310R05002
      Profile of the
      Healthcare  Industry
      EPA Office of Compliance Sector Notebook Project
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                         I
 SECTOR
NOTEBOOKS

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Healthcare Industry                                            Sector Notebook Project

This report is one in a series of volumes published by the U.S. Environmental Protection Agency
(EPA) to provide information of general interest regarding environmental issues associated with
specific industrial sectors. A listing of available Sector Notebooks is included on the following
page.

The Notebook will orient readers from a wide audience to the environmental responsibilities and
challenges facing health service providers including major medical centers, ambulatory
healthcare clinics, dental offices, doctors offices and veterinary clinics. The Notebook will be
especially useful in educating those in industry as well as government and the general public
who are unfamiliar with the complex environmental regulations that apply to the healthcare
industry. With references for more detailed information, the Notebook will nicely complement
new resources on compliance, environmental management systems, pollution prevention, and the
nascent on-line healthcare environmental resource center.

Obtaining copies:

Electronic versions  of all Sector Notebooks are available on EPA's web site at
www.epa.gov/compliance/sectornotebooks.html,

A limited number of complimentary volumes are available to certain groups or subscribers,
including public and academic libraries; federal, state, tribal, and local governments; and the
media. You can order from EPA's National Service Center for Environmental Publications at
(800) 490-9198 or www. epa.gov/ncepihom.  When ordering, use the applicable EPA publication
number from those listed on the following page.

The Sector Notebooks were developed by the EPA's Office of Compliance. Direct general
questions about the Sector Notebook Project to:

             Coordinator, Sector Notebook Project
             U.S. EPA Office of Compliance
             1200  Pennsylvania Ave., NW (2224-A)
             Washington, D.C. 20460
             (202)564-2310
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Healthcare Industry
                                         Sector Notebook Project
                        AVAILABLE SECTOR NOTEBOOKS

Questions and comments regarding the individual documents should be directed to Compliance
Assistance and Sector Programs Division at (202) 564-2310 unless otherwise noted below. See
the Notebook web page at: www.epa.gov/compliance/sectornoteboofcs.html for the most
recent titles and links  to refreshed data.
EPA Publication
    Number
EPA/310-R-95-001.
EPA/310-R-95-002.
EPA/310-R-95-003.
EPA/310-R-95-004.
EPA/310-R-95-005.
EPA/310-R-95-006.
EPA/3LO-R-95-Q07.
EPA/310-R-95-008.
EPA/310-R-95-009.
EPA/310-R-95-010.
EPA/310-R-95-011.
EPA/310-R-02-001.
EPA/310-R-95-013.
EPA/310-R-95-014.
EPA/310-R-02-002.
EPA/310-R-95-017.
EPA/310-R-95-018.
EPA/310-R-97-001.
EPA/310-R-97-002.
EPA/310-R-97-003.
EPA/310-R-97-004.
EPA/310-R-97-005.
EPA/310-R-97-006.
EPA/310-R-97-007.
EPA/310-R-97-008.
EPA/310-R-97-009.
EPA/310-R-98-001.
EPA/310-R-00-001.

EPA/310-R-00-002.

EPA/310-R-00-003.

EPA/310-R-00-004.
EPA/310-R-05-002.
EPA/310-R-05-003.
EPA/310-R-99-001.
EPA/300-B-96-003.
EPA/310-R-05-001.
      Industry
Profile of the Dry Cleaning Industry
Profile of the Electronics and Computer Industry*
Profile of the Wood Furniture and Fixtures Industry
Profile of the Inorganic Chemical Industry*
Profile of the Iron and Steel Industry
Profile of the Lumber and Wood Products Industry
Profile of the Fabricated Metal Products Industry*
Profile of the Metal Mining Industry
Profile of the Motor Vehicle Assembly Industry
Profile of the Nonferrous Metals Industry
Profile of the Non-Fuel, Non-Metal Mining Industry
Profile of the Organic Chemical Industry, 2nd Edition*
Profile of the Petroleum Refining Industry
Profile of the Printing Industry
Profile of the Pulp and Paper Industry, 2nd Edition
Profile of the Stone, Clay, Glass, and Concrete Industry
Profile of the Transportation Equipment Cleaning Industry
Profile of the Air Transportation Industry
Profile of the Ground Transportation Industry
Profile of the Water Transportation Industry
Profile of the Metal Casting Industry
Profile of the Pharmaceuticals Industry
Profile of the Plastic Resin and Man-made Fiber Industry
Profile of the Fossil Fuel Electric Power Generation Industry
Profile of the Shipbuilding and Repair Industry
Profile of the Textile Industry
Profile of the Aerospace Industry
Profile of the Agricultural Crop Production Industry
Contact: Ag Center, (888) 663-2155
Profile of the Agricultural Livestock Production Industry
Contact: Ag Center, (888) 663-2155
Profile of the Agricultural Chemical, Pesticide and Fertilizer Industry
Contact: Agriculture Division, (202) 564-2320
Profile of the Oil and Gas Extraction Industry
Profile of the Healthcare Industry
Profile of the Rubber and Plastic Industry, 2nd Edition

          Government Series
Profile of Local Government Operations
Profile of Federal Facilities
Profile of Tribal Government Operations
    Spanish translations of lsl Editions available in electronic format only.
www. hercenter. ore/links
                  11
February 2005

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Healthcare Industry                                          Sector Notebook Project
                             DISCLAIMER

This Sector Notebook was created for employees of the U.S. Environmental Protection Agency
(EPA) and the general public for informational purposes only. This document has been
extensively reviewed by experts from both inside and outside the EPA, but its contents do not
necessarily reflect the views or policies of EPA or any other organization mentioned within.
Mention of trade names or commercial products or events does not constitute endorsement or
recommendation for use. In addition, these documents are not intended and cannot be relied
upon to create any rights, substantive or procedural, enforceable by any party in litigation with
the United States.
www. hercenter. org/links                    Hi                             February 2005

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Healthcare Industry                                        Sector Notebook Project

Healthcare Industry - Including Hospitals, Physicians Offices, Dental Offices,
                             Nursing Homes, etc.
                                  (NAICS 62)

                           TABLE OF CONTENTS

                                                                           Page

LIST OF ACRONYMS	viii

I.           INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT	1
            I.A.   Summary of the Sector Notebook Project    	1
            I.E.   Additional Information  	2

II.          INTRODUCTION TO THE HEALTHCARE INDUSTRY	3
            II. A.  Introduction, Background, and Scope of the Notebook	3
            II.B.  Characterization of the Healthcare Industry 	5
                  II.B. 1. Service Characterization 	5
                  II.B.2. Industry Size and Geographic Distribution	5
                  II.B.3. Economic Trends	10

III.          ACTIVITY DESCRIPTIONS	14
            III.A. Healthcare Activities	14
            III.B. Waste Streams Generated by the Healthcare Industry	26
                  IH.B.1. Municipal Solid Waste	27
                  III.B.2.Biohazardous Waste (Regulated Medical Waste)	28
                  III.B.3.Hazardous Waste	29
                  III.B.4. Wastes by Media Category  	41
            III.C. Assessment of Wastes Generated by Functional Activity	42
            III.D. Management of Waste Streams	48

IV.          WASTE AND EMISSIONS PROFILE	52
            IV.A. Solid, Biohazardous, and Hazardous Waste Production Data for thev
                  Healthcare Industry	52
                  IV.A.l.       Municipal Solid Waste	52
                  IV.A.2.       Biohazardous Waste	53
                  IV.A.3.       Hazardous Chemical Waste	54
            IV.B. Wastewater Discharge Data for the Healthcare Industry	54
            IV.C. Air Emissions from the Healthcare Industry	56

V.          POLLUTION PREVENTION OPPORTUNITIES	59
            V.A.  General Pollution Prevention Opportunities	59
                  V. A. 1. Environmental Management Systems (EMS)	59
                  V.A.2. Purchasing/Product Substitution/Source Reduction 	59
                  V.A.3. Process Change  	60
                  V.A.4. Recycling	62

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Healthcare Industry D                                       Sector Notebook Project

            V.B.  Pollution Prevention Opportunities by Waste Type  	63

VI.         SUMMARY OF FEDERAL STATUTES AND REGULATIONS  	72
            VI.A. Industry-Specific Requirements  	72
            VLB. Regulations by Waste Category	98
            VI.C. Pending and Proposed Regulatory Requirements	99
            VI.D. Additional Applicable Regulations (Non-EPA Administered)	100

VII.         COMPLIANCE AND ENFORCEMENT HISTORY	103
            VILA. Background 	103
            VII.B. Compliance and Enforcement Description  	104
            VII,C. Compliance and Enforcement Data Definitions  	105
            VII.D. Healthcare Industry Compliance History  	106
            VILE. Comparison of Enforcement Activity Among Selected Industries .... 112
            VII.F. Review of Major Legal Actions	117

VIII.        COMPLIANCE ACTIVITIES AND INITIATIVES 	125
            VIII. A. Healthcare Related Programs and Activities	125
            VIII,B. Summary of Trade Organizations and Industry Organizations	132

IX.         CONTACTS/ACKNOWLEDGMENTS/RESOURCE MATERIALS/"
            BIBLIOGRAPHY	136
            IX.A. Contacts/Document Reviewers  	136
            IX.B. Bibliography 	138
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Healthcare Industry                                          Sector Notebook Project

                               LIST OF TABLES

                                                                               Page

II-1          Number of Healthcare Establishments, Number of Healthcare Employees,
             and Total Healthcare Receipts, by State  	9

III-l         Examples of RCRA Listed Hazardous Waste Found in Healthcare Facilities  ..31

III-2         Healthcare Facility Wastes 	43

IV-1         Direct Dischargers Included in PCS  	55

IV-2         Pollutant Discharge from Direct Discharging Healthcare Facilities	55

IV-3         Total Emissions for VOC, NOx, and HAPs (Tons/Year)  	57

V-l          Pollution Prevention and Waste Management Strategies by Waste Category  .. 64

VI-1         Summary of Potentially Applicable EPA Regulations  	73

VI-2         EPA Regulations by Waste Category 	98

VII-1         5-Year Enforcement and Compliance Summary for the Healthcare
             Industry (SIC 8000), By Region  	108

VII-2         5-Year Enforcement and Compliance Summary for the Healthcare
             Industry (SIC 8000), by Region and Statute 	109

VII-3         5-Year Enforcement and Compliance Summary for Selected Industries  	113

V1I-4         5-Year Enforcement and Compliance Summary by Statute for
             Selected Industries	115
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Healthcare Industry                                          Sector Notebook Project

                               LIST OF FIGURES

                                                                               Page

II-1          Number of Establishments in the Healthcare Industry  	6

II-2          Number of Paid Employees (millions) by Type of Healthcare Facility  	7

II-3          Value of Revenue in the Healthcare Industry (millions)	8

II-4          National Healthcare Expenditures as a Share of the GDP	11

II-5          The Nation's Health Dollar, CY 2000	12

II-6          Community Hospital Expenditures: Inpatient and Outpatient
             Shares for All Payers	13

IV-1         Hospital Solid Waste Composition	53
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Healthcare Industry
                    Sector Notebook Project
                            LIST OF ACRONYMS

ADA               American Dental Association
AFS               Air Facility Subsystem
AHA               American Hospital Association
AHCA             American Health Care Association
AHERA            Asbestos Hazard Emergency Response Act
AIRS               Air Facility Indexing and Retrieval System
AMA               American Medical Association
ANA               American Nurses Association
ANSI               American National Standards Institute
ASHE              American Society for Healthcare Engineers
ASHES             American Society for Healthcare Environmental Services
AST               Aboveground Storage Tanks
AVMA             American Veterinary Medical Association
BBP               Blood Borne Pathogens
BIF                Boilers and Industrial Furnaces
BOD               Biochemical Oxygen Demand
BRS               Biennial Reporting System
C&D               Construction and Demolition
CAA               Clean Air Act
CAM               Compliance Assurance Monitoring
CAP               College of American Pathologists
Cd                 Cadmium
CDC               Centers for Disease Control
CERCLA           Comprehensive Environmental Response, Compensation, & Liability Act
CERCLIS           Comprehensive Environmental and Liability Information System
CESQG            Conditionally Exempt Small Quantity Generator
CFC               Chlorofluorocarbon
CFR               Code of Federal Register
CMS               Centers for Medicare and Medicaid Services
CSRD              Central Sterile Reprocessing and Distribution
CWA               Clean Water Act
DMR               Discharge Monitoring Reports
DOT               Department of Transportation
e-CFR              Electronic Code of Federal Regulations
ECHO              Enforcement and Compliance History Online
ECOS              Environmental Council of the States
EEG               Electroencephalograph
EMS               Environmental Management System
EPA               Environmental Protection Agency
EPCRA            Emergency Planning and Community Right-to-Know Act
EPP               Environmentally Preferable Purchasing
EtO                Ethylene Oxide
FDA               Food and Drug Administration
FIFRA             Federal Insecticide, Fungicide, and Rodenticide Act
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February 2005

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Healthcare Industry
                                         Sector Notebook Project
FQPA
FRN
FRS
GDP
H2E
Hal
HAP
HAZWOPER
HBN
HCWH
Hg
HHS
HMIWI
HVAC
ICIS
IDEA
IS
ISO
JCAHO
LDR
LEPC
LQG
MACT
MCL
MCLG
MMS
MOU
MRI
MS4
MSDS
MSW
MWTA
NAAQS
NAICS
NCDB
NEETF
NESHAP
NET
NIHE
NLIC
NOVs
NOX
NPDES
NPIC
NRC
NSPS
Food Quality Protection Act
Federal Register Notice
Facility Registry Systems
Gross Domestic Product
Hospitals for a Healthy Environment
Hydrochloric Acid
Hazardous Air Pollutants
Hazardous Waste Operations and Emergency Response
Healthy Building Network
Health Care Without Harm
Mercury
Health and Human Services
Hospital/Medical/Infectious Waste Incinerators
Heating Ventilation and Air Conditioning
Integrated Compliance Information System
Integrated Data for Enforcement Analysis
Information Services
International Organization for Standardization
Joint Commission on Accreditation of Healthcare Organizations
Land Disposal Restrictions
Local Emergency Planning Committees
Large Quantity Generators
Maximum Achievable Control Technology
Maximum Containment Levels
Maximum Containment Level Goals
Minerals Management Service
Memorandum of Understanding
Magnetic Resonance Imaging
Municipal Separate Storm Sewer Systems
Material Safety Data Sheet
Municipal Solid Waste
Medical Waste Tracking Act
National Ambient Air Quality Standards
North American Industry Classification System
National Compliance Database
National Environmental Education & Training Foundation
National Emission Standards for Hazardous Air Pollutants
National Emission Trends
National Institute for Health and the Environment
National Lead Information Center
Notices of Violation
Nitrogen Oxides
National Pollutant Discharge Elimination System
National Pesticide Information Center
Nuclear Regulatory Commission
New Source Performance Standards
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                     IX
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Healthcare Industry
                                         Sector Notebook Project
NSR
NTI
OAR
OB/GYN
OECA
OSHA
OSWER
P2
P2OSH
Pb
PCB
PCS
PEER
POTW
PSD
PVC
RCC
RCRA
RCRAInfo
RMW
SARA
SDWA
SERC
SHP
SIC
SIP
SO2
SPCC
SQG
SWDA
TCLP
TIP
TRI
TRIS
TSCA
TSS
UIC
USDW
USPS
UST
VOC
New Source Review
National Toxics Inventory
Office of Air and Radiation
Obstetrics and Gynecology
Office of Enforcement and Compliance Assurance
Occupational Health and Safety Administration
Office of Solid Waste and Emergency Response
Pollution Prevention
Pollution Prevention and Occupational Safety and Health
Lead
Polychlorinated Biphenyls
Permit Compliance System
Public Entity Environmental Resource Center
Publicly Owned Treatment Works
Prevention of Significant Deterioration
Polyvinyl Chloride
Resource Conservation Challenge
Resource Conservation and Recovery Act
Resource Conservation and Recovery Act Information System
Regulated Medical Waste
Superfund Amendments and Reauthorization Act
Safe Drinking Water Act
State Emergency Response Commissions
Sustainable Hospitals Project
Standard Industrial Classification
State Implementation Plan
Sulfur Dioxide
Spill Prevention Control & Countermeasure
Small Quantity Generators
Solid Waste Disposal Act
Toxicity Characteristic Leaching Procedure
Tribal Implementation Plans
Toxic Release Inventory
Toxic Release Inventory System
Toxic Substances Control Act
Total Suspended Solids
Underground Injection Control
Underground Sources of Drinking Water
United States Postal Service
Underground Storage Tanks
Volatile Organic Compounds
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                                                   February 2005

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Healthcare Industry                                            Sector Notebook Project

I.             INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT

LA.          Summary of the Sector Notebook Project

              Environmental policies based upon comprehensive analysis of air, water, and land
pollution (such as economic factors and community-based approaches) are becoming an
important supplement to traditional single-media approaches to environmental protection.
Environmental regulatory agencies are beginning to embrace comprehensive, multi-statute
solutions to facility permitting, compliance assurance, education/outreach, research, and
regulatory development issues. The central concepts driving this policy are that pollutant
releases to each environmental medium (air, water,  and land) affect each other, and that
environmental strategies must actively identify and address these interrelationships by designing
policies for the whole facility.  One way to achieve  a whole-facility focus is to design
environmental policies for similar industrial facilities.  By doing so, environmental concerns that
are common to the manufacturing of similar products can be addressed in a comprehensive
manner. Recognition of the need to develop the industrial sector-based approach within EPA's
Office of Compliance led to the creation of this document.

              The Sector Notebook Project was initiated by the Office of Compliance within the
Office of Enforcement and Compliance Assurance (OECA) to provide its staff and managers
with summary information for specific industrial sectors. As other EPA offices, states, the
regulated community, environmental groups, and the public became interested in this project, the
scope of the original project was expanded. The ability to design comprehensive, common-sense
environmental protection measures for specific industries is dependent on knowledge of several
interrelated topics. The key topics examined for this project are:  general industry information
(economic and geographic); a description of activities; pollution outputs; pollution prevention
opportunities; federal statutory and regulatory framework; compliance history; and a description
of partnerships that have been formed between regulatory agencies, the regulated community,
and the public.

              For any given industry, each topic listed above could alone be the subject of a
lengthy volume.  However, in order to produce a manageable document, this project focuses on
providing summary information for each topic. This format provides the reader with a synopsis
of each issue, and references where more in-depth information is available. Text within each
profile was researched from a variety of sources, and was usually condensed from more detailed
sources pertaining to specific topics. This approach allows for a wide coverage of activities that
you can further explore using references listed at the end of this profile. As a check on the
information included, each Notebook went through  an external document review process. The
Office of Compliance appreciates the efforts of all those who participated in this process and
enabled us to develop more complete, accurate, and up-to-date summaries. Many of those who
reviewed this Notebook are listed as contacts in Section IX and may be sources of additional
information. The individuals and groups on this list do not necessarily concur with all
statements within this Notebook.
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Healthcare Industry                                            Sector Notebook Project

I.B.          Additional Information

             Providing Comments

             OECA's Office of Compliance plans to periodically review and update the
Notebooks and will make these updates available both in hard copy and electronically. If you
have any comments on the existing Notebooks, or if you would like to provide additional
information, please send them to: EPA Office of Compliance, Sector Notebook Project (2224-
A), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460.  Comments can also be sent
electronically via the Sector Notebooks web page at:
www. epa.gov/compliance/sectornotebooks. html.  If you are interested in assisting in the
development of new Notebooks, or if you have recommendations on which sectors should have a
Notebook, please contact the Office of Compliance at (202) 564-2310.

             Adapting Notebooks to Particular Needs

             This Sector Notebook is meant to generally describe the healthcare industry on a
national basis. In many instances, facilities within specific geographic regions or states may
have unique characteristics that are not fully captured in these profiles.  The Office of
Compliance encourages state, tribal, and local environmental agencies and other groups to
supplement or repackage the information included in this Notebook to include more specific
industrial and regulatory information that may be available. Additionally, interested states and
tribal governments may want to supplement the "Summary of Applicable Federal Statutes and
Regulations" section with state, tribal, and local requirements. Compliance or technical
assistance providers may also want to develop the "Pollution Prevention" section in more detail.

             Updated Web Site Links

             An updated list of all of the web links contained in this Notebook can be found at
www. hercenter. ors/links.
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Healthcare Industry                                Introduction, Background, and Scope

II.           INTRODUCTION TO THE HEALTHCARE INDUSTRY

             This section provides background information on the size, geographic
distribution, employment, and economic condition of the healthcare industry. Facilities
described within the document are also described in terms of their North American Industry
Classification System (NAICS) codes.  The NAICS, which was developed jointly by the United
States, Canada,  and Mexico to provide new comparability in statistics about business activity
across North America, has replaced the U.S. Standard Industrial Classification (SIC) system,
under which Health Services is designated 80.  Facilities in the healthcare industry are identified
under NAICS code 62.

             Note that, while there are benefits to the NAICS codes for organizing categories
of business, there are disadvantages in the case of the healthcare sector.  For the most part,
healthcare organizations, whether large or small, in-patient or outpatient, have some level of
complexity to their operations and functions. Even small multi-service hospitals have complex
service offerings, and generate a large variety of waste.  Therefore, the NAICS code information
presented below is supplemented with a more robust picture of the rapidly changing healthcare
universe.

II.A.        Introduction, Background, and Scope of the Notebook

             The healthcare and social assistance industry (NAICS code 62) comprises many
subsectors including ambulatory healthcare services, hospitals, nursing and residential care
facilities, and social assistance. This Notebook focuses primarily on the activities performed at
hospitals. However, many of these activities can be performed by others in the healthcare
industry, and as such, this notebook applies to those providers as well.

             The specific subsectors covered in this industry document are:

             •      NAICS 621.  Ambulatory Healthcare Services. The following types of
                    facilities are covered under this NAICS code:
                    —     Physicians' offices,
                    —     Dentists' offices,
                    —     Other health practitioners' offices,
                    —     Outpatient care centers,
                    —     Medical and diagnostic laboratories,
                    —     Home healthcare services, and
                    —     Other ambulatory healthcare services.

                    These entities may be free standing and perhaps privately owned or may
                    be part of a hospital or health system. Currently, most hospitals (NAICS
                    622) also offer ambulatory healthcare services. For some facilities, these
                    services represent as much as 60-70 percent of hospital business.  Much of
                    this change has been driven by adjustments in healthcare finance and
                    reimbursement, advances in technology, and new and effective
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Healthcare Industry                                 Introduction, Background, and Scope

                     Pharmaceuticals, that eliminate the need for inpatient and invasive care
                     services.

                     Also of note is the growing emergence of complementary healthcare
                     services that are also ambulatory in nature. These include chiropractic
                     care, massage, acupuncture, and acupressure,

              •       NAICS622.  Hospitals. The following types of facilities are covered
                     under this NAICS code:
                     —     General medical and surgical hospitals,
                     —     Psychiatric and substance abuse hospitals, and
                     —     Specialty (except psychiatric and substance abuse) hospitals.

                     This category potentially includes many types of hospitals such as
                     academic medical center/university-based/teaching hospitals, community
                     hospitals, speciality hospitals (i.e., orthopedic or pediatric), and tertiary
                     care facilities that are qualified to handle major trauma cases (i.e., burns
                     and catastrophic accidents). There are also distinctions between public
                     and private hospitals, hospitals that are part of a healthcare system (i.e.,
                     organizations such as Kaiser Permanente),  Veterans Administration
                     hospitals, and other types of facilities.

                     Hospitals and healthcare systems are continually changing their service
                     offerings, and responding to various internal and external forces including
                     reimbursement issues, advances in technology, and shifts in  the
                     populations they serve.

              *       NAICS 623.  Nursing and Residential Care Facilities. The following
                     types of facilities are covered under this NAICS code:
                     —     Nursing care and assisted living facilities,
                     —     Residential mental retardation/health and substance abuse
                            facilities,
                     —     Community care facilities for the elderly, and
                     —     Other residential care facilities.

                     Nursing care and residential care facilities offer nonacute care to
                     individuals, either those suffering from a chronic condition (e.g.,
                     dementia, developmental delay, multiple sclerosis, Parkinson's disease,
                     autism), aging, or mental health problems.

                     As population demographics in the United States shift and demand for
                     care services and facilities increases, more and more facilities offering
                     some component of the above services will arise.
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Healthcare Industry                                Introduction, Background, and Scope

              The veterinary services industry (NAICS 541940) also performs many activities
similar to the healthcare industry.  Veterinary facilities may find some of the information in this
Notebook relevant and useful,

              •      NAICS 541940. Veterinary Services. This industry includes
                     establishments of licensed veterinary practitioners primarily in the practice
                     of veterinary medicine, dentistry, or surgery for animals, and
                     establishments providing testing services for licensed veterinary
                     practitioners.

II.B.         Characterization of the Healthcare Industry

II.B.l.        Service Characterization

              The healthcare industry provides a variety of services to support the healthcare
needs of a community or individuals. Many of the activities in healthcare result in waste outputs
and air or water pollution.  In order to understand which activities generate polluting waste
outputs, it is necessary to look at various functions within healthcare, and understand the
products and supplies used and the resulting wastes. Much of the waste in healthcare is solid
waste consisting of paper, cardboard, glass, plastic, and metals. A subcomponent of healthcare
waste is biohazardous, or infectious waste. Another component is Resource Conservation and
Recovery Act (RCRA) hazardous waste.

              Healthcare is vastly different from the many industries that have a defined
'product line,' a finite number of input materials and defined and consistent 'waste outputs.'
There are thousands of procedures, tests, processes, and activities, which encompass as many
materials, The hazardous component in healthcare waste tends to be made up of small amounts
of many different wastes, emanating from many different departments. Due to the decentralized
nature of service delivery in healthcare, there can  be various departments with different functions
all generating various amounts of hazardous waste.

              Hospitals are most often described by speciality or service areas. Some of these
areas include, but are not limited to:  cardiology, critical care, emergency services, family
practice, facility engineering, general surgery, gynecology, infectious disease, internal medicine,
laboratory and analysis, medical monitoring/computer services, morgue, neurology,
neurosurgery, obstetrics, oncology, pathology, pharmacy, radiology, residential care, and
urology.

TI.B.2.        Industry Size and Geographic Distribution

              The healthcare industry impacts the lives of nearly every person in the United
States. According to the 1997 Census of the Healthcare Industry  (NAICS codes 621, 622, and
623), there are more than 500,000 healthcare facilities throughout the country, employing almost
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Healthcare Industry
Introduction, Background, and Scope
12 million people, with an annual payroll of more than $353 billion. In 2002, the 5,794
registered1 hospitals included 975,962 staffed beds and admitted 36,325,693 patients.

              Hospitals alone contribute more than $1.3 trillion to the nation's economy,
according to a TrendWatch report by the Lewin Group released at the 2004 AHA Annual
Meeting in Washington. Hospitals employ nearly five million people, rank second as a source of
private sector jobs, and directly or indirectly support one of every nine jobs in the United States.

              Figure II-1 demonstrates how the healthcare industry is divided among
ambulatory  healthcare facilities, hospitals, and nursing and residential care facilities. The
majority of the facilities, 88 percent, are ambulatory healthcare facilities. The remainder of the
industry is divided between nursing and residential care facilities (11 percent) and hospitals (1
percent).

            Figure II-l: Number of Establishments in the Healthcare Industry
                                                  455,381
                              H Ambulatory health care services
                              • Hospitals
                              D Nursing & residential care facilities
            Source: The 1997 Economic Census of the Healthcare and Social Assistance Industry.

              Although ambulatory healthcare facilities make up 88 percent of the healthcare
facilities, hospitals have the most employees, totaling more than 42 percent of the industry.
Ambulatory healthcare facilities have 37 percent of the healthcare staff, while nursing and
residential care facilities have only 21 percent. Figure II-2 shows the number of employees by
type of healthcare facility.
1 Registered hospitals are those hospitals that meet the American Hospital Association's (AHA) criteria for
registration as a hospital facility. Registered hospitals include AHA member hospitals as well as nonmember
hospitals. For a complete list of the criteria used for registration, please see
http://www. hospitalconnect. com/aha/resource center/
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     Figure II-2:  Number of Paid Employees (millions) by Type of Healthcare Facility
                                 2.47
                                                        4.41
                                   4.93
                           • Ambulatory health care services
                           • Hospitals
                           D Nursing & residential care facilities
            Source:  The 1997 Economic Census of the Healthcare and Social Assistance Industry.

              The revenue for healthcare facilities is divided unevenly across the number of
ambulatory healthcare, hospitals, and nursing and residential care facilities.  As shown in Figure
II-3, the majority of the revenues, 46 percent, are from hospitals.  It is important to once again
note, however, that a large part of a hospital's service offerings are ambulatory healthcare
offerings. There are also many hospitals/health systems that have affiliated nursing homes,
residential care facilities and other healthcare sector entities that deliver service, which may not
be reflected in the value of claims and revenues. The remainder is divided between ambulatory
healthcare facilities (43 percent) and nursing and residential care facilities (11 percent).  In the
healthcare industry, these revenues come from:

              •      Patient care services (which includes laboratory services, diagnostic
                     testing, and direct patient care);

              •      Home healthcare services, including sales of blood, blood products,
                     organs and tissues, and ambulance services;

              •      Rental and leasing of goods and equipment, including both medical and
                     "other"; and

              •      Other services and medical equipment related to prescription and
                     nonprescription drugs, vision care services, orthopedic services, and other
                     related needs.
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           Figure II-3: Value of Revenue in the Healthcare Industry (millions)
                                  93,080
                           379,178
                                                         355,441
                             • Ambulatory health care services
                             • Hospitals
                             D Nursing & residential care facilities
            Source: The 1997 Economic Census of the Healthcare and Social Assistance Industry.

              Healthcare establishments are concentrated in areas with high population density.
California has the highest number of facilities, followed by New York, Texas, Florida, and
Pennsylvania. California has more than 67,000 ambulatory healthcare, hospital, and nursing and
residential facilities, which employ over one million people per year. Table II-1 presents the
number of healthcare establishments, the number of healthcare employees, and the total
healthcare receipts in each of the 50 states and the District of Columbia.  The information is
ordered by number of establishments.
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 Table II-l: Number of Healthcare Establishments, Number of Healthcare Employees, and
                         Total Healthcare Receipts, by State
State
California
New York
Texas
Florida
Pennsylvania
Illinois
Ohio
Michigan
New Jersey
Georgia
Massachusetts
North Carolina
Virginia
Washington
Maryland
Indiana
Missouri
Tennessee
Wisconsin
Arizona
Colorado
Minnesota
Louisiana
Connecticut
Oregon
Alabama
Kentucky
Oklahoma
South Carolina
Iowa
Kansas
Arkansas
Mississippi
Utah
Establishments
67,049
37,640
35,543
33,863
25,826
21,107
20,872
19,135
18,508
12,802
12,799
11,669
11,273
11,157
10,709
10,076
9,813
9,756
9,173
8,800
8,334
8,081
8,026
7,444
7,212
6,706
6,647
6,601
5,783
5,355
4,868
4,471
3,828
3,658
Paid Employees
1,084,719
968,004
790,629
664,362
626,842
519,598
535,457
431,813
354,546
290,674
389,529
319,631
247,869
222,782
225,103
263,591
274,628
257,050
245,975
159,723
151,265
157,894
214,367
93,899
127,530
180,407
171,005
147,287
136,320
98,979
66,756
108,101
112,359
71,790
Receipts
($1,000)
93,742,883
68,576,184
53,894,354
49,513,538
42,445,050
36,820,144
34,537,846
29,168,412
27,056,992
22,242,191
25,146,242
21,908,538
17,692,485
15,460,294
15,968,224
16,950,896
17,365,887
18,489,619
15,368,388
11,947,321
10,772,791
9,864,404
13,843,010
6,241,205
8,518,910
12,688,762
11,345,390
8,832,649
9,597,946
5,129,312
3,667,767
6,870,149
7,577,714
4,795,081
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        Introduction, Background, and Scope
  Table II-l:  Number of Healthcare Establishments, Number of Healthcare Employees,
                   and Total Healthcare Receipts, by State (Continued)
State
West Virginia
Nevada
New Mexico
Nebraska
Maine
Hawaii
Idaho
New Hampshire
Rhode Island
Montana
District of
Columbia
South Dakota
Delaware
Vermont
Alaska
North Dakota
Wyoming
Establishments
3,461
3,010
2,933
2,847
2,777
2,430
2,351
2,256
2,143
1,967
1,496
1,363
1,356
1,274
1,141
1,064
972
Paid Employees
83,485
49,295
64,709
48,392
37,388
22,932
43,029
55,401
31,298
23,902
47,742
41,507
19,353
27,330
20,740
27,686
17,728
Receipts
($1,000}
5,526,231
4,434,559
4,134,335
2,865,939
2,272,419
2,090,765
2,678,189
3,618,105
2,197,746
1,294,100
4,194,304
2,371,023
1,367,588
1,589,182
1,787,722
1,339,141
1,076,409
           Source: The 1997 Economic Census of the Healthcare and Social Assistance Industry.

             The 1997 Census information did not separate Veterinary Services (NAICS
541940) from the other industries within the 5419 code category. However, according to the
American Veterinary Medical Association, as of September 2002, there are 61,477 veterinarians
employed in about 21,044 veterinary practices located across the United States. These practices
have a mean gross practice revenue of $677,823 per practice per year.  This information includes
both private clinical practices and public and corporate employment.

II.B.3.       Economic Trends

             Healthcare Expenditures as a Share of the Gross Domestic Product

             According to the Centers for Medicare and Medicaid Services (CMS), the
healthcare industry currently accounts for about 13 percent of the Gross Domestic Product
(GDP) of the United States. By the year 2010, healthcare expenditures are expected to increase
to 17 percent of the GDP.  As shown in Figure II-4, the growth of spending has stabilized since
1993 because medical prices averaged only a 2.9 percent annual growth between 1993 and 1999.
This growth is relatively minimal compared to the 11.2-percent average annual growth between
1980 and 1982, and the 6-percent average annual growth between 1982 and  1993.  Another
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Healthcare Industry
         Introduction, Background, and Scope
factor to consider in this stabilization is the growth in the complementary care industry (i.e.,
nonallopathic healthcare services), which was reported to be about 42 billion dollars in the mid-
1990s.

           Figure II-4: National Healthcare Expenditures as a Share of the GDP
                                                                  Period of
                                                                 stabilization
              1980
                          1984
                                      1988         1992
                                        Calendar Years
                                                             1996
                                                                        2000
          Source: CMS. Office of the Actuary, National Health Statistics Group.
                  Source: June 2002 Centers for Medicare and Medicaid Services Report.

              Healthcare Spending

              In calendar year 2000, the United States spent $1.3 trillion on healthcare (NAICS
code 62). Most of this money was split between hospital care (32 percent) and physician and
clinical services (22 percent).

              As shown in Figure II-5, prescription drugs accounted for 9 percent of the total
healthcare spending in 2000.  According to the CMS, between 1990 and 2000, prescription drug
spending increased by more than 3 percent while the amount of money spent at hospitals
decreased by 4.8 percent.
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Healthcare Industry
         Introduction, Background, and Scope
                     Figure II-5: The Nation's Health Dollar, CY 2000
                       Other Spending
                            24%
                   Program"
                 Administration
                     and"
                   Net Cost"
                        Prescription
                           Drugs
                            9%
                              Nursing Home
                                  Care
                                   7%
         Physician and
        Clinical Services
             22%
                             Total Health Spending = $1.3 Trillion
               Note: Other spending includes dentist services, other professional services, home health,
               durable medical products, over-the-counter medicines and sundries, public health, research and
               construction.
               Source: CMS, Office of the Actuary, National Health Statistics Group.
                  Source: June 2002 Centers for Medicare and Medicaid Services Report.

              Inpatient Care Versus Outpatient Care

              The implementation of Medicare prospective payment systems and the increased
enrollment into various managed care programs have contributed to the decreased length of
patient hospital stays since 1980. According to the CMS, in 1980, the average length of a
hospital stay was between 7 and 8 days. In 1999, it was about 2 to 3 days. These factors, along
with advances in technology and Pharmaceuticals available to treat diseases, have also led to a
decline in the number of inpatient hospital procedures. As shown in Figure II-6, inpatient care
accounted for 87 percent of hospital procedures in 1980. In 2000, that number was down to 63
percent.
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                Introduction, Background, and Scope
     Figure II-6: Community Hospital Expenditures: Inpatient and Outpatient Shares
                                          for AH Payers
               100 -i
                            1980
Inpatient   oOutpatfent
                                                76
                                                  1990
                                                                     63
                             2000
       Note: Community hospitals are all non-federal, short-term general, and special hospitals whose activities are available to the public.
       Source: CMS, Office of the Actuary, National Health Statistics Group.
                   Source: June 2002 Centers for Medicare and Medicaid Services Report.
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Healthcare Industry                                                 Activity Descriptions

III.           ACTIVITY DESCRIPTIONS

              As discussed in Section II.B. 1 of this Notebook, the healthcare industry is most
often described by speciality or service area. This section describes key functions within the
healthcare industry that create wastes that must be carefully managed to mitigate environmental
pollution.

              Healthcare is a very dynamic field. Institutions are changing at a rapid rate,
adding new activities and shedding others. To understand what wastes might be generated in
any given facility, it is important to have a clear understanding of the activities that are housed in
the facility.  This section describes selected key activities and the wastes these activities create,
and discusses issues related to proper handling and disposal. In some cases, it is the disposal
decisions that are responsible for the pollution created, as in the case of waste incineration (i.e.,
dioxins and mercury air emissions) or mislabeled red bag waste.  In other cases, it is the actual
materials necessary to be used in healthcare processes that create the pollution (e.g., ethylene
oxide used in sterilizing critical healthcare devices).

III.A.         Healthcare Activities

              Thousands of activities take place daily within the healthcare sector. While the
desired outcome of delivering healthcare services is improved health for patients and the
community, many of the activities of the healthcare sector are not directly related to patient care.
Maintaining physical facilities,  substantial amounts of diagnostic and testing activities, key
administrative services, and research activities are not direct forms of patient care.  In fact, the
majority of wastes produced in  a hospital (more than 50 percent of waste can be cardboard and
office paper) never comes in direct contact with patients.

              In some healthcare facilities, activity areas may be separately owned and
operated, or run by contractors. It would not be unusual to find laboratory services at a hospital
owned and run by a private firm, housekeeping run by a contract cleaning service, food service
operated by another vendor or series of vendors, and dialysis run by another private service. As
a result, knowledge of and control over environmental issues and wastes can be decentralized
and scattered.

              Producing an exhaustive list of every healthcare activity would be  extremely
cumbersome and ultimately would not focus on those functions within healthcare that create
problem wastes and pollution. Nor would it equip the reader with information and strategies for
identifying and mitigating the waste. Instead, this Notebook identifies 17 key functions and
major activities that are the major sources of waste and pollution within health sector
institutions. These activities, and the wastes produced and environmental impacts that may be
associated with them, are described below.
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              Administrative Activities and Services

              All healthcare settings include administrative functions, which can include
offices, billing services, medical records, public relations/marketing, nursing care
documentation, human resources, security services, social services/care management, retail
services, shipping and receiving, and printing/copying.

