[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Proposed Rules]
[Pages 10654-10691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3045]




[[Page 10653]]

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Part II





Environmental Protection Agency





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40 CFR Part 60



Standards of Performance for New Stationary Sources and Emission 
Guidelines for Existing Sources: Medical Waste Incinerators; Proposed 
Rule

Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / 
Proposed Rules
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[[Page 10654]] 


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[AD-FRL-5150-9]
RIN 2060-AC62


Standards of Performance for New Stationary Sources and Emission 
Guidelines for Existing Sources: Medical Waste Incinerators

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed standards and guidelines, and notice of public 
hearing.

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SUMMARY: Today, EPA is proposing standards and guidelines for new and 
existing medical waste incinerators (MWI's) that will reduce air 
pollution from MWI's. Once implemented, these standards and guidelines 
will protect public health by reducing exposure to air pollution.
    This proposal would add subparts Ec and Cc to 40 CFR part 60. 
Subpart Ec would limit emissions from new and modified MWI's. The 
proposed standards would implement sections 111(b) and 129 of the Clean 
Air Act (Act) as amended in 1990, and would require new MWI's to 
control emissions of air pollutants to levels that reflect the degree 
of emission reduction based on maximum achievable control technology 
(MACT). In addition, this notice includes proposed standards for 
fugitive fly ash/bottom ash emissions, MWI operator training and 
qualification, siting, and permitting.
    Subpart Cc would establish emission guidelines and compliance 
schedules for use by States in developing State regulations to control 
emissions from existing MWI's. The proposed emission guidelines 
implement sections 111(d) and 129 of the Act, and would initiate State 
action to develop State regulations. These State regulations would 
control air pollutant emissions from existing MWI's to levels that 
reflect the degree of emission reduction based on MACT. In addition, 
this notice includes proposed guidelines for fugitive fly ash/bottom 
ash emissions, equipment inspections, training and qualification of MWI 
operators and permitting.

DATES: Comments. Comments must be received on or before April 28, 1995.
    Public Hearing. The EPA will hold at least one public hearing in 
Washington, D.C. in mid- to late-March 1995. Additional hearings may 
also be held. A Federal Register notice will be published within the 
next 2 weeks to announce the details of the hearing(s) and to confirm 
the date(s) and location(s) for the hearing(s).

ADDRESSES: Comments. Comments on the proposal should be submitted (in 
duplicate, if possible) to: 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.
    Commenters wishing to submit proprietary information for 
consideration should clearly distinguish such information from other 
comments, and clearly label it ``Confidential Business Information.'' 
Submissions containing such proprietary information should be sent 
directly to the following address, and 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. EPA 
Confidential Business Manager, 411 W. Chapel Hill Street, Room 944, 
Durham, North Carolina 27701. 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 by the 
EPA, the submission may be made available to the public without further 
notice to the commenter.
    Background Information Documents. Two ``Fact Sheets'' are available 
that succinctly summarize the proposed standards and guidelines. The 
Fact Sheets are suggested reading for persons requiring an overview of 
the proposal. The Fact Sheets can be obtained by (1) calling Ms. Julia 
Latta at (919) 541-5578 or (2) accessing the EPA's Technology Transfer 
Network (TTN) electronic bulletin board. See SUPPLEMENTARY INFORMATION 
for instructions on accessing the TTN (electronic bulletin board). The 
background information documents (BID's) for the proposed standards and 
guidelines may be obtained from the docket; from the U.S. EPA Library 
(MD-35), Research Triangle Park, North Carolina 27711, telephone number 
(919) 541-2777; or from the National Technical Information Services, 
5285 Port Royal Road, Springfield, Virginia 22161, telephone number 
(703) 487-4650. See SUPPLEMENTARY INFORMATION for a listing of these 
documents.
    Docket. Docket No. A-91-61, containing supporting information used 
in developing the proposed 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.

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. EPA, Research Triangle Park, North Carolina 27711.

SUPPLEMENTARY INFORMATION: Incineration is a common method of medical 
waste disposal in the United States and around the world. However, 
while it is a very effective method of medical waste treatment with 
regard to rendering waste non-infectious, incineration results in the 
production of air pollutants. The EPA estimates that there are about 
3,700 MWI's currently in operation in the United States. While these 
incinerators are small in size relative to municipal waste combustors, 
their large number makes MWI's a significant source of air pollution. 
The EPA recently released a draft report reassessing the health effects 
of exposure to dioxin. In the draft report, currently undergoing public 
review, MWI's are identified as a significant source of dioxin 
emissions. In addition, MWI's emit substantial quantities of hydrogen 
chloride (HCl), lead (Pb), cadmium (Cd), and mercury (Hg).
    Today's proposed standards and guidelines will result in greater 
than 95 percent reduction in air pollution from MWI's. Once 
implemented, these standards and guidelines will protect public health 
by reducing exposure to air pollution.
    The EPA, the Sierra Club, and the Natural Resources Defense Council 
(NRDC) have 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 
requires the EPA Administrator to sign a notice of proposed rulemaking 
not later than February 1, 1995 and a notice of final rulemaking not 
later than April 15, 1996.
    The EPA will hold at least one public hearing to provide interested 
parties an opportunity for oral presentation of data, views, or 
arguments concerning the proposal. Additional hearings may also be held 
(see discussion of public hearing above).
    The EPA seeks full public participation in arriving at its final 
decisions and strongly encourages comments on all aspects of this 
proposal from all interested parties. Whenever applicable, full 
supporting data and detailed analysis should accompany all 
[[Page 10655]] comments to allow the EPA to adequately respond to the 
comments.
    The key documents used to develop the proposed standards and 
guidelines include:
    1. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Industry Profile Report for New and 
Existing Facilities,'' EPA-453/R-94-042a, July 1994;
    2. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Process Description Report for New 
and Existing Facilities,'' EPA-453/R-94-043a, July 1994;
    3. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Control Technology Performance 
Report for New and Existing Facilities,'' EPA-453/R-94-044a, July 1994;
    4. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Model Plant Description and Cost 
Report for New and Existing Facilities,'' EPA-453/R-94-045a, July 1994;
    5. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Environmental Impacts Report for New 
and Existing Facilities,'' EPA-453/R-94-046a, July 1994;
    6. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Analysis of Economic Impacts for New 
Sources,'' EPA-453/R-94-047a, July 1994 (see also item 9 below);
    7. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Analysis of Economic Impacts for 
Existing Sources,'' EPA-453/R-94-048a, July 1994 (see also item 9 
below);
    8. ``Medical Waste Incinerators--Background Information for 
Proposed Standards and Guidelines: Regulatory Impact Analysis for New 
and Existing Facilities, EPA-453/R-94-063a, July 1994 (see also item 9 
below); and
    9. B. Strong and S. Shoraka-Blair, MRI, to R. Copland, EPA/ESD. 
January 30, 1995. Regulatory Impacts of the Proposed New Source 
Performance Standard (NSPS) and Emission Guidelines (EG) for Medical 
Waste Incinerators (MWI's). Docket A-91-61, II-B-108.
    An electronic copy of the items listed below are available from the 
EPA's TTN electronic bulletin board. The TTN is accessible 24 hours per 
day, 7 days per week, except Monday morning from 8:00 a.m. to 12:00 
p.m. EST, when the system is updated. The TTN contains 12 electronic 
bulletin boards, and information relating to this proposal is contained 
in the Clean Air Act Amendments (CAAA) bulletin board. Instructions for 
accessing the TTN can be obtained by calling (919) 541-5384.

MWI Items in the Electronic Bulletin Board (TTN/CAAA)

    1. Fact Sheet--Proposed subpart Ec Emission Standards for New 
MWI's.
    2. Fact Sheet--Proposed subpart Cc Emission Guidelines for Existing 
MWI's.
    3. This Federal Register notice (preamble).
    4. Proposed subpart Ec Emission Standards.
    5. Proposed subpart Cc Emission Guidelines.
    Other technical documents, including the key documents listed under 
the SUPPLEMENTARY INFORMATION section, are contained in Docket No. A-
91-61.
    The following outline is provided to aid in locating information in 
this notice (the preamble to the proposed standards and guidelines):

I. Introduction
    A. Overview of this Preamble
    B. New Source Performance Standards (NSPS)--General
    C. NSPS Decision Scheme
    D. Emission Guidelines--General Goals
    E. Additional Requirements Under Section 129
II. Summary of the Standards and Guidelines
    A. Source Category to be Regulated
    B. Pollutants to be Regulated
    C. Affected Facility and Designated Facility
    D. Proposed Standards and Guidelines
    E. Operator Training and Qualification Requirements
    F. Siting Requirements--New MWI's
    G. Inspection Requirements--Existing MWI's
    H. Compliance and Performance Test Methods and Monitoring 
Requirements
    I. Reporting and Recordkeeping--New MWI's
    J. Reporting and Recordkeeping--Existing MWI's
    K. Compliance Times
    L. Permit Requirements
III. Impacts of the Proposed Standards for New MWI's
    A. Air Impacts
    B. Water and Solid Waste Impacts
    C. Energy Impacts
    D. Control Cost Impacts
    E. Economic Impacts
IV. Impacts of the Proposed Guidelines for Existing MWI's
    A. Air Impacts
    B. Water and Solid Waste Impacts
    C. Energy Impacts
    D. Control Cost Impacts
    E. Economic Impacts
V. Rationale for the Proposed Standards and Guidelines
    A. Background
    B. Selection of Source Category
    C. Modification of Existing MWI's
    D. Selection of Pollutants
    E. Selection of Affected and Designated Facilities
    F. Selection of Format for the Proposed Standards and Emission 
Guidelines
    G. Selection of Classes, Types, and Sizes
    H. Performance of Technology
    I. MACT Floor and MACT for New MWI's
    J. MACT Floor and MACT for Existing MWI's
    K. Selection of Fugitive Fly Ash/Bottom Ash Standards and 
Guidelines
    L. Operator Training and Qualification Requirements
    M. Siting Requirements--New MWI's
    N. Inspection Requirements--Existing MWI's
    O. Compliance and Performance Test Methods and Monitoring 
Requirements
    P. Reporting and Recordkeeping--New MWI's
    Q. Reporting and Recordkeeping--Existing MWI's
    R. Compliance Times
    S. Permit Requirements
VI. Request for Comment
    A. Procedure to Determine MACT
    B. Alternatives to Onsite Incineration
    C. Definition of Medical Waste
VII. Administrative Requirements
    A. Public Hearing
    B. Docket
    C. Clean Air Act Procedural Requirements
    D. Office of Management and Budget Reviews
    E. Regulatory Flexibility Act Compliance

I. Introduction

A. Overview of This Preamble

    The 1990 Clean Air Act Amendments reflect growing public concern 
about the large volume of toxic air pollutants released from numerous 
categories of emission sources. Title III of the Amendments 
specifically enumerated 189 hazardous air pollutants and instructed EPA 
to protect public health by reducing emissions of these pollutants from 
the sources that release them. The EPA's standards are to be issued in 
two phases. The first phase standards are designed to bring all sources 
up to the level of emissions control achieved by those that are already 
well-controlled, using pollution prevention measures as well as ``end-
of-pipe'' methods. The second phase standards, due approximately a 
decade later, are to require further emission reductions in any case in 
which the first phase measures were not by themselves sufficient to 
fully protect the public health.
    In this context, the 1990 Amendments singled out waste incineration 
for special attention. Congress recognized both a high level of public 
concern about the incineration of municipal, medical and other wastes, 
and a number of special management concerns for these types of sources. 
Consequently, section 129 of the Act directs EPA to apply the two-phase 
control approach of Title III to various categories of waste 
incinerators, including medical waste [[Page 10656]] incinerators. 
Today's action proposes standards and guidelines for new and existing 
MWI's under section 129.
    Current methods of medical waste incineration cause the release of 
a wide array of air pollutants, including several pollutants of 
particular public health concern. In September of 1994, EPA released a 
review draft of a report reassessing the health effects associated with 
dioxin, which suggests that dioxin exposure can result in a number of 
cancer and noncancer health effects in humans. In the report, MWI's are 
identified as the largest known source of dioxin emissions, emitting 
more than municipal waste combustors, hazardous waste incinerators, and 
cement kilns. Because of this, the reduction of dioxin emissions from 
all sources is one of the Administrator's highest air quality 
protection priorities. Consequently, the development of MWI regulations 
has received increased attention.
    In addition to dioxin, MWI's also emit significant quantities of 
heavy metals including lead, cadmium, and mercury. Once again, MWI's 
have been identified as the largest known source of mercury emissions, 
emitting more than municipal waste combustors and coal-fired electric 
utility boilers. The MWI's also emit nitrogen oxides (a contributor to 
ozone smog), particulate matter, sulfur dioxide, and other acid gases.
    Several States, including New York, California, and Texas, have 
adopted relatively stringent regulations in the past few years limiting 
emissions from MWI's. The implementation of these regulations has 
brought about very large reductions in MWI emissions and the associated 
risk to public health in those States. It has also significantly 
reshaped how medical waste is managed in those States. Many facilities 
have responded to the State regulations by switching to other medical 
waste treatment and disposal options to avoid the high cost of add-on 
air pollution control equipment. The two most commonly chosen 
alternatives have been off-site contract disposal in larger, commercial 
incinerators dedicated to medical waste, and on-site treatment by other 
means (e.g., steam autoclaving). Other alternatives include chemical 
treatment and microwave irradiation. The availability of alternatives 
to onsite incineration has mitigated the economic impacts that might 
have been associated with the State regulations.
    Today EPA proposes nationally applicable emission standards and 
guidelines for MWI's that build on the experience of these leading 
States. Like the State regulations, the standards and guidelines 
proposed today are based on the use of add-on air pollution control 
systems.
    These standards and guidelines will implement the first phase 
requirements of section 129, described above.
    The commercial medical waste disposal industry has indicated that 
sufficient commercial medical waste disposal capacity is available to 
handle the amount of waste that would no longer be treated onsite. In 
addition, as mentioned earlier, onsite alternatives are available for 
facilities that choose to treat their medical waste onsite. In fact, 
even in the absence of Federal regulations, most facilities that 
generate medical waste do not operate onsite MWI's. This indicates that 
there currently are viable alternatives to onsite incineration.
    As described in detail below, section 129, like section 112, of the 
Clean Air Act instructs the Agency to set performance standards that 
challenge industry to meet or exceed the pollution control standards 
established by better controlled similar facilities. In this way, the 
overall state of environmental practice is raised for large segments of 
industry, a basic level of health protection is provided to all 
communities, situations in which uncertainty about total risk and 
hazard result in no protection for the exposed public are avoided, and 
yet the cost of pollution control to industry is constrained to levels 
already absorbed by similar operations. Eight years later, in a second 
phase, EPA must evaluate whether the residual public health risk 
warrants additional control.
    For new MWI's, the proposed emissions standards would reduce 
nationwide emissions of dioxins/furans by 99 percent; PM, CO, HCl, Pb, 
and Cd by greater than 95 percent; and Hg by 92 percent. In addition, 
the standards would achieve an emission reduction of about 25 percent 
for SO<INF>2 and NO<INF>x. Because wastewater, solid waste, and energy 
requirements associated with implementation of the proposed standards 
are not significant, adverse water, solid waste, or energy impacts are 
not anticipated.
    The nationwide annual costs associated with the proposed standards 
for new MWI's will increase by approximately $74.5 million/yr from the 
regulatory baseline cost of $63.3 million/yr. This results in an 
increase in the cost of waste incineration per unit of waste treated of 
approximately $177/Mg ($161/ton) compared to the regulatory baseline 
cost of $150/Mg ($136/ton).
    The results of the economic impacts analyses for new MWI's indicate 
that no medical waste-generating industry would need to be 
significantly reconstructed (e.g., through closures or consolidations) 
as a result of the proposed standards. The market price increase 
resulting from the standards is relatively small for each industry. The 
corresponding decreases in output, employment, and revenue were also 
low, never exceeding 0.05 percent.
    With regard to existing MWI's, an estimated 3.4 million tons of 
waste are produced annually by medical waste generators in the United 
States. The EPA believes that approximately 3,700 MWI's are currently 
burning waste generated at health care facilities. The proposed 
guidelines for existing MWI's would reduce nationwide emissions of 
dioxins/furans and Pb by 99 percent; PM, CO, and HCl by 98 percent; Cd 
by 97 percent; and Hg by 94 percent. The guidelines would also achieve 
an overall emission reduction of 37 percent for both SO<INF>2 and 
NO<INF>x. Because wastewater, solid waste, and energy requirements 
associated with implementation of the proposed guidelines are not 
significant, adverse water, solid waste, or energy impacts are not 
anticipated.
    The nationwide annual costs associated with the proposed guidelines 
for existing MWI's will increase by approximately $351 million/yr from 
the regulatory baseline cost of $265 million/yr. This results in an 
increase in the cost of waste incineration per unit of waste treated of 
approximately $245/Mg ($222/ton) compared to the regulatory baseline 
cost of $185/Mg ($168/ton).
    The results of the economic impacts analyses for existing MWI's 
indicate that no medical waste-generating industry would need to be 
significantly restructured (e.g., through closures or consolidations) 
as a result of the proposed emission guidelines. The market price 
increase resulting from the emission guidelines is relatively small for 
each industry. The corresponding decreases in output, employment, and 
revenue were also low, never exceeding 1 percent.
    Considering the benefits to be gained from the reduction of air 
pollution from MWI's along with the availability of alternative 
treatment methods and the clear Congressional intent, these proposed 
standards and guidelines are considered reasonable.
    This preamble will:
    1. Summarize the important features of the proposed standards and 
guidelines;
    2. Describe the environmental, energy, and economic impacts of 
these standards and guidelines; [[Page 10657]] 
    3. Present a rationale for each of the decisions made regarding the 
proposed standards and guidelines;
    4. Request public comment on specific issues; and
    5. Discuss administrative requirements relevant to this action.

B. New Source Performance Standards--General

    The proposed new source performance standards (NSPS, or 
standard(s)) for MWI's would implement section 111(b) of the Act. The 
NSPS are issued for categories of sources that cause, or contribute 
significantly to, air pollution that may reasonably be anticipated to 
endanger public health or welfare. They apply to new stationary sources 
of emissions (i.e., sources whose construction or modification begins 
after a standard is proposed). An NSPS requires these sources to 
control emissions to the level achievable by the best system of 
continuous emission reduction, considering costs and other impacts.

C. NSPS Decision Scheme

    An NSPS is the end product of a series of decisions related to 
certain key elements for the source category being considered for 
regulation. The elements in this decision are generally the following:
    1. Source category to be regulated--usually an emission source 
category, but can be a process or group of processes within an 
industry.
    2. Affected facility--the pieces or groups of equipment that 
comprise the sources to which the standards will apply.
    3. Pollutants to be regulated--the particular substances emitted by 
the affected facility that the standards control.
    4. Best system of continuous emission reduction--the technology on 
which the standards will be based, i.e., application of the best system 
of continuous emission reduction that (taking into consideration the 
cost of achieving such emission reduction and any nonair-quality health 
and environmental impacts and energy requirements) the Administrator 
determines has been adequately demonstrated (section 111(a)(1)).
    5. Format for the standards--the form in which the standards are 
expressed, i.e., as pollutant concentration emission limits, as a 
percent reduction in emissions, or as equipment or work practice 
standards.
    6. Actual standards--generally, emission limits based on the level 
of reduction that the best demonstrated technology (BDT) can achieve. 
Only in unusual cases do standards require that a specific technology 
be used. In general, the source owner or operator may select any method 
for complying with the standards.
    7. Other considerations--(in addition to emission limits) NSPS 
usually include: standards for visible emissions, modification 
provisions, monitoring requirements, performance test methods and 
compliance procedures, and reporting and recordkeeping requirements.

D. Emission Guidelines--General Goals

    The Act requires the promulgation of standards of performance under 
section 111(b) for categories of new sources that may contribute to the 
endangerment of public health or welfare. When standards of performance 
are promulgated under section 111(b) for a designated pollutant, the 
Act requires States under section 111(d) to submit plans that: (1) 
establish emission standards for this designated pollutant from 
existing sources and (2) provide for implementation and enforcement of 
these emission standards. In most cases, this means that control under 
section 111(d) is appropriate when the pollutant may cause or 
contribute to endangerment of public health or welfare but is not known 
to be ``hazardous'' within the meaning of section 112 and is not 
controlled under sections 108 through 110 because, for example, it is 
not emitted from ``numerous or diverse'' sources as required by section 
108.
    As specified in 40 CFR part 60.23, States are required to adopt and 
submit to the Administrator a plan implementing the section 111(d) 
guidelines within 1 year after the promulgation of the guidelines. The 
Act further requires that the procedure for State submission of a plan 
shall be similar to the procedure for submission of State 
implementation plans (SIP's) under section 110. The Act also provides 
that the EPA shall prescribe a plan according to procedures similar to 
those in section 110(c) if a State fails to submit a ``satisfactory 
plan.''

E. Additional Requirements Under Section 129

    The Amendments of 1990 added section 129, which includes specific 
requirements for solid waste combustion units. Section 129 requires the 
EPA, under Sec. 111(b), to establish new source performance standards 
(NSPS) for new MWI's and, under Sec. 111(d), to establish emission 
guidelines for existing MWI's.
    1. New Sources The NSPS must specify numerical emission limitations 
for the following: Particulate matter (PM), opacity, sulfur dioxide 
(SO<INF>2), hydrogen chloride (HCl), oxides of nitrogen (NO<INF>X), 
carbon monoxide (CO), lead (Pb), cadmium (Cd), mercury (Hg), and 
dioxins/furans (CDD/CDF). Section 129 also includes requirements for 
operator training as well as siting requirements for new MWI's.
    Section 129 requires that emission standards reflect the maximum 
degree of reduction in air emissions that the Administrator, taking 
into consideration the cost of achieving such emission reduction, and 
any nonair-quality health and environmental impacts and energy 
requirements, determines is achievable. This requirement is referred to 
as maximum achievable control technology (MACT). The degree of 
reduction in emissions that is deemed achievable for new MWI's may not 
be less stringent than the emissions control that is achieved in 
practice by the best controlled similar unit. This requirement that the 
standards must be no less stringent than certain levels of emission 
control currently achieved is referred to as the ``MACT floor'' for new 
MWI's.
    For NSPS, the control technology used to achieve the standards is 
not specified. Only the emission limits achievable by MACT are included 
in the standards. Any control technology that can comply with these 
emission limits may be used.
    2. Existing Sources Notwithstanding the limitations of setting 
guidelines for existing sources under section 111(d), section 129 
directs EPA to issue guidelines for existing MWI's that specify 
numerical emission limitations for the same pollutants listed above for 
new MWI's. Section 129 also includes requirements for operator 
training.
    Section 129 provides that the State plan for existing MWI's be at 
least as protective as the guidelines.
    Section 129 also provides that emission guidelines for existing 
MWI's reflect MACT, as described above. However, while the guidelines 
for existing MWI's may be less stringent than the standards for new 
MWI's, the guidelines may be no less stringent than the average 
emission limitation achieved by the best performing 12 percent of units 
in the category. This requirement that the guidelines must be no less 
stringent than certain levels of emission control currently achieved is 
referred to as the ``MACT floor'' for existing MWI's.
    For emission guidelines (EG), the control technology used for 
compliance is not specified. Only the emission limits achievable by 
MACT are included in the guidelines. Any control 
[[Page 10658]] technology that can comply with these emission limits 
may be used.
    Under section 129, States are required to submit to the 
Administrator a plan implementing the emission guidelines within 1 year 
after promulgation of the guidelines. Section 129 also requires that a 
State plan shall provide that each unit subject to the guidelines shall 
be in compliance with all requirements of the proposed guidelines 
within 3 years after the State plan is approved by the Administrator 
but in no case later that 5 years after promulgation of these 
guidelines. The compliance schedule in today's proposed emission 
guidelines would supersede and is more comprehensive than the 
compliance schedule and timetable specified in section 129.
    The proposal requires that a State plan shall provide that each 
source subject to the guidelines shall be in compliance with all 
requirements of the guidelines within 1 year after the State plan is 
approved by the Administrator. The proposal allows two exceptions to 
this compliance schedule: extensions for facilities planning to install 
the necessary air pollution equipment and extensions under a petition 
process for other reasons. State plans that include such provisions may 
allow designated facilities up to 3 years after the State plan is 
approved by the Administrator (but no more than 5 years after 
promulgation of the guidelines) to achieve compliance. The only 
exception to these compliance times involves the operator training and 
qualification requirements and the maintenance inspection requirement. 
The proposed emission guidelines require that a State plan provide that 
each designated facility shall be in compliance with the operator 
training and qualification requirements and the maintenance inspection 
requirements within 1 year after the State plan is approved by the 
Administrator.
    Section 129 specifies that the EPA, in reviewing State plans for 
any variation from the emission guidelines, must ensure that State 
plans and their resulting MWI control requirements are at least as 
protective as the EPA emission guidelines, including incorporation of 
the compliance schedule requirements established by the guidelines.

II. Summary of the Standards and Guidelines

A. Source Category To Be Regulated

    The proposed standards for new MWI's would limit emissions of air 
pollutants from each MWI for which construction is commenced after 
today's date, or for which modification is commenced after the 
effective date of the standards. The effective date of the proposed 
standards is specified in the Act as the date 6 months after 
promulgation of the standards. The proposed guidelines for existing 
MWI's would require States to develop emission standards limiting 
emissions of air pollutants from each MWI for which construction was 
commenced on or before today's date. Changes made to an existing MWI 
solely for the purpose of complying with the emission guidelines would 
not bring an existing MWI under the NSPS for new MWI's.
    The proposed standards and guidelines would require facilities that 
employ technologies such as pyrolysis/gasification in medical waste 
destruction to meet the emission limits and all other requirements in 
today's proposal. The pyrolysis/gasification industry does not object 
to be covered under today's proposed MWI standards and guidelines and 
believes that they can meet and exceed the proposed emission 
limitations. However, the pyrolysis/gasification industry believes that 
their process is unique enough to warrant a separate category for the 
purpose of regulations. The agency is requesting comment on whether 
these units should be regulated as MWI's or as a separate source 
category. Also, comment is requested on the definitions of medical 
waste incineration and medical waste pyrolysis/gasification that would 
differentiate these two categories of waste destruction for the purpose 
of regulation.
    An MWI is defined as any device used to burn medical waste, with or 
without other fuels or types of waste, including the heat recovery 
device, if one is present. Medical waste is 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 production or 
testing of biologicals. Biologicals refer to preparations made from 
living organisms and their products, including vaccines, cultures, 
etc., intended for use in diagnosing, treating, or immunizing humans or 
animals or in research pertaining thereto. Medical waste includes 
materials such as sharps, fabrics, plastics, paper, waste chemicals/
drugs that are not RCRA hazardous waste, and pathological waste. 
Medical waste does not include household waste, hazardous waste, or 
human and animal remains not generated as medical waste.
    Most MWI's burn a diverse mixture of medical waste (referred to in 
this preamble as general medical waste), that may include some 
pathological waste (human and animal body parts and/or tissue). 
However, larger amounts of pathological waste require special operating 
conditions for combustion. Thus, some facilities maintain MWI's 
designed and operated to burn pathological waste exclusively.
    The proposed standards and guidelines focus on regulating emissions 
from general medical waste incinerators and include very minor 
requirements for pathological MWI's. Under this proposal, pathological 
MWI's would only be required to submit quarterly reports of the amount 
and type of materials charged to the incinerator. Pathological MWI's 
will be considered in future regulatory action under section 129 in the 
source category of ``other solid waste incinerators.''

B. Pollutants To Be Regulated

    Section 129 of the Act requires the EPA to establish numerical 
emission limits for PM, opacity, CO, CDD/CDF, HCl, SO<INF>2, NO<INF>x, 
Pb, Cd, and Hg. All pollutants to be regulated would be reported as 
concentrations and are corrected to 7 percent oxygen. Particulate 
matter and metals (Pb, Cd, and Hg) would be reported as milligrams per 
dry standard cubic meter (mg/dscm). For Hg, the proposed standards and 
guidelines would also establish an alternative percent reduction 
requirement. Carbon monoxide, HCl, SO<INF>2, and NO<INF>x would be 
reported as parts per million by volume (ppmv), dry basis. As an 
alternative, the proposed standards and guidelines for HCl would also 
establish a percent reduction requirement. Emissions of CDD/CDF would 
be reported in units of total nanograms per dry standard cubic meter 
(ng/dscm) or ng/dscm toxic equivalency (TEQ). Measurements of TEQ are 
determined by first measuring the total concentration of CDD/CDF 
congeners and adjusting the results to account for the varying toxicity 
of each congener. Opacity is reported on a percentage basis. The 
proposed standards and guidelines also establish fly ash/bottom ash 
fugitive emission limitations, reported on a percentage basis.

