# Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Medical Waste Incinerators > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A96-15585 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** June 20, 1996 - **Citation:** 61 FR 31736 ## Text SUMMARY: On February 27, 1995, EPA proposed new source performance standards (NSPS or standards) and emission guidelines (EG or guidelines) for new and existing medical waste incinerator(s) (MWI) that will reduce air pollution from MWI. Once implemented, these standards and guidelines will protect public health by reducing exposure to air pollution. In the proposal preamble, EPA made a commitment to reconsider the proposed NSPS and EG based on new information submitted. Today's action presents an assessment of the supplemental information submitted following the proposal and solicits public comment on this assessment. Today's action also serves to address comments received on the proposal and reopens the comment period for development of the MWI standards and guidelines. DATES: Public Meeting. A public meeting will be held on July 10, 1996 beginning at 9:00 a.m. At the public meeting, EPA will review the contents of this notice and answer questions so that commenters can better prepare their written comments. See ADDRESSES below for the location of the meeting. Comments. Comments are requested on all information associated with the development of MWI standards and guidelines. Written comments must be received on or before August 8, 1996. See ADDRESSES below. ADDRESSES: Public Meeting. The public meeting will take place at the Holiday Inn, Hotel and Suites, 625 First Street, Alexandria, Virginia, 22314, (703) 548-6300. Persons interested in attending the meeting should notify Ms. Donna Collins, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone (919) 541-5578. Comments. Comments should be submitted (in duplicate, if possible) to the following: The Air and Radiation Docket and Information Center, ATTN: Docket No. A-91-61, U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC 20460. Submissions containing proprietary information (Confidential Business Information) should be sent directly to the following address, not to the public docket, to ensure that proprietary information is not inadvertently placed in the docket: Attention: Mr. Rick Copland, c/o Ms. Melva Toomer, U.S. Environmental Protection Agency Confidential Business Manager, 411 W. Chapel Hill Street, Room 944, Durham, North Carolina 27701. See SUPPLEMENTARY INFORMATION for further discussion of confidential business information. Docket. Docket No. A-91-61, containing supporting information used in developing the standards and guidelines, is available for public inspection and copying between 8:00 a.m. and 4:00 p.m. , Monday through Friday, at the Air and Radiation Docket and Information Center, U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC 20460, telephone (202) 260-7548, fax (202) 260-4000. A reasonable fee may be charged for copying. See SUPPLEMENTARY INFORMATION for a list of documents most directly related to today's notice. FOR FURTHER INFORMATION CONTACT: Mr. Rick Copland at (919) 541-5265 or Mr. Fred Porter at (919) 541-5251, Emission Standards Division (MD-13), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711. SUPPLEMENTARY INFORMATION: Regulated Entities. Entities potentially regulated by the standards and guidelines are those which operate medical waste incinerators. Regulated categories and entities include those listed in Table 1. Table 1.--Regulated Entities a ---------------------------------------------------------------------------------------------------------------- Category Examples of regulated entities ---------------------------------------------------------------------------------------------------------------- Industry.................................................... Hospitals, nursing homes, research laboratories, other healthcare facilities, commercial waste disposal companies. Federal Government.......................................... Armed services, public health service, Federal hospitals, other Federal healthcare facilities. State/local/Tribal Government............................... State/county/city hospitals and other healthcare facilities. ---------------------------------------------------------------------------------------------------------------- a This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the standards or guidelines for MWI. This table lists the types of entities that EPA is now aware could potentially be regulated. Other types of entities not listed in the table could also be regulated. To determine whether your facility is regulated by the standards or guidelines for medical waste incinerators, you should carefully examine the applicability criteria in sections 60.50(c) and 60.51(c) of the February 1995 proposal and sections II(B), II(H), and II(I) of today's notice. If you have questions regarding the applicability of the MWI standards and guidelines to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. Confidential Business Information. Commenters wishing to submit proprietary information for consideration should clearly distinguish such information from other comments and clearly label it ``Confidential Business Information.'' Information covered by such a claim of confidentiality will be disclosed by the EPA only to the extent allowed and by the procedures set forth in 40 CFR part 2. If no claim of confidentiality accompanies a submission when it is received, the submission may be made available to the public without further notice to the commenter. Documents Available Electronically. An electronic version of this action as well as the February 1995 Federal Register proposal notice are available for download from EPA's Technology Transfer Network (TTN), which is a network of electronic bulletin boards developed and operated by EPA's Office of Air Quality Planning and Standards. The TTN provides information and technology exchange in various areas of air pollution control. The service is free, except for the cost of a telephone call. Dial (919) 541-5742 for data transfer of up to 14,400 bits per second. The TTN is also available on the Internet (access: TELNET ttnbbs.rtpnc.epa.gov). For more information on the TTN, contact the systems operator at (919) 541-5384. Documents in the Docket. The documents listed below are not available through the TTN, but are available through Air Docket No. A- 91-61 located at the Air and Radiation Docket and Information Center (see the ADDRESSES section earlier in this [[Page 31737]] notice). These documents provide the analyses that are summarized in this notice. ------------------------------------------------------------------------ Item No. Title ------------------------------------------------------------------------ IV-A-7................... National Dioxin Emission Estimates from Medical Waste Incinerators. IV-A-8................... Revised Economic Impacts: Existing Medical Waste Incinerators. IV-A-9................... Revised Economic Impacts: New Medical Waste Incinerators. IV-B-23.................. PM MACT Floor Emission Levels for Potential Subcategories of the MWI Source Category. IV-B-24.................. Determination of the Maximum Achievable Control Technology (MACT) Floor for Existing Medical Waste Incinerators that Incinerate General Medical Waste. IV-B-25.................. Definition of Medical Waste. IV-B-26.................. Operator Training and Qualification and Incinerator Inspection Requirements. IV-B-30.................. Approach Used to Estimate the Capital and Annual Costs for MWI Wet Scrubbers. IV-B-32.................. Revised Costs for Dry Injection/Fabric Filter Controls for MWI. IV-B-33.................. Revised Costs for Secondary Chamber Retrofits for MWI. IV-B-37.................. Projections for New MWI Population. IV-B-38.................. Determination of the Maximum Achievable Control Technology (MACT) Floor for New Medical Waste Incinerators. IV-B-39.................. Annual Costs for the Operator Training and Qualification Requirements for MWI Operators. IV-B-43.................. Alternative Methods of Medical Waste Treatment: Availability, Efficacy, Cost, State Acceptance, Owner Satisfaction, Operator Safety, and Environmental Impacts. IV-B-44.................. Determination of Medical Waste Incinerator (MWI) Size. IV-B-45.................. Updated Medical Waste Incinerator Data Base. IV-B-46.................. PM, CO, and CDD/CDF Average Emission Rates and Achievable Emission Levels for MWI with Combustion Controls. IV-B-47.................. Acid Gases and Metals Typical Performance and Achievable Emission Levels for Medical Waste Incinerators with Good Combustion Control. IV-B-48.................. Wet Scrubber Performance Memorandum. IV-B-49.................. Dry Scrubber Performance Memorandum. IV-B-50.................. Cost Impacts of the Regulatory Options for New and Existing Medical Waste Incinerator (MWI). IV-B-51.................. Air Emission Impacts of the Regulatory Options for New and Existing Medical Waste Incinerators (MWI). IV-B-52.................. Potential Solid Waste, Wastewater, and Energy Impacts of the New Source Performance Standards and Emission Guidelines for New and Existing Medical Waste Incinerators. IV-B-54.................. Testing and Monitoring Options and Costs for MWI--Methodology and Assumptions. IV-B-56.................. Standards of Performance for Medical Waste Pyrolysis Units. ------------------------------------------------------------------------ Acronyms, Abbreviations, and Measurement Units. The following list of acronyms, abbreviations, and measurement units is provided to aid the reader. AHA................................. American Hospital Association Btu................................. British thermal unit Cd.................................. cadmium CEMS................................ continuous emission monitoring system(s) CFR................................. Code of Federal Regulations CO.................................. carbon monoxide dioxin.............................. dioxins and dibenzofurans DI/FF............................... dry injection/fabric filter dscf................................ dry standard cubic foot dscm................................ dry standard cubic meter EG.................................. emission guidelines EPA................................. Environmental Protection Agency ft3................................. cubic feet FTE................................. full time equivalent g................................... grams gr.................................. grains HCl................................. hydrogen chloride Hg.................................. mercury hr.................................. hour IV.................................. intravenous lb.................................. pound MACT................................ maximum achievable control technology m3.................................. cubic meter MW.................................. megawatt MSA................................. Metropolitan Statistical Area Mg.................................. megagram mg.................................. milligram MM.................................. million MWI................................. medical waste incinerator(s) MWTA................................ Medical Waste Tracking Act MWC................................. municipal waste combustor ng.................................. nanogram NOX................................. Oxides of nitrogen NRDC Natural Resources Defense Council NSPS................................ new source performance standards NYSDOH.............................. New York State Department of Health O2.................................. oxygen Pb.................................. lead PM.................................. particulate matter ppmdv............................... parts per million by volume (dry basis) SO2................................. sulfur dioxide STAATT.............................. State and Territorial Association of Alternate Treatment Technologies SWDA................................ Solid Waste Disposal Act TEQ................................. Toxic Equivalency Quality (dioxin emissions) TTN................................. Technology Transfer Network TCLP................................ Toxicity Characteristics Leachate Procedure yr.................................. year Outline of this Notice. The information in this section is organized as follows: I. Introduction A. The Clean Air Act B. February 1995 Proposal C. New Information Since Proposal D. Purpose of this Supplemental Notice E. New Timeline for Promulgation II. Review of New Information A. MWI Inventory 1. Existing Population 2. Future Installations B. Subcategorization C. Performance and Cost of Technology 1. Good combustion 2. Wet scrubbers 3. Dry scrubbers D. MACT Floor 1. Existing MWI 2. New MWI E. Baseline Emissions F. Operator Training and Qualification G. Testing, Monitoring, and Inspection H. Definition of Medical Waste I. Pyrolysis Units J. Alternative Medical Waste Treatment Technologies III. Regulatory Options and Impacts for Existing MWI A. Regulatory Options B. National Environmental and Cost Impacts 1. Analytical approach 2. Air Impacts 3. Water and solid waste impacts 4. Energy Impacts 5. Cost Impacts C. Economic Impacts 1. Analytical approach 2. Industry-wide economic impacts 3. Facility-specific economic impacts IV. Regulatory Options and Impacts for New MWI A. Regulatory Options B. National Environmental and Cost Impacts 1. Analytical approach 2. Air impacts 3. Water and solid waste impacts [[Page 31738]] 4. Energy Impacts 5. Cost Impacts C. Economic Impacts 1. Analytical approach 2. Industry-wide economic impacts 3. Facility-specific economic impacts V. Inclinations for Final Rule I. Introduction A. The Clean Air Act The Clean Air Act amendments of 1990 added section 129, which includes specific requirements for solid waste combustion units. Section 129 requires the EPA, under section 111(b), to establish NSPS for new MWI and under section 111(d), to establish EG for existing MWI based on maximum achievable control technology (MACT). Section 129 establishes specific criteria that must be analyzed in developing these standards and guidelines. In general, this involves (1) determining appropriate subcategories within a source category; (2) determining the ``MACT floor'' for each subcategory; (3) assessing available air pollution control technology with regard to achievable emission limitations and costs; and (4) examining the cost, nonair-quality health and environmental impacts, and energy requirements associated with standards and guidelines more stringent than the MACT floor. Section 129 also directs EPA to establish operator training requirements for new and existing MWI