vvEPA
              United States
              Environmental Protection
              Agency
Office of Water
Regulations and Standards
Washington, DC 20460
              Water
              TECHNICAL SUPPORT
              DOCUMENT
              Pathogen/Vector Attraction

              Reduction in Sewage Sludge

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                                  PREFACE

    Section 405(d)  of the Clean Water Act requires  the  U.S.  Environmental
Protection Agency (EPA)  to develop and issue  regulations  that  identify:

    •    Uses  for  sludge,  including various means of disposal
    •    Factors,  including costs, which must be considered when determining
         the measures and practices applicable to each use or disposal method
    •    Pollutant concentrations  that interfere with each use or disposal
         method
    To comply with this  statutory mandate,  EPA has  embarked on a  program to
develop five major technical regulations:   land application,  distribution and
marketing;  monofilling;  surface disposal;  incineration;  and reduction of
pathogens and vector attraction.  EPA has also proposed regulations  governing
the establishment of State sludge management  programs,  which will implement
both existing and future criteria (40 CFR 501).

    The principal goal of the proposed regulation for pathogen and vector
attraction reduction is  to protect human health.   These requirements apply co
sewage sludge that is applied to the land,  distributed and marketed, or placed
in a monofill or impoundment.   This document  provides the technical  background
and justification for the provisions contained in Subpart F of the proposed
regulation.

    Public comment on the technical adequacy  and scientific validity of this
document as well as the requirements contained in the proposed regulation
should be submitted during the public comment period.  Any questions related
to this document may be directed to:

                 Dr.  Joseph B. Farrell
                 U.S. Environmental Protection Agency
                 Risk Reduction Environmental Laboratory
                 26 West Martin Luther King Drive
                 Cincinnati,  OH 45268
                 513-569-7645
                               Martha Prothro, Acting Director
                               Office of Water Regulations and Standards

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                            TABLE OF CONTENTS



                                                                 Page

LIST OF UNITS AND ACRONYMS                                         v

1.  INTRODUCTION                                                  1-1

      1.1  Sludge Use on Land Before  Federal Regulation            1-1
      1.2  Federal Regulations                                    1-3


2.  COMPONENTS OF DISEASE RISK AND THEIR CONTROL                   2-1

      2.1  Pathogens of Concern                                   2-1
           2.1.1  Bacteria                                        2-1
           2.1.2  Viruses                                         2-6
           2.1.3  Protozoa                                        2-11
           2.1.4  Helminths                                       2-12
      2.2  Transport of Organisms                                 2-14
           2.2.1  Air Transport                                   2-15
           2.2.2  Groundwater Transport                            2-16
           2.2.3  Surface Water Transport                         2-17
           2.2.4  Adherence to Objects                            2-18
           2.2.5  Transport by Vectors                            2-18
      2.3  Vector Attraction                                      2-19
      2.4  Infective Dose                                         2-22


3.  THE PROPOSED REGULATION                                       3-1

      3.1  Background                                             3-1
      3.2  Scientific Basis of the Proposed Regulation            3-3
           3.2.1  Specialized Definitions (Section 503.51)         3-3
           3.2.2  Class A Requirements                            3-5
           3.2.3  Class B Requirements                            3-16
           3.2.4  Class C Requirements                            3-23
           3.2.5  Septage                                         3-26


4.  REFERENCES                                                    4-1
                                     -iii-

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-iv-

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           LIST OF UNITS AND ACRONYMS
CFU               colony-forming units

cm                centimeter

EPA               U.S.  Environmental  Protection Agency

g                 gram

ha                hectare

m                 meter

mg                milligram

mL                milliliter

mm                millimeter

MPN               most probable number

NP/LSA            no primary/long-sludge  age

no./g VSS         number pathogens/gram volatile  suspended  solids
                  sludge

PFRP              process to  further  reduce pathogens

PFU               plaque-forming units

PSRP              process to  significantly reduce pathogens

VS                volatile solids

VSS               volatile suspended  solids
                        -v-

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                               SECTION ONE
                              INTRODUCTION
    Human bodily waste  has  been  applied to soil for its fertilizer value and
organic content since the beginning of recorded history and, no doubt, before
that time.  Land application  of  human wastes has many beneficial aspects;
however, most countries of  the world now regulate this practice to minimize
the potential for the spread  of  disease by pathogens (disease-causing
microorganisms) in human wastes  and the possibility that contaminants in
sludge may reduce soil  productivity and crop wholesomeness.

    This technical support  document describes sludge utilization in the United
States and the risks of disease  from sludge utilization.  It summarizes the
existing Federal regulations  for controlling pathogens in sludge, discusses
their shortcomings, and presents new knowledge relevant to creating an
improved regulation.  Section 3  presents the principal aspects of the proposed
new regulations concerning  sludge pathogen control and discusses the available
scientific information that supports these regulations, as well as data gaps
and areas in which additional information would be helpful.
1.1 SLUDGE USE ON LAND BEFORE FEDERAL REGULATION

    Most cities and towns in the  United  States  have processed their wastewater
in centralized facilities since the  early  1900s.  This processing produced
large volumes of sludge that had  to  be disposed of.  Widely disparate disposal
practices developed,  ranging from ocean  disposal  to incineration; each
municipality chose the  practice that best  suited  its particular circumstances.
Frequently, muncipalities simply  gave their  sludge away to farmers or
processed it into a fertilizer product.
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    Agricultural use of  sludge was  important enough that, in 1946, members of
the Federation of Sewage Works Associations (the forerunner of the Water
Pollution Control Federation) made  it  the subject.of their second manual of
practice:   "Utilization  of Sewage Sludge as Fertilizer"  (FSWA, 1946).  Their
manual details a variety of utilization practices in use at that time.
Several large municipalities were heat drying waste-activated sludge and
selling it  as a fertilizer.  Air-dried digested sludge,  generally dried on
sand beds,  was used on orchards.  The  manual recommended using the material in
the same manner as manure  for vegetable crops, including root crops.  It also
described use of municipal sludge on farms growing oats  and wheat, and tank
truck delivery of sludge for use on lawns and parks.  The manual cautions
about pathogenic organisms in sludge,  but notes that only 1 of 33 states chat
responded to a survey had  regulations  to protect public health from this
potential threat.

    Although the manual  indicates some awareness of the  potential health
hazard from sludge use  (for example, the manual recommends that raw primary
sludge not  be used on  the  land) , the land application practices in use at that
time were not uniform  and, in some  cases, apparently posed a high risk to
health.  Burd (1968) listed similar uses of sludge in the late 1960s and noted
that the hygienic considerations relating to sludge use  were primarily under
the authority of local health boards.

    The  1972 Federal Water Pollution Control Act  (PL 92-500) encouraged land
application of sludge  by explicitly endorsing nutrient recycling and by
stimulating construction of wastewater treatment  facilities.  Large cities
became interested  in land  application. Chicago developed its "Prairie Plan"
for agricultural use of  most of  its sludge  (Dalton and Murphy, 1973).  The
great interest in  and  diverse approaches being suggested for land application
of sludge necessitated strong guidance to protect human  health and  the
environment.
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1.2  FEDERAL REGULATION

    In 1976, Congress passed the Resource Conservation and Recovery Act,  which
mandated the U.S.  Environmental Protection Agency (EPA)  to regulate the
application of solid waste to land.   Sludge was  defined as a solid waste  to be
regulated under the Act.   "Criteria for Classification of Solid Waste Disposal
of Municipal Wastewater Sludge" (hereafter, "Criteria")  were published in
September 1979 (Federal Register, 1979).   Requirements relevant to sludge
covered allowable loadings of certain toxicants  and criteria to control risk
of disease.  The major features of the regulation relating to control of
disease risk were:

    •  Unstabilized sludge could not be used on  the land.
    •  Sludge could be used on land if it was treated by processes that
       reduced pathogens and the sludge's attractiveness to  disease vectors
       (flies, rodents, etc.), and if certain restrictions relating to access,
       grazing, and type of crop grown were observed.
    •  If pathogen levels were reduced to below  detection levels and vector
       attraction was reduced, there were no restrictions to sludge use.
    •  The rules for septage were similar to those for sludge,  except that
       unstabilized septage could be applied to  soil if crops for direct human
       consumption were not grown.

    The regulations created a uniform approach for land application.  They did
not appear to substantially affect the practice  of land application.  They
mostly impacted new construction where plans for sludge treatment would be
examined by State and Federal authorities.  Although statistics on land
utilization have not been kept, the practice appears to have kept pace with
the increase in mass of sludge generated in this country.  According to a 1984
EPA report (EPA, 1984), up to 40% of the sludge  produced by  municipal
wastewater treatment plants is used on the land or distributed and marketed to
the public.
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                               SECTION TWO
           COMPONENTS OF DISEASE RISK AND THEIR CONTROL
2.1  PATHOGENS OF CONCERN

    2.1.1 Bacteria

    2.1.1.1  Types and Measurement

    Pathogenic bacteria (i.e., bacteria  chat create disease) are not normal
inhabitants of the human enteric  (intestinal) system.  They are present when.
an individual has  contracted a bacterial disease or illness.  Consequently,
they rarely occur  in fecal waste, but when  they do, high levels are found.
Since wastewaters  from a sewage  treatment plant contain Che wastes from many
people, pathogens  are usually present, but  their densities vary depending on
Che prevalence of  bacterial disease  in the  local community.  Frequently, there
are long periods when certain pathogenic bacteria are below detection limits
in municipal wastewater and in  the sludges  produced (Farrell et al., in
press).  Bacterial species present in wastewater and cheir densities are
therefore highly unpredictable.

    Kowal (1985) lists several  pathogenic enteric bacteria and bacterial
species that are of major concern in sludge and a greater number that are of
minor concern.  The selection was based  on  the density of the bacteria in
sludge, the extent of the disease, and the  seriousness of the illness
produced.  Among bacteria species singled out are Shigella spp., Salmonella
spp., and Yersinia spp.  All cause enteric  disease in large numbers of people
in the United States.  Most research on  bacterial survival in sludge has
focussed on Salmonella spp., which include  over 1,000 serotypes.  These
organisms may cause salmonellosis, an acute gastroenteritis.  Salmonellae have
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been emphasized because they are more  frequently  identified in sludge than
other bacterial species,  they cause  severe  illness with relative frequency,
and a reliable quantitation method exists  that  can detect them.

    The densities  of pathogenic bacteria in the stool of an infected person
may be 106/gram (g)  (Kowal,  1985).  Typical values in sludge  are  much lower.
For example,  densities of Salmonella spp.  over  103/g are encountered
infrequently.  On  the other hand,  the  normal bacterial  inhabitants of the
lower intestines are found at much higher  densities.  Obligate anaerobic
bacteria have densities approaching  109/g in feces.   Facultative  bacteria,
such as the  fecal  coliform group,  have densities  around 108/g-

    Monitoring sludge on a regular basis to determine the types and densities
of pathogenic bacteria present is desirable but,  in  practical  terms,
unattainable.  Quantitation methods  for some bacterial  species are difficult
and unreliable, and require high skill levels.  Too  many species would have to
be measured,  even  if measurement were  restricted  to  bacteria of major concern.

    The presence of one pathogenic species cannot be used as an indicator of
the presence of other pathogenic species because  there  is no reason for the
high incidence of  one enteric bacterial disease in a community to correlate
with other  enteric bacterial diseases.  The best  indicators of the potential
presence of bacterial enteric pathogens in sludge are the facultative enteric
organisms  that normally inhabit the  intestines, such as Escherichia coli. the
fecal coliforms, and fecal streptococci.  Though  these  indicators do not
correlate  well with any individual enteric bacterial pathogen  species, they do
indicate the presence of human fecal waste, which is the carrier of  the
pathogens.   Thus,  they are good long-term indicators of pathogenic bacteria,
but will not always correlate well in the short term.

    Indicator organisms are frequently used as  surrogates for  the pathogenic
enteric bacteria  to reflect their response to environmental exposure or sludge
treatment  processes.  This offers advantages over attempting to measure
effects on pathogens directly, because pathogens  are generally present in low
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densities in sludge and are sometimes absent; consequently,  unreasonably long
experimental programs are frequently needed to obtain definitive results,
especially when the exposure causes large reductions in pathogen densities.
The sludge or wastewater can be "spiked" with cultured pathogenic bacteria to
increase their densities; however, the responses of cultured organisms are not
always the same as those of naturally occurring organisms (Farrah et al.,
1986).  Indicator organisms, on the other hand, are expected to behave
similarly to the pathogenic enteric bacteria because their life processes and
ecological niches are similar (they belong to the same class,
Enterobacteriaceae).   Experimental results indicate that the responses of the
indicators and salmonellae to sludge processing do correlate satisfactorily
(Farrell et al., in press; Farrah et al., 1986).
    2.1.1.2  Effects of Processing

    The pathogenic bacteria in wastewater are insoluble solids.  The bacteria
are small particles with densities only slightly greater than water.
Consequently, they settle poorly unless flocculated.  They can be removed from
the wastewater by filtration.  In primary wastewater treatment, bacteria are
associated with solids.  These solids (and the associated bacteria) settle
fairly well, but many escape this step.  Collection is greatly improved in the
secondary clarifier, where they become enmeshed in the biological solids.
These solids autoflocculate and settle, carrying with them most of the
bacteria that escaped collection in the primary clarifier.
    Wastewater Treatment

    Besides merely collecting solids, the wastewater treatment processes may
actually reduce numbers of pathogens.  Simple sedimentation in a clarifier
causes little change (Farrell et al., in press), but biological processes,
such as the trickling filter and activated sludge process, may substantially
reduce the numbers of pathogens (Farrell et al., in press).  These reductions
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may be caused by  the  time  of contact,  temperature, lytic effect of bacterial
enzyme systems, action of  bacterial viruses  (bacteriophages),  and "grazing of
protozoa"  (Farrah et  al. ,  1986).   Farrell  et al.  (in press) and Lee et al. (in
press) report bacterial reductions (based  on number of organisms per unit mass
of suspended solids)  of 1.5 logs  in extended aeration systems.
    Digestion

    The conventional processes of anaerobic  and aerobic digestion cause
substantial  bacterial reductions.  -Farrell et al.  (1985) show reductions of
indicator  organism densities (colony-forming units  [CFU]/100 mL) of about 1
log for salmonellae and 1.7 logs for indicator organisms.  Martin (in press)
showed that  aerobic digestion for 10 days at temperatures averaging 30°C
causes reductions of similar magnitude.
    Storage

    Storage  time has an important effect on the density  of bacterial pathogens
and indicator organisms.  Stern and Farrell (1978)  have  shown  that  storage at
208C  reduces Salmonella spp. by 2 logs in 3 months  and indicator densities by
about the same amount.  Storage at 58C was much less  effective.  Storage of
sludge cake  would probably show the same effect.
     Lime Stabilization

     Lime is frequently used to condition or stabilize sludge  before  disposal.
 A pH of about 12 essentially eliminates salmonellae and greatly reduces  the
 density of indicator organisms (Counts and Shuckrow,  1975).
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    Elevated Temperature

    The enteric bacteria of concern do not form heat-resistant spores, so they
are easily destroyed by elevated temperatures.  Stabilization processes chat
elevate the sludge temperature to 53°C or above for a sufficient time
effectively eliminate pathogenic bacteria.
    2.1.13  Environmental Effects

    When sludge is applied to land, environmental conditions reduce bacterial
densities.   Kowal (1985) reviewed the literature on the survival times of
pathogenic bacteria in the environment.   Survival times vary widely depending
on the initial densities of the pathogens and on environmental factors such as
temperature, degree of desiccation, and amount of ultraviolet radiation.
Bacterial pathogens in sludge on plant surfaces die off more quickly than
those in the sludge on the soil surface, because of more exposure to sunlight
and greater desiccation.  Kowal indicates that the risk from pathogens
deposited on plant surfaces during application should become minimal 1 month
after application; however, he recommends that low-growing food crops, such as
strawberries, that touch the soil or are splattered by soil aerialized by
rainfall not be harvested until 6 months after sludge use.

    Bacteria in sludge are effectively filtered by the soil except in cases
where the soil is a coarse sand.  Gerba et al. (1975) observed that over 91%
of the coliforms were trapped in the first centimeter of soil.  Soils subject
to cracking, such as clay soil in dry weather, pose special problems.  Sludge
application on such soils after a dry period could be unwise, depending on the
proximity of the surface to ground or surface water.  Farm soils used to grow
row crops (e.g., feed corn, soybeans) are probably superior co forest soils
for protecting ground water.  Root, insect, and animal holes are destroyed by
the soil preparation required for crop production, and soil layers are usually
much deeper on farms than in forests.  If bacteria should reach ground water,
transport within that media is extremely slow and should give ample time for
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further reductions  in  pathogen density.   In  certain kinds of geology, such as
limestone or fractured structures,  soil  leachate  can  travel rapidly.  Use of
sludge on soil where such geology  is  not protected by a thick soil layer poses
an elevated risk.

    Bacteria are unique among sludge  pathogens  in their ability to regrow.
Enteric bacteria are facultative and  can multiply under aerobic or anaerobic
conditions.  If they encounter a suitable food  source such as bruised or
cracked fruit, they can regrow to  high densities.  They can also regrow to
high densities when competition from  other bacteria  is reduced, even in a low-
energy substrate such  as well-stabilized compost.  Burge et al. (1986) showed
that salmonellae innoculated into  sterilized compost  grew to a higher level
for a longer time  than salmonellae innoculated  into  unsterilized compost.
    2.1.2  Viruses

    2.1.2.1  Types  and Measurement

    Kowal's extensive review lists the human enteric viruses  likely  to be
present  in'wastewater and sludge (Kowal, 1985).   These viruses  are not normal
inhabitants of the gastrointestinal tract and their presence  indicates an
infection that may show no symptoms.   Viruses are released from cells  in the
gastrointestinal  tract in which they are replicating into the intestines and,
consequently,  are present in fecal discharges.  They are generally adsorbed to
or  enmeshed in solids.

    Kowal lists five subclasses of enteroviruses (e.g., polio-, Coxsackie-,
Echo-) as well as hepatitis A virus and rotaviruses.  These viruses  cause  a
wide  variety of illnesses; for example, hepatitis A. virus causes approximately
40,000  to 50,000 cases of infectious hepatitis in the United  States.
Rotavirus causes acute gastroenteritis, primarily in children.   The
enteroviruses cause many diseases including paralysis, diarrhea, meningitis,
heart disease, and respiratory illness.  Most infections are  asymptomatic,  so

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many more infected people shed viruses than indicated by disease incidence
numbers.  A particular virus may or may not be present in the wastewater,
depending on the presence or absence of infected people in the community.

    There are a variety of methods for identifying viruses in sludge.  The
most common procedure, the plaque assay method, is described by Bitton (1970).
A viral suspension extracted from sludge is placed on the surface of an animal
cell monolayer that has been grown on the interior wall of a glass bottle.
After providing time for adsorption of the viruses to the cell layer, an
overlay of agar is poured over the monolayer to immobilize the system and
provide nutrient and moisture for the cells.  Time is allowed for the viruses
to invade the cells and replicate.  Each virus invasion leads to a zone of
infection where cells have been destroyed.  This localized area is called a
plaque.  Staining or other techniques are used to identify plaques.
Unfortunately this and other virus identification methods are expensive and
require skilled personnel.

    The plaque-forming method currently in use identifies a wide variety of
enteroviruses (Bitton, 1980).  The number depends on the types of cells used
in the test.  Some important viruses -- Hepatitis A and rotavirus -- are not
enumerated by this method.  Serological methods can be used to determine the
specific viruses that formed the plaques but this adds another level of
complexity to an already complex procedure.

    The densities of viruses found in sludge range widely.  Brashear and Ward
(1982) report 5-145 PFU/raL (plaque-forming units per milliliter) of a raw
sludge.  Assuming 2% solids in the sludge, this is equivalent to 250-7,000/g
of solids.  Other sludges could show higher or lower densities.

    Less information is available on virus densities than on indicator
bacteria or Salmonella spp. densities because of the complexity of the method
for determining densities and the special skills and equipment needed.
Although the plaque-forming method does not indicate the presence of some
viruses, it can enumerate enteric viruses of several types.  It could serve as
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a useful indicator  test  for all  enteric viruses, except for its aforementioned
cost and complexity.

    An alternative  to  the  enteric  virus test  to  indicate viral densities is to
use the fecal coliforms  and/or fecal  streptococci test for this purpose.  As
with pathogenic bacteria (see above),  the  fecal  indicators are not expected to
correlate over the  short term with virus densities; however, since they
indicate the presence  of fecal wastes,  they will correlate well over the long
term.  Indicator  organism densities can be used  to  indicate the effect of
sludge processing conditions on  viral densities  if  available data indicate a
satisfactory correlation between the  effect of the  condition on viral
densities and indicator  organisms.

    Such correlations  appear to  be adequate for  some processing procedures but
not for others.   For example, Berg and Herman (1980) demonstrated that, in
anaerobic digestion, the decline in viruses showed  a reasonable relationship
to the decline in fecal  coliforms  and fecal streptococci.  On the other hand,
irradiation of sludge  by gamma rays or high-energy  electrons requires 20-30
kilorads to reduce  coliforms by  1  log (Ward,  1981), and ten times that dose to
achieve the same  reduction in viruses.  With  irradiation, a relationship
exists between the  declines in the two types  of organisms, but it is
inappropriate.  The coliforms could not be an indicator for viruses because
they could be reduced  to negligible values while viruses were still present.
    2.1.2.2  Effects of Processing

    Wastewater Treatment

    Viruses are  subcolloidal in size and would not be expected to  settle out
or  to be  filtered out in wastewater treatment; however,  they have  a  strong
tendency  to adsorb to solids.  Consequently,  most of them are  removed with  the
solids  and are found in the sludge streams.   The sedimentation processes in
clarifiers do little to reduce viral numbers.   However,  biological processes,

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such as the activated sludge process, do reduce viruses.   Time of exposure is
a factor.  Virus densities decline with time even in nonaggressive
environments such as river water (Clarke et al.,  1964).   Because sludges are
retained in wastewater treatment processes for periods ranging from a few days
to 30 days, declines based on time and temperature of exposure occur.
Bacterial enzyme systems may reduce the numbers of some viruses.
    Digestion

    Conventional anaerobic and aerobic digestion of sludge reduces viral
densities depending on the temperature, time, type of processing, and
operation of the system.  Farrell et al. (1988) have shown chac che manner of
feeding and withdrawing che sludge (fill/draw versus draw/fill) has a small
effect on virus survival.  Draw/fill feeding yields better viral reductions.
Berg and Berman (1980) and Farrell et al. (1985) show the reductions achieved
by digestion at a large wastewater treatment plant.  Farrah et al. (1986) and
Martin (in press) show effects of aerobic digestion on viral survival.
    Lime Treatment

    Strauch (1982) presented data demonstrating that lime treatment to pH  12
produces rapid and large reductions in viral populations.  Chlorine treatment
is expected to cause similar reductions.  Acid treatment is less effective  in
reducing virus densities.  Exposure to pH 3.5 is typically a step in the
procedure for enumerating viruses.
    Elevated Temperature

    Stabilization processes that elevate the sludge temperature  to greater
than 53°C reduce or even totally eliminate enteric viruses.  These processes
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include thermophilic  anaerobic and aerobic  digestion, composting, and
pasteurization.
    Storage

    Storage  for  a  period of time is effective  in reducing viral densities.
The reduction is a function of temperature.   Stern and Farrell  (1978) found
that less  than 3%  of viruses survived in digested sludge stored for 4 months
at 20°C, whereas 33% survived at 5°C.
    2.1.23  Environmental Effects

    Adverse environmental effects reduce viral densities  when  sludge  is
applied  to  land.   The rapidity of reduction depends  in part  on the  proximity
of  the sludge to  the land surface.  Sorber and Moore (1986)  compare data  from
several  investigators and show that the longest times for 1-log and 2-log
reductions  in densities were 30 and 52 days when sludge was  applied to or
within 5 centimeters (cm) of the soil surface.  The  average  time for  die-off
was generally much shorter than these figures.  For  deeper application (15
cm),  they cite the" work of Damgaard-Larsen et al. (1977)  which showed 56  and
100 days required for 1- and 2-log reductions.

