banner

Regulations

Regulations are the engine that drives our business. Rather than reacting to regulatory factors, BioSAFE Engineering and the WR2 patented technology have been instrumental in helping to shape the regulatory guidelines that make up public policies on bio-safety and bio-hazard handling.

BioSAFE Engineering's WR2 Tissue Digestor™ technology exceeds the standards of every jurisdiction thus far worldwide for thermal sterilization of human and animal disease agents, and our Tissue Digestor™ installations worldwide have been approved or permitted routinely.

In the case of one category of disease agents - prions (which are proteins that do not consist of living cells), the alkaline hydrolysis process has been specifically approved in EU legislation for the treatment of Mad Cow disease and other "Category 1" (TSE transmissable spongiform encephalopathy) wastes, in addition to approval for use with Categories 2 and 3 wastes in Europe. The same process has been used for years for prion waste at USDA laboratories and has been cited as an acceptable method of prion waste treatment in USDA and EPA regulations. Recently the US EPA determined that prions were to be treated as "pests" under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and BioSAFE Engineering/WR2 has registered its systems under FIFRA.

BioSAFE Engineering's WR2 Effluent Decontamination Systems (EDS), like its Tissue Digestors™, uniformly exceed all jurisdictions' standards for steam sterilization of disease agents and have encountered NO permitting difficulties in any of the domestic or foreign jurisdictions in which they have been installed or ordered.

BioSAFE Engineering's WR2 STI medical/clinical waste treatment systems have been approved in all US jursidictions that have approval standards for medical waste treatment technologies. More importantly, the STI Systems, unlike many competitive auto-clave systems, will meet future standards being developed worldwide that will require waste shredding as an integral first step in the treatment process.