C. Affected Facility and Designated Facility

    The affected facility to which the proposed standards applies is 
each individual MWI for which construction is commenced after today's 
date or for which modification is commenced after the effective date of 
these standards. The effective date of the proposed standards is 
specified in the Act as the date 6 months after promulgation of the 
standards. [[Page 10659]] 
    The designated facility to which the proposed emission guidelines 
apply is each individual MWI for which construction is commenced on or 
before today's date.

D. Proposed Standards and Guidelines

    Table 1 lists the emission limitations under the proposed standards 
and guidelines, Tables 2 and 3 list other requirements of the proposed 
standards and guidelines, and Tables 4 and 5 list the compliance times 
for the proposed standards and guidelines.

   Table 1.--Summary of Proposed Emission Limits for New and Existing   
                       Medical Waste Incinerators                       
------------------------------------------------------------------------
                     Pollutant                        Emissions limits  
------------------------------------------------------------------------
Particulate matter................................  30 mg/dscm (0.013 gr/
                                                     dscf) 12-hour      
                                                     average.           
Opacity...........................................  5 percent 6-minute  
                                                     average.           
Carbon monoxide...................................  50 ppmv 12-hour     
                                                     average.           
Dioxins/furans....................................  80 ng/dscm total CDD/
                                                     CDF (35 gr/10\9\   
                                                     dscf) or 1.9 ng/   
                                                     dscm TEQ (0.83 gr/ 
                                                     10\9\ dscf) 12-hour
                                                     average.           
Hydrogen chloride.................................  42 ppmv or 97%      
                                                     reduction 9-hour   
                                                     average.           
Sulfur dioxide....................................  45 ppmv 12-hour     
                                                     average.           
Nitrogen oxides...................................  210 ppmv 12-hour    
                                                     average.           
Lead..............................................  0.10 mg/dscm (44 gr/
                                                     10\6\ dscf) 12-hour
                                                     average.           
Cadmium...........................................  0.05 mg/dscm (22 gr/
                                                     10\9\ dscf) 12-hour
                                                     average.           
Mercury...........................................  0.47 mg/dscm (210 gr/
                                                     10\6\ dscf) or 85% 
                                                     reduction 12-hour  
                                                     average.           
------------------------------------------------------------------------
Note: Tables 1 through 5 depict the major provisions of the proposed    
  standards and guidelines and do not attempt to show all requirements. 
  The full text of Subparts Ec and Cc should be relied upon for a full  
  and comprehensive statement of the requirements of the proposed       
  standards and guidelines.                                             


   Table 2.--Summary of Additional Requirements Under the NSPS for New  
                       Medical Waste Incinerators                       
------------------------------------------------------------------------
                         Additional Requirements                        
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:                       
    <bullet> Complete MWI operator training course.                     
    <bullet> Qualify operators.                                         
    <bullet> Develop a site-specific operating manual and update        
     annually.                                                          
Siting Requirements:                                                    
    <bullet> Prepare a siting analysis.                                 
    <bullet> Conduct a public meeting at which comment is accepted on   
     the siting analysis.                                               
    <bullet> Prepare responses to the comments and make them available  
     to the public.                                                     
    <bullet> Include in the initial notification to construct the       
     results of siting analysis and a letter from the State air         
     pollution control office approving the construction and operation  
     of the affected facility.                                          
Compliance and Performance Testing Requirements:                        
    <bullet> Conduct an initial and annual performance test to determine
     compliance with the emission limitations for all pollutants and to 
     establish operating parameters.                                    
    <bullet> Facilities may conduct performance tests for CDD/CDF, PM,  
     Cd, Pb, and Hg every third year if the previous three MWI          
     performance tests demonstrate that the facility is in compliance   
     with the emission limits.                                          
Continuously monitor emissions and measure and record operating         
 parameters.                                                            
    <bullet> Perform monthly fugitive testing.                          
Monitoring Requirements:                                                
    <bullet> Install and maintain equipment to continuously monitor     
     emissions/operating parameters as appropriate.                     
    <bullet> Obtain monitoring data at all times during MWI operation.  
Reporting and Recordkeeping Requirements:                               
    <bullet> Maintain for 5 years records of results from initial       
     performance test and all subsequent performance tests, operating   
     parameters, and any maintenance.                                   
    <bullet> Maintain for the life of the incinerator records of siting 
     analysis and operator training and qualification.                  
    <bullet> Submit the results of the initial performance test and all 
     subsequent performance tests.                                      
    <bullet> Submit, within 30 days following the end of the quarter of 
     occurrence, reports on emission rates or operating parameters that 
     have not been recorded or that exceeded applicable limits.         
    <bullet> Provide notification of intent to construct, of planned    
     initial start-up date, and of planned waste type(s) to be          
     combusted.                                                         
------------------------------------------------------------------------
Note: Tables 1 and 2 depict the major provisions of the NSPS and do not 
  attempt to show all requirements. The regulatory text of Subpart Ec   
  should be relied upon for a full and comprehensive statement of the   
  requirements of the proposed NSPS.                                    


 Table 3.--Summary of Additional Requirements Under the EG for Existing 
                       Medical Waste Incinerators                       
------------------------------------------------------------------------
                         Additional Requirements                        
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:                       
    <bullet> Complete MWI operator training course.                     
    <bullet> Qualify operators.                                         
    <bullet> Develop a site-specific operating manual and update        
     annually.                                                          
Inspection Requirements:                                                
    <bullet> Provide for an annual equipment inspection by an MWI       
     service technician not employed by the owner or operator of the    
     affected facility until source demonstrates compliance with        
     emission limits.                                                   
Compliance and Performance Testing Requirements:                        
    <bullet> Conduct an initial and annual performance test to determine
     compliance with the emission limitations for all pollutants and to 
     establish operating parameters.                                    
[[Page 10660]]
                                                                        
    <bullet> Facilities may conduct performance tests for CDD/CDF, PM,  
     Cd, Pb, and Hg every third year if the previous three performance  
     tests demonstrate that the facility is in compliance with the      
     emission limits.                                                   
    <bullet> Continuously monitor emissions and measure and record      
     operating parameters.                                              
    <bullet> Perform monthly fugitive testing.                          
Monitoring Requirements:                                                
    <bullet> Install and maintain equipment to continuously monitor     
     emissions/operating parameters as appropriate.                     
    <bullet> Obtain monitoring data at all times during MWI operation.  
Reporting and Recordkeeping Requirements:                               
    <bullet> Maintain for 5 years records of: results from initial      
     performance test and all subsequent performance tests, operating   
     parameters, annual inspections, and any maintenance.               
    <bullet> Maintain for the life of the incinerator records of        
     operator training and qualification.                               
    <bullet> Submit the results of the initial performance test and all 
     subsequent performance tests.                                      
    <bullet> Submit, within 30 days following the end of the quarter of 
     occurrence, reports on emission rates or operating parameters that 
     have not been recorded or which exceeded applicable limits.        
------------------------------------------------------------------------
Note: Tables 1 and 3 depict the major provisions of the emission        
  guidelines (EG) and do not attempt to show all requirements. The      
  regulatory text of Subpart Cc should be relied upon for a full and    
  comprehensive statement of the requirements of the proposed           
  guidelines.                                                           


                    Table 4.--Compliance Times for New MWI's New Source Performance Standards                   
----------------------------------------------------------------------------------------------------------------
                    Requirement                                            Compliance Time                      
----------------------------------------------------------------------------------------------------------------
Effective date....................................  6 months after promulgation of NSPS.                        
Operator training and qualification requirements..  On effective date or upon initial start up, whichever is    
                                                     later.                                                     
Initial compliance test...........................  On effective date or within 180 days of initial start up,   
                                                     whichever is later.                                        
Performance test..................................  Within 12 months following initial compliance test and      
                                                     annually thereafter.                                       
CEMS and parameter monitoring.....................  Continuously, upon completion of initial compliance test.   
Recordkeeping.....................................  Continuously, upon completion of initial compliance test.   
Reporting.........................................  Quarterly, upon completion of initial compliance test.      
----------------------------------------------------------------------------------------------------------------


                        Table 5.--Compliance Times for Existing MWI's Emission Guidelines                       
----------------------------------------------------------------------------------------------------------------
                    Requirement                                            Compliance Time                      
----------------------------------------------------------------------------------------------------------------
State Plan submittal..............................  Within 1 year after promulgation of EPA emission guidelines.
Effective date....................................  Within 1 year after EPA approval of State Plan.             
Operator training and qualification requirements..  Within 1 year after EPA approval of State Plan.             
Recordkeeping.....................................  Continuously, upon completion of initial compliance test.   
Initial compliance test...........................  Within 1 year after EPA approval of State plan or up to 3   
                                                     years after EPA approval of State plan if the source is    
                                                     granted an extension.                                      
Performance test..................................  Within 12 months following initial compliance test and      
                                                     annually thereafter.                                       
CEMS and parameter monitoring.....................  Continuously, upon completion of initial compliance test.   
Inspection requirements...........................  Within 1 year after EPA approval of State Plan.             
Reporting.........................................  Quarterly, upon completion of initial compliance test.      
----------------------------------------------------------------------------------------------------------------

  A brief discussion of the emission limitations is presented below. 
Further discussion of the additional requirements can be found in 
sections II.E through II.L of this section.
1. Numerical Emission Limits
    The numerical emission limits in this section are corrected to 7 
percent O<INF>2.
    Particulate Matter--The proposed emission limitation for PM for 
both new and existing MWI's is 30 milligrams per dry standard cubic 
meter (mg/dscm).
    Opacity--The proposed emission limitation for stack opacity for 
both new and existing MWI's is 5 percent (6-minute average).
    Carbon Monoxide--The proposed emission limitation for CO for both 
new and existing MWI's is 50 parts per million by volume (ppmv), dry 
basis.
    Dioxins/Furans--The proposed emission limitation for CDD/CDF for 
both new and existing MWI's is 80 ng/dscm total CDD/CDF or 1.9 ng/dscm 
TEQ. This limit would be measured as total tetra- through octa-
chlorinated dibenzo-p-dioxins and dibenzofurans as determined by 
Reference Method 23 and converted to TEQ's using the toxic equivalency 
factors (TEF's) shown in Table 6.

                   Table 6.--Toxic Equivalency Factors                  
------------------------------------------------------------------------
                                                                Toxic   
                      CDD/CDF congener                       equivalency
                                                                factor  
------------------------------------------------------------------------
2,3,7,8-tetrachlorinated dibenzo-p-dioxin..................       1     
1,2,3,7,8-pentachlorinated dibenzo-p-dioxin................       0.5   
1,2,3,4,7,8-hexachlorinated dibenzo-p-dioxin...............       0.1   
1,2,3,7,8,9-hexachlorinated dibenzo-p-dioxin...............       0.1   
1,2,3,6,7,8-hexachlorinated dibenzo-p-dioxin...............       0.1   
1,2,3,4,6,7,8-heptachlorinated dibenzo-p-dioxin............       0.01  
octachlorinated dibenzo-p-dioxin...........................       0.001 
[[Page 10661]]
                                                                        
2,3,7,8-tetrachlorinated dibenzofuran......................       0.1   
2,3,4,7,8-pentachlorinated dibenzofuran....................       0.5   
1,2,3,7,8-pentachlorinated dibenzofuran....................       0.05  
1,2,3,4,7,8-hexachlorinated dibenzofuran...................       0.1   
1,2,3,6,7,8-hexachlorinated dibenzofuran...................       0.1   
1,2,3,7,8,9-hexachlorinated dibenzofuran...................       0.1   
2,3,4,6,7,8-hexachlorinated dibenzofuran...................       0.1   
1,2,3,4,6,7,8-heptachlorinated dibenzofuran................       0.01  
1,2,3,4,7,8,9-heptachlorinated dibenzofuran................       0.01  
octachlorinated dibenzofuran...............................       0.001 
------------------------------------------------------------------------

  Hydrogen Chloride--The proposed emission limitation for HCl for 
both new and existing MWI's is 42 ppmv, dry basis (or 97-percent 
reduction).
    Sulfur Dioxide--The proposed emission limitation for SO<INF>2 for 
both new and existing MWI's is 45 ppmv, dry basis.
    Nitrogen Oxides--The proposed emission limitation for NO<INF>X for 
both new and existing MWI's is 210 ppmv, dry basis.
    Lead--The proposed emission limitation for Pb for both new and 
existing MWI's is 0.10 mg/dscm.
    Cadmium--The proposed emission limitation for Cd for both new and 
existing MWI's is 0.05 mg/dscm.
    Mercury--The proposed emission limitation for Hg for both new and 
existing MWI's is 0.47 mg/dscm (or 85-percent reduction).
2. Fly Ash/Bottom Ash Emissions
    The proposed standards and guidelines would establish a limit of 
zero percent opacity of fly ash or bottom ash from any fly ash or 
bottom ash storage or handling area within the facility's property 
boundary.

E. Operator Training and Qualification Requirements

    The proposed standards and guidelines include operator training and 
qualification requirements for each MWI operator. For new MWI's, these 
requirements would become effective six months after promulgation of 
the NSPS. For existing MWI's, these requirements would become effective 
one year after approval of the State plan. An acceptable training 
course would provide the operator with a minimum 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. To be qualified, an operator must complete the 
training course and have either a minimum level of experience or 
satisfy comparable or more stringent criteria that are established by a 
national professional organization. The proposed standards and 
guidelines also would require that the owner or operator of the 
facility develop and annually update a site-specific operating manual. 
The manual would summarize State emissions regulations, operating 
procedures, and reporting and recordkeeping requirements in accordance 
with the proposed standards and guidelines.

F. Siting Requirements--New MWI's

    Site selection criteria are being proposed for MWI's that commence 
construction after the date of promulgation of this rule. The proposed 
siting requirements would address the impact of the facility on ambient 
air quality, visibility, soils, vegetation, and other factors that may 
be relevant in determining that the benefits of the proposed facility 
significantly outweigh the environmental and social costs imposed as a 
result of its location and construction. A document presenting the 
results of the analyses would be prepared and submitted to EPA, State, 
and local officials and would be made available to the public. 
Provisions for a public meeting and the preparation of a comment and 
response document are also included in the proposed siting 
requirements.

G. Inspection Requirements--Existing MWI's

    The proposed emission guidelines include a requirement for an 
initial equipment inspection of the designated facility. These 
requirements would become effective 1 year after the EPA approval of 
the State plan. The inspection must be performed by an MWI service 
technician not employed by the owner or operator of the designated 
facility. The proposed guidelines provide minimum requirements for 
inspection of the designated facility. Following the initial inspection 
and until compliance with the emission limitations has been 
demonstrated, facilities are required to conduct annual inspections of 
the MWI.

H. Compliance and Performance Test Methods and Monitoring Requirements

    Testing and monitoring requirements are proposed to demonstrate 
compliance with the emission limits. The proposed standards and 
guidelines require that the owner or operator of the facility: (1) 
conduct initial and annual performance tests to demonstrate compliance 
with the emission limits and (2) demonstrate continuous compliance with 
the emission limits following the initial performance test.
    The initial and annual performance tests would be conducted using 
the following EPA-approved methods:
    1. Method 1 would be used to select the sampling site and number of 
traverse points;
    2. Method 3 or 3A would be used for gas composition analysis, 
including measurement of oxygen;
    3. Method 5 or Method 29 would be used to measure PM emissions;
    4. A continuous emissions monitoring system (CEMS) would be used to 
measure opacity;
    5. A CEMS would be used to measure CO emissions;
    6. Method 23 would be used to measure CDD/CDF emissions;
    7. Method 26 would be used to measure HCl emissions;
    8. Method 29 would be used to measure Pb, Cd, and Hg emissions; and
    9. Method 9 would be used to measure opacity of fugitive emissions.
    The proposed standards and guidelines include provisions for less 
frequent testing if the facility consistently demonstrates compliance. 
These provisions are described in detail in section V of this preamble. 
Following the initial performance test, the owners or operators must 
demonstrate continuous compliance with the limits by monitoring the 
output of a CEMS, where a CEMS is required, and by monitoring site-
specific operating parameters where a CEMS is not required. Facilities 
are required to:
    1. Demonstrate continuous compliance with the CO emission limit 
based on the output from the CO CEMS;
    2. Demonstrate continuous compliance with the opacity emission 
limit based on the output from the opacity CEMS; and
    3. Demonstrate compliance with the fugitive emission limit by 
conducting a performance test using Method 9 at least once per calendar 
month when ash is removed from the incinerator and when ash is removed 
from the air pollution control device (APCD).
    In addition, facilities equipped with a dry scrubber followed by a 
fabric filter are required to demonstrate compliance in the following 
ways: [[Page 10662]] 
    1. Demonstrate compliance with the Hg emission limit by 
continuously monitoring the Hg sorbent flow rate (typically activated 
carbon) and continuously measuring the weight and time of each load of 
waste charged to the incinerator. The minimum Hg sorbent flow rate, the 
maximum charge weight, and the maximum hourly charge rate are to be 
established during the initial performance test to determine compliance 
with the Hg emission limit. Operation of the facility below the minimum 
sorbent flow rate, or above the maximum charge weight or maximum hourly 
charge rate would constitute a violation of the Hg emission limit.
    2. Demonstrate compliance with the CDD/CDF emission limit by 
continuously monitoring the CDD/CDF sorbent flow rate (typically 
activated carbon) and the temperature measured at the inlet to the PM 
control device. The minimum CDD/CDF sorbent flow rate and the maximum 
PM control device inlet temperature are to be established during the 
initial performance test to determine compliance with the CDD/CDF 
emission limit. Operation of the facility below the minimum sorbent 
flow rate or above the maximum PM control device inlet temperature 
would constitute a violation of the CDD/CDF emission limit.
    3. Demonstrate compliance with the HCl emission limit by 
continuously monitoring the HCl sorbent flow rate (typically hydrated 
lime) and continuously measuring the weight and time of each load of 
waste charged to the incinerator. The minimum HCl sorbent flow rate, 
the maximum charge weight, and the maximum hourly charge rate are to be 
established during the initial performance test to demonstrate 
compliance with the emission limit for HCl. Operation of the facility 
below the minimum sorbent flow rate, or above the maximum charge weight 
or maximum hourly charge rate would constitute a violation of the HCl 
emission limit.
    The proposed standards and guidelines require the owner or operator 
of an MWI using a control device other than a dry scrubber followed by 
a fabric filter to petition the Administrator for other site-specific 
operating parameters to demonstrate continuous compliance with the 
emission limits for CDD/CDF, Hg, HCl, and/or opacity. These parameters 
would be established during the initial performance test for these 
pollutants and would be continuously monitored to demonstrate 
compliance with the emission limits. As discussed in section VI, the 
EPA requests comment on appropriate parameters for wet scrubbers and 
for other control systems that may be used to control emissions from 
MWI's.

I. Reporting and Recordkeeping--New MWI's

    The proposed standards would require owners of affected facilities 
(i.e., new or modified MWI's) to submit notifications concerning 
construction and initial startup of the affected facility. Owners and 
operators are also required to maintain thorough records documenting 
the results of the initial and annual performance tests, records 
demonstrating continuous monitoring of site-specific operating 
parameters, and CEMS output data and quality assurance determinations. 
These records must be kept on file for at least 5 years.
    Additional records must be kept on file for the life of the 
affected facility. These records are required to document compliance 
with the siting requirements and the operator training and 
qualification requirements. The records to be maintained include all 
documentation produced as a result of the siting requirements and 
records of the names of the persons who have completed the operator 
training requirements, the names of the persons who have been qualified 
as MWI operators, and the names of the persons who have completed 
review of the site-specific MWI operating manual. All records must also 
include dates associated with operator training and qualification, and 
dates associated with review of the operating manual.
    Under the proposed standards, owners or operators of affected 
facilities are required to submit the results of the initial 
performance test and all subsequent performance tests. Also, reports on 
emission rates or operating parameters that have not been obtained or 
that exceed applicable limits must be submitted within 30 days after 
the end of the quarter of occurrence. If no exceedances occur during a 
quarter, the owner of the affected facility would be required to submit 
a letter stating so. All reports submitted to comply with the 
requirements of the proposed standards must be signed by the facilities 
manager.

J. Reporting and Recordkeeping--Existing MWI's

    The proposed emission guidelines would require owners of designated 
facilities (i.e., existing MWI's) to maintain thorough records 
documenting the results of the initial and annual performance tests, 
records demonstrating continuous monitoring of site-specific operating 
parameters, CEMS output data and quality assurance determinations, and 
records of the initial and annual inspections. These records must be 
kept on file for at least 5 years.
    Additional records must be kept on file for the life of the 
designated facility. These records are required to document compliance 
with the operator training and qualification requirements and include 
records of the names of the persons who have completed the operator 
training requirements, the names of the persons who have been qualified 
as MWI operators, and the names of the persons who have completed 
review of the site-specific MWI operating manual. All records must also 
include dates associated with operator training and qualification, and 
dates associated with review of the operating manual.
    Under the proposed emission guidelines owners or operators are 
required to submit the results of the initial and annual maintenance 
inspections and the results of the initial performance test and all 
subsequent performance tests. Additionally, reports of data on emission 
rates or operating parameters that have not been obtained or that 
exceed applicable limits must be submitted within 30 days after the end 
of the quarter of occurrence. If no exceedances occur during a quarter, 
the owner of the designated facility would be required to submit a 
letter stating so. All reports submitted to comply with the 
requirements of the proposed emission guidelines must be signed by the 
facilities manager.
K. Compliance Times

1. New MWI's
    The effective date of the standards for new MWI's is the date 6 
months after promulgation of the standards.
2. Existing MWI's
    In accordance with the proposed guidelines, for approval, a State 
plan must require that designated facilities comply with all 
requirements of the guidelines within 1 year after EPA approval of the 
State plan. The proposal allows two exceptions to this compliance 
schedule. First, State plans may allow facilities that are planning to 
install the necessary air pollution control equipment up to three years 
after EPA approval of the State plan to comply, provided the State plan 
specifies that the facility submit measurable and legally enforceable 
incremental steps of progress that will be taken to comply with the 
State plan. Second, State plans may include provisions for a petition 
process through which designated facilities could 
[[Page 10663]] request an extension for other reasons. The proposed 
guidelines specify minimum requirements to be included in State plans 
with such provisions. If an extension is granted, compliance must be 
required within 3 years after EPA approval of the State plan.
    Regardless of the status of the State plans, all designated 
facilities must be in compliance within 5 years after promulgation of 
the emission guidelines. The proposed emission guidelines require the 
EPA to develop, implement, and enforce a plan for any State that has 
not submitted an approvable plan within 2 years after promulgation of 
the emission guidelines.
    The proposed emission guidelines also require that, for approval, a 
State plan provide that each designated facility must be in compliance 
with the operator training and qualification requirements and the 
inspection requirements within 1 year after EPA approval of the State 
plan. No extension is available for training, qualification, or 
inspection.

L. Permit Requirements

    The proposed standards and guidelines include a requirement that 
facilities operate pursuant to permits issued under the EPA-approved 
State operating permit program. Permits would be required beginning 36 
months after the date of promulgation of the standards and guidelines, 
or on the effective date of an EPA-approved operating permit program in 
the State in which the facility is located, whichever date is later. 
The operating permit programs are developed under Title V of the Act 
and the implementing regulations under 40 CFR part 70.

III. Impacts of the Proposed Standards for New MWI's

    This section presents a description of the air, water, solid waste, 
energy, control cost, and economic impacts of today's proposed 
standards for new MWI's. All of the impacts presented are nationwide 
impacts that are expected to result from the implementation of the NSPS 
in the fifth year after adoption. As discussed below, it is expected 
that as many as 80 percent of the projected number of new MWI's will 
not be constructed to avoid the increased costs associated with 
installation of control equipment. Therefore, impacts are presented 
assuming 80 percent of projected new MWI's are not constructed, with 
the waste being disposed of by other means (i.e., the ``switching 
scenario'').
    Based on historic sales to date, in the absence of regulation, an 
estimated 700 new MWI's are expected to be installed over the next 5 
years. However, onsite incineration is only one of several medical 
waste treatment and disposal options. For some MWI's, the equipment 
necessary to comply with the proposed regulations will make onsite 
incineration more expensive than other waste treatment and disposal 
options. Consequently, many facilities that would have chosen onsite 
incineration are likely to consider less expensive methods of treatment 
and disposal. The EPA expects that as many as 80 percent of the 
projected number of new MWI's will not be constructed if the standards 
are promulgated as proposed. This is referred to in this notice as the 
``switching scenario'' because of the expectation that potential owners 
of MWI's will switch to another method of waste treatment and disposal.
    Recent experience at the State level confirms that switching to 
lower cost alternatives is a likely impact of the implementation of MWI 
regulations that require add-on air pollution control. For example, 
recent regulations adopted by the State of New York require the use of 
add-on acid gas scrubber systems. As a result, the State estimates that 
as many as 90 percent of previously existing MWI's in New York have 
ceased operation. New York's regulations are similar to the proposed 
EPA standards in that they require the use of add-on air pollution 
control systems or use of an alternative waste disposal approach. While 
these State regulations have increased the cost of waste disposal, it 
appears that the availability of alternatives to onsite incineration 
has mitigated the economic impacts that might have been associated with 
the State regulations.
    One concern that has recently been raised related to switching away 
from onsite incineration is the availability of alternatives to onsite 
incineration. Two common alternatives are offsite contract disposal 
(most commonly commercial medical waste incineration) and onsite 
autoclaving (steam treatment). Other less common alternatives include 
onsite chemical treatment and onsite microwave irradiation. The 
commercial medical waste disposal industry believes that there 
presently exists sufficient offsite capacity to treat the waste that 
would no longer be treated onsite. In addition, autoclaves and other 
onsite waste disposal options are available. In fact, even today in the 
absence of Federal regulations, most facilities that generate medical 
waste do not operate onsite MWI's. This indicates that there currently 
are viable alternatives to onsite incineration.
    A second concern regrading a shift away from onsite incineration is 
the increased transportation and handling of untreated medical waste. 
However, the Department of Transportation (DOT) has promulgated 
regulations (49 CFR parts 171, 172, and 173) that address the safe 
transportation and handling of medical waste. The DOT regulations 
include provisions for packaging and labeling of medical waste. Also, 
the Occupational Safety and Health Administration (OSHA) promulgated 
regulations on December 5, 1991 (29 CFR part 1910) that address 
occupational exposure to bloodborne pathogens. Using a combination of 
engineering and work practice controls, personal protective clothing 
and equipment, training, medical follow-up of exposure incidents, 
vaccinations (where appropriate) and other provisions, the OSHA 
regulations minimize or eliminate health risk as a result of 
occupational exposure to bloodborne pathogens. The Agency believes 
these DOT and OSHA regulations will provide sufficient protection from 
potential increases in exposure to these wastes.

A. Air Impacts

    As discussed earlier, impacts are presented assuming the more 
likely ``switching scenario.'' Baseline emissions and emissions under 
the proposed NSPS based on the switching scenario are presented in 
Tables 7a and 7b.

 Table 7a.--Baseline Emissions Compared With Emissions After NSPS (With 
                               Switching)                               
                             [Metric Units]                             
------------------------------------------------------------------------
                                                                 After  
              Pollutant                   Units     Baseline   NSPS with
                                                               switching
------------------------------------------------------------------------
PM...................................  Mg/yr.....    1,670        81.7  
CO...................................  Mg/yr.....    1,630        61.7  
CDD/CDF..............................  kg/yr.....       21.7       0.032
HCl..................................  Mg/yr.....   10,000       230    
SO<INF>2..................................  Mg/yr.....      192       144    
NO<INF>X..................................  Mg/yr.....    1,240       944    
Pb...................................  Mg/yr.....       19.2       0.29 
Cd...................................  Mg/yr.....        1.38      0.042
Hg...................................  Mg/yr.....       14.5       1.10 
------------------------------------------------------------------------


                                                                        
[[Page 10664]]
 Table 7b.--Baseline Emissions Compared With Emissions After NSPS (With 
                               Switching)                               
                             [English Units]                            
------------------------------------------------------------------------
                                                              After NSPS
             Pollutant                  Units      Baseline      with   
                                                               switching
------------------------------------------------------------------------
PM................................  Tons/yr.....    1,850         90.0  
CO................................  Tons/yr.....    1,790         68.0  
CDD/CDF...........................  Lb/yr.......       47.9        0.070
HCl...............................  Tons/yr.....   11,100        254    
SO<INF>2...............................  Tons/yr.....      212        159    
NO<INF>X...............................  Tons/yr.....    1,370      1,040    
Pb................................  Tons/yr.....       21.2        0.32 
Cd................................  Tons/yr.....        1.52       0.046
Hg................................  Tons/yr.....       16.0        1.21 
------------------------------------------------------------------------

  The proposed standards would reduce nationwide emissions of PM by 
1,590 megagrams per year (Mg/yr) (1,750 tons per year (tons/yr)) from 
estimated emission levels under the typical existing control or the 
``regulatory baseline'' of 1,670 Mg/yr (1,850 tons/yr). This reduction 
represents a decrease of about 95 percent from baseline PM emission 
levels in the absence of the proposed standards.
    Nationwide emissions of CO would be reduced by 1,570 Mg/yr (1,730 
tons/yr) from estimated emission levels under the regulatory baseline 
of 1,630 Mg/yr (1,790 tons/yr). This reduction equates to an overall 
control level of about 96 percent for CO emissions.
    As a result of today's proposal, nationwide emissions of CDD/CDF 
would be reduced by 21.70 kilograms per year (kg/yr) (47.8 pounds per 
year (lb/yr)) from estimated emission levels under the regulatory 
baseline of 21.73 kg/yr (47.9 lb/yr). The CDD/CDF emissions would be 
reduced by over 99 percent from the regulatory baseline.
    The proposed standards would reduce nationwide emissions of HCl by 
9,820 Mg/yr (10,800 tons/yr) from estimated emission levels under the 
regulatory baseline of 10,000 Mg/yr (11,100 tons/yr). This reduction 
represents a decrease of about 98 percent in HCl emissions.
    Nationwide emissions of SO<INF>2 and NO<INF>X would be reduced by 
48.1 Mg/yr (53.0 tons/yr) and 300 Mg/yr (331 tons/yr), respectively, 
from estimated emission levels under the regulatory baseline of 192 Mg/
yr (212 tons/yr) for SO<INF>2 and 1,240 Mg/yr (1,370 tons/yr) for 
NO<INF>X. These reductions equate to an overall emissions decrease of 
about 25 percent for SO<INF>2 and about 24 percent for NO<INF>X.
    As a result of today's proposal, the nationwide emissions of Pb, 
Cd, and Hg would be reduced by 18.9 Mg/yr (20.9 tons/yr), 1.34 Mg/yr 
(1.47 tons/yr), and 13.4 Mg/yr (14.8 tons/yr), respectively, from 
estimated emission levels under the regulatory baseline of 19.2 Mg/yr 
(21.2 tons/yr) for Pb, 1.38 Mg/yr (1.52 tons/yr) for Cd, and 14.5 Mg/yr 
(16.0 tons/yr) for Hg. These reductions equate to overall control 
levels of about 98 percent for Pb, 97 percent for Cd, and 92 percent 
for Hg.

B. Water and Solid Waste Impacts

    Under the proposed NSPS, no significant water pollution impacts are 
projected because the emission control technologies on which the 
emission limits are based do not produce a wastewater stream. However, 
to the extent that wet scrubber systems could be used to comply with 
the proposed emission limitations, water pollution impacts could be 
more significant. As discussed in section VI of this preamble, the 
Agency solicits information regarding water pollution impacts 
associated with the use of wet scrubber systems.
    With regard to solid waste impacts, about 421,000 Mg (464,000 tons) 
of medical waste are projected to be burned annually in new MWI's in 
the fifth year after adoption of the NSPS in the absence of Federal 
regulations (i.e., at the regulatory baseline). This quantity of waste 
burned would result in about 42,100 Mg/yr (46,400 tons/yr) of solid 
waste (bottom ash) disposed of in landfills. The addition of acid gas 
control using dry lime injection, and CDD/CDF and Hg control using 
activated carbon injection, would increase the quantity of solid waste 
for final disposal by adding baghouse ash to the amount of bottom ash 
already generated under the regulatory baseline. In addition, switching 
to onsite alternatives to incineration will result in an increase in 
solid waste for final disposal because the nonincineration treatment 
methods do not reduce the volume of waste as much as incineration.
    Under the switching scenario, the amount of solid waste ultimately 
sent to landfills would increase by about 135,000 Mg/yr (149,000 tons/
yr). This includes the increase in ash from the air pollution control 
devices (APCD's) and the increase in waste that is treated and 
landfilled without being incinerated. Compared to municipal waste, 
which is disposed in landfills at an annual rate of over 91 million Mg/
yr (100 million tons/yr), the increase in solid waste from the 
implementation of the MWI standards is insignificant. Therefore, no 
adverse solid waste impacts are anticipated under the proposed 
standards.

C. Energy Impacts

    The emission control technologies upon which the emission limits 
are based would require additional energy consumption for all new 
MWI's. Under the switching scenario, it is not clear whether energy 
consumption will increase, decrease, or remain the same. Alternatives 
to incineration require energy to operate. However, information is not 
available to estimate whether alternatives use more or less energy than 
MWI's. It is expected that the increase in energy consumption resulting 
from the switching scenario will be less than the increase under the 
no-switching scenario.
    The estimates of energy impacts assuming all new MWI's are 
constructed and install air pollution control (no-switching scenario) 
include additional auxiliary fuel (natural gas) for combustion controls 
and additional electrical energy for operation of the add-on control 
devices. In the fifth year after adoption, the proposed standards would 
increase total national usage of natural gas by about 25 million cubic 
meters per year (MMm<SUP>3/yr) (895 million cubic feet per year 
(10<SUP>6 ft<SUP>3/yr)) compared to fuel consumption determined from 
the regulatory baseline. Total national usage of electrical energy 
would increase by about 41,400 megawatt hours per year (MW-hr/yr) (141 
billion British thermal units per year (10<SUP>9 Btu/yr)) of 
electricity compared to electrical energy consumption determined from 
the regulatory baseline.

D. Control Cost Impacts

    The control cost impacts on individual facilities will vary 
depending on the cost of compliance with the regulation; the cost of 
alternative treatment and disposal methods; and other factors such as 
proximity to an offsite contract disposal facility, liability issues 
related to the transportation and final disposal of the waste, and 
State and local medical waste treatment and disposal requirements. In 
general, facilities requiring a smaller waste treatment capacity will 
have a greater incentive to use a less expensive treatment and disposal 
option because their onsite incineration cost (per ton of waste burned) 
will be higher. Facilities with larger amounts of waste to be treated 
may have some cost advantages if they use lower cost alternatives, but 
these advantages are not as significant due to economies of scale.
    Under the switching scenario, the nationwide annual costs 
associated with the NSPS will increase by about 74.5 million/yr (from a 
baseline cost of 63.3 [[Page 10665]] million/yr). The nationwide 
annualized cost of waste disposal per unit of medical waste treated 
would increase by $177/Mg ($161/ton) from the estimated nationwide 
annualized cost of $150/Mg ($136/ton) under the regulatory baseline.

E. Economic Impacts

    The goal of the economic impact analysis was to estimate the market 
response to the NSPS and to determine whether there would be adverse 
impacts associated with the proposed standards. The proposed standards 
would affect five major industry sectors (hospitals, nursing homes, 
veterinary facilities, commercial research laboratories, and commercial 
medical waste incineration facilities) within which some facilities 
operate an onsite MWI. In addition, the proposed standards would affect 
a number of other industry sectors in which facilities do not typically 
operate an onsite MWI (e.g., blood banks). The economic impact analysis 
for new MWI's examined each of these sectors as a whole to determine 
industrywide impacts.
    To assess the industrywide impacts of control costs, the market 
price increase resulting from the proposed standards was estimated for 
each regulated industry. The market price increases, presented in Table 
8, may be thought of as an average price increase across each industry 
required to recover control costs within each industry. Table 8 
reflects the more likely switching scenario. For example, under the 
switching scenario, the hospital industry would have to raise prices by 
an average of about 0.03 percent (over current revenues of about $224 
billion/yr) to cover the increased cost of waste disposal. This table 
shows that the price increase is relatively small for each industry. 
This result is mainly due to the projection that most facilities do not 
(or will not, within the next 5 years after adoption of the standards) 
operate an onsite incinerator.

Table 8.--Market Price Increases in the Major Industry Sectors Under the
                        NSPS--Switching Scenario                        
------------------------------------------------------------------------
                                                                 Price  
                          Industry                             increase,
                                                                percent 
------------------------------------------------------------------------
Hospitals...................................................        0.03
Nursing Homes...............................................        0.01
Veterinary Facilities.......................................        0.01
Commercial Research Laboratories............................        0.03
Physicians' Offices.........................................        0   
Dentists' Offices...........................................        0   
Freestanding Bloodbanks.....................................        0.02
Commercial Medical Waste Incineration Facilities............     <SUP>aN/A   
------------------------------------------------------------------------
<SUP>aIndustrywide impacts were not calculated for commercial medical waste  
  incineration facilities because estimates of the change in demand for 
  commercial medical waste incineration were not available. However,    
  this industry is expected to be able to recoup all control cost       
  increases through price increases.                                    

    Output, employment, and revenue impacts were also estimated. As a 
result of the low market price increases and/or relatively inelastic 
demand, the corresponding decreases in output, employment, and revenue 
were also low, never exceeding 0.05 percent under the more likely 
switching scenario. This result implies that no medical waste-
generating industry would need to be significantly reconstructed (e.g., 
through closures or consolidations) as a result of the proposed 
standards.

IV. Impacts of the Proposed Guidelines for Existing MWI's

    This section presents a description of the air, water, solid waste, 
energy, control cost, and economic impacts of today's proposed 
guidelines. All impacts are nationwide impacts that are expected to 
result from the implementation of the emission guidelines. As discussed 
below, it is expected that as many as 80 percent of existing facilities 
currently using onsite incineration will switch to an alternative 
method of treatment and disposal to avoid the increased cost of 
installing air pollution control equipment. Therefore, impacts are 
presented assuming 80 percent of existing facilities using onsite MWI's 
will switch to a lower cost alternative treatment and disposal methods 
(i.e., the ``switching scenario'').
    Onsite incineration is only one of several medical waste treatment 
and disposal options, and for some MWI's, the cost of the equipment 
necessary to comply with the proposed emission guidelines will make 
onsite incineration more expensive than other treatment and disposal 
options. Consequently, many facilities that currently operate onsite 
MWI's are likely to switch to a less expensive method of treatment and 
disposal. The EPA expects that as many as 80 percent of the existing 
facilities currently using onsite MWI's will switch to a lower cost 
alternative method of treatment and disposal if the guidelines are 
promulgated as proposed. This is referred to in this notice as the 
``switching scenario'' because of the expectation that owners of MWI's 
will switch to another method of waste treatment and disposal.
    Recent experience at the State level confirms that switching to 
lower cost alternatives is a likely impact of the implementation of MWI 
regulations that require add-on air pollution control. For example, 
recent regulations adopted by the State of New York require the use of 
add-on acid gas scrubber systems. As a result, the State estimates that 
as many as 90 percent of previously existing MWI's in New York have 
ceased operation. New York's regulations are similar to the proposed 
EPA guidelines in that they require the use of add-on air pollution 
control systems or use of an alternative waste disposal approach. While 
these State regulations have increased the cost of waste disposal, it 
appears that the availability of alternatives to onsite incineration 
has mitigated the economic impacts that might have been associated with 
the State regulations.
    One concern that has recently been raised related to switching away 
from onsite incineration is the availability of alternatives to onsite 
incineration. Two common alternatives are offsite contract disposal 
(most commonly commercial medical waste incineration) and onsite 
autoclaving (steam treatment). Other less common alternatives include 
onsite chemical treatment and onsite microwave irradiation. The 
commercial medical waste disposal industry believes that there 
presently exists sufficient offsite capacity to treat the waste that 
would no longer be treated onsite. In addition, autoclaves and other 
onsite waste disposal options are available. In fact, even today in the 
absence of Federal regulation, most facilities that generate medical 
waste do not operate onsite MWI's. This indicates that there currently 
are viable alternatives to onsite incineration.
    A second concern regarding a shift away from onsite incineration is 
the increased transportation and handling of untreated medical waste. 
However, the Department of Transportation (DOT) has promulgated 
regulations (49 CFR parts 171, 172, and 173) that address the safe 
transportation and handling of medical waste. The DOT regulations 
include provisions for packaging and labeling of medical waste. Also, 
the Occupational Safety and Health Administration (OSHA) has 
promulgated regulations on December 5, 1991 (29 CFR part 1910) that 
address occupational exposure to bloodborne [[Page 10666]] pathogens. 
Using a combination of engineering and work practice controls, personal 
protective clothing and equipment, training, medical follow-up of 
exposure incidents, vaccinations (where appropriate) and other 
provisions, the OSHA regulations minimize or eliminate health risk as a 
result of occupational exposure to bloodborne pathogens. The EPA 
believes these DOT and OSHA regulations will provide sufficient 
protection from potential increases in exposure to those wastes.

A. Air Impacts

    As discussed earlier, impacts are presented assuming the more 
likely ``switching scenario.'' Baseline emissions and emissions under 
the proposed EG based on the switching scenario are presented in Tables 
9a and 9b.

       Table 9a.--Baseline Emissions Compared With Emissions After      
       Implementation of the Emission Guidelines (With Switching)       
                             [Metric Units]                             
------------------------------------------------------------------------
                                                               After EG 
              Pollutant                  Units     Baseline      with   
                                                               switching
------------------------------------------------------------------------
PM..................................  Mg/yr.....   11,300         272   
CO..................................  Mg/yr.....   13,100         207   
CDD/CDF.............................  kg/yr.....      285           0.11
HC1.................................  Mg/yr.....   41,200         777   
SO<INF>2.................................  Mg/yr.....      766         479   
No<INF>x.................................  Mg/yr.....    5,040       3,160   
Pb..................................  Mg/yr.....       77.5         0.97
Cd..................................  Mg/yr.....        5.62        0.14
Hg..................................  Mg/yr.....       58.6         3.67
------------------------------------------------------------------------


       Table 9b.--Baseline Emissions Compared With Emissions After      
       Implementation of the Emission Guidelines (With Switching)       
                             [English Units]                            
------------------------------------------------------------------------
                                                               After EG 
             Pollutant                  Units      Baseline      with   
                                                               switching
------------------------------------------------------------------------
PM................................  Tons/yr.....   12,400         300   
CO................................  Tons/yr.....   14,500         228   
CDD/CDF...........................  Lb/yr.......      628           0.23
HC1...............................  Tons/yr.....   45,400         857   
SO<INF>2...............................  Tons/yr.....      844         528   
NO<INF>x...............................  Tons/yr.....    5,560       3,490   
Pb................................  Tons/yr.....       85.5         1.07
Cd................................  Tons/yr.....        6.20        0.16
Hg................................  Tons/yr.....       64.6         4.05
------------------------------------------------------------------------

    The proposed guidelines would reduce nationwide emissions of PM by 
11,000 megagrams per year (Mg/yr) (12,100 tons per year (tons/yr)) from 
the estimated emission levels under the typical existing control or the 
``regulatory baseline'' of 11,300 Mg/yr (12,400 tons/yr). This 
reduction represents an overall decrease of about 98 percent of 
baseline PM emission levels in the absence of the proposed emission 
guidelines.
    Nationwide emissions of CO would be reduced by 12,900 Mg/yr (14,200 
tons/yr) from the estimated emission levels under the regulatory 
baseline of 13,100 Mg/yr (14,500 tons/yr). This reduction represents an 
overall control level of about 98 percent for CO emissions.
    The proposed guidelines would reduce nationwide emissions of 
dioxins/furans by 284.8 kilograms per year (kg/yr) (627.9 pounds per 
year (lb/yr)) from the estimated emission levels under the regulatory 
baseline of 284.9 kg/yr (628.1 lb/yr). Dioxin/furan emissions would be 
reduced by over 99 percent from the regulatory baseline.
    Nationwide emissions of HCl would be reduced by 40,400 Mg/yr 
(44,600 tons/yr) from the estimated emission levels under the 
regulatory baseline of 41,200 Mg/yr (45,400 tons/yr). This reduction 
represents a decrease of about 98 percent in HCl emissions from the 
regulatory baseline.
    Nationwide emissions of SO<INF>2 and NO<INF>X would be reduced by 
287 Mg/yr (316 tons/yr) and 1,880 Mg/yr (2,070 tons/yr), respectively, 
from the estimated emission levels under the regulatory baseline of 766 
Mg/yr (844 tons/yr) for SO<INF>2 and 5,040 Mg/yr (5,560 tons/yr) for 
NO<INF>X. These reductions equate to an overall emissions decrease of 
about 37 percent for both SO<INF>2 and NO<INF>X.
    As a result of today's proposal, nationwide emissions of Pb, Cd, 
and Hg would be reduced by 76.6 Mg/yr (84.4 tons/yr), 5.48 Mg/yr (6.04 
tons/yr), and 54.9 Mg/yr (60.5 tons/yr), respectively, from the 
estimated emission levels under the regulatory baseline of 77.5 Mg/yr 
(85.5 tons/yr) for Pb, 5.62 Mg/yr (6.20 tons/yr) for Cd, and 58.6 Mg/yr 
(64.6 tons/yr) for Hg. These reductions equate to overall control 
levels of about 99 percent for Pb, 97 percent for Cd, and 94 percent 
for Hg.

B. Water and Solid Waste Impacts

    Under the proposed guidelines, no significant water pollution 
impacts are projected because the emission control technologies upon 
which the emission limits are based do not produce a wastewater stream. 
However, to the extent that wet scrubber systems could be used to 
comply with the proposed emission limitations, water pollution impacts 
could be more significant. As discussed in section VI of this notice, 
the Agency solicits information regarding water pollution impacts 
associated with the use of wet scrubber systems.
    With regard to solid waste impacts, about 1.43 million Mg (1.58 
million tons) of medical waste are burned annually in existing MWI's 
producing about 143,000 Mg/yr (158,000 tons/yr) of solid waste (bottom 
ash) disposed of in landfills. The addition of acid gas control using 
dry lime injection, and CDD/CDF and Hg control using activated carbon 
injection, would increase the quantity of solid waste for final 
disposal by adding baghouse ash to the amount of bottom ash already 
generated under the regulatory baseline. In addition, switching to 
onsite alternatives to incineration would result in an increase in 
solid waste for final disposal because the nonincineration treatment 
methods do not reduce the volume of waste as much as incineration.
    Under the switching scenario, the amount of solid waste ultimately 
sent to landfills would increase by about 631,000 Mg/yr (696,000 tons/
yr). This quantity includes the increase in ash from the APCD's and the 
increase in waste that is treated and landfilled without being 
incinerated. Compared to municipal waste, which is disposed in 
landfills at a rate of over 91 million Mg/yr (100 million tons/yr), the 
increase in solid waste from the implementation of the MWI emissions 
guidelines is insignificant. Therefore, no adverse solid waste impacts 
are anticipated under the proposed guidelines.

C. Energy Impacts

    The emission control technologies upon which the emission limits 
are based would require additional energy consumption for all existing 
MWI's. Under the switching scenario, it is not clear whether energy 
consumption will increase, decrease, or remain the same. Alternatives 
to incineration require energy to operate. However, information is not 
available to estimate whether alternatives use more or less energy than 
MWI's. It is expected that the increase in energy consumption resulting 
from the switching scenario will be less than the increase under the 
no-switching scenario.
    The estimates of energy impacts assuming all existing MWI's install 
air pollution control (no-switching scenario) include additional 
auxiliary fuel for combustion controls and additional electrical energy 
for operation of the add-on control devices. The proposed guidelines 
would increase total national usage of natural gas for combustion 
controls by about 100 million cubic meters per year (MMm<SUP>3/ 
[[Page 10667]] yr) (3,490 million cubic feet per year (10<SUP>6 
ft<SUP>3/yr)) compared to fuel consumption determined from the 
regulatory baseline. Total national usage of electrical energy for the 
operation of add-on control devices would increase by about 175,000 
megawatt hours per year (MW-hr/yr) (599 billion British thermal units 
per year (10<SUP>9 Btu/yr)) of electricity compared to energy 
consumption determined from the regulatory baseline.

D. Control Cost Impacts

    The control cost impacts on individual facilities will vary 
depending on the cost of compliance with the guidelines; the cost of 
alternative treatment and disposal methods; and other factors such as 
proximity to an offsite contract disposal facility, liability issues 
related to the transportation and final disposal of the waste, and 
State and local medical waste treatment and disposal requirements. In 
general, facilities requiring a smaller waste treatment capacity will 
have a greater incentive to use a less expensive treatment and disposal 
option because their onsite incineration cost (per ton of waste burned) 
will be higher. Facilities with larger amounts of waste to be treated 
may have some cost advantages if they use a lower cost alternative, but 
these advantages are not as significant due to economies of scale.
    Under the switching scenario, the nationwide annual costs 
associated with the proposed emission guidelines will increase by about 
$351 million/yr. The nationwide annual cost of waste disposal per unit 
of medical waste treated would increase by $245/Mg ($222/ton) to a 
total cost of $430/Mg ($390/ton) from the estimated nationwide 
annualized cost of $185/Mg ($168/ton) under the regulatory baseline.
E. Economic Impacts

    The goal of the economic impact analysis was to estimate the market 
response to the emission guidelines and determine whether there would 
be adverse impacts associated with the proposed guidelines. The 
proposed guidelines would affect five major industry sectors 
(hospitals, nursing homes, veterinary facilities, commercial research 
laboratories, and commercial medical waste incineration facilities) 
within which some facilities operate an onsite MWI. In addition, the 
proposed guidelines would affect a number of other industry sectors in 
which facilities do not typically operate an onsite MWI (e.g., 
bloodbanks). The economic impact analysis for existing MWI's examined 
each of these sectors as a whole to determine industry wide impacts.
    To assess the industrywide impacts of control costs, the market 
price increase resulting from the proposed guidelines was estimated for 
each regulated industry. The market price increases, presented in Table 
10, may be thought of as an average price increase across each industry 
required to recover control costs within each industry. Table 10 
reflects the more likely switching scenario. For example, under the 
switching scenario, the hospital industry would have to raise prices by 
an average of about 0.1 percent (over current revenues of about $224 
billion/year) to cover the increased cost of waste disposal. This table 
shows that the price increase is relatively small for each industry. 
This result is mainly due to the fact that the majority of the 
facilities in each industry sector do not operate an onsite 
incinerator.

  Table 10.--Market Price Increased in the Major Industry Sectors Under 
               the Emission Guidelines--Switching Scenario              
------------------------------------------------------------------------
                                                                 Price  
                          Industry                             increase,
                                                                percent 
------------------------------------------------------------------------
Hospitals...................................................         0.1
Nursing Homes...............................................         0.1
Veterinary Facilities.......................................         0.6
Commercial Research Laboratories............................         0.4
Physicians' Offices.........................................         0  
Dentists' Offices...........................................         0  
Freestanding Bloodbanks.....................................         0.1
Commercial Medical Waste Incineration Facilities............    \9\N/A  
------------------------------------------------------------------------
\9\Industrywide impacts were not calculated for commercial medical waste
  incineration facilities because estimates of the change in demand for 
  commercial medical waste incineration were not available. However,    
  this industry is expected to be able to recoup all control cost       
  increases through price increases.                                    

    Output, employment, and revenue impacts were also estimated. As a 
result of the low market price increases and/or relatively inelastic 
demand, the corresponding decreases in output, employment, and revenue 
were also low, never exceeding 1 percent under the more likely 
switching scenario. This result implies that no medical waste-
generating industry would need to be significantly restructured (e.g., 
through closures or consolidations) as a result of the proposed 
emission guidelines.

V. Rationale for the Proposed Standards and Guidelines

A. Background

    An estimated 3.4 million tons of waste are produced annually by 
medical waste generators in the United States. Hospitals are the single 
largest generator of medical waste, producing over 70 percent of the 
annual total. Approximately 5,000 MWI's are believed to exist 
nationwide (3,700 burning general medical waste and 1,300 burning 
pathological waste). Over 60 percent of these MWI's are found at 
hospitals. Medical waste incinerators are also found at commercial 
medical waste disposal facilities, research laboratories, nursing 
homes, and veterinary facilities. Based on historic sales data, an 
estimated 700 new MWI's will be installed over the next 5 years.
    Medical waste incinerators are subject to State and local 
regulations that vary widely both in format and scope. A survey in 
April 1990 showed that in 38 States, regulations or permit guidelines 
specific to MWI's were either in place or were in the planning stages. 
The remainder of the States regulate MWI's under general incinerator 
requirements, which typically are less stringent that those specific to 
MWI's. The most common State requirements for MWI's are limits for PM, 
HCl, and secondary chamber temperature and residence time. Some States 
also regulate metals, CDD/CDF, and CO. About one third of the States 
require operator training.
    On November 1, 1988, the Medical Waste Tracking Act (MWTA) was 
signed by Congress. The MWTA required EPA to establish a 2-year 
demonstration program to track medical waste from its origin to its 
disposal. In early 1989, EPA established this program in 40 CFR 259. 
The program was in effect from June 22, 1989, to June 22, 1991, and 
applied to the States of New York, New Jersey, Connecticut, and Rhode 
Island, and to Puerto Rico. The MWTA required EPA to prepare a series 
of Reports to Congress on medical waste and the demonstration program. 
Now that the demonstration program has concluded, Congress will decide 
if a medical waste tracking program should be implemented nationwide.
    The current air emissions standards development effort for MWI's 
was initiated in 1989. The data-gathering effort was designed to take 
advantage of information gathered under the auspices of the MWTA. Also, 
in 1989, an MWI operator training course and manual were developed with 
recommendations on the proper operation and maintenance of MWI's.
    The Amendments of 1990 added section 129 to the Act. Section 129 
specifically addresses development of standards for MWI's. Section 129 
requires EPA to establish an NSPS for new MWI's and emission guidelines 
for existing MWI's that combust hospital [[Page 10668]] waste, medical 
waste, and infectious waste. The standards and guidelines must specify 
numerical emission limitations for the following: PM, opacity, 
SO<INF>2, HCl, NO<INF>X, CO, Pb, Cd, Hg, and CDD/CDF. Section 129 also 
includes requirements for operator training as well as siting 
requirements for new MWI's.
    The standards and guidelines must reflect MACT ``* * * the maximum 
degree of reduction in emissions of air pollutants * * * that the 
Administrator, taking into consideration the cost of achieving such 
emission reduction, any nonair quality health and environmental impacts 
and energy requirements, determines is achievable * * *'' Section 129 
states that ``The degree of reduction in emissions that is deemed 
achievable for new units in a category shall not be less stringent than 
the emissions control that is achieved in practice by the best-
controlled similar unit * * *'' Also section 129 requires that 
``Emissions standards for existing units in a category may be less 
stringent than standards for new units in the same category but shall 
not be less stringent than the average emissions limitation achieved by 
the best performing 12 percent of units in the category * * *'' The 
standards and guidelines must be no less stringent than these levels of 
emission control currently achieved. These levels are referred to as 
the MACT floor.

