EPA Pharmaceutical Hazardous Waste Management Guide | KenBay

Hazardous waste is defined by the EPA (Environmental Protection Agency) to be liquids, solids, gases or sludges. This blog will focus on the management of hazardous waste solids in the pharmaceutical industry. The EPA has a long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. This policy addresses the issues highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.

Biohazardous waste, not discussed here, is primarily concerned with liquids such as blood and chemicals and have different processes for compaction, where possible, and disposal of solids.

P-listed and U-listed Drug Waste

The EPA’s P and U lists designate as hazardous waste pure and commercial grade formulations of certain unused chemicals that are being disposed of at primarily pharmaceutical manufacturing facilities. For a waste to be considered a P- or U-listed waste it must meeting the following three criteria:

1. The waste must contain one of the chemicals listed on the P or U list;
2. The chemical in the waste must be unused; and
3. The chemical in the waste must be in the form of a commercial chemical product.

The EPA defines a commercial chemical product for P and U list purposes as a chemical that is either 100 percent pure, technical (e.g., commercial) grade or the sole active ingredient in a chemical formulation.

The P-list identifies acute hazardous wastes from discarded commercial chemical products. Currently, The EPA has issued an extensive list of P-list and U-list waste at www.epa.gov which goes from A to Z (Aluminum phosphide to Zinc cyanide).

Ignitable, Toxic, Corrosive and Reactive Waste

EPA’s regulations establish two ways of identifying solid wastes as hazardous under the Resource Conservation and Recovery Act (RCRA). A waste may be considered hazardous if it
exhibits certain hazardous properties the EPA has determined are hazardous because they were found to pose substantial present or potential hazards to human health or the environment. In its advocacy for pollution prevention, the EPA designates a number of different categories in regards to pharmaceutical hazardous waste; ignitable, toxic, corrosive, and reactive.

Ignitable wastes such as waste oils and solvents can create fires under certain conditions, are spontaneously combustible, or have a flash point less than 60 °C (140 °F). Toxic wastes such as substances including mercury and lead are harmful or fatal when ingested or absorbed. When toxic wastes are land disposed, contaminated liquid may leach from the waste and pollute ground water. Corrosive wastes such as battery acid are acids or bases which are capable of corroding metal containers, such as storage tanks, drums, and barrels. Reactive wastes such lithium-sulfur batteries and explosives are unstable under “normal” conditions. They can cause explosions, undergo violent reactions, generate toxic fumes, gases, or vapors or explosive mixtures when heated, compressed, or mixed with water.

Hazardous Radioactive Waste

If waste has a hazardous component and a radioactive component it is classified as a mixed waste and is regulated under both the Resource Conservation and Recovery Act and the atomic Energy Act. We are only concerned here with solids that are not mixed. Therefore, it is necessary to first determine waste that does not contain any radioactive material managed by EPA regulations.

When disposing of solid wastes, it is usually beneficial to compact it into one of the following containers: bulk bags, cardboard boxes or metal drums. In doing so, the containers must be selected according to characteristics of the materials they contain that are EPA established as: ignitability, corrosivity, reactivity and toxicity.

Of special interest in compacting hazardous waste that may itself not be ignitable but hazardous, it is important to use compaction equipment such as the KenBay Industrial Waste Compactor that if placed in a gaseous environment that it be protected against igniting the atmosphere in which it is placed.

Reasons to try the KenBay RotoPac for your Pharmaceutical Waste

1. Reduces your costs of transporting waste to hazardous waste facilities
2. The small footprint (4’ x 5’) allows for strategic placement in pharmaceutical manufacturing facilities
3. The high compaction rate means you are shipping waste, not air
4. You improve your company’s safety compliance when you minimize waste material handling
5. Biodegradable bags are available for use with the RotoPac
6. KenBay is the only U.S. supplier of the unique rotary arm continuous compaction machines