ILLINOIS POLLUTION CONTROL B02½RD

June 17, 1993

IN THE MATTER OF:          

)

POTENTIALLY INFECTIOUS MEDICAL  

)

WASTE (P1MW): TREATMENT, STORAGE, 

)

R91-20

AND TRANSFER FACILITIES and    

)

(Rulemaking)

TRANSPORTATION, PACKAGING, AND

LABELING (35 Ill. Adm. Code    

)

1420, 1421, and 1422)        

)

Adopted Rule.       

Final Action.

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 amendments to 35 Iii. Adm. Code

Part 1420 and new Parts 1421 and 1422 to meet these legislative

mandates.

The Board is charged under the Illinois Environmental

Protection Act (Act) to “determine, define and implement the

environmental control standards applicable in the State of

Illinois”2. The Board is thereby responsible for promulgating

the State’s substantive environmental regulations, such as

represented by today’s action. More generally, the Board’s

rulemaking authority is based on the system of checks and

balances integral to Illinois environmental governance: the Board

is charged with the rulemaking and principal adjudicatory

functions and the Illinois Environmental Protection Agency

(Agency) is charged with carrying out the principal

administrative functions.

Today’s regulations closely follow the recommendations of

the Governor’s Medical Waste Tracking Study Group (Study Group)

as that group’s consensus has been proposed to the Board by the

Agency. Today’s regulations also are identical to the

regulations adopted for second notice, with the exception of a

modification at subsection 1422 

•

122 (a) (1) and several format and

nonsubstantive modifications made at the recommendation of the

Joint Committee on Administrative Rules (JCAR).

1 The mandates occur at Section 

56.2 

of the Illinois

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

2 Act at Section 5(b).

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The Board wishes to acknowledge the special contributions

made to this proceeding by staff scientist LouAnn Burnett in her

roles as technical consultant and participant in regulatory

meetings with the Study Group, and to Board attorney Michelle C.

Dresdow in her roles as hearing officer, contact person, and

advisor in drafting of the several opinions and orders. The

Board also expresses its appreciation for the quality and

magnitude of the contributions made by the members of the Study

Group and other participants, and for the leadership provided by

the Agency.

HI STORY

Prior to discussing the particulars of the instant

regulations, it is instructive to place their development in

historical perspective. Although concern about infectious

materials is long standing, the impetus to today’s particular

action is more recent, with antecedents at both the federal and

state level.

National Concern with Medical Wastes

Broad public and national concern about medical waste

reached a heightened consciousness after medically—related

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

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

Lake Michigan in the summer of 1988. In addition to general

health and aesthetic concerns, fear of AIDS contributed heavily

to the public’s anxiety regarding these wastes. (Exh. 7 at iii.)

Following the second season of wash—ups, Congress passed

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

(MWTA). The NWTA has a research and information component that

has provided for an expanded understanding of the nature and

hazards associated with medical wastes3.

In addition, the MWTA requires that the United States

Environmental Protection Agency promulgate regulations to

establish a demonstration tracking system for medical waste.

Several states along the Atlantic Coast (Connecticut, New York,

New Jersey) were required to participate in the demonstration

program. Participation of states bordering the Great Lakes was

made optional.

~ Among the important MWTA documents is “The Public Health

Implications of Medical Waste: A Report to Congress”, prepared by

the Agency for Toxic Substances and Disease Registry (ATSDR) of

the Public Health Service, U.S. Department of Health and Human

Services. This document is Exhibit 7 in the instant record.

0 L~3-O26i.~

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

federal MWTA demonstration program. Governor James R. Thompson

outlined several reasons for Illinois’ choice not to participate

(Exh. 5 at 8):

1.  Illinois already had a system in place which

tracked the potentially infectious waste from

hospitals. It was estimated at that time that

approximately 60 percent of the potentially

infectious waste generated in Illinois came from

hospitals.

2.  The intent of the MWTA was to prevent beach

closings, yet even USEPA concluded that the

program would have a very limited effect on the

beaches.

3.  No funding would be available from USEPA to

implement the program in Illinois.

Medical Waste Trackinc~Study Group

Governor Thompson recognized, however, that there was need

for additional study and planning for Illinois’ medical waste

program. Accordingly, on December 28, 1989, he announced the

formation of the Medical Waste Tracking Study Group. The Study

Group consisted of elected officials4 and representatives of

state agencies5, the health community6, academia7, waste handling

groups8, agriculture9, and the City of Chicago’°.

~ State Senators Judy Baar Topinka, Margaret Smith, and

Virginia MacDonald, and State Representative Myron Kulas.

~ The Agency, the Board, and Illinois Department of Public

Health. Board Member Joan Anderson participated initially.

6 Including the Illinois State Medical Society (Dr. Larry A.

Von Behren), the veterinary community (Dr. Raymond 0. Hill),

Illinois Council on Long Term Care (Mr. Peter P. Peters), the

Illinois Hospital Association (Ms. Ann Guild), public health

departments (Mr. J. Maichle Bacon), the Association for

Practitioners in Infectious Control (Ms. Carol Mason), and the

Illinois Dental Society (Dr. Robert Colantino).

~ Dr. Van Allen Anderson, University of Illinois Urbana-

Champaign, and John Klaire, University of Chicago Hospital.