    Viruses in sludge adhering to the surface of crops die off even more
rapidly  because exposure is more severe.  Larkin et  al. (1976) showed an  over
2-log (base 10) reduction in poliovirus densities on lettuce and radishes
about 14 days after spray-irrigation with sludge.
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    2.13 Protozoa

    2.13.1  Types and Quantification

    Numerous protozoa invade the human gastrointestinal system and cause
disease.  Their cysts are found in wastewater and sludge.   The three most
important noted by Kowal (1985) are Entamoeba histolvtica. Giardia Iambiia.
and Balantidium coli.  These organisms are known to transmit human disease
through a water route and by direct contact.  The characteristic illness is
diarrhea.

    Protozoan cysts are excreted in great numbers from infected persons.
Infection rates in the population are low except for Giardia lamblia. where
the carrier rate may range from 1.5-20% (Benenson, 1975).   Levels in
wastewater have been estimated to be 4 cysts/L for Entamoeba histolvtica
(Foster and Englebrecht, 1973) and 10" to  2  x  10s cysts/L for Giardia lamblia
(Jakubowski and Ericksen, 1979).  The densities of protozoa in sludge are not
known.  If, as expected, most are trapped in the sludge, densities on a volume
basis would be about 200 times these figures.
    2.13.2  Effects of Processing

    Little is known about the survival of protozoan cysts when sludge is
processed.   Based on the lack of information in the literature, Pedersen
(1981) suggests it is unlikely that many survive anaerobic digestion.  Recent
information from Seattle (Metro, 1983) indicates that G. lamblia is present in
raw sludge but absent from digested sludge.  Yanko (1988) was unable to
recover protozoan cysts from composted sludges, heat-dried sludges, and some
air-dried sludges.  However, processing conditions for these sludge products
were severe.
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    The acknowledged transmission  of  protozoan cysts by water should not lead
to the conclusion that  transmission by  sludge is likely.  Transport of cysts
in wastewater to a susceptible host is  possible in a matter of hours after
discharge, whereas transport of  cysts in sludge to a susceptible host may take
many days.
    2.133 Environmental Effects

    Kowal's review  (Kowal,  1985)  cites  work by Rudolfs et al. (1951) that
shows very short  survival  of Entamoeba  histolvtica on soil:  18-24 hours on
dry soil  and 42-72  hours on moist soil.   In dry  soil, Beaver et al. (1949)
showed survival of  10  days.

    Survival on plants should be  shorter  than on soil.  However, Tay (1980)
reported  isolation  of  both G.  lamblia and E. histolvtica on fruits and
vegetables from farms  irrigated with wastewater.  No information was found in
the literature on the  survival of G.  lamblia.
    2.1.4  Helminths

    2.1.4.1  Types and Quantification

    The helminths  of concern are the nematodes,  or  roundworms, and the
cestodes,  or tapeworms.   The most common helminths  pathogenic to man and
likely to  be found in sludge are:

    Ascaris lumbricoides (human roundwonn)
    Ascaris suum (pig roundworm)
    Trichuris trichiura (human whipworm)
    Taenia saginata (beef tapeworm)
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    Taenia solum (pork tapeworm)
    Toxacara canis (dog roundworm)

    Details of the intricate life cycles of these helminths and the diseases
they cause are discussed by Kowal (1985) and Faust et al. (1975).  Ascaris
create pneumonitis when the ingested larvae migrate through the lungs.  The
human roundworm develops in the small intestine with potential blockage if a
number of worms are present.  Toxacara canis larvae migrate blindly in the
human body, where they can do serious damage to viscera and other organs,
including the eyes.  The tapeworms can cause pain and digestive disturbances.
Tapeworm eggs primarily are a hazard to livestock.  When eggs are ingested,
larvae are produced that eventually form cystercerci that cause damage to the
animal's organs.  Humans ingest the cysts from poorly cooked meat, develop the
tapeworm, and release the eggs in the feces.  Animals ingest eggs when they
graze, which completes the cycle.

    Reimers et al. (1981) report that Ascaris spp. have the highest
concentration of any helminth in sludge.  Ascaris spp. are the hardiest of all
helminths to sludge processing and environmental exposure.
    2.1.4.2  Effects of Processing

    Because of their high density and relatively large size (0.07 millimeters
(mm)), helminth eggs in wastewater are concentrated into the sludge by
wastewater treatment.  Conventional sludge stabilization processes, such as
aerobic or mesophilic anaerobic digestion, have little effect on the number  of
viable eggs.  Even exposure to harsh conditions, such as treatment with lime
to pH 12, has little effect.  The use of strong acid embryonates the larvae
but does not significantly reduce their viability.  Thermal treatment above
53°C, such as is attained in thermophilic aerobic or anaerobic digestion,
composting, or pasteurization, is effective in destroying helminth eggs.
Combinations of processing steps, such as alkali treatment to high pH combined
with desiccation for an adequate time period, are effective in destroying
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helminths  (Burnham,  1988).   Long-term  storage  (2 years) in simulated lagoons
at 25°C has been  shown  to  destroy  the  helminth eggs found in sewage sludge
(Kaneshiro and  Stern, 1986).   Reimers  et al. (in press) have confirmed this
finding in a  full-scale demonstration  in Louisiana and Texas.
    2.1.43 Environmental Effects

    Kowal's  review (Kowal,  1985)  observes  that  the eggs of the hardier
helminths  survive  for long  periods  in  the  soil.  Jakubowski (unpublished)
reported quantitative information showing  that  helminth eggs in surface-
applied sludge  died off within a  year  after  application, whereas helminth  eggs
in sludge  mixed with soil showed  only  a  50%  reduction after 5 years.  Periodic
cultivation  of  the soil increased the  die-off for a porous soil but not for a
heavier soil.

    Helminth survival on  the soil surface  or on crops is reduced by
desiccation  and other adverse conditions such as freeze-thaw cycles and
sunlight.  Densities appear to be reduced  to negligible levels in less than a
year.
2.2  TRANSPORT OF ORGANISMS

     The  pathogens in sludge applied to land pose a disease risk only if there
are  routes  by which they can contaminate man.   The principal means of
contamination are ingestion and inhalation.  Absorption through the skin is
believed to be a minor risk.  Sludge may be transported to man by many routes:
aerial,  ground water,  or surface water;  adherence to objects that are inhaled
or  ingested;  surficial or internal contamination of crops eaten by humans; and
vectors.  The vectors may be flies, mosquitoes, fleas, or rodents, as well as
other  animals that transport disease organisms  to humans either mechanically
or by  biological processes.
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    2.2.1 Air Transport

    Exposure Co aerially transported sludge can occur if dust or spray is
inhaled.  Sludge is frequently applied to land as a liquid using a splash
plate on the back of a truck;  sometimes the sludge applicator is a high-
pressure nozzle with a range of over 100 meters (m).   Heat- or air-dried
sludge may be dry enough to create a dust when handled and applied.  Movement
of equipment may also create dust if the soil dries out after sludge
application.  The dust or aerosol may be inhaled and usually ends up in the
gastrointestinal system.

    Kowal (1985) notes that "aerosol shock" substantially reduces bacteria and
virus numbers when sprayed wastewater forms an aerosol; however, this
information may not be directly translatable to sludge spraying.  Sludge
typically contains 2-5% suspended solids and, when sprayed, forms relatively
large particles.  These particles settle to the ground faster than the drops
of a wastewater spray and are less likely to evaporate down to a fine aerosol
that can be transported long distances.  Harding et al. (1981) found fecal
indicator organisms in air samples taken when sludge was applied by high-
pressure sprays, but at much lower levels than at wastewater application
sites.  Tank truck application using low-intensity sprays produced little
elevation of fecal indicator densities.  Sorber (1984) concluded that spraying
sludge with high-energy sprays would not represent a health threat to
individuals more than 100 m downwind.  A buffer zone between a site using
high-energy spraying to apply sludge and any area open to the public seems
appropriate.

    No precautions to reduce aerial transport appear to be necessary when
liquid sludge or sludge cake is applied using low-energy means.  By the time,
this sludge has dried sufficiently to create dust, the pathogens have probably
been greatly reduced.  In dusty environments, workers generally work in
enclosed cabs on equipment or wear dust masks.  Travel of dust is generally
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limited  (e.g.,  Che  dust from plowing or  disking  on a farm field is primarily
local).

    For  sludge  products that create  dust as  they are applied (as might occur
with a heat-dried sludge),  the only  precautions  that can be taken to protect
the person applying the sludge are using a respirator or reducing the sludge
pathogens to  insignificant  levels.

    Aerosols  created by low-energy spraying  create negligible effects.  High-
energy spraying poses a hazard primarily to  workers; however, this hazard can
be minimized  or eliminated  by equipping  workers  them with protective devices.
Other work practices, such  as spraying only  in the day time and ensuring that
distance from near  neighbors exceeds 100 m,  will also help reduce any
potential health hazard from sludge  spraying to  insignificant levels.
    2.2.2  Groundwater Transport

    When  sludge is applied to the land surface,  the  soil and the sludge
particles form an effective filter mat.   For the most part, only soluble and
colloidal particles enter the soil.   The larger  organisms, such as helminth
eggs, are retained on the land surface;  however,  virus particles and,
sometimes,  bacteria are small enough to potentially  pass through the soil to
ground water.   The mechanisms of removal of these organisms during soil
transport are  quite different:  bacteria are primarily removed by filtration
processes whereas viruses are removed by adsorption.

    The literature cited by Kowal (1985) shows  that  coarse sand is the soil
medium most conducive to pathogen transport; it  does not provide a good filter
medium to remove bacteria and is a poor adsorbent for viruses.  Fine-grained
soils, on the  other hand, provide good removals  for  both.  Cracks in soils
caused by desiccation and root,  insect,  and animal holes can allow substantial
transport of organisms  to the subsoil.  Similarly, fissured rock and limestone
beneath the soil can allow transport.   However,  because liquid is only
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occasionally present in soil - - as a result of sludge application or rainfall
-- the risk of potential transport of sludge or sludge pathogens to ground
water is minimized.  By contrast, a septic tank leach field creates a far
greater risk of groundwater contamination because the leach field contains
flowing pathogen-laden water that directly encounters all the subsurface
pathways that may exist in the soil.  Similarly, a wastewater application site
that receives the wastewater equivalent of 200 cm of rainfall per year
provides a far greater driving force for virus movement than sludge addition,
which ordinarily contributes only about 2 cm additional water loading to the
annual rainfall loading at a site.

    Viruses in particular appear to have a potential to migrate to ground
water; however, their movement to and within ground water is slow because the
water itself moves slowly, and because the viruses adsorb and desorb on the
soil, further slowing their progress (Landry et al., 1980).  A typical maximum
survival time for viruses is 170 days (see Table 12 in Kowal's 1985 review).
If, as is likely, movement to ground water is slow, and the movement of ground
water itself beyond the site boundary is also slow, the potential for virus
contamination of ground water beyond the site will be negligible.  At sites
where sludge loadings are high, soil layers are thin, and/or subsurface
conditions are unknown (such as in forests), buffer strips should be provided
to avoid movement of viruses to ground water with subsequent potential
transmission off site.
    2.2 J  Surface Water Transport

    Surface water can potentially be contaminated by runoff from a land
application site, or by rainwater moving pathogens transversely below the
ground surface through root holes,  animal burrows,  and fissures in rock
strata.  Movement through fissures is likely only for sludge applied to forest
soil.  Helminth eggs are transported by rainwater but, because of their high
density, they tend to drop out of moving streams and concentrate in deposits
in a manner roughly analogous to deposits of gold in stream beds.  On the
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other hand, bacteria and viruses  can be  carried  by fine solids wherever the
runoff goes.  As  noted earlier, bacteria and viruses generally die off about 1
month after application to the soil surface, so  the potential health hazard
from runoff disappears after this time.   Runoff  can be controlled by using
buffer strips of  vegetation to remove solids from runoff.  Runoff can be
controlled more directly by collecting and holding it in ponds for a
sufficient time to reduce microbiological densities.
    2.2.4  Adherence to Objects

    Sludge  will adhere to crops,  soil,  and equipment.  Viruses and bacteria on
exposed surfaces die off in less  than a month;  some  helminths probably die off
less  rapidly.   Risk can be controlled by restricting the movement of objects
from  the  site  until at least 1 month following application.  Equipment or
animals that must move on and off the site shortly after sludge  application
should be washed to eliminate risk.
     2.2.5 Transport by Vectors

     Transport of sludge by vectors is difficult to quantify.   Several
varieties of flies are attracted to and breed in sludge.   Primary  sludge
contains food wastes attractive to rodents and some birds.

     Vectors carry disease in several ways:  by complex means  (such as  in  some
mosquito-borne illnesses), by becoming infected themselves (as with
salmonellosis) ,  or by mechanical transport.  The only effective way to
eliminate vector transport is to make the sludge unattractive to vectors
(i.e.,  by treating the sludge prior to land application).
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23  VECTOR ATTRACTION

    Sludge from wastewater treatment processes  is  generally noxious and
therefore attractive to vectors.   Sludge produced  in primary treatment (simple
settling) is especially noxious.   It contains identifiable  fecal material and
food scraps and is usually devoid of oxygen.   Primary sludge putrefies rapidly
and releases odorous compounds,  a process that  eventually results in vector
attraction.  Sludge from secondary treatment, such as waste-activated sludge,
contains suspended solids that escaped primary  clarification,  as veil as
biological solids.  Though not as unpleasant  as primary sludge,  secondary
sludge also attracts vectors.   Some sludges may be processed for such a long
time that they do not attract vectors.  For example, an extended aeration
sludge may be so thoroughly stabilized by long-term aeration that it does not
putrefy and is unlikely to attract vectors.

    The attractiveness of a sludge to vectors can  be reduced in various ways,
some permanent and some temporary.  For example, reduction of sludge food
value and odor by long digestion permanently  reduces the sludge's
attractiveness to vectors.  Drying temporarily reduces vector attractiveness,
but the sludge will attract vectors again if it is rewetted.  Both permanent
and temporary methods are valid approaches to reducing vector attraction,
although for methods that offer only a stasis in vector attraction, the period
of stasis must last until the sludge has been utilized.

    Scientific tests to measure the attractiveness of a sludge to vectors have
not been developed, although there appears to be no great technical difficulty
in developing appropriate tests.   Essentially,  there are three requirements:
a standardized population of vectors, a standard way of presenting the sludge
to the vectors, and a measure of the interest of the vectors in the sludge
(e.g., number of visits to the sludge by a "standard" group of flies).
Different tests would be needed for different vectors.  If such tests were
developed, their results could be correlated to more easily measured
properties of the sludge, such as specific oxygen uptake rates after aerobic
digestion or reduction in percent volatile solids  by anaerobic digestion.
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Interest of vectors would  be  expected  to be inversely related to the specific
oxygen uptake  rate or  the  percent  reduction in volatile solids.

    Any vector attractant  test  result  would not be an absolute property of a
sludge but would be influenced  by  the  sludge's temperature and solids content,
the test duration, ambient temperature and humidity, and even wind speed.   For
example, vectors might not be attracted to a sludge at 15°C but might be drawn
to the same sludge at  25°C.   Consequently, a satisfactory test result or a
satisfactory value of  some correlated  parameter such as percent volatile
solids reduction does  not  ensure that  the sludge would not attract vectors
under adverse  conditions.

    "Criteria" (Federal Register,  1979) lists several processes that have been
determined to  reduce vector attraction.  Since tests to measure vector
attraction did not exist when the  Criteria were developed, field experience
was used for some processes to  determine whether the resulting sludge would
attract vectors.  In this  "cut  and try" approach, sludges with a range of
values of a parameter  thought to be associated with vector attraction were
placed in the  field, and  the degree of vector attraction was observed.  This
route was formally followed for lime stabilization  (Farrell et al. , 1974;
No land et al., 1978; Counts and Shuckrow, 1975), one of the processes listed
in "Criteria"  (Federal Register, 1979).  Prior field experience with other
processes, such as anaerobic and aerobic digestion, permitted specifying the
conditions for these processes  that reduced vector  attraction.

    The processes  listed  in "Criteria" that reduce  vector attraction are
listed below along with a brief note on the action  that reduces vector
attraction.

    •  Aerobic digestion  (mesophilic or thermophilic).  Reduction in food
       value.
    •  Anaerobic digestion (mesophilic or thermophilic).  Reduction in food
       value.
    •  Lime stabilization.  Temporary  stasis  in bacterial activity caused by
       high pH.  The  effect disappears when pH falls.

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    •  Air drying on sand beds.   Reduction in food value and reduced moisture.
       The sludge would have to  be biologically stabilized before it would be
       possible to expose it to  the environment on sand beds.   Additional
       biological oxidation occurs as the sludge slowly dries  on the sand
       beds.
    •  Heat drying.  Temporary stasis that disappears when sludge moisture
       content increases.
    •  Composting (mesophilic or thermophilic).  Reduction in food value.
    •  Heat treatment.  Temporary.  Vector attraction is unlikely only if the
       sludge is kept sterile.  The proposed regulation imposes certain
       restrictions on this form of treatment in order to reduce vector
       attraction.

    The processes in "Criteria"  that reduce vectors also"have to reduce
pathogens to either of two levels.  The proposed regulation disentangles
vector attraction from pathogen reduction.  Greater freedom is available to
develop new processes or combinations of processes to reduce pathogens,
because it has been possible to establish a common performance target for
pathogen reduction.  No common target for vector attraction appears possible,
primarily because there is no standardized test to measure vector attraction.
The subjective target that "vector attraction be reduced" is unusable for
regulatory purposes.  Consequently, the regulation proposes four alternative
performance standards and one method of application for demonstrating
reduction of vector attraction.

    If a field test to quantify vector attraction is developed, future
regulations could conceivably establish a common performance target for
reduction of vector attraction.   This would allow plant operators the freedom
to select any types or combinations of processes to reduce vector attraction
as long as the end point is met.  As discussed above, the likelihood  that such
a test can be developed  is small.
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2.4  INFECTIVE DOSE

    To establish a level  of  concern about the disease risk posed by a
particular sludge pathogen,  the  infective dose for that organism must be
known.  Infective dose  is the minimum dose of a pathogen needed to cause
infection.

    Kowal (1985) critically  reviewed the literature on infective dose for all
pathogen groups of concern.  He  concludes that although infective doses for
most species of bacteria  are high  (i.e., many thousands of organisms are
required to cause infection), they can be low in some circumstances.  He cites
Blaser and Newman (1982), who indicate that  the infective dose for Salmonella
spp. may be less than 1,000  organisms.  For  Shigella. the infective dose is
low -- 10 to 100 organisms (Keusch, 1970).   Ward and Akin (1984) are even more
pessimistic, citing  work  by  D'Aoust (1985) indicating that Salmonella spp. may
be infective at doses below  10 organisms.

    Currently, the infective dose  for viruses is thought to be low  (Kowal,
1985)  --on the order of  10  virus  particles  or less.  For protozoa, the
infective dose is likewise low.  Kowal  (1985) observes that single cysts of
Entamoeba coli have  produced infections.  For helminths, single eggs are
infective to man.  The extent of the infection is dose-related, since most of
the worms produced do not multiply in man.   However, an infection may
sensitize individuals so  that subsequent light infections cause allergic
reactions.

    For all pathogens of  concern,  the  infectious dose is small.  It is
therefore prudent  to minimize exposure.  If  the conditions of  land  application
make sludge ingestion probable  (e.g.,  sludge is applied to food crops to be
harvested shortly after application),  the sludge should be essentially devoid
of pathogens.
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                              SECTION THREE

                        THE PROPOSED REGULATION

3.1  BACKGROUND

    Nine years have elapsed since the publication of  the  "Criteria"  in 1979.
Experience in this period has demonstrated that the pathogen  requirements  have
posed no great burden for most large treatment plants,  but  some  large  and  many
smaller treatment plants have encountered compliance  problems.   These  plants
generally produced an adequately treated product and  utilized it in  a  safe
manner, but they had difficulty consistently meeting  the  technology-based
requirements of the regulation.   This experience suggested  that  the  regulation
should be reviewed and adjustments made to address inequities, while
continuing to provide adequate protection from disease  risk.

    The major difficulties with the current regulation  and  the proposed
solutions are briefly described below:

    (1)  Shifting from Technology-based to Performance-based  Standards.  As
noted earlier, "Criteria" defines two classes of treatment:   PSRP (Processes
to Significantly Reduce Pathogens) and PFRP (Processes  to Further Reduce
Pathogens).  These processes reduce pathogens and vector  attraction.  Some
pathogens survive PSRP treatment and remain in the sludge;  for this  reason,
the existing regulation imposes constraints on crops  grown  and access  at sites
treated with sludge produced by a PSRP.  With PFRPs,  pathogens are reduced to
such a low level that constraints are not needed.  The  PSRP and PFRP processes
were "technology-based."  The process descriptions (time, temperature, and
other process conditions) were given but performance  was  not  specified.   This
created an inflexible condition.  New technology was  difficult to introduce
because there was no identified goal.  The proposed regulations  replace all
technology-based standards with performance-based standards.   This allows  much
freer exercise of creativity because the goals for new processes or process
combinations are clearly identified.

