ILLINOIS POLLUTION CONTROL BOARD

December

3,

1992

IN THE MATTER OF:

)

POTENTIALLY INFECTIOUS MEDICAL

)

WASTE

(P1MW): TREATMENT,

STORAGE,

)

R9l—20

AND

TRANSFER FACILITIES and

)

(Rulemaking)

TRANSPORTATION,

PACKAGING, AND

LABELING

(35

Ill. Adm. Code

1420,

1421,

and 1422)

Proposed Rule.

First Notice.

OPINION

AND

ORDER OF THE BOARD

(by R.C.

Flemal):

This matter comes before the Board upon the mandates of the

Illinois General Assembly that the Board

1)

adopt rules

regulating facilities for the treatment,

storage, and transfer of

potentially infectious medical waste

(P1MW)

and

2)

adopt

standards for the transportation, packaging, and labeling of

P1MW.

In its action today the Board adopts for first notice

amendments to

35

Ill. Adm.

Code Part 1420 and new Parts 1421 and

14221 intended to meet these legislative mandates.

Today’s first notice proposal closely follows the

recommendations

of the Governor’s Medical Waste Tracking Study

Group as that group’s consensus recommendations have been

presented to the Board

in the proposal submitted by the Illinois

Environmental Protection Agency

(Agency).

The few substantive

departures from that proposal are identified and discussed in

today’s opinion.

Pursuant to the Illinois Administrative Procedure Act,

a 45-

day public comment period will commence upon publication in the

Illinois Register

of today’s proposal.

Persons

interested

in

providing additional comment on this proposal,

or in responding

to inquiries posed by the Board herein,

should submit such

response in writing to the Clerk of the Board prior to the

expiration

of this

45-day period.

HISTORY

Prior to discussing the particulars of today’s proposal,

it

is instructive to place the proposal

in historical perspective.

1

The Board

is today proposing that the three parts that

comprise the

P1MW

subchapter be consecutively numbered.

This

is

reflected in the caption of the instant action.

The

organizational plan for Subtitle N is discussed later

in this

opinion.

137-0629

---

—2—

Although concern about

infectious materials

is long standing,

the

impetus to today’s particular action is more recent, and threads

through both federal and state actions.

National Concern with Medical Wastes

Broad public and national concern about medical waste

reached a heightened consciousness after medically—related

material washed up on beaches on the east coast during the summer

of 1987 and again on the east coast and on the Michigan shores of

Lake Michigan in the summer of

1988.

In addition to general

health and aesthetic concerns,

fear of AIDS contributed heavily

to the public’s anxiety regarding these wastes.

(Exh.

7 at iii.)

Following the second season of wash-ups, Congress passed

Public Law 100-582, the Medical Waste Tracking Act of 1988

(MWTA).

The MWTA has a research and information component,

which

has provided for an expanded understanding of the nature and

hazards associated with medical wastes2.

In addition,

the

MWTA

requires that the United States

Environmental Protection Agency promulgate regulations to

establish a demonstration tracking system for medical waste.

Several states bordering

a portion of the Atlantic Coast

(Connecticut, New York,

New Jersey) were required to participate

in the demonstration program.

Participation of states bordering

the Great Lakes was made optional.

All

of the Great Lakes States have elected to opt out of the

federal MWTA demonstration program.

Governor James R.

Thompson

explained the reasons that Illinois chose not to participate

(Exh.

5 at

8):

1.

Illinois already had a system in place which

tracked the potentially infectious waste from

hospitals.

It was estimated at that time that

approximately

60 percent of the potentially

infectious waste generated

in Illinois came from

hospitals.

2.

The intent of the

MWTA

was to prevent beach

closings,

yet even USEPA concluded that the

program would have

a very limited effect on the

beaches.

2

Among

the

important MWTA documents

is

“The Public

Health

Implications

of Medical Waste: A Report to Congress”,

prepared

by

the Agency for Toxic Substances and Disease Registry

(ATSDR) of the

Public

Health

Service,

U.S.

Department

of

Health

and

Human

Services.

This document is Exhibit

7 in the instant record.

01 37-Ub’JU

---

—3—

3.

No funding would be available from USEPA to

implement the program in Illinois.

Medical Waste Tracking Study Group

Governor Thompson recognized,

however, that there was need

for additional study and planning for the Illinois’ medical waste

program.

Accordingly,

on December

28,

1989, he announced the

formation of the Medical Waste Tracking Study Group

(Study

Group).

The Study Group consisted of elected officials3 and

representatives

of state agencies4, the health community5, waste

organizations6,

academia7,

agriculture6,

and the City of

Chicago9.

The Study Group met on many occasions and reviewed many

scientific,

technical and legal materials preparatory to issuing

its findings.

(Exh.

5 at cover letter.)

The culmination of

these activities was the submission to Governor Jim Edgar on June

10, 1991 of the Study Group’s report entitled “The Regulation

of

Potentially Infectious Medical Waste in Illinois”10.

The report

contains background information on the scope of the

P1MW

problem

and recommendations

for managing P1MW in Illinois.

These

~ State Senators Judy Baar Topinka, Margaret Smith,

and

Virginia MacDonald,

and State Representative Myron Kulas.

~ The Agency,

the

Board,

and Illinois Department

of

Public

Health.

Board Member Joan Anderson participated

initially.

~ Including the Illinois State Medical Society

(Dr.

Larry A.

Von Behren),

the veterinary community

(Dr. Raymond

0.

Hill),

Illinois Council on Long Term Care

(Mr.

Peter

P.

Peters), the

Illinois Hospital Association

(Ms. Ann Guild)

,

public health

departments

(Mr.

3. Maichle Bacon),

the Association for

Practitioners

in Infectious Control

(Ms.

Carol Mason),

and the

Illinois Dental Society

(Dr.

Robert Colantino)

6

Including Waste Management,

Inc.

(Ms.

Janet

S. Emmerman),

Sexton Environmental Services

(Mr.

Larry Lawrence), National

Environmental Services Corp.

(Mr.

Bill Smith),

Browning-Ferris

Industries

(Mr.

Francis

3. O’Brien),

and Compliance Resources,

Inc.

(Mr.

Ed Juracek)

~‘

Dr. Van Anderson,

University

of Illinois Urbana-Champaign,

and John Klaire,

University of Chicago Hospital.

~ Mr.

Richard

P.

Myers.

Ms. Nancy Marren.

~ This report

is found in the instant record

as Exhibit

5.

Q

37-0631

---

—4—

recommendations are directed to modifications of

law,

as well as

educational

and voluntary actions.

The recoimnendations with

respect to the law formed the basis for subsequent legislative

actions and for the regulations today under consideration.

Members of the Study Group have continued to participate

in

P1MW legislative and regulatory developments, including

presentation of much of the proposal, testimony,

and general

record upon which today’s action is based.

The Board expresses

its appreciation for the quality and magnitude of these

contributions.

Legislative Action

During the spring 1991 legislative session, the Illinois

General Assembly

in House Bill 2491 adopted

a variety of

amendments to the Illinois Environmental Protection Act

(“Act”)

(Ill.

Rev.

Stat.

1991,

ch.

111½,

par.

1001 et seq.)

in response

to the Study Group’s recommendations.

These were signed into law

on September

26, 1991

by

Governor Edgar as Public Act 87-752,

effective January

1,

1992.

A definition11 for potentially infectious medical waste is

one of the cornerstones of P.A.

87-752;

its importance

is that

it

specifically

limits the types

of waste to which P1MW regulations

apply.

P.A.

87-752

also added to the Act new Title XV: Potentially

Infectious Medical Waste.

This title consists of seven sections,

numbered Sections 56 through

56.6.

Section 56 consists of the

findings of the General Assembly on the matter of P1MW and the

statement

of purpose for Title XV.

In its entirety Section

56

reads:

a.

The General Assembly finds:

1.

that potentially infectious medical waste,

if

not handled properly, may constitute an

environmental

or public health problem.

2.

that potentially infectious medical waste,

if

not handled properly, may present a health

risk to handlers of the waste at the facility

where the waste

is generated,

during

transportation

of the waste,

and at the

facility receiving the waste.

~ The definition was originally placed at Section 3.81

of

the Act.

Pursuant to P.A.

87-1097

it has been renumbered to

Section 3.8~.

0137-0632

---

—5—

b.

It

is the purpose of this Title

to

reduce the

potential environmental and public i~ealthrisks

associated with potentially infectious medical

waste by establishing statutory and regulatory

requirements to ensure that such waste will be

handled in

a safe and responsible manner.

Section 56.1 is

a lengthy12 section consisting

of

a list of

prohibitions against

P1MW

activities.

The principal prohibitions

are against:

1.

Disposal

of any P1MW (Section 56.1(a));

2.

The landfill disposal of sharps unless their

infectious potential has been eliminated and

they are properly packaged

(Section 56.1(a));

3.

The delivery

of

P1MW

for transport,

storage,

treatment,

or transfer except where the

P1MW

is properly packaged

(Section 56.1(b));

4.

The delivery of

P1MW

to

a person or facility

that does not have an Agency-issued permit

for storage, treatment,

or transfer of P1MW,

where such permit

is required

(Section

56.1(c));

5.

The delivery or transfer of P1MW unless the

transporter has an Agency—issued permit,

where such permit

is required

(Section

56.1(d));

6.

The delivery or transfer of

P1MW

unless a

P1MW

manifest is completed for the waste,

where such manifest

is required

(Section

56.1(d))

;

7.

The acceptance of any P1MW for transport,

storage, treatment,

or transfer except where

the

P1MW

is properly packaged

(Section

56.1(e));

8.

The conducting of any P1MW transportation

operation without an Agency-issued permit

(where such permit

is required),

in violation

12

A substantial portion of the length of Section 56.1 arises

from the inclusion of various effective dates

(all now past except

for the incineration date

found

at Section

56.1(j))

plus interim

regulations which

are to be

in effect until

the adoption of the

instant regulations.

0137-0633

---

—6—

of any permit condition,

or in violation of

a

Board regulation or order (Section 56.1(f));

9.

The conducting of any P1MW treatment,

storage,

or transfer operation without an

Agency—issued permit (where such permit is

required),

in violation of

any permit

condition,

or

in violation of

a Board

regulation

or order

(Section 56.1(g));

10.

The transport of unmanifested

P1MW,

where a

manifest is required (Section 56.1(h)); and

11.

The incineration of

P1MW

after January

1,

1994

at an existing incinerator

in violation

of standards established under Section 129

of

the Clean Air Act (Section 56.1(j)).

Section

56.2 consists principally of mandates to the Board,

including the mandates under which the instant action

is being

undertaken13.

The first of these mandates

is found

at Section

56.2(a), and requires that the Board adopt regulations

“prescribing design and operating standards and criteria for all

potentially infectious waste treatment,

storage,

and transfer

facilities”.

The mandate also directs that the Board,

“at a

minimum” require that

P1MW

be treated at a facility that:

1.

eliminates the infectious potential of the

waste;

2.

prevents compaction and rupture of containers

during handling operations;

3.

disposes of treatment residuals

in accordance

with

this

Act

and

regulations

adopted

thereunder;

4.

provides for quality assurance programs;

13

In addition to the mandates to which today’s action is

addressed,

Section 56.2 also requires at subsection

(d) that the

Board repeal its previous infectious waste regulations and at

subsection

(e) that the Board adopt the list of Class

4

etiologic

agents.

These

two

actions

have been completed.

The first was

undertaken

as

In

the

Matter

of:

Repeal

of

35

Ill.

Adm.

Code

809.Subpart

I:

Hazardous

(Infectious)

Hospital Waste,

R9l—18,

Final Order December 19,

1991.

The second was undertaken as ~fl

the Matter

of: Potentially Infectious Medical Wastes:

Etiologic

Agents,

R9l—19,

Final Order January

23,

1992.

0! 37-063L~.

---

—7—

5.

provides for periodic testing using

biological testing, where appropriate,

that

demonstrate proper treatment of the waste;

6.

provides for assurances that clearly

demonstrate that potentially infectious

medical waste has been properly treated; and

7.

is

in compliance with all Federal and State

laws and regulations pertaining to

environmental protection.

The second mandate that today’s action addresses occurs at

Section 56.2(c).

It specifies that the Board shall adopt

regulations “prescribing standards and criteria for transporting,

packaging,

segregating,

labeling,

and marking potentially

infectious medical waste”.

Sections 56.3,

56.4,

56.5,

and 56.6 of Title XV generally

deal with the Agency’s direct role

in P1MW matters,

including

reporting, manifesting,

permit

issuance,

and fee collection.

Some of these matters bear peripherally on today’s action.

In the spring 1992 legislative session, the General Assembly

revisited P.A.

87-752 for the purpose of making certain

corrective amendments.

These were proposed as House Bill 3666

and signed into law as P.A.

87—1097

on September

15,

1992.

Among

pertinent provisions,

P.A.

87-1097 clarifies the definition of

P1MW,

clarifies various exceptions to the prohibitions

of Section

56.1,

and specifies July

1,

1993

as the required date of

completion of the instant

rulemaking14.

Actions before the Board

In anticipation of the need to take action in the

P1MW

arena,

the Board on August

9,

1991 reserved several rulemaking

dockets.

On August

23, 1991 the Board called

a public hearing

(inquiry hearing),

which was held on September

18,

1991.

The

purpose of this hearing was to determine the proper scope of the

regulations to be developed under the Section 56.2 mandates.

On August 26,

1991 the Board issued orders formally opening

the dockets.

Included were separate dockets for the rulemaking

covering treatment,

storage, and transfer facilities

(R9l—20)

and

1/.

The amendments

of P.A.

87-1097

are not effective until

January

1,

1993.

For the purposes of this first notice action,

however, the Board

will

treat the amendments

as

if they are

in

force

since they will become effective well before the instant

rulemaking

is completed.

0137-0635

---

—8—

for the rulemaking covering transportation,

packaging,

and

labeling

(R9l-21)

At the inquiry hearing testimony was received from Mr. Henry

Henderson from the City

of Chicago,

Dr. Van Anderson of the

University

of Illinois at Urbana-Champaign and the Study Group;

Ms. Ann Guild

of the

Illinois Hospital Association and the Study

Group;

Dr. Larry Von Behren of the Illinois State Medical Society

and the Study Group; Mr. Joe Suchecki from Waste Management

of

Illinois,

Inc.;

Mr. Francis

J. O’Brien from Browning Ferris

Industries Medical Waste Systems and the Study Group; Ms.

Jacquelyn Flora from Browning Ferris Industries Medical Waste

Systems; and Mr. Larry Lawrence of Sexton Environmental Systems

and the Study Group.

Testimony and questioning included the

implementation provisions of the legislation requiring

segregation,

packaging, marking and labeling,

transporting,

storing and treating of P1MW

(Tn.15 at 98-144)

Based upon the inquiry hearing and

in recognition that

matters of

P1MW

facilities and transportation,

packaging,

and

labeling overlapped,

the Board on February 27,

1992

ordered

dockets R9l-20 and R9l-2l to be consolidated,

docket R91-21 to be

closed,

and the materials

in docket R9l—2l to be incorporated

into R91-20

for the purpose of all further considerations.

On April

27,

1992 the Agency filed the draft proposal upon

which the merit hearings have been held and upon which today’s

first notice proposal

is based; the Agency has also subsequently

acted as proponent for the instant rulemakings.

Accordingly,

for

purposes of the following discussions,

the Board will identify

the April 27 draft proposal

in short form as the “Agency

Proposal’1.

It

is to be acknowledged, however, that the Study

Group and other interested persons contributed to the development

of the Agency Proposal, and moreover that the Agency undertook

extensive outreach and regulatory development meetings16 prior

to formalizing and filing its proposal.

The Board extends

its

appreciation to the Agency and its personnel for the quality

of

its leadership role.

~ Citations to the pages of transcripts of the inquiry hearing

are in the form “Tn.

at

____“;

citations to the transcripts of the

merit hearings,

which are consecutively numbered,

are

in the form

“Tr2.

at

“.

16

Meetings were held on December

10 and

19,

1991,

January

7,

23,

and

24,

1992,

and February

6,

7,

and 24,

1992.

Participants

included members of the Study Group in addition to other interested

persons.

Ms.

LouAnn Burnett and Mr. Philip Van Ness, Board staff,

also participated in these meetings.

Minutes of these meetings are

included in this record as Exhibits 38—5,

38—13, 38—35,

38—64,

38—

65, and 38—66.

0

I 37-0636

---

—9—

On April 27,

1992 the Agency also filed a recommendation

(Exh.

37), pursuant to then Section 27 of the Act17, that an

Economic Impact Study

(EcIS) not be conducted;

on May 11,

1992

the Illinois Department of Energy and Natural Resources joined in

that recommendation

(PC #7).

On June

4,

1992 the Board issued an

order finding that the EcIS need not,

at that time,

be conducted.

The Board noted:

The Agency states that representative members of the

regulated community* have participated

in the

development of the Agency’s proposal,

and that these

representatives will attend the hearings and present

information on the economic reasonableness

of the rule.

