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New Label Claims for Quatricide PV and Quatricide PV-15As many of you may know, suppliers of quaternary intermediates and holders of EPA approved master registrations have been engaged in the EPA's reregistering process which was launched in 1988. The fifth and final phase of this reregistration process is the recertifying of end use products.Since the prototypes are end use products, the manufacturer of the intermediates and the holder of the EPA approved master registration has started preparing for the QUAT "reregistration notice." This preparation consisted of reviewing data and identifying what studies must be done to bring the master label into compliance with current standards. When our products were originally registered with the EPA, the AOAC Use-dilution test was the standard test used to determine virucidal effectiveness. Under a Cooperative agreement with the EPA, testing labs have created the first standardized virucidal test. Based on testing done utilizing this more scientifically sound virucidal testing, they have identified three viruses claimed on our quaternary prototypes that are no longer capable of passing the virucidal test. Attached is an explanation entitled "Virus Update" that provides a more detailed description regarding the evolution of the virucidal test. Therefore in view of the above, we have been advised by the supplier of those quaternary intermediates with the canine parvovirus claim that effective 31 August 1997, the following organisms are being voluntarily removed from the EPA approved master label:
We have spoken in depth with the manufacturer and it appears that the new testing procedure makes it difficult to establish if the product is less effective than originally believed or if the procedure has been refined to the point where the results varied from technician to technician making consistency impossible. Please be advised that, to the best of our knowledge, the removal of these claims from the master label applies to all dilutable quat formulations. Any company that continues to promote their products with these claims after 31 August 1997 does so at the risk of having their registration canceled and possible fines if the product fails to pass an EPA review. Back to Index Virus UpdateDuring the past several years various testing labs in the United States and Canada have been working to refine and establish standardized efficacy test methods. Under the guise of several Cooperative Agreements and with the assistance of the AOAC, the Use-dilution Test, neutralization methods, Sporicidal test, and Tuberculocidal test have been reevaluated and the first standardized virucidal test has been created.Over the years, EPA and Health Canada have allowed a number of virology methods to be used as long as the method adheres to sound scientific principles. Therefore, if a method was found to work well for a given virus, it was accepted as proof for demonstrating the efficacy of the germicide. However, Huntington's position has always been to utilize the most scientifically sound current test methods to support all efficacy claims. We recognize the AOAC method for testing a disinfectant against bacteria. In the 1980's, this methodology was used when testing viruses and fungi. The fact is, virucidal testing is now substantially more sophisticated than the AOAC Use-dilution test. So where are we today? The virucidal cooperative method (#3) will shortly be accepted as the recognized standard test procedure for virucidal effectiveness. Compared to the older test methods (#1) and (#2) the differences are vast. To illustrate the differences between the three accepted methods we will discuss Canine parvovirus. The virucidal testing can be broken down into three main components. The areas are: hard surface, host cell, and perhaps the most critical with parvovirus, the method of detection.
By utilizing a petri dish (or vial) less viral wash off takes place. In method #1 a stainless steel ring (which holds the virus) is lifted out of a test tube which contains the test solution or neutralization media. Some of the virus may be washed off from the solution and thus lost from further testing. For each ring moved from one test tube to the next, a loss of virus takes place. The change from rings to petri dish or vial eliminates the loss of virus due to transfer. This change improves the repeatability of the test which may make the test harder to pass. The A-72 cell line has been shown to more readily support viral growth. This change improves the reliability and recovery of the virus; however, this may increase the difficulty of passing the test. The most important change with the newer methods of testing is with the detection of the virus. Traditionally, the detection of host cell infected with virus is done visually (This is known as cytopathic effect or CPE). This requires a very experienced technician to detect infected cells with a microscope. Although in the 1980's the Canine parvovirus infection was easily observed by virologists, it has now been reported that the virus has mutated to appear as though the host cells are not infected. Therefore a second method of detection had to be employed to fully quantify the virus. One of the methods used is Hemagglutination (HA) which uses blood cells to visualize the viral infection. Compared to CPE (visual), HA is far more definitive. This change vastly improves the sensitivity of the test which may contribute to the difficulty of passing this test. Virologists are still learning and will continue developing tests which are more reliable and reproducible. As the quality of all testing improves so may the degree of difficulty for certain viral types to pass the test. As the test methods have changed, Huntington Laboratories contracted several labs to perform the various test methods on Ascend. In addition, Huntington Laboratories reviewed available published literature discussing the effectiveness of quaternary ammonium compounds on Canine parvovirus and related viruses. Based on the research using the new methods and numerous published articles, Huntington is removing the following organisms from their quaternary based labels: Efficacy of Quatricide PV and PV-15Although we must remove these three claims from Quatricide PV and Quatricide PV-15 labels, these two products still have the claims against a full range of pathogenic bacteria, fungi and enveloped viral microorganisms along with Adenovirus Type 4 and Feline picornavirus, which are non-enveloped pathogens.Why We Produced This Special IssuePharmacal Research Laboratories has always stressed the importance of education and knowledge for our customers. While we are certainly disappointed with the latest EPA testing methods concerning Quatricide PV and Quatricide PV-15, we feel that it is extremely important for our customers to know what has occurred, why this has occurred, and how this impacts your animal husbandry program. We remind our customers to read the labels of all disinfectants presented for your consideration, as this ruling by the EPA will affect all suppliers of chemical disinfectants, not just Pharmacal.We remain committed to excellence in sanitation for animal care programs. Our Quality Assurance and Research and Development programs are in high gear working to answer many of the questions raised by this recent ruling. We will continue to keep our customers updated on all developments as they occur, by using forums such as direct customer mailings and the PharmacalFactSheet. If you have additional questions concerning this recent ruling, contact your Pharmacal representative at 1-800-243-5350. Water HardnessWater hardness is common throughout the United States and Canada. More companies are using water softeners than ever before. It is important that they are used properly and checked regularly. Water hardness is caused by dissolved minerals, usually calcium and magnesium. These minerals combine with other ions and compounds to leave deposits on surfaces. Cleaning agents in detergents react with oils and grease, and when in the presence of hard water, soap curd deposits will occur. Hard water is measured in Grains per Gallon (GPG) or parts per million (PPM). The standard degree of water hardness established by the Water Quality Association and the American Society of Engineers is summarized in this table.