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    (2)  Separating  the  Requirements  for Pathogen Reduction and Reduction of
Vector Attraction.   "Criteria"  identifies a  limited number of single-step
processes that accomplish  the goals of pathogen  reduction and reduction in
vector attraction.   There  is no benefit in connecting these goals or requiring
them to be accomplished  in a single step.  The proposed regulation separates
these requirements and allows for  combinations of more than one process to
accomplish either or both  goals.

    (3)  Incorporating the Contribution of Wastewater Treatment to Pathogen
Reduction.   "Criteria" implicitly  assumes that sludges from all wastewater
treatment units  have about the  same pathogen density; however, continuing
research (see below) has revealed  that the pathogen burden in raw sludges
varies depending on  the  nature  of  the wastewater treatment process that
produces the sludge.  It now appears  to be much  more likely that the pathogen
densities  (number/gram volatile suspended solids sludge  [no./g VSS]) in the
incoming wastewater  to different  treatment plants will be similar, than that
the sludges  produced by  wastewater treatment will have similar pathogen
densities  (no./g VSS).  In the  proposed regulation, emphasis has therefore
shifted to require  that  the reduction in pathogens from untreated wastewater
to treated sludge be made  equivalent  rather  than requiring that all raw
sludges get  equivalent treatment  after collection.

    (4)  New Requirements  for Well-Stabilized Sludges.  Operators of extended
aeration plants  have frequently experienced  difficulty in meeting PSRP
requirements for their sludges  because their untreated sludges were well
stabilized and  could not meet  requirements  for further stabilization.  A new
classification  has  been  created that  allows  these well-stabilized sludges to
be applied to land  provided they meet tighter crop and access restrictions.

    By making the changes  outlined above,  the proposed regulation effectively
addresses  the difficulties that have  been  encountered with the existing
"Disease"  section of 40  CFR 257 without  compromising protection of human
health and the  environment.
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3.2  SCIENTIFIC BASIS OF THE PROPOSED REGULATION

    This section discusses the component parts of the proposed regulation
following the exact format of the regulation.   It presents the underlying
logic supporting the approach as well as the scientific support for selecting
specific requirements.  Each topic discussed is keyed into the numbering
system used in the regulation.
    3.2.1  Specialized Definitions (§503.51)

    Some of the definitions in the regulation need no explanation.  Those
discussed below are unique or different from common usage and require
elaboration.
    3.2.1.1 Average Density of Microbial Organisms

    This  term is defined as  the number of organisms per unit volume of sludge
 divided by mass of volatile  suspended solids per unit volume of sludge.  It is
 the number of organisms per  unit mass of volatile suspended solids in the
 sludge.   Number is a count which, for bacteria, may be predicted by an MPN
 (most  probable number) or a  count of colony-forming units (CFU);  for viruses,
 it may be a plaque count; for helminth eggs or protozoan cysts, it may be an
 actual one-for-one enumeration.  The density is determined by measuring  (1)
 the number of pathogens in a given volume of sludge, and (2) the suspended
 volatile  solids in the same  volume, and then dividing these two results  to
 obtain the number per unit mass.  In the following discussion, density is
 identified by its actual density units (e.g., CFU/g VSS) or as "density  (mass
 basis)."

    The density as defined above (no./g VSS) is different from the organism
 density used in drinking water  technology, where density is appropriately
 defined as the number of organisms per unit volume.  This volume-based
 definition would be of little value in sludge processing, where the interest

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is in numbers related  to  sludge  solids.  For example, in dewatering, where
little organism destruction occurs,  density per unit volume increases
dramatically when the  water is removed  from the sludge.  Comparing organism
densities on a volume  basis before  and  after dewatering tells little about the
fate of microorganisms.   Tracking the density per unit mass of volatile solids
gives us the information  we desire,  that is, that densities on the mass basis
show little change,  indicating the  minimal effect of the process on
microorganisms.
    3.2.1.2 Pathogen Reduction

    In the proposed regulation,  pathogen  reduction means the reduction in
densities of pathogens  on a mass basis  (number per unit mass of volatile
suspended solids).  A quantitative  measure  of pathogen reduction is a concern
primarily for bacteria  and viruses.   The  densities (mass basis) in the sludge
leaving the plant  are compared to the densities  (mass basis) in the incoming
wastewater.  For a batch or a plug-flow process,  reductions could be
determined from a  measurement at the start  (or inlet) and at the end (or
outlet) of the operation.   In wastewater  and sludge processing, flow is
usually continuous or periodic,  flowing streams  are usually mixed or
recirculated, and  sludge residence  times  can exceed 20 days.  Consequently, on
a given day, inlet and  outlet concentrations may bear no relationship to one
another.  Reductions  in bacterial and viral densities (mass basis) are best
estimated by comparing  the average  of the logarithmic densities determined on
samples collected  before and after  treatment over several weeks of steady
operation.
    3.2.13  Specific Oxygen Uptake Rate (SOUR)

    This  parameter  is determined in a  standard test  that measures the rate at
which a sludge  consumes oxygen per unit mass  of solids present.  A high SOUR
indicates a large and active bacterial mass and is likely  to putrefy rapidly
A low SOUR indicates that bacteria present are not metabolically active.  This

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generally indicates that the bacteria have consumed the available food
resources and that the sludge will not putrefy rapidly.  The test is only
appropriate for sludges that have a high proportion of aerobic bacteria.  It
is not appropriate for untreated, limed, or anaerobically digested sludges.
    3.2.1.4  Volatile Suspended Solids

    The volatile solids concentration and the changes that occur in it are
parameters of concern for some of the processes that reduce vector attraction,
such as digestion.  Volatile solids include volatile matter in both suspended
and dissolved solids.  Volatile suspended solids concentration is the
parameter of concern when quantifying microbial densities, because the
microbes are primarily associated with or are particulate solids.
Analytically, it is easier to determine volatile solids concentration than
volatile suspended solids concentration.  When the dissolved volatile solids
concentration is less than 5% of the total volatile solids concentration,
volatile solids concentration can be used in place of volatile suspended
solids concentration without introducing serious error.
    3.2.2  Class A Requirements

    The regulation proposed performance-based standards for three classes  of
pathogen reduction:  Class A, Class B, and Class C.  Classes B and C also
include sludge use and site access restrictions.  The specific requirements
for these classes of pathogen reduction and the scientific basis for them  are
discussed in the rest of this section.
    3.2.2.1 Pathogen Reduction Requirements (§503.52)

    Class A pathogen reduction requires that densities of pathogenic bacteria,
animal viruses, protozoa, and helminth ova be reduced to nondetectable  levels.
This requirement  is necessary because there are no restrictions  on  the  use of
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sludge that has  received Class  A treatment.   People can come into direct
bodily contact with sludge at any time  after  application, possibly inhaling
dust or ingesting  small amounts of sludge.  Consequently, the presence of
concentrations of  pathogens that could  cause  disease must be avoided.  As
observed earlier,  ingestion of  only one viable  animal virus, protozoa, or
helminth egg  can cause an infection (Kowal, 1985).  For bacteria, the
infective doses  are normally much higher,  but may be less than 10 organisms
during outbreaks (D'Aoust, 1985).  In view of these low minimum  infective
doses, it appears  appropriate to require all  pathogens to be below detectable
limits in Class  A  sludges.
    Use of Fecal Indicators for Thermal Processes

    The regulation allows the use of reduction of fecal  indicators  to  indicate
elimination of pathogens,  if the mechanism that destroys  the pathogens is
primarily  thermal.  If temperatures of 53°C or above  are  used  to destroy the
pathogens,  reduction of fecal coliforms and fecal streptococci to densities
below  100/g VSS will ensure that pathogens are eliminated.  Exposure to 70°C
for one-half hour will produce reductions of this magnitude; exposure  to 55°C
for three  days or 53°C for five days is expected to produce similar results.

    Both laboratory and field experience suggest that reduction of  fecal
indicators to low levels satisfactorily indicates the reduction of  pathogens
to insignificant  levels by thermal processes.  The fecal  indicators are
reduced at rates  generally comparable to many of the  pathogens, particularly
to bacterial pathogens, but their initial concentrations  are ordinarily many
orders of  magnitude (i.e., factors of ten) higher than the pathogens.  Even if
they should decline faster than some pathogens (and they do decline faster
than some  viruses), appreciable numbers would still  survive to serve as
indicators when  the pathogens have long since diminished to negligible values.

    Berg and Berman (1980) showed that when sludge was thermophilically
digested at 49°C  in a full-scale digester, viruses were eliminated  or  reduced
to low values while substantial numbers of fecal coliforms and fecal

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streptococci survived.  The ratios of fecal coliforms to viruses and fecal
streptococci to viruses in the final product averaged 12,000:1.  Median viral
density (volume basis) in the raw sludge fed to the digester was 1,500 PFU/100
ml, which is a typical viral density in untreated sludge.  The indicator
organisms would clearly serve as a good indicator:  An indicator density of
100/g VSS would indicate a viral density of 0.01/g VSS, a factor of 30 below
the detectable limit.  For the same thermophilic digester,  Farrell et al.
(1985) reported results from 27 measurements of bacterial densities.
Salmonellae, which averaged in the normal range -- about 210/g VSS -- in the
undigested sludge, were reduced to below detectable levels  in all cases.
Fecal coliform density (mass basis) was reduced 5 logs but  final densities
averaged 390 CFU/g.  Fecal streptococci densities (mass basis) were reduced
2.7 logs and fecal densities averaged 7,600 CFU/g.

    For composting -- another process that destroys pathogens using thermal
means -- lacaboni et al. (1984) reported reductions in fecal and total
coliform densities and salmonellae densities during full-scale windrow
composting in Los Angeles.  Their work was divided in three phases.  In Phase
I, data were obtained with low windrows and relatively dry sludge cake.  Phase
II data were obtained with wetter sludge cake, and temperatures above 55"C
were frequently hard to sustain.  Salmonellae and coliform densities were
elevated and provided a good test of the utility of using coliforms to
indicate the presence of salmonellae.  In a third phase, these investigators
used high windrows.  During these tests, fecal indicators were generally less
than 100/g solids and salmonellae were rarely detected.

    The coliform and salmonellae data are shown in Table 3-1.  These results
show that total and fecal coliforms survive the thermal  stress of composting
(temp, range 45-65°C) better than salmonellae.  When their densities were  low
(less than 100/g), salmonellae were absent.  When coliform densities were
above 100/g solids, the likelihood that salmonellae were present was high.
Salmonella spp. densities in the incoming sludge were approximately 1.7 X  10'
MPN/g for Phase I and 5.8 X 104 MPN/g for  Phase II studies.   (In such
comparisons, it is important to know that ample salmonellae were entering.  If
salmonellae are not present in the incoming sludge, their absence in the final
product is no evidence that the process kills salmonellae.)
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    In recent work  reported by Yanko  (1988),  complete microbiological analyses
was carried out  on  composts and other sludge  products.  The composts were
prepared at thermophilic conditions  (40-70°C).  Results showed substantial
survival of indicators but complete  absence of viruses.  In an appendix to the
cited report by  lacaboni et al.  (1984),  Yanko does not recommend fecal
indicators as indicators of virus  density, but his reason appears to be that
the fecal indicators  may regrow.   Thus,  a high indicator density might not
indicate a correspondingly high viral density.  In this case the indicators
might be excessively  conservative  indicators  of the presence of viruses.
Nevertheless, the conclusion that  low fecal  indicators indicate the absence of
viruses  is still valid.

