Inspections, Compliance, Enforcement, and Criminal Investigations
Chiyoda Sushi New York, Inc. 8/16/05
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
August 16, 2005
RETURN RECEIPT REQUESTED
Etsuji Ito, President
Chiyoda Sushi New York, Inc.
42-25C Vernon Boulevard
Long Island City, NY 11101
Dear Mr. Ito:
On March 14, 2005 through March 18, 2005, we inspected your seafood processing facility, located at 42-25C Vernon Boulevard, Long Island City, New York. We collected two samples during this inspection and received the laboratory analyses on March 18 and April 4, 2005, respectively. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and from the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 this part, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your raw ready-to-eat Harnachi Nigiri Sushi is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.
Your significant deviations were 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 for each kind of fish and fishery product you process and have and implement a HACCP plan for each of these food safety hazards to comply with 21 CFR 123.6. The HAACP plan must list 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 raw ready-to-eat Hamachi Nigiri Sushi does not list the food safety hazard of Clostridium botulinum toxin formation. Your firm receives and stores refrigerated vacuum packaged raw yellowtail, which is associated with this food safety hazard.
• However, your firm's HACCP plan for raw ready-to-eat Hamachi Nigiri Sushi does not list the food safety hazards of pathogen growth and toxin formation, which are reasonably likely to occur in your sushi product.
Pathogen growth and toxin formation, including Clostridium botulinum toxin formation, are hazards that may be reasonably likely to occur in your sushi product if exposed to time/temperature abuse during transit and cold storage. For reduced-oxygen packaged products in which refrigeration is the sole barrier to outgrowth of nonproteolytic Clostridium botulinum, and the spores have not been destroyed (e.g. vacuum-packaged raw fish), FDA recommends that the temperature be maintained at 38° F (3.3° C) or below from packing to consumption. To ensure that time/temperature abuse does not occur during transport prior to your receipt, FDA recommends either monitoring 1) the internal temperature of the fishery product or the ambient temperature within the carrier continuously throughout transportation or 2) visually inspecting for the adequacy of ice or cooling medium at the time of delivery.
Once you have identified the hazards of Clostridium botulinum, and pathogen growth and toxin formation in your HACCP plan, you must list critical control points (i.e., receiving, refrigerated storage via continuous temperature monitoring, checking TTI changes prior to opening vacuum-packaged raw fish, etc.) to comply with 21 CFR 123.6(c)(2), and also establish and list appropriate critical limits (21 CFR 123.6(c)(3)), monitoring procedures and frequencies (21 CFR 123.6(c)(4)), corrective actions (21 CFR 123.6(c)(5)), verification procedures and frequencies (21 CFR 123.6(c)(6)) and recordkeeping activities (21 CFR 123.6(c)(7)) to control these hazards. You may consider referring to Chapters 12 and 13 of the FDA Fish &Fisheries Products Hazards and Controls Guidance. Third Edition. June 2001 for information on how to control the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum formation, in your fishery products.
In addition to controlling pathogen growth and toxin formation in the ready-to-eat fish, your HACCP plan must include controls for ingredients including cooked rice, which are subject to significant handling. On March 14, 2005, FDA observed cooked rice exposed to potential time/temperature abuse conditions. Pathogen growth and toxin formation are reasonably likely to occur in your sushi products in the absence of time/temperature controls during processing and refrigerated storage.
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 for Hamachi Nigiri Sushi lists a critical limit of "Internal fish temperature must not be higher than (b)(4) at the receiving critical control point that is not adequate to control scombrotoxin formation. An appropriate monitoring procedure/frequency may be to require that each incoming lot of product be accompanied by continuous monitoring records that show temperatures throughout transit. Alternatively, your firm may consider receiving vacuum packaged raw fish which is adequately packed on ice, whereby an appropriate monitoring procedure may be to perform a visual check of the adequacy of ice or chemical cooling media to ensure that fish is completely surrounded and covered with ice upon receipt.
• However, your HACCP plan for Hamachi Nigiri Sushi lists a critical limit of "Storage temp" at the raw material and finished product cold storage critical control points that is not adequate to control scombrotoxin formation. FDA recommends that you maintain cooler temperatures at or below 38° F. Intermittent monitoring of ambient or internal temperatures does not supply the necessary safety assurance that ready-to-eat or refrigerated vacuum-packed products have been consistently stored under safe conditions. FDA recommends that a continuous monitoring device be used to monitor temperatures instead. Alternatively, you may consider storing your vacuum packaged raw fish and/or finished product sushi rolls on ice; an appropriate monitoring procedure in this case would be to perform a visual check of the adequacy of ice or chemical cooling media, to ensure that product is completely surrounded and covered with ice during refrigerated storage.
3. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for raw ready-to-eat Hamachi Nigiri Sushi at the raw material and finished product storage critical control points is not appropriate to control histamine formation. Your corrective action should address how a product deviation has been corrected, how the cause of the deviation has been corrected, and whether any affected lots need to be held before distribution to evaluate the safety of product after time/temperature abuse.
4. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However:
(A.) Your firm did not adequately monitor the prevention of cross-contamination from insanitary objects to food as required by 21 CFR 123.11(b)(3) with sufficient frequency to ensure control as evidenced by the below observations:
• Two workers were observed on 3/14/05 handling boxes of wasabi, then handling raw ready-to-eat sushi without changing gloves or sanitizing hands;
• A worker was observed on 3/14/05 removing a box of wasabi from the surface of a cutting board then continuing to cut tuna on the same cutting board without sanitizing;
• A worker was observed on 3/15/05 cutting frozen salmon without-using any hand sanitation;
• At 6:50 am on 3/17/05, a worker was observed cutting tuna and packing sushi without sanitizing hands;
• On 3/17/05, a worker also observed packing various raw ready-to-eat products while wearing a glove only on the left hand. The right hand was unprotected; and
• Throughout the inspection, unclean processing utensils and equipment were observed stacked on tables during the processing of raw ready-to-eat sushi. After being washed, the utensils and processing equipment were observed stacked on racks, tables or on shelves under tables during processing.
(B) Your firm did not adequately monitor the conditions and cleanliness of food contact surfaces as required by 21 CFR 123.11(b)(2) with sufficient frequency to ensure control as evidenced by the following observations:
• Workers were observed cutting various ready-to-eat vegetables on 3/14/05 including: carrots, gobo and lotus root on dirty/worn encrusted cutting boards;
• On 3/15/05, the (b)(4) was disassembled and was already cleaned, yet rice residue was observed inside of the machine;
• Cutting boards in the sushi processing room were gouged and had visible product residue in the gouges. Raw ready-to-eat sushi came in direct contact with these boards during processing;
• Knives and cleavers used throughout the facility were observed to have wooden handles, making cleaning difficult. Employees were observed using these knives/cleavers in direct contact with raw ready-to-eat products; and
• At 8: 10 pm 011 3/15/05, the (b)(4) was observed with pieces of rice residue inside prior to use for forming sushi rice at 8:31 pm.
(C.) Your firm did not adequately monitor the control of employee heath conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces, as required by 21 CFR 123.11(b)(7) with sufficient frequency to ensure control as evidenced by the following observation:
• At 6:10 am on 3/15/05, a worker, not wearing any gloves, was observed to have a cut/bloody finger wrapped in a paper towel while handling packing material in the sushi processing room.
5. You must maintain sanitation control records, that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11 (c). However, your firm did not maintain sanitation monitoring records for: the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests required for the processing of raw ready to eat Hamachi Nigiri Sushi.
Based on its review on March 15, 2005, FDA observed missing and incomplete sanitation monitoring records. Specifically, sanitation control records for sushi processing on the dates of March 8, 2005, and February 11, 14, 22-24, 2005, were incomplete in that they only included the pre-operational portion of the sanitation monitoring performed on those days.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining 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 (21 CFR part 123) 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Ms. Aveta at (718) 662-5576..
Jerome G. Woyshner