It is not necessary to soften the water down to zero. Over softening is not only expensive but the excess sodium carbonate may leave deposits that will lead to spotting. When autoclaving, these deposits may lead to degradation of polycarbonate cages. If you are experiencing spotting you may consider raising your hardness level to between 1 and 3.5. If you would like to discuss your water quality, please contact your Pharmacal representative or call Tammy at 1-800-243-5350. R.O. System Installed at PRLPharmacal Research Laboratories has installed a new reverse osmosis system in our manufacturing plant to improve production of our disinfectants. The new system will easily allow our productivity to keep pace with customer demand. We feel that the use of deionized or reverse osmosis water will be necessitated by federal guidelines concerning the manufacture of disinfectants and sterilants. Impure water, when used in the chemical preparation of these E.P.A. registered disinfectants, can inhibit the abilities of these products. In layman's terms, bad water can alter a quaternary ammonium disinfectant, perhaps rendering it less effective. Pharmacal has designated mixing tanks in our production plant for our Clidox-S and our quaternary ammonium disinfectants. Our quality assurance standard operating procedures require that only those products are mixed in the designated tanks. If you are not using our disinfectants, you may wish to check with your supplier to see if they offer you these high standards of excellence. Chlorine Bleach versus Clidox-SChlorine bleach is well known for its virucidal abilities. However, there are several serious drawbacks to its use in animal facilities. Because chlorine bleach's effectiveness as a disinfectant is quickly reduced by organic soil load, precleaning is required before its use. Bleach reacts with acids to release chlorine gas which is highly toxic. Therefore, the use of bleach must be restricted if any acids are used in the cleaning process. Once diluted, the effectiveness of bleach diminishes with time and can become ineffective. Bleach is volatile and can cause severe respiratory problems in both animals and humans. When using bleach, rinsing is recommended. The Centers for Disease Control (CDC) recommends 600 ppm dilution of household bleach to inactivate the Human Immunodeficiency Virus. Careful reading of the label of the bleach product will tell you what the solution contained when it left the plant. Generally, household bleach is 5.25% sodium hypochlorite. Therefore a 1:10 dilution with water will offer 5250 ppm solution of chlorine. However, not all bleach manufacturers list the percentage of sodium hypochlorite on the label, especially those manufacturers who do not seek an EPA registration label for their products. And over time, the solution will begin to degrade and the active chlorine will dissipate. Managers will need to know how long that bottle of bleach has been on site to make an accurate determination of the amount of sodium hypochlorite available inside the bottle. Facilities considering the use of hypochlorites as disinfectants should be aware that Clidox-S (chlorine dioxide) offers a broad spectrum of disinfecting ability, including tuberculosis, without the major drawbacks of chlorine bleach. Organic soil load does not diminish the disinfecting ability of Clidox-S. The product must be mixed on site and has a specific shelf life, so there is no guessing about its effectiveness. Once mixed the product is relatively safe for use in animal care areas. The extremely short contact time required for disinfection means that exposure can be minimized. Chlorine dioxide's entry into the animal care area has allowed supervisors to use one product rather than two or three different disinfectants to perform the same process in a short period of time. If you have questions about the use of Clidox-S please contact your Pharmacal representative or call us at 1-800-243-5350. Ask PRLWe hope that you have found this newsletter informative.Do you have questions about sanitation that we can answer? Call us at the Pharmacal Research Laboratories office (1-800-243-5350) with your questions, comments, and suggestions. CopyrightPharmacal FactSheet is written and copyrighted by Pharmacal Research Laboratories, Naugatuck, Ct 1997. |
