Inspections, Compliance, Enforcement, and Criminal Investigations
Tyson Foods, Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
November 13, 2009
RETURN RECEIPT REQUESTED
John H. Tyson, Chairman of the Board, and
Leland E. Tollett, Interim President and CEO
Tyson Foods, Inc.
2200 Don Tyson Parkway
Springdale, AR 72762-6999
We inspected your seafood soup manufacturing facility, located at 7401 Will Rogers Blvd., Fort Worth, TX 76140-6019 from August 19-21, 2009. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and 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 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 seafood soups and sauces are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violation is as follows:
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 HACCP plan for "FDA Seafood Soups and Sauces" does not list the food safety hazard of pathogen growth and toxin formation, specifically the potential for Clostridium botulinum toxin formation.
Pathogen growth and toxin formation is a reasonably likely hazard for products packaged in oxygen impermeable films that are held under refrigerated conditions for extended time periods due to the potential for time/temperature abuse. Our investigators observed shrimp and crab meat thawing in your firm's (b)(4) Storage cooler at temperatures between 40-55°F for approximately 18 hours, in preparation for manufacturing your firm's Seafood Gumbo. Consequently, in order to address the hazard of pathogen growth and potential toxin formation, we suggest that your revised HACCP plan include a critical control point (CCP) for the refrigerated storage/thawing step. We additionally suggest that products be continuously maintained at or below 40°F in order to control pathogen growth and toxin formation during these extended time periods when the products are held under refrigerated conditions.
We received your September 9, 2009, e-mailed response letter in which you indicate your firm has discarded crab meat and shrimp products that were observed and measured during the inspection. Additionally, you note that your firm has implemented a new standard operating procedure for the thawing step to control the hazard of pathogen growth and toxin formation during this processing step and that based on this revised procedure, you have determined that this hazard is not likely to occur and that a CCP in your HACCP plan is not necessary. Your correction is insufficient in that new standard operating procedures cannot be used in lieu of HACCP controls in a HACCP plan. Pathogen growth and potential toxin formulation is a hazard reasonably likely to occur in the absence of control, consequently, the hazard needs to be addressed in your HACCP plan to ensure implementation of adequate critical limits, monitoring procedures, recordkeeping, etc.
Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure or injunction. 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 this violation. 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, you should explain the reason for your delay and state when you will correct the violation.
This letter may not list all the violations 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 Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Sherrie L. Krolczyk, Compliance Officer at the letterhead address. If you have questions regarding any issues in this letter, please contact Sherrie L. Krolczyk at 214-2535312.
Reynaldo R. Rodriguez, Jr.
Dallas District Director