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.

-------An error occurred while trying to OCR this image.

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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

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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
                         iiinmin  	mi 11  i i i  mi in 111 ii 11  in n i in i	

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