- TOV "Universal Fish Company"
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
NOV 7, 2016
VIA EXPRESS DELIVERY
Ms. Yana Babenko
Head of Production and Quality Departments
TOV "Universal Fish Company"
DzerzhynskyStreet 55, Kupyansk
Kharkivska Oblast, Ukraine 63700
Reference # 506838
Dear Ms. Babenko:
On June 14, 2016, a representative of the United States Food and Drug Administration (FDA) obtained a copy of your firm's HACCP plan entitled "Herring in Oil" (copy enclosed) via email from an importer located in New York, OLMA XX, found to be importing fishery products from your firm. Our review of your HACCP plan revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), as further explained in this letter.
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 herring products covered by your HACCP plan entitled "Herring in Oil" 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 links in FDA's home page at www.fda.gov.
We note the following significant deviations:
1. You must conduct or have conducted a hazard analysis for each kind of fish and fishery product produced 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 HACCP plan entitled "Herring in Oil" does not list the food safety hazards of Clostridium botulinum growth and toxin formation, scombrotoxin (histamine) formation and allergens. Although your HACCP plan identifies the hazard of pathogenic microorganism including for example, Listeria monocytogenes and Salmonella, you have not identified the specific pathogen of concern, Clostridium botulinum, which is reasonably likely for products such as your products that are packaged in oxygen impermeable non-flexible pouches. Also, as a scombroid species of fish, herring poses a hazard for scombrotoxin (histamine) formation as a result of time and temperature abuse. Additionally, your firm has potential allergenic substances listed in the ingredient statements for some of your herring products which pose a hazard that should be addressed.
Once these hazards are identified in your HACCP plan, your firm should evaluate the need for any additional critical control points along with corresponding critical limits, monitoring procedures, etc., to ensure adequate control of these hazards. For additional information related to the hazard of Clostridium botulinum growth and toxin formation, please refer to Chapter 13 of the Hazards Guide. For additional information related to the hazard of scombrotoxin (histamine) formation, please refer to Chapter 7 of the Hazards Guide and for information related to the hazard of allergens, please refer to Chapter 19 of the Hazards Guide.
2. 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 HACCP plan entitled "Herring in Oil" lists critical limits, at the "01.2 Storage" and "01.13 Storage" critical control points that are not adequate to control the food safety hazard of pathogenic microorganisms. Specifically, your HACCP plan lists a critical limit of "(b)(4)", however FDA recommends an ambient air temperature of 4.4°C (40°F) or below as the critical limit during refrigerated storage. Additionally, FDA recommends that firms use equipment capable of continuously monitoring and recording the ambient air temperature of the cooler with a visual check of the recorded data at least once per day.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). Corrective actions must address both the disposition of the affected products and address the cause of the deviation. However, your corrective action plans listed in your HACCP plan entitled "Herring in Oil" list inadequate corrective actions at the "(b)(4)" and "(b)(4)" critical control points to address the hazards of pathogen growth and toxin formation and scombrotoxin (histamine) formation. FDA recommends the corrective actions include holding the affected product (i.e., chilled) and evaluating the level of safety, based on the total cumulative time and temperature exposures at unrefrigerated/un-chilled conditions, including exposures at unrefrigerated/un-chilled conditions during processing. FDA also recommends the listed corrective actions address correcting the cause of the deviation by making repairs or adjustments to the cooler.
You should respond in writing within fifteen (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, 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.
Additionally, 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 herring in oil 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.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 11 0). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Doriliz De Leon, Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Doriliz De Leon via email at Doriliz.DeLeon@fda.hhs.gov. Please reference CMS# 506838 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition