13 replies to this topic

[sarahqa]

Hi, I am working on our juice HACCP plan. We wash produce in a peracetic acid solution (60-80ppm) and test the concentration with titration.

 

I know the max limit of PAA by FDA is 100ppm according to 40 CFR § 180.1196, but I am struggling to find any information on what the actual hazard is if your concentration in the wash solution is too high. 

 

If anyone has any insight as to what hazards occur if the concentration is too high, I appreciate the insight!

[Panos]

Hi Sarah

As you stated the limit is 100ppm so by definition it is not a hazard since you are making sure that the ppm in the wash are bellow that limit. PAA breaks down very fast so it requires monitoring to ensure that  the correct concentration is maintained through the wash. The only hazard that I have come across is the effect it might have on staff (if it is above the recommended dose) again because of its high reactivity.

[Slab]

Hi, Saraqa;

 

Title 40 is for environmental regulations. As a food manufacturer (under the scope of the USFDA) you will have to reference Title 21 CFR Part 178. The precise ruling will depend on the formulation of the sanitizer. 

 

As mentioned, PAA breaks down rapidly and is essentially nothing more than water as a byproduct when used properly. However, excessive levels of PAA do become an occupational hazard as the compound is extremely corrosive and an oxidizer. 

 

 

[sarahqa]

Thanks for the responses! I agree that our bases are covered because we do monitor, but I am wondering why there is a max limit listed if there is no hazard associated with washing the produce at too high of a limit. The 100ppm established for produce wash is lower than the recommended limits for use as an equipment sanitizer, so I don't believe the 100ppm limit is based on occupational hazard. It must be based on some sort of risk being in direct contact with food, right? 

[Panos]

Great questions. The limits are placed by the chemical company you are buying the chemical from and it has to do with the concentrations that provides you the most kill (Lowest amount of chemical for the most kill). They should have info  on their effectiveness of their product. I am sure that the chemical company adheres to chemical standards that I am not familiar with. 

[Dr Vu]

I work with PAA.. It breaks down but at different rates

The same properties of PAA we so love when sanitizing  make it equally dangerous to any employees  that are exposed to it....if its dangerous to you.. Then it is dangerous to other living things. EPA and therefore, FDA, have a duty to protect you, the worker as well..

 

Ps you may not feel immediate effects by using higher concentrations but . Give it 2years or so.. Your vision starts getting blurry and other symptoms  come  up..so don't use more than the limit ..

 

Besides PAA will oxidize your floors, eat away at steel and copper material.. The higher the ppm the more  it chews..

[Slab]

I provide the incorrect source in a previous post. The correct part of 21 CFR is 173.315 (washing of fruits...) Part 178 applying to the sanitizing of food contact surfaces.
 

... so I don't believe the 100ppm limit is based on occupational hazard. It must be based on some sort of risk being in direct contact with food, right? 

 

I wasn't suggesting the EPA guidance you cited limited the usage of PAA based on occupational hazards (strictly beyond the scope of that entity), just making a side comment from personal experience.

 

As far as regulations and limits:

 

Part 173.315 states:

Prepared by reacting acetic acid with hydrogen peroxide. Not to exceed 80 ppm in wash water.

 

 

Part 180.1196 states:

An exemption from the requirement of a tolerance is established for residues of peroxyacetic acid in or on all food commodities, when such residues result from the use of peroxyacetic acid as an antimicrobial treatment in solutions containing a diluted end use concentration of peroxyacetic acid up to 100 ppm per application on fruits, vegetables, tree nuts, cereal grains, herbs, and spices.

 

This exemption seems to apply to end-use residual levels, if I'm reading this correctly, when used as a pesticide. Post-harvest wash would fall under part 173.315.

 

Why the limits? Perhaps industry has determined a 5-log reduction of target organisms is achieved at this level, and the risk(?) to increased levels is unnecessary? It affect flavors or denatures proteins? 

