26 replies to this topic

[Weebus90]

Hi Everyone, 

We are trying to convert our food safety plan over to a HARPC plan and am having some issues with Radiological Hazards. I am looking for some guidance documents on how you made the determination as to what has this potential hazard. 

 

I have done some research on the areas throughout the world that have high levels of radiation, but is there a certain level that would need to make the hazard significant?

[QAGB]

Hi Everyone, 

We are trying to convert our food safety plan over to a HARPC plan and am having some issues with Radiological Hazards. I am looking for some guidance documents on how you made the determination as to what has this potential hazard. 

 

I have done some research on the areas throughout the world that have high levels of radiation, but is there a certain level that would need to make the hazard significant?

 

Hi Weebus90,

 

 Below is a list of foods permitted to be irradiated under FDA CFR regs. If you work with these, be sure to indicate that there is a potential of radiation hazard (even if you require one of those products not to be irradiated, but treated by steam or other manner). For most other foods the hazard would be low, or not present at all. You could also ask for irradiation statements from all of your suppliers and determine your risk based on the information you receive.

 

Table  6.2. Foods Permitted to be Irradiated Under FDA's Regulations (21 CFR 179.26).

• Fresh, non-heated processed pork
• Fresh foods
• Foods (arthropod disinfection process)
• Dry or dehydrated enzyme preparations
• Dry or dehydrated spices/seasonings
• Fresh or frozen, uncooked poultry products
• Frozen packaged meat products
• Fresh shell eggs
• Seeds for sprouting
• Fresh or frozen molluscan shellfish

Here's the link to the page with information presented in the table.

 

http://www.fda.gov/F...g/ucm081399.htm

 

QAGB

[Charles.C]

Hi QAGB,

 

The list may require some caution due vintage(s). The references are all  pre-2007 despite the page updated to 2015.

 

The last item on yr list was sourced from 2005.

 

But I'm only speculating since not my area at all. TBH I had thought irradiation was confined to only a few things these days, too many consumer labelling headaches.

[QAGB]

Hi QAGB,

 

The list may require some caution due vintage(s). The references are all  pre-2007 despite the page updated to 2015.

 

The last item on yr list was sourced from 2005.

 

But I'm only speculating since not my area at all. TBH I had thought irradiation was confined to only a few things these days, too many consumer labelling headaches.

 

 

Hi Charles,

 

I just checked on the eCFR information (since that is supposed to be the most updated), and the list pretty much remains the same.

 

There are a couple of items they expanded on it seems. From the fresh foods section, an extension was added for fresh iceberg lettuce, and fresh spinach. Another addition appears to be for frozen, uncooked meat products (not just poultry). The link to the eCFR document is below.

 

Either way, Weebus90, most suppliers have irradiation statements. If you are ever in doubt, just ask them for their statements on the products you receive. It never hurts to have this information on hand.

 

 

 

http://www.ecfr.gov/...79_126&rgn=div8

 

QAGB

[Weebus90]

Thank you everyone for your help!

[Charles.C]

Thank you everyone for your help!

 

Hi Weebus,

 

Do note that there appear to be (21 CFR 179.26) some detailed mandatory  logo/labelling requirements which should indicate the irradiated history of the particular item.

 

I assume such logo is commonplace in US supermarkets. ? Just curious.

[QATX12]

Hello,

   I noticed some mention on some replies to your post so I'll drop this from the EPA website:

 

"Currently, food irradiators use one of three kinds of radiation: gamma rays (from cobalt-60 sources), electron beams, or x-rays.

All three methods work the same way. Bulk or packaged food passes through a radiation chamber on a conveyor belt. The food does not come into contact with radioactive materials, but instead passes through a radiation beam, like a large flashlight.

Irradiating food does not make it radioactive. Members of the public are not exposed to radiation used in the irradiation of food. As a result, you do not need to do anything to protect yourself from the process."

 

source: http://www3.epa.gov/...rradiation.html

 

 

So food irradiation isn't your hazard.

 

 

 

FDA has established Derived Intervention Levels (DILs) for Each Radionuclide Group for Food in Domestic Commerce and Food Offered for Import. These radionuclides are the following:

 

• Strontium-90
• Iodine- 131
• Cesium-134 + Cesium-137
• Plutonium-238 + Plutonium-239 +Americium-241
• Ruthenium-103 + Ruthenium-106^c

 

source: http://www.fda.gov/F...s/ucm078331.htm

 

 

One would want to research if their raw ingredients have a possibility of being contaminated with any of these radionuclides.

 

 

 

 

 

 

 

 

 

Regards,

     

 

[Charles.C]

Hi QATX12,
 

Thanks for the input.

 

 

So food irradiation isn't your hazard.

 

Similarly to GMO perhaps ?.

[Charles.C]

I was interested to compare USA to Canada (same looking logo).  The latter apparently has a considerably more restricted list -

 

 

What foods are currently permitted to be irradiated and sold in Canada?

Currently, onions, potatoes, wheat, flour, whole wheat flour, and whole or ground spices and dehydrated seasonings are approved for irradiation and sale in Canada.

 

http://www.inspectio...8/1332358680017

 

I wonder why the substantial difference ?

 

USA -

 

What foods are irradiated?
The FDA first approved the use of irradiation in 1963 to kill pests in wheat and flour. To date, the FDA and the USDA have approved food irradiation for use on fruits, vegetables, spices, raw poultry, and red meats.

http://www.fsis.usda...sh0VAdVfMYw!/#3

(slightly different to earlier list, eg no seafood, maybe abbreviated)

[QATX12]

Hi QATX12,
 

Thanks for the input.

 

 

Similarly to GMO perhaps ?.

 

Don't even get me started on the whole GMO nonsense. Nonsense to me at least.

 

 

GE- Genetically Engineered as FDA has decided to refer to them are GRAS, so no hazard there. I'm not sure I understood your question.

[QAGB]

 

Hello,

   I noticed some mention on some replies to your post so I'll drop this from the EPA website:

 

"Currently, food irradiators use one of three kinds of radiation: gamma rays (from cobalt-60 sources), electron beams, or x-rays.

All three methods work the same way. Bulk or packaged food passes through a radiation chamber on a conveyor belt. The food does not come into contact with radioactive materials, but instead passes through a radiation beam, like a large flashlight.

Irradiating food does not make it radioactive. Members of the public are not exposed to radiation used in the irradiation of food. As a result, you do not need to do anything to protect yourself from the process."

 

source: http://www3.epa.gov/...rradiation.html

 

 

So food irradiation isn't your hazard.

 

 

 

FDA has established Derived Intervention Levels (DILs) for Each Radionuclide Group for Food in Domestic Commerce and Food Offered for Import. These radionuclides are the following:

 

• Strontium-90
• Iodine- 131
• Cesium-134 + Cesium-137
• Plutonium-238 + Plutonium-239 +Americium-241
• Ruthenium-103 + Ruthenium-106^c

 

source: http://www.fda.gov/F...s/ucm078331.htm

 

 

One would want to research if their raw ingredients have a possibility of being contaminated with any of these radionuclides.

 

 

 

 

 

 

 

 

 

Regards,

     

 

 

Hi QATX12,

 

Thanks for the information. I had not seen most of that before.

 

I found a document on the FDA website that lists common products associated with the irradiation hazard for domestic and foreign products. The document is from 2008, so I would say - use at your own risk. The link to the PDF is below. It is stated that most of the domestic sampling and so forth is done around food production for certain products and crops within 10 miles of a nuclear plant. There's also information listing common products and countries abroad affected by irradation.

 

I'd still say that even if the amounts of radiation are low in foods allowed to be irradiated, this does present a hazard. There's always the potential for something to go extremely wrong, even if the likelihood is small. We have products that are refined, bleached, and deodorized, so the likelihood for allergen proteins to be present are pretty much "zero", but the risk is still there.

 

One could combine both the foods allowed to be irradiated, and the foods commonly known to be affected by the hazard as well to form an in-depth risk analysis.

 

 

 

http://www.fda.gov/d...t/UCM073204.pdf

[RMAV]

Silly question perhaps as I have not looked into it just yet.  I know Radiological hazards was proposed, did it make it into the final rule?

[Charles.C]

Hi QATX12,

 

I had a look through the link on radionuclides.

 

Other than mentions to events ca.1986 etc,  I could not see a single reference as to how these numbers were "established".

 

Odd.

 

Correction - Just spotted the reference to cfr (1986,1998). No links apparently. More research necessary.

[CMHeywood]

I work for a company that produces food packaging so I am not totally familiar with the new HARPC requirements.

 

For radioactive hazards, do you have to consider any equipment that contains a radioactive material - scanners, smoke detectors, etc.?

 

In our production lines, we use beta scanners (electron emitting radioactive material).  Replacing or repairing these scanners requires a person who is trained in handling radioactive material.  We also include it in our food safety risk analysis to list the control plan to make sure the radioactive material never falls out of the scanner and into our product.

[GMO]

If food irradiation is a hazard, where do you sit if you have an x-ray control for metal?  Just thought I'd throw that in there to mix things up! 

 

I would suspect, but I don't know, that they would be most interested in foods which could naturally contain radioactive material.  Now this may be more common than you think.  I'm from the UK and so the two obvious places I would think of are the Cornwall where there are high radon levels; can that affect any foodstuffs produced there?  Also Welsh lamb had restrictions imposed after Chernobyl due to the fact that low levels of contamination went over the UK and then (unsurprisingly) it rained in Wales.  These have been lifted now but I would imagine this is the kind of thing they are thinking of?  Rare though.

http://www.bbc.co.uk...-wales-17472698


 

[GMO]

Just realised I said it would be both more common and rare...

 

Ooops!  My point was we probably have never considered it and perhaps should have because it has happened but still rare.  Worth considering perhaps if you source Japanese seaweed for example after Fukushima...

[QATX12]

If food irradiation is a hazard, where do you sit if you have an x-ray control for metal?  Just thought I'd throw that in there to mix things up! 

 

I would suspect, but I don't know, that they would be most interested in foods which could naturally contain radioactive material.  Now this may be more common than you think.  I'm from the UK and so the two obvious places I would think of are the Cornwall where there are high radon levels; can that affect any foodstuffs produced there?  Also Welsh lamb had restrictions imposed after Chernobyl due to the fact that low levels of contamination went over the UK and then (unsurprisingly) it rained in Wales.  These have been lifted now but I would imagine this is the kind of thing they are thinking of?  Rare though.

http://www.bbc.co.uk...-wales-17472698


 

Hi GMO,

   Food irradiation is not a radiological hazard as irradiation does not make food radioactive, decades of research worldwide has determined so. Radioactivity in foods can occur by two routes: contamination of foods with radioactive substances or by penetration of energy into the nuclei of the atoms that make up the food.

The irradiation process involves passing food through an irradiation field; however, the food itself never contacts a radioactive substance. Also, the ionizing radiation used by irradiators is not strong enough to disintegrate the nucleus of even one atom of a food molecule.

 

source: http://www.fda.gov/F...s/ucm261680.htm

source: http://www3.epa.gov/...rradiation.html

source: http://www.physics.i...radinf/food.htm

source: http://www.cdc.gov/n...radiation_food/

 

One would not consider x-ray machine for metal control as a radiological hazard because the radiation dose typically received by objects scanned by a cabinet x-ray system is 1 millirad or less. The average dose rate from background radiation is 360 millirad per year. The minimum dose used in food irradiation for food preservation or destruction of parasites or pathogens is 30,000 rad.

 

source: http://www.fda.gov/R...s/ucm116421.htm

 

The radiological hazards that do need to be taken into consideration are the examples that you provided: crops grown in regions where high levels of radionuclides are known or have been detected such as Chernobyl, Fukushima and other areas that may have been affected by these disasters.

 

With FSMA the FDA wants to make sure we are taking these hazards into consideration when conducting our hazard analysis regardless of how rare they may seem because a product can be contaminated.

[QATX12]

Silly question perhaps as I have not looked into it just yet.  I know Radiological hazards was proposed, did it make it into the final rule?

Hi RMAV,

   Yes, radiological hazards have been added under the chemical hazard portion.

[Charles.C]

With FSMA the FDA wants to make sure we are taking these hazards into consideration when conducting our hazard analysis regardless of how rare they may seem because a product can be contaminated.

Hi QATX,

 

I presume by contaminated you mean radioactive ?. Is there specific recent evidence of the above fear occuring  in USA, anywhere ?

 

I note the original OP query remains unanswered. i guess it's also related to link in next paragraph.

 

I'm interested to see the (presumably recent) data which has agitated  the FDA/FSMA sufficiently  to justify making this (radiological) anaysis a routine requirement. Is it available ? I daresay it's somehow related to the data in 3rd link of post 7.

 

 

(slightly OT)

I was informed by a dentist recently that many people forego routine 6-monthly check-ups due to fear of accumulated radiation. i have sometimes equally wondered about routine chest X-rays.

