vvEPA
United States
Environmental Protection
Agency
Solid Waste and
Emergency Response
(OS-305)
EPA/530-SW-89-023
September 1989
Managing and Tracking
Medical Wastes
A Guide to the Federal Program
for Treatment, Destruction, and
Disposal Facilities
Printed on recycled paper.
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Introduction
In response to the growing public concern over mismanagement of medical wastes,
Congress enacted trie Medical Waste Tracking Act.
The Act charges the Environmental Protection Agency with responsibility for
implementing a two-year demonstration medical waste tracking program that will help
determine the best medical waste management procedures for the future. The
program's goal is to find an effective means to ensure that regulated medical wastes get
from their point of generation to their point of disposal.
Generators of regulated medical wastes will be part of the new demonstration tracking
program in the States of Connecticut, New Jersey, New York, and Rhode Island, and
the Commonwealth of Puerto Rico. Transporters and facilities that store, treat, destroy,
and dispose of these wastes will also be part of the program.
This guide offers general information about the tracking program (Section 1) and
specific instructions for facilities that treat, destroy, or dispose of regulated medical
waste (Section 2). Section 2 includes requirements for facilities that dispose of these
wastes—destination facilities—and slightly different requirements for facilities that
treat or destroy wastes—intermediate handlers. Separate guides in this series are
provided for generators and transporters of regulated medical wastes.
This guide describes the federal program only. It is designed to help facilities that treat,
destroy, or dispose of wastes generated in participating states comply with the
program. For more complete information, facility owners and operators should refer to
"Standards for the Tracking and Management of Medical Waste," interim final rule (40
CFR Part 259). In addition, states participating in the program have their own rules for
managing medical waste. For further assistance, addresses and phone numbers of EPA
Regional Offices are listed in Appendix A.
For additional copies of Managing and Tracking Medical Wastes or a copy of 40 CFR Part
259, call the RCRA Hotline at (800) 424-9346 or, in Washington, D.C., 382-3000.
i
The cooperation of all participants in the management of regulated medical wa^te will
assure the success of this important demonstration program and reduce public
exposure to the waste.
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Contents
SECTION 1: The Medical Waste Tracking Program
Waste Managers Participation
Regulated Medical Waste
Pre-Transporting Procedures
Tracking Regulated Medical Wastes
The Waste Management System
Generators
Transporters
Treatment, Destruction, and Disposal Facilities
SECTION 2: A Detailed Guide for Regulated Medical Waste Treatment,
Destruction, and Disposal Facilities
Profile of a Destination Facility or Final Disposer
Profile of an Intermediate Handler
Facilities Subject to All Requirements
Exceptions to the Full Tracking Program
Tracking Medical Wastes
Intermediate Handler Special Rules
Tracking Form Discrepancies id
Keeping Records id
Other Reports id
Medical Waste Facility Checklist 1 j
Glossary
List of Figures
Figure 1 Tracking Form
Figure 2 Medical Waste Tracking System
Figure 3 Tracking for Destination Facility
Figure 4 Tracking for Intermediate Handler
Figure 5 Receiving Wastes by Rail 1(1
Appendix EPA Regional Offices 14
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Section T:
The Medical Waste Tracking Program
In response to public concern over the mismanagement of medical wastes, the Medical
Waste Tracking Act was enacted in the fall of 1988. The law directs the Environmental
Protection Agency (EPA) to establish a two-year demonstration program for tracking
medical wastes.
Under this law, EPA has issued regulations entitled "Standards for the Tracking and
Management of Medical Waste" (40 CFR Part 259). The regulations list the medical
wastes to be tracked and cover standards for separating, packaging, and labeling
medical wastes before sending them for treatment or disposal. The results of the
demonstration program are intended to help determine whether such a program
should be extended nationwide.
Waste Managers
Participation
The Medical Waste Tracking Act amends the Resource Conservation and Recovery Act
(RCRA) by adding Subtitle J. It defines medical waste as "... any solid waste which
is generated in the diagnosis, treatment, or immunization of human beings or animals,
in research pertaining thereto, or in the production or testing of biologicals. ..."
