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Hospital/Medical/Infectious Waste Incinerators; Final Rule

  >[Federal Register: September 15, 1997 (Volume 62, Number 178)]
  >[Rules and Regulations]
  >[Page 48347-48391]
  >>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
  >[[Page 48347]]
  >Part II
  >Environmental Protection Agency
  >40 CFR Part 60
  >Standards of Performance for New Stationary Sources and Emission
  >Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
  >Incinerators; Final Rule
  >[[Page 48348]]
  >40 CFR Part 60
  >RIN 2060-AC62
  >Standards of Performance for New Stationary Sources and Emission
  >Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
  >AGENCY: Environmental Protection Agency (EPA).
  >ACTION: Final rule.
  >SUMMARY: This action promulgates new source performance standards (NSPS
  >or standards) and emission guidelines (EG or guidelines) to reduce air
  >emissions from hospital/medical/infectious waste incinerator(s) (HMIWI)
  >by adding subpart Ec, standards of performance for new HMIWI, and
  >subpart Ce, emission guidelines for existing HMIWI, to 40 CFR part 60.
  >The standards and guidelines implement sections 111 and 129 of the
  >Clean Air Act (CAA) as amended in 1990. The standards and guidelines
  >apply to units whose primary purpose is the combustion of hospital
  >waste and/or medical/infectious waste. Sources are required to achieve
  >emission levels reflecting the maximum degree of reduction in emissions
  >of air pollutants that the Administrator has determined is achievable,
  >taking into consideration the cost of achieving such emission
  >reduction, any nonair-quality health and environmental impacts, and
  >energy requirements. The promulgated standards and guidelines establish
  >emission limits for particulate matter (PM), opacity, sulfur dioxide
  >(SO<INF>2</INF>), hydrogen chloride (HCl), oxides of nitrogen
  >(NO<INF>X</INF>), carbon monoxide (CO), lead (Pb), cadmium (Cd),
  >mercury (Hg), dioxins and dibenzofurans (dioxins/furans), and fugitive
  >ash emissions. Some of the pollutants being regulated are considered to
  >be carcinogens and at sufficient concentrations can cause toxic effects
  >following exposure. The standards and guidelines also establish
  >requirements for HMIWI operator training/qualification, waste
  >management plans, and testing/monitoring of pollutants and operating
  >parameters. Additionally, the guidelines for existing HMIWI contain
  >equipment inspection requirements and the standards for new HMIWI
  >include siting requirements.
  >DATES: Effective Dates. The standards for new sources (Sec. 60.17 and
  >Secs. 60.50c through 60.58c) are effective as of March 16, 1998 and the
  >emission guidelines for existing sources (Sec. 60.30 and Secs. 60.30e
  >through 60.39e) are effective as of November 14, 1997. The
  >incorporation by reference of certain publications listed in the
  >regulations is approved by the Director of the Federal Register as of
  >March 16, 1998. See SUPPLEMENTARY INFORMATION for a discussion of the
  >schedule for judicial review.
  >    Comments. Comments on the Information Collection Request (ICR)
  >document associated with the final standards for new sources are
  >requested, as discussed in section VI.B of this preamble. Comments on
  >the ICR document must be received on or before November 14, 1997. Refer
  >to Section VI.B for further information on this request for comment.
  >ADDRESSES: Comments. As noted above, comments on the ICR document
  >associated with the final standards for new sources are requested. See
  >section VI.B and the SUPPLEMENTARY INFORMATION section of this preamble
  >for further information on obtaining a copy of the ICR document and
  >addresses for submitting comments on the ICR document.
