On April 22nd 2007 the Florida Department of Environmental Protection amended its hazardous waste regulations to include a new rule entitled: Universal Pharmaceutical Waste (62-730.186 F.A.C).
The amendments are intended to allow flexibility in the management of hazardous waste pharmaceuticals by regulating such waste as universal waste in Florida, and to clarify standards applicable to handlers of hazardous waste pharmaceuticals. The new rule does not require generators to manage hazardous waste pharmaceuticals as universal waste. The new rule does not impose any new regulatory requirements. It merely allows a less stringent management option for persons who generate hazardous waste pharmaceuticals So what does this mean?
Generators of pharmaceutical waste now have a choice. They can either choose to manage hazardous waste pharmaceuticals under the Resource Conservation and Recovery Act (RCRA) or Florida's Universal Pharmaceutical Waste (UPW) rule.
RCRA regulations are more stringent and were intended to address industrial waste and bulk quantities, not healthcare setting pharmaceuticals in finished dosage forms. However, RCRA is the only Federal regulation under which waste pharmaceuticals can be treated. The absence of any RCRA treatment facilities in the state of Florida means that generators have to ship less than bulk quantities of waste out of state for treatment. Additionally, being a RCRA waste generator is subject to stringent planning, training and reporting requirements. The increased costs associated with this are obvious.
While managing pharmaceutical waste in Florida, generators can take advantage of the UPW rule by managing it under Universal Waste regulations. These are the standards the EPA set forth for fluorescent light bulbs, mercury containing devices, batteries and pesticides and were adopted by the Florida Department of Environmental Protection (FDEP). The reason why EPA developed these standards, are the very same reasons outlined above: to manage these waste streams under RCRA was too cumbersome and expensive and as a result were not being managed at all. EPA successfully streamlined the regulations to allow incentives to comply, and it worked! Florida is the second state in the nation to develop a rule for the management of waste pharmaceuticals as Universal Waste. The first was Michigan. The EPA is now looking to draft a similar rule, though it will be several years before they come up with anything final.
The bottom line: generators can still manage waste batteries, light bulbs, mercury devices and waste pharmaceuticals under RCRA regulations. The fact that they can be managed as Universal doesn't make them any less hazardous to the environment and human health. The fact is that the Universal Waste rules make it impractical to manage them any other way.
Medical waste haulers (often referred to as ‘red-bag’) and incineration firms that specifically handle biomedical waste routinely specify in their waste acceptance protocols that only administering paraphernalia such as tubing, gloves, gowns, etc. and EMPTY vials, syringes, and IVs can be accepted for disposal.
These items are incinerated at medical waste temperatures or sterilized, shredded, and land-filled. Disposing of partially filled vials or syringes in these waste streams violates these acceptance protocols and in many cases also violates the Resource Conservation and Recovery Act regulations. The burden of liability, however, rests with the waste generating facility since it is they who package and prepare these wastes for disposal. The law states that the generator is responsible for their waste from cradle to grave.
In practice, chemotherapy drugs pose another serious issue. Because the law has not been updated in this area, only nine chemotherapy drugs are regulated as hazardous chemical waste by EPA. These nine drugs must be segregated from chemotherapy waste or red sharps containers and placed into RCRA hazardous waste containers when present in bulk or residue amounts. Since many of the non-regulated chemotherapeutic agents are at least as hazardous, good risk management should involve treating all bulk and residue chemotherapy agents as hazardous waste when discarded as a Best Management Practice (BMP). Since spill clean-up materials involve more than trace amounts, these materials should also be managed as hazardous chemical waste and segregated accordingly.
Chemotherapy drugs are pharmaceuticals and as such, chemotherapy waste can be handled as Universal Pharmaceutical Waste (UPW) when managed in Florida.