S Including Waste Management, Inc. (Ms. Janet S. Emmerman),

Sexton Environmental Services (Mr. Larry Lawrence), National

Environmental Services Corp. (Mr. Bill Smith), Browning-Ferris

Industries (Mr. Francis J. O’Brien), and Compliance Resources,

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P91

J~3

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The Study Group met on many occasions and reviewed a large

number of scientific, technical and legal materials preparatory

to issuing its findings. (Exh. 5 at cover letter.) The

culmination of these activities was the submission to Governor

Jim Edgar on June 10, 1991 of the Study Group’s report entitled

“The Regulation of Potentially Infectious Medical Waste in

Illinois”. The report contains background information on the

scope of the P1MW problem and recommendations for managing P1MW

in Illinois. These recommendations are directed to modifications

of law, as well as educational and voluntary actions. The

recommendations with respect to the law formed the basis for

subsequent legislative actions and for the regulations today

adopted.

Members of the Study Group have continued to participate in

P1MW legislative and regulatory developments, including

presentation of much of the proposal, testimony, and general

record upon which today’s action is based.

Legislative Action

During the spring 1991 legislative session, the Illinois

General Assembly in House Bill 2491 adopted a variety of

amendments to the Illinois Environmental Protection Act (Act) in

response to the Study Group’s recommendations. These were signed

into law on September 26, 1991 by Governor Edgar as Public Act

87-752, effective January 1, 1992.

One of the cornerstones of P.A. 87-752 is the definition for

potentially infectious medical waste’2 its greatest importance

is that it specifically limits the types of waste to which P1MW

regulations apply.

P.A. 87-752 also added to the Act new 

Title XV: Potentially

Infectious Medical Waste. 

This title consists of seven sections,

numbered Sections 56 through 56.6. Section 56 consists of the

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

statement of purpose for Title XV. In its entirety Section 56

reads:

Inc. (Mr. Ed Juracek).

~ Mr. Richard P. Myers.

10 Ms. Nancy Marren.

~ This report is found in the instant record as Exhibit 5.

12 The definition was originally placed at Section 381 of

the Act. Pursuant to P.A. 87-1097 it was renumbered to Section

3.84.

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a.  The General Assembly finds:

1.  that potentially infectious medical waste, if

not handled properly, may constitute an

environmental or public health problem.

2.  that potentially infectious medical waste, if

not handled properly, may present a health

risk to handlers of the waste at the facility

where the waste is generated, during

transportation of the waste, and at the

facility receiving the waste.

b.  It is the purpose of this Title to reduce the

potential environmental and public health risks

associated with potentially infectious medical

waste by establishing statutory and regulatory

requirements to ensure that such waste will be

handled in a safe and responsible manner.

Section 56.1 is a lengthy’3 section consisting of a list of

prohibitions against P1MW activities. The principal prohibitions

are against:

1.  Disposal of any P1MW (Section 56.1(a));

2.  The landfill disposal of sharps unless their

infectious potential has been eliminated and

they are properly packaged (Section 56.1(a));

3.  The delivery of P1MW for transport, storage,

treatment, or transfer except where the P1MW

is properly packaged (Section 56.1(b));

4.  The delivery of P1MW to a person or facility

that does not have an Agency-issued permit

for storage, treatment, or transfer of P1MW,

where such permit is required (Section

56.1(c));

5.  The delivery or transfer of P1MW unless the

transporter has an Agency—issued permit,

where such permit is required (Section

56.1(d));

‘~ A substantial portion of the length of Section 56.1 arises

from the inclusion of various effective dates (all now past

except for the incineration date found at Section 56.1(j)) plus

interim regulations which are to be in effect until the adoption

of the instant regulations.

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6.  The delivery or transfer of P1MW unless a

P1MW manifest is completed for the waste,

where such manifest is required (Section

56.1(d));

7.  The acceptance of any P1MW for transport,

storage, treatment, or transfer except where

the P1MW is properly packaged (Section

56.1(e));

8.  The conducting of any P1MW transportation

operation without an Agency-issued permit

(where such permit is required), in violation

of any permit condition, or in violation of a

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

9.  The conducting of any P1MW treatment,

storage, or transfer operation without an

Agency-issued permit (where such permit is

required), in violation of any permit

condition, or in violation of a Board

regulation or order (Section 56.1(g));

10. The transport of unmanifested P1MW, where a

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

11. The incineration of P1MW after January 1,

1994 at an existing incinerator in violation

of standards established under Section 129 of

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

Section 56.2 consists principally of mandates to the Board,

including the mandates under which the instant action is being

undertaken’4. The first of these mandates is found at Section

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

“prescribing design and operating standards and criteria for all

potentially infectious waste treatment, storage, and transfer

facilities”. The mandate also directs that the Board, “at a

minimum” require that P1MW be treated at a facility that:

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

addressed, Section 56.2 also requires at subsection (d) that the

Board repeal its previous infectious waste regulations and at

subsection (e) that the Board adopt the list of Class 4 etiologic

agents. These two actions have been completed. The first was

undertaken as In the Matter of: Repeal of 35 Ill. Adin. Code

809.Subpart I: Hazardous (Infectious) Hospital Waste, R91—l8,

Final Order December 19, 1991. The second was undertaken as In

the Matter of: Potentially Infectious Medical Wastes: Etiologic

Agents, R9l—19, Final Order January 23, 1992.

