Water Line Cleaners and the Regulation and Labeling Behind Them
It has been stated in presentations and articles over the last couple of years from some companies that ALL products used to clean water lines without animal’s present must be EPA registered. It has also been stated that if you use a product that is not EPA registered to clean lines without animal’s present that you are violating federal law and could be fined and even incur jail time if found guilty for these ‘crimes’. Those are some serious allegations and have, of course, made some of you reading this article think about what you are using to clean water lines in your operation.
So, are those allegations true? Do all products that are used to clean lines need to be EPA registered? Does the EPA distinguish a difference between cleaning a general surface in your building and cleaning water lines? I hope to help answer those questions in my article and hopefully eliminate any confusion that is being associated with this subject. In doing this I believe we need to dig deeper into this subject, so you understand how the EPA views all these products, so this is going to be a long winded write up that hopefully stays on task in helping clarify this subject.
By nature, this is a very confusing topic because it involves government regulation and policies. Of course, our federal government is always here to help and wants to make things as easy as possible for you to understand. (Note: strong sarcasm). It is very difficult to find a warm body in the EPA or any BVS Midwest Poultry Show Edition March 2018 www.bestvetsolutions.com government agency that can answer these questions. They do have websites and lots of material online that can be viewed to help answer some of these questions. I have been forced, which I will explain later, to look at this and I think I have the answers to these questions. The key word there is think. All this information I am going to write about below is from EPA employees, consultants and their websites stating these rules and how they interpret these regulations based on the rules set forth by these agencies. We have tried to get as many people to give us feedback as possible. It is not uncommon for one EPA or FDA regulator to have a different interpretation of the rules compared to another EPA or FDA regulator. If you have ever had an EPA or FDA audit you know exactly what I am talking about. I have been through both EPA and FDA audits, so I have more experience with this then I wish I did. Having said that, all the employees and consultants that gave us feedback came back with the same answers. So that is encouraging and gives me confidence that what I am stating below is accurate and true.
The EPA basically classifies the type of products we use in animal agriculture for Cleaning and Disinfecting and Biosecurity into 3 categories. Cleaners, Sanitizers and Disinfectants. FIFRA (Federal Insecticide, Fungicide and Rodenticide Act) is the federal law that set the standards on how pesticides can be used, and the testing needed to determine safety for applicators, consumers and the environment. These rules set out in FIFRA are generally administered and regulated by the EPA (Environmental Protection Agency) and the EPA breaks down these pesticides into 3 categories: antimicrobials, biopesticides and conventional pesticides when applying for registration. All pesticides distributed or sold in the United States must be registered (licensed) by EPA. Sanitizers and Disinfectants fall under the antimicrobial category for registration with the EPA. The EPA has set standards and testing protocols that would allow a product to be called a sanitizer or a disinfectant. This allows the consumer to know the product it is using to be safe and effective against whatever the product is claiming. So, if a product is claiming to ‘sanitize’ certain surfaces it would need to have been tested and approved to make those claims. If a certain product is claiming to ‘kill’ certain bacteria or viruses it would have needed to be tested and approved to make those claims. A claim can only be used on EPA registered products that have gone through the registration and testing protocol set up by the EPA. The EPA sets protocol and standards that allow products to be called sanitizers or disinfectants typically using an AOAC dilution and test method to substantiate the claims wanting to be made. Sanitizers will reduce the number of bacteria on a surface deeming it safe to use after a short period of time. A food contact surface sanitizer reduces 99.999% of the bacteria in 60 seconds. A nonfood contact surface sanitizer reduces 99.9% of bacteria within 5 minutes. Sanitizers only pertain to bacteria and after that time the surface would be safe to use due to the reduction in bacteria. A disinfectant goes through a completely different set of protocols and standards by the AOCA and can be used for bacteria, virus and fungus. The maximum contact time required is typically 10 minutes and a complete ‘kill’ must be shown depending on what is being tested on that surface. A product could be called both a sanitizer and disinfectant if it wants to make claims for each. It is important to remember that even if a product is registered as a disinfectant that doesn’t mean it ‘kills’ all types of bacteria, fungi or viruses. It only ‘kills’ what it has been tested for and what it is making claims for on its label. A lot of registered disinfectants do not kill bacteria spores or certain types of viruses. Once a product is registered by the EPA it can only make claims for what it has been tested for. This is very important to understand. That is also true for how the product is used. It can only be used per label directions for the applications on the label of the product. A disinfectant can also be considered a ‘broad spectrum’ disinfectant meaning it has been tested against all three categories of bacteria, fungi and viruses. Specific bacteria, fungi and viruses must be tested to make this claim. VIROCID™ has the proper testing and is considered a ‘broad spectrum’ disinfectant for example.
Cleaners on the other hand are not regulated or tested by the EPA for product registration. They represent a broad category of products like detergents (soaps) or other ingredients to physically remove dirt, debris and grime (some portion of the germs) from surfaces. Since cleaners are not typically registered by the EPA they can not make any claims as described above. IF a cleaner makes claims, it needs to be EPA registered. IF the cleaner does NOT make any claims it does NOT need to be registered. So, for cleaners to be sold in the U.S. companies need to be very careful with the wording and usage directions it has on their labels to ensure none of this happens. The EPA does have a list of ingredients it approves for use as cleaners, so they do regulate some aspects of cleaners to ensure their safety. Companies want to make sure what they use for ingredients as cleaners are on that list. The biggest difference between cleaners and sanitizers / disinfectants is they have never been tested to verify its effectiveness at reducing or killing certain bacteria, virus or fungi. Which to me is ok, you generally don’t want your cleaners to perform this task. That shouldn’t be the job of your cleaner. Also, just because cleaners haven’t been tested doesn’t mean they aren’t effective at doing what their label specifies. Most of them are very effective. Those cleaners just can’t make any claims as mentioned above. Cleaners and cleaning is by far the most important step to any quality Cleaning and Disinfecting program.
I think we need to understand there is a difference between using cleaners and completely clean. That is something others try to lump together by claiming if you are using a cleaner, the surface is clean or ‘free from biology’ and because the product is making the surface clean or ‘free from biology’ that product needs to be EPA registered. That is a completely erroneous statement and meant to mislead all of you.
Cleaning a surface at no point has ever meant ‘free from bacteria or living organisms’ and the EPA views this the same way. If you are cleaning a surface the purpose of ‘cleaning’ is to remove 85 to 90% of the dirt, debris and grime on that surface. Then you would use a Disinfectant to ‘kill’ the remaining microbes. The main purpose of cleaning is to prepare the surface for the disinfecting step. It allows the disinfectant to work better. ALL disinfectants are neutralized by organic matter. When cleaning you want to remove as much of the organic matter as possible which allows disinfectants to do their job more effectively. At no point when you clean a surface are you trying to make it sterile. Sterile means ‘free from bacteria’. This is no different for water lines and water disinfectant products. You can use a ‘cleaner’ between flocks to remove the grime in the water line which then allows your continuous sanitizer / disinfectant to work better with animals present.
It really boils down to if the cleaner you are using is making statements or claims that would fall into the category of needing to be EPA registered. To make this even more complicated the EPA has certain words or phrases that if used would automatically make that product a pesticide and require registration. Biofilm is a big word for the EPA. At no time can a ‘cleaner’ ever use the word ‘removes biofilm’. Phrases like cleans away, washes away or removes biofilm or scum or phrases like cleans, precipitates or removes containments, nutrients or matter that provide food or habitat for pests. You cannot discuss biofilm, bacteria, slime, germs or diseases on cleaning labels without them needing to be registered. So, what you must do when labeling a cleaner is avoid any of those catch phrases or words. Using phrases like ‘removes heavy soils’ would be considered allowable on a cleaning product. It is always acceptable to use ‘removes scale’ from cleaning products because that is considered an inorganic matter and something that would not be ‘living’ according to the EPA. Honestly it comes down to wordsmithing and how well you can label your products to not use any phrases that EPA does not allow on non-registered products. Sounds simple and not complicated, right! (Note: Strong Sarcasm)
It has been said by others in presentations that the EPA distinguishes a difference between cleaning general surface areas and cleaning water lines. As you know there are many unregistered cleaning products used to clean general surfaces in and around agriculture buildings. So, if those cleaners where doing the same thing as water line cleaners would they need to be registered as well? The answer to that is NO. The statement that the EPA distinguishes a difference between surfaces being cleaned is also erroneous and not true. It does not depend on the surface being cleaned (porous, non-porous, water lines etc.) but it depends on the label and if the product is making claims. That is the only distinction the EPA makes when determining if a product needs to be registered. It does NOT matter what surface is being cleaned.
Any product used for continuous water sanitation / disinfection that is making claims should be EPA registered and have a label claim for ‘disinfecting livestock and poultry drinking water’. No product used to clean lines should ever come in contact with animals at the percentages they are used. They should be thoroughly rinsed and levels undetectable before animals come in contact with that water and the labels on those products should indicate those requirements. After the cleaning product is flushed from the water line system, you should follow that with a registered water line disinfectant that is available to the animals when the are moved into that facility.
IF a product is labeled as a Cleaner/Disinfectant then it absolutely needs to be registered. Due to the disinfectant claims it is making registration would be required. Again, you can have Cleaners/Disinfectants or Sanitizers/Disinfectants for one product. That product however must be registered and labeled for whatever claims it is making. Stating that all water line cleaners are cleaners/disinfectants is also muddying the water and confusing the end user. If they were all labeled as cleaners/disinfectants, then they would all need to be registered. However, there are many water line cleaners that do not use or associate with disinfecting. If the cleaner is not making any claims, it doesn’t matter what surface you are cleaning. The product would NOT need to be EPA registered.
It also matters what chemistry the product is using to determine if it can be used as a cleaner or disinfectant. Some chemicals can never be considered cleaners no matter what the label or claims state. If you are using Glutaraldehyde at no time could any of those products be considered a cleaner. Glutaraldehyde only has pesticide claims according to the EPA so regardless of the product or its usages any product containing Glutaraldehyde would need to be registered and could never be considered a cleaner. However, the EPA does allow for Peracetic Acid and Hydrogen Peroxide chemicals to be used as either a cleaner and / or sanitizers and disinfectants. So, with those chemicals the label claims and wording are what matters whether it is allowable for a cleaner or needs to be registered as a sanitizer / disinfectant.
Peracetic Acid and Hydrogen Peroxide are some of the most widely used chemicals in animal agriculture for water line cleaning. I believe Peracetic Acid based products are more effective overall due to the chemistry and ability to remove heavy soils and scale at the same time. Hydrogen Peroxide products can only clean away heavy soils and will not affect scale build up in your lines. Regardless of these facts, if those chemistries are being used to clean water lines and those products are properly labeled they do NOT need to be EPA registered to clean water lines.
Cid 2000 Pro is typically one of the products brought up in these presentations on products being used illegally due to not being EPA registered. As it stands now, Cid 2000 Pro by our research and current label is completely legal to use and no one should have any concerns using Cid 2000 Pro as a water line cleaner. At one-time Cid 2000 was not labeled correctly and did receive violations from the EPA due to using some of the phrases I mentioned above on its label and literature. When Cid 2000 was first introduced into the United States Cid Lines used many of the same wording and phrases it used on labels it sold in other countries. Cid Lines is an international company and sells products including Cid 2000 to multiple countries throughout the world. On Cid 2000’s initial label it had the phrases ‘removes biofilm’ and ‘reduction in microbial load’ because cleaners in other countries can freely use these phrases on labels. As you know now those phrases indicate the product needing to be registered because you are making claims. Once this was brought to our attention we moved forward in changing the label. At NO time were our customers in any jeopardy from using Cid 2000. The product has always remained the same with the same usage directions. When mislabeling of a product like that occurs the EPA always goes after the manufacturer or distributor selling the product and NOT the end user. In this case BVS was the one targeted due to selling and distributing the product in the U.S. Due to BVS being proactive and cooperative in working through this situation, the initial fine that was released to the public was significantly reduced. The end user would be in jeopardy if it is using a registered product off label or not as intended based on usage label directions that brought harm to its animals. That is why we always recommend using products as directed and always include your Veterinarian for usages of these products.
Cid 2000 Pro as mentioned is constantly used as an example for a product being used illegally because of the past experiences I explained above. I believe some people are trying to take advantage of those past situations and imply that Cid 2000 Pro today still has improper labeling. I can verify this is completely NOT true. Since going through this with the EPA we have confirmed that every label used since then complies with their requirements and regulations. Cid Lines has changed the labeling as needed to meet these demands. This happened almost 5 years ago. I can’t really explain why some say ALL water line cleaners need to be EPA registered. Cid 2000 Pro is also not registered and is considered just a cleaner. So, saying that all products need to be registered would also push people to other products. As you can see from my notes above as long as it is not making any claims the EPA considers that to be acceptable. And we have received verification from many different sources that Cid 2000 Pro’s current label is acceptable and completely legal. I guess since Cid 2000 Pro is a great product and probably one of the most popular water line cleaners used in animal agriculture, people will do whatever it takes to diminish those products to sell their own products.
There are EPA registered disinfectants that do have water line cleaning usage directions on their labels. If you do feel like using an EPA registered product for water line cleaning, that is fine. KENO™ X5 (although that is never mentioned by others in their presentations as a EPA registered product with water line cleaning on its label) does fit into this category. It is a EPA registered broad spectrum disinfectant that has water line cleaning directions on its label.
I know there are many products used for water line cleaning like Cid 2000 Pro, Proxy Clean, Cid Clean Pro and Aqua-Oxy 34 for example that are not EPA registered. If all those products meet the requirements above with their labels and do not make any claims, then they don’t need to be registered to be used as a water line cleaner. The only products I can speak for are Cid 2000 Pro and Cid Clean Pro since those are the products we sell. I do know that both products are safe and legal for you to use as a water line cleaner without animals present. We always recommend following the label directions for all products we sell. If these products are used in other ways that is up to the end user and done at your discretion.
As you can see by this article this subject is very difficult to follow and cannot be sorted through easily. For others to use the complexity of these issues as fear mongering is disingenuous at best. I do not say that to take this subject likely. Following the directions and usages of the products you use should be taken seriously. As you all have experience with the new VFD rules now, it is very important to track, and use antibiotics as intended and directed from your veterinarian. Not doing so would be a serious violation of the law. The same can be said for EPA regulated and registered products. I hope this allows you to better understand how the EPA views cleaners, sanitizers and disinfectants and how they are intended to be used and labeled. As it stands now we know Cid 2000 Pro is safe to use as a water line cleaner and we have verification to prove this. If a product is claiming to ‘kill’ an organism, then it must have an EPA registration number. However, to claim that cleaners by nature ‘kill’ organisms is ridiculous and not what cleaners are intended to be used for. Thanks for taking the time to read this article and better understand this complex subject.
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