Sometimes a little knowledge can truly be a dangerous thing, or not ? I guess it depends on the minimum safety level limit if  >> 18 years old. Presumably << 0.1 rem/calendar quarter

[QATX12]

Hi QATX,

 

I presume by contaminated you mean radioactive ?. Is there specific recent evidence of the above fear occuring  in USA, anywhere ?

 

I note the original OP query remains unanswered. i guess it's also related to link in next paragraph.

 

I'm interested to see the (presumably recent) data which has agitated  the FDA/FSMA sufficiently  to justify making this (radiological) anaysis a routine requirement. Is it available ? I daresay it's somehow related to the data in 3rd link of post 7.

 

 

(slightly OT)

I was informed by a dentist recently that many people forego routine 6-monthly check-ups due to fear of accumulated radiation. i have sometimes equally wondered about routine chest X-rays.

Sometimes a little knowledge can truly be a dangerous thing, or not ? I guess it depends on the minimum safety level limit if  >> 18 years old. Presumably << 0.1 rem/calendar quarter

Hi Charles,

   I don't know how the FDA established Derived Intervention Levels (DILs) for Each Radionuclide Group but they exist and one can reference them. Further research on the topic will provide you with information on how they came about those limits.

 

I don't know what type of product you work with but  many raw ingredients for example spices come from all over the world. As a food manufacturer you must know the Country of Origin of these materials to properly assess them. I have not heard of any radioactive sites in the U.S, but I am still in the research process of that as there are nuclear power plants in the states. Again, it's all a part of your raw ingredient hazard analysis.

 

The radiological analysis is required by FSMA Preventive Controls for Human Food Rule which has a compliance date of Sept. 2016 (depending on your company size it may begin 2017). Further research on that should provide you with your answer.

 

 

 

 

Regards,

[GMO]

Hi GMO,

   Food irradiation is not a radiological hazard as irradiation does not make food radioactive, decades of research worldwide has determined so. Radioactivity in foods can occur by two routes: contamination of foods with radioactive substances or by penetration of energy into the nuclei of the atoms that make up the food.

The irradiation process involves passing food through an irradiation field; however, the food itself never contacts a radioactive substance. Also, the ionizing radiation used by irradiators is not strong enough to disintegrate the nucleus of even one atom of a food molecule.

 

 

 

I know.  That was my point.  I was being sarcastic...

[Charles.C]

Hi QATX,

 

Sadly, further research revealed nothing. Maybe it's all hidden down in the dockets.

 

I did notice a few pre-emptive hazard analysis examples with "Not significant" neatly entered into the radio.column and no justification given.

 

On the other hand i did find this maybe useful clause comparison between FSSC22000 and FSMA -

 

 fssc22000 vs fsma-draft-2014.pdf   484.23KB   179 downloads

(I half-suspect maybe posted before, if so, my apologies to the poster)

 

PS - i did notice this slightly interesting (2013) comment on the radio. situation from a supplier which I believe was subsequently (1st part)  implemented by FDA -

 

117.130(b)(4) “Radiological hazards”. We recognize that FSMA directed FDA to consider
radiological hazards separately from chemical hazards. FDA has recognized the rarity of
a radiological hazard reasonably likely to occur, and that frequency does not deserve a
special category of consideration. Therefore, we recommend that FDA include
radiological hazards as a subset within “chemical”, and not require all food safety plans
to specifically address the likelihood of radiological hazards. If situations change, FDA
has the authority to act in case of special circumstances.

 

[Tomato Country Girl]

go to this site:

 

www.iit.edu/ifsh/alliance

 

This is the FSPCA website under FSPCA Material you have a link to download the PCQI training manual link below 

 

http://www.iit.edu/i...2_Watermark.pdf

 

Hope this helps.

 

 

 

  

 

[Charles.C]

go to this site:

 

www.iit.edu/ifsh/alliance

 

This is the FSPCA website under FSPCA Material you have a link to download the PCQI training manual link below 

 

http://www.iit.edu/i...2_Watermark.pdf

 

Hope this helps.

 

Thanks for input -

 

 US- radiological.png   201.06KB   0 downloads

[Parkz58]

Is anyone else still struggling with this?  From the research I've done, there isn't much practical advice out there as to how to determine what radiological concerns you should be evaluating, or how to find information to establish the hazard level(s) appropriately.

 

Am I missing something?