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1.  eliminates the infectious potential of the

waste;

2.  prevents compaction and rupture of containers

during handling operations;

3.  disposes of treatment residuals in accordance

with this Act and regulations adopted

thereunder;

4.  provides for quality assurance programs;

5.  provides for periodic testing using

biological testing, where appropriate, that

demonstrate proper treatment of the waste;

6.  provides for assurances that clearly

demonstrate that potentially infectious

medical waste has been properly treated; and

7.  is in compliance with all Federal and State

laws and regulations pertaining to

environmental protection.

The second mandate that today’s action addresses occurs at

Section 56.2(c). It specifies that the Board shall adopt

regulations “prescribing standards and criteria for transporting,

packaging, segregating, labeling, and marking potentially

infectious medical waste”.

Sections 56.3, 56.4, 56.5, and 56.6 of Title XV generally

deal with the Agency’s direct role in P1MW matters, including

reporting, manifesting, 

permit

issuance, and fee collection.

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

In the spring 1992 legislative session, the General Assembly

revisited P.A. 87—752 for the purpose of making certain

corrective amendments. These were proposed as House Bill 3666

and signed into law as P.A. 87-1097 on September 15, 1992. Among

pertinent provisions, P.A. 87-1097 clarified the definition of

P1MW, clarified various exceptions to the prohibitions of Section

56.1, and specified July 1, 1993 as the required date of

completion of the instant rulemaking.

Actions before the Board

In anticipation of the need to take action in the P1MW

arena, the Board on August 9, 1991 reserved several rulemaking

dockets within which it intended to conduct the various

rulemakings. On August 23, 1991 the Board called a public

hearing (inquiry hearing), which was held on September 18, 1991.

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

the regulations to be developed under the Section 56.2 mandates.

On August 26, 1991 the Board issued orders formally opening

the dockets. Included were separate dockets for the rulemaking

covering treatment, storage, and transfer facilities (R91—20) and

for the rulemaking covering transportation, packaging, and

labeling (R9l—21).

At the inquiry hearing testimony was received from Mr. Henry

Henderson from the City of Chicago, Dr. Van Allen Anderson of the

University of Illinois at Urbana-Champaign and the Study Group;

Ms. Ann Guild of the Illinois Hospital Association and the Study

Group; Dr. Larry Von Behren of the Illinois State Medical Society

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

Illinois, Inc.; Mr. Francis 3. O’Brien from Browning Ferris

Industries Medical Waste Systems and the Study Group; Ms.

Jacquelyn Flora from Browning Ferris Industries Medical Waste

Systems; and Mr. Larry Lawrence of Sexton Environmental Systems

and the Study Group. Testimony and questioning included the

implementation provisions of the legislation requiring

segregation, packaging, marking and labeling, transporting,

storing and treating of P1MW (Tn.’5 at 98-144).

Based upon the inquiry hearing and in recognition that

matters of P1MW facilities and transportation, packaging, and

labeling overlapped, the Board on February 27, 1992 ordered

dockets R91-20 and R91-21 to be consolidated, docket R91-21 to be

closed, and the materials in docket R91-2l to be incorporated

into R9l-20 for the purpose of all subsequent considerations.

On April 27, 1992 the Agency filed the draft proposal upon

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

adopted rules are based; the Agency has also subsequently acted

as proponent for the instant rulemakings. Accordingly, for

purposes of the following discussions, the Board will identify

the April 27 draft proposal in short form as the “Agency

Proposal”. It is to be acknowledged, however, that the Study

Group and other interested persons contributed to the development

of the Agency Proposal, and moreover that the Agency undertook

extensive outreach and regulatory development meetings16 prior to

~ Citations to the pages of transcripts of the inquiry

hearing are in the form “Tn. at 

____“;

citations to the

transcripts of the merit hearings, which are consecutively

numbered, are in the form “Tr2. at

16

Meetings were held on December 10 and 19, 1991, January 7,

23, and 24, 1992, and February 6, 7, and 24, 1992. Participants

included members of the Study Group in addition to other

interested persons. Ms. LouAnn Burnett and Mr. Philip Van Ness,

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formalizing and filing its proposal. The Board extends its

appreciation to the Agency and its personnel for the quality of

its leadership role.

On April 27, 1992 the Agency also filed a recommendation

(Exh. 37), pursuant to then Section 27 of the Act’7, that an

Economic Impact Study (EcIS) not be conducted; on May 11, 1992

the Illinois Department of Energy and Natural Resources joined in

that recommendation (PC 

#7)18. 

On June 4, 1992 the Board issued

an order finding that the EcIS need not be conducted. The Board

noted:

The Agency states that representative members of the

regulated community have participated in the

development of the Agency’s proposal, and that these

representatives will attend the hearings and present

information on the economic reasonableness of the rule.

The Agency has also presented some economic information

with its proposal (see Attachments 1—10), and will

present additional information at hearing. The

Department concurs in the Agency’s comments, and

further states that interested parties will have “ample

opportunity to present testimony regarding technical

feasibility and economic reasonableness during the

Board’s merit hearings.” (P.C.#7 at 1). The

Department further states that additional economic

information will be available from the Agency at or

before hearing.

Some of these representatives also participated on

the Medical Waste Tracking Study Group (Study

Group) formed by Governor Thompson. The Study

Group was instrumental in drafting the legislation

mandating the adoption of medical waste

regulations.

Board staff, also participated in these meetings. Minutes of

these meetings are included in this record as Exhibits 38-5, 38-

13, 38—35, 38—64, 38—65, and 38—66.

~ PA 87—860, effective July 1, 1992, deleted those portions

of the Act that required economic impact studies for this type of

rulemaking. The Board’s EcIS determination aside, the need for a

formal EcIS study is accordingly now moot.