B. Selection of Source Category

    Section 129 of the Act directs the EPA to issue standards and 
guidelines pursuant to section 111 for solid waste incineration units 
combusting hospital waste, medical waste, and infectious waste (i.e., 
MWI's). An MWI is defined as any device that burns medical waste, with 
or without other types of waste (e.g., municipal solid waste [MSW]) and 
with or without heat recovery.
    Medical waste is defined pursuant to the Solid Waste Disposal Act 
as codified in 40 CFR 259 subpart B 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. Medical waste consists of, but is not limited 
to, the following types of materials:
    1. Sharps (e.g., hypodermic and suture needles, scalpel blades, 
syringes, pipettes, vials, other types of broken or unbroken glassware, 
etc.);
    2. Fabrics (e.g., gauze, garments, bandages, swabs, etc.);
    3. Plastics (e.g., trash bags, sharps containers, IV bags, tubes, 
specimen cups, etc.);
    4. Paper (e.g., disposable gowns, sheets, etc.; premoistened 
towels; paper towels; etc.);
    5. Waste chemicals/drugs that are not RCRA hazardous waste (e.g., 
lab chemicals, leftover and out-of-date drugs, disinfectants, etc.); 
and
    6. Pathological waste (e.g., human and animal body parts and 
tissue).
    Medical waste does not include any hazardous waste identified or 
listed under 40 CFR 261, or any household waste as defined in 40 CFR 
261.4(b)(1). On the other hand, mixtures of medical waste with 
hazardous waste or household waste would be considered medical waste 
for the purposes of these proposed standards and guidelines. The 
definition of household waste includes waste generated at single and 
multiple residences. Nursing homes or retirement homes with a health 
care facility could be considered multiple residences. For the purpose 
of the proposed standards and guidelines, the definition of medical 
waste includes waste materials that meet the definition of medical 
waste and are generated by retirement homes/nursing homes.
    Medical waste also does not include human and animal remains that 
are not generated as medical waste. A device that burns solely human or 
animal remains (and the caskets or containers carrying the remains, or 
the bedding included with the animal remains) for the purpose of 
cremation is not an MWI and, therefore, is not subject to the 
requirements of the standards and guidelines. For example, a facility 
that burns the remains of animals that have been euthanized at animal 
shelters and animal hospitals is not an MWI because the remains are not 
considered medical waste. On the other hand, a facility that burns 
human and/or animal remains that are generated as medical waste or a 
facility that burns general medical waste in addition to human and/or 
animal remains is an MWI and is subject to the standards and 
guidelines. For example, a facility that burns the remains of research 
laboratory rats is an MWI because the remains are considered medical 
waste (they are generated in research pertaining to the diagnosis, 
treatment, or immunization of human beings or animals or in the 
production or testing of biologicals).
    The range of waste types included in this definition is broader 
than that defined in the now expired Medical Waste Tracking Act (40 CFR 
part 259) as Regulated Medical Waste. Regulated Medical Waste consisted 
of seven categories of medical waste based on potential for infection 
or aesthetic concerns. The definition of medical waste in this proposal 
classifies medical waste more broadly based on materials' composition. 
Consequently, the estimated amount of waste generated by medical waste 
generators (3.4 million tons/yr) and the estimated amount of waste 
burned in medical waste incinerators (1.8 million tons/yr) is greater 
than the Medical Waste Tracking Act estimated amount of Regulated 
Medical Waste generated (922,000 tons/yr). It has been suggested that 
EPA's definition of medical waste in this proposal is inappropriate. 
The EPA specifically requests comment on the definition of medical 
waste as applied to the regulation of medical waste incinerators.
    Most MWI's burn a diverse mixture of medical waste (referred to in 
this preamble as general medical waste), which may include some 
pathological waste (human and animal body parts and/or tissue). Most of 
the materials that make up the general medical waste stream burn 
readily, and given the proper conditions, will continue to burn once 
they are ignited. Metal and glass sharps do not burn but also do not 
greatly impede combustion of other materials. Pathological waste has a 
very high moisture content and will not support self-sustained 
combustion but will burn if adequate heat is applied to drive off 
excess moisture. As a result, larger amounts of pathological waste 
require special operating conditions for combustion. Thus, some 
facilities maintain MWI's designed and operated to burn pathological 
waste exclusively.
    Because of differences in waste composition and the combustion 
process, uncontrolled emissions from pathological MWI's contain 
significantly lower levels of the pollutants of concern for this source 
category than uncontrolled emissions from general medical waste 
incinerators. General medical waste typically contains more metals and 
chlorine than does pathological waste, resulting in higher emissions of 
metals and HCl from general medical waste incinerators than from 
pathological incinerators. For example, typical uncontrolled Hg 
emissions are about 3.1 mg/dscm for general medical waste incinerators 
and about 0.05 mg/dscm for pathological MWI's. Overall pollutant 
emissions from pathological MWI's represent less than 3 percent of the 
uncontrolled nationwide emissions from MWI's burning general medical 
waste.
    Additionally, onsite alternatives to incineration are available for 
the treatment of general medical waste, while most of these 
technologies are not applicable to the treatment of purely pathological 
waste. As a result, pathological MWI's are more likely to 
[[Page 10669]] face adverse economic impacts associated with 
installation of pollution control equipment, while general medical 
waste incinerators could use available alternatives to incineration. 
For these reasons, the proposed standards and guidelines focus on 
regulating emissions from general medical waste incinerators and 
include very minor requirements for pathological MWI's. Under the 
proposed standards and guidelines, pathological MWI's would only be 
required to submit quarterly reports of the amount and type of 
materials charged to the incinerator.
    Finally, in addition to developing standards and guidelines for 
medical waste incinerators, section 129 of the Act directs the EPA to 
develop standards and guidelines for municipal waste incinerators, 
commercial or industrial waste incinerators, and other categories of 
solid waste incinerators. The Agency intends to consider pathological 
incinerators (along with crematory incinerators) when evaluating the 
category of other solid waste incinerators for regulation.
C. Modification of Existing MWI's

    Previously, the terms ``modification'' and ``reconstruction'' were 
defined under sections 60.14 and 60.15 of subpart A of part 60. Section 
129 of the Act has specified a new definition of ``modified'' that 
combines and revises the previous definitions of ``modification'' and 
``reconstruction.'' Specifically, ``modified'' refers to:
    (1) modifications for which the
    * * * cumulative costs of the modifications, over the life of the 
unit, exceed 50 per centum of the original cost of the construction and 
installation of the unit (not including the cost of any land purchased 
in connection with such construction or installation) updated to 
current costs * * *

or (2) modification involving

    * * * a physical change in or change in the method of operation of 
the unit which increases the amount of any air pollutant emitted by the 
unit for which standards have been established under [section 129] or 
sections 111 * * *.
    A special provision has been included in the proposed NSPS and 
emission guidelines to address certain modifications to existing 
facilities. This provision states that if an existing MWI is modified 
for the purpose of meeting the requirements of the proposed guidelines 
for existing MWI's or State regulations developed to implement these 
guidelines, then the MWI would not be considered a ``modified'' MWI and 
would not be subject to the NSPS (40 CFR part 60, subpart Ec).
    On the other hand, if the existing facility is modified in ways not 
required to meet the emission guidelines, then the facility could be 
considered a ``modified'' MWI and could become subject to the NSPS. For 
example, if an existing pathological MWI, which was not originally 
designed to accommodate general medical waste, begins burning general 
medical waste, then that MWI may be considered a modified MWI and, as a 
result, will be subject to the NSPS.

D. Selection of Pollutants

    Section 129 of the Act requires that the standards and guidelines 
promulgated under sections 111 and 129 and applicable to all solid 
waste incineration units shall specify numerical emission limitations 
for the following substances or mixtures: PM (total and fine), opacity, 
SO<INF>2, HCl, NO<INF>X, CO, Pb, Cd, Hg, and CDD/CDF. For this reason, 
the MWI standards and guidelines specify numerical emission limits for 
these pollutants.

E. Selection of Affected and Designated Facilities

    As required by section 129 of the Act, the affected facility to 
which the proposed new source performance standards apply is each 
individual MWI for which construction is commenced after today's date 
or for which modification is commenced after the effective date of 
these standards. The designated facility to which the proposed emission 
guidelines apply is each existing MWI for which construction commenced 
on or before today's date. A facility that burns both municipal waste 
and medical waste could be subject to both the municipal waste 
combustor standards and guidelines and the medical waste incinerator 
standards and guidelines.

F. Selection of Format for the Proposed Standards and Emission 
Guidelines

    The format selected for the proposed standards and guidelines is a 
combination of emission limitations and percent reductions to ensure 
control of emissions. The specific format of the proposed standards and 
guidelines and the reasons for selection are discussed below.
    As required by section 129 of the Act, the proposed standards and 
guidelines would establish numerical emission limitations for PM, CO, 
CDD/CDF, HCl, SO<INF>2, NO<INF>X, Pb, Cd, and Hg. For the purpose of 
regulating PM and metals (Pb, Cd, and Hg) the format selected is a 
numerical concentration limit in units of mg/dscm corrected to 7 
percent oxygen. For the purpose of regulating Hg an alternative percent 
reduction is also proposed. The numerical Hg emission limit reflects 
the emission level that can be achieved based on a fabric filter (FF) 
system with activated carbon injection. Emissions of Hg can be highly 
variable and depend on the Hg input level. In cases where Hg levels are 
temporarily elevated due to variability in the waste feed, the 
numerical emission limit may not be consistently achievable. However, 
the control device is capable of achieving 85 percent reduction of 
elevated Hg levels.
    Under the proposed standards and guidelines, CDD/CDF emissions are 
measured in units of total ng/dscm or ng/dscm toxic equivalency (TEQ). 
To arrive at the TEQ, measured emissions of each tetra- through octa-
CDD and CDF congener are multiplied by the corresponding toxic 
equivalency factor (TEF) specified in the standards and guidelines (see 
Table 6). The products are then added to obtain the total concentration 
of CDD/CDF emitted in terms of TEQ.
    For CO, SO<INF>2, NO<INF>X, and HCl, the proposed standards and 
guidelines are volume concentrations corrected to 7 percent oxygen. For 
HCl, an alternative percent reduction is also proposed. A percent 
reduction is generally appropriate for acid gases emissions from MWI's. 
However, in cases where inlet levels are very low and the specified 
percent reduction would result in concentrations below the specified 
volume concentration (42 ppmv, which is a 97 percent reduction from 
typical uncontrolled emissions), these percent reductions may not be 
achievable. Therefore, the proposed HCl emission limits would require 
either a 97 percent reduction or a 42 ppmv HCl outlet concentration, 
which is based on reduction from typical uncontrolled emission levels, 
whichever is less stringent. An alternative percent reduction is not 
proposed for emissions of SO<INF>2 because at the low inlet levels 
associated with medical waste, EPA emission test data shows that acid 
gases controls are not effective in reducing SO<INF>2 emissions and as 
a result, SO<INF>2 limits are based on uncontrolled emissions.
    Under the proposed standards and guidelines, emission limits for Hg 
and HCl include stack concentrations as well as percent reductions. The 
EPA is requesting comments on the appropriateness of including a 
percent reduction along with a stack concentration limit in the 
standards and guidelines for these two pollutants.

G. Selection of Classes, Types, and Sizes

    Section 129 states that the Administrator may distinguish among 
[[Page 10670]] classes, types, and sizes of units within a category in 
establishing the standards and guidelines. In other words, EPA may 
subcategorize the MWI source category in establishing standards and 
guidelines. After reviewing the population of MWI's, the EPA believes 
that, for the purpose of regulatory development and of determining 
MACT, the MWI population should be divided into three subcategories: 
(1) continuous MWI's, (2) intermittent MWI's, and (3) batch MWI's. 
These three subcategories are based on differences in the design of the 
MWI's as discussed in the following paragraphs.
    In each of the design systems, sequential combustion operations 
typically are carried out in two separate chambers: primary and 
secondary. In the primary chamber, the waste is loaded and ignited, the 
volatile organic components driven off, and the nonvolatile materials 
combusted to ash. The volatile organic components released from the 
primary chamber are combusted in the secondary chamber. Newer MWI's are 
typically designed with 1-second (1-sec) residence time secondary 
chambers; older MWI's were designed with smaller, 0.25-second (0.25 
sec) residence time secondary chambers.
    While there are similarities in the three design types of MWI's, 
there are also key design differences that make each type unique. The 
primary differences between the three design types of MWI's are the 
methods of charging waste to and removing ash from the primary chamber. 
These differences cause variations in the way the waste is burned and 
in the pollutant emission profile for each MWI design type.
    Continuous units, which are the largest of the three types, have 
mechanical ram feeders and continuous ash removal systems. These 
features allow the unit to operate 24 hours per day for many days at a 
time. Continuous MWI's achieve steady-state operation in the beginning 
of their operating cycle and maintain this mode of operation throughout 
the remainder of the cycle. Waste is charged and ash is removed 
simultaneously (i.e., on a continuous basis). During operation, waste 
is burned at the same rate as it is charged into the unit, and 
pollutant emission rates and primary and secondary chamber temperatures 
tend to be relatively constant.
    Most intermittent MWI's also have mechanical ram feeders that 
charge waste into the primary chamber at about 5- to 10-minute 
intervals. However, because there is no means for ash removal during 
the burning phase of the operating cycle, the unit can only be operated 
for a limited number of hours before the accumulation of ash in the 
primary chamber requires the unit to be shut down for ash removal. 
Intermittent units, which are usually much smaller than continuous 
units, typically operate on a daily burn cycle of 10 to 14 hours. While 
these units tend to approach steady-state operation during the middle 
of their operating cycle, waste is normally being charged faster than 
it is being burned. Primary chamber temperatures tend to climb 
throughout the operating cycle until waste is no longer charged into 
the unit. Because there is a significant accumulation of unburned 
material in the primary chamber at the end of the charging period, 
these units are designed with a burndown/cooldown phase. Generally, 
pollutant emissions continue through this phase, which can continue for 
several hours after charging has ceased.
    The batch operating cycle consists of three phases: low-air, high-
air, and cooldown. All of the waste to be burned during a complete 
cycle is loaded into the primary chamber before the unit begins 
operation. Once the unit is filled with waste and the burning cycle 
begins, the charging door is not opened again until the cycle is 
complete and the unit is cool. This cycle normally takes 1 or 2 days, 
depending on the size of the unit and the amount of waste charged. 
During the low-air phase, temperatures in the primary chamber rise 
slowly because combustion is occurring only on the surface of the waste 
pile and because combustion air is restricted. When the high-air phase 
begins, the temperatures climb more rapidly, more volatiles are exposed 
to the flame front, and the combustion process quickens. Batch MWI's 
tend to approach steady-state operation at the end of the low-air 
phase, when the primary chamber temperature reaches the design 
operating range. Pollutant emission rates also tend to increase in the 
second half of the low-air phase, then level off, and continue steadily 
during the high-air and cooldown phases. Pollutant concentrations 
during the high-air phase of batch MWI's are similar to concentrations 
during the charging period for continuous and intermittent units.
    The differences in typical hours of operation, discussed above, 
affect the potential for total emissions (on a mass basis) from each 
MWI type. Continuous MWI's, which can accommodate waste charging for an 
unrestricted length of time, will have the greatest potential emissions 
because waste burning and subsequent emissions can occur continuously. 
Intermittent MWI's, designed to accept waste charges at periodic 
intervals for between 8 and 14 hours, will be limited in potential 
emissions by periods of shutdown required to remove ash from the 
incinerator. The hours of operation, limited by the time required to 
remove ash, result in less potential emissions from intermittent MWI's 
than from continuous MWI's. Batch MWI's are designed to burn only one 
load of waste at a time. The operating cycle normally takes 1 or 2 
days, depending on the size of the unit and the amount of waste 
charged. Potential emissions from batch MWI's are lower than continuous 
and intermittent MWI's because of the significant difference in the 
total amount of waste burned over a given period of time.
    Typical uncontrolled emission levels for each of the three 
subcategories are presented in Tables 11a and 11b. Table 11a shows 
uncontrolled emissions from new MWI's, while Table 11b shows 
uncontrolled emissions from existing MWI's. These emission levels 
reflect concentrations when the MWI is operating at steady-state 
conditions, which include the high-air phase for the batch MWI and the 
charging period for continuous and intermittent MWI's. As noted 
elsewhere, the EPA specifically solicits comment on the determination 
to distinguish between continuous, intermittent, and batch units.

        Table 11a.--Typical Uncontrolled Emissions From New MWI's       
------------------------------------------------------------------------
           Pollutant             Continuous   Intermittent      Batch   
------------------------------------------------------------------------
PM, mg/dscm...................        300           300           300   
CO, ppmv......................        300           300           300   
CDD/CDF, ng/dscm..............      6,600         6,600         6,600   
HCI, ppmv.....................      1,400         1,400         1,400   
SO<INF>2, ppmv.....................         16            16            16   
NO<INF>X, ppmv.....................        140           140           140   
[[Page 10671]]
                                                                        
Pb, mg/dscm...................          4.2           4.2           4.2 
Cd, mg/dscm...................          0.29          0.29          0.29
Hg, mg/dscm...................          3.1           3.1           3.1 
------------------------------------------------------------------------


                         Table 11b.--Typical Uncontrolled Emissions From Existing MWI's                         
----------------------------------------------------------------------------------------------------------------
                                                           Continuous    Continuous                             
                        Pollutant                          (0.25-sec)      (1-sec)    Intermittent      Batch   
----------------------------------------------------------------------------------------------------------------
PM, mg/dscm.............................................        570           300           570           570   
CO, ppmv................................................        690           300           690           690   
CDD/CDF, ng/dscm........................................     25,000         6,600        25,000        25,000   
HCI, ppmv...............................................      1,400         1,400         1,400         1,400   
SO<INF>2, ppmv...............................................         16            16            16            16   
NO<INF>X, ppmv...............................................        140           140           140           140   
Pb, mg/dscm.............................................          4.2           4.2           4.2           4.2 
Cd, mg/dscm.............................................          0.29          0.29          0.29          0.29
Hg, mg/dscm.............................................          3.1           3.1           3.1           3.1 
----------------------------------------------------------------------------------------------------------------

  One specific approach which EPA is considering and on which EPA 
requests comment is that of further subcategorizing batch and 
intermittent MWI's by size or capacity to burn medical waste. Some have 
suggested, for example, that EPA examine alternatives, such as 
subcategorizing these categories into incinerators with capacities of 
50 pounds per hour or less, 100 pounds per hour or less, 200 pounds per 
hour or less, etc. A number of States have already established 
subcategories based on size which exempt the smallest incinerators or 
impose less stringent requirements on such incinerators. Current State 
regulations, therefore, may provide a basis for further subcategorizing 
the categories of batch and intermittent MWI's.
    To fully consider subcategorization by size within the batch and 
intermittent categories, however, a mechanism must be available to 
accurately and consistently determine the capacity of an MWI. Only if 
such a mechanism exists, will enforcement personnel, as well as owners 
and operators of MWI's, be assured that MWI's are subject to a 
consistent set of requirements.
    The EPA believes this may be a serious problem. It appears there is 
no common or widely used mechanism or ``standard'' within the MWI 
industry for sizing or determining the capacity of an incinerator to 
burn medical waste. As a result, it seems that one vendor's 50 pound 
per hour capacity incinerator can be another vendor's 100 pound per 
hour capacity incinerator. It also appears the same vendor may sell one 
customer a 50 pound per hour capacity MWI and then sell another 
customer the same incinerator as a 100 pound per hour MWI. The EPA 
believes that a manufacturer's or vendor's ``nameplate capacity'' is 
not an accurate and reliable means for determining the size or capacity 
of an MWI.
    The EPA recognizes that the composition of medical waste changes 
across generators, over time, and in response to changes in waste 
handling or recycling practices in a way that may affect the amount of 
medical waste a specific incinerator is able to burn. For the purposes 
of enforcing regulations that may vary by size or capacity, a common 
mechanism or ``standard'' to measure or determine the capacity of MWI's 
is necessary.
    Consequently, EPA specifically requests comments on a mechanism or 
``standard'' for accurately and consistently determining the capacity 
of MWI's in the enforcement of whatever regulation might be adopted. 
For example, the comments might outline the mechanisms or approaches 
used by States to ensure all MWI's of the same capacity are subject to 
the same requirements. Or, the comments may offer alternative measures 
of capacity that serve as a better basis for identifying small 
intermittent and/or small batch MWI's. Finally, the manufacturers may 
choose to develop a voluntary approach providing a consistent measure 
of rated capacity.

H. Performance of Technology

    Medical waste incinerator emissions are mixtures of pollutants 
including acid gases (HCl and SO<INF>2), NO<INF>X, CO, PM, CDD/CDF, and 
metals (Pb, Cd, and Hg). There are basically two approaches to 
controlling these emissions: combustion control and add-on air 
pollution control. These approaches will be discussed in sections 1. 
and 2. below.
    The first approach, combustion control, can be broken down into 
three levels that are based on the flue gas residence time in the 
secondary chamber. These three levels are 0.25-sec combustion, 1-sec 
combustion, and 2-sec combustion.
    The second approach can be further broken down into various add-on 
control systems, including wet systems, fabric filter systems without 
activated carbon injection, and fabric filter systems with activated 
carbon injection. The control of NO<INF>X will also be discussed under 
add-on control systems.
    One additional area that has been suggested for consideration is 
waste segregation. This topic will be discussed in paragraph 3. of this 
section.

1. Combustion Control

    Combustion control includes the proper design, construction, 
operation, and maintenance of an MWI to destroy or prevent the 
formation of air pollutants prior to their release to the atmosphere. 
Test data indicate that as secondary chamber residence time and 
temperature increase, emissions decrease. Combustion control is most 
effective in reducing CDD/CDF, PM, and CO emissions.
    The 0.25-sec combustion level includes a minimum secondary chamber 
temperature of 927  deg.C (1700  deg.F) and a 0.25-sec secondary 
chamber residence time. These combustion conditions are typical of 
older MWI's.
    The 1-sec combustion level includes a minimum secondary chamber 
temperature of 927 deg.C (1700 deg.F) and residence time of 1-sec. 
These combustion conditions are typical of newer MWI's. Compared to 
0.25-sec combustion, 1-sec combustion will achieve substantial 
reductions in CDD/CDF and CO emissions, and will [[Page 10672]] provide 
some control of PM, but will not reduce emissions of acid gases (HCl 
and SO<INF>2), NO<INF>X, or metals (Pb, Cd, and Hg).
    The 2-sec combustion level includes a minimum secondary chamber 
temperature of 1800 deg.F and residence time of 2-sec. These combustion 
conditions will provide additional control of CDD/CDF, CO, and PM, but 
will not reduce emissions of acid gases (HCl and SO<INF>2), NO<INF>X, 
or metals (Pb, Cd, and Hg). The 2-sec combustion conditions are 
considered to be the best level of combustion control that is applied 
to MWI's.

2. Add-On Control

    Add-on control refers to various add-on air pollution control 
systems used in addition to 2-sec combustion to capture pollutants as 
they leave the incinerator. Add-on controls include wet systems, fabric 
filter systems without activated carbon injection, and fabric filter 
systems with activated carbon injection. Because Pb and Cd are 
associated with PM in the flue gas and are removed by PM control 
devices, these three pollutants are considered as a group when 
evaluating MACT. Similarly, SO<INF>2 and HCl are considered together 
because generally, they are both reduced using acid gas controls.
    a. Wet systems. Wet systems include scrubbing systems such as a 
venturi scrubber (VS) or a venturi scrubber followed by a packed-bed 
absorber (VS/PB). Compared to combustion control, wet systems achieve 
substantial reductions in HCl emissions, provide some control of Pb and 
Cd, and further reduce PM and CDD/CDF emissions, but do not add to the 
control of NO<INF>X, CO, or Hg. However, at the low SO<INF>2 levels 
associated with MWI's, wet systems are not, in EPA's experience, 
effective in reducing SO<INF>2 emissions. As discussed in section VI, 
EPA requests comment on the performance and costs of wet scrubber 
systems.
    b. Fabric filter systems without carbon injection. Fabric filter 
systems include a fabric filter followed by a packed bed absorber (FF/
PB), dry sorbent injection followed by a fabric filter (DI/FF), or a 
spray dryer followed by a fabric filter (SD/FF). The SD/FF and the DI/
FF systems have the same performance based on EPA MWI test data. The 
fabric filter alone was not examined because wet systems achieve 
greater overall emission reduction at a lower cost.
    Compared to wet systems, fabric filter systems generally provide 
additional control of PM, Pb, and Cd, but do not add to the control of 
acid gases, NO<INF>X, CO, or Hg. The performance of the three fabric 
filter systems in reducing CDD/CDF emissions varies significantly. 
Compared to combustion control, the DI/FF and SD/FF systems provide no 
additional control of CDD/CDF, while formation of CDD/CDF is a 
potential problem with the FF/PB system.
    Formation of CDD/CDF occurs when there is intimate contact between 
a gas stream containing CDD/CDF precursors and fly ash, which acts as a 
catalyst for CDD/CDF formation. The optimum temperature window for fly 
ash catalyzed CDD/CDF formation is between 300 deg. and 600 deg.F. The 
formation of CDD/CDF is minimized when using combustion control or wet 
systems because these options provide: (1) rapid cooling of the gas 
stream through the temperature window; and/or (2) quick dispersion (or 
removal in the case of wet systems) of CDD/CDF precursors and fly ash. 
In DI/FF and SD/FF systems, the presence of an acid gas sorbent (lime, 
for example) also limits the formation of CDD/CDF. The fabric filter in 
a FF/PB system, on the other hand, can provide those conditions 
conducive to CDD/CDF formation. In fact, test data have shown CDD/CDF 
formation in the FF/PB system.
    c. Fabric filter systems with carbon injection. Data from a DI/FF 
system and a SD/FF system show that the injection of activated carbon 
upstream of the fabric filter results in significant reductions in CDD/
CDF and Hg emissions, compared to wet systems and FF systems without 
carbon. Because no data are available from a FF/PB system with carbon 
injection, and because CDD/CDF formation occurred in a FF/PB system, it 
is not known exactly what CDD/CDF emission reductions can be achieved 
with this system. However, it is expected that the injection of carbon 
will improve the performance of a FF/PB system in reducing CDD/CDF 
emissions.
    d. Nitrogen oxides control. During combustion, NO<INF>X is formed 
through oxidation of fuel-bound nitrogen (N<INF>2) contained in the 
medical waste and oxidation of atmospheric N<INF>2 (from the combustion 
air). Selective noncatalytic reduction (SNCR) add-on technology has 
been used to control NO<INF>X emissions from municipal waste combustors 
(MWC's) by reducing NO<INF>X to N<INF>2 without the use of catalysts. 
Techniques include Thermal DeNO<INF>X<SUP>TM, which injects ammonia 
into the combustor as a reducing agent; the NO<INF>XOUT<SUP>TM process, 
which injects urea with chemical additives; and a two-stage urea/
methanol injection process. Maximum emissions reduction occurs when the 
reducing agents are injected into a gas stream within a narrow 
temperature range and the gas is maintained in that range for a 
sufficient length of time.
    A discussion of SNCR NO<INF>X control was presented in the recent 
proposal preamble for the MWC NSPS (59 FR 181 page 48228). The use of 
SNCR at MWC's results in NO<INF>X emission reductions of about 45 
percent.
    There are some concerns about the applicability of SNCR to MWI's. 
The SNCR technology has never been applied to MWI's, and several 
factors may complicate the use of SNCR and may reduce its performance 
level. The periodic charging of waste may cause corresponding 
temperature fluctuations, and the varying moisture and nonhomogeneous 
nature of the waste burned. When the temperature rises above the 
required injection temperature window, the reducing agent is oxidized 
to NO<INF>X, and NO<INF>X emissions can increase. In the event of low 
temperatures, unreacted ammonia (NH<INF>3) emissions can occur.
    Furthermore, uncertainties exist regarding the injection pattern 
necessary to achieve adequate mixing and residence time in the 
operating temperature window and in the design and engineering work 
necessary to develop equipment that could be used in applications with 
much smaller gas flow rates than those for MWC's. Consequently, SNCR is 
not considered a demonstrated control technology for MWI's.
    Although SNCR is not considered a demonstrated control technology 
for MWI's, the EPA specifically solicits comments on the technical 
feasibility of applying NO<INF>X control to MWI's. Specifically, the 
EPA solicits information on the performance, including control device 
inlet and outlet emissions data, costs, applicability, and operating 
experience associated with specific NO<INF>X control technologies for 
MWI's.
    3. Waste segregation. One area that has been suggested for 
consideration is waste segregation. It has been suggested that removal 
of batteries would reduce Hg emissions and that removal of chlorinated 
plastics would result in reductions in HCl and CDD/CDF. The EPA data 
indicate that these emissions vary from facility to facility which 
could be a result of differences in the amount of Hg and chlorine found 
in the waste stream. The types of materials that are sent to the 
incinerator will vary from facility to facility depending on facility 
operating practices, which are defined by purchasing decisions, waste 
handling procedures, and other practices that affect the types of 
materials incinerated. The EPA has no data on the effect of waste 
handling practices on emissions [[Page 10673]] of various pollutants 
and is requesting comments on the extent to which operating practices 
could influence emissions. To evaluate the effectiveness of waste 
segregation programs, the EPA is specifically soliciting detailed 
descriptions of the programs and results of performance tests conducted 
to demonstrate pollutant emission levels from the MWI prior to 
implementation of the program and subsequent to implementation of the 
program. This information is critical to a thorough evaluation of the 
effectiveness of the program. In addition, the EPA solicits comments on 
how such a program could be incorporated into the MWI regulations. 
Whenever information is submitted relative to Hg emissions, the EPA 
requests that, if available, Hg emissions data be broken out by various 
species emitted (for example mercury chloride or elemental mercury).

I. MACT Floor and MACT for New MWI's

    Section 129 of the Clean Air Act requires that emission standards 
reflect MACT. According to section 129, the degree of reduction in 
emissions that is deemed achievable for new MWI's may not be less 
stringent than the emissions control that is achieved in practice by 
the best controlled similar unit. As a result, the emission limits 
selected to reflect MACT for new MWI's must, at a minimum, be as 
stringent as the emission levels achieved by the best controlled 
similar unit. This minimum performance level is known as the MACT 
floor. Beyond the MACT floor, in determining what performance level 
should be adopted in the standards as MACT, the Administrator is to 
consider the costs, any nonair-quality health and environmental impacts 
and energy requirements associated with such emission limits.
    The basis for MACT determinations are presented for each 
subcategory in paragraphs I1, I2, and I3 of this section. The EPA 
solicits comments on whether test data are available from MWI's that 
are achieving better control than the systems used as the basis for the 
MACT determinations. If submitting Hg data, EPA specifically requests 
that, if available, Hg emission data be broken down by various species 
emitted (for example, mercury chloride and elemental mercury).
    While the paragraphs that follow focus on specific control 
technologies in determining the MACT floor and MACT for new MWI's, the 
standards do not require the use of any specific technology. The 
Agency's assessment of the performance of specific technologies is used 
to develop emission limitations, which appear in the regulation. Any 
control technology that can comply with the emission limitations may be 
used.
1. MACT Floor and MACT for New Continuous MWI's
    As discussed in section VI, the discussion that follows is based in 
part on limited test data on wet scrubber systems. The EPA requests 
comment on the performance and costs of wet scrubber systems.
    The MACT floor for continuous MWI's consists of the emission levels 
that are achievable with DI/FF with carbon injection. The MACT floor is 
based on these emission levels because DI/FF with carbon injection 
achieves the lowest emission levels for all pollutants, and it is used 
to control emissions from at least one existing continuous MWI. While 
the lowest emission levels for most of the pollutants are achieved by 
several different control technologies (including DI/FF with carbon 
injection), the lowest Hg and CDD/CDF emission levels for continuous 
MWI's are achieved only with DI/FF with carbon injection.
    Because the MACT floor is the most effective level of control for 
continuous units, there are no alternatives beyond the MACT floor to 
consider. The level of emission control achieved by a DI/FF system with 
carbon injection is considered MACT for continuous MWI's.
    As discussed earlier, NO<INF>X control has not been demonstrated on 
MWI's and acid gas controls are not effective in reducing SO<INF>2 
emissions from MWI's. Therefore, MACT reflects no control of NO<INF>X 
and SO<INF>2. However, because the Act requires EPA to set numerical 
emission limits for NO<INF>X and SO<INF>2, the limits are proposed at 
210 ppmv for NO<INF>X and 45 ppmv for SO<INF>2, the highest 
uncontrolled NO<INF>X and SO<INF>2 emission rates measured during the 
EPA test program. The EPA specifically solicits comments on the 
emission limits of 45 ppmv set for SO<INF>2 and 210 ppmv set for 
NO<INF>X and whether these levels accurately reflect uncontrolled 
emissions of NO<INF>X and SO<INF>2 at MWI's.
2. MACT Floor and MACT for New Intermittent MWI's
    As discussed in section VI, the discussion that follows is based in 
part on limited test data on wet scrubber systems. The EPA requests 
comment on the performance and costs of wet scrubber systems.
    The MACT floor for intermittent MWI's is based on the emission 
levels that are achievable with a combination of two control 
technologies. The VS/PB and DI/FF without carbon injection technologies 
are each used to control emissions from at least one intermittent MWI. 
The MACT floor is based on both of these technologies because VS/PB 
achieves the lowest CDD/CDF emissions, but DI/FF without carbon 
injection achieves the lowest PM, Pb, and Cd emissions. The MACT floor 
emission levels for the other pollutants can be achieved with either 
technology. Therefore, one way to achieve all of the MACT floor 
emission levels for intermittent MWI's would be to use a combination of 
both VS/PB and DI/FF without carbon injection.
    Another approach, which is less complex and less costly than the 
above combination of controls, could also be used to achieve the MACT 
floor emission levels. As noted in the discussion of the MACT floor for 
continuous MWI's, the CDD/CDF emission levels achievable with the DI/FF 
with carbon injection are even lower than those achievable with the VS/
PB system. Even though this technology is not known to be used with 
existing intermittent MWI's, it could achieve better performance for a 
much lower cost than the combination of controls described above, and 
therefore the MACT floor for new intermittent MWI's is based on these 
emission levels.
    Because the MACT floor is the most effective level of control for 
intermittent units, there are no alternatives beyond the MACT floor to 
consider. The level of emission control achieved by a DI/FF system with 
carbon injection is considered MACT for intermittent MWI's.
    As discussed earlier, NO<INF>X control has not been demonstrated on 
MWI's and acid gas controls are not effective in reducing SO<INF>2 
emissions from MWI's. Therefore, MACT reflects no control of NO<INF>X 
and SO<INF>2. However, because the Act requires EPA to set numerical 
emission limits for NO<INF>X and SO<INF>2, the limits are proposed at 
210 ppmv for NO<INF>X and 45 ppmv for SO<INF>2, the highest 
uncontrolled NO<INF>X and SO<INF>2 emission rates measured during the 
EPA test program. The EPA specifically solicits comments on the 
emission limits of 45 ppmv set for SO<INF>2 and 210 ppmv set for 
NO<INF>X and whether these levels accurately reflect uncontrolled 
emissions of NO<INF>X and SO<INF>2 at MWI's.
3. MACT Floor and MACT for New Batch MWI's
    As discussed in section VI, the discussion that follows is based in 
part on limited test data on wet scrubber systems. The EPA requests 
comment on the performance and costs of wet scrubber systems. 
[[Page 10674]] 
    Like the MACT floor for intermittent MWI's, the MACT floor for new 
batch MWI's consists of the emission levels that are achieved with a 
combination of two control technologies. The 2-sec combustion control 
is used to control emissions from many existing batch MWI's, and FF/PB 
is used to control emissions from at least one batch MWI; no other add-
on control technologies have been identified on batch units. The FF/PB 
achieves lower PM, Pb, Cd, and HCl emissions than 2-sec combustion 
control, but because CDD/CDF formation can occur in a FF/PB system, 2-
sec combustion control alone achieves lower CDD/CDF emissions. 
Equivalent emission levels for other pollutants are achieved with both 
technologies. The MACT floor for all pollutants can be achieved with 
the use of another technology: DI/FF without carbon injection. Except 
for CDD/CDF, this technology achieves the same emission levels as FF/
PB, and the CDD/CDF emissions are the same as those for 2-sec 
combustion control alone. Therefore, the MACT floor for new batch MWI's 
consists of the emission levels that are achievable with DI/FF without 
carbon injection.
    Unlike continuous and intermittent MWI's, there is a level of 
control more effective than the MACT floor for batch MWI's. This level 
of control is achieved by adding carbon to the DI/FF system. The result 
is further reduction in CDD/CDF emissions along with significant Hg 
control. The incremental national annual cost of this option is about 
$740,000, or about $170/ton of waste burned nationwide. The national 
annual costs increase by only about 3 percent. Therefore, the level of 
control achieved by the DI/FF system with carbon injection is 
considered MACT for batch MWI's.
    As discussed earlier, NO<INF>X control has not been demonstrated on 
MWI's and acid gas controls are not effective in reducing SO<INF>2 
emissions from MWI's. Therefore, MACT reflects no control of NO<INF>X 
and SO<INF>2. However, because the Act requires EPA to set numerical 
emission limits for NO<INF>X and SO<INF>2, the limits are proposed at 
210 ppmv for NO<INF>X and 45 ppmv for SO<INF>2, the highest 
uncontrolled NO<INF>X and SO<INF>2 emission rates measured during the 
EPA test program. The EPA specifically solicits comments on the 
emission limits of 45 ppmv set for SO<INF>2 and 210 ppmv set for 
NO<INF>X and whether these levels accurately reflect uncontrolled 
emissions of NO<INF>X and SO<INF>2 at MWI's.

J. MACT Floor and MACT for Existing MWI's

1. MACT Floor for Existing MWI's
    Section 129 of the Act requires that emission guidelines reflect 
MACT. According to section 129, the degree of reduction in emissions 
that is deemed achievable for existing MWI's must not be less stringent 
than the average emission limitation achieved by the best performing 12 
percent of units in the category. In setting MACT standards, the EPA 
must establish the MACT floor for a source category because the Act 
specifies that each standard must be at least as stringent as the floor 
for the relevant source category. For the MWI source category, the EPA 
did not have sufficient emissions data to determine the MACT floor. 
Data was only available from 7 MWI facilities (8 emissions tests), to 
represent 3,700 existing MWI's. As a result, the EPA examined air 
quality permits and State regulations to determine the emission 
limitations achieved by the best-performing 12 percent of units in each 
subcategory.
    Emission limitations were determined for the estimated total MWI 
population by examining air quality permits where available and by 
assuming that the estimated population of MWI's for which permits were 
not available are subject to emission limitations specified by State 
regulations. It was assumed that all MWI's are either achieving their 
permit limits or are achieving their State regulatory emission limits.
    For each subcategory, the emission limitations for each pollutant 
were ranked from most stringent to least stringent and the MACT floors 
for each pollutant were determined by averaging the emission 
limitations of the top 12 percent of units in that subcategory. In some 
cases, the number of MWI's subject to specific emission limitations did 
not comprise 12 percent of the population in a subcategory. Where this 
occurred, numerical emission limits were established for the MACT floor 
by including uncontrolled emission values for the additional number of 
MWI's necessary to make up 12 percent of the existing population.
    The MACT floors define the minimum level of emissions control. 
Beyond these levels, in determining what performance levels should be 
adopted in the guidelines as MACT, the Administrator is to consider the 
costs, any nonair-quality health and environmental impacts, and energy 
requirements associated with such emission limits.
    An estimated 338 continuous, 3,018 intermittent, and 336 batch 
MWI's exist nationwide. For each of these subcategories, the MACT floor 
emission levels for each pollutant are calculated as the averages of 
the emission limitations reported by the top 12 percent of units in 
that subcategory. The top 12 percent of units in each subcategory is 
represented by the 41 continuous, 363 intermittent, and 41 batch MWI's 
with the most stringent permit or state regulation limitations. The 
MACT floor emission levels for each pollutant in each subcategory are 
presented in Table 12.

        Table 12.--MACT Floor Emission Levels for Existing MWI's        
------------------------------------------------------------------------
                                                  MWI type              
             Pollutant             -------------------------------------
                                    Continuous  Intermittent     Batch  
------------------------------------------------------------------------
PM, mg/dscm.......................       46            69           69  
CO, ppmv..........................       76            90           91  
CDD/CDF, ng/dscm..................    1,619        12,906       14,606  
HC1, ppmv.........................       43           115          911  
SO<INF>2, ppmv.........................      284           414        1,166  
NO<INF>X, ppmv.........................      257           216          220  
Pb, mg/dscm.......................        8.7          11.8         23.1
Cd, mg/dscm.......................        0.56          1.8          3.4
Hg, mg/dscm.......................        4.0          15.6         18.5
------------------------------------------------------------------------


[[Page 10675]]


    As noted above, EPA is also considering further subcategorizing 
batch and intermittent MWI's by size or capacity to burn medical waste. 
Specifically, some have suggested EPA consider alternatives, such as 
subcategorizing these categories into incinerators with capacities of 
50 pounds per hour or less, 100 pounds per hour or less, 200 pounds per 
hour or less, etc. A number of States have regulations which exempt the 
smallest medical waste incinerators or impose less stringent 
requirements on such incinerators.
    Subcategorization of the batch and intermittent MWI categories 
could find that the MACT floor for small intermittent and/or small 
batch incinerators is less stringent than the MACT floor for larger 
incinerators in these categories. The MACT floor for small intermittent 
and/or small batch MWI's within these categories, for example, could be 
much less stringent than the MACT floor of 69 mg/dscm identified above 
for both batch and intermittent incinerators.
2. MACT for Existing Continuous MWI's
    As discussed in section VI, the discussion that follows is based on 
limited test data on wet scrubber systems. The EPA requests comment on 
the performance and costs of wet scrubber systems. Also, while the 
paragraphs that follow focus on specific control technologies in 
determining MACT for existing continuous MWI's, the guidelines do not 
require the use of any specific technology. The Agency's assessment of 
the performance of specific technologies is used to develop emission 
limitations, which appear in the guidelines. Any control technology 
that can comply with the emission limitations may be used.
    a. MACT for PM, Pb, and Cd. Uncontrolled PM emissions typically are 
570 mg/dscm for MWI's with 0.25-sec combustion and 300 mg/dscm for 
MWI's with 1-sec combustion. The MACT floor for PM is 46 mg/dscm. A 
fabric filter system is necessary to meet the MACT floor level. The FF 
system is capable of achieving PM emission levels of as low as 30 mg/
dscm.
    Typical uncontrolled Pb and Cd emission are 4.2 mg/dscm and 0.29 
mg/dscm, respectively. The MACT floors for Pb and Cd are 8.65 mg/dscm 
and 0.56 mg/dscm, respectively. Although no control is necessary to 
achieve the MACT floor levels for Pb and Cd, the fabric filter system 
that would be needed to meet the MACT floor emission level for PM, 
would reduce Pb and Cd emissions to 0.10 mg/dscm and 0.05 mg/dscm, 
respectively. Because this system is already necessary to meet the MACT 
floor level for PM, there is no cost associated with reducing emissions 
of Pb and Cd from the uncontrolled MACT floor levels to the level of 
control achieved by the FF system. Additional control beyond the FF 
system has not been demonstrated for any of these pollutants. As a 
result, the proposed MACT for PM, Pb, and Cd for continuous MWI's are 
the levels achievable with the FF system: 30 mg/dscm for PM, 0.10 mg/
dscm for Pb, and 0.05 mg/dscm for Cd.
    b. MACT for Carbon Monoxide. Typical uncontrolled emissions of CO 
at continuous MWI's are 690 ppmv for units with 0.25-sec combustion and 
300 ppmv for units with 1-sec combustion. As discussed earlier, the 
MACT floor for CO is 76 ppmv. Two-second combustion control is 
necessary to meet the MACT floor level for CO and is capable of 
achieving CO levels as low as 50 ppmv at no additional cost. Further 
reduction of CO emissions has not been demonstrated. Therefore, the 
proposed MACT for CO is 50 ppmv, the level achievable by 2-sec 
combustion.
    c. MACT for Dioxins and Furans. Typical uncontrolled emissions of 
dioxins and furans (CDD/CDF) are 25,000 ng/dscm for MWI's with 0.25-sec 
combustion and 6,600 ng/dscm for MWI's with 1-sec combustion. The MACT 
floor for CDD/CDF is 1,619 ng/dscm. Two-second combustion control is 
necessary to meet the MACT floor level for CDD/CDF and is capable of 
achieving CDD/CDF levels of 1,500 ng/dscm, at no additional cost.
    As discussed earlier, an FF system is needed to achieve the MACT 
floor for PM. Control of CDD/CDF beyond the level of emissions 
achievable with 2-sec combustion control can be attained either by 
adding a wet system or by injecting activated carbon into the FF 
system. Although the wet system is capable of reducing CDD/CDF 
emissions, the less expensive approach would be to inject carbon into 
the FF system because the FF system is already needed to meet the MACT 
floor level for PM. By injecting carbon into the FF system, CDD/CDF 
emissions could be reduced to about 80 ng/dscm and Hg emissions could 
substantially be reduced. The nationwide incremental annual cost of 
carbon injection is about $9.4 million/yr, or about $12/ton of waste 
burned in continuous MWI's. This incremental cost represents an 
increase of only about 5.8 percent over the cost of the FF system 
without carbon injection. As a result, MACT for CDD/CDF is the level of 
control achievable with an FF system with carbon injection, 80 ng/dscm 
total CDD/CDF, or 1.9 ng/dscm TEQ. To arrive at the TEQ, measured 
emissions of each tetra- through octa- CDD and CDF congener are 
multiplied by the corresponding toxic equivalency factor (TEF) 
specified in Sec. 60.36c of the proposed emission guidelines. The 
products are then added to obtain the concentration of CDD/CDF emitted 
in terms of TEQ.
    d. MACT for Mercury. Typical uncontrolled Hg emissions are 3.1 mg/
dscm. The MACT floor for Hg is 4.04 mg/dscm. No control of Hg is 
necessary to meet the MACT floor emission level.
    The only control system capable of consistently reducing Hg 
emissions is the FF system with carbon injection, which can achieve 
emissions of 0.47 mg/dscm Hg or 85 percent reduction from uncontrolled 
emissions. The FF system without carbon injection is necessary to meet 
the MACT floor for PM and the injection of carbon is necessary to meet 
the proposed MACT emission level for CDD/CDF. As mentioned above in the 
discussion on CDD/CDF, the nationwide incremental annual cost of 
injecting carbon is about $9.4 million/yr, or about $12/ton of waste 
burned. This additional cost represents an increase of only about 5.8 
percent over the cost of the FF system without carbon injection. 
Therefore, the proposed MACT for Hg is 0.47 mg/dscm or 85 percent 
reduction.
    e. MACT for acid gases (HCl and SO<INF>2). Typical uncontrolled 
emissions of HCl and SO<INF>2 from continuous MWI's are 1,400 ppmv for 
HCl and 16 ppmv for SO<INF>2. In general, acid gases controls are 
capable of reducing emissions of both HCl and SO<INF>2. However, in 
EPA's experience, acid gases controls are not effective in reducing 
emissions of SO<INF>2 from MWI's because of the low SO<INF>2 inlet 
levels associated with the incineration of medical waste. The emissions 
of HCl from MWI's, on the other hand, are reduced by acid gas controls. 
As discussed earlier, the MACT floor for HCl is 43 ppmv. A reduction of 
97 percent from uncontrolled levels is necessary to achieve the MACT 
floor for HCl. Wet systems and FF systems are each capable of reducing 
HCl emissions to 42 ppmv or by 97 percent from uncontrolled levels. 
Therefore, MACT for HCl is 42 ppmv or 97 percent reduction.
    Typical uncontrolled emissions of SO<INF>2 are 16 ppmv, but can 
range as high as 45 ppmv. The MACT floor for SO<INF>2 is 284 ppmv, and 
can be achieved at uncontrolled levels. Consequently, the MACT floor 
requires no control of SO<INF>2. As discussed earlier, acid gas 
controls are not effective in reducing SO<INF>2 emissions from MWI's. 
Therefore, MACT also reflects no control of SO<INF>2. 
[[Page 10676]] However, because the Act requires the EPA to set a 
numerical emission limit for SO<INF>2, the limit is proposed at 45 
ppmv, the highest SO<INF>2 emission rate measured during the EPA test 
program. The EPA specifically solicits comments on the emission limit 
of 45 ppmv set for SO<INF>2 and whether this level accurately reflects 
uncontrolled emissions of SO<INF>2 at MWI's.
    f. MACT for Nitrogen Oxides. Typical uncontrolled emissions of 
NO<INF>X are 140 ppmv but range as high as 210 ppmv. The MACT floor for 
NO<INF>X is 257 ppmv, and can be achieved at uncontrolled levels. As 
discussed earlier, NO<INF>X control has not been demonstrated on MWI's. 
Therefore, MACT also reflects no control of NO<INF>X. However, because 
the Act requires the EPA to establish a numerical emission limit for 
NO<INF>X, the limit is proposed as 210 ppmv, the highest NO<INF>X 
emission rate measured during the EPA test program. The EPA 
specifically solicits comments on the emission limit of 210 ppmv set 
for NO<INF>X and whether this level accurately reflects uncontrolled 
emissions of NO<INF>X at MWI's.
3. MACT for Existing Intermittent MWI's
    As discussed in section VI, the discussion that follows is based on 
limited test data on wet scrubber systems. The EPA requests comment on 
the performance and costs of wet scrubber systems. Also, while the 
paragraphs that follow focus on specific control technologies in 
determining MACT for existing intermittent MWI's, the guidelines do not 
require the use of any specific technology. The Agency's assessment of 
the performance of specific technologies is used to develop emission 
limitations, which appear in the guidelines. Any control technology 
that can comply with the emission limitations may be used.
    a. MACT for PM, Pb, and Cd. Typical uncontrolled emissions of PM 
from intermittent MWI's are about 570 mg/dscm. The MACT floor for PM 
emissions from intermittent MWI's is 69 mg/dscm. A fabric filter system 
is necessary to meet the MACT floor level. In fact, the FF system can 
reduce PM emissions even further, to 30 mg/dscm, at no additional cost.
    Uncontrolled emissions of Pb and Cd are 4.2 mg/dscm and 0.29 mg/
dscm, respectively. The MACT floors for Pb and Cd are 11.78 mg/dscm and 
1.76 mg/dscm, respectively. Although no control is necessary to achieve 
the MACT floor levels for Pb and Cd, the FF system necessary to meet 
the MACT floor level for PM would also reduce emissions of Pb and Cd to 
0.10 mg/dscm and 0.05 mg/dscm, respectively. Because this system is 
already necessary to meet the MACT floor level for PM, there is no cost 
associated with reducing emissions of Pb and Cd from the uncontrolled 
MACT floor levels to the level of control achieved by the FF system. 
Further reduction of Pb and Cd has not been demonstrated. Therefore, 
the proposed MACT for intermittent MWI's is the level of control 
achievable with the FF system: 30 mg/dscm for PM, 0.10 mg/dscm for Pb, 
and 0.05 mg/dscm for Cd.
    b. MACT for Carbon Monoxide. Typical uncontrolled emissions of CO 
at intermittent MWI's are about 690 ppmv. The MACT floor is 90 ppmv. 
Two-second combustion control is necessary to meet the MACT floor level 
and is capable of achieving CO levels as low as 50 ppmv at no 
additional cost. Further reduction of CO emissions has not been 
demonstrated. Therefore, the proposed MACT for CO is 50 ppmv, the level 
achievable with 2-sec combustion.
    c. MACT for Dioxins and Furans. Uncontrolled levels of dioxins and 
furans (CDD/CDF) are typically about 25,000 ng/dscm. The MACT floor for 
CDD/CDF is 12,906 ng/dscm. One-second combustion control is necessary 
to achieve the MACT floor emission level and is capable of reducing 
CDD/CDF emissions to 7,000 ng/dscm. However, 2-second combustion 
control is already needed to achieve the MACT floor emission level for 
CO and would reduce CDD/CDF emissions even further, to about 1,500 ng/
dscm, at no additional cost.
    The level of control associated with the FF system is already 
needed to meet the MACT floor for PM. Further reduction in CDD/CDF 
emissions beyond the level of emissions achievable with 2-sec 
combustion control can be attained either by adding a wet system or by 
injecting carbon into the FF system. Although the wet system is capable 
of reducing CDD/CDF emissions, the less expensive approach would be to 
inject carbon into the FF system that is already needed to meet the 
MACT floor level for PM. An FF system with carbon injection can reduce 
CDD/CDF emissions to about 80 ng/dscm and can substantially reduce Hg 
emissions. The nationwide incremental annual cost of carbon injection 
is about $24.4 million/yr, or about $31/ton of waste burned in 
intermittent MWI's. This incremental cost represents an increase of 
only about 3.6 percent over the cost of the FF system without carbon 
injection. As a result, MACT for CDD/CDF is the level of control 
achievable with an FF system with carbon injection, 80 ng/dscm total 
CDD/CDF, or 1.9 ng/dscm TEQ.
    d. MACT for Mercury. Typical uncontrolled Hg emissions are about 
3.1 mg/dscm. The MACT floor for Hg is 15.56 mg/dscm, and can be 
achieved at uncontrolled levels. The only control system capable of 
consistently reducing Hg emissions is the FF system with activated 
carbon injection, which can achieve emissions of 0.47 mg/dscm Hg or 85 
percent reduction from uncontrolled emissions. The FF system without 
carbon injection is necessary to meet the MACT floor emission level for 
PM and the injection of carbon is necessary to meet the proposed MACT 
emission level for CDD/CDF. As mentioned above in the discussion on 
CDD/CDF, the nationwide incremental annual cost of injecting carbon is 
about $24.4 million, or about $31/ton of waste burned. This additional 
cost represents an increase of only about 3.6 percent over the cost of 
the FF system without carbon injection. Therefore, the proposed MACT 
for Hg is 0.47 mg/dscm or 85 percent reduction.
    e. MACT for Acid Gases (HCl and SO<INF>2). Uncontrolled levels of 
HCl and SO<INF>2 from MWI's are 1,400 ppmv and 16 ppmv, respectively. 
As discussed previously, acid gases controls are not effective in 
reducing emissions of SO<INF>2 from MWI's. The MACT floor for HCl is 
115 ppmv and requires a reduction of 92 percent from uncontrolled 
levels. Wet systems and FF systems are each capable of reducing HCl 
emissions to 42 ppmv or by 97 percent from uncontrolled levels. The FF 
system is already needed to meet the MACT floor emission levels for PM. 
The costs associated with reducing emissions of HCl from the MACT floor 
level (92 percent reduction) to the level of control achievable with 
the FF system (97 percent reduction) include costs for additional lime 
and ash disposal costs. These additional costs are negligible compared 
to the total cost of the system. Therefore, the proposed MACT for HCl 
is 42 ppmv or 97 percent reduction.
    The MACT floor for SO<INF>2 is 414 ppmv and can be achieved at 
uncontrolled emission levels. As discussed earlier, no controls have 
been demonstrated to consistently reduce SO<INF>2 emissions from MWI's. 
Therefore, the proposed MACT for SO<INF>2 is also based on uncontrolled 
emissions. Analyses of test data from MWI's show that typical 
uncontrolled emissions of SO<INF>2 are about 16 ppmv, but can range as 
high as 45 ppmv. Because the Act requires the EPA to set numerical 
emission limit for SO<INF>2, MACT for SO<INF>2 is set at 45 ppmv, the 
highest SO<INF>2 emission rate measured during the EPA test program. 
The EPA specifically solicits comments on the emission limit of 45 ppmv 
set for SO<INF>2 [[Page 10677]] and whether this level accurately 
reflects uncontrolled emissions of SO<INF>2 at MWI's.
    f. MACT for Nitrogen Oxides. Typical uncontrolled emissions of 
NO<INF>X are 140 ppmv but range as high as 210 ppmv. The MACT floor for 
NO<INF>X is 216 ppmv and requires no control of NO<INF>X. As discussed 
earlier, NO<INF>X control has not been demonstrated on MWI's. 
Therefore, MACT is also based on no control. However, because the Act 
requires the EPA to set a numerical emission limit for NO<INF>X, the 
NO<INF>X limit is proposed to be 210 ppmv, the highest uncontrolled 
NO<INF>X level measured during the EPA test program. The EPA 
specifically solicits comments on the emission limit of 210 ppmv set 
for NO<INF>X and whether this level accurately reflects uncontrolled 
emissions of NO<INF>X at MWI's.
4. MACT for Existing Batch MWI's
    As discussed in section VI, the discussion that follows is based on 
limited test data on wet scrubber systems. The EPA requests comment on 
the performance and costs of wet scrubber systems. Also, while the 
paragraphs that follow focus on specific control technologies in 
determining MACT for existing batch MWI's, the guidelines do not 
require the use of any specific technology. The Agency's assessment of 
the performance of specific technologies is used to develop emission 
limitations, which appear in the guidelines. Any control technology 
that can comply with the emission limitations may be used.
    a. MACT for PM, Pb, and Cd. Typical uncontrolled PM emissions from 
batch MWI's are about 570 mg/dscm. The MACT floor for PM emissions from 
batch MWI's is 69 mg/dscm. A fabric filter system is necessary to meet 
the MACT floor level. In fact, the FF system can reduce PM emissions 
even further, to 30 mg/dscm, at no additional cost.
    Uncontrolled emissions of Pb and Cd from batch MWI's are about 4.2 
mg/dscm and 0.29 mg/dscm, respectively. The MACT floor emission levels 
for Pb and Cd are 23.10 mg/dscm and 3.44 mg/dscm, respectively. 
Although no control is necessary to achieve the MACT floor levels for 
Pb and Cd, the FF system necessary to meet the MACT floor level for PM 
would also reduce emissions of Pb and Cd to 0.10 mg/dscm and 0.05 mg/
dscm, respectively. Because this system is already necessary to meet 
the MACT floor level for PM, there is no cost associated with reducing 
emissions of Pb and Cd from the uncontrolled MACT floor levels to the 
level of control achieved by the FF system. Further reduction of Pb and 
Cd has not been demonstrated. Therefore, the proposed MACT for batch 
MWI's is the level of control achievable with the FF system: 30 mg/dscm 
for PM, 0.10 mg/dscm for Pb, and 0.05 mg/dscm for Cd.
    b. MACT for Carbon Monoxide. Typical uncontrolled emissions of CO 
at batch MWI's are about 690 ppmv. The MACT floor is 91 ppmv. Two-
second combustion control is necessary to meet the MACT floor level and 
is capable of achieving CO levels as low as 50 ppmv at no additional 
cost. Further reduction of CO emissions has not been demonstrated. 
Therefore, the proposed MACT for CO is 50 ppmv, the level achievable 
with 2-sec combustion.
    c. MACT for Dioxins and Furans. Uncontrolled levels of dioxins and 
furans (CDD/CDF) are typically about 25,000 ng/dscm. The MACT floor for 
CDD/CDF is 14,606 ng/dscm. One-second combustion control is necessary 
to achieve the MACT floor emission level and is capable of reducing 
CDD/CDF emissions to 7,000 ng/dscm. However, 2-second combustion 
control is already needed to achieve the MACT floor emission level for 
CO and would reduce CDD/CDF emissions even further, to about 1,500 ng/
dscm, at no additional cost.
    The level of control associated with the FF system is already 
needed to meet the MACT floor for PM. Further reduction in CDD/CDF 
emissions beyond the level of emissions achievable with 2-sec 
combustion control can be attained either by adding a wet system or by 
injecting carbon into the FF system. Although the wet system is capable 
of reducing CDD/CDF emissions, the less expensive approach would be to 
inject carbon into the FF system that is already needed to meet the 
MACT floor level for PM. An FF system with carbon injection can reduce 
CDD/CDF emissions to about 80 ng/dscm and can substantially reduce Hg 
emissions. The nationwide incremental annual cost of carbon injection 
is about $1.5 million/yr, or about $170/ton of waste burned in batch 
MWI's. This incremental cost represents an increase of only about 2.7 
percent over the cost of the FF system without carbon injection. As a 
result, MACT for CDD/CDF is the level of control achievable with an FF 
system with carbon injection, 80 ng/dscm, or 1.9 ng/dscm TEQ.
    d. MACT for Mercury. Typical uncontrolled Hg emissions are about 
3.1 mg/dscm. The MACT floor for Hg is 18.54 mg/dscm, and can be 
achieved at uncontrolled levels. The only control system capable of 
consistently reducing Hg emissions is the FF system with carbon 
injection, which can achieve emissions of 0.47 mg/dscm Hg or 85 percent 
reduction from uncontrolled emissions. The FF system without carbon 
injection is necessary to meet the MACT floor emission level for PM and 
the injection of carbon is necessary to meet the proposed MACT emission 
level for CDD/CDF. As mentioned above in the discussion on CDD/CDF, the 
nationwide incremental annual cost of injecting carbon is about $1.5 
million/yr, or about $170/ton of waste burned. This additional cost 
represents an increase of only about 2.7 percent over the cost of the 
FF system without carbon injection. Therefore, the proposed MACT for Hg 
is 0.47 mg/dscm or 85 percent reduction.
    e. MACT for Acid Gases (HCl and SO<INF>2). Uncontrolled levels of 
HCl and SO<INF>2 from MWI's are 1,400 ppmv and 16 ppmv, respectively. 
As discussed earlier, acid gases controls are not effective in reducing 
emissions of SO<INF>2 from MWI's. The MACT floor for HCl is 911 ppmv 
and requires a reduction of 35 percent from uncontrolled levels. Wet 
systems and FF systems are each capable of reducing HCl emissions to 42 
ppmv or by 97 percent from uncontrolled levels. The FF system is 
already needed to meet the MACT floor emission levels for PM. The costs 
associated with reducing emissions of HCl from the MACT floor level (35 
percent reduction) to the level of control achievable with the FF 
system (97 percent reduction) include costs for additional lime and ash 
disposal costs. These additional costs are negligible compared to the 
total cost of the system. Therefore, the proposed MACT for HCl is 42 
ppmv or 97 percent reduction.
    The MACT floor for SO<INF>2 is 1,166 ppmv and can be achieved at 
uncontrolled emission levels. As discussed earlier, no controls have 
been demonstrated to consistently reduce SO<INF>2 emissions from MWI's. 
Therefore, the proposed MACT for SO<INF>2 is also based on uncontrolled 
emissions. Analyses of test data from MWI's show that typical 
uncontrolled emissions of SO<INF>2 are about 16 ppmv, but can range as 
high as 45 ppmv. Because the Act requires the EPA to set numerical 
emission limit for SO<INF>2, MACT for SO<INF>2 is set at 45 ppmv, the 
highest SO<INF>2 emission rate measured during the EPA test program. 
The EPA specifically solicits comments on the emission limit of 45 ppmv 
set for SO<INF>2 and whether this level accurately reflects 
uncontrolled emissions of SO<INF>2 at MWI's.
    f. MACT for Nitrogen Oxides. Typical uncontrolled emissions of 
NO<INF>X are 140 ppmv but range as high as 210 ppmv. The MACT floor for 
NO<INF>X is 220 ppmv and can be achieved at uncontrolled 
[[Page 10678]] emission levels. As discussed earlier, NO<INF>X control 
has not been demonstrated on MWI's. Therefore, MACT is also based on no 
control. However, because the Act requires the EPA to set a numerical 
emission limit for NO<INF>X, the NO<INF>X limit is proposed to be 210 
ppmv, the highest uncontrolled NO<INF>X level measured during the EPA 
test program. The EPA specifically solicits comments on the emission 
limit of 210 ppmv set for NO<INF>X and whether this level accurately 
reflects uncontrolled emissions of NO<INF>X at MWI's.

K. Selection of Fugitive Fly Ash/Bottom Ash Standards and Guidelines

    Combusting medical waste in an incinerator creates noncombustible 
ash in the primary chamber of the incinerator. This ``bottom'' ash is 
removed from the primary chamber either periodically (intermittent and 
batch MWI's) or continuously (continuous MWI's). While removing ash, 
airborne fugitive emissions may be created.
    Another potential source of fugitive emissions from MWI's is the 
collected fly ash that is removed from the exhaust gas stream by fabric 
filters. Facilities that use fabric filters as part of an air pollution 
control system must remove the collected fly ash periodically. Fugitive 
emissions of this fly ash can occur during the removal and disposal 
process.
    While there is a potential for fugitive emissions from MWI's, 
precautions can be taken that virtually eliminate these emissions. The 
proposed 0 percent opacity limit can be achieved by employing measures 
such as wetting or covering the dry ash, providing covers for ash 
containers, and providing wind screens around outdoor sites. The 
following sections describe the different types of MWI operations that 
may release fugitive emissions.
    1. Continuous MWI's. For an MWI to operate continuously, the 
combustor must be designed so that accumulated bottom ash can be 
removed while the unit operates. All designs incorporate a stepped, 
solid grate with internal ash rams or a moving hearth to move ash 
toward the discharge point at the end of the primary chamber opposite 
the waste charging door. At the discharge point, the ash falls off the 
hearth into a wet sump or a dry collection hopper. Because these units 
either quench the bottom ash (in a wet sump) or confine the ash in a 
close-fitting hopper (dry collection), there is virtually no potential 
for fugitive emissions during normal operation. With the wet sump 
arrangement, there are no fugitive emissions when the ash is conveyed 
to the disposal container, usually a dumpster. With dry ash, the 
transfer from the collection hopper to the dumpster may be a source of 
fugitive emissions, but normal precautions such as covering the ash or 
wetting it down can effectively eliminate fugitive emissions.
    2. Intermittent and Batch MWI's. Intermittent and batch MWI's are 
allowed to cool before the bottom ash is removed, usually on a daily 
basis. Few of these units use any automated mechanism to assist in the 
removal of bottom ash. The ash is simply shoveled or raked from the 
primary chamber manually through the ash door.
    Some larger units have an ash ram that is used to push bottom ash 
toward the ash door. With this type of system, the ash may be allowed 
to fall from the primary chamber into a collection bin as the ram 
pushes it out of the unit. Mechanical rams are usually somewhat 
ineffective at removing the ash because the ram face is considerably 
narrower than the primary chamber. Ash that is not in the path of the 
ram must be raked or shoveled out manually.
    Removing the bottom ash from these MWI's is a potential source of 
fugitive emissions. Applying a water spray to the ash as it is removed 
from the MWI, reducing the distance the ash falls or is conveyed, and 
providing wind screens for outdoor sites are ways in which fugitive 
emissions may be eliminated.
    3. Collected Fly Ash from Control Devices. Facilities utilizing 
fabric filters as part of their air pollution control system must use 
precautions to avoid fugitive emissions resulting from the removal of 
collected fly ash from the fabric filter collection hopper. In most 
cases, the collection hopper discharges from the bottom directly into a 
disposal bin. By including a flexible ``sleeve'' to connect the 
collection hopper to the disposal bin (often a 55-gallon drum) and a 
close-fitting cover over the disposal bin, fugitive emissions can be 
eliminated. Likewise, a wind screen around this operation is helpful 
for outdoor installations. Once the disposal bin is filled, it should 
be sealed for transport to the ultimate disposal site. If the disposal 
bin is emptied onsite into a dumpster, the transfer must be performed 
in a manner to avoid creating fugitive emissions. Wetting the fly ash 
in the disposal bin prior to dumping it or performing the transfer in a 
covered enclosure are effective ways to eliminate fugitive emissions.

L. Operator Training and Qualification Requirements

    Section 129 of the Act requires the EPA to develop and promote a 
model program for the training and qualification of MWI operators. 
Section 129 specifies that ``any person with control over processes 
affecting emissions from a unit * * *'' must successfully complete an 
acceptable training program. For new MWI's, the proposed standards 
require that an affected facility be operated by a trained and 
qualified operator or by an individual under the direct supervision of 
a trained and qualified operator. For existing MWI's, the proposed 
emission guidelines would require that 1 year after approval of the 
State plan, designated facilities be operated by a trained and 
qualified operator or by an individual under the direct supervision of 
a trained and qualified operator. The 3-year option for complying with 
all other requirements of the emission guidelines is not provided for 
the training and qualification requirements. The accelerated compliance 
schedule proposed for the operator training and qualification 
requirements will assist in preparing the operators to properly operate 
the MWI and associated air pollution control equipment before the 
initial compliance test.
    The proposed standards and guidelines also would require that each 
owner or operator of an MWI develop and update, on an annual basis, a 
site-specific operating manual to be reviewed by all qualified 
operators annually. The standards and guidelines include minimum 
criteria for the training course, the qualification program, and the 
contents of the manual.
1. Training Requirements
    The owner or operator of an MWI would be responsible for ensuring 
that one or more operators receive training by an instructor not 
employed by the owner or operator that provides, at a minimum, the 
following: (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 classroom training would be required to cover, at a minimum, 
the following subjects:
    1. Environmental concerns, including pathogen destruction and types 
of emissions;
    2. Basic combustion principles, including products of combustion;
    3. Types of incinerator designs and components of MWI's;
    4. Incinerator operation, including startup and shutdown 
procedures;
    5. Combustion controls and monitoring; [[Page 10679]] 
    6. Types of air pollution control equipment;
    7. Operation of air pollution control equipment and factors 
affecting performance;
    8. Methods to monitor pollutants (CEM's) and equipment calibration 
procedures;
    9. Inspection and maintenance of the MWI, APCD, and CEM's;
    10. Actions to correct malfunctions or upsets;
    11. Bottom and fly ash characteristics and handling procedures;
    12. Applicable Federal, State, and local regulations; and
    13. Work safety procedures.
    Hands-on training would be required on either an intermittent or 
continuous MWI that is similar, but not necessarily identical, to the 
unit(s) that the operator(s) would be operating. The MWI used in hands-
on training also must have an APCD. Material to be covered during the 
hands-on training must include: (1) prestartup inspections, (2) proper 
startup, waste charging, and shutdown procedures; (3) monitoring 
operating conditions (visually and with automated equipment), (4) 
responses to upset conditions, and (5) recordkeeping. The instruction 
also must identify differences between the MWI used for the hands-on 
training and other types of MWI's (i.e., batch, intermittent, and 
continuous) and APCD's (i.e., wet scrubbers and dry scrubbers).
    An examination would be required for the operator to demonstrate an 
understanding of the material presented. A handbook covering the 
subjects discussed during the course would give the operator a 
reference to supplement more detailed literature from the manufacturer 
that is specific for the equipment being operated at the facility.
2. Qualification Procedures
    The owner or operator of an MWI would be responsible for ensuring 
that one or more operators at the facility are qualified. Under the 
proposed standards and guidelines, operators would be qualified by one 
of two methods, designated option 1 and option 2.
    a. Option 1. To be qualified under option 1, operators would be 
required to complete a training course that satisfies the criteria 
described above and have one of the following levels of experience: (1) 
at least 6 months experience (1,040 hours) as an MWI operator, (2) at 
least 6 months experience as the direct supervisor of MWI operators, or 
(3) experience performing a minimum of two burn cycles under the 
observation of two qualified operators. The experience must be on 
either the MWI at the operator's facility or an MWI of the same type 
(i.e., batch, intermittent, or continuous).
    Qualification would be valid from the date the training examination 
is passed or the date on which the experience requirements are met, 
whichever is later. The owner or operator of the MWI would be required 
to demonstrate to enforcement personnel that the operator has the 
necessary training and experience.
    To maintain qualification, the operator would be required to 
complete an annual review or refresher course administered by an 
instructor not employed by the owner or operator and pass the 
examination administered by the instructor at the end of the course. An 
acceptable review course would provide at least 4 hours of classroom 
training and cover, at a minimum, the following subjects: (1) update of 
regulations; (2) incinerator operation, including startup and shutdown 
procedures; (3) inspection and maintenance; (4) responses to upset 
conditions; and (5) discussion of operating problems encountered by the 
attendees.
    A lapsed qualification may be renewed by one of two methods, 
depending on the length of the lapse. For a lapse of less than 3 years, 
the operator would be required to complete and pass a standard review 
course, as described above in this section. For a lapse of 3 years or 
more, the operator would be required to complete and pass a training 
course that meets the criteria described earlier.
    b. Option 2. Option 2 would allow qualification by national 
professional organizations. The same initial and annual training 
described under option 1 would be required. National organizations 
would be able to specify criteria that are at least as stringent as 
those under option 1. Qualification programs developed by national 
organizations also would specify procedures to maintain and renew 
qualifications.
3. Operating Manual
    The proposed standards and guidelines also would require that each 
owner or operator of an MWI develop and update, on an annual basis, a 
site-specific operating manual to be reviewed by all qualified 
operators annually. The manual would summarize State regulations, 
operating procedures, and reporting and recordkeeping requirements in 
accordance with the proposed standards and guidelines.
4. Request for Comments
    The EPA solicits comments on whether and to what extent EPA should 
allow States or certain specific national professional organizations 
(e.g., the American Hospital Association or the American Society of 
Mechanical Engineers) to pre-approve training courses and qualification 
programs that meet the above criteria. Commenters should identify by 
name any national organizations that they believe should be granted 
this authority.
    An advantage of allowing States or national organizations to 
preapprove courses is that the burden of demonstrating that the course 
is in compliance with the criteria would be removed from the owner or 
operator. An additional advantage of allowing national organizations to 
pre-approve courses is that the training would be valid in all States, 
whereas a State-approved course would only be valid in the State that 
approved it. As a result, all operators in a company with facilities in 
several States could take the same course, and operators would not need 
to take another training course if they move from one State to another.

M. Siting Requirements--New MWI's

    Section 129 of the Act states that performance standards for MWI's 
must incorporate siting requirements that minimize, on a site-specific 
basis and to the maximum extent practicable, potential risks to public 
health or the environment. In accordance with section 129, site 
selection criteria are being proposed for MWI's that commence 
construction after the date of promulgation of this rule. The siting 
requirements would not apply to existing or modified MWI's.
1. Options Considered for Siting Requirements
    The EPA considered three approaches in the development of proposed 
siting requirements. These approaches are summarized below.
    The first approach would be a regulatory review approach. Under 
this approach, the MWI owner/operator would prepare a document listing 
all current Federal, State, and local regulatory requirements and 
permit conditions that apply to the proposed MWI, along with a 
discussion of the equipment, construction practices, operating 
practices, and other conditions used to comply with each requirement. 
The document would be submitted to the EPA and to State and local 
officials and would be made available to the public. This approach also 
includes provisions for a public [[Page 10680]] meeting and the 
preparation of a comment/response document that would be made available 
to the public. This approach addresses relevant siting issues and would 
not require duplicate analyses of health or environmental impacts that 
may already be required under other authorities (e.g., New Source 
Review (NSR) air permits; National Pollution Discharge Elimination 
System [NPDES] water discharge permits; stormwater permits; wetland 
permits; State solid waste permits; or local zoning permits).
    The second approach would require that an environmental assessment 
(EA) be conducted, patterned after requirements under the National 
Environmental Policy Act (NEPA). This approach would require an 
examination of impacts in all media (i.e., air, water, solid waste, 
energy, and land use). Also, a description of alternatives to the 
proposed project, including alternative sites, technologies, or designs 
necessary to determine a finding of no significant impact (FNSI) would 
be required. The EA and the description of alternatives to the proposed 
project would be documented and submitted to the EPA and to State and 
local officials and would be made available to the public.
    The third approach sets forth general siting requirements patterned 
after the Prevention of Significant Deterioration (PSD) requirements 
within the New Source Review (NSR) program. This approach requires 
comprehensive air quality analyses in regard to National Ambient Air 
Quality Standards (NAAQS) and PSD increments. An impacts analysis, 
which studies the potential effect of air, solid waste, and water 
pollution on visibility, soils, and vegetation also would be required. 
This approach also includes provisions for a public meeting and the 
preparation of a comment/response document that would be made available 
to the public.
2. Proposed Siting Requirements
    The third approach is being proposed as the basis for the siting 
requirements for MWI's. Under the proposed approach, MWI owners would 
be required to conduct analyses of the impacts of the proposed facility 
on ambient air quality, visibility, soils, and vegetation. A document 
presenting the results of the analyses would be prepared and submitted 
to the EPA and State and local officials. This document would also be 
made available to the public. The proposed siting requirements include 
provisions for a public meeting (chaired by EPA or a delegated 
enforcement agency) where comments on the proposed MWI siting analyses 
would be accepted. At least 30 days prior to the public meeting, the 
owner of the affected facility is required to announce the public 
meeting in newspapers of general circulation that serve the communities 
located within the area where the affected facility is to be located. 
The public meeting would be conducted in the county in which the 
affected facility is to be located and would be scheduled to occur 30 
days or more after making the siting analyses available to the public. 
A comment/response document, summarizing and responding to the comments 
received at the public meeting, would then be prepared and would be 
made available to attendees of the public meeting, the State air 
pollution control board, and the EPA.
    The siting requirements would apply to any MWI that commences 
construction after the date of promulgation of this rule. The siting 
requirements would not apply to existing or modified MWI's. The siting 
information required above would be submitted to EPA sufficiently in 
advance of the intent to commence construction of the facility. 
Construction would be allowed to commence only after approval by EPA 
and the appropriate State/local agency. The Agency invites comments 
regarding the proposed siting requirements, including suggestions of 
alternative approaches.
N. Inspection Requirements--Existing MWI's

    The proposed emission guidelines include a requirement for an 
initial equipment inspection of the designated facility. The purpose of 
the equipment inspection is to ensure that the MWI is in good working 
order until emission control equipment is installed and compliance with 
emission limits is demonstrated. A poorly maintained MWI will likely 
have higher emissions than a well-maintained MWI.
    These requirements would become effective 1 year after approval of 
the State plan. Installation of air pollution control equipment may 
take up to 3 years (as discussed elsewhere in today's notice). Until 
the time that the source demonstrates compliance with the emission 
limits, the facility would be required to perform the equipment 
inspection annually. The inspection service would have to be performed 
by an MWI service technician not employed by the owner or operator of 
the designated facility.
    The minimum requirements for an inspection include:
    1. Inspecting all burners, pilot assemblies, and pilot sensing 
devices for proper operation and cleaning as necessary;
    2. Adjusting primary and secondary chamber combustion air;
    3. Inspecting hinges and door latches;
    4. Inspecting dampers, fans, and blowers for proper operation;
    5. Inspecting door and door gaskets for proper sealing;
    6. Inspecting motors for proper operation;
    7. Inspecting primary chamber refractory lining and cleaning/
repairing as necessary;
    8. Inspecting incinerator shell for corrosion and/or hot spots;
    9. Inspecting secondary/tertiary chamber and stack and cleaning as 
necessary;
    10. Inspecting mechanical loader, if applicable;
    11. Visually inspecting waste bed, as appropriate;
    12. Test burning the incinerator with typical waste to make any 
necessary adjustments;
    13. Inspecting air pollution control devices for proper operation, 
if applicable; and
    14. Generally ensuring that the equipment is maintained in proper 
operating condition.
    If any problems that affect emissions are uncovered during the 
inspection, the owner or operator of the designated facility would be 
required to take corrective action within 10 operating days. All 
records of any inspection services and any subsequent maintenance 
services would have to be maintained at the facility for a period of at 
least 5 years.

O. Compliance and Performance Test Methods and Monitoring Requirements

    Section 129(c) of the Act requires the Administrator to promulgate 
regulations that include monitoring requirements as necessary to 
protect public health and the environment. The regulations must also 
include provisions for recordkeeping and reporting of such monitoring. 
This section discusses the proposed requirements to satisfy section 
129(c).
    As discussed in section VI, the requirements of the proposed 
standards and guidelines are based primarily on the use of dry scrubber 
systems to comply with the proposed emission limitations. As a result, 
the proposed testing and monitoring requirements discussed below are 
structured around the use of dry scrubber systems. To accommodate MWI's 
using an APCD other than a dry scrubber system, the proposed standards 
and guidelines include provisions for petitioning the Administrator to 
allow monitoring of alternative operating parameters to demonstrate 
continuous compliance [[Page 10681]] with the emission limits. 
Petitions for alternative operating parameter monitoring would be 
approved on a case-by-case basis. This procedure could become an 
awkward and lengthy one. To the extent that wet scrubber systems could 
be used to comply with the proposed emission limitations, the Agency is 
soliciting information from wet scrubber vendors regarding the 
operation of wet scrubber systems. Specifically, the Agency solicits 
information on a set of operating parameters that could be included as 
a means of demonstrating continuous compliance with the emission 
limitations for PM, CDD/CDF, HCl, opacity, and metals, including 
information on how the proposed parameters to be monitored would be 
established. The EPA envisions the final standards and guidelines would 
be structured in such a way to provide specific operating parameter 
monitoring requirements for wet scrubber systems as well as for dry 
scrubber systems directly in the regulation. To accommodate MWI's using 
an APCD other than a dry scrubber system or a wet scrubber system, 
provisions would be included for petitioning the Administrator to allow 
monitoring of alternative operating parameters to demonstrate 
continuous compliance with the emission limits.
    The performance testing and monitoring requirements included in the 
proposed standards and guidelines would apply to all MWI's subject to 
the standards and guidelines. As stated in the part 60 general 
provisions (40 CFR 60.8), performance tests must, unless otherwise 
specified in the regulation, consist of three separate valid runs using 
the applicable test method, and the arithmetic mean of the three runs 
shall be used to determine compliance. All emission limits for MWI's 
are corrected to 7 percent oxygen (dry basis).
    Testing and monitoring requirements are proposed to demonstrate 
compliance with the emission limits. The proposed standards and 
guidelines require that the owner or operator of an MWI conduct initial 
and annual performance tests to demonstrate compliance with the 
emission limits. Also, following the initial performance test, the 
owner or operator of each MWI is required to demonstrate continuous 
compliance with the emission limits.
1. Initial and Annual Performance Testing
    To demonstrate initial compliance with the emission limits for each 
pollutant, all facilities must conduct an initial performance test. 
Except as noted below, the minimum sample time for each test run would 
be 4 hours. This minimum time is required to allow enough sample to be 
collected and to account for the heterogeneity of medical waste. The 
following test methods and procedures would be used to measure 
pollutant emissions.
    Particulate Matter--The performance test for PM would be conducted 
in accordance with Method 5. Method 1 would be used to determine the 
number and location of sampling points. Method 3 or 3A would be used 
simultaneously with each Method 5 run for flue gas analysis.
    Opacity--A CEMS would be used to measure opacity;
    Carbon Monoxide--A CEMS would be used to measure CO emissions;
    Dioxins/Furans--Method 23 would be used to measure dioxin/furan 
emissions;
    Hydrogen Chloride--Method 26 would be used to measure HCl 
emissions;
    Metals (lead, cadmium, and mercury)--The performance test to 
determine compliance with the emission limits for Pb, Cd, and Hg would 
be conducted in accordance with Method 29. Method 3 or 3A would be used 
simultaneously with each Method 5 run for flue gas analysis.
    Fugitive emissions--Method 9 would be used to measure the opacity 
of fugitive emissions.
    Following the initial performance tests for all pollutants, 
subsequent annual performance tests would be required to demonstrate 
compliance with the emission limits. The test methods and procedures 
used for the annual testing are identical to those proposed for the 
initial tests.
    Under the proposed standards and guidelines, if three consecutive 
annual compliance tests indicate compliance with the emission limit for 
a pollutant, the owner of the MWI would be allowed to wait 3 years 
before retesting for that pollutant. If the next test conducted in the 
third year shows compliance with the emission limit for the pollutant, 
then the facility could again wait 3 years to test for that pollutant. 
If noncompliance with the emission limit for the pollutant occurs, 
corrective action would be required and the annual testing requirement 
would resume until 3 consecutive years of compliance with the emission 
limit is demonstrated. At a minimum, performance tests for all 
pollutants must be conducted once every 3 years (no more than 36 months 
following the date of the previous performance test). This provision is 
included to minimize costs while still retaining periodic testing to 
ensure compliance.
2. Methods to Demonstrate Continuous Compliance
    Following the initial performance test, the owners or operators of 
MWI's are required to demonstrate continuous compliance with the 
emission limitations. Section 702(b) of the Clean Air Act Amendments of 
1990 added section 114(a)(3) to the Act, which states:

    The Administrator shall in the case of any person which is the 
owner or operator of a major stationary source, and may, in the case 
of any other person, require enhanced monitoring and submission of 
compliance certifications. Compliance certifications shall include 
(A) identification of the applicable requirement that is the basis 
of the certification, (B) the method used for determining the 
compliance status of the source, (C) the compliance status, (D) 
whether compliance is continuous or intermittent, (E) such other 
facts as the Administrator may require. Compliance certifications 
and monitoring data shall be subject to subsection (c) of this 
section. Submission of a compliance certification shall in no way 
limit the Administrator's authorities to investigate or otherwise 
implement this Act.

