Proceedings of Meeting on
MEDICAL
WAST
DEFINITION TRACKING INFORMATION NEEDS
Segregation
Packaging
Labeling
Manifesting
November 14-16, 1988
Annapolis, Maryland
United States Environmental Protection Agency
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Proceedings of Meeting on
Medical Waste
November 14-16, 1988
Prepared by
Science Applications International Corporation
8400 Westpark Drive
McLean, Virginia 22102-3522
EPA Contract 68-01-7490
SAIC Project 1-828-07-911-81
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CONTENTS
Page
INTRODUCTION
SUMMARY OF KEY ISSUES
Definitions, November 14 4
Segregation, Packaging, and Labeling, November 15 11
Tracking and Recordkeeping, November 15 15
Information Needs, November 16 21
APPENDICES
A. Meeting Agenda A-l
B. List of Participants B-l
C. Summary of Small Working Group Sessions,
November 14 and 15 C-l
D. Summary of Small Working Group Sessions,
November 16 D-l
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INTRODUCTION
The U.S. Environmental Protection Agency (EPA) sponsored the Medical
Waste Meeting held at the Governor Calvert House in Annapolis, Maryland,
during November 14-16, 1988. The purpose of the meeting was to allow EPA to
draw on the knowledge and experience of experts to support the development of
a demonstration medical waste tracking program as required by the Medical
Waste Tracking Act of 1988. The Agency requested information from
participants on the categories of medical waste that should be regulated and
on the procedures that should be developed to handle the identified wastes.
As requested by the EPA, the attendees discussed definitions of medical
wastes on November 14; the associated requirements for segregating,
packaging, labeling, tracking, and recordkeeping on November 15; and the
information EPA needs for its reports to Congress on November 16.
This volume concentrates on the key issues identified by meeting
participants. Appendix A presents the agenda and Appendix B the list of
participants, who represented a diversified group of Federal and State
agencies, as well as national professional associations. Appendices C and D
summarize the discussions and decisions of the small working groups.
Finally, these proceedings are intended only as a summary of the
discussions that occurred. Any conclusions reached represent a general sense
gathered from the discussions and in no way imply a consensus of the group.
Also, when the text indicates that a "group recommended" a certain provision,
this generally means that a majority of members in that group favored the
provision. Individual members of the group may have disagreed or had
reservations concerning the issue.
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Summary of Key Issues
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SUMMARY OF KEY ISSUES
Sylvia Lowrance, Director of the EPA Office of Solid Waste, convened
the meeting as scheduled, at 10:00 a.m. on November 14, 1988. She welcomed
the participants, then focused their attention to the demonstration tracking
program required by the Medical Waste Tracking Act of 1988. The Agency
needed the expertise and assistance of meeting participants, she explained,
in developing this program, particularly in:
Defining the categories of medical wastes for inclusion in the program
Developing uniform procedures for:
Segregation
- Packaging
- Labeling
- Tracking and recordkeeping
Identifying the data required and the sources of information for the
three reports EPA is required to submit to Congress concerning' the
demonstration program.
As Ms. Lowrance noted, the meeting agenda involved discussions of these
topics. The major issues pertinent to each area, as defined by meeting
participants, are itemized within the body of this text.
As discussions facilitator for the entire group, Peter Schneider of
Environmental Research Management, New England, outlined the meeting process,
shown in figure 1. He also identified the roles of the small group members
as facilitators in coordinating the discussions; recorders in capturing the
group's basic ideas; and group members in participating in the
decision-making.
Participants were then organized into four groups to discuss the issues.
On day one, the four groups discussed definitions with each group. They
considered three different categories and then chose up to two additional
categories to address. Group 1 concentrated on animal waste, wastes from
surgery, and waste from animals known to carry zoonotic diseases. Group 2
addressed pathological waste, discarded medical equipment and parts, and used
and unused sharps. Group 3 addressed blood and blood products, dialysis
wastes, and isolation waste. Group 4 addressed the categories of cultures
and stocks, other laboratory wastes, and miscellaneous material from patient
care. On day two, all groups discussed the same issues, while on day three
only three groups convened. They discussed information needs and generator
models for three industry categories: physicians' offices, hospitals, and
medical research facilities and clinical laboratories.
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MEETING PROCESS
EPA PRESENTATION |
Introduce the Topic
Provide Legislative Context
Explain EPA's Approach
Give the Small Groups Their Assignments
|SMALL GROUP WORKING SESSIONS 1
Discuss the Topic
Provide EPA with Comments and Suggestions on Their Approach
Identify Unresolved Issues
Identify Issues That Need More Attention
ISMALL GROUP REPORTS!
Description of General Discussion
Brief Summary of Outcome
Presentation to Entire Group Using Overhead Transparencies
Compare Group Reports
Brief Open Discussion
Figure 1. Meeting participants accomplished most of their work in small
groups.
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DEFINITIONS, November 14
To provide a common basis for the small group discussions, Denise
Zabinski of the EPA Office of Solid Waste identified the medical wastes
covered by the Medical Waste Tracking Act of 1988. The Act requires EPA to
include five categories of medical wastes in the demonstration program:
Cultures and stocks
Pathological waste
Blood and blood products
Sharps used in patient care or in medical, research, or industrial
laboratories
Contaminated animal carcasses.
The Act specifies that EPA may exclude from regulation any of the
following five categories if it is determined that they do not pose a
substantial hazard to human health or the environment when improperly
handled:
Wastes from surgery and autopsy
Laboratory wastes
Dialysis wastes
Discarded medical equipment and parts
Isolation wastes.
In addition, the Act allows EPA to regulate other types of medical waste
if it is determined that they represent a threat to human health or the
environment. The Agency accordingly asked meeting participants to consider
the following categories:
Unused sharps
Miscellaneous disposable material from patient care
Waste from animals known to carry zoonotic diseases.
In concluding her remarks, Ms. Zabinski asked meeting participants to
assist EPA in developing a list of medical waste categories for inclusion in
the tracking demonstration program. She requested them to:
Include all wastes that may be infectious or cause aesthetic
degradation
Exclude those medical wastes that can be reasonably classified as
general refuse
Use commonly accepted terminology in listing the medical waste types.
Kev Issues
To provide the Agency with the requested support, the participants
divided into four small working groups, each of which discussed five
categories of waste. An overriding concern among many group participants was
that EPA's listing of medical wastes is too broad a universe for practical or
sensible management. They noted that the public has been incensed over the
mismanagement of only a few types of medical wastes, such as syringes,
needles, tubing, and vials. In general, they thought that these are the
wastes that should be regulated.
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Cultures and Stocks
The one group that discussed cultures and stocks felt that this category
of wastes should be handled as Infectious until treated. The statutory
language was thought to be ambiguous throughout and duplicative, in some
cases, of language in other categories. With respect to ambiguities, group
members asked EPA to provide better definitions for the terms "biologicals"
and "infectious agent." (See Appendix C for elaboration on the group's
suggestions.) In addition, they suggested that EPA clarify this definition
by limiting it to human and cell cultures, thereby excluding plant
engineering wastes. Finally, group members felt that EPA should rely on
existing guidance from EPA and the Centers for Disease Control (CDC) for
descriptions of cultures and stocks. The current definition was thought to
be too broad. For example, the glassware items currently listed could be
regulated as sharps.
Pathological Wastes
The group welcomed EPA's clarification of the statutory language to
ensure that this category be limited to human pathological waste. However,
the group rejected some of EPA's further elaborations of the category with
respect to pathological wastes from obstetrical procedures. The group
finally resolved problems with the scope of the definition, such as the issue
of including body fluids under the pathological waste category, and it
constructed its own definition (see Appendix C). Another group questioned
whether there are existing practices particular to the handling/disposal of
body parts, as well as the appropriateness of including body fluids in this
category. It did not, however, specifically resolve any of the issues
raised. In addition, this group expressed the need for clarification of some
of the statutory language (see Appendix C).
Terminology continued to be a concern during the discussion of the
regulatory designation appropriate for pathological wastes. Alternative
treatment technologies to incineration and standards for rendering such
wastes "unrecognizable" were discussed'in the context of the difficulty in
being able to enforce compliance (i.e., ensure thorough treatment). Finally,
one group was hesitant to concede the assumption that all pathological wastes
should be treated initially as Infectious, since pathological waste might not
always be infectious. This issue was not resolved, although it was suggested
that generators should have the option of using proper containment as a
method for removing pathological waste from the Infectious or Decontaminated
Medical waste regulatory categories.
Hunan Blood and Blood Products
Two groups discussed the definition of human blood and blood products and
expressed opposing opinions in two general areas. First, the groups
disagreed on the volume of the item(s) listed in this category that would
warrant special handling precautions. One group felt that EPA should adopt
criteria based on specific amounts (New Jersey's standard of liquids in
excess of 20 cc. was suggested). However, not all participants could agree
whether or not all materials contaminated with blood should be included.
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Group members believed that facilities need to be able to consider various
factors affecting the risks posed by this waste category, including the
quantity, origin, specific waste type, and degree of contamination when
determining appropriate procedures for handling the subject wastes.
The second difference of opinion centered around EPA's draft
interpretation of this category, which includes disposable materials
contaminated with blood and blood products. One group could not reach
agreement on this issue, while the other group emphasized that the
definition should include any materials contaminated with blood items
listed in this category, regardless of quantity or volume. In addition,
this group rejected the suggested requirement that such contaminated
materials show evidence of "visible" contamination because many blood
products are colorless. The appropriateness of regulating body fluids in
this category was also discussed, but not resolved. Other concerns were
raised with respect to disposal practices and the universe of
facilities/generators that should be required to handle this waste
category according to the regulation (see Appendix C).
Sharps
There was unanimous recognition of the need to stringently regulate
the handling of this medical waste category, given the bio- and physical
hazards posed by sharps, as well as the unique aesthetic problems caused
by mismanagement of these particular wastes. Several issues were raised
by two groups that centered around: 1) refining the definition to
eliminate ambiguity, 2) avoid regulating all sharp or potentially sharp
objects originating in medical or research facilities, and 3) developing
treatment and disposal techniques that would help reduce the potential for
the mismanagement of sharps.
The groups generally supported the idea that "unused but discarded"
sharps be subject to regulation because of the physical and aesthetic
problems they pose; however, they suggested that EPA simplify the
regulatory process by including unused sharps in the sharps category and
by limiting unused sharps to needles, syringes, tubing, and vials.
Finally, both groups emphasized that EPA allow and advocate the use of
alternative treatment and disposal technologies so that facilities are not
wholly dependent on incineration (see Appendix C).
Contaminated Animal Waste
One group discussed this waste category and proposed changes mostly in
regard to the statutory language, while rejecting EPA's broader
interpretation of wastes for this waste type. EPA's broader
interpretation included contaminated animal carcasses, body parts, and
bedding of animals that were known to be exposed to infectious agents
during research (including that which is conducted at a veterinary
hospital), products of biologicals, or testing of Pharmaceuticals. For
regulation of this category to be enforceable, the group suggested that
the statutory language clarify that only animals known to have been
exposed to infectious agents be subject to the requirements. The group
also suggested that the universe of affected generators be expanded to
include veterinary hospitals engaged in research.
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The group emphasized that EPA publish and support alternative
treatment technologies for these wastes and that certain language in the
treatment requirements be clarified (see Appendix C). Finally, group
members discussed EPA's interpretation of the term "infectious agent" for
the purposes of this regulation and suggested the Agency consult the
guidelines on contamination with etiologic agents published by the CDC and
the National Institutes of Health (NIH) for clarification on this central
topic.
Wastes From Surgery and Autopsy
Host questions raised concerning this category of waste were directed
toward defining some of the terminology in the statutory description. For
instance, some group members wanted "in contact with" clarified and
suggested that "surgery" be defined broadly as any invasive procedure.
Other group members expressed a general concern that the items listed in
this category overlapped with those listed in the pathological waste and
human blood and blood products categories and that EPA could help minimize
confusion by amending the categories accordingly. Finally, participants
thought that facilities should have the flexibility to designate wastes
from this category to proper treatment methods based on specific criteria
such as: 1) evidence of visible contamination, or 2) knowledge that waste
came from a patient with an infectious disease.
Other Laboratory Wastes
The group that discussed this category of waste agreed that
miscellaneous laboratory wastes that come in contact with infectious
agents should be tracked under the regulation. It recommended that
generators use discretion when determining whether an item has been "in
contact with infectious agents" and emphasized that such agents be defined
as those listed in the CDC/NIH guidelines. A provision to exclude
laboratory materials that are routinely cleaned and reused from tracking
requirements when shipped offsite for cleaning was recommended. Finally,
the group suggested that EPA clarify the universe of laboratories subject
to this regulation as those engaged in services or analyses that produce
wastes containing infectious agents.