as well as siting requirements for new MWI. Section 129 requires the EPA to include numerical emission limitations in the standards and guidelines for the following air pollutants: particulate matter (PM), opacity, sulfur dioxide (SO2), hydrogen chloride (HCl), oxides of nitrogen (NOx), carbon monoxide (CO), lead (Pb), cadmium (Cd), mercury (Hg), and dioxins and dibenzofurans (referred to in this notice as ``dioxin''). Section 129 requires that these emission limitations reflect the maximum degree of reduction in air emissions that the Administrator determines is achievable, taking into consideration the cost of achieving such emission reduction and any nonair-quality health and environmental impacts and energy requirements. This requirement is referred to as MACT. The MACT for new MWI may not be less stringent than the emissions control achieved in practice by the best controlled similar unit. The guidelines for existing MWI may be less stringent than the standards for new MWI; however, the guidelines may be no less stringent than the average emission limitation achieved by the best performing 12 percent of units in the category. These requirements that the standards and guidelines must be no less stringent than certain levels are referred to as the ``MACT floor.'' The Clean Air Act requires EPA to consider standards and guidelines more stringent than the MACT floor, considering costs and other impacts described above. If EPA concludes that more stringent standards and/or guidelines are achievable considering costs and other impacts, then the standards and/or guidelines would be established at these more stringent levels (i.e., MACT would be more stringent than the MACT floor). The EPA may establish NSPS or EG at the MACT floor only if it concludes that NSPS or EG more stringent than the MACT floor are not achievable, considering costs and other impacts. In no case may EPA establish emission limitations less stringent than the MACT floor. Because standards and guidelines developed under Section 129 are to reflect the performance capabilities of air pollution control technology, EPA must assess air pollution control technologies and draw conclusions regarding their performance. This is often misunderstood and some assume that the regulations require the use of specific technology. However, the control technology used to achieve the standards or guidelines is not specified in the regulations. The regulations only include specific air pollution emission limits that a source (i.e., an MWI) must achieve. Any control technology that can comply with the final emission limits may be used. B. February 1995 Proposal On February 27, 1995 (60 FR 10654), EPA published proposed NSPS and EG for MWI. The proposal was the result of several years of effort reviewing available information in light of the Clean Air Act requirements described above. During the data-gathering phase of the project, it was difficult to get an accurate count of MWI nationwide. In addition, it was difficult to find MWI with add-on air pollution control systems in place. Information from a few State surveys led to an estimated population of 3,700 existing MWI. Subcategories were determined based on design differences among different types of incinerators: continuous, intermittent, and batch. These three design types roughly correlate to MWI size. A few MWI with various levels of combustion control (no add-on air pollution control) were tested to determine the performance of combustion control in reducing MWI emissions. One MWI equipped with a wet scrubber (add-on control) was tested to determine the performance capabilities of wet scrubbing systems. A few other MWI equipped with dry scrubbing systems (add-on control) were tested to determine the performance capabilities of dry scrubbing systems. These systems were considered typical of air pollution control systems available at the time, and the data indicated that dry scrubbing systems could achieve much lower emissions than wet scrubbing systems. As mentioned above, the MACT floor for new MWI is to reflect the emissions control achieved by the best controlled similar unit. Dry scrubbing systems were identified on at least one MWI in each of the three subcategories (continuous, intermittent, and batch). Consequently, the MACT floor emission levels for the proposed NSPS reflected the performance capabilities of dry scrubbing systems. For existing MWI under the emission guidelines, State regulations and permits were used to calculate the average emission limitation achieved by the best performing 12 percent of units. These results were then compared with the results of the emission tests on wet and dry scrubbing systems. This comparison led to the conclusion that the MACT floor for existing MWI would require the use of a dry scrubbing system, even for small existing batch MWI. Following determination of the MWI population, subcategories, performance of technology, and MACT floors, the Clean Air Act requires EPA to consider standards and guidelines that are more stringent than the floors. However, because the MACT floors calculated for the proposal were so stringent, EPA was left with few options to consider. Emission limits reflecting the capability of dry scrubbing systems were proposed for all sizes and types of new and existing MWI. As mentioned earlier, the proposed standards and guidelines included numerical emission limits reflecting the performance capabilities of dry scrubbing systems; however, the proposed regulations would not require the use of a dry scrubbing system. Emission limits are included in these regulations rather than control equipment requirements to encourage competition and further the development of new technologies. Any technology capable of achieving the emission limitations in the regulations may be used. [[Page 31739]] C. New Information Since Proposal A proposal is essentially a request for public comment on the information used, assumptions made, and conclusions drawn from the evaluation of available information. Following proposal, more than 700 comment letters were received, some including new information and some indicating that commenters were in the process of gathering information for EPA to consider. The large amount of new information that was ultimately submitted addressed every aspect of the proposed standards and guidelines, including: the existing population of MWI, the performance capabilities of air pollution control systems, monitoring and testing, operator training, alternative medical waste treatment technologies, and the definition of medical waste. In almost every case, the new information has led to different conclusions, as outlined below. D. Purpose of This Supplemental Notice This notice announces the availability of new information, reviews EPA's assessment of the new information, provides EPA's inclination as to how the new information might change the final standards and guidelines, and solicits comments on EPA's assessments and inclinations. This new information and these assessments are documented in more detail in a series of memoranda included in Air Docket No. A- 91-61. A listing of these documents can be found at the beginning of this notice. This action also reopens the public comment period for the development of standards and guidelines for MWI. Today's action serves not only as a review of new information and request for comment, but also as a response to comments on the proposed rule. This notice is not a reproposal. The proposal date for the MWI standards and guidelines remains February 27, 1995. Any MWI that has commenced construction after February 27, 1995, is considered a new MWI and will be subject to the NSPS, while any MWI that commenced construction on or before February 27, 1995, is considered an existing MWI. E. New Timeline for Promulgation In 1993, the EPA, the Sierra Club, and the Natural Resources Defense Council (NRDC) filed a consent decree with the U.S. District Court for the Eastern District of New York (Nos. CV-92-2093 and CV-93- 0284) that required the EPA Administrator to sign a notice of proposed rulemaking no later than February 1, 1995 and a notice of final rulemaking no later than April 15, 1996. Because of the large amount of new information and conclusions drawn from the new information, the EPA deemed it necessary to issue this supplemental Federal Register notice to provide the public sufficient opportunity to comment on all information used by the Agency in developing the NSPS and EG. The Agency requested an extension of the April 15, 1996 court-ordered deadline, and the court order has been revised to require the EPA Administrator to sign a notice of final rulemaking no later than July 25, 1997. II. Review of New Information As mentioned earlier, more than 700 comment letters were received following the February 27, 1995 proposal. An assessment of this information and some of EPA's inclinations in light of this new information are presented below. In general, the following process was used to assess the new information. The public comment letters were reviewed and categorized by area of comment. Information related to specific issues (e.g., wet scrubber performance) was reviewed; meetings were then held to discuss specific areas of comment with relatively small groups who were believed to have expertise in specific areas. For example, meetings with wet scrubber vendors were held to discuss the new information related to the performance capabilities of wet scrubbers. During the smaller meetings, additional information was received and comment was taken. Following the smaller meetings, EPA conducted larger public meetings on June 15, 1995, September 26, 1995, and February 14, 1996, to review the assessment of new information and take further public comment. This Federal Register notice provides EPA's review of all information received since proposal. A. MWI Inventory One of the essential starting points in developing EG and NSPS is compiling an inventory of existing sources and projecting the number of new sources expected to be built in the future. The MWI inventory is the basis for the development of MACT floors, environmental impacts, cost impacts, and economic impacts. The results of these analyses are then used to determine MACT. The inventory of existing sources used in this analysis is a ``snapshot'' of the current population of existing MWI. The inventory of new MWI potentially subject to the NSPS is a prediction of the number of MWI that will be built over the next 5 years in the absence of Federal regulations. The MWI inventories are not exact, but are representative of current and future MWI populations. Consequently, they are adequate to allow EPA to make informed decisions in developing standards and guidelines for new and existing MWI. 1. Existing Population To estimate the nationwide population of existing MWI at proposal, available State MWI inventory information was gathered. Where MWI information was not available for a particular State, the State's human population was used to estimate the MWI population. Human population was selected as the basis for extrapolation because it is logical that the amount of medical waste generated (and, therefore, the MWI population) would correlate with human population. This extrapolation was a straightforward computation with readily available data; however, detailed State inventory data were only available from 11 States. This method resulted in an estimated 3,700 MWI burning general medical waste. Following proposal, a number of comments were received regarding the inventory of existing MWI. Several commenters suggested that the population of MWI was overestimated. The American Hospital Association (AHA) submitted comments that included a compilation of approximately 2,200 existing MWI. To compile a new EPA inventory, the AHA inventory was used as a starting point. Other sources of information, including State surveys and a data base of MWI operating permits, were also used to refine the inventory. Following this initial compilation, the inventory contained approximately 2,600 MWI. During the September 26, 1995 public meeting, several stakeholders voiced concern that many of the incinerators listed in EPA's MWI inventory had ceased operation. To address this concern, the Agency requested additional information to update the inventory. Additional information was received from State agencies, commercial medical waste disposal companies, and MWI vendors. Medical waste incinerator units were deleted or added based on the new information provided. Following these revisions, the final EPA inventory contains approximately 2,400 MWI; this inventory is located in the docket as item No. IV-B-45. The inventory also contains information such as MWI type (continuous/intermittent or batch fed), capacity, and location, as well as State [[Page 31740]] regulatory or permit emission limits. Every MWI in the inventory is assigned an MWI capacity in pounds per hour (lb/hr) or pounds per batch (lb/batch). Location information includes rural or urban designations based on Metropolitan Statistical Area (MSA) boundaries for the U.S. Facilities within MSA boundaries were considered urban MWI; facilities outside MSA boundaries were considered rural MWI. Emission limitations were determined by examining air quality permits, where available, or examining the emission limitations included in State regulations. 