BIOTECHNOLOGY FOCUS

Waste regulations can be difficult to understand, and it can be challenging to comply. Regulatory citations often seem like they are in a different language and the terminology used by inspectors can be confusing and difficult to decipher. Compliance often requires speaking not only the lab/industry language, but also the regulator’s language.

To get a true understanding of what regulations apply, it is important to start by asking two fundamental questions:

• What wastes does my company generate?
• What activities does my company carry out that are covered by waste requirements?

Through an evaluation of chemicals onsite, development of an inventory of both chemicals used and waste generated, and identification of processes to efficiently and effectively manage waste, businesses/labs can ensure they understand and meet their EHS regulatory obligations in the most efficient ways possible.

Environmental Protection Agency (EPA): Where Do You Start?

EPA regulates much of the waste generated by industry. Over the past ten years, the Agency has demonstrated an even stronger focus on labs. The most commonly cited EPA penalties under the Resource Conservation and Recovery Act (RCRA), which governs the disposal of solid and hazardous waste, have resulted from the items listed below:

• Dumping hazardous wastes down the drain
• Not having or having inadequate hazardous waste manifests
• Failing to properly train employees in hazardous waste management, handling, and emergency preparedness
• Lack of or improper labeling
• Open containers of hazardous waste onsite
• Failing to comply with hazardous waste generator regulations
• Improperly managing expired paints or spray paints
• Failing to have hazardous waste determinations on file
• Improper consolidation of waste from other nearby facilities
• Noncompliance with underground storage tank regulations

In order to avoid these citations, it is important to first understand your wastes. This is done through an EPA-required waste determination. In addition to reviewing chemicals that are used in processes and the different types of risk they present, a waste determination should evaluate all waste being generated by processes throughout the facility. The following waste streams are of particular regulatory concern, as they have strict regulatory requirements for their management and disposal.

Hazardous Waste
Hazardous wastes are found in a variety of processes in labs and in industry.  Solvents used to operate equipment, chemicals to conduct reactions and create products, maintenance chemicals, and new innovations are all potential sources of hazardous waste and should be included in a comprehensive waste determination.

The most frequently generated hazardous waste type in labs and in industry is flammable liquids. Chemicals such as acetone, toluene, xylenes, and methanol are commonly used flammable liquids that must be managed as hazardous waste. These wastes cannot be dumped down the drain without significant risk of fire, danger to personnel, and regulatory penalty. One of the first questions a regulator will ask in a lab or industrial process setting is to see waste containers. If a facility has chemicals but no waste containers, the regulators immediately jump to the conclusion that waste is not being managed correctly.

Other common hazardous waste streams found in labs and industry include toxic chemicals; corrosive acids and caustic bases; reactive chemicals, such as oxidizers and polymerizing chemicals; and chemicals that are radioactive. All of these are regulated by compliance agencies and require special management.

Examples of EPA regulations applying to labs include such things as identification of the amount of hazardous waste generated in a calendar month by a lab or in industry. The more hazardous waste generated, the more rigorous the EPA regulations.

Universal Waste
EPA also regulates a class of waste referred to as universal waste. Universal wastes are hazardous in their composition but can be recycled (e.g., fluorescent lightbulbs or lamps, CRTs and electronic waste, rechargeable batteries, and mercury-containing items). Failure to collect, label, store, and recycle these types of waste properly can also result in substantial threat of compliance penalty.

EPA regulators have focused on these waste streams as a source of penalty for the past decade. This is one of the most frequent citations issued to businesses. Although not as complex as the requirements for proper hazardous waste management, universal waste has nuances that a generator must be aware of to properly meet the regulatory requirements.

Biohazardous, Sharps, Pharmaceuticals, Unwanted Equipment, and Other Waste Types
Labs and industry have many additional sources of waste that are confusing and present head-scratching challenges as a waste determination is conducted. For example:

• If a facility wants to remove an outdated x-ray machine or electron microscope from service, what are the compliance requirements and is there a way to recycle it?
• If a lab process results in debris that is contaminated with bodily fluids, can they just be thrown in the trash? At what point are they considered “biohazardous?”

Beyond EPA

Additional regulatory agencies that oversee lab and industry operations include the Occupational Safety & Health Administration (OSHA), Department of Transportation (DOT), Department of Homeland Security (DHS), fire department, and others depending upon the type of work being done, chemicals being used, and resulting end products. As with EPA, identifying the other regulations that apply can be quite challenging and overwhelming. For example:

• Under OSHA, evaluation of worker personal protective equipment (PPE), respiratory protection, safety equipment, including safety showers and eye wash stations, and fire extinguishers requires plans, inspections, and training of workers. These programs should be set up as best practice to protect employees.
• As discussed in our previous article, DOT is often forgotten about in labs; however, there are general DOT requirements for any entity receiving or shipping hazardous materials. Failure to have proper DOT training or to know how to properly ship can result in significant financial penalty.

The waste scenarios seen in labs and industry are countless, and each may hold associated regulatory compliance requirements. While this clearly presents business risks, it also provides a unique opportunity to create strategies to manage wastes more effectively and efficiently, improve safety, and reduce the potential costs of regulatory compliance.