‘~

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

#xat

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The Board has held three merit hearings. These were held on

June 16, 1992 in Bloomington, Illinois, and on July 14, 1992 and

August 25, 1992 in Chicago, Illinois.

The June 16, 1992 hearing was devoted to presentation of the

Agency Proposal and the taking of questions on the proposal.

Providing testimony on behalf of the Agency were three members of

the Permit Section of the Agency’s Bureau of Land: Mr. Douglas

Clay, Manager of the Disposal Alternatives Unit; Dr. Shirley

Baer, Co-coordinator of the P1MW waste program, Disposal

Alternatives Unit, and Mr. Theodore Dragovich, Permit Reviewer.

Among persons posing questions to the Agency were ABB Sanitec,

Inc., Sexton Environmental Systems (Sexton), Winfield

Environmental Corporation, the National Solid Waste Management

Association (NSWMA), Chemical Waste Management, Isolyser Company,

and the Board.

The July 14, 1992 hearing focused on testimony directed to

the merits of the Agency Proposal. Among those testifying were

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

of Greater Chicago; Dr. Van Allen Anderson of the University of

Illinois,

Urbana-Champaign and the Study Group; Dr. Edward Cohen

of University of Illinois, Chicago, on behalf of Sexton; Mr.

Travis Honeycutt of Isolyser Company; Mr. Robert Rechner of the

Illinois State Dental Society and the Study Group; Ms. Ann Guild

of the Illinois Hospital Association and the Study Group; Dr.

Larry Von Behren of the Illinois State Medical Society and the

Study Group. Drs. Anderson and Von Behren, Mr. Rechner, and Ms.

Guild each spoke to the general support they and their

organizations give to the Agency Proposal, with Dr. Anderson

providing additional documentation in support of the position.

The other presenters generally spoke to specific concerns.

The August 25, 1992 hearing continued the opportunity for

testimony regarding the Agency Proposal and response testimony to

that given at the July 14 hearing. Witnesses included Ms. Jean

Furlan of the National Solid Waste Management Association; Mr.

Connie Frank of Rose Cartage; Mr. Harry Eiler of Recovery

Corporation of Illinois; Ms. Carol Mason of the Association for

Practitioners in Infection Control and the Study Group; Dr. John

Keene from the Society for Hospital Epidemiology of America; Mr.

Joseph Wilson of Ecomed; and Mr. Larry Eastep of the Agency and

the Study Group. Dr. Cohen also testified again. Ms. Mason

noted the support of her association for the Agency Proposal.

The other presenters generally spoke to specific concerns.

Public Comments

Thirty-nine public comments have been filed with the Board,

including nineteen filed subsequent to the start of merit

hearings and fourteen filed in the post—first notice comment

period.

These are dominantly expansions upon or responses to

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matters addressed at hearing or raised in the first notice

opinion. The Board has reviewed all public comments, with

citations herein where pertinent.

The Board notes that it recently received comment from Medx

Inc. and Custom Compactors Corporation. These comments were

received on May 10, 1993 and May 13, 1993, respectively, three

months after the February 11, 1993 close of the public comment

period and well after the Board adopted today’s rules for second

notice (see below). The Board is not able to react to such late—

filed comments; the Board is statutorily prohibited from altering

any proposal subsequent to second notice, except at the

recommendation of JCAR (see below).

First and Second Notices

Based on the record as then developed, the Board on December

3, 1992 adopted the first notice proposal’9. The proposed rules

were accompanied by a 39-page opinion, the major elements of

which are repeated in the instant opinion. In its outlines and

particulars, the first notice proposal closely tracked the Agency

Proposal.

On March 25, 1993 the Board adopted the second notice

proposal. The changes adopted for second notice were few and

generally were of the nature of giving greater specificity to the

regulations. The second notice proposal was accompanied by an

opinion of 28 pages, the major elements of which are incorporated

into today’s opinion.

Among changes made at second notice was adoption of a

recommendation of the National Solid Waste Management Association

that the operational definition of “eliminates the infectious

potential of the waste” found at Section 1422.122 (a) (1) be

clarified (PC #36 at 3). The intent was to provide a definition

that “more clearly reflects the treatment standards and more

clearly articulates the specific standards that constitute

elimination of infectious potential”. (Second Notice Opinion at

17.) The NSWMA comment, plus a similar comment from Stericycle

(PC #35), were filed prior to the end of the public comment

period, and prior to the time the Agency filed its comment. The

Agency, however, did not address this issue until after today’s

rules had gone to JCAR.

‘~ 

Publication of Part 1420 occurred at 16 Ill. Reg. 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).

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Action Before JCAR

Immediately upon adoption of the second notice rules, the

Board on March 26, 1993 forwarded them to JCAR pursuant to the

Illinois Administrative Procedure Act (5 ILCS 100/1-1 et seq.);

JCAR set the matter for consideration at its May 11, 1993

meeting.

On May 10, 1993 the Agency asked JCAR to object to adoption

of these rules on the basis that the modification made to Section

1422.122(a) (1) 

see above 

at second notice resulted in an

internal inconsistency between that subsection and some other

portions of Part l422~0. On May 11 JCAR voted the objection.

Under the terms of an objection, the Board is required to address

the objection.

This objection presented a number of concerns for the Board.

The first was that the objection delayed the adoption of the

entire set of rules pending resolution of the objection.

