Inspections, Compliance, Enforcement, and Criminal Investigations
Morgan Mill Trout Farm 02-Nov-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309
November 2, 2005
VIA FEDERAL EXPRESS
Jonathan D. Orr, Owner
Morgan Mill Trout Farm
8 Good Neighbor Lane
Brevard, NC 28712
Dear Mr. Orr:
We inspected your seafood processing facility located at 8 Good Neighbor Lane, Brevard, North Carolina on June 8 and 9, 2005. 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 Part 123). 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 to 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 products, including fresh and hot-smoked trout, and smoked trout dip, 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 regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov. In addition, during the inspection our investigators collected copies of your labels for hot-smoked trout and smoked trout dip; we have reviewed the labels and found that your Morgan Mill Smoked Mountain Trout HICKORY is misbranded within the meaning of Section 403 of the Act.
Your significant violations of the seafood HACCP regulation are as follows:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish or fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for fresh refrigerated trout to control the food safety hazard of unsafe aquaculture drugs.
2. Your HACCP plan must, at a minimum, list 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 id ' ed food safety hazard." Your firm's HACCP plan for hot-smoked trout lists [redacted] CUP SALT PER [redacted] GALLONS OF WATER" as the critical limit at the "BRINE" critical control point to control the hazard of C. botulinum toxin production in the finished product. FDA recommends not less than 3.5% water phase salt for controlling C botulinum toxin formation in refrigerated vacuum packed smoked fish when nitrates/nitrites are not added controls or are added at levels less an 100 ppm (See Fish and Fisheries Products Hazards & Controls Guidance, third edition, page 177). Your salt solution does not appear to contain any nitrates/nitrites and in accordance with 21 CFR Sections 172.170 and 172.175 these are not permitted in trout products. However, FDA believes that other parameters in addition to brine concentration are critical in assuring that the fish achieves a minimum water phase salt level of 3.5% during the brining step in order to control the hazard of C. botulinum toxin production in the finished product. These include the minimum time the fish needs to soak in the brine solution, the maximum fish thickness, and/or the minimum ratio of brine to fish. These parameters should be based on a sound scientific study. FDA recommends that you keep this study on a file at your plant as part of your verification procedures for this product/HACCP plan
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4) . However, your firm did not follow the monitoring procedure of obtaining a "Copy of Certificate" at the "RECEIVING" critical control point to control the hazard of aquaculture drugs listed in your HACCP plan for smoked trout.
4. You must conduct or have Conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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, you firm's HACCP plan for smoked trout dip does not list the food safety hazards of pathogen growth & toxin formation, and/or Clostridium botulinum toxin formation at the "PACKAGING" and "REFRIGERATTON" critical control points.
In addition, your HACCP plan for hot-smoked trout does not list the food safety hazard of pathogen growth & toxin formation at the "TEMP. OF COOLERS" critical control point.
5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections' set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for: (1) safety of the water that conies into contact with food or food contact surfaces, or is used in the manufacture of ice; (2) proper labeling, storage, and use of toxic compounds; and (3) exclusion of pests from the food plant.
Your significant food labeling violation is as follows:
Additionally, during the inspection, our investigators collected copies of your labels for hot-smoked trout, and smoked trout dip; we reviewed the labels and found that your Morgan Mill Smoked Mountain Trout HICKORY product is misbranded within the meaning of Section 403(ix2) of the Act [21 U.S.C. 343(i)(2)] in that it is fabricated from two or more ingredients, but the label fails to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(1). Specifically, the ingredient "Old Bay Seasoning" is a multi-component ingredient, which itself contains two or more ingredients; however, the ingredient statement does not include the sub-components of each of the ingredients which make up these products [21 CFR 101.4(a)(1) and 101.4(b)(2)] . This requirement may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the parenthesis; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
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, 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 violations.
We acknowledge receipt on or about October 7, 2005 of your written response to the Form FDA 483 (Inspectional Observations) issued by our investigator at the conclusion of his inspection. You may refer to it in your response to this letter.
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, and the food labeling regulations. You also have a responsibility to use procedures to prevent farther violations of the Act and all applicable regulations.
Please be aware that the temperature probe in your smoker should be positioned in the "cold spot" of the smoker. FDA recommends determining this placement by conducting a heat distribution study of your smoker. The placement of the probe in the "cold spot" assures that all fish portions receive an adequate heat treatment during the smoking process to control pathogens.
We also note that your firm makes smoked trout dip in 8 oz and 4.5 lb container sizes. Since these products are fabricated from two or more ingredients, in accordance with Section 403(i)(2) of the Act the labels must bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(1).
Furthermore, we note that the nutrition labeling for your Morgan Mill Smoked Mountain Trout HICKORY product contains conflicting information regarding the levels of Vitamin A and C. If the product is eligible for a declaration of 4% of the Daily Value, these nutrients should not be included in the "Not a significant source . .." statement.
Please send your reply to the Food and Drug Administration, Attention: Carlos A. Bonnin, Compliance Officer, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issues in this letter, please contact Mr. Bonnin at 404-253-1277.
Mary H. Woleske, Director