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From: Enrique Bertullo (ebertullo@redfacil.com.uy)
Date: Sun Nov 14 2004 - 20:47:41 PST

  • Next message: oscar.doporto: "Re:"

    GlacierDear Oscar:

    As you know I have worked also as a fisheries international consultant for many years and I have been involved in latin america's training courses on seafoods´ HACCP systems from 1990 during the activities performed by the FAO/DANIDA projects, during FAO´s Regular program (FAO/FIIU) and teaching at my University in Uruguay.

    One of the main changes involving seafood´s engineers and veterinarians were the mentality followed before, both in the final seafoods quality control and hygene practices. During the 90's a great progess was achieved by applying Codex's HACCP principles for developing industry's HACCP Plans required by local and international regulations, as the 94/356/CE Decision and also the mandatory US-FDA HACCP regulation published in December 18, 1995 (Final Rule, 21 CFR 123 and 1240).

    As I know, the inspectors of most national agencies reviewed the HACCP Plans to the fishery industry and they normally introduced technical changes from their points of view. As an example, they approve the Plans and in some situations they bring to the fishery company a "Warning Letter" to avoid any problem with CCP's.

    This situation happened also with the HACCP Plans to the beef industry in which the USDA-FSIS inspectors "recommend" some changes to adapt the Plans to their views in according to the approved Rules, i.g. related to some CCP's or the control measures or the verification procedures.

    I don't think you have any chance in any country of the world to have a "confidential" HACCP Plans when you have a sanitary competent authority which gives you a Plans' approval for exportation, or give your company a lot-by-lot health certificate under those HACCP Rules for international markering.

    Nevertheless, nobody could think that a HACCP Plan for the export fishery industry could be "confidential", because most of the undeveloped countries governement authorities usually request for "copies" (paper edited or electronic), but in the beef industry the local and foreign inspectors (i.g. USDA-FSIS) read the Plans in the private Plant but they don´t ask about "copies" (most beef private industries print in their HACCP Plans "copies are not allowed"); may be this is a good example to the competent authorities of most of the fishery industries of the Region. As I know, the HACCP and SSOP records are usually consulted at Factory's level but copies are not required.

    In relation to your comment about my country: "In fact in Uruguay that is written in the law- from a list of people trained by them, as their employee to be in-charge of quality assurance and Hygiene, to satisfy their views" is an untrue fact because the Governement Decree Nr. 213/997 says "the acredited veterinarians (with HACCP Courses approved at University level)) should be the technicians responsibles of industry's HACCP Plans on the private industry for relationships to the competent Government authority", but they have no involvement in quality assurance or commercial quality control. This Decree recognised also the multidisciplinary integration of HACCP teams in the fishery industry with other qualified professionals (chemists, engineers, biologists, production manager, etc.) and in some processing Plants the quality control has another people in charge, besides the veterinarians involved in seafood safety.

    Regards,

    Enrique Bertullo

     ----- Original Message -----
      From: oscar.doporto
      To: CHARLES DAXBOECK ; seafood@ucdavis.edu
      Sent: Friday, November 12, 2004 3:03 PM
      Subject: Re: HACCP plans

      Dear Charles,
      Working as a consultant in the area of consideration, in many countries and frequently in connetion with EU requierements and modalities, I have to say that the situation in the mayority of those countries is worst than that. In fact, when the matter is managed by Veterinarians with a clasic sanitary police point of view, (what happens in most cases in Europe), you have not the right to any secret and some times either to any technical opinion even correctly founded in science and legislation. One think is what the HACCP or "self-control" supose to be (including if you take the EU legislation as the only refference) and a different one is how most "competent authorities" understund for that.
      I observed for exemple, the "competent authority" imposing to the companies to accept a person (to not say a Vet), -In fact in Uruguay that is written in the law- from a list of people trained by them, as their employee to be in-charge of quality assurance and Hygiene, to satisfy their views.
      That way the plans not only are not private but are frequently not corresponding wth the company view, copied and "corrected" by the inspectors convinced that they are doing their job.
      I understand your point and I agree with you in the sence that the manners observed are not correct at all.
      Cheers,
      Oscar do Porto

       ----- Original Message -----
        From: CHARLES DAXBOECK
        To: seafood@ucdavis.edu
        Sent: Friday, November 12, 2004 10:28 PM
        Subject: HACCP plans

         
        Dear Group :

        Thanks to those who responded to my last set of queries.

        I now have another more "legal" sort of question. Under the USFDA seafood HACCP regulation, the agency does not "validate" plans. FDA must nonetheless have access to existing plans for inspections and can make comments and recommendations as their appropriateness for controlling identified CCPs. FDA may also recommend additional control measures should there be missing food safety hazards for the particular commodity, that may not not been identified or considered in the particular plan. As far as I know, FDA does not keep individual plans on file, since again as far as I know these plans remain in the domain of private, individual property which may contain trade secrets/proprietary information. The situation is a bit different in other countries, and especially in the EU, where plans MUST BE submitted for validation and verification before an "export permit" can be issued. In addition, at least for EU, the facility in which the export commodity is produced must also pass inspection. Only when BOTH PLAN and FACILITY pass muster can the company export. Now the question remains, under the latter situation, would it then be "legal" for the "competent authority" to keep a photocopy of each "validated" plan despite the fact that the plans have been elaborated by the private sector, at private sector expense (or sometimes subsidised by public funds/assistance) ? Don't these plans still remain private property, but as such must still be available for official review and inspection upon request in the facility of commodity production ? The potential for unauthorized "sharing" of plans among persons outside of the "official circle" to me seems to be a fairly serious issue. The obvious way around this is the USFDA system whereby the plans stay in place and are available for consultation in place upon request and therefore there is less of an "unauthorized sharing" problem. Would anyone on the list care to enlighten me on this issue, either in group or off-line ?

        Thanks again all in advance.

        Dr. Charles Daxboeck
        Tahiti, French Polynesia
        biodax@mail.pf


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