Dear ALL:
I believe what Anne Espedal quoted “need to do quarterly histamine testing on a representative sample of raw material” was referring to the Verification Step of the CCP on histamine. CCP on histamine requires lot by lot inspection. It may be by obtaining “harvest vessel record” i.e. harvesting site, temperature chart etc of every lot (I believe it should be from trusted vessels only) for the primary (first) processor. In this case, verification by testing histamine periodically is necessary from raw material to product at the verification step. However, if one’s CCP for histamine is with lot by lot testing of histamine from representative samples, then he may argue that he can omit quarterly histamine testing on raw material but he still have to do quarterly verification test on products due to many factors that might have elevated histamine during processing steps. I think Anne Espedal asked two questions: First is what should the amount of
representative sample be. I think it is an art and depends on what confidence level she what it to be. Whereas for the second question how to do verification step on her products sitting in the cold storage for whole year is very much depends on what and how has she done to control histamine(CCP) at the first stage.
Ed
----- Original Message ----
From: Brendan McHugh <criticalcontrolpoints@yahoo.com>
To: PDIONPDA@aol.com; james.hungerford@fda.hhs.gov
Cc: seafood@ucdavis.edu
Sent: Friday, February 15, 2008 3:01:01 AM
Subject: Re: Frozen production of Histamine
Very good point. The original question was basically " Is it necessary to keep testing the same lot of frozen product every two months"
The answers would seem to indicate that it isn't because if Histamine formation is halted, then the same conditions exist at the start of the frozen period as exist at the end even if it is ten months later.
PDIONPDA@aol.com wrote:
James,
Thank you for interjecting this VERY important piece of information regarding histamine formation; "Please keep in mind the enzymatic aspect: If there was time/temperature abuse onboard the vessel (even though cold storage temperatures will prevent additional formation of histamine)".
Long standing times in the seine in warm surface water temps or overload of refrigeration systems on small boat operations would be the cause of histamine formation. Cold storage after the boat has caught up with the catch will not erase the initial thermal abuse.
Regards,
Paul Dion
Paul Dion Associates, Inc.
Plymouth, MA
USA
In a message dated 2/14/2008 1:25:13 P.M. Eastern Standard Time, james.hungerford@fda.hhs.gov writes:
Yes those are the facts regarding frozen storage for that study, but I want to point out here that there are some cases where the histamine levels can go up much faster than the 36 hr period mentioned in that abstract.
Please keep in mind the enzymatic aspect: If there was time/temperature abuse onboard the vessel (even though cold storage temperatures will prevent additional formation of histamine) as soon as the product is thawed, (say in a restaurant or retail setting) the preformed histidine decarboxylase already in the fish can produce high histamine levels in the consumed product. This has certainly figured in illnesses in restaurants, for example, and we also see the effect in the lab - portions for a later confirmatory analysis for histamine are best stored in smaller masses so they can be thawed and analyzed rapidly before more histamine generated.
I understand that the current discussion is focused more on storage conditions but I point this out so that we keep in mind what can happen "from boat to plate"
James Hungerford, Ph.D.
Chair of AOAC Task Force and GR, Marine and Freshwater Toxins,
Research Chemist
FDA, ORA, ATC
22201 23rd Dr SE
Bothell, WA 98021
USA
Phone 425-483-4894
FAX 425-483-4996
James.Hungerford@fda.hhs.gov
From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf Of AJ Simpson
Sent: Wednesday, February 13, 2008 8:47 PM
To: Brendan McHugh
Cc: Sanchez, Sergio; seafood@ucdavis.edu
Subject: Re: Frozen production of Histamine
Dear List Members,
A good question and important points raised in response. Mr McHughs' comment is critical " once the uniformity of freezer temperature is assured " The scientific validation on frozen storage / histamine formation is appreciated and well noted.
Would like to contribute re: Basic HACCP -
My understanding of HACCP is that Analysis should be performed on site for the prevalent conditions on that site by the on site HACCP team for the species, process and location including specific Hazards in the guide. This includes consideration for distribution to end user. This would in effect mean that no hard and fast rules can be applied universally.
This issue has been raised by USFDA during an actual audit and should be by all auditors during audit of plant HACCP. Page 98 in the guide refers to " control strategy examples".
Other considerations include :-
Is the risk reasonably likely to occur ?
Can the risk be adequately controlled ? (Equipment capacity under all loading conditions, maintenance programs, back up generators / compressors.....)
Are calibrated cold store TTR's used in appropriate locations to assure monitoring with effective hold/recall procedures in place for deviations ? (in practice have found manual readings unreliable, this would be critical also in refrigerated storage after testing prior to freezing. Deviations assessed by T&T abuse per case).
Is verification appropriate, effective and reviewed within an appropriate period ?
Assurance of lab testing procedures.....
Is validation reassessed at least annually ?
Regards / AJ Simpson
Shining Sea Foods
Thailand
On 14/02/2008, Brendan McHugh <criticalcontrolpoints@yahoo.com> wrote:
Based on the abstract copied below, it would seem that Histamine production is stopped by frozen storage so it would not be necessary to conduct Histamine tests on frozen product once they have been tested and once the uniformity of freezer temperature is assured
English Title: Histamine production by Enterobacter aerogenes in sailfish and milkfish at various storage temperatures.
Personal Authors: Tsai YungHsiang, Chang ShiouChung, Kung HsienFeng, Wei, C. I., Hwang DengFwu
Author Affiliation: Department of Food Science and Technology, Tajen Institute of Technology, Pingtung, Taiwan.
Editors: No editors
Document Title: Journal of Food Protection, 2005 (Vol. 68) (No. 8) 1690-1695
Abstract:
Enterobacter aerogenes was studied for its growth and ability to promote the formation of total volatile base nitrogen (TVBN) and histamine in sailfish (Istiophorus platypterus) and milkfish (Chanos chanos) stored at various temperatures from -20 to 37°C. The optimal temperature for bacterial growth in both fish species was 25°C, whereas the optimal temperature for histamine formation was 37°C. The two fish species inoculated with E. aerogenes, when not properly stored at low temperatures such as 15°C for 36 h, formed histamine at above the U.S. Food and Drug Administration hazardous guideline level of 50 mg/100 g. Milkfish was a better substrate than sailfish for histamine formation by bacterial histidine decarboxylation at elevated temperatures (>15°C). Although higher contents of TVBN were detected in the spiked sailfish than milkfish during the same storage time at temperatures above 15°C, the use of the 30-mg/100 g level of TVBN as a
determination index for fish quality and decomposition was not a good criterion for assessing potential histamine hazard for both fish species. Bacterial growth was controlled by cold storage of the fish at 4°C or below, but histamine formation was stopped only by frozen storage. Once the frozen fish samples were thawed and stored at 25°C, histamine started to accumulate rapidly and reached levels greater than the hazardous action level in 36 h.
Publisher: International Association for Food Protection
"Sanchez, Sergio" <Sergio.Sanchez@inspectorate.com> wrote:
Anne,
You should continue performing the histamine testing every quarter. Even with frozen product, temperature variances inside the cold storage could trigger the production of biogenic amines (e.g., histamine). For the actual test, you need 250g for the HPLC method and 150g for the ELISA method.
Representative sampling information should be done in accordance with the FAO/WHO Codex Alimentarius standards (http://www.codexalimentarius.net/web/standard_list.jsp). For example, CODEX Standard 70 - Sampling Plans for Prepackaged Foods (1969) (AQL-6.5) (Ref. CAC/RM 42-1977).
Regards,
Sergio Sanchez
Inspectorate America Corp.
________________________________
From: owner-seafood@ucdavis.edu on behalf of Anne Espedal
Sent: Wed 2/13/2008 1:50 PM
To: seafood@ucdavis.edu
Subject:
I have a question regarding Albacore tuna histamine testing and HACCP. Page 98 of Hazards guide says you need to do quarterly histamine testing on a representative sample of the raw material. How do you determine what that sample amount should be? If you purchase only two months of the year and hold the product in cold storage, would you still be expected to continue quarterly sampling when you send lots out for production when you have already tested those lots?
thank you
Anne Espedal
Bornstein Seafoods
Astoria, Or
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