New APVMA Guidelines For Pool & Spa Sanitisers July 1st 2014

[JoPrice]

Hi , there appears to be a number of chemical experts on this site. I am here to see if anyone has the scientific data to verify the latest APVMA efficacy requirements.

On the 1st July 2014 the APVMA in Australia implemented new guidelines for demonstrating efficacy of new pool & spa sanitizers. The majority of branded chemical sanitizers on their list of approved products use either Chlorine, Hydrogen Peroxide or Polyhexanide hydrochlorite. When compared to the rest of the world the APVMA laboratory efficacy requirements and range of test organisms appear to be somewhat excessive and prohibitive from a cost point a view for companies looking to gain approval using innovative methodologies. It is my understanding the APVMA has not tested any of their currently registered products to demonstrate they can meet the new guidelines. They have given the existing registered chemicals a free pass on the grounds that the efficacy is already well documented. I have searched for, but cannot find any scientific data that suggests any of the aforementioned chemicals can meet the new efficacy requirements. The following APVMA link http://new.apvma.gov.au/node/1039 will take you to the laboratory test requirements see section 1.1.13

Is there anyone on these forums that can supply me with recent scientific data proving that chlorine, hydrogen peroxide and Polyhexanide hydrochlorite can achieve the guideline efficacies at typical pool & spa residual levels against all the test organisms and required CT listed?

I also draw attention to this extract from the same document re operating residual levels.

Extract"1.1.3. Establishing a safety margin
The sanitiser needs to remain effective against pathogens at 50 per cent of its recommended operating concentration. This efficacy margin can be established by testing against the single species Pseudomonas aeruginosa, according to the performance characteristics indicated in Table 1.

In relation to bather health, the sanitiser must have been independently demonstrated to be safe for bathers at two times the highest recommended concentration of the active constituent(s)."End.

Is this realistic? Your comments please.


 

[chem geek]

Welcome to TFP!

Yes, I just saw that recently and had to update links in this post as a result.

The field tests are closer to what is seen in DIN 19643 from Germany and used in some other countries in Europe that for field testing require no detectable Pseudomonas aeruginosa, Escherichia coli in 100 ml or Legionella pneumophila in 1 ml and a maximum CFU of 100/ml. It just looks like they've added some of those to the laboratory testing and added tests against viruses and protozoan oocysts as well. It has more tests than EPA DIS/TSS-12 that only test against 2 bacteria for the laboratory efficacy test.

The EPA test with a 6-log reduction requirement is more stringent than the APVMA test for bacteria. The EPA test limit is roughly equivalent to 0.4 ppm FC with no CYA at a pH of 7.5. I would estimate the APVMA limits to roughly correspond to 0.25 ppm FC of chlorine for the bacteria tests. For the virus tests, it's less than 0.1 ppm FC. For Giardia, it's around 0.5 ppm FC (at pH 7.5) while for Neagleria fowleri (based on info from this link and this link using a CT of 46 or this link using a CT of 52.9) is 1.5 to 1.8 ppm so that is one of the strictest of all of the tests and seems to be an outlier so maybe a mistake. Note that their Legionella pneumophila criteria would not be met by chlorine except at 4 ppm FC and I believe their spa pool minimum is 2 ppm FC so that is inconsistent. You can look at the CDC page for chlorine effectiveness and CT values.

So all the chlorine products should work to pass the tests except that the Neagleria fowleri test might put the minimum level at 1.5 ppm FC and the Legionella pneumophila test might put the minimum for spa pools at 4 ppm FC. Ignoring that, then the minimum including the "half" rule against Pseudomonas aeruginosa would imply 0.5 ppm FC so seems consistent with EPA tests in terms of the minimum chlorine level required.

As for hydrogen peroxide and Polyhexanide hydrochlorite (Baquacil/biguanide/PHMB), I don't believe they have been tested against the viruses and protozoan oocysts generally and I suspect they would fail for at least some of these tests. I did find biguanide tested against adenovirus and it was NOT effective (see this link) so you can use that as a clear example of a failure. However, the only pool biguanide product is listed as a "pool algicide", not a "pool sanitiser". There are studies showing kill times for hydrogen peroxide used in wipes on surfaces, but that is not the same as being used at 100 ppm concentrations in pool water. As for swimming pools, this paper indicates that silver ions combined with hydrogen peroxide in the Nanosil product at 20 mg/L (ppm) prevented uncontrolled bacterial growth but killed Staphylococcus aureus slowly requiring 20,000 ppm for 30 minutes (a bacterial species chlorine kills in seconds). As noted in this paper, some bacteria are resistant to hydrogen peroxide because they produce the enzyme catalase (this is why silver ions are also needed since they interfere with catalase). This paper indicates that hydrogen peroxide vapor was effective at inactivating viruses possibly in the rough timeframes required by the APVMA. While APVMA could certainly say that the listed products have passed the earlier bacterial tests, they can't say that (except for chlorine) they meet the additional tests, especially against viruses and protozoa.

Note that Table 1 that you showed is described as coming from the following:

While there is no specific requirement for a parallel chlorine standard (control) to be incorporated into a laboratory test protocol, in testing a new pool or spa sanitiser, we expect you to show that the performance characteristics of the sanitiser being tested are essentially equivalent to recognised hypochlorous acid or hypochlorite antimicrobial efficacy characteristics. These established characteristics are detailed in Table 1.

and note the following:

Where a product is shown to be slower acting than free chlorine, it may still be acceptable, provided the data demonstrates that the difference in activity is not significant and efficacy against key indicator organisms is equivalent to or better than comparable features of chlorine.

Results from other efficacy studies with other indicator organisms may be accepted by the APVMA, provided that additional scientific information and argument can satisfy us that those studies prove the product meets the efficacy criteria.

So it is not clear that you would have to meet all of the criteria exactly though you'd probably need to be pretty close. They also say the following:

Table 1 shows the performance characteristics of an effective sanitiser against the recommended test organisms. The performance characteristics of one milligram per litre of free chlorine (from hypochlorous acid or hypochlorite) have been demonstrated in the scientific literature to be equivalent to the performance characteristics shown in Table 1.

though I'm not sure what literature they are looking at since their numbers are off a bit in some cases. So they were thinking that the table represented 1 ppm FC levels, but in fact except for the Neagleria fowleri species it's really around 0.5 ppm FC or less and that makes sense given their 50% rule.

I just wrote to APVMA about some of these issues so we'll see what they say.

 

[kathrynbright]

Chemgeek,

“I just wrote to APVMA about some of these issues so we'll see what they say.”

Good luck with this!

For me this is a very timely post as I am currently investigating the Waterco Hydroxypure system. During the last six months I have had communications with both the APVMA and also Gold Coast City Council who are running a trial of the Hydroxypure system in a children’s water park on the Gold Coast, Queensland, home of the "inventor".

You may not be aware, but currently there is much discussion in Australia regarding the safety of this much-publicised system. I have now come to the opinion that Waterco have hurried this to market in a reckless rush of commercialization without any thought for public health and safety. I also believe the APVMA are demonstrating double standards, when it comes to the Wateco Hydroxypure system and they are putting the interests of the chemical industry before public health and safety, my reasoning for this as follows.

Waterco, a public listed company have pitched their launch to primarily financial/investment media, example here, as expected this has created a lot if industry interest, scrutiny & concern example here. Not really red tape in my opinion more like safe guards.

There are two possibilities as I see it.

1. The inventor claims a new invention, if this is correct, public safety comes first, it should be tested to the APVMA guidelines before trialing in a childrens water park.

2. The Hydroxypure is not a new invention and falls under existing APVMA registered sanitisers. It appears that in the APVMA's reply to me they do not consider it new technology. They also highlighted that UV/Ozone does not come under their authority, they only have jurisdiction over the chemical hydrogen peroxide.

• The Waterco Hydroxypure System contains an ozone generating device. Devices do not fall within the legal jurisdiction of APVMA. Ozone generated on-site for treatment of pool or spa water is declared not to be an agricultural chemical product by the Agricultural and Veterinary Chemical Code Regulations 1995 at Schedule 3, Part 3, Item 17.

and this

• There are current registered chemical products containing hydrogen peroxide that can be legally used in conjunction with ozone generating devices, noting that some of these chemical products are currently approved for use in domestic situations only. Please note that information on the APVMA’s website relating to the testing of efficacy for pool and spa products is guideline material. The APVMA has recently published draft guideline information regarding demonstrating efficacy for pool and spa sanitisers at:http://new.apvma.gov.au/node/1039.

and this

The registered products are described variously on the website as ‘chlorine’, ‘sanitiser’ or algaecide’. Of these there are two products registered to Waterco and containing hydrogen peroxide which are described as ‘sanitisers’. These are P39380 Poppit Sanitiser and P40742 Poppit Sanosil Pool & Spa Sanitiser

more

Based on the approved label P39380 could be used in a commercial pool. The label refers to other products such as ‘Quick fix oxidiser’, ‘Poppit filter cleaner’ as well as use of Poppit Test Kit or Poppit Peroxide test Strip. As far as we can determine none of these products would require registration. The label is silent as to whether the product could be used with ozone however compatibility claims are not assessed and as stated above ozone does not require registration. In general any registered pool product can be used in conjunction with any other pool product (registerable or not) provided such use is not precluded on the label.

According to the APVMA feedback above, they have approved hydrogen peroxide for use in any commercial pool in Australia as a residual sanitiser despite most state health departments ruling that the methodology is unsatisfactory for use as a disinfectant in commercial pools. I have since asked APVMA for the scientific data they have relied upon to support approval. That was six weeks ago and despite frequent follow up requests I have not received the courtesy of a reply to date. The more I investigate this the more I feel there is protectionism within the APVMA and possible influenced by the chemical industry rather than putting public safety first. As an example, in my research I came across a lot of references to the APVMA when it comes to copper/silver ionisation, a methodology shown to reduce chemical volumes. TFP also makes regular reference to the APVMA ioniser recall as peer review material.

This document could also be construed as bias in favour of ionisation but does raise some questions on the APVMA's position and modus operandi. Interestingly the following extract from the document shows that the Hydroxypure methodology using ozone/hydrogen peroxide was incorrectly used by the APVMA in their case against ionisers. Ref 5.4 pg14 Extract


Despite the similarities, an ioniser is the only system to be registered. Although the APVMA has clearly stated that it is not willing to guarantee the efficacy of any other systems it has chosen to exempt the systems from registration and testing.

The system known as Ultra Violet + Hydrogen Peroxide also presents a situation where there is one rule for one and another rule for another.

An article published in a Commonwealth Government publication - CDI (Communicable Diseases Intelligence), Volume 21 No23, 25 December 1997 notes an incident of infections from a spa in Victoria that used Ultra Violet + Hydrogen Peroxide. The extract is self explanatory - "The outdoor spa pool was being treated with hydrogen peroxide solution.......... The use of UV - hydrogen peroxide systems is not allowed in public pools in Victoria due to poor performance levels."

The APVMA was made aware of the problem at the time and since then. The APVMA has chosen to do nothing and when quizzed about its inaction the reasons could be interpreted as it could not be bothered.

Even though the Victorian Government unambiguously states "The use of UV- hydrogen peroxide systems is not allowed in public pools in Victoria due to poor performance levels." The APVMA has not acted on the expressed risk to public health but yet acts against ionisers with no evidence.

Interestingly, as part of the tactics of half truths, misrepresentation and innuendo adopted by the APVMA, it has used the reference to the incident published in the CDI article as justification of its actions against ionisers and for continued warnings on its web site.

Many years have passed since the ioniser recall but it appears the APVMA's actions are still questionable when it comes to chemicals of concern.

I contacted Gold Coast City Council asking what efficacy data they are relying on to allow the trial to be conducted in a childrens water park. The reply was alarming, they are acting on advice from the manufacturer and are using a local council sub law to allow the trial to run even though Queensland State Health Department does not endorse the system. I am told that when contacted Queensland Health commented that "they can not take action until someone becomes sick as a result of swimming in the pool".


Right now my investigation is on the Hydroxypure system. TFP's expert opinions and comments would be much appreciated. This forum regularly refers to CDC documentation to back up the science. I came across the following CDC documentation that highlights the ineffectiveness of hydrogen peroxide + ag as a pool or spa disinfectant. link

Extract pg 52/53

Hydrogen peroxide is not registered by the US EPA as a disinfectant for recreational water. Since it is not registered, the use of hydrogen peroxide as a recreational water disinfectant, or any market claims that implies hydrogen peroxide provides any biological control in recreational water is a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Hydrogen peroxide has been granted registration by the US EPA as a hard surface disinfectant and several other applications. The US EPA Registration Eligibility Document (RED) on hydrogen peroxide is available from the EPA website at www.epa.gov/oppsrrd1/REDs/old_reds/peroxy_compounds. pdf. The US EPA posts PDF copies of accepted product labels on the National Pesticide Information Retrieval System website http://ppis.ceris.purdue.edu/#. Product claims for uses and concentration may be verified by reading the PDF of the US EPA stamped and accepted copy of the product use directions at this website.
When used as a hard surface disinfectant hydrogen peroxide is normally used at around 3%. When used in recreational water, hydrogen peroxide is used at 27 to 100 PPM (MG/L), which is 1111 and 300 times, respectively, more dilute than that used on hard surfaces. Borgmann- Strahsen evaluated the antimicrobial properties of hydrogen peroxide at 80 and 150 PPM (MG/L) in simulated POOL conditions.71 Whether 150 PPM (MG/L) of hydrogen peroxide was used by itself or in combination with 24 ppb of silver nitrate it had negligible killing power against Pseudomonas aeruginosa, E. coli. Staphylococcus aureus, Legionella pneumophila or Candida albicans, even with a 30 minute contact period. In the same tests the sodium hypochlorite controls displayed typical kill patterns widely reported in literature. Borgmann-Strahsen concluded that hydrogen peroxide, with or without the addition of silver ions, was, “no real alternative to CHLORINE-based DISINFECTION of swimming POOL water from the microbiological point of view.”

Conclusion: The APVMA are going against all the available scientific data and worldwide health departments advise in their recent confirmation to me on the approval of hydrogen peroxide for use as the residual sanitiser in public pools. I personally think they have opened up a pandora's box. Despite their claims to the contrary the APVMA is not putting public health & safety first when it comes to the approval and registration pool sanitising products.

Extract: The Board also discussed the matters raised in the Four Corners' program of 22 July relating to spray drift and dioxins in chemicals. The Board stressed the importance of taking a scientific, evidence-based approach to protecting the health and safety of the Australian community in relation to these matters. Close”

Since it's launch I have discovered many problems and issues with Waterco's Hydroxypure system. The manufacturer is acting irresponsibly, making deceiving and unsubstantiated claims and attempting to circumvent the efficacy test stage, most likely in the knowledge that it would fail. Children are currently being used as human guinea pigs in a commercial waterpark and Gold Coast City Council's "approval" of the trial has being deliberately misrepresented as a national approval of the system in company press releases aimed at consumers and investors.

I would appreciate you and your fellow advisors responses to this? Do you agree with the APVMA approval of hydrogen peroxide or the CDC document and most world health departments views that it is an unsatisfactory pool sanitiser.

In closing, I have just being informed that a request under freedom of information act has recently being submitted to the APVMA for the efficacy data they have relied upon for the approval of Hydrogen peroxide along with a request for a review of all registered pool sanitisers to demonstrate that they can meet the new efficacy guidelines.

KB

 

[chem geek]

Kathy,

Thank you for your post. I had trouble finding efficacy data on hydrogen peroxide used in pool water at those concentrations (most studies were for contact usage such as wipes) so I'm glad you found the info from the CDC. I should have thought to have looked at the Model Aquatic Health Code (MAHC) since I've made extensive comments on that document. This paper is the one they refer to that shows hydrogen peroxide to be ineffective against bacteria at swimming pool concentrations. In fact, it showed log reductions lower than 0.301 (a 50% kill rate) in 30 minutes against Pseudomonas aeruginosa (0.16-log reduction) and Escherichia coli (0.13-log reduction) and just 0.33-log reduction after 30 minutes for Staphylococcus aureus and just 0.41-log reduction for Legionella pneumophila. This isn't even enough to prevent uncontrolled bacterial growth under ideal conditions for such growth.

However, something smells fishy about this study because they found no improvements when using silver ions in the water. Other studies have shown silver ions to have at least a slow kill against fecal bacteria. This paper in Figure 2(a) shows 1.5 hours for a 3-log reduction of Staphylococcus aureus with silver ion at 0.05 ppm (50 ppb) while Figure 2(b) shows around 20 minutes for a 3-log reduction of Escherichia coli at 0.05 ppm (50 ppb). The Borgmann-Strahsen study used 23.6 ppb silver so perhaps this difference is a minimal inhibitory concentration effect.

As for Hydroxypure, it uses a combination of ozone and hydrogen peroxide which is a process that produces significantly greater numbers of hydroxyl radicals relatively quickly (so before much of the ozone has a chance to react with other chemicals). Interestingly, they generate the ozone via UV and not corona discharge (CD) and generally UV production of ozone is inefficient. Pretty much all commercially-sized ozone units use CD and some use oxygen concentrators as well. This EPA document describes the peroxone process. Its main benefit is its ability to oxidize chlorinated organics, but if hydrogen peroxide is used in the bulk pool water then that is incompatible with chlorine because hydrogen peroxide is also a reducing agent in the presence of chlorine (i.e. it is a dechlorinator). So the Hydroxypure system does not provide a residual disinfectant of any value since hydrogen peroxide was shown above to not be an effective bactericide.

The document from Aquamatics to the APVMA regarding metal ionization systems has some inaccuracies in it. They deceitfully imply that Nature² is approved by the EPA, but for swimming pools that is not true unless chlorine is used in conjunction with the copper and silver ions in that system. It is only for spas where Nature² with MPS is approved because only under hot water conditions does the combination of silver ions and MPS provide disinfection fast enough to pass EPA DIS/TSS-12. As I note in detail in this post, copper ions alone do not kill fecal bacteria so a metal ion system needs to be a combination copper/silver system to provide sufficient kill for a variety of bacteria, but such kill times are slow and may not prevent person-to-person transmission of disease. In particular, metal ions do not appear effective against viruses nor protozoan oocysts. This is why they are not approved by themselves (i.e. without chlorine) for any commercial/public pool in the U.S., Canada, nor many countries in Europe. Such metal ion systems are allowed in residential pools but cannot make bactericidal or disinfection claims -- the residential market is a "let the buyer beware" market similar to how commercial kitchens are highly regulated for safety while residential kitchens are not.

I don't have the details of the Aquamatics tests but they claim that in tests using tap water with urea added "that chlorine did not disinfect as well as claimed and showed the Aquamatics’ ioniser performed very well in those circumstances". I can only suppose that this is similar to adding ammonia to such water in that if the chlorine level is not MAINTAINED, then it gets used up oxidizing the contaminant being unavailable for disinfection. That obviously is not a fair test since Free Chlorine levels are supposed to be maintained so any test criteria should similarly maintain that level if the demand would be high enough to deplete it. Aquamatics also uses an oxidizer called Aquabrite that sounds like potassium monopersulfate (MPS) non-chlorine shock. The combination of copper/silver ions with MPS likely controls bacteria growth, may inactivate viruses, and might slowly inactivate protozoan oocysts but would not be fast enough to meet the person-to-person transmission of disease criteria except at hot spa temperatures.

Richard

 

[chem geek]

So, JoPrice from Sydney and kathyrynbright from Melbourne, how is it that you both have the same IP address? And you appear to be the same person, KarenG, who posted in this thread. Who are you really?

 

[duraleigh]

Who are you really?

Certainly seems like a fair question.

 

[kathrynbright]

No problem, Yes, I know Jo Price we work in the same office. We have been requested to look at both the APVMA and Hydrogen Peroxide use in particular the recently launched hydroxypure system. Jo is now handling the APVMA side and I am looking at the Hydrogen peroxide side of the research.

In regards to IP addresses, our office uses a VPN.

May I also ask you a few questions?

As a forum contributor, how do you have access to each individuals IP data? There are 10’s of thousands of posts on the internet under your handle Chemgeek and Richard Falk. The time devoted to this would be considerable. Are you an individual or are there others posting under your handles? Do you receive any remuneration for this work from anyone who has a vested interest in the promotion of pool systems or chemicals?

Also fair questions I think, given the amount of posting by you on many different sites on the Internet.

The pool industry appears to have many "experts", problem is they all have different views and agendas, this makes it very difficult to get the true information, hence our method of approach.

KB

 

[duraleigh]

Re: New APVMA Guidelines For Pool & Spa Sanitisers July 1st 2014

No problem, Yes, I know Jo Price we work in the same office.

This ends now. What do you mean, "No problem"?

You have apparently posted under three different names without identifying the connection of the three.

Troublefreepool exists for the sole purpose of understanding pool water chemistry, management and pool hardware management.

TFP has no interest in Waterco Hydroxypure system nor any interest in proving it to be effective or not.......Your agenda appears to differ drastically from that.

I am closing the thread and banning all three of your usernames from participation on the forum.

There are thousands of places on the net where one can be duplicitous with his identity and agends. We fight hard to keep ours from being one of those places.

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This thread is permanently closed