ILLINOIS POLLUTION CONTROL BOARD

March 25,

1993

IN THE MATTER OF:

)

POTENTIALLY INFECTIOUS MEDICAL

)

WASTE

(P1MW): TREATMENT, STORAGE,

)

R91-20

AND TRANSFER FACILITIES and

)

(Rulemaking)

TRANSPORTATION,

PACKAGING, AND

LABELING

(35 Iii.

Adm.

Code

)

1420,

1421,

and 1422)

)

Proposed Rule.

Second 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’.

Today the Board adopts for second notice amendments to 35

Ill.

Adm.

Code Part 1420 and new Parts 1421 and 1422 intended to

meet these legislative mandates.

Today’s second notice proposal closely follows the first

notice proposal2, which in turn closely follows the

recommendations of the Governor’s Medical Waste Tracking Study

Group (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 Board will not in today’s opinion repeat the lengthy

background materials that were presented

in the first notice

opinion; the interested reader is directed to the first notice

opinion for this material.

Rather, today the Board focuses

solely on the issues raised in regard to the first notice

proposal and the Board’s response to these issues.

The mandates occur at Section 56.2 of the Illinois

Environmental Protection Act, 415 ILCS 5/1 et seq.

(formerly Ill.

Rev.

Stat.,

ch.

111½,

par. 1001 et seq.).

2

IN THE MATTER OF: POTENTIALLY INFECTIOUS MEDICAL WASTE

(P1MW): TREATMENT, STORAGE, AND TRANSFER FACILITIES and

TRANSPORTATION. PACKAGING, AND LABELING

(35 Ill.

Adm. Code 1420,

1421, and 1422), R91-20.

Adopted by order of the Board on

December 3,

1992.

Publication of Part 1420 occurred at 16

Ill.

Req.

19625

(Dec.

18,

1992), Part 1421 at 16

Ill.

Reg. 19615

(Dec.

18,

1992)

,

and Part 1422 at 16 Ill. Reg. 20002

(December 28,

1992)

OI~O-O327

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—2—

PUBLIC

COMMENTS

Fourteen

public

comments

(PC)

have

been

filed

regarding

the

first

notice

proposal.

These

are

as

follows:

PC

Author

#26

Metropolitan

Water

Reclamation

District

of

Greater

Chicago,

by

Cecil

Lue-Hing

#27

Medical

SafeTec,

by

William

D.

Farrington

#28

ABE

Sanitec,

Inc.,

by

Suzanne

E.

Helton

#29

Sexton

Environmental

Systems,

Inc.,

by

Erich

H.

Pearson

#30

Isolyser

Company,

Inc.,

by

Francis

W.

Stanton

#31

Administrative

Code

Division,

Office

of

the

Illinois

Secretary

of

State,

by

Connie

Bradway

#32

Mediclean

Technology,

Inc.,

by

Joel

A.

Schulman

#33

City

of

Chicago

Law

Department,

by

Maribeth

F lowers

#34

Illinois Hospital Association,

by Ann Guild

#35

Stericycle,

Inc., by Linda

D. Lee

#36

National Solid Waste Management Association

(NSWMA),

by

Jean

Furlan

#37

Dr.

Van

Allen

Anderson,

Director,

Division

of

Environmental Health and Safety, University

of

Illinois

at

Urbana-Champaign

#38

Ecomed,

Inc.,

by

Joseph

H.

Wilson

#39

Illinois Environmental Protection Agency

(Agency), by Susan Schroeder

Most

of

the

public

comments

are

directed

to

the

substance

of

the

proposed

rules,

in

many

cases

in

response

to

questions

posed

by

the

Board

at

first

notice

regarding

particular

provisions

of

the

proposed

rules.

These

comments

are

discussed

below,

according

to

the

section

of

the

proposal

to

which

they

are

addressed.

The

comments

of

the

Administrative

Code

Division

(PC

#31)

address

required

form

changes.

All

the

changes

noted

by

the

0 ~i~,Q-Q328

---

—3—

Administrative Code Division have been incorporated into today’s

second notice proposal.

All references to the Illinois Revised Statutes have also

been amended by addition of the parallel citation to the Illinois

Compiled Statutes.

Additionally, several inadvertent occurrences

of the phrase “owners

~

operators” have been changed to “owners

Q~

operators”, which is the appropriate regulatory construct.

DISCUSSION BY SECTION

Definitions

(Section 1420.102)

Low—level disinfection.

The Agency recommends deletion of

the definition of “low-level disinfection”, noting that the term

is not used in the proposal as presented at first notice.

(PC

#39 at

1.)

The Board accepts this recommendation,

and the term

is accordingly deleted.

P1MW

——

test kits.

In response to a question regarding

whether discarded unused test kits should be considered P1MW,

the

Board

in the first notice opinion proposed that any waste

containing blood components was

P1MW:

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

.

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 cámponents, or somehow

otherwise covered under the statutory

P1MW

definition,

is not P1MW.

(First notice opinion at p.

22, emphasis

added.)

The Agency and Dr. Anderson contend that a discarded unused test

kit that contains blood components should not be considered to be

P1MW.

The Agency observes that

P1MW

is by statutory definition

waste generated in connection with:

(1) the diagnosis, treatment

or immunization of human beings or animals; or

(2) research

pertaining to the provision of medical

services; or

(3) provision

or testing of biologicals.

(PC #39 at 2.)

The Agency further

observes that unused test kits that contain blood components

should not be regulated as

P1MW

since they are not generated

in

connection with any of these situations.

(~c~.)Dr. Anderson

also observes that the blood components in test kits have been

sterilized,

and as such have no infectious potential.

(PC #37 at

1.)

These points with regard to unused test kits are well taken,

and the Board accordingly today recedes from its prior proposed

position on this matter.

01

L~O-O329

---

—4—

Registered professional land surveyor and engineer.

The

definition for the term “registered professional engineer” has

been amended to include the correct proper short name of the act

cited, pursuant to the use of the short names

in the Illinois

Compiled Statutes.

The term “registered professional land

surveyor” has been deleted because it is not used

(see discussion

of Section 1420.105, below).

Reusable container.

Stericycle,

Inc., recommends deletion

of the word “smooth” from the definition of “reusable container”,

observing that “smooth” would otherwise need to be defined.

Stericycle also contends that inclusion of “smooth” might

unnecessarily preclude the use of some containers made from

recycled plastic.

(PC #35 at

1.)

The Board accepts this

recommendation,

and the word

is accordingly deleted.

Site.

The definition of “site” has presented one of the

more difficult parts of this regulation, as is witnessed by the

number of comments generated on this topic, both prior to and

during the first notice comment period.

The latter include the

comments of ABB Sanitec,

Inc.

(ABB), the Illinois Hospital

Association

(IHA),

Stericycle,

Inc.

(Stericycle), the National

Solid Waste Management Association

(NSWNA),

Dr. Van Allen

Anderson, and the Agency.

In the Board’s previous opinion and order,

the Board

addressed the comments received prior to first notice, and a

draft proposed definition was given.

That proposed definition,

found at Section 1420.102

is:

“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

Subtitle, each campus of an educational institution is

considered to be a single site.

Several commenters continue to voice concern that the first

notice proposal’s definition of site is insufficient to allow

flexibility in determining the nature of a site, especially in

the case of hospitals.

(PC #28 at

1; PC #34 at

1; PC #35 at

1;

PC #36 at

1)

Prior to first notice,

NSWMA

asked the Board to

propose a definition that NSWMA had submitted:

(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 adiacent properties and which are owned

or operated by the same person

(or by any person which

ORO-0330

---

—5—

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 buildings,

equipment,

structures and other

stationary items located within the same county which

are owned and operated by the institution of higher

education.

(PC #36;

Exh.

53).

(emphasis added).

That language is again presented to the Board by NSWMA and

supported by ABB and Stericycle.

The IHA supports some of the

language of NSWMA, with modifications.

IHA again expresses

concern about the regulation of hospitals, which can have

differing ownership and control arrangements.

The Board elects not to use the modifications suggested by

NSWMA and IHA, for the reasons stated in the Board’s previous

opinion, and because the concepts are already embodied in the Act

and these proposed regulations.

The

NSWMA

definition is more

restrictive since it contains the requirement that the

structures,

etc., be on contiguous or adjacent properties.

Such

location requirement goes beyond the current definition of site.

The Board believes that the current definition of site would

provide sufficient flexibility regarding location, without any

changes.

In addition, the NSWMA definition contains the concept of

ownership by a person.

“Person”

is already defined in the Act,

and as such the definition is applicable to these regulations.

To make the connection more clear, the Board today adds the

definition of “person” from the Act to these regulations as

follows:

“PERSON”

is any individual,

partnership, co-

partnership,

firm,

company, corporation, association,

joint stock company, trust,

estate, political

subdivision, state agency,

or any other legal entity,

or their representative, agent,

or assigns.

(Section

3.26 of the Act)

It

is probable that a hospital would be considered a person under

this definition.

A reading of the definitions of person and site,

and the

exceptions found in the Act and repeated at Section 1420.105,

shows that many hospital situations would not be overregulated as

feared by IHA.

The exceptions are in pertinent part:

O1~O-O331

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—6—

Section

1420.105

Permit

and

Manifest

Requirements

and Exceptions

*

*

*

c)

A person who conducts a

P1MW

treatment,

storage, or transfer operation is required to

obtain a permit from the Agency,

except:

1)

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

2)

ANY

HOSPITAL THAT TREATS,

STORES, OR

TRANSFERS ONLY

P1MW

GENERATED BY ITS OWN

ACTIVITIES OR BY MEMBERS OF ITS MEDICAL

STAFF.

(Section 56.1(g)

of the Act)

*

*

*

e)

Any person who transports

P1MW

is

required to carry a completed

P1MW

manifest except for the transportation

of:

1)

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

*

*

*

Regarding permits, the requirement for a treatment,

storage,

or

transfer facility permit, pursuant to Section 1420.105(c) (1), may

be excepted,

if a “person” is conducting an operation for

P1MW

generated by that person’s own activities and the wastes are

treated or stored on the site where the

P1MW

is generated.

Also,

the exemption in the proposal found at Section 1420.105(c) (2),

specifically for hospitals,

is not limited to a particular site

as in

(c) (1).

This means that hospitals that treat their own

P1MW

or

P1MW

generated by its medical staff are also exempted

from the permit requirement.

The statutory exemption of Section 56.1(h)

of the Act

pertaining to manifesting requirements,

contained in these

regulations at Section.l420.105(e), uses plural “sites” in

addition to the singular “site”.

This usage acknowledges the

potential for multiple sites controlled by the same person.

A

hospital with multiple sites under common control would not be

0

I ~O-O332

---

‘-7—

required to manifest, pursuant to subsection

(e) (1).

The issue

here is what “person” encompasses rather than what site is.

In addressing these issues, the Board cautions that it

is

not possible to cover each and every situation under a

definition.

For that reason the

IHA

suggested that the Agency be

given discretion in determining what a site is based on certain

criteria.

The Board believes that the Agency,

in the course of

administering this program and in applying rules of the Board to

particular situations, will most likely conclude what each site

is based on these regulations.

The Board does not believe any

express authority is necessary to give the Agency powers it

already possesses and exercises.

This is

not. to say that there

exists any implied delegation of authority,

for we are not

stating that the Agency can determine what defines a site.

Unrecognizable.

In its first notice opinion the Board at

page 26 discussed the addition, based upon an Agency

recommendation,

of the phrase “or perceived as usable” within the

definition of “unrecognizable”.

The definition would thus have

read:

“Unrecognizable” means relating to a sharp that has

undergone physical alteration

(e.g., melting, charring,

corroding, or grinding)

so that the sharp may no longer

be used,

or perceived as usable, for its intended

purpose.

This addition was not included in the text of the rule.

The

Agency now contends, and the Board agrees, that the addition

should not be adopted because of indeterminacy that the concept

of perception would introduce into the definition.

(PC #39

at

5.)

Also at first notice the Board discussed the encapsulation

and solidification process of Isolyser Company,

Inc.,

as a method

for the treatment of sharps.

(First notice opinion at p.

25.)

The Board stands behind that discussion.

However, based upon

that discussion Isolyser now asks that “encapsulating

—

solidifying” be specified in the definition of “unrecognizable”

as an example of physical alteration.

(PC #30 at ¶1.)

This the

Board declines to do.

The Board does not believe that the record

supports a blanket endorsement of all processes that involve

encapsulation or solidification.

Incorporations by Reference (Section 1420.103)

The Agency requests that the citation to the reference

“Standard Methods for the Examination of Water and Wastewater” be

updated from the 17th Edition,

1989,

to the 18th Edition,

1992.

This change is today made.

(PC #39 at 4.)

01L~O-O333

---

—8—

Prohibitions

(Section 1420.104)

Disposal of sharps.

Stericycle,

Inc., requests

clarification regarding the issue of sharps disposal, as

referenced at Section 1420.104(a).

(PC #35 at 2.)

Stericycle

notes the absence of a requirement that sharps be rendered

“unrecognizable” before disposal

in a landfill.

In addressing

Stericycle’s concern, the Board notes that there are two portions

of the Illinois Environmental Protection Act and one section of

the proposed regulations that address this issue.

The first is

the definition of

P1MW3

at Section 3.81(b)

of the Act:

(b)

Potentially infectious medical waste does not

include:

*

*

*

(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.

This

definition

thereby

establishes

that

sharps

that

have

had

their

infectious

potential

eliminated

and

have

been

treated

and

are

rendered

unrecognizable

no

longer

meet

the

definition

of

P1MW.

It

is

further

established

at

Section

56.1(a)

of

the

Act

that:

No

person

shall:

(a)

cause

or

allow

the

disposal

of

any

potentially

infectious

medical

waste.

Sharps

may

be

disposed

in

any

landfill

permitted

by

the

Agency

under

Section

21

of

this

Act

to

accept

municipal

waste

for

disposal,

if

both:

(1)

the

infectious

potential

has

been

eliminated

from

the

sharps

by

treatment;

and

(2)

the

sharps

are

packaged

in

accordance

with:

‘

The

same

definition

is

repeated

at

Section

1420.102

of

the

instant

proposed

regulations.

o~o-033’~

---

—9—

(A)

Board regulations; or

(B)

subsection

(b) (2),

until

Board

regulations

relating

to

the

packaging of potentially

infectious medical waste are

adopted

and

effective.

(emphasis added.)

The reference to sharps

in this section is contained in an

exception to the prohibition of disposal of

P1MW

in landfills.

Pursuant to Section 3.81(b) (3), sharps that are unrecognizable

and treated are 11Q~

P1MW

at

the

time

of

disposal.

Thus,

Section

56.1 applies only to those sharps that remain

P1MW

after

treatment

(i.e.

sharps that have not been rendered

unrecognizable)

Read

together,

these

two

sections

of

the

Act

therefore

establish that there are two pathways by which sharps may

ultimately be disposed.

