Regulations

Stabilized Aqueous Ozone, or SAO, is certified safe by many top regulatory bodies.

Not only is SAO approved by many top regulatory bodies around the world, it’s even safe for use in the most sensitive environments.

uses

Tersano has obtained the following regulatory approvals for its SAO:

Regulations
Environmental Protection Agency (EPA)

Why this is important: The CDC, as well as many state departments of health, follow the EPA’s guidance on and approval of disinfectants, including those effective for the CoVid-19 causing virus. The EPA manages, List(N) for approved disinfectants effective against emerging pathogens.

Anything that kills pests, including microbial pests, are considered pesticides.  The EPA regulates pesticides, both chemical pesticides and pesticide devices. Because SAO is generated onsite through the dispenser, SAO is considered a pesticide device, is grouped along with ultraviolet lights and mouse traps, and is regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Unfortunately, having two groups of pesticides has created a “recognition problem” for SAO and ultraviolet lights.

Because 99.99% of all disinfectants are chemical pesticides, pesticide devices are often overlooked and not included in disinfectant discussions, even though they are one of the most effective, safe and sustainable disinfectants available. This is the case with the infamous List(N).  Only chemical disinfectants can appear on List(N). Nonetheless, both chemical pesticides and pesticide devices can be approved by the EPA, so long as they are registered and undergo efficacy testing.

SAO has fulfilled the EPA’s regulatory requirements of registration and testing.  Tersano’s facility registration # is 89093-CAN-1.  SAO’s efficacy was tested and can be found in Tersano’s Pathogen Study included in the resources section of this document. Additionally, SAO has been tested against a SARS-CoV-2 approved surrogates (the Coronavirus MHV-3) and found to reduce the virus by 99.99% in 1 minute, significantly better than most listed chemical disinfectants. For a more comprehensive review on EPA approval see the Aqueous Ozone Summary document in the Resources section of this manual.

Food & Drug Adminstration (FDA)

Why this is important:The FDA is responsible for overseeing the manufacturing, distribution, and importing of all foods and drugs, with the exception of those that are regulated by the USDA (primarily meats and poultry).  Here, the FDA and USDA regulates what products can be used to clean and sanitize surfaces that come into contact with food during the manufacturing or preparation. Basically, approval states that residues left by the cleaning and sanitizing products are safe for human consumption.

FDA approved as a food additive and ozone may be safely used in the treatment, storage, and processing of foods, including meat and poultry; recognized as Generally Recognized As Safe (GRAS) (21 CFR s 178.1010(b), 3/16/1977)FDA approved as a Secondary Direct Food Additives Permitted in Food for Human Consumption (21 CFR s173.368, 6/26/2001)FDA approved for bottled water plant sanitizing of contact surfaces (21 CFR s 129.80, 4/4/2012)

US Department of Agriculture (USDA)

Why this is important: Like the FDA, the USDA regulates what products can be used to clean and sanitize surfaces that come into contact with meat and poultry during the manufacturing or preparation. Basically, approval states that residues left by the cleaning and sanitizing products are safe for human consumption.

Aqueous ozone approved for use as a microbial agent in the production of meat and poultry and requires no special labeling. (Advisory Letter, 11/27/2001)

US Department of Agriculture National Organic Program (USDA NOP)

Why this is important: The use of certain ingredients, additives, or even cleaning and sanitizing products can render an organic product to non-organic status.  Basically, approval states that residues left by the cleaning and sanitizing products also qualify as organic.

Approved as nonagricultural (non-organic) substance allowed as an ingredient in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” (NOP Final Rule, s 205.605(b)(20))

Occuupational Safety and Hazard Administration (OSHA)

Why this is important: OSHA oversees the health and safety of workers and has established maximum levels of exposure to chemicals and potentially harmful substances.

Aqueous ozone is within permissible ozone limits for workers permissible exposure limit (PEL) as listed in Table Z-1, an 8-hour, time-weighted average value of 0.1 part of ozone per million parts of air (ppm). (29 CFR 1910.1000)

NSF International Testing Lab

Why this is important: The NSF is an internationally recognized testing lab that has validated the efficacy of aqueous ozone.

The leading, internationally recognized testing lab, performed numerous, independent, EPA approved methods tests on aqueous ozone that further supports the fact that aqueous ozone is a highly effective sanitizer and disinfectant.  The NSF Registration # is 152236.      

Green Seal Certification

Why this is important: Green Seal Certification ensures that products are produced using environmentally responsible and resource efficient methods.

SAO received the Green Seal Standard for Cleaning Products for Industrial & Institutional Use (GS-37) and the standard for Specialty Cleaning Products for Industrial & Institutional Use (GS-53).

HACCP International Food Safety

Why this is important: Hazard Analysis and Critical Control Points (HACCP) is a systematic preventative approach to keeping food safe during the production and distribution that is required of food manufacturers by the FDA.

SAO and iClean mini certified as generators of food-safe cleaning and sanitizing liquids that are suitable for use in food facilities and food handling operations governed by a HACCP based Food Safety Program.