by Bureaucracy Buries Additions to Public Health
A handwashing-without-water protocol has perplexed the FDA and its Conference for Food Protection (CFP) for 12 years, unable to resolve it at six successive biennial sessions. This recurring issue, Hand Cleanse-Sanitize Protocol Not Requiring Running Water (SaniTwice) was presented one more time at the 2018 CFP in Richmond Virginia, April 16-20. The FDA’s Center for Drug Evaluation and Research (CDER) again failed to deliver an official definition for a handwash. Without a minimum standard of effectiveness, no altervative protocols could be considered, even with strong scientific support. Many feel another two year wait will not produce a definition of a handwash as the FDA continues its search for perfection which has become the enemy of good.
Council III was successful in a recommendation to eliminate hand cleansing towelettes from The Model Food Code. Losing towelettes and the SaniTwice protocol, now restricts code-approved handwashing to only handsinks with water, either running or gravity fed. One of CDER’s reasons for not supplying a minimum standard may be related to the poor handwashing that results from these temporary event gravity fed setups which have taps that are easily contaminated and water reservoirs which are often compromised. These setups also beg the question as to why the code seeks a water flow of 2.2 gallons per minute for effective handwashing but accepts the trickle of these gravity fed options.
Besides its military use, this two-step ABHS process now serves as a consideration for farm use as part of FSMA’s Produce Rule and has two more years of successful use by the Clark County School District (Las Vegas) when protecting students during periods of water-outages when serving food. These effective uses are based on science rather than Food Code approval.
Handwashing issues and any hope of a CFP Hand Hygiene Committee were taken off the table at Conference For Food Protection 2016 in Boise Idaho as the regulatory community decided that a definition of a handwash could not be reached thus any proposed alternatives could not be measured, considered or approved. Research was shut down for two years which now stretches to four or more likely 6. The official CFP Hand Hygiene Committee was dissolved and a motion to renew it in 2016 was rejected as neither the FDA nor CDC could say what a handwash is or does.
Reasons to reject this Hand Cleanse-Sanitize Protocol Not Requiring Running Water have ranged from lack of research and use-history to the lack of CDER approval. Some regulators mistakingly interpreted this as an issue of supporting a commercial product when the process was given the more concise name of SaniTwice® and trademarked by Handwashing For Life®. This was done to define, normalize and control the process for training, much like the IAFP did when trademarking their food safety icons, free for everyone to use. SaniTwice is simply a two step handwash following the often favored sequence in foodservice of a cleaning process followed by a kill step.
The FDA, CDC and CFP Council III have ignored the fact that SaniTwice is just a process and works for all approved hand sanitizers (considered hand antiseptics by regulatory). The reality appears to be a deep FDA or CDC bias in foodservice against these hand sanitizers while they have been credited with safely saving untold lives in healthcare for decades.
The alleged bias ends up restricting the use of SaniTwice at outdoor events, food trucks, and emergency situations, even at petting zoos, although there are unofficial accounts of it being deployed by CDC teams during disaster relief efforts. Cruiselines like it for use on land excursions to places where no handsinks exist.
