6 replies to this topic

[Urban Explorer]

I'm reevaluating our HACCP program currently for 2013, so I am trying to address the FSMA now rather than later. A few questions that I hope someone can provide insight:

1. In each current HACCP plan (we have 6), we of course identify P:Physical, C:Chemical, B:Biological in every step of the process. Am I to understand that I now have to include R:Radiological also? Meaning I can't write up a separate hazard analysis in the foreword of the manual addressing this since it applies to all?

2. How in depth would I have to go? Basically right now all I have is mercury (located in minute quantities in fluorescent lights and in two MIG thermometers kept in the lab). Should irradiated spices be included? Potable water?

3. The addition of controls is confusing. This is one thing that irritates me with the USDA and the FDA. FDA wants you to write a complete analysis. USDA tells me to leave everything blank if there is no hazard, not even explaining why there is no hazard, unless questioned. Since USDA is in my facility every day, I follow their rules. Will they eventually accept the FSMA or continue to fight it?

[Charles.C]

I'm reevaluating our HACCP program currently for 2013, so I am trying to address the FSMA now rather than later. A few questions that I hope someone can provide insight:

1. In each current HACCP plan (we have 6), we of course identify P:Physical, C:Chemical, B:Biological in every step of the process. Am I to understand that I now have to include R:Radiological also? Meaning I can't write up a separate hazard analysis in the foreword of the manual addressing this since it applies to all?

2. How in depth would I have to go? Basically right now all I have is mercury (located in minute quantities in fluorescent lights and in two MIG thermometers kept in the lab). Should irradiated spices be included? Potable water?

3. The addition of controls is confusing. This is one thing that irritates me with the USDA and the FDA. FDA wants you to write a complete analysis. USDA tells me to leave everything blank if there is no hazard, not even explaining why there is no hazard, unless questioned. Since USDA is in my facility every day, I follow their rules. Will they eventually accept the FSMA or continue to fight it?

Dear Destinee,

I am essentially uninformed regarding FSMA but the link below (Feb.2013) gave this scope for radiological hazards -

Radiological Hazards: Radium-226,228, Uranium-235,238; Strontium-90; Iodine-131; Cesium-137
http://web.cals.uida...logical-hazard/

Whether validated or guesswork, I have no idea. Maybe the info. has already been posted here?

Rgds / Charles.C

PS - another recent (March 2013) snippet -

Those who have dissected the proposed rules are surprised by some of them. Robert Rogers, senior advisor-food safety & regulations for Mettler-Toledo Product Inspection in Columbus, OH, says the inclusion of radiological hazards to the contaminants manufacturers must guard against “raised a little bit of a flag.” Many inline quality assurance instruments, such as fill-level sensors and X-ray inspection machines, rely on technology that uses small amounts of radioactive material. However, the emerging consensus is that FDA is primarily concerned with raw materials contamination. The 2011 tsunami that caused a nuclear meltdown at three Japanese reactors raised the specter of soil contamination and compromised crops for centuries to come. Migratory birds are being monitored to detect radioactive transfers to North America.

http://www.foodengineeringmag.com/articles/90341-the-devils-in-the-details

[Urban Explorer]

Thanks Charles. I had come across that article the other day in my research, which had confused me even more. How many food plants have radioactive materials that this was incorporated into law?! I've never heard of any food manufacturer having Cesium and Strontium laying around, much less Radium or Uranium.

It seems like a lot of bureaucracy and ego-boosting by the American government.

[mgourley]

I think the inclusion of Radiological in the FSMA is basically a knee jerk reaction.
Certainly those food manufacturers that use some sort of irradiation already take that into account as part of their process hazard analysis.
FDA, as I understand the rule, is saying that you need to consider a nuclear plant meltdown as part of your hazard analysis. Is this a "reasonably likely" situation? Hardly. And just how are you supposed to put into place some control for that?

I'm hoping that gets stripped out in the final rule.

Marshall

[Urban Explorer]

I hope so too, Marshall.

With the now-radioactive crops growing in Japan after the Fukushima accident, I can see this becoming part of a business contingency plan, or something that has to be addressed in your disaster plan, but as an everyday monitoring, it's a ridiculous waste of time and money that could be spent focusing on the tangible hazards in food processing.

[williamw]

Keep in mind that we do not yet know what FSMA rules for HACCP will be. We have a proposed rule which is will likely be a lot like the final rule, but undoubtedly there will be some changes so a reevaluation will be needed when the final rule is published whatever you do now.

[KTD]

Destinee -

With regard to your question about USDA FSIS acceptance of FSMA, unless in the extremely unlikely event that FDA and FSIS are some day forced into one organization, FSIS will not accept FSMA documentation in place of FSIS HACCP. FSIS has too many resources tied up in thier version of regulatory HACCP to change course now. You should be able to use some of your FDA HACCP information to support FSIS HACCP decisions with regards to non-FSIS regulated ingredients and processing aids though...