Is IPA a Registered Sanitizing Solution?

[johnallin]

This may get me in hot water...

Lately there has been an increased interest in cleaning-sanitizing 3/16 tube and what is an effective/proper/legal sanitizer.
It seems that most of the negative warnings regarding IPA come from maple related sources. I wanted to see for myself if the use of IPA as a sanitizer for food processing equipment is in fact accepted in the US. I came across the following information on the use of IPA as a Sanitizing Solution on the Access Data FDA.Gov web site.

The link to the full article :
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=178.1010

Following is a list of four mentions of accepted use of IPA in Sec. 178.1010 Sanitizing Solutions of the Code , there are many more should you choose to open the link.

Under PART 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS -Subpart B--Substances Utilized To Control the Growth of Microorganisms.
Paragraph (5) "Additionally, the aqueous solution may contain isopropyl alcohol as an optional ingredient."
Paragraph (7) "An aqueous solution containing dodecylbenzenesulfonic acid and either isopropyl alcohol or polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular weight of 2,800). In addition to use on food-processing equipment and utensils, this solution may be used on glass bottles and other glass containers intended for holding milk."
Paragraph (9) " An aqueous solution containing n -alkyl (C12-C18) benzyldimethylam-monium chloride compounds having average molecular weights of 351 to 380. The alkyl groups consist principally of groups with 12 to 16 carbon atoms and contain not more than 1 percent each of groups with 8 and 10 carbon atoms. Additionally, the aqueous solution may contain either ethyl alcohol or isopropyl alcohol as an optional ingredient."
Paragraph (17) " An aqueous solution containing di-n -alkyl(C8-C10)dimethyl ammonium chlorides having average molecular weights of 332-361 and either ethyl alcohol or isopropyl alcohol. In addition to use on food-processing equipment and utensils, this solution may be used on food-contact surfaces in public eating places."

It is Not my intention to start a war or to argue, it simply comes down to keeping equipment clean, if it's good enough for Dairy - I would think it's good enough for Maple. Thanks for reading, John

[buckeye gold]

I'm sorry to disappoint you, but none of those solutions are IPA. They simply allow IPA as an ingredient and in most cases it's a small amount. FDA registrations are quite literal. If it does not say IPA is registered as a sole ingredient for Maple syrup equipment, it is not legal for use as such. I know, I have spent a whole career dealing with FDA registration and legalities of drug and pesticide use. If it is not on the label it is not allowed, period. I does not matter if it is ok for dairy, food counters, dishes,etc. it does not say maple syrup production. I knew a guy in my old profession who thought the FDA was full of crap and he'd just use a drug because it was labeled for similar uses and if it was safe for that it was safe for his use. He was arrested, lost his job, lost his retirement, spent time in jail and was sued. I'm not taking that chance for a little Maple syrup. Oh yeah, they then proceeded to inspect and crack down on the whole industry....it literally cost the industry millions as a whole and a lot of anguish. The maple syrup industry does not need someone swatting the hornets nest with a stick, we all get stung.

[Bucket Head]

Yes, what Buckeye said.

Just listened to Dr. Tim on Sat. at the N.Y. maple conference speak about this. IPA is not registered as a sanitizer in the U.S. The short version of his story is; irritate the government and see what happens.

[maple flats]

IPA is used in Canada, but not the US. If you are caught using IPA your entire crop could be confiscated and you get zero.
The whole issue sounds like no manufacturer jumped thru the hoops and expense to get it approved in the US, the FDA does not care that Canada approved it. IPA may not ever be approved in the US, the approval process costs too much for such a limited use to be profitable for the manufacturer of the IPA. Additionally, if company A ever did get approved, but you use company B's IPA, you loose again, even though they may be 100% identical.

[johnallin]

[QUOTE=maple flats;361587 ...
The whole issue sounds like no manufacturer jumped thru the hoops and expense to get it approved in the US, the FDA does not care that Canada approved it. IPA may not ever be approved in the US, the approval process costs too much for such a limited use to be profitable for the manufacturer of the IPA. Additionally, if company A ever did get approved, but you use company B's IPA, you loose again, even though they may be 100% identical. [/QUOTE]

Dave - I appreciate your response, please help me get this through my thick skull...

Are FDA Approvals product specific, ie: Dairy, Beverage or Maple? And if so; is there an available list of sanitizers approved specifically for Maple that we can refer to?

It certainly seems like whatever is used must be an approved substance/solution or all hell's going to break loose.

I respect your input and the work you do here on Trader. Thank you.

[Bucket Head]

John,

"Must be approved" is correct. IPA is not a registered, or registered as a sanitizer in the U.S. anyway, so its not "approved" to use as sanitizer. Besides, sanitizer leaves a film- it's supposed to, but it isn't what you want inside your tubing.
I do not know of a maple suitable or 'maple only' sanitizer. I don't think such an item exists.

