Sherri L. Hutchens
U.S. Army Center for Health Promotion and Preventive Medicine, ATTN: MCHB-DC-EAP, 5158 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5422

Abstract

The U.S. Army Center for Health Promotion and Preventive Medicine (USACHPPM) has witnessed recurring problems with medical waste incinerators throughout the Army. These problems can impact the installation by causing a build-up of medical waste, environmental violations, additional disposal costs, and injuries to personnel. Most problems can be avoided by good communication, prior planning, and proper training.

On February 27, 1995 U.S. Environmental Protection Agency (USEPA) published proposed standards and guidelines to limit air pollution emissions from new and existing medical waste incinerators. The proposed standards were very stringent and were expected to shutdown approximately 85% of all medical waste incinerators in the United States. However, reaction to the proposed rule has caused the USEPA to reevaluate all aspects of the rule. The rule will: define medical waste; contain medical waste incinerator emission standards; and establish requirements for operator training, testing and monitoring, operating parameters, and siting. The medical waste incinerator rule is expected to be promulgated in the summer 1997 and may have significant impacts on medical waste disposal in the United States. Existing Department of Defense (DOD) incinerators may not be able to meet the emission limits set forth in the rule. Furthermore the rule may impact medical waste disposal at installations that use disposal contracts.

This paper will discuss the most common problems with medical waste incinerators, ways to prevent them, and the impacts of the proposed USEPA medical waste incinerator rule on DOD installations.

Introduction

Incineration is a common method of medical waste disposal in the United States and worldwide. The U.S. Environmental Protection Agency (USEPA) estimates that there are approximately 2,300 medical waste incinerators (MWIS) in operation in the United States (reference 1). The Department of Defense (DOD) currently operates 41 MWIs (14 Army, 23 Air Force, 4 Navy) in the continental United States (reference 2). In addition, the Army operates several MWIs outside the continental United States. Incineration of medical waste offers the benefits of sterilizing the waste, reducing the volume of waste, and rendering the waste unrecognizable (reference 3). However, in recent years, public perception of incineration has been declining and environmental regulation of incineration has become increasingly more stringent.

Common Problems, Causes, and Solutions

Inadequate Equipment

Often inadequate incinerators are being used to burn medical waste. This problem frequently occurs when incinerators that were designed to burn pathological waste are used to treat medical waste. Pathological waste has a very high moisture and a low volatile content; therefore can be completely combusted in an incinerator with a small secondary chamber. [secondary chambers are specifically used to combust the volatile portion of the waste (reference 3).] On the other hand, medical waste typically has a high volatile content and a lower moisture content, due to the large quantity of plastics in the waste stream. Thus, medical waste requires a larger secondary chamber to facilitate complete combustion of the volatile portion of the waste (reference 3). An incinerator designed strictly for the combustion of pathological waste should not be used to burn medical waste. Many states have implemented standards for MWIs which include equipment requirements. In some cases, MWIs are simply old and unable to meet the current state standards. These incinerators need to either be upgraded or replaced to meet the standards.

Poor Equipment Specifications

Poorly written equipment specifications is another incinerator problem. In the contract, it should state that the equipment must meet all Federal, state, and local regulatory requirements, to include emission limits, residence times, training, etc. Incinerators and air pollution control devices (APCD) should be ordered and delivered as a package whenever possible. In addition, it is beneficial to have the manufacturer install the equipment and provide training (training aspect should be specified in the contract). The contract specifications should require that at least three copies of any equipment operating manuals be provided to the installation. The contract should include an environmental enclosure for the equipment, especially for wet scrubbing systems. (Scrubbing solutions typically used in wet scrubbers freezes, at approximately 500F, so heating units are required in most areas of the country.) It is also beneficial to have a third party familiar with MWIs review the specifications prior to releasing them to contracting. Often, personnel whom write specifications do not have much experience with incinerators or the associated environmental regulations.

Lack of Standard operating Procedures

The USACHPPM has observed that few installations have formal written standard operating procedures (SOPS) for MwIs. Site-specific SOPs provide a good reference for personnel associated with the MWI and assist new personnel whom are being trained to operate the incinerator. A good SOP should include information on waste handling, waste storage, ash handling, incinerator operation, equipment maintenance, safety requirements, training requirements, and points of contact. Preventative maintenance schedules should be specified in the SOP, as well as maintenance points of contact. The MWIs are frequently owned by medical activities on installations. These medical activities are usually tenants on installations and may not have the proper personnel to provide preventative maintenance or to correct problems with MWIS. It is extremely important that maintenance be conducted on a regular basis. This;requires good communication between the medical activity and the installation maintenance personnel. A maintenance agreement between the medical activity and the installation personnel should be developed prior to the purchase of the equipment. It is also important for the incinerator operator to know the chain of command and who is responsible for the incinerator. In turn the chain of command should stress to the incinerator operator the importance of reporting problems immediately. Communication between all personnel involved is imperative to the proper operation of the MWI.

Lack of MWI Operator Training

The hospital housekeeping staff is frequently responsible MWI operation. These personnel are often given no formal training on how to operate the MWI. An improperly operated MWI can cause environmental regulation violations, equipment damage, and injury to the operator. Personnel responsible for the operation of the MWI should be given formal training that includes the basic principles of combustion, incinerator design, incinerator operation, incinerator controls, safety, environmental regulations, maintenance, and typical problems.

This training gives the operator the knowledge to operate the equipment properly, to recognize problems when they are occurring and before the equipment is damaged, to protect himself/herself from occupational hazards, and to protect the environment from unnecessary pollution. Several states have recognized the importance of operator training and have made it a regulatory requirement.

Lack of Waste Segregation Plans

Problems such as clogged air ports, damaged refractory, and even explosions can occur if installations have not implemented waste segregation and employee training plans. Waste segregation has a direct affect on MWI operator safety and equipment operation. The MWI operator has no control over what is placed in the red bags. Certain materials can cause explosions or other damage to the incinerator. In addition, burning the wrong things can reduce the life of the incinerator and its associated equipment. The operator should be trained to pay attention to the waste and ash. Bags and containers should be labeled so that problems can be reported to the appropriate department or activity. All employees should be trained on waste segregation and proper waste handling and storage. Problems such as heavy metals and hydrogen chloride emissions from the stack and heavy metals in the ash can often be solved by an aggressive waste segregation and tracking program.

Proposed Rule

Compliance Schedule (reference 4)

On 27 February 1995, the USEPA proposed regulations to limit air pollution emissions from MWIS. The USEPA felt that the large number of MWIs in the United States makes them a significant source of air pollution. This proposal adds Subparts Ec and Cc to Title 40, Code of Federal Regulations (CFR), Part 60. Subpart Ec will limit emissions from new and modified MWIS. The standards will implement Sections 111(b) and 129 of the CAAA of 1990. Subpart Cc will establish emission guidelines and compliance and schedules to be used by states in developing their regulations to control emissions from existing MWIS. The guidelines will implement sections 111(d) and 129 of the CAAA of 1990.

The preamble to the proposed MWI rule defines new incinerators as those incinerators for which a contract with significant funding obligated is in place and all construction/operating permits are received after 26 February 1995. New incinerators must be in compliance with the new regulations within 6 months of the rules being promulgated by the USEPA. The Subpart Cc guidelines give states I year from the date of promulgation to submit a plan to the EPA Administrator. The states must require that all MWIs subject to the guidelines comply with the requirements within 3 years of the state plan approval by the Administrator. The states may grant an extension, but compliance with these guidelines is mandatory within 5 years of promulgation. Originally, the USEPA expected greater than eighty percent of all MWIs to be removed from service because of these regulations. However, the USEPA received over 600 comment letters on the proposed regulations (reference 5). Additional data on the existing MWIs was provided, which prompted the USEPA to re-evaluate the proposed rule.

Definition of Medical Waste (references 4 and 6)

The definition of medical waste in the proposed rule is a great concern to the medical community. The definition is very broad and could have huge impacts an the way all waste from hospital facilities are treated and disposed. The proposed rule defines medical waste as all waste from a hospital to include paper, plastic, fabrics, and unbroken glassware, as well as infectious waste. The medical community is concerned that this definition could result in hospitals being charged extremely high fees for the disposal of waste or being unable to dispose of their waste. This has the potential to effect the cost of health care. The DOD cannot pass the additional cost of waste disposal to patients, which is likely to occur at commercial hospitals.

Emission Standards (reference 4)

The USEPA was mandated by Congress in the CAAA of 1990 to develop emission standards for new MWIS. Section 129 of the CAAA requires that emission standards reflect the maximum degree of reduction in air emissions that the USEPA Administrator determines is achievable. This requirement is referred to as maximum achievable control technology (MACT). The degree of reduction in emissions may not be less stringent than the emission control that is achieved in practice by the best controlled similar unit. This is referred to as the MACT floor for new MWIS. In addition, Section 129 of the CAAA requires the USEPA to specify emission limits for existing MWIS. The emission guidelines for existing MWIs reflect MACT. However, the guidelines for existing units may be less stringent then those for new MWIS, but they must be no less stringent than the average emission limitation achieved by the best performing 12 percent of similar units. In the 27 February 1995 proposal, the USEPA proposed the same MACT floor for both new and existing incinerators. These emission limits are very stringent and would require an APCD, which would force most DOD incinerators out of operation. Table I presents the proposed emission limits. The USEPA indicated that a dry scrubber followed by a baghouse with carbon injection would be required to meet the standards. It would be very difficult to retrofit the existing DOD MWIs with these types of APCDS. The cost to upgrade/replace the equipment to meet the standards would be prohibitive for DOD facilities.

Monitoring Requirements (reference 4)

In addition to the stack emissions limits, the proposal requires continuous emission monitoring of opacity and carbon monoxide. This requires the installation and certification of continuous emission monitors (CEMs), which adds to the cost of the MWI equipment and also increases the maintenance requirements. Fugitive emissions monitoring is also required by the proposal. Fugitive describes emissions that are not discharged through a flue or a stack. Fugitive emissions from MWIs are most typically emitted from ash clean out and improper ash storage. Therefore, the proposal requires fugitive emissions to be visually monitored on a monthly basis when ash is removed from the incinerator and the APCD. Fugitive emissions are monitored using USEPA Reference Method 9 (reference 7). Reference Method 9 requires emissions to be monitored by a certified observer who must be recertified every 6 months. Initial and annual performance tests to demonstrate compliance with the emission limits will also be required. The USEPA testing methods must be used to demonstrate compliance with the emission limits for particulate matter (PM), hydrogen chloride (HC1), lead (Pb), cadmium (Cd), mercury (Hg), dioxin/furans (CDD/CDF), carbon monoxide (CO), and opacity. The proposal requires an initial test followed by annual testing. However, if a facility demonstrates compliance with the emission limits for 3 consecutive years, testing will only be required every 3 years. This is based on each individual pollutant. Existing MWIs are required to be inspected by a qualified third party annually until compliance with the emission standards is demonstrated.

In addition, facilities are required to monitor operating parameters from the MWI and associated APCD. Specific operating parameters for MWI and APCD equipment are listed in the proposed rule. If a facility is using an APCD other than those specified in the proposal, it must petition the USEPA Administrator for site-specific operating parameters to demonstrate compliance.

Siting Requirements (reference 4)

New or modified MWIs are required to submit notifications concerning construction and initial start up of the affected facility. Owners and operators are also required to maintain thorough records documenting the results of the initial and annual performance tests, operating parameter monitoring data, CEMS output data, and quality assurance determinations. These records must be kept on file for at least 5 years.

The proposal also requires that documentation be kept for the life of the facility, which shows compliance with the siting and operator training/qualification requirements. This data includes all documentation produced as a result of ,the siting requirements; names and dates of personnel completing the operator training requirements; names and dates of personnel qualifying as MWI operators; and the names and dates of personnel completing the review of the site-specific MWI operating manual.

Facilities are required to submit the results of the initial and all subsequent performance tests. In addition, facilities must submit a report indicating any operating parameter limits that have not been met or any emissions that exceed applicable limits. These reports must be submitted within 30 days of the end of the quarter of occurrence. If no exceedences occur during a quarter, the owner or operator of the facility must submit a letter stating that there were no exceedences. All reports must be signed by the facilities manager. All of the recordkeeping and reporting requirements for existing MWIs are the same as those for new or modified MWIS. (There are no siting requirements or construction/start-up notification requirement for existing MWIS.) In addition, existing MwIs must maintain documentation relating to the initial and annual inspections for 5 years and must submit the inspection reports. All documentation and records must be available for inspection by the USEPA or its delegated enforcement agent upon request.

Operatox Training and L)ualification (reference 4)

The proposal requires that a fully trained and qualified MWI operator be on duty at the facility if the MWI is operating. The trained and qualified operator may directly operate the MWI or may be the direct supervisor of one or more individuals that charge waste, remove ash, etc. The training must be conducted by an instructor not employed by the affected facility and must include 24 hours of classroom training and 4 hours of hands-on training. The training must include an examination, designed and administered by the instructor, and reference materials on course topics. The course topics are also specified in the proposal. In addition to this training, an annual refresher course is required. Two options were given for operator qualification. The first option required completion of the operator training course and either 6 months experience as an MWI operator or 6 months experience as the direct supervisor of an MWI operator, or completion of at least two burn cycles under the observation of two qualified operators. Option 2 required the above mentioned training program and satisfaction of all criteria for MWI qualification specified by a national professional organization. In addition, the owner operator of an affected facility shall develop and annually update a site-specific operating manual or SOP. A system must be in place to ensure that MWI operators review the manual at least once per year. The manual must be kept in a location that is easily accessible to personnel. This manual must be available for inspection by the USEPA or its delegated enforcement agent upon request.

Possible Changes to the Proposed Rule (reference 1)

On 14 February 1996 the USEPA held a public meeting to discuss possible changes to the proposal. The changes were a direct result of information and comments that the USEPA received during the public comment period. Over 600 comment letters were received by the USEPA. Large quantities of technical data such as stack test reports and cost analysis studies were received. The technical analysts indicated that they would present several options to the USEPA Administrator and who would choose which options to sign. There was still no guarantee on what the actual rule will contain. However, the USEPA technical representatives are recommending some significant changes in the proposed rule.

Definition of Medical Waste (reference 1)

The first significant change is the definition of medical waste. As is stated above, the definition in the proposed rule is extremely broad and includes all waste from hospital facilities. The technical representatives are currently recommending that the New York State Department of Health definition be used in the final rule. This definition is very similar to the definition of medical waste in the Solid Waste Disposal Act and is included as an attachment. The non-infectious waste in hospitals will probably not be covered by this rule. These wastes will be addresses in the 'Other Incinerator" rule which is expected to be proposed in 2001. The USEPA is planning to.include pathological, pharmaceutical, and all types of waste that were not included in either the MWI or the municipal waste combustor rules in the "Other Incinerator' rule.

Revised MACT Floor for Existing MWIs (reference 1)

In the proposed rule, the MACT Floor for new and existing MWIs was identical. After reviewing the comments and analyzing the additional stack test data, the USEPA established a revised MACT Floor for existing MWIS. In addition to establishing new emission limits, the MWIs were categorized by size. Smaller units have a less stringent MACT Floor than larger units. See Table 2 for the revised MACT Floor for existing MWIS. These emission limits may be met by some of the existing DOD MWIS.

Operator Training and Qualification (reference 1)

The USEPA has reviewed the cost associated with the annual monitoring and testing cost. This data is presented in Table 3. The estimated annual costs of the monitoring and testing required in the proposal is $120,000 to $128,000. This option includes the opacity and CO CEMS, the monitoring of the required operating parameters, and the initial and annual stack testing requirements. The USEPA representatives indicated that they were considering recommending a less expensive option. At the 14 February 1996 meeting, they were strongly considering an option that is estimated to cost between $5,800 and $11,000 per year. This option would not require any CEMs and, at most, would require an initial stack test with a regular equipment inspection by a qualified third party.

Alternative Treatment Technologies (reference 1)

The remainder of the 14 February 1996 meeting was spent discussing alternative treatment technologies that the USEPA feels are viable options. The USEPA reviewed autoclave systems, chemical treatment systems, microwave systems, and other types of thermal systems. They examined the sterilization properties, availability, environmental impacts, costs, user satisfaction, and operator safety of the treatment technology. Based on the data that was examined, the USEPA feels that alternative treatment technologies are available and are viable options for medical waste treatment.

Current Status of the Rule (reference 8)

The USEPA did not meet the court ordered deadline of 15 April 1996 for the promulgation of the MWI rule. On 15 April 1996, the USEPA filed an unopposed motion with the court to amend the order and change the date for promulgation to 25 July 1997. The USEPA plans to publish a supplemental notice to the proposed rule. This supplemental notice is expected to appear in the Federal Register in late June or early July 1996 and will effectively reopen the public comment period on the proposed regulation. The purpose of the supplemental notice is to summarize the additional information that the USEPA received and the associated revised an-alyses. It will also outline several options which may serve as the basis for the final rule.

It is important that the DOD continue to monitor the rule and provide comments as necessary. Until the rule is promulgated, changes may continue to occur that could have an impact on DOD medical facilities, even those hospitals that do not use MWIs for medical waste treatment. The definition of medical waste is of particular interest. The broad definition in the proposal could make it difficult to dispose of medical waste and make disposal costs increase dramatically.

Summary

1. Public Meeting, U.S. Environmental Protection Agency, subject: Medical Waste Incinerator Rule, 14 February 1996.

2. Department of Defense Clean Air Act Implementation Services Steering Committee Consolidated Comments on the Proposed Standards of Performance for New Stationary Source and Emission Guidelines for Existing Sources: Medical Waste Incinerators (60 FR 10654, 27 February 1995), 28 April 1995.

3. EPA-450/3-89-003, Hospital Incinerator Operator Training Course: Volume I, Student Handbook.

4. Standards of Performance for New Stationary sources and Emission Guidelines for Existing sources: Medical Waste Incinerators, 60 Federal Register 10654, 27 February 1995.

5. Public Meeting, U.S. Environmental Protection Agency, subject: Medical Waste Incinerator Rule, 26 September 1995.

6. Public Meeting, U.S. Environmental Protection Agency, subject: Medical Waste Incinerator Rule, 31 October 1995.

7. Title 40, Code of Federal Regulations, Part 60, Appendix A, Revised July 1, 1994.

8. Letter, U.S. Environmental Protection Agency, subject: Medical Waste Incinerator Rule Status, 17 April 1996.

9. EPA-450/3-89-002, March 1989, Operation and Maintenance of Hospital Medical Waste Incinerators, Control Technology Center.

10. Public Meeting, U.S. Environmental Protection Agency, subject: Medical Waste Incinerator Rule, 8 June 1994.

11. Public Meeting, U.S. Environmental Protection Agency, subject: Medical Waste Incinerator Rule, 15 February 1995.

EXCERPT FROM THE NEW YORK STATE DEPARTMENT OF HEALTH DEFINITION OF REGULATED MEDICAL WASTE (Reference 11)

1. "Regulated medical waste" shall mean any of the following waste which is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production and testing of biologicals, provided however, that regulated medical waste shall not include hazardous waste identified or listed pursuant to Section 27-0903 of the Environmental Conservation Law, or any household waste promulgated under such section.

(a) Cultures and stocks. This waste shall include cultures and stocks of agents infectious to humans, and associated biologicals, cultures from medical or pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live or attenuated vaccines, or culture dishes and device used to transfer, inoculate, or mix cultures.

(b) Human pathological wastes. This waste shall include tissue, organs, and body parts (except teeth and the contiguous structures of bone and gum), body fluids that are removed during surgery, autopsy, or other medical procedures, or specimens of body fluids and their containers, and discarded material saturated with such body fluids other than urine, provided that the Commissioner, by duly promulgated regulation, may exclude such discarded material saturated with body fluids from this definition if the Commissioner finds that it does not pose a significant risk to public health. this waste shall not include urine or fecal materials submitted for other diagnosis of infectious diseases.

(d) Sharps. This waste shall include, but not be limited to, discarded unused sharps and sharps used in animal or human patient care, medical research, or clinical or pharmaceutical laboratories, hypodermic, intravenous, or other medical needles, hypodermic or intravenous syringes to which a needle or other sharps is still attached, Pasteur pipettes, scalpel blades, or blood vials. This waste shall include, but not be limited to, other types of broken or unbroken glass(including slides and cover slips in contact with infectious agents. This waste shall not include those parts of syringes from which sharps are specifically designed to be easily removed and from which sharps have actually been removed, and which are intended for recycling or other disposal, so long as such syringes have not come in contact with infectious agents.

(e) Animal waste. This waste shall mean discarded materials including carcasses, body parts, body fluids, or bedding originating from animals known to be contaminated with infectious agents (i.e., zoonotic organisms) or from animals inoculated during research, production of biologicals, or pharmaceutical testing with infectious agents.