Draft Manual for Infectious Waste Management
SW-957 -- September 1982

Apparently, this manual was never finalized after EPA decided to put infectious sewage sludge on agricultural land as
pathogen contaminated sludge is not mentioned. Changing the name to biosolids did not change the nature of the
pathogens in sludge nor did testing the sludge at an elevated temperature..

RCRA defines infectious characteristics of solid waste as hazardous waste.

"Infectious or infective is defined as "capable of producing infection; pertaining to or characterized by the presence of
pathogens" (4) . A
pathogen is "any disease-producing microorganism or material" (4). Etiologic agent is defined as "a
viable microorganism or its toxin which causes, or may cause, human disease" (5). The related term "biohazard" —
which is defined as an "infectious agent presenting a risk or potential risk to the well-being of man, either directly
through his infection or indirectly through disruption of his environment" (6) — is commonly used, and the biological
hazard symbol (see Figure 3-1) is used universally to denote the presence of etiologic agents."

Twenty-seven years after this manual was written, EPA still  reserves space for listing the following etiologic agents in
the  current hazardous waste regulation part 261 Appendix V & VI  and a space for the treatment of infectious waste.  
Escherichia coli
(fecal coliform), and all enteropathogenic serotypes are Etiologic agents.

In 1989 EPA posted a short list of documented disease causing organisms in the Federal Register which are found in
sludge - biosolids.

However, this list was removed from the final Part 503 Regulation because no one would accept sludge/biosolds
knowing these etiologic agents were in the material causing it to be a hazardous waste.

The gram negative pathogens on the 1989 list are now referred to by the name of the tests, coliform and fecal coliform,
which are run at 37 deg C and 44.5 deg C.  E. coli is the primary pathogenic bacteria that still shows some activity at the
elevated test temperature. The pathogenic Kelbsiella bacteria also has some activity at elevated test temperature.
These bacteria are also the most sensitive to heat and disinfectant, but they still are not destroyed by any current
treatment process.

Urine and feces are infectious medical laboratory waste --  
[but ok on your food crop?]

Draft Manual for Infectious Waste Management
SW-957 -- September 1982


Bacterial Agents

Acinetobacter calcoaceticus
Actinobacillus — all species
Actinomycetaceae — all members
Aeromonas hydrophila
Arachnia propionica
Arizona hinshawii — all serotypes
Bacillus anthracis
Bacteroides spp.
Bartonella — all species
Bordetella — all species
Borrelia recurrentis, .B. vincentii
Brucella — all species
Campylobacter (Vibrio) foetus, C_. (Vibrio) Jejuni   [Primary pathogen in sewage sludge]
Chlamydia psittaci, C. trachomatis
Clostridium botulinumV Cl. chauvoei, Cl. haemolyticvon, Cl. histolytictim, Cl. novyi, Cl. septicum, Cl. tetanl
Corynebacterium diphtheriae, C_. equi, C_. haemolyticum, C_, pseudotuberculosis, C_. pyogenes > C_. renale
Edwarsiella tarda
Eryaipelothrix Insidiosa
Escherichia coli, all enteropathogenic serotypes    [Primary pathogen in sludge]  [coliform -- fecal coliform]
Francisella (Pasteurella) tularensis
Haemophilus ducreyi, H. influenzae
Klebsiella — all species and all serotypes                                               [coliform -- fecal coliform]
Legionella — all species and all Legion-ella-like organisms
Leptoapira Interrogans — all serovars
Listeria — all species
Mimae polymorpha
Moraxella — all species
Mycobacteriuin — all species
Mycoplasma — all species
Neisseria gonorrhoeae, N_. meningitidis
Nocardla asteroldes
Pasteurella — all species
Plesiomonas shigelloides
Proteus — all species
Pseudomonas mallei
Pseudomonas pseudomallei
Salmonella — all species and all serotypes          [Primary pathogen in sludge]
Shigella — all species and all serotypes               [Primary pathogen in sludge]
Sphaerophorus necrophorus
Staphylococcus aureus
Streptobacillus moniliformis
Streptococcus pneumoniae
Streptococcus pyogenes
Treponema carateum, T^. pallidum, and ^.pertenue
Vibrio cholerae, V^ parahaemolyticus                            [Primary pathogen in sludge]
Yersinia (Pasteurella) pestis, Y. enterocoli-tica