The first is to package,

treat,

and

render unrecognizable the sharps.

After this processing, the

sharps are not considered to be

P1MW

and

may

be

disposed

of

like

any solid waste.

However,

if the sharps are packaged and treated

appropriately but are not rendered unrecognizable,

those sharps

may

still be landfilled under the exception provided in Section

56.1 of the Act.

This dual disposal pathway is reflected in the

recommendation of the Illinois Medical Waste Study Group, the

Agency’s

proposal,

and

the

instant

proposal

at

Section

1422.126:

Section

1422.126

Sharps

Sharps may be disposed in a landfill only if they have

been treated to eliminate the infectious potential and:

a)

Have

been

rendered

unrecognizable

and

therefore

are no longer

P1MW;

or

b)

Have been:

1)

Packaged,

marked, and labeled in accordance

with Part 1430, Subparts C and D;

2)

Delivered by a transporter with a

P1MW

hauling permit as required by Section

1420.104 of this Subtitle, unless

specifically exempted.

01 L~Q-O335

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—10—

3)

Accompanied by a P1MW manifest as required by

Section 1420.104 of this Subtitle, unless

specifically exempted.

(emphasis added)

The “or” in subsection 1422.126(a)

indicates that either route is

an acceptable handling of sharps.

Therefore, the Board finds

that the existing language of Section 1420.104(a)

is a correct

use of the statutory language and declines to append Stericycle’s

suggested language regarding unrecognizability.

Transportation permit.

Stericycle,

Inc., raises the

question of whether Section 1420.104(c)

should be applicable to

companies transporting waste from Illinois without transfer,

storage, or treatment.

(PC #35 at 3.)

Stericycle also suggests

that a specific exemption from treatment,

storage, and transfer

permits be provided at Section 1420.105 for companies that do not

treat,

store, or transfer

P1MW

within Illinois

(u.).

The Board notes that the issue of applicability of the

instant regulations to persons who conduct only part of their

activities within Illinois

is addressed at Section 1420.101:

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.

(emphasis added.)

If the activity (transfer,

storage, treatment)

does not occur in

any part within the state, the requirement for the appropriate

permits does not apply, pursuant to Section 1420.101.

Specific

exemptions are not required to clarify this issue.

Cleaning residues.

At first notice at the recommendation of

the Metropolitan Water Reclamation District of Greater Chicago

(MWRDGC) the Board added a provision found at Section 1420.104(1)

that prohibits the discharge of

P1MW

into sewers.

The MWRDGC

additionally asks that an explicit reference be added at several

subsequent portions of the P1MW4 regulations identifying that

cleaning residues from

P1MW

treatment are also prohibited from

discharge into sewers; NWRDGC “is concerned that these wastes

could contain,

in part at least, the same inert or solid

P1MW

‘~

Sections

1421.121(f),

1421.141(f),

1422.111(a)(9),

and

1422.122(b) (1).

01 L~O-0336

---

—11—

prohibited from discharge under Section 1420.104(1)”.

(PC #26 at

2.)

The Board believes that the prohibition at Section

1420.104(1)

should be sufficient to address the consideration

raised by the MWRDGC,

as far as the instant regulation is

concerned.

The Board also notes that it today changes the “Board Note”

that follows Section 1420.104(1)

and is repeated at other similar

parts of the regulations5 to read “Interested persons should

note that discharges to sewer systems can also be regulated by

units of local government.”

This change is made to clarify that

it is units of local government that may also have regulations

relating to discharges to sewer systems.

Permit and Manifest Requirements and Exceptions

(Section

1420.105)

A new subsection

(a)

is inserted today that make explicit

that the permit provisions of Section 39 and 40 of the Illinois

Environmental Protection Act apply to

P1MW

permits.

This

specification is requested by the Agency.

(PC #39 at 13-18.)

This changes requires relettering of the remaining subsections of

Section 1420.105.

The language of subsection

(d)

is also today modified to

conform to the additions made at Sections 1422.105 through

1422.107

(see following discussion).

Both ABB Sanitec,

Inc.,

(PC #28 at

1)

and Isolyser Company,

Inc.,

(PC #30 at ¶4) request clarification of how the permit

requirements of Section 1420.105(c)

cover mobile treatment

units6.

The Board’s reads the Act at Section 56.1(g), from

which the Section 1420.105(c)

language is repeated, as requiring

a permit for a mobile treatment unit, unless operation of the

unit somehow falls under the exceptions listed at Section

56.1(g); each possible exception would have to analyzed on a

case—by—case basis.

The generator of

P1MW

who treats,

stores, or

transfers

P1MW

——

whether using the services of a mobile

treatment unit or otherwise

——

is similarly required to have a

permit, unless qualifying for an exception under Section 56.1(g).

~ Sections 1421.121(f), 1421.141(f), 1422.121(f), and

1422.141(f).

6

A mobile treatment unit is a treatment facility that

travels between

P1MW

generators to treat

P1MW

onsite.

81L~0-0337

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—12—

Cleaning and Disinfection (Section 1420.107)

Use of abbreviations.

The Agency recommends that the terms

“liter” and “milliliter” as used at Section 1420.107(a) (2) (C) be

written out rather than abbreviated so as to eliminate possible

confusion over the meaning of the abbreviated forms.

(PC #39 at

p.

18.)

This recommendation is accepted.

Hvpochlorite concentration.

Stericycle,

Inc.,

also requests

clarification as to whether the concentration of hypochlorite

cited is intended to be 50 ppm or 500 ppm.

(PC #35 at 3.)

The

intended concentration is 50 ppm, the number used in the Agency

proposal and at first notice.

(See Tr27.

at 64 and 243—5.)

Packaging Standards and Criteria (Section 1421.121)

At first notice the Board proposed the requirement that

packaging of oversized

P1MW

be done in a manner “so as to avoid

contact with transportation workers and the public”.

This

language was chosen to impart a high degree of specificity to the

requirement.

Dr. Anderson recommends that the wording be “that minimizes

contact with transportation workers and the public”.

He observes

that this was the language originally recommended by the Agency

and Study Group,

as well as the language retained at first notice

in the parallel construction found in the transportation subpart

at Section 1421.141(b).

(PC #37 at 1.)

Dr. Anderson observes:

The wording “that minimizes” was chosen to provide

flexibility in the handling of oversize wastes that

cannot be packaged in a conventional sense

(e.g.,

boxed)

to totally avoid contact with transport workers.

A specific example of such a waste would be large

animals “inoculated during research, production of

biologicals, or pharmaceutical testing with agents

infectious to humans”

(See definition of Animal Waste,

Section 1420.102).

The carcasses of these animals are

considered

P1MW.

Trying to “package”

a large animal

carcass would increase the handling of the carcass,

thereby increasing contact with the material.

Other

types of oversized

P1MW

could be equally difficult to

“package”.

(PC #37 at 1—2.)

‘~

Citation to the pages of transcripts are in the same form

today as used at first notice.

That is, the inquiry hearing are

in the form “Trl.

at

____“;

citations to the transcripts of the

merit hearings, which are consecutively numbered, are in the form

“Tr2.

at

a 1L~0-0338

---

—13—

The Board accepts Dr. Anderson’s observations, and today uses the

“that minimizes” construction at Section 1421.121(c).

Labeling and Marking

(Section 1421.130)

Stericycle,

Inc., requests clarification as to whether the

“unique identification number” described at Section

1421.130(a) (2)

is one assigned to a full trailer on the date that

the trailer is removed from the generator.

(PC #35 at 4.)

Stericycle observes that this interpretation would “eliminate the

need for labeling each container on the trailer with a shipment

date”

(Id.).

The concept behind the “identification number”

is indeed

intended as Stericycle conceives it.

The Agency addressed this

matter at hearing in the testimony of Dr. Shirley Baer:

The use of a unique identification number for the

shipment date was recommended by Mr. Karls

(Attachment

13).

It

is common for

a truck to be parked in a

specific location at a hospital

...

Essentially the

truck acts as a storage unit at the hospital.

Once the

truck is full,

the

P1MW

is transported off—site

...

It

would be burdensome, as well as costly,

to mark each

outer container with the shipment date,

since it would

probably require (rehandling of each individual

P1MW

.parcel.

(Tr2.

at 97-8.)

Transportation Recruirements

(Section 1421.141)

Manifests.

The Environmental Protection Act sets out

various requirements of

P1MW

handlers that are met through the

use of manifests.

Most specifics regarding the form and use of

these manifests are either statutory or statutorily within the

purview of the Agency8.

This notwithstanding, the Board at first

notice raised the issue of whether, for the sake of clarity

within the instant proposal, some additional presentation of the

use of manifests is needed in the proposed rule.

None of the

commenters have risen to this issue9, which the Board accepts as

endorsement of the manifest provisions as presented at at first

notice.

~ See, for example,

the Act at Sections 56.1(d) (2), 56.1(h),

and 56.4,

~ The Agency has presented an addendum to its view of how

the manifest system in intended to work on pages 19—20

of its

public comment

(PC #39).

Interested persons are directed to this

document.

o~.1~00339

---

-14—

NSWMA

requests that the term “manifest” be replaced with the

term

“shipping

paper”,

wherever

the

former

appears

in

today’s

rule,

so as to distinguish it from the manifests required under

some federal

law.

(PC #36 at 3.)

The Board sympathizes with

problems

arising

from

different

meanings

applied

to

the

same

word.

However,

“manifest”

is the term used for shipping paper in

the

P1MW

statute (see 415 ILCS 5/Subtitle XV), and references

in

today’s proposal are to this same statutory manifest.

The Board

is not empowered to alter the use in the statute, and believes it

unwise to use a term in the regulations different from that used

in the statute.

Dedicated vehicles.

As proposed at first notice the

regulations at Section 1421.141(i) contain a prohibition against

the transportation of non—PINW materials in vehicles otherwise

used to transport

P1MW.

However, the Board did, based upon

concern from trucking interests, request comment on whether

alternating of loads might be made permissible under some

circumstances

(e.g.,

backhauling if preceded by decontamination).

Sexton Environmental Systems,

Inc.

(PC #29 at 5),

Stericycle,

Inc.

(PC

#35

at

4),

and

the

NSWMA

(PC #36 at

2)

each responded in

opposition to any exception beyond those already specified within

1421.141(i).

On this basis the Board does not today alter the

language of the first notice proposal.

Permit Applications

(Sections 1422.105 through 1422.107)

At

first

notice

the

Board

raised

an

issue

concerning

the

need for further specificity and clarification in the regulations

regarding the procedures for, and contents of, applications for

permits for treatment,

storage, or transfer operations.

(First

notice opinion at p.

18-19.)

The Agency in response (while

questioning the need for specificity) has submitted recommended

provisions addressing these application requirements.

(PC #39 at

5—12.)

Today’s proposal contains new Sections 1422.105,

1422.106,

and 1422.107 that respond to the Agency’s recommendation.

The

additions are gathered into three new sections for the purpose of

organizational clarity.

The specific language in these sections in large measure

draws upon the Agency’s recommendations.

However, there are some

suggested requirements in the Agency comment that are not

utilized in the Board’s proposed regulations because they could

constitute new showings or restrictions not previously

“aired” in

this rulemaking.

Examples include certain location standards and

mapping requirements that would not apply to

P1MW

facilities

unless those requirements are already mandated elsewhere, such as

in other regulations.

Oi1~O030

---

—15—

Storacre Requirements

(Section 1422.111)

“Elevated” storage.

Stericycle,

Inc.

(PC #35 at 4),

inquires of the meaning of the word “elevated” used in the

requirement of Section 1422.111(b) (3):

Cardboard packages must be elevated and stored in an

enclosed area.

This issue was addressed in the testimony of the Agency as

presented Mr. Theodore Dragovich:

Cardboard packages must be elevated during storage to

insure that their structural integrity is not

compromised by moisture resulting from spills or normal

housekeeping activities,

such as floor mopping.

If packages are stored directly on the floor, the

opportunity for contact with moisture is much higher

than in situations where the packages are elevated.

(Tr2.

at 167.)

“Elevated” is accordingly equivalent to “above the floor”.

To

insure that this meaning is clear to all, the Board today revises

Section 1420.111(b) (3) as follows:

3)

Cardboard packages must be elevated and stored in

an enclosed area at an elevation above that of the

floor.

Personnel training.

As regards the personnel training

requirement of Section 1422.111(b) (8)10, ABB Sanitec,

Inc.,

contends that not all personnel at a

P1MW

storage facility

(e.g.,

clerical staff) would seemingly need P1MW training.

(PC #28 at

2.)

The Board disagrees.

Every employee of a P1MW facility

should be made aware of at least the basic guidelines of

P1MW

management.

This is not, however, to say that all personnel need

to receive the same depth of the training.

As the Agency

observed in presenting the rationale for this training provision:

The amount of training involved depends upon the

person’s job but must be adequate to insure that they

can safely perform their job, avoid occupational

exposure and respond properly during emergency

situations.

(Tr2.

at 170.)

Stericycle,

Inc., also inquires whether the personnel

training requirement of Section 1422.111(b) (8) applies only to

permitted facilities.

(PC #35 at 4.)

The answer is “yes”.

10

The same question is raised by ABB with regard to proposed

Section 1422(c) (3); the Board’s response is the same.

0R0-03i~I

---

—16—

Section 1422.111(b)

specifies that “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

.

Subsection

(b) (8)

is one of these requirements.

Time limit for storage.

Section 1422.111(b) (12)

sets

limits1’ on the time that

P1MW

may be stored.

Stericycle,

Inc.,

noting that an intent of this provision is to avoid putrescence,

questions whether it is necessary to prescribe a storage time

limit as long as the waste has not become putrescent.

(PC #35 at

4.)

The Board believes that the time limit is necessary to avoid

common occurrences of putrescence; setting the test for continued

storage at the presence of putrescence would surely and

needlessly increase the instances of

P1MW

being kept until

it

became putrescent.

Moreover, the purpose of the storage time

limit is broader than just avoidance of putrescence.

It is also

intended to prevent indefinite storage from being used as a means

of disposal.

(Tr2.

at 173.)

Treatment Facility Certification (Section 1422.121)

Isolyser,

Inc.,

reads Section 1422.121 as requiring a

generator/treatment facility operator to supply a landfill with

documentation of efficacy of the treatment unit;

Isolyser

contends that this is inappropriate.

(PC #30 at ¶2.)

The Board

believes that Isolyser reads more into this section than has been

intended.

The crux of the provision at issue is that a treater

of

P1MW

must be prepared to demonstrate to the disposer that the

P1MW

has been properly treated,

including,

if requested, data

verifying efficacy of the treatment unit.

Nevertheless, the Board appreciates that clarification of

this provision is appropriate.

