Jump to content

  • Quick Navigation
Photo

Bio Terrorism Registration / Requirements

Share this

  • You cannot start a new topic
  • Please log in to reply
9 replies to this topic
- - - - -

moshes

    Grade - AIFSQN

  • IFSQN Associate
  • 34 posts
  • 0 thanks
0
Neutral
  • Gender:Male
  • Location: Israel

Posted 26 August 2004 - 03:59 AM

Hi everybody in the SDF!
It seems to become the leading standard for retailers worlwide more than BRC, IFS and of course ISO 22000. Just to support my last comment, SQF has a number of modules provided as voluntary options to suppliers whose markets require additional assurances for matters in addition to food safety and quality. They include Social Accountability, Environment, Animal Welfare, Organic and Bio-terrorism. All of them could be in the certification scope of one or multi-sites.

<{POST_SNAPBACK}>


Hi Luis,
Read with interest your comments and all the answers.
Can you (or anyone in the Forum) be more specific on bio-terrorism. I went through the standard but was not able to pinpoint specific issues to enhance your comment in the SQF 2000.
Thanks,
Moshes


Charles Chew

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,178 posts
  • 54 thanks
15
Good

  • Malaysia
    Malaysia
  • Gender:Male
  • Location:Malaysia
  • Interests:Food, food and food!

Posted 29 August 2004 - 05:15 AM

Can you (or anyone in the Forum) be more specific on bio-terrorism


Hi Moses,

I am involved in getting registration for my clients on "Bio-Terrorism (BT) Registration" as required by US FDA. What do you wish to know on this matter?

However, briefly, SQF or HACCP are not essential for registration but helps. BT helps to ensure that terrorism does not strike the US Food Chain that would lead to significant threat to the lives of Americans via this source. Since this area is a political issue, I shall not indulge in it.

To protect the food chain, facilities must be registered where foods are imported into US essentially to ensure traceability to facilities in the event of a crisis. Hence, SQF and HACCP are food safety systems that will help to provide that assurance since yr facility and systems are auditable and food products traceable if ever yr facility is suspected.

Regards
Charles Chew

Cheers,
Charles Chew
www.naturalmajor.com

moshes

    Grade - AIFSQN

  • IFSQN Associate
  • 34 posts
  • 0 thanks
0
Neutral
  • Gender:Male
  • Location: Israel

Posted 29 August 2004 - 08:46 AM

I am involved in getting registration for my clients on "Bio-Terrorism (BT) Registration" as required by US FDA. What do you wish to know on this matter?


Hi Charles,
I follow with interest all your remarks and informations and really appreciate your knowledge and contribution to the forum. :clap:
On bio terrorism i.e. food security, I am interested to have your opinion on the 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 certification, in order to help controlling the tampering and danger of bio-terrorism. :doh:
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 ?
Moshes


Charles Chew

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,178 posts
  • 54 thanks
15
Good

  • Malaysia
    Malaysia
  • Gender:Male
  • Location:Malaysia
  • Interests:Food, food and food!

Posted 29 August 2004 - 02:46 PM

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

Cheers,
Charles Chew
www.naturalmajor.com

moshes

    Grade - AIFSQN

  • IFSQN Associate
  • 34 posts
  • 0 thanks
0
Neutral
  • Gender:Male
  • Location: Israel

Posted 30 August 2004 - 03:10 AM

Hi Charles,
Very detailed and useful information. :thumbup: Our main concern is to avoid intentional food poisoning, in the food supply chain (from field to fork) by using the HACCP (or extended HACCP) as a means of control by producers. :uhm:

Regards,
Moshes



Charles Chew

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,178 posts
  • 54 thanks
15
Good

  • Malaysia
    Malaysia
  • Gender:Male
  • Location:Malaysia
  • Interests:Food, food and food!

Posted 30 August 2004 - 05:33 AM

Hi Moses,

As mentioned earlier, your facility is ONLY part of a mutiple food chain from farm to fork. Therefore, it is the reason why you should request from your suppliers under the Suppliers Assurance Program (SAP) "Certificate of Analysis" (other countries may use different terms but they mena the same).