Viral and Rickettsial Agents

Adenoviruses — human — all types
Arboviruses — all types
Coxiella burnetil
Coxsackie A and B viruses — all types                 [Primary pathogen in sludge]
Creutzfeldt-Jacob agent
Dengue viruses — all types
Ebola virus
Echoviruses — all types                                         [Primary pathogen in sludge]
Encephalomyocarditis virus
Hemorrhagic fever agents including, but not limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses,
and Korean hemorrhagic fever viruses
Hepatitis associated materials
(hepatitis A, hepatitis B, hepatitis nonA-nonB)     [Primary pathogen in sludge]
Herpesvirus — all members
Infectious bronchitis-like virus
Influenza viruses — all types
Kuru agent
Lassa virus
Lymphocytic choriomeningitis viruse
Marburg virus
Measles virus
Mumps virus
Parainfluenza viruses — all types
Polioviruses — all types
Poxviruses — all members
Rabies virus — all strains
Reoviruses — all types                              [Primary pathogen in sludge]
Respiratory syncytial virus
Rhinoviruses — all types
Rlckettsia — all species
Rochalimaea quintana
Rotaviruses — all types                            [Primary pathogen in sludge]
Rubella virus
Simian virus 40
Tick-borne encephalitis virus complex, including Russian spring-summer encephalitis, Kyasanur forest disease, Omsk
hemorrhagic fever, and Central European encephalitis viruses
Vaccinia virus
Varicella virus
Variola major and Variola minor viruses
Vesicular stomatis viruses — all types
White pox viruses
Yellow fever virus

Fungal Agents

Blastomyces dermatltidis
Coccidioides immitis
Cryptococcus neoformans
Histoplasma capsulatum
Paracoccidioides brasiliensis

2.1  Introduction
The question of how to define infectious waste has been discussed for years without resolution satisfactory to all
interested parties. Regulatory agencies, hospitals, and research laboratories, for example, all have different
perspectives that influence their views of infectious waste. There is no general unanimity of opinion about which types
of waste should be classified as infectious. Even the terminology that has been used for this type of waste is imprecise
— the terms infectious, pathological, biomedical, biohazardous, toxic, and medically hazardous have all been used at
various times to describe similar material. The result has been a proliferation of definitions that are often confusing and
sometimes even contradictory. Because the purpose of this manual is to discuss methods of infectious waste
management, it is first essential to clarify what constitutes infectious waste.

Infectious or infective is defined as "capable of producing infection; pertaining to or characterized by the presence of
pathogens" (4) . A pathogen is "any disease-producing microorganism or material" (4). Etiologic agent is defined as "a
viable microorganism or its toxin which causes, or may cause, human disease" (5). The related term "biohazard" —
which is defined as an "infectious agent presenting a risk or potential risk to the well-being of man, either directly
through his infection or indirectly through disruption of his environment" (6) — is commonly used, and the biological
hazard symbol (see Figure 3-1) is used universally to denote the presence of etiologic agents.

From these definitions it would appear to be simple enough to define infectious waste as "waste that contains
pathogens." However, infectiousness as a characteristic of some wastes is difficult to define and impossible to quantify.
The difficulties in establishing the definition of infectious waste derive from the characteristics of pathogens, the nature
of disease, and the factors that determine the induction of disease. These topics are discussed briefly in this chapter as
they relate to the determination of which wastes should be classified as infectious because of their potential for causing
illness in people or animals.