Section 114(a)(3) requires enhanced monitoring and compliance 
certifications of all major stationary sources. The annual compliance 
certifications must state whether compliance has been continuous or 
intermittent. Enhanced monitoring shall be capable of detecting 
deviations from each applicable emissions limitation or standard with 
sufficient representativeness, accuracy, precision, reliability, 
frequency, and timeliness to determine if compliance is continuous 
during a reporting period. The monitoring requirements in these 
proposed standards and guidelines satisfy the requirements of enhanced 
monitoring, except as noted below.
    The most direct means of ensuring compliance with the emission 
limits on a continuous basis is the use of a CEMS to measure emissions 
of each pollutant. However, a CEMS for specific pollutants is not 
always available because of technology constraints. Where a CEMS for 
specific pollutants is not available, the next best option is to use a 
CEMS to measure surrogate pollutants whose emission profiles closely 
parallel those of the pollutants of concern. Continuous emissions 
monitoring systems for surrogate pollutants are also not always 
available. Where a CEMS is not available for surrogate pollutants, the 
next best option is to monitor MWI and/or APCD operating parameters 
that affect emissions of the pollutants of concern.
    Where a CEMS is not available and a correlation has been 
demonstrated [[Page 10682]] between MWI and/or APCD operating 
parameters and emissions, the proposed standards and guidelines include 
MWI and/or APCD operating parameters to be monitored. Maximum or, in 
some cases, minimum values for these parameters are established during 
the initial performance test to demonstrate compliance with the 
emission limits. Once these values are established, a facility 
operating outside of these values is considered to be in violation of 
the emission limits. The following paragraphs discuss methods available 
to demonstrate continuous compliance with emission limits for each 
pollutant.
    a. HCl, CO, Opacity. Continuous emission monitoring systems 
measuring HCl, CO, and opacity are available to determine continuous 
compliance with the emission limits for these pollutants. Opacity and 
CO CEMS's are widely used. On the other hand, a CEMS for HCl is not 
widely used and has not been commercially proven to be economically and 
technically feasible for MWI's. Also, Federal performance 
specifications for a HCl CEMS have not been established to date. The 
EPA test data from facilities equipped with a dry scrubber system 
followed by a fabric filter show a direct relationship between HCl 
sorbent (lime) flow rate and HCl removal efficiency. A decrease in the 
sorbent flow rate results in a decrease in HCl removal efficiency and 
therefore higher HCl emissions. Also, for a given amount of chlorine 
content in the waste stream, the amount of waste charged to the 
incinerator could be directly related to the amount of HCl emitted. An 
increase in the amount of waste charged would result in higher HCl 
emissions. For facilities equipped with a dry scrubber followed by a 
fabric filter, the minimum HCl sorbent flow rate, the maximum charge 
weight, and the maximum hourly charge rate would be established during 
the initial performance test for HCl and would be monitored to 
demonstrate continuous compliance with the emission limit for HCl.
    While the proposed standards and guidelines do not require a CEMS 
for monitoring HCl emissions, the EPA specifically solicits further 
information on the availability, reliability, accuracy, status of 
development, and costs for continuous HCl monitors.
    b. Dioxins and Furans. Currently CDD/CDF emissions cannot be 
measured using a CEMS. While CO is occasionally mentioned as a 
surrogate for CDD/CDF emissions, it is not a precise indicator of CDD/
CDF emissions. However, good combustion conditions minimize CDD/CDF 
formation and lower CO emissions indicate that good combustion is 
occurring. Therefore, continuous compliance with the emission limit for 
CO based on the CO CEMS output would ensure good combustion conditions 
and minimized CDD/CDF formation.
    As discussed elsewhere, the proposed standards and guidelines for 
CDD/CDF are based on add-on air pollution control, which reduces CDD/
CDF emissions even more than good combustion. Air pollution control 
system operating parameters have been correlated with CDD/CDF 
emissions. For MWI's using a dry scrubber system followed by a fabric 
filter, the operating parameters correlated with CDD/CDF emissions are 
CDD/CDF sorbent flow rate and temperature measured at the inlet to the 
PM control device. The EPA test data on a DI/FF system with carbon 
injection show a direct relationship between carbon flow rate and CDD/
CDF removal efficiency. A decrease in the sorbent flow rate results in 
a decrease in CDD/CDF removal efficiency and therefore higher CDD/CDF 
emissions. It has been shown that the optimum temperature window for 
fly ash catalyzed CDD/CDF formation is between 300 deg. and 600 deg.F. 
Available data indicate that cooling flue gases and operating the PM 
control device below the temperature window where formation may occur 
minimizes formation of CDD/CDF in the flue gas. A minimum value for the 
CDD/CDF sorbent flow rate and a maximum value for the temperature 
measured at the inlet to the PM control device would be established 
during the initial performance test for CDD/CDF and would be monitored 
to demonstrate continuous compliance with the emission limit for CDD/
CDF.
    c. Mercury. Mercury emissions cannot be measured using a CEMS. The 
EPA test data from facilities equipped with a dry scrubber followed by 
a fabric filter show a direct relationship between Hg sorbent 
(activated carbon) flow rate and Hg removal efficiency. A decrease in 
the sorbent flow rate results in a decrease in Hg removal efficiency 
and therefore higher Hg emissions. Also, depending on the presence of 
Hg in the waste stream, the amount of waste charged could be directly 
related to the amount of Hg emitted. An increase in the amount of waste 
charged could result in higher Hg emissions. For facilities equipped 
with a dry scrubber followed by a fabric filter, the minimum Hg sorbent 
flow rate, the maximum charge weight, and the maximum hourly charge 
rate would be established during the initial performance test for Hg 
and monitored to demonstrate continuous compliance with the emission 
limit for Hg.
    While the proposed standards and guidelines do not require a CEMS 
for monitoring Hg emissions, the EPA specifically solicits further 
information on the availability, reliability, accuracy, status of 
development, and costs for continuous Hg monitors. The EPA is 
requesting data that could be used to determine whether Hg monitors 
measure all Hg or just certain species of Hg and if only certain 
species of Hg are measured, how such a monitor could be used in 
determining compliance with the Hg emission limit.
    d. PM, Pb, and Cd. Particulate matter, Pb, and Cd emissions cannot 
currently be measured using a CEMS. The EPA has not, to date, 
identified surrogate pollutants or MWI/APCD operating parameters that 
could be monitored to measure compliance. The Agency is currently 
working to develop applicable MWI/APCD operating parameters for lead, 
cadmium, and PM that are sufficiently representative, accurate, 
precise, reliable, frequent, and timely to determine whether a 
deviation from the proposed emission limits has occurred, thus enabling 
owners and operators to certify whether compliance with the proposed 
emission limits is continuous or intermittent. The Agency will include 
operating parameters for the pollutants lead, cadmium, and PM in the 
final rule. Today the Agency is requesting comment on appropriate 
operating parameters for lead, cadmium, and PM that will satisfy the 
requirements of enhanced monitoring and also requests any associated 
supporting data.
    e. SO<INF>2 and NO<INF>X. No monitoring requirements are proposed 
for SO<INF>2 and NO<INF>X because the emission limits are based on 
uncontrolled emission levels.
    f. Fugitive Emissions. Continuous compliance with the emission 
limits for fugitive emissions would be demonstrated by conducting a 
performance test using Method 9 at least once per month when bottom ash 
is removed from the incinerator and when fly ash is removed from the 
add-on air pollution control device.
    g. Other Air Pollution Control Systems. To accommodate MWI's using 
an APCD other than a dry scrubber followed by a fabric filter, 
provisions are included in the standards and guidelines for petitioning 
the Administrator to allow monitoring of alternative operating 
parameters to demonstrate continuous compliance with the emission 
limits for CDD/CDF, Hg, HCl, and/or opacity. The petition must include 
a discussion illustrating the relationship between the alternative 
operating parameters and emissions of [[Page 10683]] CDD/CDF, Hg, HCl, 
and/or opacity. The petition must also describe by what means and how 
often the parameters would be monitored and must specify the 
recommended minimum/maximum values of the parameters that are not to be 
exceeded. Petitions for alternative operating parameter monitoring 
would be approved on a case-by-case basis.
3. Continuous Compliance Requirements
    To demonstrate continuous compliance following the initial 
performance test, facilities are required to:
    a. Demonstrate compliance with the CO emission limit based on the 
output from the CO CEMS;
    b. Demonstrate compliance with the opacity emission limit based on 
the output from the opacity CEMS; and
    c. Demonstrate compliance with the fugitive emission limit by 
conducting a performance test using Method 9 at least once per calendar 
month when ash is removed from the incinerator and when ash is removed 
from the APCD.
    In addition, facilities equipped with a dry scrubber followed by a 
fabric filter are required to:
    d. Demonstrate compliance with the Hg emission limit by 
continuously monitoring the Hg sorbent flow rate, the charge weight, 
and the hourly charge rate. The minimum Hg sorbent flow rate, the 
maximum charge weight, and the maximum hourly charge rate are to be 
established during the initial performance test to determine compliance 
with the Hg emission limit. Operation of the MWI below the minimum 
sorbent flow rate, or above the maximum charge weight or maximum hourly 
charge rate would constitute a violation of the Hg emission limit.
    e. Demonstrate compliance with the CDD/CDF emission limit by 
continuously monitoring the CDD/CDF sorbent flow rate and the 
temperature measured at the inlet to the PM control device. The minimum 
CDD/CDF sorbent flow rate and the maximum PM control device inlet 
temperature are to be established during the initial performance test 
to determine compliance with the CDD/CDF emission limit. Operation of 
the MWI below the minimum sorbent flow rate or above the maximum PM 
control device inlet temperature would constitute a violation of the 
CDD/CDF emission limit.
    f. Demonstrate compliance with the HCl emission limit by 
continuously monitoring the HCl sorbent flow rate and continuously 
measuring the weight and time of each load of waste charged to the 
incinerator. The minimum HCl sorbent flow rate, the maximum charge 
weight, and the maximum hourly charge rate are to be established during 
the initial performance test to demonstrate compliance with the 
emission limit for HCl. Operation of the MWI below the minimum sorbent 
flow rate, or above the maximum charge weight or maximum hourly charge 
rate would constitute a violation of the HCl emission limit.
    The proposed standards and guidelines require the owner or operator 
of an MWI using a control device other than a dry scrubber followed by 
a fabric filter to petition the Administrator for other site-specific 
operating parameters to demonstrate continuous compliance with the 
emission limits for CDD/CDF, Hg, HCl, and/or opacity. These parameters 
would be established during the initial performance test for these 
pollutants and would be continuously monitored to demonstrate 
compliance with the emission limits.
P. Reporting and Recordkeeping--New MWI's

    The proposed standards would require owners of affected facilities 
to submit notifications concerning construction and initial startup of 
the affected facility. The information to be submitted includes: (1) a 
statement of intent to construct along with the date of commencement of 
construction, (2) the anticipated date of startup, (3) a statement of 
the type of waste to be burned, (4) the letter from the State air 
pollution agency approving the construction and operation of the 
affected facility, and (5) all documentation produced as a result of 
the siting requirements.
    The proposed standards also require that the owner or operator of 
an affected facility maintain the following information for a period of 
at least 5 years: (1) the results of the initial, annual, and any 
subsequent performance tests; (2) data demonstrating continuous 
monitoring of site-specific operating parameters; (3) CEMS output data; 
and (4) results of CEMS quality assurance determinations.
    Additional records must be kept on file for the life of the 
facility. These records include: (1) all documentation produced as a 
result of the siting requirements, (2) the letter from the State air 
pollution agency approving the construction and operation of the 
affected facility, (3) records showing the names of the persons who 
have completed the requirements for MWI operator training and dates of 
training (along with documentation of the training program completed), 
(4) records showing the names of those who have completed review of the 
site-specific MWI operating manual and dates of review, and (5) records 
showing the names of the qualified MWI operators and dates of 
qualification.
    The proposed standards require that certain documentation be 
submitted to the Administrator. Owners or operators are required to 
submit the results of the initial performance test and all subsequent 
performance tests. Also, reports on emission rates or operating 
parameters that have not been obtained or that exceed applicable limits 
must be submitted within 30 days after the end of the quarter of 
occurrence. If no exceedances occur during a quarter, the owner of the 
affected facility is required to submit a letter stating so. All 
reports submitted to comply with the requirements of the proposed 
standards must be signed by the facilities manager--the individual 
responsible for purchasing, maintaining, and, in many cases, operating 
the MWI. This individual is likely to have different titles at 
different facilities, for example, director of facilities or vice 
president of support services.
    The reporting and recordkeeping requirements in the proposed 
standards are necessary to inform enforcement personnel of the 
compliance status of new MWI's. In addition, they would provide the 
data and information necessary to ensure continued compliance of these 
MWI's with the proposed standards. At the same time, these requirements 
would not impose an unreasonable burden on MWI owners or operators.

Q. Reporting and Recordkeeping--Existing MWI's

    The proposed emission guidelines would require owners or operators 
of MWI's to maintain the following information for a period of at least 
5 years: (1) the results of the initial and annual performance tests, 
(2) data demonstrating continuous monitoring of site-specific operating 
parameters, (3) CEMS output data, (4) results of CEMS quality assurance 
determinations, and (5) results of the initial and annual inspections.
    Additional records must be kept on file for the life of the 
facility. These records include: (1) records showing the names of the 
persons who have completed the requirements for MWI operator training 
and dates of training (along with documentation that the training 
program was completed), (2) records showing the names of those who have 
completed review of the site-specific MWI operating manual and dates of 
review, and (3) records showing [[Page 10684]] the names of the 
qualified MWI operators and dates of qualification.
    Under the proposed emission guidelines owners or operators are 
required to submit the results of the initial maintenance inspection 
and any subsequent inspections completed prior to demonstrating initial 
compliance with the emission limits. This documentation must include a 
discussion of any repairs performed in response to the inspection and 
when the repairs occurred. Additionally, MWI owners or operators are 
required to submit to the Administrator the results of the initial 
performance test and all subsequent performance tests. Also, reports on 
emission rates or operating parameters that have not been obtained or 
that exceed applicable limits must be submitted within 30 days after 
the end of the quarter of occurrence. If no exceedances occur during a 
quarter, the owner of the designated facility is required to submit a 
letter stating so. All reports submitted to comply with the 
requirements of the emission guidelines must be signed by the 
facilities manager--the individual responsible for purchasing, 
maintaining, and, in many cases, operating the MWI. This individual is 
likely to have different titles at different facilities, for example, 
director of facilities or vice president of support services.
    The reporting and recordkeeping requirements in the proposed 
guidelines are necessary to inform enforcement personnel of the 
compliance status of existing MWI's. In addition, they would provide 
the data and information necessary to ensure continued compliance of 
these MWI's with the proposed guidelines. At the same time, these 
requirements would not impose an unreasonable burden on MWI owners or 
operators.
R. Compliance Times

1. New MWI's
    As stated in section 129, the effective date of standards for new 
MWI's is to be the date 6 months after promulgation of the standards. 
Consequently, while any MWI for which construction is commenced after 
today's date will be subject to the standards, they will not be subject 
to the standards until the effective date of the standards.
2. Existing MWI's
    Under section 129, States are required to submit to the 
Administrator a plan implementing the emission guidelines within 1 year 
after promulgation of the guidelines. Section 129 also requires that a 
State plan shall provide that each unit subject to the guidelines shall 
be in compliance with all requirements of the proposed guidelines 
within 3 years after the State plan is approved by the EPA but in no 
case later than 5 years after promulgation of the emission guidelines. 
The compliance schedule in today's proposal would supersede and is more 
comprehensive than the compliance schedule specified in section 129.
    The proposal requires that a State plan shall provide that each 
source subject to the emission guidelines shall be in compliance with 
all requirements of the guidelines within 1 year after EPA approval of 
the State plan. The proposal allows two exceptions to this compliance 
schedule. First, State plans may allow facilities that are planning to 
install the necessary air pollution control equipment up to three years 
after EPA approval of the State plan (but not later than 5 years after 
promulgation of the guidelines) to comply if the State plan specifies 
that the facility submit measurable and legally enforceable incremental 
steps of progress towards compliance. Suggested incremental steps of 
progress to be included in the State plans are specified in the 
emission guidelines.
    Second, State plans may include provisions allowing designated 
facilities to petition the State for extensions for compliance. Under 
the proposed emission guidelines, State plans that include such 
provisions must require that the designated facility requesting an 
extension submit information to assist the State in deciding whether to 
grant or deny the extension. The schedule for submittal of this 
information must allow the State sufficient time to grant or deny the 
extension within one year after EPA approval of the State plan.
    This information must include documentation of the analyses 
undertaken to support the need for an extension, including an 
explanation of why up to 3 years after EPA approval of the State plan 
is sufficient time to comply with the State plan while one year after 
EPA approval of the State plan is not sufficient time to comply. The 
documentation must also include an evaluation of the option to send the 
waste offsite to a commercial medical waste treatment and disposal 
facility, either in the interim, while the facility is taking steps 
towards achieving compliance, or on a permanent basis.
    State plans that allow extensions must also include procedures for 
granting or denying an extension. Under the proposed guidelines, if an 
extension is granted, compliance shall be required within 3 years after 
EPA approval of the State plan, but not later than 5 years after the 
date of promulgation of the emission guidelines.
    While the EPA expects that States will grant extensions for 
facilities planning to install the necessary air pollution control 
equipment, the Agency does not expect many extensions will be granted 
for facilities planning to switch to an alternative method of treatment 
and disposal. Alternatives to onsite incineration include either 
offsite contract treatment and disposal or onsite alternative treatment 
technologies, such as autoclaves.
    It is expected that facilities choosing to switch to an alternative 
could do so within the 1 year following EPA approval of the State plan. 
The commercial waste disposal industry has indicated that sufficient 
excess capacity currently exists to handle the amount of waste that 
would no longer be treated onsite and that commercial facilities are 
located such that most areas could be served by this excess capacity. 
Also, they have indicated that short term contracts are available.
    As a result, if a facility chooses to install an alternative onsite 
treatment technology and the installation takes longer than the time 
allowed for compliance, offsite contract disposal could be used as a 
temporary means of compliance while the alternative technology is 
installed and made operational. The provision for extensions is 
included only to address cases where absolutely no other options are 
available and is not intended to allow up to three years for any 
facility that requests an extension.
    Regardless of the status of the State plans, all designated 
facilities must be in compliance within 5 years after promulgation of 
the emission guidelines. To ensure that each designated facility is in 
compliance with the provisions of the emission guidelines within 5 
years, the EPA will develop, implement, and enforce a plan for any 
State that has not submitted an approvable plan within 2 years after 
promulgation of the emission guidelines.
    The proposed emission guidelines also require that, for approval, a 
State plan provide that each designated facility must be in compliance 
with the operator training and qualification requirements and the 
inspection requirements within 1 year after EPA approval of the State 
plan. The rationale for not granting extensions for these requirements 
is presented in sections V.L and V.N.

S. Permit Requirements

    Section 129 of the Act requires MWI's subject to the standards and 
guidelines [[Page 10685]] to be operated pursuant to a permit issued 
under the EPA-approved State operating permit program. In accordance 
with section 129, under the proposed standards and guidelines, a permit 
would be required on the date 36 months after the date of promulgation, 
or on the effective date of an EPA-approved operating permit program in 
the State in which the facility is located, whichever date is later. 
The operating permit programs are developed under Title V of the Act 
and the implementing regulations under 40 CFR part 70.

VI. Request for Comment

    This section is included in this notice to request public comment 
on certain issues raised during the development of these proposed 
standards and guidelines. As mentioned at the beginning of this notice, 
the EPA seeks full public participation in arriving at its final 
decisions and strongly encourages comments on all aspects of this 
proposal from all interested parties.
A. Procedure To Determine MACT

    Section 129 of the Act establishes specific criteria that must be 
analyzed in developing standards and guidelines for solid waste 
combustion units. 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. The 
details of how this process was applied to the MWI source category are 
described in section V.
    In the process of developing the proposed standards and guidelines, 
the EPA met with representatives from environmental groups, States, MWI 
and air pollution control equipment vendors, commercial waste disposal 
companies, and trade associations that represent owners or operators of 
MWI's to discuss the proposed standards and guidelines. During these 
discussions, various groups have called into question some of the 
conclusions reached in developing the proposed standards and 
guidelines.
    Specifically, questions were raised about: (1) appropriate methods 
for subcategorizing the source category, (2) information and 
assumptions used in determining the MACT floor, (3) conclusions drawn 
regarding the performance of air pollution control technology, and (4) 
decisions made regarding MACT for MWI's. This section describes the 
regulatory development process in general terms and requests public 
comments on the information used and assumptions made in drawing 
conclusions. Following proposal, a reassessment of the four criteria 
listed above will be made that may result in the establishment of 
standards and guidelines that are different from this proposal.
1. Subcategorization
    Section 129 of the Act enables EPA to distinguish among classes, 
types, and sizes within categories of new and existing sources in 
establishing standards and guidelines. The Agency has determined that 
subcategorizing the source category by type of unit is appropriate 
because of distinct technical differences among three types of MWI's. 
Therefore, three subcategories based on MWI type have been identified 
for the purpose of regulating MWI's: batch, intermittent, and 
continuous. While these subcategories were selected because of 
technical differences between the three types of units, as described in 
section V.G, they also generally follow differences in size within the 
source category. Typically, continuous units are large capacity MWI's 
and batch units are small capacity MWI's. Intermittent units tend to 
fall between the continuous and batch units in size. The EPA 
specifically solicits comment on its determination to distinguish 
between continuous, intermittent, and batch units.
    It has been suggested that subcategories could have been identified 
according to size or capacity: small capacity, medium capacity, and 
large capacity, or that EPA might establish a subcategory of small 
intermittent and/or small batch MWI's in addition to establishing 
subcategories on the basis of continuous, intermittent, and batch 
units. Such a distinction by size, or tiering, is currently used by 
many State air pollution control agencies. Current State regulations, 
therefore, may provide a basis for subcategorization by size in 
establishing the standards and guidelines. The Agency is considering 
subcategorization by size and specifically solicits comment on the 
basis for subcategorization by size.
    The EPA recognizes that there may be a relatively large number of 
very small incinerators within the categories of batch and 
intermittent. If so, further subcategorizing batch and intermittent 
incinerators by size or capacity could provide an alternative for 
consideration which might significantly reduce the cost of today's 
proposed standards and guidelines. If the MACT floor is less stringent 
for small intermittent and or small batch MWI's, the EPA could consider 
less stringent requirements for these incinerators. Also, if these 
incinerators contribute little to total national medical waste 
incineration capacity, adoption of less stringent requirements for them 
could result in little loss in the environmental benefits associated 
with today's proposal. This alternative, therefore, could have 
substantial merit and the EPA requests comment on such an approach.
    To fully consider subcategorization by size, however, a mechanism 
must be available to accurately and consistently determine the capacity 
of an MWI. Only if such a mechanism exists, will enforcement personnel, 
as well as owners and operators of MWI's, be assured that MWI's are 
subject to a consistent set of requirements.
    The EPA believes this may be a serious problem. It appears there is 
no common or widely used mechanism or ``standard'' within the MWI 
industry for sizing or determining the capacity of an incinerator to 
burn medical waste. As a result, it seems that one vendor's 50 pound 
per hour capacity incinerator can be another vendor's 100 pound per 
hour capacity incinerator. It also appears the same vendor may sell one 
customer a 50 pound per hour capacity MWI and then sell another 
customer the same incinerator as a 100 pound per hour MWI. The EPA 
believes that a manufacturer's or vendor's ``nameplate capacity'' is 
not an accurate and reliable means for determining the size or capacity 
of an MWI.
    The EPA recognizes that the composition of medical waste changes 
across generators, over time, and in response to changes in waste 
handling or recycling practices in a way that may affect the amount of 
medical waste a specific incinerator is able to burn. For the purposes 
of enforcing regulations that may vary by size or capacity, a common 
mechanism or ``standard'' to measure or determine the capacity of MWI's 
is necessary.
    Consequently, EPA specifically requests comments on a mechanism or 
``standard'' for accurately and consistently determining the capacity 
of MWI's in the enforcement of whatever regulation might be adopted. 
For example, the comments might outline the mechanisms or approaches 
used by States to ensure all MWI's of the same capacity are subject to 
the same requirements. Or, the comments may offer alternative measures 
of capacity that serve as a better basis for identifying small 
intermittent and/or small batch MWI's. Finally, the 
[[Page 10686]] manufacturers may choose to develop a voluntary approach 
providing a consistent measure of rated capacity.
    It has also been suggested that subcategories could be identified 
according to the geographic location of the MWI. Facilities located in 
isolated, rural areas may be different than facilities located in urban 
areas based on their economic environment. For example, alternatives to 
onsite incineration (e.g., commercial medical waste treatment services) 
may be more limited and/or more expensive in isolated locations. The 
Agency specifically solicits comment on the advantages and 
disadvantages of subcategorizing by geographic location.
2. MACT Floor
    The MACT floor refers to the minimum level of control required by 
the Act. For new units, the standards must not be less stringent than 
the emissions control that is achieved in practice by the best 
controlled similar unit. The MACT floors for the proposed standards 
were determined by evaluating the performance of control technologies 
and identifying MWI's that currently use what is considered to be the 
best control technology for each pollutant within each subcategory, as 
described in section V.I. Comments are requested on the Agency's 
conclusions regarding the MACT floors for new MWI's in each 
subcategory.
    For existing units, the guidelines must not be less stringent than 
the average emission limitation achieved by the best performing 12 
percent of units. The MACT floors for the proposed guidelines were 
determined by examining emission limitations found in air quality 
permits and State regulations, as described in section V.J. Because of 
widely varying formats used from State to State to regulate MWI's, many 
assumptions are necessary to standardize the regulations to a common 
basis. As a result, State regulations are subject to different 
interpretations depending on the assumptions made in standardizing them 
for comparison. Comments are requested on the basis for the Agency's 
conclusions on the MACT floors for existing MWI's in each subcategory.
    Subcategorization based on size rather than, or in addition to, MWI 
type (as discussed above) could result in different MACT floors. For 
example, the MACT floor level for particulate matter emissions for a 
subcategory including small intermittent and/or small batch MWI's may 
be much less stringent than the 69 mg/dscm MACT floor identified above 
for intermittent and batch MWI's. If the MACT floors are found to be 
significantly different than those under today's proposal, the Agency 
will determine if MACT levels more stringent than the MACT floors are 
achievable considering cost, any nonair quality health and 
environmental impacts, and energy requirements. The MACT floors will be 
reassessed following proposal.
3. Performance of Technology
    While the standards and guidelines are required to reflect MACT, 
the Agency establishes emission limitations, rather than equipment 
specifications, to encourage competition and further the development of 
technology. Individual facilities have the flexibility of selecting the 
method of control used to comply with the established pollutant 
emission limitations. The benefits of this approach include increased 
competition among vendors of control devices, further development and 
refinement of control technologies, and lower costs, as competing 
control device vendors strive to meet or exceed the required 
performance levels at lower costs than their competitors. Competition 
among vendors of air pollution control equipment will ensure that the 
benefits of emission reduction are realized at the lowest possible 
costs to MWI users and to society.
    In developing the proposed standards and guidelines, the EPA 
concluded that dry scrubbers are the only technology capable of 
achieving the MACT floor levels. Consequently, the proposed emission 
limitations have been established at levels reflecting dry scrubber 
performance. Once again, this does not mean that MWI's are required to 
use dry scrubbers. Any technology that can achieve the emission 
limitations may be used. On the other hand, the EPA conclusion about 
the performance capabilities of wet scrubbers is based on emissions 
data from only one MWI facility using a wet scrubber system. Vendors of 
wet scrubber systems believe that the wet scrubber tested by EPA is not 
reflective of current wet scrubber technology. They believe that 
current wet scrubber technologies are not only capable of achieving the 
MACT floor levels, but may also be capable of achieving the proposed 
emission limitations for all pollutants. As a result, while the 
preamble assumes the use of a dry scrubber system to comply with the 
proposed emission limits, it appears that high efficiency wet scrubber 
systems as well as dry scrubber systems may be capable of achieving the 
proposed emission limits.
    In addition, vendors of wet scrubber systems believe that wet 
scrubber systems are able to achieve the proposed emission limitations 
at about half the estimated total annual costs of dry scrubber systems. 
Wet scrubber vendors also claim that wet scrubber systems currently not 
capable of complying with the proposed emission limitations could be 
retrofitted to do so at a reasonable cost. Users of MWI's that have 
already installed less efficient wet scrubber systems to comply with 
State and/or local regulations may be able to upgrade their existing 
wet scrubber system to comply with the proposed emission limits. The 
Agency is interested in this alternative in part because a number of 
facilities have installed wet scrubber controls in recent years in an 
effort to meet State standards. If the alternative is not available, 
these facilities may have to remove their wet scrubbers and replace 
them with more expensive dry scrubbers. The Agency is interested in 
data on the number of facilities that have installed wet scrubbers and 
the likely cost of replacing the wet scrubbers with dry scrubber 
technology.
    While upgrading an existing wet scrubber system may result in lower 
total annual costs than installing a new dry scrubber system, most 
facilities may still find that alternative disposal options, such as 
offsite contract disposal or onsite autoclaving, are less expensive. 
Consequently, the EPA believes that the use of wet scrubber systems to 
comply with the proposed standards and guidelines will have essentially 
the same impact on shifts away from onsite incineration as the use of 
dry scrubber systems. In fact, the use of any add-on control system 
will increase the costs of onsite incineration such that alternatives 
to onsite incineration become more economical.
    Because the issue of wet scrubber performance is important to MWI 
users, EPA specifically solicits further information on wet scrubber 
systems. The EPA is requesting emissions data that could be used to 
evaluate the performance of wet scrubber systems and to determine the 
capability of these systems in achieving the MACT floor levels and/or 
the proposed emission limitations. Sufficient data are available on 
emissions of CO, opacity, NO<INF>X, SO<INF>2, and HCl for use in 
developing the proposed standards and guidelines. The Agency 
specifically solicits data on PM, Pb, Cd, Hg, and CDD/CDF emissions.
    If new data on wet scrubber performance shows that wet scrubbers 
are capable of achieving the MACT floor levels, then EPA would have to 
review the decision to base the emission limitations on dry scrubbers 
by examining the additional costs and emission reductions achieved by 
dry [[Page 10687]] scrubbers relative to wet scrubbers. In this case, 
the EPA may conclude that the additional costs associated with dry 
scrubber limits are unreasonable relative to the emission reductions 
achieved. On the other hand, if new data on wet scrubber performance 
shows that wet scrubbers are capable of achieving the proposed emission 
limitations, then it is likely that the emission limitations will 
remain unchanged. In this case, the emission limitations would reflect 
the use of either wet scrubbers or dry scrubbers.
    The performance of air pollution control equipment can best be 
established when both APCD inlet and APCD outlet concentration data are 
measured and compared. Several pollutants are waste related. The EPA 
test program identified significant variations in the uncontrolled 
concentrations of these pollutants from source to source, which could 
be a result of differences in the types and amounts of various 
materials included in the waste stream. Therefore, the Agency solicits 
APCD inlet concentration data, to the extent available, wherever outlet 
concentration data are provided.
    Additionally, the Agency solicits comments on the technical 
feasibility of injecting activated carbon into wet scrubber systems to 
control CDD/CDF and Hg emissions. Specifically, the Agency is 
requesting information on whether carbon injection is necessary to 
reduce CDD/CDF and Hg using wet scrubbers and if so, what problems are 
associated with the injection of carbon into a wet system or what other 
means of using the carbon adsorption mechanism are available to reduce 
emissions of these pollutants. If carbon injection is not necessary to 
reduce emissions of CDD/CDF and Hg, the EPA is soliciting information 
on what wet scrubber mechanisms reduce emissions of CDD/CDF and Hg. The 
EPA specifically requests that, if available, Hg emissions data be 
broken down by various species emitted (e.g., Hg chloride versus 
elemental Hg).
    In addition to performance data, the EPA is requesting information 
on the costs associated with the installation of new higher efficiency 
wet scrubber systems and with the retrofit of existing wet scrubber 
systems to achieve the same performance capabilities of the higher 
efficiency wet scrubber systems. The Agency also solicits information 
on the performance and cost of dry scrubber systems, as well as 
information on whether there are technical limitations associated with 
the application of air pollution control systems to various sizes and 
types of MWI's.
    There is some concern about the impacts on other media from the use 
of wet scrubber systems--specifically, the fate of metals transferred 
from the stack gas to the scrubber water with subsequent disposal to a 
sewer system. Wastewater pretreatment may be necessary to remove these 
metals. As a result, the Agency is soliciting information on 
pretreatment techniques that are, or could be, used to remove metals 
from the scrubber effluent prior to discharge to a sewer system and on 
the costs associated with these techniques. The additional costs of 
scrubber effluent pretreatment may increase the total annual costs 
associated with wet scrubber systems to a level that is more comparable 
to the use of a dry scrubber system. Because the Act directs the Agency 
to consider all media in developing regulations, the final standards 
and guidelines may include requirements that address the pretreatment 
of MWI wastewater to ensure that water quality is not compromised.
4. Determining MACT for MWI's
    While section 129 of the Act requires that the standards and 
guidelines be no less stringent than the MACT floor, it does provide 
EPA with the authority to establish emission limitations that are more 
restrictive than the MACT floor. In deciding whether the standards and 
guidelines should be more restrictive than the MACT floor, section 129 
requires the Administrator to consider the cost, any nonair quality 
health and environmental impacts, and energy requirements associated 
with the more restrictive standards and guidelines.
    As described in section V of this notice, EPA has concluded that 
dry scrubbers are the only technology available to meet the MACT floor. 
Furthermore, dry scrubbers achieve substantially lower emissions than 
the MACT floor for little, if any, additional cost. Consequently, EPA 
was faced with two options: (1) propose more restrictive emission 
limitations that reflect the performance of the technology needed to 
meet the MACT floor (i.e., scrubber limits); or (2) propose less 
restrictive emission limitations that reflect the MACT floor (i.e., 
floor limits). On one hand, there is essentially no cost associated 
with the scrubber limits relative to the floor limits because the dry 
scrubber would be installed to meet the floor limits. On the other 
hand, the installation of a dry scrubber will result in the lower 
emissions associated with a dry scrubber. Therefore, it can be argued 
that there is also no environmental benefit associated with the more 
restrictive emission limits.
    The EPA specifically requests comment on the advantages and 
disadvantages of MACT floor-based emission limits versus dry scrubber-
based emission limits. The Agency has chosen the more restrictive dry 
scrubber-based emission limits for the following reasons. First, as 
discussed above, the EPA believes that a dry scrubber is the only 
technology capable of meeting the MACT floor. In addition, activated 
carbon can be injected into a dry scrubber to further reduce dioxin and 
Hg emissions for a relatively small cost. Other technologies have not 
been identified that are able to incorporate carbon injection for 
dioxin and Hg removal. Incineration of medical waste has been 
identified as the largest known source of dioxin and Hg emissions. The 
additional reduction of dioxin and Hg emissions achieved by the 
injection of activated carbon is discussed earlier in this preamble. 
The EPA believes that the benefits of activated carbon injection 
outweigh the costs.
    Secondly, by setting emission limitations rather than control 
equipment specifications, EPA encourages and promotes the development 
of new emission control technologies that can meet the emission limits 
at lower costs. If the Agency proposes the MACT floor emission limits, 
it will promote new technologies that are only capable of meeting the 
floor. In this case, the use of new technologies capable of meeting the 
MACT floor may result in higher emissions than current technologies 
(i.e., dry scrubbers). The Agency believes that new technologies should 
be promoted and encouraged, but that the dry scrubber based emission 
limits are the more appropriate target for these new technologies. 
Therefore, today's proposal has set dry scrubber emission limits as the 
target for new technologies. The Agency specifically requests comment 
on the appropriate target emission limits for developing technologies.
    As noted above, however, vendors of wet scrubbers believe that 
current wet scrubber technologies are not only capable of achieving the 
MACT floor levels, but may also be capable of achieving more stringent 
control levels. If EPA receives additional data that confirms this 
level of performance, then EPA would have to review the decision to 
base the emission limits on dry scrubbers. Thus, EPA would consider the 
potential incremental emission reductions and the potential gains from 
technology development with the [[Page 10688]] differential retrofit 
costs of these two alternative control technologies.
    In addition, as noted above, EPA is considering further 
subcategorization by size. If EPA decides to establish a subcategory of 
``very small MWI's'' in the final rule, it is possible that one or more 
additional control approaches (in addition to fabric filters) would be 
able to achieve (or exceed) the MACT floor levels for this subcategory. 
The Agency would then undertake a careful review of the alternative 
control approaches available for this category of ``very small MWI's'' 
by considering the incremental emission reductions of the more 
stringent control options with the differences in retrofit cost across 
alternatives.
    The Agency requests comment on the appropriate emission limits 
under these alternative options.
B. Alternatives to Onsite Incineration