Participating in the demonstration program are the States of Connecticut, New Jersey,
New York, and Rhode Island, and the Commonwealth of Puerto Rico. The regulation
is an interim final rule. It will be in effect for two years, until June 22, 1991. In
Connecticut, New Jersey, and New York, the program is effective beginning June 22,
1989; in Rhode Island and the Commonwealth of Puerto Rico, the program is effective
beginning July 24,1989.
The demonstration program involves only regulated medical wastes generated in one
of the states participating in the program, even when these wastes leave the state. The
program sets' up a system for tracking the waste from the generator to the disposal site.
A tracking form that accompanies this waste is signed and a copy is retained by a
representative of the waste generator and each transporter, transfer station, and
treatment, destruction, and disposal facility handling it. When the final disposer—the
destination facility—accepts the waste, a copy of the signed tracking form is returned
to the generator. In this way the generator is assured that the waste was received for
disposal. The tracking system includes "exception" and "discrepancy" reporting to
alert EPA and the states if wastes are not being handled properly.
To minimize contact with regulated medical wastes by workers, handlers, and the
public, the program includes specific requirements for segregating, packaging,
labeling, marking, and storing medical wastes before they are shipped to another site
for treatment, destruction, or disposal. Other requirements include recordkeeping,
reporting, and enforcement. EPA will evaluate the success of the program and report
the results to Congress.
This booklet is intended to help facilities that treat, destroy, or dispose of regulated
medical wastes generated in the participating states comply with the federal rules.
Facilities in these states must also follow rules required by the individual states.
Owners and operators of facilities should check with their state officials for clarification
of state rules. While participating states use the same basic tracking form as EPA's,
some states might regulate more wastes or require special permits or licenses.
Participating states are authorized to enforce this program.
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Regulated Medical
Wastes
Pre-transporting
Procedures
Tracking Regulated
Medical Wastes
The demonstration program includes medical waste generators in participating states; I
transporters of those wastes; and owners and operators of treatment, destruction, and I
disposal facilities that manage waste generated in participating states, even if their I
facilities are located in nonparticipating states. Similarly, the program includes!
transporters carrying regulated medical wastes from participating states, even if the I
wastes are then taken to nonparticipating states. The program includes vessels and I
transporters that take medical wastes to shore from ships docked in participating!
states. Federal facilities generating regulated medical wastes in participating states are!
also covered under this program.
Medical wastes affected by the pilot program include
• cultures and stocks of infectious agents.
• human blood and blood products.
• human pathological wastes, including those from surgery and autopsy.
• contaminated animal carcasses from medical research.
• wastes from patients isolated with highly communicable diseases.
• all used sharp implements, such as needles and scalpels, and certain
unused sharps.
These regulated medical wastes fall into two categories: untreated or treated. The!
Glossary provides detailed descriptions of these medical wastes.
The demonstration program focuses on wastes that historically have been improperly!
managed and are most likely to pose a substantial threat to human health and the!
environment. However, any additional waste that a health care professional believes]
may pose a risk should be handled as a regulated medical waste.
Mixtures of regulated medical waste and general trash are regulated as medical waste.]
Mixtures of regulated medical waste and hazardous waste are usually regulated as I
hazardous waste. However, if medical waste is mixed with hazardous waste, which!
falls under the small quantity hazardous waste exemption, then the waste mixture [
must be tracked as medical waste under this program.
Regulated medical wastes that are to be transported to an off-site facility for treatment!
or disposal must be properly prepared for shipping. First, the wastes must be I
separated from general trash, and then sharp items, fluids, and other medical wastes!
must be separated from each other. They are then packaged to prevent tearing, J
breaking, or leaking during shipping and handling.
Packages are to be labeled and marked to identify the contents of the package and!
generator and transporter of the waste. In addition, stored wastes must be maintained I
to prevent them from coming into contact with workers or the public.
At the core of the medical waste demonstration tracking system is a MEDICAL WASTE I
TRACKING FORM (see Figure 1). This form must accompany each off-site shipment!
that weighs 50 pounds or more. Shipments from generators of less than 50 pounds a!
month may be combined onto one tracking form by the transporter. Generators,!
transporters, and treatment, destruction, and disposal facilities are responsible for!
filling in, forwarding, and retaining a copy of this form for their records. Figure 2J
illustrates how the medical waste tracking system works.
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MEDICAL WASTE TRACKING FORM
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1. Generator's Name and Mailing Address
3. Telephone Number ( )
5. Transporter's Name and Mailing Address
EPA Med. Waste ID No.
I I I I I I I I I I I I I
8. Destination Facility Name and Address
2. Tracking Form Number
4. State Permit or ID No.
6. Telephone Number
7. State Transporter Permit or ID No.
9. Telephone Number
10. State Permit or ID No.
1 1 . US EPA Waste Description 1 2. Total No.
Containers
a. Regulated Medical Waste (Untreated)
b. Regulated Medical Waste (Treated)
c. State Regulated Medical Waste
14. Special Handling Instructions and Additional Information
13. Total Weight
or Volume
15. Generator's Certification:
Under penalty of criminal and civil prosecution for the making or submission of false statements, representations, or
nnijepionp, i Oeolarp, on o»hai' of th" generator
that the contents of this consignment are fully and accurately described above and are classified, packaged, marked, and
labeled in accordance with all applicable State and Federal laws and regulations, and that 1 have been authorized, in writing,
to make such declarations by the person in charge of the generator's operation.
Printed/Typed Name Signature
Date
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INSTRUCTIONS FOR COMPLETING MEDICAL WASTE TRACKING FORM
Copy 1 — GENERATOR COPY: Mailed by Destination Facility to Generator
Copy 2 — DESTINATION FACILITY COPY: Retained by Destination Facility
Copy 3 — TRANSPORTER COPY: Retained by Transporter
Copy 4 — GENERATOR COPY: Retained by Generator
As required under 40 CFR Part 259:
1 . This multicopy (4-page) shipping document must accompany each shipment of regulated medical
waste generated in a Covered State.
2. Items numbered 1-14 must be completed before the generator can sign the certification. Items 4, 7,
10, 1 1c, & 19 are optional unless required by the State. Item 22 must be completed by the
destination facility.
For assistance in completing this form, contact your nearest State office or Regional EPA office, or
call (800) 424-9346.
16. Transporter 1 (Certification of Receipt of Medical Waste as described in items 11, 12, & 13)
Printed/Typed Name • Signature
17. Transporter 2 or Intermediate Handler
(name and address)
EPA Med. Waste ID No.
I I I I I I I I I I I I I
Date
18. Telephone Number
1 9. State Transporter
Permit or ID No.
20. Transporter 2 or Intermediate Handler (Certification of Receipt of Medical Waste as
described in items 11, 12, & 13)
Printed/Typed Name Signature
Date
21 . New Tracking Form Number (for consolidated or remanifested waste)
22. Destination Facility (Certification of Receipt of Medical Waste as described in items 1 1 , 12, & 13)
fj Received in accordance with items 1 1 , 1 2, & 1 3
Printedfiyped Name Signature Date
(II other than destination facility, indicate address, phone, and permit or ID no. in box 14.)
23. Discrepancy Box (Any discrepancies should be noted by item number and initials)
FIGURE 1. Medical waste tracking form.
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FIGURE 2. Medical waste tracking system. All medical waste shipments required to be
accompanied by a tracking form are tracked from generator to final disposal, or
destination facility.
GENERATOR
TRANSPORTER/TRANSFER
FACILITY
DESTINATION FACILITY
A generator of more than 50 Ibs. per month who ships off
site or a generator of less than 50 Ibs. per month who ships
more than 50 Ibs. in a shipment.
Generator initiates Tracking Form, completes Generator
information section, signs Generator's certification.
Transporter verifies accuracy of Generator information,
signs Tracking Form, gives Generator signed copy, and
retains all other copies.
I
OR
Transporter may consolidate loads and initiate a
new Tracking Form.*
Destination (final disposal) facility accepts waste, signs
Tracking Form, gives one copy to the Transporter, keeps
copy for its own records, and returns a completed copy to
the initiator (party that fills in Generator block) of the Form.
*Initiators of Tracking Forms become Generators in effect under this Tracking System.
The Waste Management
System
There are special requirements for generators, transporters, and facilities to help
ensure that regulated wastes are handled safely and received by the appropriate
destination facility.
Generators
A person or institution located in a participating state, generating 50 pounds or more of
regulated medical waste monthly and shipping it off site, is fully covered by the
demonstration program. These generators must separate, package, label, mark, and
track medical wastes according to the regulation.
Generators producing and shipping less than 50 pounds a month must also prepare
their wastes properly for shipment. They may use a log to account for wastes, however,
instead of a tracking form.
On the other hand, generators that dispose of waste on site or in the sewer system are
not covered by the requirements of this program. Generators that treat and destroy
waste on site, such as by incineration, are subject to certain reporting and
recordkeeping requirements. Wastes that are treated and destroyed or disposed of on
site or into sewers are not counted toward the 50 pound monthly limit. All medical
wastes—even those treated, destroyed, 'and disposed on site—must be stored
properly.
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Transporters
Transporters must notify EPA of their intention to comply with the program to be
allowed to accept regulated medical wastes for transport. EPA maintains a list of
transporters who have notified EPA of their intent to transport regulated medical
wastes generated in each participating state. This list is available to generators.
Transporters must follow rules governing their vehicles and addressing tracking,
recordkeeping, and reporting of waste shipments. They must also make sure that
wastes they pick up have been properly prepared for shipping and that the tracking
form is accurate.
Treatment, Destruction, and Disposal Facilities
The demonstration tracking program rules apply to owners and operators of
treatment, destruction, and disposal facilities receiving regulated medical wastes.
These facilities include incinerators, landfills, and treatment operations that grind,
steam sterilize, or treat wastes with disinfectants, heat, or radiation.
Like generators and transporters, treatment, destruction, and disposal facilities must
keep track of medical wastes and maintain records. Facilities must send a signed copy
of the tracking form back to the generator or initiator of the tracking form when the
wastes have been accepted for disposal: The facility owners or operators must
investigate any discrepancies between the accompanying papers and the shipments
they receive; if, after investigation, there is still a discrepancy, they must report it to
EPA and the generator state agency.
Generatoi packaging
medical waste
Steam sterilizing,
or autoclaving,
before disposal
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Section 2:
A Detailed Guide for Regulated Medical Waste
Treatment, Destruction, and Disposal Facilities
This section includes instructions for facilities that treat, destroy, or dispose of
regulated medical wastes to help them comply with federal regulations. It outlines
separate requirements for "destination" facilities and "intermediate handlers."]
Checklists are included.
This program does not address the actual treatment, destruction, or disposal!
processes for the waste; these processes may be covered by state or local laws and
regulations.
Profile of a Destination
Facility, or Final Disposer
Profile of an
Intermediate Handler
Facilities Subject to All
Requirements
Exceptions to the Full
Tracking Program
Destination facilities treat and destroy or dispose of regulated medical wastes. These
facilities include landfills, incinerators, and operations that treat and destroy wastes
using techniques such as steam sterilizing combined with grinding. Facilities that
treat and destroy or landfill regulated medical wastes are end points for the tracking
system. Moreover, a facility that accepts treated waste by a process such as steam
sterilization and then destroys it by grinding or shredding is also a destination facility,
thus an end point for tracking. Under this program, tracking is not required after the |
waste has been both treated and destroyed or received at a landfill or incinerator.
Facilities that treat but do not destroy medical wastes or destroy but do not treat them
are not end points for regulated medical wastes. They are referred to as intermediate
handlers. Intermediate handlers include facilities that just shred or grind untreated]
wastes or that just steam sterilize medical wastes that are not yet destroyed.
Fully covered by the tracking program are facilities—final destination and
intermediate handlers—accepting regulated medical waste generated in a
participating state and required to be accompanied by a tracking form. (Each shipment I
of 50 pounds or more must have a tracking form.) Facilities located in nonparticipating 1
states accepting waste from a participating state are also regulated under the program.
As explained in the following pages, covered facilities must inspect packages, noting
any discrepancies between the tracking form and the shipment received; sign and
return tracking forms; file discrepancy reports, as necessary; and keep records.
Generally, transporters consolidate smaller shipments and prepare tracking forms to
accompany them. However, in some cases facilities may accept shipments of less than
50 pounds not accompanied by a tracking form from small generators producing 50 j
pounds or less in a month. These shipments may be recorded in a log if
• the facility has a written agreement with the generator to accept the waste and
• the generator transports the waste in the generator's or an employee's vehicle.
For each small shipment accepted, the facility must keep records, such as a log, that]
include the
• date the waste was accepted.
• name and state permit or identification number of the generator that initiated the
shipment, or the generator's address if the state does not issue numbers.
• total weight of the waste.
• signature of the person accepting the waste.
Facilities may also accept sharps sent through the U.S. Postal Service registered mail, j
return receipt requested.
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Facilities incinerating regulated medical waste generated on site are not required to
track wastes under this program. There are special requirements for on-site
incinerators, however. These can be found in 40 CFR Part 259, Subpart G.
Steam autoclave
Incinerator
Landfill
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Tracking Medical Wastes
The tracking form ensures that each shipment of waste reaches its destination.
Therefore, it is crucial for a destination facility or an intermediate handler receiving a
shipment of waste to sign a copy of this form, give a copy to the transporter upon
accepting the waste, and follow the correct procedure for returning a copy to the
generator or initiator of the tracking form. Figure 3 shows the medical waste tracking I
process for destination facilities; Figure 4, foflhtermediate handlers. Facilities receiving j
wastes by rail should refer to Figure 5.
FIGURE 3. Tracking Process for Destination Facility.
Destination facility receives waste
accompanied by Tracking Form.
Destination facility inspects the packages in the
shipment to verify Tracking Form is properly filled
out, number of containers and descriptions are
correct, and outer packaging is in order.
Destination facility signs tracking form certifying
receipt and noting any discrepancies in Box 23.
Destination facility hands signed copy of the form
to the transporter.
Destination facility sends a copy of the original
back to the shipment initiator within
15 days of receipt.
Destination facility keeps copies of tracking form
received and discrepancy reports filed
for at least three years.
Discrepancies must be
resolved between
shipment initiator,
transporter, and
destination facility.
Any discrepancies not
resolved within 15 days
must be reported to
appropriate agencies.
Intermediate Handler Special Rules
When an intermediate handler accepts regulated medical waste with a tracking form,
the handler must first check the shipment, note any discrepancies, sign, and give a
signed copy of the form to the transporter. Since the intermediate handler does not
both treat and destroy or dispose of waste, the handler is required to continue tracking
the waste to a destination facility for final disposal.
After treating or destroying the waste, the intermediate handler must initiate a new
tracking form to indicate any changes in the number, weight, or contents of the
processed waste, and the handler must enter a new tracking form number in Box 21 of
the original form (see Figure 1) as a link between the new waste shipment and the one
received for processing. In addition, the handler must assume the role of a generator,
meeting all the pre-transporting and generator rules (refer to Managing and Tracking
Medical Wastes: A Guide to the Federal Program for Generators).
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Furthermore, the intermediate handler must maintain a log that further links the
information on the new tracking form with that on the original tracking form. The log
must include the
• name of generator.
• generator's state permit or identification number, or address if the state does not
issue a permit or identification number.
• date of the original shipment or generator's tracking form number.
• new tracking form number.
When the intermediate handler receives the signed and returned new tracking form
from the destination facility acknowledging receipt of the waste for disposal, the
handler attaches this new form to a copy of the original form and sends both to the
original generator. These forms are to be sent within 15 days to assure the original
generator that the waste was received at the destination facility and that no exception
reporting is needed. (The generator is required to file an exception report if the original
form is not returned within 45 days.)
FIGURE 4. Tracking Process for Intermediate Handler.
Intermediate handler receives regulated medical waste
accompanied by Tracking Form.
Intermediate handler inspects packages in shipment to verify
Tracking Form is properly filled out, number of containers
and descriptions are correct, and outer packaging is in order.
intermediate handler signs Tracking Form certifying receipt
and noting any discrepancies.
Intermediate handler hands transporter copy of signed
Tracking Form.
After treating or destroying waste, intermediate handler
issues new tracking form number and initiates shipment to
destination facility. Intermediate handler holds original
tracking form and maintains log linking shipments.
