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Miscellaneous Statutory Provisions SECTION V

Chapter 2: Medical Waste Regulations

CHAPTER 2

MEDICAL WASTE REGULATIONS

New York, Rhode Island, and the Commonwealth

of Puerto Rico all participated in the two-year

tracking program. For purposes of this program,

they were known as covered states. This

demonstration program began June 22, 1989 and

ended June 22, 1991. Currently, the program is

expired and no federal medical waste tracking and

management regulations are in effect. As a result,

the provisions in Part 259 have been removed

from the CFR. States, however, have become

active in managing medical waste and a majority

have developed programs similar to the federal

model. This chapter will discuss what was

considered medical waste under the two-year

demonstration program.

WHAT WAS MEDICAL WASTE?

Medical waste included:

• Cultures and stocks of infectious

agents

• Human pathological wastes (e.g.,

tissues, body parts)

• Human blood and blood

products

• Used sharps (e.g.,

hypodermic needles and

syringes used in animal or

human patient care)

In this chapter...

Overview........................................................... V-9

What is Medical Waste? ................................... V-9

Medical Waste vs. Hazardous Waste ............... V-10

The Demonstration Program ............................ V-10

- Generators .................................................... V-11

- Transporters .................................................. V-11

- Treatment, Destruction, and Disposal

Facilities ....................................................... V-12

Interstate Shipments ........................................ V-12

Reports to Congress ........................................ V-12

Current Requirements ...................................... V-13

Summary .......................................................... V-13

OVERVIEW

During the summer of 1988, syringes and

other used medical materials washed up on

beaches along the Atlantic seaboard. In response

to public concern about this problem, Congress

enacted the Medical Waste Tracking Act in

November 1988, which added medical waste

tracking provisions in RCRA Subtitle J. The

Medical Waste Tracking Act directed EPA to

establish a two-year demonstration program for

the tracking and management of medical waste.

Under this statutory authority, EPA codified

regulations in 40 CFR Part 259 identifying the

medical wastes to be tracked and creating

management standards for handlers of medical

waste. The States of Connecticut, New Jersey,
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 SECTION V Miscellaneous Statutory Provisions

Chapter 2: Medical Waste Regulations

• Certain animal wastes

• Certain isolation wastes (e.g., wastes from

patients with highly communicable diseases)

• Unused sharps (e.g., suture needles, scalpel

blades, hypodermic needles).

For purposes of the demonstration program,

the definition of medical waste excluded

household waste. In addition, residues from

treatment and destruction processes, or from the

incineration of regulated medical wastes, were not

considered medical

waste, nor were

human remains

intended to be buried

or cremated. Etiologic

agents (i.e., infectious

substances) being shipped

pursuant to other federal regulations,

and samples of medical waste that were

shipped for enforcement purposes were exempt

from the 40 CFR Part 259 requirements.

MEDICAL WASTE VS. HAZARDOUS

WASTE

Because medical wastes met the RCRA

regulatory definition of solid waste, these wastes

were also subject to the Subtitle C hazardous

waste characterization. In other words, once a

facility identified a waste as a medical waste, it

then had to determine if this waste was also listed

or characteristic. (The hazardous waste

identification process is fully discussed in Section

III, Chapter 1.) If medical waste was a hazardous

waste, it was subject to the Subtitle C hazardous

waste requirements. When the Subtitle J medical

waste tracking standards were in place, such

hazardous medical wastes were excluded from the

tracking requirements and were subject to those

requirements in RCRA Subtitle C (see Figure V-3).

MEDICAL WASTE TRACKING

THE DEMONSTRATION PROGRAM

The medical waste tracking demonstration

program set up provisions for tracking medical

waste from the generator to the disposal site,

similar to Subtitle C’s hazardous waste manifest

system. The program was designed to ensure

proper handling, tracking, and disposal of medical

waste. The system required that a tracking form

accompany the waste and a signed copy be

retained by the generator, each transporter,

transfer station,

and the treatment,

destruction, and

disposal facility

that handled the

waste. When the

final disposal

facility accepted

the waste a copy

of the signed

tracking form was

returned to the

generator.