              From this standpoint, healthcare institutions can be viewed similarly to office
settings.  From an environmental management perspective, the majority of waste from these
functional areas is paper.  Specific activity locations within this category that deserve closer
scrutiny include:

              •       Shipping and Receiving - The majority of "product" coming into any
                     facility will pass through a central receiving area, where it is inventoried,
                     temporarily warehoused, and then distributed to various departments. A
                     number of hazardous materials used in any facility pass through this point,
                     and some are stored here. It is important to note that some individual
                     departments in some facilities may have direct ordering, bypassing
                     shipping and receiving. These may include areas such as the lab, facilities
                     management, food service, or housekeeping.

              •       Retail Services - Increasingly, hospitals are changing to respond to
                     patient demands and to seek alternative revenue streams. To accomplish
                     these goals, some facilities are bringing banking, childcare centers,
                     shopping, and food services onto the hospital campus through a lease or
                     other arrangements to provide patients with the ability to access their daily
                     needs without running to different locations.

              •       Printing and Copying Services - These services range from individual
                     printers and copiers found throughout the facility to centralized copy
                     shops or even professional print shops.

              Support Services

              Both large and small facilities have a wide range of support services.  These
support services can include information services, food services,  laundry services, pharmacy,
central sterile reprocessing, and biomedical engineering. In some cases, the support services are
contracted services. Wastes from support services vary greatly by support area.

              •       Information Services (IS) - The reliance on computers and electronic
                     technologies for all levels of function is growing at a rapid pace. IS might
                     be responsible for managing portable electronic devices and repairing or
                     disposing of dysfunctional or older equipment including computers and
                     monitors.
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              •      Purchasing - All of the products that are handled by shipping and
                    receiving are bought through the purchasing department.  Wastes in this
                    department consist mostly of paper and paper products but can also
                    include pallets, shrink wrap, and cardboard.

              •      Food Services - Facilities use a large number and amount of products,
                    from meats and vegetables, to canned goods, cleansers, disinfectants, and
                    pesticides which generate solid and organic wastes. The food service at a
                    large healthcare facility can be the largest restaurant in the community,
                    and should be  examined in that light from a compliance standpoint. These
                    facilities store and use numerous chemical cleaners, and if "pest" control
                    is not contracted out, a number of pest control devices and chemicals can
                    be present. Additionally, chlorofluorocarbons might be present in freezer
                    and refrigeration units. Special  wastes, such as kitchen grease from
                    fryalators need separate collection and disposal to avoid drain disposal or
                    disposal as a "solid" waste. Drain disposal of wastewater from
                    dishwashing and food preparation must also be  monitored to avoid excess
                    grease, harsh chemicals, or an excessive amount of organic substances
                    (increased BOD) from being discharged to  the sanitary sewer.

              •      Laundry Services - Although many healthcare facilities have contracted
                    out to commercial laundries, some laundry  services still exist within
                    hospitals. Water use, boilers for hot water, detergents and disinfectants
                    are all environmental areas of concern. Hospital laundries may process
                    large quantities of linens contaminated by blood and body fluids. This is
                    seldom of concern to a publicly  owned treatment works (POTW) directly,
                    but is the reason for the use of industrial detergents and disinfectants.

              •      Pharmacy Services - This is an essential service that includes the
                    compounding  and dispensing of Pharmaceuticals. As they are received
                    and prepared,  large quantities of paper and  plastic waste from product
                    packaging and inserts are generated. Administering Pharmaceuticals to
                    patients and the resulting residual waste can take place in any number of
                    clinical areas within a healthcare setting, including patient care floors,
                    surgical suites, and free-standing clinic settings. Pharmaceuticals can also
                    be packaged for administration in home-care settings. There are a number
                    of common Pharmaceuticals that are listed as RCRA P- or U- listed waste
                    and many others that meet the criteria for RCRA characteristic waste. The
                    pharmacy function may take place in one central location, may be off site,
                    or may have a number of satellite sites throughout a facility.  Of particular
                    importance is  the management of the large  amounts of expired, unused, or
                    partially used  Pharmaceuticals, the control of chemotherapeutic agents,
                    and management of contaminated materials and containers, as well as
                    residual or bulk amounts of chemotherapy product. Drug classes to be
                    concerned about include: antineoplastic (toxic,  mutagenic, persistent,
                    accumulative), steroids (persistent, reproductive effects),  antibiotics
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                    (persistent, bacterial resistance), antifungal (toxic, mutagenic, target
                    organs, endocrine effects), antiviral (toxic, mutagenic, chronic effects),
                    vaccines with thimerosal (contains mercury), and contrast reagents (with
                    barium). Of less concern are recombinant proteins, analgesics,
                    antihistamines, antiemetics, and electrolytes.

              •      Central Sterile Reprocessing and Distribution (CSRD) - This service
                    function provides support for surgical services and other departments
                    requiring sterile products.  Typically a CSRD unit includes a 'dirty' or
                    decontamination area that receives and cleans used equipment, and a
                    'clean* area that manages sterilized and cleaned products for redistribution
                    throughout the  facility.  CSRD units usually work very closely with
                    surgical services units, endoscopy units and other care units requiring a
                    ready supply of key materials routinely cleaned and distributed from
                    within the organization. Often these areas house ethylene oxide
                    sterilizers, steam sterilizers (autoclaves) and chemical treatment (steris,
                    sterrad) units. Solid and biohazardous wastes are regularly generated in
                    these areas.  Select hazardous chemical wastes may be generated
                    depending upon the types of processes used at a given site.  Water
                    discharges from chemical processes and autoclaves should be monitored.
                    Air discharges should be monitored if ethylene oxide (EtO) is usedd.

              •      Biomedical Engineering - This service function provides support to the
                    many types of equipment and devices used in providing direct patient care
                    and support services.  Biomedical engineering can be an in-house function
                    or a contracted service and would include calibrating blood pressure
                    monitoring devices (both mercury and nonmercury). Often,  a mercury
                    sphygmomanometer and/or barometer is used to aid in calibration.
                    Biomedical engineering often handles the increasingly large quantity of
                    batteries (including NiCD, NiHydride, Lead acid, Lithium, dry cell) that
                    have to be tested and changed out in many different types of equipment.

              Facilities Management, Maintenance, and Plant Operations

              The maintenance of a hospital or healthcare facility includes housekeeping,
maintenance shops (paint, electric, plumbing), heating ventilation and air conditioning (HVAC)
systems, water treatment, waste treatment, aboveground tanks, underground tanks,  fleet
management, groundskeeping, and pest management.  It is similar in many ways to the
maintenance of a large commercial or light manufacturing facility.  It has many of the same
functions and generates many of the same environmental concerns involving waste, air, and
water issues.

              •      Housekeeping or Environmental Services - Cleaning complex facilities
                    with many varying needs for cleanliness, ranging from "clean" to
                    "sterile," requires the use of chemical agents, technologies, and water.
                    Maintaining surfaces (e.g., floors, walls, counters, sinks, toilets, furniture,
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                    and equipment) requires the use of a large range of cleaners, disinfectants,
                    and treatments. Cleaning floors can involve the use of strippers and
                    waxes, as well as cleansers. Housekeepers are also often charged with
                    collecting, transporting, and overseeing the storage of all the wastes
                    generated, including solid waste, biohazardous waste, and hazardous
                    chemical wastes.  In addition, housekeepers often operate equipment that
                    uses hydraulic fluids (compacters and balers).

              •      Engineering and Maintenance - These functions and the scope of this
                    service is defined differently in different settings.  Often, there is overlap
                    between the housekeeping staff, maintenance staff, and engineering staff
                    duties. Maintenance functions, including painting, electrical work,
                    plumbing, and carpentry, are sometimes internal functions with full shop
                    areas in place to provide these services. Solvents, degreasers, cleaners, oil
                    paints, and a number of toxic and often flammable products are regularly
                    used, stored, and disposed of.  Large amounts of chemicals are required in
                    maintaining the HVAC and water treatment systems, boilers, and coolers.
                    Monitoring systems for air emissions and water discharges must be
                    maintained. Staff serving in these functions also are often responsible for
                    changing  out lighting fixtures and bulbs, generating waste fluorescent
                    bulbs and lighting ballasts. Mercury management is often a primary
                    concern in this service, as mercury is often found in devices throughout
                    the facility in thermostats, mercuric oxide batteries, switches and relays in
                    alarms and other electrical equipment, gauges and switches on boilers, as
                    well as in additives to paints, cleaners, and other chemicals.

              •      Waste Treatment - Technologies might be on site and in operation to
                    treat the facility wastes. These technologies could range from wastewater
                    pre-treatment, an incinerator (solid and biohazardous waste), to an
                    autoclave (biohazardous waste) to distillation units for solvents, alcohols,
                    and formalin (usually located in conjunction with the lab), to bulb crushers
                    (fluorescent bulbs). Emissions (primarily air) are of concern with all of
                    these, as are residual wastes.  Additionally, the treatment and disposal
                    process may convert some materials that are nonhazardous into hazardous
                    waste. Incineration of PVC plastics, products, and packaging (which
                    comprise  a portion of plastic wastes in healthcare) can create dioxins
                    when incinerated.  Many facilities collect biohazardous waste in red bags
                    and red sharps containers and certain chemotherapy wastes in yellow
                    bags. The colors in these containers can be from cadmium-based
                    pigments, although the use of cadmium has been phased out in recent
                    years. Cadmium, a hazardous air pollutant, can be released if these
                    containers are combusted as part of the treatment process.

              •      Fleet Management - Vehicles of various kinds can be owned, leased, or
                    used through a contracted service. Facilities that maintain a fleet (this can
                    range from golf carts, to cars, trucks and vans, to ambulances, to
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                     helicopters) must determine how to address maintenance and cleaning of
                     the vehicles, as well as fuel storage. Wastes to be addressed include waste
                     oil, solvents, tires, batteries, and coolants/CFCs.

              •       Groundskeeping - Landscaping, mowing, snow removal, and pest
                     management increasingly are services that are contracted out.  Use of
                     fertilizers, herbicides, pesticides, and deicing substances needs to be
                     carefully monitored for releases and run-off. Similarly, pest control is
                     often a contracted service.

              Laboratory Services

              Thousands of medical and diagnostic tests and services are performed on a daily
basis, even in small labs serving healthcare facilities. These services can include hematology,
microbiology, chemistry, blood bank, surgical pathology, and histology. The functions of
laboratory testing are highly varied, and involve a number of separate processes. Labs use large
volumes of a few chemicals (e.g., xylene, alcohol, formalin) and small quantities of a large
number of other substances.  Labs tend to expend many of the chemicals used in testing through
evaporation or dilution and disposal to the sanitary sewer. Both air and water emissions are of
concern. Larger quantities of some chemicals may be collected for disposal, or in some cases
may be reprocessed for reuse within  the lab. More information is available at: Environmental
Management Guide for Small Laboratories, EPA 233-B-00-001, May 2000, Office of the
Administrator (2131), ht tp://www. epa. gov/sbo/smalllabguide_500.pdf.

              Labs can be free-standing entities or part of a larger facility. If they are within a
larger facility, they still may be privately owned and operated, or operated under contract.
Consequently, responsibility for managing hazardous materials and wastes can be complicated.

              Disinfecting equipment and materials is important to the accuracy of lab
functions, so a range of disinfecting solutions is often found in labs.  Autoclaves are often used
to sterilize equipment that has been cleaned for reuse, and they may be available in labs to
pretreat some wastes (e.g., culture plates) prior  to disposal.

              Many labs have automated chemical analyzer systems.  These systems contain
many reagent reservoirs and reagents with preservatives.  It is often necessary to contact the
manufacturer to identify all potential chemical waste locations within the system.

              A range of mercury-containing devices in labs is still not uncommon, sometimes
due to the age of equipment or interpretation of laboratory accreditation standards that require
mercury calibration equipment.

              Wastes that are commingled (biological samples and chemicals) are also
common, especially in surgical pathology where tissue samples in formalin have to be processed
and in many cases stored for extended periods.
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              Diagnostic Services

              An increasingly diverse and large number of diagnostic services are now
available. These can include, but are not limited to endoscopy, cardiac catheterization, radiology
(CT, MRI, digital imaging), nuclear medicine, sleep studies labs, and electroencephalograph
studies (EEG).  Diagnostic services are often found in association with medical centers but in
some cases can be free-standing facilities.

              •      Endoscopy and Cardiac Catheterization - New techniques in these
                     areas have resulted in less biohazardous waste generation but an increased
                     use of high-level disinfectants (e.g., glutaraldehyde) or sterilants (e.g.,
                     ethylene oxide (EtO) gas), both of which represent significant hazards as
                     releases to water or air.

              •      Radiology - These functions have traditionally involved the use of film
                     and film-developing chemicals.  Radiology activities can occur within a
                     hospital center, urgent care setting, outpatient clinic, dental offices, or
                     other care areas that require X-rays to help evaluate healthcare conditions.
                     Although many healthcare organizations are transitioning away from wet
                     processing and silver-containing films to digital imaging and PAX-it
                     brand systems, heavy metals waste is generated through a number of
                     activities in Radiology. In particular, lead shields are used to shield
                     patients from exposure. These shields wear out over time, and should be
                     managed as a hazardous waste or sent back to the supplier for
                     remanufacture into a smaller shield device. Additionally, contrast
                     reagents are not always fully consumed by the patient  and will result in
                     hazardous waste if discarded unused.

              •      Nuclear Medicine - This branch of diagnostic testing  primarily offers
                     diagnostic imaging and radioisotope treatment.  Radionuclides are used in
                     various tests and procedures and require careful management, storage, and
                     monitoring until they are safe for disposal. Radioactive waste may also be
                     RCRA hazardous waste, which should be separated from the
                     nonhazardous waste prior to decay storage.

              Surgical Services

              Surgical services include anesthesia, preoperative services, ambulatory outpatient
services, surgery, and post-anesthesia care.  Advances in surgery have vastly reduced the
invasive nature of different procedures and correspondingly reduced the amount of biohazardous
wastes (e.g., blood and body-fluid-contaminated wastes) generated.  However, surgery functions
still represent one of the highest waste-generating  areas. Many of the new surgical devices
represent environmental challenges, such as batteries with heavy rnetals that must be managed,
or devices that require special chemical disinfection or sterilization.
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              In most areas, the majority of surgery is performed as ambulatory, or "day"
surgery.  These procedures do not require that patients stay overnight.  As a result, what was
previously a highly centralized function is now very decentralized, with many of the specialized
wastes being generated outside of large institutions.

              Special wastes can be found in anesthesia services and surgical pathology units.
Anesthesiologists and nurse anesthetists administer to patients during surgical procedures and
provide pain management services.  Waste anesthetic gases from care delivery must be managed
to prevent releases. Careful management of compressed gas cylinders (e.g., oxygen, nitrogen,
and argon) is also a safety concern.  Surgical pathology units can present a host of hazardous
chemicals to monitor, as tissue samples are taken and preserved in formaldehyde, or a dilute
version, formalin (e.g., biopsies and surgical excisions).

              Inpatient Care Services

              The need for inpatient care services has declined in the last decade, with an
increasing number of services being offered on an out-patient basis (e.g., stay at the facility is
less than 24 hours). Specialized treatment for many acute and chronic conditions or more
serious illness or injury still requires overnight and longer terms stays in hospitals and other
types of healthcare institutions.  The primary concerns in waste  are usually limited to the
management of biohazardous wastes (mostly sharps), the use of cleaners and disinfectants, and,
as in all patient care areas, the possible presence of mercury-containing devices (e.g., fever
thermometers, sphygmomanometers, and a variety of pharmaceutical products).  Some services,
such as dialysis and oncology (discussed below), can be delivered in these areas. Inpatient care
services include medical surgical care, orthopedic care, neurology care, urology care, cardiac
care, psychiatric/behavioral health, geriatric care, palliative care, cancer care, maternal child care
(labor and delivery/birthing, postpartum care, nursery, pediatrics), pediatric care, and
rehabilitative care.

              Critical Care Services

              Critical care inpatient services such as surgical intensive care, medical intensive
care, pediatric intensive care, cardiac intensive care, burn care, and neonatal intensive care are
conducted in hospital facilities.  Many critical care waste concerns are the same as in other
inpatient service areas (discussed above). In addition, specialized monitoring equipment and an
array of pharmaceuticals are used in these areas.  Two common drugs used in critical care areas
that become hazardous when disposed of are epinephrine and warfarin (Coumarin).

              Emergency Care Services

              Emergency care services are offered in different types of settings, both in very
large and small hospitals, as well as in free-standing units.  While care offered in these types of
service units is meant to be limited in time and scope, they are often designed to provide a wide
range of services, as their goal is to respond to "emergencies." These services entail a large
degree of response to unpredictable situations, including emergency response to industrial
accidents and bioterrorism incidents. Additionally, as the ranks of uninsured Americans grows,
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it is common for individuals to seek routine care in emergency department settings, rather than at
physicians' offices.

              Emergency service areas are also responsible for disaster response management,
and many institutions have set up decontamination rooms in association with emergency
services. Such rooms are designed to allow individuals who have been exposed to chemicals or
biological agents to be safely decontaminated before entering the emergency service area.
Decontamination can involve using chemicals and copious amounts of water. Facilities should
have a system of trapping the wastewater so that they can test and then properly manage the
wastes.

              Many emergency service waste concerns are the same as in other patient care
service areas (see above) and include biohazardous wastes, chemicals for cleaning and high-level
disinfection or sterilants, the possible presence of mercury-containing devices, and the
possibility of pharmaceutical wastes.

              Other activities that may also be present as part of emergency services include
storing formalin for preserving specimens, operating X-ray technology, and managing
photographic chemicals, wastewater, silver recovery, and films. Given the range of instruments
used, there may also be disinfectant chemicals, such as glutaraldehyde, or other high-level
disinfectants present.

              Respiratory Care Services

              A variety of wastes are generated through respiratory care functions, which
include pulmonary function testing and oxygen therapies. Reprocessing some equipment may
involve using high-level disinfectants. As in other patient care areas, mercury devices and
batteries could be used.  Special management concerns include pressurized tanks such as
oxygen.

              Dialysis

              Dialysis can be conducted in a wide variety of settings, from homes to specialty
clinics to large hospital facilities. There are different types of dialysis. Hemodialysis involves
external technologies that filter the blood using a mechanical dialyzer.  Peritoneal dialysis
involves pumping dialyser fluids into the patient's abdominal cavity and using the peritoneum
liner as a natural filter.  Areas conducting hemodialysis can generate larger amounts of
biohazardous wastes due to the nature of the process.  The waste often contains large amounts of
liquid and is heavy.

              Hemodialysis equipment requires water treatment and the use of high-level
disinfectants.  In the past, formaldehyde was commonly used to clean machinery. Today, less
toxic disinfectants  are primarily used.
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              Physical Therapy/Occupational Therapy

              Generally, these areas generate little waste of concern. As in other patient care
areas, mercury devices could be used.  Biohazardous waste, such as sharps, forceps, blades, or
lancets may be generated, especially if wounds/burns are debrided and treated in these areas. If
prosthetic devices are made on site, chemicals related to leather working (tanning chemicals,
adhesives) and plastics molding may be used.

              Outpatient Services (Nonsurgical)

              Outpatient services include womens' health/gynecology, general medicine, family
practice, specialty clinics (e.g., orthopedics, urology, pulmonology, allergy), pediatrics, and
rehabilitative services.

              Generally, these areas generate little waste of concern. As in other patient care
areas, mercury devices could be used.  In some cases, formalin may be used to preserve tissue
samples (biopsy). Sharps management is the biohazardous waste management concern.  As in
many patient care functions, a variety of pharmaceutical products may be present.  For example,
trichloroacetic acid and potassium hydroxide, both characteristic (corrosive) wastes are usually
used in OB/GYN practices.

              Oncology/Cancer Care Services

              Oncology care includes administering chemotherapy medications to cancer
patients. In radiation oncology, treatment can involve intravenously administering radioactive
isotopes and applying radiation externally to cancer patients. These treatment activities are
sometimes grouped together but are often found separately. They may take place in either
outpatient or inpatient settings.  In some cases, chemotherapy is administered through home-
based treatment programs.

              Antineoplastic, or cytotoxic, agents that are used to produce chemotherapy
solutions are generally procured through a central purchasing area or directly from the pharmacy.
Chemotherapy medications may either be prepared in a special area within the hospital pharmacy
or prepared in a special area in the oncology unit (in-patient or outpatient type of unit).  The
amount and type of chemotherapy found in any institution depends on the amount of care/
number of procedures provided and physician preferences for ordering pharmaceuticals.  In the
preparation area, work is conducted in a safety cabinet equipped with the appropriate filters.
Facilities must maintain the filters and determine if they require special disposal, which is often
done under a maintenance contract.  Residuals from preparation include any contaminated
materials including vials, bottles, IV bags, packaging, and personal protective equipment.
Proper segregation containers need to be available for materials determined to be RCRA waste,
or as nonhazardous materials (often personal protective equipment and packaging) that can be
collected separately.  Chemotherapy wastes that are not classified as RCRA waste must be
properly labeled as chemotherapy-containing materials (e.g., collected in yellow bags) but they
can be sent out for incineration (or other technologies as they become available) with the
institution's biohazardous waste. Note that if an unregulated chemotherapy waste is
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contaminated with a RCRA hazardous waste, RCRA regulations apply. Radiation therapy areas
will contain radioactive materials that must.be properly handled and monitored.

              Dentistry

              Dentistry services, including oral surgery, periodontics, and oral healthcare, are
provided in a wide range of settings from individual private practices to dental surgery centers
that are free standing or located within large teaching and research hospitals. It is estimated that
dental facilities in the United States used 40  metric tons of mercury in 1997, which may be
placed in teeth, recycled, discharged into wastewater, or disposed of as waste.2 About 50 percent
of dental amalgam is mercury. A study by the Association of Metropolitan Sewerage Agencies
found that dental offices are the largest source of mercury to POTWs, contributing more than 35
percent of mercury influent to the POTWs studied.3 Other studies have estimated the
contributions to be as high as 80 percent.4

              Mercury in dental amalgam can enter the environment in a variety of ways.
Dental amalgam waste that is generated  (for instance, excess amalgam that is not placed in a
tooth, or amalgam that is captured by traps and filters in the dental office) can release mercury
into the environment if it is not managed properly. When amalgam restorations are placed in or
removed from teeth during dental work, amalgam can enter dental wastewater; when it reaches a
wastewater treatment plant, a small percentage of the mercury in the amalgam will be discharged
by the plant.

              While amalgam has very low solubility in water, a small percentage can be
released in a bioavailable form and be converted to methylmercury, the form that accumulates in
the food chain, presenting potential health risks to humans and wildlife who consume
contaminated fish. Most of the mercury that reaches sewage treatment plants (in excess of 90
percent) is  likely to be captured by the treatment plant and enter the  sewage sludge, or biosolids.5
These biosolids may be land-applied, landfilled, or incinerated. Incineration will likely volatilize
mercury back into the environment.

              Other wastes from dentistry include X-ray wastes (developer chemicals, silver
discharges, lead shields), high-level disinfectants, chemical sterilizers, nitrous oxide, and
biohazardous wastes, especially sharps. A simple  guide to waste management specific to
dentistry practices and wastewaters can be found at the following web sites:
2 Stone, Mark E., DOS, 2004. "The Effect of Amalgam Separators on Mercury Loadings to Wastewater Treatment
Plants," CDA Journal, Vol. 32, No.7, July 2004.

3 Association of Metropolitan Sewerage Agencies (2002). Mercury Source Control & Pollution Prevention Program
Evaluation: Final Report. March 2002 (Amended July 2002).

4 Stone, 2004.

s Options for Dental Mercury Reduction Programs: Information for State/Provincial and Local Governments, A
Report of the Binational Toxics Strategy, Mercury Workgroup Co-chairs
Alexis Cain, U.S. Environmental Protection Agency, Robert Krauel, Environment Canada,
http://www.epa.gov/region5/air/mercury/dentaloptions3.pdf, December 16, 2003, Revised August 4,2004.

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              •      A Guide for Dentists:  How to Manage Waste From Your Dental Practice
                    University of Wisconsin—Extension
                    http://www. uwex. edu/skwec/Pubs/pdf/%uidefordentists.pdf

              •      Guidelines for New Mexico Dental Facilities Waste-Management,
                    Education and Research Consortium
                    http://wwwfeabq.eov/p2/Ddfs/dentalbooklet.pdf

              •      Characteristics and Treatment of the Dental Wastewater Stream
                    University of Illinois, Chicago http:/Avww. wmrc. uiuc. edu/main_sections/
                    info_services/librarv_docs/rr/RR-97.pdf

              •      Options for Dental Mercury Reduction Programs: Information for
                    State/Provincial and Local Governments, U.S. EPA and Environment
                    Canada http^//www.epa.gov/region5/air/mercury/dentaloptions3.pdf

              •      Northeast Waste Management Officials' Association (NEWMOA) has
                    both a Dental Mercury Topic Hub http://wwwjtewmoa.org/Newmoa/
                    htdocs/prevention/topichub/toc.cfm?hub=103&subsec=7&nav=~/rand a
                    list of links to articles, fact sheets, and case studies
                    http://www.newmoa.org/Newmoa/htdocs/prevention/topichub/bibliograph
                    v.cfm?hub-103&subsec=7&nav=100

              •      The Environmentally Responsible Dental Office: A Guide to Proper
                    Waste Management http://www.deHa-
                    institute.org/pollprev/mercury/linkfiles/VTdentalguide.pdf

              Animal Research and Testing

              This testing represents a wide rage of activities that can occur at free-standing
research laboratories or in association with healthcare facilities. The research is usually
independently funded, varied, and conducted out of the usual  system of procurement at the
facility. The activities and wastes of concern can encompass all of those usually encountered in
labs, with the addition of animal care and housing. Animal care facilities  may have antibiotics
and Pharmaceuticals in the animal's drinking water.  Also, the facility may wash the animal
cages with corrosive reagents. The waste can also include chemicals and materials not usually
associated with the general delivery of healthcare services.  Any facility sponsoring animal
research and testing  should maintain an inventory of materials currently in use and stored at the
facility.

              Clinical Research

              Like animal research and testing, clinical research represents a wide rage of
activities that can take place at free-standing research laboratories or in association with
healthcare facilities.   The research is usually independently funded, varied, and conducted out of
the usual system of procurement at the facility. The activities and wastes  of concern can
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encompass all of those usually encountered in labs and under many patient care and treatment
activities. It can also include chemicals and materials not usually associated with the general
delivery of healthcare services.  Any facility sponsoring clinical research should maintain an
inventory of materials currently in use and stored at the facility.

              Construction and Renovation

              Construction and renovation are constant activities in healthcare settings.  The
largest portion of wastes is that common in any construction and demolition (C&D) waste
stream, mainly solid waste.  However, there may be some special concerns, including stormwater
control, asbestos and lighting ballasts, as well as less obvious ones like mercury.  While mercury
would be commonly associated  with thermostats and other switches or gauges, a number of
healthcare facilities undergoing  renovation projects have found residual mercury in drains and
traps.

HI.B.         Waste Streams Generated by the Healthcare Industry

              There are many variables affecting healthcare waste generation, including:

              ซ       The type  of products and materials purchased for use;

              •       The type  of waste segregation systems in place;

              •       The degree to which problem wastes are identified and mitigation
                     strategies are implemented; and

              •       The location of care delivery (in a hospital, clinic, or home).

              This subsection presents a brief overview of the major waste streams in
healthcare. Chapter IV of this Notebook will provide a broader profile of the major wastes and
waste streams. Note that states and local regulating bodies may impose more stringent
definitions of waste and more stringent waste  requirements than those established by EPA and
other federal agencies.

              In response to the Medical Waste Tracking Act (MWTA) of 1988, the Society for
Hospital  Epidemiology produced a position paper entitled Medical Waste6. Its focus was on the
majority  of wastes that are produced by healthcare activities and are generally classified as solid
waste or  biohazardous wastes.  It did not address the chemical or radioactive wastes from the
sector. This paper provided the most authoritative and comprehensive definition,
characterization, profiling, and analysis of risks from healthcare wastes to date.
6 (Rutala WA, Mayhall CG, "The Society for Hospital Epidemiology of American (SHEA) Position Paper: Medical
Waste." Infection Control Hospital Epidemiology. 1992; 13:38-48).

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              Healthcare wastes can be categorized as follows:

              •      Municipal solid waste;

              •      Biohazardous waste (regulated medical waste);

              •      Hazardous waste:
                    —    Listed and characteristic waste,
                    —    Commingled waste,
                    —    Pressurized containers and ignitable compressed gas, and
                    —    Universal waste; and

              •      Waste by media category:
                    —    Wastewater,
                    —    Stormwater, and
                    —    Air emissions.

              Each of these areas is described in detail below.

III.B.1.       Municipal Solid Waste

              The majority of healthcare wastes are produced under circumstances identical to
restaurants and food industry facilities, hotels, and office complexes. The industry generates
large volumes of solid wastes (much of what could be subcategorized as recyclable wastes).
Studies indicate that 1 percent of all solid waste produced in the United States is generated by
healthcare facilities. There have been numerous studies of these wastes, including ways to
manage them to minimize waste and environmental impacts.  In 1993, the American Hospital
Association (AHA) published a manual for its members, An Ounce of Prevention:  Waste
Reduction Strategies for Health  Care Facilities (Bisson, McRae and Shaner). Since then, state
hospital associations, state solid waste agencies, and a number of private organizations have
produced additional manuals.  A cooperative program between the EPA and the American
Hospital Association, Hospitals for a Health Environment (H2E) is compiling recent materials;
this compilation can be found at: http://www.h2e-online.org/.

              A special subcategory of municipal solid waste to be considered is construction
and demolition (C&D) debris. During remodeling, C&D debris can fall into several categories
of waste. Healthcare facilities must identify which materials are RCRA Subtitle C hazardous
waste (discussed in Section VI of this document), including lead shielding, lead paint, and
demolished equipment containing lead, mercury, silver and/or cadmium (especially batteries,
fluorescent light bulbs, and computer monitors). Facilities may identify some construction and
demolition debris that is recyclable, which can reduce disposal cost. Also, some C&D debris is
municipal solid waste, but is generated at a large enough volume to warrant separate disposal in
a construction and debris landfill.
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III.B.2.       Biohazardous Waste (Regulated Medical Waste)

              The concern with and need for better management of healthcare waste that
triggered the Medical Waste Tracking Act largely relates to those wastes in healthcare that can
potentially harbor and transmit infectious diseases.  This includes a wide range of materials that
are considered contaminated or pose special risks (e.g., sharps).  This category of wastes is
defined by regulation at the state, tribal, or local level.

              There is general agreement on certain characteristics and components of this
waste as noted in the list below, but the specific definitions of this waste are defined on a state-
by-state basis, and there are sometimes significant differences in those definitions between
states.  Further, what and how much waste falls into this category can vary widely depending on
the interpretation of these regulations by the generator on a facility-by-facility basis, even within
states.

              Terminology used to describe this waste category is often confusing and used
interchangeably. Words such as "biohazardous waste" "infectious waste," "infectious medical
waste," "'potentially infectious material" "contaminatedtrash," and "regulatedmedical waste,"
are examples of the terms used in describing this segment of healthcare wastes.

              Wastes usually considered in this category include7:

              •      Cultures and stocks of infectious agents and associated biologicals,
                     including: cultures from medical and pathological laboratories; cultures
                     and stocks of infectious agents from research and industrial laboratories;
                     wastes from the production of biologicals; discarded live and attenuated
                     vaccines; and culture dishes and devices used to transfer, inoculate, and
                     mix cultures.

              •      Human pathological waste, including tissues, organs, and body parts and
                     body fluids that are removed during surgery or autopsy, or other medical
                     procedures, and specimens of body fluids and their containers.

              ซ      Human blood and blood products including: (i) liquid waste  human blood;
                     (ii) products of blood;  (iii) items saturated and or  dripping with human
                     blood; or (iv) items that were saturated and or dripping with human blood
                     that are now caked with dried human blood, including serum, plasma, and
                     other blood components, and their containers, which were used or
                     intended for use in either patient care, testing and laboratory analysis or
                     the development of Pharmaceuticals. Intravenous bags are also included
                     in this category.
7 Definition taken from the Federal Plan Requirements for Hospital/Medical/Infectious Waste Incinerators
Constructed On or Before June 20, 1996.

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              •      Sharps that have been used in animal or human patient care or treatment or
                    in medical, research, or industrial laboratories, including hypodermic
                    needles, syringes (with or without the attached needle), Pasteur pipettes,
                    scalpel blades, blood vials, needles with attached tubing, and culture
                    dishes (regardless of presence of infectious agents). Also included are
                    other types of broken or unbroken glassware that were in contact with
                    infectious agents, such as used slides and cover slips.

              •      Animal waste including contaminated animal carcasses, body parts, and
                    bedding of animals that were known to have been exposed to infectious
                    agents during research (including research in veterinary hospitals),
                    production of biologicals, or testing of Pharmaceuticals.

              •      Isolation wastes including biological waste and discarded materials
                    contaminated with blood, excretions, exudates, or secretions from  humans
                    who are isolated to protect others from certain highly communicable
                    diseases, or isolated animals known to be infected with highly
                    communicable diseases.

              •      Unused sharps including unused, discarded hypodermic needles, suture
                    needles, syringes, and scalpel blades.

III.B.3.       Hazardous Waste

              There are some special waste streams that fall most logically under the heading of
"hazardous" but because of their unique nature and the risks inherent in each of them, they are
discussed separately below as  Mixed Waste, Pharmaceutical Waste, Pressurized Containers and
Ignitable Compressed Gas, and Universal Waste. The RCRA standard is cited below.  States
must at least accept these standards but have the right to impose stricter standards and list
additional wastes.

              To be considered hazardous waste under RCRA, waste must either be listed or
characteristic. Listed wastes are specifically named in 40 CFR Section 261.  Characteristic
wastes are either ignitable, reactive, corrosive, or toxic. This subsection gives a quick overview
of listed and characteristic hazardous wastes, and lists the most common healthcare hazardous
wastes. The following EPA web site provides a flowchart that outlines the major steps in the
hazardous waste identification process: www.fedcenter.gov/resources/facilitvtour/hazardous/
whatis/flowchart/

              RCRA Listed and Characteristic Wastes

              •      Listed Waste - The four types of RCRA listed waste are F, K, P, or U,
                    with a three-digit identifier (e.g., F005, P039, U135).  EPA listed these
                    wastes as hazardous because they are known to be harmful to human
                    health and the environment when not managed properly, regardless of
                    their concentrations. Some states may list more wastes as hazardous than
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                    EPA. Visit www. her center, org to locate state-listed wastes. The lists
                    include the following four types of waste:

                    —    F-listed wastes.  These non-specific-source wastes are
                           material-specific, such as solvents, generated by several different
                           industries.  Waste codes range from F001 to F039. Examples of
                           healthcare facility wastes that fit this category are solvents often
                           used in research laboratories, pharmacies, and morgues (e.g.,
                           methanol, acetone, and methylene chloride).

                    —    K-listed wastes. These source-specific wastes are from
                           specifically identified industries and range from K001 to K161.
                           Healthcare facilities typically do not produce K-Hsted wastes.
                    —    U-listed wastes. These discarded commercial chemical products
                           include off-specification products, container residuals, spill residue
                           runoff (pure or mixed with non-active ingredients such as
                           colorants, flavoring agents, emulsifiers, fragrances, water, etc.),
                           technical grades (e.g., 95% pure Acetone), off-specification
                           species, or active ingredients that have spilled or are unused and
                           that have been, or are intended to be, discarded. Waste codes
                           range from U001 to U411. Examples of healthcare facility wastes
                           that fit into this category are ethylene oxide (Ul 15),  some waste
                           Pharmaceuticals such as lindane (U129) and selenium sulfide
                           (U205), and some waste chemotherapy drugs such as
                           chloroambucil (U035).

                    —    P-listed wastes.  Like U-listed wastes, these discarded commercial
                           chemical products include off-specification products, container
                           residuals, spill residue runoff spill residue runoff (pure or mixed
                           with non-active ingredients such as colorants, flavoring agents,
                           emulsifiers, fragrances, water, etc.), technical grades (e.g., 95%
                           pure Acetone), off-specification species, or active ingredients that
                           have spilled or are unused and that have been, or are intended to
                           be, discarded. Waste codes range from P001 to P205. These
                           wastes are considered acutely hazardous waste and as little as 2.2
                           Ibs of these wastes generated in a given calendar month, or one
                           quart of these wastes stored in a satellite accumulation area
                           designates a facility as a large quantity generator. An example of a
                           healthcare  facility waste in this  category is epinephrine (P-042).