2.2 Pathogens
Pathogenic microorganisms include bacteria, fungi, viruses, viroids, rickettsiae, and protozoa. They cause a variety of
diseases in many hosts in the animal and plant worlds. In addition to the natural strains of pathogens, there are now
strains that are characterized by resistance to antibiotics; such resistant strains are often found in hospitals and other
health-care facilities. Most pathogens cause a single disease whereas a few may induce different diseases depending
on the route of transmission and the susceptibility of the host. Pathogens are diverse in their physiology and life cycle.
Some microorganisms are obligate pathogens (i.e., they can survive only in specific hosts) while others are facultative
pathogens (i.e., they can infect hosts to induce disease but they can also survive without a host when environmental
conditions are suitable). Similarly, no generalizations can be made about the type of environmenal conditions that are
necessary for pathogen survival. Some pathogens are obligate aerobes or anaerobes (i.e., they require aerobic or
anaerobic conditions, respectively, for survival) whereas others are facultative aerobes or anaerobes (i.e., they flourish
under one set of conditions but they are able to survive under the other). Because of the great natural diversity in
environmental conditions, pathogens are ubiquitous in the environment.

Not all pathogens are microorganisms. Many parasites such as the nematodes (helminths) and trematodes (flukes) are
higher forms of life. Other pathogenic agents are not viable, but they are produced by living organisms. Bacterial toxins
and mycotoxins are examples of this last type of pathogenic agent, specific examples being the bacterial toxins that
cause diphtheria and botulism and the mycotoxin aflatoxin that can cause cancer. Disease-causing materials that are
neither .living organisms (or parts thereof) nor produced by living organisms — e.g., chemical carcinogens — are not
discussed in this guidance manual.

The pathogens of relevance to this document are those whose presence in various wastes renders the waste
hazardous — that is, a potential cause of disease. The pathogens of greatest concern are those that cause diseases
that are severe, difficult to treat, and for which there are no effective and reliable immunizations. Theoretically, it would
be useful to have a comprehensive list of all pathogens, especially one which ranks pathogens according to hazard.
Different schemes for classifying pathogens have been developed by various experts and organizations. For example,
some of these are based on the severity of the hazard that the pathogen presents to the public health (7,8) or to
laboratory and

research workers (9-16). None of these classifications, however, is appropriate for use in defining infectious wastes
because none takes into consideration all relevant factors such as the obligate nature of some pathogens, resistant
strains, pathogen concentrations, the nature of the waste, and the conditions within the waste to which the pathogens
are exposed. Nevertheless, as one example, Appendix A presents the list of etiologic agents that was published by the
Centers for Disease Control for use in setting minimum packaging requirements for the interstate shipment of materials
containing etiologic agents (17).

2.3 Diseases and Disease Induction
Diseases differ greatly in type and severity. Illness need not even be manifest as a disease; it can be subclinical and
asymptomatic. Some of the difficulties in establishing a definition of infectious waste are related to the variabilities in
disease and in the disease-causing process.

The principal factors that are necessary for the induction of disease include:
0 the presence of a pathogen,
0 the presence of a susceptible host,
0 a route of exposure for transmission of the pathogen to the host,
0 exposure to a virulent pathogen, and 0 exposure to an infective dose.

These factors are discussed below in general terms as they relate to the definition of infectious waste.
The presence of a pathogen. The induction of disease by pathogens requires the presence of pathogens. Therefore, in
order for a waste to be infectious, it must contain pathogens with sufficient virulence in adequate numbers to provide an
infective dose. See Section 2.2 for a detailed discussion of pathogens. Pathogen virulence and infective dose are
discussed below.

The presence of a susceptible host. Pathogens cause disease in a host, and therefore disease induction requires the
presence of a susceptible host. In the general population, there is great variation in susceptibility to disease.
Susceptibility depends on a variety of factors that include the person's state of health (or illness), age, general immune

state, and the degree of immunity to a particular pathogen that may have been conferred by previous exposure or
immunization. The groups that are most susceptible are the very young, the very old, the chronically ill, and the immune-
deficient (as the result of genetics, illness, or treatment).