    As discussed in sections III and IV of this notice, in evaluating 
costs associated with MACT for each MWI, it was determined that many 
facilities would have the option of using an alternative method of 
treatment and disposal that would be less expensive than onsite 
incineration under the proposed standards and guidelines. The most 
common alternatives to onsite incineration are offsite contract 
disposal (most commonly commercial medical waste incineration) and 
onsite autoclaving. While data are available to estimate costs for 
these two alternatives and to estimate emissions from commercial 
medical waste incineration, data are not available to quantify 
emissions or energy requirements from onsite autoclaving of medical 
waste. The EPA solicits emissions data, energy use data, and cost 
information on the use of autoclaves and other nonincineration methods 
to treat and dispose of medical waste.
    Several concerns related to the use of alternatives to onsite 
incineration have been raised. One concern is the ability of 
alternative technology manufacturers to meet the increased demand for 
installations. Also, questions have been raised about the general 
stability in the alternative technology marketplace. Specifically, 
questions have been raised about whether vendors of alternative 
technologies will be able to service the equipment that has been 
installed over the life of that equipment. To respond to these 
concerns, the EPA solicits information on the number of companies that 
currently manufacture alternatives to onsite incineration, the number 
of U.S. installations, the number of installations the individual 
companies are capable of on an annual basis, and the number of years 
the individual companies have been in business.
    Concerns about environmental impacts associated with the use of 
these alternatives have also been raised. Specifically, questions have 
been raised about air and water pollution impacts. As discussed 
earlier, data are not available to quantify air emissions from the use 
of alternative technologies. Data are also not available to quantify 
other environmental impacts resulting from the use of alternatives. In 
addition to air emissions data (requested earlier), the EPA solicits 
data related to other media impacts, including water pollution impacts, 
resulting from the use of alternative technologies.

C. Definition of Medical Waste

    As discussed above, the definition of medical waste included in 
today's proposed regulations is very broad. Medical waste is any solid 
waste generated in the treatment, diagnosis, or immunization of humans 
or animals, or research pertaining thereto, or in the production or 
testing of biologicals.
    Section 129 of the Clean Air Act directs the EPA to adopt 
regulations for solid waste incineration units burning medical waste. 
This section also states that ``* * * ``solid waste'' and ``medical 
waste'' shall have the meanings established by the Administrator 
pursuant to the Solid Waste Disposal Act.''
    The Solid Waste Disposal Act was amended extensively and, for all 
practical purposes replaced, by the Resource Conservation and Recovery 
Act (RCRA) in 1976. The RCRA, in turn, was amended in 1984 and, as it 
pertains to medical waste, was amended again in 1988 by the Medical 
Waste Tracking Act (MWTA). The MWTA included a definition of medical 
waste, which was added to the RCRA. In implementing the amendments to 
the RCRA, this statutory definition of medical waste was adopted by the 
Administrator. The definition of medical waste included in today's 
proposal, therefore, is in EPA's opinion the definition of this term 
established by the Administrator pursuant to the Solid Waste Disposal 
Act.
    As mentioned above, some have suggested the definition of medical 
waste included in today's proposal is inappropriate and the EPA 
requests comment on this definition. It appears the basis for this 
suggestion stems from the following concern. If the impact of today's 
regulation is as widespread as the EPA believes, in terms of the large 
number of medical waste generators who may decide to switch from the 
use of onsite incineration to the use of alternative waste disposal 
techniques, there may not be enough medical waste disposal capacity 
currently available to safely and properly dispose of this medical 
waste.
    To reduce the amount of medical waste covered by today's proposed 
regulations, some have suggested that the EPA narrow the definition of 
medical waste. Various definitions have been offered, such as 
``regulated medical waste'' (a term used by the EPA in implementing the 
MWTA amendments to the RCRA), ``red bag medical waste'', ``infectious 
medical waste'', etc. These wastes are included under the broad 
definition of medical waste, but are generally viewed as constituting 
only about 15 to 20 percent of the total quantity of medical waste. If 
today's proposal covered only these types of medical wastes, as opposed 
to all types of medical wastes, the amount of medical waste which might 
be displaced from onsite incineration at medical waste generators to 
alternative waste disposal techniques would be much less and, as a 
result, more easily handled by these alternative techniques.
    It appears to the EPA, however, that there are several reasons to 
believe there is or would be sufficient capacity available to safely 
and properly treat and dispose of all the medical waste that might be 
displaced from onsite incineration at medical waste generators as a 
result of today's proposed regulations. Since this issue concerns 
medical waste presently being treated by onsite medical waste 
incinerators at medical waste generators, it concerns existing 
incinerators, not new incinerators. Thus, the focus of this issue is 
today's proposed emission guidelines, not the proposed new source 
performance standards.
    Today's proposed emission guidelines provide time for medical waste 
generators currently using onsite medical waste incinerators to 
consider alternatives for treating and disposing of their medical 
waste. The guidelines will not be adopted by the EPA for at least 1 
year (the EPA is under Court Order to adopt final regulations by April 
15, 1996). States are provided 1 year by the Clean Air Act to adopt 
plans for implementing the guidelines and to submit these plans to the 
EPA for approval. The Act then provides EPA 180 days to review and 
approve these State plans. Finally, today's proposed guidelines provide 
1 year following EPA approval of the State plan for existing medical 
waste incinerators to comply with the proposed emission limits.
    Medical waste generators currently operating onsite incinerators, 
therefore, [[Page 10689]] have about 3\1/2\ years from today's date to 
consider how to treat and dispose of their medical waste in the future. 
In addition, today's proposed emission guidelines include provisions to 
permit an extension of up to 3 years following EPA approval of the 
state plan for individual medical waste generators currently operating 
medical waste incinerators to comply with the proposed emission limits. 
Consequently, where circumstances dictate the need for additional time, 
medical waste generators currently operating medical waste incinerators 
could have up to 5\1/2\ years from today's date to consider how to 
treat and dispose of their medical waste.
    Turning to the alternatives, the EPA believes medical waste 
generators currently operating medical waste incinerators have three 
choices to consider. These are: (1) continued operation of their onsite 
incinerator and compliance with the proposed emission limits; (2) 
installation of an alternative medical waste treatment technology 
onsite, such as autoclaving, microwaving, macrowaving, chemical 
treatment, etc.; or (3) contracting with a commercial medical waste 
disposal service for offsite treatment and disposal of medical waste.
    As discussed above, the EPA believes many medical waste generators 
currently operating onsite medical waste incinerators will select the 
second or third choice in response to today's proposed emission 
guidelines. With regard to the second choice, installation of an 
alternative medical waste treatment technology onsite, several 
manufacturers and vendors of autoclave, microwave, macrowave, and 
chemical treatment systems have indicated informally that 3\1/2\ to 
5\1/2\ years is more than enough time to purchase and install one of 
these alternative treatment systems. In fact, some manufacturers and 
vendors have indicated informally that they could supply their 
equipment within months for installation.
    These informal comments have led the EPA to conclude that today's 
proposed emission guidelines provide ample time for medical waste 
generators currently operating onsite medical waste incinerators, who 
may select the second choice, to purchase and install the appropriate 
equipment. The EPA, however, specifically requests manufacturers and 
vendors of these alternative treatment systems to comment formally on 
the time necessary for a medical waste generator to obtain the 
necessary permits to install and operate their systems, the time 
necessary to obtain and install their systems, and their ability to 
respond to increased orders for their systems over the next 3 to 6 
years, as a result of today's proposal.
    Based on a survey of current practices regarding landfill disposal 
of medical waste, the EPA believes that medical waste may be disposed 
of in most landfills provided it has been properly treated to destroy 
infectious agents and is not recognizable as medical waste. It appears 
the first criteria is met through the use of these alternative 
treatment systems. The second criteria is met by grinding and/or 
shredding the waste, which is common practice where these alternative 
treatment systems are in operation today. If this belief is correct, it 
would seem clear that there is more than enough landfill capacity 
available in the United States for disposal of medical waste treated by 
these alternative waste treatment disposal systems.
    With regard to the third choice, contracting with a commercial 
medical waste disposal service, representatives and operators of these 
services have indicated informally that their industry is currently 
operating at very low capacity. They have indicated informally that the 
industry currently treats and disposes of about 20 percent of the 
medical waste generated in the United States and that the industry has 
the capacity today to treat and dispose of possibly as much as 40 
percent of the medical waste generated. Finally, given the time frame 
of 3\1/2\ to 5\1/2\ years provided in the proposed emission guidelines 
for medical waste generators currently operating medical waste 
incinerators to decide how to dispose of their medical waste in the 
future, the commercial medical waste disposal industry has indicated 
informally that sufficient additional capacity could be permitted, 
constructed, and brought on line by the industry to service all those 
medical waste generators who may select this third choice.
    It appears, therefore, the commercial medical waste disposal 
industry has a great deal of capacity today and could add substantial 
capacity in the near future to meet any increase in the need for their 
services which may result. The EPA, however, specifically requests that 
the representatives and operators of commercial medical waste disposal 
services comment formally on the capacity within their industry today 
to dispose of medical waste, the current utilization of this capacity, 
and their ability to permit, construct, and bring on line major 
additions to this capacity in the next 3 to 6 years.
    Finally, while not related to questions of the capacity of 
alternatives to treat and dispose of medical waste displaced by medical 
waste generators which currently use onsite medical waste incinerators, 
there are other reasons EPA believes all medical waste should be 
covered by today's proposed regulations. The suggestions to narrow the 
applicability of today's proposal would basically narrow the proposal 
to cover ''red bag'' medical wastes. Testing during the EPA test 
program to examine differences in emissions between red-bag medical 
waste and general medical waste showed no significant difference in 
emissions of air pollutants, such as hydrogen chloride (HCl), dioxins, 
lead, mercury, etc.
    The EPA believes, therefore, that there is no significant 
difference between red-bag medical waste and general medical waste in 
emissions of those air pollutants which section 129 of the Clean Air 
Act directs the EPA to regulate. In addition, there appears to be no 
significant difference in the applicability, performance, or cost of 
various technologies to reduce these emissions from medical waste 
incinerators burning red-bag medical waste or general medical waste. 
There is, therefore, no compelling reason EPA sees for narrowing the 
definition of medical waste included in today's proposed regulations.

VII. Administrative Requirements

A. Public Hearing

    The EPA will hold at least one public hearing to provide interested 
parties an opportunity for oral presentation of data, views, or 
arguments concerning the proposal. Additional hearings may also be 
held. A Federal Register document will be published within the next 2 
weeks to announce the details of the heading(s). At the public 
hearing(s), the proposed standards and guidelines will be discussed in 
accordance with section 307(d)(5). Oral presentations will be limited 
to 15 minutes each. Any member of the public may file a written 
statement before, during, or within 30 days after the hearing. Written 
statements should be mailed to the Air and Radiation Docket and 
Information Center at the address given in the ADDRESSES section of 
this preamble.
    A verbatim transcript of the hearing and written statements will be 
available for public inspection and copying during normal working hours 
at the EPA's Air and Radiation Docket and Information Center in 
Washington, DC (see ADDRESSES section of this preamble).

B. Docket

    The docket is an organized and complete file of all the information 
[[Page 10690]] submitted to or otherwise considered in the development 
of the proposed standards and guidelines. The principal purposes of the 
docket are: (1) to allow interested parties to identify and locate 
documents so that they can effectively participate in the rulemaking 
process, and (2) to serve as the record in case of judicial review 
(except for interagency review material [section 307(d)(7)(A)]). The 
docket number for this rulemaking is A-91-61.

C. Clean Air Act Procedural Requirements

1. Administrator Listing--Section 111; Section 129 of the Act
    Section 129 of the Act calls for the Administrator to promulgate 
standards for new MWI's and guidelines for existing MWI's pursuant to 
section 111 and 129.
2. Periodic Review--Section 111 and Section 129 of the Act
    Section 111 and section 129 of the Act require that the standards 
and guidelines be reviewed not later than 5 years following the initial 
promulgation. At that time and at 5-year intervals thereafter, the 
Administrator is to review the standards and guidelines and make 
revisions if necessary. This review will include an assessment of such 
factors as the need for integration with other programs, the existence 
of alternative methods, enforceability, improvements in emission 
control technology, and reporting requirements.
3. External Participation--Section 117 of the Act
    In accordance with section 117 of the Act, publication of this 
proposal was preceded by consultation with appropriate advisory 
committees, independent experts, and Federal departments and agencies. 
The Administrator welcomes comments on all aspects of the proposal, 
including economic and technological issues.
4. Economic Impact Assessment--Section 317 of the Act
    Section 317 of the Act requires the EPA to prepare an economic 
impact assessment for any emission standards and guidelines promulgated 
under section 111 of the Act. An economic impact assessment was 
prepared for the proposed standards and guidelines. In the manner 
described above under the discussions of the impacts of, and rationale 
for, the proposed standards and guidelines, the EPA considered all 
aspects of the assessment in proposing the standards and guidelines. 
The economic impact assessment is included in the docket listed at the 
beginning of today's notice under SUPPLEMENTARY INFORMATION.

D. Office of Management and Budget Reviews

1. Paperwork Reduction Act (PRA)
    The information collection requirements in this proposed rule have 
been submitted for approval to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An 
Information Collection Request (ICR) document has been prepared by the 
EPA (ICR No. 1730.01) and a copy may be obtained from Sandy Farmer, 
Information Policy Branch (2136); U. S. Environmental Protection 
Agency, 401 M Street, SW., Washington, DC 20460 or by calling (202) 
260-2740.
    This collection of information is estimated to have an average 
annual reporting burden of 0.01 person years per pathological MWI and 
an average of about 2.4 person years for MWI's burning general medical 
waste. This includes time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing the collection of information.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden to Chief, Information Policy Branch (2136), U.S. Environmental 
Protection Agency, 401 M Street, SW., Washington, DC 20460; and to the 
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Washington, DC 20503, marked ``Attention: Desk Officer for the 
EPA.'' The final rule will respond to any OMB or public comments on the 
information collection requirements contained in this proposal.
2. Executive Order 12866 Review
    Under Executive Order (E.O.) 12866, the EPA must determine whether 
the proposed regulatory action is ``significant'' and therefore, 
subject to the Office of Management and Budget (OMB) review and the 
requirements of the Executive Order. The Order defines ``significant'' 
regulatory action as one that is likely to lead to a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety in State, local, or tribal governments or communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that the proposed standards and guidelines are 
``significant'' because the annual effect on the economy will exceed 
$100 million. As such, this action was submitted to OMB for review. 
Changes made in response to OMB suggestions or recommendations are 
documented in the public record.
3. Executive Order 12875
    Under Executive Order 12875, the EPA is required to consult with 
representatives of affected State, local, and tribal governments, and 
keep these affected parties informed about the content and effect of 
the proposed standards and guidelines. The following discussion 
provides a brief summary of the content, need for, and cost of the 
proposed standards and guidelines, as well as the actions that the EPA 
has taken to communicate and consult with the affected parties.
a. Summary of the Proposed Standards and Guidelines
    The proposed standards and guidelines would establish emission 
limitations for new and existing MWI's. The proposed standards and 
guidelines do not specify which type of air pollution control equipment 
must be used at MWI's to meet the proposed emission limitations. 
However, the EPA expects that, to meet the proposed emission 
limitations, most MWI's would use dry scrubbing systems (DI/FF) with 
activated carbon injection for dioxins/furans, metals, and acid gas 
control. Refer to section II of this preamble for a more detailed 
discussion of the proposed standards and guidelines.
b. Need for the Proposed Standards and Guidelines
    Under the Act Amendments of 1990, section 129 includes a schedule 
that requires the EPA to develop standards and guidelines for MWI's by 
November 1992. The EPA did not comply with that schedule and is now 
under court order to propose the standards and guidelines by February 
1, 1995 and promulgate the standards and guidelines by April 15, 1996. 
As required by section 129, the proposed standards and guidelines would 
establish emission limitations for PM, opacity, CO, CDD/CDF, HCl, 
SO<INF>2, NO<INF>X, Pb, Cd, and Hg. See section I of 
[[Page 10691]] this preamble for further discussion of the regulatory 
history and general goals of the proposed standards and guidelines.
c. Cost of the Proposal
    The nationwide annual costs associated with the proposed standards 
for new MWI's would increase by approximately $74.5 million/yr from the 
regulatory baseline cost of $63.3 million/yr. The cost of compliance 
with the proposed standards for an individual facility will vary 
depending on the method chosen to comply with the proposed emission 
limitations. Of the projected number of new MWI's, some will be 
constructed with air pollution control equipment to comply with the 
proposed emission limitations. However, as discussed in Section III of 
this preamble, the EPA expects that, to avoid the increased costs 
associated with the installation of control equipment, as many as 80 
percent of the projected number of new MWI's will not be constructed. 
Instead, these facilities are likely to consider less expensive methods 
of treatment and disposal.
    Under the proposed standards, the average annualized cost of 
incineration for a typical small MWI would be about $326 thousand per 
year. The two most common alternatives to onsite incineration include 
offsite contract disposal and onsite steam sterilization. Instead of 
installing an MWI with air pollution control equipment, the facility 
may choose to use offsite contract disposal at an estimated average 
annualized cost of $98.8 thousand per year, or onsite steam 
sterilization at an estimated average annualized cost of $65.6 thousand 
per year. Either of these alternatives is considerably less expensive 
than onsite incineration under the proposed standards.
    Under the proposed standards, the average annualized cost of 
incineration for a typical large MWI would be about $520 thousand per 
year. The cost to dispose of the same amount of waste using offsite 
contract disposal is estimated at about $1.01 million per year, which 
is considerably higher than the costs of onsite incineration. Onsite 
steam sterilization of the same amount of waste would cost about $158 
thousand per year. Instead of installing an MWI with air pollution 
control equipment, the facility may choose to use onsite steam 
sterilization at a much lower cost. A more complete summary of the cost 
and economic impacts of the proposed standards are presented in Section 
III of this preamble.
    The nationwide annual costs associated with the proposed guidelines 
for existing MWI's would increase by approximately $351 million/yr from 
the regulatory baseline cost of $265 million/yr. As with new MWI's, the 
cost of compliance with the proposed guidelines for an individual 
facility will vary depending on the method chosen to comply with the 
proposed emission limitations. Some facilities may choose to keep their 
incinerator and install air pollution control equipment to comply with 
the proposed emission limitations. However, as discussed in Section IV 
of this preamble, the EPA expects that as many as 80 percent of 
existing facilities currently using onsite incineration will switch to 
an alterative method of treatment and disposal to avoid the increased 
cost of installing air pollution control equipment.
    For a typical small MWI, the installation of control equipment 
would increase the average annualized cost of incineration to about 
$329 thousand per year. Instead of installing air pollution control 
equipment, the facility may choose to use offsite contract disposal at 
an estimated average annualized cost of $98.8 thousand per year, or 
onsite steam sterilization at an estimated average annualized cost of 
$65.6 thousand per year. The costs for either of these alternatives is 
considerably less than the costs for installing control equipment to 
meet the proposed emission limitations.
    The average annualized cost of incineration for a typical large MWI 
would increase to about $533 thousand per year. The cost to dispose of 
the same amount of waste using offsite contract disposal is estimated 
at about $1.01 million per year, which is substantially higher than the 
estimated costs of onsite incineration. Onsite steam sterilization of 
the same amount of waste would cost about $158 thousand per year. 
Instead of installing air pollution control equipment to meet the 
proposed emission limitations, the facility may choose to use onsite 
steam sterilization at a much lower cost. A more complete summary of 
the cost and economic impacts of the proposed guidelines are presented 
in Section IV of this preamble.
d. Communication With Affected Parties
    As previously mentioned, Executive Order 12875 requires the EPA to 
consult with representatives of affected State, local, and tribal 
governments, and prior to promulgation of final standards, summarize 
concerns of the governmental entities and respond to their comments. 
The EPA has already initiated consultations with numerous governmental 
entities including, but not limited to, the U.S. Conference of Mayors, 
the National Association of City and County Health Officials, the 
National Association of Counties, the National Association of Public 
Hospitals, and the National Governors Association. These groups have 
been informed of the content of the proposal and the estimated impacts. 
In drafting the proposal, the EPA has considered the concerns expressed 
by these groups, and discussions with these groups will continue 
following proposal. The EPA awaits comments from these groups on the 
proposal and will respond to their comments.

E. Regulatory Flexibility Act Compliance

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) 
requires Federal agencies to give special consideration to the impact 
of regulations on small entities, which are small businesses, small 
organizations, and small governments. The major purpose of the RFA is 
to keep paperwork and regulatory requirements from getting out of 
proportion to the scale of the entities being regulated, without 
compromising the objectives of, in this case, the Act.
    If a regulation is likely to have a significant economic impact on 
a substantial number of small entities, the EPA may give special 
consideration to those small entities when analyzing regulatory 
alternatives and drafting the regulation. In the case of the proposed 
standards and guidelines, the results of the economic analysis indicate 
that the standards and guidelines will not have a significant impact on 
a substantial number of small entities. Less than 20 percent of 
``small'' government jurisdictions are expected to be significantly 
impacted. In addition, although some small medical waste generators 
would be significantly impacted by the regulation's control 
requirements, the majority of these impacts could be avoided by 
switching to less expensive alternatives for medical waste disposal. 
Therefore, it is expected that the number of facilities that are 
significantly impacted will not be ``substantial.''

List of Subjects in 40 CFR Part 60

    Air Pollution control, Incorporation by reference, 
Intergovernmental relations, Medical waste, Reporting and 
recordkeeping.

    Dated: February 1, 1995.
Carol M. Browner,
Administrator.
[FR Doc. 95-3045 Filed 2-24-95; 8:45 am]
BILLING CODE 6560-50-P