ILLINOIS POLLUTION CONTROL BOARD

October 24,

1991

IN THE

MATTER OF:

)

)

R91—18

REPEAL OF

35 ILL.

ADM. CODE

)

(Rulemaking)

809.SUBPART

I:

HAZARDOUS

)

(INFECTIOUS) HOSPITAL WASTE

)

PROPOSED RULE.

SECOND NOTICE.

OPINION AND ORDER OF THE BOARD

(by R.C. Flemal):

The Board opened this docket on our own Motion by an Opinion

and Order dated August 22,

1991.

Public Act 87-752

(House Bill

2491),

signed by the Governor on September 26,

1991,

prompted

that action.

Effective January

1,

1991,

P.A.

87—752 amends

various provisions of the Environmental Protection Act as they

relate to potentially infectious medical wastes.

New Title XV:

Potentially Infectious Medical Waste includes several new

legislative mandates for Board rulemaking.

One such mandate

is

new Section 56.2(d), which requires that the Board repeal 35

Ill.

Adm.

Code 809.Subpart

I:

Hazardous

(Infectious)

Hospital Waste

by January 1,

1992.

New Section 56.2(d)

requires the Board to use the rulemaking

procedures of Title VII of the Act for this repeal--i.e.,

the

Board must use the First Notice-Second Notice-Adopted Rule

sequence,

including public hearings.

Because this mode of

rulemaking will require over three months to complete, the Board

initiated this repeal process before the Governor signed the bill

into law.

The Notice of Proposed Repeal appeared in the Illinois

Register at volume 15, page 13017,

on September

6,

1991.

Public

hearings occurred September

18,

1991,

in Chicago,

and September

19,

1991,

in DeKalb.

Members of the public attended and

participated

in the Chicago hearing.

The public comment period

ended on October 21,

1991.

PUBLIC COMMENTS AND PUBLIC HEARING TESTIMONY

At hearing, Henry Henderson,

an attorney with the City of

Chicago,

stated the City

S

concern that no repeal occur until

after the Governor signed H.B. 2491

(now P.A. 87-752).

He

testified that the operative effect of the City’s medical waste

regulations is at least partly dependent on the state—level laws.

He further stated that the City intended to regulate those areas

not covered by state law.

He concluded that the City lacks the

resources to police operations falling out of the state

regulatory system before the operative provisions of H.B.

2491

become effective

(Tr. at 5—9

& 13—14).

Francis

J. O’Brien, manager of BFI Medical Waste, similarly

126—645

---

2

stated that the repeal of 35

Ill. Adm.

Code 809.Subpart I should

occur concurrently with the effective date of H.B.

2491.

He

cited about six municipal and county ordinances that regulate

wastes not covered under state laws,

like that of the City of

Chicago ordinance.

Mr. O’Brien stated that the enforcement

defense of Section 809.906 should appear in any future body of

rules governing potentially infectious medical wastes.

That

provision allows reasonable reliance on a generator’s

representations as to the character and identity of its wastes.

In his opinion, the operative interim provisions of Sections

56.1,

56.2(b),

56.3, and 56.4 do not include this defense until

the Board adopts regulations pursuant to Sections 56.2(a) and

(c)

(Tr.

15—25).

The Board received two public comments on the proposed

repeal:

PC #1

Department of Energy and Natural Resources

(DENR),

by Stanley Yonkauski, General Counsel

(received

September 10,

1991); and

PC #2

Office of the Secretary of State, Administrative

Code Division

(Code Unit), by John Kenworth,

Rules/Research Analyst

(received October 10,

1991)

By PC #1, DENR stated that consideration of the economic

impact of regulating potentially infectious medical wastes will

be an essential part of the companion dockets:

R9l-18, R91-20,

and R91-21.

DENR opined that an economic impact study was not

appropriate as to the repeal of

35 Ill.

Adm. Code 809.Subpart

I.

By PC #2,

the Code Unit stated that the proposed repeal meets the

codification requirements.

SECOND NOTICE ACTION

The effective date of P.A.

87—752 is January

1,

1992.

Section 56.2(d) requires that the Board repeal Subpart

I of Part

809 by January

1,

1992.

In light of the concerns expressed at

hearing over a disparity between the effective date of the

statutory amendments and the effective date of this repeal, the

Board will ultimately file this repeal in a manner that renders

it effective January

1,

1992.

The Board proposes for Second Notice the repeal of Subpart

I

of Part 809 in the same terms as it proposed the repeal for First

Notice by the Opinion and Order of August 22,

1991.

