Inspections, Compliance, Enforcement, and Criminal Investigations
Bristol Seafood, Inc. 4/16/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 395464
UNITED PARCEL SERVICE
April 16, 2013
Mr. Darrell S. Pardy, President
Bristol Seafood Inc.
PO Box 486
Portland, ME 04112
Dear Mr. Pardy:
We inspected your seafood processing facility, located at 5 Portland Fish Pier, Portland, ME on February 25 through March 21, 2013. 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 refrigerated and frozen raw shucked scallops 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.
Your significant violation was as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 and (c)1 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) 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.
- You do not have a written HACCP plan to control the hazard of Clostridium botulinum for refrigerated raw scallops in metal cans, similar in design to paint cans, which are distributed packed on ice.
You incorrectly conclude in your hazard analysis that no hazards were identified as pertinent to any of your processing steps. In a March 21, 2013 affidavit you state that your firm does not have a HACCP plan for scallops and you determined through a written hazard analysis that for fresh and frozen scallops there were no safety hazards. The raw scallop meat containers observed by the FDA investigator at your facility were metal containers with friction closure lids similar to paint cans. We understand that there is no known vacuum draw or gas injection (controlled or modified), nor thermal application (e.g. hot fill) applied when packaging the product whereby a reduced oxygen environment was deliberately created in the closed can. However, while there may initially be trapped oxygen when the can is sealed, and there may be some oxygen transmission through the non-hermetically sealed lid ridge, there will also be a consumption of available oxygen during the normal respiration of bacterial activity in the raw product, especially if the product is subject to abusive time-temperature exposures. Because the metal can itself is clearly not oxygen permeable and, while there may be the possibility of slight oxygen replenishing at the surface of the container through the lid seal, the development of an anaerobic environment conducive to the botulinum toxin hazard deeper in the can is considered reasonably likely. In your April 9, 2013 response to the FDA 483 observations, you supplied a document from your can supplier that states that the air transmission rate for these the metal gallon container falls between (b)(4) and you acknowledge that rate is (b)(4) the FDA Fish and Fishery Products Hazards and Controls Guidance (4th ed.) rate of 10,000cc/24hr. Unless your firm has scientific evidence to show that the oxygen transmission through the lid seam is sufficient to inhibit Clostridium botulinum growth and toxin formation throughout the container during time-temperature abuse, or that spoilage of the product in these containers will occur well in advance of toxin formation during time-temperature abuse, then your firm needs to control the hazard with an effectively implemented written HACCP plan.
For information concerning the hazards of pathogens and Clostridium botulinum toxin formation please refer to Chapters 12 and 13 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition.
We acknowledge receipt of an email dated April 9, 2013, which included your response to the FDA-483. In your response, you confirm that the air transmission rate of the metal gallon container falls between (b)(4) and you recognize that rate is (b)(4) the FDA Fish and Fishery Products Hazards and Controls Guidance (4th ed.) rate of 10,000cc/24hr. You did not provide any scientific evidence, such as a study, or an effectively written HACCP plan that would provide assurance that this type of container would inhibit the growth of C. botulism growth and toxin formation during time-temperature abuse. Therefore, your response is unacceptable as there is no assurance your proposed corrections, such as the proposed HACCP plan you state you are preparing and outline in the response, and training of employees would prevent the growth of C. botulism growth and toxin formation during time-temperature abuse of the product in this type of container.
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, 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) 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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Diane M. Prince, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Prince at 781-587-7442.
Amber G. Wardwell
Acting District Director
New England District Office