Accordingly, today the Board

amends the second last sentence of the Section as follows:

Data to verify the efficacy of the treatment unit must

be made available to the receiving facility upon

request of the receiving facility.

Treatment Facility Design and Operation (Section 1422.122)

Applicability of Section 1422.122 requirements.

Stericycle,

Inc., requests clarification of whether the requirements of this

section apply only to permitted facilities or to anyone treating

P1MW.

(PC #35 at 5.)

The answer is found at Section 1422.120,

~‘

The time limits specified are those recommended by the

Illinois Medical Waste Study Group

(Tr2.

at 174):

72 hours for

unrefrigerated

P1MW

and 30 days for refrigerated

P1MW.

It is

further specified that either or both of these limits may be set

differently by permit.

0IL10-tj3t~~

---

—17—

which is the Scope and Applicability Statement for the whole of

Subpart C,

including Section 1422.122.

Pursuant to Section

1422.120 the Subpart C requirements apply to the owner or

operator of any

P1MW

treatment facility.

Elimination of infectious potential.

The first notice

proposal at Section 1422.122(a) (1) provided an operational

definition of the statutory phrase “eliminates the infectious

potential of the waste”:

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.

However, given the large amount of concern generated by the

general issue of the treatment standard (see first notice opinion

at pp.

14-18,

34-40), the Board requested interested persons to

focus on this definition

(La.

at 18).

Several commenters

responded,

including the National Solid Waste Management

Association, which proposes alternative language of the following

form:

ELIMINATES THE INFECTIOUS POTENTIAL OF THE WASTE.

The

infectious potential is eliminated by treatment in a

process that results in a 6—log reduction in vegetative

organisms and, at a minimum,

a

3-lo.g reduction in

bacterial spores as indicated by the Initial Efficacy

Test and Periodic Verification Test conducted pursuant

to Sections 1422.124 and 1422.125 of this Part.

(PC

#36 at 3).

Stericycle,

Inc., proposes similar language, although it

recommends a standard for bacterial spores of a 6—log reduction.

(PC #35 at 5.)

Ecomed,

Inc., recommends that the first notice

language be left intact.

(PC #38 at 3.)

As it did at first notice, the Board affirms its intention

to retain the treatment standards proposed by the Agency as

reflected in the first notice proposal.

The language proposed by

NSWMA more clearly reflects those standards and more clearly

articulates the specific standards that constitute elimination of

infectious potential.

For these reasons, the Board today

replaces Section 1422.122(a) (1) with the language recommended by

NSWMA.

Compaction and rupture exception.

At Section 1422.122 (a) (2)

the first notice proposal contained the following language:

01 ~ü-03~3

---

—18—

a)

Treatment of

P1MW

must be conducted in a manner

that:

*

*

*

2)

PREVENTS THE COMPACTION

AND RUPTURE

OF

CONTAINERS DURING HANDLING OPERATIONS, except

when the package is in a treatment unit;

The Board observed at first notice that the exception clause at

the end of this subsection was based on the principle that:

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).

(First notice opinion at p.

35.)

Both Stericycle,

Inc.

(PC #35 at 5), and the National Solid

Waste Management Association

(PC #36 at 3-4)

observe that the

language in the exception clause presents possible difficulties.

NSWMA

contends, for example, that emissions to the environment

would not be excluded under the language in question.

The Board agrees with Stericycle’s and the NSWMA’S

observations and today’s amends Section 1422.122(a) (2)

as

recommended by the NSWMA as follows:

2)

PREVENTS THE COMPACTION

AND

RUPTURE OF CONTAINERS

DURING HANDLING OPERATIONS, except when compaction

or rupture is an integral part of the treatment

process and the treatment process is conducted

without discharge of P1MW to the environment ~e

package

ic in a treatment unit;

Recordkeeping requirements.

Stericycle,

Inc., suggests that

the recordkeeping requirements at Section 1422.122(c) (5)

“seem to

be somewhat redundant”, and that they be at least partially

deleted.

(PC #35 at 5.)

The Board disagrees.

The requirements

are fairly standard and of the type that have been useful in

tracking wastes.

Treatment Units (Section 1422.123)

In the first notice opinion at pages 35-37 the Board

discussed and expressed concern regarding the proposed provisions

that address use of treatment units at permit—exempt treatment

facilities.

These provisions are found at Section 1422.123(b)

of

the first notice proposal, as follows:

*

*

*

b)

A treatment unit may be used by a treatment

facility not required to have a permit pursuant to

35 Ill. Adm. Code 1420.105 of this Subtitle,

if

0 1j40_Q3t4J~

---

—19—

the requirements of subsection

(b) (1)

or

(2) below

are met.

1)

The treatment unit meets the standards of

subsections

(a)(1)-(5)

of this Section, and:

A)

The treatment unit utilizes a thermal,

chemical, or irradiation treatment,

as

defined in 35 Ill. Adm. Code 1420.102 of this

Subtitle; or

B)

The treatment unit is mechanically identical

to one previously permitted in Illinois for

the treatment of

P1MW,

is operated under the

same operating conditions and feed rate,

and

uses the same Periodic Verification Test

method and frequency.

2)

The Board has granted the owner’s or operator’s

petition for an adjusted standard pursuant to 35

Ill. Adm. Code l06.Subpart G or a site—specific

rulemaking pursuant to 35 Ill. Adm.

Code 102.

In

considering a petition, the Board will determine

whether the treatment unit meets, at a minimum,

the standards of subsection

(a) (1)—(5)

of this

Section.

The record shows that the Study Group and the Agency

proposed these provisions to allow easy consideration for new

technologies that do not fit the definition of chemical, thermal,

or irradiation treatment.

The Board supports this concept.

Several cominentors have added additional perspective to the

Section 1422.122(b)

provisions.

Among these are observations

regarding the degree of oversight proposed for permit—exempt

facilities.

The City of Chicago,

for example,

is concerned that

“municipalities could be burdened by the regulation of these

unpermitted facilities if the State fails to adequately regulate

these facilities’ treatment units”.

(PC #33 at 2.)

Ecomed,

Inc.,

observes,

in part to the concerns of the City of Chicago,

that

“(as

the manufacturer of low cost on—site treatment

technology,

it is critical for us to be able to satisfy the

permit requirements of specific units on a multi—site basis”.

(PC #38 at

1.)

The Illinois Hospital Association encourages the

Board to retain the Agency-proposed mechanism noting that

although,

“no specific permit would be required,

there is still

regulatory

oversight

by

multiple

state

agencies.

These

(instant)

rules specify operational parameters and require all operators to

ensure that treatment units are operating effectively through

monthly periodic verification tests.”

(PC #34 at 3.)

---

—20—

A second issue is that of the use of adjusted standards.

The Agency expresses concern that “(i)t would be overly

burdensome for the Board,

industry and the IEPA to conduct

adjusted standards for identical treatment units because the IEPA

anticipates that thousands of identical treatment units will be

used by the medical community”.

(PC #39 at

21..)

The Board notes

that the Agency appears to interpret citation to the adjusted

standard procedure in this section as limited to site-specific

adjusted standards.

Although requests to the Board for adjusted

standards have generally been of a site—specific nature’2, an

adjusted standard can also be technology—specific, and that is

the sort that the Board has envisioned here.

The Board emphasizes that it is sympathetic with the

concerns of the Agency regarding the administrative burden of

adjusted standards.

An adjusted standard proceeding is resource

consuming not only for the Board,

but for the Agency and the

petitioning party as well.

Accordingly, reliance on the adjusted

standard process must be contemplated with care that an

unnecessary and onerous administrative burden is not created.

As a final matter regarding Section 1422.123(b),

Dr.

Anderson recommends alternative language (PC #37 at

2)

that

addresses many of the concerns raised by the Board at first

notice and by the first notice commentors.

The Board accepts

this recommendation with some changes, and accordingly today

substitutes the following language:

b)

A treatment unit may be used by the owner or operator

of a treatment facility not required to have a permit

pursuant to 35

Ill. Adm. Code 1420.105 of this

Subtitle,

if the requirements of subsection

(b) (1)

or

(2)

below are met.

12

The statutory requirements governing the adjusted standard

procedure are articulated

at Section 28.1

of the Act.

Section

28.1(a) allows the Board to grant an adjusted standard for persons

who can justify such adjustment consistent with Section 27(a)

of

the Act.

Section 27(a) requires the Board, among other things,

tc

consider existing physical conditions, the character of the area,

surrounding

land

uses,

zoning

classification,

environmental

conditions etc., when granting an adjusted standard.

By requiring the Board to. grant adjusted standards consistent

with Section 27(a),

the statute requires the Board to consider the

implications of certain site—specific conditions when granting ar

adjusted standard.

However,

the statute does not prohibit the

Board from granting a technology-specific adjusted standard.

AE

long

as

informational

requirements

are

met

to

the

extent

applicable,

a

technology-specific

adjusted

standard

may

be

granted.

01 ~o-03L6

---

—21—

1)

The treatment unit meets the standards of

subsections

(a) (l)—(5) of this Section, and:

A)

The treatment unit utilizes a thermal,

chemical,

or irradiation treatment,

as

defined in 35 Ill. Adm. Code 1420.102 of this

Subtitle; or

B)

The owner or operator maintains a copy of the

Initial Efficacy Test results for the

treatment unit.

In addition, the owner or

operator shall conduct Periodic Verification

Tests in accordance with the manufacturer’s

instructions and Section 1422.125.

Test

results shall be retained and made available

for inspection in accordance with Section

1422.125(d)

and

(g); and

C)

The owner or operator retains any

notification from the manufacturer of a

permitted commercially available treatment

unit of a permit modification.

2)

The Board has granted the owner’s or operator’s

petition for an adjusted standard pursuant to 35

Ill.

Adm. Code 106.Subpart G or a site—specific

rulemaking pursuant to 35 Ill. Adm. Code 102.

The

petition must include a demonstration that the

treatment unit meets the standards of subsection

(a)(1)—(5)

of this Section.

Initial

Efficacy

Test

(Section

1422.124)

Waiver of test.

Stericycle recommends that today’s proposal

contain a provision that would allow the Agency to waive the

Initial Efficacy Test where a treatment unit could be shown to

meet the more stringent efficacy standards of another state.

(PC #35 at 6.)

This the Board declines to do.

Aside from

problems of whether this would constitute an unacceptable

delegation of authority to another state, there is no adequate

record before the Board upon which the Board could find that the

requirements of any other state are consistent with the

requirements laid down in today’s regulations.

Model number.

Several commentors noted difficulties with

equating “the same model number” with the concept of mechanical

identity,

as

found

at

Section

1422.124(a)

(2)

of

the

first

notice

proposal.

Isolyser,

for example, notes that its treatment unit

uses batch numbers rather than model numbers.

(PC #30 at ¶5.)

Both ABB Sanitec, Inc.

(PC #28 at 2), and Ecomed,

Inc.

(PC #38 at

3), note that model number is an artificial construct of the

manufacturer, and may have little relationship to the technology

01 1~O-O3’47

---

—22—

involved.

ABB

Sanitec

cites

the

example

of

a

manufacturer

differently numbering units depending upon how the units are

house or mounted.

(PC #28 at 2.)

Ecomed observes that a

manufacturer may choose to use different model numbers depending

upon marketing outlet.

(PC #38 at 3.)

The Board agrees that model number is only weakly associated

with the concept of mechanical identity.

Accordingly, the model

number provision is today deleted.

Manufacturer’s instructions.

In its first notice opinion,

the Board asked for clarification regarding the term “applicable

manufacturer” found in first notice Sections 1422.124(e) (2)

and

1422.125(b) (4).

The Agency responded that the “methods to be

used in culturing and enumerating the microorganisms are

prescribed by the commercial or clinical laboratory providing the

test and/or indicator microorganisms”.

(PC #39 at 22.)

ABB and

Ecomed each responded that the treatment unit manufacturer should

supply the owner or operator with the necessary methods

(PC #28

at 2; PC #38 at

3, respectively).

The Board defers to the Agency’s interpretation as the

authors of the subsections in question and accordingly today

replaces the term “applicable manufacturer’s recommendations”

with “instructions provided by the supplier of the

microorganisms”.

Document of Initial Efficacy.

At first notice the Board

observed and questioned as follows:

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?

Ecomed,

Inc., observes that a copy of the Document of Initial

Efficacy is obtainable from manufacturers.

(PC #38 at 3.)

The

Agency further notes that “IEPA discussions and written

correspondence with many treatment unit manufacturers” indicates

that the Document of Initial Efficacy can easily be provided to

an owner/operator.

(PC #38 at 22.)

The Board notes that, pursuant to these comments, the

Document of Initial Efficacy Demonstration is generally prepared

~

the manufacturer rather than the treatment facility.

The

Board has accordingly altered subsection

(f) by deleting the

phrase “prepared by”, thereby requiring that the treatment

facility only retain the Document of Initial Efficacy

Demonstration.

Thus,

a treatment facility must take the

0iL.~0-U3~8

---

—23—

responsibility of obtaining the document from the manufacturer so

that it is available at any time for reference and inspection.

Periodic

Verification

Test

(Section

1422.125)

Commercially-available

spore

test

kits.

The

Illinois

Hospital Association proposes an addition at Section 1422.125(a)

addressing

the

use

of

a

commercially available spore test kit for

periodic verification testing:

Using a commercially available test kit which will

demonstrate a 6—log reduction of the indicator

microorganism using the relevant treatment process.

Commercially available test kits must be used according

to manufacturers instructions.

(PC #34 at

4.)

It is the Board’s understanding that the periodic

verification test is to be performed with a spore test kit

containing one of the indicator organisms given in Section

1422.Appendix B.

The owner or operator of the treatment unit is

responsible for determining that the test kit will show the

appropriate spore reduction as related to the reduction of

vegetative microorganisms in the Initial Efficacy Test.

Because

the manufacturer of a treatment unit will most likely determine

the correlation between the Periodic Verification Test and the

Initial Efficacy Test, the owner or operator should be able to

refer to the manufacturer for recommendations regarding the

appropriate commercial test kit and operating instructions.

The

Board also notes that because initial efficacy can be proven

using a 6—log reduction of spores, nothing prohibits an owner or

operator of a treatment unit from demonstrating periodic

verification using a commercial test kit.

Incinerator alternative verification.

The proposal at

Section 1422.125(a) (3) provides an example of an alternative

verification method

(i.e., visual inspection of ash)

applicable

only to incinerators.

The Illinois Hospital Association observes

that “incineration is a common treatment method for

P1MW”

for

which “the efficacy of treatment

.

.

.

is well established”.

(PC

#34 at 4.)

On this basis the

IHA

recommends that these

regulations not require case by case Agency approval for visual

ash inspection,

and that periodic verification for incinerators

be split out into a separate subsection.

(u.)

Ecomed,

Inc.,

in contrast, recommends retention of the

language as presented at first notice as the best method of

assuring that new,

innovative technologies can be accommodated.

(PC #38 at 3.)

The Board is not inclined to provide blanket alternatives to

periodic verification tests as suggested by IHA for incinerators.

The standards established by these rules and the methods by which

01

L~O-33t1g

---

—24—

compliance

is

determined

are

applicable

to

every

treatment

technology unless the owner, operator,

or manufacturer can

provide scientific data to prove otherwise.

Notification of results.

IHA

has expressed concern

regarding the requirements of Section 1422.125(d):

Results of the Period Verification Test(s) must be

received, verified, and available for inspection by the

Agency within two weeks of when the test was conducted,

except in the case of when a Periodic Verification Test

is used to confirm the failure of a treatment unit.

In

this case, the results of the Periodic Verification

Test(s) must be received, verified, and available for

inspection by the Agency within one week of when the

test was conducted.

IHA notes that this subsection, read in conjunction with Section

1422.125(g), could be interpreted to require an owner or operator

of

a treatment unit to send the Agency the results of the

Periodic Verification Test within two weeks of when the test was

conducted.

(PC #34 at 4.)

The Board reads these subsections as

requiring the owner or operator to receive the results

(in the

case where the test is analyzed elsewhere)

,

verify the results,

and make those results available to the Agency within two weeks.

To clarify this point,

the Board today changes the wording of

Section 1422.125(d)

as follows:

Results of the Periodic Verification Test(s) must be

received, verified,

and made available for inspection

by the Agency within two weeks of when the test was

conducted~,except in the cace of

w~jhena Periodic

Verification Test is used to confirm the failure of a

treatment unit.

In thic pace,

the results of the

Periodic Verification Test(s)

must be received,

verified, and made available for inspection by the

Agency within one week of when the test was conducted.

Results of Periodic Verification Tests must be made

available in accordance with the requirements of

subsection

(g).

below.

“Log—reduction” efficacy standard.

At first notice, the

Board requested comment on whether a “log—reduction” or “log—

kill” standard was appropriate for these rules.

(First notice

opinion at 17.)

Extensive comment was filed on this issue,

including by Sexton Environmental Systems,

Inc.

(PC #29 at 1-5),

City of Chicago

(PC #33 at 1),

the National Solid Waste

Management Association

(PC #36 at 4),

and Dr. Anderson

(PC #37 at

3).

All voice support for the “log—reduction” standard and

calculations proposed by the Agency and by the Board at first

notice.

No comments supporting “log—kill” have been tendered

during the first notice comment period.

Accordingly, the Board

Ol1~O-Q350

---

—25—

stands by its first notice decision to retain the standard and

calculations proposed by the Agency.

Initial Efficacy Test Procedures

(Section 1422.Ap~endixA)

Treatment efficacy standard.

Based on the extensive record

developed on the issue, the Board at first notice declined to

alter the proposed efficacy standard to focus on bacterial

spores,

as was then recommended by Sexton Environmental Systems.

(see first notice opinion at p.

15-16.)

Dr. Anderson (PC #37 at

3),

Ecomed,

Inc.

(PC #38 at 2), and the Agency

(PC #39 at 23-28)

add additional record on this matter, which further reinforces

the Board’s determination as proposed at first notice.

Substitution liquid.

The dilution provisions of the Phase

I

of Option I provided at first notice that the dilutant be sterile

saline solution or phosphate buffer solution.

Medical SafeTec

recommends that “tap water not be prohibited from selection as

the substitution liquid.

The use of tap water may not be

appropriate in all instances,

but neither should it be

prohibited.”

(PC #27 at

2.)

Ecomed,

Inc.,

also observes that

“(t)ap water is perfectly acceptable, as that is what the systems

are going to use in normal operation”.

(PC #38 at

4.)

The

Agency now supports the use of any liquid because the “effect of

the liquid will impact the quantity of microorganisms that will

need to be used in

Phase 2.”

(PC #39 at 23).

Because the

number of organisms recovered in Phase

1 must be greater than 6-

log, any reduction of organisms by substitution liquid will

require a larger inoculum prior to testing.

The Board has

accordingly altered this section of Section 1422.Appendix A to

read:

The container of test microorganisms and challenge

loads must be processed together without the physical

and/or chemical agents designed to kill the test

microorganisms.

For example,

in treatment units that

use chemical disinfectant(s)

an equal volume of liquid

(e.g., sterile saline solution

(0.9,

volume/volume)

e~ phosphate buffer solution, or tapwater) must be

substituted in place of the chemical disinfectant(s).

Alternative organisms.

Mediclean Technology,

Inc., requests

that the Board allow submission of efficacy test data on other

organisms of resistance equivalent to or greater than those

listed in Section l422.Appendix A, Tables A and B, as approved by

an appropriate Illinois governmental agency.

(PC #32 at 1.)

The

Board notes that the Agency addressed this issue at hearing,

observing that “no alternatives will be permitted to

(the

proposed rules since it was the consensus of the study group that

all treatment technologies be evaluated by the same standards”

(Tr2. at 231).

The Board supports the Agency and the Study Group

01L~0-035

I

---

—26—

position in this matter and will not modify the rule as requested

by Mediclean.

ECONOMIC IMPACT

The Board is charged under the Act to take into account the

technical feasibility and economic reasonableness of all

regulatory proposals before it.

(Act at Section 27(a).)

Compliance can be achieved with existing technology,

so the

technical feasibility of reducing this type of pollution is not

an issue in this proceeding.

Therefore,

by this discussion the

Board examines the economic reasonableness of reducing this

particular type of pollution by considering the information

presented in the record on this topic.

In general,

a small percentage of the testimony and comments

address economic matters.

A summary of that information is given

below.

Affected Facilities and Costs

The record contains information on the facilities that

generate medical waste as approximately: 2,500 health care

facilities

(including hospitals, long term care facilities,

local

health clinics), 24,000 physicians,

6,500 dentists13,

and 3,906

funeral directors.

(Exh.

~14

at

10, appendix 2).

It

is

estimated that 103 Illinois colleges have programs that

potentially generate medical waste.

(Exh.

37 Att.

16).

The

Agency submitted a 63 page list of 1400 special waste haulers

that may or may not opt to haul medical waste.

A list of haulers

who contacted the Agency requesting information on the

requirements of commercial transportation of

P1MW

prior to

submittal of the proposal was also included in the record

(See,

Exh.

37 Atts.

11 and 12).

The Agency also states that there are

currently seven off—site transfer/storage/treatment facilities

permitted for

P1MW

by the Bureau of Land.

There are 191 hospital

incinerators and 148 sites and 88 ethylene oxide units at 56

sites currently permitted by the Bureau of Air.

(See,

Exh.

37

Atts.

14 and 15).

All these facilities and businesses are

estimated to be affected to some degree by these rules.

The Report to the Governor discusses costs of

P1MW

disposal

as follows:

13

Robert A.

Rechner,

Illinois Dental Association,

estimates

that 7,000 dentists practice in Illinois.

(Exh. 41).

14

Report

to

the

Governor,

The

Regulation

of

Potentially

Infectious Medical Waste

in

Illinois,

June

1991,

Medical

Waste

Tracking Study Group.

O1L~0-

0352

---

—27—

The Study Group recognized the problem of escalating

health care costs and the increasing difficulty of

access to health care.

It is the intent of the Study

Group that the effect of waste handling on health care

costs be limited as much as possible.

The cost to dispose of

P1MW

in Illinois depends on

several factors and obviously will vary within the

state.

However, based on the waste management

companies polled,

a common pricing arrangement is to

charge larger generators,

such as hospitals, on a per

pound basis and the smaller ones per pickup or per

carton.

A common conversion in comparing the weight

and volume of

P1MW

is 4.5 to 5.0 pounds/cubic foot.

*

*

*

A May 1989 American Hospital Association estimate

placed the range of costs for

P1MW

disposal for a 200

bed hospital to be between $63,000 and $173,000 per

year.

Other factors could increase costs such as the

recent Clean Air Act amendments, regulatory changes,

etc.

(Exh.

5).

Throughout the hearing, members of the Study Group urged the

Board to be sensitive to costs.

(Exh 45 at

7; Tn.

at 109).

In addition, the NSWMA submitted a document it entitled an

Economic Impact Analysis.

NSWMA states that its intent and that

of the Medical Waste Tracking Study Group has been to minimize

cost impact the health care community in developing these

regulations.

NSWMA states that the proposed

P1MW

regulations

will have little appreciable economic impact on currently

regulated hospital generators.

Although the

P1MW

regulations

will expand the scope of generators regulated beyond the

hospitals currently regulated,

NSWIMA states that these generators

“should be able to reduce the collection fee and treatment cost

burden by employing one of the several on—site treatment options,

or by transporting the limited quantity of

P1MW

they generate to

a hospital with which they are affiliated for treatment.

NSWMA

estimates that 40 to 50

of these newly regulated small quantity

generators will be able to utilize on-site or off—site hospital

treatment.”

(Exh.

37 Att.

10).

NSWMA gives other estimates of economic impact as follows:

The economic impact for the estimated remaining 17,500

generators, who select commercial management of

P1MW,

should be negligible for two reasons.

First,

P1MW

is

defined by the new regulations in a way that permits

generators to be more selective in the types of waste

01k0

Q353

---

—28—

requiring

P1MW

management.

Overall, this should reduce

the volume of

P1MW.

Second, increased competition has

reduced the cost for commercial

P1MW

management, and

this trend should continue.

(Exh.

37 Att. 10).

Finally, NSWMA estimates that efficient waste segregation,

increased competition, and increased employee safety and

awareness should all serve to reduce costs.

(Exh.

37 Att.

10)..

Robert A. Rechner of the Illinois Dental Society estimated

that the costs of purchasing sharps containers and outer

packages,. and the pick—up fee increases costs to dentists

approximately $25.00 per month.

He also estimated that the

periodic verification tests, assuming the tests were conducted

monthly for one autoclave for

2 dentists in the state would

result in costs of $4,410,000 for all the dentists in the state.

(Exh.

41)

Cost—Benefit Analysis

The benefit to the rule, put most simply,

is the lessening

of the public health risks of infection from medical waste.

The

information in the record indicates that the costs associated

with the proposed rule have been minimized to the extent

possible.

In addition to the discussion above,

it is worth noting that

the costs of these rules would be additionally offset when

compared with similar programs already in place at health care

facilities.

The Agency states that OSHA’s Occupational Exposure

to Bloodborne Pathogens Rule

(29 CFR 1910.1030

(1991))

(Exh.

37

Att.

6)

contains requirements for segregation, packaging,

labeling, marking, transportation, storage, and treatment of

regulated medical waste that meets or exceeds the requirements

for these proposed rules.

(Exh.

37 at 3).

The Board has considered the information in the record

pertaining to the economic reasonableness of these rules,

including comments, testimony,

and exhibits.

Actual dollar

figures of the costs associated with these proposed rules has

been difficult to ascertain from the record.

However, the Board

concludes that the record supports the finding that the instant

rule will not be economically unreasonable.

ORDER

The

Board

hereby

directs

that

second

notice

of

the

following

proposed

amendments

to

35

Ill.

Adm.

Code

1420

and

the

following

01 kO-035”~

---

—29—

new Parts 35 Ill. Adm. Code 1421 and 1422 be submitted to the

Joint Committee on Administrative Rules.

TITLE 35:

ENVIRONMENTAL PROTECTION

SUBTITLE N:

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-(-e--

~

~

of

the

Environmental

Protection

Act

(Ill.

Rev.

Stat.

19?-9-~j~,

ch.

111

1/2,

par~.

1056.2(c),

as

added

by

P.A.

87-752

effective

January

1,

1992,

as

amended

by

P.A.

87—1097,

effective

January

1,

1993,

and 1027)

1415 ILCS 5/56.2 and 5/27.

SOURCE:

Adopted in R91-19,

at 16

Ill.

Reg.

2594, effective

February

3,

1992;

amended

in

R91—20

at

____

Il1.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

ueL~niL±onsthat

apply

throughout

cnic Subtitle

r~r~rit

aS specifically rn-nvided

otherwise.

BOARD

NOTE:

Section 56.2(d)

requires

the

Board

to

repeal prc-cxisting rules for handling medical wastes

by January 1,

1992.

Section 56.2(c)

requires

the Board

to adopt by January 1,

1992 a list of Class

4 ctiologic

agents, which lends operative meaning to “isolation

waste,”

as that term is used in the statutory

definition of potentially infectious medical waste at

01 ~O-0355

---

—30—

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

oh.

111½, par.

1001

ct

seq.,

as

amended

by

P.A.

87-752,

effective

January

1,

1992).

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.

“6—log reduction” means

a

6 decade reduction or a one

millionth (0.000001)

survival probability in a

microbial population.

“Act” means the Environmental Protection Act

(Ill.

Rev.

Stat.

19~-92j,, 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,

1992)

415

ILCS 5/1 et seq.).

“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)

01 L~0-0356

---

—31—

Hemorrhagic fever agents

(including Crimean

hemorrhagic fever (Congo), Junin, and Machupo

viruses, and other not yet defined)

Herpesvirus simiae (Monkey B virus)

Lassa virus

Manburg 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.

01 L~0-0357

---

—32—

“Enclosed compartment” means a compartment that

provides

protection

from

the

elements,

prevents

~pillage. and prevents containers from falling off the

vehicle.

The enclosed compartment cannot be used to

meet the ~acka~ing requirements of 35 Ill. Adm. Code

l421..Subpart C.

“Equivalent lo~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~(a)(6)

of the Act)

“Indicator microorganisms” means those microorganisms

listed in 35

Ill.

Adm. Code 1422.Ap~endixA, Table B,

as classified by ATCC.

“International Biohazard Symbol” means the symbol that

is shown in 35 Ill. Adm. Code l421.Illustration 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

CONTANINATED WITH BLOOD,

EXCRETIONS,

EXUDATEC,

AND

SECRETIONS FROM HUMANS THAT ARE ISOLATED TO PROTECT

OTHERS FROM HICHLY COMMUNICABLE DISEASES.

(Section

3.81(a) (6)

of the 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.

“Oversized P1MW” means a single waste item that is too

large to be placed into a thirty-three

(33) gallon bag

or container.

“Package” means a receptacle that contains

P1MW.

“PFU” means ~la~ue forming unit.

“PERSON” IS

ANY

INDIVIDUAL, PARTNERSHIP. CC-

PARTNERSHIP, FIRM,

COMPANY, CORPORATION, ASSOCIATION,

JOINT STOCK COMPANY, TRUST,

ESTATE. POLITICAL

01 i~,~-0358

---

—33—

SUBDIVISION, STATE AGENCY, OR ANY OTHER LEGAL ENTITY,

OR THEIR REPRESENTATIVE, AGENT,

OR ASSIGNS.

(Section

3.26 of the Act)

“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:

ANIMAL

WASTE;

CULTURES AND STOCKS;

riurw...14

BLOOD

AND

BLOOD PRODUCTS

HUMAN PATHOLOCICAL WASTES;

i~uj..~vi’iur~

w~,’r

AND

UNUSED

SHARPS.

USED

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, OR

MIX CULTURES.

HUMAN

PATHOLOGICAL WASTES.

THIS WASTE SHALL

INCLUDE TISSUE,

ORGANS, AND BODY PARTS

(EXCEPT

TEETH AND THE CONTIGUOUS STRUCTURES OF BONE AND

GUN),

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

---

—34—

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

SHARPS THAT MEET BOTH OF THE FOLLOWING

CONDITIONS:

THE INFECTIOUS POTENTIAL

HAS

BEEN

ELIMINATED FROM THE SHARPS BY TREATMENT;

AND

THE SHARPS ARE RENDERED UNRECOGNIZABLE

BY TREATMENT.

(Section 3.8~4of the

Act)

0jL~Ø_0360

---

—35—

“Putrescence” means the partial decomposition of

organic matter by microorganisms so as to cause

malodors, gases,

or other offensive conditions,

or that

is cai~ableof providing food for vectors.

“Registered professional engineer” means a person

registered under the Illinois Professional Engineering

Practice Act

(Ill.

Rev.

Stat.

1991,

ch.

111, par. 5201

et

sect.)

225

ILCS 325/1 et seq.).

“Reusable container” means a receptacle that meets the

requirements of 35 Ill.

Adm. Code 1421. 121 (a) and

(b);

is made and repaired with materials that are corrosion

resistant and non—absorbent; 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 ap~1icationto inanimate obiects or

surfaces for the purpose of reducing the microbial

count to safe levels.

.

The sanitizer must be registered

bY the United States Environmental Protection Agency,

as identified on its label.

“Shares” mean unused sharps and used shares 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

chancte 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

Subtitle,

each campus of an educational institution

is

considered to be

a single site.

“STORAGE”

MEANS THE CONTAINMENT OF WASTE. EITHER ON A

TEMPORARY

BASIS OR FOR A PERIOD OF YEARS,

IN SUCH A

01

~~0-O36I

---

—36—

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.A~pendixA, 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

heatinct. 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)

“Unrecognizable” means relating to a sharp that has

undergone physical alteration

(e.g., melting, charring,

corroding,

or grinding)

so that the share may no longer

be used for its intended Purpose.

“Vector” means any living agent,

other than human,

capable of transmitting, directly or indirectly, an

infectious disease.

01~O-O362

---

—37—

“Vehicle” means any device used to transport special

waste in bulk or in packages. tanks or other

containers.

Section 1420.1O~3

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 al.

(1015 Fifteenth Street, N.W., Washington,

D.C.

20005)

(18th Edition,

1992).

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

NO PERSON

SHALL

Prohibitions

~j

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:

jj.

THE INFECTIOUS POTENTIAL HAS BEEN ELIMINATED FROM

THE SHARPS BY TREATMENT;

AND

~J

THE SHARPS ARE PACKAGED IN ACCORDANCE WITH Part

1421,

Subpart C of this Subtitle.

j~j

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

ISSUED BY THE AGENCY TO RECEIVE

P1MW

pursuant to

Section 39 of the Act, UNLESS NO PERMIT IS REQUIRED

pursuant to subsection 1420.105(c) of this Part.

~j

BEGINNING JULY 1,

1992, CAUSE OR ALLOW THE DELIVERY OR

TRANSFER OF ANY

P1MW

FOR TRANSPORT UNLESS:

jj

THE TRANSPORTER

HAS

A PERMIT ISSUED BY THE AGENCY

TO TRANSPORT P1MW, OR THE TRANSPORTER IS EXEMPT

01 ~0-O363

---

—38—

FROM THE PERMIT REQUIREMENT Pursuant to subsection

1420.105(b)

of this Part.

Permit applications

must be submitted on forms provided bY the Agency.

~

A P114W MANIFEST IS COMPLETED FOR THE WASTE unless

no manifest is required pursnant to subsection

1420.105(e)

of this Part.

~

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.

Zi

BEGINNING JULY 1,

1992,

CONDUCT

ANY P1MW TRANSPORTATION

OPERATION:

~j

WITHOUT A PERMIT ISSUED BY THE AGENCY TO TRANSPORT

P1MW,

unless no permit is rectuired pursuant to

subsection 1420.105(b)

of this Part.

21

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.

41

IN VIOLATION OF ANY ORDER ADOPTED BY THE BOARD

UNDER the ACT.

gi

BEGINNING JULY 1.

1992. CONDUCT ANY

P1MW

TREATMENT,

STORAGE, OR

TRANSFER OPERATION:

fl

WITHOUT A PERMIT ISSUED BY THE AGENCY THAT

SPECIFICALLY AUTHORIZES THE TREATMENT,

STORAGE. OR

TRANSFER OF

P1MW pursuant with Section 39 of the

Act. unless no permit

is reciuired pursuant to

subsection 1420.105(c)

of this Part.

Permit

applications must be submitted on forms provided

by the Actency.

21

IN VIOLATION OF

ANY

CONDITION OF ANY PERMIT ISSUED

BY THE AGENCY UNDER the ACT.

IN VIOLATION OF ANY REGULATIONS ADOPTED BY THE

BOARD.

41

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 required

pursuant to subsection 1420.105(e)

of this Part.

~ti~O-036~

---

—39—

fl

OFFER FOR TRANSPORTATION.

TRANSPORT,

DELIVER. RECEIVE

OR ACCEPT P1MW FOR WHICH A MANIFEST IS REQUIRED, UNLESS

THE MANIFEST INDICATES THAT THE FEE REQUIRED UNDER

SECTION 56.4 OF the ACT

HAS

BEEN PAID.

jI

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.

fl

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 should note that

discharges to sewer systems can also be regulated by

units of local government.

Section 1420.105

Permit and Manifest Requirements and

Exceptions

gi

The permit and~permitappeal provisions of Sections 39

and 40 of the Act and Board regulations adopted

thereunder apply to this Subtitle.

ki

A person who conducts a

P1MW

transportation operation

is required to obtain a

P1MW

hauling permit from the

Agency.

except:

fl

A PERSON TRANSPORTING

P1MW

GENERATED SOLELY BY

THAT PERSON’S ACTIVITIES; OR

21

NONCOMMERCIAL TRANSPORTATION OF LESS

THAN

50

POUNDS OF POTENTIALLY INFECTIOUS MEDICAL WASTE AT

ANY

ONE TIME: OR

.~J

THE U.S. POSTAL SERVICE.

(Section 56.1(f) of the

Act).

01130-0365

---

—40—

çj

A person who conducts a

P1MW

treatment,

storage, or

transfer operation is required to obtain a permit from

the Agency, except:

fl~

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

21

ANY

HOSPITAL THAT TREATS,

STORES, OR TRANSFERS

ONLY P114W GENERATED BY ITS

OWN

ACTIVITIES OR BY

MEMBERS OF ITS MEDICAL STAFF.

(Section 56.1(g)

of

the Act).

If the transportation of

P1MW

is

interrupted so as not to constitute storage, no

permit

is rectuired under Section 56.1(g)

of the

Act.

For example, transportation of P1MW

interrupted by vehicle repairs or inblement

weather does not constitute storage.

~fl

A person applying for a permit for a

P1MW

treatment,

storage, or transfer operation shall file an

application with the Actencv in accordance with the

requirements and Procedures of 35 Ill Adm. Code

1422.105 through 1422.107.

gi

Any person who transports P1MW

is required to carry a

com~1eted

P1MW manifest except for the transportation

of:

Lj

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

21

LESS THAN

50 POUNDS OF

P1MW AT ANY ONE TIME FORE A

NONCOMMERCIAL TRANSPORTATION ACTIVITY; OR

fl

P1MW BY THE U.S. POSTAL SERVICE.

(Section 56.1(h)

of the Act)

Section 1420.106

Penalty Factor

IN MAKING ITS ORDERS AND

DETERMINATIONS RELATIVE TO PENALTIES,

IF

ANY, TO BE IMPOSED FOR VIOLATING SECTION

56.1(a) OF the ACT, THE

BOARD,

IN ADDITION TO THE FACTORS IN SECTIONS 33(c) AND 42(h)

OF

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.

(Section

56.1(k)

of the Act)

01

---

—41—

Section 1420.107

Cleaning and Disinfection

~j

Cleaning and disinfection comprises:

.~j,

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;

and

21

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 Actency.

as

identified on its label and used in

accordance with the manufacturer’s

instructions

çj

Rinsing with,

or immersion in,

a

hvpochlorite

solution at a concentration of 50 ppm.

For

example, 1/8 cup of common household bleach

(5.25

sodium hvpochlorite) per gallon of tap

water

(31 milliliters bleach to 3.78 liters

of water); or

Q1

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

If any Section. subsection, sentence or clause of this Subtitle

is adludcted unconstitutional, invalid or otherwise not effective

for any reason, such adiudication does not affect the validity of

this Subtitle as p whole or of any Section, subsection, sentence

or clause thereof not adiudged unconstitutional, invalid or

otherwise not effective for any reason.

01

~0-O367

---

—42—

TITLE 35:

ENVIRONMENTAL PROTECTION

SUBTITLE

14:

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

Section 1421.Illustration A

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)

415

ILCS

5/56.2 and 5/27J.

SOURCE:

Adopted in R91-20,

at

____

Ill.

Reg.

______,

effective

NOTE:

Capitalization denotes statutory language.

SUBPART A:

GENERAL PROVISIONS

Section 1421.101

Compliance Dates

01130-0368

---

—43—

Persons subject to this Part shall comply with its standards and

criteria by

____________________,

1993

(effective date).

SUBPART B:

SEGREGATION

Section 1421.110

Scope and Applicability

This Subpart applies to persons who generate or transport P1MW,

and to owners or 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;

01130_0359

---

—44—

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

that minimizes 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 combinatior

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 PIM~

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 should note that

discharges to sewer systems can also be regulated by

units of local government.

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

30-0370

---

—45—

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:

1)

The International Biohazard Symbol as

shown in Section 1421.Illustration 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.

01130-0371

---

—46—

c)

If a sharps container is packaged within an outer

container,

the inner sharps container must be marked

with indelible ink in lettering that is legible as

follows:

1)

The International Biohazard Symbol as shown in

Section 1421.Illustration 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.Illustration 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,

DI

140-0372

---

..47...

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.

01130-0373

---

—48—

e)

During transport,

a

P1MW

package must not be compacted

or subject to stress that compromises 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 should note that

discharges to sewer systems can also be regulated by

units of local government.

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

I 13O-037L~

---

—49—

PRESCRIBED AND PROVIDED BY THE AGENCY.

(Section 56.3

of the Act)

Section 1421.Illustration A

---

—50—

TITLE 35:

ENVIRONMENTAL PROTECTION

SUBTITLE M:

BIOLOGICAL MATERIALS

CHAPTER

I:

POLLUTION CONTROL BOARD

SUBCHAPTER b:

POTENTIALLY INFECTIOUS MEDICAL WASTES

PART 1422

DESIGN

AND

OPERATION OF FACILITIES

SUBPART A:

GENERAL PROVISIONS

Section

1422.101

Compliance Date

1422.105

P1MW Permit Application Contents

1422.106

P1MW Permit Application Certifications

1422.107

P1MW

Permit Application Filing Requirements

SUBPART

B:

STORAGE OR TRANSFER OPERATIONS

Section

1422.110

Scope and Applicability

1422.111

Design and Operating Standards and Criteria

SUBPART

C:

TREATMENT FACILITIES

Section

Scope and Applicability

Treatment Facility Certification

Design and Operating Standards

Treatment Units

Initial Efficacy Test

Periodic Verification Test(s)

Sharps

Experimental Permits

Section

1422.Appendix A

Table A

Table B

Table C

1422.Appendix B

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)

415

ILCS 5/56.2 and 5/27.

SOURCE:

Adopted in R9l-20, at

_____

Ill. Reg.

_______,

effective

NOTE:

Capitalization denotes statutory language.

1422.120

1422.121

1422.122

1422.123

1422.124

1422.125

1422.126

1422.127

Initial Efficacy Test Procedures

Test

Microorganisms

Indicator Microorganisms

Challenge Loads

Correlating Periodic Verification Test

Procedures

01140-0376

---

—51—

SUBPART

A:

GENERAL

PROVISIONS

Section 1422.101

Compliance Date

Persons subject to this Part shall comply with its requirements

by

,

1993

(effective date).

Section 1422.105

P1MW

Permit Application Contents

An application for a permit for a P1MW treatment,

storage, or

transfer operation must contain the information specified in this

section.

If the applicant believes that the documentation or

information required pursuant to any subsection of this section

is not applicable for reasons such as irrelevancy, the

application must include the reasons in support of such belief.

a)

Legal description of the site at which the facility is

to be located.

b)

Maps and floor plans showing the location of the

facility, the facility boundary, and the location of

all units included in the facility.

c)

Process flow diagrams or schematic drawings showing the

flow of waste through the facility.

The diagrams or

drawings must show, but not be limited to, the

locations of residuals,

recycled streams, sample

points,

equipment,

and process monitoring devices.

Equipment must be labeled on the process flow diagram

to correspond to an equipment number.

d)

Written description of the facility or facility

operations with supporting documentation describing the

procedures and plans that will be used at the facility

to comply with the requirements of Parts 1420 through

1422 of this Subtitle and any other applicable Parts of

35 Ill. Adm. Code:

Chapter 1.

Such description must

include, but not be limited to, the following

information:

1)

The type of waste management units and the types

and volumes of waste;

2)

The overall process to be used for treating or

storing

P1MW

and the anticipated performance of

the process;

3)

In detail, the major activities at the facility,

such as transfer, storing, screening, weighing,

processing and treatment (including the number of

units)

of P1MW;

01140-0377

---

—52—

4)

The operations for initial facility startup, daily

startup, and scheduled and unscheduled shutdowns;

5)

The days and hours of operation;

6)

The operating parameters for the treatment units;

7)

The safety and monitoring equipment for the

treatment units;

8)

A cleaning and disinfection plan describing the

daily cleanup procedures,

including the methods to

disinfect emptied reusable

P1MW

containers,

transport vehicles, and facility surfaces and

equipment contaminated with

P1MW;

9)

The methods to control:

emissions of odors and

aerosols generated, including all supporting

design and engineering data;

dust, noise,

litter

and vectors; and handling and storing;

10)

The methods to treat,

transfer,

or dispose of

residual wastes generated from the operation of

the facility;

11)

Adequacy of the utilities to operate the facility

and to respond to emergency situations;

12)

Numbers and duties of employees directly

responsible for, the operation of the site or

facility; and

13)

Location and type of security devices to prevent

unauthorized access.

e)

A waste screening plan that describes procedures to be

used to identify and prevent the acceptance of

unauthorized wastes.

f)

Description of procedures to be used for inspection,

contingency, recordkeeping, and closure plans as

required by this Part.

g)

For a facility at which the owner or operator is

required to conduct either Initial Efficacy Tests or

Periodic Verification Tests,

a written description of

procedures to be used for recordkeeping, classifying

residuals, and collecting data for the Document of

Initial Efficacy Demonstration and Correlating Periodic

Verification Demonstration.

Section 1422.106

P1MW Permit Application Certifications

i~O-

0378

---

—53—

An application for a permit for

P1MW

treatment,

storage,

or

transfer operation must contain the certifications specified in

this section.

a)

The permit application must contain a certificate of

ownership of the permit area or a copy of the,lease and

its duration.

The lease must clearly specify that the

owner authorizes the construction of a

P1MW

waste

management facility on the leased premises.

The owner

or operator shall certify that the Agency will be

notified 30 days prior to any changes in ownership or

conditions in the lease affecting the permit area.

b)

All permit applications must be signed by a duly

authorized agent of the operator and the property

owner, must be accompanied by an oath or affidavit

attesting to the agent’s authority to sign the

application and must be notarized.

The following per-

sons are considered duly authorized agents of the

operator and the property owner:

1)

For corporations,

a principal executive officer of

at least the level of vice president;

2)

For a sole proprietorship or partnership,

a

proprietor or general partner, respectively; and

3)

For a municipality, state,

federal or other public

agency,

by the head of the agency or ranking

elected official.

C)

All permit applications must contain the name,

address,

and telephone number of the duly authorized agent of

the operator and the property owner to whom all

inquiries and correspondence must be addressed.

d)

All designs presented in the application must be

prepared by, or under the supervision of,

a

professional engineer.

The professional engineer shall

affix the name of the engineer, date of preparation,

registration number,

a statement attesting to the

accuracy of the information and design,

and a

professional seal to all designs.

e)

The applicant must state whether the facility is a

new

regional pollution control facility, as defined in

Section 3.32 of the Act, which is subject to the site

location suitability approval requirements of Sections

39(c) and 39.2 of the Act.

If such approval by a unit

of

local government is required, the application must

identify the unit of local government with

jurisdiction.

The application must contain any

approval issued by that unit of local government.

If

01140-0379

---

—54—

no approval has been granted, the application must

describe the status of the approval request.

Section 1422.107

P1MW

Permit Application Filing Requirements

a)

All permit applications must be made,

and mailed or

delivered, on forms as prescribed by the Agency.

Hand

delivered applications must be delivered during the

Agency’s normal business hours to the offices of the

Permit Section.

The Agency shall provide a dated,

signed receipt only if the applicant requests.

The

date of filing must be that recorded by the Agency,

unless proven otherwise by

a dated,

signed receipt.

b)

The permit application must be accompanied by all

filing fees required pursuant to Section 5(f) of the

Act.

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

AUTHORIZED EMPLOYEES.

5)

STORE THE P114W 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.

ILJ1-0380

---

—55—

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. Adm.

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

discharged into a sanitary or combined sewer in

accordance with 35 Ill. Adm. Code Subtitle C.

BOARD NOTE:

Interested persons should note that

discharges to sewer systems can also be regulated

by units of local government.

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

f

or

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.)

225

ILCS

470/1 et seq..

2)

P1MW

packages must be stored in designated areas

so as not to contaminate other waste or materials.

01140-0381

---

—56—

3)

Cardboard packages must be stored in an enclosed

area at an elevation above that of the floor.

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

are readable.

A vehicle containing

P1MW

is exempt

from the above aisle space requirement:

A)

When loading or unloading a vehicle; or

B)

When a fully-loaded vehicle is on a site.

C)

Either exemption,

or both exemptions, must

not exceed five

(5) calendar days.

6)

Material handling equipment must be designed so as

to maintain the integrity of the package.

7)

Signs identifying the storage operation must be

prominently displayed at the points of access to

the secured storage area.

Signs must be marked in

lettering that is readable at a minimum distance

of five

(5)

feet.

At a minimum, the signs must

display the International Biohazard Symbol as

shown in 35 Ill. Adm. Code l421.Illustration A and

the word “biohazard”.

8)

Personnel training must be provided to all staff

prior to the handling of

P1MW.

Annual personnel

training must include, at a minimum,

a thorough

explanation of the operating procedures to be

taken during normal and emergency situations.

The

owner or operator shall keep records verifying

training of personnel.

9)

Storage operations must have a written contingency

plan and the applicable sections must be

implemented in the event of a discharge or

personal injury.

The contingency plan must

describe the actions that personnel shall take in

response to emergency situations such as, but not

limited to, personal injury, discharges of

P1MW,

rupture of plastic bags, and equipment failure.

This contingency plan must,

at a minimum,

include

a list of all emergency equipment at the storage

operation, an up—to—date list of names, addresses

and phone numbers

(office and home)

of all persons

01140-0382:

---

—57—

qualified to act as •emergency coordinator,

procedures for cleanup, protection of personnel,

disposal of spill residue, repackaging of P1MW,

and alternate arrangements for

P1MW

storage and

transfer.

A copy of the contingency plan must be

maintained at the storage operation.

Emergency

phone numbers and a brief description of the

emergency procedures must be posted at the storage

operation.

10)

The owner or operator shall keep a written

operating record at the storage operation.

At a

minimum, the following information must be

recorded and maintained

in the operating record:

A)

Quantities and disposition of

P1MW

stored or

transferred;

B)

Date and time the

P1MW

arrived at the

permitted storage operation site;

C)

Date and time the

P1MW

left the storage

operation;

D)

Waste stream permit number (authorization

number),

if applicable, issued by the Agency;

E)

Generator name(s), location(s), and if

applicable, the generator identification

number(s)

issued by the Agency for each

P1MW

load received at the storage operation;

F)

Temperature(s) the

P1MW

load was maintained

at the storage operation;

G)

Destination of packages, which must include

at a minimum the name of the receiving

facility, the location of the receiving

facility, the identification number of the

receiving facility issued by the Agency

(if

applicable), and the disposition

(i.e.,

storage, transfer, treatment, or disposal);

and

H)

In a separate log, the date,

time, nature and

extent of all discharges and personal

injuries and the date,

time,

nature and

result of any response(s)

taken.

11)

The records required by subsections

(b) (8)

and

(10) of this Section must be retained by and kept

at the storage operation and must be made

available at the storage operation during normal

01140-0383

---

—58—

business hours for inspection and photocopying by

the Agency.

These records must be kept until

closure of the storage operation.

The retention

period is extended automatically during the course

of any unresolved enforcement action regarding the

storage operation or as requested in writing by

the Agency.

12)

Unless otherwise authorized by the Agency in the

permit,

P1MW

must not be stored for more than:

A)

Seventy-two

(72) hours at the storage

operation unless the surface temperature of

the package is maintained at or below 45’

degrees Fahrenheit,

and

B)

Thirty

(30) days at the storage operation

regardless of temperature.

13)

At least sixty

(60) days prior to closing a

storage operation, the owner or operator shall

notify the Agency of the planned closure.

W±thifl

ninety

(90) days after the date the final load of

P1MW is received at the storage operation,

the

owner or operator shall certify to the Agency that

final closure has been completed in accordance

with the permit, the Act, and all applicable

regulations promulgated thereunder.

SUBPART C:

TREATMENT FACILITIES

Section 1422.120

Scope and Applicability

This Subpart applies to the owner or operator of a facility in

IllInois that is designed to treat

P1MW

to eliminate its

infectious potential.

This Subpart also applies to owners or

operators of treatment facilities where the treated

P1MW

residual

is disposed of in Illinois.

For purposes of this Part,

a

facility or operation that is designed to treat

P1MW

to eliminate

its infectious potential is referred to as a “treatment

facility”.

Section 1422.121

Treatment Facility Certification

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 must be made available to the

receiving facility upon request of the receiving facility.

No

‘‘~fl-O3813

---

—59—

person shall falsely certify that

P1MW

has been treated in

accordance with this Part.

Section 1422.122

Design and Operating Standards

a)

Treatment of

P1MW

must be conducted in a manner that:

1)

ELIMINATES THE INFECTIOUS POTENTIAL OF THE WASTE.

The infectious potential is eliminated by

treatment in a process that results in a 6—log

reduction in vegetative organisms and, at a

minimum,

a 3—log reduction in bacterial spores as

indicated by the Initial Efficacy Test and

Periodic Verification Test conducted pursuant to

Sections 1422.124 and 1422.125 of this Part;

2)

PREVENTS THE COMPACTION

AND

RUPTURE OF CONTAINERS

DURING HANDLING OPERATIONS, except when compaction

or rupture is an integral part of the treatment

process and the treatment process is conducted

without discharge of P1MW to the environment;

3)

DISPOSES OF TREATMENT RESIDUALS IN ACCORDANCE WITH

THIS ACT AND REGULATIONS ADOPTED THEREUNDER;

4)

PROVIDES FOR QUALITY ASSURANCE PROGRAMS that must

include, at a minimum,

a written plan that:

A)

Designates responsibility to personnel;

B)

Describes operating parameters that must be

monitored to insure effectiveness of the

treatment process;

C)

Identifies monitoring devices;

D)

Insures monitoring devices are operating

properly;

E)

Establishes appropriate ranges for all

operating parameters;

F)

Identifies the person(s) who shall collect

and organize data for inclusion in the

operating record;

G)

Identifies the person(s) who shall evaluate

any discrepancies or problems;

H)

Identifies the person(s) who shall propose

actions to correct any problems identified;

and

01140-0385

---

—60—

I)

Identifies the person(s) who shall assess

actions taken and document improvement;

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.

(Section 56.2(a)(1)-(7)

of the Act)

b)

In addition to the requirements in subsection

(a)

of

this Section:

1)

Residues from cleaning a P1MW contaminated

container, equipment or work surface are regulated

under this Subtitle, except when directly

discharged into a sanitary or combined sewer in

accordance with 35 Ill. Adm. Code Subtitle C.

BOARD NOTE:

Interested persons should note that

discharges to sewer systems can also be regulated

by units of local government.

2)

Ash resulting from the incineration of

P1MW

is an

industrial process waste,

as defined in Section

3.17 of the Act, and must be managed as a special

waste in accordance with 35 Ill. Adm. Code 807 and

809.

3)

Copies of P1MW manifests required by 35 Ill.

Adin.

Code 1420.105 of this Subtitle must be retained by

and kept at the treatment facility for

(3) three

years and must be made available at the treatment

facility 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 treatment

facility or as requested in writing by the Agency.

4)

COMMENCING MARCH 31,

1993,

AND ANNUALLY

THEREAFTER, EACH TREATMENT FACILITY FOR WHICH A

PERMIT IS REQUIRED pursuant to 35 Ill. Adm. Code

1420.105 of this Subtitle and EACH FACILITY NOT

REQUIRED TO HAVE A PERMIT pursuant to Section

1420.105 of this Subtitle THAT TREATS MORE

THAN

50

POUNDS PER MONTH OF POTENTIALLY INFECTIOUS MEDICAL

WASTE SHALL FILE A REPORT WITH THE AGENCY

01 140-0385A

---

—61—

SPECIFYING THE QUANTITIES AND DISPOSITION OF

POTENTIALLY INFECTIOUS MEDICAL WASTE TREATED

DURING THE PREVIOUS CALENDAR

YEAR.

SUCH REPORTS

SHALL BE ON FORMS PRESCRIBED

AND

PROVIDED BY THE

AGENCY.

(Section 56.3 of the Act)

5)

Upon closure of a treatment facility, the owner or

operator shall clean the area, equipment and

structures in accordance with 35 Ill. Adm. Code

1420.107 of this Subtitle.

c)

In addition to the requirements listed in subsections

(a) and

(b) of this Section, owners or operators of

treatment facilities required to have a permit pursuant

to 35

Ill. Adm. Code 1420.105 of this Subtitle shall

also comply with the following requirements that the

Agency shall review during the permitting process:

1)

Amounts of

P1MW

received must be weighed in pounds

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.)

225

ILCS 470/1 et seq..

2)

Signs identifying that the facility treats P1MW

must be prominently displayed at the points of

access to the treatment area.

Signs must be

marked in lettering that is readable at a minimum

distance of five

(5)

feet.

At a minimum, the

signs must display the International Biohazard

Symbol as shown in 35 Ill. Adm. Code

1421.Illustration A and the word “biohazard”.

3)

Personnel training must be provided to all staff

prior to the handling of

P1MW.

Annual personnel

training must include, at a minimum,

a thorough

explanation of the operating procedures to be

taken during normal and emergency situations.

The

owner or operator shall keep records verifying

training of personnel.

4)

Treatment facilities must have a written

contingency plan and the applicable sections must

be implemented in the event of a discharge,

equipment failure or personal injury.

The

contingency plan must describe the actions that

personnel shall take in response to emergency

situations such as, but not limited to, personal

injury, discharges of P1MW,

and equipment failure.

This contingency plan must,

at a minimum, include

a list of all emergency equipment at the treatment

facility, an up—to—date list of names, addresses

and phone numbers

(office and home)

of all persons

---

—62—

qualified to act as emergency coordinator,

procedures for cleanup, protection of personnel,

disposal of spill residue, alternative

arrangements for

P1MW

treatment.

A copy of the

contingency plan must be maintained at the

treatment facility.

Emergency phone numbers and

a

brief description of the emergency procedures must

be posted at the treatment facility.

5)

The owner or operator shall keep a written

operating record at the treatment facility.

At a

minimum, the following information must be

recorded and maintained in the operating record:

A)

Quantities and disposition of

P1MW

treated;

B)

Date and time the

P1MW

arrived at the

permitted

P1MW

site;

C)

Date and time the

P1MW

was treated;

D)

The operating parameters of the treatment

unit

(e.g., temperature, pressure, residence

time,

chemical concentration, irradiation

dose);

E)

Date and time the

P1MW

left the treatment

facility;

F)

Generator name(s), location(s), and if

applicable,

the generator identification

number(s) issued by the Agency for each

P1MW

load received at the treatment facility;

G)

The destination of the treated waste’which

must include, at a minimum, the name of the

receiving facility, the location of the

receiving facility, the identification number

of the receiving facility issued by the

Agency

(if applicable), and the disposition;

and

H)

In a separate log, the date,

time, nature and

extent of all discharges and personal

injuries and the date,

time,

nature and

result of any response(s)

taken.

6)

The records required by subsections

(C)

(3) and

(c) (5) of this Section must be retained by and

kept at the treatment facility and must be made

available at the treatment facility during normal

business hours for inspection and photocopying by

the Agency.

These records must be kept until

‘~‘

kfl-0387

---

—63—

closure of the treatment facility.

The retention

period is extended automatically during the course

of any unresolved enforcement action regarding the

treatment facility or as requested in writing by

the Agency.

7)

At least sixty

(60) days prior to closing a

treatment facility, the owner or operator shall

notify the Agency of the planned closure.

Within

ninety

(90) days after the date the final load of

P1MW is received at the treatment facility, the

owner or operator shall certify to the Agency that

final closure has been completed in accordance

with the permit, the Act, and all applicable

regulations promulgated thereunder.

Section 1422.123

Treatment Units

a)

A treatment unit must be:

1)

Designed and operated to eliminate the infectious

potential of

P1MW

as demonstrated by the Initial

Efficacy Test and Periodic Verification Tests,

pursuant to Sections 1422.124 and 1422.125 of this

Part;

2)

Operated according to the manufacturer’s

instructions,

if it is a commercially available

unit;

3)

Operated under the same conditions that have been

used to demonstrate that the infectious potential

was eliminated in accordance with this Part;

4)

Operated with a

P1MW

feed rate not to exceed that

which was used to demonstrate that the infectious

potential was eliminated; and

5)

Designed and operated to limit the emission of

microorganisms into the air.

b)

A treatment unit may be used by the owner or operator

of a treatment facility not required to have a permit

pursuant to 35 Ill. Adm. Code 1420.105 of this

Subtitle,

if the requirements of subsection

(b) (1)

or

(2) below are met.

1)

The treatment unit meets the standards of

subsections

(a) (1)-(5) of this Section,

and:

A)

The treatment unit utilizes a thermal,

chemical, or irradiation treatment, as

~~o-O388

---

—64—

defined in 35 Ill.

Adin.

Code 1420.102 of this

Subtitle; or

B)

The owner or operator maintains a copy of the

Initial Efficacy Test results for the

treatment unit.

In addition, the owner or

operator shall conduct Periodic Verification

Tests in accordance with the manufacturer’s

instructions and Section 1422.125.

Test

results shall be retained and made available

for inspection in accordance with Section

1422.125(d)

and

(g); and

C)

The owner or operator retains any

notification from the manufacturer of the

permitted commercially available treatment

unit of a permit modification.

2)

The Board has granted the owner’s or operator’s

petition for an adjusted standard pursuant to 35

Ill. Adm. Code 106.Subpart G or a site—specific

rulemaking pursuant to 35 Ill. Adm. Code 102.

The

petition must include a demonstration that the

treatment unit meets the standards of subsection

(a)(1)-(5)

of this Section.

c)

For an autoclave,

incinerator,

or ethylene oxide unit

installed or operated prior to the effective date of

these regulations, an Initial Efficacy Test is not

required.

The first Periodic Verification Test must be

performed within three

(3) months of the effective date

of these regulations to demonstrate that the infectious

potential has been eliminated.

d)

For treatment facilities required to have a permit

pursuant to 35

Ill.

Adm. Code 1420.105 of this

Subtitle, the permit application must include, at a

minimum, the following information regarding the

treatment unit:

1)

An operating plan that includes a description of

the treatment facility’s operating procedures and

parameters; and

2)

Test data and supporting documentation

demonstrating that the infectious potential has

been eliminated from either similar existing

P1MW

treatment units,

or pilot projects.

e)

The treated P1MW is managed in accordance with this

Subtitle and 35 Ill. Adm.

Code.Subtitle G.

Section 1422.124

Initial Efficacy Test

o~o_o38eJ

---

—65—

a)

The manufacturer, owner,

or operator of a treatment

unit shall conduct an Initial Efficacy Test,

pursuant

to Appendix A of this Part,

for each model prior to its

operation.

If significant mechanical changes are made

to a treatment unit, the Initial Efficacy Test must be

repeated.

Treatment units are considered to be the

same model if they:

1)

Are manufactured by the same company;

2)

Have the same capacity; and

3)

Have no significant mechanical changes.

b)

The Initial Efficacy Test must be conducted by the use

of Options

1,

2 or

3 of Appendix A of this Part,

and

the challenge loads as described in Table C of Appendix

A of this Part.

If any of the challenge loads fails

the Initial Efficacy Test,

the operating conditions

must be revised and the Initial Efficacy Test must be

repeated for all challenge loads.

The Initial Efficacy

Test must also meet the requirements of this Section.

1)

Option

1 must be used for a treatment unit that

does not maintain the integrity of the container

of test microorganisms

(e.g., grinding followed by

chemical disinfection).

This option is a two

phase test.

A)

The first phase is to determine the dilution

of each test microorganism from the operation

of the treatment unit for each challenge

load.

The log of the number of viable test

microorganisms in the processed residue must

be greater than or equal to six

(6).

B)

The second phase is to determine the

effectiveness of the treatment unit.

The log

kill

(L)

for each test microorganism after

treatment must be greater than or equal to

six

(6).

2)

Option

2 must be used for a treatment unit that

maintains the integrity of the container of test

microorganisms

(e.g., autoclaving).

The log kill

(L)

for each test microorganism after treatment

must be greater than or equal to six

(6).

3)

Option

3 can only be used for a thermal treatment

unit that maintains the integrity of the container

of indicator microorganism spores

(e.g.,

autoclaving, incinerating).

The log kill

(L) of

01140-0390

---

—66—

indicator microorganism spores after treatment

must be greater than or equal to six

(6).

c)

Composition of Challenge Loads

1)

For treatment units designed to treat all types of

P1MW,

all three

(3)

types of challenge loads must

be used in conducting the Initial Efficacy Test.

The three

(3) types of challenge loads represent

P1MW

with a high moisture content,

low moisture

content, and high organic content.

The quantity

of each challenge load must equal 100

of the

maximum capacity of the treatment unit.

Each

challenge load must include, at a minimum,

5

of

each of the following categories:

blood/broth

cultures, fibers, metals,

sharps, plastics,

pathological waste,

glass, non—woven fibers,

and

bottles of liquids.

Table C of Appendix A of this

Part contains the moisture and organic content

requirements that must be met in each type of

challenge load.

2)

For treatment units designed to treat only select

categories of

P1MW

(e.g.,

a sharps treatment

unit),

a modification in the composition of the

challenge load(s) may be used if approved by the

Agency in writing.

d)

The Initial Efficacy Test must be conducted under the

same operating conditions under which the treatment

unit operates on a day—to—day basis.

The feed rate for

the treatment unit must remain constant throughout the

Initial Efficacy Test.

This feed rate must never be

exceeded during the operation of the treatment unit.

e)

The Initial Efficacy Test must be performed so that:

1)

Each container of test microorganisms and/or

indicator microorganism spores is placed in the

load to simulate the worse case scenario (i.e.,

that part of the load that is the most difficult

to treat).

For example, the worst case scenario

for an autoclave would be to place the container

of test microorganisms and/or indicator

microorganism spores within a sharp container tha

must in turn be deposited in a plastic biohazard

bag that is then located centrally within each of

the challenge loads.

2)

Test microorganisms and/or indicator

microorganisms must be cultured and enumerated

accordance with instructions provided by the

supplier of the microorganisms and Standard

01140_0391

---

—67—

Methods for the Examination of Water and

Wastewater,

incorporated by reference at 35 Ill.

Adm. Code 1420.103.

f)

A

Document of Initial Efficacy Demonstration must be

retained at the treatment facility, and made available

at the treatment facility during normal business hours

for inspection and photocopying by the Agency.

The

Document of Initial Efficacy Demonstration must

include,

at a minimum:

1)

A detailed description of the test procedures

used,

including all test data generated, with

descriptions of data handling,

and a presentation

and interpretation of final test results;

2)

A detailed description and verification of the

operating parameters

(e.g., temperatures,

pressures, retention times, chemical

concentrations,

irradiation doses,

and feed

rates);

3)

A description of quality assurance/quality control

procedures and

practices for the culture,

storage, and preparation of test and/or indicator

microorganisms (including, but not limited to,

organism history,

source,

stock culture

maintenance, and enumeration procedures).

The

purity of the test microorganisms and/or indicator

microorganism spores must be certified by a

commercial or clinical laboratory;

4)

A description of microorganism preparation and

packaging, challenge load weight and composition,

unit testing scheme

(numbers of test rows),

and

sampling strategy (e.g., number and weight of

solid and/or liquid samples);

5)

A description and demonstration of microorganism

recovery including sample processing,

incubation,

and effective neutralization, and absence of toxic

compounds due to neutralization (as applicable);

6)

,

Appendices containing raw data and assumptions in

tabular form;

7)

The names(s),

date, and signature(s),

and’ title(s)

of person(s) conducting the Initial Efficacy Test;

and their qualifications;

and

8)

A list of references used to evaluate the data and

obtain the final conclusion.

01140-0392

---

—68—

Section 1422.125

Periodic Verification Test(s)

a)

The effectiveness of the treatment unit is verified by

the Periodic Verification Test(s), which must be

conducted in accordance with this Section.

The

manufacturer,

owner, or operator of a treatment unit

must perform Periodic Verification Test(s)

that satisfy

at least one

(1)

of the following:

1)

Passing the Initial Efficacy Test by using Options

1,

2, or 3 of Appendix A of this Part

(whichever

is applicable).

The three challenge loads

described in Appendix A, Table C, do not need to

be used.

The test microorganisms or indicator

microorganisms must be placed in a representative

load in accordance with Section 1422.124(e) (1)

of

this Part.

For example, an autoclave may use

Option

3

(e.g.,

demonstrate at a minimum the

destruction of one million

(1,000,000)

Bacillus

stearothermophilus spores) to meet the Periodic

Verification Tests(s)

requirement.

In the case of

an incinerator,

a stainless steel pipe with

threaded ends and removable caps lined with a

ceramic insulation may be used to contain a glass

culture vial with Bacillus subtilis spore strips.

The pipe with the spore strips may be placed in a

load of

P1MW

for the Periodic Verification Test.

After the treatment,

the pipe with the spore

strips may be recovered and the spores may be

cultured to assess whether, at a minimum, one

million spores have been destroyed to meet the

Periodic Verification Test(s)

requirement.

2)

Correlating the log kill

(L) of the test

microorganisms in the Initial Efficacy Test to an.

equivalent log kill

(T)

of the indicator

microorganism spores in accordance with Appendix B

of this Part.

The equivalent log kill

(T)

of the

indicator microorganism spores must be used for

all subsequent Periodic Verification Tests.

The

correlation must be done with the three

(3)

challenge loads identified in Table C of Appendix

A of this Part.

(See subsection

(b) of this

Section for further requirements);

or

3)

Submitting and obtaining written approval by the

Agency for a procedure that is equivalent to

subsection

(a) (2) of this Section.

Examples of

alternatives include, but are not limited to, use

of another indicator microorganism or measurement

of disinfectant concentrations in the treated

residue.

For incinerators only,

an example of an

alternative is visually inspecting the ash from

ç~140_03~~

---

—69—

each load of treated

P1MW

to insure that all

P1MW

within the load is completely combusted.

The

approval of an alternative by the Agency may

require more frequent testing and/or monitoring of

the treatment unit.

b)

For the Correlating Periodic Verification Test,

which

provides the correlation of log kill

(L)

of the test

microorganisms with the equivalent log kill

(T) of the

indicator microorganisms,

the following procedures

apply:

1)

At a minimum,

an initial population of one million

(1,000,000) indicator microorganism spores per

gram of waste solids in each challenge load must

be used;

2)

The fraction of surviving indicator microorganisms

that correlates to a log kill

(L)

of six (6)

for

each test microorganism must be used in future

Periodic Verification Test(s).

(For example,

if a

log kill

(L)

of four

(4) for the indicator

microorganism spores per gram of waste solids is

achieved during this demonstration, then a

population of ten thousand (10,000)

of the

indicator microorganism must be used in all future

Periodic Verification Test(s)).

For future

Periodic Verification Tests, the three challenge

loads described in Appendix A, Table C, do not

need to be used.

The test microorganisms or

indicator microorganisms spores must be placed in

a representative load in accordance with Section

1422.124(e) (1) of this Part;

3)

An equivalent log kill

(T)

of three

(3)

for the

indicator microorganism spores must be the minimum

threshold death rate to insure that all test

microorganisms are destroyed; and

4)

Test microorganisms and/or indicator

microorganisms must be cultured and enumerated in

accordance with instructions provided by the

supplier of the microorganisms and Standard

Methods for the Examination of Water and

Wastewater,

incorporated by reference at 35 Ill.

Adm. Code 1420.103.

5)

The Periodic Verification Test and the Initial

Efficacy Test may be run concurrently to verify

the correlation.

c)

If a load of

P1MW

fails a Periodic Verification

Test(s), the Periodic Verification Test(s) must be

0t14U-039L~

---

—70—

repeated.

The operator shall implement the quality

assurance program (in Section 1422.122

(a)(4) of this

Part)

and contact the manufacturer,

if applicable,

to

identify and correct the problem(s)

until the unit can

eliminate the infectious potential of the

P1MW.

If

the

operating parameters are altered, another Initial

Efficacy Test must be performed to demonstrate the

effectiveness of the unit and,

if applicable, another

Periodic Verification Test’ correlation, pursuant to

subsection

(a)

of this Section, must also be repeated.

Loads of

P1MW

that were first processed prior to

receiving results showing a failure of the Periodic

Verification Tests are considered treated.

A second

Periodic Verification Test must be run immediately

after the first Periodic Verification Test indicates a

failure.

The second Periodic Verification Test is to

determine whether or not the treatment unit is

eliminating the infectious potential of the waste.

After the second Periodic Verification Test shows a

failure of the treatment unit,

the processed waste

is

considered P1MW and must be managed in accordance with

this Subtitle.

d)

Results of the Periodic Verification Test(s) must be

received, verified, and made available for inspection

by the Agency within two weeks of when the test was

conducted.

When a Periodic Verification Test is used

to confirm the failure of a treatment unit, the results

of the Periodic Verification Test(s) must be received,

verified, and made available for inspection by the

Agency within one week of when the test was conducted.

Results of Periodic Verification Tests must be made

available in accordance with the requirements of

subsection

(g), below.

e)

Periodic Verification Test(s) must be conducted

monthly, or more frequently if required by the permit

or recommended by the manufacturer.

f)

A Document of Correlating Periodic Verification

Demonstration must be prepared by and retained at the

treatment facility, and must be available at the

treatment facility during normal business hours for

inspection and photocopying by the Agency.

The

Document of Periodic Verification Demonstration must

include, at a minimum:

1)

A detailed description of the test procedures used

and documentation showing the correlation between

the log kill

(L)

of the test microorganisms and

the equivalent kill

(T)

of the indicator

microorganism spores.

An evaluation of the test

results must include:

All test data generated,

n

I

hi1-0395

---

—71—

with description of data handling,

and a

presentation and interpretation of final test

results;

2)

A detailed description of the operating parameters

(e.g., temperatures, pressures, retention times,

chemical concentrations,

irradiation dose,

and

feed rates);

3)

A description of quality assurance/quality control

procedures and

practices for the culture,

storage, and preparation of test and/or indicator

microorganisms (including, but not limited to,

organism history, source, stock culture

maintenance, and enumeration procedures).

The

purity of the test microorganisms and/or indicator

microorganism spores must be certified by a

commercial or clinical laboratory;

4)

A description of microorganism preparation and

packaging, challenge load weight and composition,

unit testing scheme (numbers of test rows),

and

sampling strategy (e.g.,

number and weight of

solid and/or liquid samples);

5)

A description and demonstration of microorganism

recovery including sample processing,

incubation,

and effective neutralization,

and absence of toxic

compounds due to neutralization;

6)

Appendices containing raw data and assumptions in

tabular form;

7)

The names(s),

date, and signature(s), and title(s)

of person(s)

conducting the Initial Efficacy Test,

and their qualifications; and

8)

A list of references used to evaluate the data and

obtain the final conclusion.

g)

Records of Periodic Verification Test(s) must be’

prepared by and retained at the treatment facility, and

made available at the treatment facility during normal

business hours for inspection and photocopying by the

Agency.

These records must include, at a minimum:

1)

The dates the Periodic Verification Test(s) were

performed;

2)

Operating parameters

(e.g., temperatures,

pressures, retention times, chemical

concentrations,

irradiation dose,

and feed rates);

01140-0396

---

—72—

3)

Test protocols;

4)

Evaluation of test results; and

5)

The name(s),

dates,

signatures(s), and title(s) of

person(s) conducting the Periodic Verification

Test(s).

h)

Periodic Verification Test(s) must be conducted under

the same operating conditions under which the treatment

unit operates on a day—to—day basis.

The feed rate for

the treatment unit is the maximum feed rate at which

the unit operates on a day—to—day basis.

The feed rate

must remain constant throughout the Periodic

Verification Test(s).

This feed rate must never be

exceeded during the operation of the treatment unit.

Section 1422.126

Sharps

Sharps may be disposed of in a landfill only if they have been

treated to eliminate the infectious potential and:

a)

Have been rendered unrecognizable and therefore are no

longer P1MW; or

b)

Have been:

1)

.

Packaged, marked, and labeled in accordance with

Part 1421,

Subparts C and D;

2)

Delivered by a transporter with a P1MW hauling

permit as required by 35

Ill. Adm. Code 1420.105

of this Subtitle, unless specifically exempted.

3)

Accompanied by a

P1MW

manifest as required by 35

Ill.

Adm. Code 1420.105 of this Subtitle, unless

specifically exempted.

Section 1422.127

Experimental Permits

a)

The Agency may issue Experimental Permits for processes

or techniques that do not satisfy the standards set

forth in this subpart if the applicant can provide

proof that the process or technique has a reasonable

chance for success and that the environmental hazards

are minimal.

A description of the type of residuals

anticipated and how they will be managed and disposed

of must be included.

b)

A valid Experimental Permit constitutes

a prima facie

defense to any action brought against the permit holder

for a violation of the Act or regulations promulgated

01140-0397

---

—73—

thereunder, but only to the extent that such action is

based upon the failure of the process or technique.

c)

All Experimental Permits have a duration not to exceed

two

(2) years.

These permits can only be renewed once.

d)

Application for renewal of an experimental permit must

be submitted to the Agency at least ninety

(90) days

prior to the expiration of the existing permit.

To the

extent the information to be supplied for renewal is

identical with that contained in the prior permit

application, the applicant shall so note on the renewal

application, and the Agency shall not require the

resubmittal of data and information previously supplied

to it.

e)

A report must be submitted at the end of the

experimental permit period, or as required by the

Agency, which includes, at a minimum, the following:

1)

A summary of operating data,

including results of

the Initial Efficacy Test(s) or Periodic

Verification Test(s);

2)

A discussion of how the equipment performed;

3)

A discussion of how residuals were managed; and

4)

A demonstration that the infectious potential has

been eliminated.

Section 1422.APPENDIX A

INITIAL EFFICACY TEST PROCEDURES

All

P1MW

treatment units must demonstrate that the infectious

potential has been eliminated by using an Initial Efficacy Test

in accordance with this Appendix.

This Option

1 is for a treatment unit that compromises the

integrity of the container of test microorganisms

(e.g., grinding

followed by chemical disinfection).

The purpose of this Phase

1 is to determine the dilution of each

test microorganism from the treatment unit for each challenge

load

(Types A through C)

identified in Table C of this Appendix.

a)

Prepare and sterilize by autoclaving, two

(2) challenge

loads of

Type A

as identified in Table C of this

Appendix.

Reserve one

(1)

challenge load for Phase

2.

b)

Each test microorganism must be processed in separate

runs through the treatment unit.

Prior to each run,

the number of viable test microorganisms in each

container must be determined in accordance with

01140-0398

---

—74—

applicable manufacturer’s recommendations, and Standard

Methods for the Examination of Water and Wastewater,

incorporated by reference at 35 Ill. Adm. Code

1420.103.

c)

Processing of the P1MW must occur within thirty

(30)

minutes after introducing the container of test

microorganisms into the treatment unit.

d)

The container of test microorganisms and challenge

loads must be processed together without the physical

and/or chemical agents designed to kill the test

microorganisms.

For example,

in treatment units that

use chemical disinfectant(s) an equal volume of liquid

(e.g., sterile saline solution (0.9,

volume/volume),

phosphate buffer solution, or tapwater) must be

substituted in place of the chemical disinfectant(s).

e)

A

minimum

of

five

(5) representative grab samples must

be

taken

from

the

processed

residue

of

each

challenge

load

in

accordance

with Test Methods for Evaluating

Solid

Waste,

Physical/Chemical

Methods

(SW-846),

incorporated

by

reference

at

35

Ill.

Adm.

Code

1420.103.

The

number

of

viable

test

microorganisms

in

each

grab

sample

must

be

determined

in

accordance

with

applicable

manufacturer’s

recommendations,

and

Standard

Methods

for

the

Examination

of

Water

and

Wastewater,

incorporated

by

reference

at

35

Ill.

Adm.

Code

1420. 103.

f)

Calculate

the

effect

of

dilution

for

the

treatment

unit

as

follows:

SA

=

Log

N0A

-

Log

N1A;

where

Log

N1A ?

6

where:

SA

is

the

log

of

the

number

of

viable

test

microorganisms

(CFU/gram

of

waste

solids

and

PFU/gram

of

waste

solids)

that

were

not

recovered

after

processing

challenge

load

Type

A.

N0A

is

the

number

of

viable

test

microorganisms

(CFU/gram

of

waste

solids

and

PFU/gram

of

waste

solids)

introduced into the

treatment

unit

for

challenge

load Type A.

N1A is the number of viable test

microorganisms (CFU/gram of waste solids and

PFU/gram of waste solids)

remaining in the

processed residue for challenge load Type A.

If Log N1A is less than 6, then the number of viable

test microorganisms introduced into the treatment unit

01~+0-’0399~

---

—75—

must be increased and steps

(a) through

(f)

in Phase

1

must be repeated until Log N1A is ?

6.

N0A is the

inoculuin size for challenge load Type A in Phase

2

below.

g)

Repeat steps

(a) through

(f)

in Phase 1 for challenge

loads of

P1MW

for Types B and C identified in Table C

of this Appendix to determine the effect of dilution

(SB and SC, respectively).

The purpose of this Phase

2 is to determine the log kill of each

test microorganism in each challenge load (Types A through C)

identified in Table C of this Appendix.

a)

Using the inoculum size (N0A)

determined in Phase

1

above, repeat Phase

1 steps

(a) through

(e) under the

same operating parameters, except that the physical

and/or chemical agents designed to kill the test

microorganisms must be used.

b)

Calculate the effectiveness of the treatment unit by

subtracting the log of viable cells after treatment

from the log of viable cells introduced into the

treatment unit as the inoculum, as follows:

LA

=

Log N0A

-

SA

-

Log N2A ?

6

where:

LA is the log kill of the test microorganisms

(CFU/gram of waste solids and PFU/gram of

waste solids) after treatment in the

challenge load Type A.

N0A is the number of viable test

microorganisms (CFU/gram of waste solids and

PFU/gram of waste solids)

introduced into the

treatment unit as the inoculum for challenge

load Type A as determined in Phase 1 above.

SA is the log of the number of viable test

microorganisms

(CFUfgram of waste solids and

PFU/gram of waste solids) that were not

recovered after processing the challenge load

Type A in Phase

1 above.

N2A is the number of viable test

microorganisms

(CFU/gram of waste solids and

PFU/gram of waste solids) remaining in the

treated residue for challenge load Type A.

c)

Repeat steps

(a) through

(b)

in Phase

2 for challenge

loads Types B and C identified in Table C of this

Appendix to determine the effectiveness of the

treatment unit

(LB and LC, respectively).

UI 14O-OL~00

---

—76—

This Option

2 is for a treatment unit that maintains the

integrity of the container of test microorganisms

(e.g.,

autoclaves)

a)

One microbiological indicator assay containing one of

the test microorganisms at numbers greater than one

million

(1,000,000) must be placed in a sealed

container that remains intact during treatment.

The

inside diameter of the container must be no larger than

required to contain the assay vial(s).

The vial(s)

must only contain the test microorganisms.

b)

The container of test microorganisms must be placed

within a Type A challenge load as identified in Table C

of this Appendix.

c)

Calculate the effectiveness of the treatment unit by

subtracting the log of viable cells after treatment

from the log of viable cells introduced into the

treatment unit as the inoculum, as follows:

LA

=

Log No

-

Log N2A ?

6

where:

LA is the log kill of the test microorganisms

(CFU and PFU) after treatment in challenge

load Type A.

No is the number of viable test

microorganisms (CFU and PFU)

introduced into

the treatment unit as the inoculum.

N2A is the number of viable test

microorganisms (CFU and PFU) remaining after

treatment in challenge load Type A.

d)

Repeat steps

(a) through

(C)

in this option for

challenge loads Types B and C identified in Table C of

this Appendix to determine the effectiveness of the

treatment unit

(LB and LC, respectively).

This Option

3 is for a treatment unit that uses thermal treatment

and maintains the integrity of the container of indicator

microorganism

spores

(e.g.,

autoclaves

and

incinerators).

a)

One microbiological indicator assay containing at least

one million (1,000,000)

spores of one of the indicator

microorganisms listed in Table B of this Appendix must

be placed in a sealed container that remains intact

during treatment.

The inside diameter of the container

must be no larger than required to contain the assay

vial(s).

The vial must contain only the indicator

microorganism vial.

01140_01401

---

—77—

b)

The container of indicator microorganisms must be

placed within a Type A challenge load as identified in

Table C of this Appendix.

c)

Calculate the effectiveness of the treatment unit by

subtracting the log of viable cells after treatment

from the log of viable cells introduced into the

treatment unit as the inoculum, as follows:

LA

=

Log No

-

Log N2A ?

6

where:

LA is the log kill of the viable indicator

microorganisms

(CFU)

after treatment in

challenge load Type A.

No is the number of viable indicator

microorganisms

(CFU)

introduced into the

treatment unit as the inoculum.

N2A is the number of viable indicator

microorganisms (CFU) remaining after

treatment in challenge load Type A.

d)

Repeat steps

(a) through

(c)

in this option for

challenge loads Types B and C identified in Table C of

this Appendix to determine the effectiveness of the

treatment unit

(LB and LC, respectively).

Section 1422.APPENDIX A:

Initial Efficacy Test Procedures

Table A:

Test Microorganisms

1.

Staphylococcus aureus

(ATCC 6538)

2.

Pseudomonas aeruginosa

(ATCC 15442)

3.

Candida albicans

(ATCC 18804)

4.

Trichophyton inentagrophytes

(ATCC 9533)

5.

MS-2 Bacteriophage (ATCC l5597—B1)

6.

Mycobacterium siuegmatis

(ATCC 14468)

Section 1422.APPENDIX A:

Initial Efficacy Test Procedures

Table B:

Indicator Microorganisms

1.

Bacillus subtilis

(ATCC 19659)

2.

Bacillus stearothermophilus (ATCC 7953)

3.

Bacillus puinilus

(ATCC 27142)

Section 1422.APPENDIX A:

Initial Efficacy Test Procedures

01140-01402

---

—78—

Table

C:

Challenge Loads

This table identifies the three types of challenge loads of

P1MW that must be used as part of the Initial Efficacy Test

and Periodic Verification Test(s).

COMPOSITION OF CHALLENGE LOADS

(w/w)

A

B

C

Moisture

?50

Organic

?70

Section 1422.APPENDIX B:

Correlating Periodic Verification Test

Procedures

a)

A certified microbiological indicator assay containing the

test microorganisms and indicator microorganism spores is

introduced into each challenge load as identified in Table C

of Appendix A.

b)

The

test

microorganisms

and

indicator

microorganism

spores

must

be

placed

in

a

sealed

container

that

remains

intact

during

treatment.

c)

The

container

must

be

placed

in

each

challenge

load

to

simulate

the

worst

case

scenario

(i.e.,

that

part

of

the

load

that

is

the

most

difficult

to

treat).

For

example,

the

worst case scenario for an autoclave would be to place the

test microorganisms and indicator microorganism spores

container within a sharps container that must in turn be

deposited in a plastic biohazard bag that is then located

centrally within the treatment unit.

d)

The effectiveness of the treatment unit is demonstrated by

calculating the log kill

(L) of the test microorganisms in

accordance with Option

2 of Appendix A of this Part.

The

equivalent log kill

(T)

of the indicator microorganism

spores is calculated by subtracting the log of viable cells

after treatment from the log of viable cells

introduced into

the treatment unit as the inoculum as follows:

TA

=

Log No

-

Log N2A ?

3

where:

TA is the equivalent log kill of the viable

indicator microorganisms

(CFU)

after treatment in

challenge load Type A.

01140 -01403

---

—79—

No is the number of viable indicator microorganism

spores

(CFU)

introduced into the treatment unit as

the inoculum (?

6)

N2A is the number of viable indicator

microorganism (CFU)

remaining after treatment in

challenge load Type A.

e)

Repeat steps

(a) through

(d)

for challenge loads Types B and

C identified in Table C of Appendix A to determine the

correlation between the log kill of the test microorganisms

and the equivalent kill of the indicator microorganism

spores

(LB and LC, respectively).

IT IS SO ORDERED.

I, Dorothy M.

Gunn, Clerk of the Illinois Pollution

Control Board, hereb~certify that theabove opinion and order

was adopted on the

‘‘.~5~ day of __________________________

1993, by a vote of

6~O

~

Dorothy M. 9~hn,Clerk

Illinois Pot).ution Control Board

DI 140-0140~~