Risk vs. Inspection
[Notes for those interested in enhancing the Model Food Code via the Conference For Food Protection (CFP) process.]
Unintended consequences are many as the FDA's Model Food Code strives to further protect public health. The operators have prime accountability for serving safe food and the more than 30,000 health inspectors look to help them. Both have the same goal. It can be a team effort and often is. But there is tension baked into their respective DNAs. The power to close a restaurant is intimidating and discourages frank dialog.
Inspectors inspect, armed with quickly read thermometers and test strips. The Model Food Code is built first around inspection while operators line up their food safety processes based on risk. Here are situations where Food Code changes could help operators make better hand hygiene decisions and better protect public health:
- Add two simple definitions (Food code section 1-201.10) - Define handwashing as the removal of contaminants with soap and water. Define hand cleansing as the removal of contaminants with means other than soap and water. This would open up a menu of handwashes from which the operator can choose based on risk. Whoops! No, based on the ability to observe during an inspection. That's the rub.
Choose your handwashing regimen carefully »
Operators need to know that there are more options available in how to wash, beyond that covered in the Cleaning Procedure (2-301.12) (A) " … clean their hands … for at least 20 seconds, using a cleaning compound in a handwashing sink 5-202.12 and subpart 6-301 (B) "… cleaning procedure .. Rinse under clean, running water … Apply cleaning compound … rub vigorously for at least 10-15 seconds, …thoroughly rinse. Dry according to 6-301.12
The standard for handwash effectiveness from page 414 in the annex should be moved into the Model Code – “Handwashing as specified in the Food Code will reduce microbial contamination of the hands by 2-3 logs.” This would encourage research to identify innovations that match or exceed the Food Codes soap-water standard. As it stands it is the Code standard without a standard and will continue to frustrate CFP Hand Hygiene Committees.
- Prioritize the nine occasions of When to Wash (2-301.14). Currently there is no weighting - all share an equal risk. A touch of the hair signals a wash, after deboning raw chicken triggers the same wash. This is counterintuitive to the workers and dangerously engenders doubts for all compliance guidelines regarding hand hygiene.
This is best understood looking at the CDC observational study (LR Green 2006) where it was calculated that food workers would have to wash 8.6 times per employee hour (HW/EH). No one, not even the FDA, expects that to happen. The operator apprehensively makes the choice of which washes to skip. A priority ranking or grouping built in to the Model Food Code would result in more respect of the Food Code and enhanced compliance.
- Drop the requirement to wash hands between glove changes when using a double barrier gloving technique for operations such as handling raw and cooked burgers on a grill.
- Lower the temperature minimum in Section 5-202.12, Handwashing Sink, where the code states " … equipped to provide water at least 38 C (100F) …" This well-intended minimum is interpreted by both operators and inspectors as the definitive base for effectiveness while the goal is largely user comfort. All temperatures between ambient and 107F are comfortable. As to cleaning effectiveness, the body’s 98.6F heats the soap and initial scrub-water. Suspended contaminants are easily and comfortably rinsed away at room temperature. This guidance number should be lowered to ambient temperature.
Operators would then more freely specify hygienic, water saving electronic faucets as they do in Europe - saving almost a gallon of water with each handwash. Right now, the Food Code interpretations are minimizing their use and the industry is wasting huge amounts of water.
- The Food Code values the killing of pathogens higher than their removal. This leans heavily on what is in the bottle and minimizes what is done with it. Process trumps product in many situations.
Label claims do not spell out total performance and can leave operators with a false sense of security. A friction aided cleaning process is often more effective than the killing of germs, especially in one-step protocols for high-touch non-food contact surfaces.
- In the Where to Wash section (2-301.15) "… shall clean their hands in a handwashing sink …" but what if there isn't one, like at an outdoor event? How about using an alternative which doesn't require running water - like the one used by some to facilitate glove changes at catered sites by using the two-step cleanse-sanitize method for their hands.
Let's describe such a protocol and codify here in the reserved space, 2-301.13, Special Handwash Procedures.
For reference, section 5-203.11 "If … handwashing sinks are not conveniently available … employees may use chemical treated towelettes for handwashing."
- For the Food Code Annex … Scheduled inspections are a reward for consistently following food safety processes with regulatory clearance. A scheduled inspection system as in Olmsted County Minnesota, “PTV”, converts the common “raid” atmosphere into teachable moments. Let’s encourage this improvement and free our 30,000+ inspectors to first instruct. This provides a better alignment with the prevention-focused FSMA and Active Managerial Control as well as opening the door to hire coaches rather than a police force.
- Prioritize drying methods or eliminate air dryers. Section 6-301.12, Hand Drying Provision represents a view not shared by many food safety scientists and the US Military. The friction afforded by (A) paper towels and (B) continuous roll systems is a significant element in contaminant removal from hands. Hot air (C) and ambient air (D) dryers do not provide this added cleansing. The Military code has dropped both.
- Resolving inherent conflict between innovation and model food code »
- Active Managerial Control http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006812tm »
Food Code Annexes for reference:
- Food employees and conditional employees infected with fecal-oral pathogens can shed viral and protozoan pathogens in the feces at levels up to 108 viral particles or oocysts per gram of feces. Having a high potential contamination level on the hands combined with a very low infectious dose necessary to cause infection are the reasons that FDA believes that handwashing alone is not an effective single barrier in the transmission of these fecal-oral pathogens. The infective dose for Giardia and Cryptosporidium is believed to be as low as 1-10 oocysts, and as few as 10 virus particles can infect an individual with Norovirus or hepatitis A.
- 5-202.12 Handwashing Facility, Installation. The CDC now estimates that Norovirus is the leading cause of foodborne illness in the United States. Contaminated hands are a significant factor in the transmission of enteric viruses, including Norovirus and hepatitis A virus. Further, contamination of food by an infected food worker is the most common mode of transmission of hepatitis A in foodborne disease outbreaks. Research has shown the viral transfer rate from contaminated hands to ready-to-eat food to be about 10% and that proper handwashing will significantly reduce the chance of transmitting pathogenic viruses. However, with heavy initial contamination of the hands, especially in the subungal space of the fingers, a basic 2-3 log reduction handwash procedure may not be adequate to prevent the transmission of viral foodborne illness
- 6-301.12 The method in which hands are dried is a critical factor in reducing chances of cross-contamination by hands to food and environmental surfaces (Patrick et al., (1997)).
With regard to the addition of air knife technology for hand drying, data reviewed by FDA scientists at the FDA’s National Center for Food Safety Technology (Moffitt Center) demonstrates that the use of this technology in hand dryers has been found to be equivalent to the hand drying treatment in existing heated-air devices.