA recommends that:
 
o   For fish delivered refrigerated (not frozen):
 
All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;
 
OR
 
o   For fish delivered under ice:
 
Fish are completely surrounded by ice at the time of delivery;
 
OR
 
o   For fish delivered under ice on an open-bed truck:
 
Fish are stored completely surrounded by ice;
 
AND
 
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
 
OR
 
o   For fish delivered under chemical cooling media such as gel packs:
 
There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit;
 
AND
 
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
 
OR
 
o   For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy):
 
Time of transit does not exceed 4 hours;
 
AND
 
Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C)
 
In addition, your corrective action plan should include the corrective actions you will take when a deviation from the critical limit for internal temperature occurs.
 
iii) List a critical limit of “Sensorial characteristics changed” that does not include a maximum or minimum value for sensory examination. FDA recommends that sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample.
 
FDA recommends that you monitor the amount of decomposition in a lot at receiving by examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish). Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species. All fish within a lot should have a similar history of harvest. In addition, your corrective action plan should include the corrective actions you will take when a deviation from the critical limit for decomposition occurs.
 
b.    At the “Beheading” and “Grading” critical control points, your HACCP plans for “Fresh Gutted Fish Beheaded or Not” and “Fresh Fish Filets” do not include maximum values for cumulative time and temperature of exposure. FDA recommends that during processing (e.g., butchering, cleaning, brining, salting, smoking, drying, fermenting, pickling, mixing, fermenting, stuffing, packing, labeling, and staging) of scombrotoxin-forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:
 
(i)    The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
 
OR
 
(ii) The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C)
 
Please Note: You may want to list a single “Processing” critical control point that includes all unrefrigerated processing step from the time the first fish in a marked batch is removed from ice prior to the washing step until the last finished product from that marked batch is packed in ice at the packing/weighing step.

4)     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 HACCP plans for “Fresh Whole Fish”, “Fresh Gutted Fish Beheaded or Not”, and “Fresh Fish Filets” list a monitoring procedure at the “Receiving Fish at the Plant” critical control point that are not adequate to control scombrotoxin (histamine) formation.
 
Your HACCP plans indicate that “(b)(4)” for “determining histamine level.” FDA recommends that you monitor the histamine content in the scombrotoxin-forming fish flesh by testing a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot) in every lot of scombrotoxin-forming fish received. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species.
 
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 HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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.
 
In addition to the above referenced violations, we also have the following comment:
 
Your firm’s HACCP plan for Fresh Whole Fish does not list the unrefrigerated processing steps of Washing, Grading, Packing, and Weighing as critical control point(s). Please provide an explanation as to why you chose not to include these processing steps as critical control point(s) in your HACCP plan for Fresh Whole Fish and describe how long it takes to process a batch of whole fish from the time the first fish in a marked batch is removed from ice prior to the washing step until the last fish in that marked batch is packed in ice at the packing/weighing step.
 
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. A re-inspection is 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 consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Aleta T. Flores, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: aleta.flores@fda.hhs.gov. Please reference #CMS 491504 on any submissions and within the subject line of any emails to us. You may also contact Aleta T. Flores via email if you have any questions about this letter. 
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition