additional recomendations/requirments that should be asked from a food or food-packaging plant outside USA, and not supplying to the U.S. market, having the HACCP and ISO 9000
Dear Moses,
It is a pleasure to be of help afterall this is a great forum site. On your question of additional recommendations/requirements on bio-terrorism (BT), it is practically impossible for any companies in the world to control or stop "product sabotage / terorrism" Past events have shown us that product sabotage had resulted in massive product withdrawal costing millions of dollars down the drain let alone the value of brand tarnished etc.
If you are not exporting to USA, why bother with the issue of bio-terrorism unless you are in a country that is harboring terrorists or is considerd as a suspect country. As a matter of interest, NZ and Australia have their own Bio-Hazards Act but it is for the control of imports that may affect their industries / forest/ agriculture/ dairy industries etc rather than for human terrorism..........hence, different objectives.
While in the area of providing tamper proof measures for your specific product, it depends on the type of product and the packaging format that you are currently using. It would be good if you could share with us as we have numerous packaging experts in this forum.
What are the steps to achive registration in the U.S. ? Do they have the plan to put HACCP as mandatory ? Do they separate between safety and security ?
You may go to US FDA Web Site for e-registration under FORM 3537. It is FREE. All the details are there.
Actually,
HACCP is not a pre-requisite for registration and has nothing to do with BT. It may sound funny but it is true. However,
HACCP's indirect role here is that you have a
food safety system to proof that your facility has strict visitors control program against potential external product sabotage during process or prior to shipment........All my clients have "Visitor's Entry Request Form" prior to entering a
HACCP Certified Factory.....and visitors are checked from top to bottom.....but primarily for food safety reasons only however, BT issues can be incorporated if suitable. Hence, No!
HACCP is not mandatory right now but I doubt so in the near future however, a valid
traceability system seems almost certain especially if transhipments are allowed and need to be traced out. The main purpose of BT is that as a registered facility, you would need to inform US FDA your intention and provide relevant information prior to your shipments. (They will know what to do from there on)
At this stage, safety and security issues are not separated due to the huge tasks involved in such a control exercise. US is calling upon the cooperation of not only the food suppliers but government as well. But I do know that they are "planting" custom personnel all over the world to help USFDA BT between Govt to Govt work.
I hope the information is useful in the course of what you wish to do with it.
Regards
Charles Chew