Inspections, Compliance, Enforcement, and Criminal Investigations
Riverfront Fish Market 31-Jul-07
Department of Health and Human Services
Public Health Service
July 31, 2007
RETURN RECEIPT REQUESTED
Mr. William O. Prince, Owner
and Mrs. Patsy Y. Prince, Owner
Riverfront Fish Market
135 Cook Road
Biscoe, Arkansas 72017
Dear Mr. and Mrs. Prince:
We inspected your roe processing facility, located at 1211 Riverfront Road,Biscoe, Arkansas on January 18, 19, and February 5, 2007. 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 (21CFR Part 123), the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110), and the Food Labeling Regulations (21 CFR Part 101). You may find the Act, the seafood HACCP and food labeling regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Seafood HACCP violations
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 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, Sturgeon roe, and Grinnell roe products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Your significant violations 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 and have and implement a written 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 Paddlefish roe and Sturgeon roe does not list the food safety hazards of pathogen growth and toxin formation at the Receiving critical control point (CCP).
Once you have identified the food safety hazard of pathogen growth and toxin formation in your HACCP plan, you must take steps to control this hazard at the CCPs(e.g., identify appropriate critical limits, monitoring activities, recordkeeping, etc.). For instance, if your firm receives iced fish and/or iced roe from local fishermen, and checks for the presence of ice upon receipt, your HACCP plan should reflect this monitoring activity and you must maintain applicable records to document such monitoring. FDA recommends making visual observations upon receipt of the adequacy of ice or cooling median in a sufficient number of containers to represent all of the product.
2. You must have and implement a written HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). "Critical Limit" is defined at 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 HACCP plan for Paddlefish roe and Sturgeon roe does not list a critical limit at the Storage CCP that is adequate to control pathogen growth and toxin formation, such as Clostridium botulinum toxin formation, in your refrigerated finished product.
Specifically, you do not list an appropriate critical limit (e.g., 40° Fahrenheit (F)) at the Storage CCP to control this hazard. You maintain one cooler at approximately [redacted]F and one cooler at [redacted]F; however, there is no documentation of temperatures for the [redacted]F cooler where the roe is stored before and during processing.
In addition, we note that your HACCP plan indicates that you monitor cooler temperatures for refrigerated product four times daily. This monitoring frequency is not adequate to ensure that intermittent temperature fluctuations do not occur. During refrigerated (not frozen) storage of in-process or finished product roe, FDA recommends use of either a digital time/temperature data logger to continuously monitor ambient cooler temperature, or at least two visual observations per day of the adequacy of ice surrounding refrigerated product to ensure that products are not exposed to ambient temperatures above 40F. For more information on controlling pathogen growth and toxin formation,and specifically, Clostridium botulinum toxin formation, please refer to Chapters 12 and 13 of the Fish and Fisheries Products Hazards and Controls Guidance: Third edition.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with current good manufacturing practices specified in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, during the inspection, the investigator noted that your firm is not monitoring and maintaining sanitation conditions as they relate to seafood HACCP and ensuring conformance to 21 CFR Part 110. The following conditions were observed during the inspection:
Safety of Water that Comes in Contact with Food [21 CFR 123.11(b)(1)]:
Water used in processing and in the manufacture of ice is supplied from a well that has not been tested for safety.
Condition and Cleanliness of Food Contact Surfaces [21 CFR 123.11(b)(2)]:
No backflow device was on a hose that was used in the processing room.
The combination of water and bleach solution is not tested for strength. This solution is used to sanitize all food contact surfaces, equipment used in processing, and the floors of the processing area.
Prevention of cross-contamination from insanitary objects to food, food packaging materials, and other food contact surfaces [21 CFR 123.11(b)(3)]:
You were observed to process roe product after touching insanitary objects (e.g., processing room door) without, washing and sanitizing hands, or wearing gloves.
Maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 123.11(b)(4)]:
There is no hand washing sink in or near the toilet facility.
There is no sink in the processing area designated as a hand washing area
Hand soap and towels were not observed in the processing area.
4. 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, condition and cleanliness of food contact surfaces, and maintenance of hand washing, hand sanitizing, and toilet facilities required for the processing of ready to eat paddlefish and sturgeon roe.
The following items were not documented:
There is no certificate of testing for the well water used in processing the roe.
The sanitizer strength that is used to wash and sanitize equipment is not checked and recorded.
In addition to the aforesaid deviations, your 1/2 lb, 1 lb, and 3 lb containers of Paddlefish, Sturgeon, and Grinnell roe are misbranded within the meaning of sections 403(e)(1) and (2) [21 U.S.C. § 343(e)(1) and (2)] and 403(i)(1) and (2)[21 U.S.C. § 343(i)(1) and (2)] of the Act for failing to bear required labeling statements. Specifically, your finished products of Paddlefish, Sturgeon and Grinnell roe fail to bear labels containing
the name and place of business of the manufacturer, packer, or distributor, as required by section 403(e)(1) [21 U.S.C. § 343(e)(1)] and 21 CFR 101.5(a);
a net quantity of contents statement, as required by section 403(e)(2) [21 U.S.C. § 343(e)(2)] and 21 CFR 101.105(a);
the common or usual name of the food, as required by section 403(i)(1)[21 U.S.C. § 343(i)(1)] and 21 CFR 101.3(a); and
the common or usual name of each ingredient in the ingredient list, as required by section 403(i)(2) [21 U.S.C. § 343(i)(2)] and 21 CFR 101.4(a)(1).
Your products also fail to meet the labeling requirements of section 403(w) of the Act [21 U.S.C. § 343(w)] because the fish ingredients are not identified as required by the Food Allergen Labeling and Consumer Protection Act (FALCPA). We recognize that this violation will be addressed when you add an ingredient list to the label to address the 403(i)(2) violation as long as you list the fish ingredients by their market names identified in the seafood list found at http://www.cfsan.fda.gov/~frf/seaintro.html. We note that "Grinnell" is not the market name for a fish according to the seafood list.
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.
You should 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 violations. You should include in your response documentation such as HACCP and verification records, and samples of corrected product labeling, 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 any remaining violations.
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) the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the Food Labeling Regulations (21CFR Part 101). 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5220.
Virginia R. Connelly
Acting Dallas District Director