Inspections, Compliance, Enforcement, and Criminal Investigations
Unifish Canning S.A. 18-Jun-04
Department of Health and Human Services
Public Health Service
June 18, 2004
Mr. Adrian Rodriguez
Unifish Canning S.A.
Avenida Gran Bretana 825
Dear Mr. Rodriguez,
On March 4 & 5, 2004, we inspected your seafood canning processing facility, Unifish Canning S.A., located at Avenida Gran Bretaiia 825, Talcahuano, Chile. Upon evaluation of the documentation obtained during the inspection, we have found that your firm has serious deviations from the Seafood Hazard Analysis and Critical Control Points ("HACCP") regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), which could preclude entry of your products into the United States. Pursuant to 21 CFR 123.6(g), the 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 this part, renders the fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act"). Accordingly your Canned Mackerel in Brine in 300 x 407 cans is adulterated, in that the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links on FDA's home page at www.fda.gov.
The specific deviations we found are as follows:
(1) Pursuant to 21 CFR 123.6(a) your firm must conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish or fishery product processed by your firm. Subsequently, pursuant to 21 CFR 123.6(b) and (c)(2), you must have and implement a written HACCP plan that, at a minimum, lists the critical control points for each of the identified food safety hazards. 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."
Your firm's HACCP plan for Canned Jack Mackerel in Brine and Canned Jack Mackerel in Tomato Sauce, however, does not list the critical control point of "Harvest Vessel Offloading" for controlling the food safety hazard of histamine formation. By failing to monitor the internal temperature at the point of offloading the fish from the vessel, your firm is unable to provide assurances that the fish were held at an appropriate temperature. According to scientific research, the appropriate temperature at this point is at or below 4.4°C(40°F).
Your firm's HACCP plan also omits another critical control point. It appears that your firm receives raw material at its processing plant, and then pumps it into a holding tank with ice water until further processing. Your firm subsequently samples the fish for internal temperatures at +7°C every two hours, and +8°C after six hours. This holding step should be included as a critical control point in your HACCP plan to control histamine formation. Moreover, as indicated previously, we recommend holding the fish at an internal temperature of 4.4°C or below.
(2) Pursuant to 21 CFR 123.6(c)(3), your firm must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points. 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."
Your firm's HACCP plan for Canned Jack Mackerel in Brine and Canned Jack Mackerel in Tomato Sauce, however, lists a critical limit of "Fast - Cooling (<10°C, 6 hours post-capture) Holding at this temperature up to delivery" at the "Storage of raw material on board fisher ship" critical control point that is not adequate to control the food safety hazard of histamine formation. Scientific research indicates fish should be chilled to below 10°C within 6 hours after capture and then held at or below 4.4°C until processed.
(3) Moreover, your firm's HACCP plan lists a critical limit of "Fish temperature < 10°C (Delivery)" at the "Raw Material Reception in plant" critical control point that is not adequate to control the food safety hazard of histamine formation. As explained above, the adequate holding temperature should be 4.4°C or below.
(4) Pursuant to 21 CFR 123.6(c)(4), your firm must have a HACCP plan that, at a minimum, lists the procedures and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits. The procedure set forth in your firm's HACCP plan to monitor decomposition at the "Raw Material Reception in plant" critical control point, however, lists "Sensorial inspection on cooked sample" on "Every tank of ship," which is inadequate. FDA recommends sensory evaluation be performed on at least 118 fish in each lot (or entire lot for lots smaller than 118 fish). The fish should show no more than 2.5% decomposition (persistent and readily perceptible) in the sample.
In addition, at the same critical control point, your firm's HACCP plan lists a monitoring frequency that is not adequate to control the food safety hazard of histamine formation. Specifically, your firm's HACCP plan indicates a frequency of "every tank of ship." The frequency, however, should list the number of fish from which internal temperatures are recorded. For example, when receiving 10 tons of fish or more, measure a minimum of 1 fish per ton; when receiving less than 10 tons of fish, measure a minimum of 1 fish per 1000 pounds. Measure a minimum of 12 fish per lot, unless there are fewer than 12 fish in the lot, then measure all fish in the lot. Randomly select fish from throughout the lot. Please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 7 (Scombrotoxin (Histamine) Formation), found at www.cfsan.fda.gov/~comm/haccp4.html for specific guidance and control strategies.
Please respond in writing within six (6) weeks from receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. You should include in your response documentation such as a copy of your revised HACCP plan reflecting the changes you made, including five (5) days monitoring records after the corrections are made, and other useful information that will assist us in evaluating your corrections. If you cannot complete the correction before you respond, we expect that you will explain the reason for your delay and state when you will correct these deviations.
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, the Seafood HACCP regulation, the Good Manufacturing Practice regulation (21 CFR Part 110), and the Low Acid Can Foods Regulation (21 CFR 108.35 & 113). 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: Giselle Jordan, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Import Branch HFS-606, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Jordan at (301) 436-1576 or via e-mail at firstname.lastname@example.org.
Judith A. Gushee
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition