Summary


The United States Resource Conservation and Recovery Act (RCRA) sets out a comprehensive regulatory system governing the treatment, storage, and disposal of hazardous wastes. The United States Environmental Protection Agency (EPA) is the federal agency responsible for administering RCRA. In 1985, Florida received authorization from EPA to administer its own hazardous waste management and regulatory program under RCRA. One of the conditions of the authorization is that Florida’s program be no less stringent than the Federal program. EPA maintains oversight of Florida’s program and must approve any amendments thereto. In 2007, Florida adopted the Universal Pharmaceutical Waste rule to provide specific alternative handling requirements for pharmaceuticals that are determined to be hazardous waste pharmaceuticals by the generator. When a generator of pharmaceutical wastes determines it to be “hazardous waste,” Florida’s RCRA regulations require that the hazardous waste pharmaceuticals be managed as a universal pharmaceutical waste in accordance with Rule 62 730.186, F.A.C., or as a hazardous waste in accordance with Chapter 62 730, F.A.C. Accordingly, subsequent handlers or transporters of the hazardous waste pharmaceuticals are not permitted to change the waste determination, and the waste must ultimately be sent to either a destination facility or a hazardous waste treatment, storage or disposal facility except as expressly provided in Rule 62-730.186, F.A.C. That rule expressly allows subsequent handlers of the universal pharmaceutical waste to sort, disassemble and remove hazardous waste pharmaceuticals from packing when (1) the innermost container of each individual pharmaceutical remains intact and closed or (2) the innermost container is placed into another individual sealed container. See Rule 62-730.186(7)(c), F.A.C. In the event the solid waste – i.e., the packages from which the pharmaceuticals were removed – is not hazardous, it can be managed as non-hazardous waste. See Rule 62-730.186(7)(d), F.A.C. Other than the removal of packaging, Florida’s regulations do not provide for handlers to otherwise treat or dispose of pharmaceutical waste that was determined to be hazardous by the generator of such waste. On August 17, 2015, Zenith Environmental Services, LLC, notified the Department that it perceived this above requirement – that all pharmaceuticals determined to be hazardous by the generator to be managed as hazardous waste in accordance with the Department’s Universal Pharmaceutical Waste rule – to be an unadopted rule. In the spirit of cooperation and in an effort to promote regulatory certainty, the Department is amending its Universal Pharmaceutical Waste rule to further clarify that it does not relieve handlers of waste that is marked as hazardous by the generator from managing all such waste in accordance with the requirements of Chapter 62 730, F.A.C.