NOVEfffiER 12, 1987

Prepared by:

Nelson S. Slavik, Ri.D.

Ehvircjrmental Health ffenagemerrt

Systans, Inc.

Chanpaign, IL



•Jn November 12. 1987. the U.S. EPA convened a panei of experts represen-:ru
healthcare professionals and practitioners from aoverrunent, acaaemm,
ir.dusrrv and professional and trade associations ro discuss and evaluate rhe
nature and extent of the risks posed by wastes that contain infectious
mat>:r iii.-; on human health and the environment. ['he meeting was he-id in
response to am. in* c:oncerr3 about the management of infectious wastr to
nelp evaluate whether EPA should ^indert.ike any additional action under rhe
Resource ( onservat icn and Recovery V-t.

This document" i* intended to present those issues of concern as defined bv
-he -.nrlfina aroup and to provide the EPA with recommendations for a course
•>f a. ' ion. Thr issues discussed were controversial and concurrence vn
reco.nmendations for EPA consideration was not realized for each issue
debuted. The majority of material presented in this document was discussed
during the rceetina, however some statements have been provided to add
:jfurk»rour.d for assistance in issue clarification and definition. The issues
and recommendations are summarized below.

Determining the decree of risk posed bv the improper manacement of
infectious waste on human health and the environment is one of the critics^
issues requiring resolution and the one that influences all other issues f
pertainin* to infectious wastes. Due in part to the subjectivity of
assianin* infectious potential to a waste, the lack of epidemiological iata.
and to the fear of the unknown or the not understood, there exists a
Jreeption that is a threat to public health from infectious wastes or
from all medical wastes in general.

¦r assessir.« fhe decree of risk posed bv infectious wastes, exposure
DOtcntial is a primary factor which dictates the extent to which human
hi ilvh >r the environment may be threatened. Exposures may be
ovulational lv derived or they may be viewed as environmental, threatening
•a-1	or the enviconment of the general public. Many of the concerns

¦¦i-h iV*ctious wastes raised by the public have resulted from incidences of
LtwiiH.;riir.inate infectious wait* disposal. These incidences have been
L'mLt.V wi"h actual exposures to the general public from known infectious
•..Istea^occurring only in a few instances. Exposures to infectious wastes
~hat could result in disease transmission are more likely to occur in those
V.upaticSal settings that generate, transport, store treatordispose of
.hPSe uastM. Education of those who generate, transport, and dispose or
; nfectioua wastes was viewed as the key to reducing any potential risks from
these wastes.

Attempts have teen made by the Center, for DUeue Control and the,L.S.
Environmental Protection Mency to standardize the definition of what
^Snititute. an infection wMte. However, problem, develop when attempt!!*
to applv anv definition to aedical «.te. .inc. it i. not realistic or
feasible to awav a ra»te to deterain. that pathown. exist in mmber.
capable of disease transmission. Identification therefore remain,
qualitative .it best, and i. determinant on the subjectmti of the


.r.di". ;ju> "t sr'iii; irivjj.'. ed in " z.ccision makins; process.

•.^f-.M.t.hsi-.andir.i r.hc risk p->r: :pr i^,ns and anxieties associated uitn tne r'---n'-
^¦f contracting AIDS, chose categories -;t infectious -astes that are
reoognirod by both the CDC and the t?.\ as possessing a r-ai potential t.:.
transmit disease are contaminated shui ps. human blood and blood produce3.
pat. hoi £ical wastes (body parts and tissues:, and laooratorv wastes.

3«»cause jf the known disease association with the t.-aste (iaboratorv

, i 11! ¦ ii ¦¦ i * *ii«.* ¦ 1 • a[>jc 1 .nens * b Iood, or body t luidsf or the do t ^nt' a 1 c*"*"*
arc M.rr.rai .r..:?'.;'Li.n (needles!. those waste streams were recognized as
hnv.r.j thA Mahest potential fir causing disease transmission, dictating
•hat "hoy handled and disposed of properly.

