&EPA
United States
Environmental Protection
Agency
EPA/530-SW-89-020
May 1989
Office of Solid Waste
Tracking
Medical Wastes
Printed on recycled paper.
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The summer of 1988 will be remembered for the closing of East
Coast beaches after the discovery of medical wastes along the
shore. In other places, syringes and needles have been discovered in
and around dumpsters, gutters, and other public areas. Such alarm-
ing incidents are a reminder that medical wastes have too often
been mismanaged. The public has expressed concern over the aes-
thetic blight and the potential threat these wastes pose to their
health and the environment In response to public concerns, the
Environmental Protection Agency (EPA) and many states are de-
veloping programs to control the disposal of medical wastes.
The regulation is designed
vent packages from being i
during shipping and handli
preventing accidental cont<
workers or the public. Then
rigid outer container, or sec
packaging, is generally req
ing shipping. Specific stanc
apply to regulated wastes t
stored during preparation f
ping and disposal.
Congress Acts
In the fall of 1988, Congress
passed The Medical Waste Tracking
Act. The law calls for a two-year
demonstration tracking program for
medical wastes. The program is to
serve as a first step in controlling
the irresponsible disposal of medical
wastes. In enacting the law, Con-
gress recognized that medical wastes
require special handling and disposal
and that experience gained from a
pilot program would serve as a
guide to their proper management.
Moreover, Congress anticipated that
a regionwide demonstration pro-
gram would provide a realistic test
for determining the need for a na-
tional program to track medical
wastes.
The Medical Waste Tracking Act
amends the Resource Conserva-
tion and Recovery Act (RCRA)
by adding Subtitle J. It defines
medical waste as "... any solid
waste which is generated in the
diagnosis, treatment, or immu-
nization of human beings or ani-
mals, in research pertaining
thereto, or in the production or
testing of biologicals. ..."
The Medical Waste Tracking Act re-
quires EPA to establish a two-year
demonstration program in New
York, New Jersey, Connecticut, and
the states bordering the Great Lakes.
The program is to provide genera-
tors of medical wastes with a uni-
form method of tracking these
wastes to help ensure that the
wastes are disposed of properly.
EPA is also directed to set standards
for safely separating, packaging, and
labeling these wastes before they
are shipped to authorized treatment
or disposal facilities.
Under the legislation, the States of
New York, New Jersey, and Con-
necticut could choose to either
participate in the demonstration
program or implement their own no-
less-stringent medical waste tracking
programs. The Great Lakes States
could choose not to participate at
all. Any other state wishing to par-
ticipate could petition EPA to do so.
A state governor could elect to par-
ticipate or not, but had to notify EPA
within 30 days after EPA set up the
demonstration program.
Tracking Medical Wast
When a generator finishe
ing a package of medical w
bound for treatment or disp
another site, the generator
tracking form. Only transpo
who have registered with E
carry these wastes from the
tor to the disposer. In the ca
generator of small quantitie
medical wastes, a log show:
carrying the wastes and wh
wastes are going, and a tra(
form is initiated by the tranj
More Information
For a copy of the "Standa
the Tracking and Managers
Medical Waste" interim fina
and for up-to-date informath
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EPA Sets Up A Demonstration Program
EPA is required, as part of the law,
to publish a regulation establishing
the medical waste demonstration
program by May 1989. EPA issued
the rule in March 1989 to give states
enough time to ensure that a dem-
onstration program would be in
place by summer. New York, New
Jersey, and Connecticut have been
joined by Rhode Island and Puerto
Rico as participants in the two-year
federal demonstration program.
In developing the regulation, EPA
worked cooperatively with a variety
of interested parties such as affected
states, other federal agencies, the
health care community, the waste
management industry, and environ-
mental groups. EPA considered the
concerns of these groups as it de-
veloped the regulation.
In addition, EPA created an in-house
task force to guide activities related
to medical waste management. To
help ensure the safe disposal of
these wastes, EPA will continue to
work with states, Congress, industry
and environmental groups, and the
medical community, including physi-
cians, hospitals, nursing and funeral
homes, and veterinarians. Other
communication with the public is
being planned as well.
The regulation establishing the pilot
program is an interim final rule,
which takes effect in early summer
of 1989. EPA will consider public
comments that were received dur-
ing the public comment period, as
well as lessons learned from actual
program operations, as the Agency
refines the medical waste tracking
program.
What This Demonstration Program Will Accomplish
For the first time, certain medical
wastes will be regulated by federal
law and tracked in a special way—
not as hazardous waste or general
trash. The program is an important
step in preventing public exposure
to medical wastes. It will assure that
regulated medical wastes are prop-
erly packaged and separated from
general refuse to protect workers,
the public, and the environment
from possible risk. Since many of
these wastes no longer will be
thrown into the trash, EPA expects
that less medical waste will wash up
on beaches and float on waterways.
The new program will also set up a
tracking system to identify and in-
crease the accountability of those
who generate, transport, and dis-
pose of these wastes.
EPA, in cooperation with participat-
ing states, will review and evaluate
the demonstration program. As re-
quired by the law, the Agency will
report to Congress on program ac-
complishments, limitations, and any
problems that occur during the two
years. In this way, everyone can
learn what works and what does
not work to control this difficult
problem.
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What The Program Does Not Address
The demonstration program will
control institutional and commercial
sources of medical waste in the par-
ticipating states. But some sources,
such as diabetics in private house-
holds, cannot be controlled by this
program. However, these and other
individuals can take responsibility
for protecting their families and
neighbors by safely disposing of
their used needles and other med-
ical wastes. For example, sharp im-
plements can be put into boxes
especially designed for the disposal
of sharps or sealed in a rigid con-
tainer, such as a coffee can. Other
medical wastes can be securely tied
in a heavy plastic bag. The wastes
can then be taken to a medical facil-
ity for disposal. If this is not possi-
ble, the wastes can be placed in a
garbage can with a tightly fitting lid.
Nurses and other home health care
professionals can also handle home
wastes in this way and inform their
patients about these safe methods
for disposing of medical wastes. EPA
will soon provide more specific
guidance on proper home medical
waste disposal.
Also not addressed by the law are
people who litter or who use illegal
drugs. Medical wastes carelessly
tossed into streets or open trash
cans can land in city storm sewers
and eventually find their way to
rivers and streams. Drug enforce-
ment and Clean Water Act programs
usually address such problems. Cit-
izen cleanup and litter control proj-
ects also work to eliminate the
flagrant dumping of waste.
Wastes Covered By The EPA Rule
The EPA rule concerns only regu-
lated medical wastes generated in
participating states. Specifically, the
following medical wastes—and
other wastes that have been mixed
with them—are regulated:
• Cultures and stocks of infectious agents
• Pathological wastes
• Human blood and blood products
• Sharp implements—used and unused
• Contaminated animal waste
• Isolation waste from patients with
highly communicable diseases
Pre-transporting Requirements
Before medical wastes leave the
site where they are produced, gener-
ators must take certain precautions
to protect workers, handlers, and the
public from exposure to these mate-
rials. First, generators must separate
them from general trash. Then, to
ensure that wastes are packed se-
curely and will not leak, the regula-
tion specifies that medical wastes
are to be packaged in rigid, leak-
resistant containers. Sharps, such as
needles and scalpels with their re-
sidual fluids, are separated from
other medical wastes and packed in
puncture-resistant containers.
Uncontained fluids are poured into
tightly-stoppered and break-
resistant containers. Other medical
wastes may be placed together in a
package that is rigid and resistant to
leaks.
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The regulation is designed to pre-
vent packages from being damaged
during shipping and handling, thus
preventing accidental contact with
workers or the public. Therefore, a
rigid outer container, or secondary
packaging, is generally required dur-
ing shipping. Specific standards also
apply to regulated wastes that are
stored during preparation for ship-
ping and disposal.
When secondary packages, such as
bins, buckets, and boxes, are re-
used, they must be cleaned thor-
oughly. Primary packages—inner
containers—are not reusable and
are handled as medical wastes.
Finally, generators must label and
mark packages clearly, identifying
the content, the generator, and the
transporter. As these wastes move
through the disposal process, they
are carefully tracked.
Tracking Medical Wastes
When a generator finishes prepar-
ing a package of medical wastes
bound for treatment or disposal at
another site, the generator fills out a
tracking form. Only transporters
who have registered with EPA may
carry these wastes from the genera-
tor to the disposer. In the case of a
generator of small quantities of
medical wastes, a log shows who is
carrying the wastes and where the
wastes are going, and a tracking
form is initiated by the transporter.
As the wastes travel to their final
disposal, the tracking form goes
with them. Each transporter and
owner or operator of a treatment or
disposal facility signs and keeps one
copy of the tracking form. The gen-
erator receives the final copy, indi-
cating that the wastes were received
at an authorized disposal facility.
The operations at the facility may be
controlled by other federal, state,
and local laws and regulations.
More Information
For a copy of the "Standards for
the Tracking and Management of
Medical Waste" interim final rule
and for up-to-date information con-
cerning states' participation and
contacts, call the RCRA Hotline at
(800) 424-9346 or 382-3000 in
Washington, D.C.
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Office of Solid Waste
United States
Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460
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