While it is almost impossible to test every raw ingredient that comes into your facility for further processing, it would practically break the camel's back when it comes to the financial means in doing so. Hence, a sound SAP would certianly heighten your case against implications of internal fraud or sabotage.

While all of the above are still a possibility, no body can fault you that you have done everyting that is possible to keep your food chain as safe and protected as practicable.

Well, the issues of external sabotage is another chapter. The moment you have released ownership to another party of the food chain, it is really up to the next party in line to assume that responsibility to maintain product safety and integrity.

Hope this helps.

Regards
Charles Chew


Cheers,
Charles Chew
www.naturalmajor.com

Charles Chew

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,178 posts
  • 54 thanks
15
Good

  • Malaysia
    Malaysia
  • Gender:Male
  • Location:Malaysia
  • Interests:Food, food and food!

Posted 30 August 2004 - 01:06 PM

Hi Moses,

I received this note a few days ago from FDA but have not time to read them through yet. Might be of interest to you.

On Thursday, August 12, 2004, the United States Food and Drug Administration  (FDA) and the U.S. Customs and Border Protection (CBP) issued a revised  compliance policy guide (CPG) that describes their strategy for enforcing  the requirements of the prior notice interim final rule (IFR) while  maintaining an uninterrupted flow of food imports.    FDA and CBP also announced a corresponding three month delay in their  projected date for issuing the prior notice final rule from March 2005 to  June 2005.  This will allow FDA and CBP to retain the three month assessment  period to determine whether the prior notice time frames can be reached  further as they develop the prior notice final rule.    Lastly, the agencies announced the issuance of an updated prior notice  compliance summary, and a new "Guidance for Industry: Prior Notice of  Imported Food Contingency Plan for System Outages."  The compliance summary  states that since increased enforcement began in June, entries submitted to  FDA and CBP with no prior notice have been almost eliminated.  Although some  problems still exist, only a small percent fail to submit any prior notice  information.  Most prior notice data are being submitted; however,  completion of registration number and bill of lading is lower than  completion of most other data elements.    More detailed information is available at the FDA web site on The  Bioterrorism Act of 2002 under the heading "Recent Activities" located at  http://www.fda.gov/o...ism/bioact.html  This information  includes:    *    The FDA Talk Paper issued on Thursday, August 12, 2004  http://www.fda.gov/b...4/ANS01304.html    *    Compliance Summary Information: Prior Notice  http://www.cfsan.fda.../~pn/pnsum.html    *    Revised Compliance Policy Guide  http://www.cfsan.fda...~pn/cpgpn3.html    *    Revised Joint Plan  http://www.cfsan.fda...pn/pnplan2.html    *    Prior Notice Contingency  http://www.cfsan.fda...pn/pndguid.html 


Charles Chew

Cheers,
Charles Chew
www.naturalmajor.com

moshes

    Grade - AIFSQN

  • IFSQN Associate
  • 34 posts
  • 0 thanks
0
Neutral
  • Gender:Male
  • Location: Israel

Posted 31 August 2004 - 02:24 AM

Hi Charles,
Appreciate all information. Have a lot to look at and decide. :o Your hints are also very useful.
Regards,
Moshes



Franco

    Grade - PIFSQN

  • IFSQN Principal
  • 752 posts
  • 15 thanks
2
Neutral

  • Italy
    Italy

Posted 26 September 2005 - 02:02 PM


An ancient Chinese proverb teaches that the person who waits for a roast duck to fly into their mouth must wait a very long time.

Franco

    Grade - PIFSQN

  • IFSQN Principal
  • 752 posts
  • 15 thanks
2
Neutral

  • Italy
    Italy

Posted 03 October 2005 - 06:26 AM

Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

Final Rule :bye: Franco


An ancient Chinese proverb teaches that the person who waits for a roast duck to fly into their mouth must wait a very long time.



Share this

0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users