Medical waste,

which was neither 

listed nor 

characteristic

RCRA Subtitle J

Medical waste, 

which was also 

listed or 

characteristic

RCRA Subtitle C

Hazardous waste, 

which was listed or 

characteristic, but not 

a medical waste

RCRA Subtitle C

If medical waste was neither listed nor characteristic, it was 

subject to regulation as medical waste under RCRA Subtitle J. 

If medical waste was also listed or characteristic, it was subject 

to regulation as hazardous waste under RCRA Subtitle C.

Figure V-3:

MEDICAL WASTE VS. HAZARDOUS WASTE
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Miscellaneous Statutory Provisions SECTION V

Chapter 2: Medical Waste Regulations

Through this process the generator was assured

that the waste was actually received for disposal.

The tracking program also included exception and

discrepancy reporting to alert EPA and the states if

wastes were not being handled properly.

To minimize

contact with

medical wastes by

workers, handlers,

and the public, the

program also

included specific

requirements for

segregation,

packaging,

labeling, marking, and storing of medical wastes

before they were shipped to another site for

treatment, destruction, or disposal.

The demonstration program focused on three

groups of medical waste handlers:

• Generators

• Transporters

• Treatment, destruction, and disposal facilities.

■ Generators

A medical waste generator was any person

whose act or processes produced medical waste

or caused medical waste to become subject to

regulation. These tracking provisions applied to

persons or facilities that generated 50 pounds or

more of medical waste in a month and shipped

such waste off site. These generators were

required to separate, package, label, mark, and

track medical wastes according to the regulations.

Generators producing and shipping less than 50

pounds a month were required to prepare their

wastes properly for shipment, but could use a log

to account for wastes instead of a tracking form.

With the exception of medical waste burned

in on-site incinerators, generators who disposed of

medical wastes on site or in a sewer system were

not covered by the requirements of this program.

Similarly, wastes that were treated and destroyed

or disposed of on site or in sewers were not

counted as part of the 50-pound monthly total.

Generators burning waste in on-site incinerators

were required to report the volume of waste

burned. All medical wastes, even those that were

to be treated, destroyed, and disposed of on site,

were required to be stored properly.

These provisions applied to medical wastes

generated by federal facilities in covered states.

These provisions also applied to ships and ocean

vessels that brought medical wastes to shore by

docking in a covered state.

■ Transporters

A medical waste transporter was any person

engaged in the off-site transportation of medical

waste by air, rail, highway, or water. Transporters

were required to notify EPA of their intent to

comply with the tracking program before they

could accept medical waste for transport.

Transporters were required to follow rules

governing the transport, tracking, recordkeeping,

and reporting of waste shipments. They were also

required to make sure that the wastes they

accepted for transport had been properly

prepared for shipping and that the tracking form

was accurate.
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 SECTION V Miscellaneous Statutory Provisions

Chapter 2: Medical Waste Regulations

■ Treatment, Destruction, and Disposal Treatment, Destruction, and Disposal

Facilities

Treatment facilities were facilities that changed

the biological character or composition of medical

waste to substantially reduce or eliminate its

potential for causing disease. Destruction facilities

were facilities that destroyed medical waste by it,

mutilating it, or tearing it apart to render it less

infectious and unrecognizable as medical waste.

Once medical waste was properly treated and

destroyed, it no longer needed to be tracked.

These treatment and destruction facilities included

incinerators and treatment operations that ground,

steam-sterilized, or treated the waste with

disinfectants, heat, or radiation. Disposal facilities

were facilities where medical waste was placed in

or on the land (e.g., landfills).

The demonstration program did not regulate

the operation of these treatment, destruction, and

disposal processes, but rather required tracking

from generation to disposal and recordkeeping.

When the wastes were accepted for disposal,

these facilities had to send a signed copy of the

tracking form back to the generator or initiator of

the tracking form. The facility owners and

operators were required to investigate any

discrepancies between the accompanying papers

and the shipments they received. If after

investigation there was still a discrepancy, they

were required to report to EPA and the generator’s

state agency. Once treated and destroyed,

however, such wastes were no longer subject to

the tracking requirements.

INTERSTATE SHIPMENTS

While only the States of Connecticut, New

Jersey, New York, Rhode Island, and the

Commonwealth of Puerto Rico participated in the

tracking program, the medical waste tracking

provisions also applied when shipments

originating in these covered states were

transported to states that did not participate in the

program.

According to the provisions of the tracking

program, if medical waste was generated in a

covered state, any subsequent handling by a

transporter or treatment, destruction, and disposal

facility in that state, another covered state, or a

noncovered state was subject to the tracking

provisions. For example, if a medical waste was

generated in New Jersey (a covered state) and

transported by truck to Pennsylvania (a

noncovered state) for treatment and disposal, the

waste would still be subject to the medical waste

tracking provisions since the waste was originally

generated in a covered state.

REPORTS TO CONGRESS

The Medical

Waste Tracking

Act also required

EPA to submit

two interim

reports and a

final report on

medical waste

management and

the

demonstration

program to

Congress. The

information

SHIPMENTS TO STATES NOT PARTICIPATING

IN THE DEMONSTRATION PROGRAM

While only the Commonwealth of Puerto Rico and the

States of Connecticut, New Jersey, New York, and

Rhode Island participated in the tracking program, the

medical waste tracking provisions also applied when

shipments originating in these covered states were

transported to states that did not participate in the

program.

REPORT TO CONGRESS:

MEDICAL WASTE
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Miscellaneous Statutory Provisions SECTION V

Chapter 2: Medical Waste Regulations

gathered during the demonstration program will

be used to determine whether such a program

should be extended nationwide and what other

options are available for medical waste

management. The first and second interim reports

were released in 1990; the final report is still

under development.

CURRENT REQUIREMENTS

While medical waste is not regulated under

the current federal RCRA regulations, there are

federal requirements for medical waste under

CAA and FIFRA.

In 1997, under CAA, EPA established new

source performance standards (NSPS) and

emissions guidelines to reduce air emissions from

new and existing hospital, infectious, and medical

waste incinerators. These guidelines also

established standards for incinerator operator

training and qualification, equipment inspections,

and siting. In 1997, EPA estimated that there

were approximately 2,400 such incinerators in

operation in the United States that combust

approximately 846,000 tons of medical and

infectious waste annually.

Under FIFRA, antimicrobial pesticides and

disinfectants used in medical waste treatment

technologies must be registered with EPA.

SUMMARY

Congress enacted the Medical Waste Tracking

Act in November 1988, which added medical

waste tracking provisions to RCRA Subtitle J. The

Act directed EPA to establish a two-year

demonstration program for the tracking of medical

waste. The States of Connecticut, New Jersey,

New York, Rhode Island, and the Commonwealth

of Puerto Rico all participated in the tracking

program. This demonstration program began June

22, 1989 and ended June 22, 1991. Currently,

the program is expired and no federal tracking

regulations are in effect. States, however, have

become active in managing medical waste and

many have developed programs similar to the

federal model.

Medical wastes included:

• Cultures and stocks of infectious agents

• Human pathological wastes (e.g., tissues, body

parts)

• Human blood and blood products

• Used sharps (e.g., hypodermic needles and

syringes used in animal or human patient care)

• Certain animal wastes

• Certain isolation wastes (e.g., wastes from

patients with highly communicable diseases)

• Unused sharps (e.g., suture needles, scalpel

blades, hypodermic needles).

The medical waste demonstration program set

up provisions for tracking the waste from the

generator to the disposal site, similar to Subtitle

C’s hazardous waste manifest system.

The demonstration program focused on three

groups of medical waste handlers:

• Generators

• Transporters

• Treatment, destruction, and disposal facilities.

The medical waste tracking provisions also

applied when shipments originating in states

covered by the program were transported to states

that did not participate in the program.
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 SECTION V Miscellaneous Statutory Provisions

Chapter 2: Medical Waste Regulations

The Medical Waste Tracking Act also required

EPA to submit two interim reports and a final

report on medical waste management and the

demonstration program to Congress. The first and

second interim reports were released in 1990, the

final report is still under development.

While medical waste is not regulated under

the current federal RCRA regulations, there are

federal requirements for medical waste under

CAA for medical waste incinerators and under

FIFRA for pesticides and disinfectants used in

medical waste treatment technologies.