I would recommend consulting with your sanitizer mfg. for an answer. 

 

Again as a side-note, I have attached   FCN699.pdf   715.4KB   55 downloads for a biocide processing aid we used in our plant in excess of 100 ppm (usually around 150 ppm) with no consequential issues, and still compliant to regulation.

 

 

[KTD]

I am thinking that the concern has to do with PAA residuals left on the product, even though those do not last for an extended period of time.

 

In the US, PAA is approved for use up to 2,000 PPM as a direct food contact antimicrobial on poultry. In our case, if the PAA concentration were too high, we would look at rinsing the product with fresh water or PAA at a lower concentration. Since PAA is such a strong oxidizer, it can discolor/damage some foodstuffs, as well as cause the aforementioned equipment and facility damage.

 

OSHA regulations and NIOSH requirements should be consulted for people exposure concerns.

 

KTD

[Sdurbanfarmer]

Thanks everyone for your replies. I was researching the same question the original poster asked and grappling with the spray of PAA on produce as a CCP , however I could not find any reason in the actual hazard analysis to constitute elevating it out of being covered under a GMP.

[FurFarmandFork]

Hi Sdurbanfarmer.

 

FDA has a lot of upper limits that aren't necessarily safety oriented. E.g. they don't allow more than 0.4ppm ozone in finished bottled water at time of bottling. Ozone has a half life of about 20 minutes in clean water, so that limit makes no sense as there will be none left when it gets to the customer, and it will degrade into harmless oxygen.

 

My assumption has always been that FDA puts upper limits on because they only had data showing that the products were safe at that limit and not higher for their internal validation. Just like validating a medical device, or anything else, you can only set what you test.

 

The other assumption I typically make is that FDA wants to discourage excessive sanitizer use on actual foods, to fight producers that may want to try and save "dirty" products. This is something that we regularly see in retorted pet foods, where they just stop refrigerating ingredients because the products are going to be retorted anyway and therefore they stop keeping things clean and safe upstream. If FDA puts an upper limit on sanitizers then people won't be tempted to "just add a few glugs" and run some obviously contaminated product.

[Charles.C]

I suppose one could consider asking the FDA ?

[Ryan M.]

The potential hazard is remaining chemical residues if concentration is too high.

 

Discuss with your chemical supplier.  They can give you guidance and regulatory citations and how the PAA should be used in your application and stay within the regulatory framework.

 

I'm curious, you are saying "wash" which eludes to a rinse afterwards.  Are you rinsing the fruit after the PAA application?  If so that factors into the potential hazard of PAA.

[Sdurbanfarmer]

Hi all,

 

I had already emailed the manufacturer and their response was as follows, I will also attach a link to FCN 1738 for those interested in diving further into PAA. 

 

In my research in trying to understand the upper limits of PAA I came across this bulletin from the manufacturer "SOP for Exceeding Maximum Concentration of Peracetic Acid in Produce Processing" , this added some confusion for me because of the opening statement around its use on raw agricultural commodities (RAC) so I followed up and this was the statement that follows:

 

"Thank you for the message. The Perasan A, BioSide HS 15%, and Perasan MP-2 can be used on further processed produce (non-RAC) up to 500-ppm under FCN 1738 since it’s an FDA application. The Perasan A and BioSide HS 15% can be used on RAC up to 500-ppm per the EPA registration. Below is a link to the produce document from our website. Please let me know if you have any additional questions.

 

https://envirotech.c...ocessing-13.pdf"

 

Hope this helps anybody!

[FurFarmandFork]

I suppose one could consider asking the FDA ?

HAHAHAHAHAHAH

 

I had a good experience ONCE with a rep from the low acid food division.

It took 3-4 months to make contact.

 

There is no manfuacturer help line, there is active dodging. FSIS has support for manufacturers, but all FDA says is that "it is the manufacturers responsibility to provide legal safe food". It's a policy and enforcement agency, not a partner.