Moreover, it is statutorily required that this rulemaking process

be completed by July 1, 1993, further necessitating that action

be expeditious.

A second whole area of concern for the Board is that the

Board is statutorily and by its own rules and established

practices bound to the principle of equitable and impartial

hearing of the concerns of all interested parties on the public

record. Accordingly, if any person, the Agency included, wishes

the Board to modify the Board’s rules, it has available to it

clearly established public procedures by which petition may be

made.

Given the circumstances of the objection, the Board at its

first opportunity on Nay 20, 1993 ordered a special and short

public comment period to address solely the matter of the

appropriate language for subsection 1422.122(a) (1). To expedite

the matter, the Board suggested language that it believed would

address the JCAR concern. Further, the Board both invited

comment on the new proposed language and invited acceptable

alternatives; only the Agency responded.

On June 3, 1993 the Board voted adoption of the language

today found at subsection 1422.122 (a) (1) (see discussion below

for specifics), and submitted that language to JCAR via a Board

resolution as the Board’s response to the JCAR objection.

20

The Agency’s letter to JCAR requesting that an objection

be voted has not been served upon the Board; the Board

nevertheless takes official notice of it as a public document.

At no time, in fact, has the Agency addressed any of its

perceived problems with subsection 1422.122(a) (1) on the record.

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GENERAL CONSIDERATIONS

In addition to the history of P1MW matters, there are a

number of general considerations necessary to put today’s

regulations into perspective.

Immediacy of the P1MW Problem

While it is generally conceded that P1MW presents a real

problem, it is also generally conceded that the problem should be

addressed by a reasoned consideration of existing rules and

regulations and awareness of the professional practices employed

in those fields where P1MW is generated and handled. It was in

recognition of this situation that Illinois opted out of the MWTA

program (see above). It was also in recognition of this

situation that the broad interests represented in the Study Group

were brought together to recommend a concerted P1MW program.

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

(Exh. 7), made in accordance with the MWTA (see above), observed

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

affected by medical waste generated in the traditional health

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

Pathogens” rule should decrease workplace medical waste—related

injuries and infections nationwide. (Exh. 7 at E.9.) ATSDR also

concluded that medical waste can be effectively treated by

chemical, physical, or biological means and that research

indicates that medical waste does not contain any greater

quantity or different types of microbiological agents than does

residential waste. Medical waste is approximately 0.3 of the

solid wastestream in the U.S. (Exh. 7 at E.11.)

Design of Rules

Today’s rules are designed as a multi—pronged attack on the

chain of events leading to infection and disease. For infection

to occur, each of these events must take place:

1)  A person must come in contact with medical

waste;

2)  An injury must occur following this contact,

thereby creating an appropriate portal of

entry, or a portal of entry must already

exist; and

3)  A sufficient number of viable infectious

agents must enter a susceptible individual

via this portal of entry, then cause

infection.

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Infection does not always result in disease. (Exhs. 7 at E.5,

38—26, and 39—30 at 3.)

Appropriate segregation of P1MW from other wastes allows a

generator to apply more extensive safety measures to a smaller

waste stream. Proper packaging should nearly eliminate the

possibility of contact (Tr2. at 84) or the creation of a portal

of entry (i.e., packaging sharps in a puncture—proof container).

Storage and transportation requirements also help limit the

exposure of handlers or the general public to potentially

infectious agents. Treatment reduces the number of potentially

infectious agents, thereby reducing the possibility of infection

if contact and injury does occur. Any of these preventive

methods applied individually should reduce the possibility of

infection, but used in concert and properly, the entire P1MW

management system should reduce the possibility of infection

almost completely. (Tr2. at 113.)

Today’s rules are also designed to complement the

Occupational Safety and Health Administration rules issued

December 6, 1991 that contain provisions requiring employers to

protect their employees from bloodborne pathogens through

training, engineering controls, work practices, personal

protective equipment, recordkeeping, and Hepatitis Type-B virus

vaccinations (Exhibit 37-6; Tr2. at 72, 84).

Definition of Potentially Infectious Medical Waste (P1MW)

The definition of potentially infectious medical waste, or

P1MW, is set by statute at Section 3.84 of the Act. In its

entirety, that definition is as follows:

a. “Potentially infectious medical waste” or “P1MW” means

the following types of waste generated in connection

with the diagnosis, treatment (i.e., provision of

medical services), or immunization of human beings or

animals; research pertaining to the provision of

medical services; or the provision or testing of

biologicals:

1. Cultures and stocks. This waste shall include but

not be limited to cultures and stocks of agents

infectious to humans, and associated biologicals;

cultures from medical or pathological

laboratories; cultures and stocks of infectious

agents from research and industrial laboratories;

wastes from the production of biologicals;

discarded live or attenuated vaccines; or culture

dishes and devices used to transfer, inoculate, or

mix cultures.

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2. Human pathological wastes. This waste shall

include tissue, organs, and body parts (except

teeth and the contiguous structures of bone and

gum), body fluids that are removed during surgery,

autopsy, or other medical procedures; or specimens

of body fluids and their containers.

3. 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.

4. Used sharps. This waste shall include but not be

limited to discarded sharps used in animal or

human patient care, medical research, or clinical

or pharmaceutical laboratories; hypodermic,

intravenous, or other medical needles; hypodermic

or intravenous syringes; pasteur pipettes; scalpel

blades; or blood vials. This waste shall also

include but not be limited to other types of

broken or unbroken glass (including slides and

cover slips) in contact with infectious agents.