The Agency has also presented some economic information

with its proposal

(see Attachments 1—10),

and will

present additional information at hearing.

The

Department concurs

in the Agency’s comments,

and

further states that interested panties will have “ample

opportunity to present testimony regarding technical

feasibility and economic reasonableness during the

Board’s merit hearings.”

(P.C.#7 at

1).

The

Department further states that additional economic

information

will

be available from the Agency at or

before hearing.

*Son~eof these representatives also participated

on

the Medical Waste Tracking Study Group

(Study Group)

formed by Governor Thompson.

The Study Group was

instrumental

in drafting the legislation mandating the

adoption of medical waste regulations.

The Board has held three merit hearings.

These were held on

June

16,

1992

in Bloomington,

Illinois,

and on July

14,

1992 and

August

25,

1992 in Chicago, Illinois.

The June 16,

1992 hearing was devoted to presentation

of the

Agency Proposal and the taking of questions on the proposal.

Providing testimony on behalf

of the Agency were three members of

the Permit Section of the Agency’s Bureau of Land:

Mr. Douglas

Clay,

Manager of the Disposal Alternatives Unit;

Dr. Shirley

Baer,

Co-coordinator of the

P1MW

waste program,

Disposal

Alternatives Unit,

and

Mr.

Theodore Dragovich, Permit Reviewer.

Among persons posing questions to the Agency were ABB Sanitec,

Inc.,

Sexton Environmental Systems

(Sexton), Winfield

Environmental Corporation, the National Solid Waste Management

17

PA 87-860,

effective July

1,

1992,

deleted those portions

of

the

Act that

required economic impact studies for this type of

rulemaking.

The

Board’s EcIS determination aside,

the need for

a

formal EcIS study

is accordingly now moot.

0137-0637

---

—10—

Association

(NSWMA), Chemical Waste Management,

Isolyser Company,

and the Board.

The July

14,

1992 hearing focused on testimony directed to

the merits

of the Agency Proposal.

Among those testifying were

Dr. Cecil Lue-Hing of the Metropolitan Water Reclamation District

of Greater Chicago;

Dr. Van Anderson of the University

of

Illinois, Urbana-Champaign and the Study Group;

Dr.

Edward Cohen

of University

of Illinois,

Chicago on behalf of Sexton;

Mr.

Travis Honeycutt

of Isolyser Company;

Mr. Robert Rechner of the

Illinois State Dental Society and the Study Group;

Ms. Ann Guild

of the Illinois Hospital Association and the Study Group;

Dr.

Larry Von Behren of the Illinois State Medical Society and the

Study Group.

Drs. Anderson and Von Behren, Mn. Rechner,

and Ms.

Guild each spoke to the general support they and their

organizations give to the Agency Proposal,

with Dr. Anderson

providing additional documentation in support of the position.

The other presenters generally spoke to specific concerns,

as

will be discussed

in subsequent sections of this opinion.

The August

25,

1992 hearing continued the opportunity for

testimony regarding the Agency Proposal and response testimony to

that given

at the July

14 hearing.

Witnesses

included Ms. Jean

Furlan of the National Solid Waste Management Association;

Mr.

Cornie Frank of Rose Cantage; Mr. Harry Eiler of Recovery

Corporation of Illinois;

Ms. Carol Mason of the Association for

Practitioners

in Infection Control and the Study Group; Dr. John

Keene from the Society for Hospital Epidemiology

of America; Mr.

Joseph Wilson of Ecomed;

and Mr. Larry Eastep of the Agency and

the Study Group.

Dr. Cohen also testified again.

Ms. Mason

noted the support of her association for the Agency Proposal.

The other presenters generally spoke to specific concerns,

as

also will be discussed

in subsequent sections of this opinion.

Public Comments

Twenty-four public comments have been filed with the Board,

including nineteen filed subsequent to the start of merit

hearings.

These are dominantly expansions upon or responses to

matters addressed at hearing.

The Board has reviewed all public

comments,

with citations18 herein where pertinent.

GENERAL CONSIDERATIONS

In addition to the history

of P1MW matters, there are

a

number

of general considerations necessary to put today’s

proposal

in perspective.

18

Public comments are cited to in this opinion in the form “PC

#xat

0

37-0638

---

—11—

Immediacy of the P1MW Problem

While

it

is generally acceded that P1MW presents a real

problem,

it

is also generally acceded that the problem should be

addressed by a reasoned consideration of existing rules and

regulations and awareness of the professional practices employed

in those fields where P1MW is generated and handled.

It was in

recognition of this situation that Illinois opted out of the

MWTA

program

(see above).

It was also

in recognition of this

situation that the broad interests represented in the Study Group

were brought together to recommend a concerted P1MW program.

It

is also worth noting that the ATSDR’s report to Congress

(Exh.

7), made

in accordance with the MWTA

(see above), observed

that the general public’s health is not likely to be adversely

affected by medical waste generated

in the traditional health

care setting and that OSHA’s “Occupational Exposure to Bloodborne

Pathogens”

rule should decrease workplace medical waste—related

injuries and infections nationwide.

(Exh.

7 at E.9.)

ATSDR also

concluded that medical waste can be effectively treated by

chemical,

physical,

or biological means and that research

indicates that medical waste does not contain any greater

quantity or different types of microbiological agents than does

residential waste.

Medical waste

is approximately 0.3

of the

solid wastestream in the U.S.

(Exh.

7 at E.ll.)

Design of Rules

Today’s proposed rules are designed as

a multi—pronged

attack on the chain of events leading to infection and disease.

For infection to occur,

each of these events must take place:

1)

A person must come

in contact with medical

waste;

2)

An injury must occur following this contact,

thereby creating

an appropriate portal of

entry,

or

a portal of entry must already

exist;

and

3)

A sufficient number of viable infectious

agents must enter a susceptible individual

via this portal of entry,

then cause

infection.

Infection does not always result

in disease.

(Exhs.

7 at E.5,

38—26,

and 39—30 at

3.)

Appropriate segregation of

P1MW

from other wastes allows

a

generator to apply more extensive safety measures to a smaller

waste stream.

Proper packaging should nearly eliminate the

possibility of contact

(Tr2.

at 84)

or the creation of a portal

0137-0639

---

—12—

of entry

(i.e., packaging sharps

in a puncLure—proof container).

Storage and transportation requirements also help limit the

exposure

of handlers or the general public to potentially

infectious agents.

Treatment reduces the number of potentially

infectious agents,

thereby reducing the possibility of infection

if contact and injury does occur.

Any of these preventive

methods applied individually should reduce the possibility of

infection,

but used in concert and properly,

the entire proposed

P1MW management system should reduce the possibility of infection

almost completely.

(Tr2.

at 113.)

Today’s proposed rules are also designed to complement the

Occupational Safety and Health Administration rules issued

December

6,

1991 that contain provisions requiring employers to

protect their employees from bloodborne pathogens through

training, engineering controls,

work practices,

personal

protective equipment,

recordkeeping,

and Hepatitis Type-B virus

vaccinations

(Exhibit 37—6;

Tr2.

at 72,

84)

Definition

of Potentially Infectious Medical Waste

(P1MW)

The definition of potentially infectious medical waste,

or

P1MW,

is set by statute at Section 3.84

of the Act.

In its

entirety,

that definition

is as follows:

a.

“Potentially infectious medical waste” or “P1MW” means

the following types

of waste generated

in connection

with the diagnosis, treatment

(i.e., provision of

medical services)

,

or immunization of human beings or

animals; research pertaining to the provision of

medical services;

or the provision or testing

of

biologica ls:

1.

Cultures and stocks.

This waste shall include but

not be limited to cultures and stocks

of agents

infectious to humans,

and associated biologicals;

cultures from medical

or pathological

laboratories; cultures and stocks of infectious

agents from research and industrial

laboratories;

wastes from the production of biologicals;

discarded live or attenuated vaccines; or culture

dishes and devices used to transfer,

inoculate,

or

mix cultures.

2.

Human pathological wastes.

This waste shall

include tissue,

organs,

and body parts

(except

teeth and the contiguous structures

of bone and

gum)

,

body fluids that are removed during surgery,

autopsy,

or other medical procedures;

or specimens

of

body fluids and their containers.

C’

I 37-06140

---

—13—

3.

Human blood and blood products.

This waste shall

include discarded human blood,

blc;od components

(e.g.,

serum and plasma),

or saturated material

containing free flowing blood or blood components.

4.

Used sharps.

This waste shall include but not be

limited to discarded sharps used in animal or

human patient

care, medical research,

or clinical

or pharmaceutical laboratories; hypodermic,

intravenous,

or other medical needles; hypodermic

or intravenous syringes;

pasteur pipettes;

scalpel

blades;

or blood vials.

This waste shall also

include but not be limited to other types of

broken or unbroken glass

(including slides and

cover slips)

in contact with infectious agents.

5.

Animal waste.

Animal waste means discarded

materials,

including carcasses,

body parts,

body

fluids,

blood,

or bedding originating from animals

inoculated during research,

production

of

biologicals,

or pharmaceutical testing with agents

infectious to humans.

6.

Isolation waste.

This waste shall include

discarded materials contaminated with blood,

excretions,

exudates,

and secretions from humans

that are isolated to protect others from highly

communicable diseases.

“Highly communicable

diseases” means those diseases identified by the

board in rules adopted under subsection

(e)

of

section 56.2 Of the act.

7.

Unused sharps.

This waste shall

include but not

be limited to the following unused,

discarded

sharps:

hypodermic,

intravenous,

or other

needles; hypodermic or intravenous syringes;

or

scalpel blades.

b.

Potentially infectious medical waste does not include:

1.

waste generated as general household waste;

2.

waste

(except for sharps)

for which the infectious

potential has been eliminated

by treatment;

or

3.

sharps that meet both of the following conditions:

A.

the infectious potential has been eliminated

from the sharps

by

treatment; and

B.

the sharps are rendered unrecognizable by

treatment.

0137-06141

---

—14—

Early

in the history of this proceeding there was concern

raised by various persons about the appropri~teness of this

definition.

A portion of that concern was addressed by the

corrective amendments undertaken in P.A.

1097; these amendments

limited the types of waste that is

P1MW19.

The remaining questions regarding the P1MW definition are

largely concerned with interpretation and implementation

of

certain phrases used within the definition,

as,

for example, the

meaning of

“rendered unrecognizable”

found in the last subsection

of the definition.

These will be discussed in context

in the

following part-by-part analyses.

The Treatment Standard

The fundamental provision around which the instant proposed

regulations are built is the provision of treatment to render

waste non—PIMW.

Because

a waste that is

P1MW

may not be disposed

of

in Illinois, and because treatment

is the process by which

a

waste ceases to be

P1MW20,

the ultimate disposition of P1MW

depends upon its being treated.

Suitably, treatment standards and criteria form the largest

single portion,

Subpart B of Part

1422,

of today’s proposal.

Moreover,

treatment has been the single greatest focus of

participant interest,

both at hearing and in public comments.

Much of that interest has focused on the question of what

constitutes successful treatment.

Today’s proposal follows the Agency Proposal

in requiring

two

demonstrations

of treatment efficacy.

The first is the

Initial Efficacy Test21,

in which

it

is required that the

~ The principal changes were to eliminate the phrase

“...

but

not limited to

.

.

.“

prior to the lists of materials included in the

definitions

of

human pathological

wastes,

human blood

and blood

products,

and isolation waste,

and to rephrase the definition

of

animal waste.

20

A

partial exception occurs for sharps.

These must be both

treated and “rendered unrecognizable”

in order to leave the

P1MW

wastestream.

“Recognizable”

sharps,

which

remain

P1MW,

may

be

disposed

of

provided

that

they

are

both

treated

and

packaged,

pursuant to proposed Section 1422.126.

See discussion of the term

“recognizable”

in the part—by—part discussion,

below.

?~

See proposed Section

1422.124.

Ø~37-061~2

---

—15—

manufacturer assure that six types of “test” microorganisms22

that are surrogates

for 3pathogens be reduced to very low

concentrations

(a

6—log2

reduction)

by the tieatment process.

The second demonstration

is made by operators of individual

treatment units.

They are required to verify that the

manufacturer—demonstrated efficacy continues by conducting

Periodic Verification

Tests24.

These are accomplished by

showing that concentrations of bacterial spores

(typically the

most resistant forms of microorganisms)

are reduced to a number

that correlates with the 6-log reduction of the organisms used

in

the manufacturer’s efficacy test.

This program represents the consensus view of members the

Study Group.

Nevertheless, there have been several questions

raised regarding particulars of the program, notably by Sexton

Environmental Systems

(Sexton),

Dr.

Eugene Cole,

and Winfield

Environmental Corporation (Winfield).

Sexton believes that “the efficacy standards for P1MW

treatment processes which are contained

in the proposed

regulations are inadequate to insure that the infectious

potential of the P1MW will be eliminated”.

(PC #21 at

1.)

It

also contends that:

a

requirement that efficacy should be demonstrated

using vegetative microorganisms which are surrogates

for human pathogens

is both more complicated and less

reliable.

Any P1MW treatment process which is capable

of

a

6-log bacterial spore reduction will result

in

even greater reductions

in test microorganism

populations and thereby will insure that “all”

of the

vegetative pathogenic microorganisms present

in the

waste will be killed.

(PC #21 at 3.)

Sexton also argues that the Agency and Sexton disagree on

the definition

of “high-level disinfection”.

Sexton cites Dr.

22

Staphylococcus aureus

(representative of gram—positive

bacteria)

,

Pseudomonas aeruginosa

(representative of gram-

negative bacteria),

Candida albicans

(representative of

vegetative fungi-—yeast),

Trichophyton mentagrophytes

(representative vegetative

fungi--mold)

,

MS—2 bacteriophage

(hepatitis virus surrogate,

and

Mycobacterium smegmatis

(tuberculosis bacteria surrogate).

23

At various places

in the record this term

is also given

as

“6log”.

The hyphenated

form

is used here and

in the text

of the

regulations.

24

See proposed Section 1422.125.

01 37-06~3

---

—16—

Van Anderson’s testimony that

“...

high level disinfection

means that

it destroys all forms of microbia:

life except high

numbers of bacterial spores”

(Tr2.

at 503).

Sexton cites Dr.

Edward Cohen’s belief that “high—level disinfection”

is achieved

by a 6-log reduction

in bacterial spores

(PC #21 at 3).

Sexton

further states that neither Dr. Cohen nor Sexton propose that

P1MW should be sterilized

(PC #21 at 4).

Sexton believes that in order to adopt treatment standards

within the mandates of the Act, to “eliminate the infectious

potential”

of the waste,

the Board must require that

a treatment

unit demonstrate a 6—log reduction of bacterial spores.

Sexton

also states that “no representative from the infectious waste

management industry other than Mr.

Joseph

Wilson of Ecomed,

testified that any existing or planned

P1MW

treatment facility

could not meet

a 6-log spore reduction standard’t

(PC #21 at 9).

Most

of the participants

in this proceeding,

aside from

Sexton,

argue that there

is very little extra benefit afforded by

a treatment standard that focuses on bacteria spores as the

microorganism upon which the 6—log reduction must be demonstrated

(e.g.,

Tr2.

at 500—5,

695—6,

706,

894,

952,

982;

Exh.

45 at

2,

14-16;

Exh.

45-6).

They also emphasized that treatment

is only

one aspect of today’s proposal.

(Tr2.

at 505—10,

514—5,

697,

704,

726,

896.)

In light

of this very strong and diverse support

for maintaining the treatment standard as presented

in the Agency

Proposal, the Board today declines to alter this facet of the

Agency Proposal.

We

also note that,

upon review of the extensive

record

in this proceeding, the scientific consensus for what

constitutes “high-level disinfection~” is comparable to the

Agency’s proposal rather than that asserted by Sexton.

(Tr2.

at

910—11,

952—4;

Exhs.

38—8,

38—12,

38—71,

and 45—6.)

The issue of how the phrase “eliminate the infectious

potential”

is to be interpreted

is also raised by Dr.

Cole25.

One of Dr. Cole’s primary concerns

is the proposal’s use of

a ~

log reduction standard to determine treatment efficacy.

Dr. Cole

contends that the correct standard

is

a

106 kill

(a destruction

of one million organisms per gram of waste)

.

Winfield

(PC #8)

commented similarly.

The treatment efficacy standard proposed by the Agency at

Section 1422.124(b)

requires the “log kill” for each test

microorganism after treatment to be greater than or equal to

6

25

Dr.

Cole has authored two public comments.

The first

(PC

#16),

submitted to the Board by National Solid Waste Association,

is

a report entitled,

“Assessment

of

Illinois

EPA Proposed Rules

for the Treatment

of Potentially Infectious Medical

Waste”.

The

second public comment

(PC #23)

contains comments to the Board from

Dr.

Cole.

0137-061414

---

—17—

(6-log reduction).

The Board notes that the term “log kill”

as

used by the Agency incorporates the concept ~f “log reduction”

which

is different than the interpretation proposed by Dr.

Cole.

“Log reduction” means the logarithm of the number of times the

initial concentration of test microorganisms

is reduced by

treatment.

