Inspections, Compliance, Enforcement, and Criminal Investigations
National Federation Of Fisheries Co-Operatives 1/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD
JAN 6, 2011
VIA OVERNIGHT MAIL
National Federation of Fisheries Co-Operatives
Republic of South Korea
In October 2010, you submitted a copy of your firm’s HACCP plan for your anchovy product to the U.S. Food and Drug Administration (FDA), following our request. This request by FDA for your HACCP plan was the result of a detention of an entry, (b)(4) that was a product described as “Dried Anchovies”. We have conducted an assessment of that plan to determine your firm’s compliance with the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). Upon further review of that HACCP plan we find that your firm is in serious violation of the Federal Food, Drug, and Cosmetic Act (the Act).
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 Act [21 USC 342(a)(4)]. Accordingly, your firm’s anchovy products are adulterated in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
You may find the Act, the Seafood HACCP regulation and the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition through links in FDA’s home page at www.fda.gov.
We note the following deviations with respect to the Seafood HACCP regulation:
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, the HACCP plan provided by your firm for your anchovies does not list the food safety hazard of scombrotoxin (histamine) formation. Scombrotoxin (histamine) development is reasonably likely when scombroid species, such as anchovies, are exposed to time and temperature abuse. Please be advised that in addition to control of time and temperature at receipt and during any processing and storage of the fish where time/temperature abuse is reasonably likely to result in histamine formation, primary processors receiving the anchovies directly from the harvest vessels, are responsible for controls that address the handling conditions of the anchovies on board the harvest vessels as part of the receiving controls.
In addition, (b)(4) are referenced in your HACCP plan and some products are described as ready-to-eat; however, there is no information provided in the plan or hazard analysis to indicate which (b)(4) are to be controlled and how your firm intends to implement any necessary controls. We note that the entry we detained was listed as a “dried anchovy” product. This implies some type of drying process. There is no reference to any drying process in either your hazard analysis or in your HACCP plan. When conducted, the drying process will likely pose a risk for both histamine development and pathogens. Moreover, any anchovies that are dried or further processed without evisceration would pose a food safety hazard specifically for Clostridium botulinum growth and toxin formation during the drying process, due to the fact that the fish are handled when not completely eviscerated. Please keep in mind that FDA recommends that larger fish, such as those 5 inches or more in length, be completely eviscerated prior to further processing (i.e., prior to drying, salting, etc).
Additionally, when products are packaged in oxygen impermeable materials and/ or are vacuum packaged or packaged under modified atmosphere conditions (i.e., reduced oxygen,) Clostridium botulinum growth and toxin formation is a potential hazard due to the lack of any oxygen transfer in to the packages. Your HACCP plan references both frozen and refrigerated conditions.
• When intended to be held frozen, FDA recommends labeling on each package to indicate “Keep frozen, thaw under refrigeration immediately before use”, or similar statements to indicate that thawing is to be conducted under refrigerated conditions.
• When intended to be held under refrigerated conditions, Clostridium botulinum continues as a hazard during all subsequent storage and handling (i.e. following packaging). FDA recommends a secondary barrier to refrigeration, such as drying, salting, pickling, etc. to control toxin formation. Alternatively, when not controlled via a processing procedure, FDA recommends the use of time/temperature indicators on each package to alert the end user to any time/temperature abuse of each individual package.
2. 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 plan for your anchovies lists a monitoring procedure and frequency at the Storage critical control point that is not adequate to control (b)(4) (and scombrotoxin (histamine) formation) in products intended to be held under refrigerated conditions. Specifically, your HACCP plan lists a monitoring procedure/frequency at the storage critical control point as (b)(4)
For additional information regarding the hazard of pathogen growth and potential toxin formation, please refer to Chapters 12, 13, 14 and 15 in the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition. For additional information regarding scombrotoxin (histamine) development, please refer to chapter 7.
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (21 CFR Part 110) and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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. This alert can be found on FDA’s web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html.
You should respond in writing within thirty (30) 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, such as a copy of your revised HACCP plan; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration 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 by phone at (301) 436- 1424 or by email at: Mildred.Benjamin@fda.hhs.gov
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition