vvEPA
United States ' ,
Environmental Protection
Agency
Solid Waste and
Emergency Response
• iOS-305)
EPA/530-SW-89-021
September 1989
Managing and Tracking
Medical Wastes
A Guide to the Federal Program
for Generators
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 regulated medical waste generators (Section 2). Section 2
includes requirements for generators of more than 50 pounds a month, such as
hospitals, and special requirements for those producing less, such as physicians,
dentists, and veterinarians. Separate guides in this series are provided for transporters
and for facilities that treat, destroy, and dispose of regulated medical wastes.
This guide describes the federal program only. It is designed to help generators comply
with the program. For more complete information, generators should refer to
"Standards for the Tracking and Management of Medical Waste," interim final rule (40
CFR Part 259). hi addition, states participating in the program have their own rules for
managing medical waste. The Appendix lists addresses and phone numbers for offices
in participating states and for EPA Regional Offices.
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 1
Waste Managers Participation 1
Regulated Medical Waste 2
Pre-Transporting Procedures 2
Tracking Regulated Medical Wastes 2
The Waste Management System 4
Generators 4
Transporters • 5
Treatment, Destruction, and Disposal Facilities : 5
SECTION 2: A Detailed Guide for Generators of Regulated Medical Wastes 6
Profile of a Generator 6
Generators Subject to All Requirements 6
Generators with Special Requirements or Exemptions 7
Pre-Transporting Procedures 7
Segregating and Separating Wastes 7
Packaging Regulated Medical Wastes 9
Labeling 11
Marking 11
Storing Medical Wastes , 12
Tracking Medical Wastes 12
Preparing a Tracking Form 12
Exception Reporting 12
Exporting Medical Wastes 13
Keeping Records 13
Other Reports 13
Medical Waste Generator Checklists 14,15,16
Glossary 17
List of Figures and Tables
Figure 1 Tracking Form , 3
Figure 2 Medical Waste Tracking-System 4
Figure 3 Examples for Small Generators 9
Figure 4 Generator Shipment Log 10
Figure 5 Log for Institutions Transporting Between Their Own Facilities 10
Figure 6 Tracking Medical Waste 13
Table 1 Examples of Medical Waste by Generator 6
Table 2 Medical Waste Generator Requirements 7
Table 3 Generator Exemptions and Special Requirements 8
Appendix Participating State Programs and EPA Regional Offices 19
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Section 1:
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 theproduction 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 generators comply with the federal rules in the
participating states. Generators of regulated medical waste in these states must also
follow rules required by the individual states. Generators 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. In addition, individual states might not recognize some of the
special exceptions allowed under EPA rules. 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 also includes owners and operators of treatment,
destruction, and disposal facilities that manage waste generated in a participating
state, even if their facilities are located in a nonparticipating state. Similarly, the
program includes transporters carrying regulated medical waste from a participating
state, even if the waste is then taken to a nonparticipating state. The program includes
vessels and transporters that take medical wastes to shore from ships docked in
participating states. Federal facilities generating regulated medical waste 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
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. They are then packaged to prevent tearing,
breaking, or leaking during shipping and handling.
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
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
a. Regulated Medical Waste (Untreated)
b. Regulated Medical Waste (Treated)
c. State Regulated Medical Waste
12. Total No.
Containers
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 classified, 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.
Printednyped Name
Signature
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,
10,11 c, & 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
Date
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
18. Telephone Number
19. 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
21. New Tracking Form Number (for consolidated or remanifested waste)
22. Destination Facility (Certification of Receipt of Medical Waste as described in items 11,12, & 13)
fj Received in accordance with items 11,12, & 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)
FIGURE 1. Medical waste tracking form.
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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 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
EPA and the generator state agency.
Generator packaging medical waste
Steam sterilizing,
or autoclaving,
before disposal
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Section 2:
A Detailed Guide for Generators of
Regulated Medical Wastes
Profile of a Generator
This section includes instructions for generators of regulated medical wastes to help
them comply with the federal regulations. It outlines requirements for generators of
more and less than 50 pounds a month. Checklists are included.
Health care providers, veterinarians, research laboratories, and establishments
involved in treating, diagnosing, or immunizing humans or animals probably generate
medical wastes. (Table I presents some examples of regulated medical wastes that
might be generated.) If so, they have to determine how they are affected by the medical
waste demonstration tracking program. To understand their responsibilities, these
generators must determine which of their wastes are regulated. They must then keep
track of the quantity of regulated medical waste they generate and of how they dispose
of it. All generators are affected by the program, but some may be subject only to
certain parts (see Table 2).
A hospital is considered a single generator even though there might be many
practitioners on staff, each producing medical waste. In contrast, a medical building
shared by several practitioners, each with independent practices, is not a single
generator; each practitioner is a generator.
TABLE 1. Examples of medical wastes generated by
institutions or practitioners
Institution/Practitioner
Family physician
Dentist
Veterinarian
Hospital
Laboratory
Medical Wastes
Syringes; tissue removed during
minor surgery.
Disposable needles; teeth and
tissue. (Teeth given back to
children are not considered
waste in this program.)
Syringes used for vaccination.
Blood-soaked materials from
the emergency room; needles,
syringes, scalpels; amputated
limbs and other body parts
from surgery; and IV bags from
patient-care rooms.
Blood vials; glassware that was
in contact with infectious
agents; discarded body fluids
or specimens.
Generator marking box
Generators Subject to All Requirements
The following generators must comply with all program requirements.
Persons, institutions, or companies that
• are located in a participating state.
• generate 50 pounds or more of regulated medical waste monthly on
site (on a contiguous piece of property).
• ship that waste off site for treatment, destruction, or disposal.
Vessels at port in a participating state where regulated medical wastes are taken to
shore for transport and disposal. These vessels operate as co-generators with their
shore bases, thus sharing responsibilities under the program.
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Generators subject to the full requirements must
• follow all pre-transporting requirements: segregate, package, label,
and mark.
• initiate a tracking form to track their wastes.
• use a transporter that has notified EPA of its intent to participate.
• comply with recordkeeping and reporting requirements.
TABLE 2. Medical waste generator requirements
Generator of
> 50 Ib./month
shipping waste
off site
< 50 Ib./month
shipping > 50
Ib./month off site
in a shipment
< 50 Ib./month
shipping < 50
Ib./month off
site3
Pre-Transportation
Requirements
Must follow
requirements.
Must follow re-
quirements.
Must follow
requirements.
Tracking and
Reporting
Must use Tracking
Form1 and file Ex-
ception Reports, if
necessary.
Must use Tracking
Form1 and file Ex-
ception Reports, if
necessary.
May maintain a
Log instead of
using a Tracking
Form; not required
to file Exception
Reports.
Transporting
Must use transpor-
ter that has noti-
fied EPA of intent
to participate.2
Must use transpor-
ter that has noti-
fied EPA of intent
to participate.1
Must use transpor-
ter that has noti-
fied EPA of intent
to participate or
use own vehicle2
or mail (sharps) by
U.S. Postal Ser-
vice.
Recordkeeping
Must comply with
recordkeeping and
reporting require-
ments.
Must comply with
recordkeeping and
reporting require-
ments.
Must comply with
recordkeeping and
reporting require-
ments.
Except when shipping within institutions or company.
2Only when taking wastes to generator's place of business, or to a hospital or other facility with which
there is a contract.
3See Table 3.
Pre-transporting
Procedures
Generators with Special Requirements and Exemptions
Generators must determine the quantity of regulated medical waste they generate and
ship off site in a month to see if they qualify for the special requirements or exemptions
for small generators. Wastes disposed of on site or in sewers are not counted or tracked.
Wastes that have been both treated and destroyed on site, such as incinerator ash, are
not tracked either. Table 3 outlines generator exemptions and special requirements.
All regulated medical wastes that are to be transported to an off-site facility for
treatment or disposal must be segregated and separated, packaged, labeled, and
marked.
Segregating and Separating Wastes
Before packaging, medical waste generators must segregate the waste from general
trash. If general trash is placed in a container with regulated medical waste, the trash
must be handled as a regulated medical waste. Once segregated from general trash,
medical waste must be separated to the extent practical into the following groups:
• sharps, such as needles, scalpels, glassware, and syringes, with
residual fluids.
• fluids in quantities greater than 20 cubic centimeters.
• other regulated medical wastes such as body parts, blood-soaked
bandages, and research animal carcasses. 7
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Generator
<50ib./monih
shipping < 50
lb./month off
site1
Institutional,
with satellites
or branches3
< 50 Ib./month
sending < 50
Ib. of sharps/
••••••
•••••
•••••
•••••
PR&TRANSPOfmNG
Packaging
Must
follow
rules.
Must
follow
rules.
Must
follow
rules.
Labeling
Must
follow
rules.
Must
follow
rules.
Must
follow
rules.
Marking
Must
follow
rules.
Must
follow
rules.
Must
follow
rules.
Storing
Must
follow
rules.
Must
follow
rules.
Must
follow
rules.
Tracking
Exempt from
using Tracking
Form; must
maintain a log.2
Exempt from
using Tracking
Form; must
maintain a log.4
Exempt from
using Tracking
Form; send by
Transporting
Must use trans-
porter on EPA
list or own (or
authorized em-
ployee's) vehicle
or send sharps
by U.S. Mail.
Must use trans-
porter on EPA
list or use own
(or authorized
employee's)
vehicle
N/A
Disposing
If using own
vehicle, must
take wastes to
own place(s) of
business, a hos-
pital, or a"
treatment
destruction, or
disposal facility
with which
there is an
agreement.
Must transport
waste from a sat-
ellite or branch
operation—
original opera-
tion point — to
central collection
point within the
same state.
N/A
Recordkeeping
Must maintain
log for three
years.
Must maintain
log for three
years.
Must maintain
receipt and log
for three years.
Exempt Exempt Exempt
month by U.S. registered mail,
Mail return receipt
requested,
showing deliv-
ery date and re-
ceiver's name
and address;
keep log.5
Must Must maintain N/A
follow log if waste
rules. treated and de-
stroyed on site
by method other
than incinera-
tion.6
Must Must comply N/A
follow with record-
rules, keeping and
reporting
requirements (40
CFR Part 259,
Subpart G).
2Figure 3 shows how a small generator might manage medical wastes.
2See Figure 4.
3Exemption ends when waste is shipped off site from central collection point.
4See Figure 5.
5Log must show date, name and address of facility, weight, and category of waste.
6Log must show weight of all waste treated and approximate percentage that is medical.
Treating and
destroying or
disposing of
wastes on site
Incinerating
own waste on
site
N/A
Exempt Exempt Exempt
N/A
Must maintain
log for three
years.
N/A
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Packaging Regulated Medical Wastes
All regulated medical wastes must be placed in a container or combination of
containers that are rigid and leak resistant, impervious to moisture, strong enough
to prevent tearing or bursting under normal handling, and sealed securely. Often
generators place medical waste other than sharps or fluids into plastic bags; the
transporter then puts the bags into a box.
Sharps and fluids may also be boxed by the transporter. But first sharps, such as
needles and scalpels, must be packaged in a rigid container resistant to punctures;
fluids must be poured into a container resistant to breaking and equipped with a
tightly fitting stopper or lid.
Oversized medical waste—animal carcasses and other items too large for standard
bags and containers—should be handled and transported, minimizing contact with
transportation workers, other handlers, and the public.
Non-rigid packaging and inner liners, such as plastic bags, are likely to become
contaminated through use. Therefore, they are considered regulated medical waste
and may not be reused. Rigid containers, including bins, barrels, and boxes can be
reused, but must be made free of any visible contamination. If rigid containers cannot
be cleansed of visible contamination, then they too are handled as regulated medical
wastes.
Example 1
Doctors in a small group medical practice accumulate used needles and syringes,
cultures of infectious agents, and other regulated medical wastes resulting from tests or
out-patient surgery. They plan to dispose of the wastes off site. Because the doctors are
in a group practice, the waste from each is added together. They must make sure that
the wastes are segregated from other trash and are packaged and labeled properly at
the office where they first became medical wastes. The wastes from their combined
practice amount to less than 50 pounds a month. One of the doctors carries it in his own
private car to a hospital where it is incinerated. The small group practice must have a
written agreement that the facility will accept the waste, and they must maintain a log
for three years. The log contains the weight and category of the medical waste, its date
of shipment, the name and address of the facility receiving the waste, and the signature
of the doctor who transported the waste to the facility.
Example 2
The same group medical practice arranges to have the waste picked up by a transporter
on the EPA notification list. In this case, the doctors are responsible for preparing the
waste for snipping and keeping the doctors' office log. One of the doctors can assume
the paperwork duties and make all the arrangements, but the group of doctors remains
responsible for all the wastes.
Example 3
Several doctors have unrelated practices in a single medical building. Each practice
produces less than 50 pounds of medical waste in a month. The doctors choose to
arrange for a single transporter. In this case, each doctor keeps a separate log and
packages, labels, and marks his or her waste properly.
FIGURE 3. Examples for small generators: physicians, veterinarians, dentists, and
other health services.
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GENERATOR SHIPMENT LOG
Transporter Name
and Address
.
Transporter
State Permit
or ID Number
Quantity and Ca
Waste Transp
Containers
Untreated
Treated
Untreated
Treated
Untreated
Treated
Untreated
Treated
Untreated
Treated
Untreated
Treated
Untreated
Treated
egory of
sited
Pounds
Date of
Shipment
/__/
^_-_
-,-L-
-<-<-
_,_-_
->->-
Signature of Representative
Accepting Waste for
Transport
FIGURE 4. Generator shipment log for generators of less than 50 pounds of regulated
medical waste per month, who ship less than 50 pounds per shipment.
OPERATING LOG—ORIGINAL GENERATION POINT
• Date of shipment.
• Weight of waste transported, by category: treated or untreated.
• Address/location of central collection point.
• Signature of the generator's employee who accepts and transports the waste.
OPERATING LOG—CENTRAL COLLECTION POINT
• Date of receipt.
• Quantity by weight and waste category (treated or untreated) accepted, by
category.
• Address/location of original generation point.
• Signature of operator who accepts the waste.
The logs are retained for three years.
FIGURE 5. Log for institutions transporting between their own facilities.
10
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Labeling
Generators shipping untreated medical wastes are required to label packaging, or
containers, to alert handlers. Generators must affix a water-resistant label to all
packaging of untreated wastes. When there is inner and outer packaging, or
containers, each container of waste must be labeled INFECTIOUS WASTE or
MEDICAL WASTE or display the universal biohazard symbol as illustrated below. Red
plastic bags, when used as inner packaging for untreated wastes, need no labels.
However, the outer packaging must still carry the proper label or symbol.
Universal Biohazard Symbol
Treated medical wastes do not require such warning labels, but must be marked as
specified below.
Marking
Before shipment, all packaging—inner and outer—must be marked with indelible ink
or with a water-resistant identification tag. Each inner container, if used, must show
the name and identifying numbers or address of the generator. Each outer container
must identify the contents as medical waste and include the information as it appears
on the sample tag shown below.
MEDICAL WASTE
GENERATOR: Date of Shipment: 8/1/89
Name General Hospital
Address Firstaid Avenue
Hollvwood. N.J. 00000
TRANSPORTER:
Name We-Haul MedWaste
Address 123 Haula Wa7
Towtown, Anystate 00000
MEDICAL WASTE
11
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Tracking Medical Wastes
12
Storing Medical Wastes
Some facilities store their medical wastes before disposing of them on site or sending
them to another location for disposal. Stored medical waste must be
• protected from water, rain, and wind.
• kept nonputrescent.
• kept in locked dumpsters, sheds, tractor trailers, or other secure
containers, if outdoors.
• protected from unauthorized employees and animals and pests.
The full tracking system (see Figure 6), including tracking forms, must be used if
• generators of 50 pounds or more a month, including vessels, transport
regulated medical waste off site.
• generators of less than 50 pounds a month ship 50 pounds or more in
a single shipment.
For generators that initiate tracking forms, a tracking form may be obtained from
different sources, depending on the waste destination. If the waste is shipped to a
participating state, which prints the form,the transporter must provide that state's form
to the generator. If the waste is shipped to a nonparticipating state or a state that does
not print the form, the generator must get the form from its own state. But if the
generator state does not require its own form, the generator may reproduce the
tracking form in this booklet or obtain a copy of the federal form from another source,
such as the transporter.
Preparing a Tracking Form
The generator must prepare enough copies of the tracking form for itself, transporters
as required, all intermediate handlers, the owner or operator of the final facility
accepting the waste, and one copy to be returned to the generator. Each handler keeps
a copy for its own records. When the final disposal site or destination facility accepts
the waste, a copy is returned to the generator with all signatures in place.
The tracking form is usually a four-part form: Copy I travels with the waste and is
returned to the generator by the destination facility; copy 2 is retained by the
destination facility; copy 3 is retained by the transporter; and copy 4 is held by the
generator when the waste is released for transport. If more than one transporter is
used or an intermediate handler is required, then enough copies of the form are
needed for each to keep a copy. More specific instructions appear in 40 CFR Part 259,
Appendix I. If shipping by rail directly from the site, a generator should refer to 40 CFR
259.52(e) for specific instructions.
Exception Reporting
Within 35 days, the generator should receive a copy of the completed tracking form
bearing the signature of the destination facility's owner or operator. If a form is not
received, a generator must try to determine the location of the waste.
If, after 45 days, a signed tracking form is still not received, then an Exception Report
must be filed by the next day with the state and the EPA Regional Administrator.
The Exception Report includes both a letter from the generator explaining its efforts
to locate the waste and the results of such efforts, and a legible copy of the original
tracking form.
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Generator initiates
Tracking Form.
Generator prepares
multiple copies of form as
needed.
Generator signs
certification statement on
form.
Generator gets signature
and date of acceptance
from initial transporter on
Tracking Form.
Generator retains one
copy.
Generator, within 35 days,
receives notice of receipt
by disposer(s).
Generator retains all
records for 3 years.
For export to foreign
country for treatment or
disposal:
• Confirmation within 45
days of receipt is to be
requested and received.
• If not, exception report
submitted by generator.
If completed tracking
forms not received within
45 days of initial
shipment, exception
report submitted by
generator on day 46.
FIGURE 6. Tracking medical wastes.
Keeping Records
Other Reports
Exporting Medical Wastes
Generators exporting regulated medical waste to another country for treatment,
destruction, or disposal must request written confirmation from the destination
facility that the waste was received. If notification has not been received within 45
days, the generator has to submit an Exception Report by the 46th day.
As part of routine recordkeeping, generators using the tracking system are to maintain
information for three years about medical waste transporters with whom they contract.
These records must include copies of all tracking forms. All logs, receipts, and
Exception Reports must also be retained for three years. EPA or state agencies may ask
to inspect these records or ask the generators to provide copies.
EPA may require generators to provide additional reports concerning quantities of
regulated medical waste and their management methods. Furthermore, EPA may
require an inspection of a generator's premises.
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Medical Waste Generator Checklists
Do These Rules Apply To You?
A "person" under these rules is 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.
Person generates regulated medical waste in a participating state. (If yes,
continue.)
Port receiving regulated medical waste from a vessel is located in a
participating state. (If yes, continue.)
Vessel from which regulated medical waste is carried to shore in a
participating state. (If yes, continue.)
Person generates on site 50 pounds a month or more of regulated
medical waste and sends it off site. (If yes, continue to Full
Requirements Checklist.)
Person generates less than 50 pounds a month, but ships more than 50
pounds in a shipment. (If yes, continue to Full Requirements Checklist.)
Person incinerates medical waste on site. (If yes, see 40 CFR Part 259,
Subpart G.)
Person generates regulated medical waste and treats and destroys it on
site. (If yes, exempt from this program for that waste, except for
maintaining a log. May be subject to state regulations.)
Person transports within its own facility's branch or satellite
operations—from generation point to central collection point. (If yes,
exempt from tracking requirements and certain transporting
requirements. See Figure 5 Log.)
Person generates less than 50 pounds a month and sends off site less
than 50 pounds in a shipment. (If yes, see Figures 3 and 4, and Small
Generator Checklist.)
Person generates less than 50 pounds a month and uses U.S. Postal
Service to transport sharps. (If yes, see specific requirements and Small
Generator Checklist.)
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Full Requirements Checklist
Shipments of More
than 50 Pounds
If you are subject to the full requirements, the following list is designed to help you
comply.
Do you separate regulated medical waste from general trash?
Do you separate sharps and fluids from each other and from other
regulated medical wastes?
Are sharps in puncture-resistant containers and are fluids in break-
resistant, tightly-lidded or stoppered containers?
Are all IV bags and sharps, such as needles and syringes, from patient-
care rooms included as regulated medical waste?
Are the packages rigid, resistant to leaks, impervious to moisture,
strong enough to prevent tearing or bursting, and sealed?
Are they properly labeled and marked?
Do you store these wastes properly while awaiting shipment?
Do you contract with a transporter on the EPA notification list?
Do you have enough copies of the tracking form so that each
transporter, intermediate handler, and the destination facility may retain
a copy, with one left over to be sent back to you for your recordkeeping
requirements?
Do you fill out the form accurately and sign the certification box? (See 40
CFR Part 259, Appendix I: Medical Waste Tracking Form and
Instructions.)
Do you get a signature from the first transporter along with your copy of
the signed form?
Do you understand that
Your copy of each tracking form is to be retained for three years?
When the waste is accepted at a destination facility a copy of the
completed, signed tracking form should be received within 35 days and,
if it has not:
It is your responsibility to find out what happened to the
waste; and
You must file an Exception Report if a completed tracking
form is not received within 45 days?
You must allow EPA inspection, if requested?
You must also follow all applicable state and local regulations?
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Small Generators Checklist
Generators of Less
Than 50 Pounds Per
Month Who Ship
Less Than 50 Pounds
Per Shipment
If you are a small generator, the following list is designed to help you comply with the
requirements.
Do you keep regulated medical wastes separate from general trash?
Do you separate sharps and fluids from each other and other regulated
medical wastes?
Are sharps in puncture-resistant containers and are fluids in break-
resistant, tightly-lidded or stoppered containers?
Are the packages rigid, resistant to leaks, impervious to moisture,
strong enough to prevent tearing or bursting, and sealed?
Are they properly labeled and marked?
Do you store these wastes properly while awaiting shipment?
Do you contract with a transporter on the EPA notification list;
OR
Do you personally take the waste in your own vehicles to a hospital or
other facility that has agreed to accept it?
If so, do you record the shipment in a log (see Figure 4)?
OR
Do you mail sharps using the U.S. Postal Service, keeping receipts and
an operating log?
Do you understand that you must retain records for three years?
Do you understand that you must also follow applicable state and local
rules?
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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.
Biologicals
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
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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Office of Solid Waste
United States
Environmental Protection
Agency
401 M Street, S.W.
Washington, DC 20460
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