    Yanko's work included enumeration of Ascaris  eggs  in sludge products
intended for  distribution and marketing. These products were either composted
at temperatures  exceeding 53°C or  were air-dried  in hot climates.  In 350
examinations, Ascaris were recovered but none were viable.  It is therefore
reasonable to conclude that if the process  destroying  microorganisms utilizes
thermal  means at temperatures above 53°C, Ascaris will also be destroyed.
Fecal  indicators less than 100/g and temperatures above 53°C are good evidence
of their destruction.  Yanko also  observed  that  it was extremely unlikely  that
protozoan  cysts  could survive conditions that would destroy viruses and
Ascaris  spp.

    The  origin  of the 53°C requirement requires  discussion.  This critical
temperature  is  derived from results obtained by  Brannen et al.  (1975).  These
authors  showed that Ascaris egg densities were  reduced 2  logs  (base 10) in
about  5  minutes  at 55°C,  in 60 minutes at 51°C,  and  showed no  reduction at all
after  2  hours at 47°C.  Thus, to ensure Ascaris  destruction,  the required
minimum  sludge  processing  temperature must exceed this threshold for Ascaris
sensitivity.   Based on Brannen et al.'s data, a temperature of 53°C was
selected as  sufficient to  cause a rapid reduction in  Ascaris  density.
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    Nonthermal Processes

    For processes Chat use nonthermal means to destroy pathogens,  fecal
indicators are not adequate for indicating pathogen reduction.  Generally,
pathogen reduction can be adequately gauged by focusing on the one pathogen
type least susceptible to the adverse conditions of the process.   For example,
Ward (1981) points out that the radiation dose to inactivate 90% of viable
viruses in sludge is about 10 times the dose required to inactivate enteric
bacteria.  Larger organisms, such as helminth ova, are even more susceptible
to radiation than bacteria.  Consequently, for processes that use radiation 'to
destroy pathogens, adequate pathogen destruction can be ensured at doses
sufficient to reduce typical maximum viral densities to below detection
limits.

    For processes that treat sludge by chemicals, helminth ova are likely to
be the most resistant organism type, since the shells of the ova are resistant
to penetration by chemicals.
    Unique and Novel Processes

    For unique and novel processes, data on all the various pathogen types are
necessary to demonstrate adequate destruction.  If one organism type proves
hardier than the others it can then be used as an indicator.  If test data
demonstrate that this organism was present initially at typical concentrations
and was reduced by treatment to below detection limits, then it can be safely
assumed that the other pathogens are likewise absent.
    Protecting Against Regrowth

    The regulation specifies that, to meet Class A requirements, vector
attraction must be reduced simultaneously with or after the pathogen
reduction.  This requirement is necessary for the following reason.  To meet
Class A requirements, pathogens must be reduced to below detectable levels.
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In achieving these  reductions,  the nonpathogenic bacteria in sludge are also
destroyed.  These bacteria normally  act as competitors with pathogenic
bacteria and help prevent  regrowth.  When they are absent, as in Class A
sludges, explosive  regrowth can occur.  Processes that reduce vector
attraction add nonpathogenic bacteria back into the sludge, so when vector
attraction occurs simultaneously with or shortly after pathogen reduction,
explosive regrowth  is  prevented.

    Several sludge  treatment processes simultaneously reduce pathogens and
vector attraction.   This  is not the  case, however, with heat treatment.
Though sterilized,  heat-treated sludges still provide a good medium for
bacterial regrowth.   Clements  (1983) describes experience in Switzerland where
pasteurization was  used at approximately 70  plants to disinfect sludge before
land application.   A subsequent investigation conducted under governmental
auspices showed  that the majority of the pasteurized products were
contaminated with pathogenic bacteria.  The  presence of the bacterial
pathogens was attributed to contamination downstream with bacteria that grew
rapidly, even in sludge that had been  thoroughly digested before
pasteurization.  Since that time, most post-pasteurization operations have
been abandoned.  Current practice in Germany and Switzerland is to pre-
pasteurize sludge before digestion or  to use thermophilic aerobic digestion
for agricultural applications  that require minimal pathogen densities in  the
sludge.  With sludge digested after pasteurization, bacteria do not rapidly
grow to high and sustained levels when contamination occurs.

    Sludge  injected into the ground is removed  from potential contact with
humans, and  its  moisture is rapidly removed  by  the soil.  Underground
injection could  be  a suitable way to reduce  vector attraction in pasteurized
sludges if  the sludge is injected very shortly  after pasteurization.  However,
it  is  difficult  to  define the allowable  time between pasteurization and
injection.   If a very fluid sludge becomes  contaminated,  the mixing caused by
pumping or  transport could promote rapid growth of bacterial contaminants to
high densities.

    Good housekeeping could reduce  (but  hardly  eliminate)  sources  of
contamination.   Rather than specifying some  time period,  it  seems  more

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reasonable to look for evidence of regrowth.  Fecal indicators would very
likely still be present in the pasteurized sludge and would almost certainly
be among the contaminating organisms.  If these organisms increased from their
acceptable level of below 100/g solids to over 1,000/g VSS, this would
indicate contamination that could pose a health concern.  If densities are
below 1,000/g VSS at the time of disposal, the likelihood of high densities of
contaminating bacterial pathogens is considered unlikely.

    Sludge cake is much less likely to become contaminated than liquid sludge
because its drier nature limits mixing of any contamination into the entire
sludge mass.  The potential for contamination of sludge cake could be
controlled by establishing a reasonable time limit between pasteurization and
disposal; however, this might be difficult to establish.  Therefore, the
requirement that regrowth of indicator organisms be limited to 1,000/g VSS at
the time of injection seems reasonable for protecting against regrowth in both
liquid sludge and sludge cake injected underground.  This is the approach
taken in the regulations to ensure that substantial regrowth has not taken
place in Class A sludges prior to underground injection.

    In the 1979 "Criteria," heat treatment was considered a process to further
reduce pathogens.  In the present regulation, heat-treated sludge would need
to either (1) be treated by a process to reduce vector attraction, or (2) be
injected underground under the conditions stated above.  This requirement
applies to both heat-treated liquid sludge and dewatered sludge cake.  It may
be possible to establish that sludge cake produced from a heat-treated sludge,
with a solids content above a certain percentage, would not attract vectors.
Information supporting such a contention would have to be presented to EPA's
Pathogen Equivalency Committee for a determination.
    3.2.2.2 Vector Attraction Reduction (§503.53)

    The potential for sludge to attract vectors must be reduced to break  an
important  link in the disease cycle.  Vectors can transmit pathogens  from
sludge, and  they can contaminate sludges with pathogens.  Therefore,  even

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sludges that have  received Class  A pathogen reduction treatment require
reduction  in vector  attraction.   The regulation lists five means to reduce
vector attraction.   These are discussed below.
    Volatile Solids Reduction

    If  the  sludge  volatile solids content has  been  reduced  38% by anaerobic or
aerobic biological treatment or chemical oxidation,  it  is presumed to be
adequately  reduced in vector attraction.  This requirement, which is the same
as was  used in "Criteria," was drawn from the  Water Pollution Control
Federation  Manual  of Practice No. 8 (WPCF, 1967).   The  selection was largely
judgmental  but has been reinforced by 9 years  of usage  under the present
regulation.   Volatile solids reduction is calculated by a volatile solids
balance around the digester or by the Van Kleek formula (Fisher, 1984).

    The proposed regulation allows use of an alternative means to determine
whether a 38% volatile solids reduction has been achieved.  In many  treatment
plants, treated sludge is recycled back to the aerator  for  more treatment or
back  to the inlet of the digester to improve the fluidity of the incoming
sludge.   The sludge entering the digester has  already been  partially digested
so  it is  extremely difficult to achieve an additional 38% volatile solids
digestion.

    Jeris et al. (1985) experimented with several sludges and attempted
unsuccessfully to develop a single index that would characterize the stability
of  a  sludge.  They did demonstrate that most of their anaerobically  digested
sludges could be further digested to a modest degree, while a few of the
sludges showed much more ability to digest further.  This  "ability to  digest
further"  appears to be as close as we can come to an index  of ability  to
putrefy further and attract vectors.  The only problem  is  that 20-40 days are
needed to complete the determination.  The time requirement makes the  method
useless if a sludge must be immediately evaluated,  but  is no obstacle  to
evaluating an operating process.  The test must simply  be  started 20-40 days
before the result is needed.

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    Jeris et al.'s data showed the following additional percent  volatile
solids reduction after 40 days of additional digestion for  six sludges:   9,
10,  13, 22, 36, and 38.  The three sludges with the lowest  volatile solids
(VS) reduction also showed low volatile acid concentrations before the
additional digestion period commenced.   Because the percent VS versus time
curves had essentially flattened out at 30 days,  a VS reduction of 15% or less
on additional batch digestion for 30 days was selected as adequate evidence of
satisfactory vector attraction reduction.  This reduction is stated to be
equivalent to the aforementioned 38% volatile solids based on volatile solids
entering and leaving the digester.

    It is expected that a procedure for conducting this VS reduction test will
be described in forthcoming EPA guidance.  Jeris et al. (1985) used an 18-L
digester with continuous mixing and gas release measurement.  Because only
volatile solids concentration would need to be measured, a smaller digester
(e.g., 4-L) with no gas collection and intermittent stirring (once per shift)
would be adequate.  In the interim between proposed and final issuance of
regulations, additional information should be obtained that supports this
approach.
    Specific Oxygen Uptake Rates (SOUR)

    If a sludge has been treated aerobically to the point at which the
biological organisms present are consuming very little oxygen, the value of
the sludge as a food source for microorganisms is evidently very low.  The
likelihood that such a sludge will attract vectors when applied to the land
surface or injected shallowly  into the ground is likewise low.  Eikura and
Paulsrud (1977) have shown that both the odor index of aerobically digested
sludges and the oxygen uptake  level decline at about the same rate with
increasing nominal residence time in a continuous flow (fed once a day)
digester.  The relationship between odor intensity and oxygen uptake rate is
approximately in direct proportion.  Eikum and Paulsrud's results indicate
that  at 208C, an oxygen uptake  rate of 1.5 g/hr/g VSS or less indicates a

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well-stabilized  sludge.   The oxygen uptake  rate depends on the temperature of
digestion.  Within  a  range  of ± 5eC,  the  oxygen uptake rate obtained at
another temperature can be  converted to the uptake rate of 20°C by the
following relationship:

    SOUR (20°C)  - SOUR (t"C) x 1.10*2*0

The oxygen uptake rate depends on the conditions  of  the test and, to some
degree, on the nature of the original sludge before  aerobic treatment.
Similarly the temperature-correction also depends on the nature of the sludge.
EPA's forthcoming guidance  will provide information  on test procedures and
sludge-dependent factors.
    Alkali Addition

    Vector  attraction can be reduced by alkali addition; however,  the
reduction is  not permanent.  Alkali addition does not  significantly change the
nature of the substances in the sludge but instead  causes stasis  in biological
activity.   If the pH should drop,  the surviving bacterial spores  would become
biologically  active, and the sludge would putrefy and  attract vectors.  The
regulation  provides target conditions that,  if met,  will ensure that the
sludge can  be stored briefly at the treatment plant, transported,  and applied
to the soil without the pH falling to a point where putrefaction  occurs and
vectors  are attracted.

