Proceedings of Meeting on

             • Segregation
             • Packaging
             • Labeling
             • Manifesting
         November 14-16, 1988
         Annapolis, Maryland
     United States Environmental Protection Agency

          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





    Definitions, November 14 	   4

    Segregation, Packaging, and Labeling, November 15  	  11

    Tracking and Recordkeeping, November 15  	  15

    Information Needs, November 16 	  21


    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


    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.

Summary of Key Issues

                             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:
         -  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

    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.

                     MEETING PROCESS

   • Introduce the Topic
   • Provide Legislative Context
   • Explain EPA's Approach
   • Give the Small Groups Their Assignments


   • Discuss the Topic
   • Provide EPA with Comments and Suggestions on Their Approach
   • Identify Unresolved Issues
   • Identify Issues That Need More Attention

   • 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

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
    •  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

       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
    •  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.

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.

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).


    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.

    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

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

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

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

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

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,


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

    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

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.


    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.


    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

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.


    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

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.


    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.

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

•  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.

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

    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.

MI n
ID a
rt i*
H« o
O f»
3 M
pi rr
O rt
3 n
n pi
H. n

s s

• £
ft 3
t— M
< rt
"> r-
O M-
fl O
a H-
(U rt

           The Proposed Medical Waste Tracking Form
SIME INFOMAIKM) BLOCK (Name. Address. Contacts. Phone Numbers, etc.)
MEDICAL W A S 1 E SUIE Tracking Fora Ho. (If applicable)

1. Generator's Name and lulling Address
I. Generator's Phone ( 1
5. Transporter's Nam* end Itolllng Address
8. DM (grated facility IMC end Address
• 11. US EPA WMie Description cunte Type
end Quantity Information)
I a. Sharps
1 b. Fluids
0 	 _.
c. Other Potent lei ly Infectious
R Medical Waste
d. Spec nl Medical
e. Other Medical
Waste (e.g., equipment)

2. tracking Docuamt Ho.
4. Generator Panait Mo .
6. telephone ( )
7. transporter Feral t Ho.
9. Telephone ( )
10. Facility Peralt Ho.
12. Total No.

15. total

U. Special Handling Instructions and Additional InfonaMion

0" "KRAIOR CERIIFICAIKM: I declare the contents of this consignment
e fully and accurately described above and are classified, packed
rted. and labeled, and are in accordance mth all applicable State
J Federal laws and regulations.
inted/fvned Mane Sionature nmtm

(See reverse side for additional Information)
•*w« « VIMVML rMi.ii.iii u*>i • axiMiaxD IT DISPOSAL FACILITY
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


Prlnted/Tvped Name Signature Date

ttate Penal t Na. Tracking Fona No.

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




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.

    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

    •  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

       language of the Act that may require the manifesting of General

    •  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.

    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.


    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

    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
    •  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.

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.

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.


    •  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.

   Appendix A
Meeting Agenda

                            EPA MEDICAL WASTE MEETIHG

                             Governor  Calvert House
                               Annapolis,  Maryland

                              November 14-16, 1988

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

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

     Appendix B
List of Participants

                            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
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

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
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
Joint Commission on Accreditation
  of Healthcare Organizations
875 N. Michigan Avenue
Chicago, IL  60611
(312) 642-6061

Ms. Lisa Haley
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

 Mr.  William A.  Howard
 Connecticut Department of Environmental
 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
 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
 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

 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
 1730  Rhode Island Avenue,  NW
 Suite 1000
 Washington,  DC  20036
 (202) 659-4613

 Mr. Howard Raether
 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

 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
 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
 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

Mr. Peter Wise
Manager, Environmental Programs
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

       Appendix C
   Summary of Small
Working Group Sessions
  November 14 and 15, 1988

                         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

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

                         GROUP  1. November 14 and 15


     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

     •  "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.

     •  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

     •   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.


     •   Alternative disposal  technologies werq discussed for the
        destruction of sharps,  including the use of ovens and  "destructive

     •   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."

        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.
        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

        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:
          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."
       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."

        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.
       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.

     •  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 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.

     •   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.


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.

                         GROUP 2, November 14 and 15


     Group 2 was assigned four waste types for discussion:   pathological
 waste,  discarded medical equipment and parts, used sharps,  and unused

     The  group selected Laboratory Wastes as one of two possible additional
 categories.   The members did not have time,  however,  to address this

 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

     •  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

    •  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

    • Fixation,  thermal processing,  and autoclaving are  viable treatment
      methods  for decontamination,  but these methods  alone  make
      enforcement difficult.


     •  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

 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

     •   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

    •  Delete any reference to specific equipment types, such  as
       hemostats, forceps,  and needle holders;  instead,  list "disposable
       components of medical equipment, including IV tubing."

     •  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."

 Additional Comments



 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

 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.


  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


Specific Issues

    •  The outer label should identify the category of waste in the

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.

 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

     •   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

    •  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

    •   Acknowledge transfer facilities  as a group subject to  the

                         GROUP 3,  November 14 and 15


     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

         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

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

 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

   •  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.


    •  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?

    •  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

       -  Residues left in emptied containers may be sharps (glass).

          Safe containment of fluids sometimes involves not emptying

    •  What quantity of liquids defines a "liquid"?

    •  Could sharps and liquids be combined and placed in rigid

    •  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).

       How should Che integrity of sharps be destroyed;  through
       grinding, incineration and/or other means?
       Additional identification of "red" bags is needed.   Also,  it
       would be useful if bags would change appearance (color) after

       Will the new requirements be a dramatic change from current
       packaging requirements?  Sharps are now often put in cardboard

       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.
    •  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.


     •  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?


 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

    •  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.

     •  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

     •  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

     •  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

     •   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.

•  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.

                       GROUP 4, November 14 and 15
     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

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.

 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

     •   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

Laboratory Wastes

Objectives for Discussion

    •  Define "contact with infectious agents."

    •  Define "laboratories."

    •  Track all laboratory waste?

 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

     •  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."


      •   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

     •  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.

 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

     •   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.


 Specific Recommendations

     •  Limit the categories for segregation to:

        -  Fluids
        -  Other Infectious Waste.

     •  State clearly that these requirements apply only to wastes
        intended for offsite transport.

     •  Definition of fluid—the 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

        -   Bulk  liquids  would certainly  be  included but those
           discharged  to sewers would  not be included in the

        -   Saturated materials from which liquids can drain under
           normal waste  management conditions should  be  included,
           though no consensus could be  reached concerning a


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).

         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

     •  Label the outer layer of packaging only.

     •  Use the universal biohazard symbol on the outer layer of

     •  The panel's previous recommendation to eliminate the Special
        Medical waste category would eliminate the need for separate


     •  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.


    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.


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.

 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

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)?

       Appendix D
   Summary of Small
Working Group Sessions
     November 16, 1988

                        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.

                   PHYSICIANS'  OFFICES  GROUP,  November 16


     •  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

     •  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

     •   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?


    •  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.

 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.

                         HOSPITAL GROUP, November 16


 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

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

       -  Allowing treatment  alternatives  to  render  waste  "General

       -  Providing for  consumer exemptions.


     •   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).


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

    •  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

    •  Consider conducting a hospital  survey to  estimate  waste generation
       rates for wastes decontaminated and rendered non-recognizable or

    •  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

   •  Follow trends  in costs of offsite disposal.

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

       -   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

       -   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.

                       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 •                                               °
    •  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).

     •  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

     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

    •  The group thought "decontaminated" should be used when discussing

    •  The group expressed a need  to consider regulation,  implementation
       and enforcement needs  and considerations  in tracking  Special
       Medical waste.

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.