Pursuant To: 15A NCAC 18A .2600, .1300, .1800, 2800 and North Carolina Food Code Manual, Sections 4-703.11 and 4-501.19
Source: Larry Michael, Branch Head, Food Protection and Facilities Branch
Question: Can establishments use a chemical sanitizer generated by a device located on-site?
Discussion and Rationale
A variety of hard surface cleaners and sanitizers, such as sodium hypochlorite, can be generated on-site by technologies known as electrolyzed water, electrochemically activated water, and electro-activated water in pesticide-generating devices. In general, these devices produce cleaning and sanitizing products through electrically activating water and salt into ionic compounds containing oxidizers (e.g., oxygen, chlorine), as well as weak ionic reducing agents used as degreasers.
The products lack an EPA registration number because EPA does not require registration of solutions generated and used onsite. When process equipment is used to generate the product on-site for use within the facility, only the process equipment is given an EPA pesticide producing establishment number. This means the product labels will not bear an EPA registration number that Environmental Health Specialists would generally expect to see, but the device will have an EPA registration number for the process equipment.
The user of the equipment should look to the device manufacturer for data to validate efficacy of the solution produced by the equipment as well as the conditions for use of the solution (e.g., concentration, temperature, contact time, pH, and other applicable factors). This data must be available on-site in the establishment. The manufacturer must also provide a testing method to verify that the equipment consistently generates a solution at the necessary concentration.
In the supplement to the 2009 FDA Food Code (Paragraph 4-501.114 (F)), chemical sanitizers generated by a device located on-site may be used if the device (1) Complies with the Federal Insecticide, Fungicide and Rodenticide Act, (2) Complies with 40 CFR 152.500 Requirement for Devices, 40 CFR 156.10 Labeling Requirements, (3) Displays the EPA device manufacturing facility registration number on the device, and (4) is operated and managed in accordance with the manufacturer’s instructions.
Response / Interpretation
Since the solutions produced by electrolyzing devices are subjected to the same testing requirements as EPA-registered sanitizers and disinfectants, then sanitizers and disinfectants produced on-site by EPA-registered equipment are accepted as being equivalent to an EPA-registered sanitizer or disinfectant. Efficacy and conditions for use data must be available and a test kit or device must also be readily available to ensure compliance with the required solution concentrations.
Reference
Supplement to the 2009 FDA Food Code
Note: Position statements are policy documents to clarify how to interpret or enforce a law or rule. They are not enforceable on their own but are intended to promote uniform interpretation and enforcement of the underlying law or rule.