    No land  et al. (1978) have shown that with addition of quicklime or slaked
lime, sludge  pH remains high for extended periods.   His Figure 9  shows that
for a sludge  raised to pH 12.5, pH did not fall to  below 12  for 25 days.  One
reason the  pH stays high for such a long period is  that a substantial portion
of the lime is still not dissolved; this excess lime dissolves as the pH
starts to drop below 12.5.  Other alkalis, such as  cement kiln dust or wood
ash, are more soluble, so at pH 12 or above little  undissolved alkali may be
present  to  help maintain the pH as it starts to fall.   The requirement for pH
to exceed 11.5 for 24 hours after lime addition is  to  ensure that it will be

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high long enough to dispose of the sludge even if a large proportion of the
alkali is soluble.  Obviously, collection of additional data using soluble
alkalies to raise pH will be helpful in substantiating these time-pH
requirements.
    Moisture Reduction

    Drying sludge to near total dryness causes a stasis in biological
activity.  Sludge products such as Milorganite (Milwaukee's heat-dried wasre-
activated sludge) contain less than 10% moisture.  They exhibit no biological
activity when kept dry and resist recontamination unless water is added.
Yeager and Ward's (1981) data show that bacterial densities in sterilized raw
sludge inoculated with several bacterial species declined rapidly when the
solids contents were over 75%, indicating diminished bacterial activity
Thus, it can be concluded that significant biological activity will not occur
if sludge is maintained above 75% solids.  However, the nature of the sludge
and the manner in which it is handled can influence the degree of vector
attraction.  Most air- or heat-dried sludges do not contain raw sludge from a
primary clarifier.  Raw sludge from a primary clarifier could contain
undegraded or partially degraded food fragments, including rancid fats   It is
therefore prudent not to use the 75% dryness level as a measure of reduced
vector attractiveness in sludges that contain raw sludge from primary
clarifiers.  Heat drying of such sludges to a much higher solids content will
further limit biological activity and will strip off or decompose volatile
compounds that attract vectors.  Permit conditions may allow reduction in
vector attraction to be demonstrated by such means if supported by
experimental findings.

    The conditions of handling dried sludge before disposal can create or
prevent vector attraction in dried sludge.  For example, sludge that was air-
dried to 75% solids on a sand bed and stored in piles under a roof could
become a problem in periods of cool weather with high humidity (e.g., during a
prolonged rainy period or a change of seasons).   The outer surface of the
sludge would equilibrate to a lower solids content and could attract vectors.

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This possibility can be  avoided by devising appropriate permit conditions and
is not sufficient justification for  either rejecting drying as a method to
reduce vector attraction or including a  requirement to store the dried sludge
in climate-controlled  storage  or  in  bags.
    Subsurface Injection

    When sludge  is  injected under the  soil  surface and does not leak
substantially  to the  surface,  vectors  no  longer have easy access to the
sludge, and  the  odors that might  attract  vectors  are reduced.  The sludge
intimately contacts the soil and,  in ordinary  circumstances, the soil extracts
water  from the sludge and dewaters it.  The method could fail if loading rates
(mg dry solids basis/hectare)  were unusually high and the soil was saturated
with water.  When sludge is applied at agronomic  rates to soils that do not
have a high  moisture  content,  problems are  not expected.  Permit conditions
should specify maximum liquid loading  rates and should specify that sludge not
be injected  into moist soil.
    3.23  Class B Requirements

    Class  B  requirements are based on the observation that wastewater sludges
produced by  conventional treatment (including anaerobic digestion) and used in
a careful  fashion on farmland pose a minimal disease  risk.  Class B
requirements specify that sludge be treated to produce log average reductions
in pathogenic bacteria and animal viruses equivalent  to the reductions
achieved by  this conventional treatment.   They also require reduction of
vector  attraction,  and establish controls over site access, crops grown and
harvested, and animals grazed.  Together, these requirements  reduce  the
disease risk to minimal levels.

    Class  B  does not require reduction of protozoan cysts or  helminth eggs.
Protozoan  cysts are believed to  be greatly reduced in numbers by sludge
processing and are relatively susceptible to adverse  environmental exposure.

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Even if survival were substantial,  they would be effectively controlled by che
access and use restrictions.  Helminth eggs are hardly reduced at all by
processing, and densities decline slowly in the environment.  The requirements
forbidding growth of certain crops for 18 months and restricting site access
for 12 months are designed to protect the public against possible ingestion of
helminth eggs.
    3.23.1  Pathogen Reduction (§503.52)

    Class B pathogen reduction requires that the logarithm (base 10) of the
average density of pathogenic bacteria per unit mass of volatile suspended
solids in the processed sludge is at least 2.0 lower than the logarithm (base
10) of the average density of pathogenic bacteria per unit mass of suspended
solids in the influent to the treatment works.  For viruses, the difference in
these two densities must be 2.0 or greater.

    The use of the difference in pathogen log densities in suspended solids in
influent wastewater and suspended solids in processed sludge is a new
development.  In "Criteria," the objective of the processes to significantly
reduce pathogens was to ensure that all sludges received at least a certain
minimum degree of treatment.  Farrell et al.  (in press) and Lee et al.  (in
press) established that this approach is inequitable for some treatment plants
because the sludge from certain wastewater processes is lower in fecal
indicators and bacterial pathogens than other processes.  The implication of
their work is that the wastewater treatment process itself is part of the
sludge treatment.  One is then forced to look upstream before wastewater
treatment starts to find a measurement against which residual pathogen
densities in sludge can be compared to measure performance.

    Two upstream measurements have been selected as indices of pathogen
burden:  the pathogen densities and the bacterial fecal indicator densities in
the entering wastewater as related to the mass of the volatile suspended
solids in the wastewater.  The volatile suspended solids was selected as  the
"solids" stream of concern because it contains the great bulk of the pathogens
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(including the viruses  that are  adsorbed on  solids).  The nonvolatile fraction
of sludge (dirt, grit)  mechanically  carries  along pathogens, but the pathogens
are part of the volatile  solids  fraction of  the  sludge solids.

    Selection of the pathogen densities as an  index needs no explanation.  As
for the fecal indicator densities, they are  direct measures of fecal
contamination provided  the wastewater has not  yet been subjected to treatment
adverse to bacterial survival, which is a reasonable assumption at the
treatment plant inlet.  Because  fecal matter is  directly related to pathogen
burden (at least in the long term),  fecal indicators at the plant inlet will
be related to pathogen  burden also,  and their  densities (mass basis) will
serve as an index  of pathogen burden in the  sludge.

    For the purposes of evaluating Class B  (and  Class C) treatment to reduce
pathogens, wastewater  treatment  and  sludge  treatment are considered as steps
taken to reduce the pathogen density (no./g  VSS) in the incoming wastewater
solids.  For those processes for which  fecal indicators fall  in a manner that
correlates uniformly with the fall in pathogen content, the fall in fecal
indicator densities (mass basis) can be used to  indicate the  fall in pathogen
densities.

    What is needed now is information on  typical wastewater and sludge
treatment processes that  shows that  fecal  indicators, bacterial pathogens, and
animal viruses  all fall in about the same  fashion.  Information is available
that shows that this  is true for aerobic  treatment and mesophilic anaerobic
digestion.  Martin (in press) obtained  data on the relative declines in  fecal
indicators and  animal  viruses at temperatures  from 8-40"C.  In the temperature
range of 15-31°C,  the  reductions did not  show  marked  trends with temperature.
Ratios of log reductions  for fecal indicators  relative to  log reductions for
viruses were calculated for seven temperatures in this temperature range.
Average ratios  and standard error of the  mean  are shown  in Table 3-2, and  are
compared with Farrell  et  al.'s (1985) data for anaerobic digestion at 358C.

    The differences are not great.  The agreement is  particularly good  for
fecal streptococci.  It is reasonable then to  conclude that for aerobic  and
anaerobic processes in the commonly used temperature  ranges,  a decline  in
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fecal indicator densities can be used to indicate declines in viruses for both
cases.  Because of the scarcity of data (there were insufficient numbers of
salmonellae in Martin's influent for him to observe the fate of this
pathogen),  it is necessary to assume that the declines in salmonellae relative
to the indicators would be similar for both types of processes.

    For processes conducted at temperatures higher than 35°C, available
information (Farrell et al., in press; Martin, in press; Berg and Berman,
1980) indicates that viruses fall faster than indicators.  However, this issue
does not require discussion because bacterial and viral reductions are much
greater than two logs at thermophilic temperatures.

    The situation for chemical treatment of sludge by lime or chlorine is
similar to that for biological treatment in the thermophilic range.  Under
these treatments, bacteria and viruses fall to a much greater extent than the
minimum requirement for Class B treatment.  For lime treatment, results by
Counts and Shuckrow (1975) and Strauch (1982) show that bacteria and viruses
are greatly reduced at pHs exceeding 12.  When wastewater is treated by
chlorine to a pH near 7, the free chlorine inactivates polio virus and E. coli
to a  similar extent (Table 5-11 in EPA, 1986).  In sludge treatment the bulk
of the chlorine would be converted to chloramines.  Reduction  in viruses would
occur but more slowly.  Adequate contact time with the sludge would be
necessary.  Typically, contact times of fewer than 30 minutes provide adequate
virus destruction.

    For  those processes  for which the fall in indicators correlates with the
fall  in pathogenic bacteria and viruses, the proposed regulation sets a
criterion for pathogen reduction based on  the absolute densities of fecal
indicators in treated sludge for certain processes.  This criterion requires
that  the average log fecal coliform densities (no./g VSS) shall be less  than
6.0 and  the average log  fecal streptococci densities  (no./g  VSS) shall be  less
than  6.0 in the processed sludge.  The rationale  for  this is as follows.
Until now, reductions in pathogen densities have  been estimated by correlating
them  to  reduction  in indicator densities.  Absolute densities  of the fecal
indicators can be  used as a criterion because the densities  of the indicators
in entering wastewater are  surprisingly similar  for different  wastewater

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treatment plants;  as  a  result,  indicator densities after adequate treatment to
reduce pathogens  are  also  expected to  be similar.  Farrell et al. (in press)
found that  the  ranges in log densities for total coliforms, fecal coliforms,
and fecal streptococci  were 0.55,  0.43,  and 0.43, respectively,  for four
NP/LSA (no  primary/long sludge  age)  plants and one conventional  plant.
Densities in  this study were on a total solids basis.   It is expected that
Olivieri and  Sarai's  results (1988,  in press)  will confirm this  observation,
when their  investigation is completed.

    For unique  processes that might not adequately destroy viruses or
pathogenic  bacteria,  it will be necessary to either  (1) collect  information to
show that fecal indicators can  be used as indicators  of bacteria and virus
destruction,  or (2) measure either pathogenic bacteria  or animal virus
densities (whichever  is the least sensitive to the process) to indicate
performance.
    3.23.2  Vector Attraction Reduction (§503.53)

    All vector attraction processes for Class B are  the  same  as  for  Class A,
except, for Class  B,  the vector attraction process may precede,  follow, or
occur  simultaneously with pathogen reduction.  The Class A requirement  that
the vector  attraction reduction process cannot precede the pathogen  reduction
process is  unnecessary for Class B because regrowth  of bacterial pathogens is
unlikely  in Class  B sludges, because some competitor bacteria remain in the
sludge following treatment.  For the same reason, no requirement exists to
determine fecal indicator densities to ensure that regrowth has  not  occurred
when vector attraction is reduced by underground injection.
    3.233  Access and Use Restrictions (§503.52)

    Class  B requirements reduce pathogenic bacteria and animal viruses,  but
some  of  these organisms still survive in the sludge.   Protozoan cysts,
although probably the most susceptible pathogen to wastewater and sludge

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treatment, may also be present.   Helminth eggs,  if present in the untreated
wastewater, are very likely to be present because they are the least affected
of the pathogen types by wastewater and sludge treatment.   Access and use
restrictions have been imposed for Class B sludges that either limit exposure
or provide time for attenuation of pathogens so that the risk of disease is
minimal.