Steve

[maple flats]

I will not try to figure this one out, I fully trust Dr. Tim. I also attended his presentation and his warnings about IPA and the FDA hit loud and clear.
It is still my belief that the reason might be the cost for a manufacturer to submit a product for approval is cost prohibitive because, while there are a lot of maple producers in the US and growing every year, the potential profits for the IPA manufacturer in maple just don't appeal to the manufacturer. In other words, it would take far too long to recover the approval investment.

[johnallin]

Thanks, both good and civil, replies.

[buckeye gold]

The registration process involves a lot of work and expense. Before a manufacturer will do all that they have to evaluate the potential as a profitable product. Yes you are right in assuming that products are use specific.
I think the best way to explain this is too simply give you an example. I used animal drugs in my past career (rearing fish) and we only had a few drugs approved for use. Now our predecessors used a whole myriad of products, but when research started determining that many things were harmful the FDA stepped in and started enforcing label restrictions. Companies quickly moved to get antibiotics approved for common veterinary uses on hogs, cattle chickens, dairy, etc. Fish were left out because they could not see a market for the product lable that was profitable on an industrial scale. That left us with drugs we knew would work, but no label to use them, they were one moment legal and the next illegal. Leadership in the Natural Resource Agencies and Dept. of Ag asked companies to apply for labeling, but they declined because of cost. We desperately needed these drugs, but were lost for an avenue. Some defied the law and used them anyway and I know of one case I already sighted that a man was caught and paid a horrible price for, he ruined his life. Not only that he got the rest of us looked at. So we asked what can we do? They finally came to an agreement that with the cooperation of the center for veterinary medicine vets could write us specific off label or as it is called "Extra label" use for specific outbreaks of disease. Other than that it had to have FDA approval. We then established a consortium of agencies and developed a plan to do all the research ourselves. Between state and federal agencies we built a plan and a pool of approximately 1 million dollars and started doing the research. Individuals like me applied for permits to do parts of this research, they were called INAD (investigation New Animal Drug) permits. We were allowed to use them as a means of gaining the necessary data to label a drug. This was coordinated by a Federal office and subject to review constantly. They involved things like toxicity, effectiveness, residual retained in meat, environmental, application rates and more. You had to isolate various lots and replicate processes and maintain controls....it was very labor intensive and detailed. It took five years to do a complete study and three years of review but we finally got approval for some antibiotics to use on fish. We then handed this to a drug manufacturer and they started making the drug, but tripled the common price. In the mean time cattle, chicken and hog farmers were going to farm stores and buying this same drug off the shelf.

[Louie]

If getting caught using IPA would get your crop taken or destroyed why can syrup come into the US from Canada?

Is hydrogen peroxide approved for cleaning?

[buckeye gold]

It is not a matter of what is safe alone it is a matter of what is an approved use. The EPA established allowable residue levels, if a product has been labeled and manufactured legally in another country then you can apply to import it. It is subject to inspection and testing, but that does not mean it always is. See regs below

Imports:
The requirements of section 402 of the FFDCA apply equally to domestically produced and
imported food and feed found to contain pesticide residues. Therefore, even though the use of a
pesticide in a foreign country is not subject to EPA registration requirements under FIFRA, a
pesticide residue in imported food or feed must be in conformity with a tolerance, tolerance
exemption, or food additive regulation established by EPA or, if the pesticide residue is
unavoidable, an action level established by FDA.

Many substances are considered generally safe. The issue is it has never been approved for manufacturing use in the US, not if it is safe. EPA and FDA both accept that syrup produced in Canada is safe. Again it is not about that is about complying with our laws. Below is a list of sanitizing used for IPA, maple syrup is not on there

Isopropanol, isopropyl alcohol - SOLV, REG, <250 ppm as residue in modified hop extract - 172.560; <50 ppm as residue - In mfr of spice oleoresins - 173.240; 6 ppm - In mfr of lemon oil - 173.240; 2% by wt - In hop extract as residue from extraction of hops in mfr of beer - 173.240; AF, REG, GMP, Comp of defoaming agent for processing beet sugar and yeast - 173.340; SANI, REG, GMP, Adequate drainage - May be used on food processing equip and on food-con-tact surfaces - 178.1010(b)(17); SANI, REG, < 40 ppm Adequate drainage; May be used on food processing equip and on glass containers for holding milk - 178.1010(b)(7)

There are pages on pages of regs, I just tried to post enough to kind of help understand....it is by no means complete

I have to say the simplest thing is to just do what you know is right. When people in the know like Dr. Tim and your Dept of Ag representative tells you what is ok and what is not, why argue...just do what is approved. If you want to change law then go see your congressman, but if you go you better have done your homework. They don't change laws on I want to be different.

[Louie]

Wish I could find the approved list of cleaners for maple. The only thing I came up with was the last Maple News video of the guy cleaning with Zappit swimming pool cleaner.

[johnallin]

Wish I could find the approved list of cleaners for maple. The only thing I came up with was the last Maple News video of the guy cleaning with Zappit swimming pool cleaner.

Kind of what I'm thinking, does such a list even exist?

[buckeye gold]

I think it would be great if someone like Dr. Tim or USDA/FDA would print such a list. A public service document from an ag extension office or something. All I know is what I have been told by Dept. of Ag and extension agents, I have never seen a document spelling it out. Maybe state Maple producer Associations could work on this.

[n8hutch]

I've got my own concerns about using swimming pool cleaner. Understand that it dissolves and the residue left over is not harmful but I'm not certain that even that would be considered an approved use. Or at the minimum might be hard to sell to your customers. No doubt in my mind that 3/16 tubing is going to need to be cleaned somehow but until they figure out the best and approved way I'm just going to continue to cut out the bad spots and keep on going with uncleaned lines.

That was a great video they put out on what they ate trying to do but it was in no way a (Best Practice) or a seminar on how to clean Tubing. It is a trial ,at best.

[johnallin]

Nate, those are my sentiments exactly. I'm beginning to think that none of the cleaners/sanitizers that have been suggested as approved, list Maple Syrup individually on any kind of list, and that after all of the stern warnings, there is nothing to back them up.

We know that IPA is approved and registered as an ingredient in certain sanitizers for use in dairy and other food processing applications, and I'm fine with the fact that it's not specifically listed for use with Maple Syrup and therefore not a legal use. Although, using that logic, It would seem imperative that Hydrogen Peroxide does list tubing for use in collecting maple sap as an approved use of the product.

Not trying to be "different" or difficult, but as buckeye gold said, " I have never seen a document spelling it out. Maybe state Maple producer Associations could work on this." It would sure clear the air on this one.

[dsaw]

I've never used IPA, however, here's a hypothetical: Can I use IPA to clean my lines of water/dark spots? It's all in the use. In a past life, I purchased biocides for a major company that supplied the oilfield and became somewhat familiar with the rules regulating them. There was one biocide that only one company owned the registration to use it as a biocide in the oilfield, so they charged something like $20/lb for it. However, the chemical was actually duel use and also acted as a corrosion inhibitor. You could buy the same chemical from China for about $2/lb and legally use it in the US, as long as you only advertised it as a corrosion inhibortor and didn't mention it was a biocide. So is there another legitimate use for IPA that isn't as a sanitizer (regulated), like a cleaner (I'm not an expert, but guessing not regulate)?
This also brings up why no one has bothered to register IPA in the US. Let's say company A jumps through the hops and gets it registered. That registration only applies to company A's IPA. So obviously, company A is going to charge ? times the normal price for their product. Just because they have it registered doesn't mean you can use anyone's IPA, the registration is only for that company's product or someone who pays a fee for access to their approval research (not likely in what is already a generic product). But after you buy one container from the registered company, who's to know if you aren't refilling it with generic stuff at 1/? the price? That's probably why no one has bothered to do it in the US.

[buckeye gold]

dsaw, I have done similar things with sanitizers my past career, but when the EPA and FDA come looking they will frown real big and shake their head no. It might get you off with a warning, but ultimately your wrong. You need to show a regular approved need and maintenance plan. Positive side effects are good, and in your case, in the oil field, there was a regular commonly accepted practice of using the compound in approved applications. IT's a hard nut to crack when there is no accepted regular use of a product within the industry. I really struggle with why we as people have to constantly push the limits. It's like children always testing their parents, until they get their hind end spanked or some other form of discipline. The common response in our house was we all got in trouble when one of us pushed mom and dad too far. Just do what we know we can, it works just fine.

[johnallin]

dsaw, ... Just do what we know we can, it works just fine...

I agree with your thinking regarding doing what "we know" we can do....but has a list of approved/registered sanitizers specific to Maple been found? If not, do we really know what we can and cannot use?

[buckeye gold]

I'm still waiting on that official document too. All we can do is go by what we are told and hold people to that word. I don't think anyone is going to make an issue of what we are using if it is in line with what Dept of ag and accepted authorities have verbally stated. There are too many witnesses for a rebuttal. At worse it would be a stop use from this point on warning.

[Bucket Head]

Nate summed it up well a few post's ago- "would be a hard sell to your customers". Good manufacturing practices come after common sense. Would you want anyone to see a bucket of pool chemicals (or any other questionable chemical) anywhere near your syrup operation?
As an inspector here at the bread factory explained it when it came to those guy's looking closely for non-compliant items- when they see something that stands out, they immediately think, "If they are using that stuff there, what else are they using incorrectly?".
That kind of questioning and doubt is the last thing you want an inspector or customer walking away with.