              Table III-l below lists some specific examples of RCRA hazardous waste from
healthcare facilities.
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 Table III-l: Examples of RCRA Listed Hazardous Waste Found in Healthcare Facilities
Chemical or Device Containing Chemical
RCRA Listing
Note: This list is not exhaustive but provides some common healthcare hazardous wastes.
Solvents used in the laboratory such as xylene, ethanol, toluene, and
methanol. Solvents are also used in inks for forms and menus.
2-Chloroethyl Vinyl Ether
3-Methylchloranthrene
Acetone
Acetyl Chloride
Acrylonitrile
Aniline
Bromoform
Cacodylic Acid
Carbon Tetrachloride
Chloral Hydrate
Chlorambucil
Chloroform
Creosote
Cresols
Cyclophosphamide
Daunomycin
Dichlorobenzenes
Ethyl Acetate
Ethyl Carbamate
Ethyl Ether
Ethylene Oxide
Formaldehyde
Formic Acid
Hexachloroethane
Hexachlorophene
Lindane
Maleic Anhydride
Melphalan
Mercury
Methanol/Methyl alcohol
Mitomycin C
Xylene, U239
Methanol, U154
Several ethanol compounds are U-listed
U042
U157
U002
U006
U009
U012
U225
U136
U211
U034
U035
U044
U051
U052
U058
U059
U070,U071,U072
U112
U238
U117
U115
U122
U123
U131
U132
U129
U147
U150
U151
U154
U010
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            Table IIM: Examples of RCRA Listed Hazardous Waste From
                          Healthcare Facilities (Continued)
Chemical or Device Containing Chemical
Naphthalene
N-butyl Alcohol
Paraldehyde
p-Chloro-m-Cresol
Phenol
Reserpine
Resorcinol
Saccharin
Selenium Sulfide
Streptozotocin
Tetrachloroethylene
Thiram
Trichloroethylene
Uracil Mustard
Warfarin (Coumarin) < 0.3%
RCRA Listing
U165
U031
U182
U039
U188
U200
U201
U202
U205
U206
U210
U244
U228
U237
U248
Waste codes range from P001 to P205 and should be noted as acutely hazardous waste, as 2.2 Ibs of these
wastes generated in a given calendar month designates a facility as a large quantity generator.
3-Benzyl Chloride
Arsenic
Arsenic Trioxide
Chloropropionitrile
Cyanide Salts
Epinephrine
Nicotine
Nitroglycerin (unless the state adopted the federal exclusion for
healthcare facilities)
Osmium Tetroxide
Phentermine
Phenylmercuric Acetate
Physotigmine
Physotigmine Salicylate
Potassium Silver Cyanide
P028
P012
P012
P027
P030
P042
P075
P081
P087
P046
P092
P204
P188
P099
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             Table III-l:  Examples of RCRA Listed Hazardous Waste From
                            Healthcare Facilities (Continued)
Chemical or Device Containing Chemical
Sodium Azide
Sodium azide is often used as a preservative in a variety of laboratory
reagents usually at concentrations of less than 0.1%. It is not the sole
active ingredient in these cases and would not be a P-listed waste.
Warfarin (Coumarin) > 0.3%
Mercury compounds such as thimerosal, amalgam, and mercury-
containing fixatives. Mercury-containing equipment such as
thermometers, sphygmomanometers (blood pressure measuring
device), thermostats, weighted feeding tubes and fluorescent bulbs. If
the state adopted the Universal Waste Rule, then fluorescent bulbs are
considered universal waste.
Lead-containing equipment such as lead aprons, bitewings, lead pigs,
lead shielding removed during construction or renovation, batteries,
and computer monitors. If the state adopted the Universal Waste Rule,
then batteries are considered universal waste.
Silver from X-rays. Silver can come from fixer/developer solutions or
from film or from devices employed to harvest silver.
RCRA Listing
P105
P001
Mercury is listed as U151, but several
other mercury compounds are also
listed. The RCRA toxicity
characteristic (discussed below) also
lists mercury (D009) and requires a limit
of0.2mg/L.
The RCRA toxicity characteristic
(discussed below) lists lead (D008) and
requires a limit of 5.0 mg/L.
The RCRA toxicity characteristic
(discussed below) lists silver (DO 1 1 )
and requires a limit of 5.0 mg/L,
Sources: EPA Region 2 presentation dated February 2004, entitled "Identification and Management of Regulated
Hazardous Waste, A Workshop Geared Toward Healthcare Facilities" and H2E's web page, at
http-J/www. h2e-online. orz/yubs/chemmin/master.pdf.

              Note that some chemicals used in healthcare are toxic and harmful to the
environment, but RCRA does not list them as hazardous waste.  These include glutaraldehyde
and many chemotherapy drugs (other than the nine that are listed). A best management practice
is to handle such materials as if they were hazardous waste, to protect workers, patients, and the
environment. For an explanation of RCRA requirements, see Section VI of this Notebook.

              •      Characteristic Waste - Even if waste does not appear on one of the
                     hazardous waste lists, it still might be regulated as hazardous waste if it
                     exhibits one or more of the following characteristics:

                     —     Ignitability. (40 CFR ง 261.21) Ignitable wastes create fires under
                            certain conditions, are spontaneously combustible, and have a flash
                            point of less than 60ฐC (140ฐF), are ignitable compressed gas, or
                            are an oxidizer (such as a chlorate or peroxide). The waste code
                            for these materials is D001.  They are liquids, other than aqueous
                            solutions containing less than 24 percent alcohol by  volume and
                            with a flash point less than 60 "C (140 ฐF).

                     —     Corrosivity. (40 CFR ง 261.22) Corrosive  wastes are acids or
                            bases that are aqueous and have a pH less than  or equal to 2 or
                            greater than or equal to 12.5; or are liquid capable of corroding
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                           metal containers, such as storage tanks, drums, and barrels. A
                           liquid is considered corrosive if it can corrode steel at a rate of at
                           least 0.25 inches per year at 55ฐ C (130ฐ F). Wastes are aqueous if
                           they contain 20 percent water, measured quantitatively or
                           separated from the waste by pressure or vacuum filtration as
                           described in EPA Method 1311. Note, waste that is not aqueous
                           and contains no liquid falls outside the definition of EPA
                           corrosivity.  Examples include pharmaceutical compounding
                           chemicals such as sodium hydroxide solution. The waste code for
                           these materials is D002.

                    —     Reactivity. (40 CFR ง 261.23) Reactive wastes are unstable under
                           normal conditions. They can cause explosions, toxic fumes, gases,
                           or vapors when mixed with water.  They can be a cyanide or
                           sulfide-bearing waste that can generate fumes in a quantity
                           sufficient to present a danger to human health when mixed with an
                           acid or base. They may be capable of detonation or a forbidden
                           explosive, or a Class A or Class B explosive, as defined in
                           Department of Transportation regulations in 49 CFR Part 173.
                           Examples include picric acid and lithium-sulfur batteries (such as
                           those used in electronic thermometers). The waste code for these
                           materials is D003.

                    —     Toxicity Characteristic. (40 CFR ง 261.24) Toxicity characteristic
                           wastes are harmful or fatal when ingested or absorbed.  When
                           toxicity characteristic wastes are disposed of on land,
                           contaminated rain or liquid may drain (leach) from the waste and
                           pollute ground water.  Toxicity is defined through a laboratory
                           procedure called the Toxicity Characteristic Leaching Procedure
                           (TCLP).  Toxicity characteristic healthcare wastes include those
                           exceeding regulatory values for chloroform, lindane, m-cresol,
                           mercury and mercury compounds (thimerosal), and certain metals
                           (such as arsenic).  A number of other pesticides and solvents are
                           also regulated under the TCLP rule.  The waste codes for these
                           materials range from D004 to D043. Research chemicals (TSCA
                           exempt) do not always have toxicity data established for them.
                           Most of the time these chemicals are incinerated as hazardous
                           waste because not enough information is available. For mixed
                           reagents, the toxic effects should be considered additive.

              Highlighted below are eight hazardous waste types that are commonly used in
healthcare facilities:  mercury, chemotherapy and antineoplastic chemicals, formaldehyde,
photographic chemicals, radionuclides, solvents, anesthetic gases, and toxic, corrosive, and
miscellaneous chemicals.
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             •      Mercury - The primary sources of mercury waste at most hospitals
                    include:

                    —     Broken or obsolete medical equipment - sphygmomanometers,
                           thermometers, tilt switches (e.g.  in electric wheel chairs),
                           intraocular pressure reducers (little bags of mercury used in past
                           for eye surgery), esophageal dilators, cantor tubes, and miller
                           abbott tubes.

                    —     Broken or obsolete components of facility equipment or capital
                           medical equipment and or calibration or process monitoring
                           devices - manometers, barometers, oven and refrigerator
                           thermometers, thermostats, mercury switches (tilt switches, reed
                           switches, float switches), flow meters, flame sensors, boiler gauge
                           controls, and fluorescent light bulbs. These can be found in
                           pulmonary and blood gas labs, HVAC and facilities areas, laundry,
                           kitchen, and laboratories as well as general areas.

                    —     Laboratory reagents and chemicals - as a preservative (e.g.,
                           thimerosol) or contaminant.

                    —     Plumbing - pipes and fittings, especially drain traps, can be
                           contaminated with mercury because of spills that occurred in the
                           past.

                    Mercury wastes are decreasing in quantity due to the substitution of solid
                    state electronic sensing instruments (thermometers, blood pressure gauges,
                    etc.), and greater awareness of the hazards of mercury in the workplace.
                    Mercury is also found as a preservative in many Pharmaceuticals
                    (thimerosal or phenylmercuric acetate); however, this is less common as
                    awareness of the health and environmental hazards has increased.  Finally,
                    mercury has  been identified as a "tramp" contaminant in a number of
                    other common products including bleach. In these cases, the mercury is
                    not intentionally added to the product.

             •      Chemotherapy and Antineoplastic Chemicals - Nine of the
                    chemotherapy and antineoplastic drugs of concern from a waste
                    perspective are on either the P or the U list of RCRA hazardous wastes,
                    which was created in the 1970s.  These are: Chlorambucil (Leukeran)
                    (U035), Cyclophosphamide (Cytoxan, CTX, Neosar, Procytox) (U058),
                    Daunomycin (Daunorubicin, Cerubidine, DaunoXome,  Rubidomycin,
                    Liposomal Daunorubicin) (U059), Diethylstilbestrol (Diethylstilbesterol,
                    DES, Stilbestrol, Honvol, Stilbesterol) (U089), Melphalan (Alkeran, L-
                    PAM) (U150), Mitomycin C (Mitomycin, Mutamycin) (U010),
                    Streptozotocin (Streptozocin, Zanosar) (U206),  Uracil Mustard (U237),
                    and Arsenic Trioxide (Trisenox) (P012).  Since  that  time, hundreds of new
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                    formulations have come into the healthcare marketplace due to advances
                    in pharmaceutical research. Some of these substances may have RCRA
                    characteristics, which would place them in the hazardous waste category.
                    It is important to note that not all chemotherapy medications are
                    considered RCRA characteristic or listed wastes. However, because a
                    single drug may have more than a dozen synonym names, determining
                    collection and disposal methods for these drugs can be confusing and
                    time-consuming. Healthcare facilities will need to determine the best
                    collection method (e.g., maintain a list of RCRA characteristic or listed
                    chemotherapy and antineoplastic drugs so that they may be collected and
                    disposed of as RCRA waste or collect all chemotherapy and antineoplastic
                    as RCRA waste) for their facility.

              •      Formaldehyde - Formaldehyde can be a significant source of hazardous
                    waste at many hospitals.  Formaldehyde (usually found in a dilute form
                    called formalin) may be used in pathology, autopsy, dialysis, and in some
                    nursing units. Formaldehyde is a U-listed waste that is regulated as an
                    unused chemical product.  Formaldehyde use in healthcare applications
                    has diminished  in recent years as greater understanding of the
                    occupational risks and hazards has been recognized.  In some cases,
                    formalin that had been used to preserve specimens is discharged to the
                    sewer. Healthcare facilities should determine if the spent formalin meets
                    the definition of a characteristic waste (e.g. ignitability). Even if the waste
                    is not hazardous, it is still a best management practice not to dispose of
                    formalin down the drain, even if sanitation authorities allow such disposal.
                    Some facilities that still use formalin in quantity have found that
                    commercially available distillation and filtration technologies are cost-
                    effective ways to reclaim reusable formalin. Additionally, some states
                    may permit the  use of formalin recycling units.

              •      Photographic Chemicals - Many healthcare facilities offer X-ray and
                    radiology services. In the past, nearly all X-rays were developed using
                    wet processing  and chemicals. The photographic developing solutions
                    used in X-ray departments consisted of two parts, a fixer and a developer.
                    For facilities using the wet processing method for developing, the silver-
                    containing effluent from the fixer solution is passed through a filter or is
                    otherwise treated to recover this precious metal. The remaining aqueous
                    waste, containing about 1.4 percent glutaraldehyde, 0.3 percent
                    hydroquinone, and 0.2 percent potassium hydroxide, is typically
                    discharged to the sewer.  Discharges containing potentially regulated
                    chemicals should be  evaluated to determine if they contain hazardous
                    waste, and if allowed by the POTW, approved for discharge in writing
                    (See Section VI. A. RCRA Domestic Sewage Exclusion). Some hospitals
                    use X-ray services that also provide silver recovery, through ion exchange
                    or electrostatic  techniques, as part of the customer service package.
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                     Much has changed in radiology in the past decade. New films contain less
                     silver and can be developed with dry processing.  Digital imaging has
                     taken the place of the standard X-ray. Many facilities are moving away
                     from traditional radiology practice and going to a PAX-it brand system
                     and digital X-rays. Facilities that have made this change have
                     dramatically reduced the pollution outputs of fixer/developer and silver
                     associated with films.  New low-silver content films are also available on
                     the market.

              •      Radionuclides - Radioactive wastes are generated in nuclear medicine
                     and clinical testing laboratory departments.  At some hospitals, short-lived
                     radioactive materials in nuclear medicine are retained on site until they
                     decay to nonhazardous levels. Depending on what the waste material is, it
                     is then disposed of as solid or hazardous waste. For longer-lived
                     radionuclides, storage times may be more limited and decay might only
                     reduce the radionuclide to levels that can be more easily managed as low-
                     level waste.  Note that "mixed wastes" (defined by RCRA as low-level
                     radioactive waste that is also hazardous) must be identified as such and
                     disposed  of properly.  In cases where 'sharps' waste is associated with the
                     radioactive material, such wastes are stored on site for proper decay, then
                     disposed  of as biohazardous waste once they are judged to be
                     indistinguishable from natural background radiation.

              •      Solvents  - Solvent wastes are  typically generated by various activities
                     throughout a hospital,  such as pathology, histology, engineering, morgue,
                     and laboratories. Volumes of solvent wastes generated at many hospitals
                     are small. Specific solvents used in medical settings include halogenated
                     compounds such as methylene chloride, chloroform, freon,
                     trichloroethylene, and 1,1,1-trichloromethane.  Other solvents include
                     nonhalogenated compounds such as xylene,  acetone, ethanol,  isopropanol,
                     methanol, toluene, ethyl acetate, and acetonitrile. Xylene, methanol, and
                     acetone are the most frequently used solvents at many hospitals.

                     Solvent waste (e.g., xylene, acetone, and methanol) are normally handled
                     as hazardous waste.  Some of these wastes are  absorbed in tissue
                     specimens, which are then treated instead as infectious wastes. Solvent
                     wastes are typically stored in 30- or 55-gallon drums and can be recycled
                     on site in solvent distillation units, or transported off site for recycling or
                     for disposal as hazardous waste. Healthcare facilities  should check with
                     their state regulations before installing recycling units.

              •      Anesthetic Gases - Nitrous oxide, the halogenated agents halothane
                     (Fluothane), enflurane (Ethrane), isoflurane (Forane),  and other substances
                     are used as inhalation anesthetics.  Nitrous oxide is supplied as a gas in
                     cartridges or cylinders that are attached directly to the anesthesia
                     equipment. Used containers may be returned to the supplier.  The
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                    halogenated anesthetic agents are supplied in liquid form, in glass bottles.
                    Once empty, the bottles and any residual must be properly disposed of.

                    Waste anesthetic gases are generally removed from the operating room, or
                    the site of application, in one of two ways. At some larger hospitals, a
                    scavenging unit is attached to the anesthesia unit to remove the waste
                    gases. The scavenging unit may have a charcoal filter that absorbs
                    halogenated anesthetic gases but not nitrous oxide. Spent charcoal filters
                    are sent off site as hazardous waste.  If there is no scavenging unit, or if
                    the scavenging unit does not have a filter,  then vacuum lines are used to
                    collect waste anesthetic gases and vent them to the outside. These waste
                    gases may cause air emission concerns.

              •      Toxics, Corrosives, and Miscellaneous Chemicals - Poisons, oxidizers,
                    and caustics are used throughout most hospitals, generally in small
                    quantities. Waste oils and solvents from maintenance may also be
                    considered hazardous wastes as may some boiler water conditioning
                    chemicals. Major toxic, corrosive, and miscellaneous chemical wastes
                    include:

                    —    Sterilants (e.g., ethylene oxide),

                    —    Disinfecting cleaning solutions,

                    —    Utility wastes: boiler feed water treatment residuals (resin
                           regeneration brine, spent resin), boiler blowdown, boiler cleaning
                           (layup) wastes, cooling tower blowdown, and cooling tower
                           sludges/sediments, and

                    —    Maintenance wastes: waste Jube oils, vacuum pump oils, cleaning
                           solvents, paint stripping wastes, and leftover paints and painting
                           accessories.

              Certain Pharmaceutical Waste

              Pharmacies store and  dispense medications and maintain a small inventory of
chemicals for compounding purposes. Healthcare facilities routinely discard partial vials, IVs,
and other unused drugs.  In cases where medication formularies change, and unused
Pharmaceuticals accumulate, these items must be properly managed (see the discussion of
reverse distribution below).  In some cases,  the items are RCRA  listed or RCRA characteristic
wastes.  Some preparations of Pharmaceuticals may also involve the use of solvents, which also
may be RCRA hazardous waste. For these chemicals, disposal should follow the RCRA
hazardous waste requirements explained in Section VI.  Table III-l lists more pharmaceutical
wastes.  For resources and more overview information refer to:
httD://www.h2e-online.ors/tools/chem-vharm.htm
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              Reverse distribution is a product management strategy that allows pharmacies to
return unused products to the manufacturer for potential credit, often through a reverse
distributor. Pharmacies can remove pharmaceuticals that are not going to be used from their
inventory, and quarantine them as a "product for return."  The reverse distributor will either
return them to the manufacturer for credit and final disposition or properly discard them if they
cannot be used. (Note: It is not legal for a reverse distributor to redistribute outdated drugs,
which are considered adulterated by FDA.) With this practice, unused/unexpired
Pharmaceuticals can be returned as  product. This includes materials that have gone beyond the
manufacturer's expiration date. Healthcare facilities should be careful not to use reverse
distribution as a waste management strategy or as a means of avoiding proper disposal of waste
(i.e., items that are obviously waste with no potential for reuse.) See the Returns Industry
Association web page for more information: http://www. returns industry, com.

              Commingled Waste

              There are several examples of commingled wastes that need special consideration.
These are wastes that include characteristics of different waste streams,  that fall under different
regulatory regimes, and pose special management concerns.

              •      Commingled "biohazardous" and chemical wastes (e.g., tissue soaked
                     in formalin) - Many tissue samples are kept by healthcare institutions,
                     labs, and research facilities in containers of formalin or formaldehyde. As
                     a commingled waste, management techniques should be applied to
                     separate the substances, as appropriate, and properly characterize, treat,
                     and dispose of the residuals.

              •      Mixed radioactive wastes - Many healthcare facilities generate low-level
                     radioactive waste as a by-product of administrating radiopharmaceuticals,
                     radioimmunology, and nuclear medicine procedures. Contaminated
                     materials may include solid wastes, biohazardous wastes, and chemical
                     wastes. For healthcare facilities, low-level waste includes clothing, linens,
                     cleaning materials, medical tubes, swabs, injection needles, syringes, and
                     laboratory animal carcasses and tissues that came into contact with
                     radioactivity. To manage low-level radioactive waste, hospitals normally
                     store materials on site, either until the materials are no longer radioactive
                     (and can be handled as municipal solid waste (MSW) or state Regulated
                     Medical Waste (RMW)), or until enough material has accumulated for
                     transfer to  a proper disposal facility. If the low-level radioactive waste is
                     mixed with a hazardous waste, it meets the RCRA definition of a "mixed
                     waste" and cannot be disposed of as MSW or RMW. Separating the
                     hazardous  and nonhazardous radioactive wastes prior to decay storage will
                     help prevent  hazardous waste from entering the solid waste stream during
                     post-decay disposal.

              •      Commingled nonhazardous and hazardous wastes - EPA's "Mixture
                     Rule" states that mixtures of solid waste and listed hazardous waste must
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                    be regulated as hazardous waste. There are two ways to determine if a
                    material is regulated under the mixture rule: (1) if the material is a mixture
                    of a solid waste and a hazardous waste, and the mixture exhibits one or
                    more of the characteristics of hazardous waste; or (2) if the material is a
                    mixture of a solid waste and a listed waste. The mixture rule is intended
                    to discourage generators from mixing wastestreams.

                    However, the mixture rule does have a number of exemptions for
                    wastewaters that are subject to the Clean Water Act [see 40 CFR
                    261(a)(2)(iv)]. One exemption is for laboratory wastewater that either (1)
                    does not exceed one percent of the total  wastewater flow, or (2) has an
                    average concentration of toxic constituents less than one part per million.

             Pressurized Containers and Ignitable Compressed Gas

             Pressurized containers sometimes use a flammable propellant (the can is labeled
"Flammable"), in which case they are hazardous waste (D001, ignitable). Ignitable compressed
gas is also hazardous waste (D001). Healthcare facilities should dispose of these as D001 waste.

             Some examples of pressurized containers and ignitable compressed gas include:

             •      Oxygen gas cylinders;

             •      Liquid nitrogen cylinders;

             •      Ethyl chloride (chloroethane); and

             •      Fluoro-ethyl (25 percent ethyl chloride,  75 percent
                    dichlorotetrafluorethane).

             In addition, propellants may contain chlorofluorocarbons (CFCs), which may be
F- or U-listed hazardous wastes. CFC-containing wastes should be managed separately from
incineration wastes.  Finally, large quantities of aerosols should be stored in a secure, fire-safe
area to prevent fire hazards.

             Universal Waste

             Under a special provision of RCRA, universal waste is exempted from Subtitle C
requirements and are regulated under the Universal Waste Rule (40 CFR ง273). There are four
types of universal waste: batteries containing hazardous substances (e.g., lead, acid, nickel, or
cadmium), pesticides containing RCRA hazardous components that are recalled or sent to a
collection program, mercury-containing thermostats, and spent fluorescent lamps and other
hazardous lamps (e.g., with mercury or lead). Note that many  states manage their own universal
waste programs and many have included electronic wastes in their universal waste programs.
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              EPA created the Universal Waste Rule (40 CFR ง273) in May 1995. Universal
waste labeling and storage requirements are less stringent than for hazardous waste. This allows
hospitals to more easily recycle batteries, thermostats, and fluorescent lamps. However,
hospitals must still comply with special requirements for labeling, storage, and manifesting.
More specific information can be found at the EPA web site;
http://mvw.epa.gov/epaoswer/hazwaste/id/univwast.htm More information on management of
universal wastes at hospitals can be found at: http://www. h2e-online.org/tools/univwast. htm

III.B.4.       Wastes by Media Category

              Hospitals generate several types of media-specific wastes, as described below.

              Wastewater

              Healthcare facilities wastewater sources include:

              •      Sinks, floor drains, showers, toilets, dish and laundry washing machines,
                    and tubs;

              *      Photographic development drains from radiology (X-rays), other imaging,
                    and dentists; and

              •      Stormwater.

              A large healthcare facility contains thousands of drains. Proper drain disposal
practices should be in place in each area. Most facilities discharge sink, shower, toilet,  and tub
wastewater to POTWs, known as indirect discharge.  Some facilities may discharge this
wastewater directly to surface water, known as direct discharge. All drains that discharge
directly should be given special  consideration to ensure that no hazardous chemicals are being
sent down the drain.  Photographic development (X-ray) wastewater is generally filtered to
recover silver before it is discharged.  Section VI discusses the Clean  Water Act (CWA)
regulatory requirements  for stormwater and direct and indirect discharges from healthcare
facilities. Mechanical shop floor drains should drain to a POTW and not simply empty into the
soil. Drains that empty to the  soil would be considered a Class V Injection Well, which would
require a permit under the Underground Injection Control Program of the Safe Drinking Water
Act.

              EPA conducted a Preliminary Data Summary8 on hospitals in 1989 and sampled
four hospitals. Although five pollutants were detected at levels higher than expected for
municipal wastewater (e.g., silver, phenols, barium, acetone, and mercury), the discharge
concentrations of these pollutants were determined to be low enough that they would not cause
pass-through  or interference at POTWs.
8 EPA, 1989. Preliminary Data Summary for the Hospital Point Source Category, EPA-440-1 -89-060-n, September
1989.

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              Healthcare facilities generate stormwater from building and parking lot areas or
from aboveground or underground oil or fuel storage tank areas. Hospitals with construction
areas of one acre or larger need stormwater permits. Public hospitals in urban areas may
discharge to municipal separate storm sewer systems (MS4s) and must  also comply with
stormwater regulations, as discussed in Section VI of this Notebook.

              Healthcare facilities with underground storage tanks (USTs) or aboveground
storage tanks (ASTs) need to consider the Oil Pollution Prevention requirements (discussed in
Section VI of this Notebook). Facilities with fleet vehicles, such as ambulances, may keep fuel
or oil in USTs or ASTs and may also have USTs for on-site diesel generators.

              The management of unused prescription drugs may involve oversight by state and
local governments and several federal agencies, including the EPA. The Agency does not
currently have specific regulations regarding the disposal of expired or  waste prescription
medications into sanitary sewer systems, nor does EPA's Office of Water have analytical
methods to assess the existence of many pharmaceutical compounds in  water or wastewater. The
Agency, however, is aware of increasing concerns about the potential for Pharmaceuticals in
water and is reviewing the current state of knowledge and coordinating with other governmental
and research agencies.

              Air Emissions

              At hospitals, air emissions come from air conditioning and refrigeration, boilers,
medical waste incinerators (if on site), asbestos, paint booths, ethylene oxide sterilization units,
emergency generators, anesthesia, laboratory chemicals,  and laboratory fume hoods.

              Hospital/medical/infection waste incinerators (HMIWI)  are used by hospitals,
healthcare facilities, and commercial waste disposal companies to burn hospital waste and or
medical/infectious waste. When burned, hospital waste and medical/infectious waste may emit
various air pollutants, including hydrochloric acid, dioxin/raran, and the toxic metals lead,
cadmium, and mercury (as discussed in Section IV.C of this Notebook).

III.C.         Assessment of Wastes Generated by Functional Activity

              Table III-2 identifies 18 key functions and major activities that are likely to be
found within health sector institutions.  The chart can be  used to identify the types of EPA
regulated wastes likely to be found and the  areas in which they would be generated.
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                                    Activity Descriptions
                              Table III-2:  Healthcare Facility Wastes
           Functional Activities
                    Wastes Produced
  Administrative Activities and Services
  •   Offices
  •   Billing services
  •   Medical records
  •   Public relations/marketing
  •   Nursing care documentation
  •   Human resources
  •   Security
  •   Social services/care management
  •   Retail services
  •   Shipping and receiving
  •   Printing/copying
Municipal solid waste from all service areas
Batteries from cell phones, special pagers, PDAs, digital
cameras, and communication devices
Mercury-containing switches from greeting cards and other
'gifts' in the gift shop
Solvents possibly associated with a print shop
Oils from a printing press
Toner cartridges from copiers and printers
Cleaning chemicals associated with retail establishments
Kitchen grease associated with retail food establishments
Wastewater from retail services
  Support Services
  •   Information services
  •   Food services
  •   Laundry services
  •   Pharmacy
  •   Central sterile reprocessing
  •   Biomedical engineering
Municipal solid waste from all service areas
Biohazardous waste from laundry services and central sterile
reprocessing
Electronics/computer wastes (CRTs, hard drives) from
information services, and biomedical engineering
Chemicals associated with cleaning, laundry, and food services
(decalcifiers, degreasers, chlorine bleach)
Pesticides associated with cleaning services or food services
RCRA listed and RCRA characteristic pharmaceuticals from the
pharmacy
EtO from central sterile reprocessing
High-level disinfecting agents associated with central sterile
reprocessing
Cleaning chemicals
Peracetic acid from central sterile reprocessing
Batteries (nicad, lithium, mercuric oxide, and others) from
biomedical engineering
Kitchen grease from food services
Degreasers, solvents from food services or laundry
Mercury-containing devices such as thermometers in
refrigerators, incubators, and heating units
Wastewater from all service areas including food services and
laundry services
Air emissions from laundry services, refrigeration, and
sterilization
Sharps waste from the pharmacy, central sterile, and from
accidental disposal in laundry  and food service
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                                   Activity Descriptions
                      Table III-2: Healthcare Facility Wastes (Continued)
          Functional Activities
                   Wastes Produced
 Facilities Management, Engineering and
 Maintenance, and Plant Operations
 Housekeeping
 •  Maintenance shops (paint, electric,
    plumbing)
 •  Heating Ventilation and Air
    Conditioning (HVAC)
 •  Waste treatment
 •  Water treatment
 •  Fleet management
 •  Grounds keeping
 •  Pest management
Municipal solid waste from all facility areas
Air emissions from boilers
Cleaning chemicals
Chemicals associated with paint shop - turpentine, strippers,
solvents, adhesives
Chemicals associated with electric and plumbing shop including
oils, adhesives
Chemicals associated with air handling system
Chemicals associated with water treatment systems (decalcifiers,
disinfecting solutions)
Radioactive or mixed waste residues in water treatment system,
drains and piping
Chemicals associated with elevator care and maintenance
(hydraulic fluids)
Chemical associated with groundskeeping and pest management
Mercury-containing switches, manometers, pressure gauges,
fluorescent lamps, and thermostats
PCB-containing fluorescent light ballasts and electrical
transformers
Asbestos
Pressurized gas canisters/containers from all facility areas
Wastewater from drains, water treatment, and fleet management
Air emissions from HVAC systems and maintenance shops
(paint booths)
 Laboratory Services
 •   Hematology
 •   Microbiology
 •   Chemistry
 •   Blood Bank
 •   Surgical Pathology
 •   Histology
Municipal solid waste from all service areas
Biohazardous waste from all service areas
Mixed biohazardous wastes
Chemicals associated with laboratory testing including: alcohols,
xylene, toluene, formaldehyde, b5 fixatives, picric acid, other
acids and  bases chemicals, and cleaning solutions  (see chemical
inventory in each laboratory area to identify RCRA listed and
characteristic wastes)
Mercury-containing devices such as calibration manometer,
water bath thermometer, incubator and refrigerator thermometers
Cleaning chemicals
Radioactive or mixed waste residues
Pressurized gas cylinders (blood gas analysis area)
Wastewater from sinks and drains
Air emissions from laboratory chemicals and hoods
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Healthcare Industry
                                    Activity Descriptions
                      Table III-2:  Healthcare Facility Wastes (Continued)
          Functional Activities
                   Wastes Produced
  Diagnostic Services
  •   Endoscopy
  •   Cardiac Catherization lab
  •   Radiology (CT, MRI, digital imaging)
  •   Nuclear medicine
  •   Sleep studies (EEG)
Municipal solid waste from all service areas
Biohazardous waste from all service areas
Mixed waste from tissue samples and chemical, or radioactive
and solid, or radioactive and chemical
Glutaraldehyde or other disinfectant/cleaner associated with
endoscopy
RCRA listed and RCRA characteristic Pharmaceuticals
Formalin for tissue samples obtained from any of the listed
diagnostic services
Silver from radiology films, fixer and developer
Radioisotopes from nuclear medicine
Collodion (ether/alcohol) from EEG areas
Cleaning chemicals
Lead shielding from radiology
Wastewater from sinks and drains and photographic developing
Air emissions from sterilization and disinfection
 Surgical Services
 •   Ambulatory outpatient services
 •   Surgery
 •   Post-anesthesia care
 •   Preoperative services
 •   Anesthesia
Municipal solid waste from all service areas
Biohazardous waste from all service areas
Mixed waste from tissue samples
RCRA listed and RCRA characteristic Pharmaceuticals
Mercury-containing monitoring equipment (thermometers,
sphygmomanometers, and esophageal dilators)
Used batteries (Nicad, lithium, other)
Waste anesthetic gases and compressed gas cylinders
Cleaning solutions; high-level disinfectants
Phenol
Collodion
Formalin
If surgical pathology unit is present in surgical services area,
look for xylene, toluene
Wastewater from sinks and drains
Air emissions from anesthetic gases
 Inpatient Care Services
 •   Medical surgical care
 •   Orthopedic care
 •   Neurology care
 •   Urology care
 •   Cardiac care
 •   Psychiatric/behavioral health
 •   Geriatric care
 •   Palliative care
 •   Maternal child care (labor and
     delivery/birthing, postpartum care,
     nursery, pediatrics)
 •   Pediatric care
 •   Cancer care
 •   Rehabilitative care
Municipal solid waste from all service areas
Biohazardous waste from most service areas
RCRA listed and RCRA characteristic pharmaceuticals
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Cleaning solutions; high-level disinfectants
Chemicals related to leatherwork, plastic casting, etc. for
rehabilitation/prosthesis device producing settings
Wastewater from sinks and drains
Air emissions from sterilization and disinfection
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                                   Activity Descriptions
                      Table 111-2: Healthcare Facility Wastes (Continued)
          Functional Activities
                   Wastes Produced
 Critical Care Services
 •  Surgical intensive care
 •  Medical intensive care
 •  Pediatric intensive care
 •  Cardiac intensive care
 •  Burn care
 •  Neonatal intensive care
Municipal solid waste from all service areas
Biohazardous waste from all service areas
RCRA listed and RCRA characteristic Pharmaceuticals
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Used batteries (Nicad, lithium, other)
Cleaning solutions; high-level disinfectants
Wastewater from sinks and drains
Air emissions from sterilization and disinfection
 Emergency Care Services
Municipal solid waste from all service areas
Biohazardous waste from all service areas
RCRA listed and RCRA characteristic Pharmaceuticals
Mercury-containing monitoring equipment (thermometers,
sphygmomanometers, and especially hypothermia thermometers)
Chemical or biological agents from decontamination
(chemical/biological) area for incoming patients
Waste anesthetic gases and compressed gas cylinders
Cleaning solutions; high-level disinfectants
Formalin
Silver from radiology films, fixer and developer
Lead shielding from radiology
Wastewater from sinks and drains, ensure that decontamination
area drains connect to containment tank for potentially hazardous
fluids.
Air emissions from sterilization and disinfection, ensure that
decontamination area ventilation system connects to filter or
separate system for potentially hazardous pollutants
 Respiratory Care Services
 •  Pulmonary function testing
 •  Oxygen therapies
Municipal solid waste from all service areas
RCRA listed and RCRA characteristic pharmaceuticals
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Compressed gas cylinders (oxygen tank management)
Used batteries
Cleaning solutions; high-level disinfectants
Wastewater from sinks and drains
Air emissions from sterilization and disinfection
 Dialysis
 •   Hemodialysis
 •   Peritoneal dialysis
Municipal solid waste from all service areas
Biohazardous waste from all service areas
RCRA listed and RCRA characteristic pharmaceuticals
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Formaldehyde, formalin
Cleaning solutions; high-level disinfectants
Wastewater from sinks and drains
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                                   Activity Descriptions
                      Table III-2: Healthcare Facility Wastes (Continued)
          Functional Activities
                   Wastes Produced
 Physical Therapy
 Occupational Therapy
Municipal solid waste from all service areas
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Cleaning solutions
Chemicals related to leatherwork, plastic casting, etc. for
rehabilitation/prosthesis device producing settings
Wastewater from sinks and drains
 Outpatient Services (Nonsurgical)
 •   Womens' health/gynecology
 •   General medicine
 •   Family practice
 •   Specialty clinics (orthopedics,
     urology, pulmonology, allergy)
 •   Pediatrics
 •   Rehabilitative services
Municipal solid waste from all service areas
Biohazardous waste (mostly sharps)
RCRA listed and RCRA characteristic Pharmaceuticals from
sample medications
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Cleaning solutions; high-level disinfectants
Wastewater from sinks and drains
 Oncology/Cancer Care Services
 •   Radiation oncology
 •   Chemotherapy
 •   Lead molds - Cerrobend
Municipal solid waste from all service areas
Biohazardous waste
RCRA listed and RCRA characteristic pharmaceuticals
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Chemotherapy waste - RCRA listed and RCRA characteristic
Chemotherapy waste - non-RCRA regulated
Mixed radioactive and hazardous waste
Radioisotopes from nuclear medicine
Cleaning solutions; high-level disinfectants
Wastewater from sinks and drains
 Dentistry
 •   Oral surgery
 •   Periodontics
 •   Oral healthcare
Municipal solid waste from all service areas
RCRA listed and RCRA characteristic pharmaceuticals
Waste anesthetic gases and compressed gas cylinders
Residual mercury amalgam
X-Ray materials; lead shields
Cleaners, disinfectants
Wastewater from sinks and drains
Air emissions from sterilization and disinfection
Biohazardous and sharps waste
 Animal Research and Testing
Municipal solid waste from all service areas including animal
care
Biohazardous waste from all service areas
RCRA listed and RCRA characteristic pharmaceuticals
Mercury-containing monitoring equipment (thermometers and
sphygmomanometers)
Research chemicals
Radioactive or mixed waste residue
Wastewater from sinks and drains
Air emissions from laboratory chemicals and hoods, and from
sterilization and disinfection
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                                                        Activity Descriptions
                   Table 111-2:  Healthcare Facility Wastes (Continued)
         Functional Activities
                    1
Wastes Produced
 Clinical Research
                         Municipal solid waste from all service areas
                         Biohazardous waste from all service areas
                         RCRA listed and RCRA characteristic pharmaceuticals
                         Mercury-containing monitoring equipment (thermometers and
                         sphygmomanometers)
                         Research chemicals
                         Wastewater from sinks and drains
                         Air emissions from laboratory chemicals and hoods, and from
                         sterilization and disinfection
 Construction and Renovation
                         Municipal solid waste from all service areas
                         Mercury-containing monitoring equipment (thermometers and
                         sphygmomanometers)
                         PCB-contaminated light ballasts
                         Asbestos
                         Radioactive or mixed waste residue in drains and piping
                         Stormwater
                         Lead paint	
III.D.
Management of Waste Streams
              Healthcare facilities may treat, recycle, or dispose of the waste streams that they
produce. This subsection presents some examples of management techniques (and example
waste types). This is not meant to be a comprehensive list, but an introduction only; refer to the
sources at the end of this Notebook for more detail.

              EPA ranks options for managing waste in descending order of preference. This
ranking encourages reliance on those approaches that minimize the generation of waste and
environmental releases. SOURCE REDUCTION is assigned the highest priority because it
emphasizes eliminating or reducing wastes at the point of generation. Purchasing a digital
thermometer, rather than one containing mercury, for example, reduces the heavy metal content
in the waste and reduces the need for recycling, treatment, or disposal. Source reduction is
typically less expensive than collecting, treating, and disposing of waste. It also reduces risks for
workers, the community, and the broader environment.

              REUSE is the next preferred option. Implementing measures to reuse products
and packages for their original purpose reduces purchasing costs and packaging wastes as well as
wastes from patient care activities. Healthcare facilities find that reusable  linens, reusable
patient supplies, such as bedpans and emesis basins, as well as reusable dishes and cutlery for
food service are generally economically and environmentally preferable to their disposable
counterparts, although there are costs incurred in cleaning and sterilizing equipment for reuse.

              RECYCLING encourages regenerating materials or reclaiming constituents of the
waste stream into usable items. Paper and paper products, such as corrugated cardboard, glass
food and beverage containers, metals, and certain plastics may be recyclable. However, facilities
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should evaluate the local environmental and economic consequences associated with collecting
and recycling materials as well as the associated energy and resource costs.

              TREATMENT to reduce the volume or the potentially harmful environmental
impacts of the waste is ranked at the lower end of the hierarchy. Medical waste treatment
technologies include autoclaving, hydropulping, pyroiysis, microwave, incineration, chemical
treatment, and irradiation. Treatment precedes disposal, the least favored option. Ultimately,
however, some wastes and medical waste treatment residues require land disposal. The costs of
treatment and disposal are significant, and both  have inherent environmental impacts, including
emissions to air and water.

              Reduction/Prevention

              The amount of almost all wastes  produced through healthcare activities can be
reduced. This can be as easy as a manufacturer using less packaging or replacing corrugated
shipping containers with reusable totes. It can also mean not using certain materials (e.g.,
mercury) that become problematic wastes, through a technique called Environmentally
Preferable Purchasing (EPP). This technique can be used by the purchasing agency for any
healthcare facility. For more information regarding EPP go to http://www.epa.gov/opptmtr/epp/.

              Waste can also be prevented through vendor return programs, which encourage
product stewardship.  A common program is returning cartridges from printers and copiers.
Many healthcare facilities are now signing contracts for computers and peripherals that require
the vendor to take back units when new units  are purchased. There is also a "returns" industry
for pharmaceuticals that takes back unused pharmaceuticals as product, not waste.

              Segregation

              As wastes are generated, the most important management technique to ensure
worker safety, ensure proper treatment and disposal, and minimize environmental risk, is to
strictly segregate wastes. The general principle is to segregate wastes so that most of the waste
ends up in categories that can be reused, recycled, or that are safer and cheaper to dispose of
(e.g., municipal solid waste). The principle of segregation is most commonly used to reduce the
generation of biohazardous wastes, to ensure that only those wastes truly contaminated or posing
a risk are placed in "red" bags or sharps containers. This principle is also very important when
considering separating wastes for recycling and for management of chemical wastes.

              Reuse

              Common chemicals (xylene, formalin, alcohol) used in some activities can be
reprocessed and reused. Newer technologies have made this option safer and more affordable.

              A number of common medical devices have now been designed for reprocessing
and reuse (e.g., pulse oximeters). Numerous other reusable items can be used in healthcare
activities including linens, gowns, drapes, bedpans, dishware, utensils, and cutlery.
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             Recycling

             Much of the municipal solid waste generated from healthcare activities is easily
recyclable, when one considers that up to 40-50 percent of the waste from most activities is
paper and cardboard. Another large portion consists of other commonly recycled metals, plastics
and glass. Aggressive recycling programs can divert a very large portion of waste from
healthcare activities.

             Pressurized containers, universal wastes, and construction and demolition debris
are also commonly recycled materials generated at healthcare institutions.

             Composting

             Some hospitals have identified options for segregating and disposing of food
waste and landscaping discards at authorized composting operations.

             Landfill

             Waste from healthcare activities that is classified as municipal solid waste is often
sent to a landfill for final disposal. In some states or tribal regions, untreated biohazardous
wastes may be sent to landfills under special conditions.  Proper segregation is important to keep
hazardous materials from being disposed of in landfills, many of which have specific bans on
such items.

             Incineration (Off-site Municipal Plant)

             Waste from some healthcare activities classified as municipal solid wastes may be
sent to a municipal solid waste incinerator. The waste ash will then have to be disposed of as
either municipal solid waste or hazardous ash depending on testing. A key issue in the
incineration of healthcare wastes is that the municipal solid waste stream from healthcare tends
to be rich in PVC plastics, which when combusted can produce dioxins.

             Medical Waste Incinerator (On-site or Off-site)

             Depending on state or tribal regulation, at least a small portion of biohazardous
waste, including sharps, may have to be incinerated. This will likely include pathological wastes
and wastes contaminated with small amounts of chemotherapy substances. The incineration of
large amounts of biohazardous wastes has decreased in the United States, due to concerns over
emissions and the implementation of the EPA air emission regulations for Hospital/Medical/
Infectious Waste Incinerators (HMIWI).  Most treatment has moved to other noncombustion
technologies.
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              Noncombustion Biohazardous Treatment Technologies (e.g., Autoclave/
              Microwave Treatment/Chemical Mechanical Treatment) (On-site or Off-site)

              The majority of biohazardous wastes is now being treated using noncombustion
technologies. More than 40 certified noncombustion treatment technologies are in use or being
tested in the United States. These devices use heat and pressure or chemicals to render the
wastes generally noninfectious and suitable for disposal in landfills.

              Hazardous Waste Treatment Facilities, Incinerators, Landfills

              Of the wide variety of hazardous materials generated through healthcare
activities, some will have to be packaged and transported for special treatment and disposal at
specialized licensed facilities to manage hazardous waste. These range from waste oils to toxic
chemicals such as phenol.

              Treatment atPOTWs

              Many wastes, from body fluids, to kitchen food scraps, to a wide mix of
chemicals, cleaners and disinfectants are discharged to the wastewater system, and must be
managed by a POTW. Stormwater run-off from facilities may also have to be discharged to
these treatment plants or to a municipally maintained stormdrain network. Local and state
regulations may specifically require pollutant prevention measures, waste segregation, and or
treatment of these waste streams prior to discharge.

              Treatment/Control On-site

              A variety of technologies to pretreat wastewater and various air emissions (e.g.,
ethylene oxide) have been used at healthcare facilities to reduce direct emissions.
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IV.           WASTE AND EMISSIONS PROFILE

              This section provides information on the volume of waste released by the
healthcare industry.  The Toxics Release Inventory (TRI) is a publicly available EPA database
that contains information on toxic chemical releases and other waste management activities
reported annually by certain covered industry groups as well as federal facilities. Because only
federal facilities in the healthcare industry are required to report pollutant release and other
waste management information to TRI, little quantitative waste information is available for this
sector. The data provided in this section are for hospitals, the segment of the healthcare industry
for which the most data are available.

IV.A.         Solid, Biohazardous, and Hazardous Waste Production Data for the
              Healthcare Industry

              According to the information published in the SHEA9 position paper on medical
waste, the United States healthcare industry generates 6,670 tons per day of waste, most of
which is solid or municipal waste.  In January 1992, it was estimated that about 15 percent of
this waste was infectious waste, or about 1,000 tons per day.  A small fraction of healthcare
waste is hazardous chemical or radioactive waste.

              There have been limited studies evaluating healthcare waste comprehensively.
Those studies were often conducted in preparation for a waste treatment technology, or were
conducted on a small segment of healthcare wastes. Healthcare waste has continued to shift
qualitatively as medical advances have occurred, changing the nature of many procedures, and
thus wastes, within the industry. Laparoscopic procedures, cautery devices, and laser surgery
have all contributed to procedures that generate less biological waste.  Advances in
pharmaceutical technology have reduced the need for surgical interventions. Adjustments in
healthcare reimbursements have contributed to decreased length of stay in hospitals and
increases in home care and outpatient or ambulatory healthcare.  The supply industry has
streamlined many aspects of product packaging, and the use of plastics instead of glass has
lessened the weight of many products.  Medical waste definitions vary from state to state, which
can impact the waste segregation programs set up in a given facility.

IV.A.1.       Municipal Solid Waste

              Of the about 3.4 billion pounds of solid waste produced annually by hospitals,
more  than half is composed of paper and cardboard. Figure IV-1  demonstrates the composition
of hospital solid waste.
9 Rutala WA, Mayhall CO, "The Society for Hospital Epidemiology of American (SHEA) Position Paper: Medical
Waste." Infection Control Hospital Epidemiology. 1992; 13:38-48.

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                     Figure IV-I:  Hospital Solid Waste Composition
                           1 5%
                                17%
                        • Paper • Food/Organics • Plastic a Metals • Other    :

                     Source: Healthcare Without Harm, "Setting Healthcare's
                     Environmental Agenda" Conference Proceedings: Waste
                     Management White Paper.

              Much of the waste that is considered municipal solid waste (MSW) is composed
of corrugated cardboard, paper, glass, plastics, wood, metals, food waste, leaf and yard waste,
and a variety of mixed materials. For hospitals in areas that have community infrastructures to
support recycling, up to 40 percent of the solid waste can be recyclable.  Other wastes that can
also be recycled include kitchen grease, durable goods (furnishings), toner cartridges, and X-ray
film.

IV.A.2.       Biohazardous Waste

              As stated above, in January 1992, it was estimated that about 15 percent (an
estimated 1,000 tons per day) of hospital waste was infectious waste. Biohazardous waste, also
referred to as infectious waste or regulated medical waste, is that component of healthcare waste
that includes sharps, pathological waste, blood and blood products, blood-soaked items, and non-
regulated chemotherapy waste.

              In evaluating biohazardous waste handling, it is important to understand the
distinctions between state EPA biohazardous waste definitions, which help define this category
of waste for treatment and disposal, and Universal Precautions, an OSHA blood-borne pathogens
(BBP) rule, which is designed to protect workers from exposure to blood-borne diseases. The
OSHA BBP rule provides guidance on the use of personal protective equipment when caring for
patients, and has requirements for labeling and handling biohazardous waste, along with other
types of waste.
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              It is not uncommon for workers in a healthcare facility to refer to biohazardous
waste as contaminated trash, infectious waste, medical waste, medical infectious waste,
regulated medical waste, or some other similar term. From a regulatory perspective, this waste
stream should be collected in a consistent manner, with sharps being segregated at the source of
generation in leakproof, puncture-resistant containers, and other regulated medical waste
collected in biohazard containers or bags. Pathological wastes,  or tissue waste, are also
considered biohazardous waste, and should be collected and labeled for disposal via incineration
(or as otherwise regulated by the state).  Nonregulated chemotherapy wastes are also collected in
distinctive containers with the chemotherapy label, packaged for disposal along with
biohazardous waste, and labeled for incineration only (or other technologies that may become
available).

IV.A.3.       Hazardous Chemical Waste

              The healthcare industry is not required to report pollutant release and other waste
management information to the TRI.  Therefore, little quantitative hazardous chemical waste
generation information is available for this sector. However, healthcare facilities tend to
generate small quantities of various hazardous chemicals relative to the amount of municipal
solid waste or biohazardous waste. The amount and type of hazardous chemical waste generated
is directly related to the type of facility and the quantity of various products used.

              Hazardous chemical waste generation is related to key functions within the
healthcare sector. These include laboratory testing areas, facility maintenance areas,
groundskeeping areas, and some diagnostic areas. Facilities that include research units usually
generate greater volumes and more diverse hazardous chemicals.  A small amount of
Pharmaceuticals  commonly in use are also listed or characteristic RCRA wastes. EPA has found
that many hospitals are small quantity generators unless they are part of a large facility, such as a
university or military base, in which case they tend to be large quantity generators. Facilities
may also be temporarily large quantity generators when disposing of waste chemicals during
laboratory cleanouts.

IV.B.         Wastewater Discharge Data for the Healthcare Industry

              A majority of healthcare facilities discharge wastewater  to POTWs.  These
facilities complete discharge monitoring reports (DMR) according to their state, tribal, and local
water discharge guidelines, but there is not a centralized data collection system for the
information.

              Facilities that discharge directly to waters of the  United States are considered
direct dischargers.  Effluent discharge data from these facilities are collected in EPA's Permit
Compliance System (PCS). According to calendar year 2000 data from PCS, there are only three
major dischargers in the healthcare industry. Dischargers are classified as major based on an
assessment of six characteristics: (1) toxic pollutant potential; (2) flow/stream flow  volume;
(3) conventional pollutant loading; (4) public health impact; (5) water quality factors; and
(6) proximity to nearby coastal waters.
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             The database includes data for only a limited set of minor dischargers when the
states choose to include these data. As a consequence, extensive data are not available for minor
dischargers in PCS; data for 103 minor direct dischargers are in PCS.

             The 106 direct dischargers in healthcare that are included in PCS fall into the
categories in Table IV-1 (note that PCS uses Standard Industrial Classification (SIC) codes).

                     Table IV-1: Direct Dischargers Included in PCS
SIC Code
8011
8021
8051
8052
8059
8062
8063
8069
8071
8082
8092
8099

SIC Description
Offices & Clinics of Medical Doctors
Outpatient Care Facilities
Skilled Nursing Care Facilities
Intermediate Care Facilities
Nursing and Personal Care, NEC
General Medical & Surgical Hospitals
Psychiatric Hospitals
Specialty Hospitals, Except Psychiatric
Medical Laboratories
Home Health Care Services
Kidney Dialysis Centers
Health & Allied Services, NEC
Total
Minor
Dischargers
4
2
21
18
18
20
7
4
3
1
1
4
103
Major
Dischargers
0
0
0
0
0
2
1
0
0
0
0
0
3
      Source: PCS 2000 data.

             Table IV-2 provides the total pounds of pollutants discharged annually by these
106 facilities. The totals shown are a result of summing the pounds per year contained in the
PCS 2000 data.  Note that only annual discharges of one pound or greater are shown.

      Table IV-2: Pollutant Discharge from Direct Discharging Healthcare Facilities
Parameters
Solids, Total Dissolved
Oxygen, Dissolved (DO)
Phosphorus, Total (As P)
Solids, Total Dissolved- 180 Deg. C
Oil & Grease Freon Extr-grav Meth
Solids, Total Dissolved (TDS)
Chloride (As Cl)
Pounds Per Year
8,065,304
822,943
739,632
430,840
300,913
199,682
190,842
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      Table IV-2: Pollutant Discharge from Direct Discharging Healthcare Facilities
                                      (Continued)
IV.C.
Parameters | Pounds Per Year
Solids, Total Suspended
BOD, 5-day (20 Deg. C)
BOD, Carbonaceous 05 Day, 20C
Sulfate (As S)
Nitrogen, Ammonia Total (As N)
Hardness, Total (As CaCOS)
Oxygen Demand, Chem. (Low Level) (Cod)
Chlorine, Total Residual
Nitrogen, Total (As n)
Nitrite Plus Nitrate Total 1 Det. (As N)
Nitrogen, Nitrate Total (As N)
Nitrogen, Kjeldahl Total (As N)
Carbon, Tot Organic (TOC)
Oxygen Demand, Chem. (High Level) (COD)
Sulfide, Total (As S)
Magnesium, Total (As Mg)
Bromine Chloride
Zinc, Total (As Zn)
Fluoride, Total (As 0
Copper, Total (As Cu)
Hydrocarbons, in H2O, IR, CC14 Ext. Chromat
Surfactants (MBAS)
Zinc Total Recoverable
Copper Total Recoverable
Silver, Total (As Ag)
100,996
36,244
'20,821
15,504
10,061
7,796
4,961
1,374
730
632
547
413
205
176
106
77
40
30
16
9
4
3
2
2
1
        Source: PCS 2000 data.
Air Emissions from the Healthcare Industry
              Hospitals generate air emissions from medical waste incinerators, boilers,
sterilization chemicals, air conditioning and refrigeration, and laboratory fume hoods. Air
emissions data for certain pollutants are available from the National Emission Trends (NET)
database (1999), and hazardous air pollutant emissions data are available from the National
Toxics Inventory (NTI) database (1996).  These databases have since been replaced by the
National Emission Inventory database, but no final data are yet available. For the SIC codes
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80xx (Health Services), the total emissions for volatile organic compounds (VOC), nitrogen
oxides (NOX) and hazardous air pollutants (HAPs) are shown in Table IV-3.

           Table IV-3:  Total Emissions for VOC, NOx, and HAPs (Tons/Year)
SIC Code
8011
8051
8052
8059
8061
8062
8063
8069
8071
8081
8082
8092
8093
8099
8050

SIC Description
Offices and Clinics of Medical Doctors
Skilled Nursing Care Facilities
Intermediate Care Facilities
Nursing And Personal Care, NEC
Hospitals
General Medical & Surgical Hospitals
Psychiatric Hospitals
Specialty Hospitals, Except Psychiatric
Medical Laboratories
Outpatient Care Facilities (1977)
Home Health Care Services
Kidney Dialysis Centers
Specialty Outpatient Clinics, NEC
Health And Allied Services, NEC
Nursing and Personal Care Facilities
Total, All Health Services Subsectors
VOC
7
16

9
0
1,204
115
53
17


2
0
16
0
1,445
NOx
74
88
1
228
6
12,440
3,412
760
15
0

126
2
68
4
17,429
HAP
5
0
5
0

607
53
31
15

1
0

14

731
       Source: Environmentally Conscious Manufacturing Strategic Initiative Group at the National
       Center for Manufacturing Sciences (NCMS).

             Incinerator Emissions

             In the September 15,1997 Federal Register Notice (FRN) for the Hospital/
Medical/Infectious Waste Incinerators (HMIWI) Final Rule, EPA identified about 1,139 small
HMIWI, 692 medium HMIWI, 463 large HMIWI, and 79 commercial HMIWI in operation.
EPA estimated that, as a result of the final rule, 93 to 100 percent of small "nonremote"
HMIWI, 60 to 95 percent of medium HMIWI, and as many  as 35 percent of large HMIWI would
cease operation. All 79 commercial units and 114 small units meeting the "remote" criteria
were assumed to remain in operation.  Facilities that ceased operation were  assumed to find
alternate methods of waste disposal.

             As a result of the HMIWI rule, most  facilities have phased out their on-site
incinerators. Based on the January 2004 inventory conducted of the existing hospital/infectious/
medical waste incinerators, only 111 units are in operation in all the EPA regions.  A list of those
facilities currently operating incinerators can be found at:
htiD://www.et}a.ฃov/ttn/atw/129/hmiwi/2004hmiwi inventory.xls.
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              Boilers

              Many hospitals operate industrial boilers, which can generate criteria pollutants
(e.g., NOX, SO2, particulates, CO) and hazardous air pollutants (HAPs).  NOX emissions from
combustion in boilers and waste incinerators is the most serious criteria air pollutant generated
by the healthcare industry. Currently, information is not available on the number of boilers, and
their associated emissions, in the healthcare industry. EPA recently finalized a rule for
industrial/commercial/institutional boilers.  EPA's air toxics web site
http://www. epa.gov/ttn/atw/boUer/boilerpg. html provides information regarding EPA's HAP
regulations for industrial/commercial/institutional boilers and process heaters.  Because the rule
only applies to major sources (i.e., those that emit at least 10 tons per year of a specific HAP or a
combined total of 25 tons per year of all HAPs), most medical facilities will be exempt from the
regulations. However, medical facilities that are colocated with other HAP-emitting facilities,
such as on military bases or college/university campuses, could be subject to the new standards if
the "site" as a whole meets the definition of major.

              Most hospital boilers are subject to the federal New Source Performance
Standards (NSPS) regulations.  The applicable regulations can be found at 40 CFR Part 60
Subparts Db and DC. Depending on the type of fuel combusted, the regulations have emission
standards  for sulfur dioxide, nitrogen oxides and particulate matter. Additionally, expansion of
the facility may lead to Clean Air Act Prevention of Significant Deterioration (PSD)/New Source
Review (NSR) requirements. See Section VI of this Notebook for more information.
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Healthcare Industry                                  Pollution Prevention Opportunities

V.           POLLUTION PREVENTION OPPORTUNITIES

             Pollution prevention is a way to reduce the impact that a business makes on the
environment. This includes reducing waste, emissions, accidental releases, fires, global waste
and emissions, and depletion of raw materials and using nonrenewable energy. The healthcare
industry has numerous opportunities to prevent pollution. By implementing well-planned
pollution prevention strategies, facilities can improve efficiencies, save money, minimize
adverse environmental impacts, and offer a healthier workplace. Opportunities vary from
facility to facility and relate to the volumes and types of activities.

             This section is intended to provide the reader with an understanding of some of
the most common pollution prevention opportunities available to the healthcare industry.  Many
programs are not specifically covered by this document. For more information on the various
pollution prevention opportunities available to the healthcare industry, visit the industry web
sites discussed in Section VIII of this document.

V.A.        General Pollution Prevention Opportunities

V.A.1.       Environmental Management Systems (EMS)

             Environmental Management Systems work to apply the building blocks of
effective organizational management (accountability, assigned responsibilities, employee
involvement, written policies, training, periodic review and corrective action, senior
management support and involvement) to environmental performance.  They do this by
challenging a hospital to identify all of its significant environmental impacts, determine which
are most important, and set performance-based objectives and targets to minimize these impacts
on an ongoing basis. A comprehensive EMS will include all feasible aspects of pollution
prevention.

             EPA has developed a resource titled "Healthcare Guide to Pollution Prevention
Implementation through Environmental Management Systems," which is a comprehensive
resource for understanding the components of an EMS and for developing  an EMS specific to a
healthcare facility. The first edition of this document can be found at:
http://www.epa.gov/region02/healthcare/.

V.A.2.       Purchasing/Product Substitution/Source Reduction

             Selection of less toxic or less polluting products can reduce pollution generation.
Source reduction opportunities exist in many functional areas within healthcare. Purchasing
products with minimum waste or minimum toxicity (i.e., environmentally preferable purchasing
(EPP) strategy) can reduce the waste generated at the facility. Web sites with resource
information for source reduction include Hospitals for a Healthy Environment (H2E) at
www.h2e^online.org and the Sustainable Hospitals project at www.sustainablehospitals.org.
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              Examples of these approaches in healthcare include:

              •      Non-mercury-containing products and devices - Purchasing and using
                    non-mercury-containing fixatives in the laboratory and technologies for
                    vital sign monitoring (thermometers and sphygmomanometers) help to
                    reduce mercury pollution.

              •      Purchasing a less hazardous product for use in adhering electrodes to
                    the scalp for EEGs - Using less hazardous products instead of flexible
                    collodion, which is made from alcohol and ether, is a direct strategy for
                    source reduction.

              •      Mattress selection (reduces solid waste generation) - Using mattresses
                    with built-in egg crates reduces the need for foam mattress overlays.
                    Healthcare bedding items are changed out every 5 to 7 years, or more
                    frequently depending on usage.  Patient comfort, ease of cleaning, and bed
                    sore prevention are goals to be considered in bedding purchases.
                    Selecting mattresses with built-in, rather than disposable, egg-crate foam
                    layers, allows for the desired attributes to be available in a semidurable,
                    versus readily disposable, product.

              •      Respiratory care products (reduces solid waste generation) - Using
                    reusable respiratory therapy products can help reduce waste volumes.
                    Specific products such as ambu bags (used in respiratory resuscitation)
                    and ventilator circuit tubing (used as a channel for air in ventilators) are
                    available as reusable products. The energy, chemicals, labor, and space
                    needs for having a reusable/reprocessing function on site should be
                    evaluated.  In cases where the cost benefit is favorable, this strategy makes
                    sense.

              •      Microfiber mopping - This type of product substitution can have multiple
                    benefits including reduced water and cleaner/disinfectant use and disposal
                    (reduces cost, chemical hazards, storage space), less weight to lift
                    (ergonomic benefit, lower potential for injury), reduced mopping time
                    (more productive use of staff, lower labor cost), reduced opportunity for
                    slips and falls on a wet floor, no cross-contamination, and preferred by
                    patients because it is quieter and less intrusive.

V.A.3.        Process Change

              Process changes are intentional modifications in activities that reduce pollution.
Examples of this are abundant in healthcare. Some of the process changes that have
environmental benefits also have  other benefits, such as cost containment or improved quality of
a service or product.
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              Examples of process changes in healthcare include:

              •      Switch to digital imaging for radiology processing (reduces silver
                    waste outputs).  Digital imaging and PAX-it brand systems use digitaJ
                    images instead of silver-laden X-ray films; this negates the need for fixer/
                    developer solutions, which also contain silver, and reduces water
                    consumption.

              •      Right-sizing formaldehyde collection containers (reduces formalin
                    waste outputs).  This practice involves having a variety of sizes of
                    collection containers filled with the preserving fluid (usually formalin),
                    and matching the tissue sample to the appropriate container size.
                    Previously, many facilities stocked only a few sizes of container, with the
                    smallest being a 4-ounce container. Carrying seven or eight different size
                    containers allows the practitioner to select the most appropriate size
                    container based on specimen size.  In one case study, this approach
                    reduced formalin use by as much as 70 percent, and minimized waste
                    formalin by a similar amount. The facility saved money by using less
                    formalin, purchasing smaller containers, and saving on space, as greater
                    quantities of the smaller containers could be stored on site.

              •      Pharmaceutical Return Programs (reduces pharmaceutical product
                    outputs).  Implementing a pharmaceutical returns program can be a
                    valuable practice in reducing pollution associated with Pharmaceuticals.
                    The change involves switching from disposal via drains, solid waste
                    receptacles, and biohazard waste receptacles to a system where unused
                    and partially used pharmaceutical products are returned to a reverse
                    distribution company for cataloging, return credit, characterization, and
                    disposal. Note, reverse distribution should only be used for items that are
                    not expired and not for pharmaceuticals that are obviously waste with no
                    potential for reuse.  More information on the return program can be found
                    at http://www. returnsindustry. com.

              •      Improve pharmaceutical dispensing practices and minimize product
                    packaging. Minimizing the amount of wasted pharmaceuticals produced
                    through inefficient dispensing practices can help reduce the amount of
                    pharmaceuticals that the healthcare facility needs to purchase.
                    Additionally, minimizing the amount of packaging will help reduce the
                    amount of municipal waste produced.

              •      Improved segregation and management of chemotherapy
                    medications. Setting up concise waste segregation programs for
                    managing chemotherapy wastes can reduce pollution and improve worker
                    safety.  Some chemotheraputic drugs are RCRA listed. Other
                    chemotherapy medications may be RCRA characteristic.  Best
                    management of such wastes involves setting up management programs to


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Healthcare Industry                                  Pollution Prevention Opportunities

                    separate bulk chemotherapy wastes (where there is an identifiable residual
                    amount present) from non-regulated chemotherapy wastes (e.g., gloves,
                    personal protective equipment, and packaging from non-regulated
                    materials), which can usually be packaged and disposed of with biohazard
                    waste. These are fine distinctions and require careful planning and staff
                    education. This type of program, coupled with a reverse distribution
                    program for unused pharmaceutical products, can mitigate pharmaceutical
                    waste outputs that can impact all media.

              •      Improved waste segregation systems (reduces biohazardous waste
                    outputs, can increase solid waste outputs and recyclable waste
                    outputs).  Establishing waste segregation systems that allow for the
                    separate collection of solid wastes, recyclable wastes, and biohazardous
                    wastes increases the likelihood that wastes can be collected and handled in
                    the most appropriate and cost-effective fashion.  In the case of
                    biohazardous waste collection, by implementing staff education, installing
                    appropriately labeled and convenient containers, and establishing relevant
                    collection schedules, an organization can realize substantive reductions in
                    biohazardous waste outputs and costs. In large part, this results from staff
                    having the option to discard packaging wastes and other waste materials
                    that are not contaminated, as solid waste or a recyclable waste.

V.A.4.        Recycling

              Waste volumes can dramatically be reduced if systems are in place to capture
recyclable materials such as cardboard, paper, glass and aluminum beverage containers, scrap
metals, wood waste, kitchen grease, and selected plastics.  Recycling success and opportunities
are usually linked to recycling infrastructure at the community level.

              Opportunities for Reducing Solid Waste

              Setting up programs to recycle paper, cardboard, glass, plastic, wood and other
types of waste can dramatically reduce a facility's solid waste output. Other factors to consider
include:

              •      Paper wastes - measures must be implemented to ensure the
                    confidentiality of patient information.

              •      Beverage container collection/recycling (aluminum and plastic) - suitable
                    storage and timely collection schedules are needed to prevent rodent and
                    insect problems and foul odors, and to minimize the environmental benefit
                    if the facility has to use pesticides.

              •      Durable goods such as furniture, equipment, pallets - these items can be
                    recycled and reduce waste volumes. Mattresses are a bulky and
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                     problematic waste for many facilities; they can hire companies that
                     recycle bedding materials to collect and recycle bedding.

              ซ      Environmentally Preferable Purchasing (EPP) - Purposely purchasing
                     recycled materials or materials made of recycled products in place of non-
                     recycled materials reduces solid waste generation. Examples of products
                     containing recycled materials are available on www. epa.gov/cpg.

              *      Universal Wastes - Collecting universal wastes separately helps streamline
                     recycling efforts for facilities as these wastes are regulated by streamlined
                     management rules. Universal wastes found in healthcare facilities include
                     nickel cadmium or sealed lead-acid batteries, mercury-containing
                     thermostats, and lamps that have a hazardous component.

              Opportunities for Reducing Hazardous Waste Through Recycling Initiatives

              As technologies continue to advance, more opportunities for recycling hazardous
waste become available. For example,

              •      Reducing waste solvents, alcohols, formalin, and formaldehyde - hospital
                     laboratories can use technologies that recycle solvents, formalin, and
                     alcohols, making them essentially continually reusable products, that can
                     be used over and over. There is a very small residual, referred to as 'still
                     bottoms' that is generated during the recycling process and requires
                     disposal as a hazardous waste. Healthcare facilities should check with
                     their state regulations before installing recycling units.

              •      Reducing fluorescent bulb wastes - Collecting fluorescent bulbs for
                     recycling as a universal waste reduces the measurable volume of
                     hazardous waste.

V.B.          Pollution Prevention  Opportunities by Waste Type

              Table V-l highlights some examples of pollution prevention and waste
management strategies by each waste type. Facilities can use this table with Table III-2 in
Section III of this Notebook to help recognize the areas where these waste categories are
generated. These strategies are meant to be illustrative examples and not a comprehensive list.
For more information on recycling opportunities in the healthcare industry, visit the web sites
discussed in Section VIII of this document.
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Healthcare Industry
                                            Pollution Prevention Opportunities
  Table V-l: Pollution Prevention and Waste Management Strategies by Waste Category
                                            (Continued)
      Waste
     Category
 Specific Wastes/Emissions Found
         in this Category	
          Waste Management Strategy
 Biohazardous
 Waste,
 Regulated
 Medical Waste
 (RMW)
Sharps waste, blood and blood
products, pathological waste,
selected isolation wastes, cultures
and stocks from laboratories, blood-
soaked bandages, etc.
Sharps - collect sharps waste in leakproof, puncture-
resistant, cadmium-free containers. In some regions,
reusable sharps collection container programs are
available.  This can reduce overall volumes
associated with collection container wastes. Educate
staff to ensure that sharps containers are solely for
sharps, and items such as batteries or broken
mercury thermometers should NEVER be discarded
in such containers.

RMW - use cadmium-free red bags to collect waste.
Where feasible, explore using reusable
packing/shipping containers to eliminate cardboard
shipping boxes. Ensure that staff have proper
education about what items can be discarded into
biohazardous waste containers/red bags. Note: in
Oncology and Pharmacy, ensure that only non-
regulated chemotherapy is disposed of in biohazard
waste containers.

Non-regulated  chemotherapy waste is allowed to be
discarded in biohazardous waste in some states while
other states require that it is collected in yellow bags.
Set up systems that collect 'soft' non-regulated
chemotherapy wastes in the required bags and
'sharp' non-regulated chemotherapy wastes in rigid
leakproof containers.  This measure will reduce the
volume of packaging wastes.  Label  this waste 'for
incineration only" (or for other technologies as they
become available) and label the waste at point of
generation.

Pathological waste - label pathological wastes for
appropriate treatment such as incineration only, or
other treatment technologies that become available
such as plasma arc or alkaline treatment. Ensure that
formalin or formaldehyde has been decanted from
specimens prior to packaging for disposal.

Pollution prevention strategies for this category of
wastes can also be associated with selection of
disposal route/technology.
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Healthcare Industry
                                           Pollution Prevention Opportunities
  Table V-l: Pollution Prevention and Waste Management Strategies by Waste Category
                                            (Continued)
      Waste
     Category
 Specific Wastes/Emissions Found
	in this Category	
          Waste Management Strategy
 Biohazardous
 Waste,
 Regulated
 Medical Waste
 (RMW) (cont.)
                                   These can include:

                                   1) Minimizing use of incineration.

                                   2) Consider on-site treatment technologies such as
                                   autoclaving or chemical/mechanical systems for the
                                   majority of RMW to reduce pollution associated
                                   with transporting wastes great distances over
                                   roadways.

                                   3) Use drain disposal for liquid wastes (such as
                                   common body fluids) that are routinely generated
                                   and flushed down the toilet in household settings.
  Hazardous
  Waste
Solvents

Selected pharmaceuticals
                   Ethylene oxide (EtO)

                   Mercury-containing equipment or
                   compounds
                   Lead-containing equipment
Collect and recycle solvents.

Identify RCRA listed and characteristic
pharmaceuticals.  Implement inventory control and
management options. As a product management
strategy, use a reverse distribution company for
unused/unexpired product returns. Monitor auto
dispensing machines for expired pharmaceuticals.
Dispose of residual amounts of liquid properly.

Minimize use of EtO where possible.

Discontinue use of mercury-containing instruments
and chemicals. Notify suppliers/vendors of NO
MERCURY policy.  Send mercury-containing
products for reclamation (retorting).

Identify lead-containing supplies and equipment,
particularly in radiology areas, and designate for
reuse, recycling or hazardous waste disposal. Note:
Much lead-shielding material, when no longer
suitable for use in intended purpose, can be adapted
for other uses within the radiology department.
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Healthcare Industry
                                           Pollution Prevention Opportunities
  Table V-l: Pollution Prevention and Waste Management Strategies by Waste Category
                                            (Continued)
      Waste
     Category
 Specific Wastes/Emissions Found
	in this Category	
          Waste Management Strategy
 Hazardous
 Waste (cont.)
Hazardous chemicals
Implement chemical purchasing, inventory and
management systems in laboratory settings, plant
operations, boiler areas, paint, electric and plumbing
shops, and other areas.  Label and store waste in
accordance with RCRA regulations. Use secondary
containment measures for storage of hazardous
chemicals and storage of hazardous chemical wastes.

Develop appropriate facilities to store hazardous
chemical wastes. Have spill preparedness systems in
place, secondary containment, neutralizing agents,
and other resources to minimize problems associated
with managing hazardous materials and wastes.

Seek less harmful alternatives through
environmentally preferable products from such
places as the Sustainable Hospital Project
(www.sustainablehosDitals.orz).
 Radioactive
 Wastes
Radioactive materials and residues in
drains and piping
Work with radiation safety officer to establish
protocols for radioactive waste decay, strategies to
minimize the amounts of radioactive wastes
generated, etc.
 Pressurized
 Containers
Gas cylinders, gas cartridges, aerosol
cans, oxygen farms
Eliminate any gas cylinders on site that are not
currently in use or that do not have a specific
purpose. Return to vendor for recycling where
possible.
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Healthcare Industry
                                            Pollution Prevention Opportunities
  Table V-l:  Pollution Prevention and Waste Management Strategies by Waste Category
                                             (Continued)
      Waste
     Category
 Specific Wastes/Emissions Found
	in this Category	
          Waste Management Strategy
  Universal
  Wastes
Mercury-containing thermostats, and
spent fluorescent lamps and other
hazardous lamps.  Hazardous waste
batteries, hazardous waste pesticides
- recalled or sent to collection
program. States may have additional
universal wastes such as electronics.
Collect and recycle mercury-containing bulbs and
thermostats.

Develop a separate storage area for universal wastes;
use proper labeling and storage methods.

Contact the vendor or service representative to
determine if mercury-free alternatives exist.
Discontinue use, where feasible, of mercury-
containing switches, thermostats, etc.

Clearly label the device as one containing mercury
and requiring special care and handling. Maintain a
list of where mercury-containing devices are located
in the facility.

Train and advise maintenance staff to routinely
monitor for leakage and to respond appropriately if a
leak occurs.

Develop a maintenance protocol for when the article
needs to be recalibrated, handled, or replaced.

Have mercury spill cleanup materials available in
areas where mercury cannot be phased out in the
near term (e.g., boiler switches in boiler room areas).

When the device needs replacement due to  age or
efficiency, replace it with a nonmercury alternative.
 Construction and
 Demolition
 Debris
 containing
 asbestos or other
 hazardous
 material
Asbestos
Mercury
                   Lead

                   PCBs from old fluorescent lights and
                   transformers
Conduct thorough walk-throughs prior to
renovations to identify possible sources of asbestos,
mercury, or lead materials.

Conduct drain trap cleanouts prior to renovations in
areas that once used mercury-containing products or
materials.

Work with a certified vendor to manage lead or PCB
waste materials as they are encountered during
renovations.
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Healthcare Industry
                                            Pollution Prevention Opportunities
  Table V-l:  Pollution Prevention and Waste Management Strategies by Waste Category
                                             (Continued)
      Waste
     Category
 Specific Wastes/Emissions Found
	in this Category	
          Waste Management Strategy
 Wastewater
Potentially, any hazardous substance
in any clinical area

Oils

Hydraulic fluid

Chemical spills

Recycle and heat recovery from
boilers, cooling towers, and laundry
facilities wastewater
Identify all direct discharge drains within the facility.
Examine materials used and stored in proximity to
the drains. If materials are potentially problematic
(e.g., oils, hydraulic fluids, formaldehyde, or other
hazardous chemicals), ensure that drain mat covers,
spill cleanup materials, and training for spills are part
of the operations plan for the area.

Examine decontamination areas in emergency
departments (areas where victims of chemical or
biological exposures are cleansed prior to receiving
medical treatment) to ensure that systems are in
place to capture contaminated fluids resulting from
decontamination activities.
 Stormwater
Runoff from building, lawns, parking
areas, underground storage tank
areas, aboveground storage tank
areas, disturbed soils during
construction
Identify storm drains outside the facility, and explore
what substances might be inadvertently discharged
into them. For example, if the on-site solid waste
compactor is uphill from the nearest storm drain,
ensure that spill cleanup materials are nearby in the
event of a hydraulic fluid leak in the compactor.  If
the loading dock (shipping and receiving) is near a
storm drain, ensure that spill cleanup materials are
nearby in the event of a chemical spill (e.g., from a
large barrel of floor stripper or other potentially toxic
substance).

Minimize use of fertilizers and pesticides.

Clean oil spills from vehicles.

Cover storage tanks areas.

Have spill cleanup materials readily available in
relevant locations.

Ensure staff have adequate training to respond to
spills to minimize resulting damage.

For construction project, use stormwater best
practices to keep sediment and other contaminants
out of run-off.
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Healthcare Industry
                                           Pollution Prevention Opportunities
  Table V-l: Pollution Prevention and Waste Management Strategies by Waste Category
                                           (Continued)
      Waste
     Category
 Specific Wastes/Emissions Found
	in this Category
          Waste Management Strategy
  Air Emissions
Air conditioning and refrigeration
units

Boilers
                   Medical waste incinerators
                   Asbestos removal
                   Paint booths
                   EtO sterilizers
                   Anesthesia services
CFC/Freon management systems.
Use steam generated from incinerators to partially
replace boilers. Purchase ENERGY STAR qualified
boilers, which use about 10% less energy than a
standard boiler.

Minimize biohazardous waste quantities to reduce
frequency of needing to run incinerator. Establish
definitive waste segregation programs to minimize
inappropriate segregation of hazardous wastes {e.g.,
mercury spill cleanup materials) in biohazardous
waste stream.  Minimize the use of PVC (polyvinyl
plastic) products and packaging materials to reduce
the likelihood of creating dioxin emissions (2,3,7,8
dioxin).

Work with a certified vendor to conduct this process
safely.

Install a filtering ventilation system to collect paint
fumes.

Minimize use of EtO where feasible. Use EtO
scavenging units on external stacks.  Use air
monitoring systems within the facility to monitor for
EtO leaks.

Employ scavenger systems.
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Healthcare Industry                                    Federal Statutes and Regulations

VI.           SUMMARY OF FEDERAL STATUTES AND REGULATIONS

              This section discusses the federal regulations that may apply to the healthcare
sector. The purpose of this section is to highlight and briefly describe the applicable federal
requirements, and to provide citations for more detailed information. The four following
subsections are included:

              •      Section VI.A contains a list of regulations specific to this industry;

              •      Section VLB contains a list of regulations by waste category;

              •      Section VI.C contains a list of pending and proposed regulatory
                    requirements; and

              •      Section VI.D contains a list of additional applicable non-EPA regulations.

              The descriptions within Section VI are intended solely for general information.
While EPA has made every effort to ensure the accuracy of this information, depending upon the
nature or scope of the activities at a particular facility, these summaries may or may not
necessarily describe all applicable environmental requirements.  Moreover, they do not
constitute formal interpretations or clarifications of the statutes and regulations. States and local
regulating bodies may impose more stringent requirements than those established by EPA and
other federal agencies. It is beyond the scope of this compliance chapter to list the requirements
of all federal, state and local regulatory bodies. For further information, consult the Code of
Federal Regulations (CFR) and other state, tribal, or local regulatory agencies.

              To search the CFR, go to the Electronic Code of Federal Regulations (e-CFR) at
http://www. gpoaccess.gov/ecfr/. The e-CFR consists of two linked databases: the "current Code"
and "amendment files." The Office of Federal Register updates the current Code database
according to the effective dates of amendments published in the Federal Register. The Federal
Register is  the official daily publication for rules, proposed rules, and notices of federal agencies
and organizations, as well as executive orders and other presidential documents.  The Federal
Register can be searched at http://vtrww.gpoaccess.gov/1r/index.html.

VI.A.        Industry-Specific Requirements

              The healthcare industry is affected by multiple federal environmental statutes. In
addition, the industry is subject to numerous laws and regulations from state, tribal, and local
governments designed to protect and improve the nation's health, safety, and environment.
Table VI-1  summarizes the major federal regulations affecting air, water, and waste outputs from
the healthcare industry.
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Healthcare Industry
             Federal Statutes and Regulations
            Table VI-1: Summary of Potentially Applicable EPA Regulations
Water Programs (CWA and SWDA)
40 CFR Part 1 12
40 CFR Part 122
40 CFR Part 141
40 CFR Part 142
40 CFR Part 143
40 CFR Part 144
40 CFR Part 145
40 CFR Part 146
40 CFR Part 147
40 CFR Part 148
40 CFR Part 403
40 CFR Part 430
40 CFR Part 460
Oil Pollution Prevention
EPA-Administered Permit Programs: The National Pollutant Discharge Elimination
System
National Primary Drinking Water Regulations
National Primary Drinking Water Regulations Implementation
National Secondary Drinking Water Regulations
Underground Injection Control ("UIC") Program
State UIC Program Requirements
UIC Program: Criteria and Standards
State UIC Programs
Hazardous Waste Injection Restrictions
General Pretreatment Regulations for Existing and New Sources of Pollution
Effluent Guidelines for Direct Dischargers
Effluent Guidelines for the Hospital Point Source Category
Solid and Hazardous Wastes (RCRA)
40 CFR Part 260
40 CFR Part 261
40 CFR Part 262
40 CFR Part 263
40 CFR Part 264
40 CFR Part 265
40 CFR Part 266
40 CFR Part 268
40 CFR Part 273
40 CFR Part 279
40 CFR Part 280
Hazardous Waste Management System
Identification and Listing of Hazardous Waste
Standards Applicable to Generators of Hazardous Waste
Standards Applicable to Transporters of Hazardous Waste
Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and
Disposal Facilities
Interim Status Standards for Owners and Operators of Hazardous Waste Treatment,
Storage, and Disposal Facilities
Standards for the Management of Specific Hazardous Wastes and Specific Types of
Hazardous Waste Management Facilities
Land Disposal Restrictions
Standards for Universal Waste Management
Standards for the Management of Used Oil
Technical Standards and Corrective Requirements for Owners and Operators of
Underground Storage Tanks ("USTs")
Hazardous Substances and Chemicals, Environmental Response, Emergency Planning, and Community
Right-to-Know Programs (CERCLA and EPCRA)
40 CFR Part 302
40 CFR Part 355
40 CFR Part 370
40 CFR Part 372
Designation, Reportable Quantities, and Notification
Emergency Planning and Notification
Hazardous Chemical Reporting: Community Right-to-Know
Toxic Chemical Release Reporting: Community Right-to-Know
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Healthcare Industry
             Federal Statutes and Regulations
            Table VI-1: Summary of Applicable EPA Regulations (Continued)
Air Programs (CAA)
40 CFR Section 52.21
40 CFR Part 60
40 CFR Part 61
40 CFR Part 62 Subpart
HHH
40 CFR Part 63
40 CFR Part 68
40 CFR Part 70
40 CFR Part 82
Prevention of Significant Deterioration of Air Quality
Standards of Performance for New Stationary Sources
National Emission Standards for Hazardous Air Pollutants, Subpart M, National
Emission Standard for Asbestos
Federal Plan Requirements for Hospital/Medical/Infectious Waste Incinerators
National Emission Standards for Hazardous Air Pollutants for Source Categories (all
applicable provisions)
Chemical Accident Prevention Provisions
State Operating Permit Programs
Protection of Stratospheric Ozone
All applicable provisions of State Implementation Plan Regulations (promulgated pursuant to Section 110 of the
Clean Air Act) including the New Source Review regulations
Toxic Substances (TSCA)
40 CFR Part 745
40 CFR Part 761
40 CFR Part 763
Lead-Based Paint Poisoning Prevention in Certain Residential Structures
Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in
Commerce, and Use Prohibitions
Asbestos
Pesticide Programs (FIFRA)
40 CFR Part 160
40 CFR Part 162
40 CFR Part 170
40 CFR Part 171
40 CFR Part 172
Good Laboratory Practice Standards
State Registration of Pesticide Products
Worker Protection Standard
Certification of Pesticide Applicators
Experimental Use Permits
             Note that, in the healthcare industry, compliance with environmental regulations
may be handled in many different ways. Though ideally all employees should help comply,
official responsibility could lie at the corporate level, it could lie within the healthcare facility as
either a centrally or non-centrally organized activity, or it could be part of a function for
vendored-out services.  EPA observes that the organizations that successfully achieve
compliance engage all or many employees in the various facility operations.

             Clean Water Act

             The primary objective of the Federal Water Pollution Control Act, commonly
referred to as the Clean Water Act (CWA), is to restore and maintain the chemical, physical, and
biological integrity of the nation's surface waters.  Pollutants regulated under the CWA are
classified as either "toxic" pollutants (priority pollutants); "conventional" pollutants, such as
biochemical oxygen demand (BOD), total suspended solids (TSS), fecal coliform, oil and grease,
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and pH; or "nonconventional" pollutants, including any pollutant not identified as either
conventional or priority,

              The CWA regulates both direct (those that discharge directly to waters of the
United States) and indirect dischargers (those who discharge to POTWs). The National Pollutant
Discharge Elimination System (NPDES) permitting program (CWA Section 402) controls direct
discharges into navigable waters.  NPDES permits, issued by either EPA or an authorized state
(EPA has authorized 45 states, one territory, and no tribes to administer the NPDES program),
contain industry-specific, technology-based and water-quality-based limits and establish
pollutant monitoring and reporting requirements.  A facility that proposes to discharge into the
nation's waters must obtain a permit prior to initiating a discharge. A permit applicant must
provide quantitative analytical data identifying the types of pollutants present in the facility's
effluent. The permit will then set forth the conditions and effluent limitations under which the
facility may discharge.

              EPA has established technology-based discharge standards for hospitals that are
direct dischargers.  These standards limit 5-day biochemical oxygen demand (BOD5) and total
suspended solids as a mass value calibrated per 1,000 occupied beds. pH is also limited. In
contrast, water-quality-based discharge limits are based on federal or EPA-approved state or
tribal water quality criteria or standards that were designed to protect designated uses of surface
waters, such as supporting aquatic life or recreation. These standards, unlike the  technology-
based standards, generally do not take into account technological feasibility or costs.  Water
quality criteria and standards vary from state to state and site to site, depending on the use
classification of the receiving body of water.  Most states and territories follow EPA effluent
guidelines, which propose aquatic life and human health criteria for many of the 126 priority
pollutants. The permitting agency (EPA or the authorized state) is obligated to impose the  more
stringent of these two types of limits in the permit issued to the applicable hospital.

              As stated in Section I11.B.4 of this document, healthcare facilities wastewater
sources include sinks, drains, showers, toilets, and tubs; photographic development drains from
radiology (X-rays),  other imaging, and dentists; and stormwater. The healthcare industry is
subject to various provisions of the CWA including:

              •       Wastewater Discharges - NPDES Effluent Limitations and Guidelines for
                     Direct Dischargers (guidelines for direct discharging hospitals with more
                     than 1,000 occupied beds) and General Pretreatment Standards.

              •       Stormwater Permits: Municipal separate storm sewer systems (MS4),
                     such as those from hospitals, and construction activities are subject to
                     stormwater permitting requirements.

              •       Oil Pollution Prevention Requirements: Hospitals that have a total
                     aboveground oil storage capacity exceeding 1,320 gallons or an
                     underground storage capacity exceeding 42,000 gallons are subject to spill
                     prevention control and countermeasure (SPCC) plan requirements.
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              Wastewater Discharges

              As stated above, the water regulations establish different permitting programs for
direct and indirect wastewater discharges. EPA's NPDES web site http://cfpub. epa.gov/npdes
provides technical and regulatory information about the NPDES permit program that controls
water pollution by regulating point sources (e.g., pipe, ditch) that discharge pollutants into
waters of the United States. Most hospitals are indirect dischargers.

              •      Indirect Dischargers: Hospitals that are indirect dischargers are subject to
                    regulations by the local sewer authority.  At present, about 1,500 of the
                    nation's largest municipalities are required to implement industrial
                    pretreatment programs that include issuing industrial user permits to
                    significant industrial users. Some municipalities  have determined
                    hospitals to  be significant industrial users.

                    Most municipalities have established local prohibitions that apply
                    specifically to medical waste discharges. For example, some
                    municipalities have set a prohibition on "all medical waste." Other
                    prohibitions include, for example, no discharge of discernible body parts,
                    no human remains greater than 0.5 inches in diameter, and or no
                    radioactive wastes. The ability of municipalities to establish prohibitions
                    to meet their specific needs/interests is very flexible.

                    Federal Pretreatment Regulations prohibit discharges of fire or explosion
                    hazards; corrosive discharges (pH < 5.0); solid or viscous pollutants; heat
                    (in amounts that cause the treatment plant influent to exceed 104 degrees
                    F); pollutants that cause toxic gases, fumes, or vapors; and any other
                    pollutant (including oil and grease) that will interfere with or pass through
                    the treatment plant.

              •      Direct Dischargers: There are very few direct discharging hospitals as
                    reported to PCS in 2004 (e.g., 11 with non-major NPDES permits and 1
                    with major NPDES permit using SIC Code 806).  Hospitals that are direct
                    dischargers  of process and sewer wastes must be permitted (i.e., obtain a
                    permit) for any point source discharge of pollutants to waters of the
                    United States. These permits are issued either by EPA or the state, where
                    the state has been authorized to implement the NPDES Permit Program.
                    The federal regulations establish the permit application and permit
                    requirements.  Specific numeric limitations that apply to a medical facility
                    depend on the more stringent limits determined by the applicable
                    technology-based discharge standards (40 CFR 460) and water quality
                    standards for the receiving stream of the  discharge. For detailed
                    information on numeric  limitations, contact your  EPA Regional
                    pretreatment coordinator.  Contact information can be found at the
                    following web site.
                    httD://cfDub.eDa,eov/nDdes/contacts.cfm?Droeram id=0&tvpe=NPDES
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              Stormwater Discharges

              The stormwater program is part of the NPDES program and is designed to prevent
the discharge of contaminated stormwater into navigable waters. See the web site at:
http://cfpub.epa.gov/npdes/home.cfm?nrogram^id=6

              Phase I of the stormwater program was promulgated in 1990 and applied to
medium and large municipal separate storm sewer systems (MS4), certain industrial facilities
(not hospitals), and any construction activity disturbing greater than 5 acres (large construction
sites).

              Phase II of the stormwater program was promulgated in 1999 and applies to small
municipal separate storm sewer systems (MS4) and construction activity greater than 1 acre and
less than 5 acres (small construction sites). Hospitals located in urbanized areas are regulated
under this new rule. Any hospital located in urbanized or rural areas that are planning
construction activities should look into obtaining a stormwater NPDES permit for construction.

              The term MS4 does not solely refer to municipally owned storm sewer systems,
but rather is a term with a much broader application that can include, in addition to local
jurisdictions, state departments of transportation, universities, local sewer districts, hospitals,
military bases, and prisons. A MS4 also is not always just a system of underground pipes - it can
include roads with  drainage systems, gutters, and ditches.  Hospitals in urbanized areas should
consult with their state NPDES authority  to evaluate whether a permit authorization is required.

              The regulatory definition of an MS4 is provided in 40 CFR 122.26(b)(8).  General
stormwater information can be found at http://cfpub.epa.gov/npdes/home.cfm?program_id=6
and the Stormwater Phase II Compliance  Assistance Guide, at
httv://www.epa.gov/npdes/Dubs/comguide.pdf.

              Aboveground or Underground Oil Storage Containers

              EPA's oil spill program web site, http://www. eva.sovJoilsvilll, provides
information about EPA's program for preventing, preparing for, and responding to oil spills that
occur in and around inland waters of the United States. If a hospital uses or stores oil it may be
subject to the Spill  Prevention Control Countermeasure (SPCC) rule. Hospitals with an above
ground oil storage capacity of greater than 1,320 gallons, or total completely buried oil storage
capacity greater than 42,000 gallons must prepare and implement a SPCC plan to prevent any
discharge of oil into or upon navigable waters of the United States or adjoining shorelines.

              On July 16, 2002, EPA promulgated a revised final SPCC Regulation which
became effective August 17, 2002.  EPA subsequently extended the regulatory compliance
schedule included in the new SPCC rule.
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             The current compliance dates for the new rule are:

             •      February 17,2006: Facilities must prepare and a Professional Engineer
                    (P.E.) certify an SPCC Plan in accordance with the new SPCC rule by this
                    date.

             •      August 18,2006: The revised SPCC Plan must be implemented.

In the interim, facilities are required to maintain their existing SPCC Plan and amend it in
accordance with 40 CFR ง 112.5.

             CWA Common Areas for Inspections

             While an EPA inspector is authorized to examine a wide range of documents and
operations, he/she will probably be interested in three areas of a hospital: wastewater discharges,
stormwater discharges, and any aboveground or underground oil storage containers.

             Typical Records an EPA Inspector May Ask to Review under the CWA

             •      Industrial User permit (IU permit) for discharges to the local municipality
                    (indirect discharge).  Most hospitals are indirect dischargers.

             •      Spill Prevention, Control, and Countermeasure (SPCC) Plan. The plan is
                    to prevent any discharge of oil into or upon navigable waters of the United
                    States or adjoining shorelines.

             •      Phase II stormwater permits under the NPDES program for public
                    hospitals located in an urbanized area.

             •      NPDES construction stormwater permits (Phase I and Phase II) are also
                    required for any construction activity  greater than 1 acre for any hospital
                    located in urban or rural areas.

             •      NPDES general permit for discharging directly to a water body (direct
                    discharge).

             EPA's Office of Water operates a Water Resource Center with a 24-hour voice
mail system for publication orders or reference questions at (202) 566-1729 (e-mail address:
center.\vater-resource(a),epa.gov}.  Long-distance callers in the United States may also use the
Wetlands Helpline ((800) 832-7828), operating weekdays from 8:30 a.m. to 4:30 p.m., EST,
excluding federal holidays.  Visit the Office of Water web site (http://www,epa.gov/water/) and
the NPDES web site  (http://cfpub. epa.gov/npdes/) for additional material
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              Safe Drinking Water Act

              The Safe Drinking Water Act (SDWA) mandates that EPA establish regulations
to protect human health from contaminants in drinking water.  The law authorizes EPA to
develop national drinking water standards and to create a joint federal-state (or federal-tribal)
system to ensure compliance with these standards.  The SDWA also directs EPA to protect
underground sources of drinking water by controlling underground injection of fluid wastes.

              EPA has developed primary and secondary drinking water standards under its
SDWA authority. EPA and authorized states and territories enforce the primary drinking water
standards, which are contaminant-specific concentration limits that apply to certain public
drinking water supplies. Primary drinking water standards consist of maximum contaminant
level goals (MCLGs), which are nonenforceable health-based goals, and maximum contaminant
levels (MCLs), which are enforceable limits set generally as close to MCLGs as possible,
considering cost and feasibility of attainment.

              A hospital would be considered a nontransient, noncommunity water system (i.e.,
a public water system) if it regularly serves at least 25 of the same persons 6 months per year
from its own water source. The hospital would thus be required to comply with SDWA
monitoring and reporting requirements.  Healthcare facilities that have their own drinking water
treatment to comply with MCLs should be aware that they could generate hazardous or
radioactive waste (e.g., some areas have elevated arsenic levels in groundwater.)

              Part C of the SDWA mandates EPA to protect underground sources of drinking
water from inadequate injection practices. EPA has published regulations codified in 40 CFR
Parts 144 to 148 to comply with this mandate. The Underground Injection Control (UIC)
regulations break down injection wells into five different types, depending on the fluid injected
and the formation that receives it. The regulations also include construction, monitoring, testing,
and operating requirements for injection well operators. All injection wells have to be
authorized by permit or by rule depending on their potential to threaten Underground Sources of
Drinking Water (USDW).  RCRA also regulates hazardous waste  injection wells and a UIC
permit is considered to meet the requirements of a RCRA permit.  EPA has authorized
delegation of the UIC for all well classes in 34 states, implements the program directly in 10
states and all Indian country areas, and shares responsibility with 6 states.  For a hospital, an
injection well can constitute any bored, drilled or driven shaft or a dug hole, where the depth is
greater than the largest surface dimension that is used to discharge fluids underground as well as
any on-site drainage systems, such as septic systems, cesspools, and stormwater wells, that
discharge fluids only a few feet underground. Hospitals and doctors' offices must make sure that
what they pour down a drain goes to a sewer, and not to a drywell or septic system.

              The SDWA also provides for a federally implemented Sole Source Aquifer
program, which prohibits federal funds from being expended on projects that may contaminate
the sole or principal source of drinking water for a given area, and for a state-implemented
Wellhead Protection program, designed to protect drinking water wells and drinking water
recharge areas.
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              EPA's Safe Drinking Water Hotline, at (800) 426-4791 (or (703) 412-3330 for
local and international calls), answers questions and distributes guidance pertaining to SDWA
standards (e-mail: hotlme-sdwa(a).epa.gov).  The Hotline operates from 9:00 a.m. through 5:00
p.m., EST, excluding federal holidays.  Visit the web site at www.epa.gov/ogwdw for additional
material.

              Resource Conservation and Recovery Act

              The Resource Conservation and Recovery Act (RCRA) aims to manage the
disposal of waste from municipalities and industries.  It regulates facilities that generate,
transport, treat, store, or dispose of hazardous waste.  Under RCRA, most healthcare facilities
are hazardous waste generators. RCRA hazardous waste regulations are in the Code of Federal
Regulations (CFR), Title 40, Parts 260 to 280. A series of hazardous waste evaluation
flowcharts are available on EPA Region 2's web site at
http://www.epa.gov/region02/healthcare/. The flowcharts are based on the federal requirements.
Most states are authorized the hazardous waste program and may have more stringent
requirements. Healthcare facilities should check with their states for additional requirements.

              Although RCRA is a federal statute, most states are authorized to administer the
RCRA hazardous waste program under their own authority. Currently, EPA has authorized 48
of the 50 states and two United States territories to administer various provisions of RCRA
Subtitle C. States must have regulations consistent with and at least as stringent as the federal
program; some states have additional reporting requirements. Healthcare facilities should
contact their state or tribal authority to determine which state or tribal requirements apply to their
business.  RCRA does not enable EPA to authorize tribal hazardous waste programs in lieu of
the federal program; therefore, EPA directly implements RCRA hazardous waste programs in
Indian country, but tribes may have their own, independent hazardous waste programs.

              RCRA defines hazardous waste as a subset of solid waste. Solid waste is defined
as garbage, refuse, sludge, or other discarded material (including solids, semisolids, liquids, and
contained gaseous materials). Once a waste is considered solid waste, determine if it is
hazardous waste. EPA defined hazardous wastes as either listed or characteristic.  If a waste is
specifically named on one of four lists of hazardous wastes, it is a listed waste. If a waste
exhibits one of four characteristics, it is a characteristic  waste. Section III.B.3 describes the
listed and characteristic hazardous wastes commonly found in the healthcare field.

              Under RCRA, a facility must determine its generator status. Reporting and other
regulatory requirements are different for each generator type. Hazardous waste generators are
divided into three categories, according to how much hazardous waste they generate in a
calendar month:

              •      Large Quantity Generators (LQGs) generate greater than  or equal to
                     1,000 kg (about 2,200 Ibs) of hazardous waste per month, or greater than 1
                     kg (about 2.2 Ibs) of acutely hazardous waste per month. EPA considers
                     acute hazardous wastes the P-listed wastes. If facilities generate more
                     than 1 kg (about 1 quart)  of acutely hazardous waste, then they are LQGs
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                    and must comply with all LQG reporting requirements. See Table III-l
                    for a list of some common acute and toxic healthcare hazardous wastes.

             •      Small Quantity Generators (SQGs) generate greater than 100 kg (about
                    220 Ibs) but less than 1,000 kg of hazardous waste per month and or  less
                    than 1 kg (about 2.2 Ibs) of acutely hazardous waste per month.

             •      Conditionally Exempt Small Quantity Generators (CESQGs) generate
                    less than or equal to 100 kg of hazardous waste per month, and less than
                    or equal to 1 kg of acutely hazardous waste per month.  Not all states
                    recognize the CESQG classification.

             •      Large Quantity Handler of Universal Waste (LQHUW) store greater
                    than 5,000 kg of universal waste on site.

                    Small Quantity Handler of Universal Waste (SQHUW) store less than
                    5,000 kg or about 11,000 Ibs of universal waste (all types combined) on
                    any given day during the calendar year.

             Entities that generate hazardous waste are subject to Federal standards applicable
to generators of hazardous waste (e.g., hazardous waste manifest, pre-transportation,
recordkeeping and reporting, etc). Storage of hazardous waste generally requires a permit under
RCRA hazardous waste regulations, but provisions under RCRA do allow generators to
"accumulate" hazardous waste on site without a permit or interim status as long as they comply,
among other things, with the technical standards for the containment unit(s). The length of time
a generator is allowed to accumulate hazardous waste on site without a permit or interim status
depends on the generator's classification.  For instance, Large Quantity Generators may
accumulate any quantity on-site for 90 days or less without a permit or interim status. Small
Quantity Generators may accumulate no more than 6,000 kg of hazardous waste without a permit
or interim status for 180 days or less (or for 270 days or less depending on transport distance).
CESQGs may accumulate 1,000 kg of waste, 1kg acute waste, or 100 kg residue or contaminated
soil from a cleanup of an acute hazardous waste spill. Generators also may treat hazardous
waste in accumulation tanks or containers (in accordance with the requirements of 40 CFR Part
262.34) without a permit or interim status. Facilities that treat, store, or dispose of hazardous
waste generally are required to obtain a RCRA permit.

             Generator status is determined by calendar month; therefore, one month a facility
may be a CESQG, and the rest of the year it may be an SQG. In this case, it might be easier to
comply with SQG reporting requirements for consistency. On the other hand, if the facility is
usually an SQG, a store room or laboratory cleanout might push it into  being an LQG. In
exceptional cases like this when it is a one time occurrence, some states have made exceptions so
that the cleanout does not trigger LQG status.

             Generators "count" the amount of waste generated, by adding up the total weight
of all quantities of characteristic and listed waste generated at a particular facility. Certain
wastes, such as those that are reclaimed or recycled continuously on site, are not counted under


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the federal regulations but might be counted under some state regulations. Facilities should also
determine if their state has adopted the universal waste rule, which would cover mercury-
containing thermostats, certain batteries, and fluorescent light bulbs. Universal wastes do not
count toward determining generator status.

             Most RCRA requirements are not industry-specific but apply to any company that
generates, transports, treats, stores, or disposes of hazardous waste. Below are some important
RCRA regulatory requirements that apply to healthcare facilities:

             Identification of Solid and Hazardous Wastes (40 CFR Part 261) establishes the
standard to determine whether the material in question is considered a solid waste and, if so,
whether it is a hazardous waste or is exempted from regulation.

             Standards for Generators of Hazardous Waste (40 CFR Part 262) establishes the
responsibilities of hazardous waste generators including obtaining an EPA identification number,
preparing a manifest, ensuring proper packaging and labeling, meeting standards for waste
accumulation units, and recordkeeping and reporting requirements. Generators can accumulate
hazardous waste on site for up to 90 days (or 180 days depending on the amount of waste
generated) without obtaining a permit. If the waste must be transported more than 200 miles
away for recovery, treatment, or disposal, the generator may accumulate the waste for up to 270
days.

             Standards for Transporters of Hazardous Waste (40 CFR Part 263) apply to
persons transporting manifested shipments of hazardous waste within the United States.
Transport requires an EPA identification number, a hazardous waste manifest, compliance with
Department of Transportation (DOT) requirements, and proper recordkeeping.

             Land Disposal Restrictions (LDRs) (40 CFR Part 268) are regulations prohibiting
the disposal of hazardous waste on land without prior treatment. Under the LDRs program,
materials must meet treatment standards prior to placement in a RCRA land disposal unit
(landfill, land treatment unit, waste pile, or surface impoundment). Generators of waste subject
to the LDRs must provide notification of such to the designated TSD facility to ensure proper
treatment prior to disposal.

             Used Oil Management Standards (40 CFR Part 279) impose management
requirements affecting the storage, transportation, burning, processing, and re-refining of used
oil. For parties that merely generate used oil, regulations establish storage standards.  A party
considered a used oil processor, re-refiner, burner, or marketer (one who generates and sells off-
specification used oil directly to a used oil burner), must meet additional tracking and paperwork
requirements.

             RCRA contains unit-specific standards for all units used to store, treat, or dispose
of hazardous waste, including Tanks and Containers. Tanks and containers used to store
hazardous waste with a high volatile organic concentration must meet emission standards under
RCRA. Regulations (40 CFR Part 264-265, Subpart CC) require generators to test the waste to
determine the concentration of the waste, to satisfy tank and container emissions standards, and
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to inspect and monitor regulated units.  These regulations apply to all facilities that store such
waste, including large quantity generators accumulating waste prior to shipment off site.

             Underground Storage Tanks (USTs) containing petroleum and hazardous
substances are regulated under Subtitle I of RCRA. Subtitle I regulations (40 CFR Part 280)
contain tank design and release detection requirements, as well as financial responsibility and
corrective action standards for USTs. The UST program also includes upgrade requirements for
existing tanks that were to be met by December 22,1998.

             Boilers  and Industrial Furnaces (BIFs) that use or burn fuel containing hazardous
waste must comply with design and operating standards. BIF regulations (40 CFR Part 266,
Subpart H) address unit design, provide performance standards, require emissions monitoring,
and, in some cases, restrict the type of waste that may be burned.

             Imminent Hazard RCRA Section 7003 gives EPA a broad and powerful
enforcement tool to use in abating imminent hazards caused by hazardous or solid wastes.
Section 7003 states that upon receipt of evidence that the past or present handling, storage,
treatment, transportation,  or disposal of any solid waste or hazardous waste may present
imminent and substantial endangerment to human health or the environment, EPA may bring suit
against any person who has contributed or who is contributing to the handling of the waste to
restrain the person, order the person to take any action that may be necessary, or both. This
authority is used only in extreme circumstances.

             Some wastes have special exclusions for practices that are not considered to be
hazardous, as determined  by federal policy. Several exclusions and exemptions pertain
specifically to healthcare facilities.  Keep in mind that some states do not recognize the federal
exclusions. Some federal exclusions, exemptions, and other special circumstances that are
relevant to healthcare facilities are listed below:

             •      Domestic Sewage Exclusion. Mixtures of domestic sewage and other
                    wastes that discharge to a sewer system to a POTW for treatment are
                    excluded from the definition of solid waste. For example, employees may
                    generate a hazardous waste by washing hands with a soap containing a
                    listed hazardous waste.  The mixture will be going through a POTW;
                    therefore,  it is excluded from the facility's hazardous waste "count."
                    Generators need to contact their local POTW for prior approval.  Note that
                    wastes must actually reach the POTW to be covered by this exclusion.
                    Waste that volatilizes in the drain or corrodes the pipes does not reach the
                    POTW.

             •      Point Source Exclusions. Point source discharges of industrial waste
                    waters  that are subject to regulation under Section 402 of the CWA are
                    excluded from the definition of solid waste.

             •      De  Minimis Exclusion. Small quantities of some solvents and other
                    chemicals are exempt from the regulations when they are mixed with
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                    wastewater in a wastewater treatment system discharging, according to the
                    Clean Water Act.

             •      Elementary Neutralization Unit. Tanks used for neutralizing waste that
                    is hazardous solely because of its corrosive characteristic are excluded
                    from the permitting requirements.

             •      Nitroglycerine Formulation. As of August 14, 2001, federal
                    regulations of nitroglycerine formulations are exempt from hazardous
                    waste regulation as long as they do not exhibit the characteristic of
                    reactivity. Medicinal nitroglycerine are typically not reactive and
                    therefore would not be regulated. This interpretation is based on the
                    revised mixture and derived-from rules [40 CFR 261.3(g)(l)]. Healthcare
                    facilities should check with their state environmental regulatory agency to
                    see if this rule applies in the state in which they operate.

             •      Wastewater Treatment Unit.  Any hazardous waste tank system used to
                    store or treat the wastewater that is managed at an on-site wastewater
                    treatment facility with an NPDES permit or that discharges to a POTW is
                    exempt from the RCRA regulations.  Most healthcare facilities do not
                    perform this type of wastewater treatment but instead perform elementary
                    neutralization, discussed below.

             •      Mixed Wastes. In May 2001, EPA issued a rule offering a conditional
                    exemption from RCRA requirements for mixed waste as long as it is
                    managed in accordance with NRC or Agreement State licenses (40 CFR
                    Part 266, Subpart N). This exemption covers on-site storage and means
                    that facilities no longer have to obtain RCRA storage permits for mixed
                    waste stored beyond 90 days. The rule has been adopted by 20 states, but
                    is authorized in only two.

             •      Reverse Distribution of Pharmaceuticals.  Unused pharmaceutical
                    products shipped to reverse distributors are not considered discarded and
                    are therefore not classified as hazardous waste.  The materials must be
                    shipped as product and not identified as waste.  Check with state
                    regulatory authorities to understand specific restrictions or requirements in
                    each state.

             •      Epinephrine Syringes. Epinephrine residue in syringes is not considered
                    P042 under federal RCRA hazardous waste rules. Some states may not
                    have adopted this policy.  See also http://www.epa.gov/epaoswer/hotline/
                    94report/12_94. tot. Note that this federal interpretation does not apply to
                    epinephrine in other formulations (such as vials), and note that the syringe
                    may still be hazardous waste by characteristic.
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             Typical Physical Features to Inspect under RCRA

             •      Universal waste storage area;
             •      Used oil storage areas;
             •      Vehicle maintenance facilities;
             •      Battery storage areas;
             •      Building maintenance and repair shops;
             •      Laboratories;
             •      Bulk storage tank farms;
             •      Transfer terminals;
             •      Secondary containment structures;
             •      Tank peripheral piping, manifolds, filling and dispensing areas;
             •      Dispenser pumps and check valves;
             •      Tank sumps, manway areas;
             •      Leak detection equipment;
             •      Overflow alarms or other audible and visual alarms, sight gauges;
             •      Fill ports, catchment basins;
             •      Oil/water separators;
             •      Cleanup equipment (e.g.  absorbent materials, fuel recovery pumps,
                    personal protective gear);
             •      Hazardous waste generation sites (x-ray, chemotherapy, morgue,
                    pathology);
             •      Waste storage areas;
             •      Satellite accumulation points;
             •      Vehicles used for transport;
             •      Container storage areas; and
             •      Shop activities.

             Typical Records an Inspector May Ask to Review under RCRA

             •      Notification of Hazardous Waste Activity (EPA ID No.);
             •      Hazardous waste manifests;
             •      Manifest exception reports;
             •      Biennial reports;
             •      Inspection logs;
             *      Land disposal restriction certifications;
             •      Employee training documentation;
             *      Hazardous substance spill control and contingency plan;
                    Material Safety Data Sheets (MSDSs);
             •      Inventory records;
             •      Spill records - Spill Prevention Control and Countermeasure (SPCC)
                    Plans;
             •      Emergency plan documents;
             *      Placarding of hazardous waste and hazardous materials;
             •      Permits, if issued;
             •      Waste analysis plan(s);
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              •      Operating record;
              •      Universal waste transportation/shipping records;
              •      Used oil analysis records;
              •      Used oil transportation related documentation; and
              •      Underground Storage Tanks (UST) leak detection performance and
                    maintenance including the following:

                    —    Monitoring results over the last 12 months,
                    —    Most recent tank tightness test(s),
                    —    Manual tank gauging records,
                    —    Copies of performance claims provided by leak detection
                           equipment manufacturers,
                    —    Records of recent maintenance, repair and calibration of on-site
                           leak detection equipment,
                    —    Records of required  inspections and test of corrosion protection
                           systems,
                    —    Records of repairs or upgrades of UST systems,
                    —    Site assessment results of closed USTs,
                    —    Results of AST integrity assessments, sampling, monitoring,
                           inspection and repair work,
                    —    Notification forms and registration records for all in-service,
                           temporarily out-of service, and permanently closed tanks, and
                    —    Waste determinations.

              RCRA information is available to the public on the web at www. epa.gov/osw.  The
Office of Solid Waste (OSW) has also compiled a list of phone numbers and waste program web
sites maintained by EPA Regional offices and state environmental agencies to help users locate
site-specific information on RCRA facilities within their states.  This compilation is found at
www.epa. gov/epaoswer/osw/comments.htm.  This site also provides links to the RCRA OnLine
database (www. epa. gov/rcraonline). to a searchable database of Frequently Asked Questions
(FAQs) about RCRA, and to an on-line order form for RCRA publications
(www.epa.gov/epaoswer/osw/publicat.htm).  More information on RCRA Subtitle C can be found
at www.epa. gov/epaoswer/osw/hazwaste.htm. State specific information related to RCRA can be
found at www.herc.org.

              See Section VI.C of this document  for information  pertaining to pending
regulations under RCRA.

              Universal Waste Rule

              EPA created the Universal Waste Rule to encourage and streamline recycling
efforts.  It allows facilities to count wastes as universal instead of hazardous, which does not
count toward generator status. Segregating universal wastes from the rest of the hazardous waste
streams can save hospitals money on disposal costs, as well as on recordkeeping. Federal
universal wastes include hazardous waste batteries, mercury-containing thermostats, certain
pesticides, and fluorescent light bulbs. Facilities should make sure that their state or territory has
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adopted these universal wastes.  Some states may have additional types of waste such as
electronics on their list of universal wastes. Section III.B.3 also discusses this rule.

             Medical Waste Tracking Act

             In 1988, Congress enacted the Medical Waste Tracking Act under RCRA Subtitle
J, which directed EPA to begin a two-year demonstration program for medical waste tracking.
The demonstration program operated from June 1989 to June 1991. The program is expired and
no federal tracking requirements are in place; however, many states have developed similar
tracking and management programs.

             Emergency Planning And Community Right-To-Know Act

             This act, also known as Superfund Amendments and Reauthorization Act (SARA)
Title III, was designed to promote emergency planning and preparedness at both the state and
local level.  It provides citizens, local governments, and local response authorities with
information regarding the potential hazards in their community. EPCRA requires the use of
emergency planning and designates state and local governments as recipients of information
regarding certain chemicals used in the community. SARA Title III, better known as EPCRA,
originated from the Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA, or better known as the Superfund law). Like EPCRA Section 304, CERCLA also
has hazardous substance release reporting regulations under CERCLA Section 103; 40 CFR Part
302.  Under CERCLA, the person in charge of a facility is required to report to the National
Response Center ((800) 424-8802 or www.nrc.uscg.mil) "immediately upon knowledge of a
reportable release" any environmental release of a listed hazardous substance that equals or
exceeds a reportable quantity.

             EPCRA establishes the following types of reporting obligations for facilities that
store or manage specified chemicals:

             Emergency Planning (Sections 302 and 303)

             Any healthcare facility that has any chemical listed on the extremely hazardous
substances list at or above its planning threshold quantity must perform the following:

             •     Notify the State Emergency Response Commission (SERC) and Local
                   Emergency Planning Committee (LEPC) within 60 days of receiving the
                   shipment (or producing the substance) on site;

             •     Provide the LEPC with a facility representative who will participate in the
                   emergency planning process; and

             •     Provide requested information for the LEPC necessary for development
                   and implementation of the emergency plan.
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             Emergency Release Notification (Section 304)

             If there is a reportable release into the environment of a hazardous substance,
healthcare facilities must provide an emergency notification and a written follow-up notice to the
LEPC and SERC (for any area likely affected). A release is reportable under EPCRA Section
304 if the amount of hazardous substance releases meets or exceeds the minimum reportable
quantity set in the regulations. Two types of chemicals fall under this regulation: 1) extremely
hazardous substances; and 2) CERCLA hazardous substances.

             Annual Inventory (Sections 311 and 312)

             Under EPCRA Section 311 requirements, healthcare facilities must submit copies
of hazardous chemical material safety data sheets (MSDS) or a list of MSDS chemicals to the
LEPC, SERC, and local fire department.  Under Occupational Safety and Health Administration
(OSHA) regulations, employers must maintain a MSDS for any hazardous chemical stored or
used in the work place.

             Under EPCRA Section 312, healthcare facilities that meet Section 311
requirements for a hazardous chemical must submit an annual inventory report for that chemical.
The inventory report (called a Tier II report) must be submitted to the LEPC, SERC, and local
fire department by March 1 of each year.

             Certain chemicals are exempt from the EPCRA Section 311 and 312 definition of
a hazardous chemical. One exemption that applies to the healthcare industry is the exemption of
medical and research lab materials (i.e., any substance,  to the extent it is used in a research
laboratory or a hospital or other medical facility under the direct supervision of a technically
qualified individual). A technically qualified individual meets the following definition:

             •      Capable of understanding the health and environmental risks associated
                    with the chemical substance that is used under his or her supervision
                    because of education, training, or experience, or a combination of these
                    factors;

             •      Responsible for enforcing appropriate methods of conducting scientific
                    experimentation, analysis, or chemical research to minimize such risks;
                    and

             •      Responsible for the safety assessments and clearances related to the
                    procurement, storage, use, and disposal of the chemical substance as may
                    be appropriate or required within the scope of conducting a research and
                    development activity.

             In addition, EPCRA requirements do not apply to the transportation, including
storage, of any substance, with the exception of Section 304  reporting. Therefore, materials
being distributed or stored incident to transportation (i.e., under active shipping papers) would
not be included  in a facility threshold determination under Sections 311  and  312.
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              EPCRA Section 313 (Toxic Release Inventory. TRD

              The healthcare industry primarily falls under SIC codes 0741 and 0742
(veterinary services), 4119 (land ambulances), 4522 (air ambulances), 80 (hospitals and doctors'
offices/clinics), 83 (social services), and 8734 (veterinary testing laboratories).  These SIC codes
are not required to report to TRI (i.e., submit annual reports of toxic chemical releases) under
EPCRA Section 313.  Federal facilities however, are subject to EPCRA Section 313. These
include federal hospitals such as veterans hospitals, military hospitals, or clinics in federal
prisons.

              Healthcare facilities that are defined as auxiliary facilities (i.e., supports another
establishments's activities) can assume the SIC code of the covered establishment that it
supports. For the purposes of TRI, auxiliary facilities are defined as one primarily engaged in
performing support services for another establishments) of a facility (in a covered SIC code)
and is in a different physical location than the primary facility. If the healthcare facility meets
this definition, the facility meets the SIC code criterion.

              Typical Records an EPA Inspector May Ask to Review under the EPCRA

              •      Proof of notification for all environmental releases of a listed hazardous
                     substance. "Failure to notify" violation will be sited if the National
                     Response Center, State Hotline, and LEPC is not notified in a timely
                     fashion.

              •      Emergency Response Plans.

                     MSDS.

              •      Tier I or Tier II inventory reporting forms. This inspection is done
                     together with the MSDS. The inspector will look at what materials are
                     stored and in what quantity and if they are subject to reporting
                     requirements. The federal government prefers the more detailed Tier II
                     inventory form.

              •       EPA Toxic Release Inventory Form R for federal healthcare facilities
                     report on every chemical manufactured, processed, or used.  Form R
                     contains facility identification  information and chemical specific
                     information (toxic chemical identity; mixture component; activity and
                     uses; maximum amount of chemical on site during calendar year; quantity;
                     transfers; discharges; on-site waste treatment; on-site energy recovery; on-
                     site recycling; source reduction/recycling).

              Visit these web sites for more information:  http://yosemite. epa. gov/oswer/
cepyoweb.nsf/content/EPCRA.htm and http://www.epa.gov/ceppo/piibs/hotline/hazchem.html.
Visit the TRI web site fhttp://www. epa.gov/tn/) for more details.  "List of Lists " is a
consolidated list of chemicals  subject to EPCRA andCAA Section 112(r) used to help facilities
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handling chemicals determine whether they need to submit reports under Sections 302, 304, 311,
312, or 313 ofEPCRA and, for a specific chemical, what reports may need to be submitted. It
will also help facilities determine whether they will be subject to accident prevention regulations
under CAA Section 112(r) and lists "unlisted hazardous wastes" under RCRA.  It is available at
http://www. epa. gov/ceppo/pubs/title3.pdf

              Clean Air Act

              The CAA and its amendments are designed to "protect and enhance the nation's
air resources so as to promote the public health and welfare and the productive capacity of the
population." The CAA consists of six sections, known as Titles, which direct EPA to establish
national standards for ambient air quality and for EPA, states, and tribes to implement, maintain,
and enforce these standards through a variety of mechanisms. Under the CAA, many facilities
are required to obtain operating permits that consolidate their air emission requirements. State,
tribal, and local governments oversee, manage, and enforce many of the requirements of the
CAA.  CAA regulations appear at 40 CFR Parts  50-99.

              As discussed in Section III.B.4 of this document, healthcare air emissions come
from air conditioning and refrigeration, boilers, medical waste incinerators (if on site), asbestos,
paint booths, ethylene oxide sterilization units, emergency generators, anesthesia, laboratory
chemicals, and laboratory fume hoods.

              Pursuant to Title I of the CAA, EPA has established national ambient air quality
standards (NAAQSs) to limit levels of "criteria pollutants," including carbon monoxide, lead,
nitrogen dioxide, particulate matter, ozone, and sulfur dioxide. Geographic areas that meet
NAAQSs for a given pollutant are designated as attainment areas; those that do not meet
NAAQSs are designated as nonattainment areas. Under Section 110 and other provisions of the
CAA, each state must develop a State Implementation Plan (SIP) to identify sources of air
pollution and to determine what reductions are required to meet federal air quality standards.
Tribes may, but are not required, to develop Tribal Implementation Plans (TIP), which play the
same role as SIPs, but apply within Indian country. Revised NAAQS for particulates and ozone
became effective in 2004.

              Title I also authorizes EPA to establish New Source  Performance Standards
(NSPS), which are nationally uniform emission standards for new and modified stationary
sources falling within particular industrial categories. NSPSs are based on the pollution control
technology available to that category of industrial source (see 40 CFR Part 60).

              New Source Performance Standards

              NSPS at 40 CFR 60 include process-specific operational standards. Individual
states may impose stricter requirements. The following NSPS are particularly relevant to the
healthcare industry:

              •      Boilers - Most hospital boilers are subject to the NSPS regulations.  The
                    applicable regulations can be found at 40 CFR Part 60, Subparts Db and


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                    DC. Subpart Db applies to the larger boilers (greater than 100 million
                    BTU/hr) that were constructed after June 19,1984.  Subpart DC applies to
                    the smaller boilers (between 10 and 100 million BTU/hr) that were built
                    after June 8,1989.  Depending on the type of fuel combusted, the
                    regulations have emission standards for sulfur dioxide, nitrogen oxides,
                    and paniculate matter. The NSPS also have requirements for monitoring
                    and recordkeeping. http://www.epa.gov/ttn/atw/boiler/boilerps.html.

             •      Medical Waste Incinerators - Under the CAA, EPA regulates air
                    emissions from hospital and or medical/infectious wastes incinerators
                    (HMIWI). The applicable regulations can be found at 40 CFR Part 60,
                    Subparts EC and Ce. Subpart EC applies to HMIWI that were constructed
                    after June 20, 1996. Subpart Ce applies to HMIWI that were constructed
                    before June 20, 1996. When burned, medical waste may emit air
                    pollutants, including hydrochloric acid (Hal), dioxins and furans, and
                    metals, such as lead (Pb), cadmium (Cd), and mercury (Hg).  Therefore,
                    EPA has developed emission standards that apply to incinerators used by
                    hospitals and healthcare facilities as well as those used by commercial
                    waste treatment and disposal companies to treat medical waste. The
                    emission guidelines are intended to meet the requirements of the CAA,
                    and states must establish standards that are at least as protective. These
                    standards will result in reductions in the air emissions of concern from
                    HMIWI. For additional information visit:
                    http://www.epa.gov/ttn/atw/l29/hmiwi/rihmiwi.html.

             Hazardous Air Pollutants

             Under Title I, EPA establishes and enforces National Emission Standards for
Hazardous Air Pollutants (NESHAPs), nationally uniform standards oriented toward controlling
specific hazardous air pollutants (HAPs).  Section 112(c) of the CAA further directs EPA to
develop a list of source categories that emit any of 188 HAPs, and to develop regulations for
these categories of sources.  To date, EPA has listed 185 source categories and developed a
schedule for establishing emission standards. The emission standards are being developed for
both new and existing sources based on "maximum achievable control technology" (MACT).
The MACT is defined as the control technology achieving the maximum degree of reduction in
the emission of the HAPs, taking into account cost and other factors. Air toxics regulations
apply to several operations at healthcare facilities.  The NESHAPs that apply to the industry are:

             •      Asbestos (40 CFR 61 Subpart M) - A hospital that performs demolition
                    and renovation operations will be subject to the CAA NESHAP for
                    asbestos. Asbestos must be removed prior to demolition or renovation and
                    proper precautions must be made such as wetting down the material to
                    keep in intact.  No asbestos is to be stripped, removed, or otherwise
                    handled or disturbed unless at least one authorized representative trained
                    in NESHAP asbestos regulations is present.  A written notice of intention
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                    to demolish or renovate must be submitted to EPA at least 10 working
                    days prior to the start of construction.

              •      Industrial, Commercial and Institutional Boilers and Process Heaters
                    (40 CFR 63 Subpart DDDDD) - This NESHAP may apply at hospitals that
                    are major hazardous air pollutant emitters under the CAA. A major
                    emitter is defined as emitting 10 tons/year of a single HAP or 25 tons/year
                    of combined HAPS. For additional information visit:
                    www.epa.gov/ttn/atw/boiler/boilerpg/html.

              Chemical Accident Prevention Provisions

              The CAA sets forth a list of regulated substances and thresholds, a petition
process for adding or deleting substances to the list of regulated substances, requirements for
owners or operators of stationary sources concerning the prevention of accidental releases, and
state accidental release prevention programs.

              Title V Permits

              Title V of the CAA requires that all "major sources" (and certain minor sources)
obtain an operating permit.  Healthcare facilities that qualify as a major  source are required to
have a Title V permit, and may be required to submit information about emissions, control
devices, and the general process at the facility in the permit application. Permits may limit
pollutant emissions and impose monitoring, recordkeeping, and reporting requirements.

              Monitoring requirements for many facilities  with Title V permits are specified in
the Compliance Assurance Monitoring (CAM) regulations.  For facilities that meet emissions
requirements on their permits by using pollution control equipment,  CAM may require that the
facilities monitor the control equipment to assure that it is operated and  maintained as prescribed
in their permits.

              Refrigerant Recycling Rule

              The purpose of Section 608 of the CAA is to maximize the recovery and
recycling of refrigerants during the servicing and disposal of stationary air conditioning and
refrigeration equipment. Requirements include prohibition of venting, service requirements,
equipment certification, leak repair, proper disposal, and recordkeeping. More information can
be found at http://www.epa.gov/resion02/cfc/.

              EPA's Clean Air Technology Center, at (919) 541-0800 (in Spanish: (919) 541-
1800)  or http://www.epa.gov/ttn/catc. provides general assistance and information on CAA
standards (e-mail: catcmaiKSs.epamail. epa. gov). The Stratospheric Ozone Information Hotline,
at (800) 296-1996, or the Ozone Depletion web site (www.epa.gov/ozone). provides general
information about regulations promulgated under Title VI of the CAA. RCRA information
pertaining to questions about accidental release prevention under CAA  Sectionll2(r), is
available in the RCRA OnLine database (www. epa. gov/rcraonline).  a searchable database of
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Frequently Asked Questions (FAQs) about RCRA, and through an on-line order form for RCRA
publications Cwww.epa.gov/epaoswer/osw/publicat.htm). Information on air toxics can be
accessed through the Unified Air Toxics web site at http://www.epa.gov/ttn/atw/. In addition, the
Clean Air Technology Center's web site includes recent CAA rules, EPA guidance documents,
and updates of EPA activities.  Visit the Office of Air and Radiation (OAR) homepage for more
information: Chttp://www.epa.gov/air/).

              See Section VI.C of this document for information pertaining to pending
regulations under CAA.

              Toxic Substances Control Act

              The Toxic Substances Control Act (TSCA) granted EPA authority to create a
regulatory framework to collect data on chemicals in order to evaluate, assess, mitigate, and
control risks that may be posed by their manufacture, processing, and use. TSCA provides a
variety of control methods to prevent chemicals from posing unreasonable risk.  It is important to
note that pesticides as defined in the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) are not included in the definition of a "chemical substance" when manufactured,
processed, or distributed in commerce for use as a pesticide. Healthcare facilities may be subject
to TSCA through:

              •      Lead hazard reduction regulations;

              •      Hexavalent chromium regulations under 40 CFR 749.68,  replace
                    hexavalent chromium compounds with phosphate based chemicals for
                    water treatment in industrial cooling towers;

              •      Polychlorinated Biphenyls (PCB) hazard reduction regulations; and

              ซ      Asbestos hazard reduction regulations.

              TSCA Regulations for Lead

              •      National Lead Laboratory Accreditation Program (TSCA Section
                    405(b))  establishes protocols, criteria, and minimum performance
                    standards for laboratory analysis of lead in paint, dust, and soil.

                    Hazard Standards for Lead in Paint, Dust, and Soil (TSCA Section
                    403) establishes standards for lead-based paint hazards and lead  dust
                    cleanup levels in most pre-1978 housing and child-occupied facilities.

              •      Training & Certification Program for Lead-Based Paint Activities
                    (TSCA Section 402/404) ensures that individuals conducting lead-based
                    paint abatement, risk assessment, or inspection are properly trained and
                    certified, that training programs are accredited, and that these activities are
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    EPA ORDERS CLOSURE OF MEDICAL WASTE INCINERATORS AT GUAM
                              MEMORIAL HOSPITAL

FOR RELEASE: June 2004

             HONOLULU — In response to an order from the U.S. Environmental Protection
Agency, the Guam Memorial Hospital Authority has shut down one of its medical waste
incinerators and will soon shut down a second in order to meet federal Clean Air Act standards.

             Guam Memorial Hospital Authority has agreed to comply with the EPA's order
by ceasing to operate its incinerators and putting an alternative medical waste treatment method
into place.

             The first of two incinerators was shut down on May 18. The second incinerator
was switched to emergency back-up status on June 11 and will be permanently shut down by
Nov. 30. The EPA determined that both incinerators were violating the emissions standards set
by the Clean Air Act.

             "It is critical that medical waste incinerators meet all of the required emission
standards to protect the public's health," said Deborah Jordan, the EPA's air division director for
the Pacific Southwest region.  "Developing alternative medical waste treatment will further
ensure clean air and proper disposal of medical waste for Guam's residents."

             During the initial source tests, one of the incinerators violated the paniculate
matter, dioxins and furans, hydrogen chloride and lead emissions limits, white the second
incinerator violated the particulate matter and hydrogen chloride emission limits. At that time,
Guam Memorial Hospital Authority also failed to submit to the EPA the required waste
management plan and necessary incinerator operating parameters and other required data for
both incinerators.

             In response to the order, Guam Memorial Hospital Authority has given the EPA a
plan to transport all hospital, medical and infectious waste to a commercial medical waste
treatment and disposal facility while the hospital develops an alternative waste treatment system.
             The EPA's order also requires the Guam Memorial Hospital Authority to:

             •      Provide to the EPA a copy of its waste management plan which will
                    include plans to separate solid waste from medical waste and other waste
                    minimization opportunities; and

             •      Complete the shut down of both incinerators by Nov. 30 and complete
                    final removal and proper disposal of the two incinerators by Dec.  30.

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Healthcare Industry                                    Federal Statutes and Regulations

Frequently Asked Questions (FAQs) about RCRA, and through an on-line order form for RCRA
publications fwww,epa.gov/epaoswer/gsw/publicqt.htm).  Information on air toxics can be
accessed through the Unified Air Toxics web site at http://www.epa.gov/ttn/atw/.  In addition, the
Clean Air Technology Center's web site includes recent CAA rules, EPA guidance documents,
and updates of EPA  activities.  Visit the Office of Air and Radiation (OAR) homepage for more
information: (http://www.epa.gQv/air/).

              See Section VI.C of this document for information pertaining to pending
regulations under CAA.

              Toxic Substances Control Act

              The Toxic Substances Control Act (TSCA) granted EPA authority to create a
regulatory framework to collect data on chemicals in order to evaluate, assess, mitigate, and
control risks that may be posed by their manufacture, processing, and use. TSCA provides a
variety of control methods to prevent chemicals from posing unreasonable risk. It is important to
note that pesticides as defined in the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) are not included in the definition of a "chemical substance" when manufactured,
processed, or distributed in commerce for use as a pesticide. Healthcare facilities may be subject
to TSCA through:

              •      Lead hazard reduction regulations;

              •      Hexavalent chromium regulations under 40 CFR 749.68, replace
                    hexavalent chromium compounds with phosphate based chemicals for
                    water treatment in industrial cooling towers;

              •      Polychlorinated Biphenyls (PCB) hazard reduction regulations; and

              •      Asbestos hazard reduction regulations.

              TSCA Regulations for Lead

              •      National Lead Laboratory Accreditation Program (TSCA Section
                    405(b)) establishes protocols, criteria, and minimum performance
                    standards for laboratory analysis of lead in paint, dust, and soil.

              •      Hazard Standards for Lead in Paint, Dust, and Soil (TSCA Section
                    403) establishes standards for lead-based paint hazards and lead dust
                    cleanup levels in most pre-1978 housing and child-occupied facilities.

              •      Training & Certification Program for Lead-Based Paint Activities
                    (TSCA Section 402/404) ensures that individuals conducting lead-based
                    paint abatement, risk assessment, or inspection are properly trained and
                    certified, that training programs are accredited, and that these activities are
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                    conducted according to reliable, effective, and safe work practice
                    standards.

             •      Pre-Renovation Education Rule (TSCA Section 406(b)) ensures that
                    owners and occupants of most pre-1978 housing are provided information
                    concerning potential hazards of lead-based paint exposure before
                    beginning certain renovations on that housing.

                    Lead-Based Paint Disclosure Rule (TSCA Section 1018) requires
                    disclosure of known lead-based paint and or lead-based paint hazards by
                    persons selling or leasing housing constructed before the phase-out of
                    residential lead-based paint use in 1978.

             TSCA Regulations for PCBs

             The PCB regulations and requirements apply to both PCB waste materials and
PCBs still in use.  Because of potential harmful effects on human health and the environment,
federal law banned U.S. production of PCBs as of July 2, 1979. However, PCB-containing
materials may be present at facilities and PCB-laden wastes may be generated during
renovations.

             Items with a PCB concentration of 50 ppm or greater are regulated for disposal
under 40 CFR Part 761. Some potential sources of PCBs include:

             •      Mineral-oil filled electrical equipment such as motors or pumps
                    manufactured prior to July 2, 1979;

             •      Capacitors or transformers manufactured prior to July 2, 1979;

             •      Plastics, molded rubber parts, applied dried paints, coatings or sealants,
                    caulking, adhesives, paper, Galbestos, sound-deadening materials,
                    insulation, or felt or fabric products such as gaskets manufactured prior to
                    July 2, 1979;

             •      Fluorescent light ballasts manufactured prior to July 2,  1979;

             •      Waste or debris from the demolition of buildings and equipment
                    manufactured, serviced, or coated with PCBs; and

             •      Waste containing PCBs from spills, such as floors or walls contaminated
                    by a leaking transformer.

             The general requirements for handling PCB materials and equipment include:
identifying and labeling the material, notifying EPA, properly storing the material, and properly
disposing of the material.
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             TSCA Regulations for Asbestos

             EPA and the OSHA have promulgated rules regulating asbestos production, use,
and disposal. OSHA regulates private sector and some public sector employees' exposure to
asbestos and specifies work practices and engineering controls for removing and handling
asbestos. Along with EPA and OSHA, some states also have established asbestos requirements
that extend the federal requirements.  Asbestos programs implemented under TSCA include the
following:

             •      Asbestos Hazard Emergency Response Act (AHERA), which regulates
                    asbestos contained in schools and all public and commercial buildings
                    including hospitals; requires the development of management plans;
                    specifies work practices and engineering controls for removing and
                    handling asbestos; and sets emissions limitations in schools after an
                    abatement activity is completed.  EPA Region 6 provides a list of
                    suspected asbestos-containing materials at:
                    http://www. epa. gov/Region06/6pd/asbestos/asbmatl. htm.

             Typical Physical Features to Inspect for Lead-based Paint. PCBs. and Asbestos
             under TSCA

             •      PCB storage areas;

             •      Equipment, fluids, and other items used or stored at the facility containing
                    PCBs.  PCBs are most likely to be found in electrical equipment such as
                    transformers, capacitors, and possibly fluorescent light ballasts (in older
                    fixtures);

             •      Pipe, spray-on, duct, and troweled cementitious insulation and boiler
                    lagging; and

             •      Ceiling and floor tiles.

             EPA's TSCA Assistance Information Service, at (202) 554-1404 (e-mail: tsca-
h0t!ine(a),epa.gov). answers questions anddistributes guidance pertaining to TSCA standards.
The Service operates from 8:30 a.m. through 5:00 p.m., EST, excluding federal holidays. For
more information on TSCA programs for lead, visit the web site
www. epa.gov/lead/regulation. htm.  EPA's PCB Homepage includes links to the regulatory text
(40 CFR Part 761) as well as lists of approved PCB waste handlers:  http://www. epa. gov/pcb/.
EPA operates the Asbestos Ombudsman Clearinghouse/Hotline ((800) 368-5888, or (202) 260-
0490) to provide general asbestos information. Also visit the EPA Asbestos Management &
Regulatory Requirements web site (http://www.epa.gov/qsbestos/help.html) for additional
material.
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              Federal Insecticide, Fungicide and Rodenticide Act

              FIFRA was first passed in 1947 and amended numerous times, most recently by
the Food Quality Protection Act (FQPA) of 1996.  FIFRA provides EPA with the authority to
oversee, among other things, the registration, distribution, sale and use of pesticides. The Act
applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides and
antimicrobials. FIFRA covers both intrastate and interstate commerce.

              Product Registration

              Under Section 3 of FIFRA, all pesticides (with few exceptions) sold or distributed
in the United States must be registered by EPA.  Pesticide registration is very specific and
generally allows use of the product only as specified on the label. Each registration specifies the
use site (i.e., where the product may be used) and the amount that may be applied. The person
who seeks to register the pesticide must file an application for registration. The application
process often requires either the citation or submission of extensive environmental, health, and
safety data.

              Use Restrictions

              As a part of the pesticide registration, EPA classifies the product as unclassified,
general use, or restricted use (40 CFR Section 152.160(a)).  The Administrator may prescribe
restrictions relating to the product's composition, labeling, or packaging. For pesticides that
may cause unreasonable adverse effects on the environment, including injury to the applicator,
EPA may require that the pesticide be applied either by, or under the direct supervision of, a
certified applicator.

              Good Laboratory Practices

              EPA prescribes good laboratory practices under 40 CFR Part 160 for conducting
studies that support research or marketing permits for pesticide products regulated by EPA.
These practices are intended to assure the quality and integrity of the submitted research data.

              Typical Physical Features to Inspect for under FIFRA

              •       Personnel protection equipment;
              •       Pesticide application equipment;
              •       Pesticide storage areas, including storage containers; and
              •       Cleaning disinfectants and labels.

              Typical Records a EPA Inspector May Ask to Review under the FIFRA

              •       Records of pesticides purchased (purchase orders, inventory);
              •       Pesticide application records;
              •       Description of the pest control program;
              •       Certification status of pesticide applicators;
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Healthcare Industry                                     Federal Statutes and Regulations

              •      Pesticide disposal manifests;
              •      Contract files; and
              •      Recent ventilation rating for pesticide fume hood and pesticide
                     mixing/storage areas.

              Antimicrobials

              In healthcare settings, EPA regulates disinfectants that are used on environmental
surfaces (housekeeping and clinical contact surfaces).  Disinfectants intended for use on clinical
contact surfaces (e.g., light handles, radiographic-ray heads, or drawer knobs) or housekeeping
surfaces (e.g., floors, walls, or sinks) are regulated by EPA, under the authority of FIFRA. Under
FIFRA, any substance or mixture of substances intended to prevent, destroy, repel,  or mitigate
any pest, including microorganisms but excluding those in or on living man or animals, must be
registered before sale or distribution. To obtain a registration, a manufacturer must  submit
specific data regarding the safety and the effectiveness of each product.

              FIFRA requires users of products to follow the labeling directions on each
product explicitly. The following statement appears on all EPA-registered product labels under
the Directions for Use heading: "It is a violation of federal law to use this product
inconsistent with  its labeling." This means that users, including the healthcare industry, must
follow the safety precautions and use directions on the labeling of each registered product. Not
following the specified dilution, contact time, method of application, or any other condition of
use is considered misuse of the product.

              The Centers for Disease Control (CDC) recommends disinfecting environmental
surfaces or sterilizing or disinfecting medical equipment, and medical facilities should use
products approved by EPA unless no such products are available for use against certain
microorganisms or sites. However, if no  registered or approved products are available for a
specific pathogen or use situation, medical facilities are advised to follow the specific guidance
regarding unregistered or unapproved (e.g., off-label) uses for various chemical germicides. For
example, no antimicrobial products are registered for use specifically against certain emerging
pathogens (e.g., Norwalk virus), potential terrorism agents (e.g., variola major or Yersinia
pestis), or Creutzfeldt-Jakob disease agents.

              Microorganisms vary in their resistance to disinfection and sterilization, enabling
CDC's designation of disinfectants as high-, intermediate-, and low-level, when compared with
EPA's designated organism spectrum. However, exceptions to this general guide exist, and
manufacturers' label claims and instructions should always be followed.

              For more information on the use of hospital disinfectants, refer to: MMWR
Recommendation and Report  on Dental Infection Control Guidelines, (http://ww\v. cdc. gov/
mmwr/preview/mmwrhtml/rr5 217al.htm) and Guidelines for Environmental Infection Control in
Health-Care Facilities, (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr52IOal.htm).

              Additional information on FIFRA and the regulation of pesticides can be
obtained from a variety of sources, including EPA 's Pesticide Program at
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Healthcare Industry
                                         Federal Statutes and Regulations
http://www. epa.gov/pesticides, EPA's Office of Compliance, Pesticide Compliance Assistance at
http://www. epa. gov/cgmpHance/assistance/pesticides/mdex. html. EPA's Office of Compliance
Agriculture and Ecosystem Division at http://~www.epa.gov/compliance/assistance/
sectors/agriculture, html or The National Agriculture Compliance Assistance Center, (888) 663-
2155 or http://www. epa.eov/agriculture/ (e-mail: agcenter(d),epa. gov). Other sources include the
National Pesticide Information Center, (800) 858-7378 or http://npic.orst.edu/. and EPA's
Antimicrobial hotline, (703) 308-0127, operating weekdays from 9:00 a.m. to 4:00 p.m., EST,
excluding federal holidays (e-mail: infojmtimicrobial^epa.gov} or -web site,
httv://www. eva. eov/opyadOO I/.
VLB.
Regulations by Waste Category

Table VI-2 lists the applicable regulations for each waste category.

      Table VI-2: EPA Regulations by Waste Category
Waste
Category
Municipal Solid
Waste v
Biohazardous
Waste, Regulated
Medical Waste
(RMW)
Hazardous Waste
Pressurized
Containers
Universal Wastes
Construction and
Demolition Debris
Wastewater
Stormwater
Specific Wastes Found in this Category1
Cardboard, paper, boxboard, magazines,
newspaper, metals (steel and aluminum), glass,
plastics, food waste, leaf and yard waste, mixed
materials, mattresses, furniture, pallets, carpet,
packaging materials
Sharps waste, blood and blood products,
pathological waste, selected isolation wastes,
cultures and stocks from laboratories, non-regulated
chemotherapy waste, blood-soaked bandages, etc.
Solvents, selected Pharmaceuticals, ethylene oxide
(EtO), mercury-containing equipment or
compounds, lead-containing equipment, hazardous
chemicals
Gas cylinders, gas cartridges, aerosol cans, oxygen
farms
Mercury-containing thermostats, and spent
fluorescent lamps and other hazardous lamps.
Hazardous waste batteries, hazardous waste
pesticides - recalled or sent to collection program
Asbestos, mercury, lead, C&D debris
Potentially, any hazardous substance in any clinical
area, oils, hydraulic fluid, chemical spills
Contaminated runoff from building, lawns, parking
areas, underground storage tank areas, aboveground
storage tank areas, and disturbed soils from
construction sites
Applicable Statute
RCRA, EPCRA, FIFRA
RCRA, CAA
RCRA
RCRA
RCRA
RCRA, CWA, CAA, TSCA
CWA
CWA, FIFRA
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Healthcare Industry                                    Federal Statutes and Regulations

              Table VI-2: EPA Regulations by Waste Category (Continued)
Waste
Category
Air Emissions
Specific Wastes Found in this Category1
Air conditioning and refrigeration, boilers, medical
waste incinerators, asbestos, paint booths,
sterilization using ethylene oxide, emergency
generators, anesthesia
Applicable Statute
CAA, EPCRA
'See Section III for more examples.

VI.C.         Pending and Proposed Regulatory Requirements

              The following pending and proposed regulations affect the healthcare industry:

              Clean Water Act

              EPA is working with dental offices to begin collecting dental amalgam before it
enters the waste stream.  As part of its pretreatment standards review process, EPA is reviewing
industrial sources of mercury, including dental facilities, for potential technology-based options
for controlling mercury discharges to wastewater treatment plants. In addition, the Agency is
working with wastewater treatment plants to begin implementing best management practices for
collecting mercury from other industrial sources, as well as modifying surface water discharge
permits to reflect stricter requirements in mercury discharges. See EPA's Effluent Guidelines
Program web site (http://www. epa. gov/guide/) for more information.

              Clean Air Act

              Ethvlene Oxide
              Some hospitals use ethylene oxide as a sterilant for certain types of healthcare
supplies and devices, primarily due to manufacturers' recommended practice to ensure the
sterility of a product. Hospital sterilizers are one of 55 area source categories may be subject to
Area Source Category NESHAP regulations. Go to:
http://www. epa.gov/ttn/atw/urban/arearules. html for more information.

              Resource Conservation and Recovery Act

              Universal Waste Regulations

              In June 2002, EPA proposed to add mercury-containing equipment to the
universal waste list. The Universal Waste Rule allows facilities to streamline the waste
management of certain widely generated hazardous wastes. The waste management
requirements of universal wastes are less strict than those for other RCRA listed hazardous
wastes. Visit the web site www.epa.gov/epaoswer/hazwaste/id/univwast/regs.htm for more
information.
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VI.D.        Additional Applicable Regulations (Non-EPA Administered)

             The following non-EPA administered environmental or wastes related regulations
affect the healthcare industry:

             Mercury Ordinances/Resolutions

             Many states have passed ordinance and resolutions banning the manufacture or
sale of mercury-containing items, such  as thermometers, thermostats, and switches containing
mercury.

             "One Plan "/Integrated Contingency Plan

             The "One Plan" (EPA HQ), also known as Integrated Contingency Plan (ICP),
allows a facility to comply with multiple federal planning requirements by consolidating them
into one functional emergency response plan.  A number of statutes and regulations,
administered by several federal agencies, include requirements for emergency response planning.
A particular facility may be subject to one or more of the following federal regulations:

             •      EPA's Oil Pollution Prevention Regulation (SPCC and Facility Response
                    Plan Requirements) - 40 CFR Part 112.7(d) and 112.20-.21;

                    MMS's Facility Response Plan Regulation - 30 CFR Part 254;

                    RSPA's Pipeline Response Plan Regulation - 49 CFR Part 194;

                    USCG's Facility Response Plan Regulation - 33 CFR Part 154, Subpart F;

             •      EPA's Risk Management Programs Regulation - 40 CFR Part 68;

             •      OSHA's Emergency Action Plan Regulation - 29 CFR 1910.38(a);

                    OSHA's Process Safety Standard - 29 CFR 1910.119;

                    OSHA's HAZWOPER Regulation - 29 CFR 1910.120; and

             •      EPA's RCRA Contingency Planning Requirements - 40 CFR Part 264,
                    Subpart D, 40 CFR Part 265, Subpart D, and 40 CFR 279.52.

             In addition, facilities may also be subject to state emergency response planning
requirements that this guidance does not specifically address.  Facilities are encouraged to
coordinate development of their ICP with relevant state and local agencies to ensure compliance
with any additional regulatory requirements.
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              Visit the National Response Team's Integrated Contingency Plan Guidance (One
Plan) web site for more information:
http://vosemite. epa. gov/oswer/ceppoweb. nsf/content/sta-loc. htm

              Federal Hazardous Materials Transportation Law (HAZMA T)

              The Department of Transportation (DOT), along with other agencies, regulates
the transportation of hazardous materials (including certain medical wastes) under 49 CFR Parts
171-180. The regulations cover five areas: (1) hazardous materials definition/classification; (2)
hazard communication; (3) packaging requirements; (4) operational rules; and (5) training.
Biohazardous wastes are classified as a Class 6 DOT hazard.

              The Hazardous Materials Information Center can be contacted at (800) HMR-
4922 ((800) 467-4922) or (202) 366-4488, Monday through Friday from 9:00 am to 5:00pm
EST.  Visit the HAZMAT web site at http://hazmat.dot.sov/hazhome.htm for additional material.

              Nuclear Regulatory Commission (NRC)

              The NRC, under authority of the Atomic Energy Act, regulates the use of nuclear
by-product material in the fields of nuclear medicine, radiation therapy,  and research. The
nuclear by-product material is regulated by either the NRC or the state (currently 33 states have
agreements with NRC to regulate the by-product material).  The NRC issues licenses to
authorized users and provides regulations and guidance for the use of nuclear by-product
material. Note that radium, a radioactive material that has historically been used in
brachytherapy and may be present in healthcare facilities, is not regulated by NRC. It is only
regulated by states (although legislation is pending that would bring it under NRC authority).

              Visit the NRC web site (http://www.nrc.gov) for more information.

              Occupational Safety and Health Administration (OSHA)

              OSHA provides regulatory standards to protect workers from injury.  OSHA
requirements  that apply to healthcare facilities include the Bloodborne Pathogens Standard
(1910.1030), Hazardous Waste Operations and Emergency Response (HAZWOPER) Standard
(1910.120), and Asbestos Standards (1910.1001) for any renovation work.

              Visit the OSHA web site (http://www. osha. gov/)  for more information. OSHA
also has a Hospital eTool (http://www.osha.gov/SLTC/etools/hospital/mainpage.html) that
addresses the following areas: administration, central supply, clinical services, dietary,
emergency, engineering, heliport, housekeeping, ICU, laboratories, laundry, pharmacy, surgical
suite, healthcare wide hazards, and other healthcare wide hazards.
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             U.S. Postal Service (USPS)

             The Domestic Mail Manual, C023, as well as D.O.T. have certain requirements
and restrictions for mailing or shipping hazardous pharmaceuticals to patients (i.e. consumer
commodities that are hazardous).  USPS also has regulations pertaining to mailing sharps,
biological specimens, and other healthcare related materials.

             Visit the USPS web site and reference the Domestic Mail Manual at
(http://pe. usps.gov/) for more information.

             National Institutes of Health, Centers for Disease Control (CDC)

             The CDC publishes guidelines and recommendations for the healthcare industry
on many areas including infection control, sterilization, hand hygiene, and immunizations.

             Visit the CDC web site Cwww.cdc.gov} for more information. The CDC we6 site
also has access to the National Institution of Safety and Health (NIOSH) publication, Preventing
Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings
(http://www. cdc.gov/niosh/docs/2004-165/)

             U.S. Department of Health and Human Services (HHS)

             The HHS provides information on laws and regulations pertaining to healthcare
from a variety of organizations including the Food and Drug Administration, Centers for
Medicare and Medicaid Services, Health Resources and Services Administration, Substance
Abuse and Mental Health Services Administration, and Indian Health Services.

             Visit the HHS web site (www.hhs.gov) for more information.
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Healthcare Industry                               Compliance and Enforcement History

VII.         COMPLIANCE AND ENFORCEMENT HISTORY

VILA.       Background

             Until recently, EPA focused much of its attention on ensuring compliance with
specific environmental statutes. This approach allows the Agency to track compliance with the
Clean Air Act, the Resource Conservation and Recovery Act, the Clean Water Act, and other
environmental statutes. Within the last several years, the Agency has begun to supplement
single-media compliance indicators with facility-specific, multimedia indicators of compliance.
In doing so, EPA is in a better position to track compliance with all statutes at the facility level,
and within specific industrial sectors.

             A major step in building the capacity to compile multimedia  data for industrial
sectors was the creation of EPA's Integrated Data for Enforcement Analysis (IDEA) system.
IDEA has the capacity to "read into" the Agency's single-medium databases, extract compliance
records, and match the records  to individual facilities. IDEA uses the Facility Registry System
(FRS) maintained Master Source ID identification number to "glue together" separate data
records from EPA's databases.  This is done to create a "master list" of data records for any
given facility. Some of the data systems accessible through IDEA are:  AIRS (Air Facility
Indexing and Retrieval System, Office of Air and Radiation), PCS (Permit Compliance System,
Office of Water), RCRAInfo (Resource Conservation and Recovery Information System, Office
of Solid Waste), NCDB (National Compliance Data Base, Office of Prevention, Pesticides, and
Toxic Substances), CERCLIS (Comprehensive Environmental and Liability Information System,
Superfund), and TRIS (Toxic Release Inventory System). IDEA also contains information from
outside sources such as Dun and Bradstreet and OSHA.

             The IDEA system can match Air, Water, Waste, Toxics/Pesticides/EPCRA, TRI,
and Enforcement Docket records for a given facility, and generate a list of historical permit,
inspection, and enforcement activity. IDEA also has the capability to analyze data by
geographic area and corporate holder. As the capacity to generate multimedia compliance data
improves, EPA will make available more in-depth compliance and enforcement information.
Additionally, sector-specific measures of success for compliance assistance  efforts are under
development.

             EPA has also developed Enforcement and Compliance History Online (ECHO).
This database was developed in partnership with the Environmental Council of the States
(ECOS), a national association representing state and territorial environmental commissioners.
ECHO provides users detailed facility reports, which include:

             •     Federal and state compliance inspections;
             •     Environmental violations;
             •     Recent formal enforcement actions taken; and
             •     Demographic profile of surrounding area.

The data in ECHO covers a two-year period of information and includes information drawn from
the following EPA databases:
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Healthcare Industry                                Compliance and Enforcement History

                    AIRS;
                    PCS;
                    RCRAInfo;
             •      Integrated Compliance Information System (ICIS);
                    Facility Registry System (FRS); and
             •      U.S. Census Data.

             The ECHO database can be found at http://www.epa.gov/echo/index.htmL

VII.B.       Compliance  and Enforcement Description

             This section discusses how EPA collects data on the historical compliance and
enforcement activity of each sector. The Agency compiles compliance and enforcement records
from its data systems to the facility level using the Facility Registry System's (FRS) Master
Source ID, which links records from virtually any of EPA's data systems to a facility record. For
each facility (i.e., Master Source ID), EPA uses the facility-level SIC code that is designated by
IDEA, as follows:

              1.     If the  facility reports to TRI, then  the designated SIC code is the primary
                    SIC reported in the most recent TRI reporting year.

             2.     If the  facility does not report to TRI, the first SIC codes from all linked
                    AFS,  PCS, RCRAInfo, BRS ID/permits are assembled. If more than one
                    permit/ID exists for a particular program, then only one record from that
                    data system  is used. The SIC code that occurs most often, if there is one,
                    becomes the designated SIC code.

             3.     If the  facility does not report to TRI and no SIC code occurs more often
                    than others, the designated SIC code is chosen from the linked programs.
                    If more than one permit/ID exists  for a particular program, then only one
                    record from  that data system is used.

             Note that EPA does not attempt to define the actual number of facilities that fall
within each sector. Instead,  the information presented in this section reflects the records of a
subset of facilities within the sector that are well defined in EPA databases.

             To compare the number of reported facilities in EPA's database to the total sector
universe, most Sector Notebooks contain an estimated number of facilities within the sector
according to the Bureau of Census (See Section II). With sectors dominated by small businesses,
such as metal finishers and printers, the reporting universe in the EPA databases may be small in
comparison to Census data.  However, the group selected for inclusion in this data analysis
section should be consistent with this sector's general make-up.

             This subsection contains four tables that summarize enforcement and compliance
activities for the healthcare industry.  Tables VII-1 and VII-2 look exclusively at the healthcare
industry for the past five years.  Tables VII-3 and VII-4 provide a general overview of
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Healthcare Industry                               Compliance and Enforcement History

compliance and enforcement activities across each of the sectors discussed in a Sector Notebook,
for the past five years. Following this introduction is a list defining each column in the tables
presented in this section. The data in these tables solely reflect EPA, state, and local compliance
assurance activity data that have been entered into EPA databases. EPA ran data queries, for the
past five calendar years (February 19, 1998 to February 19, 2004). For up-to-date compliance
data, visit the Sector Notebook data refresh web page at: http://epa.gov/compliance/resources/
publications/assistance/sectors/notebooks/data refresh.html.

              Because most inspections focus on single-media requirements, the data presented
in this section result from queries of single-medium databases. These databases do not provide
data on whether inspections are state/local- or EPA-led. However, the table presenting the
universe of violations generally measures EPA's and states1 efforts within each media program.
The presented data illustrate the variations across Regions for certain sectors10. This variation
may result from state/local data entry variations, specific geographic concentrations, proximity
to population centers, sensitive ecosystems, highly toxic chemicals used in production, or
historical noncompliance. Therefore, the data do not rank regional performance or necessarily
reflect which regions may have the most compliance problems.

VII.C.        Compliance and Enforcement Data Definitions

              Facilities in Search (Tables VIM, 2,3, and 4) ~ the number of the FRS-
maintained Master Source IDs that were designated to  the listed SIC code range.

              Facilities Inspected (Tables VII-1,2,3, and 4) - the number of EPA and state
agency inspections for the facilities in this data search. These values show what percentage of
the facility  universe is inspected in a 24- or 60-month period.

              Number of Inspections (Tables VII-1,2,3, and 4) — the total number of
inspections conducted in this sector.  An inspection is counted each time it is entered into a
single-medium database.

              Average Months Between Inspections (Tables VII-1 and 3) — the average
length of time, expressed in months, between compliance inspections at a facility within the
defined universe.

              Facilities with One or More Enforcement Actions (Tables VII-1 and 3) — the
number of facilities that were party to at least one enforcement action within the defined time
period. This category is broken down further into federal and state actions in subsequent
columns. EPA obtained these data for administrative, civil/judicial, and criminal enforcement
actions. Administrative actions include Notices of Violation (NOVs). A facility with multiple
10 EPA Regions include the following states: 1 (CT, MA, ME, RI, NH, VT); 2 (NJ, NY, PR, VI); 3 (DC, DE, MD,
PA, VA, WV); 4 (AL, FL, GA, KY, MS, NC, SC, TN); 5 (IL, IN, MI, MN, OH, WI); 6 (AR, LA, NM, OK, TX); 7
(IA, KS, MO, NE); 8 (CO, MT, ND, SD, UT, WY); 9 (AZ, CA, HI, NV, Pacific Trust Territories); 10 (AK, ID, OR,
WA).

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Healthcare Industry                               Compliance and Enforcement History

enforcement actions is counted only once in this column. All percentages that appear are
referenced to the number of facilities inspected.

             Total Enforcement Actions (Tables VII-1,2,3, and 4) -- the total number of
enforcement actions identified for an industrial sector across all environmental statutes. In this
column, a facility with multiple enforcement actions is counted multiple times (e.g., a facility
with three enforcement actions counts as three).

             State-Led Actions (Tables VII-1 and 3) - the percentage of the total
enforcement actions taken by state and local environmental agencies. Note that this number may
not reflect the total number of state enforcement actions; some states extensively report
enforcement activities to EPA to include in its data systems, while other states may use their own
data systems.

             Federal-Led Actions (Tables VII-1 and 3) - the percentage of the total
enforcement actions taken by EPA. This number includes cases that were referred to EPA from
state agencies. Many of these actions result from coordinated or joint state/federal efforts,

             Enforcement-to-inspection Ratio (Tables VII-1 and 3) — shows how often
enforcement actions result from inspections; this number is presented for comparative purposes
only. This number simply indicates historically how many enforcement actions can be attributed
to inspection activity. This ratio includes and enforcement actions under the CWA (PCS), CAA
(AFS) and RCRA. Inspections and enforcement actions from the TSCA/FIFRA/EPCRA
databases are not factored into this ratio because most of the actions taken under these programs
are not the result of facility inspections. This ratio also does not account for enforcement actions
arising from noninspection compliance monitoring activities (e.g., self-reported water
discharges) under the CAA, CWA and RCRA.

             Media Breakdown of Enforcement Actions and Inspections (Tables VII-2
and 4) — four columns identify the proportion of total inspections and enforcement actions
within EPA's Air, Water, Waste, and TSCA/FIFRA/EPCRA databases.

VII.D.       Healthcare Industry Compliance History

             Table VII-1 provides an overview of the reported compliance and enforcement
data for the healthcare industry over the past five years (February 19, 1998 to February 19,
2004). These data are broken out by EPA Region, thereby permitting geographical comparisons.
Observations from the data are listed below:

             •      Regions 2, 3, and 4 contain the most healthcare facilities and conducted
                    the most inspections;

             •      Region 3 conducted, by far, the most inspections of healthcare facilities
                    and had the lowest average time between inspections; and
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Healthcare Industry                                Compliance and Enforcement History

             *      Region 2 had both the most enforcement actions, and the most
                    enforcement actions per inspection.

             Table VII-2 provides a more in-depth comparison between the healthcare industry
and other sectors by breaking out the compliance and enforcement data by environmental statute
for the same five-year period (February 19, 1998 to February 19,2004). These data are also
broken out by EPA Region, thereby permitting geographical comparisons.  Observations from
the data are listed below:

             •      The majority of inspections and actions are conducted under the C AA,
                    followed by RCRA; and

             •      Regions 7 and 8 have only conducted enforcement actions under the C AA.

             EPA's Region 2 office identified  the following most common healthcare facility
violations based on the inspections performed in their region, listed below.

             Most Common CAA Healthcare Facility Violations

             •      Failure to use properly trained and accredited asbestos personnel;

             •      Failure to notify EPA of asbestos removal projects and to keep required
                    documentation/records;

             •      Failure to properly dispose of asbestos debris;

             •      Failure to have CFC leak rate records for chillers and air conditioning
                    units more than 50 pounds of charge;

             ป      Failure to have EPA certified technicians for CFC-containing air
                    conditioning and refrigeration systems;

             •      Failure to get boilers permitted with the state agency;

             •      Failure to apply for Title V operating permit;

             •      Failure to close parts washer  lids when not in use; and

             •      Failure to include spray paint booths and parts degreasers in air permit.
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    Healthcare Industry
Compliance and Enforcement History
          Table VII-1: 5-Year Enforcement and Compliance Summary for the Healthcare Industry (SIC 8000), By Region
Region
National
1
2
3
4
5
6
7
8
9
10
Facilities in
Search
1,798
205
277
314
321
218
til
142
53
96
59
Facilities
Inspected
1,187
126
136
256
235
120
75
105
40
55
37
Number of
Inspections
3,953
265
391
1,413
854
296
131
268
127
138
67
Average
Months
Between
Inspections
27
46
43
13
23
44
51
32
25
42
53
Facilities with
1 or More
Enforcement
Actions
195
21
66
20
24
25
9
6
1
18
5
Total
Enforcement
Actions
343
31
130
51
37
35
14
11
1
28
5
Percentage of
State Actions
96%
100%
93%
98%
95%
97%
100%
100%
100%
96%
100%
Percentage of
Federal
Actions
4%
0%
7%
2%
5%
3%
0%
0%
0%
4%
0%
Enforcement-
to-Inspection
Ratio
0.09
0.12
0.33
0.04
0.04
0.12
0.11
0.04
0.01
0.2

o
00
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Healthcare Industry
Compliance and Enforcement History
 Table VII-2: 5-Year Enforcement and Compliance Summary for the Healthcare Industry (SIC 8000), by Region and Statute
Region
National
1
2
3
4
5
6
7
8
9
!0
Facilities In
Search
1,798
205
277
314
321
218
111
142
53
96
59
Facilities
Inspected
1,187
126
136
256
235
120
75
105
40
55
37
Number of
Inspections
3,953
265
391
1,413
854
296
131
268
127
138
67
Total
Enforcement
Actions
343
31
130
51
37
35
14
11
1
28
5
Clean Air Act
% of Total
Inspections
78%
81%
71%
88%
73%
83%
45%
80%
67%
70%
43%
% of Total
Actions
82%
74%
85%
90%
60%
80%
79%
100%
100%
86%
80%
Clean Water Act
% of Total
Inspections
0%
0%
2%
0%
0%
2%
0%
0%
0%
0%
0%
% of Total
Actions
2%
0%
2%
0%
0%
6%
0%
0%
0%
0%
0%
RCRA
% of Total
Inspections
21%
19%
24%
12%
27%
15%
55%
20%
33%
29%
52%
% of Total
Actions
16%
26%
12%
10%
41%
11%
21%
0%
0%
14%
20%
FIFRA/TSCA/EPCRA
% of Total
Inspections
1%
0%
3%
0%
0%
0%
0%
0%
0%
1%
4%
% of Total
Actions
1%
0%
!%
0%
0%
3%
0%
0%
0%
0%
0%
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Healthcare Industry                               Compliance and Enforcement History

             Most Common RCRA Healthcare Facility Violations

             •      Failure to comply with hazardous waste generator regulations and lack of
                    documentation;

             •      Failure to comply with Underground Storage Tank regulations and lack of
                    documentation;

             •      Improper or lack of hazardous waste labeling;

             •      Failure to have waste batteries/fluorescent lamps stored in proper
                    universal waste containers and labeled;

             •      No or infrequent weekly inspections of hazardous wastes storage/satellite
                    areas;

             •      Open containers of hazardous wastes;

             •      Failure to have hazardous waste determinations on file for all wastes (i.e.,
                    some pharmaceutical wastes are classified as RCRA hazardous wastes);

             •      Failure to have procedures in place to ensure spent aerosol containers are
                    empty before disposal as solid waste;

             •      Malfunctioning leak detection systems on underground storage tanks;

             •      Labeling of hazardous waste not done or incorrect;

             •      Improper disposal of chemotherapy drugs;

             •      Hazardous waste determination not done or incorrect;

             •      No or inadequate hazardous waste manifest;

             •      Disposal of hazardous waste down the drain;

             •      Improper management of expired pharmaceutical, paints, etc.;

             •      Lack of contingency plan;

             *      Lack of or inadequate training for employees in hazardous waste
                    management;

             •      Failure to ensure that hazardous waste meets Land Disposal Restrictions;

             •      Failure to upgrade or close USTs by December 22,1998; and
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Healthcare Industry                                Compliance and Enforcement History

              *      Improper consolidation of wastes from nearby facilities.

              Most Common CWA Healthcare Facility Violations

              •      No permit for noncompliance with wastewater discharges;

              •      Failure to know about local treatment plant sewer use regulations and
                    possible prohibited discharges for indirect dischargers;

              •      No or inadequate secondary containment for storage tanks;

              •      Improper disposal down floor drains; and

              •      No Spill Prevention, Control and Countermeasure Plan.

              Most Common EPCRA Healthcare Facility Violations

              •      Failure to report certain accidental chemical releases to the local
                    authorities along with emissions data; and

              •      Storage of chemicals (i.e., heating oil and gasoline) on site above
                    threshold amounts (hazardous chemicals above 10,000 Ibs and or
                    extremely hazardous substances present at 500 Ibs or the threshold
                    planning quantity, whichever is lower).

              Most Common FIFRA Healthcare Facility Violations

              •      Misuse of a registered pesticide product;

              •      Use of an unregistered product;

              •      Lack of proper records concerning pest control application within the
                    hospital and or on the hospital grounds; and

              •      Failure to report pesticide poisonings either occurring within the hospital
                    or of admitted patients.

              Common Violations and Problems Found at Hospitals for TSCA Issues

              TSCA inspectors are primarily interested in any PCBs and lead-based paint at
hospitals.  Typical staff residential area lead paint violations/issues  are:

              •      Failure to notify residents of lead paint in building or lack of knowledge
                    of any lead hazard; and
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Healthcare Industry                               Compliance and Enforcement History

              •      Failure to provide EPA's pamphlet, "Protect Your Family from Lead in
                    Your Home" as required under 40 CFR Part 745.107(a)(l) (see
                    http://www.epa.gov/opptintr/leafi/leadpdfe.pdf).

              Visit the Healthcare Environmental Resource Center at http://www.here.org for
plain language explanations on how to comply with environmental regulations and to learn about
pollution prevention opportunities. The Center web site also links to state rules and permitting
contacts. Its resource sections contain selected compliance assistance and pollution prevention
tools. If you don't have access to the Internet, refer to Section VI and to the Bibliography in
Section IX.B for additional resources.

VILE.        Comparison of Enforcement Activity Among Selected Industries

              Table  VII-3 compares the compliance history of the healthcare sector to the other
industries covered by the industry Sector Notebooks.  Observations from these  five years of data
are listed below:

              ซ      Sixty-six percent of healthcare facilities have been inspected over the past
                    five years, which is about equal to the average (62 percent) for all other
                    sectors listed;

              •      The inspected healthcare facilities have been inspected an average of three
                    times each; and

              •      The healthcare, ground transportation, and oil and gas extraction
                    industries have the highest percentage of state-led enforcement actions (96
                    percent).

              Tables VII-4 provides a more in-depth comparison between the healthcare
industry and other sectors by breaking out the compliance and enforcement data by
environmental statute. As in Table VII-3, the data cover the last five years. Observations from
the data are listed below:

              •      The majority of inspections and actions are conducted under the C AA,
                    followed by RCRA;

              •      The healthcare industry has a higher percentage of CAA inspections (78
                    percent) than the average of the other sectors (60 percent); and

              •      The healthcare industry has one of the lowest percentages of CWA
                    inspections and actions of any of the sectors listed in these tables.
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Healthcare Industry
Compliance and Enforcement History
                  Table VI1-3: 5-Year Enforcement and Compliance Summary for Selected Industries
Sector
Healthcare (SIC Code 8000)
Aerospace
Ag Chem Pesticide & Fertilizer
Ag Crop Production
Ag Livestock Production
Air Transportation
Dry Cleaning
Electronics & Computer
Fossil Fuel Elec Power Gen
Ground Transportation
Inorganic Chemical
Iron and Steel
Lumber & Wood Products
Metal Casting
Metal Fabrication
Metal Mining
Motor Vehicle Assembly
Non-Fuel, Non-Metal Mining
Nonferrous Metals
Oil & Gas Extraction
Organic Chemical
Petroleum Refining
Pharmaceutical
Plastic Resins & Fibers
Printing
Pulp and Paper
Facilities In
Search
1,798
764
585
131
53
428
3,345
1,852
3,520
4,970
1,007
683
3,038
1,346
8,279
281
1,886
3,778
531
2,783
1,050
438
572
709
2,384
566
Facilities
Inspected
1,187
526
345
69
17
211
1,620
906
2,543
3,338
629
480
2,045
797
5,092
183
1,21 1
2,005
327
1,681
787
297
414
502
1,460
467
Number of
Inspections
3,953
2,704
2,123
165
58
619
2,944
2,486
18,758
13,612
5,291
6,060
10,728
3,549
16,568
980
5,531
9,291
2,968
6,371
8,483
5,405
2,108
4,637
4,913
5,830
Average
Months
Between
Inspections
27
17
17
48
55
41
68
45
11
22
11
7
17
23
30
17
20
24
II
26
7
5
16
9
29
6
Facilities with
1 or More
Enforcement
Actions
195
246
138
12
14
80
232
286
1,170
1,084
352
312
872
348
2,138
70
500
522
242
1,120
558
352
174
344
476
336
Total
Enforcement
Actions
343
238
107
7
28
62
178
196
1,582
880
414
536
814
340
1,716
71
448
524
395
949
846
1,335
199
444
435
498
Percentage
of State-Led
Actions
96%
65%
57%
86%
11%
71%
92%
75%
78%
96%
79%
78%
85%
79%
76%
85%
77%
95%
88%
96%
73%
69%
84%
85%
90%
90%
Percentage of
Federal-Led
Actions
4%
35%
43%
14%
89%
29%
8%
25%
22%
4%
21%
22%
16%
21%
24%
16%
23%
6%
12%
4%
27%
31%
16%
15%
10%
10%
Enforcement-
to-inspection
Ratio
0.09
0.09
0.05
0.04
0.48
0.1
0.06
0.08
0.08
0.06
0.08
0.09
0.08
0.1
0.1
0.07
0.08
0.06
0.13
0.15
O.I
0.25
0.09
0.1
0.09
0.09
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                      February 2005

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Healthcare Industry
Compliance and Enforcement History
             Table VII-3: 5-Year Enforcement and Compliance Summary for Selected Industries (Continued)
Sector
Rubber and Plastic
Shipbuilding & Repair
Stone Clay Glass&Concrete
Textiles
Water Transportation
Wood Furniture & Fixtures
Facilities In
Search
3,823
235
3,388
1,226
269
1,652
Facilities
Inspected
2,294
168
2,013
814
158
1,047
Number of
Inspections
9,239
870
12,190
3,859
384
5,515
Average
Months
Between
Inspections
25
16
17
19
42
18
Facilities with
1 or More
Enforcement
Actions
962
96
876
304
40
440
Total
Enforcement
Actions
787
83
930
310
36
382
Percentage
of State-Led
Actions
90%
81%
89%
87%
89%
89%
Percentage of
Federal-Led
Actions
10%
19%
11%
13%
11%
12%
Enforcement-
to-inspection
Ratio
0.09
0.1
0.08
0.08
0.09
0.07
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                     February 2005

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Healthcare Industry
Compliance and Enforcement History
              Table VII-4: 5-Year Enforcement and Compliance Summary by Statute for Selected Industries
Sector
Healthcare
(SIC Code 8000)
Aerospace
Ag Chem Pesticide &
Fertilizer
Ag Crop Production
Ag Livestock Production
Air Transportation
Dry Cleaning
Electronics & Computer
Fossil Fuei Elec Power Gen
Ground Transportation
Inorganic Chemical
Iron and Steel
Lumber & Wood Products
Metal Casting
Metal Fabrication
Metal Mining
Motor Vehicle Assembly
Non-Fuel, Non-Metal Mining
Nonfenrous Metals
Oil & Gas Extraction
Organic Chemical
Petroleum Refining
Pharmaceutical
Plastic Resins & Fibers
Printing
Pulp and Paper
Rubber and Plastic
Shipbuilding & Repair
Stone Clay Glass&Concrete
Facilities In
Search
1,798
764
585
131
53
428
3,345
1,852
3,520
4,970
1,007
683
3,038
1,346
8,279
281
1,886
3,778
531
2,783
1,050
438
572
709
2,384
566
3,823
235
3,388
Facilities
Inspected
1,187
526
345
69
17
2!1
1,620
906
2,543
3,338
629
480
2,045
797
5,092
183
1,211
2,005
327
1,68!
787
297
414
502
1,460
467
2,294
168
2,013
Number of
Total
Inspections
3,953
2,704
2,123
165
58
619
2,944
2,486
18,758
13,612
5,291
6,060
10,728
3,549
16,568
980
5,531
9,291
2,968
6,371
8,483
5,405
2,108
4,637
4,913
5,830
9,239
870
12,190
Total
Enforcement
Actions
343
238
107
7
28
62
178
196
1,582
880
414
536
814
340
1,716
71
448
524
395
949
846
1,335
199
444
435
498
787
83
930
Clean Air Act
% of Total
Inspections
78%
52%
55%
50%
53%
38%
26%
31%
75%
78%
48%
61%
75%
60%
45%
56%
60%
97%
64%
97%
47%
57%
40%
51%
65%
67%
71%
59%
85%
% of Total
Enforcement
Actions
82%
43%
34%
71%
89%
23%
35%
14%
88%
76%
54%
67%
76%
59%
46%
52%
56%
99%
70%
98%
55%
83%
49%
59%
66%
75%
73%
34%
87%
Clean Water Act
% of Total
Inspections
0%
3%
12%
0%
0%
1%
0%
4%
18%
0%
13%
13%
1%
3%
2%
28%
1%
1%
9%
0%
12%
15%
7%
19%
0%
26%
1%
6%
1%
% of Total
Enforcement
Actions
2%
3%
8%
0%
7%
2%
0%
5%
8%
1%
10%
10%
0%
2%
1%
39%
1%
0%
5%
1%
13%
6%
8%
17%
0%
18%
0%
8%
1%
RCRA
% of Total
Inspections
21%
44%
27%
46%
47%
61%
74%
64%
6%
21%
37%
26%
24%
36%
52%
15%
38%
2%
27%
3%
39%
27%
52%
29%
34%
7%
27%
35%
13%
% of Total
Enforcement
Actions
16%
51%
31%
29%
0%
74%
65%
67%
3%
23%
31%
20%
23%
33%
46%
7%
40%
1%
22%
2%
28%
10%
37%
22%
33%
4%
23%
57%
10%
FIFRA/TSCA/
EPCRA/Other
% of Total
Inspections
1%
0%
6%
4%
0%
0%
0%
1%
0%
0%
1%
0%
1%
]%
1%
1%
0%
0%
0%
0%
2%
1%
1%
1%
1%
0%
1%
1%
1%
% of Total
Enforcement
Actions
1%
3%
27%
0%
4%
2%
0%
15%
1%
1%
6%
3%
1%
6%
7%
1%
3%
0%
2%
0%
5%
1%
6%
3%
1%
3%
5%
1%
2%
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                      February 2005

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Healthcare Industry
Compliance and Enforcement History
        Table VII-4: 5-Year Enforcement and Compliance Summary by Statute for Selected Industries (Continued)
Sector
Textiles
Water Transportation
Wood Furniture & Fixtures
Facilities In
Search
1,226
269
1.652
Facilities
Inspected
814
158
1.047
Number of
Total
Inspections
3,859
384
5.515
Total
Enforcement
Actions
310
36
382
Clean Air Act
% of Total
Inspections
76%
42%
76%
% of Total
Enforcement
Actions
59%
50%
75%
Clean Water Act
% of Total
Inspections
12%
1%
0%
% of Total
Enforcement
Actions
23%
0%
1%
RCRA
% of Total
Inspections
12%
56%
23%
% of Total
Enforcement
Actions
14%
50%
23%
FIFRA/TSCA/
EPCRA/Other
% of Total
Inspections
1%
1%
0%
% of Total
Enforcement
Actions
3%
0%
2%
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                     February 2005

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Healthcare Industry                               Compliance and Enforcement History

VII.F.       Review of Major Legal Actions

             This subsection discusses major legal cases and pending litigation within the
healthcare industry.  Following are several press releases that discuss recent major cases
regarding healthcare facilities:

 DEPARTMENT OF VETERANS AFFAIRS AGREES TO $133.000 SETTLEMENT FOR
    LEAD PAINT DISCLOSURE VIOLATIONS IN MAINE AND MASSACHUSETTS

EXCERPTS FROM: EPA Region 1 Press Release, April 6, 2004, Release # 04-04-04

             BOSTON - The U.S. Department of Veterans Affairs has agreed to pay a $10,068
penalty and perform environmental projects worth $123,050 to settle claims by the U.S.
Environmental Protection Agency that it failed to properly inform tenants about potential lead
hazards at employee housing provided by the department.

             The three EPA complaints allege violations of the federal Lead Disclosure Rule
for employee housing at VA Medical Centers in Northampton and Bedford, Mass, and Togus,
Maine. The three medical centers include a total of about 41 on-site housing units, which the VA
leases to employees and their families. Settlement of this case represents the first time a federal
facility has paid a penalty for violations of the Lead Disclosure Rule.

             In addition to paying the fine, the VA agreed to assign a person to be responsible
for environmental compliance at each facility, and to implement a lead-based paint abatement
project in employee housing at a total cost of $123,050. Of the case penalty, the Bedford facility
will pay $3,080; the Togus facility will pay $3,908; and the Northampton facility will pay
$3,080. This case abates health risks posed by lead paint in 16 units of employee housing divided
between the three locations and addresses the facilities' underlying barriers to compliance.

             The case is among numerous lead-related civil and criminal cases EPA New
England has taken to make sure landlords and property owners and managers are complying with
the federal Lead Disclosure Rule. EPA New England's work to implement the Residential Lead-
Based Paint Hazard Reduction Act has included more than 150 inspections around New
England, as well as numerous compliance assistance workshops.

             Low-level lead poisoning is widespread among American children, affecting as
many as three million children under the age of six, with lead paint the primary cause. Elevated
lead levels can trigger learning disabilities, decreased growth, hyperactivity, impaired hearing
and even brain damage. Lead is also harmful to adults. Adults can suffer from difficulties during
pregnancy, other reproductive problems, high blood pressure, digestive problems, nerve
disorders, memory and concentration problems, and muscle and joint pain.
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Healthcare Industry                               Compliance and Enforcement History

    EPA ORDERS CLOSURE OF MEDICAL WASTE INCINERATORS AT GUAM
                              MEMORIAL HOSPITAL

FOR RELEASE: June 2004

             HONOLULU — In response to an order from the U.S. Environmental Protection
Agency, the Guam Memorial Hospital Authority has shut down one of its medical waste
incinerators and will soon shut down a second in order to meet federal Clean Air Act standards.

             Guam Memorial Hospital Authority has agreed to comply with the EPA's order
by ceasing to operate its incinerators and putting an alternative medical waste treatment method
into place.

             The first of two incinerators was shut down on May 18. The second incinerator
was switched to emergency back-up status on June 11 and will be permanently shut down by
Nov.  30. The EPA determined that both incinerators were violating the emissions standards set
by the Clean Air Act.

             "It is critical that medical waste incinerators meet all of the required emission
standards to protect the public's health," said Deborah Jordan, the EPA's air division director for
the Pacific Southwest region.  "Developing alternative medical waste treatment will further
ensure clean air and proper disposal of medical waste for Guam's residents."

             During the initial source tests, one of the incinerators violated the particulate
matter, dioxins and furans,  hydrogen chloride and lead emissions limits, while the second
incinerator violated the particulate matter and hydrogen chloride emission limits. At that time,
Guam Memorial Hospital Authority also failed to submit to the EPA the required waste
management plan and necessary incinerator operating parameters and other required data for
both incinerators.

             In response to the order, Guam Memorial Hospital Authority has given the EPA a
plan to transport all hospital, medical and infectious waste to a commercial medical waste
treatment and disposal facility while the hospital develops an alternative waste treatment system.
             The EPA's order also requires the Guam Memorial Hospital Authority to:

             •      Provide to the EPA a copy of its waste management plan which will
                    include plans to separate solid waste from medical waste and other waste
                    minimization opportunities; and

             •      Complete the shut down of both incinerators by Nov.  30 and complete
                    final removal and proper disposal of the two incinerators by Dec.  30.

             All medical waste incinerators need to be permitted and have the necessary air
pollution controls to meet all Clean Air Act standards. Medical waste can be a source of
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Healthcare Industry	Compliance and Enforcement History

pollution from the pathological and biological waste, along with any chemicals produced during
incineration from plastics and other medical waste materials.

        SLOAN-KETTERING FINED FOR FAILURE TO PROPERLY MANAGE
                                HAZARDOUS WASTE

FOR RELEASE: Tuesday, January 27, 2004

              New York, N.Y. - The U.S. Environmental Protection Agency (EPA) announced
today that it has cited Memorial Sloan-Kettering Cancer Center in New York City for violating
numerous hazardous waste management requirements.  The Agency is seeking full compliance
and $214,420 in penalties for the violations.

              "Hospitals and healthcare facilities must consider the proper handling of
hazardous waste an integral part of their mandates to protect people's health," said Jane M.
Kenny, EPA Regional Administrator. "Chemotherapy waste is an especially toxic waste
produced by many  medical facilities. Hazardous waste regulations are in place to help to ensure
that facilities like Sloan-Kettering do not release these or other toxic chemicals into the
environment.

              EPA discovered violations of the Resource Conservation and Recovery Act
(RCRA) at Sloan- Kettering during a March 2003 inspection.  They included improper storage
and disposal of chemotherapy and dental solid wastes, as well as a general failure to determine
whether they were hazardous wastes. Sloan-Kettering has 30 days to respond to the complaint.

              In 2002, EPA started the Hospital and Healthcare Initiative to help hospitals and
healthcare facilities comply with environmental regulations as part of a larger EPA voluntary
audit policy. The Agency established the policy to encourage prompt disclosure and correction
of environmental violations, safeguarding people's health and the environment. Many hospitals
and healthcare facilities were not aware of their responsibilities under various environmental
laws or had failed to implement effective compliance strategies. As part of the initiative, EPA
sent letters to 480 facilities in New Jersey, New York, Puerto Rico and the U.S. Virgin Islands
and held free workshops to help hospitals comply. In addition, the Agency established a web
site that provides information about their duties under the law, and warned hospitals that EPA
inspections of their facilities - with risk of financial penalties - were imminent.

              Hospitals that wish to take advantage of the Agency's voluntary self-audit
program can investigate and disclose environmental violations to EPA and, if certain conditions
are met, receive a partial or complete reduction in financial penalties. To date, fourteen
healthcare organizations have entered into voluntary self-audit disclosure agreements with EPA.
The Agency is continuing to conduct inspections. More information about the healthcare
initiative can be found on EPA's web site at:  www.epa.gov/Region2/healthcare/index.html and
about hazardous waste regulation in general at: www, epa.gov/epaoswer/osw/index. htm.
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Healthcare Industry                               Compliance and Enforcement History

      EPA FINES NASSAU HEALTH CARE CORPORATION FOR VIOLATING
                       HAZARDOUS WASTE REGULATIONS

FOR RELEASE: Monday, October 20, 2003

             New York, N.Y. - The U.S. Environmental Protection Agency (EPA) announced
today that it will seek $279,900 in penalties from the Nassau Health Care Corporation Nassau
University Medical Center in East Meadow, New York for violating numerous requirements of
the federal and New York State hazardous waste regulations.  The medical research, diagnostic
and treatment facility must comply with all hazardous waste management requirements under the
Resource Conservation and Recovery Act (RCRA).

             "Hazardous waste regulations help to ensure that facilities like Nassau Health do
not release toxic chemicals into the environment and protect workers, patients and visitors at the
hospital," said EPA Regional Administrator  Jane M. Kenny.  "Many toxic compounds easily
contaminate air, ground or water and exposure can cause or aggravate many illnesses.  Though
there were no releases in this case, it is essential that companies with hazardous chemicals in
their waste follow EPA and state regulations very carefully to ensure that they don't endanger
people or the environment."

             The discovery of violations at Nassau Health grew out of EPA inspections of the
facility this past winter.  These violations included storage or abandonment of several types of
solid waste and chemicals, and failure to determine whether or not they were hazardous wastes.
In addition, the hospital did not have a permit to store hazardous waste, and did not meet the
protective management requirements needed to be exempt from a permit.  Hazardous waste
containers were not identified with the required markings or inspected regularly; emergency
response agencies were not notified of hazardous waste being stored; and the hospital did not
minimize the possibility of fire, explosion or unplanned release of hazardous substances into the
environment.  Finally, a number of hospital personnel responsible for hazardous waste
management were not trained in how to handle it, and no hazardous waste emergency response
plan was in place. Since the inspection, Nassau Health has been correcting the violations. The
company has 30 days to respond to the complaint.

             Nassau Health could have avoided this enforcement action by taking advantage of
EPA's Hospitals and Healthcare Initiative. EPA Region 2 started the Hospital and Healthcare
Initiative in the fall of 2002 to help hospitals and healthcare facilities comply  with environmental
regulations as part of a larger EPA Voluntary Audit Policy. The Agency established the policy
to encourage prompt disclosure and correction of environmental violations, safeguarding human
health and the environment.  Many hospitals and healthcare facilities were not aware of their
responsibilities under various environmental laws or failed to implement effective compliance
strategies. As part of the initiative, EPA sent letters to 480 facilities in New Jersey, New York,
Puerto Rico and the U.S. Virgin Islands and held free workshops to help hospitals comply. In
addition, the Agency established a web site that provides information about their duties under the
law, and warned hospitals that EPA inspections of their facilities - with risk of financial penalties
- were imminent.
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             Hospitals can take advantage of the Agency's Voluntary Audit Policy, through
which they can investigate and disclose environmental violations to EPA and, as a compliance
incentive, receive a partial or complete reduction in financial penalties. To date, eleven hospitals
have entered into voluntary self-audit disclosure agreements with EPA.

             More information about hazardous waste regulations can be found on EPA's web
site at: http://www. epa.sov/epaoswer/osw/index. htm.

  NORTH SHORE PAYS FINES FOR VIOLATING FEDERAL HAZARDOUS WASTE
                                 HANDLING RULES

FOR RELEASE: Thursday, June  12, 2003

             NEW YORK, N. Y. - North Shore University Hospital on Community Drive in
Manhasset has agreed to pay $40,000 in penalties to the federal government for violations of the
Resource Conservation and Recovery Act (RCRA) hazardous waste regulations, the U.S.
Environmental Protection Agency (EPA) announced today.

             EPA Regional Administrator Jane M. Kenny explained. "The only way hospitals
and other healthcare facilities can  ensure that wastes that have the potential to harm people and
the environment are properly handled is to strictly adhere to federal hazardous waste rules."

             As part of a region-wide initiative to bring hospitals into compliance with federal
rules, EPA is inspecting healthcare facilities in New York, New Jersey, Puerto Rico and the U.S.
Virgin Islands. The discovery of the violations at North Shore Hospital grew out of EPA
inspections of the facility in April  and May of 2002.

             EPA issued a complaint last year against North Shore hospital alleging it failed to
determine if spent fluorescent bulbs and chemotherapy waste were  hazardous prior to disposal,
and had improperly documented the transport of hazardous waste.  The Agency also cited North
Shore for failing to properly label  storage drums containing hazardous waste and to minimize the
risk of explosion, fire and release that could have affected people's health and the environment.
As part of the settlement between  the facility and EPA, the  facility  agreed to take corrective
actions that would prevent any recurrence of the violations  in the future.

             EPA operates a Voluntary Audit Policy, through which the Agency can
substantially reduce civil penalties for those that voluntarily disclose and promptly correct
violations that are identified through self-policing and meet certain other specified conditions,
except in cases involving serious harm to public health or the environment. In most cases, the
punitive component of the penalty may be fully eliminated, but EPA would still be able to collect
any economic benefit as a result of non-compliance.
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     EPA PROPOSES TO FINE PONCE HOSPITAL FOR ILLEGAL DISCHARGE

FOR RELEASE: Wednesday, November 19, 2003

             New York, N.Y. - The U.S. Environmental Protection Agency (EPA) has
proposed a $137,500 penalty against Quality Health Services of Puerto Rico, Inc. (Hospital San
Cristobal) for discharging wastewater to a small creek, a tributary to the Rio Inabon, in violation
of the federal Clean Water Act. The EPA issued a complaint based on the hospital's continuing
failure to comply with the requirements of its wastewater discharge permit.

             "Wastewater discharge permits protect public health and the environment," said
EPA Regional Administrator Jane M. Kenny. "The hospital has been out of compliance since
February 2000.  As a healthcare facility, Hospital San Cristobal should understand the
importance of properly managing its waste."

             The September 30, 2003 complaint charges that Quality Health Services violated
the requirements of its National Pollutant Discharge Elimination System (NPDES) permit, issued
under the Clean Water Act. In March 2003, EPA inspected the hospital and ordered Quality
Health Services to comply with the requirements of its NPDES permit. However, Quality Health
Services allegedly continued to violate the Clean Water Act (for a total of 226 times from
February 2000 through May 2003) with its discharge of sanitary wastewaters from the hospital's
wastewater treatment plant. Specifically, the discharge exceeded permit limitations for
ammonia, biochemical oxygen demand, color, fecal coliform, flow, fluoride, nitrate-nitrite,
phenolics, phosphorus, silver, sulfide, surfactants and zinc. Under federal regulations, Quality
Health Services has the right to request a hearing on the proposed penalty.

                      NEW YORK PRESBYTERIAN HOSPITAL

BASED ON NOVEMBER 2004 PRESS RELEASE

             New York Presbyterian Hospital was charged with failing to provide tenants,
including pregnant women and families with young children, with the required lead paint hazard
information (i.e., failing to provide a lead warning statement, statement disclosing any
knowledge of lead-based paint, and list of any existing records or reports pertaining to lead-
based paint, nor obtaining a statement by the lessee of receipt of a lead hazard information
pamphlet.) These failures are violations of 42 U.S.C. Section 4852d(b)(5) and ง 409 of TSCA,
15U.S.C. ง2689.

             Lead poisoning presents an environmental health hazard for young children living
in apartments constructed before 1978, due to the potential chipping or peeling of lead paint, or
lead-contaminated dust. New York Presbyterian Hospital owned and leased at least twenty-nine
housing units to families of physicians at their facility in White Plains, New York.  Region 2
suggested possible activities that could be undertaken as Supplemental Environmental Projects,
and New York Presbyterian Hospital submitted a proposal for a SEP that involved exterior
maintenance and repair, but the parties were unable to reach agreement on an appropriate SEP.
New York Presbyterian Hospital entered into a cash settlement with EPA for $248,000, which is


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the largest monetary settlement in the history of the Lead-based Paint Disclosure Program. On
July 10,2003, the Regional Administrator signed the Final Order memorializing the settlement
in the Consent Agreement and Final Order.  (T. Bourbon/L. Livingston)

   EPA FINES ATLANTIC HEALTH SYSTEMS INC. FOR FAILURE TO PROPERLY
                           MANAGE HAZARDOUS WASTE

FOR RELEASE: Tuesday, November 25,2003

             New York, N.Y. - The U.S. Environmental Protection Agency (EPA) announced
today that it will seek $64,349 in penalties from Atlantic Health System Inc., owner and operator
of Mountainside Hospital in Montclair, New Jersey. The Agency cited the company for violating
numerous hazardous waste management requirements under the Resource Conservation and
Recovery Act (RCRA).

             "Hospitals and healthcare facilities should consider the proper handling of
hazardous waste as an integral part of their mandates to protect people's health," said Jane M.
Kenny, EPA Regional Administrator."We are pleased that Mountainside Hospital has  recognized
its responsibility to its patients, employees and neighbors, and is taking action to correct the
violations."