Intermediate handlers sends copies of both the new Tracking
Form and the original back to the shipment originator within
15 days of receipt of the signed copy of the new Tracking
Form from the destination facility.
Intermediate handler keeps copies of Tracking Forms,
Discrepancy Reports, and logs for at least three years.
Discrepancies must be
resolved between
generator, transporter,
and intermediate handler.
4
Any discrepancies not
resolved within 15 days
must be reported to
appropriate agencies.
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Figure 5. Receiving Medical Wastes by Rail
A destination facility or an intermediate handler may accept medical wastes shipped by
rail. These wastes are to be accompanied by a tracking form or, in some cases, by
shipping papers containing all information required on the tracking form, except
signatures. If no tracking form comes with the waste, the facility owner or operator
should expect to receive it by mail or other means from the last non-rail transporter. In
any case, the owner or operator upon receipt of the rail shipment
• checks the shipment and notes discrepancies, if any.
• signs and dates each copy of the tracking form or, if no tracking form has been
received, shipping papers.
• gives a copy of the signed tracking form, or shipping papers, immediately to the
rail transporter.
• sends (if a destination facility) a copy of the signed and dated form within 15 days
to the generator or the initiator of the tracking form. If the tracking form has not
been received within 15 days, the destination facility sends a signed and dated
copy of the shipping papers to the shipment initiator.
• holds (if an intermediate handler) a copy of the tracking form or shipping papers.
When the handler receives a signed new tracking form from the destination
facility indicating that the waste was received, the handler sends copies of both
the new and original tracking forms to the generator or initiator of the original
form (or shipping papers).
Keeping Records
Other Reports
Tracking Form Discrepancies
In some cases, a tracking form may indicate differences between what is received and
what is noted on the form or shipping papers. For example, the actual number of
containers or the categories of waste may not be consistent with the information on
the form, the packaging may be leaking, or the tracking form may be missing or
incomplete. If such significant discrepancies .occur, the owner or operator of a
destination facility or an intermediate handler must try to resolve the problem. If the
discrepancy cannot be resolved, it must be reported in writing within 15 days to the
EPA Regional Administrator for both the generator and the facility states, and to the
generator state agency. The letter is to describe the problem and any attempts to solve
it; a legible copy of the tracking form or shipping papers is to be attached. If a tracking
form is required to accompany the waste but is missing or incomplete, the report is to
specify the quantity of waste received and identify the generator and transporter.
Facility owners or operators receiving regulated medical waste are to maintain records
for three years after accepting the waste. The following information must be on file:
• copies of all tracking and shipping forms and logs.
• name and state identification or permit number of each generator that
delivered waste directly to the facility, or the generator's address if the
state does not issue numbers; the total weight accepted; and the date
the waste was accepted.
• copies of all discrepancy reports.
Owners and operators may be required to provide reports to EPA concerning how
much medical waste was received and what treatment and disposal methods were
applied.
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Medical Waste Facility Checklist
If you represent a facility receiving medical waste regulated under this program, the
following list is designed to help you comply with the program requirements.
Facility (owner or operator) is located in a participating or
nonparticipating state and receives regulated medical waste generated
in a participating state. (If yes, continue.)
Facility accepts shipment of 50 pounds or less of sharps through U.S.
Postal Service. (If yes, sign mail receipt.)
Facility accepts shipments of 50 pounds or less from generator that has a
contract and delivers waste in generator vehicle. (If yes, maintain facility
log for three years.)
Facility accepts regulated medical waste accompanied by a tracking form
or shipping papers. (If yes, continue.)
Facility owner or operator examines tracking form to see that it is filled
out and signed by both the generator (Box 15) and transporter (Box 16),
and if applicable, the intermediate handler (Box 20). (Continue.)
Facility owner or operator examines the shipment and notes any
discrepancies (Box 23) between the tracking form and the shipment,
such as piece count. (Continue.)
Facility owner or operator signs tracking form or shipping papers.
Facility owner/operator hands copy to transporter.
Discrepancies are investigated and, if not resolved within 15 days, letter
sent to EPA Regional Administrator(s) for generator and facility state(s),
and generator state agencies.
