Medical Waste. Medical Waste Audit Members. Nathan Braly Matthew Hendrix Chris Kilpatrick Jill Yandle Lisa Young. Information Contacts

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1 Medical Waste Medical Waste Audit Members Nathan Braly Matthew Hendrix Chris Kilpatrick Jill Yandle Lisa Young Information Contacts June Brock, Environmental/Health Manager II, Clemson University Colleen Caracciolo, Environmental Health/Safety Administrative Assistant, Clemson University Jim Clark, Environment/Health Manager III, Clemson University Joe Edick, President, Medical Waste Systems, Inc Jack Howard, Vice President Business Development, Medical Waste Systems, Inc Jamey Lowdermilk, Graduate Research Assistant, Clemson University Terms and Definitions Autoclave: An airtight steel vessel used to heat substances and objects under very high pressures (The American Heritage Science Dictionary, 2005). Biohazard: A biological agent, such as an infectious microorganism, that constitutes a threat to humans or to the environment, especially one produced in biological research or experimentation (The American Heritage Science Dictionary, 2005). Dioxin: Any of a family of compounds known chemically as dibenzo-p-dioxins. Concern about them arises from their potential toxicity as contaminants in commercial products. Tests on laboratory animals indicate that it is one of the more toxic anthropogenic (man-made) compounds (U.S. Environmental Protection Agency, 2007). Incineration: A treatment technology involving destruction of waste by controlled burning at high temperatures (U.S. Environmental Protection Agency, 2007). Infectious: Capable of causing infection, caused by or capable of being transmitted by infection, caused by a pathogenic microorganism or agent (The American Heritage Science Dictionary, 2000). Medical waste: Any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals (U.S. Environmental Protection Agency, 2008). Mercury: Heavy metal that can accumulate in the environment and is highly toxic if breathed or swallowed (U.S. Environmental Protection Agency, 2007).

2 Medical Waste 2 Noninfectious: Not infectious; -of diseases, opposite of infectious (Webster's Revised Unabridged Dictionary, 1913). Background According to the United States Environmental Protection Agency (EPA) (2008), medical waste is defined by the Medical Waste Tracking Act of 1988 as 'any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals.' This definition includes, but is not limited to: blood-soaked bandages culture dishes and other glassware discarded surgical gloves discarded surgical instruments discarded needles used to give shots or draw blood (e.g., medical sharps) cultures, stocks, swabs used to inoculate cultures removed body organs (e.g., tonsils, appendices, limbs) discarded lancets For all intents and purposes concerning Clemson University, in this section of the audit, medical waste and biohazard waste are synonymous. Incinerators/Autoclaves As defined by the EPA, incineration is a treatment technology involving destruction of waste by controlled burning at high temperatures (EPA, 2007). The EPA approves of three types of incinerators for medical waste disposal: controlled air, excess air, and rotary kiln. Incineration gives off emissions such as carbon dioxide, water vapor, excess oxygen and nitrogen, and trace elements. Unfortunately harmful mercury and dioxin contaminants are released during incineration. As a result, the EPA has developed guidelines for industries to follow in order to keep the emissions to a minimum (EPA, 1995). One alternative to incineration is autoclaving. An autoclave is an airtight steel vessel used to heat substances and objects under very high pressures (The American Heritage Science Dictionary, 2005). Autoclaving allows the sterilization of medical waste without the possibility of polluting emissions of mercury and dioxins. This sterilization method is still under investigation by the national industry as a whole as a possible alternative to incineration. Comparing the two possible methods of waste disposal shows that even though autoclaving may be environmentally safer due to the lack of emissions, the waste produced by autoclaving fills up the landfill much faster than using incineration. Waste which has been incinerated is reduced to ash while waste which has been autoclaved must be made unrecognizable either by shredding or incineration (June Brock, personal communication, May 1, 2009). Also according to June Brock, autoclaving is a complicated procedure in itself (personal communication, April 13, 2009). Records must be stringently kept in regard to test batching, temperature levels, and certification and maintenance of each autoclave. In the autoclaving process, not only is the waste subjected to

3 Medical Waste 3 temperatures to kill all organisms but also the waste must be rendered unrecognizable before removal to a landfill. Mercury and Dioxin Contaminants Environmentally, the main concern of medical waste disposal is the byproducts of incineration - mercury and dioxin contaminants. Mercury, in all of its forms, has been deemed potentially dangerous (Travis & Blaylock, 1997). While the incineration of medical waste, which Clemson University produces, does not directly affect Clemson since the incineration process is completed in Matthews, NC, these contaminants remain an environmental concern to communities beyond Clemson as a result of on-campus classes and research. The United States Department of Agriculture (USDA) registered dioxin (2,4,5-T), also known as TCDD, as a pesticide in Dioxin is not technically medical waste, but dioxin is produced when waste is incinerated. Over the next 40 years, many occurrences led to the belief that TCDD was toxic, so the EPA cancelled the registration of TCDD as a pesticide, which previously had TCDD classified it as not harmful (Moore, Kimbrough, & Gough, 1993). Currently, it is known that all incinerators release dioxins during the incineration process (Allen, 2004). U.S. Greenpeace scientist Pat Costner believes that the chlorine material that is present during incinerations reacts to organic matter thus creating dioxin. It is then dispersed into the air through emissions and consequently enters the food chain and also settles in the soil. Dioxin is stored in the fat cells of animals with levels ranging from slightly toxic to harmful. One of the main challenges with identifying dioxin as lethal is that animals and humans do not die from the toxin but from complications caused by it. A simple description of how dioxin affects animals and humans is that it enters the body, binds to an enzyme, attaches to DNA, and then disrupts biological functions. This disruption is generally what kills animals or humans. Laws/Regulations The South Carolina Legislature website outlines the South Carolina Infectious Waste Management Act. This act gives current definitions, regulations, procedures, and standards. In addition, it outlines principles for storage, transportation, treatment, and disposal of infectious waste, among other procedures (South Carolina Legislature, 2008). The EPA has a website for Hospital/Medical/Infectious Waste Incinerators which provides rule information (policy and guidelines), technical information, implementation information (also providing additional information on mercury), and other related websites. Table 1 provides a summary of all regulations and guidelines for bio-hazardous waste management. The summary is from a study entitled Defining and Managing Bio-hazardous Waste in U.S. Research-Oriented Universities: A Survey of Environmental Health and Safety Professionals (Mecklem and Neuman, 2003, p. 18).

4 Medical Waste 4 Table 1: Summary of Regulations and Guidelines Impacting Bio-hazardous Waste Management Agency Regulations/Guideline Relevance U.S. EPA (1989) Medical Waste Tracking Act Although not reauthorized, serves as a basis for most state medical waste programs OSHA (1990) Blood borne Pathogens Standard Defines medical waste; requirements for handling, storage, and labeling of medical waste U.S. DOT (1991) Hazardous Materials Regulations Packaging, labeling, and documentation requirements for transportation of bio-hazardous waste Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (1995) Accreditation requirements for health care settings Requires written plan addressing state and federal requirements biohazardous waste as well as goals and performance standards for waste management Institute of Laboratory Animal Resources (1996) Accreditation requirements for animal resource operations Procedural requirements addressing packaging, labeling, transportation storage, and decontamination of waste USDA/Animal and Plant Health Inspection Service (1997) Animal and Plant Health Inspection Service (APHIS) requirements Permit requirements regarding environmental release of genetically modified organisms that may be plant pests U.S. EPA (1997) Medical Waste Incinerators Final Rule Part of Clean Air Act Amendments that has set restriction emission standards on HMIWIs CDC and NIH (1999) Bio-safety in Microbiological and Biomedical Laboratories Outlines requirements for waste decontamination when working with human pathogens NIH (2001) Guidelines for Research Involving Recombinant DNA Molecules Outlines requirements for waste decontamination when working with genetically modified organisms including plants

5 Medical Waste 5 Scope Clemson University spends nearly $18 per box annually to dispose of the medical waste generated on campus. Clemson University has spent approximately $61, on disposal of medical waste in the past six years. Over the past six years Clemson has spent an average of $10, per year on disposal. In 2008, Clemson University spent $15, on medical waste disposal. Medical waste that is produced on campus is disposed of bi-monthly. The amount of medical waste collected averaged boxes per year and with an average pick-up of 22.5 times per year from 2003 through The current method of waste disposal at Clemson University is by incineration; further research into autoclaving may be beneficial. The waste is currently picked up by Medical Waste Disposal, Inc and transported to BMWNC in Matthews, NC for incineration and final disposal. Disposal Methods According to June Brock, Clemson University has disposed of medical waste according to state and federal laws in compliance with DHEC or Department of Health and Environmental Control (personal communication, February 13, 2009 and personal interview, February 18, 2009). Currently Clemson contracts with Medical Waste Disposal, Inc. out of Florence, South Carolina which provides transportation of wastes to a subcontractor, BMWNC, where the waste is incinerated. BMWNC is located in Matthews, NC. This contract is reviewed annually. Medical waste is collected from the following locations on campus: Redfern Health Center, Sullivan Nursing Center, Fike Recreation Center, Clemson University Fire Department (CUFD), Jervey Training Room, Chemistry labs, Animal and Veterinary Service, Biology labs, Bio- Engineering Department, Entomology Soils & Plant Sciences (ESPS), and Genetics/Biochemistry labs. Ms. Brock stated that all research departments follow an Institutional Biosafety Committee (IBC) protocol that clearly instructs on the disposal method. If the waste is potentially infectious, then it is autoclaved beforehand. This kills the organisms to avoid any potential contamination outbreak. If the waste is not potentially infectious, then it is not autoclaved. Each location has its own specified room where the waste is taken, whether autoclaved or not. It is double or triple bagged and then placed in specially marked biohazard boxes that are supplied by Medical Waste Disposal, Inc. These locations are kept secured and are only accessible to trained personnel (personal correspondence, April 25, 2009). Once it is determined that enough waste has been accumulated for a pick-up, then the department or facility contacts June Brock for a pick-up by filling out the Biohazardous Waste Removal Request found on Clemson s website ( Only Redfern Health Center and the Bio-Engineering Department are on a bi-monthly schedule for pick-ups due to the amount of waste regularly produced.

6 Medical Waste 6 Once Ms. Brock receives the request, she picks up the waste and transports it to the Hazardous Waste Central Accumulation Area on campus where it is weighed, labeled, and classified as infectious or non-infectious. This last step is required by DHEC, which determines how much infectious waste Clemson generates per year. All waste, whether it is labeled infectious or noninfectious and whether it has been autoclaved or not, is disposed of as infectious waste. The boxes are then placed in the Hazardous Waste Central Accumulation cooler for no more than two weeks. Medical Waste Disposal, Inc. retrieves the waste and takes it to the subcontractor s incineration site in North Carolina. Quantity Clemson University did not start weighing the waste produced until the year Before this time, all waste was simply transported for disposal. Table 2 documents the yearly amount of biohazardous waste (medical waste) collected from the different locations on Clemson University s campus. Overall, Clemson has shipped an average of 22.5 times per year with an average of boxes each year. Medical waste production has varied from year to year, showing increases, decreases, and constants for the amount of waste produced on campus. The general trend, however, is an increase in waste. According to June Brock (personal communication, May 8, 2009), the trend for the increase is mainly due to Clemson striving to be a top 20-research university. Although there are no records of the amount of waste produced by each department/facility, she has not noticed any considerable increase from the undergraduate departments. The increase is mainly originating from the graduate departments. Also noted in Table 2 is the number of manifests shipped and tracked each quarter. This is required due to the nature of the potentially infectious waste. Ms. Brock is required to show proof of pick-up by Medical Waste Disposal, Inc. and its delivery at BMWNC. Finally, Table 2 documents the weight in pounds and the number of boxes that Clemson University generates yearly. Graph 1 shows the broad trend for an increase in medical waste production over the course of the last six years. The graph indicates a larger increase in 2008 due to an additional location of waste disposal pick-up from Clemson s off-campus site in Columbia, SC. Graph 1 Bio-hazardous Waste Managed (lbs.) Per Year

