MEDICAL WASTE. Product stewardship - extended producer responsibility MEDICAL WASTE

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1 Alice P Jacobsohn, Esq, National Solid Wastes Management Association MEDICAL WASTE Product stewardship - extended producer responsibility Resource conservation has become an important issue internationally, especially in communities suffering from economic difficulty. Resource conservation is dependent on markets, locations willing to accept used materials and reprocess them to put them back on the market, or turn the materials into something else for resale. More recently, with concern that recycling efforts have reached a plateau, communities are considering product stewardship, sometimes called extended producer responsibility. The objective of product stewardship is to ensure that everyone involved in the lifecycle of a product shares responsibility for reducing that product s health and environmental impacts, with the producer of the product accepting primary financial responsibility. These financial incentives are used to force manufacturers to design and make products that are more environmentally friendly or to develop reuse, buy-back, and recycling programmes. Product stewardship The most common products subject to product stewardship laws are those that contain hazardous materials, including mercury, batteries, electronics, automobile switches, thermostats, and packaging. Some have covered paint and carpeting. In the last few years, interest has increased in product stewardship for pharmaceuticals and sharps - syringes, needles and lancets. Advocates of product stewardship claim that there are three important benefits. The first is the internalisation of post-consumer management costs in the overall cost of a product. Secondly, when manufacturers are required to accept financial responsibility, incentives are created for design improvements that increase recycling and reduce the use of toxins in the manufacturing process and in the product itself. Thirdly, the claim is that product stewardship will reduce the cost to local governments and consumers for solid and healthcare waste management. A number of organisations promote product stewardship. For example in the United States, there is the Product Stewardship Institute and in Europe, PRO EUROPE s.p.r.l. (Packaging Recovery Organisation Europe). Founded in 1995, PRO EUROPE is the umbrella organisation for European packaging and packaging waste recovery and recycling schemes. Programmes in Europe include a scheme for waste electrical and electronic equipment (WEEE) in the Netherlands; a packaging take-back scheme in France; Switzerland s arrangements for the collection and recycling of packaging waste; and a take-back programme for spent batteries in Belgium. In the United States, the first product stewardship laws were enacted in the states of Minnesota, New Jersey and Vermont in 1991, and covered the management of batteries. Interest in this approach waned until 2004, when the state of Maine enacted an electronics recycling law and New Jersey enacted a mercury switch automobile law. By 2011, 25 laws were in place, including ten for thermostats, nine for different types of batteries, nine for fluorescent lights, paint, mobile phones, pesticide containers and carpets. In 2010, Maine expanded its coverage to a framework law that allows state regulators to add products to a list of those subject to product stewardship requirements. Today, there are 32 states with product stewardship requirements. In a medical context Pharmaceutical waste generated by consumers or homegenerated drugs is beginning to be regulated. Rhode Island and Utah now have take-back programmes. A few states have banned the disposal of pharmaceuticals in sewer systems. These bans have the potential of forcing the development of product stewardship efforts, but this is yet to be seen. Some states such as Wisconsin and California have programmes for sharps collection, but most of these activities in the United States as a whole are taking place through private business relationships such as sharps containers placed in airport and hotel bathrooms where a medical waste collection company is hired to pick up the containers and take them to a permitted or authorised disposal facility. More specifically, for healthcare, the province of Ontario in Canada is considering regulations aimed at preventing disposal of post-consumer waste of pharmaceuticals and sharps in landfills and sewage treatment facilities. The regulations are geared toward the residential sector, not items generated at industrial, commercial, or institutional facilities. Manufacturers or producers would be required to develop collection and management systems that would meet minimum service standards to provide an accessible collection network for consumers to drop off their pharmaceuticals and sharps. The regulation would essentially require drop off locations at 90 percent of Ontario s accredited pharmacies. Pharmacies are accredited in Ontario under the Drug and Pharmacies Regulation Act of A major concern in the proposed product stewardship regulation is the ability to properly transport pharmaceutical and sharps waste after collection to an appropriate facility for final disposal. October

2 To some degree establishing these programmes in Canada is easier because the provision of healthcare is managed through government-controlled services. Medical waste disposal can be viewed as an extension of this service. Regional aspects In the Middle East, product stewardship has focused more on the remediation of contaminated oil-production facilities rather than consumer products. Green chemistry also affects the Middle East even where the requirements were not developed in Middle-Eastern countries. With green chemistry, chemical manufacturers agree not to use or develop products with toxic materials. These non-toxic chemicals are used throughout the world. In addition, a number of companies operating in the Middle East have pledged to operate in a more environmentally safe manner, such as using non-toxic materials. Some of these efforts come from pressure at the United Nations that has established a harmonisation system for the labelling and classifying of chemicals that many countries have adopted. This harmonisation makes labelling easier for companies manufacturing chemicals used throughout the world and for consumers to understand exactly what they are using. In turn, better disposal mechanisms can be put in place where there is political pressure to enact environmental health laws. Consider the lifecycle Product stewardship laws in the lifecycle management of a product, however, are often not sufficient to address complete resource recovery and conservation. Manufacturers often do not want to take responsibility for post-consumer management. With product stewardship is a belief that product prices do not include the external costs imposed by these products. These costs include the beginning of the cycle with the extraction of raw materials and end with the cost of final disposal of the product. if communities can create a link between production and waste management, the incentive to make products with greater capability for reuse and recycling would increase If communities can create a link between production and waste management, the incentive to reduce costs by using less hazardous materials and make products with greater capability for reuse and recycling would increase through market pressure. 19 October 2012

3 In developing complete lifecycle management programmes, two options have been implemented - individual manufacturer responsibility and collective manufacturer responsibility. Through the individual system, each company is required to establish its own retrieval operation. These programmes are more expensive because of their inability to reach economies-of-scale. For example, in New York City, each company was required to send a truck to each consumer s home to collect a used computer. This is very inefficient. Sharing the load The better approach is a collection system where a product stewardship organisation composed of industry players is responsible for developing a programme and managing the end-of-life disposal or recycling costs. Each of the players contributes a proportional amount to fund the programme, based on the player s market share. This allows for better sharing of environmental costs and as an added benefit provides increased expertise when developing a programme. Convincing all of the players to work together is not easy, however. Perhaps the most compelling reason for product stewardship laws is a claim that they are less burdensome on governments and consumers. Costs are less in the manufacturing process, thus, overall lifecycle costs are less. Manufacturers also are better equipped to spread the costs more evenly among consumers, especially when they are only burdening those that use their products. Determining the exact costs to government and consumers, however, is difficult. In the United States, the National Solid Wastes Management Association in 2006 determined that the average household pays between $12 and $20 per month for garbage, recycling and yard waste collection. Not all waste or recyclables are collected by or through arrangements with local governments through the collection of taxes, though. This makes programme development difficult and also makes cost estimates difficult to determine or to compare between localities. In addition, costs will vary in other countries where management structures and cultural differences impact the lifecycle of a product. Pharmaceutical waste For pharmaceutical waste, the costs of manufacturing are even more difficult to determine. How much each company has spent on the research to develop a drug, on authorisations needed to put the drug on the market for use, the level of consumer need for the drug (the prevalence of the medical problem in which the drug is directed), and, in some instances, revealing the contents of a drug, all contribute to the costs and may be proprietary. In addition, when a variety of pharmaceuticals are all placed in one container for disposal, each container will be different in terms of the lifecycle cost of the container s contents. Unlike the cost of production for electronics are other products subject to product stewardship laws, the focus on product stewardship for pharmaceuticals and sharps is on the cost of the spread of disease. October

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5 Studies have shown endocrine disrupters in fish and other aquatic animals and reduced immunity in children from pharmaceutical disposal in water systems. Needle-sticks from contaminated needles is an international problem stemming from misuse of used needles and improper disposal, where needles either go to landfills or are dropped in local parks and on the street. Medical devices Although not called product stewardship, the reuse of medical devices is a market-based product stewardship system. There are two types of medical device programmes. The first is when a manufacturer designs a device for reuse. The second is the reuse of devices designed by the original manufacturer for single-use. Allowing the reuse of medical devices requires quality-control standards to recalibrate, clean, sterilise, remanufacture, and test some medical equipment, such as non-invasive items (compression sleeves, pulse oximeters), operating room devices (trocars, harmonic scalpels) and electrophysiology equipment (EP catheters). Some devices should not be reused because they cannot be easily cleaned and sterilised such that the risk of spreading disease is too great. allowing the reuse of medical devices requires quality-control standards to recalibrate, clean, sterilise, and test medical equipment, such as non-invasive items, operating room devices and electrophysiology equipment Reusable medical devices are equipment that healthcare providers can reuse to diagnose and treat multiple patients. Examples include surgical forceps, endoscopes, and stethoscopes. Because these devices are designed to be reused, the reprocessing methods are fairly easy. With detailed instructions, these devices can be cleaned and sterilised. The manufacturer provides these instructions and either arranges for reprocessing by returning the devices to the manufacturing plant, using a third party to reprocess in accordance with the manufacturer s instructions, or training is provided to the healthcare facility on how to reprocess themselves without collection and transportation. The manufacturer will provide information on how many times a device can be reused based on tests the manufacturer has conducted before the device is placed on the market. The reuse of single-use devices is more complicated. The reprocessing may be the same as multi-use devices in terms of cleaning and sterilising, but the original manufacturer has not tested the device for material integrity - how many times the device can be reused before the device will not function properly or can no longer be effectively cleaned. To reuse these devices a third party must play the role of a manufacturer and test the device for reuse and establish a protocol for cleaning and sterilising. In the United States, the federal Food and Drug Administration (FDA) has published regulations on reusing devices. For multi-use devices, the regulations detail how a manufacturer should test a device. For single-use, the FDA s regulations also include testing and a reporting requirement such that the FDA knows who is conducting the reprocessing, and where the devices are being used. Today, there are more than 100 original manufacturer, single-use devices that the FDA allows for reuse. Acknowledgement Special thanks to Chaz Miller, Director of State Programs, National Solid Wastes Management Association, for providing some of the information found in this article. Author Alice P Jacobsohn, Esq is a licensed attorney employed with the National Solid Wastes Management Association (NSWMA), a non-profit trade association located in Washington, DC, US. Her job duties include the NSWMA director of education and director of the Healthcare Waste Institute (HWI). NSWMA represents solid and healthcare waste management companies throughout the US, offering member representatives information and education on technological changes and existing and proposed laws and regulations; advocating industry positions before government and community decision makers, and creating business networking opportunities. Thirty-two state chapters offer members support at the local level. The headquarters office provides federal advocacy, legal counsel, community relations, technical support, meeting and event planning, and educational programmes. 23 October