Dialysis Wastes
Inclusion of this category elicited little discussion, but the general
response was that wastes actually produced from hemodialysis are included
in existing categories. Specifically, since the only wastes from
hemodialysis are items such as needles and tubing, these wastes can be
regulated under the sharps category and/or the human blood and blood
products category. By this reasoning it was suggested that EPA make a
finding to exclude this particular category of wastes from regulatory
requirements.
Discarded Medical Equipment and Parts
The group that discussed this waste type felt it was vague but was
also reluctant to accept EPA's broader interpretation of wastes presumed
to fall into this category. The question was raised as to whether this
category should exist at all because of its probable overlap with other
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categories. Group members recognized, however, that such medical wastes
have been included to address the aesthetic concerns central to this
regulation. Given that this category will likely be left in the
regulation at the Agency's initiative, the group sought to guide EPA in
establishing sensible parameters for this category by clarifying the
language in the draft interpretation of the statutory definition (see
Appendix C). Finally, the group discussed appropriate treatment methods
for discarded medical equipment.
Isolation Wastes
This category received attention from three different groups. The
general feeling of many participants was that isolation wastes should be
included in the regulatory definition, but should be limited to wastes
associated with treatment of highly communicable diseases, as defined by
the CDC. One group noted that this determination is consistent with New
Jersey laws that include only wastes emanating from treatment of specific
diseases. One group that advocated using CDC's 1983 recommendations for
isolation patients noted that in the health care setting there is
currently a shift away from CDC's recommendations toward a practice of
"body substance isolation." The groups' rationale in including only
specific diseases was that wastes associated with less communicable
diseases would be captured by other categories.
The groups also questioned the appropriateness of including animal
wastes from isolation in this category. They recommended that wastes from
quarantined animals not be included in this category until those animals
are diagnosed as carrying zoonotic or other diseases. It was suggested
that EPA and CDC conduct additional research on animals under isolation as
a precaution to determine the necessity of including animal wastes in this
category.
Unused Sharps
The group that discussed this category determined that unused sharps
were already covered as part of the used sharps category. Members of the
group recommended combining the two categories under the name "used
sharps." Refer to the discussion of used sharps for additional
clarification.
Miscellaneous Disposable Material Fron Patient Care
One group reviewed this waste category and strongly recommended that
it be deleted from the regulatory definition. Members of the group
concluded that wastes in this category that pose aesthetic concerns will
already be included in other waste categories. Furthermore, this group
could not identify any other examples of wastes in this category for which
evidence exists demonstrating that the wastes pose a threat to human
health or the environment.
Vaste From Animals Known to Carry Zoonotic Diseases
The group that discussed this waste type did not suggest that this
category should be dropped from tracking regulations. It expressed
concerns, however, about the likelihood of disease transmission,
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practicality of regulations, overregulation by more than one agency, and
treatment alternatives. While the group agreed that zoonotic diseases
pose a threat to human health, it questioned the likelihood of disease
transmission from animal wastes. Members of the group also expressed
concern about the practicality of regulating zoonotic wastes from both
small and large animals. Regarding regulatory authority, the group
questioned whether or not the Department of Agriculture or other
organizations had already established regulations for zoonotic wastes,
since the majority of zoonotic wastes were believed to originate from
veterinary practices in rural areas. Finally, the group concluded that if
EPA was to require tracking of zoonotic wastes, it should allow exemptions
from tracking for more "popular" treatment methods than incineration, such
as rendering.
Special Medical Wastes
Two discussions regarding EFA's proposed regulatory (i.e., treatment)
classification of Special Medical waste arose due to general concern that
the Agency was recommending overly stringent requirements for the
treatment of medical waste prior to disposal. Of major interest and
concern was that the statute allows incineration as the only treatment
method that exempts medical wastes from further tracking prior to
disposal. Group members pointed out that this provision would likely
prompt an increase in incineration as a treatment/destruction method.
Based on this, all meeting participants were asked to discuss the
appropriateness of retaining the Special Medical waste classification to
include wastes that have been decontaminated such that they no longer pose
a threat to human health, but are still recognizable as medical wastes and
thus still subject to packaging, labeling, tracking, and recordkeeping
requirements.
The group initially proposed dropping this classification because no
one perceived of significantly different management practices required by
this classification as opposed to those required for infectious waste, and
its inclusion in the regulation was thought to confuse medical waste
handling/management practices. Further discussion of various management
practices as well as medical waste disposal requirements at the State
level led the group to agree that the classification should be retained to
allow generators the option of segregating wastes that should be handled
as infectious from those that can be or were treated (i.e., decontami-
nated) onsite and disposed of according to applicable State regulations.
Concerns remained regarding the regulatory, implementation, and
enforcement issues affecting wastes designated to this category. From a
regulatory perspective, group members suggested EPA clarify the
terminology used to describe aspects of treatment criteria; the terms
"disinfected" and "sterilized" have specific meanings in the medical
community and are inappropriate for discussing waste treatment. Instead,
the term "decontaminated" should be used. Similarly, from an enforcement
perspective, the group raised the problem of proving that decontamination
has occurred.
From this discussion the group raised another option for EPA to
consider in regulating medical wastes. The proposal was to allow medical
wastes that have been decontaminated and rendered "unrecognizable" to be
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handled as general refuse and thus exempt from tracking requirements.
Many of the participants supported providing generators with this option
because it would remove the emphasis on incineration as the only treatment
method exempting medical wastes from further tracking and enable
generators to use currently approved disposal practices without having to
track the wastes. Implementation and enforcement problems that might
arise in the context of such a treatment/management option are discussed
in more detail in Appendix C.
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SEGREGATION, PACKAGING, AND LABELING, November 15 (morning)
Michael Fetruska, Chief of the Special Projects/Characteristics
Section, EPA Office of Solid Waste, introduced segregation, packaging, and
labeling by identifying the purposes of each. The objectives of
segregation and packaging are identical:
To ensure containment of the waste until the point of disposal
To protect the safety of workers and the general public.
The purposes of labeling, often called marking, are:
To identify the waste as a regulated waste
To identify the generator of the waste.
Mr. Fetruska then asked the small working groups to spend the morning
addressing the following questions:
Are the segregation standards reasonable and practical?
What volume of fluid should we consider a fluid?
Should there be a requirement to segregate other categories of
waste (e.g., other infectious, special medical waste)? Are there
other categories that EPA is overlooking?
Should the Department of Transportation (DOT) standards for
packaging be used for the outside rigid container?
Kev Issues
The four working groups identified a number of issues pertinent to the
assigned topics. As indicated below, more participants achieved agreement
on segregation and packaging than on labeling.
Segregation
All four groups concluded that some form of segregation was
appropriate, but each group suggested a different combination of waste
types that should be subject to segregation. One group recommended that
generators be required to segregate for Infectious waste, while another
group suggested that segregation be required either by specific waste
types (i.e., sharps, pathological waste, etc.) or by category (i.e.,
Infectious, Special Medical), but not both ways. Another group
recommended that segregation be required for only three categories of
medical waste: sharps, fluids, and other infectious waste.
Two groups questioned the need for segregation of sharps and fluids;
one group recommended that sharps not be separated from fluids, while
another group recommended that EPA "assess the practicability" of
segregating these two waste types. This latter group raised the question
of whether sharps should be separated from "free" liquids.
Two groups wanted to limit segregation to wastes intended for offsite
transport. One of these groups recommended that EPA state clearly that
segregation requirements apply only to wastes intended for offsite
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transport, while the other group recommended that if segregation is required
for fluids, it should be limited to fluids going offsite.
One group expressed general concern that "scientific versus political
realities need to be considered," and expressed concern that sanitary
landfills may not accept medical wastes segregated for landfilling.
Two groups expressed concern about the mixture rule as it applies to
medical wastes. One group questioned how workable (i.e., enforceable) the
mixture procedures would be and asked whether there were existing regulations
that dealt with the handling, transportation, and disposal of chemical and
radiological waste generated by the targeted facilities. This group
recommended that mixed wastes be handled on a case-by-case basis to ensure
that appropriate procedures are followed, even though it was agreed that the
general hierarchy of handling procedures be as follows:
Radioactive
Hazardous chemical
Medical waste.
This group also thought that if the generator has to handle a mixed waste,
the generator should not have to use two manifests. Another group
recommended that mixtures of sharps and fluids be handled as sharps.
Packaging
All four groups made specific suggestions regarding EPA's proposed
packaging standards. Two groups had general concerns about packaging as
well: One recommended that the EPA Guide for Infectious Waste Manaeement be
used to develop regulations for packaging, while another group recommended
that EPA's approach be reviewed for consistency with Occupational Safety and
Health Administration (OSHA) and DOT requirements. This group also
recommended that EPA's packaging standards reference the American Society for
Testing and Materials (ASTM) and other materials standards. There was also
general concern that the definitions for containers, including "breakable,"
"unbreakable," "leakproof," and "rigid," are not sufficiently clear.
Two groups expressed concerns about primary and secondary containment.
One group questioned the need for double containers in general and
recommended that EPA define the characteristics of the primary container to
preclude the need for a secondary container. This group also recommended
that the secondary container be provided by the transporter. They suggested
that a single bag should be acceptable for Special Medical Wastes as long as
the bag meets certain standards, such as being puncture proof. Another group
recommended that EPA allow for greater flexibility in selecting appropriate
containers, since some containers currently in use are designed to contain
specific waste types (i.e., sharps containers). This group also questioned
the need for secondary containment, such as in the use of special sharps
containers that are leak-resistant, puncture-resistant, and specifically
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designed for transportation. This group recommended the use of less specific
language to direct the generator to use primary and secondary containment as
defined below:
Primary containment is designed to provide safety to health care
workers during inhouse handling and transport of medical wastes.
Secondary containment is designed to fully contain wastes, protect
transportation workers, and maintain packaging integrity during
routine practices used to transport medical waste to offsite waste
management facilities.
All four groups recommended the use of less stringent standards for
packaging sharps. Two groups recommended that packaging requirements for
sharps be changed from "leak-proof and puncture-proof" to "leak-resistant and
puncture-resistant." In addition, one group recommended that only the outer
container need be "leak-resistant" and that a red bag would provide adequate
secondary containment for the rigid, puncture-resistant container commonly
used to collect discarded sharps. A second group recommended that no
secondary containment be required for sharps. A third group questioned
whether the new requirements would represent a dramatic change from current
packaging requirements, noting that sharps are often collected in cardboard
boxes. Finally, a fourth group recommended that sharps containing fluids be
packaged to meet all requirements for both categories.
There was little discussion about packaging of fluids, except for a
general concern that having packaging requirements for fluids might appear to
discourage onsite disposal via the sewer system. Only one group had specific
concerns: That a double container for fluids should be required only if the
primary container is glass and that the term "unbreakable" should be changed
to "puncture resistant."
Some discussion was devoted to the use of bags for packaging medical
wastes. Specifically, one group recommended the use of non-PVC containers to
avoid incineration air pollution problems. This group also recommended that
wastes be placed in a single 3 mil thick bag, sealed, and placed in a
cardboard box. Other ideas included using bags that conform to ASTM
standards, which are based on the composition of the plastic as well as its
thickness, and developing bags that would change color or show markings
during treatment, thereby indicating to the waste hauler that the waste has
been treated.
Labeling
Comments on labeling ranged from general concerns about the purpose of
labeling to specific suggestions for the materials from which labels are
made. There were no predominant themes in this discussion, as all four
groups provided different recommendations. These recommendations are
summarized on the following page.
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General Recommendations
Set labeling standards that are consistent with existing practices,
recognizing that different facilities will have different labeling
requirements depending on the level of hazard posed to employees.
Inner Versus Outer Labels
One group suggested labeling only the outer layer of packaging,
while another supported the use of inner labels to track the waste
source if the outer container is destroyed.
The universal biohazard symbol should be used rather than the
red-border label on the outer layer of packaging, since the
biohazard symbol is already recognized by employees.
Bar codes or identification numbers should be used on the outer
label to identify the generator and transporter without revealing
their identity to the general public. This level of discretion
will protect the generator or transporter in the case of improper
disposal. Simple, preprinted labels should be used for the inside
package.
The category of waste in the container should be identified on the
outer label.
Consideration should be given to the use of buoyant labels to
identify the source of floatable mismanaged wastes.
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TRACKING AND RECORDKEEPING, November 15 (afternoon)
Paul Mushovic of the EPA Office of Solid Waste introduced the topics
to be discussed during the afternoon sessions of November 15. He
concentrated first on the tracking system, saying that it should:
Implement the demonstration program
Proceed with a uniform tracking form
Assure generators that regulated wastes reach disposal facilities
Use whenever practicable the New York and New Jersey emergency
system.
