Welcome to Professional and Technical Services (PTS) – experts in chemical disinfection for infection prevention. Our goal is to educate and provide you the latest resources related to cleaning and disinfection of environmental surfaces, medical devices and hands. As specialists in disinfectant chemistries, microbiology, environmental cleaning and disinfection, facility assessments and policy and procedure creation we are dedicated to helping any person or facility who uses chemical disinfectants.

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Thursday, May 31, 2012

Is the EPA condoning the use of Steroids?

The baseball season has started and for those of you diehard fans watching your favorite player hitting yet another ball out of the park, like me you may be wondering “How the heck do they do that!” 

Professional sports are a great example of an industry that has perhaps raised the bar too high and set too many unrealistic goals for players to achieve. We wonder who will be the next Barry Bonds.  We get caught in the thrill of watching these talented players and rarely think to ask “How did they get that good, that strong, or that big?” Then we open the front pages of the sports section and hear of yet another steroid scandal. 

The disinfectant world is not unlike professional sports.  There are new bugs cropping up that Infection Prevention and Control, Public Health and Environmental Services expect their disinfectant of choice to kill.  The bar is being raised to unrealistic expectations – kill a greater spectrum of bugs in a shorter contact time.  To meet these demands, disinfectant manufacturers “juice up” or increase the chemical concentration or combination of chemicals in their disinfectant formulations in order to achieve the desired claims.  Like the long term affect steroids can have on a baseball player, “juicing up” a disinfectant formulation means the safety profile of the disinfectant will be compromised. 

Let me give you an example of this.  There is a popular disinfectant brand on the market advertising that in recent years they have knocked their contact time down from 5 minutes to 3 minutes and now 1 minute!  From an infection prevention perspective you may be screaming “FANTASTIC”!  But have you taken the time to look at the MSDS in order to determine how they have performed such a feat?  I have.  It’s “juiced up”, one of the active ingredients has tripled in concentration and they have added a second type of alcohol.  What is the end result?  A 1 minute disinfectant that now carries a HMIS Rating of 2/3/0.  To handle this product you should wear gloves and goggles and the toxicity profile shows it is Toxic by inhalation per OSHA regulations, slightly irritating to eyes and skin, contains material which can cause target organ damage and contains material which both causes and may cause damage to the organs.  That’s just the health effects.  The Flammability rating of 3 indicates the product is highly flammable and should be stored in a segregated and approved area and all possible sources of ignition (spark or flame) should be avoided.  Is this a product you want to use?  Is a one minute contact time so important that we would knowingly choose a product that would put cleaning and nursing staff at risk?

Federal law requires that before selling or distributing a pesticide in the United States, a person or company must obtain registration, or license, from EPA.  Before registering a new pesticide (including disinfectants) or new use for a registered pesticide, EPA must first ensure that the pesticide, when used according to label directions, can be used with a reasonable certainty of no harm to human health and without posing unreasonable risks to the environment.   Herein lays the crux of the problem. 

To generate bactericidal efficacy data, the EPA requires the use of a test method that was introduced in the early 1950’s and is known to have flaws.  In a study recently published in the Journal of AOAC International, titled “Should the AOACUse-Dilution Method be Continued for Regulatory Purposes?” a statistical evaluation of the Use-Dilution Method (UDM) was conducted.  I won’t bore you with the details or formulas used – you can read the study at your own leisure.  Suffice it to say, the study showed that there was a significant disconnect between the probabilities of a pass/fail result when compared to the random testing conducted by the EPA’s Antimicrobial Testing Program.  The difference can in part be attributed to the fact that the method shows significant variability in the numbers of bacteria that adhere to carriers, however, the main cause is in fact highly operator sensitive such as how the lab technician places of the cylinders into the test tubes or places the test specimens for drying as well as any variations in growth conditions.

Further, UDM is not representative of real world conditions, especially for products with rapid evaporation rates (alcohol based products) as the concentration of the active decreases rapidly when exposed to a surface.  UDM provides a much higher ratio of disinfectant volume to surface and does not account for evaporation rate that occurs when used in accordance to the product’s label.  Similarly, the ratio of disinfectant to inoculum is very different than what is encountered in practice and lastly, there is limited ability to include other environmental surfaces which can also alter the outcomes of efficacy capabilities of a given disinfectant.

It is also important to consider the affect development of very robust formulations have from an environmental impact perspective. Globally, users of chemicals are looking for and demanding access to more environmentally friendly products, however, the EPA’s rigid stance and refusal to transition to methodologies that have been shown to be more accurate and consistently reproducible such as Quantitative Carrier Tests impacts both the environment through higher carbon footprints in the production of the disinfectants, unnecessary disposal of higher concentrations of disinfectants by the end user and also increased risk to the user as a result of less favorable health profiles.

By no means am I saying that from an infection prevention perspective we should use inferior products with contact times that are unrealistic.  I am saying that we as a community who uses disinfectants on a daily basis should consider not just what a product kills, but also the safety profile of the product and lobby the EPA for the use of test methods that have been shown to be reproducible, reliable and more accurate than the Use-Dilution Method.  Formulation of disinfectants is a complex process that involves finding the balance between the desired efficacy traits and the desired safety and environmental profile of a product.  The EPA’s mandate is to ensure that the use of disinfectants “can be used with a reasonable certainty no harm to human health and without posing unreasonable risks to the environment”. The use of UDM completely contraindicates this mandate as it forces disinfectant formulators to “juice up” their formulations in order to achieve the kill claims and knowingly decrease the safety profile of the product. 

I hope you’ll consider this the next time someone comes your way with the next “fastest” disinfectant on the market.  A fast kill is a double edged sword.  Are you willing to forego safety for speed knowing that the test methods used to determine efficacy are faulty?

Bugging Off!
Nicole 

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