Although the treatment and disposal of medical waste is regulated primarily by the states, several federal agencies have maintained regulatory authority over medical waste since the passage of the MWTA. As stated previously, RCRA authorizes the EPA to regulate waste management activities primarily under subtitles C, D and I for those wastes also classified as hazardous (e.g. mercury or other toxic metals). Id. Regulatory Overview §. However, RCRA allows states to develop and enforce their own waste management program if approved by the EPA. 42 U.S.C. §§ 6905 et seq. The Clean Air Act (CAA) authorizes the EPA to regulate all emissions from Hospital/Medical/Infectious Waste Incinerators (HMIWI), while the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) allows the EPA to control antimicrobial pesticides and chemicals used in treating medical waste before disposal. The Occupational Safety and Health Administration (OSHA) also regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training to protect healthcare workers from the risk of exposure to bloodborne pathogens. Other federal agencies that regulate other aspects include:
- Department of Transportation (DOT) regulates transportation of hazardous material
- Nuclear Regulatory Commission (NRC) regulates radioactive medical waste
- Food & Drug Administration (FDA) regulates medical devices like sharps containers
- U.S. Postal Service (USPS) regulates medical waste in the postal system
There is often overlap between state program rules and those of federal agencies, such as the OSHA bloodborne pathogens standard. Healthcare facilities are often advised to follow the more stringent guidelines when a conflict is noted (HERC, n.d., Regulatory Overview §).
Regulation of Incinerators (HMIWI)
In response to growing public concern about poor air quality near incinerators handling medical waste, the CAA was amended in 1997 to authorize the EPA to regulate emissions generated by HMIWIs during the treatment and disposal of RMW. This amendment created arguably the strongest federal regulation of medical waste to date. EPA established new source performance standards (NSPS), which outlined requirements for emissions, testing, operator training, site locations, equipment inspections and reporting from new and existing HMIWIs. 40 CFR §§ 60.30e to 60.39e and §§ 60.51c to 60.58c. CAA requires states to submit a plan to EPA for approval, outlining standards of performance at least as stringent as the federal guidelines in order to be approved by EPA. An approved state plan is managed by the respective state EPA or the Department of Health (DOH). Id. §§ 62.1440 to 62.14465.
Hospital/medical/infection waste incinerators (HMIWI) are used by hospitals, healthcare facilities, and commercial waste disposal companies to burn RMW, including infectious and/or pathological waste. The advantages of medical waste incineration include the dramatic reduction of up to 45% of the total volume, the decrease in the volume of waste going to landfill sites and the destruction of toxic chemicals and/or infectious pathogens in the RMW (FedCenter, n.d., Incinerators §). Although widely utilized by hospitals and healthcare facilities over the past 50+ years, the number of HMIWIs declined significantly over the past 10 years as organizations decided the equipment upgrades and staff monitoring necessary to comply with the EPA guidelines proved cost-prohibitive. This provided a catalyst for the investigation and eventual adoption of alternative waste disposal methods by some hospitals while others transport their medical waste to commercial disposal companies for incineration. As of June 2004, the EPA estimates that only 95 incinerators operate in the United States to combust medical and infectious waste annually compared to the estimated 1,600 active during the 1980s and 1990s (EPA, 1997).
Detrimental Effects of Incineration
Despite its effectiveness in reducing the volume of waste, incineration releases toxic air emissions and produces toxic ash residue (e.g. hydrochloric acid and toxic metals like mercury and lead). Health Care Without Harm describes these effects: “The air emissions affect the local environment and may affect communities hundreds or thousands of miles away. The ash residue is sent to landfills for disposal, where the chemical pollutants have the potential to leach into groundwater.” (HCWH, 2002, Alternatives for Incineration §). In addition, the burning of RMW consistently creates new toxic compounds such as dioxins, PCBs and flurans. The World Health Organization (WHO) classifies dioxin as a known human carcinogen. EPA identified HMIWIs as the third largest source of dioxin air emissions and as the contributor of 10% of the mercury emissions into the environment. Id.
Although strict causal relationships are difficult to identify for a single individual, current scientific thought associates these compounds with a significant increased risk for adverse health effects such as cancer, birth defects, immunosuppression, respiratory disease, developmental delays, hyperactivity, allergies and endocrine disorders. Dioxin is formed as a by-product when products or wastes containing chlorine are burned, such as PVC (polyvinyl chloride) plastic. PVC is a used extensively in hospitals and other healthcare facilities, for common disposable products such as IV and blood bags, gloves, tubing, ID bracelets and mattress covers. Office supplies like binders and chart holders are also made with PVC and typically disposed of. Id.
When hospitals incinerate these waste products containing chlorine or heavy metals (e.g. mercury used in thermometers and blood pressure gauges), particles of dioxin and mercury are emitted into the air and carried by the wind before settling on land/plants or in water. Allsop et al acknowledged these and other toxic pollutants “are known to be persistent (very resistant to degradation in the environment), bioaccumulative (build up in the tissues of living organisms) and toxic. These three properties make them arguably the most problematic chemicals to which natural systems can be exposed.” (Allsop et al, 2001, Executive Summary §, pg. 6). While it is possible for humans to ingest these particles from the air, the typical exposure begins with the ingestion by grazing animals and fish. They are unable to break these chemicals down, so the contamination travels up the food chain. The Agency for Toxic Substances and Disease Registry estimates that 96% of the major sources for human dioxin exposure are animals fats found in meats, full fat dairy products and fatty fish (ATSDR, pg. 2). Dioxin accumulates in our body and organ fat and exhibits a half-life of 7-12 years before metabolism and excretion transpires. Infants are at high risk for dioxin exposure, since breast milk contains such a high fat content, and are the most vulnerable to its effects on their developing body. Low-level exposure to this toxic chemical throughout our lifetime leads to a ‘build-up’ in our tissues. Id. pg. 5. Mercury is a potent neurotoxin that can cross the blood-brain barrier and the placenta, so infants and young children are again at the highest risk for mercury poisoning by means of self-ingestion or through the breast milk of their mother. The effects of mercury poisoning can include slurred speech, impaired hearing, peripheral vision, and walking, muscle weakness, mood swings, memory loss and/or mental disturbances (HCWH, 2002, Alternatives for Incineration §).
Alternatives for Treatment of Medical Waste
The availability of non-incineration treatment alternatives continues to grow, as demand for cost-effective and environmentally friendly solutions increases. Disinfection and sterilization of the medical waste are the ultimate functions of each of these systems, so that the resultant waste product resembles typical municipal waste and can be disposed of accordingly. The disinfection process “reduces the number of microorganisms or pathogens to as low a level as possible, at least below the level at which exposure to a susceptible host could not result in an infectious disease.” Actual sterilization, the complete destruction of all the microorganisms or pathogens, is not usually maintained once the waste leaves the treatment instrument so the more accurate term is disinfection (HCWH, 2001, § 2).
A brief description of the main treatment alternatives, along with associated drawbacks and cost in relation to incineration, follows (Id., §§ 2.1 to 2.6):
- Autoclave/Rotoclave – a steam sterilizer where wastes are subjected to 130° - 190° steam and high pressure for 30-90 minutes. Reduces volume by 75% and residue is inert. Cannot handle pathological and low radioactive wastes. Costs ~ 20-30% less.
- Disinfection with superheated steam – similar to the autoclave but temps of 480° - 705° are utilized. Reduces volume by 50%. Handles all wastes. Same cost.
- Hydroclave – uses 135° steam for the heating up and dehydration of the wastes, for 1 hour. Reduces volume by 80%, weight by 50% and residue is inert. Handles all wastes. Costs ~ 15% less.
- Microwave – destroys microorganisms using microwaves for 20-30 minutes, with no emission. Reduces volume by 80%. Cannot treat blood and hazardous chemicals. Same cost.
- Vitrification (uses heat to turn hazardous wastes into glass) and bioremediation (uses anaerobic bacteria to degrade wastes and detoxify soil) are emerging treatments.
Necessary Change
Although incinerators effectively reduce the amount of RMW from hospitals and other healthcare facilities, the detrimental effects to the environment and human health resulting from this practice outweigh its benefits. While new incinerators in compliance with the Maximum Achievable Control Technology (MACT) standard from EPA show a reduction in the number of particle emissions, numerous toxic chemicals continue to escape into the environment and end up in the food chain. EPA acknowledges “When burned, hospital and medical/infectious wastes emit a number of toxic air pollutants, including hydrochloric acid, dioxin/furan, lead, cadmium, and mercury.” (EPA, 2000, pg. 1). The total output volume of these toxic chemicals during the incineration process remains the same, even with this new technology. The new incinerators simply trap more particle emissions in the combustion chamber, reducing the gaseous output into our skies while increasing the concentration of these chemicals in the residue and ash collected during the incineration. The subsequent disposal of this residue and ash in a landfill significantly increases the risk for eventual groundwater contamination. Many of the detrimental effects of medical waste incineration remain, with a mere change of the transmission mechanism. There is no evidence to suggest that any pending technological advancement will eliminate the production of these toxic by-products during incineration. The National Research Council (NRC) expressed “substantial concern about the impacts of incinerator-derived dioxin releases on the health and well-being of broader populations, regardless of the implementation of MACT” (NRC, 2000).
With this in mind, an urgent need exists for a complete phase-out of waste incineration by 2020.
In conjunction with this phase-out, the Center for Medicare & Medicaid Services (CMS) must establish guidelines that require hospitals and other healthcare facilities to reduce the overall volume of their waste 50% by 2012 through waste prevention, re-use and recycling. CMS will institute a comprehensive education program for healthcare facilities across the nation, providing detailed information on creating a waste reduction and recycling program with three additional recommendations:
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Stop purchasing products containing heavy metals like mercury or those substantially made out of PVC plastic. Cost-effective alternatives for many of the disposable products utilized in a hospital exist, such as those offered by Isolyser. It has developed a natural compound called OREX that is used to make gloves, bags and other disposables utilized repeatedly throughout the day. These OREX disposables dissolve in water after use. This eliminates a large portion of the daily waste stream created in healthcare facilities, reducing disposal costs and environmental impact.
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Begin investigating alternatives to incineration for wastes like autoclaving. The educational program will provide a cost-benefit analysis of the various treatment alternatives to reduce the start-up time for facility investigation.
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Establish a comprehensive waste segregation program on-site. Many hospitals throw the majority of their waste into RMW containers, despite the estimate that 85-90% of this waste is normal, solid waste. Treatment and disposal of RMW costs up to 10 times as much as solid waste disposal. Significant disposal cost savings are available to hospitals that commit to this type of project (Allsop et al., 2001, Solution §) .
A substantial reduction in the overall volume of RMW and general waste produced by hospitals will help to mitigate the damaging effects of incineration to the environment and the publics’ health. This regulatory mechanism serves two purposes: 1) decreasing the market demand for and reliance on incineration as waste volumes decrease, and 2) creating an economic incentive to pursue ‘green’ business practices (e.g. purchasing, materials and waste management) as disposal savings are realized. The potential for revocation of a facility’s participation in the Medicare program will ensure compliance with these requirements.
Some hospitals have taken major steps to reduce their use of potentially toxic materials and to decrease the total volume of incinerator waste. A waste reduction program at the Fletcher -Allen Health Care System in Vermont reduced the volume of regulated medical waste at one campus by 75% in a few months. Beth Israel Medical Center in New York City has a program to rigorously reduce the amount of solid waste going into the "red bags" for biohazardous waste. This effort saves the hospital $900,000/year in disposal costs by reducing the amount of RMW that must be treated. Naples Community Hospital switched from incineration to autoclaving of medical waste, reducing disposal operating costs by up to 80%. Significant potential exists for healthcare facilities to reduce incineration use while saving costs (HCWH, 2001).
Conclusion
The Pollution Prevention Act (PPA) requires the prevention and/or reduction of pollution at the source, with disposal into the environment utilized only as a last resort in an ecologically safe manner (PPA, 1990). With our knowledge of the detrimental effects of incineration, we realize that immediate action is necessary to not only ensure compliance with the PPA mandates but also to avoid further environmental contamination and public health effects. With this in mind, an urgent need exists for legislative and regulatory action to ensure a complete phase-out of waste incineration by 2020 and the implementation of rigorous waste management principles to reduce the overall RMW 50% by 2012 through waste prevention, re-use and recycling.
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