'U-sritaii have been perceived to be the major, if not the oniv source -f
infectious waste warranting proper management procedures. Typical
jeneratots of infectious waste could also include private and public healtr
ciinics. nursing homes and other chronic care facilities, dental cliriic3.
diagnostic Laboratories, and blood bank3. Although the volumes ot'
infoo? ious wastes generated would normally be less than those generated by a
hospital, wastes containing blood, blood products, needles and syringes ir«»'
commonlr generated by these facilities and could pose an equivalent risk (as
.ho implementation -A a track ma -,r .nanif-stms 3vSrem has been 	

i solution to minimize or eliminate the risk to the public from	^

inappropriate infectious waste disposal oractiees. aefc-o -he

*u Lit ions or standards, fhe ncccssitv or a rricJ-ino	- lr-j-t'-iticn :r

usSrs,,n '--hother a tracking "r manifest 3vsrem was justified hv -1-1-	¦

by the benefits rhat could bo achieved upon the institution 0} Ech	^

Frrm the discussions that took place during the meeting, education was
virwed as a common denominator to resolving many of the issues debated
Chaos is perceived by the public and by the States on infectious wast*'
management issues primarily due to the lack of Federal agency consistency
and direction in these matters. EP.Vs role to resolve these issues 4Sd be
via the issuance of guidance documents or through the promulgation of
regulations. Since these problems exist now and since they appear to
require education in their resolution. EPA should direct its irUtial efforts
m providing the direction and information needed through the development of
guidance docianents.	wwnt Ul


These small venerators also typically will relv on the building's management
to provide waste disposal services. As such, what thought the small
aenerator may have had with regard to the infectious potential of his waste
will be forgotten once the waste Leaves the office. The management service,
generally not knowledgeable of infectious waste, will dispose of these
materials into the general waste stream.

Those 5.xall quantitv generators concerned about the management of their
infectious •...ij.tes ..ften are faced with the problem of not having a mechanism
for disposal. As with many small or independent generators, the equipment
to treat this waste is not available and is economically prohibitise to
purchase. Many areas of the country do not have commercial off-site
-tispo^al sen-ices available which want to or can properly treat or dispose
of these wastes. Hospitals having the capability to treat these wastes are
also reluctant to accept these wastes for disposal because of the waste's
oorential Liability or because of state requirements prohibiting or
interfering with the disposal process.

Packaging and Containment of Infectious Wastes

To minimize exposure to infectious wastes requires the proper packaging of
these materials. The integrity of the packaging is important during the
collation, transport, and storage processes to prevent release of the
infectious waste materials contained within the bag or container.

The selection of proper packaging materials that are appropriate for the
types of wastes being contained is critical to ensure containment
integrity. For bulk wastes containing contaminated disposables and residual
liquids, polyethylene or polypropylene bags are most appropriate for intra-
t'aeility use. Polyethylene bags are generally used for primary waste
collection. However, they are not heat resistant and must be overbasged
with heat-resistant, polypropylene bags for treatment by steam
sterilization. Resistance to tearing is dependent on thickness (mil gauge)
or tensile strength as determined by the ASTM dart drop test (ASTM Standard
D 1709-75).

Puncture-resistant containers should always be used for all sharps or any
material that has the capability of puncturing a plastic bag. Selection of
appropriate sharps containers is dependent on treatment method and residual
liquid associated with the sharps. Typically, many healthcare facilities
are using polypropylene containers specifically designed for sharps waste.

Any container or bag used should have the capability of being closed-off or
tied to prevent spills during m-house transfer, storage, or collection.
Any container holding infectious liquid wastes should be capped with leak-
proof Lids, double- bagged, placed in a corrugated container to minimize the
release of potentially infectious liquids. No compaction or grinding of
infectious wastes should occur before treatment since violation of the
packaging could cause release of pathogenic microorganisms.

Off-site disposal of infectious wastes, treated or untreated, has posed
problems to haulers, operators of transfer stations, municipal incinerator
curators, and Landfill personnel due to improper packaging by the generator


or through the vj.oLati.on of the container during the transfer, storage or
disposal process. Because of the physical nature of these wastes, needles
and syringes and liquid infectious wastes (notably blood) have been cued
most frequently as being the greatest potential threat to the sanitation
worker. Although bags and boxes used for the containment of infectious
wastes work well in the healthcare environment, in containing their contents,
once these materials besin their journey toward ultimate disposal thev arc
subjected to external pressures that easily rupture the container. This
process begins in the healthcare facility's compactor-receiver where the
bass and boxes may be initially broken or torn during compaction. In those
instances where waste is taken to a transfer station, these containers mav
also may be ruptured during those dumping and compaction processes thus
subjecting the operators to potential exposure. At the landfill or
municipal incinerator, containers sure also roughly treated before disposal,
further adding possible direct exposure to these wastes.

