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Friday, April 22, 2016

EPA Emerging Pathogen Update - Cause for a Happy Dance!

When it comes to dealing with regulatory bodies, it is notoriously tricky and I am sorry to say that many of my interactions have not left me in “my happy” place.  However, the announcement by the EPA on April 7th was exciting enough for me to jump up and dance!   The ruling is equally important for both human and animal health so I did not just do a happy dance, I did a Puppy Monkey Baby dance!  For those who did not watch the Super Bowl and were lucky enough to have escaped seeing the Puppy Monkey Baby (PMB) I will apologize for any mental scaring or nightmares I may cause as a result of you watching the video.  Without a doubt Mountain Dew produced one of the most disturbing commercials of Super Bowl 50 and probably in the life of commercials with its terrifying puppy-monkey-baby hybrid.

Until the announcement of the Updated Emerging Pathogens Guidance disinfectant registrants were forced to test each and every virus they wanted to make a claim against.  This of course causes significant issues when new viruses “pop up” leading to significant outbreaks such as Ebola, Enterovirus D68 or Porcine Endemic Diarrhea virus (PEDv).  When an outbreak erupts as a result of a new virus, it can take a considerable amount of time to identify what the new virus is (e.g. think back to SARS when we had no clue what the virus was).  If we have not yet identified the virus, a disinfectant manufacturer cannot have their product tested against it.  Even if the virus has been identified it can be months or years before a method is developed that meets the EPA’s requirements to allow for label claims.  There can also be times such as with Norovirus where surrogates must be used because the actual virus just cannot be cultured and grown in a lab in the way needed to conduct disinfectant efficacy testing.

The need for considering the hierarchy of susceptibility is not new.  There was an excellent article written in 2007 by Dr. Syed Sattar, a world renowned microbiologist who recommended “In the case of new and emerging viruses still awaiting culture and full characterization, it is proposed that any official recommendations for disinfectant use be based on the well-established hierarchy of susceptibility to such chemicals as related to virus particle size and structure”.  Several countries including Canada, Australia and several in Europe have implemented a “General Virucide Claim” whereby a disinfectant, if it has shown efficacy against one or more viruses such as poliovirus, adenovirus or parvovirus, allows a product to state that it has the ability to kill both enveloped and non-enveloped viruses.  This claim can then be applied in the event of an outbreak by a virus of unknown origin.  This is exactly what Canada did in 2003 during the SARS outbreak.

The EPA’s Emerging Pathogen Guidance is not perfect, but it is certainly better than nothing!  Under the new guidance document, the EPA outlines to registrants the viral hierarchy that can be used to identify effective disinfectant products for the use against emerging pathogens. In addition to this, it now permits registrants to make limited claims of their product’s efficacy against such pathogens. According to the EPA, the intention of the new guidance applies only to emerging viruses and is intended to allow for a voluntary, two stage process that involves product label amendments and modified terms of registration.  Unlike the countries noted above where there is a blanket General Virucide Claim, the EPA has decided that this guidance may be taken for eligible products ONLY after the Centers for Disease Control and Prevention or the World Organization for Animal Health (OIE) has identified an emerging pathogen (new or re-emerging) where environmental surface disinfection has been recommended to help control its spread. 

According to the EPA, in order to be eligible to meet the Emerging Pathogen Guidance, the disinfectant product must meet the following 2 criteria. 
  1. The product is an EPA-registered, hospital/healthcare or broad-spectrum disinfectant with directions for use on hard, porous or non-porous surfaces
  2. The currently accepted product label (from an EPA registered product as described above) should have disinfectant efficacy claims against at least one of the following viral pathogen groupings:

a.      A product should be approved by EPA to inactivate at least one large or one small non-enveloped virus to be eligible for use against an enveloped emerging viral pathogen.
b.      A product should be approved by EPA to inactivate at least one small, non-enveloped virus to be eligible for use against a large, non-enveloped emerging viral pathogen.
c.       A product should be approved by EPA to inactivate at least two small, non-enveloped viruses to be eligible for use against a small, non-enveloped emerging viral pathogen.

For example, this means that if the virus associated with the outbreak is caused by a small, non-enveloped virus, the disinfectant must already be registered and proven effective against two (2) small, non-enveloped viruses.  If the product only has claims against enveloped viruses it will not qualify.  The product is also not eligible to have a claim on the actual product label, and can instead use language akin to the following on marketing materials, technical sheets etc for two years from the announcement of the outbreak.

[Product name] has demonstrated effectiveness against viruses similar to [name of emerging virus, which must be a small non-enveloped, large non-enveloped, or enveloped virus] on [eligible surface type(s)]. Therefore, [product name] can be used against [name of emerging virus, which must be a small non-enveloped, large non-enveloped, and/or enveloped virus] when used in accordance with the directions for use against [name of supporting virus(es)] on [hard, porous/non-porous surfaces]. Refer to the [CDC or OIE] website at [pathogen-specific website address] for additional information.
As I said, it’s not perfect, but it’s better than nothing and still worth doing my Puppy Monkey Baby dance!

Bugging Off!


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