    Food crops whose harvested parts are above the ground and touch the sludge
or soil-sludge mixture cannot be grown for 18 months after application of a
Class B sludge.  Food crops whose harvested parts are above the ground and do
not touch the sludge may be grown at any time.  The 18 months provides time
for attenuation of pathogens -- particularly helminth eggs.  Kowal's (1985)
review points out that helminth eggs are degraded by exposure to sunlight and
desiccation but survive for years when protected by the soil.  The long time
period allows time for sun and desiccation to inactivate the helminth eggs,
which are the pathogen type most resistant to environmental stress.

    The proposed regulation requires that food crops whose harvested parts are
below the surface shall not be grown for 5 years after land application of
Class B sludge, or 18 months if it is demonstrated at that time that there are
no viable helminth eggs in the soil.  Research has shown that helminth eggs
below the soil surface survive in some soils  for periods well in excess of 18
months (Jakubowski, 1988).  After 5 years their survival is expected to be
low.  Some sludges are initially low in helminth eggs.  Initial low densities
coupled with the declines that occur after 18 months may produce trivial
densities  in soil.  It is reasonable to allow use of the soil for root crops
after 18 months if helminth eggs are demonstrated to be absent.  Measurement
of low densities of helminth eggs in soil requires proper methodology and
training.  A demonstration that helminth eggs are absent will be accepted  only
if the ability to recover small numbers of helminths in soil  is also
demonstrated.

    Any food crops grown on agricultural land where Class B sludge has been
applied shall not be harvested for 30 days after sludge application.  This
protection is needed because animals and humans may contact these harvested
crops very soon after harvesting.  A period of exposure to environmental

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conditions before harvesting allows wind  action and rainfall to reduce the
amount of sludge adhering to the  crops  and  to attenuate pathogens.  Exposure
of pathogens on the  plant surface is  especially severe because the sludge
layers are thin and  desiccate quickly.  As  noted earlier, viruses on low-
growing vegetables have  been shown to decline to low values in less than 2
weeks (Larkin et al. ,  1976).  Consequently, prevention of harvesting for 1
month is considered  sufficiently  protective.

    The proposed regulation requires  that animals be prevented from grazing
for 30 days after sludge is applied to  the  land.  This requirement is
primarily designed  to  protect human health.  Animals can physically carry
sludge off the site  where humans  may  inadvertently come in contact with it.
Prevention of any grazing for 1 month after sludge use to allow attenuation of
pathogens and removal  of sludge  from  plant  surfaces by rain and wind is
appropriate and  is  considered to  be sufficiently protective.  The requirement
also protects animals  against bacterial or  viral diseases, such as
salmonellosis, which can be transmitted to  humans; however, it is less
protective against  helminths such as  Taenia saginata (beef tapeworm).  These
organisms are somewhat attenuated within  a  month, and agricultural inspection
of meat for cysticercosis reduces the risk  of creating a cycle of infestation.

    The proposed regulations require  that public access to a site be prevented
for 12 months after application  of Class  B  sludge.  This restriction does not
apply to  farm owners and agricultural workers who are aware of the presence of
sludge; it does  apply  to the uninformed public.  The 12-month period is fully
protective against  viruses, bacteria, and helminths.  The restriction on
access is shorter  than the restriction  against  growing food crops because the
exposure  to helminths  by walking or  sitting on  the ground is assumed to be
less than exposure  by  ingesting  food  crops  grown on soil containing sludge.
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    3.2.4  Class C Requirements

    3.2.4.1 Pathogen Reduction (§503.52)

    Class C requirements stem from the observation by Farrell et al. (in
press) and Lee et al. (in press) that sludge produced by "no primary/long
sludge age" (NP/LSA) plants (i.e., by wastewater treatment plants that do not
use primary clarification but expose wastewater and sludge to aerobic
conditions for long periods) is more reduced in salmonellae and fecal
indicator densities than untreated sludge from a conventional treatment plant
that utilizes primary clarification and the conventional activated sludge
process.  It is well known that NP/LSA sludges are better stabilized than the
typical mixed primary and waste-activated sludge from a conventional plant.
In the past, NP/LSA plants have frequently had difficulty meeting the volatile
solids reduction for aerobic digestion specified in "Criteria" because they
already had lost much of their volatile solids in the wastewater treatment
step.  The "Criteria" treatment of these sludges was inequitable.  Class C
acknowledges that these sludges are nearly but not quite as reduced in
pathogens as sludges that have received Class B treatment.

    Estimation of the pathogen reduction across NP/LSA plants is approximate
because almost no experimental work has been done relating pathogens and
indicator densities  (mass basis) in inlet wastewater solids to their densities
(mass basis) in the waste sludge at these plants.  The pathogen reductions of
1.5 logs  (base 10) shown in the proposed regulation are estimates based on
reductions in densities of fecal indicators achieved by processing.

    Table 3-3 shows densities of indicator organisms in the processed sludge
from several conventional treatment plants that anaerobically digest their
sludge and from several NP/LSA plants.  The data show suggested ranges and
standards for fecal  indicators for these sludges.  Considering only fecal
coliforms and fecal streptococci, the NP/LSA sludges show densities that
averaged  about 0.5 logs higher than for the conventional sludges.  Using the
estimates of the ratio of log viral to indicator reductions presented in Table
3-2, log viral reductions are estimated to be approximately 0.5 log poorer for

                                    3-23

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NP/LSA processes.   For bacteria,  Che NP/LSA processes  showed  an overall  log
reduction  in  fecal  streptococci of about 1.4 and a Salmonella spp.  reduction
of 1.2 (Farrell  et  al. ,  in press;  Lee et al.,  in press).   For bacteria,  the
0.5 less reduction  in fecal indicators will mean approximately 0.4  log less
reduction  in  pathogenic bacteria.

    On this basis,  the proposed regulation states that average log  fecal
coliform densities  (no./g VSS)  shall be less than 6.3,  and average  log fecal
streptococci  shall  be less than 6.7.  As noted in Section 3.2.3,  it is
possible to use  absolute densities (as opposed to reductions  in densities) as
standards  because densities of fecal indicators in the incoming wastewater
(no./g VSS) are  nearly the same at wastewater treatment plants.

    The fact  that the proposed 1.5-log reduction in pathogenic bacterial and
viral densities  for NP/LSA plants has been estimated is recognized.   For the
most part, this  creates no difficulties because most facilities will be  able
to use absolute  fecal indicator densities of the treated sludge to  demonstrate
conformance with regulations.  The primary objective is to show that the
intent of  the regulation is to control pathogen densities and not indicator
organism densities.
    3.2.4.2  Vector Attraction Reduction (§503.53)

    The  Class C vector attraction reduction requirements are exactly the same
as  the Class B requirements.  No further discussion is needed.
    3.2.43  Access and Use Restrictions (§503.52)

    Class  C access and use restrictions are similar to but more rigorous than
Class  B  requirements.  The 1-month time restrictions in the Class B
requirements,  which are designed to protect primarily against risks from
pathogenic bacteria and viruses,  are increased for Class C requirements.   The
18-month and 5-year time restrictions in the Class B requirements are designed

                                     3-24

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to protect against risk from helminth eggs.   Sludge processing used to achieve
Type B and C pathogen reduction requirements will have a similar slight effect
on helminth eggs survival;  consequently,  the time periods- chosen to protect
human health from helminth risk associated with Type fi sludges will also be
protective for Type C sludges.

    The proposed regulation requires that feed crops whose harvested parts
touch the sludge and are above ground cannot be grown for 18 months after
application of Class C sludge.  Feed crops whose harvested parts are below the
surface shall not be grown for 5 years after application of Class C sludge to
the land, or 18 months if it is demonstrated that no viable helminth eggs can
be found in the soil.  These requirements are the same as for Class B.

    Any food crops grown on agricultural land where Class C sludge has been
applied shall not be harvested for 2 months after sludge has been applied.
This is an increase of 1 month over Class B requirements.  Additional time is
required for attenuation because bacterial and viral pathogen levels are
slightly higher in Class C sludges than Class B sludges.

    Animals must be prevented from grazing for 2 months after Class C sludge
is applied to land.  This is an increase of 1 month over Class B requirements.
Additional time is needed for attenuation of viruses and pathogenic bacteria
because the initial pathogenic bacterial and viral content is higher in Class
C sludges.

    The Class C access restrictions are more rigorous than the Class B
restrictions.  Both classes require control of site access for 12 months  in
both cases; however, for Class C, only agricultural workers are allowed access
to the site during the 12 months.  For example, members of farm families  who
were not directly involved in crop production activities could visit fields
where Class B sludge had been applied, but would not be allowed in areas  where
Class C sludge had been applied.  Only workers actively managing crops would
be allowed access to an area where Class C sludge had been applied.
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    3.2.5  Septage

    The proposed regulation defines septage as 'sewage sludge, so all the
requirements, including  chose concerning control of disease risks,  apply to
septage.  Thus the regulation requires that septage cannot be disposed to the
land surface unless  it meets Class A, B, or C requirements.  This is a
departure from "Criteria," which allowed septage to be utilized on the land
without any  treatment under a slightly different set of restrictions than
those for sewage sludge.

    Septage  pumped from  a  septic tank is ordinarily an extremely noxious
substance.   However, if  the septic tank has experienced little use,
particularly recent  use, the septage could be low in pathogens and fecal
indicators and well  stabilized.  Except for the temporary burst of noxious
odor when such a material  is applied to the soil, it might pose few problems
and little disease or vector attraction threat.  Finding practical ways to
demonstrate  that the typical 1,000-galIon tank truck load of septage poses
little disease risk  is difficult.  Almost any sampling and analysis scheme
would be more expensive  than paying to have the sludge processed by a
wastewater treatment plant or a special facility for treating septage.  The
regulation will probably move septage disposal in this direction.

    Some question remains  whether allowing septage to be applied after meeting
Class B or C requirements  is wise.  The nature of infection  is that a person
is free of pathogens most  of the time and only occasionally  sheds pathogens in
feces.  In the treatment of a community's wastes, an averaging effect comes
into play.   Most of  the  time the sludge has low levels of pathogens that must
be lowered still more  to be sure disposal is  safe.  On the other hand, most
septic  tanks serve a single household.  Consequently, most septage loads are
not contaminated, but  occasionally, a load will be very  "hot" with pathogens.
For example, it  is not uncommon for several family members to be carriers of
salmonellae  for  several  weeks after an  infection in the  family, or one or two
people  in a  family may have an  Ascaris  infestation.  The methods used to meet
Type B  and C requirements  reduce pathogens by factors of 10  to 100.
Ordinarily,  this provides  ample protection, but it might not if densities are

                                     3-26

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a thousand times higher than the ordinary maximum values encountered in an
untreated sludge from a wastewater treatment plant.   Considered in this light,
septage disposal should be moved toward community treatment centers or
wastewater treatment plants.
                                     3-27

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