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Thursday, 05/02/2013 7:35:05 PM

Thursday, May 02, 2013 7:35:05 PM

Post# of 197660
EMAIL FROM RENE REGARDING REPLY FROM LAB CLARIFYING STANDARD PLATE COUNT:

Thanks for posting this.
Best regards

Please see the courtesy notice for Standard Plate Count in the above pdf. This is only a courtesy because there is no FDA standards for Standard Plate Count only a guideline. There is no action necessary, and for just as much clarification please see the information below. Thank you, and please call or e-mail if you have any questions.



First, there is no true regulatory limit for the SPC. FDA has established a “guideline” value of 500 cfu’s/mL (colony forming units / milliliter). Second, it is a completely separate regulation from the actual “annual” testing. The annual testing is only for the chemical, physical, and radiological contaminants outlined in 21 CFR part 165, which is here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=165&showFR=1



The Total Coliform (TC) and SPC testing are their own separate regulation which states you have to test both the raw source and finished product, weekly, etc. - the newly update Ground Water Rule. But, this has nothing to do technically with the annual testing. Some states do specifically ask for the TC&SPC testing results as part of their state forms (GA for instance). But, for the most part, we only include the TC&SPC portion with your annual as a convenience to you. Just in case you need GA forms filled out for instance. Or, just in case you skipped your weekly micro testing and were planning on using our results from the annual for that week. Or, any other host of reasons it may become necessary to have. But, 98% of the time, it is extraneous to your annual testing and can simply be removed from the rest of the report packet if you don’t care to show anyone that page. It’s not hiding anything because it’s not part of the annual requirements.



I previously had to look up some info on Standard Plate Count (SPC)/ Heterotrophic Plate Count (HPC) for some international regulatory compliance. I researched a bunch of different regulations from various countries, industry associations, etc. Here are a couple of pieces of pertinent supporting documentation for you concerning SPC/HPC:



The World Health Organization, before making its newest version, 3rd Edition of the "Guidelines for Drinking Water Quality", had a special conference specifically addressing heterotrophic plate count and its impact as an environmental indicator on human health. It's called "Heterotrophic Plate Counts and Drinking-water Safety: The Significance of HPCs for Water Quality and Human Health" and can be found in its entirety here: http://www.who.int/water_sanitation_health/dwq/HPCFull.pdf.



Or, further in the same regulation http://edocket.access.gpo.gov/cfr_2002/julqtr/pdf/40cfr141.74.pdf:



(6)(i) The residual disinfectant concentration must be measured at least at the same points in the distribution system and at the same time as total coliforms are sampled, as specified in §141.21, except that the State may allow a public water system which uses both a surface water source or a ground water source under direct influence of surface water, and a ground water source, to take disinfectant residual samples at points other than the total coliform sampling points if the State determines that such points are more representative of treated (disinfected) water quality within the distribution system. Heterotrophic bacteria, measured as heterotrophic plate count (HPC) as specified in paragraph (a)(3) of this section, may be measured in lieu of residual disinfectant concentration.




But, none of this ever says this is an enforceable max level (MCL), and again, has nothing really to do with human health impact. This is what we consider a “guideline” value.



I also like to make sure that bottlers are comparing apples to apples regarding SPC testing. Keep this in mind. By the time a sealed finished product bottle has gotten to us by ground delivery, it has been a couple of days. And, even if you are sampling into laboratory provided containers, it is still at least 24 hours for the sample to arrive after the actual bottling. So, we are testing the sample after it has had time for the ozone to completely dissipate, and there has been adequate time for micro growth to begin. When you are testing on-site, or with a local lab the same day or even the next day, this does not adequately allow the ozone residual time to dissipate and your sample should be inherently cleaner. Plus, there are numerous growth mediums and agars which differ in their capacity to support various organisms. The medium we use is prepared and sterilized in-house according to precise regulatory protocols by certified microbiologists. It is excellent at sustaining a very wide range of heterotrophic bacteriological life.



As such, especially with natural Spring waters, plate count is constantly varying inside a product bottle. It is unlikely that every single bacterium is destroyed in the disinfection process. Remember, you are disinfecting the water, not sterilizing the water and there is a huge difference. Inevitably, these bacteria (which are hopefully of the non-invasive heterotrophic types instead of Coliform species) and other microbes begin to proliferate and the plate count goes up. As the microbes die off, the SPC goes down, and so on and so on forming a sine wave shaped graph. Of main importance is that no Coliform (E. coli more specifically) bacteria are detected, which is where the FDA would have a problem.



I hope some of this helps. So, it is a requirement that both finished product and sources should be tested weekly for total Coliform and SPC/HPC, but there is no real remediation or necessary treatment for just plate count as it is a non-enforceable guideline value.