Therefore,

the proposed efficacy standard requires at

least a 6—log reduction which means a reduction of initial

concentration of test microorganisms by

a magnitude of

6 orders

or

1 million times.

Under the Agency’s proposal,

log kill

is

calculated as follows:

log kill

=

log

(N0A/N1A)

=

log N0A

-

log N1A ~

6

where:

N0A=number

of organisms/gram before treatment;

N1A=number

of organisms/gram surviving treatment.

According to Dr.

Cole,

“log kill” means the logarithm of

number of microorganisms inactivated or killed by treatment.

Therefore,

the efficacy standard proposed by Dr.

Cole would

require at least

a 6-log kill which corresponds to inactivation

of at least one million test organisms per gram of waste.

According to Dr. Cole’s interpretation,

log kill

is determined

as

follows:

log kill

=

Log

(NoA

—

N1A) ?

6

The difference between the efficacy standards proposed by

the Agency and Dr. Cole may be illustrated by example.

If waste

containing l0~organisms/gram

(10 million)

is treated and reduced

by

106 organisms/gram

(1 million),

9.0 x 106

(9 million)

organisms\gram survive.

Under the Agency’s proposal,

the

treatment yields

a log kill of 0.05 which fails to meet the

proposed standard of

6.

On the other hand,

under

Dr. Cole’s

interpretation,

the above example yields a log kill

of

6 which

meets the efficacy standard.

In the above example,

for the

treatment process to meet Agency’s proposed standard,

only

10 or

less test microorganisms may survive after treatment; this equals

a kill 9.99999 million organisms/gram.

The Board will retain the Agency’s language and

calculations, but solicits comments as to whether

a log—reduction

calculation

is appropriate to determine efficacy and whether the

definition regarding log—reduction is sufficiently

straightforward.

Dr. Cole also suggests

a direct definition

of

“eliminates

the infectious potential”,

thusly:

ELIMINATES THE INFECTIOUS POTENTIAL OF THE WASTE.

The

infectious potential

is eliminated and indicated

by

the

01 37-06~5

---

—18—

consistent kill of

at least

1 X 106 per gram of waste

solids for at least one of each of the following:

vegetative

bacteria, vegetative fungi,

fdngal spores,

viruses,

and mycobacteria; and the kill of

1 X l0~

bacterial spores per gram of waste solids.

(PC #16 at

4.)

This contrasts with the concept definition provided

in the Agency

Proposal at Section 1422.122(a) (1):

ELIMINATES THE INFECTIOUS POTENTIAL OF THE WASTE. Proof

that the infectious potential is eliminated must be

demonstrated by the Initial Efficacy Test and Periodic

Verification Test(s), pursuant to Sections 1422.124 and

1422.125

of this Part.

Mechanical treatment may only

be conducted as an integral step of the treatment

process.

The Board reserves judgement on this definitional matter,

and requests that interested persons address it

in public

comment.

Dr. Cole also recommends the use of alternate types

of

microorganisms rather than the specific species identified

in

Section 1421.Appendix A.Table

A.

The Agency has stated,

in

response to

a similar comment from Winfield

(PC #8),

that no

substitutes for the specific organisms will be accepted in order

to provide

a consistent standard for all treatment technologies

(Tr2.

at 231)

.

The Board agrees with the Agency.

Permitting

The Agency submitted draft permit applications

in Dr.

Shirley Baer’s testimony

(Exhs.

38—lB and 38-3).

Review of these

draft permit applications reveals that some of the requirements

for permitting would not flow from the proposed rules,

and

in

part are inconsistent with them.

For example,

in the draft Agency permit application and

instructions, the paraphrase

of treatment

is different

(Exh.

38-3

at

11)

from the statutorily—derived definition

in Section

1420.101; the requirements

for land surveyor and engineer

certification,

and for demonstrating compliance with referenced

federal CFR packaging standards26

(Exh.

38-3 at

2,

11)

are not

reflected

in the proposed rules; the Initial Efficacy Test

demonstration does not appear to allow the owner

or operator to

provide

for manufacturer documentation

(Exh.

38—3 at

6)

,

as the

proposed rules allow; the narrative paragraph addressing the

Periodic Verification Test

(Exh.

38—3

at

6)

does not fully

26

~

is unclear whether this

is the proper CFR reference.

UI 37-06L~6

---

—19—

comport with the detailed regulations;

reg:arding waste types,

required identification,

such as by generation process and by

percent weight of components such as sharps,

plastics,

noncombustibles,

and cellulosic solids

(Exh.

38-3

at

4)

appear to

be at odds with Subpart B of the proposal,

which only requires

segregation by sharps,

oversized

P1MW,

and all other.

The need to avoid such problems of nonconformance

is the

reason why many

of the Board’s regulations are quite specific

regarding the information required to be submitted on

a permit

application and the conditions under which the Agency may request

modification or deny a permit27.

In many instances here,

desired provisions can be included

in the proposed regulations so

as to provide the necessary authority for their implementation

and enforcement.

As

a first step,

the Board today proposes to

include the registered

land surveyor and registered professional

engineer certification requirements and to define those terms.

However, one fundamental difficulty

in reaching such conclusions

is draft permit applications’ virtual lack of citation to,

or

otherwise no utilizing the language of, the proposed regulations.

The Board believes that the best approach is to attach

35 Ill.

Adm.

Code 8l2.Subpart A of the Board’s landfill regulations to

this opinion for further guidance and to solicit comment

regarding the need for greater specificity or clarification in

the rules

in light of these draft permit requirements.

Further discussion regarding permitting can be found in the

part-by-part discussion below.

Manifesting and Agency 0b~ection

The

P1MW

manifest

requires

classification

of

P1MW

into

the

categories used/unused sharps,

human pathological wastes,

and

animal wastes.

(Exh.

38-2.)

This classification

is not required

in the rule.

P1MW

is

considered

P1MW

and,

with the exception of

a few extra provisions for sharps,

is identical for each

classification.

Human pathological wastes and animal wastes are

not required to be segregated from the other

P1MW,

as sharps are.

Mr. Corrie Frank

of Rose—Cartage,

Inc.,

expressed concern at the

August hearing that the labeling requirements

in the proposed

rule did not provide what he needed to know for his manifest.

The

Agency

objected

to

Mr.

Frank’s

testimony

on

the

grounds

that

it deals with manifesting requirements.

(Tr2.

at 821.)

The Board overrules the objections of the Agency to the

extent that the testimony relates to the issue

of the clarity of

27

For permits,

for example, see 35 Ill. Mm.

Code

807.Subpart

B,

809.Subpart

B,

or

Part

812;

for Agency certification or waste

classification requirements see 35 Ill. Adn. Code 745.Subpart B and

808.Suhpart

D.

0137-06147

---

—20—

the proposed rules.

The Agency

is correct that the legislature

mandated that the Agency prescribe and provide manifest forms.

(Section 56.4

of the Act).

However, the Board is mandated to

adopt regulations prescribing,

among other things,

standards and

criteria for transporting, packaging,

segregating,

labeling,

and

marking P1MW.

(Section 56.2

of the Act.)

The Board solicits

further comment on the issue of clarity of the labeling

requirements and other provisions of the proposed rules

in light

of the manifest requirements.

Non—Substantive Format Changes

The proposal as today sent to first notice contains a number

of modifications made for organizational,

formatting,

grammatical,

etc., reasons.

Many of these consist of errata

offered by the Agency

(Exhs.

42,

67, and 68)

.

Because these are

generally non-substantive, most of them will not be discussed

in

the text of this opinion.

One general modification that is noteworthy,

however,

is the

change

in numbering of the two new parts.

The Board notes that

it had earlier recommended that Parts 1430 and 1440 be used for

the Section 56.2 regulations,

and that the Agency has adopted

this scheme

in presenting the Agency Proposal.

However, upon

both review of that proposal and consideration of possible future

additions to Subtitle

M, the Board now believes that the P1MW

subchapter

is best placed

in consecutively numbered parts,

as a

matter of the most economical use of Subtitle N

(see discussion

below)

.

This scheme is used today.

Another general modification to be noted

is the editing of

the proposal to establish a uniform usage with respect to

“shall”,

“must”,

“will”, and “may”.

“Shall”

is used when the

subject of a sentence has to do something.

“Must”

is used when

someone has to do something,

but that someone

is not the subject

of the sentence.

Typical usage of the latter occurs where an

object

is required to have some condition or property,

as for

example

in:

“the map must show the location of all facilities”.

“Will”

is used when the Board obliges itself to do something.

“May”

is used when a provision

is optional.

The Board does not

intend to make any substantive change

in the rules by way of

these changes.

Additionally, the Board has made several nonsubstantive

format changes to the Appendices.

ORGANI ZATIONAL

CONSIDERATIONS

The Board has established the following organizational

scheme to accommodate the P1MW and related regulations.

0131-06148

---

—21—

Subtitle

M, which

is to consist of tne 1400—1499 series

of

35

Ill. Adm.

Code,

is reserved for regulatiors that control

specific biological materials; currently, the only Board

regulations within Subtitle N are the instant P1MW regulations.

As

is the general scheme with 35

111. Adm.

Code regulations,

parts numbered 1400 to 1449

(Chapter I)

are reserved for

regulations promulgated by the Board, and parts numbered 1450 to

1499

(Chapters

II and

III)

are reserved for regulations

promulgated by the Agency or the Department of Energy and Natural

Resources.

Today’s specific regulations are collected into subchapter

b, the

P1MW

subchapter.

This subchapter,

in turn,

is subdivided

into three parts to efficiently house general provisions

(Section

1420),

and the regulations today proposed

in response to the

separate Section 56.2(a)

and 56.2(c)

mandates of the Act

(Sections 1421 and 1422)

PART-BY-PART ANALYSIS

-

Part 1420

In this portion of our opinion, the Board presents an

explanatory analysis of today’s proposal, beginning with Part

1420.

Emphasis

is on issues that have required Board resolution

and on substantive modifications

of the Agency Proposal that the

Board proposes today28.

Part 1420

is the only one of the three parts

in today’s

proposal that

is not entirely new.

Part 1420 originated

in the

Board’s R9l-l9 proceeding.

Today it is expanded to house general

provisions pertaining to P1MW.

Scope and Applicability

(Section 1420.101)

The Scope and Applicability statement for the

P1MW

regulations was adopted

in R9l—19.

Although no modification

of

this section was offered

in the Agency Proposal, the Board today

proposes to strike both subsection

(b) and the Board Note as no

longer reflective

of the overall content

of either Part 1420 or

the

P1MW

subchapter.

Definitions

(Section 1420.102)

General definitions that apply to the three P1MW parts are

found

in Section 1420.102.

Most of these definitions are

28

The interested person is directed to the testimony

of

Dr.

Baer,

Tr2.

at 52—153,

and Mr. Dragovich,

Tr2.

at 154—191,

for a

more extensive explanation of particular provisions.

31 37-06L~9

---

—22—

standard,

and need not be specifically discussed here.

However,

there are several

around which question has teen raised.

“Registered Land Surveyor” and “Registered Professional

Engineer”

As observed above under the “Permitting” discussion,

the Board today adds definitions for registered land surveyor and

registered professional engineer.

These definitions are the same

as the definitions

in the Board’s landfill regulations at 35 Ill.

Adm.

Code 810.103 and groundwater regulations at

35

Ill.

Adm.

Code 615.102.

“P1MW”

The full statutory definition of P1MW has been

presented and discussed above.

It is also presented within the

body of the rule at Section 1420.10229.

As noted above,

there

have been

a few concerns raised regarding this definition,

some

of which have now been addressed by the General Assembly.

The

Board as no authority to modify the statutory definition.

Chemical Waste Management

(CWN)

has raised a question

regarding the role that the source

of a material plays

in

determining whether

a material

is P1MW

(Tr2.

at 282-305; PC #22).

CWM specifically asks that the Board clarify the definition

of

P1MW

regarding whether unused,

discarded test kits that contain

sterilized and not free—flowing blood components should be

considered

P1MW.

The Agency has stated that

it does not believe

such

a waste

is

P1MW

because it

is not waste from a health

facility.

(Tr2.

at 299.)

As

a general

rule,

a waste

is not a P1MW if

it has no

infectious potential and

is otherwise not explicitly

identified

in the statutory definition of P1MW,

its source notwithstanding.

It follows that an unused medical test kit, where the test kit is

not

in whole or part

a culture or stock,

an unused sharp,

contains blood components,

or somehow otherwise covered under the

statutory P1MW definition,

is not

P1MW.

“Site”

The term “site” appears

in many places within the

instant proposal,

including within other definitions

(“storage

site” and “transfer station”), within provisions defining the

circumstances under which permits and manifests are required3°

and within various provisions defining on— and off-site

29

~

is to be noted

that,

in accord with standard

construction,

statutory language

in the regulations

is denoted

by

capitalization.

34

Sections 1420.105(b) (1) and

(c) (1)

0! 37-0650

---

—23—

circumstances31.

There is thus

a special ii~portanceto having

the definition be clear and precise.

The following definition

is offered in the Agency Proposal:

“SITE” MEANS ANY LOCATION,

PLACE, TRACT OF LAND,

AND FACILITIES,

INCLUDING BUT NOT LIMITED TO BUILDINGS,

AND IMPROVEMENTS USED FOR PURPOSES SUBJECT TO

REGULATION OR CONTROL BY THIS ACT OR REGULATIONS

THEREUNDER.

(Section 3.43 of the Act).

In the case of

a hospital or an educational institution,

the Agency

shall determine what constitutes

a site based on

location,

ownership,

operation, charter or license.

The first, capitalized part of this definition

is identical

to the definition of “site” found

in the Act.

There

is, however,

concern with the lowercase, Agency—proposed

language.

The

purpose

of the lowercase language is to allow for flexibility

in

determining the geographic bounds of a site, particularly

in the

circumstance where an organization

(epitomized

by

hospitals and

universities)

may

consist of geographically separated buildings

and structures.

The intent

is to assure that such organizations

need not necessarily acquire separate permits for each structure

or manifest all loads transferred between buildings.

The

Agency’s resolution

of this matter

is to allow a case—by-case

determination under its supervision.

The problem with this resolution

is that it constitutes

a

delegation

of authority of questionable validity.

Accordingly,

the Board today declines to propose the lowercase language.

Several

alternative resolutions have been proposed.

Among

these

is the proposal

of the National Solid Waste Management

Association

(Exh.

53), which offers the following definition of

“site”:

(1)

Except for an institution of higher education

owned or operated by the state of Illinois,

all

buildings,

equipment,

structures, and other stationary

items which are located on a single property or on

contiguous or adjacent properties and which are owned

or operated by the same person

(or by any person which

controls,

is controlled by or under common control

with,

such person);

(2)

In the case of an institution

of higher education

owned or operated by the state of Illinois,

all

31

Sections 1421.120,

1421.130,

1421.131(a) (2) (E),

l421.13l(e)(2)(E),

1422.111(a),

l422.lll(a)(4),

and

1422. 111(h) (5) (B)

01

~7-O65i

---

—24—

buildings,

equipment,

structures and other stationary

items

located within the same county wh.ch are owned

and operated by the institution of higher education.

Ms. Ann Guild has also suggested that all activities that

fall under

a single institutional license should be considered

a

single site

(Exh.

51;

Tr2.

at 708—9).

Dr. Van Anderson presented language that would address the

particular concerns of the four campuses of the University

of

Illinois,

by explicitly defining each as a separate site:

The campuses and facilities

of the University of

Illinois under the management and control

of the Board

of Trustees as specified

in 144

Ill.

Rev.

Stats.

22 ~

~g.,

at the following locations:

(1) Urbana—

Champaign,

(2)

Chicago,

(3) Rockford,

and

(4)

Peoria.

The Board recognizes that the matter of campuses as single

entities is worth explicit consideration in these regulations.

Accordingly,

the Board today adds language specifying that each

campus constitutes

a single site.

The Board believes that the

term “campus” has sufficient ordinary meaning

as to itself be

explicit.

The result

is as follows:

“SITE” MEANS ANY LOCATION,

PLACE, TRACT OF LAND,

AND FACILITIES,

INCLUDING BUT NOT LIMITED TO BUILDINGS,

AND IMPROVEMENTS USED FOR PURPOSES SUBJECT TO

REGULATION OR CONTROL BY THIS ACT OR REGULATIONS

THEREUNDER.

(Section 3.43 of the Act).

In the cazc of

a~hospita1 or an educational institution,

the Agcnoy

shall determinc what constitutes a site based on

location,

ownership,

operation,

charter or 1icensc~r

the purpose of this Subtitle,

each campus of an

educational institution

is considered to be

a single

site.

The Board requests comment as to whether there are any other

aggregates

of facilities,

hospitals for example, which need also

to be specifically identified at this portion of the regulations.

In this regard,

the Board requests comment on whether the “single

institutional license” description is more workable for hospitals

than the proposed language offered by the NSWMA.

While

NSWMA’s

language appears to cover hospital “campus” situations,

it may be

too restrictive.

“Unrecognizable”

Pursuant to the definition of P1MW at

Section

3.84

of

the

Act all sharps are considered to be

P1MW

unless they meet

both

of the conditions:

The infectious potential has been eliminated from the

sharps by treatment;

and

0137-0652

---

—25—

The sharps are rendered unrecognizab1’~by treatment.

This definition has raised the question

of how the phrase

“rendered unrecognizable”

is to be interpreted32.

The issue is

significant

in that

it

factors into

a determination of when a

sharp no longer

is

a

P1MW.

In the original Agency Proposal

it

is recommended that the

term “unrecognizable”

be included within the general definitions,

as follows:

“Unrecognizable” means physical alteration

(i.e.,

melted,

charred, corroded,

or ground)

so that the sharp

may no longer be used for its intended purpose.33

It may be observed that an effect of this recommendation

is to

incorporate into the definition the concept of usability.

The

Board believes that this incorporation is consistent with the

P1MW

threat posed by sharps and the circumstance under which that

threat

is allayed.

Isolyser Company has questioned how the usability concept

would apply to sharps treated

by

their encapsulation-

solidification process.

(Tr2.

at 277-8.)

Under the Isolyser

process sharps are treated and bound into

a polymer matrix.

During the binding process pressure forces the polymer into the

barrels of syringes and needles, with the whole enclosed

in an

opaque container.

Isolyser contends that this process renders

the sharps no longer usable

(Tr2.

at 279; 663-94).

The Board

concludes that such treatment renders sharps unrecognizable for

the purposes of these regulations.

Although the Board accepts the Agency’s concept of the

definition

of “unrecognizable”

as contained

in its proposal,

it

notes that the definition needs

a technical correction.

As

proposed,

the definition

is that of

a noun,

although the word

“unrecognizable”

is an adjective.

Similarly,

“alteration”

is

a

noun,

and those terms that are examples of

“alteration” must also

be nouns.

32

The meaning

of infectious potential being “eliminated”

is

also at issue

in this proceeding.

A discussion of this matter

is

found

in the “General Considerations” portion of this opinion,

above.

~ The Agency later proposed adding

“and the sharp cannot be

easily identified” to this definition.

(Exh.

67.)

The Agency

posed this change in response to Board inquiries and suggestions

at hearing.

The Board believes the Agency’s original language

satisfies these concerns.

0

37-0653

---

—26—

As

a final matter, the Agency in reponse to Board inquiries

at hearing, proposed

in its errata

(Exh.

67)

to add the phrase

“and the sharp cannot be easily identified”

at the end of the

original definition.

The Board today retains this concept, but

in

a rephrased

form.

In sum, the Board today proposes the

definition modified as

follows:

“Unrecognizable” means relating to

a sharp that has

undergone physical alteration

(i.e.,

incited,

charred,

corroded,

or grounde.g.,

melting,

charring,

corroding,

or grinding)

so that the sharp

may

no longer be used~

or perceived

as usable,

for its intended purpose.

Incorporations

by

Reference

(Section 1420.103)

Incorporations

by

reference for the full P1MW subchapter

occur

at Section 1420.103.

All incorporations are placed

in one

section to simplify future amendments and updates,

and for more

ready reference.

Today’s proposal contains two incorporations

by reference.

They are Standard Methods for the Examination

of Water and

Wastewater

(17th Edition)

and Test Methods for Evaluating Solid

Waste, Physical/Chemical

Methods

(EPA

SW—846)34.

When asked at

hearing, Agency witness Dr.

Shirley Baer testified that Part 9000

of the Standard Methods reference discusses microbiological

examinations and Chapter

9 of SW—846 describes sampling protocols

such as those necessary for the tests required by this proposal

(Tr2.

241,

398-400).

The Board today proposes these

incorporations as presented in the Agency Proposal.

However,

in

observation that both references

are fairly lengthy, the Board

does ask whether greater specificity,

such as citation to those

more specific parts cited by Dr.

Baer, would be useful and how

this could be accomplished in the rule.

Prohibitions

(Section 1420.104)

Section 1420.104 sets out the P1MW prohibitions.

Much of

the section

is statutory,

as found at Section 56.1 of the Act.

Today Section 1420.104

is presented without modification

from the

Agency Proposal,

except as noted

in the following.

Subsections

(d) (1) and

(g) (1)

contain prohibitions against

transporting,

treating,

storing,

or transferring P1MW without

permits.

The Board has deleted the phrase referring to forms

~ The former

is referenced

in the Initial Efficacy Test

procedures

at

Section 1422.124(e) (2) and l422.Appendix A,

and

in

the Periodic Efficacy Test procedures at Section 1422.125(b)

(4)

The latter

is referenced

in the Initial Efficacy Test procedures

at

1422.Appendix

A.

O!37-065L~

---

—27—

which reads “and completed

in accordance with permit application

instructions and guidelines” from subsections

(d) (1) and

(g) (1)

The Board believes that this phrase conceivably could be the

basis for an enforcement action for failure to complete permit

applications according to Agency guidelines and instructions.

The Board does not intend to propose enforcement of Agency

instructions or guidelines since these are not rules nor are

intended to be rules.

In its errata submissions,

the Agency proposed adding a

additional prohibition at subsection

(1),

as follows:

No

person shall:

Cause or allow the discharge of P1MW

into a sanitary or combined sewer except

in accordance

with

35

Ill.

Adm. Code.Subtitle

C and local ordinances.

This proposal arises from concerns of the Metropolitan Water

Reclamation District of Greater Chicago

(MWRDGC) and the Illinois

Association of Wastewater Agencies.

(Tr2.

at 468-493;

Exh.

43

and

44;

PC

#6,

11, and

12.)

MWRDGC explains that the practice of

flushing ground/shredded

inert medical solid wastes into sewers

is an inappropriate use of the public sewerage system,

and that

the public sewerage system

is neither designed to function as a

landfill nor as

a depository for inert solid wastes regardless

of

origin.

MWRDGC discussed the difficulties posed to the

biological treatment system of a sewage treatment plant and

sludges when such solid materials are received

in the waste

stream.

(Tr2.

at 478-80.)

MWRDGC accordingly asked the Board to

include

a specific prohibition of the discharge of inert or solid

P1MW

into the sewerage system:

No

person shall:

Cause or allow the discharge of any

inert

or solid

P1MW,

or an inert or solid materials

resulting from the treatment of P1MW,

into any sanitary

sewerage system,

combined sewerage system,

or storm

sewerage system directly or indirectly tributary to

waters

of

the

State.

Such prohibition applies

to, but

is not limited to, absorbents, aluminum or other

metallic foils,

ash,

bone,

bedding materials,

cellulose, culture dishes,

garments and other cloth

materials,

gauze,

glass,

pads,

plastic,

sharps,

shavings,

straw and syringes.

In response the City of Chicago points out that MWRDGC

may,

under the authority given

it

by

the legislature,

enact its own

ordinance to cover the situation of solid P1MW.

(PC #18.)

However, the Board

is charged under Section 56.2

of the Act to

prescribe design and operating standards and criteria for all

potentially infectious medical waste treatment,

storage, and

transfer facilities,

which must include treatment that disposes

of treatment residuals in accordance with the Act and Board

regulations adopted thereunder.

The Board believes that disposal

0137-0655

---

—28—

of such treatment residuals is within the province of these

regulations and a prohibition involving sewage disposal

may

then

be necessary.

The question next becomes whether the Agency’s proposed

prohibition

or MRWDGC’s prohibition

is proper for these

regulations.

The Board believes that both the general

prohibition proposed by the Agency and the specific prohibition

covering solid P1MW are necessary in order to assure that any

discharge

of

P1MW

will be done in accordance with the Act and

Board regulations.

The record indicates that there are unique

problems associated with the disposal of solid

P1MW

into sewage

systems,

such as possible damage to the biological treatment

system and difficulties

in applying sludges to land,

that require

the more specific prohibition.

(See,

Tr2.

at 491—496.)

For

these reasons,

the Board today proposes to add to the Agency

proposal

at Section 1420.105(1)

underlined language as follows:

1)

Cause or allow the discharge of

P1MW

into a

sanitary or combined sewer except in accordance

with

35 Ill. Adm.

Code.Subtitle C.

No person

shall cause

or allow the discharge of inert or

solid

P1MW,

or inert or solid materials resulting

from the treatment of P1MW,

into any sanitary

sewerage system,

combined sewerage system,

or

storm sewerage system directly or

indirectly

tributary to waters of the State.

Such

prohibition applies to,

but is not limited to,

absorbents, aluminum or other metallic foils,

ash,

bone,

bedding materials,

cellulose,

culture

dishes,

garments and other cloth materials, gauze,

glass,

pads, plastic,

sharps,

shavings,

straw,

and

syringes.

Having so noted, the Board solicits further comment on this

issue, particularly on the matter of whether this prohibition

is

sufficiently inclusive but yet allows flexibility for new

treatment technologies.

The Board also deletes the phrase “and

local ordinances”

from the Agency proposed language at this

subsection and at proposed Sections 1421.121(f),

1421.141(f),

1422.111(a) (9),

and 1422.122(b) (1) because the Board has no

authority to enforce local ordinances.

The Board adds a “Board

note”

to the rule text alerting interested persons of local

ordinances covering sewer discharges.

Permit and Manifest Exceptions

and Penalty Factor

(Sections

1420.105 and 1420.106)

These two sections basically present language from the P1MW

statute.

Although the sections are critical,

they hence are not

amenable to substantive modification

at the Board

level.

0137-0656

---

—29—

As explained above under the “permitting” discussion,

the

Board

is proposing to insert in Section 1420105

a new subsection

(c).

The new subsection

(c) requires that engineering features

of plans, specifications,

and reports

in permit applications be

certified by

a registered professional engineer and must bear the

engineer’s seal and signature along with the signature and/or

seal of

a registered land surveyor.

Cleaning and Disinfection

(Section 1420.107)

Cleaning and disinfection are general actions required at

several places

in the P1MW subchapter,

including within the

definitions

(“reusable container”)

and Parts

1421 and l422~~.

Section 1420.107 provides for a single location at which the

elements

of cleaning and disinfection are presented.

No questions have been raised regarding the content or form

of Section 1420.107.

However, the Board today adds the metric

equivalent for the household bleach/sodium hypochlorite solution

at subsection

(a) (2) (C).

The Board also adds at subsection

(a) (2) (B) the phrase “as identified on its label”, pertaining to

the chemical disinfectant registered by the United States

Environmental Protection Agency.

The same phrase

is used

elsewhere

in the Agency Proposal36.

Severability

(Section 1420.120)

Section 1420.120 contains severability language as found

generally

in Board regulations.

PART-BY-PART ANALYSIS

-

Part

1421

Part 1421

is

a new part intended to address the mandate of

Section 56.2(c)

of the Act regarding the prescription

of

“standards and criteria for transporting, packaging,

segregating,

labeling,

and marking potentially infectious medical waste”.

The

part

is divided into five subparts,

each addressing one of the

natural divisions of the topic.

Part 1421 also has an Appendix A

that contains the International Biohazard Symbol.

The entire part

is proposed today without substantive

modification from the Agency Proposal.

~ Sections 1421.121(d),

1421.121(e),

1421.141(i),

1422.lll(a)(8),

1422.lll(a)(ll),

and 1422.l22(b)(5).

36

See definitions of “detergent—sanitizer” and “sanitizer” and

Section 1420.102.

0

37-0657

---

—30—

General Provisions

(Subpart A)

This short subpart contains a single section that specifies

that the date for compliance with Part 1421

is the effective date

of the part.

That is, compliance

is required immediately upon

the regulation becoming effective.

Waste Segregation

(Subpart B)

Subpart B consists of two sections that apply to all P1MW

generators,

transporters, storage

sites, transfer stations,

and

treatment facilities

(Section 1421.110).

A principal requirement,

found in Section 1421.111(a),

is

that generators

segregate P1MW into sharps,

oversized P1MW

(a

single waste item that is too large to be placed into

a 33—gallon

bag or container),

and all other.

These three categories are

derived from similar categories used

in Section 56.1 of the Act,

including the interim

P1MW

regulations found there.

Subsections 1421.111(b)

and

(c)

specify that properly

packaged and labeled sharps and mixed waste must be handled as

though the entire wastestream originated as

P1MW.

They do not,

however, preclude the applicability of other regulations.

For

example,

if

a hazardous substance

is also P1MW,

both the

hazardous waste and P1MW rules are intended to apply.

This latter provision has raised the question of whether

rules that govern

a waste as

P1MW

and rules that govern the same

waste under another categorization

(e.g., hazardous waste)

could

be

incompatible.

(Tr2.

at 252-268.)

The Board does not

immediately see that this presents

a problem.

As the Agency

indicates,

a waste that

is both P1MW and a hazardous waste may

occur,

but

is likely to be rare.

(Tr2.

at 271—276.)

Where

overlap does occur, compliance with rules applicable to both

P1MW

and hazardous wastes is required.

Packaging

(Subpart

C)

Subpart C consists of

standards and criteria for packaging

that apply to any person who packages

P1MW

for off-site

transportation.

(Section 1421.120.)

The standards and criteria, which are found

in Section

1421.121,

are designed to prevent discharge and protect handlers

from contact with P1MW

(Tr2.

at

27).

They include packaging

requirements for all P1MW,

with different standards for sharps

and oversized P1MW.

Also included are standards for reusable

containers,

standards for the management of the outside of

containers that are contaminated by P1MW,

and standards for

residues from the cleaning of

P1MW

containers or discharges

from

packages.

The Board deletes the phrase “that minimizes”

from the

0137-0658

---

—31—

Agency proposal at subsection 1421.121(c),

and replaces it with

“so as to avoid”.

It is broadly believed that packaging is a critical element

in

P1MW

management,

and that Subpart C correctly addresses that

matter.

Subpart C is fashioned

on the premise that performance

standards,

rather than design standards,

provide the most

effective method of assuring good P1MW management

(Trl.

at 100,

137;

Exhs.

38—5,

38—13,

38—35,

38—64,

38—65,

and 38—66)

Labeling and Marking

(Subpart

D)

This subpart applies to any person who packages P1MW for

off—site transportation or who accepts packages from off—site.

The specific standards for labeling and marking are found

in

Section 1421.131.

Among these are requirements for marking the

exterior of the outer package by the generator and

transporter(s)

,

and different standards for marking sharps

containers and oversized P1MW.

No questions have been raised regarding the content of

Subpart D;

it

is proposed today substantively as recommended

in

the Agency Proposal.

Transportation

(Subpart

E)

This subpart applies to transporters required to have

a P1MW

hauling permit.

It contains requirements regarding the

conditions under which

P1MW

can be transported,

including the

condition of the vehicle,

the management of the packages,

the

information that must be displayed on the vehicle, the emergency

response plan that

is required to be kept,

and a

10 calendar-day

limitation for the transportation of P1MW.

Mr. Harry Eiler of Recovery Corporation of Illinois

Precision Energy Systems,

Inc.

(Recovery Corporation), expressed

concern regarding the proposed requirement for “dedicated

vehicles” for

P1MW

management for “long-haul” vehicles37.

(Tr2.

776-814;

Exh.

54.)

Recovery Corporation also filed a public

comment on the issue.

(PC #24.)

Mr. Eiler believes that “long-

haul” vehicles

(i.e.,

those vehicles that engage

in interstate

transport)

should be allowed to backhaul “hardgoods”

(paint,

water seal stains,

plastic,

etc.)

after the vehicle has been

~ Subsection

(i)

reads:

“Vehicles transporting P1MW cannot

be used for the hauling of non-waste materials,

with the

exception of equipment and supplies intended for the use of waste

management,

new

P1MW

containers

or

P1MW

containers that have been

cleaned and disinfected

in accordance with

35 Ill.

Adm.

Code

1420.107

of this Subtitle”.

0137-0659

---

—32—

decontaminated

in accordance with the procedures given

in Section

1420.107.

Mr. Eiler said that the cost wou1c~increase 100

if a

long-haul vehicle were required to haul P1MW to one destination

and then return with an empty vehicle.

(Tr2.

at 796,

805.)

NSWMA

concurred with the use of dedicated

P1MW

vehicles and

cited Ohio and Texas regulations that do not allow use of medical

waste vehicles until decontamination has occurred.

Mr.

Eiler

agreed,

stating that decontamination should be done prior to

backhauling any hardgoods.

(Tr2.

at 781;

795-6.)

The Agency

expressed concern about enforcing decontamination standards in an

interstate

setting.

The possible use of “certificates of

decontamination” was discussed,

as was the use of enforcement

against a hauler when present

in Illinois.

(Tr2.

at 798-814.)

Mr.

Eastep stated that treatment conducted outside Illinois could

also not be enforced by Illinois; however, he further stated that

there are performance standards for treatment.

(Tr2.

at

810,

813.)

The Board is sympathetic with the concerns expressed

by

Mr.

Eiler.

While we do not today propose language changes allowing

for such backhauling,

the Board solicits specific draft language

that might accomplish this

end.

Specifically,

the Board solicits

language that allows “backhauling” of

“hardgoods”

by “long-haul

vehicles”

after decontamination has occurred,

and that provides

definitions of those terms.

Justification for all proposed

provisions

is also sought.

Comment is also requested as to why

this exception should only apply to vehicles delivering

interstate.

The Board has questioned the provision of Section

1430.141(i)

that allows equipment and supplies intended for waste

management to be transported

in a vehicle transporting

P1MW

and

sought clarification

on the types of materials allowable.

(Tr2.

at 349-50.)

This question was reiterated to the Agency at the

August hearing and the Agency provided a list of “acceptable”

waste management supplies

(Exh.

75, attachment

1)

.

These are

incorporated into the rule as examples at subsection

(i).

Mr.

Eiler also offered an addition to the proposed rules

that would allow for multi—stop manifesting.

The Agency objected

to this testimony because

it pertains to manifesting.

The Board

overrules the objection for the same reasons as stated earlier

regarding Mr. Frank’s testimony.

Mr. Eiler stated at hearing

that he would attempt to discuss these matters with the Agency.

The concerned participants

are requested to comment

if they

believe that some additional clarification is needed

in the

proposed rules as opposed to the manifest form prescribed

by

the

Agency.

The remainder of the Subpart E provisions

are offered in the

same form as presented by the Agency.

01 37-O5~Ø

---

—33—

PART-BY-PART ANALYSIS

-

Part 1422

Part

1422

is addressed to the mandate of Section 56.2(a)

of

the Act regarding the prescription of “design and operating

standards and criteria for all potentially infectious waste

treatment,

storage, and transfer facilities”.

Like Part 1421,

Part 1422

is

a new part.

General Provisions

(Subpart A)

This short subpart contains

a single section that specifies

that the date for compliance with Part

1422

is the effective date

of the part.

That

is, compliance

is required immediately upon

the regulation becoming effective38.

Storage,’Transfer Operations

(Subpart

B)

Subpart B consists of two sections that apply to the owner

or operator of any

P1MW

storage operation39.

The subpart

is

proposed today without substantive modification

from the Agency

Proposal.

Design and operating requirements, which occur at Section

1422.111,

constitute the principal standards and criteria of the

subpart.

Standards and criteria applicable to any person who

stores

P1MW

prior to treatment or disposal on—site or transport

off—site are contained in subsection

(a); these apply whether or

not a permit

is required for the storage operation.

Many of

these standards are repeated from Section 56.1(e)

of the Act,

including requirements for maintaining the integrity

of the

packages,

limiting access to the storage operation, maintaining

the P1MW

in

a nonputrescent state,

and protecting the

P1MW

from

animals and vectors.

Other requirements

in this subsection

include the management

of reusable

P1MW

containers and residues,

retention of manifest copies,

and closure of the storage

operation.

~ This provision notwithstanding,

it should be noted that

in certain circumstances the requirements

for an existing unit

are different than those

for a unit that begins operation after

the effective date.

An example

is the Initial Efficacy Test

requirement for an autoclave,

incinerator,

or ethylene oxide unit

at Section

1422.123(c).

~ For the purpose of l422.Subpart

B a storage operation

is

defined at Section 1422.110 to collectively

include

a “storage

site”

or

a

“transfer station”.

The latter two terms are defined

in the Act at Sections 3.47 and 3.83,

respectively, and repeated

in the instant proposal

in the definitions at Section 1420.102.

0137-0661

---

—34—

Subsection 1422.111(b)

contains additional standards for

those storage operations that are required

tc

have

a permit.

These basically are facilities that receive waste from off—site.

(Tr2.

at

30).

The standards include more detailed requirements

regarding to operating records,

aisle space,

the manner of

storage,

signs, personnel training, contingency plan,

storage

time limitations,

and notification of closure.

As the Agency

notes:

These requirements are necessary to meet the intent of

the Act to reduce the potential environmental and

public health risks associated with P1MW,

since the

permitted storage operation is not normally the

generator of the waste.

The owner or operator of the

storage operation does not possess the same knowledge

of the waste

as the generator and does not maintain the

same control over what

is placed in the packages as the

original generator.

In addition,

safeguards are

necessary because

P1MW

is stored for varying lengths of

time and under varying conditions.

(Tr2.

at 165-75.)

It is to be noted that the standards and criteria

of both

1422.111(a)

and

(b) constitute requirements for the granting of

a

permit for a storage operation.

As

a general matter,

for any

permit to be issued the applicant must prove to the Agency,

pursuant to Section 39(a)

of the Act,

that it will not cause a

violation of the Act or regulations promulgated thereunder.

Accordingly,

failure to supply proof of meeting any of the

Section 1422.111 requirements could be grounds for permit denial.

Treatment

(Subpart

C)

This subpart applies to all facilities that treat P1MW to

eliminate

its infectious potential.

P1MW may not be disposed of

in Illinois unless it has been

treated

in accordance with the standards

of this subpart; the

standards apply whether the treatment occurred at a facility

located

in Illinois or elsewhere

(Section 1422.120).

At Section

1422.121

it

is required that there be certification of the

treatment:

No person shall cause

or allow the disposal of any

P1MW

where the infectious potential has been eliminated by

treatment unless the treatment facility certifies to

the transporter,

if other than the generator,

and

certifies to the landfill operator or receiving

facility operator that the P1MW has been treated in

accordance with this Part,

and,

if applicable,

with all

terms and conditions

specified

in its operating permit.

Data to verify the efficacy of the treatment unit shall

be made available to the receiving facility.

No person

0

37-0662

---

—35—

shall falsely certify that

P1MW

has been treated

in

accordance with this Part.

Design and operating requirements for

P1MW

treatment

facilities occur in Section 1422.122.

Subsections

(a) and

(b)

apply to all treatment facilities,

including those that do not

require a permit.

Requirements include proper management of

residues,

filing of an annual report,

and the cleaning and

disinfection of the facility upon closure.

Mechanical treatment

of P1MW is allowed only if

it is an integral step

in the

treatment process;

this is to minimize the dispersion of airborne

particles

(Tr2.

at 33).

Subsection

(C)

of Section 1422.122 contains additional

requirements that apply to those treatment facilities for which

a

permit

is required.

These include personnel training,

a written

contingency plan,

and a written operating record to be kept at

the facility.

As noted above in reference to Section 1422.110,

these provisions constitute requirements for the granting of a

permit.

Section 1422.123 contains standards for treatment units.

The emphasis is on performance standards rather than on

authorization of particular techniques or technologies.

Most

fundamentally,

the treatment unit must be designed and operated

to eliminate the infectious potential

of

P1MW

(subsection

(a) (1))

.

It must also be operated

in modes determined by

manufacturer’s specifications and under the same conditions that

are used

in the efficacy demonstrations

(subsections

(a) (2)

to

(a) (5)).

The same level

of treatment

is required whether Agency

permits are required or not.

Subsection

(b)

of 1422.123 allows treatment units to be used

by treatment facilities not required to have permits if the unit

meets certain requirements

of the subsection.

Subsection

(b) (2)

allows the unit to be operated under an adjusted standard granted

by

the Board.

Subsection

(b) (1) allows the unit to be operated

if the unit uses thermal, chemical,

or irradiation treatment

((b) (1) (A))

,

and the unit “is mechanically identical to one

previously permitted

in Illinois for the treatment of

P1MW”

((b)(1)(B)),

and

is operated under basically identical operating

conditions as the permitted unit.

Allowing an “identical” unit to operate under the same

conditions

as a permitted facility or unit seems as though it

would save the “identical” unit operator

(and the Agency)

the

time and expense necessary to obtain its own permit or an

adjusted standard.

However, this type of

arrangement raises many

questions pertaining

to operation and possible enforcement,

since

the unit would not be operated under

its own permit.

Some of the

questions were addressed by the Agency at hearing and

in

responses filed subsequent to hearing

(Tr2.

at 1053-9;

Exh.

75).

0137-0663

---

—36—

The Board continues to be disturbed

by

the implications of

such an arrangement.

The question was raised concerning the

subsequent modification of the permitted unit and issuance to

that unit of

a new, modified permit.

The Agency responded that

the unpermitted but identical facility may still operate under

the terms of the original permit.

(Exh.

75 at 9.)

However, the

unpermitted facility would no longer be identical,

and hence,

may

fall out of the terms of rule.

An argument can be made that the

unpermitted unit

is identical to “one previously permitted”

((b) (1) (B)

emphasis added).

This raises other questions

regarding possible difficulty with tracking older permits.

Also,

the permit—exempt facility operator would not have the same

appeal rights as a permit holder,

since the permit-exempt

facility operator was not issued any permit.

Since the permit-

exempt facility operator has chosen to operate under conditions

of another’s permit,

it may be unlikely that the permit-exempt

facility operator would ever seek appeal.

(See Exh.

75 at 9.)

It

is the permit—exempt operator who would determine whether he

or she

is

operating

a mechanically identical

unit.

This has

raised questions of whether the rule allows for an unlawful

delegation of the Agency’s authority to issue permits.

Since the

facility would be permit exempt,

and no permit

is actually

issued,

it can be argued that there

is no delegation problem.

The bottom line is that there are uncertainties and possible

greater exposure to enforcement by such an approach.

We decline

today to propose specific amendments and seek further comment

from interested persons on the matter.

One solution is that Section

1422.123(b) (1) (B)

be omitted.

Case law has held that having a permit does not insulate the

permittee,

and by extension,

any person similarly operating

in

reliance on that permit,

from an enforcement action for allegedly

violating the Act or Board regulations.

The permittee

is simply

protected from charges

of operating without a required permit;

if

the permit

is required,

it

is an authorization to operate,

not an

insulation against enforcement.

(Landfill,

Inc.

v.

IPCB

(1978),

74 I11.2d.

541,

387 N.E.2d 258;

see also Illinois Power Company

v.

IPCB

(5th Dist.

1983),

122 Ill.App.3d

457,

445 N.E.2d

820.)

For example, the Act gives any person the right to enforce

if

later periodic verification tests show that one

of the units,

whether or not it

is that of the permittee,

is not continuing to

perform as required in the Board regulations.

In so saying, we wish to emphasize that the Agency’s

detailed review under the permitting system

is considered a vital

component in the State’s environmental regulatory scheme.

We

note,

though,

that where

a permit

is not required,

operators

in

other areas also face

a similar dilemma

to that occurring here.

This was discussed

in relation to on-site landfills

in In the

Matter

of: Development,

Operating and Reporting Reguirements

for

0j37-06614

---

—37—

Non—Hazardous Waste Landfills

(June

7,

1990),

R88—7

at

6,

112 PCB

84).

We note that the proposed regulatory standards give quite

detailed directions to those who are not required to have a

permit.

We

also note that there

is nothing preventing an

unpermitted facility from complying with the additional

requirements in Section 1422.122(c)

for those needing a treatment

facility permit.

We suggest that the use of the Board’s adjusted

standard procedure may provide a remedy for many of the concerns

expressed above.

For example,

if

a commercial treatment process,

including an innovative one,

is granted an adjusted standard by

the Board after

a demonstration has been made justifying the

treatment process

in relation to the regulatory standards,

the

adjusted standard can contain conditions such

as requiring

notification to the users of the process certifying that the

adjusted standard has been granted.

Similarly,

if an adjusted

standard has been granted for a modification,

then a similar

certification can take place.

The Initial Efficacy Test requirements are set out

in

Section 1422.124, with supporting materials present in Section

1422.Appendix A.

The Initial Efficacy Test is

a one-time

demonstration made for each model of

a particular treatment unit

that demonstrates that the unit will achieve

a 6-log reduction of

all vegetative microorganisms.

(Tr2.

at 34.)

Section 1422.125,

supported by Section l422.Appendix

B,

sets

out the requirements

of the Periodic Verification Tests.

These

are tests that are designed to be performed on an ongoing basis

to ensure that treatment efficacy continues.

The Board has made one minor change worth noting.

The text

of the Agency’s proposal at

1422.125(a) (3) was moved to

(a) (4)

The text of subsection

(a) (3)

covers alternatives that are

defined and discussed mainly in

(a) (4).

The subsection was then

renumbered to accommodate this change.

The Board solicits comments,

especially from the treatment

industry,

as to the workability and clarity of the methods set

out

in Sections 1422.124 and 125 and 1422.Appendix A and B.

The

Board also solicits comment on what procedures the Agency will

use for approval of alternative periodic verification tests

discussed at renumbered Section 1422.125(a) (3).

In addition,

the Board notes that there are a number

of

issues

in the treatment Sections 1422.124 and 1422.125 for which

additional clarification of

intent is desirous.

Accordingly, the

Board requests that

interested persons, and the Agency

in

particular,

address the following questions and provide

suggestions for clarifying language where appropriate:

0)37-0665

---

—38—

1)

Section 1422.124(e) (2) requires

that test or

indicator microorganisms be cultured an~’enumerated

according to “applicable manufacturer’s”

recommendations; this language is repeated in Section

1422.125(b)(4).

Is this “manufacturer” intended to be

the manufacturer of the treatment unit, the

microorganism test unit,

or some other?

2)

Section 1422.124(f) requires that the Document of

Initial Efficacy Demonstration be prepared by and

retained

by

the treatment facility.

Since

it

is the

manufacturer of

a treatment unit that

is responsible

for conducting the Initial Efficacy Test,

is this

requirement reasonable?

3)

Section 1422.125 (a) (2) requires that the log kill

(L)

from the Initial Efficacy Test be correlated to an

equivalent log kill

(T) calculated pursuant to Section

1422.Appendix

B.

However, three equivalent log kill

(T)

calculations are made pursuant to Section

1422.Appendix B

(TA,

TB,

and TC).

Which of these

equivalent

log kills

(T)

is the appropriate standard to

be used

in Periodic Verification Testing by the

treatment facility?

4)

Section l422.Appendix B

(a) requires that a

“certified microbiological

indicator assay containing

the test microorganisms and indicator microorganism

spores”

be used.

How

is this certification obtained

and is an assay containing both the proposed test and

indicator microorganisms widely available?

5)

Section l422.Appendix B

(b) requires that the test

microorganisms and indicator microorganism spores be

placed

in

a sealed container that remains intact during

treatment for the Periodic Verification Test.

In the

method for the Initial Efficacy Test

(Appendix

A),. two

types

of testing are allowed,

one for treatment

technologies that can maintain the integrity of the

test container and one for those

in which integrity

cannot be maintained.

How does the Periodic

Verification Test differ from the Initial Efficacy Test

in this regard?

Section 1422.126 sets out those conditions,

in addition to

elimination of infectious potential,

that are necessary before

a

sharp

may

be landfilled.

Section 1422.127

also allows the Agency to issue an

experimental treatment permit

for a period of up to

two

years,

renewable

once.

Experimental permits are for processes

or

techniques that do not otherwise satisfy the standards of Subpart

0)3/-0666

---

—39—

C40.

Residues from a treatment unit with

an

experimental permit

may

or may not be considered P1MW,

depending on the experimental

permit conditions.

Discussion of the principal questions regarding the

treatment provisions of the instant proposal has been presented

above

(see “General Considerations”).

One matter which remains

is the recommendation that tap water be allowed as

a substitute

for a chemical disinfectant

in the portion

of the Initial

Efficacy Test that determines the appropriate microbial challenge

for the actual test

(Phase 1).

Winfield

(PC #8) requested that

dechlorinated water be allowed in substitute for the

disinfectant.

The Agency has proposed the use of sterile saline

solution

(0.9,

volume/volume)

or phosphate buffer solution in

place of the chemical disinfectant(s).

The Agency’s concern

is

the osmotic nature of tap water versus that of

a physiological-

like solution.

The purpose of the Phase

I method

is to determine

how many microorganisms are destroyed by the mechanical process

without any application of treatment.

If an inappropriate (non-

isosmotic)

solution

is used

in this part,

more microorganisms

may

be destroyed by the hyposmotic nature of the tap or dechlorinate

water and the Phase

I measurement may be inaccurate relative to

Phase II testing

(Tr2.

at 229)

.

Dr. Cole argues that the use of

physiological buffers like saline or phosphate buffer would

impose an immense burden on those operating chemical treatment

systems.

The Board notes that this requirement is present only

in the Initial Efficacy Test which is required of manufacturers,

not operators

(unless the operator is the

manufacturer)

,

and

is

required to be made once per model,

not per unit.

A once per

model burden to more accurately document efficacy does not appear

unduly burdensome to this Board.

However,

we solicit further

comment

on the appropriate liquid.

Dr. Cohen suggests that the six test microorganisms may be

run through the Initial Efficacy Test together rather than

separately as proposed by the Agency

in Section 1422.Appendix A

(Exh.

46 at 15).

After questioning regarding appropriate methods

to simultaneously identify and quantify multiple species of

microorganisms from a single inoculum,

Dr. Cohen submitted

a

proposed method as Exhibit

70.

The Board solicits comment about

which method

is the most appropriate and effective.

40

In

the Agency

Proposal

the word

“Part”

was used within

Section 1422.127(a)

to denote the scope

of possible experimental

permits.

This

reading

would

allow

experimental

permits

to

be

issued for both storage operations and treatment facilities.

Today

the

Board

replaces

the

word

“Part”

with

“subpart”,

to

limit

experimental

permits

to

treatment

matters,

as

is

the

seeming

intention.

