Inspections, Compliance, Enforcement, and Criminal Investigations
Byron Townsend 1/16/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Dr.
Cincinnati, OH 45237
VIA United Parcel Service
January 16, 2013
Bryon K. Townsend, Owner
266 May Hollow Branch Rd.
Tollesboro, KY 41189
WARNING LETTER CIN-DO 13-391433-10
Dear Mr. Townsend:
We inspected your seafood processing facility, located at 266 May Hollow Branch Rd., Tollesboro, KY on November 13 – 15, 2012. 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 (21 CFR 123). 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 paddlefish roe and meat 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 violations are as follows:
1. You must conduct 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 plans for paddlefish roe and paddlefish meat do not list the food safety hazard of allergens.
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 paddlefish roe does not list a critical limit at the processing (salting) critical control point to control pathogen growth and toxin formation, as well as, Clostridium botulinum (C. botulinum) toxin formation.
3. 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 paddlefish roe lists a monitoring procedure at the storage critical control point that is not adequate to control pathogen growth and toxin formation, as well as, C. botulinum toxin formation. Specifically, recording the temperature daily with a mercury dial thermometer is not adequate because intermittent temperature monitoring does not ensure that the paddlefish roe is held at a consistently safe temperature throughout storage. FDA recommends that cooler storage temperatures be monitored by some continuous monitoring method or that the product be stored surrounded by ice. In addition, if you choose to use a method where equipment continuously records the temperature of your cooler, FDA recommends that you visually check the monitoring records generated by the equipment at least once a day to ensure that your critical limit is not exceeded.
Furthermore, your firm’s HACCP plan for paddlefish roe lists a monitoring procedure at the processing (salting) critical control point that is not adequate because it does not include how the salt will be monitored or the frequency.
4. 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). However, the corrective action plan listed in your HACCP plan for paddlefish roe at the storage critical control point to control pathogen growth is not appropriate. Specifically, your corrective action plan does not assure that affected product does not enter commerce and the cause of the deviation is corrected.
Moreover, our inspection found that your paddlefish roe and paddlefish meat are not labeled in accordance with FDA’s Food Labeling regulations, 21 CFR Part 101, as such they can be deemed misbranded under Section 403 of the Act. You stated that paddlefish meat is distributed without any labeling or written labeling agreements and depending upon the customer, paddlefish roe is distributed without a listing of ingredients listed in order of predominance, responsible firm name and address, and/or statement of identity. A link to FDA’s Food Labeling Guide is included to assist you. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulations (21 CFR Part 123), the Current Good Manufacturing Practice regulations (21 CFR Part 110), and the Food Labeling regulations (21 CFR Part 101). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection. A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Reinspection costs include 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. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. Your response should outline the specific steps you have taken to correct these violations. Your response should include your revised HACCP plans and any 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 any remaining violations.
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164.
Paul J. Teitell