2. Future Installations Projections of new MWI were made to estimate the costs and other impacts associated with NSPS. To estimate the number of new MWI that would be subject to the NSPS, historical sales data were obtained from MWI vendors. For the proposal, it was estimated that, in the absence of Federal regulations, 700 MWI would be installed during the 5 years following proposal (140 MWI per year). This projection was based on historical sales data gathered from 1985 through 1989. To update the projection of new MWI that would be subject to the NSPS, additional data were gathered from MWI vendors following the proposal. Historical sales data were gathered covering years 1990 to 1995. Based on this new data, 235 MWI are expected to be installed in the next 5 years in the absence of the NSPS (47 per year). This projection covers the years 1996 to 2000. The memorandum documenting the procedures used to estimate the population of new MWI is located in the docket as item IV-B-37. B. Subcategorization Section 129 of the Clean Air Act states that the Administrator may distinguish among classes, types, and sizes of units within a category in establishing the standards and guidelines. At proposal, the Agency concluded the MWI population should be divided into three subcategories: (1) Continuous MWI, (2) intermittent MWI, and (3) batch MWI. While these three subcategories were based on design differences of the MWI, they also correlate roughly with size or MWI capacity. During the public comment period, a number of comments were received regarding subcategorization. Several commenters suggested that EPA subcategorize directly by MWI size. Others suggested that EPA subcategorize MWI based on heat input capacity. Other commenters suggested that the Agency set standards based on the location of MWI; these commenters expressed concern about the lack of medical waste disposal options in remote rural locations. Three criteria were subsequently considered in reexamining potential subcategories: size (capacity to burn medical waste); type (continuous/intermittent versus batch); and location (urban versus rural). The first two are clearly identified in Section 129 and have been used in other Federal regulations as criteria for subcategorization. Location, by itself, is not a valid criterion for subcategorization. However, in this case, it is used as a surrogate measure of the availability of alternative waste disposal options. Medical waste incinerators located in remote areas might be considered as a separate ``class'' of incinerator because of the limited availability of alternative waste disposal options in rural areas. As mentioned earlier, the MACT floor is the least stringent regulatory option allowed under the Clean Air Act. Consequently, the MACT floors were examined using the EPA MWI inventory for various potential MWI subcategories. Because PM is, by far, the most common type of emission limitation in State regulations and permits, the PM MACT floor was the focus in this analysis. Subcategories were established when significant differences in PM MACT floors were identified. The most common size breaks used by States in regulating MWI occur at 100, 200, 500, 1,000, and 2,000 lb/hr. The MACT floor emission levels for these size breaks were evaluated to determine appropriate size breaks for regulation. Significant differences in MACT floors were identified at 200 lb/hr and 500 lb/hr. Consequently, the three size ranges determined to be appropriate for the purpose of regulating MWI are presented in Table 2. Table 2.--Number of MWI and Size Ranges for Subcategories ------------------------------------------------------------------------ Number MWI subcategory Size range, lb/hr of MWI ------------------------------------------------------------------------ Small................................ 200.......... 1,139 Medium............................... >200 and 500. 692 Large................................ >500.................... 542 ------------------------------------------------------------------------ The three basic design types of MWI are continuous, intermittent, and batch. A distinction between continuous and intermittent MWI based on design type may not be appropriate because these two types of units are essentially identical with the exception of the ash handling system. Also, the information used to develop the population of existing MWI does not distinguish between continuous and intermittent MWI. Batch MWI, however, are very different from intermittent and continuous units. As a result, batch MWI were further examined to determine if the MACT floor emission levels are different than those for continuous and intermittent MWI within the same size range; no significant difference in MACT floor emission levels was found. The final criterion considered was location (urban vs. rural). This analysis focused on the small MWI because commenters were particularly concerned about small, rural MWI. The MACT floor emission levels for small urban MWI and small rural MWI, however, were found to be essentially the same. Based on the new information, the Agency is inclined to subcategorize the existing and new population of MWI into three subcategories as shown in Table 2: small (200 lb/hr), medium (>200 and 500), and large (>500). The memorandum that details the procedures used to assess the subcategories is found in the docket as item IV-B-23. Further subcategorization may be considered in examining standards and guidelines more stringent than the MACT floors (see Sections III and IV). Directly related to the question of using size or burning capacity to subcategorize MWI, the proposal requested comment on a ``standard'' method of determining MWI size for the purpose of consistent, uniform, and equitable application of whatever standards and guidelines are adopted. Comments responding to this request focused on the design heat release rate of the MWI expressed in British thermal units per hour per cubic foot (Btu/hr-ft3) in the primary combustion chamber and the heat content of medical waste expressed in British thermal units per pound (Btu/lb). Most MWI manufacturers base their design capacities on these two factors. In considering and/or adopting a ``standard'' means of determining MWI size, EPA is not attempting to establish design requirements for MWI manufacturers. Instead, the only purpose of adopting a standard method for determining the size of MWI is to ensure that all MWI of the same ``size'' are subject to the same requirements. The design heat release rate used by most vendors of continuous and intermittent MWI is typically 15,000 Btu/hr-ft3. The heat content of medical waste can vary substantially from 1,000 Btu/lb for pathological waste to over 10,000 Btu/lb for waste with a high [[Page 31741]] plastics content. The heat content generally associated with medical waste for the purpose of determining nameplate capacity has been 8,500 Btu/lb. The combination of 15,000 Btu/hr-ft3 and 8,500 Btu/lb results in a volumetric waste burning capacity of 1.76 lb/hr-ft3. The volume of the primary chamber is multiplied by 1.76 to determine the size of the MWI. A continuous or intermittent MWI with a primary chamber volume of 500 ft3 would be sized at 880 lb/hr for the purpose of determining regulatory requirements. For batch MWI, the calculation is slightly different. Batch MWI charge all waste to be burned when the unit is cold. No additional waste is added during the combustion cycle. The unit is then allowed to cool before ash is removed and more waste is charged. These units are given a designation of pounds per batch (lb/batch) rather than lb/hr and usually take about 12 hours to completely burn the waste. The density of medical waste is about 4.5 lb/ft3. Consequently, the combination of 4.5 lb/ft3 and 12 hours per batch yields a volumetric waste burning capacity of 0.375 lb/hr-ft3. The volume of the primary chamber would be multiplied by 0.375 to determine the size of the MWI. A batch MWI with a primary chamber volume of 500 ft3 would be sized at 188 lb/hr for the purpose of determining regulatory requirements. A more detailed description of the MWI size methods described above for continuous, intermittent, and batch MWI can be found in the docket as item IV-B-44. During a meeting with MWI vendors, it was suggested that MWI size should be determined by the unit's operating permit rather than its design capacity. Many States allow MWI to meet less stringent requirements associated with smaller MWI as long as the MWI is subject to a permit condition limiting the amount of waste burned. Consequently, while EPA is inclined to determine MWI size by the criteria described above, EPA is also considering inclusion of an option to allow an MWI to change its size designation by operating under a Federally enforceable requirement limiting the amount of waste burned (i.e., waste feed rate--lb/hr). For example, a continuous or intermittent MWI with a 340 ft3 primary chamber, with a design capacity of about 600 lb/hr (i.e., ``large''), using the procedure outlined above, could be considered a ``medium'' MWI by operating under a Federally enforceable requirement limiting its charge rate to no more than 500 lb/hr. A batch MWI with a 1,000 ft3 primary chamber, with a design capacity of about 4,500 lb/batch or 375 lb/hr (i.e., ``medium''), using the procedure outlined above, could be considered a ``small'' MWI by operating under a Federally enforceable requirement limiting its charge rate to no more than 2,400 lb/batch (200 lb/hr). Finally, some commenters expressed concern about facilities installing multiple small MWI at one location in an effort to be subject to less stringent requirements. Commenters believed this should not be allowed. Consequently, EPA is inclined to combine the waste burning capacity of multiple units at one location to determine size. As stated above, such facilities could still operate under a Federally enforceable permit limiting their operating capacity to change their size designation. C. Performance and Cost of Technology Section 129 of the Clean Air Act directs the EPA to develop regulations for MWI that are based on the use of MACT, which is defined as the maximum reduction in emissions of air pollution the EPA considers achievable, considering costs, environmental, and energy impacts. However, Section 129 also states that, for existing MWI, these regulations can be no less stringent than the average of the best 12 percent of existing MWI, and for new MWI, they can be no less stringent than the best similar MWI. These minimum stringency requirements for the regulations are referred to as the ``MACT floors.'' The emission limits in the final regulations can be no less stringent than the ``MACT floor'' emission levels. The ``MACT floors'' for the regulations are discussed in detail in another section of this notice. However, these ``MACT floors'' are only the starting point for determining MACT. Since MACT is the maximum reduction in air pollution emissions that is achievable, considering costs, environ-mental and energy impacts, if more stringent emission levels than the MACT floor emission levels are achievable, the EPA must identify these more stringent emission levels and consider them in selecting the MACT emission limits for MWI. The EPA determines whether more stringent emission levels than the MACT floor emission levels are achievable by identifying various air pollution control technologies used to reduce emissions from MWI. Next, the EPA gathers and analyzes data on these technologies and draws conclusions regarding their performance--in terms of their ability to reduce air pollution emissions. The EPA then is able to determine MACT as follows. After the MACT floors have been determined, the EPA can identify what air pollution control technologies would need to be used by MWI to achieve or comply with regulations based on these MACT floors. Then the EPA can identify those air pollution control technologies that are capable of achieving more stringent emission levels than the MACT floors. The EPA is then able to analyze and consider these more stringent emission levels in terms of the cost, environmental, and energy impacts associated with their use compared to the use of the air pollution control technologies that can achieve the MACT floor emission levels. This analysis and consideration serves as the basis for the EPA to determine MACT. All of this analysis, with its focus and discussion of air pollution control technology, is often misunderstood and leads some to assume that the regulations require the use of a specific air pollution control technology, which is not the case. The air pollution control technology used to achieve or comply with the regulations is not specified in the regulations. The regulations only include emission limits (i.e., concentration levels in the gases released to the atmosphere) for specific air pollutants (e.g., hydrogen chloride, lead, etc.) that an MWI must achieve. The decision on how to meet these emission limits is left to the MWI owner or operator; an MWI owner or operator may select any equipment or any means available to comply with these emission limits. At the time of proposal, relatively few emission test reports were available to the EPA from which to draw conclusions regarding the performance capabilities of various air pollution control systems. The data indicated that dry scrubbing systems could achieve much lower emission levels than wet scrubbing systems and that either type of scrubbing system could achieve much lower emission levels than combustion controls (i.e., good combustion) alone. Following proposal, a number of emission test reports were submitted to EPA. Many commenters believe that EPA misjudged the performance capabilities of various air pollution control technologies, especially the capabilities of wet scrubbing systems. The EPA has reviewed the data contained in these emission test reports and, as summarized below, EPA's conclusions regarding the performance capabilities of various air pollution control technologies have been revised. Relatively few comments were received regarding EPA's estimates of the costs of air pollution control technology. The majority of the [[Page 31742]] comments regarding cost pertained to wet scrubbing systems. The reassessment of costs is discussed briefly below for each control technology. 1. Good Combustion Combustion controls (i.e., good combustion) are effective in reducing emissions of combustion-related pollutants, such as PM, CO, and dioxin, but are not effective in reducing emissions of waste- related pollutants, such as acid gases or metals. For the combustion- related pollutants, combustion controls can be divided into two levels (i.e., 1-second and 2-second residence time) and the achievable emission levels associated with the use of each of these levels have been reassessed. In addition, achievable emission levels for waste- related pollutants were also reassessed. For waste-related pollutants, performance between the two levels of combustion control is not distinguishable. The results of the reassessment of combustion control are shown in Table 3 and are available as item Nos. IV-B-46 and IV-B-47 in the docket. Table 3.--Achievable Emission Levels For Combustion Control ------------------------------------------------------------------------ Achievable Pollutant/combustion level emission levels ------------------------------------------------------------------------ PM, gr/dscf: 1-sec................................................... 0.35 2-sec................................................... 0.25 Dioxin, ng/dscm: 1-sec................................................... 9,000 2-sec................................................... 800 TEQ dioxin, ng/discm: 1-sec................................................... 275 2-sec................................................... 15 CO, ppmdv: 1-sec................................................... 700 2-sec................................................... 40 HCl, ppmdv................................................ 3,100 SO2, ppmdv................................................ 55 NOx, ppmdv................................................ 250 Pb, mg/dscm............................................... 10 Cd, mg/dscm............................................... 4 Hg, mg/dscm............................................... 7.5 ------------------------------------------------------------------------ Most of the achievable emission levels associated with combustion control have changed little from the proposal; the exceptions are the achievable emission levels for dioxin and Hg. The conclusion drawn at proposal regarding the achievable emission level for dioxin was driven by two relatively high data points from two different MWI. A thorough review of these two MWI and the tests conducted at these two MWI raise numerous questions and doubts about whether good combustion was actually employed at these MWI during the emission tests. Consequently, EPA no longer considers these emission tests representative of good combustion. The situation is similar with regard to achievable Hg emission levels; at proposal, the conclusion regarding achievable emission level for Hg was driven by one very high data point. Following proposal, the hospital operating this MWI instituted several common waste management practices employed by other hospitals, and the MWI was retested by the EPA. The new data point is very similar to all the other data points. Consequently, the earlier data point is no longer considered representative of achievable Hg emission levels. While no specific comments were received regarding the cost of good combustion, the costs were reassessed and updated for consistent comparison with other costs. This information is described in more detail in item IV-B-33 in the docket. 2. Wet Scrubbers Following proposal, a number of comments were submitted to the EPA concerning the performance capabilities of wet scrubbing systems. Some commenters claimed that the wet scrubbing system tested by EPA was not representative of current wet scrubber technology and that the scrubber was not designed for high efficiency PM removal. The commenters submitted a number of emission test reports from wet scrubbing systems and urged EPA to reconsider the performance capabilities of these systems. The EPA has reviewed these emission test reports and revised its previous conclusions on the performance capabilities of wet scrubbing systems. Wet scrubbing systems are capable of achieving three different levels of performance, depending on their design and operation. For convenience, these three levels of performance have been termed low efficiency, moderate efficiency, and high efficiency. A summary of EPA's revised conclusions regarding achievable emission levels associated with the use of wet scrubbing systems is shown in Table 4. A full discussion of these revised conclusions is available as item No. IV-B-48 in the docket. Table 4.--Achievable Emission Levels For Wet Scrubbers ---------------------------------------------------------------------------------------------------------------- Achievable emission levels Pollutant, units ------------------------------------------------------------------------------ Low Moderate High ---------------------------------------------------------------------------------------------------------------- PM, gr/dscf...................... 0.05..................... 0.03.................... 0.015. dioxin, ng/dscm.................. 125...................... 125..................... 125. TEQ dioxin, ng/dscm.............. 2.3...................... 2.3..................... 2.3. HCl, ppmdv....................... 15 or 99%................ 15 or 99%............... 15 or 99%. Pb, mg/dscm...................... 1.2 or 70%............... 1.2 or 70%.............. 1.2 or 70%. Cd, mg/dscm...................... 0.16 or 65%.............. 0.16 or 65%............. 0.16 or 65%. Hg, mg/dscm...................... 0.55 or 85%.............. 0.55 or 85%............. 0.55 or 85%. ---------------------------------------------------------------------------------------------------------------- Percent reflects achievable percentage reduction in emissions. No levels are shown for CO, SO2, or NOx because wet scrubbers on MWI achieved no further reductions beyond good combustion for these pollutants. Note that for the waste-related pollutants, the achievable emission levels in the table are expressed as a numerical concentration level or a percent reduction. The composition of the waste burned in an MWI is not uniform; as a result, the concentration levels of waste-related pollutants from an MWI varies. On occasion, however, a momentary rise or ``spike'' in the concentration level of a waste-related pollutant may occur; while a wet scrubbing or dry scrubbing system can reduce this concentration level considerably, the system can not necessarily reduce it to the concentration levels shown in the table. For this reason, conclusions regarding [[Page 31743]] achievable emission levels associated with the use of wet or dry scrubbing systems for waste-related pollutants must include a percent reduction component to accurately reflect the performance capabilities of wet and dry scrubbing systems. Also note that the EPA has no emission data upon which to assess the performance capabilities of wet scrubbing systems that might utilize activated carbon. The EPA knows of no wet scrubbing system currently operating on an MWI using activated carbon, although vendors have mentioned this technique could be done. Activated carbon used with a dry scrubber (discussed below) provides enhanced removal of Hg and dioxin. Thus, the use of activated carbon with a wet scrubbing system, in an appropriate manner such as a fixed bed, should achieve the same enhanced performance levels. Along with new information regarding the performance of wet scrubbers, EPA received new information regarding the cost of wet scrubbing systems. Figure 1 shows the relationship between cost and size of MWI for each level of wet scrubber performance. These costs are not substantially different from those used at proposal. The key difference is the distinction in costs between wet scrubbers of different efficiency. This information is described in more detail in item IV-B-30 in the docket. BILLING CODE 6560-50-P [GRAPHIC] [TIFF OMITTED] TP20JN96.000 BILLING CODE 6560-50-C 3. Dry Scrubbers Very few comments were submitted to EPA following proposal that questioned EPA's conclusions on the performance capabilities of dry scrubbing systems. These capabilities were reassessed, however, to consider data contained in several emission test reports submitted to EPA from dry scrubbing systems using activated carbon. The results of this reassessment of dry scrubbing system performance is shown in Table 5. The conclusions summarized in this table are similar to those at proposal. Note, however, that as discussed above under wet scrubbing systems, the achievable emission levels associated with the use of dry scrubbing systems for waste- related pollutants are now expressed as a numerical concentration level or a percent reduction. A discussion of this reassessment is available as item No. IV-B-49 in the docket. Table 5.--Achievable Emission Levels For Dry Scrubbers With Activated Carbon Injection ------------------------------------------------------------------------ Pollutant, units Achievable emission levels ------------------------------------------------------------------------ PM, gr/dscf............................ 0.015. dioxin, ng/dscm........................ 25. TEQ dioxin, ng/dscm.................... 0.6. HCl, ppmdv............................. 100 or 93%. Pb, mg/dscm............................ 0.07 or 98%. Cd, mg/dscm............................ 0.04 or 90%. Hg, mg/dscm............................ 0.55 or 85%. ------------------------------------------------------------------------ Percent reflects achievable percentage reduction in emissions. No levels are shown for CO, SO2, or NOx because dry scrubbers on MWI's achieved no further reductions beyond good combustion for these pollutants. While no specific comments were received regarding the cost of dry scrubbers, the costs were reassessed and updated for consistent comparison with other costs. Figure 2 shows the relationship between cost and size of MWI for dry scrubbing systems. This information is described in more detail in item IV-B-32 in the docket. [[Page 31744]] [GRAPHIC] [TIFF OMITTED] TP20JN96.001 BILLING CODE 6560-50-C D. MACT Floor 1. Existing MWI The Clean Air Act specifies in Section 129 that the degree of reduction in emissions that is deemed achievable for existing MWI shall not be less stringent than the average emission limitation achieved by the best performing 12 percent of units in a category; this requirement is referred to as the ``MACT floor'' for existing MWI. Section 302(k) of the Clean Air Act defines the term ``emission limitation'' as ``a requirement established by the State or Administrator which limits the quantity, rate, or concentration of emissions of air pollutants on a continuous basis.'' Air quality permits and State regulations were examined to determine the average emission limitations achieved by the best performing 12 percent of MWI in each of the three subcategories considered at proposal (continuous, intermittent, and batch MWI). Table 6 presents the MACT floor emission levels identified at proposal. Table 6.--Proposed MACT Floor Emission Levels For Existing MWI [February 1995] ---------------------------------------------------------------------------------------------------------------- MWI subcategory Pollutant, units ----------------------------------------------- Batch Intermittent Continuous ---------------------------------------------------------------------------------------------------------------- PM, gr/dscf..................................................... 0.03 0.03 0.02 CO, ppmdv....................................................... 91 90 76 Dioxin, ng/dscm................................................. NF NF NF HCI, ppmdv...................................................... 911 115 43 (35%) (92%) (97%) SO2, ppmdv...................................................... NF NF NF NOX, ppmdv...................................................... NF NF NF Pb, mg/dscm..................................................... NF NF NF Cd, mg/dscm..................................................... NF NF NF Hg, mg/dscm..................................................... NF NF NF ---------------------------------------------------------------------------------------------------------------- NF=No Floor--the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction. Note that the table indicates no floor for most pollutants. While a numerical value was calculated for each pollutant, most pollutant MACT floors reflected uncontrolled emissions. Nevertheless, based on conclusions drawn at proposal regarding performance of technology, the MACT floor values included in Table 6 for CO, PM, and HCl indicated, at proposal, that all existing MWI would need good combustion and dry scrubbers to meet the MACT floors for CO, PM, and HCl. As discussed in earlier sections, the new information submitted following proposal led to changes to the MWI inventory and subcategories. Because these factors can influence the MACT floors, a review of the MACT floors was conducted. Recall that the inventory includes emission limitations for each pollutant based on State permits and regulations. For each pollutant, the MWI inventory was sorted by subcategory [[Page 31745]] and then by stringency of emission limit (most stringent to least stringent) within each subcategory. For each pollutant, the emission limitations for the top 12 percent of units in each subcategory were averaged to determine the MACT floor emission levels. The results of these calculations to determine the MACT floor emission levels for existing MWI in each subcategory based on the new MWI inventory are presented in Table 7. Table 7.--Revised MACT Floor Emission Levels for Existing MWI ---------------------------------------------------------------------------------------------------------------- MWI subcategory Pollutant, units ----------------------------------------------- Small Medium Large ---------------------------------------------------------------------------------------------------------------- PM, gr/dscf..................................................... 0.086 0.043 0.021 CO, ppmdv....................................................... 156 98 87 Dioxin, ng/dscm................................................. NF NF NF HCI, ppmdv...................................................... NF 589 101 (57%) (93%) SO2, ppmdv...................................................... NF NF NF NOX, ppmdv...................................................... NF NF NF Pb, mg/dscm..................................................... NF NF NF Cd, mg/dscm..................................................... NF NF NF Hg, mg/dscm..................................................... NF NF NF ---------------------------------------------------------------------------------------------------------------- NF=No Floor--the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction. Based on the recalculated MACT floors and the new conclusions drawn regarding the performance capabilities of air pollution control technologies (Section II.C.), it appears that large MWI would have to use good combustion and a high efficiency wet scrubber to achieve the MACT floor emission levels, while a medium-sized MWI would have to install at least good combustion and a moderate efficiency wet scrubber. Dry scrubbers could also be used in conjunction with good combustion to meet the MACT floor emission levels for medium and large MWI. Available data showing the performance capabilities of good combustion appears to indicate that the 0.086 gr/dscf PM MACT floor for small MWI is not achievable with good combustion alone. However, MWI manufacturers have indicated they routinely guarantee achieving 0.08 gr/dscf with good combustion. Consequently, the MACT floor for small MWI would require the use of good combustion practices; based on the claims of MWI manufacturers, add-on scrubbing systems would not be needed in all cases to meet the MACT floor. Regulatory options reflecting more stringent guidelines for existing MWI are examined in Section III of this notice. A memorandum that documents the procedures used to determine the MACT floors for existing MWI is located in the docket as item IV-B-24. 2. New MWI The Clean Air Act specifies in Section 129 that the degree of reduction in emissions that is deemed achievable for new MWI shall not be less stringent that the emissions control achieved by the best- controlled similar unit; this requirement is referred to as the ``MACT floor'' for new MWI. The MACT floor emission levels identified at proposal for new MWI are presented in Table 8. These MACT floor values reflect conclusions at proposal about the performance capabilities of dry scrubbing systems because such systems were identified on at least one MWI in each subcategory and because dry scrubbing systems were considered capable of achieving lower emissions than wet scrubbing systems. Table 8.--Proposed MACT Floor Emission Levels For New MWI [February 1995] ---------------------------------------------------------------------------------------------------------------- MWI subcategory Pollutant, units ----------------------------------------------- Batch Intermittent Continuous ---------------------------------------------------------------------------------------------------------------- PM, gr/dscf..................................................... 0.013 0.013 0.013 CO, ppmdv....................................................... 50 50 50 Dioxin, ng/dscm................................................. 1,500 450 80 HCl, ppmdv...................................................... 42 42 42 (97%) (97%) (97%) SO2, ppmdv...................................................... NF NF NF NOX, ppmdv...................................................... NF NF NF Pb, mg/dscm..................................................... 0.1 0.1 0.1 Cd, mg/dscm..................................................... 0.05 0.05 0.05 Hg, mg/dscm..................................................... NF NF 0.47 (85%) ---------------------------------------------------------------------------------------------------------------- NF=No Floor--the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction. Again, the new information submitted following proposal led to changes to the MWI inventory, subcategories, and conclusions about performance of technology. Because these factors can influence the MACT floors, a review of the MACT floors was conducted. The revised inventory of existing MWI was examined to identify the best-controlled [[Page 31746]] MWI in each subcategory. The revised MACT floor emission levels for new MWI are shown in Table 9. Table 9.--Revised MACT Floor Emission Levels For New MWI ---------------------------------------------------------------------------------------------------------------- MWI subcategory Pollutant, units ----------------------------------------------- Small Medium Large ---------------------------------------------------------------------------------------------------------------- PM, gr/dscf..................................................... 0.03 0.015 0.015 CO, ppmdv....................................................... 40 40 40 Dioxin, ng/dscm................................................. 125 125 25 HCl, ppmdv...................................................... 15 15 15 (99%) (99%) (99%) SO2, ppmdv...................................................... NF NF NF NOx, ppmdv...................................................... NF NF NF Pb, mg/dscm..................................................... 1.2 0.07 0.07 (70%) (98%) (98%) Cd, mg/dscm..................................................... 0.16 0.04 0.04 (65%) (90%) (90%) Hg, mg/dscm..................................................... 0.55 0.55 0.55 (85%) (85%) (85%) ---------------------------------------------------------------------------------------------------------------- NF=No Floor--the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction. The small MWI subcategory consists of MWI operating at a throughput of 200 pounds per hour (lb/hr) or less of medical waste. The MACT floor for new small MWI consists of the emission levels that are achievable with good combustion and a moderate efficiency wet scrubber. The MACT floor is based on these emissions levels because small existing MWI equipped with this air pollution control have been identified. No small existing MWI have been identified with high-efficiency wet scrubbers or dry scrubbers. The medium MWI category consists of MWI operating at a throughput of greater than 200 lb/hr and less than or equal to 500 lb/hr of medical waste. The MACT floor for new medium-sized MWI is based on emission levels that are achievable with good combustion and a combination of two control technologies, the high efficiency wet scrubber and the dry injection/fabric filter (DI/FF) dry scrubber system without carbon. At least one existing MWI in the medium subcategory is controlled with a high efficiency wet scrubber and another is equipped with a DI/FF system without carbon. The MACT floor is based on both of these technologies (i.e., a combined dry/wet scrubber system) because the wet scrubber achieves the lowest dioxin, HCl, and Hg emissions, but the DI/FF without carbon injection achieves the lowest Pb and Cd emissions. While no combined dry/wet scrubber systems were identified on medium MWI, several such systems are currently in operation on large MWI, as mentioned below. In addition, as also mentioned below, spray dryer/fabric filter systems could also meet the MACT floor emission levels for medium-sized MWI. The large MWI subcategory consists of all MWI operating at a throughput of greater than 500 lb/hr of medical waste. As with the MACT floor for new medium MWI, the MACT floor for new large MWI is based on the emission levels that are achievable with good combustion and a combination of two control technologies, the high efficiency wet scrubber and the DI/FF dry scrubber system with carbon. Several existing facilities in the large category currently control emissions with a combined dry/wet system. In addition, one existing MWI equipped with a spray dryer/fabric filter system with carbon was tested during the EPA testing program and this test demonstrated that this scrubbing technology could also meet the MACT floor emission levels presented in Table 9. Regulatory options reflecting more stringent standards for new MWI are examined in Section IV of this notice. A memorandum that documents the procedures used to determine the MACT floors for new MWI is located in the docket as item IV-B-38. E. Baseline Emissions To estimate the environmental impacts of the standards and guidelines for MWI, an estimate of baseline emissions must be made (i.e., emissions in the absence of Federal regulations). In the February 1995 proposal, baseline emissions were estimated for PM, CO, dioxin, HCl, SO2, NOx, Pb, Cd, and Hg. When this estimate was developed, very little information was available regarding the actual number of MWI and the level of air pollution control associated with each. The emission estimate was derived from an estimated 3,700 MWI assumed to be operating with little, if any, air pollution control. As discussed in previous sections, new information has led to new conclusions about the MWI inventory, performance of technology, and control levels associated with each existing MWI. As a result, revised estimates of baseline emissions from existing MWI have been calculated and are presented in Table 10. Table 10.--Annual Baseline Emissions For Existing MWI ------------------------------------------------------------------------ Baseline Pollutant, units emissions ------------------------------------------------------------------------ PM, Mg/yr................................................. 940 CO, Mg/yr................................................. 460 Dioxin g/yr............................................... 7,200 Dioxin g TEQ/yr........................................... 150 HCl, Mg/yr................................................ 5,700 SO2, Mg/yr................................................ 250 NOx, Mg/yr................................................ 1,200 Pb, Mg/yr................................................. 11 Cd, Mg/yr................................................. 1.2 Hg, Mg/yr................................................. 15 ------------------------------------------------------------------------ To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divided by 453.6. The results of these emission estimates are significantly lower than estimates developed at proposal. For example, the estimate of baseline emissions of dioxin toxic equivalency (TEQ) was 5,100 grams per year (g/yr) at proposal; the current estimate is 150 g/yr. At proposal, the estimate of Hg emissions from existing MWI was 64.6 tons per year (tons/yr); the current estimate is 16.0 tons/yr. The primary reason for the lower baseline emission estimate is the much greater level of emission control found [[Page 31747]] at existing MWI than was assumed at proposal. Comment is requested on the methodology and assumptions used to estimate baseline emissions from existing MWI. Where information on specific air pollution control equipment was not available, EPA used State regulatory emission limits to predict the type of air pollution control equipment installed on each existing MWI. Information is requested which would more accurately reflect the actual air pollution control equipment installed on each existing MWI. In addition, emission factors for each type of air pollution control equipment were developed based on compliance test reports. Comment is requested on whether these emission factors reflect actual air emissions from these control devices over the life of the equipment. At proposal, baseline emissions were also estimated for new MWI in the fifth year after adoption of the NSPS. These estimates were based on a projected number of new MWI and their associated emission controls that would be installed in the five years following promulgation of the standards. As with the estimation of baseline emissions for existing MWI, the estimate of baseline emissions for new MWI has also changed significantly. This change is due primarily to the lower projected number of new MWI and the emission control level associated with each MWI. The revised baseline emissions estimates for new MWI are presented in Table 11. Table 11.--Annual Baseline Emissions For New MWI ------------------------------------------------------------------------ Baseline Pollutant, units emissions ------------------------------------------------------------------------ PM, Mg/yr................................................. 28 CO, Mg/yr................................................. 14 Dioxin g/yr............................................... 47 Dioxin g TEQ/yr........................................... 1.1 HCl, Mg/yr................................................ 64 SO2, Mg/yr................................................ 28 NOx, Mg/yr................................................ 130 Pb, Mg/yr................................................. 0.39 Cd, Mg/yr................................................. 0.051 Hg, Mg/yr................................................. 0.21 ------------------------------------------------------------------------ To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/y to 1b/yr, divided by 453.6. The memoranda documenting these revised estimates of baseline emissions from new and existing MWI can be found in the docket as items IV-B-51 and IV-A-6. F. Operator Training and Qualification The proposed standards and guidelines included operator training and qualification requirements for each MWI operator. These operator training and qualification requirements included completion of (1) 24 hours of classroom instruction, (2) 4 hours of hands-on training, (3) an examination developed and administered by the course instructor, and (4) a handbook or other documentation covering the subjects presented during the course. The instructor of the operator training course was not to be employed by the owner or operator of the facility. To obtain qualification, an operator was to complete the training course and have either a minimum level of experience or satisfy comparable or more stringent criteria established by a national professional organization. The proposed standards and guidelines also required the owner or operator of the facility to develop and annually update a site-specific operating manual. This manual would summarize regulations, operating procedures, and reporting and recordkeeping requirements in accordance with the proposed standards and guidelines. The proposal required that each MWI be operated by a trained and qualified operator or by an individual under the direct supervision of a trained and qualified operator. The trained and qualified operator would have to be on duty and at the facility at all times while the incinerator is in operation. Many comments were received on the proposed operator training and qualification requirements. The majority of the public comments on operator training and qualification were related to the third party training requirement and to the duration that operators must be present while the MWI is burning waste. Many commenters stated that the EPA should allow facilities the option of providing training by in-house personnel because the facility's own personnel would be most familiar with the operation and maintenance of the incinerator. The commenters indicated that smaller facilities that do not have the personnel could use the services of trainers and inspectors that are not affiliated with the facility. Many commenters stated that the amount of time that the operator was required to be present was excessive. Under the proposal, the operator would have to be on-duty and at the facility during the time that the combustion air blowers are operating. Several commenters suggested that this would require operators to be at the incinerator even when waste was not being burned. Several commenters also suggested that the trained and qualified operator should be easily accessible (either at the facility or on-call) while the incinerator is operating. The EPA is inclined to adopt the operator training and qualification requirements briefly summarized below and discussed in greater length in document number IV-B-26, which is available in the Docket. Cost estimates for operator training and qualification are documented in item IV-B-39. The owner or operator of an MWI would be responsible for ensuring that one or more operators at the facility are qualified. Operator training may be obtained through a State-approved program or by completing a training course with (1) 24 hours of classroom instruction, (2) an examination designed and administered by the course instructor, and (3) reference material distributed to the attendees covering course topics. Operators may obtain qualification by completing a training course and having one of the following levels of experience: (1) at least 6- months' experience as an MWI operator, (2) at least 6-months' experience as the direct supervisor of a qualified MWI operator, or (3) completion of at least two burn cycles under the observation of two qualified operators. To maintain qualification, the operator would be required to complete and pass an annual review or refresher course of at least 4 hours. A fully trained and qualified operator would have to be easily accessible, either at the facility or on-call at all times while the incinerator is in operation. The trained and qualified operator may operate the MWI directly or be the direct supervisor of one or more individuals that charge waste, remove ash, etc. As proposed, the emission guidelines for existing MWI would require that, 1 year after approval of the State plan, MWI must be operated by a trained and qualified operator. G. Testing, Monitoring, and Inspection Section 129(c) of the Clean Air Act requires the EPA to develop regulations that include monitoring and testing requirements. The purpose of these requirements is to allow the EPA to determine whether a source is operating in compliance with the regulations. As mentioned earlier, at proposal relatively few emission test reports were available to EPA to judge the performance of air pollution control technologies. These test reports were the result of EPA emission testing at several MWI. For a variety of reasons, EPA gathered data during these emission tests using three, 4-hour test runs. The results of the three test runs were then averaged at each MWI to calculate a measured emission level. This calculated emission level represented an [[Page 31748]] average emission value over the 12-hour period (i.e., three, 4-hour runs). As a result, EPA's assessments of the performance capabilities of air pollution control technologies and conclusions regarding the appropriate emission limits to include in the proposed regulations were based on the measured performance of technology averaged over a 12-hour period. Emission levels, however, tend to fluctuate somewhat as part of normal operation. Consequently, during short periods of time, emission levels may occasionally be greater or lower than the average emission level over a 12 hour period. In developing a regulation based on the performance of a particular technology, the level of performance demanded by the regulation must be consistent with the level of performance that technology can achieve. The period of time over which emissions are measured and then averaged to determine compliance with the regulation, therefore, must correspond to the period of time over which emission levels were measured and averaged in determining the emission limits included in the regulation. If this is not the case, a regulation could include emission limits that a technology can achieve if emissions are averaged over a relatively long period of time, but not if emissions are averaged over a much shorter period of time. For this reason, the proposed regulation required emission testing to determine compliance by averaging the results of three, 4-hour test runs, consistent with the procedures followed in gathering the emission data used to establish the emission limits included in the regulation. Many comments were received regarding this proposed requirement to determine compliance using three, 4-hour test runs. These commenters noted that a 4-hour test run was much longer than the more conventional test run of about 1-hour; additionally, many hospitals and healthcare facilities would normally not have sufficient waste on hand to accommodate three, 4-hour test runs. Finally, several commenters stated that the proposed emission testing requirements would substantially increase the costs associated with emission testing. Consequently, these commenters urged EPA to revise the emission testing requirements and adopt the more conventional approach of relying on test runs of about an hour in length. As mentioned earlier, more than two dozen test reports were submitted to EPA following the proposal, and these test reports now form the basis for revised conclusions regarding the performance capabilities of technology and the emission limits these technologies can achieve. The EPA test methods were used to perform the emission testing summarized in these reports. These methods include procedures that require the collection of a sufficient sample to accurately measure emission levels. For most air pollutants, this sample generally corresponds to a test run of about an hour. The revised conclusions discussed earlier, therefore, regarding the performance capabilities of emission control technologies and the emission limits these technologies can achieve, are based (for the most part) on emission test data generated by averaging the results of three test runs of about an hour each (i.e., a 3-hour test). For this reason, the EPA is inclined to state in the final regulations adopted for MWI that EPA test methods be followed when performing any emission testing required to determine compliance with the regulations. This requirement will ensure that compliance testing follows the same procedures used to generate the emission data upon which the emission limits in the final regulation were based. In most cases, three test runs of about an hour each would be necessary to determine compliance with the final regulations. An exception to this requirement is emission testing to measure dioxin emissions. The procedures in the EPA test method to ensure sufficient sample is gathered to accurately measure dioxin emissions frequently leads to test runs longer than 1 hour. Whatever the length of the emission test, however, the emission testing procedures included in the EPA test method for measuring dioxin emissions were followed in the emission test reports submitted to EPA following proposal. As discussed earlier, these emission test reports serve as the basis for the dioxin emission limits included in the final regulations and, as a result, the length of testing necessary to determine compliance will automatically be consistent with the length of testing used to determine the emission limits included in the regulations. The proposed regulations also would have required annual emission testing to determine compliance. While some commenters supported emission testing annually or even more frequently (such as every 6 months), a number of commenters believed that annual testing would be unnecessary or that testing should be required no more than every 5 years. Commenters felt that the requirements for inspections, monitoring, and operator training are sufficient and much less expensive than annual emission testing. Other commenters suggested that the annual emission testing requirement be replaced with a requirement for annual equipment inspection/maintenance to ensure that burner settings, air flow rates, and other operation parameters are properly adjusted. While the proposal includes a requirement for annual equipment inspection and maintenance, this requirement would have applied only to existing MWI until air pollution control equipment had been installed and the MWI was in compliance with all the emission limits in the regulations. The purpose of the proposed annual equipment inspection and maintenance requirements was to ensure that the MWI was in good working order and physically capable of operating as well as it could operate until compliance with the emission limits was demonstrated. A MWI in poor operating condition will likely have higher emissions than a MWI in good operating condition. While some commenters stated inspections are not necessary and others suggested that EPA should let the States decide whether inspections are necessary, most commenters were generally supportive of annual inspection and maintenance requirements. Several commenters also stated that biannual inspections would not be unreasonable. Many of the commenters supportive of inspection requirements, however, suggested that the requirement for a ``third party'' inspection be deleted. These commenters stated in-house personnel are more familiar with the details and operating intricacies of the equipment installed at their sites. In addition, serious liability concerns could arise from injury or damage caused by ``third party'' inspection or maintenance. At this point, EPA is inclined to include inspection and maintenance requirements wherever annual stack testing is not required (see document IV-B-26 in the docket for a description of injection/maintenance requirements). The inspection would not have to be conducted by a third party. The proposal also included various monitoring requirements, requiring the use of continuous emission monitoring systems (CEMS) for some pollutants and the monitoring of operating parameters for other pollutants. Some commenters supported the proposed requirements for CO, opacity, and oxygen (O2) CEMS. Another commenter suggested that the requirements should be extended to require CEMS for Hg, HCl, and PM; the commenter suggested that such instruments are available. On the other [[Page 31749]] hand, several other commenters objected to the CEMS requirements in the proposed rule. These commenters stated that CEMS are not justified, especially for small MWI, because they are too expensive. These commenters believe that monitoring operating parameters is a sufficient substitute for CEMS once compliance has been demonstrated by an initial emission test. The monitoring requirements in the proposal for monitoring operating parameters were structured around the use of dry scrubber systems. Those who commented on these specific requirements generally agreed that monitoring of these operating parameters was appropriate for dry scrubbing systems. No monitoring requirements were included for monitoring operating parameters for wet scrubbing systems. The EPA solicited information regarding an appropriate set of operating parameters for wet scrubbing systems. The EPA was inclined and is still inclined to include specific operating parameter monitoring requirements in the final regulations for wet scrubbing systems as well as for dry scrubbing systems. To accommodate MWI using an air pollution control system other than a dry or wet scrubbing system, EPA is inclined to include provisions in the final regulations for petitioning the Administrator to monitor specific operating parameters associated with the other air pollution control system. A number of commenters responded to EPA's request for suggestions of monitoring requirements for operating parameters suitable for wet scrubbing systems. Suggested parameters included pressure drop across the system, liquor flow rate, flue gas temperature, liquor pH, and horsepower or amperage. While EPA is inclined to include the same requirements in the final regulations for monitoring operating parameters for dry scrubbing systems as proposed, EPA is inclined to include requirements in the final regulations for monitoring the following operating parameters for wet scrubbing systems: scrubber exit temperature, scrubber liquor pH, scrubber liquor flow rate, and energy input to the scrubber (e.g., pressure drop or horsepower). To consider the comments outlined above regarding the frequency of emission testing and the proposed inspection and monitoring requirements, a matrix of options was developed. This matrix of options and their annual costs are summarized in Table 12. Each cell or box in this table represents a combination of emission testing and monitoring requirements (some combinations also include inspection requirements). The range in the costs shown in each cell is a reflection of how the cost of emission testing and monitoring is likely to vary depending on the emission limits included in the final regulation (i.e., whether the emission limits are based on the use of good combustion alone or good combustion and wet or dry scrubbing). These costs vary somewhat because the operating parameters monitored in each case would be somewhat different. Table 12.--Monitoring/Testing Options and Annual Costs [Thousand $/yr] ---------------------------------------------------------------------------------------------------------------- Testing options ----------------------------------------------- Monitoring options A Initial and B Initial C Substitute repeat stack stack testing; stack testing; testing inspection inspection ---------------------------------------------------------------------------------------------------------------- 1--CO CEMS (App F); Opacity CEM (no App F); Operating Parameters 110-119 100-104 99-102 2--Opacity and CO CEMS (no App F); Operating Parameters......... 96-104 85-89 83-86 3--Opacity CEMS (no App. F); Operating Parameters............... 37-46 27-31 26-29 4--Operating Parameters; Quarterly Method 9..................... 10-15 7.5-11 5.8-8.8 ---------------------------------------------------------------------------------------------------------------- Table 12 presents the 12 possible combinations of three emission testing options and four monitoring options that the EPA is considering including in the final regulations. A more detailed explanation of these emission testing and monitoring options, as well as their costs, is available in the docket as item IV-B-54. The following discussion, however, briefly outlines the essential requirements of each of the monitoring and emission testing options. Monitoring Option 1 requires a CO CEMS with Appendix F requirements (Appendix F requirements ensure the data generated is reliable), an opacity CEMS without Appendix F requirements, and operating parameter monitoring requirements for the MWI and, if applicable, for the air pollution control device. Because the use of Appendix F is required under this option, the CO CEMS would be used for direct enforcement of the CO emission limit. The opacity CEMS without Appendix F requirements would simply provide an indication of opacity and would not be used for direct enforcement of the opacity limit. Routine opacity testing with Reference Method 9 is included in Monitoring Option 1 to compensate for not including Appendix F requirements on the opacity CEMS. Monitoring Option 2 is the same as Monitoring Option 1, except that it would not include Appendix F requirements for the CO CEMS, which would reduce costs. Without Appendix F requirements, the CO CEMS would provide an indication of CO emissions and would not be used for direct enforcement of the CO emission limit. Emission testing for CO is included in Monitoring Option 2 to compensate for excluding Appendix F requirements on the CO CEMS. An opacity CEMS and operating parameter monitoring would be required as in Monitoring Option 1. Monitoring Option 3 is the same as Monitoring Option 2, except that, instead of the more expensive CO CEMS, stack emission testing for CO would be required. An opacity CEMS and operating parameter monitoring would be required as in Monitoring Options 1 and 2. Monitoring Option 4 would require no CEMS. Instead, it would rely on manual emission test methods (including more frequent Method 9 opacity tests) and operating parameter monitoring. For each of these monitoring options, three emission testing options have been developed. Emission