A FSMA Produce Rule solution
Research has found that farmhand’s hands are a major factor in contaminating ready-to-eat produce. Conventional thinking about feces-contaminated water and manure fertilizer as the major sources was challenged in a study by Emory University. Their research included a successful field-testing of SaniTwice®, referred to as the “two-step ABHS intervention” (Alcohol-Based Hand Sanitizer.)
Responding to the FSMA Proposed Rule for Produce Safety, the goal of this study was to assess the field-effectiveness of two soap-based and two ABHS-based hygiene interventions to reduce microbes and soil on farmworker hands after harvesting produce.
The two-step ABHS intervention, SaniTwice, “led to significantly lower concentrations of coliforms and Enterococcus (spp) than the pumice soap and label-use ABHS interventions and was the only
intervention to yield significantly fewer samples with E. coli than were found in the control group.”
All interventions removed soil from hands. The complete study is available at this link: https://www.ncbi.nlm.nih.gov/pubmed/26555526
The regulatory history of SaniTwice is available at the CFP website, Council III proceedings (Conference for Food Protection). Even with years of use and the support of independent research, the CFP resolution to each of the four past submissions is to set smoke screens and defer to Hand Hygiene Committees. We await the 2016 session to complete a decade of beauracratic blockage.
Little progress is expected from the 2016 Hand Hygiene Committee report. We are hopeful that at least the CDER smokescreen can be cleared. If not, there is no purpose in recreating the “SaniTwice” driven Hand Hygiene Committee for the fifth time.
The innovator-leadership oriented operators, regulators and researchers continue to consider this 2-step ABHS solution. Their view is centered on public safety rather than regulatory codes built on inspection limitations, generally disconnected from the risk factors.
This decade-sequence of hurdles is a major disincentive for industry and researchers to invest in innovation oriented solutions.
2006, Issue III-022, Columbus, OH. Hand Antiseptics Used as a Towelette. Accepted by the delegates. Recommended for No Action.
2008 Issue III-026, San Antonio, TX. Hand Antiseptic Protocol to Clean Hands in No-Water or Remote Locations
Issue III-027, Sequential Application of Hand Antiseptic for Use in No-Water Situations
2010 Issue III-016, Providence, RI. Sequential Application of Hand Antiseptic for Use in No-Water Situations
2012 Issue III-025, Indianapolis, IN. Dual-Step Hand Cleanse-Sanitize Protocol Without Water
2014 Issue III-017, Orlando, FL. Hand Cleanse-Sanitize Protocol not Requiring Running Water
2016 Issue III-010, Boise, ID. Hand Cleanse-Sanitize Protocol Not Requiring Running Water