Interpreting an EPA Label: Sanitizer vs Disinfectant
Environmental Protection Agency (EPA), regulates all antimicrobial product labels and any associated efficacy claims. The language and claims contained on each label must be supported with extensive scientific data that is submitted to EPA in the pesticide registration approval process. These labels govern usage rates, applications and directions for use. End users of chemicals must ensure compliance with the label and should understand the meaning behind differing label claims. This is the first in a series of posts that will look at EPA label language and what it means to the end-user.
Definitions
The words sanitizer and disinfectant are often used interchangeably in the food processing industry. The Environmental Protection Agency (EPA), however, has distinct definitions for each term.
Sanitizer: a substance, or mixture of substances, that reduces the bacteria population in the inanimate environment by significant numbers, but does not destroy or eliminate all bacteria.
Disinfectant: a substance or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi, and viruses, but not necessarily bacterial spores, in the inanimate environment.
Source: EPA Website, 40 CFR 158.2203
Definitions in Practice
For commercial products, this simply means that disinfectants provide a higher level of demonstrable microbial load reduction than sanitizers. Product performance guidelines are outlined by EPA in Product Performance Test Guidelines OCSPP 810.2300 (sanitization) and OCSPP 810.2200 (disinfection). These guidelines are summarized in Table 1, with minimum surface contact times indicated in parentheses.
| Sanitizer | Disinfectant | |
| Microbial Load Reduction: Non-Food Contact Surfaces |
3 log 99.9% (5 min) |
6 log 99.9999% (10 min) |
| Microbial Load Reduction: Food Contact Surfaces |
5 log 99.999% (30 sec) |
6 log 99.9999% (10min) |
| Fungi & Viral Control | NO | YES |
On the Label
In some instances, the same product can be both a sanitizer and a disinfectant when used at different concentrations, or on a different surface, or with longer surface contact time. Sterilex® Ultra Disinfectant Cleaner Solution 1 is an example of this type of product when used with Sterilex® Ultra Activator Solution.
The label for Sterilex Ultra Disinfectant Cleaner Solution 1 (EPA Reg. No. 63761-8, accepted 9/22/16), contains a claim that allows the product to be used as both a rinsed disinfectant on food contact surfaces, and as a non-rinsed surface sanitizer on non-food contact surfaces. This section of the label is highlighted below.
DISINFECTION AND NON-FOOD CONTACT SURFACE SANITIZATION OF FOOD PROCESSING EQUIPMENT AND HARD SURFACES IN FOOD PROCESSING FACILITIES: Apply Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution as a disinfectant, per General One Step Disinfection and Cleaning Directions, or as a sanitizer, per General Sanitization Directions. Use product within 8 hours of mixing Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution.
“Disinfection” and “non-food contact surface sanitization” are separate statements and claims, an important differentiation. Per Food and Drug Administration (FDA) requirements, a no-rinse sanitizer must be used on food contact surfaces as the final step prior to production. For this reason, Sterilex specifically differentiates between disinfection claims (followed by a rinse) on food contact surfaces, and non-rinsed surface sanitization claims for non-food contact surfaces.
Therefore, on food contact surfaces, this product has demonstrated an ability to kill ≥ 6 logs of the organisms on its label on food contact surfaces, whereas products marketed as sanitizers on food contact surfaces have demonstrated an ability to kill at least 5 logs of the organisms on their label on food contact surfaces.
Please see the product label for complete directions for use.
Conclusion
Both EPA registered sanitizers and disinfectants can effectively reduce or remove bacterial load from surfaces in food processing facilities. However, when used in accordance with the label, disinfectants offer processing facilities a more complete inactivation/removal of microbial load than sanitizers.
See product label for full label claims and usage instructions.
The food industry has been increasingly focused on a risk-based approach to food safety. Control of Listeria specifically, is always at the top of every list, as it poses the largest threat. “The pathogen’s recent influx in a variety of fresh, frozen and processed foods is reinforcing the importance of understanding how contamination occurs in processing plants.” (Mackin, 2018).
Part of raising healthy calves is maintaining a healthy environment, and feed sources that are free from pathogens that cause illness. A recent article published in Hoard’s Dairyman highlighted the risks of biofilm growth in calf feeding equipment.¹ When bacteria form a biofilm, they become resistant to many of the common methods used for sanitizing calf equipment, such as bleach dips. The surviving bacteria, harbored in a biofilm can then lead to an increase in scour days, reduced growth efficiency, and sometimes death.
Adam Borger of the University of Wisconsin-Madison Food Research Institute, spoke of the new guidance, saying, “I am a proponent of what the FDA is recommending in their draft guidance regarding sampling of food-contact surfaces for Listeria genus. I feel that giving food processors the ability to sample food-contact surfaces for Listeria genus without absolutely having to place all product on hold until the result is returned, will encourage a more aggressive sampling plan to find and eliminate Listeria and niches where the microbe may persist.” [2]
Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution, or Ultra Soft Metal Activator, can also be used inside barns to disinfect between flocks. Following the removal of gross soils from the barn, the two-part solution is mixed, diluted in water, and either foamed or sprayed on surfaces.
As of Sept 2016, FSMA, the Food Safety Modernization Act is in full effect. For food manufacturers, the implications of reaching compliance, are immense. One of the key components of compliance is the requirement for preventative controls. Although this is a broad topic, it can be summarized in three sections, Hazard Analysis, development of preventative controls, and finally management of the preventative control protocols that have been created [1].
Proximity to farms introduces a number of risk factors for introduction of pathogens to processing environments. Whenever animal enclosures are present, anyone handling animals or coming into contact with animal waste can introduce microorganisms into processing environments by exchanging items between farm and processor. In addition, the movement of containers, transport vehicles, and employees between the processor and the individual barns can result in the rapid spread of transmittable diseases, affecting the animal populations. Through the exchange of farm and processing equipment, a single infected barn can result in the loss of all production animals housed on the grounds regardless of separate housing. Live production facilities can introduce disease to otherwise healthy incoming animals as well. Improper disinfection and insufficient biosecurity intervention between animal groups can result in transfer of disease through waterlines, feeding equipment, and general barn surfaces. Once introduced by even a single infected animal, these microorganisms can become a major problem—especially if they spread to other areas of the farm, or neighboring farms via feed trucks, suppliers, employees or any other traffic. With recent outbreaks of diseases such as Avian Influenza becoming both a high-profile issue and a very real threat (an AI outbreak can wipe out an entire flock very quickly, with devastating consequences to the farm’s business), farms with onsite processing facilities will want to take extra care to prevent the spread of microorganisms.