Occupational Versus Environmental Exposures Fro* Infectious Wastes

In assessing the degree of risk posed by infectious waste, exposure
potential is a primary factor which dictates the extent to which huoan
health or the environment may be threatened. Exposures may be
occupationally derived or they may be viewed as environmental, resulting ?
from inappropriate infectious waste management or disposal practices. Many
of the concerns with infectious wastes raised by the public have resulted
from incidences of indiscriminate infectious waste disposal. However frem a
public health viewpoint, actual exposures to the general public from known
infectious wastes have been very limited. Exposures to infectious waste are
more likely from those occupational settings that generate, transport,
store, treat or dispose of these wastes. Effective management plans in each
of these settings should minimize public exposure resulting from
inappropriate disposal practices.

Environmentally, public exposure to infectious wastes should only occur
through improper disposal practices that allow direct contact with
infectious waste materials. Such practices have included the disposal of
infectious waste into dumpsters that are easily accessed by the public and
the disposal of wastes in locations unsuitable for waste disposal (along the
side of the road, on farms, in absndoned warehouses, and in public waters).

Landfilling of these wastes in sanitary landfills should not be viewed with
the ssas perceived threat as hazardous chemical waste. It has not been
docunented or stiOMi epidemiologically that an environmental threat exists
when thsss	are disposed in a properly constructed sanitary landfill.

In fact. du* to ths biological instability of microorganisms recognized as
huun pethogsns, the potential of any negative environmental consequence
should diminish over time.

From the perspective that risk from infectious wastes is greater in the
occupational setting, it now becomes the employer's responsibility to insure
that these wastes are managed properly on-site and to ensure that any off-
site transport and disposal is properly conducted. For the generator of
infectious wastes, these responsibilities would include the development and
implementation of a management program that addresses waste identification.


segregation, packaging, transport, treatment, disposal and employee
training. Selection of a responsible contractor for those wastes beina
transported off-site for disposal should also be the responsibility or the
a~nerator of that waste.

For hauiers and disposers of infectious wastes, it is the employer's
responsibility to properly train all employees engaged in any activity that
could result in an exposure to an infectious waste. Such training and
education would incLude hazard recognition, personal protection practices,
decontamination procedures, treatment and disposal procedures.

Tracking (Manifesting) Infectious Wastes

The implementation of a tracking or manifesting system has been suggested as
a solution to minimize or eliminate the risk to the public from
inappropriate infectious waste disposal practices. Before the initiation of
Regulations or standards, the necessity of a tracking system should first be
assessed based upon the risk potential to the public from mismanagement of
these wastes. If it is determined that Federal standards are required, the
usefulness of a tracking or manifest system in achieving the objectives, of
those standards should be evaluated. The resulting structure of any such
tracking system should be comnensurate with the risks incurred during th*&
transportation and disposal of these wastes.

Although inappropriate infectious waste disposal practices have gained
extensive media coverage, they remain for the most part, isolated
incidences. From the previous discussion, the majority of problems
attributed to infectious wastes have been occupationally derived. As such,
the responsibility of proper waste disposal should remain with the generator
of that waste. However, infectious wastes in many regions of the country
are not treated or disposed of locally, making monitoring of the disposal
process by the generator difficult. As a result, a few unscrupulous haulers
have taken advantage of the situation and indiscriminately disposed of the
waste. To allay generator fears, several infectious waste haulers and
disposers have initiated tracking systems that log the flow of the waste to
its intended destination. Although these tracking mechanisms, in general,
do not inform the generator that the waste has made it to the disposal site,
these mechanisms are useful in retracing the path of the waste if something
goes wrong and identifying the actual generator of that package or
container. As such, this form of tracking could be viewed as a means to
reduce tIM generator's liability.

The focwt of infectious waste transport and disposal monitoring could be
viewed tt A tracking process as described above or as a manifesting process
similar to that used for hazardous chemical wastes under RCRA. The
questions needed to be resolved before any system is developed include:

t Will tracking lessen the risk of disease transmission?

*	Will tracking eliminate illegal disposal practices?

~	If a manifest form of tracking is considered, is its complexity and

economic cost commensurate with the minimal risks associated with

infectious wastes?


*	If manifesting is considered, what definitions will be used to -ie^r.e

those wastes being transported and disposed'.' Wi.lL treated wastes
also require manifesting'.'

*	If manifesting is considered, Should the manifesting of infectious

wastes be tied in with the registration of haulers.' Will a
separate generator Identification number be required for
infectious waste generators versus those for chemical wastes
t u i 1L the mamfest. system proceed only to the point of treatment or
will it *o further, monitoring the ultimate disposal of
Incinerator ash or steam sterilized infectious wastes?

« Should Federal direction be in the form of guidelines or regulations'.

Recommendations For EPA Involvement

With potential Congressional legislative action pending for EPA involvement
in infectious waste management, the necessity for EPA's involvement and the
role it may play in resolving the issues discussed above should be
evaluated from the perspective of both the nature and degree of risk
associated with infectious wastes. An assessment of both those real and
perceived risks was attempted at the November 12th meeting. The results of
this assessment are summarized below.

*	Risks from Infectious Wastes

The majority of risks from infectious wastes are occupationaJLly
derived. Most risks are at the source of generation of infectious
wastes. With proper infectious waste management in the workplace
and minimal requirements for disposal, risks to the public and the
worker should be minimized. Education of those who generate,
transport, and dispose of infectious wastes is viewed as the key to
risk reduction.

*	Infectious Waste Definition^

Of those categories of infectious waste defined by CDC and EPA,
contaminated needles, laboratory wastes, and bulk blood were cited
as having the.greatest potential for disease transmission. Of
these, contaminated needles pose a serious threat because of their
capacity to puncture the skin, providing a direct portal of entry
for disease causing agents. Laboratory wastes and bulk blood
properly decontaminated on-site should pose no threat to the
environment, public or sanitation worker.

« Stall Qiwntity Infectious Waste Generators*^

Hospitals are not the only generators of infectious wastes.

Clinics and independent physicians' offices generate small
quantities of waste that may be capable of disease transmission if
not properly nonaged and disposed. Needles generated by these
generators were cited as the infectious waste stream of most
concern. It was recommended that the small quantity generator
issue be furthered studied.

t Packaging and Containment of Infectious Waste

Examples were cited of waste containers rupturing during the


process of off-site disposal of treated and untreated infectlous
waste. Although these containers are normally sufficient for ^se
at the site of generation, thev cannot withstand compaction and the
other external physical forces exerted during transport and
disposal processes. Rupturing of these containers can result in a
workplace exposure. Although this packaging issue was not
-^solved, an awareness of and proper response to the hazards posed
Muring infectious '-asre processing through education and training
v.ore viewed as a way to minimize this workplace e?cposure.

*	OccupatioaaL Versus Environmental Exposures From Infectious Vistes

Uthough m«tia coverage* has dwelled on the potential for pubLic
exposure from inappropriate infectious waste disposal practices,
those incidences are viewed as isolated and pose minimal risk to
the public at large. From an occupational perspective, the
potential for risk becomes greater due to the increased likelihood
r.hat the venerator, the hauler, and disposer may come into contact
•-ith the waste. To minimize the risk to these workers, emphasis
should be placed on informing the worker of the hazards posed and
training them in the necessary personal protection mechanism. As
such, the Occupational Safety and Health Administration (OSHA)
has the authority for jurisdictional oversight on these worker
health and safety issues. If OSHA does become involved in thes%
i3sues, efforts should be coordinated between EPA and OSHA to
ensure'consistency on definition and approach In any rule makin*.

*	Tracking (Manifesting} Infectious Wastes

No consensus was received on the issue of tracking or of
manifesting infectious wastes. It was viewed made sense
tc know where your waste was going, but whether the initiation of a
Federal tracking or manifesting system was justified by risk
potential or by benefits that could be achieved was questionable.

From the discussions that took place during the meeting, education was
viewM as a roranon denominator to resolving many of the issues debated.

Chaos is perceived br the public and by the States on infectious waste
.¦management issues primarily due to the tack of Federal agency consistency
and direction in these matters. Although some infectious waste risk could
be visualized as environmental and under the jurisdiction of EPA, many of
rhe problems cited are occupational and may be within OSHA's jurisdiction.

such| cooperation of these two agencies may be ultimately required to
provide'that infoxmtion and training necessary to reduce the real risks
posed by infectious wastes and to provide a consistent approach to the
management of thmss materials.

EPA's role to resolve these issues could be via the issuance of guidance
documents or through the promulgation of regulations. Since these problems
exist now and since they appear to require education in their resolution.
EPA should direct its initial efforts in providing the direction and
information needed through the development of guidance docuaents. The
development and dissemination of educational materials can proceed more
quirkly than regulation promulgation. If the issues cannot be resolved in
this manner the next step that could be taken would be the issuance of


:riteria documents. Lf the fist two measures t'aii, regulations rouid be

To assist EPA in "the production of educational, materials, many crade and
professional organizations could be called upon to help develop ;ind
dissMiunatu guidance materials. Providing materials specific to r.he needs
of the various generators of infectious wastes and to those sanitation
¦-orkers who haul, store, transfer, treat or dispose of infectious ~asces
should siaiufirantiv assist in minimizing exposures to infectious wastes.