If Facility is a Destination Facility
Destination facility sends copy of tracking form or shipping papers back
to tracking form initiator.
Copies of tracking forms, receipts, shipping papers, logs, and
discrepancy reports are retained in facility records for three years.
Or If Facility is an Intermediate Handler
Intermediate handler issues a new tracking form number in Box 21,
initiates a new tracking form to accompany waste to destination facility,
and maintains log.
Intermediate handler, within 15 days of receipt of signed and returned
form from destination facility, attaches original form to new tracking
form and sends both copies to generator or initiator of original form.
Copies of tracking forms, receipts, shipping papers, logs, and
discrepancy reports are retained in facility records for three years.
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Glossary
Cultures and Stocks
Pathological Wastes
Human Blood and Blood
Products
Sharps
Animal Waste
Isolation Wastes
Unused Sharps
Following are the classes of regulated medical wastes and a description of each.
Cultures and stocks of infectious agents and associated biologicals including: cultures from
medical and pathological laboratories; cultures and stocks of infectious agents from research
and industrial laboratories; wastes from the production of biologicals; discarded live and
attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix
cultures.
Human pathological wastes, including tissues, organs, and body parts and body fluids that are
removed during surgery or autopsy or other medical procedures, and specimens of body fluids
and their containers.
Liquid waste human blood; products of blood; items saturated and/or dripping with human
blood; or items that were saturated and/or dripping with human blood that are now caked with
dried human blood including serum, plasma, and other blood components, and their
containers, which were used or intended for use in either patient care, testing and laboratory
analysis, or the development of pharmaceuticals. Intravenous bags are also included in this
category.
Sharps that have been used in animal or human patient care or treatment or in medical, research,
or industrial laboratories. These include hypodermic needles, syringes (with or without the
attached needle), pasteur pipettes, scalpel blades, blood vials, needles with attached tubing,
and culture dishes (regardless of presence of infectious agents). Also included are other types
of broken or unbroken glassware that were in contact with infectious agents, such as used slides
and cover slips.
Contaminated animal carcasses, body parts, and bedding of animals that were known to have
been exposed to infectious agents during research (including research in veterinary hospitals),
production of biologicals, or testing of pharmaceuticals.
Biological waste and discarded materials contaminated with blood, excretion, exudates, or
secretions from humans who are isolated to protect others from certain highly communicable
diseases, or isolated animals known to be infected with highly communicable diseases.
The following unused, discarded sharps: hypodermic needles, suture needles, syringes, and
scalpel blades.
Blologicals
Blood Products
Body Fluids
Central Collection Point
Container
Decontamination
Destination Facility
Destroyed Regulated
Medical Waste
The following terms are defined here to address the management of medical wastes. They may be
different from those federal definitions used for solid or hazardous waste.
Preparations made from living organisms and their products, including vaccines, cultures, etc.
intended for use in diagnosing, immunizing, or treating humans or animals, or in related
research.
Any product derived from human blood, including but not limited to blood plasma, platelets,
red or white blood corpuscles, and other derived licensed products, such as interferon.
Liquid emanating or derived from humans and limited to blood; cerebrospinal, synovial,
pleural, peritoneal, and pericardial fluids; and semen and vaginal secretions.
A location where a generator consolidates regulated medical waste brought together from
original generation points prior to its transport off-site or its treatment on-site.
Any portable device in which a material is stored, transported, disposed of, or otherwise
handled. The term container, when describing the packaging requirements, does not include
items that are regulated medical waste.
The process of reducing or eliminating the presence of harmful substances, such as infectious
agents, so as to reduce the likelihood of disease transmission from those substances.
The disposal facility, the incineration facility, or the facility that both treats and destroys
regulated medical waste to which medical wastes are shipped.
Regulated medical waste that has been ruined, torn apart, or mutilated through processes such
as thermal treatment, melting, shredding, grinding, tearing, or breaking, so that it is no longer
generally recognizable as medical waste, but has not yet been treated. It does not mean
compacted regulated medical waste.
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Destruction Facility
Facility
Generator
Infectious Agent
Intermediate Handler
Laboratory
Landfill
Medical Waste
On-site
Original Generation Point
Oversized Regulated
Medical Waste
Package or Outside
Package
Packaging
Person
Storage
Transfer Facility
Treated Regulated Medical
Waste
Treatment
A facility that destroys regulated medical waste by ruining or mutilating it, or tearing it apart.