A route of exposure for transmission of the pathogen to the host. In order for a pathogen to induce disease in a
susceptible host, there must be a route of exposure that transmits the pathogen to the host. The principal routes of
transmission that are relevant to infectious waste as a source of disease are ingestion, inhalation, and percutaneous
transfer. Every exposure route is not necessarily conducive to disease induction; for example, some pathogens are
pathogenic only in the respiratory system and they are rendered harmless or are killed in the digestive tract. Ingestion
of pathogens can result from eating material that contains the pathogens (contaminated food products, for example).
With most infectious wastes, however, it is more likely that ingestion would result from hand-to-mouth transfer of
pathogens when hands are contaminated, for example, from handling the waste. Inhalation of pathogens associated
with wastes results in the introduction into the respiratory system of air-borne pathogens associated with dust particles
or in aerosolized or splattered liquids. Percutaneous transfer occurs when pathogens, present on the skin or in waste
that is touched, penetrate the skin through cuts or abrasions, when cuts or puncture wounds are inflicted by sharps
contaminated with pathogens, and when animal vectors transmit pathogens by contact with cuts or abrasions or by
biting or stinging the host.

Exposure to a virulent pathogen. Pathogen virulence — i.e., "the degree of pathogenicity of a microorganism as
indicated by case fatality rates and/or its ability to invade the tissues of a host; by extension, the competence of any
infectious agent to produce pathologic effects" (4) — varies with the species as well as with the individual
microorganism. The virulence depends on numerous factors including the strain of the pathogen, the environmental
conditions to which it was subject, and the route of exposure.

Exposure to an infective dose. It is impossible to quantify infective dose — i.e., "that amount of pathogenic
microorganisms that will cause infection in susceptible subjects" (4) — because the number of pathogens that are
required in order to induce a disease varies greatly. The principal factors that determine infective dose are the nature
of the pathogen (i.e., species, strain, and virulence), the susceptibility of the host, and the method of transmission.

2«4 Designation of Infectious Wastes
Any definition of infectious waste must take into consideration the factors that have been discussed in this chapter. For
a waste to be infectious in the sense that it presents the hazard of causing disease, it must contain pathogens or
biologically active material in sufficient concentration or quantity so that exposure to the waste could result in disease.

Testing of wastes for the presence of pathogens is certainly not advocated. The results of such culturing of the wastes
would not be meaningful for identifying infectious waste. Negative cultures do not necessarily confirm that no pathogens
are present because many microorganisms require very specific conditions for growth and there are some pathogens
(e.g., those causing hepatitis) that cannot be cultured. The expense of providing all possible culture conditions and
specific tests for every batch of waste, or even for some batches, is not warranted.

Therefore, the most rational approach to defining infectious waste is to designate as infectious those wastes that in all
probability contain pathogenic agents that — because of their type, concentration, and quantity — may cause disease
in persons exposed to the waste. In the interests of clarity and for ease of reference, EPA recommends that 13 types of
waste be designated infectious wastes (see Section 2.5). This designation is based primarily on specific waste type
rather than on the source of the waste. Therefore, a particular type of infectious waste may be generated by different
industries and by more that one source within a facility (see Section 2.6).

2.5  Types of Infectious. Waste
After consideration of the comments submitted in response to the proposed regulation on the listing of infectious wastes
(18) and after numerous discussions with experts in the affected industries and in the biological safety field, EPA
concluded that infectious wastes can be classified into 13 categories. Certain of these wastes (e.g., pathological wastes
and sharps) are not necessarily always infectious, but they are included in the list because they should always be
handled in accordance with management practices that minimize the hazards and address the special problems of
these wastes.
EPA recommends that the following types of waste (as further defined in this section) be considered infectious waste
and that they be managed in accordance with the recommendations of this manual: