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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kato Suisan Co. Ltd. 4/19/13


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

Public Health Service
Food and Drug Administration
5100 Paint Branch Pkwy.
College Park, MD 20740 

APR 19, 2013

VIA EXPRESS DELIVERY                                                                                 
Mr. Keiichi Matsumoto
Plant Manager
Kato Suisan Co., Ltd
1-82 Ahun Mashike
Mashikegun, Hokkaido
Japan 077-0131
Reference No. 394487
Dear Mr. Matsumoto:
On November 19 and 20, 2012, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Kato Suisan Co., Ltd., located at 1-82 Ahun Mashike, Mashikegun, Hokkaido, Japan 077-0131. 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 received your firm’s response to the FDA-483 on December 17, 2012. Our review of the documentation determined that the response was not adequate, as further described 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 frozen salted herring roe is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. 
Furthermore, our inspection revealed that your frozen salted herring roe is adulterated within the meaning of Section 402(a)(2)(C) of the Act [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive.
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazard 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.
Your significant violations are as follows:
Seafood HACCP
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 revised HACCP plan for frozen salted herring roe provided with your December 17th  response does not list the following food safety hazards:
  • Undeclared allergens. Fish is a major food allergen and major food allergens are a food safety hazard. HACCP plans must include appropriate controls to assure that allergens are declared and that the finished products are correctly labeled.
  • Clostridium botulinum growth and toxin formation. During processing, the product is stored in large sealed containers with (b)(4) of product in each container and is held under refrigerated conditions (i.e., not frozen). This practice creates a potential for Clostridium botulinum growth and toxin formation unless controls are in place, such as formulation controls related to water activity (Aw) or water-phase salt (WPS). 
Additionally, your finished frozen salted herring roe is packaged in sealed plastic bags and shipped frozen. In order to ensure the finished products are properly handled by the end users, your firm should include handling instructions on each package that state “Keep Frozen: Important Keep Frozen and Thaw Under Refrigeration Immediately Before Use” to control pathogen growth and potential toxin formation, including the potential for Clostridium botulinum growth and toxin formation. Your firm should include a critical control point in your HACCP plan to monitor for the presence of the handling instructions on each bag.
  1. 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 revised HACCP plan for frozen salted herring roe provided with your December 17th response does not list critical limits associated with temperatures or time at the “(b)(4)” critical control point to control pathogen growth. FDA recommends that temperatures be maintained below 40°F or, when temperatures are not controlled, that exposure times to non-refrigerated conditions be limited.
When temperatures are not controlled to 40°F or below, cumulative exposure times at non-refrigerated conditions throughout all processing steps need to be taken into consideration to reduce time and temperature abuse. Time and temperature abuse occurs when a product is allowed to remain at temperatures favorable to pathogenic bacteria growth for sufficient time to result in unsafe levels of pathogenic bacteria or toxins in a product.
In addition, since this processing step involves (b)(4), which impacts product safety and your end product Aw and WPS, your firm should include critical limits for the soaking time necessary to achieve the Aw or WPS of the roe. FDA recommends that refrigerated seafood packaged in reduced oxygen containers achieve a Aw of less than 0.97 or a WPS concentration of 5% or more.
  1. 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 firm’s revised HACCP plan for frozen salted herring roe provided with your December 17th response does not include critical control points related to your processing steps that are necessary to control pathogen growth.
Your firm’s hazard analysis and our investigator’s observations identified that your firm is conducting numerous processing steps such (b)(4). When conducted under unrefrigerated conditions, these steps will cumulatively pose a risk for the food safety hazard of pathogen growth as a result of time and temperature abuse. Consequently, your firm needs to assess the likelihood for pathogen growth based on the cumulative exposures to time and temperature abuse, and include appropriate critical control points with adequate corresponding critical limits and monitoring procedures. Use of antimicrobial agents such as (b)(4) will not provide a safety assurance equivalent to time and temperature controls.
Additionally, your hazard analysis identified the use of prerequisite programs to control identified food safety hazards. However, FDA regulations do not permit a firm to use prerequisite programs in lieu of HACCP plan controls. All food safety hazards must be addressed in a HACCP plan in accordance with 21 CFR Part 123.
Unapproved Food Additive Violation
  1. Your frozen salted herring roe is adulterated within the meaning of Section 402(a)(2)(C) of the Act because it bears or contains an unsafe food additive. Specifically, (b)(4) is used in bleaching the herring roe; however, (b)(4) is not approved as a food additive for this use in herring roe.  
As defined in section 201(s) of the Act [21 U.S.C. § 321(s)], the term "food additive" refers to any substance the intended use of which results in it becoming a component of any food, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use. Under section 409 of the Act (21 U.S.C. § 348), a food additive is unsafe unless a regulation is in effect that prescribes the conditions under which the additive may be safely used, and the additive and its use or intended use are in conformity with that regulation. There is no food additive regulation authorizing the use of (b)(4) in herring roe. While (b)(4) is GRAS per 21 CFR 184.1366 for use in herring, it is not identified as GRAS for use in herring roe.
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 and all applicable regulations, including the Seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation, such as a copy of any revised HACCP plans; 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 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. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/ialist.html
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 reinspection-related costs. A reinspection is one or more inspections 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs. You should consider providing your U.S. Agent with a copy of this letter.
Please send your reply to the U.S. Food and Drug Administration, Attention: Stuart A. Feldman, 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 Mr. Feldman by phone at (240) 402-3006 or by email at stuart.feldman@fda.hhs.gov.
Roberta F. Wagner
Office of Compliance
Center for Food Safety
    and Applied Nutrition