All contiguous land and structures, other appurtenances, and improvements on the land used
for treating, destroying, storing, or disposing of regulated medical waste. A facility may consist
of several treatment, destruction, storage, or disposal operational units.
Any person, by site, whose act or process produces regulated medical waste or whose act first
causes a regulated medical waste to become subject to regulation. In the case where more than
one person (e.g., doctors with separate medical practices) is located in the same building, each
individual business entity is a separate generator. [Note: see definition of "person."]
Any organism (such as a virus or a bacteria) that is capable of being communicated by invasion
and multiplication in body tissues and capable of causing disease or adverse health impacts in
humans.
A facility that either treats regulated medical waste or destroys regulated medical waste but
does not do both. The term does not include transporters.
Any research, analytical, or clinical facility that performs health care-related analysis or service.
This includes medical, pathological, pharmaceutical, and other research, commercial, or
industrial laboratories.
A disposal facility or part of a facility where regulated medical waste is placed in or on the land
and which is not a land treatment facility, a surface impoundment, or an injection well.
Any solid waste which is generated in the diagnosis, treatment (e.g., provision of medical
services), or immunization of human beings or animals, in research pertaining thereto, or in the
production or testing of biologicals. The term does not include any hazardous waste identified
or listed under 40 CFR Part 261 or any household waste as defined in 40 CFR §261.4(b)(l).
The same or geographically contiguous property which may be divided by public or private
right of way, provided the entrance and exit between the properties is at a crossroads
intersection, and access is by crossing as opposed to going along the right of way. Non-
contiguous properties owned by the same person but connected by a right of way which he
controls and to which the public does not have access is also considered on-site property.
Location where regulated medical waste first becomes waste (is "generated").
Medical waste that is too large to be placed in plastic bags or standard containers.
The packaging/container and its contents.
The assembly of one or more containers and any other components necessary to assure
minimum compliance with the program's packaging requirements.
An individual, trust, firm, joint stock company, corporation (including a government
corporation), partnership, association, state, municipality, commission, political subdivision of
a state, any interstate body, or any department, agency or instrumentality of the United States.
The temporary holding of regulated medical wastes at a designated accumulation area before
treatment, disposal, or transport to another location.
Any transportation-related facility including loading docks, parking areas, storage areas and
other similar areas where shipments of regulated medical waste are held during the course of
transportation. Also, a location in which medical waste is transferred between two vehicles.
Regulated medical waste that has been treated to substantially reduce or eliminate its potential
for causing disease, but that has not yet been destroyed.
When used to refer to waste handling, it means any method, technique, or process designed
to change the biological character or composition of any regulated medical waste so as to
substantially reduce or eliminate its potential for causing disease.
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Appendix
EPA Regional Offices
Region I
State Waste Programs
Branch
JFK Federal Building
Boston, MA 02203
(617) 573-5758
Region II
Air and Waste
Management Division
26 Federal Plaza
New York, NY 10278
(212) 264-5166
Caribbean Field Office
(809) 729-6920
Region III
Waste Management
Branch
841 Chestnut Building
Philadelphia, PA 19107
(215) 597-2842
Region IV
Hazardous Waste
Management Division
345 Courtiand Street, N.E.
Atlanta, GA 30365
(404) 347-3016
Region V
RCRA Activities
23O S. Dearborn Street
Chicago, IL 60604
(312) 353-9510
Region VI
Air and Hazardous
Materials Division
1445 Ross Avenue
Suite 1200
Dallas, TX 75270
(214) 655-6652
Region VII
RCRA Branch
726 Minnesota Avenue
Kansas City, KS 66101
(913) 236-2856
Region VIII
Waste Management
Division
999 18th Street, Suite 500
Denver, CO 80202
(303) 293-1496
Region IX
Toxics and Waste
Management
215 Fremont Street
San Francisco, CA 941O5
(415) 974-8388
Region X
Waste Management Branch
1200 Sixth Avenue
Seattle, WA 98101
(206) 442-6501
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