0137-0667

---

—40—

ORDER

The Board hereby proposes for first notice the following

amendments

to 35

Ill. Adm.

Code 1420 and the following new Parts

35

Ill.

Adm.

Code 1421 and 1422.

The Clerk of the Board is

directed to file these proposed rules with the Secretary of

State.

TITLE 35:

ENVIRONMENTAL PROTECTION

SUBTITLE

M:

BIOLOGICAL MATERIALS

CHAPTER I:

POLLUTION CONTROL BOARD

SUBCHAPTER

b:

POTENTIALLY INFECTIOUS MEDICAL WASTES

PART 1420

GENERAL PROVISIONS

Section

1420.101

Scope and Applicability

1420.102

Definitions

1420.103

Incorporations by Reference

1420.104

Prohibitions

1420.105

Permit and Manifest Requirements

and Exceptions

1420.106

Penalty Factor

1420.107

Cleaning and Disinfection

1420.120

Severability

AUTHORITY:

Implementing and authorized by Section~56.2-fe

~

27

of the Environmental Protection Act (Ill.

Rev.

Stat. 19~-9~,

ch.

ill 1/2,

pars.

1056.2(c),

as added by P.A.

87—752 effective

January

1,

1002,

as amended by P.A.

87-1097, effective January 1~

1993~ and 1027)

SOURCE:

Adopted in R91-l9,

at 16

Ill.

Reg.

2594,

effective

February

3,

1992;

amended

in R91-20 at

_____

Ill. Reg.

_______

effective

____________________

NOTE:

Capitalization denotes statutory language.

1420.101

Scope and Applicability

a-)--This Subtitle applies to all persons who generate,

transport,

treat,

store,

or dispose of potentially infectious medical waste.

It sets forth standards for such activities occurring in whole or

in part within the State of Illinois.

b)

This

Part

sets forth definitions that apply throughou-t

this Subtitle cxc~nt as ~~cifica~v

r~ovidcd

otherwise.

~i-uw

r~Lrir~: ~CCLI0n

~b.~U)

requires

the Board to

repeal pre-existing rules for handling medical waste-s

by

January

1,

1992.

Section 56.2(c)

requires the Board

0137-0668

---

—41—

to adopt by January

1,

1092

a

1i3-t of Class 4

etiolog-i-e

agents,

which lends operative mcanng to “isolation

-

“

~

t.~t

tx~rm

i ~

ii~-~

in

th~

~tntntr~—v

definition of potentially infectious medical waste at

Section 3.81.

Section 56.2(a)

and

(c) require the

Board to adopt standards for the transportation,

packaging,

segregation,

labelling,

and marking of

potentially infectious medical waste by January

1,

1993.

Section 56.2(f)

authorizes additional rules to

promote the purposes of Title

XV

of the Environmental

Protection Act

(Ill.

Rev.

Stat.

1989 ch.

111½,

par.

1001 et seq.,

as amended by P.A.

87-752,

effective

January

1,

l992~.

Section 1420.102

Definitions

All definitions set forth

in this Section shall have the

following meanings throughout this Subtitle,

unless specifically

provided otherwise.

Words and terms not defined have the

meanings set forth

in the Act.

“Act” means the Environmental Protection Act

(Ill.

Rev.

Stat.

l9-8-~91, ch.

111 1/2, par.

1001 et seq.,

as

amended by P.A.

87—1097, effective January

1,

1993 752

and P.A.

87—650,

both effective January

1,

1092).

“Agency” means the Illinois Environmental Protection

Agency.

“ATCC” means American Type Culture Collection.

“Board” means the Illinois Pollution Control Board.

“CFU” means colony forming unit.

“Chemical treatment” means the treatment

of P1MW in

a

unit that uses disinfectants or chemicals as the

primary means to eliminate the infectious potential

of

the waste.

Examples of chemical treatment are ethylene

oxide,

chlorine,

and ozone.

“Class

4 etiologic agent” means

a pathogenic agent that

is extremely hazardous to laboratory personnel or that

may cause serious epidemic disease.

Class

4 etiologic

agent

includes the following viral agents:

Alastrim,

Smallpox,

Monkey pox,

and Whitepox

(when

used for transmission or animal inoculation

experiments)

0137-0669

---

—42—

Hemorrhagic fever agents

(including Crimean

hemorrhagic fever

(Congo),

Jurin, and Machupo

viruses,

and other not yet detined)

Herpesvirus simiae

(Monkey B virus)

Lassa virus

Marburg virus

Tick-borne encephalitis virus complex

(including

Absettarov,

Hanzalova,

HYPR,

Kumlinge,

Russian

spring—summer encephalitis, Kyasanur forest

disease,

Omsk hemorrhagic fever,

and Central

European encephalitis viruses)

Venezuelan equine encephalitis virus

(epidemic

strains, when used for transmission or animal

inoculation experiments)

Yellow fever virus

(wild, when used for

transmission or animal inoculation experiments)

BOARD NOTE:

A Class

4 Agent helps define an

“isolation waste” for the purposes of Section

3.8-~4(a)(6) of the Act and this Subtitle.

This

listing derives from the CDC document,

“Classification

of Etiologic Agents on the Basis

of Hazard,” and

is supplemented

from the CDC/NIH

document “Biosafety in Microbiological

and

Biomedical Laboratories.”

“Container” means

a receptacle that does not contain

P1MW.

“Detergent” means

a cleansing substance that contains

surface—active agents for rapid wetting,

penetration,

and emulsification of fats and oils,

plus

a

sequestering agent.

“Detergent—sanitizer cleaner” means an agent that is

both a detergent and sanitizer.

The sanitizer must be

registered by the United States Environmental

Protection Agency,

as identified on its label.

“Discharge” means the accidental

or intentional

spilling,

leaking,

pumping, pouring,

emitting,

emptying

or dumping of waste

into or on any land or water.

This

does not include the normal loading and unloading

of

P1MW from a vehicle.

UI 37-0670

---

—43—

“Enclosed compartment” means

a c.~mpartmentthat

provides protection from the elemerts,

prevents

spillage,

and prevents containers from falling off the

vehicle.

The enclosed compartment cannot be used to

meet the packaging requirements

of

35

Ill.

Adm. Code

1421.Subpart

C.

“Equivalent log kill”

(T) means the logarithm of the

indicator microorganisms that must be killed and

correlates,

at

a minimum, to

a 6—log reduction of

viable test microorganisms.

“HIGHLY COMMUNICABLE DISEASE” MEANS THOSE DISEASES

IDENTIFIED AS CLASS 4 ETIOLOGIC AGENTS under this Part.

(Section 3.8-14(a) (6)

of the Act)

“Indicator microorganisms” means those microorganisms

listed

in

35 Ill.

Adm.

Code 1422.Appendix A,

Table

B,

as classified by ATCC.

“International Biohazard Symbol” means the symbol that

is shown in

35 Ill.

Adm.

Code l421.Appendix

A.

“Irradiation treatment” means the treatment of

P1MW

in

a unit that uses ionizing radiation as the primary

means to eliminate the infectious potential of the

waste.

Examples of irradiation treatment are gamma

(cobalt

60) and electron beam.

“ISOLATION WASTE” MEANS DISCARDED WASTE MATERIALS

CONTAMINATED WITH BLOOD,

EXCRETIONS,

EXUDATES, AND

SECRETIONS FROM

H~NS

THAT ARE ISOLATED TO PROTECT

OTHERS FROM HIGHLY CO~~ICABLEDISEASES.

(~cction

3.81(a)

(C)

of thc Act)

“Log” means logarithm to the base ten

(10)

“Log kill”

(L) means the difference between the

logarithms of viable test microorganisms or indicator

microorganisms before and after treatment.

“Low-level disinfection” means

a process that causes

the death of most bacteria except Nycobacterium

tuberculosis and M. bovis,

lipid-enveloped

and

medium-sized viruses

(e.g., herpes simplex virus,

cytomegalovirus,

respiratory syncytial virus, hepatitis

B virus,

and human immunodeficiency virus)

,

and fungi

(e.g.

,

Trichophyton

sp.

,

Cryptococcus sp.,

and Candida

sp.)

0137-0671

---

—44—

“Oversized

P1MW”

means

a single waste item that

is too

large to be placed into

a thirty—three

(33)

gallon

b~q

or container.

“Registered land surveyor” means a person registered

under the Illinois Land Surveyors Act

(Ill.

Rev.

Stat.

1989,

ch.

111,

pars.

3201 et seq.).

“Registered professional engineer” means

a person

registered under the Illinois Professional Engineering

Act (Ill.

Rev.

Stat.

1989,

ch.

ill, par.

5101 et seq.).

“Package” means

a receptacle that contains P1MW.

“PFU” means plaque forming unit.

“POTENTIALLY INFECTIOUS MEDICAL WASTE” or

“P1MW”

MEANS

THE FOLLOWING TYPES OF WASTE GENERATED

IN

CONNECTION

WITH THE DIAGNOSIS,

TREATMENT

(I.E., PROVISION OF

MEDICAL SERVICES),

OR IMMUNIZATION OF HUMAN BEINGS OR

ANIMALS; RESEARCH PERTAINING TO THE PROVISION OF

MEDICAL SERVICES;

OR THE PROVISION OR TESTING OF

BIOLOGICALS:

CULTURES

AND

STOCKS;

HUMAN

PATHOLOGICAL WASTES;

HUMAN

BLOOD

AND

BLOOD PRODUCTS

USED SHARPS;

ANIMAL

WASTE;

ISOLATION

WASTE;

AND

UNUSED

SHARPS.

CULTURES AND STOCKS.

THIS WASTE SHALL INCLUDE BUT

NOT BE LIMITED TO CULTURES AND STOCKS OF AGENTS

INFECTIOUS TO HUMANS, AND ASSOCIATED BIOLOGICALS;

CULTURES FROM MEDICAL OR PATHOLOGICAL

LABORATORIES; CULTURES AND STOCKS OF INFECTIOUS

AGENTS FROM RESEARCH AND INDUSTRIAL LABORATORIES;

WASTES FROM THE PRODUCTION

OF BIOLOGICALS;

DISCARDED LIVE OR ATTENUATED VACCINES;

OR CULTURE

DISHES

AND

DEVICES USED TO TRANSFER,

INOCULATE, OP

MIX CULTURES.

HUMAN

PATHOLOGICAL WASTES.

THIS WASTE SHALI~

INCLUDE TISSUE,

ORGANS,

AND

BODY PARTS (EXCEPT

TEETH AND THE

CONTIGUOUS STRUCTURES OF

BONE AND

0137-0672

---

—45—

GUM),

BODY FLUIDS THAT ARE REMOVED DURING SURGERY~

AUTOPSY, OR OTHER MEDICAL PROCEDURES;

OR SPECIMENS

OF BODY FLUIDS AND THEIR CONTAINERS.

HUMAN BLOOD AND BLOOD PRODUCTS.

THIS WASTE SHALL

INCLUDE DISCARDED HUMAN BLOOD, BLOOD COMPONENTS

(E.G.,

SERUM

AND PLASMA),

OR SATURATED MATERIAL

CONTAINING FREE FLOWING BLOOD OR BLOOD COMPONENTS.

USED SHARPS.

THIS WASTE SHALL INCLUDE BUT NOT BE

LIMITED TO DISCARDED SHARPS USED IN ANIMAL OR

HUMAN PATIENT CARE,

MEDICAL RESEARCH, OR CLINICAL

OR PHARMACEUTICAL LABORATORIES; HYPODERMIC,

INTRAVENOUS,

OR OTHER MEDICAL NEEDLES; HYPODERMIC

OR INTRAVENOUS SYRINGES; PASTEUR PIPETTES; SCALPEL

BLADES;

OR BLOOD VIALS.

THIS WASTE SHALL ALSO

INCLUDE BUT NOT BE LIMITED TO OTHER TYPES OF

BROKEN OR UNBROKEN GLASS

(INCLUDING SLIDES AND

COVER SLIPS)

IN CONTACT WITH INFECTIOUS AGENTS.

ANIMAL

WASTE.

ANIMAL WASTE MEANS DISCARDED

MATERIALS,

INCLUDING CARCASSES,

BODY PARTS,

BODY

FLUIDS,

BLOOD, OR BEDDING ORIGINATING FROM ANIMALS

INOCULATED DURING RESEARCH,

PRODUCTION OF

BIOLOGICALS,

OR PHARMACEUTICAL TESTING

WITH

AGENTS

INFECTIOUS TO

HUMANS.

ISOLATION

WASTE.

THIS WASTE SHALL INCLUDE

DISCARDED MATERIALS CONTAMINATED WITH BLOOD,

EXCRETIONS,

EXUDATES, AND SECRETIONS FROM HUMANS

THAT ARE ISOLATED TO PROTECT OTHERS FROM HIGHLY

COMMUNICABLE

DISEASES.

“HIGHLY

COMMUNICABLE

DISEASES” MEANS THOSE DISEASES IDENTIFIED

BY THE

BOARD

IN RULES ADOPTED UNDER SUBSECTION

(e) OF

SECTION

56.2

OF

the

ACT.

(See Section 1420.102

of

this Part).

UNUSED SHARPS.

THIS WASTE SHALL INCLUDE BUT NOT

BE

LIMITED

TO

THE

FOLLOWING

UNUSED,

DISCARDED

SHARPS:

HYPODERMIC,

INTRAVENOUS,

OR OTHER

NEEDLES;

HYPODERMIC

OR

INTRAVENOUS

SYRINGES;

OR

SCALPEL

BLADES.

POTENTIALLY

INFECTIOUS

MEDICAL

WASTE

DOES

NOT

INCLUDE

THE

FOLLOWING:

WASTE GENERATED

AS GENERAL HOUSEHOLD

WASTE;

WASTE

(EXCEPT

FOR

SHARPS)

FOR

WHICH

THE

INFECTIOUS

POTENTIAL

HAS

BEEN

ELIMINATED

BY

TREATMENT;

OR

0)37-0673

---

—46—

SHARPS THAT MEET BOTH 3F THE FOLLOWING

CONDITIONS:

THE

INFECTIOUS

POTENTIAL

HAS

BEEN

ELIMINATED FROM THE SHARPS BY TREATMENT;

AND

THE SHARPS ARE RENDERED UNRECOGNIZABLE

BY TREATMENT.

(Section 3.84

of the

Act)

“Putrescence” means the partial decomposition of

organic matter by microorganisms

so as to cause

malodors,

gases,

or other offensive conditions,

or th~

is capable of providing food for vectors.

“Reusable container” means

a receptacle that meets th~

reguirements of

35

Ill.

Adm.

Code 1421.121(a)

and

(b) ~

is made and repaired with materials that are corrosion

resistant,

non—absorbent,

and smooth; and designed and

constructed so as to easily permit cleaning and

disinfection

in accordance with Section 1420.107 of

this Subtitle.

A reusable container

is not

a

single-use container or

is not made of cardboard.

“Sanitizer” means an antimicrobial agent that

is

intended for application to inanimate objects

or

surfaces for the purpose of reducing the microbial

count to safe

levels.

The sanitizer must be registere~

by the United States Environmental Protection Agency,

as identified

on its label.

“Sharps” mean unused sharps and used sharps as stated

in

the

definition

of

potentially

infectious

medical

waste

in

this

Section

with

or

without

residual

fluids.

“Significant

mechanical

change”

means

the

substitution

or

addition

of

mechanical

parts

that

result

in

different

operating

conditions.

A

significant

mechanical change does not mean the replacement of

a

part(s)

that meets the same specifications as the

original part.

“Single-use container” means

a container intended by

the manufacturer

for one use only,

such as biohazard

bags.

“SITE” MEANS ANY LOCATION,

PLACE, TRACT OF LAND,

AND

FACILITIES,

INCLUDING BUT NOT LIMITED TO BUILDINGS,

AND

IMPROVEMENTS

USED FOR PURPOSES SUBJECT TO REGULATION

OR

CONTROL

BY

THIS ACT OR REGULATIONS

THEREUNDER.

-

(Section 3.43

of the Act)

.

For the purpose

of this

01 37-067L~

---

—47—

Subtitle,

each campus of an educational institution

is

considered

to be

a single site.

“6—log

reduction”

means

a

6

decade

reduction

or

a

one

millionth

(0.000001)

survival

probability

in

a

microbial

population.

“STORAGE”

MEANS

THE

CONTAINMENT

OF

WASTE,

EITHER

ON

A

TEMPORARY

BASIS

OR

FOR

A

PERIOD

OF

YEARS,

IN

SUCH

A

MANNER

AS

NOT

TO

CONSTITUTE

DISPOSAL.

(Section

3.46

of

the

Act)

“STORAGE SITE” means A SITE AT WHICH WASTE

IS

STORED.

“STORAGE

SITE”

INCLUDES TRANSFER STATIONS.

(Section

3.47

of

the

Act)

“Test

microorganisms”

means

those

microorganisms listed

in Section 1422.Appendix A, Table A, as classified by

ATCC.