7 Medical Waste 7 Table 2 Biohazard Waste Yearly Reports Fiscal Year Activity 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr TOTAL 2003 Shipped & Tracked Biohazardous Waste Managed (in pounds) 3, , , , , Biohazardous Waste Managed - # Items (boxes) July 1, 2008 February 17, 2009 Shipped & Tracked Biohazardous Waste Managed (in pounds) Biohazardous Waste Managed - # Items (boxes) Shipped & Tracked Biohazardous Waste Managed (in pounds) Biohazardous Waste Managed - # Items (boxes) Shipped & Tracked Biohazardous Waste Managed (in pounds) Biohazardous Waste Managed - # Items (boxes) Shipped & Tracked Biohazardous Waste Managed (in pounds) Biohazardous Waste Managed - # Items (boxes) Shipped & Tracked Clemson, SC (in pounds) Clemson, SC - # Items (boxes) Columbia, SC (in pounds) Columbia, SC - # Items (boxes) Clemson, SC - # Items (boxes) Columbia, SC (in pounds) Clemson, SC - # Items (boxes) , , , , , , , , , , , , , , , , , , , , , , , , ,

8 Medical Waste 8 Cost Table 3 Biohazard Waste Cost Reports Months Fiscal Year Total Cost July 1, June 30, $5, July 1, June 30, $6, July 1, June 30, $6, July 1, June 30, $8, July 1, June 30, $8, July 1, June 30, $15, July 1, June 30, $17, July 1, 2009 January 1, $9, Table 3 documents the expenditure for biohazardous waste removal per year. For each fiscal year there has been an increase in the cost accumulated for medical waste disposal. The data for 2009 does not cover the entire fiscal year, but only the cost for the noted time period. The sudden increase in cost seen from the 2007 to the 2008 fiscal years can be explained by Clemson s offcampus site. As of 2008, Jim Clark started coordinating the shipment of infectious waste from Columbia using Medical Waste System, Inc. This site shipped 282 boxes of waste and accumulated costs of $5, However, unlike the process June Brock uses, waste is picked up on a weekly basis. After subtracting out the cost of the Columbia site production, maincampus medical waste disposal cost totaled $10, While this amount is still an increase from previous years, the increased production of main-campus waste is not as drastic as it appears in the graph. Graph 2 depicts the steady increase in cost of bio-hazardous waste removal over the course of the last seven years. Graph 2 Cost of Bio-hazardous Waste Removal ($) Per Year

9 Medical Waste 9 Summary Medical waste needs to be disposed of properly in order to reduce its impact on the environment. It has to be safely and efficiently removed so as to protect the health and safety of the community. The definition of medical waste by the Medical Waste Tracking Act of 1988 includes many, but not all, of the types of waste that must be disposed of according to specific regulations. Incineration and autoclaving are both used by Clemson University to dispose of medical waste. Incineration is not as effective as autoclaving and has more environmental consequences but autoclaving fills up the landfill quicker with residual waste. Auditor s Perspective Clemson University is committed to becoming one of the nation s leading research institutions. Due to the economic challenges the United States and Clemson University faces at this time, the auditors believe the best option Clemson has for medical waste disposal is to continue with the same process. Currently, each department autoclaves the waste as required, stores the waste for retrieval, collects all medical waste by trained personnel, and then transports the waste for incineration. Through our investigation, we have found there are advantages and disadvantages to incineration and autoclaving; both of these options present an environmental challenge. Incineration may emit harmful byproducts into the atmosphere, but since it turns waste to ash it consumes less space in a landfill. Autoclaving does not give off harmful byproducts, but the waste must be made unrecognizable through some other process whether by incineration, shredding, or another technology, and it still uses more space in landfills. Therefore, the auditors believe that incineration is still the best option given that companies comply with the policies and safeguards the EPA, DHEC, and regulations other agencies have enacted. Future Recommendations Medical waste incineration inevitably produces adverse effects on society, especially the contaminants produced through improper burning. Further investigation should be done on alternate means of disposal as new developments or technologies become available. The potential for autoclaving certain non-infectious medical waste should also be re-evaluated as the field becomes more advanced. Although autoclaving is an expensive endeavor, Ms. Brock and the Environmental Health and Safety (EHS) Department foresee this process as the direction of the future (June Brock, personal communication, April 13, 2009). Mecklem and Neumann (2003) published a study in which 122 educational institutions were sent a survey concerning their procedures for bio-hazardous waste. The three main questions were: 1) which regulatory guideline(s) does the university follow to define bio-hazardous waste, 2) what are the methods used for treatment and disposal, and 3) what administrative controls are in place to ensure the proper handling, treatment, and disposal. Their results determined that different universities created policies, which follow different guidelines by different agencies and governments. The most cited were Occupational Safety and Health Administration (OSHA) Blood borne Pathogens (BBP) Standard, Center of Disease Control (CDC)/National Institutes of Health (NIH) guidelines, and state regulations. Also, incineration and autoclaving were the two main forms of disposal with some of the universities using these methods on-site and others

10 Medical Waste 10 using a medical waste hauler (MWH). Finally, the survey focused on the administrative control provisions to ensure a successful bio-hazardous waste management program. The questions focused on training of personnel, tracking waste from origin to destination, emergency contact information, contingency plans for disposal, and other control provisions. In conclusion, their recommendations for the development of bio-hazardous waste programs by EHS departments were as follows: 1) identify activities and research applicable guidelines to create an effective management plan, 2) periodically evaluate techniques to ensure the safest and most costeffective procedure is followed, 3) regularly review current treatment procedures and any new technological and regulatory developments, 4) include provisions to ensure compliance with OSHA and state regulations, and 5) utilize the U.S. EPA s Guide for Infectious Waste Management and the Council of State Government s Model Guidelines for State Medical Waste Management as pertinent information to incorporate into existing university guidelines. Future audits should examine these two documents to determine if any methods could be integrated into Clemson s existing policies. Future research should also include analyzing the individual departments at Clemson to ensure they are following the appropriate guidelines and to determine if there are certain laboratories or departments on campus, which could reduce the production of medical waste. The actual waste stream production could be more closely analyzed to eliminate unnecessary production. Additionally, a more in-depth study on Clemson s policies for medical waste disposal needs to be completed. What are the exact guidelines Clemson uses from DHEC and the EPA? Are there any other regulations Clemson follows? Furthermore, the study performed by Mecklem and Neumann (2003) referred to obtaining their sample population from Higher Education Publications. This publication outlines the classifications of universities by Carnegie Foundation for the Advancement of Teaching. It may be possible to obtain this list to research other universities policies on medical waste disposal and compare Clemson s policies to those of others. As a whole, the audit should be revised each year to ensure Clemson University is up-todate with EPA guidelines, state guidelines, and all other governmental agencies and to monitor any increases in medical waste production. References Allen, R. (2004). The dioxin war: Truth and lies about a perfect poison. Ann Arbor: Pluto. Autoclave. (2005). Retrieved March 2, 2009, from Biohazard. (2000). Retrieved March 29, 2009, from Elzerman, A.W., London, D.S., & Perkl, R.M. (2006). Clemson University Environmental Audit. Infectious. (2000). Retrieved March 29, 2009, from Infectious Waste (2005). Retrieved March 29, 2009, from

11 Medical Waste 11 Mecklem, R.L., & Neumann, C.M. (2003). Defining and managing bio-hazardous waste in the U.S. research-oriented universities: A survey of environmental health and safety professionals. Journal of Environmental Health, 66(1), Moore, J.A., Kimbrough, R.D., & Gough, M. (1993). The dioxin TCDD: A selective study of science and policy interaction. In M. Uman (Ed.), Keeping pace with science and engineering: Case studies in environmental regulation (pp ). Washington, D.C.: National Academy Press. Noninfectious. (1913). Retrieved March 29, 2009, from Patnaik, P. (1992). A comprehensive guide to the hazardous properties of chemical substances. New York: Van Nostrand Reinhold. South Carolina Legislature. (2008). Retrieved February 10, 2009, from Travis, C.C., & Blaylock, B.P. (1997). Air emissions of mercury and dioxin: Sources and human exposure. In R. Landreth & P. Rebers (Ed.), Municipal solid wastes: Problems and solutions (pp ). Boca Raton: CRC Lewis. United States Environmental Protection Agency. (2009). Retrieved February 10, 2009, from United States Environmental Protection Agency. (1995). Retrieved February 10, 2009, from United States Environmental Protection Agency. (2007). Retrieved February 25, 2009, from United States Environmental Protection Agency. (2008). Retrieved March 29, 2009 from