He continued with requirements for the tracking form, noting that it
must accomplish two primary tasks: identify specific waste types
requiring special packaging, marking, and transportation criteria; and
provide the necessary paper trail. To accomplish these ends, the form
must elicit the necessary information, without being overly burdensome,
and it should be distinct in format. EPA has developed a proposed medical
waste tracking form, presented here as figure 2.
Mr. Mushovic concluded his presentation by asking the small working
groups to:
Critique the tracking system proposed by EPA
Critique the tracking form proposed by EFA
Propose an alternative tracking system that satisfies the four
basic criteria identified above
Comment on the requirements for generators, transporters, and
disposal facilities.
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I. Generator's Phone ( 1
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U. Special Handling Instructions and Additional InfonaMion
0" "KRAIOR CERIIFICAIKM: I declare the contents of this consignment
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INSTRUCTIONS F« COMPLEIINC MEDICAL WASTE 1 RACK INC FORM
(See reverse side for additional Information)
COPT 1 - GENERATOR COPT - NAILED BT DISPOSAL FACILIIT TO GEHCRATOR
*w« « VIMVML rMi.ii.iii u*>i axiMiaxD IT DISPOSAL FACILITY
COPT S - TRANSPORTER COP* - RETAINED Bf TRANSPORTER
COPT « - GENERATO* COPT - RETAINED BT GENERATOR
As required under 40 CFR Part 259:
1. this Multi-copy (4-page) shipping document Bust accaanany each shipment
__ of regulated eedlcal Haste generated or disposed In the state.
* ''* ** * ''* »' be completed before the generator can sign
the certification. Item* B. 9 1 10 may be coapleted by the transporter.
be completed by the disposal facility.
S. Copies of this fona may be obtained fro* any state EPA Office. For
assistance In completing this fona. contact your nearest EPA office
16. TRANSPORTER (Certification of Receipt of Medical Waste as described
a. Transporter 1
Printed/Timed Nam* Sionature Date
Comment*:
b. TRANSPORTER 2. RENANIFESTED HASTE or INTERMEDIATE HANDLER
Prlnted/Tvped Name Signature Date
Addr
ttate Penal t Na. Tracking Fona No.
Comments:
7. DISPOSAL FACILITY (Certification of Receipt of Medical Waste as
described in item* 11. 12. t t]>
Received in accordance mth items 11. 12. t 11
Printed/Treed Name Signature Date
*«*«n
1
S
I
U
c
1
1
o
M
S
)
E
p
O
S
A
I
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Key Issues
The four working groups concentrated their discussion on the
requirements for generators and transporters and, to a lesser extent, on the
tracking form proposed by EPA. Only two of the groups had time for
abbreviated consideration of the disposal facilities.
In addressing the assigned topics, the groups surfaced a number of
issues that they thought required resolution before implementation of the
demonstration tracking program. For several of these concerns, they
suggested modifications in the approach. The following sections itemize
these topics. Appendix D provides detail on the small group discussions of
tracking and recordkeeping.
General Concerns
A few of the issues, such as the following, cut across all topics
pertinent to tracking and recordkeeping:
The source(s) of funding needs to be resolved for tracking, permits,
compliance monitoring, and enforcement. Participants noted that the
States will require Federal assistance to implement the program.
A separate category of regulations should be developed for storage
requirements that pertain to generators, transfer facilities,
transporters, and disposal facilities.
A number of the issues identified below provide specifics on these two
matters, specifically on storage requirements.
Tracking Form
One group concentrated more on the tracking form than did the other
groups. Its conclusions were that the document should:
Provide a box for the inclusion of relevant information on the
storage of medical waste.
Provide a box certifying both receipt and destruction of waste. This
provision would replace the current "certificate of acceptance."
Combine boxes 8 and 17 into one box to eliminate duplication on the
tracking form.
One of the other groups noted that box 7 should use the language in the
regulation, requesting "Transporter Registration No." rather than
"Transporter Permit No."
Generator Requirements
This section, like the ones following, uses the headings provided in the
meeting booklet.
17
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General Provision.
The small group discussions focused on paragraph 5, page 4-4 of the
booklet: "Pathological waste and anatomical waste stored for more than 24
hours must be refrigerated." Three of the groups recommended that the
refrigeration requirement should be deleted:
One group concluded that the waste need not be refrigerated so long
as it is kept in a non-putrescent state.
Another group thought that only "unfixed" pathological waste should
require refrigeration.
Yet another group stated that a substitute provision should be
included addressing the control of noxious odors, as well as other
storage requirements.
Tracking Requirements
The discussion of tracking requirements centered on small quantity
generators (SQGs). In the small groups, there was considerable sentiment
that:
SQGs should be allowed to transport their own wastes to a hospital or
other permitted treatment facility. The facility, upon receipt of
the untracked waste, then becomes the waste generator.
- This provision is important partly because transporters may be
reluctant to accept small volumes of waste.
Only the weight of the waste, not the weight of the packaging, should
be used in making a SQG determination.
Only those wastes destined for offsite management should be counted
when making a SQG determination.
Tracking forms should be used by all generators, including SQGs.
Compared to a tracking form, a log sheet:
Provides little or no regulatory relief
Adds needless complexity to the system
- Reduces enforcement capability.
The individual groups also suggested some revisions in language:
Page 4-4, Manifesting Requirements, paragraph 1: "produces medical
waste" should be changed to "produces (and hauls) medical waste."
The revision addresses cases in which SQGs contract with
transporters, who then become generators.
Page 4-4, Manifesting Requirements, paragraph 4: "for all waste
shipped offsite" should be changed to "for all (medical) waste
shipped offsite." The change addresses ambiguity in the original
18
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language of the Act that may require the manifesting of General
Refuse.
Pages 4-4 and 4-5, Manifesting Requirements: The definition of
"offsite" should be clarified in reference to satellite facilities.
Tracking forms should not be required for facilities owned and
operated by a single entity and sharing contiguous property.
Reporting and Recordkeeping Requirements
The working groups generally agreed that a modification should be made
in the annual reports on the incineration of waste (page 4-5, Reporting
Requirements, paragraph 3). They suggested substituting "weight and/or
number of units of waste" for "the volume and type of waste."
Transporter Requirements
The small groups made a number of recommendations concerning transporter
requirements, although they generally did not allot as much time to this
topic as they had to Generator Requirements.
General Provisions
As in the discussion of Generator Requirements, the working groups
focused on the references to medical waste storage (page 4-6, General
Provisions, paragraph 8). They did not concur in their recommendations, as
the following two items indicate, but they emphasized the need for more
attention to storage regulations:
The transporter should be allowed to store waste in a vehicle for
more than 72 hours if necessary to satisfy time and travel
requirements or in the event that a treatment and/or disposal
facility cannot accept the waste (the incinerator, for example, could
need repair).
The description of storage requirements should be revised to read,
"Medical waste shall not be stored in a vehicle for more than 72
hours. Putrescible waste (i.e., body fluids, unfixed anatomical
parts, and animal carcasses) should be refrigerated if transported or
stored more than 48 hours."
This revised statement should be moved to a separate section
entitled, "Storage Requirements."
The group basically agreed on the reference to protective equipment
(page 4-6, General Provisions, paragraph 9). They suggested that employees
who handle medical waste should follow the guidelines in OSHA regulations on
the appropriate use of this equipment.
In addition, the small groups considered the designation(s) that should
be given to identify medical waste transporters. One group recommended that
transport vehicles should be required to display only the biohazard symbol.
While the groups thought the topic significant, they did not agree on any
particular type of identification.
19
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Record and Recordkeeping
The groups generally thought that the reporting requirements for
transporters were needlessly burdensome. One group recommended, with the
concurrence of a number of other participants, that the quarterly report
(page 4-8) should not require specification of waste types.
Issues
Two of the groups concentrated as well on the safety precautions for
transporters (page 4-9). They both thought the subject important, one
saying that training in cleanup and decontamination procedures would be
required, and the other suggesting that they should be recommended.
Additional Comn
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INFORMATION NEEDS, November 16
David Tomten of the EPA Office of Solid Waste introduced "Information
Needs" as the last major topic identified for group discussion. He
explained that the Medical Waste Tracking Act of 1988 requires EPA to submit
its final report to Congress in July 1991, with two interim reports in July
1989 and April 1990, respectively. The draft and final reports will include
the following topics:
Identification and characterization of medical waste generators
Waste characterization and management methods
Present and potential threats
Present and potential costs
Evaluation of demonstration program
Evaluation of management methods
Evaluation of treatment methods
Identification of factors affecting effectiveness of treatment
methods
Evaluation of waste minimization options.
Mr. Tomten asked the small groups to identify sources of information for the
reports to Congress.
He summarized the topics of discussion for the final working group
sessions as follows:
Data need for generator models
- Types and quantities of waste generated
Types and numbers of generators
- Treatment and disposal practices and costs
Evaluation of generator models
General methodology
Categories of generators
- Three example models
Other information needs for report to Congress.
Kev Issues
The participants divided into three working groups on the third day of
the conference to discuss the generator models and other information needs
as stated above. Each group reviewed one of three generator models:
Physicians' Offices, Hospitals, and Medical Research Facilities and Clinical
Laboratories. Specific comments concerning data needs and information
sources for generator models, evaluation of the model methodology and the
three model papers, and other information needs related to the report to
Congress are summarized below. Specific comments made by the three groups
during the conference are found in Appendix D.
21
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Data Needs
The groups cited general information sources relating to generators of
medical waste, as well as specific sources for the three models they
reviewed. These include:
New Jersey State survey data
EPA Region II survey
Additional data collection activities in Minnesota and other States
A 30-day audit of a representative sample of physicians' offices
American Hospital Association data
Survey of hospitals
American Society of Microbiology
American Society of Clinical Fathologists
College of American Pathologists
Health Care Financing Administration
NIH list of grant recipients
Food and Drug Administration licensing board
State licensing and registration boards
National Pollution Discharge Elimination System permit information.
Evaluation of Generator Models
The groups' comments about the general methodology for developing the
models included concerns about the definition of medical waste. Generally,
the groups felt that information on waste quantities by waste type would be
difficult to obtain and should not be used in making quantity estimates.
They concluded, however, that total quantity estimates cannot be made
accurately for each generator category until the definition of medical waste
is finalized.
All three groups indicated that the New Jersey survey data, as well as
any data generated from activities in other States, should be used in making
national waste quantity estimates. EPA and State efforts should be
coordinated and catalogued to ensure maximum use of available data and avoid
duplication of effort. Careful extrapolation of these data to the entire
country should result in a fairly accurate characterization of facilities
and waste quantities. Additionally, one group pointed out that a method
used in Canada to characterize generators of medical waste should be studied
by EPA.
One group discussed the list of generator categories identified as
potential medical waste generators. A suggestion was made to EPA that the
Medical Waste Tracking Act (Section 3) be referenced when defining
facilities that may generate medical wastes. Therefore, funeral homes may
not be included in the congressional intent of the Act. Also, when
developing a generator model for blood banks, plasma donor centers and renal
dialysis centers should be included.
Comments specifically relating to the three generator models follow.
22
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Physicians' Offices
Use of a one-time, 30-day audit of a representative sample of offices
would be a faster and less burdensome method to obtain data.
Small quantity generators, such as physicians, could keep a log
identifying amounts of waste treated in their offices. This would
enable a more accurate calculation of waste that has been treated and
rendered unrecognizable. However, this procedure may be burdensome
to small offices.
Hospitals
EPA should use a very general approach to estimate total waste
quantities. This can be accomplished with estimates of waste
generation rates and actual manifest data.
A hospital survey should be conducted to estimate waste generation
rates for treated wastes.
The occupancy rate is an important variable for estimating waste
generation rates.
Medical Research Facilities and Clinical Laboratories
Several comments were made concerning SIC code counts presented for
this generator model. The SIC code counts for manufacturing
facilities may be unnecessary if laboratories within these facilities
are included in the SIC code count for laboratories. Hospital
laboratories are apparently not counted with the medical
laboratories, or the number of labs would be close to 13,000.
The groups felt that most laboratories and research facilities are
licensed. Thus, it should not be difficult to obtain data on numbers
of facilities. They also indicated that laboratory practices and
disposal methods are tightly regulated and controlled.
Other Information Needs
In addressing the issue of costs, the groups felt that a cost-benefit
analysis of the tracking rule should be evaluated. Cost analyses would need
to include liability costs, permitting costs, transporter costs, disposal
costs, and costs to patients and institutions. One group felt that State
governments should bear the responsibility and costs for handling tracking
forms. Costs may not be substantially greater for those generators who
currently handle their wastes properly, unless transporter fees increase.