“Thermal treatment” means the treatment of P1MW in a

unit that uses elevated temperatures as the primary

means to eliminate the infectious potential of the

waste.

Examples of thermal treatment are incineration,

steam sterilization,

microwaving, radiowaving,

infrared

heating,

pyrolysis, plasma systems,

and laser

treatments.

“TRANSFER

STATION”

MEANS

A

SITE

OR

FACILITY

THAT

ACCEPTS

WASTE

FOR TEMPORARY STORAGE OR CONSOLIDATION

AND

FURTHER

TRANSFER

TO

A

WASTE

DISPOSAL,

TREATMENT

OR

STORAGE FACILITY.

“TRANSFER STATION” INCLUDES A SITE

WHERE

WASTE

IS TRANSFERRED FROM

(1) A RAIL CARRIER TO A

MOTOR VEHICLE OR WATER CARRIER;

(2)

A

WATER

CARRIER

TO

A RAIL CARRIER OR MOTOR VEHICLE;

(3)

A MOTOR VEHICLE TO

A RAIL CARRIER, WATER CARRIER OR MOTOR VEHICLE;

(4)

A

RAIL

CARRIER TO A RAIL CARRIER,

IF THE

WASTE

IS

REMOVED

FROM

A

RAIL

CAR;

OR

(5)

A

WATER

CARRIER

TO A WATER

CARRIER,

IF

THE

WASTE

IS

REMOVED FROM A VESSEL.

(Section 3.83

of the Act)

“TREATMENT”

MEANS

ANY

METHOD,

TECHNIQUE OR PROCESS,

INCLUDING

NEUTRALIZATION,

DESIGNED TO CHANGE THE

PHYSICAL,

CHEMICAL,

OR

BIOLOGICAL CHARACTER OR

COMPOSITION

OF

ANY

WASTE

SO

AS

TO

NEUTRALIZE

IT

OR

RENDER

IT

NONHAZARDOUS,

SAFER

FOR

TRANSPORT,

AMENABLE

FOR

RECOVERY,

AMENABLE

FOR

STORAGE,

OR REDUCED IN

VOLUME.

SUCH

TERM

INCLUDES

ANY

ACTIVITY

OR PROCESSING

DESIGNED

TO

CHANGE

THE

PHYSICAL FORM OR CHEMICAL

COMPOSITION

OF

HAZARDOUS

WASTE

SO

AS

TO

RENDER

IT

NONHAZARDOUS.

(Section

3.49

of

the

Act)

0137-0675

---

—48—

“Unrecognizable” means relating to

a sharp that has

undergone physical alteration

(e.g.,

melting, charri~1

corroding,

or grinding)

so that the sharp may no lonq~

be used for its intended purpose.

“Vector” means any living agent,

other than human,

capable of transmitting.

directly or indirectly,

an

infectious

disease.

“Vehicle” means any device used to transport special

waste

in bulk or

in packages,

tanks or other

containers.

Section 1420.103

Incorporations by Reference

The following materials are incorporated by reference.

This

Section incorporates no later editions

or amendments.

Standard Methods for the Examination of Water and

Wastewater, American Public Health Association

et

a?.

(1015

Fifteenth

Street.

N.W.,

Washington,

D.C.

20005)

(17th

Edition,

1989)

Test Methods for Evaluating Solid Waste,

Physical/Chemical Methods, EPA Publication SW—846

(Third Edition,

1986 as amended by Update

I

(November,

1990)).

SW—846 and Update

I are available from the

Superintendent

of Documents,

U.S. Government Printing

Office, Washington,

D.C.

20402,

(202)

783—3238,

Section

1420.104

Prohibitions

NO PERSON

SHALL

CAUSE OR ALLOW THE DISPOSAL OF ANY P1MW.

SHARPS MAY BE

DISPOSED

IN

ANY LANDFILL PERMITTED BY THE AGENCY UNDER

SECTION 21 OF the ACT TO ACCEPT MUNICIPAL WASTE FOR

DISPOSAL

,

IF BOTH:

INFECTIOUS POTENTIAL HAS BEEN ELIMINATED FROM

.~j

THE

THE SHARPS

BY

TREATMENT; AND

~J

THE

SHARPS

ARE

PACKAGED

IN ACCORDANCE WITH Part

1421,

Subpart C of this Subtitle.

CAUSE OR ALLOW THE DELIVERY OF ANY P1MW FOR TRANSPORT

STORAGE, TREATMENT OR TRANSFER EXCEPT IN ACCORDANCE

WITH

Part

1421,Subpart

C

of

this

Subtitle.

~j

BEGINNING JULY

1,

1992,

CAUSE OR ALLOW THE DELIVERY OF

ANY

P1MW

TO

A

PERSON OR FACILITY FOR STORAGE,

TREATMENT,

OR

TRANSFER

THAT

DOES

NOT

HAVE

A

PERMIT

0137-0676

---

—49—

ISSUED BY THE AGENCY TO RECEIVE

P1MW

pursuant to

Section 39

of the Act,

UNLESS NO PFRNIT

IS REQUIRED

pursuant to subsection 1420.105(b)

of this Part.

~J

BEGINNING JULY

1,

1992,

CAUSE OR ALLOW THE DELIVERY OR

TRANSFER OF ANY P1MW FOR TRANSPORT UNLESS:

,~j

THE TRANSPORTER HAS A PERMIT ISSUED BY THE AGENCY

TO TRANSPORT P1MW,

OR THE TRANSPORTER IS EXEMPT

FROM THE PERMIT REQUIREMENT pursuant to subsection

1420.105(a)

of this Part.

Permit applications

must be submitted on forms provided by the Agency.

~J.

A

P1MW MANIFEST

IS COMPLETED FOR THE WASTE unless

no manifest

is required pursuant to subsection

1420.105(c)

of this Part.

~j

CAUSE OR ALLOW THE ACCEPTANCE OF ANY

P1MW

FOR PURPOSES

OF TRANSPORT,

STORAGE, ~TREATMENT, OR TRANSFER EXCEPT IN

ACCORDANCE WITH Part

1421,

Subpart C of this Subtitle

and Part 1422,

Subpart

B of this Subtitle.

~j

BEGINNING JULY

1,

1992,

CONDUCT ANY P1MW TRANSPORTATION

OPERATION:

~j

WITHOUT A

PERMIT

ISSUED

BY THE AGENCY TO TRANSPORT

P1MW,

unless no permit

is required pursuant to

subsection

1420.105(a)

of this Part.

~J

IN

VIOLATION OF ANY CONDITION OF ANY PERMIT ISSUED

BY THE AGENCY UNDER the ACT.

~j

IN VIOLATION OF ANY REGULATION ADOPTED BY THE

BOARD.

jj

IN

VIOLATION OF ANY ORDER ADOPTED

BY THE BOARD

UNDER

the

ACT.

gj

BEGINNING

JULY

1,

1992,

CONDUCT

ANY

P1MW

TREATMENT,

STORAGE,

OR

TRANSFER

OPERATION:

~j

WITHOUT

A

PERMIT

ISSUED

BY

THE

AGENCY

THAT

SPECIFICALLY AUTHORIZES THE TREATMENT,

STORAGE,

OP

TRANSFER

OF P1MW pursuant with Section

39 of the

Act,

unless no permit

is required pursuant to

subsection

1420.105(b)

of

this

Part.

Permit

applications must be submitted on forms provided

by the Agency.

~j

IN VIOLATION OF ANY CONDITION OF

ANY

PERMIT

ISSUED

BY

THE

AGENCY

UNDER

the

ACT.

0137-0677

---

—50—

~j

IN

VIOLATION

OF

ANY

REGULATIONS

ADOPTED

BY

THE

BOARD.

il

IN

VIOLATION OF ANY ORDER ADOPTED BY THE BOARD

UNDER the ACT.

~j

TRANSPORT

P1MW

UNLESS

THE TRANSPORTER CARRIES A

COMPLETED P1MW MANIFEST, unless no manifest

is requir~

pursuant to subsection 1420.105(c)

of this Part.

Jj

OFFER FOR TRANSPORTATION, TRANSPORT,

DELIVER, RECEIVE

OR ACCEPT P1MW FOR WHICH A MANIFEST IS REQUIRED, UNLE~

THE MANIFEST INDICATES THAT THE FEE REQUIRED UNDER

SECTION 56.4 OF the ACT HAS BEEN PAID.

jJ

BEGINNING JANUARY

1,

1994,

CONDUCT A P1MW TREATMENT

OPERATION AT AN INCINERATOR IN EXISTENCE ON THE

EFFECTIVE DATE OF THIS TITLE IN VIOLATION OF EMISSION

STANDARDS ESTABLISHED FOR THESE INCINERATORS UNDER

SECTION

129

OF

THE

CLEAN

AIR

ACT

(42

USC

7429),

AS

AMENDED.

(Section

56.1

of

the

Act)

~j

Cause

or allow the discharge of P1MW from

a vehicle.

~j

Cause or allow the discharge of P1MW into

a sanitary or

combined sewer except

in accordance with 35

Ill.

Adm.

Code.Subtitle

C.

No person shall cause or allow the

discharge

of

inert or solid

P1MW,

or inert or solid

materials resulting from the treatment of

P1MW,

into

any

sanitary

sewerage

system,

combined

sewerage

system~

or storm sewerage system directly or indirectly

tributary to waters of the State.

Such prohibition

applies

to, but

is not limited

to, absorbents,

aluminum

or other metallic foils,

ash,

bone,

bedding materials,

cellulose,

culture dishes, garments and other cloth

materials,

gauze,

glass,

pads,

plastic,

sharps,

shavings,

straw and syringes.

BOARD NOTE:

Interested persons are informed that local

ordinances may also cover discharges to sewer systems.

Section 1420.105

Permit and Manifest Requirements and

Exceptions

a)

A person who conducts

a P1MW transportation operation

is

required

to

obtain

a

P1MW

hauling

permit

from

the

Agency,

except:

~J

A

PERSON

TRANSPORTING

P1MW

GENERATED

SOLELY

BY

THAT

PERSON’S

ACTIVITIES;

OR

0137 -0678

---

—51—

~J

NONCOMMERCIAL

TRANSPORTATION

OF

LESS

THAN

50

POUNDS

OF

POTENTIALLY

INFECTICUS

MEDICAL

WASTE

AT

ANY

ONE TIME;

OR

3

THE U.S.

POSTAL SERVICE.

(Section 56.1(f)

of the

Act).

~j

A person who conducts

a

P1MW

treatment,

storage,

or

transfer

operation

is

required

to

obtain

a

permit

from

the

Agency,

except:

~j

ANY

PERSON CONDUCTING A P1MW TREATMENT,

STORAGE,.

OR TRANSFER OPERATION FOR P1MW GENERATED BY THE

PERSON’S

OWN

ACTIVITIES

THAT

ARE

TREATED,

STORED,

OR TRANSFERRED WITHIN THE SITE WHERE THE P1MW

IS

GENERATED;

OR

~j

ANY HOSPITAL THAT TREATS,

STORES,

OR TRANSFERS

ONLY

P1MW

GENERATED

BY

ITS

OWN

ACTIVITIES

OR

BY

MEMBERS

OF ITS MEDICAL STAFF.

(Section 56.1(q)

of

the

Act).

If

the

transportation

of

P1MW

is

interrupted so as not to constitute storage, no

permit

is required under Section 56.1(q)

of the

Act.

For

example,

transportation

of

P1MW

interrupted

by vehicle repairs or inclement

weather

does

not

constitute

storage.

~j

In a permit application,

the engineering features of

plans,

specifications,

and

reports

must

be

certified

by

a registered professional engineer and must bear the

registered professional engineer’s seal and signature

along

with

the signature or seal of any registered

land

surveyor who has supplied data contained

in the

submittal.

References are to be included

when

such

data are obtained from published sources.

ç~j

Any person who transports P1MW

is required to carry

a

completed

P1MW

manifest except for the transportation

of:

j)j.

P1MW BEING TRANSPORTED

BY GENERATORS WHO GENERATED

THE WASTE BY THEIR OWN ACTIVITIES,

WHEN THE P1MW

IS TRANSPORTED WITHIN OR BETWEEN SITES OR

FACILITIES OWNED,

CONTROLLED,

OR OPERATED BY THAT

PERSON;

OR

~J

LESS

THAN

50 POUNDS

OF

P1MW AT ANY ONE TIME FORE A

NONCOMMERCIAL

TRANSPORTATION

ACTIVITY;

OR

~J

P1MW BY THE

U.S.

POSTAL SERVICE.

(Section 56.1(~J

of the Act)

O~37-0679

---

—52—

Section

1420.106

Penalty Factor

IN

MAKING

ITS

ORDERS AND DETERMINATIONS RELATIVE

TO

PENALTIE~I~J~

ANY,

TO BE IMPOSED FOR VIOLATING SECTION 56.1(a)

OF the ACT, T1±~

BOARD,

IN ADDITION TO THE FACTORS

IN SECTIONS

33(c) AND 42(h) O~

the ACT,

OR THE COURT SHALL TAKE INTO CONSIDERATION WHETHER THE

OWNER OR OPERATOR OF THE LANDFILL REASONABLY RELIED ON WRITTEN

STATEMENTS

FROM

THE PERSON GENERATING OR

TREATING

THE

WASTE

THAT

THE

WASTE

IS

NOT

POTENTIALLY

INFECTIOUS

MEDICAL

WASTE.

(Secti~~

56.1(k)

of

the

Act)

Section

1420.107

Cleaning

and

Disinfection

~J

Cleaning

and

disinfection

comprises:

fl

Washing

with

a

solution

of

detergent

used

in

accordance with manufacturer’s instructions and

agitation to remove visible contamination from

each surface,

followed by a clean water rinse;

ap~.

~j

One of the following methods

of low-level

disinfection:

~j

Exposure to hot water

of

at least

82 degrees

Centigrade

(180 degrees Fahrenheit)

for a

minimum of fifteen

(15) seconds

~j

Rinsing with,

or immersion

in,

a chemical

disinfectant registered by the United States

Environmental Protection Agency,

as

identified on its label and used

in

accordance with the manufacturer’s

instructions

çj

Rinsing with,

or immersion

in,

a hypochlorite

solution at a concentration of 50 ppm.

For

example,

1/8 cup of common household bleach

(5.25

sodium hypochlorite) per gallon of tap

water

(31 mL bleach to 3.78 L of water);

or

P1

Other disinfection processes as approved by

the Agency

in writing as an equivalent to one

of the methods

in subsections

(a) (2) (A) and

(B)

of this Section.

~j

A

detergent-sanitizer used in coniunction with

agitation to remove visible contamination

may

be

substituted for the methods

in subsection

(a)

of this

Section,

if used

in accordance with the manufacturer’s

instructions.

Section 1420.120

Severability

---

—53—

If any Section, subsection,

sentence or clause of this Subtitle

is adjudged unconstitutional,

invalid or otherwise not effective

for any reason,

such adjudication does not atfect the validity of

this

Subtitle

as

a

whole

or

of

any

Section,

subsection,

sentence

or

clause

thereof

not

adjudged

unconstitutional,

invalid

or

otherwise

not

effective

for

any

reason.

Cl 37-0681

---

—54—

TITLE

35:

ENVIRONMENTAL PROTECTION

SUBTITLE

N:

BIOLOGICAL

MATERIALS

CHAPTER

I:

POLLUTION

CONTROL

BOARD

SUBCHAPTER

b:

POTENTIALLY

INFECTIOUS

MEDICAL

WASTES

PART

1421

ACTIVITY

STANDARDS

SUBPART

A:

GENERAL

PROVISIONS

Section

1421.101

Compliance

Dates

SUBPART

B:

SEGREGATION

Section

1421.110

Scope

and

Applicability

1421.111

Standards

and

Criteria

SUBPART

C:

PACKAGING

Section

1421.120

Scope

and

Applicability

1421.121

Standards

and

Criteria

SUBPART

D:

LABELING

AND

MARKING

Section

1421.130

Scope

and

Applicability

1421.131

Standards

and

Criteria

SUBPART

E:

TRANSPORTATION

Section

1421.

140

Scope

and

Applicability

1421.141

Standards

and

Criteria

142l.Appendix

A

International

Biohazard

Symbol

AUTHORITY:

Implementing

and

authorized

by

Sections

56.2

and

27

of

the

Environmental

Protection

Act

(Ill.

Rev.

Stat.

1991,

ch.

111

1/2,

par.

1056.2

and

1027).

SOURCE:

Adopted

in

R9l—20,

at

_____

Ill.

Reg.

_______

,

effective

NOTE:

Capitalization

denotes

statutory

language.

SUBPART

A:

GENERAL

PROVISIONS

Section

1421.101

Compliance

Dates

0

37-0682

---

—55—

Persons

subject

to

this

Part

shall

comply

~ith

its

standards

and

criteria

by

_____________________

,

1993

(effec~tive

date)

SUBPART

B:

SEGREGATION

Section 1421.110

Scope and Applicability

This

Subpart

applies

to

persons

who

generate

or

transport

P1MW,

and to owners and operators of P1MW storage sites, transfer

stations

and

treatment

facilities.

Section

1421.111

Standards

and

Criteria

a)

Generators

shall

segregate

P1MW

as follows:

1)

Sharps,

2)

Oversized

P1MW,

and

3)

All

other.

b)

P1MW

mixed

with

other

waste

is regulated under this

Subtitle

as

P1MW

and

the

mixture

is

not

exempt

from

any

other

applicable

regulations.

c)

This

Section

does

not

prohibit

the

placing

of

previously

segregated

and

properly

packaged

(in

accordance

with

Subpart

C

of

this

Part)

sharps

with

other

waste,

provided

the

mixture

is

managed

in

accordance

with

subsection

(b)

of

this

Section.

SUBPART

C:

PACKAGING

Section

1421.120

Scope

and

Applicability

This

Subpart

applies

to

persons

who

package

P1MW

for

off—site

transportation.

Section

1421.121

Standards

and

Criteria

a)

P1MW,

except

for

oversized

P1MW,

must

be

placed

in

a

container,

or

a

combination

of

containers.

Such

container

must

be:

1)

RIGID;

2)

LEAK—RESISTANT;

3)

IMPERVIOUS

TO

MOISTURE;

Q~

37-0683

---

—56—

4)

OF

A STRENGTH SUFFICIENT

TO PREVENT

TEARING

OR

BURSTING UNDER NORMAL CONDITIONS

OF USE AND

HANDLING;

AND

5)

SEALED

TO

PREVENT

LEAKAGE

DURING

TRANSPORT.

(Section

56.1(b)

(2)

(A))

b)

Sharps must be packaged in

a container,

or

a

combination

of

containers,

that

is

puncture—resistant

and meets the requirements

of subsection

(a)

of this

Section.

C)

Oversized P1MW must be covered or packaged in a manner

so as to avoid contact

with

transport workers and the

public.

Sharps must not be packaged with oversized

P1MW in

the same

container.

d)

If the outside

of

a container

is

contaminated

by P1MW,

a person shall place the container inside another

container,

or clean and disinfect the container

in

accordance with

35 Ill. Adm.

Code 1420.107 of this

Subtitle.

In

either

case,

the

container

or

combination

of containers must meet applicable requirements

of

subsections

(a)

or

(b)

of

this

Section.

e)

Once

a

reusable

container

has

been

cleaned

and

disinfected

in

accordance

with

35

Ill.

Adm.

Code

1420.107

of

this Subtitle,

it can be used for only

waste.

If

a

reusable

container

is

not

or

cannot

be

cleaned and disinfected in accordance with Section

1420.107 of this Subtitle,

it must be regulated as

P1MW

pursuant

to

this

Subtitle.

f)

Residues

from

cleaning

a

P1MW

container,

or

discharges

from

P1MW

packages,

are

regulated

under

this

Subtitle,

except

when

discharged directly

into a sanitary or

combined

sewer

in

accordance

with

35

Ill.

Adm.

Code

Subtitle

C.

BOARD NOTE:

Interested persons are informed that local

ordinances

may

also

cover

discharges

to

sewer

systems.

SUBPART

D:

LABELING

AND

MARKING

Section

1421.130

Scope

and

Applicability

This

Subpart

applies

to

persons

who

package

P1MW for off—site

transportation

or

who

accept

packages

of

P1MW

from

off-site.

Section

1421.131

Standards

and. Criteria

01

37-068k

---

—57—

a)

The

exterior

of

the

outer

package

must

be

marked

as

follows

prior

to

shipment:

1)

The

generator

shall:

A)

Mark

on

two

opposite

sides

of

the

outer

package

in

lettering

that

is

readable

at

a

minimum

distance

of

five

(5)

feet:

i)

The

International

Biohazard

Symbol

as

shown

in

Section

l42l.Appendix

A

of

this

Part

and

the

word

“Biohazard”;

and

ii)

The

word

“sharps”,

if

the

package

contains

sharps.

B)

Mark

with

indelible

ink

in

lettering

that

is

legible

on

a

water-resistant

label

or

tag

securely

attached

to

or

marked

on

the

outer

package:

i)

The

generator’s

name,

ii)

The

generator’s

address,

and

iii)

The

generator’s

phone number

(a

24-hour

phone

number,

if

available)

2)

The

transporter

shall

mark

with

indelible

ink

in

lettering

that

is

legible

on

a

water—resistant

label

or

tag

securely

attached

to

or

marked

on

the

outer

package:

A)

The

transporter’s

name,

B)

The

transporter’s

permit

number,

C)

The

transporter’s

address,

D)

The

transporter’s

phone

number

(a

24-hour

phone

number,

if

available)

,

and

E)

For

each

P1MW

package,

the

shipment

date

when

P1MW

initially

left

the

generator’s site;

or

for

each

shipment,

a

unique

identification

number

which

directly

corresponds

to

the

initial

date

of

shipment.

b)

Except

for

subsection

(c)

of

this

Section,

inner

packages

must

be

marked

as

described

in

subsection

(a)

(1)

(A)

(i)

of

this

Section.

n

;

‘:;

7_

o

U

£

---

—58—

c)

If

a

sharps

container

is

packages

within

an

outer

container,

the inner sharps contairer must be marked

with indelible

ink in lettering that

is legible as

follows:

1)

The

International

Biohazard

Symbol

as

shown

in

Section 1421.Appendix A of this Part and the word

“biohazard”; and

2)

The

word

“sharps”.

d)

Containers which are not the inner or outer containers

are exempt from the labeling requirements

in subsection

(a)

of this Section.

Packages may be placed in a

transparent container provided that all required

markings

are

legible

through

the transparent container.

A

non—rigid

transparent

container

cannot

be

used

as

an

outer

container.

e)

For

oversized

P1MW,

the

following

requirements

must

be

met

prior

to

shipment:

1)

The

generator

shall:

A)

Mark

on

one

side

of

the

outer

package

in

lettering

that

is

readable

at

a

minimum

distance

of

five

(5)

feet

the

International

Biohazard

Symbol

as

shown

in Section

1421.Appendix

A

of

this

Part

and.

the

word

“biohazard”.

B)

Mark

with

indelible

ink

in

lettering

that

is

legible

on

a

water-resistant

label

or

tag

securely attached to or marked on the outer

package:

i)

The generator’s name,

ii)

The generator’s address,

and

iii) The generator’s phone number

(a 24-hour

phone number,

if available)

2)

The

transporter

shall

mark

with

indelible

ink

in

lettering that

is legible

on

a water-resistant

label or tag securely attached to or marked on the

outer

package:

A)

The

transporter’s name,

B)

The transporter’s

permit

number,

0137-0686

---

—59—

C)

The transporter’s address,

D)

The transporter’s phone number

(a 24—hour

phone

number,

if

available)

,

and

E)

For

each

P1MW

package, the shipment date when

P1MW

initially left the generator’s site;

or

for each shipment,

a unique identification

number which directly corresponds to the

initial

date

of

shipment.

f)

When

P1MW

is

transported

by

more

than

one

transporter,

each transporter shall mark with indelible ink in

lettering that is legible

on

a water-resistant label

or

tag securely attached to or marked on the outer package

the information listed in subsection

(a) (2)

of this

Section.

The label,

tag or mark must not obscure any

previous information on the package.

SUBPART

E:

TRANSPORTATION

Section

1421.140

Scope

and

Applicability

This Subpart applies to persons who transport

P1MW and

are

required to have

a P1MW hauling permit in accordance with

35

Ill.

Adm.

Code

1420.105

of

this

Subtitle.

Section

1421.141

Standards

and

Criteria

a)

P1MW

must be transported under conditions

to minimize

the

effects

of

putrescence.

b)

Packages

of

P1MW

must

be

transported

only

in

enclosed

compartments

of

vehicles

that

are

secured

against

public

access

when

unattended.

This

requirement

does

not apply to oversized

P1MW,

which must be handled

in a

manner

that minimizes contact

with

transport workers

and the public.

c)

Vehicles

and

associated

storage

compartments,

doors,

piping,

and

valving

must

be:

1)

Cleaned

of

visible

P1MW

contamination

after

each

use;

and

2)

In good repair when transporting

P1MW.

d)

P1MW must

be transported

in a manner that prevents a

breeding

place

or

food

source

for

vectors.

0137-0687

---

—60—

e)

During

transport,

a

P1MW

package

must

not

be

compacted

or subject to stress that compromi~es the integrity of

the

container.

f)

Residues

from

the

cleaning

of

vehicles

contaminated

by

P1MW are regulated under this Subtitle,

except when

discharged directly into

a sanitary or combined sewer

in accordance with 35

Ill.

Adm.

Code

Subtitle

C.

BOARD NOTE:

Interested persons are informed that local

ordinances may also cover discharges to sewer systems.

g)

Vehicles transporting P1MW must display

information

in

accordance with the P1MW hauling permit.

h)

The

transporter

shall

develop

and

keep

an

emergency

response plan

in the vehicle.

This plan must identify

the

names

and

telephone

numbers

of

state

and

local

authorities who must be contacted in the event

of an

emergency or discharge.

In the event of an emergency

or discharge of

P1MW,

the transporter shall take

immediate action

in accordance with the emergency

response plan to protect the health and safety of the

public

and

the

environment.

In

addition,

each

vehicle

transporting

P1MW

must carry all equipment necessary to

provide

a

response.

i)

Vehicles

transporting

P1MW must

not be used. for the

hauling of non—waste materials,

with the exception of

equipment and supplies

intended for the use of waste

management including scales,

bar coding equipment,

printers,

stampers,

manifests,

logs,

dollies,

load

locks,

conveyers,

material handling equipment, plastic

containers,

corrugated boxes, plastic bags,

tape,

sharps

containers,

drums,

labels,

signs,

stickers,

spill

kits,

new P1MW

containers or

P1MW

containers that

have been cleaned

and. disinfected

in accordance with

35

Ill. Adm.

Code 1420.107 of this Subtitle.

j)

P1MW must

not be

in transport for more than ten

(10)

calendar days.

k)

This Subpart does not apply to the United States Postal

Service.

1)

COMMENCING MARCH

31,

1993,

AND ANNUALLY

THEREAFTER,

EACH TRANSPORTER OF P1MW REQUIRED TO

HAVE

A PERMIT

UNDER SUBSECTION

(f)

OF SECTION 56.1 OF THE ACT SHALL

FILE

A REPORT WITH THE AGENCY

SPECIFYING THE QUANTITIES

AND DISPOSITION

OF P1MW TRANSPORTED

DURING THE PREVIOUS

CALENDAR

YEAR.

SUCH

REPORTS

SHALL

BE

ON

FORMS

0 37-0688

---

—61—

PRESCRIBED AND PROVIDED BY THE AGENCY.

(Section 56.3

of the Act)

Section 1421.Appendix A:

International Biohazard Symbol

0137-0689

---

—62—

Section

TITLE

35:

ENVIRONMENTAL

PROTECTION

SUBTITLE

N:

BIOLOGICAL

MATE.IALS

CHAPTER

I:

POLLUTION

CONTROL

BOARD

SUBCHAPTER

b:

POTENTIALLY

INFECTIOUS

MEDICAL

WASTES

PART

1422

DESIGN

AND

OPERATION

OF

FACILITIES

SUBPART

A:

GENERAL PROVISIONS

1422.101

Section

1422.110

1422.111

Section

Compliance Dates

SUBPART

B:

STORAGE

OR

TRANSFER

OPERATIONS

Scope and Applicability

Design

and. Operating Standards and Criteria

SUBPART

C:

TREATMENT FACILITIES

A

Initial

Efficacy

Test

Procedures

Test

Microorganisms

Indicator

Microorganisms

Table

C

Challenge

Loads

l422.Appendix

B

Correlating

Periodic

Verification

Test

Procedures

AUTHORITY:

Implementing

and

authorized

by

Sections

56.2

and

27

of the Environmental Protection Act,

(Ill.

Rev.

Stat.

1991,

oh.

111

1/2,

par.

1056.2

and

1027).

SOURCE:

Adopted

in

R9l—20,

at

_____

Ill.

Req.

_______

,

effective

NOTE:

Capitalization

denotes

statutory

language.

SUBPART

A:

GENERAL PROVISIONS

Section

1422.101

Compliance Date

0137-0690

1422.121

1422.122

1422.123

1422.124

1422.

125

1422.126

1422.127

Treatment Facility Certification

Design and Operating Standards

Treatment

Units

Initial Efficacy Test

Periodic Verification

Test(s)

Sharps

Experimental

Permits

Section

1422 .Appendix

Table

A

Table

B

---

—63—

Persons subject to this Part shall

comply with its requirements

by

,

1993

(effective

date)

SUBPART

B:

STORAGE

OR

TRANSFER

OPERATIONS

Section 1422.110

Scope and Applicability

This

Subpart

applies

to

the

owner

or

operator

of

a

P1MW

storage

site

or

transfer

station,

collectively

referred

to

as

a

“storage

operation”

in

this

Subpart.

Section 1422.111

Design and Operating Standards and Criteria

a)

ANY PERSON

WHO

STORES P1MW PRIOR TO TREATMENT OR

DISPOSAL

ON-SITE

OR

TRANSPORT

OFF-SITE

MUST

COMPLY

WITH

ALL

OF

THE

FOLLOWING

STORAGE

REQUIREMENTS:

1)

STORE THE P1MW

IN

A

MANNER

AND

LOCATION

THAT

MAINTAINS THE INTEGRITY OF THE PACKAGING AND

PROVIDES PROTECTION FROM WATER, RAIN,

AND WIND.

2)

MAINTAIN

THE

P1MW

IN

A

NONPUTRESCENT

STATE,

USING

REFRIGERATION

WHEN NECESSARY.

3)

LOCK

THE

OUTDOOR

STORAGE

AREAS

CONTAINING

P1MW

TO

PREVENT UNAUTHORIZED

ACCESS.

4)

LIMIT ACCESS TO ON-SITE STORAGE AREAS TO

AUTHORI ZED

EMPLOYEES.

5)

STORE THE P1MW IN A MANNER THAT AFFORDS PROTECTION

FROM

ANIMALS

AND

DOES NOT PROVIDE A BREEDING PLACE

OR

FOOD

SOURCE

FOR

vectors.

(Section

56.1(e)

(2)

(D)

(i)—(v)

of

the

Act)

6)

P1MW packages

must

not be compacted or subjected

to

stress

that

compromises

the

integrity

of

the

container.

7)

Multiple

generators

in

the

same

building

may

store

their

P1MW

packages in a common storage area.

8)

Reusable

P1MW

containers or facility equipment

(e.g.,

carts,

squeegees or shovels) which are

visually contaminated

with P1MW must

be cleaned

in

a

designated

area

in

accordance

with

35

Ill.

Adn.

Code

1420.107

of

this

Subtitle.

9)

Residues

from

cleaning

a

P1MW

contaminated

container,

equipment

or

work

surface

are

regulated

under

this

Subtitle,

except

when

directly

0

37-0691

---

—64—

discharged

into a sanitary or combined sewer

in

accordance

with

35

Ill.

Adm.

(‘ode

Subtitle

C.

BOARD

NOTE:

Interested

persons

are

informed

that

local ordinances may also cover discharges to

sewer systems.

10)

Copies

of

all

P1MW manifests required by

35

Ill.

Adm.

Code 1420.105 of this Subtitle must be

retained by and kept at the storage operation for

three

(3) years and must be made available at the

storage operation during normal business hours

for

inspection and photocopying by the Agency.

The

retention period for P1MW manifests is extended

automatically during the course of any unresolved

enforcement

action

regarding

the

storage

operation

or as requested.

in writing by the Agency.

11)

Upon closure of

a storage operation,

the owner or

operator shall clean the area,

equipment and

structures in accordance with

35 Ill.

Adm.

Code

1420.107

of

this

Subtitle.

b)

In

addition

to

the

requirements

listed

in

subsection

(a)

of

this

Section,

storage

operations

required

to

have

a

permit

pursuant

to

35

Ill.

Adm.

Code

1420.105

of

this Subtitle must also comply with the following

requirements that the Agency shall review during the

permitting process:

1)

Storage operations shall weigh

in pounds the

amount

of

P1MW

received,

unless

previously

weighed

by the transporter.

P1MW must be weighed with

a

device for which certification has been obtained

under the Weights and Measures Act

(Ill.

Rev.

Stat.

1991,

ch.

147, pars.

101 et seq.)

2)

P1MW packages must be stored

in designated areas

so as not to contaminate other waste or materials.

3)

Cardboard packages must be elevated and stored

in

an enclosed area.

4)

P1MW must be stored on

a surface that allows

drainage and collection of liquids and that

minimizes

exposure

to

workers

and

the

public.

5)

Adequate aisle space,

as specified

in the permit,

must be maintained

between packages to allow

inspection of at least one

(1)

side of each

package.

Packages must be stacked

so that labels

013-0692

---

—65—

are readable.

A vehicle containing

P1MW

is exempt

from

the

above

aisle

space

re~uirement:

A)

When

loading

or

unloading

a

vehicle;

or

B)

When

a

fully—loaded

vehicle

is

on

a

site.

C)

Either

exemption,