  >    Background Information. The principal background information for
  >the final standards and guidelines includes a background information
  >document entitled ``Hospital/Medical/ Infectious Waste Incinerators:
  >Background Information for Promulgated Standards and Guidelines--
  >Summary of Public Comments and Responses'' (EPA-453/R-97-006b), which
  >contains a summary of all the public comments submitted regarding the
  >changes to the standards and guidelines that were discussed in the June
  >20, 1996 Federal Register document (61 FR 31736) and the EPA's response
  >to these comments. Background information documents which present the
  >economic and regulatory impacts of the standards and guidelines
  >entitled: (1) ``Hospital/Medical/Infectious Waste Incinerators:
  >Background Information for Promulgated Standards and Guidelines--
  >Analysis of Economic Impacts for Existing Sources'' (EPA-453/R-97-
  >007b); (2) ``Hospital/Medical/Infectious Waste Incinerators: Background
  >Information for Promulgated Standards and Guidelines--Analysis of
  >Economic Impacts for New Sources'' (EPA-453/R-97-008b); and (3)
  >``Hospital/Medical/Infectious Waste Incinerators: Background
  >Information for Promulgated Standards and Guidelines--Regulatory Impact
  >Analysis for New and Existing Facilities'' (EPA-453/R-97-009b) are
  >available. Also a document entitled ``Fact Sheet: New Hospital/Medical/
  >Infectious Waste Incinerators--Promulgated Subpart Ec Standards,''
  >which succinctly summarizes the final standards, and a document
  >entitled ``Fact Sheet: Existing Hospital/Medical/Infectious Waste
  >Incinerators--Promulgated Subpart Ce Emission Guidelines,'' which
  >succinctly summarizes the guidelines, are available. See SUPPLEMENTARY
  >INFORMATION for instructions and addresses for obtaining these
  >    Docket. Docket No. A-91-61, which contains supporting information
  >used in developing the standards and guidelines, is available for
  >public inspection and copying between 8:00 a.m. and 4:00 p.m., Monday
  >through Friday except for Federal holidays at the following address:
  >U.S. Environmental Protection Agency, Air and Radiation Docket and
  >Information Center (Mail Code 6102), 401 M Street SW, Washington DC
  >20460 (phone: (202) 260-7548). The docket is located at the above
  >address in room M-1500, Waterside Mall (ground floor, central mall). A
  >reasonable fee may be charged for copying.
  >FOR FURTHER INFORMATION CONTACT: Mr. Rick Copland at (919) 541-5265,
  >Combustion Group, Emission Standards Division (MD-13), U. S.
  >Environmental Protection Agency, Research Triangle Park, North Carolina
  >27711 (copland.rick@epamail.epa.gov) or any of the EPA Regional Office
  >contacts listed in Table 1 below.
  >               Table 1.--Contacts in EPA Regional Offices
  >            Region                     Contact             Phone No.
  >I (Boston)....................  Susan Lancey.........     (617) 565-3587
  >II (New York).................  Christine DeRosa.....     (212) 637-4022
  >III (Philadelphia)............  James Topsale........     (215) 566-2190
  >IV (Atlanta)..................  Scott Davis..........     (404) 562-9127
  >V (Chicago)...................  Douglas Aburano (MI).     (312) 353-6960
  >[[Page 48349]]
  >                                Ryan Bahr (IN).......     (312) 353-4366
  >                                Scott Hamilton (OH)..     (312) 353-4775
  >                                Charles Hatten (WI)..     (312) 886-6031
  >                                Mark Palermo (IL)....     (312) 886-6082
  >                                Rick Tonielli (MN)...     (312) 886-6068
  >VI (Dallas)...................  Mick Cote............     (214) 665-7219
  >VII (Kansas City).............  Wayne Kaiser.........     (913) 551-7603
  >VIII (Denver).................  Meredith Bond........     (303) 312-6438
  >IX (San Francisco)............  Patricia Bowlin......     (415) 744-1188
  >X (Seattle)...................  Catherine Woo........     (206) 553-1814
  >Regulated Entities
  >    Entities potentially regulated by the standards and guidelines are
  >those which operate hospital/medical/infectious waste incinerators.
  >Regulated categories and entities include those listed in Table 2.
  >                      Table 2.--Regulated Entities<SUP>a
  >                                                         Examples of
  >                     Category                        regulated entities
  >Industry..........................................  Hospitals, nursing
  >                                                     homes, research
  >                                                     laboratories, other
  >                                                     health care
  >                                                     facilities,
  >                                                     commercial waste
  >                                                     disposal companies.
  >Federal Government................................  Armed services,
  >                                                     public health
  >                                                     service, Federal
  >                                                     hospitals, other
  >                                                     Federal health care
  >                                                     facilities.
  >State/local/Tribal Government.....................  State/county/city
  >                                                     hospitals and other
  >                                                     health care
  >                                                     facilities.
  ><SUP>a This table is not intended to be exhaustive, but rather provides a
  >  guide for readers regarding entities likely to be regulated by the
  >  standards or guidelines for HMIWI. This table lists the types of
  >  entities that EPA is now aware could potentially be regulated. Other
  >  types of entities not listed in the table could also be regulated. To
  >  determine whether your facility is regulated by the standards or
  >  guidelines for hospital/medical/ infectious waste incinerators, you
  >  should carefully examine the applicability criteria in sections 60.50c
  >  and 60.51c of the promulgated standards, section 60.32e of the
  >  promulgated guidelines, and in section III.A of today's notice. If you
  >  have questions regarding the applicability of the HMIWI standards and
  >  guidelines to a particular entity, consult a person listed in the
  >Documents Available Electronically
  >    This Federal Register document discusses: (1) The standards for new
  >HMIWI, (2) the guidelines for existing HMIWI, and (3) a request for
  >public comment on the ICR document. This preamble and regulatory text
  >are available electronically via the Internet. Also available
  >electronically are FACT SHEETS, which summarize the final standards and
  >guidelines. They are suggested reading for persons requiring an
  >overview of the standards and guidelines. Hard copies of the FACT
  >SHEETS can also be obtained by calling Donna Collins at (919) 541-5578.
  >The following five items are available electronically in file
  >    1. ``Fact Sheet: New Hospital/Medical/Infectious Waste
  >Incinerators--Promulgated Subpart Ec Standards.''
  >    2. ``Fact Sheet: Existing Hospital/Medical/Infectious Waste
  >Incinerators--Promulgated Subpart Ce Emission Guidelines.''
  >    3. Federal Register document for this promulgation: ``Standards of
  >Performance for New Stationary Sources and Emission Guidelines for
  >Existing Sources: Hospital/Medical/Infectious Waste Incinerators''
  >(this document).
  >    4. ``Hospital/Medical/Infectious Waste Incinerators: Background
  >Information for Promulgated Standards and Guidelines--Summary of Public
  >Comments and Responses'' (EPA-453/R-97-006b).
  >    5. Information Collection Request document for these standards for
  >new sources: ``Supporting Statement for ICR No. 1730.02--1997 Standards
  >for New Hospital/Medical/Infectious Waste Incinerators (Subpart Ec).''
  >    The documents are available via the Internet at ``http://
  >www.epa.gov/ttn/oarpg/rules.html''. The documents are also available
  >via the Internet through the Unified Air Toxics Website at ``http://
  >Judicial Review
  >    Under section 307(b)(1) of the Clean Air Act, judicial review of
  >the actions taken by this notice is available by filing a petition for
  >review in the U.S. Court of Appeals for the District of Columbia
  >Circuit within 60 days of today's publication of this rule. Under
  >section 307(b)(2) of the Clean Air Act, the requirements that are in
  >today's notice may not be challenged later in the civil or criminal
  >proceedings brought by the EPA to enforce these requirements.
  >Preamble Outline
  >    The following outline is provided to aid in locating information in
  >the introductory text (preamble) to the final standards and guidelines.
  >I. Acronyms, Abbreviations, and Measurement Units
  >    A. Acronyms
  >    B. Abbreviations and Measurement Units
  >II. Introduction
  >    A. Purpose of the Standards and Guidelines
  >    B. Implementation of the Emission Guidelines
  >    1. Implementation Activities
  >    2. Public Involvement
  >    C. Technical Basis of the Standards and Guidelines
  >    D. February 1995 Proposal
  >    E. June 1996 Re-proposal
  >    F. Stakeholders and Public Involvement
  >III. Considerations in Developing the Final Standards and Guidelines
  >    A. Applicability
  >    1. Definition of Medical Waste
  >    2. Co-fired Combustors
  >    3. Waste Types
  >    4. Cement Kilns
  >    B. Pyrolysis Units
  >    C. Waste Management Plans
  >    D. Testing, Monitoring, and Inspection
  >    E. Operator Training and Qualification
  >IV. Standards of Performance for New Sources
  >    A. Summary of the Standards
  >    B. Significant Issues and Changes
  >[[Page 48350]]
  >    1. Combined Dry/Wet Scrubbers
  >    2. Siting Analysis
  >    C. Selection of MACT
  >    D. Impacts of the Standards
  >V. Emission Guidelines for Existing Sources
  >    A. Summary of the Guidelines
  >    B. Significant Issues and Changes
  >    C. Selection of MACT
  >    D. Impacts of the Guidelines
  >VI. Administrative Requirements
  >    A. Docket
  >    B. Paperwork Reduction Act
  >    C. Executive Order 12866
  >    D. Unfunded Mandates Reform Act
  >    E. Executive Order 12875
  >    F. Regulatory Flexibility Act (RFA) and Small Business
  >Regulatory Enforcement Fairness Act of 1996 (SBREFA)
  >    G. Submission to Congress and the General Accounting Office
  >    H. Clean Air Act Procedural Requirements
  >I. Acronyms, Abbreviations, and Measurement Units
  >    The following acronyms, abbreviations, and measurement units are
  >provided to clarify the preamble to the final standards and guidelines.
  >A. Acronyms
  >APCD  air pollution control device
  >APTI  Air Pollution Training Institute
  >CAA  Clean Air Act
  >CAAA  Clean Air Act Amendments of 1990
  >CEMS  continuous emissions monitoring system(s)
  >CFBC  circulating fluidized bed combustor
  >CFR  Code of Federal Regulations
  >DI  dry injection
  >EPA  U.S. Environmental Protection Agency
  >EG  emission guidelines
  >FF  fabric filter
  >FR  Federal Register
  >HAP  hazardous air pollutant(s)
  >HMIWI  hospital/medical/infectious waste incinerator(s)
  >ICCR  Industrial Combustion Coordinated Rulemaking
  >ICR  information collection request
  >MACT  maximum achievable control technology
  >MSW  municipal solid waste
  >MWC  municipal waste combustor(s)
  >MWI  medical waste incinerator(s)
  >MWP  medical waste pyrolysis
  >MWTA  Medical Waste Tracking Act
  >NAPH  National Association of Public Hospitals
  >NSPS  new source performance standards
  >NSR  new source review
  >NYSDOH  New York State Department of Health
  >OAQPS  Office of Air Quality Planning and Standards
  >OMB  Office of Management and Budget
  >ORD  Office of Research and Development
  >PSD  prevention of significant deterioration
  >RCRA  Resource Conservation and Recovery Act
  >RFA  Regulatory Flexibility Act
  >RMW  regulated medical waste
  >SBA  Small Business Administration
  >SBREFA  Small Business Regulatory Enforcement Fairness Act
  >SMSA  standard metropolitan statistical area
  >SWDA  Solid Waste Disposal Act
  >B. Abbreviations and Measurement Units
  >bps=bits per second
  >Btu=British thermal units
  >Btu/yr=British thermal units per year
  >CO=carbon monoxide
  >dioxins=polychlorinated dibenzo-p-dioxins
  >dscf=dry standard cubic feet (at 14.7 pounds per square inch, 68 deg.F)
  >dscm=dry standard cubic meters (at 14.7 pounds per square inch,
  >68 deg.F)
  > deg.F=degrees Fahrenheit
  >ft<SUP>3</SUP>=cubic feet
  >furans=polychlorinated dibenzofurans
  >g=gram (454 grams per pound)
  >g/yr=grams per year
  >gr=grains (7,000 grains per pound)
  >HCl=hydrogen chloride
  >m<SUP>3</SUP>=cubic meter (35.3 cubic feet per cubic meter)
  >mg=milligrams (10<SUP>-3</SUP> grams)
  >Mg=megagram (1.1 tons per megagram)
  >Mg/yr=megagrams per year
  >MMm<SUP>3</SUP>=million cubic meters
  >MW-hr/yr=megawatt-hours per year
  >ng=nanogram (10<SUP>-9</SUP> grams)
  >NO<INF>X</INF>=nitrogen oxides
  >PM=particulate matter
  >ppmv=parts per million by volume
  >SO<INF>2</INF>=sulfur dioxide
  >TEQ basis=2,3,7,8-tetrachlorinated dibenzo-p-dioxin toxic equivalent
  >based on the 1989 international toxic equivalency factors
  >tons/d=tons per day
  >total mass basis=total mass of tetra-through octa-chlorinated dibenzo-
  >p-dioxins and dibenzofurans
  >II. Introduction
  >A. Purpose of the Standards and Guidelines
  >    The 1990 Clean Air Act Amendments (CAAA) reflect growing public
  >concern about the large volume of toxic air pollutants released from
  >numerous categories of emission sources. Title III of the CAAA
  >specifically enumerated 189 hazardous air pollutants (HAP) 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. The second phase standards, due
  >a few years 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 CAAA singled out waste incineration for
  >special attention. Congress recognized both a high level of public
  >concern about the incineration of municipal, medical, and other solid
  >wastes and a number of special management concerns for these types of
  >sources. Consequently, section 129 of the CAA directs EPA to apply the
  >two-phase control approach to various categories of solid waste
  >incinerators, including hospital/ medical/infectious waste
  >incinerator(s) (HMIWI). Today's action promulgates standards and
  >guidelines for new and existing HMIWI 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.
  >    The EPA estimates that there are approximately 2,400 HMIWI
  >operating in the United States, which combust approximately 767
  >thousand Mg (846 thousand tons) of hospital waste and medical/
  >infectious waste annually. Emissions from HMIWI contain organics
  >(dioxins/furans), particulates (PM), metals (Cd, Pb, and Hg), acid
  >gases (HCl and SO<INF>2</INF>), and NO<INF>X</INF>. These pollutants
  >can have adverse effects on both public health and welfare. Pollutants
  >of principal concern to public health include dioxins/furans, PM, Pb,
  >Cd, and Hg. Today's standards and guidelines are set forth as emission
  >limits and will significantly reduce HMIWI emissions.
  >    Several States, including New York, California, and Texas, have
  >adopted relatively stringent regulations in the past few years limiting
  >emissions from HMIWI. The implementation of these regulations has
  >brought about very large reductions in HMIWI emissions and the
  >associated risk to public health in those States. Today EPA is
  >promulgating nationally applicable emission standards and guidelines
  >for HMIWI that build on the experience of these leading States. Like
  >the State regulations, the standards and guidelines promulgated today
  >are based on the use of add-on air pollution control systems. These
  >standards and
  >[[Page 48351]]
  >guidelines implement the first phase requirements of section 129
  >described above. As described in detail below, section 129, like
  >section 112, of the CAA 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 will evaluate whether the residual
  >public health risk warrants additional control.
  >    The EPA's Office of Research and Development (ORD) is preparing a
  >national inventory of dioxin emissions as part of its Dioxin
  >Reassessment. This effort will include emission estimates for HMIWI.
  >Since the effort is not yet complete, the results are not included in
  >this package. The ORD is considering a very similar approach to that
  >used in this rulemaking and anticipates generating similar emission
  >B. Implementation of the Emission Guidelines
  >    The subpart Ce emission guidelines are unique in that, unlike the
  >subpart Ec NSPS, the guidelines are not direct Federal requirements for
  >HMIWI. The subpart Ec NSPS are Federal requirements that apply to all
  >new HMIWI units that commence construction after June 20, 1996 or to
  >existing HMIWI units that commence modification after March 16, 1998.
  >The subpart Ce emission guidelines require States to develop section
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