Nothing in

the record of hearing or the public comments seeks or warrants

revision of the text of the proposed repeal.

The text of the

proposed repeal follows.

ORDER

126—646

---

3

The Board hereby proposes the repeal 35

Ill. Adm.

Code 809.

Subpart

I for Second Notice and directs that the Clerk of the

Board prepare and submit a Second Notice package to the Joint

Committee

on Administrative Rules.

TITLE 35:

ENVIRONMENTAL PROTECTION

SUBTITLE G:

WASTE DISPOSAL

CHAPTER I:

POLLUTION CONTROL BOARD

SUBCHAPTER

1:

SOLID WASTE AND SPECIAL WASTE HAULING

PART 809

SPECIAL WASTE HAULING

SUBPART A:

GENERAL PROVISIONS

Section

809.101

Authority,

Policy and Purposes

809.102

Severability

809.103

Definitions

SUBPART B:

SPECIAL WASTE HAULING PERMITS

Section

809.201

Special Waste Hauling Permits

-

General

809.202

Applications

for Special Waste Hauling Permit-—Contents

809.203

Applications

for Special Waste Hauling Permit--

Signatures and Authorization

809.204

Applications

for Special Waste Hauling Permit-—Filing

and Final Action by the Agency

809.205

Special Waste Hauling Permit Conditions

809.206

Special Waste Hauling Permit Revision

809.207

Transfer of Special Waste Hauling Permits

809.208

Special Waste Hauling Permit Revocation

809.209

Permit No Defense

809.210

General Exemption from Special Waste Hauling Permit

Requirements

809.211

Exemptions for Special Waste Haulers

SUBPART

C:

DELIVERY AND ACCEPTANCE

Section

809.301

Requirements

for Delivery of Special Waste to Haulers

809.302

Requirements

for Acceptance of Special Waste from

Haulers

SUBPART D:

VEHICLE NUMBERS AND SYMBOLS

Section

809.401

Vehicle Numbers

809.402

Special Waste Symbols

SUBPART

E:

MANIFESTS, RECORDS AND REPORTING

Section

809.501

Manifests,

Records, Access to Records, Reporting

Requirements and Forms

126—647

---

4

SUBPART

F:

DURATION

OF

PERMITS

AND

TANK

NUMBERS

Section

809.601

Duration of Special Waste Hauler Permits and Tank

Numbers

SUBPART G:

EMERGENCY CONTINGENCIES FOR SPILLS

Section

809.701

General Provision

SUBPART H:

EFFECTIVE DATES

Section

809.801

Compliance Date

809.802

Exceptions

SUBPART I: HAZARDOUS

(INFECTIOUS) HOSPITAL WASTE

Section

809.901

Definitions

(Repealed)

809.902

Disposal Methods

(Repealed)

809.903

Rendering Innocuous by Sterilization

(Repealed)

809.904

Rendering Innocuous by Incineration

(Repealed)

809.905

Recordkeeping Requirements for Generators

(Repealed)

809.906

Defense to Enforcement Action (Repealed)

Appendix A

Old Rule Numbers Referenced

AUTHORITY:

Implementing Sections

5,

10,

13 and

22 and

authorized

by Section 27 of the Environmental Protection Act (Ill.

Rev.

Stat.

1989,

ch.

111½,

pars.

1005,

1010,

1013,

1022,

and 1027).

SOURCE:

Adopted

in

R76—10,

33

PCB

l~31, at

3

Ill.

Reg.

13,

p.

155,

effective

March

31,

1979;

emergency

amendment

in

R76-lO,

39

PCB

175,

at

4

Ill.

Reg.

34,

p.

214,

effective

August

7,

1980,

for

a

maximum

of

150

days;

emergency

amendment

in

R80-l9,

40

PCB

159,

at

5 Ill.

Reg.

270, effective January 1,

1981,

for a maximum of

150 days; amended in R77—12(B),

41 PCB 369, at

5

Ill. Reg.

6384,

effective Nay 28,

1981; amended in R80—19,

41 PCB 459,

at

5 Ill.

Reg.

6378,

effective May 31,

1981; codified in R8l-9,

53 PCB 269,

at

7

Ill.

Reg.

13640; recodifled in R84—5,

58 PCB 267,

from

Subchapter h to Subchapter

i at 8

Ill. Reg.

13198; amended in

R89—13A at 14

Ill.

Reg. 14076, effective August 15,

1990;

repealed in R91—18 at

Ill. Reg.

,

effective

Capitalization denotes statutory language.

SUBPART

I:

HAZARDOUS

(INFECTIOUS)

HOSPITAL

WASTE

Section

809.901

DefInitions

(Repealed)

Subpart

only

126—648

---

“hIazardous

(infectious)

Hospital Waste” means waste

which has been generated by a hospital in connection

with patient care that is contaminated with or may be

contaminated with

an. infectious agent that has the

potential of inducing an infection and which

h~

~

rendered ~

by steri1izati~..

icration.

More specifically, “Hazardou

medical and patient care items contaminated by,

—

—

—

——

——

—

—

—

~‘

‘~ —

—

—

unu

human excrci~.u

,prouueuu

~y,

peraon~

wiiu

been placed in strict or enteric isolation ~or the

contr-’

~eatment

of an infectious disease by

~a~id~

the hospita1

‘

s 1

...

~

~.

omm

h_

pursuant

to

the

infection

control

policies

and

procedures required of it by Section D of

of the Rules of the Illinois Department of

Part IX

Public

S~S

-

S~i

medical and patient care items that are

contaminated by or have been in contact with,

.~

isolation,

or the mucous or other respiratory

fluids of patients who have been placed in

espirat::~

-‘‘~~

rny

i~p.L~1Lipfl

Or

~1.riUL

i3Oi~iOfl

by

the

1

~

t

‘nrrr~f

I

r~n

~~‘nfrr~1

~r~mn~i

~

pur~nrir~f

tr~

the infection control policies and procedures

required of it by Section D of Part IX of the

Rules of the Illinois Department of Public Health,

5 Ill.

Reg.

553 ct seq.

(1081),

as

from’ time to

time

amended, and

medical and patient care items contaminated during

surgery

when the case

is infectious,

and

tissues

(human

or

animal),

pathological

waste,

and

I

tr~m~

thr,t

rrr~

rnit~~imI‘nnt~ri

h~:

nn

I

nfc~c~tIriii~

agent, and

—J

bacteriological cultures and blood or other

excreta that are products from bacteriological

testInri~and

any

other

waste

which,

because

of

its

infectious

nature,

is ordered to receive special handling and

disposal by the hospital’s

Infection

Control

Committee pursuant to the infection control

policies and procedures required of it by Section

D “Infectious Control” of Part IX

of the Rules of

126—649

5

mcii

,

~

Health,

5

Ill.

Reg.

553 Ct .~q. (lJ81),

from

time

to

time

amended,

and

---

6

the Illinois Department of Public Health,

5 Ill.

Reg.

553

et

seq.

(1081),

as

from

timc

to

time

amended.

“Hospital”

means

any

institution,

place,

building,

or

agency,

public

or

private,

whether

organized

for

profit

or

not,

devoted

primarily

to

the

maintenance and

operation

of

facilities

for

the

diagnosis

and

treatment

or

care

of

two

or

more

unrelated

persons admitted for

overnight

stay

or

longer

in

order

to

obtain

medical,

including

obstetric,

psychiatric

and

nursing,

care

of

illness, disease,

injury,

infirmity,

or deformity.

“Hospital”

includes

general

and

3pecialized

hospitals,

tuberculosis sanitaria, mental or psychiatric hospitals

and

sanitaria,

maternity

homes,

lying

in

homes,

and

homes

fnr

untjpt~i

mnt~h~r~

in

ijhi

rh

r~nrc~

~

gi

v~n

nrc

aei1v~j.

“Hospital”

doea

not

include,

for

example,

nursing

homes,

offices

of

human

or

animal

health

care

provider3,

out-patient

clinics,

or

veterinary

hospitals.

“Incineration” means the complete reduction of a

substance to ashes by means of combustion.

“Innocuous

Hospital

Waste”

is

not

a

special

waste,

but

for

the

purposes

of

this

Subpart

means

any

hazardous

hospital

waste

which

has

been

properly

sterilized

or

incinerated so as to render it incapable of causing

infection.

“Normal Hospital Waste”

is not a special waste, but for

the

purposes

of

this

Subpart

includes,

but

is

not

limited

to,

garbage,

refuse,

such

as

packaging

materials removed before a product reaches patient care

areas;

disposable

medical

and

patient

care

items

such

as

basins

and

water

pitchers

which

have

not

come

in

contact

with

a

patient

in

isolation;

and

facial

tissue

and other patient contact items which have not been

generated

by

a

patient

in

isolation.

microorganisms by moist or dry heat or by bactericidal

chemical

compounds.

(Source:

Repealed

at

Ill.

Reg.

,

effective

Section 809.902

Disposal

Methods

(Repealed)

a)

No

person shall cause or

allow hazardous

(infectious)

hospital waste to be deposited in any landfill.

126—650

---

7

b)

Hazardous

(infectious)

hospital waste shall be rendered

innocuous pursuant

t,o Sections 800.003 and 300.004,

or

may be disposed of, where

lawful,

by deposit into

a

municipal or private sewerage system.

c)

Innocuous hospital waste and normal hospital waste may

be disposed of by any lawful means,

including

incineration in any incinerator appropriate for such

waste and for which the Agency has issued a permit,

by

deposit

in

any

sanitary

landfill

or

by

deposit

into

a

niunicpal

or

private

sewerage

system.

(Source:

Repealed

at

Ill.

Reg.

effective

Section 809.903

Rendering Innocuous by Sterilization

(Repealed)

Any hazardous

(infectious) ~

innocuous hospital waste by:

a)

Sterilization of the waste

in an autoclave, provided

that

the

unit

is

operated

in

accordance

with

the

manufacturer’s recommendations and the autoclave’s

effectiveness

is

verified

at

least

weekly

with

a

biological

spore

assay

containing

B.

stearothermophilus,

or

b)

Sterilizati~o~—t~waste

i~i

~.

~~ia1

ethyl.~,~

oxide

unit

that

provides

controlled

temperature

and

humidity

conditions,

provided

that

the

unit

is

operated

in

accordance

with

the

manufacturer’s

recommendations

and the unit’s effectiveness

is

verified

during

each

use

with

a

biological

spore

assay

containing

B.

subtilis.

(Source:

Repealed

at

Ill.

Reg.

effective

—I

Rendering Innocuous by Incineration

(Repealed)

bus)

hospital waste may be

hospital

waste

by

incineration

—IS-

IS~

—-

designed

to

destroy

the

type

or

class

of

waste

introduced into it, and is operated according to

the manufacturer’s instructions, and

2)

All

permits

required

by

35

Ill.

Adm.

Code,

126—65 1

Section 809.904

rendered

an

in~

provided

that:

---

8

~-~—-1

(r~riorto codification,

~oiiution)

have

been

obtained

the

Agency,

and

the

conditions

of

those

permits

have

been

met.

—,

~

~OQUC?G

Dy

tne

incineration

or

nazara~ous

(infectious)

hospital

waate

shall

be

disposed

of

as

required

by

this

Part

and

35

Ill. Adm. Code 307 for

disposal

of

any

other

incinerator

ash.

(Source:

Repealed at

Ill.

Reg.

,

effective

Section 809.905

Recordkeeping Requirements for Generators

(Repealed)

a)

Generators of hazardous

(infectious) hospital waste who

render

such

waste

into

innocuous

hospital

wa3te

shall

keep and

make

reasonably available for Agency

inspection:

1)

Records of any required biological spore assay

tests.

2)

Records describing the approximate amount of waste

~tri1I~r1

en-

inrin,~rnti~L

3)

Records

which

sterilization

demonstrate

proper

operation

of

or

incineration

equipment

(such

the

as

time

and

tcmperature

maintenance

for

each

load).

b)

The requirements of Subsection

(a) may be satisfied by

maintenance

of

the

records

in

the

form

required

to

be

kept

by

any hospital licensing or accreditation body,

provided that such records include information

sufficient to comply with Subsection

(a).

(Source:

Repealed at

Ill. Reg.

,

effective

)

Section

809.906

Defense

to Enforcement Action (Repealed)

Reasonable

reliance

on

a

waste

generator’s

identification of

waste

as

innocuous

or

normal

hospital

waste

shall

be

a

complet-e

defense

to

an

enforcement

action

against

a

person

other

than

the

waste generator for violation of Section 000.202(a).

(Source:

Repealed at

Ill.

Reg.

,

effective

IT IS SO ORDERED.

126—652

---

9

I,

Dorothy

M.

Gunn,

Clerk

of

the

Illinois

Pollution Control

and Order was

Board, do hereby cert4~ythat the abo)

j~nic~’n

,

1991,

by

a

adopted

on

the

._t~~L

day of

____________

vote

of

7—o

Poll

Control

Board

126—653