23
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Appendix A
Meeting Agenda
-------
EPA MEDICAL WASTE MEETIHG
Governor Calvert House
Annapolis, Maryland
November 14-16, 1988
AGEHDA
Monday, November 14
9:30 am Registration (lobby)
10:00 Welcome
10:15 Presentation - Meeting Overview
10:35 Presentation - Medical Waste Included
in H.R. 3515
10:55 BREAK
11:15 Small Group Working Sessions
1:00 pm LUNCH
2:00 Small Group Working Sessions (continued)
4:00 BREAK
4:10 Reports from Working Sessions
5:30 ADJOURN
Tuesday, loveaber 15
8:30 am Presentation - Segregation, Packaging,
and Labeling
8:50 Small Group Working Sessions
10:30 BREAK
10:40 Small Group Working Sessions (continued)
11:45 Reports from Working Sessions
12:30 pm LUNCH
Sylvia Lowrance
Peter Schneider
Denise Zabinski
Michael Petruska
A-l
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Tuesday, November 15 (continued)
1:30 pm Presentation - Tracking and Recordkeeplng Paul Mushovic
1:50 Small Group Working Sessions
3:30 BREAK
3:40 Small Group Working Sessions (continued)
5:00 Reports from Working Sessions
5:45 ADJOURN
Wednesday, Hoveaber 16
8:00 am Information Needs David Tomten
8:20 Working Session
10:00 BREAK
10:10 Working Session
11:30 Group Meeting
12:30 pm Conclusion
1:15 ADJOURN
A-2
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Appendix B
List of Participants
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EPA MEDICAL WASTE MEETING
Governor Calvert House
Annapolis, Maryland
November 14-16, 1988
LIST OF PARTICIPANTS
Mr. Jerry Anderson
Department of Defense
Assistant for Safety and
Occupational Health Policy
OSD/FM&P/FSE&S, Room 3A272
The Pentagon
Washington, DC 20301-4000
(202) 695-0120
Ms. Jennifer Barker
Office of Solid Waste (OS-305)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 475-9350
Mr. Devereaux Barnes
Director, Characterization
Assessment Division
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-4637
Dr. Stanley Bauer
National Committee for Clinical
Laboratory Standards
Department of Pathology
Bronx Lebanon Hospital
1276 Fulton Avenue
Bronx, NY 10456
(212) 588-1413
Mr. Andy Bel Una
U.S. EPA, Region II
Air and Water Management Division
Hazardous Waste Programs Branch
26 Federal Plaza
New York, NY 10278
(212) 264-3384
Mr. James Blumenstock
Director
Consumer Health Services
New Jersey Department of Health
363 W. State Street
Trenton, NJ 08625
(609) 984-1364
Mr. Walter Bond
Office of Hospital Infections
Centers for Disease Control
1600 Clifton Road
Atlanta, GA 30333
(404) 639-2316
Ms. Carolyn Bosserman
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 821-4812
Ms. Marcia Brody
Legislative Assistant
American Veterinary Medical Association
1023 15th Street, NW
Suite 300
Washington, DC 20005
(202) 659-2040
Mr. Ross Campbell
General Accounting Office
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Ms. Nancy Cathcart (ASDD)
Transport of Dangerous Goods
Transport CANADA
3441 Slater Street
Ottawa, Canada A1A ON3
(613) 990-1158
B-l
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Ms. Lisa Collaton
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 734-3135
Mr. David Croxton
Office of Solid .Waste (OS-311)
U.S. Environmental Protection Agency
401 M Street, SV
Washington, DC 20460
(202) 382-2791
Dr. George Cushmac
U.S. Department of Transportation
Research & Special Programs
Administration
Mail Code DHM-21
400 7th Street, SW
Washington, DC 20590
(202) 366-4545
Dr. William DoIan
American Medical Association
Arlington Hospital
1701 N. George Mason Drive
Arlington, VA 22205
(703) 588-6551
Ms. Anna Duncan
Office of Solid Waste and Emergency
Response (OS-110)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-4617
Ms. Kathy Dunk
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 827-8172
Ms. Janet Earnerman
National Solid Waste Management
Association (WMNA)
3003 Butterfleld Road
Oak Brook, IL 60521
Ms. Mary Ficht
American Hospital Association
840 N. Lake Shore Drive
Chicago, IL 60611
(312) 280-6245
Mr. Chuck Fox
Coastal Protection Project
Environmental Policy Institute
218 D Street, SE
Washington, DC 20003
(202) 547-5330
Mr. Larry Gallagher
Plants, Technology, and Safety
Management
Joint Commission on Accreditation
of Healthcare Organizations
875 N. Michigan Avenue
Chicago, IL 60611
(312) 642-6061
Ms. Lisa Haley
Manager
Technical Programs
Governmental Refuse Collection
and Disposal Association
P.O. Box 7219
8750 Georgia Avenue
Suite 123
Silver Spring, MD 20910
(301) 585-2898
Ms. Lynn Harding
Harvard Medical School
c/o 1294 Duane Road
Chattanooga, TN 37405
(615) 756-5907
Ms. F. Ann Hoppe
Deputy Director
Division of Blood and Blood Products
Food and Drug Administration
8800 Rockvllle Pike
Building 29, Room 222
Bethesda, MD 20892
(301) 496-4396
B-2
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Mr. William A. Howard
Connecticut Department of Environmental
Protection
Solid Waste Management Unit
165 Capitol Avenue
Hartford, CT 06106
(203) 566-5847
Dr. Stephanie Irene
Health Assessment Section
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-5219
Mr. Robert Jackson
EQV Services
3612 Landmark Drive
Suite B
Columbia, SC 29204
(803) 787-0760
Ms. Abby Johnson
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 734-3198
Mr. Andrew R. Kass
Researcher
Natural Resources Defense Council
Division of Solid Waste Management
122 East 42nd Street
New York, NY 10168
(212) 949-0049
Mr. Chris Kirtz
Director, Regulatory Negotiation Project
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-7565
Ms. Robin L. Rropf
American Medical Association
1101 Vermont Avenue, NW
Washington, DC 20005
(202) 789-7400
Mr. Kevin Landkrohn
Office of Occupational Medicine
U.S. Department of Labor/OSHA
200 Constitution Avenue
Room N3653
Washington, DC 20210
(202) 523-7157
Ms. Sylvia Lowrance
Director, Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-4627
Mr. Ed McNicholas
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 821-4846
Mr. Neal Mohlmann
Acting Director
George Washington University Medical
Center
Department of Safety
DC Hospital Association
2206 I Street, NW
Suite 200
Washington, DC 20037
(202) 994-2505
Mr. Paul Mushovic
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 475-8551
Ms. Chris 0'Donne11
National Governors' Association
444 N. Capitol Street, NW
Suite 250
Washington, DC 20001
(202) 624-7871
B-3
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Mr. Jim O'Leary
Director, Office of Program
Management and Support
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-4649
Dr. Richard Parker
American Veterinary Medical Association
Suite 605
Mills Building
109 SW Ninth
Topeka, KS 66612-1271
(913) 296-5586
Mr. Mike Petruska
Chief, Special Projects Characterization
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 475-8551
Ms. Sheila M. Prindlvllle
National Solid Waste Management
Association
1730 Rhode Island Avenue, NW
Suite 1000
Washington, DC 20036
(202) 659-4613
Mr. Howard Raether
Consultant
National Funeral Directors Association
11121 W. Oklahoma Avenue
Milwaukee, WI 53227
(414) 541-2500
Ms. Donna R. Richardson
American Nurses Association
1101 14th Street, NW
Suite 200
Washington, DC 20005
(202) 789-1800
Dr. Jonathan Y. Richmond
American Biological Safety Association
Chief, Safety Operations Section
Occupational Safety and Health
Division of Safety
National Institutes of Health
Building 13, Room 3K04
Bethesda, MD 20892
(301) 496-2346
Dr. Harvey Rogers
Chief of Environmental Protection Branch
National Institutes of Health
Building 13, Room 2W64
9000 Rockvilie Pike
Bethesda, MD 20892
(301) 496-3537
Dr. William A. Rutala
American Society for Microbiology
Association for Practitioners in
Infection Control
547 Clinical Sciences Building
University of North Carolina
Medical School
Chapel Hill, NC 27599-7030
(919) 966-3242
Ms. Barbara Scharman
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 821-4889
Mr. Peter Schneider
ERM - New England, Inc.
205 Portland Street
Boston, MA 02114
(617) 742-8228
Mr. Peter Sherman
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 821-4764
Mr. Richard Silver
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 734-2530
Ms. Margaret Sirlano
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 821-4631
B-4
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Mr. Nelson Slavik
American Hospital Association
P.O. Drawer 6309
South Bend, IN 46530
(219) 272-8748
Mr. J.O. Snyder
Governor's Office
State of Michigan
116 W. Allegan
Lansing, MI 48933
(517) 484-7855
Mr. Robert A. Spurgin
Biomedical Waste Treatment Council
National Solid Waste Management
Association
c/o 1450 East 17th Street
Suite 218
Santa Ana, CA 92701
(714) 542-6685
Mr. Tom Stewart
Center for Policy Research
Milne 300
SUNY Albany
Albany, NY 12222
(518) 442-3850
Mr. Dave Tomten
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 475-8551
Mr. Kevin Tonat
Environmental Compliance Officer
National Institutes of Health
Building 13, Room 2W64
9000 Rockvllle Pike
Bethesda, MD 20892
(301) 496-3537
Ms. Marion Torch!a
Associate Director
Regulatory Affairs
American Hospital Association
50 F Street, NW
Suite 1100
Washington, DC 20001
(202) 638-1100
Dr. Joseph Van Houten
Pharmaceutical Manufacturers Association
Safety and Industrial Hygiene Manager
Schering Corporation
60 Orange Street
Bloomfield, NJ 07003
(201) 429-4033
Ms. Kathryn D. Wagner
Office of Technology Assessment
U.S. Congress
Washington, DC 20510
(202) 228-6854
Mr. Wayne Warren
Environmental Specialist
Veterans Administration
810 Vermont Avenue, NW
Washington, DC 20420
(202) 233-4105
Mr. Rob Watson
ASTSWMO
Illinois Environmental Protection Agency
Division of Land Pollution Control
2200 Church Hill Road
Springfield, IL 62794-9276
(217) 782-6762
Ms. Ginger Webster
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 589-6916
Mr. Leonard P. Wheat
American Dental Association
1111 14th Street, NW
Suite 1200
Washington, DC 20005
(202) 898-2400
Mr. Thomas X. White
Pharmaceutical Manufacturers Association
1100 15th Street, NW
Washington, DC 20005
B-5
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Mr. Peter Wise
Manager, Environmental Programs
Department
Science Applications International
Corporation (SAIC)
8400 Westpark Drive
McLean, VA 22102
(703) 734-2541
Ms. Denise Zablnskl
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(202) 382-7458
B-6
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Appendix C
Summary of Small
Working Group Sessions
November 14 and 15, 1988
-------
APPENDIX C. SUMMARY OF SMALL WORKING GROUP SESSIONS
November 14 and 15, 1988
The meeting participants divided into four working groups, each
consisting of about 15 members, to discuss the following topics pertinent
to medical waste:
Definitions
Segregation, Packaging, and Labeling
Tracking and Recordkeeping
Regarding definitions, the groups were assigned three or four categories
of medical waste for discussion. They were urged as well to select two
additional waste types for consideration.
This appendix summarizes the proceedings of each working group
according to the topics identified above.
I. Group 1
Assigned waste categories
- Animal Vaste
- Waste from surgery and autopsy
- Waste from animals known to carry zoonotic diseases
Additional waste types
- Used sharps as isolation wastes
- Unused sharps as isolation wastes
II. Group 2
Assigned waste categories
- Pathological waste
- Discarded medical equipment and parts
- Used sharps
- Unused sharps
Additional waste types
- Laboratory wastes
III. Group 3
Assigned waste categories
- Blood and blood products
- Dialysis wastes
- Isolation wastes
Additional waste types
- Pathological wastes
C-l
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IV. Group 4
Assigned waste categories
- Cultures and stocks
- Other laboratory wastes
- Miscellaneous material from patient care
Additional waste types
Human blood and blood products
Surgical and autopsy wastes
Isolated wastes
C-2
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GROUP 1. November 14 and 15
DEFINITIONS
Group 1 was asked to discuss three categories of medical waste-
contaminated animal carcasses, wastes from surgery and autopsy, and waste
trom animals known to carry zoonotic diseases. In addition, Group 1
elected to discuss used and unused sharps, as well as isolation wastes.
Animal Waste
The group noted that the statutory description of regulated animal
carcasses should also include those generated by veterinary
hospitals engaged in research.
The group also suggested clarifying the language so that only
animals Jcnowji to have been exposed to infectious agents would be
included.
"Bioengineering wastes- was deleted from EPA's draft interpretation
of the statutory definition because the group felt that wastes
generated in bioengineering procedures are already included as
items listed in the cultures and stocks category.
Finally, there was discussion about the issue of infectious agents
and EPA's interpretation of the term. Group members raised the
concern that the concept was too often discussed without regard to
other pertinent factors, such as portal of entry, quantity, or
virulence. The group suggested that EPA consult Centers for
Disease Control (CDC) /National Institutes of Health (NIH)
guidelines on contamination with listed etiologic agents.
Group members had an overall concern with respect to EPA's apparent
support for incineration as the only appropriate treatment method
for many of the wastes listed under the Act.
The term "properly sterilized- was also considered vague; the group
pointed out the differences between the terms "sterilize,"
"disinfect," and "decontaminate" to illustrate the ambiguity.
Waste from Sureerv and
The group thought that EPA should consider including the wastes
described in this optional category under the mandatory categories
of pathological wastes and/or human blood and blood products to
eliminate overlap.
C-3
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The group felt that hospitals should have the flexibility in
designating wastes generated by these procedures as infectious if
they meet certain criteria, such as evidence of visible
contamination or wastes known to have come from a patient with an
infectious disease.
Zoonotic Animal Waste
The group agreed that zoonotic diseases pose a threat to human
health, but questioned the likelihood of disease transmission from
the wastes of animals.
The issue of handling zoonotic wastes from large and small animals
was raised to illustrate the practical matter of regulating this
category of waste.
With respect to a majority of these wastes originating from
veterinary practice in rural areas, the group asked whether the
Department of Agriculture or other organizations had established
regulations addressing the proper treatment and disposal of such
wastes.
The group felt that if such wastes were to be tracked, alternative
and popular means of treatment and disposal (e.g., rendering)
should be allowed instead of advocating incineration only.
Sharps
Alternative disposal technologies werq discussed for the
destruction of sharps, including the use of ovens and "destructive
distillation."
To exclude ordinary broken glass from this category, the group felt
the language should say, "... broken glass exposed to or reasonably
expected to have been exposed to a biological agent."
The group recommended any treatment process that would eliminate
both the biohazard and the physical hazard of the sharp.
The group thought that if an unused sharps category were to be
included, the term should refer only to items such as hypodermic
needles, syringes, scalpel blades, and Pasteur pipettes.
Isolation Waste
While advocating the use of recommendations published by the CDC in
1983 for isolation patients, the group raised additional issues
pertaining to common practice with respect to this category of
waste. It was pointed out that in the health care setting there is
a shift away from using the CDC recommendations toward the practice
of "body substance isolation."
C-4
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With regard to animals, the group addressed two issues. First, the
participants suggested that quarantined animals should not be
handled under isolation precautions until diagnosed as having
zoonotic or other diseases. Second, they recommended that EPA and
CDC conduct more research on animals handled under isolation
precautions to validate the necessity of such practices.
SEGREGATION
The group recommended that generators be required to segregate for
Infectious waste.
It also recommended that wastes designated as Special Medical and
treated onsite could be moved offsite as General Refuse.
At this point in the discussion, the group was undecided about the
need for three categories of medical waste. Several participants
thought that the Special Medical category should be deleted.
With respect to EPA's suggested mixture rules, the group questioned
how workable (i.e., enforceable) the procedures would be. In
addition, the group asked whether there were existing regulations
that dealt with the handling, transporting, and disposing of
chemical and radiological wastes generated by the targeted
facilities.
The group stressed that mixed wastes be handled on a case-by-case
basis to ensure that appropriate procedures are followed, even
though it was agreed that the general hierarchy of handling
procedures be the following:
Radioactive
Hazardous Chemical
Medical Waste
The group felt that in the event the generator has to handle a
mixed waste, he or she should not have to use two manifests.
At the end of the discussion on segregation practices for listed
medical wastes, the group suggested a change in terminology that
would name Special Medical waste "decontaminated medical waste."
PACKAGING
The group continued with some consideration of EPA's terminology
and suggested that packaging requirements for sharps be changed to
"leak-resistant and puncture-resistant," rather than "leak-proof
and puncture-proof."
C-5
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In addition, when packaging sharps, the group thought the
"leak-resistant" standard should apply to the outer container only.
For sharps, it was felt that adequate packaging would involve
red-bagging the rigid, puncture-resistant container commonly used
to collect discarded sharps.
The group also discussed technological standards for bags used for
medical wastes. Bags used for "decontaminated medical waste"
should conform to American Society for Testing and Materials (ASTM)
standards, which are based on composition of the plastic as well as
thickness. This point was brought up because the latter factor
could eliminate the need for double-bagging in some cases.
The group also recommended developing bags that would indicate to
the waste hauler by a change of color or markings that the waste
has been treated.
LABELING
To set labeling standards that are already consistent for the most
part with existing practices and thereby to avoid confusion and
undue administrative burden in educating employees in new
practices, the group called attention to the need for consistency
and the problem of "over-signing" facility surroundings.
It became evident that different facilities will have differing
labeling requirements depending on the degree of threat posed to
employees handling the wastes. In response to this issue, the
group suggested that this may be a problem for OSHA and not EPA.
Another issue raised with regard to labeling was whether the
primary waste container should display the universally accepted
biohazard symbol. Attitudes varied depending on whether the
container was in the patient's room or in the laboratory.
Regardless, there was unanimous rejection of EPA's suggested
red-border label for potentially infectious waste because the group
felt that the personnel handling such waste are already familiar
with the biohazard symbol/label.
The group discussed the logic of requiring an inner label on each
container/bag of waste held in an outer compartment. The biggest
concern was the feasibility of workers taking the time to affix
individual labels to each "bundle" of waste collected. It was felt
that this would not only take substantially more time to do, but it
would also increase worker exposure to the waste.
The argument for requiring an inner label centered around the idea
that it might provide a bigger incentive for the generator to
ensure proper disposal if the waste could eventually be traced to
the point of origin.
C-6
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Alternatives were discussed regarding the amount and type of
information that EPA has suggested for the outer label. The group
suggested using bar-coded labels because they would be less time
consuming. Also, the group questioned the logic of putting
detailed information on the label, since considerable information
is required for the manifest and this was felt to be unduly
repetitive. It was not resolved, however, how varying degrees of
information on the outer label would affect the liability of the
generator and/or transporter in the case of improper disposal.
TRACKING
Tracking Fora
To clear up duplications on the tracking form, the group suggested
reconciling the information in boxes 8 and 17 and creating one box.
The form should provide a box to include any relevant information
on storage of medical wastes.
The form should also provide a space that indicates and guarantees
both receipt and destruction of the waste (this would replace the
currently used "certificate of destruction").
Section 11 of the form should provide for certification of
treatment by the generator or an intermediate handler.
In the case that medical waste is "remanifested" at a transfer
station, the group recommended that no weight limit be placed on
the amount handled. (The current limit is 220 Ibs., or 100 kg.)
Generator Requirements
The group suggested changing the requirements for waste stored for
more than 24 hours. The group would not require that the waste be
refrigerated as long as it is "kept in a non-putrescent state."
Participants amended the description of the generator (p. 4-4) to
read, "... produces [and hauls] medical waste and contracts
individually...." The revision was made to address the case in
which small quantity generators (SQGs) may contract with a
transporter who then becomes the generator.
The third paragraph under Manifesting Requirements (p. 4-4) is
amended to say, "... for all [medical] waste shipped off-site" to
address ambiguity in the original language of the Act that it may
require manifesting General Refuse.
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With regard to SQGs, the group emphasized that the regulation
provides language indicating that waste volumes are calculated
month-by-month and that the 50 Ibs. does not include the weight of
the packaging. The group did not resolve, however, how SQGs are to
weigh their wastes accurately.
The third paragraph under Reporting Requirements (p. 4.5) should
strike "volume and type of waste" and insert "weight and/or number
of units of waste" to reflect a more accurate method of quantifying
amounts. e
The group agreed that SQGs should be able to transport their wastes
to hospitals (or other permitted treatment facilities). The
facility, upon receipt of this "untracked" waste, then becomes the
generator of the waste.
Transporter Requirements
The group suggested that EPA publish the notification requirements
and a list of licensed or regulated medical waste haulers in the
Federal Register.
The group questioned whether the Department of Transportation (DOT)
requires that medical waste haulers display the biohazard symbol or
other placard indicating the vehicle is transporting infectious
waste on the outside of the truck. (It was later confirmed that it
does not.)
The group agreed that the non-compactor truck requirement apply
only to Potentially Infectious waste.
Employees handling medical waste should follow the requirements/
guidelines for "appropriate protective equipment" in accordance
with OSHA regulations (19 CFR Part 1910).
The transporter is allowed to "store" waste in a vehicle for more
than 72 hours if necessary to satisfy time-travel requirements or
in the event that a treatment and/or disposal facility is unable to
accept the waste (e.g., the incinerator is broken).
The group agreed that the quarterly reports required to be
submitted by the transporter need not include the type of medical
waste handled.
The group agreed that safety procedures for transporting medical
waste include:
- Training employees to use the cleanup kit
- Notifying appropriate authorities in the event the employee is
unable to remedy an accident or spill on his/her own
- Training employees in decontamination procedures as part of the
cleanup kit training.
C-8
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Disposal Facility Requirements
The group reemphasized the point that it should be permissible for
facilities to accept untracked waste from SQGs and that this
procedure would virtually guarantee proper disposal of medical
waste generated by SQGs since they would not incur otherwise higher
costs of waste disposal.
The group was unsure of the value of requiring the disposal
facility to submit an annual report on the amount of waste
received. It was interested to know specifically for what purposes
the data would be used.
Finally, the group discussed the usefulness of integrating any data
obtained from tracking medical waste into existing Resource
Conservation and Recovery Act (RCRA) data bases.
C-9
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GROUP 2, November 14 and 15
DEFINITIONS
Group 2 was assigned four waste types for discussion: pathological
waste, discarded medical equipment and parts, used sharps, and unused
sharps.
The group selected Laboratory Wastes as one of two possible additional
categories. The members did not have time, however, to address this
category.
Pathological Wastes
General Concerns
EPA's interpretation that this waste type should be limited to
human pathological waste is appropriate.
EPA's interpretation should not specifically mention biopsy and
obstetrical procedures; such reference would only create problems
in these two fields. "Other medical procedures" is preferable.
Body fluids should be limited to fluid specimens collected for
analysis.
The group developed its own interpretation of pathological wastes:
Pathological wastes include, for example, human tissues, organs,
body parts, and specimens of body fluids collected for further
analysis that are removed during surgery, autopsy, or other
medical procedures.
Specific Issues
The inclusion of body fluids and products of biopsies and
obstetrical procedures is more comprehensive, but is not
reasonable. Therefore, the group developed its own definition (see
above).
In the General Refuse category, the term "rendered
non-recognizable" should be deleted because incinerated wastes are
already non-recognizable.
The term "non-recognizable" is difficult to define and enforce.
In the Special Medical category, the phrase "if properly
disinfected using steam or chemical sterilization or other
appropriate means" should be changed to "if properly
decontaminated."
Fixation, thermal processing, and autoclaving are viable treatment
methods for decontamination, but these methods alone make
enforcement difficult.
C-10
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The following discussion statement, "There seems to be little
disagreement that wastes meeting the above definition should be
considered potentially infectious," raised concerns. Some
participants suggested that there could be pathological waste that
is not infectious.
Additional Comments
t Clear definitions and regulations are needed for hospitals. The
three categories, "General Refuse," "Special Medical," and
"Potentially Infectious," could cause problems.
The terms "sterilized" and "disinfected" should be replaced by the
term "decontaminated" throughout the definitions section.
Containment should be considered as a viable method for removing a
waste from an Infectious or Special Medical waste category.
The group expressed concern over how to deal with small quantity
generators.
Discarded Medical Equipment and Parts
General Concerns
By including wastes that "may be contaminated" instead of wastes
that "were in contact" with infectious agents, EPA's draft
interpretation is overly conservative and extends beyond the
statutory definition.
The list of wastes included in this definition could continue
indefinitely.
Should this category exist at all? Items of concern on this list
probably fall under other categories already.
Will this material be handled appropriately in a smaller setting,
such as a nursing home?
The concern with this category is primarily aesthetic.
Specific Issues
Throughout the definition, add the term "biomedical" before
"industrial and research laboratories," and delete "in the
production and testing of Pharmaceuticals" and "pharmaceutical
industries."
Delete any reference to specific equipment types, such as
hemostats, forceps, and needle holders; instead, list "disposable
components of medical equipment, including IV tubing."
C-ll
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Replace "contaminated with infectious agents" with "blood-
contaminated. "
Is autoclaving necessary to render materials "Special Medical"?
Additional Comments
The volume of fluids is important when determining whether or not
medical parts are potentially infectious. Containing the fluids is
difficult, if not impossible, however.
Even after decontamination, these wastes still need to be tracked.
Interpreting this category as "medical equipment" may be
reasonable, but it is not clear.
There is a need to identify risk level. This issue is one of
aesthetics versus health impacts, disease versus hysteria real
risk versus perceived risk.
Sharps. Used and
General Concerns
Combine "used" and "unused" sharps into one category. Refer to
"unused" sharps as "unused but discarded."
Unused sharps pose the same aesthetic problems as used sharps and
all sharps pose a risk of injury.
Consider new ways for handling sharps.
Specific Issues
Revise the EPA draft interpretation to include "unused but
discarded sharps"; change "syringes" to "needle-bearing syringes'"
add the term "biomedical" to define "research and industrial
laboratories"; and add "materials capable of piercing or puncturine
the skin" to the list of sharps.
Throughout this definition, replace "sterilized" with
"decontaminated. "
In the General Refuse category, replace "ground to a size" with
"reduced to a size."
In the Special Medical category, change "sharps" to "discarded
unused sharps and used sharps that have been decontaminated."
In the General Refuse category, consider changing "reduced to a
size that would prevent punctures" to "rendered incapable of
breaking the skin."
C712
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Additional Comments
None
SEGREGATION
General Concerns
Require segregation either by specific waste types (i.e. sharps
pathological waste, etc.) or by category (i.e., Infectious, Special
Medical), but not both ways. EPA's five categories are too
confusing.
Specific Issues
The category "other medical wastes" should be modified to exclude
"General Refuse." Delete the example "large equipment."
Sharps should not be separated from fluids. The mixture should be
handled as sharps.
The segregation of fluids may be of minor concern.
Segregate only those fluids going off site.
Additional Comments
Definitions - General
Add steam autoclaving and other verifiable decontamination
technologies as important treatment procedures. Use "steam
autoclaving and rendered non- recognizable" to convert all wastes to
the General Refuse category.
EPA Guide for Infectious Waste Man^^nt- (PB 86-199130)
for handling procedures.
Limit the waste types that must be rendered non- recognizable to
those that have caused the public concern, i.e.:
- Needles, syringes, hypodermics
- IV and other tubing
- Blood vials and bags
- Specimens .
Consider changing "rendered non- recognizable" to "non- reusable. "
Definitions - Fluids
Limit definition of fluids to blood and stock cultures.
C-13
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PACKAGING
General Concerns
EPA Guide for Infectious Waste M«n«p..m»nr should be used to
develop regulations for medical waste handling.
EPA should define the characteristics of the primary container to
preclude the need for a secondary container.
Specific Issues
A second container should not be used for sharps. If it is, it
should be described as a "box, pail, or drum."
A double container for fluids should be required only if the
primary container is glass.
"Unbreakable" containers for fluids should be changed to "puncture
resistant" containers. If a second container is required, it
should be described as a "drum" rather than a "box or barrel."
The secondary rigid container described throughout this section
should be provided by the transporter. A single bag should be
acceptable for Special Medical wastes as long as the bag meets
certain standards, such as being puncture proof.
Additional Comments
None
LABELING
Specific Issues
The outer label should identify the category of waste in the
container.
TRACKING SYSTEM
General Concerns
The reporting of information on transportation and disposal costs
should be required.
An annual or quarterly report from large quantity generators should
be required.
A separate section of regulations on storage should be developed
that will specify storage for generators, transfer facilities
transporters, and disposal facilities.
C-14
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Generator Requirements
Specific Issues
Only "unfixed" pathological wastes should require refrigeration.
Change the term "manifest" to "tracking form."
Block 7 on the tracking form should be consistent with language in
the regulations (e.g., registration versus permit).
Transporters may be reluctant to pick up small volumes; therefore
small quantity generators should not have to use licensed
transporters if an employee authorized by the generator uses a
private vehicle to transport the waste to a large quantity
generator. 01 j
Small quantity generators should not have to complete an annual
transporter contract report.
Small quantity generators should not have to file exception reports
unless shipping more than 50 pounds in a single shipment.
Exception reports should be filed within 30 days of shipment if
appropriate.
Waste should arrive at a designated facility within a specified
period of time, although the group was not able to determine what
would be a reasonable period of time.
The group discussed whether or not the generator should be
obligated to make an inquiry if a manifest form is not received
within 14 days.
Transporter Requirements
Specific Issues
Transporter vehicles should be required to display only the
biohazard symbol.
Delete "good sanitary conditions" and replace it with "visibly
clean of medical waste residue."
Change "avoid violent mechanical stress" to "handle with due care."
The description of storage requirements on page 4-6 should be
revised to read, "Medical waste shall not be stored in a vehicle
for more than 72 hours. Putrescible waste (i.e., body fluids
unfixed anatomical parts, and animal carcasses) should be
refrigerated if transported or stored more than 48 hours." Move
this entire statement to a separate section entitled "Storage
Requirements."
C-15
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Delete reference to gloves and coveralls; this is an OSHA issue.
Recommend, do not require, that transporters have cleanup kits and
trained personnel.
Do not require specific truck decontamination procedures.
Require transporters to segregate wastes.
Additional Comments
Should the small quantity generator exemption be eliminated?
Enforcement resources will be limited, and the relative
contribution to the medical waste stream is unknown.
If the small quantity generator exemption is not eliminated
manifesting should not be required within a common custodial
responsibility.
Acknowledge transfer facilities as a group subject to the
regulations.
C-16
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GROUP 3, November 14 and 15
DEFINITIONS
The waste categories assigned to Group 3 for discussion were blood and
blood products, dialysis wastes, and isolation wastes. The group chose
pathological wastes as an additional category for consideration.
Blood and Blood Products
General Concerns
The impact of AIDS shows us that we need to prepare for future,
potential threat from unknown/recognized viruses and diseases.'
The group discussed whether all blood should be treated as
hazardous or if only relevant risk factors should be considered.
Participants also asked if EPA regulations will supplant existing
practices, such as sewer disposal.
Risk factors such as quantity of waste, origin of waste (home,
institution), waste type (syringe, bandage), and degree of
contamination are important.
Specific Issues
Group members agreed that blood and blood products in a free,
liquid form should be managed appropriately and tracked.
They noted that a minimum of 20 cc of fluid has been used to define
"liquids" in New Jersey. This quantity equals the capacity of many
syringes and the amount of blood left after blood bags are emptied.
Participants did not reach consensus on whether to define
blood-contaminated paper, such as bandages and gauze as medical
waste or whether to track these wastes. This type of waste is not
covered by New Jersey regulations. These residuals should not be
treated as as free liquids, but the containers should be disposed
of as sharps or Discarded Medical Equipment and Parts.
Liquid disposal through the sewer leaves behind residuals in
containers and on equipment.
The group asked if there is a statutory basis for fluids in
pathological categories.
Members also discussed whether or not blood should be grouped with
fluids.
C-17
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In addition, the group discussed which of the following should be
used as criteria to define waste in this category: free liquids;
liquids in containers; wet, bloody bandages; or dried blood on
bandages. The consensus favored free liquids.
Dialysis Wastes
The group thought that waste generated through hemodialysis was
similar to those wastes covered under other categories, such as blood and
blood products, sharps, such as tubing and needles, or discarded medical
equipment; therefore, they should be subsumed within that category
Isolation Wastes
The group had one general comment: that the public perceives these
wastes as particularly dangerous and, therefore, this category deserves
some attention. The group also questioned whether or not animal waste
definitions were included in this category.
The group noted that New Jersey Department of Public Health worked
with CDC to define a list of diseases requiring extraordinary care In
their State regulations, New Jersey listed isolation wastes, associated
with these specific diseases.
There was some discussion about the criteria for including specific
diseases in this category. Some examples were offered, including:
Disease-specific (rare, unusual)
Hemorrhagic fever diseases
Level IVs
Level IV TB
Potentially infectious
Communicable.
There was a general consensus that the EPA should only regulate waste
coming from patients isolated due to a list of specific highly
communicable diseases.
Pathological Wastes
General Concerns
How should body parts be tracked? What kinds of allowances should
be made for burial as part of a religious ceremony?
Indicate how body parts are being handled--is it on an aesthetic
basis?
C-18
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Specific Issues
Can body parts be excluded by definition?
Are funeral homes and their wastes covered by statute?
What is the distinction between specimen (pathological) and waste?
Should tissue cultures be included?
Should the involved fluids be covered in the blood and blood
products category?
Should exclusions be made for veterinary wastes under some
circumstances? (New Jersey made no distinction between human and
veterinary waste.)
Additional Comments
Public concerns need to be weighed when defining medical waste
and how it should be managed. Public education should be a part
of tracking and regulatory efforts.
Aesthetics and perceptual reality need to be taken into account.
The infectious/non-infectious criteria is hard to enforce;
should treated versus untreated be used as criteria?
Should "recognizable as medical waste" be used as criteria?
A balance should be achieved between aesthetic and scientific
concerns, and scientific and public perception concerns.
There are limits to the use of incineration.
The effectiveness of incineration as a treatment method needs to
be considered.
There are environmental problems (air) associated with
incinerating 80 percent of the waste.
Is incineration technology lagging?
Public education is necessary when siting disposal and treatment
facilities as existing capacities are reached and new sites are
needed.
Universal precautions are for health care workers, not
sanitation workers.
Waste reduction, reuse (of dialysis equipment), and recycling
were discussed briefly and viewed as not feasible.
C-19
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Universal protection or precaution specifies practices that are
"virtually impossible for disease transmission."
Maintain current handling and disposal practices that work, such
as sewer disposal of blood.
There is a problem with the definition of "sterilized." Use
"decontaminated" or "rendered non-infectious" instead.
Sterilization is hard to achieve and verify.
What are the requirements of the Food and Drug Administration
(FDA) regarding blood and blood products?
What kinds of coordination are there between Government
agencies, such as EPA, CDC, and the FDA?
SEGREGATION
Scientific versus political realities need to be considered in
looking at medical waste handling and tracking.
Will sanitary landfills accept medical waste?
What will the macro-economic impacts of the regulations be?
The changes in handling practices and costs due to the
regulations will be greater for offsite than onsite disposal.
The practicability of total segregation of sharps and fluids
needs to be assessed.
Is the segregation of sharps and liquids practical?
Issues of concern when attempting to separate fluids and sharps
include:
- Residues left in emptied containers may be sharps (glass).
Safe containment of fluids sometimes involves not emptying
containers.
What quantity of liquids defines a "liquid"?
Could sharps and liquids be combined and placed in rigid
containers?
Should sharps be separated from "free" fluids? Should this be
mandated or left as a management decision?
Consider other onsite treatment practices rendering waste
"non-infectious," not just incineration (practical use of
grinders, autoclaves, etc. by SQGs).
C-20
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How should Che integrity of sharps be destroyed; through
grinding, incineration and/or other means?
PACKAGING
Additional identification of "red" bags is needed. Also, it
would be useful if bags would change appearance (color) after
treatment.
Will the new requirements be a dramatic change from current
packaging requirements? Sharps are now often put in cardboard
boxes.
There are problems wich liquids and cardboard containers, in
that cardboard is not leakproof and disintegrates when wet.
The group thought that the use of containers other than PVC
containers (incineration problem) should be recommended.
The definitions for containers, including breakable/
unbreakable, leakproof, and rigid, are not sufficiently clear.
The group recommended a universal packaging requirement based
on performance standards: Use a single 3 mil thick bag in a
cardboard box. Seal the bag to prevent leakage. Place sharps
in a rigid container. "Sharps" include all glass. Bulk fluids
should be packaged properly in unbreakable containers.
LABELING
The use of identification numbers instead of the name of a
doctor or institution is recommended. Identification numbers
would allow tracing by Departments of Health or Environment
without destroying a doctor's reputation if he or she was not
responsible for shipment loss.
The Health Care Financing Administration (HCFA) has
identification numbers for Medicare-participating physicians
that could be used.
What should go on inner and outer labels? This is determined
by the purpose of the labels.
- The reason for inner labeling is to track the source of
waste if the outer container is destroyed.
The use of small, buoyant labels would assist in identifying
the source of mismanaged wastes.
- A labeling recommendation suggested by the groups:
Identification label for generator; color-coded biohazard
label; inner label--use simple, preprinted labels, no
day-to-day changes.
C-21
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Contractor liability and contractor turnover need to be
considered when devising labels.
Additional Comments
Incineration technology, siting, capacity, and air standards
are in question.
There is a distinction between internal treatment/shipping out.
Should an incinerator be dedicated to a facility's own waste?
Interagency requirements, e.g., DOT, should be studied by EPA.
How should fluid-soaked or contaminated items be classified?
TRACKING AND RECORDKEEPING
General Concerns
The system obligates the transporter to ensure that generator
materials are disposed of properly. The paper trail ensures
that the generator and transporter are obligated. The
generator needs to be notified of exceptions.
There should be exemptions for multi-site facilities
transferring waste between sites, home health care, rural
areas, and doctors transporting waste to hospital.
Reporting requirements for generators should be reduced as much
as possible.
Specific Issues
The tracking form should ask for the number of boxes, not the
weight of the boxes.
The form should not require information on the waste
categories.
If universal-sized packages are used, the volume of containers
can be recorded.
What is the definition of a small quantity generator (50 Ibs)?
Is it a generator that produces less than 50 pounds or that
sends less than 50 pounds offsite for ultimate disposal? If
the waste is disposed via the sewer or otherwise treated onsite
so it does not meet the definition of medical waste, is the
quantity considered to count toward the 50-pound limit? The
group assumes that only generated waste requiring offsite
disposal will be tracked.
C-22
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Remanifesting presents a problem. If wastes are picked up from
multiple facilities and some packages of waste are not coded or
logged, tracking a lost package can be difficult.
"Infectious" should be changed to "medical waste" or
"biohazardous."
There is a need to track medical waste regardless of risk
because of the Act.
Will tracking require changes in transport or disposal?
The wastes to be tracked are those going offsite. not those
remaining onsite.
One of the major concerns when considering tracking is the
public perception of transportation and disposal of medical
waste.
The use of various designations, infections, and special
medical standards does not provide for any significant
difference between the handling of treated and untreated
waste. The requirement that all waste be tracked would yield
no significant savings and may be more confusing than if only a
medical waste category were used.
Sharps should be let out of the system if they were destroyed
and/or their integrity was removed by grinding, hauling to a
destruction facility, or encapsulating.
What is the impact on the public of improper disposal--should
the hauler be identified?
The complexities of changing haulers and multiple haulers need
to be considered in tracking requirements.
A question arose concerning wastes to be tracked. The ultimate
destination of wastes is considered when tracking.
Tracking exemptions should be considered for certain
generators.
EPA is considering licensing requirements for haulers.
Additional Comments
Transporters will have to be licensed.
Should a bar code system be used for logging packages?
Handlers may use bar codes, but they should not be required.
C-23
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The Special Medical category was not resolved.
The proposed regulation should be compared to EPA's hazardous
waste manifest system concerning the tracking and reporting of
lost wastes.
C-24
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GROUP 4, November 14 and 15
DEFINITIONS
Group 4 was assigned three waste types for discussion: cultures
and stocks, other laboratory wastes, and miscellaneous material from
patient care. In addition, the group selected three other waste
categories for discussion and critique: human blood and blood
products, surgical and autopsy wastes, and isolated wastes.
Time permitted the group to discuss the selected alternative
categories only briefly, however, as the discussion focused on the
three assigned wastes as well as broader consideration of the statute
EPA's work to date, and other medical waste issues.
The participants generally agreed that the Special Medical waste
category was unnecessary (though subsequent discussions appeared to
change some minds) because there was no statutory basis and the
proposed regulatory requirements were nearly identical to those for
infectious waste. They also questioned the use of incineration as the
only means to remove wastes from the regulatory requirements.
Specifically, the members recommended sterilization and rendering
wastes unrecognizable as a preferred practice for many waste types.
The group also agreed with the Agency in excluding chemical and
radioactive waste from the medical waste tracking regulations as they
are more appropriately regulated under RCRA Subtitle C, the Clean
Water Act, or by the Nuclear Regulatory Commission.
While many group members understood EPA's immediate need to
promulgate regulations, most felt that the statute under consideration
was ill-crafted and that the Agency was needlessly rushing the
regulatory development process. In that light, they expressed concern
that the development of regulations under the demonstration project
would drive future national regulations without analysis of all the
potential impacts on the regulated community or the burdens placed on
regulators.
Cultures and Stocks
Objectives for Discussion
Define "biologicals."
Improve specificity of definition.
Define "infectious agent."
Determine whether glassware currently included in this waste
category would be better defined as sharps.
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General Concerns
The group recommended that sterilization and rendering this
waste type unrecognizable should be sufficient to allow
designation as General Refuse and exclusion from segregation,
packaging, labeling, and tracking requirements.
The group agreed that this waste type should be included in the
regulatory definition and considered infectious until treated.
Specific Issues
Define "biologicals" more accurately as "microbiologicals"--
microorganisms and products of their metabolism or other
products of human origin capable of causing morbidity or
mortality in humans. The group suggested developing a detailed
list of the "biologicals" to be included and incorporating the
list into the regulatory definition by reference.
Define "infectious agents" as materials containing any of the
organisms listed in the CDC/NIH biosafety levels 2 through 4.
Glassware currently included in the cultures and stocks
definition (culture dishes, devices used to transfer,
inoculate, and mix cultures, slides, cover slips, etc.) should
be removed from this definition and included under sharps where
appropriate.
Limit definition to human and animal cell cultures only.
Rely on existing EPA and CDC guidance for defining cultures and
stocks. Do not confuse the regulated community by making the
definition too complex.
The group generally thought that most cultures and stocks are
adequately managed currently to protect human health and the
environment.
Laboratory Wastes
Objectives for Discussion
Define "contact with infectious agents."
Define "laboratories."
Track all laboratory waste?
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General Concerns
The group agreed that laboratory wastes as currently defined
should be included in the regulatory definition and considered
infectious until treated.
The group recommended that these wastes should be considered
General Refuse if sterilized and rendered unrecognizable.
Further, materials that are routinely cleaned and reused
(aprons, lab coats, etc.) should be exempt from regulation even
if shipped offsite for cleaning.
Specific Concerns
"Laboratory" should be defined as any laboratory that performs
services or analyses that produce wastes containing infectious
agents.
There is no need to further define "in contact with infectious
agents" in terms of volume, quantity, virulence, etc. The
definition should be taken literally, and left to the
discretion of the generator. Infectious agent should be
defined as discussed for cultures and stocks (organisms listed
under CDC/NIH biosafety level 2 through 4).
There is no justifiable reason to require tracking of all
wastes from laboratory operations.
Miscellaneous Material From Patient Care
Objectives for Discussion
Determine whether justification exists to include this waste
type in the regulatory definition.
Improve specificity of definition.
General Concerns
The group strongly recommended deleting this waste type from
further consideration because wastes that pose aesthetic
concerns will be included in the other categories and the lack
of evidence demonstrating that these wastes pose a threat to
human health and the environment.
While not considered in depth, the group felt that sufficient
justification may exist to add the categories of "unused
sharps" and "zoonotic animal wastes."
Surgery and Autopsy Wastes
Objectives for Discussion
Define "surgical procedure."
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Define "in contact with" (volume, quantity, visible stain)?
Track all surgery and autopsy waste?
General Concerns
The group agreed that these wastes as currently defined should
be included in the regulatory definition and considered
infectious until treated.
Specific Issues
The group suggested that "surgical procedure" should be defined
broadly as any invasive procedure. An alternative suggestion
was to rely on definitions used by insurance companies, though
this was not considered a practical method by most panel
members.
Participants concluded that there was no need to further define
"in contact with." They thought a definition should not be
given on the basis of visible stain, volume, quantity, etc.
Human Blood and Blood Products
Objectives for Discussion
Bulk blood vs. blood tainted materials. Should blood tainted
materials be included, and if so, what criteria should be used
to properly designate these wastes (volume, quantity free
liquids, visible stains)?
General Concerns
The group agreed that the waste type should be included in the
regulatory definition and considered infectious until treated.
The Agency should make a clear statement that the definition
applies to any facility handling blood, including mobile blood
collection facilities, laboratories, and blood brokers.
Participants agreed that a distinction must be made between
blood and licensed blood products.
Specific Issues
The definition should not be limited to visible stain. Many
blood products are essentially colorless.
The category should include any materials in contact with blood
or blood products regardless of volume, quantity, or the
presence of free liquids.
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Additional Comments
The Agency should require that blood and blood products
discharged to sewers should be discharged only to collection
and treatment systems with secondary treatment.
The waste type raises numerous issues associated with home
health care, self-care, and drug abuse. While the group
generally felt it impractical to attempt to regulate these
wastes, participants spent a significant amount of time
discussing the issues. They agreed that these wastes may pose
equal or greater threats and also may be significant
contributors to the recent incidents on our beaches, among
other situations.
Isolation Wastes
Objectives for Discussion
Is there a need for additional guidance beyond current CDC
recommendations?
How should definition be applied to wastes generated in
outpatient care?
What is the overlap with other categories.
General Concerns
Only wastes associated with the treatment of "highly
communicable diseases" (the only one identified by the group
was Lhasa fever) should be considered as isolation wastes.
These diseases should be listed by consulting with CDC. One
suggested approach was to use the CDC/NIH biosafety level 4 as
a starting point.
Specific Issues
No additional guidance is needed beyond existing CDC
recommendations, with the exception of identifying the specific
"highly communicable diseases."
Outpatient care wastes should be excluded.
Many wastes of concern associated with less communicable
diseases will be captured by other waste types.
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SEGREGATION
Specific Recommendations
Limit the categories for segregation to:
Sharps
- Fluids
- Other Infectious Waste.
State clearly that these requirements apply only to wastes
intended for offsite transport.
Definition of fluidthe group spent a significant amount of
time discussing the definition of a fluid. While no real
agreement was achieved, the group underscored the need to keep
any such definitions simple and clear. It was felt that any
definition would still require the generator to use discretion
in determining whether to handle a waste as a fluid.
Specifically, the following points were discussed:
- No minimum volume should be established as a criteria for
defining fluids. Such numbers are impractical and often
unmeasurable.
- Bulk liquids would certainly be included but those
discharged to sewers would not be included in the
regulation.
- Saturated materials from which liquids can drain under
normal waste management conditions should be included,
though no consensus could be reached concerning a
definition.
PACKAGING
Specific Recommendations
Clarify that regulations cover only offsite transport.
OSHA and DOT requirements should be reviewed for consistency
with the EPA approach.
Standards for packaging should reference ASTM and other
materials standards.
Modify packaging requirement to allow more flexibility in
reliance on containers currently in use and specifically
designed to contain specific waste types (e.g., sharps
containers). The requirement of multiple containers in some
cases may be unnecessary (if a sharps container is
leak-resistant, puncture-resistant, and specifically designed
for transportation, additional packaging may be unwarranted).
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The panel recommended the use of less specific language to
direct the generator to use primary and secondary containment
as defined below:
- Primary containment designed to provide safety to health
care workers during inhouse handling and transport of
medical wastes.
- Secondary containment designed to fully contain wastes,
protect transportation workers, and maintain packaging
integrity during routine practices used to transport medical
wastes to offsite waste management facilities.
Sharps containing fluids should be packaged to meet all
requirements for both sharps and fluids categories.
Use "leak resistant" and "puncture resistant" instead of "leak
proof" and "puncture proof." Avoid such terms as
"unbreakable."
LABELING
Label the outer layer of packaging only.
Use the universal biohazard symbol on the outer layer of
packaging.
The panel's previous recommendation to eliminate the Special
Medical waste category would eliminate the need for separate
labels.
GENERAL CONCERNS REGARDING SEGREGATION, PACKAGING, AND LABELING
In discussing segregation, packaging, and labeling, Group 4
used the definitions it had developed earlier.
Incineration should not be the only means for excluding waste
from the tracking requirements.
The availability of existing treatment (incineration) capacity
is a significant issue.
Requirements should conform to "Good Housekeeping" policies
used in medical institutions.
TRACKING AND RECORDKEEPING
Because of lack of time and divergence into related topics, Group
4 did not discuss some aspects of the tracking system and form in
detail. In particular, participants did not consider disposal
facility requirements or transporter reporting and recordkeeping.
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Generator Requirements
Specific Recommendations
In making an SQG determination, use only the weight of the
waste and exclude the weight of packaging. In the case of
mixed wastes (medical waste and General Refuse), use the total
weight of the waste mixture.
Count only those wastes destined for offsite management when
making an SQG determination.
Delete refrigeration requirement. The panel discussed the
inclusion of a provision to address odor nuisance control and
other storage requirements but reached no agreement on either
the need or nature of such provisions.
Clarify generator status (pg. 4-4: First Manifesting
Requirement). The group did not succeed in its attempt to
decipher the definition of a generator. Participants
emphasized that the definition should not discourage the use of
shared facilities due to a need for multiple manifests from all
individual practitioners. This includes a situation where
several individual practitioners lease office space, and as
part of that agreement, the lessee provides a centralized waste
collection and handling service. In this case, the lessee
should be able to write one manifest to cover all wastes
shipped from the site.
Clarify definition of "offsite" for purposes of
manifesting/licensing requirements. The group was unsure of
how the definition applied to satellite facilities.
Participants agreed that manifests should not be required for
facilities owned and operated by a single entity and sharing
contiguous property. The group did not reach agreement in the
case of facilities separated by longer distances and requiring
the use of public highways to transport waste. Everyone
agreed, however, that the point was essentially moot if only a
four-part manifest was used.
Clarify scope of SQG exclusion. The group saw little value in
an exclusion that does not exclude the generator from any
significant requirements (manifest versus log seemed minor).
Permit the generator to haul his own waste without a license in
some situations. This provision should not preclude the
individual practitioner from transporting waste to a hospital
or other facility for proper handling/disposal. The
regulations should not provide disincentives for this
practice. Suggested limitations include that this practice:
- Should be limited to non-commercial transport
- Enforceability may be an issue.
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Generator Reporting and Recording
To provide some enforcement capability and ability to assess
the effectiveness of the program, a six-part uniform manifest
(per Illinois) should be considered for use. This was
suggested primarily by the State officials but not strongly
objected to by other panel members.
Echoing the above comment, the group felt that there was no
incentive for generators to submit exception reports.
Manifests should be used by all generators regardless of
generator status (log sheet versus manifest provides little or
no regulatory relief, adds needless complexity to system, and
reduces enforcement capability).
Annual reports should include weights of waste, not volume or
waste type descriptions.
Transporter Requirements
Concern was expressed about the cost of transporter licensing
and who bears those costs? The State officials felt that
without Federal assistance, staff and resources were not
available to support this requirement.
« How will multi-state transport registration be handled (within
and outside of the demonstration States)? If a transporter
operates in multiple States, will licenses be required in all
States?
General Concerns Regarding Tracking and Recordkeeping
o Who bears implementation costs for manifests, compliance
monitoring, permitting, and enforcement (where will States get
funding for the demonstration program)? The State officials
did not have adequate resources to support the program and
needed Federal assistance to do so.
o How will interstate transport and disposal be handled (e.g.,
return of signed manifests from facilities operating in States
outside the demonstration program)?
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Appendix D
Summary of Small
Working Group Sessions
November 16, 1988
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APPENDIX D. SUMMARY OF SMALL WORKING GROUP SESSIONS
November 16, 1988
Discussion on the final day of the meeting focused on two topics-
the Special Medical waste category, and the models EPA is developing in
an attempt to calculate the amount of medical waste generated by a
diverse group of facilities. To address these topics, meeting
participants divided into three groups categorized according to
generator models: physicians's offices, hospitals, and laboratories
The groups generally concentrated on the generator models, as indicated
on the following pages.
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PHYSICIANS' OFFICES GROUP, November 16
PHYSICIAN'S OFFICE MODEL
The group suggested that perhaps a one-time, 30-day audit of a
representative sample of physicians' offices might be a faster
and less burdensome method for obtaining waste generation data.
Participants questioned the Agency's ability to get accurate
generation estimates, given that it might allow treated and
unrecognizable waste to be handled as General Refuse. To solve
this problem, it was suggested that small quantity generators
keep a special waste log in their offices to track the amount of
waste treated and rendered unrecognizable. The group concluded
that this procedure, however, would be overly burdensome for
low-staffed offices.
The group again took issue with what they characterized as EPA's
apparent bias toward incineration as the only option for
treatment. It suggested that the Agency devise and publish a
list of alternative technologies for both decontamination and
destruction (i.e., methods that would render waste
unrecognizable).
Given that this treatment/destruction option might be approved by
EPA, the group raised the issue of cost. For example, would it
cost more for the generator to equip the office with the
appropriate technologies than it would to contract with a vendor
who would treat and destroy the waste? This question was not
resolved.
The group stressed that in developing technologies to treat
Special Medical waste under this option, that the emphasis be
placed on rendering the waste unrecognizable rather than on the
performance standards for treatment. The group did, however,
note that verifiable decontamination standards were necessary to
protect workers handling the waste.
The group also raised the issue of the difficulty in defining a
standard for "unrecognizable." For example, does the waste have
to be unrecognizable as a medical waste or any waste at all?
GENERATOR MODELS
There were some major concerns about the validity of any model
used to estimate waste volumes. First, the group felt it was
necessary to finalize the definition of medical waste before any
estimates could be attempted. Second, there was a concern that
the models would over-project the amount of medical waste
generated because the initial assumptions made in the models
might not be accurate.
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Alternative data collection activities were suggested, including
surveys and the ongoing activities in New Jersey, New York, and
Minnesota. From these data, the group felt it might be possible
to scale up to national estimates and compare data from States
tracking their waste with those from States not tracking waste.
The group suggested that some program be devised that would
catalogue these ongoing data collection activities and then
determine their relevance to national projections.
It was suggested that EPA consult the Canadian method of
generator characterization currently used in Ontario because of
its similarity to the Resource Conservation and Recovery Act in
industry characterization and the use of audits. In addition,
the Canadian definition of medical waste includes everything
currently under consideration by EPA.
The group considered the costs of implementing the new regulation
and felt that State governments would be burdened by having to
produce the tracking forms and handle related activities required
by the Act. It was also felt that, to some extent, those
generators who currently handle their wastes properly and
responsibly would not incur substantially greater costs unless
transporter fees increased significantly.
The group briefly discussed the feasibility of recycling
materials from health care facilities and laboratories. In the
health care setting, universal precautions made immediate
recycling unlikely; however, it was also noted that there are
currently no cost incentives to pursue reuse and recycling since
plastic products are so inexpensive.
The group also talked about trends in materials, such as a
possible shift from PVC plastics.
Finally, it was suggested that EPA's information gathering
efforts address the recycling issue and obtain data from such
sources as manufacturers, laboratories, trade associations, the
EPA Waste Minimization Office, and the Federal Food and Drug
Administration (FDA) section on medical devices.
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HOSPITAL GROUP, November 16
SPECIAL MEDICAL WASTE
General Concerns
Define processes that can be used to decontaminate waste and
render it non-recoverable.
Retain the Special Medical category for those who choose not to
render materials non-recoverable. There is a need to preserve
this distinction from "infectious."
Specific Issues
Exclude certain items from "patient care wastes," such as
disposable razors brought to the hospital by the patient and
dietary items.
List items that should be rendered non-recognizable, such as
syringes, needles, scalpels, blood bags, blood-tainted tubing, and
blood vials.
o. Eliminate use of the term "non-recognizable"; use the term
"non-recoverable" instead.
« Substitute the term "decontaminate" for "sterilize" or
"disinfect."
Additional Comments
Reference the EPA Guidance Manual and Centers for Disease
Control/National Institutes of Health Biosafety Guidelines in the
Federal Register (FR) preamble.
The Fg preamble needs to recognize the aesthetic motive of the law
and discuss the issues that resulted in the legislation.
The a preamble needs to encourage onsite treatment and
alternatives to incineration (at point of generation).
Specifically, EPA should request clarification on the
applicability of non-thermal treatment alternatives.
EPA should use the time allowed by Congress to allow the public to
have some input. The interim final rule is not required until
April 2, 1988.
EPA should go to Congress during the next session and ask for
amendments:
- Allowing treatment alternatives to render waste "General
Refuse"
- Providing for consumer exemptions.
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Enforcing treatment standards is accomplished through existing
accreditation and granting processes or requirements (e g the
Joint Commission on the Accreditation of Health Care Organizations
[JCAHO] standards).
HOSPITAL MODEL
General Concerns
EPA's overall approach should be very general, using model
estimates for such variables such as waste generation rates per
patient and actual manifest data to characterize total waste
quantities.
Waste quantities should not be estimated by type or category.
Specific Issues
Use transporter quarterly reports and New Jersey and New York
transporter logs for quantity estimates and compare to other data
sources.
Consider conducting a hospital survey to estimate waste generation
rates for wastes decontaminated and rendered non-recognizable or
non-recoverable.
Use data from the American Hospital Association (AHA).
Use the hospital occupancy rate, which AHA should have, as an
important variable for estimating waste generation rates.
To address cost issues, include liability costs, direct costs to
patients for health care insurance, Medicare costs, and costs for
onsite disposal.
Assess the economic impact on health care institutions and others.
Include indirect costs to the health care industry, such as
permitting costs and costs of incinerator operator training
(including salary increases).
Consider economic impact on small transporters who cannot afford
liability insurance or costs of special equipment (i.e., trucks
providing refrigeration and special compartments for waste
segregation).
Follow trends in costs of offsite disposal.
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Additional Comments
To assess effectiveness of treatment methods:
- Consult existing assessments of treatment methods, such as the
evaluation being conducted by the Association of Toxic
Substances Disease Registry (ATSDR).
- Compare risks posed by treatment, such as air pollution from
incineration (use AHA expertise, University of Chicago study,
and California Air Resources Board data in evaluating
incineration)
- Validate the West German studies that report that medical waste
is no more infectious than household waste.
To evaluate the effectiveness of the demonstration tracking
program: °
- Use the numbers of enforcement cases as an indirect measure of
effectiveness
- Conduct a cost-benefit analysis
- Use State damage incidence data
- Compare effects on States within the study with those States
not participating
- Conduct a public perception survey.
To promote recycling and source reduction:
- Assess innovative technologies
- Coordinate with EPA's waste minimization program.
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LABORATORIES GROUP, November 16
The group that discussed the laboratories model expressed general
concern that EPA use available survey data to estimate waste quantities
and it offered more specific concerns about the models as well
General Concerns
The group recommended that EPA use results of the New Jersey State
survey and the Region 2 survey, instead of a more limited number of
facility interviews, to model facilities in the United States The
participants added that New Jersey data should be generally
representative of U.S. facilities, thereby making it possible to
extrapolate the data to the entire country. Some types of facilities may
not be fully represented in the State, however, such as biotech firms
Care should be taken in using the information from such facilities The
group also stressed that coordination of EPA and State surveys is needed
to prevent duplication of effort and ensure full use of data.
Regarding the economic impact of the regulation, the group suggested
that a cost-benefit analysis of regulatory impacts is needed, and
benefits and proposed additional burdens and practices must be shown.
Specific Issues
The group offered the following suggestions for modeling
ira + mrl ae °
laboratories:
The SIC code counts for manufacturing facilities may include
double counts for laboratories. The SIC codes for laboratories
should include laboratories within manufacturing facilities.
Free-standing laboratories are counted in the SIC code count for
medical laboratories. Internal laboratories (e.g., hospital
laboratories) are not, or there would be about 13,000 laboratories
listed since most hospitals have such facilities.
In defining wastes and facilities (e.g., laboratories) to consider
for the rule and report to Congress, reference should be made to
the statutory definition on page 9 of the Act.
o The cytotoxic category should be deleted from the waste types
discussed in the generator model papers.
Referring to the discussion of containers, apparatus, and waste
water disposal on page 4 of the lab paper, equipment is
decontaminated after particularly pathogenic procedures.
The quantity of blood, in addition to tissue, should be referenced
as a constant for specific types of analyses (page 4).
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Six or seven primate centers exist in the United States and should
be researched for their laboratory waste generation and handling.
FDA's assurance program reviews the procedures of blood banks.
Funeral homes should not be included as facilities generating
waste by definition of Section 3 - Definition of the Act.
Plasma donor centers and renal dialysis centers should be
considered.
The group raised the following questions in their discussion of the
laboratory model:
Are Federal facility laboratories included in non-commercial SIC
code counts?
Who is responsible when a laboratory goes out of business?
Finally, the group recommended that EPA use the following data
sources: 6
National Pollution Discharge Elimination System permit information
is available concerning laboratory facilities.
Data sources include the American Society of Microbiology (Bill
Rutala), American Society of Clinical Pathologists, College of
American Pathologists, HCFA, State licensing and registration
boards, and FDA licensing board (FDA regulates all blood and
biologicals shipped interstate).
NIH has a list of grant recipients it will forward to EPA.
The Department of Agriculture is developing standards for the
environmental release of genetically engineered organisms.
Additional Comments
The issue of Special Medical waste was discussed. The group
recommended it be left as a category.
The group felt that various treatments that render wastes
noninfectious or decontaminated and unrecognizable should be
considered.
The group thought "decontaminated" should be used when discussing
infectiousness.
The group expressed a need to consider regulation, implementation
and enforcement needs and considerations in tracking Special
Medical waste.
D-8
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The group recommended that standard operating procedures for
rendering wastes "decontaminated" be considered. These procedures
are often used by JCAHO and State boards, among other orglniz?
tions The practicability and enforcement aspects of using these
procedures should be evaluated. These procedures include
. oceures ncude mc
inactivation which destroys microbes on surfaces and in fluids
steam .sterilization, which destroys microbes and may change the'
appearance of plastic flasks and pipets; incineration? which
macMLr^ desruction ex«Pc ^r metals; and grinding
machines, which render waste unrecognizable (after disinfection).
providehehlhff° C°ngre"' the 8rouP recommended that ATSDR
provide the health effects portion of the medical waste analysis.
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