M. van Schaik
There is a lot of confusion whether Electrolyzed Water is allowed to be used as a disinfectant or sanitizer. EPA, FDA, USDA and local authorities have approved or allowed usage of Electrolyzed Water in many applications. Having said so, a few applications need more data about the efficacy of Electrolyzed Water and methods how disinfection or sanitation is guaranteed. Other applications may have a limitation on the HOCL concentration. The following article explain what is and what is not allowed by the US Environment Protection Agency.
EPA Regulation with regard to Onsite PRODUCTION of pesticides with AQUAOX Devices
Under Section 3 of the Pesticide Regulations under the Federal Insecticide Fungicide and Rodenticide Act, as amended (FIFRA), the EPA regulates pesticides, which are registered and sold in interstate commerce to control various forms of vermin.
Under these regulations (Subpart Z –Devices Part 152.500 ‘Requirement for devices”) Pesticide Devices are not required to be registered, but must have an approved label which meet the Section 3 Regulations, Part 162.10, and have a registered establishment in which they are produced. Under Section 7 of the FIFRA each owner of a pesticide device must produce to the EPA enforcement program a report of products produced each and every year and to whom they are sold in a standard report form.
Devices which everyone has heard about are electrically generated, ozonators for use in treating drinking water, chlorinators which derive Free Available Chlorine from the electrolysis of water and sale, copper/silver cathodes which by electrically activity cause release of silver and cupper ions into drinking water in hotels and hospitals, invisible noise mechanisms which mediate insects and rodents in small areas. In each case the device is unique and based upon the data which the device originator has in hand or can reference to EPA has a product which is efficacious and safe when used as directed.
Devices are subject to labelling and misbranding requirements under FIFRA section 2(p) and 2(q); registration and reporting requirements under FIFRA section 7; recording keeping requirements under FIFRA section 8; inspection requirements under FIFRA section 9; import and expert restrictions under FIFRA section 17; and child resistant packaging requirements imposed pursuant to FIFRA section 25 (c)(3).
AQUAOX devices hava an EPA establishment number and we report pursuant to Section 7 of the Act. Basically our device, using electric current 230 volt, produces Hypochlorous Acid (HOCL) on demand on site, which kills bacteria, mold, mildew, viruses and surface filling algae. The device uses sodium chloride (table salt) in a liquid format in water and an electric charge to generate on demand HOCL-solution. HOCL (200ppm Free Available Chlorine) does the killing of the life forms. When the electric has been turned off the device produces no HOCL-solution and has no residual in it. Our device meets all the Section 3 labelling requirements and we pay close attention to all the FIFRA requirements so as to be fully compliant No product is produced from our device for storage or later use per regulations.
Electrolyzed water is approved under 21 CFR 173.315 for direct contact with processed foods. Electrolyzed water is approved for several indirect food contract applications under 21 CFR 172.892, 21 CFR 175.105, 21 CFR 176.170 and 21 CFR 177.2800. It is an approved sanitizer that meets 21 CFR 178.1010. The EPA has also given approval (40 CFR 180.1054) for washing raw foods that are to be consumed without processing.
40 CFR 180.940. HOCL when used as ingredient in an antimicrobial pesticide formulation may be applied to: Food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. When ready for use, the end-use concentration of all Hypochlorous Acid chemicals in the solution is not to exceed 200 ppm determined as Free Available Chlorine
AQUAOX device does not require a hazardous use permit whereas chlorine in bottles must be permitted for filling, transportation or storage.
In case of doubt or for clarification AQUAOX LLC should be consulted. We are unable to anticipate all conditions under which the product may be used, and users are advised to carry out an assessment of workplace risk and carry out their own tests to determine Safety and Suitability for the process and conditions of use.
EPA regulation with regard to the USAGE and STORAGE of Neutral Electrolyzed Water generated on-site from an AQUAOX device
Under the FIFRA, EPA does not regulate water or sodium chloride (table salt) as a pesticide when used in an AQUAOX device that generates a pesticidal solution (HOCL).
The 0.2% HOCL-solution generated by the AQUAOX device is not regulated by the EPA as a pesticide as long as the solution itself is used on-site (i.e. where it is generated). If however, the solution is packaged, distributed or sold for use other than the site at which it was generated, then the product is subject to registration as a pesticide under FIFRA.
Accordingly, applying the solution on-site in e.g. 1 gallon containers would not be subject to registration, but distributing and selling the product for use other than at the site of generation would be subject to registration. Finally, the AQUAOX Device is considered to be a pesticide device and is subject to the requirements specified in 40 CFR 152.500.
As long as the HOCL-solution is applied on-site, no EPA requirements under FIFRA apply other than those specified above. EPA recommends, however, that the operator of pesticide devices provide labels for plastic containers with HOCL-solutions, so that workers and others will know what is in the containers and what precautions and directions should be followed handling and using the solution.
Thus, temporary storage of the HOCL-solution is allowed, as long as HOCL-solution is used on-site.
Finally, the operator of the AQUAOX device should check as to state and local regulatory requirements that may apply to the AQUAOX device and the generated solution.
EPA regulation with regard to TRANSPORT of Neutral Electrolyzed Water generated on-site from an AQUAOX device.
Under FIFRA, EPA does not provide a clear rule and this need to be further investigated. Most probably EPA will NOT permit transport as onsite produced HOCL-solutions are strictly intended to be used on-site.
AQUAOX’ interpretation of the FIFRA is that transport of HOCL-solution within the on-site location is permitted, as long as HOCL-solution is used on-site. Thus, transport of HOCL-solution in e.g. 1 gallon container to another department, building or place within the operator’s organization, company and/or location is permitted, as long HOCL-solution is used within the operator’s organization, company and/or location.
Accordingly, storage in trucks should be permitted, as long HOCL is used within the operator’s organization, company and/or location. In AQUAOX’ opinion Onsite generated HOCL is permitted to be transported over the public road to another location to be used within the operator’s organization, company and/or location is. However, FIFRA is very unclear about this particularly kind of transport. Likewise the EPA, AQUAOX recommends to provide labels and a MSDS of HOCL on all containers or trucks filled with HOCL.
On top of this AQUAOX advices to have a FUNCTIONAL and WORKING AQUAOX device on each truck, to be used for onsite generation of HOCL, if a user is going to transport HOCL to a client for executing a service such as e.g. fogging a premises or spraying a surface.
EPA regulation on on-site generated pesticides BOTTLED, PACKAGED, STORAGED and DISTRIBUTED (SOLD).
If the onsite produced HOCL is bottled, packaged, stored, distributed and sold, the HOCL-solution is subject to registration as a pesticide. Thus, if HOCL is bottled, packed and sold as a liquid, the user of AQUAOX’ Device MUST register HOCL as a pesticide to obtain a registration number for HOCL.
The registration of the onsite generated HOCL MUST be in the operator’s name and the operator will be exclusively responsible for the produced pesticide.
AQUAOX is NOT involved in bottling, packaging and distributing pesticides. AQUAOX manufactures, distribute and sell AQUAOX devices which are regulated by the EPA as onsite pesticide devices.
AQUAOX does not permit their distributors to register HOCL (onsite generated pesticide) as a pesticide.
AQUAOX does not advocate, nor promote users (owners/ final users of the AQUAOX Device) to register HOCL as pesticide. AQUAOX rejects all liability, if users do not comply with the FIFRA regulations for onsite pesticide devices. AQUAOX does not advocate or promote the usage of HOCL otherwise than used onsite.
For more information, visit www.aquaox.net