testing Option A would require initial and annual/skip tests. With the annual/skip test requirement, emission tests would be required for the first 3 years. If these tests show that the facility was in compliance each of these 3 years, then subsequent testing would be done every third year. Emission testing Option A, [[Page 31750]] under all four monitoring options, would require an initial stack test for all pollutants. Annual or skip emission testing under Monitoring Options 1, 2, and 3 would also require emission testing of all pollutants. However, annual or skip emission testing under Monitoring Option 4 would only require emission testing of a few key or critical pollutants (i.e., only those necessary to gain a good indication that the air pollution control system is operating properly). Emission testing Option B would require an initial emission test for all pollutants, but would not require annual emission tests. In lieu of annual or skip emission testing, MWI inspection/maintenance would be required. This inspection/maintenance would be required annually under Monitoring Options 1 and 2; however, it would be required quarterly under Monitoring Options 3 and 4, where no CO CEMS is required. The inspection/maintenance could be done by in-house personnel. With regard to any necessary repairs arising from the inspection/maintenance, the owner or operator of the MWI would be required to contact the State (or local, if delegated by the State) air pollution control agency and negotiate a date, within 10 operating days following the date of the inspection/maintenance, by which the repairs must be completed. Emission testing Option C would permit substitute emission testing. A substitute emission test is an emission test conducted on another, but identical MWI. An MWI would be required to petition the State (or local, if delegated by the State) air pollution control agency for approval, however, and the ``burden of proof'' would be on the MWI to demonstrate to the satisfaction of the agency that the substitute emission test is on an identical MWI. In addition, an initial emission test for Hg would be required; this test would ensure that appropriate measures for managing the mercury content of the waste are utilized (e.g., material separation, material purchasing, etc.). Inspection/ maintenance requirements would be the same as under Emission Testing Option B. The most direct means of ensuring compliance with emission limits included in regulations is the use of CEMS. As a matter of policy, the first and foremost option considered by EPA is to require the use of CEMS in regulations to demonstrate and ensure compliance on a continuous basis with the regulations. Only when the impacts of including such requirements are considered unreasonable, does the EPA consider other options. For MWI, it appears that almost all of the emission testing and monitoring options under consideration cost more than the emission control system that would be installed to meet the emission limits in the regulations; in some cases, the emission testing and monitoring requirements could cost twice as much as the emission control system. Consequently, the Agency is inclined to include the emission testing and monitoring requirements under Monitoring Option 4 in the final regulations to minimize costs. Where the regulations are based on good combustion and wet and/or dry scrubbing systems, the EPA is inclined to require Monitoring Option 4 with Emission Testing Option A; where the regulations are based, in part, on the use of good combustion alone, the EPA is inclined to require Monitoring Option 4 with Emission Testing Option B. The appropriate choice of emission testing and monitoring requirements (as well as inspection/maintenance requirements) is an area in which the EPA specifically solicits comments. Many of the MWI visited or inspected by the EPA in the course of gathering data and information often appeared poorly maintained and operated. Inadequate maintenance and/or operation can cause even the best equipment to perform poorly and result in excess emissions. The inspection/ maintenance and operator training requirements included in the final regulations are expected to address this problem in a satisfactory manner; however, the EPA is interested in whether others feel the inspection/maintenance requirements and operator training requirements should be supplemented with more extensive emission testing and/or monitoring requirements. In addition, CEMS vendors have expressed concern with the costs developed by EPA for the various CEMS and operating parameter monitoring requirements. In particular, they believe the costs of CEMS are much lower than those estimated by EPA. As mentioned, a detailed breakdown of the EPA estimates of the costs of these requirements is available in the docket as item IV-B-54. The EPA solicits comments on these costs and if costs are indeed much lower than estimated, EPA may consider more comprehensive monitoring requirements in the final rule. Finally, even if the costs remain similar to those previously estimated, the EPA is considering more comprehensive emission testing and monitoring requirements (including CEMS) for large MWI that burn medical waste generated offsite (i.e., generated at another location than that of the MWI). Definition of Medical Waste Section 129 of the Clean Air Act directs the EPA to adopt regulations for solid waste incineration units that combust (1) municipal waste; (2) hospital, medical, and infectious waste; (3) commercial or industrial waste; and (4) all other solid waste. The regulations limiting air emissions from solid waste incineration units combusting municipal waste (otherwise known as municipal waste combustor(s) or MWC) were promulgated on December 19, 1995 (60 FR 65387). In developing regulations to limit air emissions from solid waste incineration units combusting hospital, medical, and infectious waste (otherwise known as medical waste incinerator(s) or MWI), medical waste was defined 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. Section 129(g)(6) states that the term ``medical waste'' shall have the meaning ``established by the Administrator pursuant to the Solid Waste Disposal Act'' (SWDA). For the proposed air emission standards and guidelines for MWI, EPA adopted the definition of ``medical waste'' from solid waste regulations codified in 40 CFR part 259, subpart B because this definition was ``established by the Administrator pursuant to the [SWDA],'' as amended by the Medical Waste Tracking Act (MWTA). However, 40 CFR part 259 has since been withdrawn. Consequently, there is no definition of medical waste which has been ``established by the Administrator pursuant to the [SWDA],'' and EPA now has the flexibility to examine and consider other definitions of medical waste. While EPA is inclined to adopt a specific definition described below, EPA is considering all of the definitions discussed in this section as well as the proposed definition and solicits comment on the merits of each definition discussed as well as other definitions EPA should consider. During the public comment period, the majority of the comments on the definition of medical waste stated that the proposed definition was too broad and that it should be narrowed. Several commenters stated that this definition would aggravate an already confusing situation, where the public distinction between the terms medical waste and infectious waste has become blurred and in most cases lost; these terms are often used synonymously in public discourse. [[Page 31751]] These commenters believed that a broad definition of medical waste in the regulations for MWI would have the undesirable impact of fostering and encouraging the use and adoption of this definition in other areas and by other regulatory authorities. They suggested that as this definition becomes more widespread and adopted by others, healthcare facilities would eventually be forced to handle most, if not all, medical waste as infectious waste--whether it was burned in an incinerator or not. These commenters stated the proposed definition of medical waste, because of the loss of public distinction between this term and the term infectious waste, and the resulting impact of eventually forcing healthcare facilities to treat most waste as infectious waste, would lead to a massive increase in the volume of infectious waste. This increase would, in turn, lead to a major increase in the costs of disposal of waste from hospitals, since most waste would have to be handled as infectious waste. These commenters stated that, as in implementing the MWTA, healthcare facilities should be viewed as generating two waste streams: a medical waste stream, which is usually defined by the potential for disease transmission and requires special handling; and a noninfectious waste or ``healthcare trash'' waste stream, which has no potential for infection and is treated and handled as municipal waste. These commenters urged EPA to narrow the definition of medical waste used in the MWI regulations to one of infectious waste, analogous to the term ``regulated medical waste'' adopted in regulations resulting from the MWTA. In most--if not all--cases, these commenters indicated that, where healthcare facilities operate medical waste incinerators, they burn infectious medical waste or a mixture of infectious medical waste and noninfectious waste (i.e., healthcare trash). These commenters stated that there were very few, if any, medical waste incinerators operated by healthcare facilities that burned only noninfectious waste or healthcare trash. Consequently, by defining medical waste narrowly, in a manner consistent with infectious or regulated medical waste, and by applying the regulations to incinerators that burn this waste or any mixture of this waste and other waste, the EPA could achieve the objective, which is regulating air pollution from medical waste incinerators at healthcare facilities; this objective would be achieved without adding to the confusion or leading to the serious impacts outlined above. These commenters further stated the proposed definition of medical waste would subject MWC, which burn general nonregulated and noninfectious waste from hospitals, to the same requirements as those proposed for MWI. Consequently, even if healthcare facilities were not eventually forced to handle most waste as infectious waste (because MWC that burn general nonregulated and noninfectious waste from hospitals would be subject to the MWI regulations) this broad definition would result in higher disposal costs for healthcare facilities which send their general nonregulated and noninfectious waste to MWC for disposal. Some commenters, on the other hand, support the proposed broad definition of medical waste. These commenters pointed out that there is little difference in the air emissions created by burning infectious medical waste (e.g., regulated medical waste or ``red bag'' waste) and by burning noninfectious waste (e.g., nonregulated medical waste or healthcare trash). As a result, the regulations should apply to the burning of all medical waste, as EPA proposed. These commenters believe that EPA's use of the broad definition of medical waste, solely for the purpose of defining what type of incinerator the regulations apply to, does not imply that more waste or that all medical waste will be considered infectious waste. Merely requiring that incinerators that burn medical waste must limit air pollution will not require all healthcare facilities to handle all their medical waste as infectious waste. In fact, these commenters indicated that many healthcare facilities today routinely separate their waste into two types: infectious waste (``red bag'') and noninfectious waste (``black bag''). Numerous items of waste from healthcare facilities are not, nor need not be considered infectious waste. On the other hand, many healthcare facilities today do little to separate their waste streams; most waste is handled and treated as infectious waste. If waste disposal costs were of paramount concern to healthcare facilities, those that do little separation today could reduce their present waste disposal costs by more carefully segregating their waste into infectious and noninfectious waste streams and properly disposing of these two waste streams. Finally, several commenters questioned whether animal carcasses and pathological waste should be included in the definition of medical waste. These commenters were uncertain as to whether pathological waste incinerators were to be regulated as MWI or separately. These commenters requested clarification of this situation and urged EPA to regulate pathological wastes separately from medical waste. Similarly, several commenters questioned whether ``out-of-date'' or ``off-spec'' drugs, or radio-active type medical wastes, should be included in the definition of medical waste. These commenters requested special treatment for these types of wastes, similar to that proposed for pathological wastes. The EPA did not intend to add or contribute to the confusion that presently exists in the public discourse regarding the distinction or lack of distinction between the terms medical waste, regulated medical waste, and infectious medical waste. In fact, the EPA would like to state very clearly that numerous items within the medical waste stream are noninfectious and need not be treated as infectious. In fact, the majority of items in the medical waste stream are noninfectious, and in terms of percentages, most authorities conclude that only 10 to 15 percent of the items in the medical waste stream are infectious, or potentially infectious, and warrant special treatment or handling. In considering the public comments, an interesting and unanimous agreement emerges, even if it is not stated as such. All of the commenters seem to agree that healthcare facilities can be viewed as generating two waste streams: an infectious medical waste stream and a noninfectious healthcare trash, or ``municipal waste'' type, waste stream. The challenge for EPA, therefore, is to reconcile the agreement in this area with the requirement of the Clean Air Act to develop regulations for incinerators burning hospital, medical, and infectious waste. The Clean Air Act requires EPA to develop regulations for the burning of medical waste; but it also requires EPA to develop regulations for the burning of municipal waste. In fact, EPA adopted regulations limiting air pollution from the burning of municipal waste on December 19, 1995 (60 FR 65387). As a result, if healthcare facilities are viewed as generating two types of waste streams, an infectious waste stream and a municipal waste stream, then the burning of the municipal waste stream is already covered by regulations. The definition of municipal waste included in the regulations covering the burning of municipal waste states: Municipal solid waste * * * means household, commercial/retail, and/or institutional waste * * * Commercial/retail waste includes material discarded by stores, [[Page 31752]] offices, restaurants * * * Institutional waste includes materials discarded by schools, nonmedical waste discarded by hospitals, * * * and material discarded by other similar establishments or facilities. The regulations cover the burning of municipal waste discarded from offices and institutions. Hospitals are cited as an example of an institution and clinics and nursing homes are considered ``similar establishment(s)''. Offices include doctors' offices, dentists' offices, etc. Consequently, noninfectious, municipal-type waste discarded from healthcare facilities is considered part of the municipal waste stream and is covered by the regulations adopted for the burning of municipal waste. The remaining need, therefore, is to regulate the burning of the infectious waste stream discarded from healthcare facilities, which can be achieved by redefining medical waste in terms of infectious or potentially infectious materials. Thus, the EPA is inclined to narrow the applicability of the proposed regulations by adopting a definition of medical waste that focuses on that portion of the overall medical waste stream that is generally considered infectious or potentially infectious. Given the confusion and number of varying definitions of medical waste, regulated medical waste, infectious waste, etc., at the Federal and State level, and within the healthcare community, transportation sector, etc., EPA does not intend to add to this confusion by creating another definition. As a result, EPA is inclined to adopt a definition of medical waste, for the MWI regulations, from among those already in use. As mentioned, numerous definitions are currently in use, such as the definition of infectious waste created by the U.S. Department of Transportation, the definition of regulated medical waste created by EPA, as well as other definitions created by other regulatory agencies and national associations, such as the Occupational Safety and Health Administration, the New York State Department of Health, the American Hospital Association, etc. While these are just a few of the agencies or associations that have developed definitions of medical waste that are currently in use, they are the ones most often cited or suggested in the public comments. Each of these definitions are slightly different, but all focus on infectious or potentially infectious medical waste. These definitions are discussed in more detail in document number IV-B-25, available in the Docket. For the most part, infectious or potentially infectious wastes are defined through the use of categories or classes of wastes. The classes of wastes most commonly used include: 1. Cultures and stocks of infectious agents; 2. Human pathological wastes; 3. Human blood and blood products; 4. Used sharps; 5. Animal wastes; 6. Isolation wastes; and 7. Unused sharps. These seven waste classes are commonly used by various agencies and associations as the basis for defining medical wastes. However, while the classes of wastes included in two different definitions may be identical, the specific items included under each class and the definitions for these items may be very different. Each agency or association has developed different language to define each of these waste classes in a way that best serves their purposes. For example, some definitions include intravenous (IV) bags under class 3 wastes, while others do not. It appears that adoption of any one of these definitions or any definition at all will be controversial. No uniform or widespread agreement on a definition exists, and for each commenter who argued strongly for adoption of one particular definition, another commenter argued equally strongly for adoption of a different one. Of all these definitions, EPA is inclined to adopt the New York State Department of Health (NYSDOH) definition, which is one of the more recently developed definitions for use in the MWI air pollution emission regulations. This definition was subjected to intense discussion, consideration, and review within the medical and healthcare community. Because it was adopted fairly recently, this definition also benefits from the various controversies and discussions generated by adoption of earlier definitions by other agencies and associations. Further, this definition seems to be among the more comprehensive ones in terms of identifying and defining the various classes of infectious or potentially infectious medical waste mentioned above. The NYSDOH definition includes six of the seven waste classes; isolation wastes (class 6) are not listed as a separate category. The definitions used for waste classes 1, 2, 4, and 7 are similar to those used by the MWTA definition. As with the AHA definition, the NYSDOH definition differs from the MWTA definition in the specifics of class 3 wastes. Class 3 waste under the NYSDOH definition does not include items caked with dried blood or IV bags. These wastes are included in the MWTA definition of class 3 waste. The definitions for class 5 waste only includes wastes from animals exposed to infectious agents during research, the production of biologicals, or the testing of pharmaceuticals. Pathological waste from veterinary facilities is excluded from the MWTA definition. The NYSDOH defines class 5 wastes as wastes from animals known to be contaminated with infectious agents or from animals inoculated during research, the production of biologicals, or pharmaceutical testing. Unlike the MWTA definition, the NYSDOH definition seems to include some wastes (from animals contaminated with infectious agents) generated by general veterinary practices. The specifics of this definition are included in item IV-J-078 in the docket). Also, as stated at proposal, the EPA is inclined to exclude crematories and incinerators used solely for burning pathological waste (human or animal remains and tissues) from the medical waste incinerator regulation. However, MWI that burn animal and pathological waste co-mingled with other classes of medical waste would be subject to the regulation. Because MWI that burn mixtures of medical and pathological (or animal) waste would be covered by the regulation, it is necessary to include a description of pathological and animal waste in the definition of medical waste. Human pathological waste and animal waste are included in the NYSDOH definition of medical waste. In addition, the EPA is inclined to exclude from the regulation incinerators used solely for burning ``off-spec'' or ``out of date'' drugs or pharmaceuticals, as well as incinerators used solely for burning radio-active type medical wastes. In other words, as several comments suggested, the EPA is inclined to treat these wastes in a manner similar to pathological waste. While EPA is inclined to exclude these types of wastes from the regulation for MWI, this exclusion does not mean that EPA will not develop regulations which will cover these wastes. The Clean Air Act clearly directs the EPA to develop regulations to cover burning of these wastes. Thus, this inclination to exclude them is only to temporarily defer regulation. The Clean Air Act directs the EPA to develop regulations for all solid waste incinerators, and burning these wastes will be covered by regulations developed within the next few years. The Clean Air Act also directs the EPA to announce a schedule for development [[Page 31753]] of these other regulations, and the EPA has announced these regulations will be developed by the year 2000. I. Pyrolysis Units Incineration is only one of several medical waste treatment technologies. Other treatment technologies, such as autoclaves, microwaves, and chemical treatment, where there is clearly no combustion occurring, are referred to in this notice as ``alternative technologies'' and are discussed further in Section II.J. These ``alternative technologies'' clearly are not subject to MWI regulations. On the other hand, some medical waste treatment technologies employ plasma or gasification processes (i.e., pyrolysis). Because it appears that at least some combustion is taking place in these devices, EPA considered these pyrolysis technologies covered by the proposed MWI regulations. Comments from the vendors of pyrolysis technologies indicated they believed they could easily meet the emission limitations included in the proposed MWI standards and guidelines. However, they believed that their processes are unique enough to warrant a separate category for regulation. The vendors were particularly concerned that the proposed compliance and monitoring requirements for MWI do not apply to pyrolysis technologies. The proposal, therefore, requested comment on whether pyrolysis units should be regulated as MWI or as a separate source category. Numerous comments and suggestions were received following proposal from vendors of pyrolysis treatment technologies. Based on these comments and suggestions, a draft regulation for pyrolysis treatment technologies has been developed and is available in the docket as item IV-B-56. This draft regulatory text is incomplete at this time. It includes placeholders and requests for information where such information is lacking. Comments are requested to help EPA fill in this missing information. A separate regulation for pyrolysis treatment technologies would look very similar to the MWI regulation in that it would contain definitions, emissions limitations, monitoring and testing requirements to demonstrate compliance, and reporting and recordkeeping requirements. It would differ from the MWI regulations in that some definitions would be different, the emission limitations would, in many cases, be more stringent than the MWI regulations, and the monitoring and testing requirements would reflect the operating parameters that are unique to pyrolysis systems. The EPA is inclined to adopt separate regulations for pyrolysis treatment technologies. The EPA specifically requests comment on the merits of continued development of separate regulations for pyrolysis systems. These systems appear to be very different than incinerators. Because they are emerging technologies, however, the normal process of determining a MACT floor and MACT for these systems is not possible at this time. In fact, because they appear to be inherently clean technologies, regulation of these systems may not be warranted at this time. J. Alternative Medical Waste Treatment Technologies In the proposal, it was estimated that many owners of existing onsite MWI would discontinue use of their existing MWI in favor of less expensive medical waste disposal options to avoid the high cost of add- on air pollution control equipment. In addition, many facilities that would have chosen to purchase a new onsite MWI were estimated to be likely to choose some other method of waste disposal. This phenomenon was labeled as ``switching'' in the proposal, and it has already occurred in a few States that have adopted stringent MWI regulations in the past few years. Next to onsite incineration, the two most common methods of medical waste disposal are (1) offsite contract disposal, which usually involves larger, commercial incinerators dedicated to medical waste and (2) onsite alternative medical waste treatment technologies, which include steam autoclaving, chemical treatment, and microwave irradiation. Because the MWI regulation may encourage switching and the use of onsite alternatives, the possible impacts of other waste disposal methods were assessed. Although autoclaves, chemical treatment systems, and microwave systems are not covered by the MWI standards and guidelines, commercial medical waste incinerators would be subject to the MWI standards and guidelines. Following proposal, new data on commercial disposal facilities throughout the U.S. were obtained. Information on the costs of commercial disposal for medical waste generators in both urban and rural locations was obtained. Also, information on the environmental impacts of increased transportation of medical waste was developed. This new information pertaining to commercial disposal was factored into the economic and environmental impacts analyses presented in Sections III and IV of this notice. The remainder of this section will focus on information relating to nonincineration alternative technologies (i.e., autoclaves, chemical treatment, microwave irradiation, etc.). During the public comment period following proposal, several concerns were raised regarding the availability, effectiveness, costs, and environmental impacts of onsite alternative treatment technologies. Concerns were also raised regarding alternative technology operator safety and State acceptance of alternative technologies. Because of the concerns raised during the public comment period, the Agency has examined the available information on the effects that switching from onsite incineration to alternative technologies could have on medical waste generators and the environment. Following proposal, a great deal of information on alternative technologies was received. This information was compiled and is presented in document No. IV-B-43. The material presented in document IV-B-43 should not be considered an in-depth study of alternative technologies. Instead, it is a review of the available information. Based on this information, there appears to be no significant or substantial adverse economic, environmental, or health and safety issues associated with the increased use of these nonincineration alternative medical waste treatment technologies. The most widely used nonincineration alternative technologies are autoclaves, chemical treatment systems, and microwave systems. In autoclaves, the effects of heat from saturated steam and increased pressure are used to decontaminate the medical waste. In chemical treatment systems, an antimicrobial chemical, such as sodium hypochlorite, chlorine dioxide, or peracetic acid, is used to decontaminate the waste. In microwave technologies, medical waste is wetted and heated to decontaminating temperatures with microwave irradiation. Most alternative technologies are equipped with a shredder or grinder that is used to reduce the volume of the waste by up to 80 percent and render the waste unrecognizable. In some alternative technologies, the waste is compacted, and the waste volume is reduced by 50 percent. With most alternative technologies, the mass of the waste is not reduced due to the entrainment of liquids that are added during treatment. Because shredding or grinding pathological and animal waste may present aesthetically [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-15585. Public record. Not legal advice.