             EPA discovered the violations at Mountainside Hospital during an April 2003
inspection. The violations included improper storage or disposal of several types of solid waste,
and failure to determine whether they were hazardous wastes. In addition, the hospital did not
have a permit to store hazardous waste and did not meet the protective management
requirements needed to be exempt from a permit. Hazardous waste containers were not clearly
identified with the required markings or inspected regularly, and emergency response
information was not posted. Mountainside is working to correct the violations. Its parent
company, Atlantic Health, has 30 days to respond to the complaint.

             In 2002, EPA started the Hospital and Healthcare Initiative to help hospitals and
healthcare facilities comply with environmental regulations as part of a larger EPA voluntary
audit policy. The Agency established the policy to encourage prompt disclosure and correction
of environmental violations, safeguarding people's health and the environment. Many hospitals
and healthcare facilities were not aware of their responsibilities under various environmental
laws or had failed to implement effective compliance strategies. As part of the initiative, EPA
sent letters to  480 facilities in New Jersey, New York, Puerto Rico and the U.S. Virgin Islands
and held free workshops  to help hospitals comply. In addition, the Agency established a web site
that provides information about their duties under the law, and warned hospitals that EPA
inspections of their facilities - with risk of financial penalties - were imminent.

             Hospitals  that wish to take advantage of the Agency's voluntary self-audit
program can investigate and disclose environmental violations to EPA and,  if certain conditions
are met, receive a partial  or complete reduction in financial penalties. To date, eleven hospitals
have entered into voluntary self-audit disclosure agreements with EPA. The Agency is
continuing to conduct inspections.
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   YALE-NEW HAVEN HOSPITAL ACCEPTS EPA PLAN FOR ENVIRONMENTAL
                                      AUDIT

             Yale-New Haven Hospital and EPA say they have reached an agreement under
which the hospital will voluntarily carry out a comprehensive environmental audit. The
agreement between EPA Region I and the hospital in New Haven, Conn., is the first of its kind to
be signed in New England and is part of an agency effort to improve hospital compliance with
environmental laws. EPA Region I launched its hospital initiative earlier this year, citing the
experience of EPA's New York/New Jersey regional office, which took enforcement actions
against several hospitals after significant noncompliance was found during inspections of
hospital facilities.
Source: httD://Dubs.bna.com/w/BNA/den,nsf/is/aObOd4kld7
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VIII.        COMPLIANCE ACTIVITIES AND INITIATIVES

             This section highlights organizations, resources, and the voluntary activities being
undertaken by the healthcare sector, public agencies, and nongovernmental organizations to
improve the sector's environmental performance.  These activities include those independently
initiated by industrial trade associations.

VIII.A.      Healthcare Related Programs and Activities

             Healthcare Environmental Resource Center (Compliance Assistance Center)

             Using an EPA grant the National Center for Manufacturing Sciences with the
cooperation of the American Hospital Association, the American Nurses Association, and EPA,
via the Hospitals for a Health Environment (H2E) program and other stakeholders, is creating an
on-line compliance assistance center (or Healthcare Environmental Resource Center - HERC)
serving the healthcare industry. The HERC will address issues relevant to hospitals, ambulatory
clinics, and other specialized medical facilities. It will serve as a first stop for environmental
compliance and pollution prevention information  for the healthcare industry. Among its many
compliance assistance and pollution prevention features, the  HERC will include plain language
explanations of applicable regulations and feature links to state and local permitting agencies
where users can find information on local regulations and contacts. Look for the Healthcare
Environmental Resource Center at www.HERCenter. org.

             Hospitals for a Healthy Environment (H2E)

             Hospitals for a Healthy Environment (H2E) is a voluntary program jointly
sponsored by the EPA, the American Hospital Association, the American Nurses Association,
and Health Care Without Harm. The primary goal of the H2E effort is to educate healthcare
professionals about pollution prevention opportunities in hospitals and healthcare systems and
make significant reductions in mercury-containing healthcare waste, and waste volume overall.
Through activities such as the development of best practices, model plans for total waste
management, resource directories, and case studies, the project hopes to provide hospitals and
healthcare systems with enhanced tools for minimizing the volumes of waste generated and the
use of persistent, bioaccumulative, and toxic chemicals. Such reductions are beneficial to the
environment and health of our communities. Furthermore, improved waste management
practices will reduce the waste disposal costs incurred by the healthcare industry. For more
information, see the web site at http://www. h2e-online. org/.

             Resource Conservation Challenge (RCC)

             EPA's Resource  Conservation Challenge (www.epa.gov/rcc) is a voluntary, joint
effort between EPA, businesses, and communities. RCC aims to find flexible, yet more
protective ways of improving waste reduction, public health, and the environment. As part of the
Resource Conservation Challenge, EPA is asking the hospital industry to develop projects for the
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reuse and recycling of hospital items and the reduction of waste. For more information, see the
web site at http://www.epa.gov/epaoswer/osw/conserve/clusters/hospital.htm.

             Lead needed to protect healthcare workers from CatScan radiation, mercury in
ultraviolet lamps, and residual or expired Pharmaceuticals are just a few examples of the hospital
waste that can harm the environment if disposed of improperly. EPA's RCC is committed to
supporting projects that:

             •      Reduce the volume of nonhazardous solid waste, including paper,
                    packaging, yard waste, food waste, and electronic equipment, from the
                    healthcare industry and promote its recycling and safe reuse;

             •      Virtually eliminate all mercury waste from the healthcare industry waste
                    stream;

             *      Reduce the volume of other toxic chemicals; and

             •      Improve the management of pharmaceutical waste by reducing the amount
                    of expired/unused pharmaceuticals that are disposed of in landfills.

             Performance Track

             Performance Track is a public/private partnership recognizing top environmental
performance among participating U.S. facilities of all types, sizes, and complexity, public and
private. Program partners are providing leadership in many areas, including preventing pollution
at its source and implementing environmental management systems. Currently, the program has
about 300 members and welcomes all qualifying facilities. Applications are accepted twice a
year: February 1-April 30 and August 1-October 31.  For more information, contact the
Performance Track hotline at (888) 339-PTRK or visit the web site at
www. epa. gov/performancetrack.

             EPA Audit Policy

             EPA encourages companies with multiple facilities to take advantage of the
Agency's Audit Policy (Incentives for Self-Policing: Discovery, Disclosure, Correction and
Prevention of Violations, 65 Fed. Reg. 19618 (April  11,2000)) to conduct audits and develop
environmental compliance systems.  The Audit Policy eliminates gravity-based penalties for
companies that voluntarily discover, promptly disclose, and expeditiously correct violations of
federal environmental law. More information on EPA's Audit Policy can be obtained from the
web site at http://www. epa. gov/compliance/resources/policies/incentives/auditing/index. html.
EPA Region 2 (NY, NJ, PR, VI) has been actively promoting use of the policy; see voluntary
audit policy at http://www.epa.gov/region02/healthcare/.
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             Office of Solid Waste and Emergency Response (OSWER) Innovations Pilot

             The Office of Solid Waste and Emergency Response (OSWER) initiated a series
of innovative pilots to test new ideas and strategies for environmental and public health
protection to find creative approaches to waste minimization. For additional information on
OSWER Innovations Pilots, visit the EPA OSWER Innovations web site at
www. epa.gov/oswer/iwg.

             Expanding Pharmaceutical Waste Management in Hospitals

             Hospitals for a Healthy Environment is partnering with EPA Region 1,
Dartmouth-Hitchcock Medical Center, New Hampshire Department of Environmental Services,
New Hampshire Hospital Association, and H2E Champion, PharmEcology Associates, to
pioneer pharmaceutical management techniques that ensure regulatory compliance, implement
best management practices, and identify and implement waste minimization opportunities.
Baseline data on costs and quantities of end-of-life pharmaceuticals will be compiled and
evaluated. This information will be used to assess where pharmaceuticals are being discarded,
how much is being wasted, and how wasting can be minimized. Based on the results of the
baseline assessment, the pilot will develop best management practices incorporating waste
reduction activities. A blueprint will be developed providing a step-by-step approach to program
implementation and lessons  learned. For more detailed information on the pharmaceutical pilot,
visit H2E's web site at www.h2e-online.org.

             Collaborative Partnership to Improve Environmental Performance in the
             Healthcare Sector

             The overall goal of this project is to institutionalize regulatory compliance and
pollution prevention practices in the healthcare sector. To achieve this the project seeks to
establish a formal  lasting partnership with multiple healthcare and regulatory organizations and
JCAHO to maximize EPA compliance assistance and pollution prevention resources, improve
the  environmental performance of the healthcare sector, and create incentives for continuous
improvement. The final product will be a set of matrices for JCAHO surveyors and hospital
personnel that align environmental regulations and environmental improvement with the JCAHO
standards. The matrices will be available electronically on EPA's forthcoming Healthcare
Environmental Resource Center's web site at www.HERCenter.ors.  For more detailed
information on the JCAHO project, visit H2E's web site at: www.h2e-onUne.org.

             National Strategies for Healthcare Providers: Pesticide Initiative

             The Pesticide Initiative is an initiative created by EPA and the National
Environmental Education & Training Foundation (NEETF) in collaboration with the U.S.
Departments of Health and Human Services, Agriculture, and Labor. It is aimed at incorporating
pesticide information into the education and practice of healthcare providers. The goal is to

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improve the recognition, diagnosis, management, and prevention of adverse health effects from
pesticide exposures. This initiative also serves as a model for broader efforts to educate
healthcare providers about the spectrum of environmental health issues. Seven federal agencies
and 16 professional associations of healthcare providers were involved in launching this
initiative. For additional information, visit the EPA Pesticide Initiative web site at
http://www. epa. gov/oppfeadl/safetv/healthcare/healthcare.htm

             EPA and Veterans Health Administration (VHA) Cooperative Environmental
             Partnership

             Stemming from EPA inspections of VA medical centers in 2002 that revealed
repeated violations of environmental regulations, particularly those involving federal hazardous
waste management regulations, EPA and VHA are conducting environmental management
reviews (EMRs) at select VA medical centers.  EMRs evaluate the current status of the
management system and identify steps to establish a comprehensive management system for
environmental compliance as well as continual improvement beyond compliance. The
partnership has fostered environmental training through both EPA Headquarters and the
Regions,  and assisted in the development of the VA's Green Environmental Management
Systems (GEMS). These efforts and others are underway to improve environmental compliance
and performance at VA medical centers.  For additional information visit
http://www.epa.gov/compliance/assistance/sectors/federal/epavha.html.

             The Green Suppliers Network (GSN)

             The Green Suppliers Network (GSN) is a collaborative venture between industry,
EPA, and 360vu, the national accounts organization of the Department of Commerce's National
Institute of Standards and Technology Manufacturing Extension Partnership (NIST MEP). GSN
provides expert technical assistance to small and medium-sized suppliers, through 360vu's
national network of technical assistance centers. This assistance provided in a GSN Review
enables suppliers to optimize processes and products, eliminate waste, reduce their
environmental impacts, identify cost-saving opportunities, and remain competitive. GSN
engages both original equipment manufacturers and their suppliers to achieve environmental and
economic benefits throughout the supply chain.  GSN has launched a pharmaceutical/healthcare
initiative  piloted in Puerto Rico. For additional information on the program, contact Kristin
Pierre at pierre.kristinฎ.epa.gov or  (202) 564-8837.

             WasteWi$e Program

             The WasteWi$e Program was started in 1994 by EPA's Office of Solid Waste and
Emergency Response.  The program is aimed at reducing municipal solid wastes by promoting
waste minimization, recycling collection, and the manufacturing and purchase of recycled
products. As of February 17,2004, Waste Wise has 1,377 partners (including alumni) spanning
more than 54 industry sectors. Members agree to identify and implement actions to reduce their

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solid wastes and must provide EPA with their waste reduction goals along with yearly progress
reports. EPA in turn provides technical assistance to member companies and allows the use of
the WasteWi$e logo for promotional purposes. Sixty-one medical services companies are
partners. For more information, contact the Hotline at (800) EPA-WISE (372-9473) or the web
site at www. epa. gov/wgstewise.

              Energy Starฎ

              In 1991, EPA introduced Green Lightsฎ, a program designed for businesses and
organizations to proactively combat pollution by installing energy efficient lighting technologies
in their commercial and industrial buildings. In April 1995, Green Lightsฎ expanded into
Energy Starฎ Buildings — a strategy that optimizes whole-building energy-efficiency
opportunities.  The energy needed to run commercial and industrial buildings in the United
States produces 19 percent of U.S. carbon dioxide emissions, 12 percent of nitrogen oxides, and
25 percent of sulfur dioxide, at a cost of $110 billion a year. If implemented in every U.S.
commercial and industrial building, the Energy Starฎ Buildings upgrade approach could prevent
up to 35 percent of the emissions associated with these buildings and cut the nation's energy bill
by up to $25 billion annually.

              The more than 7,000 participants include corporations, small businesses,
universities, healthcare facilities, nonprofit organizations, school districts, and federal and local
governments.  Energy Starฎ has successfully delivered energy and cost savings across the
country, saving businesses, organizations, and consumers more  than $7 billion a year. Over the
past decade, Energy Starฎ has been a driving force behind the more widespread use of such
technological innovations as LED traffic lights, efficient fluorescent lighting, power
management systems for office equipment, and low standby energy use.  For more information,
contact the Energy Star Hotline, (888) STAR-YES ((888) 782-7937) or the web site at
http://www. energvstar. gov/healthcare.

              Small Business Compliance Policy

              The Small Business Compliance Policy promotes environmental compliance
among small businesses (those with 100 or fewer employees) by providing incentives to discover
and correct environmental problems. EPA will eliminate or significantly reduce penalties for
small businesses that voluntarily discover violations of environmental law and promptly disclose
and correct them.  A wide range of resources are available to help small businesses learn about
environmental compliance and take advantage of the Small Business Compliance Policy. These
resources include training, checklists, compliance guides, mentoring programs, and other
activities.  Businesses can find more information through links on the web site at
http://wwv.epa.sov/smaHbusiness/.
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             Healthy Building Network (HBN)

             Healthcare institutions are increasingly embracing green building goals driven by
several important factors: public health, market competitiveness, operation costs, and social
responsibility. HBN is a national network of green building professionals, environmental and
health activists, socially responsible investment advocates, and others who are interested in
promoting healthier building materials as a means of improving public health and preserving the
global environment.  For more information, contact HBN at (202) 898-1610 or the web site at
http://www.healthvbuilding.net/healthcare/index.html.

             Health Care Without Harm (HCWH)

             HCWH is an international coalition of hospitals and healthcare systems, medical
professionals, community groups, health-affected constituencies, labor unions, environmental
and environmental health organizations, and religious groups.

             In 1994, EPA's draft Dioxin Reassessment identified medical waste incineration
as the single largest source of dioxin air pollution. The HCWH campaign was formed in 1996 to
respond to this serious problem. Since then, the campaign has grown from an initial 28 founding
organizations into a broad-based international coalition. The mission of HCWH is to transform
the healthcare industry worldwide, without compromising patient safety or care, so that it is
ecologically sustainable and no longer a source of harm to public health and the environment.
For more information, contact the HCWH web site at http://www.noharm.ors/.

              The Sustainable Hospitals Project (SHP)

             SHP's mission is to provide technical support to the healthcare industry for
selecting products and work practices that reduce occupational and environmental hazards. The
SHP is based at the University of Massachusetts Lowell Center for Sustainable Production
(LCSP). The project includes in-hospital research on implementing new products and practices,
using SHP's Pollution Prevention and Occupational Safety and Health (P2OSH) model.
Additionally the SHP web site, http://www.sustainablehospitals.org. provides a list of alternative
products to help hospitals identify and evaluate more benign alternatives to existing products.
SHP also provides technical support by email (shptaluml.edu) or phone ((978) 934-3386). For
more information, contact the web site at http://www.sustainablehospitals.org.

             Nightingale Institute for Health and the Environment (N1HE)

             NIHE assists healthcare professionals recognize the inextricable link between
human and environmental health and their role in changing practices to improve the health of
humans and the environment.  There are three initiatives associated with this program: the
Trustees Initiative, the Clinicians Initiative, and the Environmental Procurement Initiative. Each
initiative is designed to educate the target audience on the environmental impact of the

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healthcare industry, and to offer resources that enable them to improve the environmental
performance of their organizations or processes and minimize the adverse ecological impact in
the communities they serve. Inherent in this project is an emphasis on sustainability, resource
conservation, and life cycle thinking. For more information, contact the web site at
http://www.nihe.org/.

              Canadian Centre for Pollution Prevention (Healthcare EnviroNet)

              Healthcare EnviroNet provides the healthcare community with access to
environmental information, products, and services that support a commitment to quality
healthcare, protection of the environment, and sustainability. Healthcare EnviroNet delivers a
unique collection of Canadian-based information including:

              •      Green alternatives for healthcare facilities;
              •      Regulatory updates and government initiatives; and
              •      Canadian case studies.

              Healthcare EnviroNet was established with funding from Environment Canada
and is developed and maintained by the Canadian Centre for Pollution Prevention in consultation
and partnership with healthcare and nongovernment organizations.  For more information, go to
the web site at http://www. c2p2online. com/main.php3 ?section =83&doc id=169.

              Recovered Medical Equipment for the Developing World (REMEDY)

              Founded in 1991 at Yale University School of Medicine, REMEDY is  a group of
healthcare professionals and others promoting the nationwide practice of recovery of open-but-
unused surgical supplies with the goal of providing international medical relief while reducing
solid medical waste from U.S. hospitals.  For more information, go to the web site at
http://www. remedyinc. org/aboutjts. cfm.

              Public Entity Environmental Resource (PEER) Center

              The PEER Center is the Public Entity Environmental Management System
Resource Center. A virtual clearinghouse, it is specifically designed to aid local, county, and
state governments that are considering implementing or have implemented an environmental
management system (EMS) and want to access the knowledge and field experience of other
public entities that have done so. For more information, go to the web site at
http://www.peercenter.net/.
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             ISO 14000

             ISO 14000 is a series of internationally accepted standards for environmental
management. The series includes standards for EMS, guidelines on conducting EMS audits,
standards for auditor qualifications, and standards and guidance for conducting product lifecycle
analysis. Standards for auditing and EMS were adopted in September 1996, while other
elements of the ISO 14000 series are currently in draft form.  While regulations and levels of
environmental control vary from country to country, ISO 14000 attempts to provide a common
standard for environmental management. The governing body for ISO 14000 is the International
Organization for Standardization (ISO), a worldwide federation of over 110 country members
based in Geneva, Switzerland. The American National  Standards Institute (ANSI) is the United
States representative to ISO. Information on  ISO is available at the following Internet site:
http://www. iso. ch/iso/en/ISOOnline. openerpage.

VIII.B.      Summary of Trade Organizations and Industry Organizations

             There are dozens of trade organizations associated with the healthcare industry.
The following list is meant to act as a representative sample, not a comprehensive list.

             Joint Commission on Accreditation  of Healthcare Organizations (JCAHO)

             JC AHO is an independent nonprofit organization whose mission is to improve the
safety and quality of care through its accreditation process. JCAHO standards promote patient
safety and care and good operational practices in all aspects of healthcare organizations. Nearly
17,000 healthcare organizations worldwide are accredited by JCAHO. Extensive on-site reviews
are conducted at least once every three years. The reviews currently only cover environmental
issues in a limited manner. See Collaborative Partnership to Improve Environmental
Performance in the Healthcare Sector in Section VIII. A of this Notebook to see how H2E is
working with JCAHO to help healthcare facilities improve their environmental performance.
Contact Information: One Renaissance Blvd,  Oakbrook Terrace, IL 60181, Phone: (630) 792-
5000, Fax: (630) 792-5005, web site: http://www.icaho.ors/.

             American Hospital Association (AHA)

             The AHA provides education for healthcare leaders and is a source of information
on healthcare issues and trends. Through its representation and advocacy activities, AHA
ensures that members' perspectives and needs are heard and addressed in national health policy
development, legislative and regulatory debates, and judicial matters.  AHA advocacy efforts
include the legislative and executive branches and the legislative and regulatory arenas.  Contact
Information: One North Franklin, Chicago, IL 60606-3421, Phone: (312) 422-3000, web site:
http://www.aha. ors/.
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              American Medical Association (AMA)

              The AMA serves as the steward of medicine and leader of the medical profession.
The AMA is the national professional organization for all physicians and the leading advocate
for physicians and their patients.  The AMA's envisioned future is to be an essential part of the
professional life of every physician and an essential force for progress in improving the nation's
health. Contact Information: 515 N.  State Street, Chicago, IL 60610, Phone: (800) 621-8335,
web site: http://www.ama-assn.ore/.

              American Dental Association (ADA)

              The ADA is the professional association of dentists committed to the public's oral
health, ethics, science and professional advancement and leading a unified profession through
initiatives in advocacy, education, research and the development of standards. Contact
Information: 211 East Chicago Ave., Chicago, IL 60611-2678, Phone: (312) 440-2500, web site:
http://www. ada. org/.

              American Nurses Association (ANA)

              ANA focuses its work on core issues of vital concern to the nation's registered
nurses - nursing shortage, appropriate staffing, health and safety, workplace rights, and patient
safety/advocacy - in addition to its cornerstone work, ethics and standards.

              The ANA, composed of professional nurses dedicated to the promotion of health
and the care of the sick, has served as the forum in which the nation's critical health issues have
been discussed throughout the last century.

              Functioning as a democracy, the ANA provided the structure in which views were
expressed, ideas were debated and evaluated, and positions and goals were formulated. Because
it represented the views of administrators, clinical practitioners in institutions and community
agencies, educators, and researchers, it has served for 100 years as the public voice for the
diversity of America's professional nurses. Contact Information: 600 Maryland Ave. SW., Suite
100W, Washington  B.C. 20024, Phone: (202) 651-7000, Fax: (202) 651-7001, web site:
http://www. ana, org/.

              American Veterinary Medical Association (AVMA)

              The AVMA, established in 1863, is a not-for-profit association representing more
than 69,000 veterinarians working in private and corporate practice, government, industry,
academia, and uniformed services. Structured to work for its members, the AVMA acts as a
collective  voice for its membership and for the profession.
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Healthcare Industry                                 Compliance Activities and Initiatives

             The AVMA provides a number of tangible benefits to its members, including
information resources, continuing education opportunities, quality publications, and discounts on
personal and professional products, programs and services.  Contact Information: 1931 North
Meacham Road - Suite 100, Schaumburg, IL 60173, Phone: (847) 925-8070, Fax: (847) 925-
1329, web site: http://www.avma.org/.

             American Health Care Association (AHCA)

             The AHCA is a nonprofit federation of affiliated state health organizations,
together representing nearly 12,000 nonprofit and for-profit assisted living, nursing facility,
developmentally disabled, and subacute care providers that care for more than 1.5 million elderly
and disabled individuals nationally.

             AHCA  represents the long-term care community to the nation at  large - to
government, business leaders, and the general public.  It also serves as a force for change within
the long-term care field, providing information, education, and administrative tools that enhance
quality at every level.

             At its Washington, D.C. headquarters, the association maintains legislative,
regulatory and public affairs, as well as member services staffs that work both internally and
externally to assist the  interests of government and the general public, as well as member
providers. In that respect, AHCA represents its membership to all publics, and national
leadership to its members.  Contact Information: 1201 L Street, N.W., Washington, D.C. 20005,
Phone: (202) 842-4444, Fax: (202) 842-3860, web site: http://www.ahca.ore/.

             American Society for Healthcare Environmental Services (ASHES)

             Setting  the standard for environmental excellence, ASHES advances healthcare
environmental services, textile care professions and related disciplines. ASHES leads, represents
and serves our members by promoting excellence, best practices, innovation, and leadership
through advocacy, education and certification. Web site: http://www.ashes.org/.

             American Society for Healthcare Engineers (ASHE)

             ASHE is the advocate and resource for continuous improvement  in the healthcare
engineering and facilities management professions. Web site: http://ww\v. as he. org/.

             College of American Pathologists (CAP)

             The CAP, the principal organization of board-certified pathologists, serves and
represents the interest  of patients, pathologists, and the public by fostering excellence in the
practice of pathology and laboratory medicine.
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Healthcare Industry                                Compliance Activities and Initiatives

             The CAP's Strategic Plan is intended to help ensure that the College fulfills its
mission in a thoughtful and effective manner. The plan contains 13 specific directions that the
College will follow in carrying out its commitment to members, their patients, and the public.
CAP members can download a copy of the Strategic Plan; log in to access the file.  Contact
Information: 325 Waukegan Road, Northfield, IL 60093-2750, Phone: (847) 832-7000, Fax:
(847) 832-8000, web site: http://www.cap.or2/.

             National Indian Health Board (NIHB)

             The NIHB represents Tribal Governments operating their own healthcare delivery
systems through contracting and compacting, as well as those receiving healthcare directly from
the Indian Health Service (IHS). Contact Information:  101 Constitution Ave. N.W., Suite 8-B02,
Washington, B.C. 20001, Phone: (202) 742-4262, Fax: (202) 742-4285, web site: www.nihb.org.
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Healthcare Industry
                                                  Contacts and References
IX.
CONTACTS/ACKNOWLEDGMENTS/RESOURCE MATERIALS/
BIBLIOGRAPHY
              For further information on selected topics within the healthcare industry, a list of
publications and contacts is provided below:
IX.A.
Contacts/Document Reviewers
                                           11
Name
Seth Heminway

Anuj K. Goel, Esq.

Charlotte A. Smith,
R. Ph., M.S., HEM

Laura Brannen
Jeffrey Keohane

Eydie Pines
Fawzi M. Awad,
M.S., E.H.S. II

Catherine Galligan
Kathleen Malone
Organization
EPA, Office of
Compliance

Director, Regulatory
Compliance,
Massachusetts
Hospital Association
President,
PharmEcology
Associates, LLC
Hospitals for a
Healthy Environment
Karshmer &
Associates (P.C.)

Hospitals for a
Healthy Environment
Saint Paul-Ramsey
County Department of
Public Health,
Environmental Health
Section
Sustainable Hospitals
Project Clearinghouse
Manager
EPA, Region 2
Telephone/Email
(202) 564-701 7 /
heminwav.seth&i.epamail.epa.sov

(781) 272-8000, ext. I40/
azoel@mhalink. org

(262) 814-2635 /
info(8),pharmecohgy. com

(603) 643-6700 /
laura. brannen@ih2e-ontine. ors
(5 1 0)841 -5056 /
keohane(a).karshmerindianlaw.com

(603)643-67107
evdie.mnes(ciih2e-online. ors
(651)773-44597
fawz i. awad@,co. ramsey. mn. us

(978) 934-3386 7
shp@,uml.edu
(212)637-40837
malone.katMeenฎฃpa.gov
Subject
Overall Notebook
Content and General
Format
Characterization of the
Healthcare Industry

Activity Descriptions

Hospital "Wastes
Environmental
Regulations on Indian
Country
Pharmaceutical Waste
Minnesota Pollution
Control Agency Fact
Sheets
Healthcare Wastes and
Sustainable Hospitals
Project Fact Sheets
Federal Statutes and
Regulations
11 Many of the contacts listed in this section have provided valuable background information and comments during
the development of this document EPA appreciates this support and acknowledges that the individuals listed do not
necessarily endorse all statements made within this Notebook.
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February 2005

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Healthcare Industry
                     Contacts and References
Name
Susan A. Moak,
CHSP
Linda Longo
Linda Martin
Michelle Yaras
Marvin Stillman
Glenn McRae
Hollie Schaner, RN,
FAAN
Dale Woodin
Cathy Knox
Chen Wen
John Gorman
Diane Buxbaum,
M.P.H.
Diane Lynne
Organization
Director of
Occupational and
Environmental Safety,
Long Island Jewish
Medical Center
Regional Compliance
Assistance
Coordinator
EPA Region 2
Veterans Health
Administration
EPA, Office of
Compliance -
Agriculture Division
Manager of
Environmental
Compliance
University of
Rochester Strong
Memorial Hospital
CGH Environmental
Strategies, Inc.
CGH Environmental
Strategies, Inc.
Deputy Executive
Director, American
Society of Healthcare
Engineering (ASHE)
Director, EHS Parker
Hughes Cancer CJinic
(PHCC)
EPA, Office of
Pollution Prevention
and Toxics
EPA, Region 2
EPA, Region 2
EPA, Federal
Facilities Enforcement
Office
Telephone/Email
(71 8) 470-4784 /
SmoakฎMLedu
(2 12) 637-3565 /
lonso. Unda(ajฃpa.gov

(3 14) 543-6719 /
linda. martin5(cb,med. va. sov
(202)564-41537
varas. michelle,ih.org

(202) 564-8849 /
wen. chentftyepa.gov

(212)637-4008/
eorman.johnda)ฃDa.zov
(212)637-39197
buxbaum.diane(3),epa.eov

(202) 564-2587 /
diane. Ivnneffbepa.Rov

Subject
Overall Notebook
Content
Federal Statutes and
Regulations
Overall Notebook
Content
FIFRA Information
Overall Notebook
Content
Overall Notebook
Content
Overall Notebook
Content
Healthcare Wastes
Healthcare Wastes
H2E
Hazardous Waste
Compliance
Industry Specific
Environmental
Requirements
EPA- Veterans Health
Administration (VHA)
Compliance Assistance
Programs
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February 2005

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Healthcare Industry
                                                 Contacts and References
Name
Linda Martin
Michael Pagan
Jan Pickrel
Daniel Schultheisz
Carey Johnston
Kristina Meson
Organization
Veterans Health
Administration
EPA, Region 10 H2E
Coordinator
EPA, Water Permits
Division, Industrial
Branch
EPA, Radiation
Division
EPA, Office of Water
EPA, Office of Solid
Waste
Telephone/Email
(3 14) 543-671 9 /
Undo. martin5a.gov
(202)566-10147
iohnston. carev(S>,eva. eov
(703) 308-8488 /
meson. kristina(3>,epa. sov
Subject
EPA- Veterans Health
Administration (VHA)
Compliance Assistance
Programs
Web Site Information
Healthcare Wastewater
Mixed Waste
Healthcare Wastewater
Hazardous Waste
IX.B.
Bibliography
             Below is a list of references used in compiling this Sector Notebook, by section.
The Healthcare Environmental Resource Center contains additional details on most of the
subjects touched on in this Notebook and is an excellent follow-up reference for locating
information on state and local requirements. For your convenience, the Center  maintains
current URLs for all of the sites mentioned in this document at www.HERCenter. ore/links.
Section II - Introduction to the Healthcare Industry	

American Hospital Association, http://www.hospitalconnect.com/aha/resource center/
       fastfacts/fast facts US_hospitals.html

The Centers for Medicare & Medicaid Services (CMS), http://www.cms.hhs.gov/.

The MedPAC reports, http://www. medpac.gov/.

U.S. Census Bureau, http://www.census.goy/prod/ec97/97s62-szJpdf.

Webster's Medical Dictionary, http://www.abms.org/Downloads/Which%20Med%20Spec.pdf.

The American Veterinary Medical Association, httt>://www. avma. org/membshp/marketstats/
       usvets.asp. Note: veterinary market statistics 2003 Economic Report on Veterinarians &
       Veterinary Practices is available for purchase
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Healthcare Industry                                            Contacts and References

The TrendWatch report by the Lewin Group released at the 2004 AHA Annual Meeting in
       Washington, www. hospitalconnect. com/aha/press room- info/specials Indies, html.

Section III - Activity Descriptions	

Centers for Disease Control and Prevention, http://wmv.cdc.gov/ncidod/hip/sterile/sterilgp.htm

Hospitals for a Healthy Environment (H2E),
       http://www.h2e-online.org/pubs/chemmm/master.pdf
       http://www. h2e-online. org/pubs/wrswde/wappe.pdf"

Occupational Health and Safety Administration,
       http://www.osha.gov/SLTC/etools/hospital/index.html.

PRO ACT, http://www.afcee. brooks, af.mil/pro~act/pro-acthome.asp.

U.S. EPA Region 2 presentation. Identification and Management of Regulated Hazardous
       Waste, A  Workshop Geared Toward Healthcare Facilities, February 2004.

U.S. EPA Region 2, Draft Healthcare Hazardous Waste Management, February 2004.

U.S. EPA Region 3, http://www.epa.gov/reg3artd/airregulations/ap22/incin2.htm.

World Healthcare Organization,
       http://www.who.int/water_sanitationmhealth/medicalwaste/en/euide2.pdf.

Emmanuel, Jorge,Ph.D., CHMM, REP, PE.  Non-Incineration Medical Waste Treatment
       Technologies. Health Care Without Harm, August 2001,
       http://www.noharm.org/nonincineration.

Hospitals for a Healthy Environment (H2E). Managing Healthcare's Waste: Developing a
       Pollution Prevention Model, http://www. h2e-online. ore/.

Shaner, H.G., C.L. Bisson, G. McRae. An Ounce of Prevention: Waste Reduction Strategies for
       Health Care Facilities. American Society of Healthcare Environmental Services,
       Chicago,  1993.

Shaner, HG, G. McRae.  Guidebook for Hospital Waste Reduction Planning and Program
       Implementation. American Society of Healthcare Environmental Services.  Chicago,
       1996.
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Healthcare Industry _ Contacts and References

Smith, Charlotte A. Identifying and Managing Hazardous Pharmaceutical Waste.
      PharmEcology Associates, LLC. H2E Teleconference, September 12, 2003,
      http://www. h2e-online. org/tools/chem-pharm. htm.

University of Iowa Virtual Hospital Site, http://www. vh. org/welcome/aboutus/index. html.

U.S. Department of Labor Program Highlights Fact Sheet No.  DOSHA 9l-3BWaste Anesthetic
      Gases, http://www.osha.gov/pls/oshaweb/owadisp.show document?
      p table=FACT SHEETS&p id=128.

Section  IV - Waste and Emissions Profile _

EPA's Hospital/Medical/Infectious Waste Incinerators,
      http://www.epa.gov/ttn/atw/129/hmiwi/rihmiwi.html.

Health Care Without Harm, http://www. noharm. org/library/docs /SHEA_Proceedinss _ Waste
      Management_White_Paper.pdf:
      http://www.noharm.org/library/docs/Going Green_4-l  Waste _Minimization_
      Sesreeation.pdf: v
      http://www.noharm.org/nonincineration: '
      http://www.npharm. org/details. cfm?type=document&id=599: and
      http://www.noharm.ore/librarv/docs/Goins GreenThe Mercury Problem-Fast Fact
Hospitals for a Healthy Environment, http://www. h2e-online. org/tools/chemplan. htm.

U.S. EPA FRN 40 CFR Part 60 Standards of Performance for New Stationary Sources and
      Emission Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
      Incinerators; Final Rule September 15, 1997,
      http://www.epa.gov/ttn/atw/129/hmiwi/fr91597.pdf.

U.S. EPA Region 2 presentation.  Identification and Management of Regulated Hazardous
      Waste, A Workshop Geared Toward Healthcare Facilities, February 2004.

U.S. EPA Region 2. Draft Healthcare Hazardous Waste Management, February 2004.

Western Regional Pollution Prevention Network,
      http://www.westp2net.org/hospital/pdf/Minimizing%20Red%20Bag%20Waste.ppt.

World Health Organization, http://www. who. int/inf-fs/en/fact253. html.

Environmentally Conscious Manufacturing Strategic Initiative Group. Hospitals and Health
Care Impacts, Risks and Regulations, http://ecm. ncms. org/eri/new/IRRhosp. htm.

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Healthcare Industry                                            Contacts and References

Kentucky Cancer Registry Online Abstractor Manual, Appendix H,
       http://www.kcr. uky. edu/manuals/abstractor/appendix_h.pdf.

Section V - Pollution Prevention Opportunities	

California Integrated Waste Management Board. Fact Sheet: Waste Reduction Activities for
       Hospitals, December 2003.

Davis, Stephanie C.  10 Ways to Reduce Regulated Medical Wastes (RMW). Waste Reduction
       Remedies, June 2002.

Health Care Without Harm.  Non-Incineration Medical  Waste Treatment Technologies, August
       2001.

Shaner, H.G., C.L. Bission, G. McRae. An Ounce of Prevention: Waste Reduction Strategies
      for Health Care Facilities. American Society of Healthcare Environmental Services,
       Chicago, 1993.

Shapiro, Karen, et.al.  Healthy Hospitals: Environmental Improvements Through Environmental
       Accounting. Tellus Institute, Submitted to U.S. EPA's Office of Prevention, Pesticides
       and Toxic Substances, Boston, MA, July 2000.

Sustainable Hospitals Project Fact Sheets: These are available online at
       http://www.sustainablehospitals.org. Over two dozen short, informative summaries
       address EPP, Glutaraldehyde, Laboratory Practices, Latex & Medical Gloves, Mercury,
       Microfiber Mopping, and Safe Sharps Devices.  (Note: A list of SHP fact sheets follows
       this table). Contact: Catherine Galligan, SHP Clearinghouse Manager, phone (978) 934-
       3386 or shp(fl),uml.edu.

Minnesota Pollution Control Agency Health Care Fact Sheets: These are available online at
       http://www.pca.state.mn.us/industry/healthcare.html. Over three dozen short,
       informative summaries covering all aspects of the healthcare industry.

Section VI - Summary of Federal Statutes and Regulations	

U.S. Army Center for Health Promotion and Preventive Medicine.  Management of Unused
       Pharmaceutical Nitroglycerin, http://chppm-www.apgea.army.mil/documents/FACT/37-
       019-702.pdf.

U.S. EPA Monthly Hotline Report December 1994 RCRA/UST, Superfund, and EPCRA.
       Notification Requirements for Exported Wastes,
       http://www. eva. sov/evaoswer/hotline/94revort/12 94. txt.
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Healthcare Industry _ Contacts and References

U.S. EPA Region 2 presentation dated February 2004. Identification and Management of
      Regulated Hazardous Waste, A Workshop Geared Toward Healthcare Facilities.

U.S. EPA Region 2. Draft Healthcare Hazardous Waste Management, February 2004.

Kentucky Pollution Prevention Center, Healthcare Guide to Pollution Prevention
      Implementation through Environmental Management Systems,
      http://www.kppc.org/Publications/Print%20Materials/Healthcare%20Guide/index.cfm.

Electronic Code of Federal Regulations (e-CFR) BETA TEST SITE for 40 CFR:
      htt://ecr.oaccess.ov/ci/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.
The Office of Wastewater Management, NPDES Stormwater Program web site:
       http://www.epa.gov/npdes/stormwater.

EPA's Office of Solid Waste and Emergency Response web site:
       http://www.epa.gov/epaoswer/osw/laws-reg.htm.

EPA's Oil Program web site: ht tp://www. epa.gov/oilspill/.

EPA's Polychlorinated Biphenyl (PCB) Homepage, http://www. epa.gov/pcb/.

EPA's Air Program Mobile Sources web site:
http://www. epa.gov/ebtpages/airmobilesources. html.

EPA's Asbestos Management and Regulatory Requirements web site:
       httu://www. eDa.sov/fedsite/cd/asbestos. html.
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