United States
Environmental Protection
Agency
Solid Waste and
Emergency Response
(OS-305)
Washington, DC 20460
EPA/530-SW-89-022
September 1989
xvEPA
Managing and Tracking
Medical wastes
A Guide to the Federal Program
for Transporters
Printed on recycled paper.
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Introduction
In response to the growing public concern over mismanagement of medical wastes,
Congress enacted the 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 transporters of regulated medical waste (Section 2). Section 2
includes requirements for transporters, including owners and operators of transfer
facilities that carry regulated medical waste generated in a participating state. It also
includes requirements for the vehicles used by transporters. Separate guides in this
series are provided for generators and facilities that treat, destroy, and dispose of
regulated medical wastes.
This guide describes the federal program only. It is designed to help transporters
comply with the program. For more complete information, transporters 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 and participating state programs 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.
The cooperation of all participants in the management of regulated medical waste 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 Wastes 2
Pre-Transporting Procedures 2
Tracking Regulated Medical Wastes 2
The Waste Management System 4
Generators /,
Transporters c
Treatment, Destruction, and Disposal Facilities 5
SECTION 2: A Detailed Guide for Transporters of Regulated Medical Waste
Profile of a Transporter ^
Transporters Subject to All Requirements 6
Special Exceptions ^
Notifying EPA and the State 7
Vehicle Requirements 7
Tracking Medical Wastes 8
Obtaining Forms 8
Accepting Waste Shipments ^ g
Delivering in the United States .10
Delivering Outside the United States ..'... 10
Consolidating Shipments JQ
Rail Shipments 12
Recordkeeping j~
Reporting -p
Transporter Reports 12
Exception Reports 12
Discrepancy Reports 13
Additional Reports 13
Medical Waste Transporter Checklists 14
Glossary -,Q
List of Figures
Figure 1. Tracking Form 3
Figure 2. Medical Waste Tracking System 4
Figure 3. Shipping Regulated Medical Waste Accompanied by a Tracking Form ... 9
Figure 4. Consolidating Shipments n
Appendix A EPA Regional Offices and Participating State Programs 20
Appendix B Packaging, Labeling, and Marking Requirements 21
Appendix C Transporter Notification Instructions and Form 22
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S ction 1:
The Medical Waste Tracking Program
Waste Managers
Participation
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.
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 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 transporters of regulated medical wastes generated in
the participating states comply with the federal rules. Transporters must also follow
rules required by the individual states and should check with 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.
The demonstration program includes medical waste generators in participating states;
transporters of those wastes; and owners and operators of treatment, destruction, and
disposal facilities that manage waste generated in participating states, even if their
facilities are located in nonparticipating states. Similarly, the program includes
transporters carrying regulated medical wastes from participating states, even if the
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Regulated Medical
Wastes
Pre-Transporting
Procedures
Tracking Regulated
Medical Wastes
wastes are then taken to nonparticipating states. The program includes vessels and
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 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
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
separated from general trash, and then sharp items, fluids, and other medical wastes
must be separated from each other to the extent possible. They are then packaged to
prevent tearing, breaking, or leaking during shipping and handling. (See Appendix B
for packaging, labeling, and marking requirements.)
Packages are to be labeled and marked to identify the contents of the package and the
generator and transporter of the waste. In addition, stored wastes must be maintained
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
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 2
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.
11 . US EPA Waste Description 1 2. Total No.
Containers
a. Regulated Medical Waste (Untreated)
b. Regulated Medical Waste (Treated)
c. State Regulated Medical Waste
13. Total Weight
or Volume
14 Special Handling Instructions and Additional Information
15. Generator's Certification:
Under penalty of criminal and civil prosecution for the making or submission of false statements, representations, or
omissions, I declare, on behalf of the generator
that the contents of this consignment are fully and accurately described above and are classif ed, packaged, marked, and
labeled in accordance with all applicable State and Federal laws and regulations, and that I 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 1 1 , 12, & 13)
Printed/Typed Name Signature
1 7. Transporter 2 or Intermediate Handler
(name and address)
EPA Med. Waste ID No.
Date
18. Telephone Number
( )
19. State Transporter
Permit or ID No.
20. Transporter 2 or Intermediate Handler (Certificat on of Receipt of Medical Waste as
described in items 1 1 , 1 2, & 1 3)
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 , 12, & 13
Printed/Typed Name Signature Date
(If 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)
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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
t
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.
FIGURE 2. All medical waste shipments required to be accompanied by a tracking form
are tracked from generator to final disposal, or destination facility.
The Waste Management
System
Because it is helpful for those involved in the demonstration program to understand
the roles of generators, transporters, and facilities, their roles are presented here.
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 often hire transporters to
provide many of these services, including supplying them with appropriate tracking
forms.
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 in sewers are not counted as part of 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'
recordkeepmg and reporting of waste shipments. They must also make sure that
wastes they p,ck up have been properly prepared for shipping and that the trackine
rorm is accurate. no 5
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 the waste 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
hPA and the generator state agency.
Generator packaging
medical waste
Transporter vehicle
Steam sterilizing,
or autoclaving,
before disposal
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Section 2:
A Detailed Guide for Transporters of Regulated
Medical Waste
Profile of a Transporter
This section presents instructions for transporters of regulated medical wastes to help
them comply with the federal programs. Detailed checklists are included.
All transporters of regulated medical waste generated in participating states are
covered by the medical waste demonstration program. Transfer facilities that handle
regulated medical wastes, generators that transport their own wastes and
intermediate handlers that carry regulated medical wastes are also subject to the
transporter requirements in this program.
Transporters must determine if they intend to handle regulated medical wastes
originating in participating states. If so, they must notify EPA of their intention
Transporters need to know which of the medical wastes they transport are regulated
and what special handling procedures apply. All transporters carrying regulated
medical waste generated in participating states are affected by the program, even if
they carry waste to a nonparticipating state.
Transporters Subject to All Requirements
In general, transporters of regulated medical waste must comply with all applicable
requirements of the regulation. They must
• notify EPA of their intent to handle regulated medical waste
originating in a participating state.
• agree to follow rules governing the vehicles they use.
• make sure that the wastes are properly packaged, labeled, and
marked.
• comply with rules for tracking, recordkeeping, and reporting of waste
shipments.
Transporters may also be
• required to initiate tracking forms.
• subject to state requirements for permitting, licensing, and registering.
Special Exceptions
Generators transporting their own medical wastes should refer to Managing and
Tracking Medical Wastes: A Guide to the Federal Program for Generators. In addition, the
following transporters are subject to exceptions to the regulations:
Transporters may arrange with generators of less than 50 pounds of regulated medical
waste a month to accept individual shipments of less than 50 pounds without
preparing a tracking form. In these instances, the transporter and the generator are
required to maintain logs containing shipment information. The transporter must
carry this log in the vehicle. Before transferring custody of these logged wastes the
transporter must initiate a tracking form, as a surrogate generator, and attach a log
sheet describing the individual shipments documented on the tracking form.
Transporters may consolidate individual shipments of less than 220 pounds by
initiating a new tracking form with combined total quantity information. They must
then attach a log sheet describing the individual shipments that comprise the
combined load.
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Notifying EPA and the
State
Vehicle Requirements
Transporters must notify both the EPA and the participating state before handling
regulated medical wastes. If transporters plan to handle waste from more than one
participating state, they must submit separate notification forms for each of those
states. Transporters are required to send the original and one copy of each notification
to EPA; another copy of the transporter notification must be sent to the director of the
waste management agency in the participating state the transporter is notifying (see
Appendix A). Appendix C includes a transporter notification form and instructions for
notifying EPA and the state.
EPA will assign each transporter that notifies the Agency an EPA Medical Waste
Identification Number. After receiving this number, transporters must enter it on the
tracking form in either Box 5 or 17, as required (see Figure 1).
Vehicles used to transport regulated medical waste must
• have a fully enclosed, leak-resistant, cargo-carrying body, such as a
cargo compartment, box trailer, or roll-off box.
• protect waste from mechanical stress or compaction.
• have a cargo-carrying body that is in good sanitary condition and that
can be locked.
• have the following identification on the two sides and back of the
cargo-carrying body in letters at least three inches high: name of the
transporter; transporter's state permit or license number, if any; the
words MEDICAL WASTE, REGULATED MEDICAL WASTE or
INFECTIOUS WASTE.
Vehicle identified as a transporter of medical waste
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Tracking Medical Waste The tracking form ensures that the transfer of each shipment of regulated medical
waste is documented and reaches its destination. Therefore, it is crucial for every
transporter to comply with tracking form requirements.
Transporter filling out a tracking form
Obtaining Forms
Transporters are responsible for providing the generator with the proper form when
waste is destined for a disposal site in another participating state. In addition, they
may assist generators by acquiring the appropriate forms based on the following
hierarchy:
• from the participating state to which the waste is to be ultimately
delivered. In this case, the transporter is required to provide tracking
forms.
• if that state does not provide tracking forms, from the state in which
the waste was generated.
• if the generator state does not print the tracking form, from other
sources including reproduction of Figure 1 from this booklet or 40 CFR
Part 259, Appendix I.
Accepting Waste Shipments
Transporters may not accept a shipment from a generator of more than 50 pounds a
month unless the shipment is accompanied by a completed tracking form signed by the
generator. Figure 3 diagrams the tracking system for transporters.
Transporters may not accept shipments of less than 50 pounds from facilities
generating less than 50 pounds a month unless the material has been logged. Logged
shipments, however, may only be accepted from the original generators, not from a
transporter.
Before accepting for transport any regulated medical waste that is accompanied by a
tracking form, the transporter must
• ensure that the waste is properly packaged, labeled, and marked (see
Appendix B).
• certify that the tracking form accurately reflects the number and total
weight of the packages.
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Then the transporter must
• sign and date the tracking form, indicating acceptance of and
responsibility for the regulated medical waste.
• return a signed copy of the tracking form to the generator before
leaving the generator site.
• be sure that the tracking form remains with the regulated medical
waste while in transit.
GENERATOR SITE
Transporter signs tracking
form, accepting RMW
shipment, and gives
generator a signed copy
DESTINATION FACILITY
Transporter transports RMW from
generator site to destination facility
Tracking form accompanies shipment
Transporter delivers shipment to
facility; facility representative
signs tracking form, accepting
RMW shipment, and gives
transporter a signed copy
Key
Waste Transport
Tracking Form
Facility mails copy of signed
tracking form back to generator
FIGURE 3. Shipping regulated medical waste accompanied by a tracking form.
Transporter inspecting
shipment of medical waste
Signing tracking form N
accepting waste shipment **>*
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Delivering in the United States
jating tracking forms
• retain one copy of the signed and dated tracking form
• give the remaining copies of the tracking form to the acceptine
transporter, mtermediate handler, or destination facility P§
Delivering Outside the United States
• sign the tracking form and verify that the waste has been delivered
• retain one copy of the signed tracking form
' gen" "tor.'6™™"8 ^ °f *e ^"Z form' ^ mai1' «° the
Consolidating Shipments
Transporters may consolidate multiple shipments of less than 9?n A ^ •
• name of each generator.
• generator state permit or identification number. If the generator state
address" "** ^ " identi&atio" nun.be™, then & ^Ltof
• date the regulated waste was originally shipped by the generator
• quantity of each category of regulated medical waste (number of
contamers and/or weight in pounds) shipped by each generator
names and state permit or identification numbers of all previous
the
accepted for disposal. The
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copies of both forms together and sends them, within 15 days, to the original
generator. In this way, the generator knows that the waste was accepted for disposal. If
a transporter consolidates or remanifests shipments, the transporter must also comply
with Exception Reporting requirements.
Consolidating shipments of less than 50 pounds
GENERATOR SITE
TRANSPORTER
DESTINATION FACILITY
Transporter signs tracking
form, accepting RMW
shipment, and gives generator
a signed copy
A
Waste
transport
Tracking form
shipment
Transporter consolidates
shipments by preparing a
consolidation log, initiating a
tracking form for the
consolidated load, and
attaching a copy of the log to
the new form. The new form's
number is entered on the
generators' original form(s)
It
Waste
transport ^
New tracking
form and log
accompany
consolidated
shipment
Transporter delivers consolidated
shipment to facility; facility
representative signs tracking form,
accepting RMW shipment, and gives
transporter a signed copy
Transporter attaches copy of signed form it
receives from facility, to generator's original
and mails both copies to generator
Facility mails copy of signed
tracking form back to transporter
who initiated the form
Key
Waste Transport
Original Tracking Form
New Tracking Form
The flow charts above illustrate the movement of the tracking form for consolidated
shipments of regulated medical waste. The top diagram shows the documentation
process for consolidation of shipments of less than 50 pounds, which are accepted
by the transporter unaccompanied by a tracking form. The bottom diagram shows
the documentation process for consolidating, or remanifesting, shipments of less
than 220 pounds, which are accompanied by tracking forms initiated by the original
generator.
Consolidating/remanifesting shipments of less than 220 pounds
GENERATOR SITE
Transporter signs generator's
log, accepting RMW shipment,
and compiles a truck log noting
that transaction
Waste
transport
TRANSPORTER
DESTINATION FACILITY
Transporter consolidates
shipments by preparing a
consolidation log, initiating a
tracking form for the
consolidated load, and
attaching a copy of the log to
that tracking form
4
Waste
transport
Tracking form
and log
shipment
Transporter delivers consolidated
shipment to facility; facility
representative signs tracking form,
accepting RMW shipment, and
gives transporter a signed copy
•
Facility mails copy of signed
tracking form back to transporter
who initiated the form
FIGURE 4. Consolidating shipments
11
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Recordkeeping
Reporting
Rail Shipments of Regulated Medical Waste
In those instances where regulated medical wastes generated in a participating state
are transported by rail, special rules apply. For further information see 40 CFR Part 259,
Subpart J. Rail shippers accepting regulated medical waste from a non-rail transporter
must
• sign and date the tracking form, acknowledging acceptance of the
regulated medical waste.
• return a signed copy of the tracking form to the transporter.
• forward at least three copies of the tracking form to the next non-rail
transporter, if any; or to the intermediate handler or destination
facility, if the shipment is delivered to that facility by rail; or to the last
rail transporter designated to handle the waste in the United States.
• ensure that the load is accompanied by shipping papers containing all
tracking form information, except permit or license numbers and
generator certification.
• retain one copy of the tracking form or rail shipping papers.
Transporters are required to keep for three years copies of all tracking forms;
transporter logs; Exception and Discrepancy Reports, if filed; and semi-annual
reports. In addition, for waste accompanied by a tracking form and consolidated by the
transporter onto another tracking form, the transporter must also retain for three years
• the transporter copy of the generator-initiated tracking form.
• a copy of the transporter-initiated consolidation tracking form signed
by the intermediate handler or destination facility.
• a copy of each required transporter report, described below.
Transporters must submit reports every six months for the two-year duration of the
program, as well as Exception and Discrepancy Reports, if necessary.
Transporter Reports
If a transporter accepts regulated medical waste directly from a generator in a
participating state or transports waste generated in a participating state during the six-
month reporting period, the transporter must submit a report summarizing those
activities for each state. These reports must be submitted to the chief of the EPA Waste
Characterization Branch and the director of the waste management agency in the
affected state. Each report contains information about the transporter, each generator
from which waste was accepted, and each facility to which waste was delivered.
Reports are due on the 45th day following the end of the six-month reporting period,
summarizing information from tracking forms and transporter logs. For further
information, refer to 40 CFR Part 259, Appendix III. For copies of the form call the
RCRA Hotline at (800) 424-9346; in Washington, D.C., call 382-3000.
Exception Reports
Transporters who have initiated a tracking form must also meet the Exception
Reporting requirements of the tracking program. If a signed tracking form bearing the
signature of the disposal facility representative is not received within 35 days from the
12
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date the regulated medical waste was accepted from the original generator, the initiator
of the tracking form must try to locate the waste. If, after 45 days, a signed tracking
form is still not received, then an Exception Report must be filed by the transporter
with the state and the EPA Regional Administrator on day 46. The Exception Report
consists of a letter describing the efforts and the results of such efforts to determine the
disposition of the waste and a legible copy of the original tracking form. A copy of this
report is to be retained for three years.
Discrepancy Reports
Transporters are generally not required to file Discrepancy Reports. However, if a
transporter learns after accepting waste that there is a discrepancy, the transporter
should try to resolve the problem. A discrepancy exists if a tracking form indicates a
difference between the waste that is accepted and that which is documented on the
accompanying tracking form. For example, the number of containers or the waste
categories might be inconsistent or the package might leak. Other types of
discrepancies include the presence of broken, torn, or leaking packaging; waste
unaccompanied by a tracking form, where one is required; or an incomplete or
improperly completed tracking form. If such discrepancies are discovered and they
cannot be resolved, they must be reported in writing within 15 days to the appropriate
EPA Regional Administrator and the generator's state agency. A legible copy of the
tracking form or shipping papers is to be attached. Discrepancy Reports must be
retained for three years.
Additional Reports
The Administrator may require transporters to furnish additional information
concerning the quantities and management methods of regulated medical waste.
13
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Regulated Medical Waste Transporter Checklist
Do these regulations apply to you?
Does your company participate, or intend to participate, in the transport of
medical wastes?
Does your company intend to continue or initiate such activities for medical wastes
that have been generated in one of the following states: Connecticut, New Jersey,
New York, Rhode Island and Puerto Rico?
Is your company authorized to transport regulated medical waste?
Has your company submitted the following notification information to the Waste
Characterization Branch, EPA Headquarters for each participating state that may
be a source of medical waste you will handle?
Company name, mailing address and EPA Hazardous Waste
Identification Number (if applicable).
Name, address, and telephone number for each site in that state from
which medical waste transport vehicles will operate.
State identification or permit number(s), if applicable, required for
handling medical or infectious waste.
Statement signed by a corporate official or owner or operator: "I certify,
under penalty of criminal or civil prosecution for the making or
submission of false statements, representations, or omissions, that I have
read, understand and will comply with the regulations at 40 CFR
Part 259, issued under authority of Subtitle J of the Resource
Conservation and Recovery Act."
Have you provided the appropriate waste management agency in each of those
participating states with a copy of the EPA notification for that state?
Has your company received a unique EPA-assigned Medical Waste Identification
Number?
Are you entering your Medical Waste Identification Number as required on the
Tracking Form?
Do individual states in which you handle or transport regulated medical waste
require other licensing or permitting requirements that may affect your company's
medical waste transportation activities?
Does your company ensure that the following requirements are met for all its vehicles that
transport regulated medical wastes?
The cargo-carrying body (i.e., cargo compartment, boxtrailer, roll-off box, freight
container) is fully enclosed, leak resistant, and capable of being locked.
The cargo-carrying body is maintained in good, sanitary condition.
The cargo-carrying body is secured and locked if the vehicle is left unattended.
The vehicles have the following identification information on both sides and rear of
the cargo-carrying body, in letters at least 3 inches in height:
(1) Company name
(2) Company's state permit or license number, if state issues and requires one, or
else company's address
(3) The words MEDICAL WASTE, INFECTIOUS WASTE, or REGULATED
MEDICAL WASTE
Waste is not subjected to mechanical stress or compaction during loading and
unloading, or during transit.
Regulated medical waste is not transported in the same container as other solid
waste unless the combined material is to be managed as regulated medical waste.
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Does your company manage transportation of regulated medical wastes in accordance with
all applicable regulations, including
Ensuring that all accepted shipments of regulated medical waste are properly
labeled, marked, and accompanied by proper paperwork?
Ensuring that all shipments, except for those of less than 50 pounds which are
from generators of less than 50 pounds per month, are accompanied by a properly
completed Tracking Form?
Do you
Ensure that the generator is provided with the proper Tracking Form if the waste is
to be disposed of in another participating state?
Ensure that the Tracking Form is properly completed and that the information on
the form accurately represents the number and/or total weight and waste
classification of the packages being accepted for transport?
Make sure generator provides information on designated treatment or disposal
facility before signing the form?
Visually inspect all packages of regulated medical waste to be accepted for
transport to ensure they are properly packaged, labeled, and marked?
Ensure that the "Generator Certification" block has been signed by an authorized
representative of the generator facility before accepting that shipment?
Sign and date the Tracking Form, acknowledging acceptance of the waste from the
generator and return the generator's copy before leaving the generator's premises?
Ensure that the Tracking Form accompanies the waste it covers at all times during
transport?
When delivering waste to another authorized transporter, intermediate handler, or
destination facility, do you
Make certain all regulated medical waste documented on the accompanying form
is transferred to the next party and, if any discrepancies are apparent, attempt
to resolve them with the recipient of the documented waste (i.e., counting
containers, reviewing all relevant logsheets, etc.)?
Obtain the signature and acceptance date from an authorized representative of that
party?
Retain the transporter's copy of the Tracking Form signed by the receiving party?
Give the remaining copies of the completed Tracking Form to the accepting
transporter, transfer or treatment or disposal facility?
When consolidating regulated medical waste shipments of 50 to 220 pounds onto a single
Tracking Form prior to transferral to another transporter, intermediate handler, or
destination facility, do you
Complete the Tracking Form as both generator and initial transporter, signing both
certification blocks (blocks 1 through 16)?
Record in a transporter's log the following information for all loads that are being
consolidated onto the single Tracking Form?
Names of generators
Generators' addresses or unique identification numbers
Original Tracking Form number(s) or dates waste was originally
accepted from generators
Quantity of waste by waste type (treated, untreated, or state-regulated),
by number of containers and/or weight in pounds, from each generator
New Tracking Form number that covers consolidated waste
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Attach a copy of the transporter's log sheet to the new Tracking Form?
Attempt to resolve any apparent discrepancies with the recipient of the
documented waste (i.e., recounting containers, reviewing all relevant logsheets,
etc.)?
Obtain the signature and acceptance date from an authorized representative of the
receiving transporter or facility?
Retain the generator's and transporter's copies of the completed Tracking Form for
recordkeeping?
Give the remaining copies of the completed Tracking Form to the authorized
recipient (accepting transporter, intermediate handler or destination facility)?
Within 15 days of receipt of the treatment/disposal facility-signed Tracking Forms
that you initiated, attach a copy to the generator's original form and return both
copies to the generator(s)?
When handling shipments of less than 50 pounds of regulated medical waste from
generators of less than 50 pounds per month, which are documented through use of logs,
do you
Ensure that all regulated medical waste to be accepted for transport is properly
packaged, labeled, and marked?
Sign and date the generator's log, which contains the shipment information
(transporter name, state identification number or address, and quantity of waste
shipped), after determining that information is accurate?
Record in your transporter's log the following information?
Names of generators
Generators' addresses or unique identification numbers
Date waste was originally accepted from generators
Quantity of waste by waste type (untreated, treated or state regulated),
by number of containers and weight in pounds, from each generator
Before transfer of the "logged" waste to the next authorized party, initiate a
Tracking Form which will account for all consignments of logged materials which
are on board the vehicle? Do you fill out the form as both "Generator" and
"Transporter," signing both certification blocks (blocks 1 through 16)?
Attach a copy of the appropriate log sheet(s) to the completed Tracking Form?
When delivering the waste to another authorized transporter, intermediate handler, or
destination facility, do you
Make certain all material documented on the accompanying form is transferred to
the next party? If any discrepancies are apparent, do you attempt to resolve them
with the recipient of the documented waste (i.e., recounting containers, reviewing
all relevant logsheets, etc.)?
Obtain the signature and acceptance date from an authorized representative of the
party accepting the waste?
Retain both the generator's and transporter's copy of the signed Tracking Form for
recordkeeping?
Give the remaining copies of the completed Tracking Form to the authorized
recipient?
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Do you understand the following recordkeeping requirements?
^T^^f ^St maintdin rec°rds of a11 '^actions involving regulated medical
waste handled for a period of 3 years from the date it accepts such waste
Records must include copies of
Generator-initiated Tracking Forms signed by company employees.
Tracking Forms your company has initiated for consolidation of
shipments or documentation of "small quantity" logged waste.
Transporter's log information recorded for all small quantity logged
shipments and consolidation transactions. ^ &&
Reports submitted by your company including Exception, Discrepancy,
and Transporter (semi-annual) Reports. F y
Do you understand that
Transporter Reports documenting your waste handling activities are required?
Transporters may be required to file Exception Reports and, if a discrepancv is
discovered after accepting waste, a Discrepancy Report? aiscreP*ncy is
***** transPorters to P™vide additional information, if
17
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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 pa hological laboratories; cultures and stocks of infectious agents from research
^1^UH laboratOTf s' TwaSteS, fr°m the P^duction of biologicals; discarded live and
cultures VaCCmeS; "* ^ deVlCeS USed tO tra"sfer' inoculate, and mix
WaSteS/ induding tissues' organs, and body parts and body fluids that are
er °r aUt°PSy " ^ ^^ Procedures' and specimens of body fluids
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 ™h
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
nSS "* deVel°Pment °f Pharmaceuticals. Intravenous bags are alsoLluded in this
and heir
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 w thout 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^
and covenr°slips ^ 8laSSWafe that Were in contact with infectious agents, such as used slides
hn' b°dy.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 pharmaceutical. *
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 dise^Ss
/ dlSCarded 8harPS: hypodermic needles, suture needles, syringes, and
The following terms are defined here to address the management of medical wastes. They may b
different from those federal definitions used for solid or hazardous waste.
Biologicals
Blood Products
Body Fluids
Central Collection Point
Container
Decontamination
Destination Facility
Destroyed Regulated
Medical Waste
n livln? orSanisms and their Products, including vaccines, cultures, etc
research "** " diagn°SmS' ionizing, or treating humans o? animals, or in related
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, svnovial
pleural, peritoneal, and pericardial fluids; and semen and vaginal secretions. synovia1'
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.
h^HF^TK16 ^^^ ^ Whi€h J material is St0red' transPorted, disposed of, or otherwise
i^ems that ar, ^^^ ^hen Ascribing 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. Destroys
Regulated medical waste that has been ruined, torn apart, or mutilated through
as thermal treatment melting shredding, grinding, tearing, or breaking,
but has not yet
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Destruction Facility
Facility
Generator
infectious Agent
•
A facility that destroys regulated rned" "
SSS^^J^^^Wast!-!;-.---^
'than
each
ntermediate Handler
aboratory
indfill
iedical Waste
i-site
SM'nal Generation Point
'rsized Regulated
«cal Waste
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Appendix A
EPA Regional Offices and Participating State Programs
Participating State
Programs
EPA Regional Offices
Connecticut Department of
Environmental Protection
Solid Waste Management Unit
State Office Building
165 Capitol Avenue
Hartford, CT 06106
(203) 566-5847
(Region I)
New Jersey Department of
Environmental Protection
Division of Solid Waste Management
401 East State Street, CN 414
Trenton, NJ 08625
(609)984-7840
(Region II)
New York State Department of
Environmental Conservation
50 Wolf Road
Albany, NY 12233
Tracking form: (518) 485-8394
Other inquiries: (518) 457-3254
(Region II)
Rhode Island Department of
Environmental Management
9 Hayes Street
Providence, RI 02907-5003
(401) 277-2771
(Region I)
Puerto Rico Environmental
Quality Board
Box 11488
Santurce, PR 00910
(809) 722-0439
(Region II)
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 Courtland Street, N.E.
Atlanta, GA 30365
(404) 347-3016
Region V
RCRA Activities
230 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 94105
(415) 974-8388
Region X
Waste Management Branch
1200 Sixth Avenue
Seattle, WA 98101
(206) 442-6501
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the
°f receiPt of *e regulated medical
waste.
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Appendix C Transporter Notification Instructions and Form
General Information:
AUTHORITY:
This information is required by the EPA under authority of Section 11003 and 11004 of the Resource Conservation and
Recovery Act.
WHO MUST NOTIFY:
Transporters who transport regulated medical waste that is generated in a Covered State must notify the U.S.
Environmental Protection Agency for each Covered State's regulated medical waste they intend to transport. This
requirement extends to transporters who do not actually transport the waste within that Covered State's boundaries but
who transport the waste, generated in the Covered State, outside that Covered State's boundaries.
Transporters planning such activity may either complete a Notification Form or submit a letter containing the information
required in 40 CFR 259.72(b). EPA will then issue a Medical Waste Identification Number unique to that transporter for
each Covered State for which they are notifying. That number will be used to identify regulated medical waste transporters
and can be used by generators to verify that the transporter has notified EPA of his intent to transport waste from their
Covered State.
WHEN TO NOTIFY:
Notification must be submitted for a Covered State before the transporter may accept regulated medical waste generated
in that Covered State. Transporters may, however, accept such waste once they have submitted their notification, but
before receiving their identification number. Upon receipt of that number, the transporter must enter it in Box 5 of the
Medical Waste Tracking Form, when that form is required. Additionally, the transporter must enter that number in Box
17 of the Tracking Form when acting as a secondary transporter, and in Box 1 when initiating a tracking form for load
consolidation purposes.
WHERE TO SEND NOTIFICATION:
Two copies of the completed Notification Form, for each Covered State, must be sent to:
Chief, Waste Characterization Branch
Environmental Protection Agency (OS-332)
401 M Street, S.W.
Washington, D.C. 20460
One copy must also be sent to the Director of the waste management agency in the State for which the transporter is
notifying.
NOTIFICATION FORM INSTRUCTIONS:
Note: All information must be typed or printed clearly.
Box 1. Covered State for which you are notifying. Enter the name of the Covered State of origin of the regulated
medical waste(s) you intend to collect and/or transport. Enter only one State in this space; if you intend
to transport waste from more than one Covered State you must submit a separate Notification Form for
each of those States.
Box 2. Transporter Name and Mailing Address. Enter your organization's name, mailing address, the name of
a contact person at that location who is knowledgeable about your operations, and include that person's
telephone number.
Box 3. EPA Hazardous Waste Identification Numbers. If the facility identified in Box 2 has an EPA Hazardous
Waste Identification Number, enter the EPA-assigned 12-character hazardous waste identification
number for the facility.
Box 4. Transporter's Facility Location(s). Enter the address, facility telephone number, and any current State
medical or infectious waste permit or license numbers for each transportation or transfer facility located
within the Covered State identified in Box 1. If there are more than four such facilities in that Covered
State you will need to use an additional sheet(s) to provide the required facility information; attach the
additional sheets to the first.
Box 5. Certification. The Certification Statement must be read and hand signed by a corporate officer or the
owner/operator of the transporter company.
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United States
Environmental Protection
Agency
Medical WasteTransporter
Notification Form
1 Covered State for which you are notifying
•
2. Transporter Name and Mailing Address
Name
Address
City
Contact
FOR OFFICIAL EPA USE ONLY
Identification No.:
Date Received:
Receiving Official:
•
JPIease Type or Print Clearly)
State Zip Code
Area Code/Telephone Number
3. EPA Hazardous Waste ID Number
(The ID number entered should be for the facility identified in Box 2)
4. Transporter's Facility Location(s) (use additional sheets if necessary)
Zip Code i City
Area Code/ Telephone Number
Area Code/ Telephone Number
Address
Zip Code j City
Area Code/ Telephone Number
- I -
required to handle
Area Code/ Telephone Number
(permit or license> «*>"'«* to handle
Area Code/ Telephone Number
Area Code/ Telephone Number
number(s) (permit or license) required to handle
'uired to handle
5. Certification
Signature
Title
Date
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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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