Maricha Ellis is the vice-president of Marketing and Sales Operations of Stericycle Environmental Solutions, a provider of environmental and regulated waste management solutions. 

Maricha Ellis

	Disposing of out-of-specification pharmaceuticals-especially controlled substances-comes with a high liability for brands, as those drugs could end up on the black market or put others in danger if not disposed of properly. Without highly trained experts handling that waste in a secure and compliant way while following the latest regulations, pharmaceutical manufacturers may face major implications, such as financial penalties or a damaged brand. In addition, manufacturers may produce other hazardous waste, such as solvents. This article describes how pharmaceutical manufacturers can stay compliant with hazardous waste disposal in a changing regulatory environment. 

	Identify key producers of hazardous waste

	In a pharmaceutical manufacturing plant, there are several areas that generate substantial levels of solvent or hazardous waste, and it’s important that facilities are able to identify these producers in order to remain compliant with current regulations. According to the US Environmental Protection Agency (EPA), a solid waste is a hazardous waste if it is specifically listed as a known hazardous waste or meets the characteristics of a hazardous waste (1). To be considered a characteristic waste, it must exhibit one or more of the following characteristic properties: ignitability, corrosivity, reactivity, or toxicity. 

	Wastes can take the form of liquids, solids, contained gases, or sludges. Examples of hazardous wastes in a pharmaceutical manufacturing plant may include some out-of-specification pharmaceuticals, some by-products of the manufacturing processes, and some discarded commercial products, such as cleaning fluids or pesticides.

	Educate employees on hazardous waste regulations 

	Another key component of compliance is to cultivate a company of knowledgeable and resourceful employees. Employees who are trained on hazardous waste regulations are more likely to ensure everything is handled in a proper way and will be more likely to identify any issues that may arise. To correctly train employees, manufacturers must ensure their teams are well aware of various types of hazardous waste and subsequent identification, as well as current regulations. 

	To guarantee proper management of hazardous wastes from beginning to end, the US EPA developed the Resource Conservation and Recovery Act (RCRA), which included an extensive set of hazardous waste management requirements and regulations in Subtitle C (2). The Subtitle C program seeks to guarantee that hazardous waste is handled in a manner that protects human health and the environment. 

	Employ the help of a skilled regulated waste management solutions provider 

	The best way for companies to dispose of waste according to current regulations is by working with a regulated waste management solutions provider. These companies can assist manufacturers with the training of personnel and disposal and management of hazardous waste. 

	Furthermore, as regulations continuously change, it can be beneficial to have knowledgeable, trained technicians on hand to help navigate new protocols that affect the manufacturer’s disposal process. Some providers communicate up-to-date information on changing regulations coming to a business’ area or industry as they happen on a local, state, or federal level to help their clients remain at zero fines and zero non-compliances. 

	Examples of new regulations affecting pharmaceutical manufacturers include the EPA’s e-Manifest system (3), which took effect June 30, 2018, as well as new, county-specific Extended Producer Responsibility (EPR) laws coming out of California (4) and Washington (5), which require manufacturers of a product to be responsible for and compliant in a product’s ultimate recycling, reuse, or disposal post-consumer.

	By identifying key producers of hazardous waste, educating employees on current regulations, and employing the help of a skilled waste-disposal company, pharmaceutical manufacturers will be able to remain compliant in a changing regulatory environment.

	1. EPA, “Defining Hazardous Waste: Listed, Characteristic and Mixed Radiological Wastes,”  www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-and-mixed-radiological-wastes, accessed Oct. 24, 2018.

	2. EPA, “Subtitle C – Hazardous Waste,” www.epa.gov/rcra/resource-conservation-and-recovery-act-rcra-overview#subtitleC, accessed Oct. 25, 2018. 

	3. EPA, “Learn About the Hazardous Waste Electronic Manifest System,” www.epa.gov/e-manifest/learn-about-hazardous-waste-electronic-manifest-system-e-manifest, accessed Oct. 24, 2018.

	4. CalRecycle, “Implementing Extended Producer Responsibility,” www.calrecycle.ca.gov/epr, accessed Oct. 25, 2018.

	5. State of Washington Department of Ecology, “Moving Washington Beyond Waste and Toxics,” fortress.wa.gov/ecy/publications/documents/1504019.pdf, accessed Oct. 25, 2018.

	Maricha Ellis is the vice-president of Marketing and Sales Operations of Stericycle Environmental Solutions, a provider of environmental and regulated waste management solutions. 

Articles

Pharmaceutical manufacturers must stay compliant with changing regulations for hazardous waste disposal. 