5. Animal waste. Animal waste means discarded

materials, including carcasses, body parts, body

fluids, blood, or bedding originating from animals

inoculated during research, production of

biologicals, or pharmaceutical testing with agents

infectious to humans.

6. Isolation waste. This waste shall include

discarded materials contaminated with blood,

excretions, exudates, and secretions from humans

that are isolated to protect others frOm highly

communicable diseases. “Highly communicable

diseases” means those diseases identified by the

board in rules adopted under subsection (e) of

section 56.2 Of the act.

7. Unused sharps. This waste shall include but not

be limited to the following unused, discarded

sharps: hypodermic, intravenous, or other

needles; hypodermic or intravenous syringes; or

scalpel blades.

b. Potentially infectious medical waste does not include:

1. waste generated as general household waste;

2. waste (except for sharps) for which the infectious

potential has been eliminated by treatment; or

UI ~~3-0277

—16—

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.

Early in the history of this proceeding there was concern

raised by various persons about the appropriateness of this

definition. A portion of that concern was addressed by the

corrective amendments undertaken in P.A. 1097; these amendments

limited the types of waste that are P1MW21.

The remaining questions regarding the P1MW definition are

largely concerned with interpretation and implementation of

certain phrases used within the definition, as, for example, the

meaning of “rendered unrecognizable” found in the last subsection

of the definition. These will be discussed in context in the

following part—by—part analyses.

The Treatment Standard

The fundamental provision around which the instant

regulations are built is the provision of treatment to render

waste non—PIMW. Because a waste that is P1MW may not be disposed

of in Illinois, and because treatment is the process by which a

waste ceases to be P1MW22, the ultimate disposition of P1MW

depends upon its being treated.

Suitably, treatment standards and criteria form the largest

single portion, Subpart B of Part 1422, of today’s regulations.

Moreover, treatment has been the single greatest focus of

participant interest, both at hearing and in public comments.

Much of that interest has focused on the question of what

constitutes successful treatment.

21

The principal changes were to eliminate the phrase 

“...

but not limited to 

...“

prior to the lists of materials included

in the definitions of human pathological wastes, human blood and

blood products, and isolation waste, and to rephrase the

definition of animal waste.

~ A partial exception occurs for sharps. These must be both

treated and “rendered unrecognizable” in order to leave the P1MW

wastestream. “Recognizable” sharps, which remain P1MW, may be

disposed of provided that they are both treated and packaged,

pursuant to Section 1422.126. See discussion of the term

“recognizable” in the part—by-part discussion, below.

0 L~3-U278

—17—

Today’s regulations follow the Agency Proposal in requiring

two demonstrations of treatment efficacy. The first is the

Initial Efficacy Test~, in which it is required that the

manufacturer assure that six types of “test” microorganisms~

that are surrogates for pathogens be reduced to very low

concentrations (a 6—log reduction~) by the treatment process.

The second demonstration is made by operators of individual

treatment units. They are required to verify that the

manufacturer—demonstrated efficacy continues by conducting

Periodic Verification Tests26. These are accomplished by showing

that concentrations of bacterial spores (typically the most

resistant forms of microorganisms) are reduced to a number that

correlates with the 6—log reduction of the organisms used in the

manufacturer’s efficacy test.

This program represents the consensus view of members of the

Study Group, and the program which today is adopted in its major

provisions. Nevertheless, several issues regarding treatment

standards constituted major areas of debate during the course of

this proceeding.

Among such issues have been the stringency of the efficacy

standard, whether the standard is properly a “log—kill” or “log—

reduction” standard, and which organisms should be used or

allowed in efficacy determinations. Greater detail regarding

these issues has been presented in the first notice opinion at

pages 15-18 and 34-40 and the second notice opinion at pages 16-

26.

ORGANIZATIONAL CONSIDERATIONS

The Board has established the following organizational

scheme to accommodate the P1MW and related regulations.

~ See Section 1422.124.

~ Staphylococcus aureus 

(representative of gram—positive

bacteria), 

Pseudomonas aeruqinosa 

(representative of gram—

negative bacteria), 

Candida albicans 

(representative of

vegetative fungi--yeast), 

Trichophyton mentaqrophytes

(representative vegetative fungi--mold), MS—2 bacteriophage

(hepatitis virus surrogate, and 

Mycobacterium smegmatis

(tuberculosis bacteria surrogate).

“

At various places in the record this term is also given as

“6log”. The hyphenated form is used here and in the text of the

regulations.

26

See Section 1422.125.

~43-027g

—18—

Subtitle M, which is to consist of the 1400—1499 series of

35 Ill. Adiu. Code, is reserved for regulations that control

specific biological materials; currently, the only Board

regulations within Subtitle M are the instant P1MW regulations.

As is the general scheme with 35 Ill. Adm. Code regulations,

parts numbered 1400 to 1449 (Chapter I) are reserved for

regulations promulgated by the Board, and parts numbered 1450 to

1499 (Chapters II and III) are reserved for regulations

promulgated by the Agency or the Department of Energy and Natural

Resources.

Today’s specific regulations are collected into subchapter

b, the P1MW subchapter. This subchapter, in turn, is subdivided

into three parts to efficiently house general provisions (Section

1420), and the regulations today adopted in response to the

separate Section 56.2(a) and 56.2(c) mandates of the Act

(Sections 1421 and 1422)

PART-BY-PART ANALYSIS 

Part 1420

In this portion of our opinion, the Board presents an

explanatory analysis of today’s regulations, beginning with Part

1420. Emphasis is on issues that have required Board

resolution~.

Part 1420 is the only one of the three parts in today’s

regulatory package that is not entirely new. Part 1420

originated in the Board’s first P1MW proceeding, R91-19, that

dealt with etiologic agents28. It is expanded to house general

provisions pertaining to P1MW.

Scope and Ai~licability (Section 1420.101)

The Scope and Applicability statement for the P1MW

regulations was adopted in R91-19. At first notice the Board

proposed, and today adopts, the deletion of both subsection (b)

and the Board Note as no longer reflective of the overall content

of either Part 1420 or the P1MW subchapter.

It is to be noted that, through the operation of Section

1420.101, the instant regulations are applicable to activities

occurring in whole or in part within the State of Illinois.

Thus, that part of any P1MW wastestream activity (e,g.,

v The interested person is directed to the testimony of Dr.

Baer, Tr2. at 52—153, and Mr. Dragovich, Tr2. at 154—191, for a

more extensive explanation of particular provisions.

28 See footnote #14.

~I4$-~J~o0

—19—

transporting) that takes places in Illinois is subject to these

regulations, even if some portion of the P1MW wastestream

activity (e.g., disposal) does not.

Definitions (Section 1420.102)

General definitions that apply to the three P1MW parts are

found in Section 1420.102. Most of these definitions are

standard, and need not be specifically discussed here. However,

there are several around which question has been raised.

“P1MW”. The full statutory definition of P1MW has been

presented and discussed above. It is also presented within the

body of the rule at Section 1420.l02~. As noted above, there

have been some concerns raised regarding this definition that

have now been addressed by the General Assembly. The Board has

no authority to modify the statutory definition.

In response to a question raised by Chemical Waste

Management (CWN) regarding whether discarded unused test kits

should be considered P1MW (Tr2. at 282-305; PC #22), the Board in

its 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 components, or somehow

otherwise covered under the statutory P1MW definition,

is not P1MW. (First notice opinion at p. 22, emphasis

added.)

During the post—first notice comment period, two commenters

observed that a discarded unused test kit that contains blood

components should not be considered to be P1MW. The Agency

observed that P1MW is by statutory definition waste generated 

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 observed 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. 

(u.)

Dr. Anderson also observed that

blood components in test kits have been sterilized, and as such

have no infectious potential. (PC #37 at 1.) In its second

~ It is to be noted that, in accord with standard

construction, statutory language in the regulations is denoted by

capitalization.

I I

‘~—

p1’)

1)1 4u L)~.

—20—

notice opinion, page 3, the Board noted that these points with

regard to unused test kits are well taken, and accordingly

receded from its first notice proposed position on this matter.

“Site”. The term “site” appears in many places within the

today’s regulations, including within other definitions (“storage

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

circumstances under which permits and manifests are required3°

and within various provisions defining on— and off—site

circumstances31. There is thus a special importance to having

the definition be clear and precise.

The following definition was offered in the Agency Proposal:

“SITE” MEANS ANY LOCATION, PLACE, TRACT OF LAND,

AND FACILITIES, INCLUDING BUT NOT LIMITED TO BUILDINGS,

AND IMPROVEMENTS USED FOR PURPOSES SUBJECT TO

REGULATION OR CONTROL BY THIS ACT OR REGULATIONS

THEREUNDER. (Section 3.43 of the Act). In the case of

a hospital or an educational institution, the Agency

shall determine what constitutes a site based on

location, ownership, operation, charter or license.

The first, capitalized part of this definition is identical

to the definition of “site” found in the Act. It has not been at

issue.

However, the second, lower case part of the definition has

been of concern. The purpose of the language is to allow for

flexibility in determining the geographic bounds of a site,

particularly in the circumstance where an organization

(epitomized by hospitals and universities) may consist of

geographically separated buildings and structures. The intent is

that such organizations need not necessarily acquire separate

permits for each structure or manifest all loads transferred

between buildings. The Agency’s resolution of this matter was to

allow a case—by—case determination under its supervision.

The problem with this resolution is that it constitutes a

delegation of authority of questionable validity. Accordingly,

the Board at first notice declined to propose the lower case

language of the Agency Proposal. Instead, at the lead of several

participants, the Board observed that the term “campus” has

sufficient ordinary meaning as to itself be explicit, and

~ Sections 1420.105(c) (1) and (e)(1).

31 Sections 1421.120, 1421.130, 1421.131(a) (2) (E),

1421.131(e)(2)(E), 1422.111(a), 1422.111(a)(4), and

1422.111(b) (5) (B).

• l.f s~_n9r~

0~) ~..O

—21—

therefore proposed to address the matter by replacing the lower

case language with:

For the purpose of this Subtitle, each campus of an

educational institution is considered to be a single

site.

This resolution did not explicitly address the issue of

hospitals. However, based on additional comments received in the

post-first notice comment period, the Board at second notice

concluded that it would be both unnecessary and unwise to attempt

more explicit consideration of hospitals within the definition of

“site”. This conclusion is based, among other matters, on the

special mention made of hospitals, and the permits required by

them, both in the statute and within the main body of the instant

regulations. (See second notice opinion at p. 4—7.) The Board

today affirms its analysis as presented at second notice.

Unrecognizable. Pursuant to the definition of P1MW at

Section 3.84 of the Act all sharps are considered to be P1MW

unless they meet both of the conditions:

The infectious potential has been eliminated from the

sharps by treatment; and

The sharps are rendered unrecognizable by treatment.

This definition has raised the question of how the phrase

“rendered unrecognizable” is to be interpreted32. The issue is

significant in that it factors into a determination of when a

sharp no longer is a P1MW, and hence is no longer subject to P1MW

treatment and disposal limitations33.

In the original Agency Proposal it is recommended that the

term “unrecognizable” be included within the general definitions,

as follows:

“Unrecognizable” means physical alteration (i.e.,

melted, charred, corroded, or ground) so that the sharp

may no longer be used for its intended purpose.

As the Board concluded at first notice, an effect of this

recommendation is to incorporate into the definition the concept

of usability. The Board also concluded that this incorporation

32 The meaning of infectious potential being “eliminated” has

also been raised in this proceeding. A discussion of this matter

is found in the “General Considerations” portion of this opinion,

above.

~ See discussion of Section 1420.104, below.

UI ~3-D283

—22—

is consistent with the P1MW threat posed by sharps and the

circumstance under which that threat is allayed. The Board

accordingly adopted the concept~. (See first notice opinion at

p. 25.) The Board today affirms these conclusions.

Also at first notice the Board discussed the encapsulation

and solidification process of Isolyser Company, Inc., as a method

for the treatment of sharps35. (First notice opinion at p. 25.)

For second notice Isolyser asked that “encapsulating/solidifying”

be specified in the definition of “unrecognizable” as an example

of physical alteration. (PC #30 at ¶1.) This the Board declined

to do because it believes that the record does not support a

blanket endorsement of all processes that involve encapsulation

or solidification. (Second notice opinion at p. 7.) The Board

today affirms these analyses.

Incorporations bY Reference (Section 1420.103)

Incorporations by reference for the full P1MW subchapter

occur at Section 1420.103. All incorporations are placed in one

section to simplify future amendments and updates, and for more

ready reference.

Today’s regulations contains two incorporations by

reference. They are Standard Methods for the Examination of

Water and Wastewater (18th Edition) and Test Methods for

Evaluating Solid Waste. Physical/Chemical Methods (EPA SW—846)~.

Prohibitions (Section 1420.104)

Section 1420.104 sets out the P1MW prohibitions. Much of

the section is statutory, as found at Section 56.1 of the Act.

Disposal of sharps. In a post-first notice public comment

Stericycle, Inc., requested clarification of sharps disposal, as

~ The actual language adopted was slightly modified for

grammatical reasons. See first notice opinion at p.26.

~ Under the Isolyser process sharps are treated and bound

into a polymer matrix. During the binding process pressure

forces the polymer into the barrels of syringes and needles, with

the whole enclosed in an opaque container. Isolyser contends

that this process renders the sharps no longer usable (Tr2. at

279; 663—94).

~ The former is referenced in the Initial Efficacy Test

procedures at Section 1422.124(e) (2) and 1422.Appendix A, and in

the Periodic Efficacy Test procedures at Section 1422.125(b) (4).

The latter is referenced in the Initial Efficacy Test procedures

at 1422.Appendix A.

r

L~ju28!4

—23—

referenced at Section 1420.104(a). (PC #35 at 2.) Stericycle

noted 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 regulations that reflect on the disposal of sharps. The

first is in the definition of P1MW37 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:

(A) Board regulations; or

~ The same definition is repeated at Section 1420.102 of the

instant regulations.

‘~

— U~

—24—

(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 not 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 the sharps unrecognizable. After this processing, the

sharps are not considered to be P1MW and may be disposed of in a

manner the same as that of 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 Study Group, the Agency Proposal, and the

instant regulations 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; ~

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.

3)  Accompanied by a P1MW manifest as required by

Section 1420.104 of this Subtitle, unless

specifically exempted.

II

I

4~U286

‘~

—25—

(emphasis added)

The “or” in subsection 1422.126(a) indicates that either route is

an acceptable handling of sharps.

Distosal into sewers. Among the changes made to Section

1420.104 during the course of this proceeding has been the

addition at subsection (1) of an explicit prohibition against the

discharge of P1MW into sewers.

This action arose from concerns of the Metropolitan Water

Reclamation District of Greater Chicago (MWRDGC) and the Illinois

Association of Wastewater Agencies that the practice of flushing

ground/shredded inert medical solid wastes into sewers is an

inappropriate use of the public sewerage system, and that the

public sewerage system is neither designed to function as a

landfill nor as a depository for inert solid wastes regardless of

origin. (Tr2. at 468—493; Exh. 43 and 44; PC #6, 11, and 12.)

MWRDGC also observed difficulties posed to the biological

treatment system of a sewage treatment plant and sludges when

such solid materials are received in the waste stream. (Tr2. at

478—80.)

Permit and Manifest Exceptions. Penalty Factor, and Cleaning and

Disinfection (Sections 1420.105, 1420.106. and 1420.107)

The first two of these sections basically present language

from the P1MW statute. The third contains at a single location

language required in support of various other sections38.

The three sections have remained basically unaltered from

the Agency Proposal, although conforming and minor amendments

have been made, as discussed in the first notice opinion at page

28-29 and in the second notice opinion at page 11-12.

Severability (Section 1420.120)

Section 1420.120 contains severability language as found

generally in Board regulations.

PART-BY-PART ANALYSIS 

Part 1421

Part 1421 is a new part intended to address the mandate of

Section 56.2(c) of the Act regarding the prescription of

“standards and criteria for transporting, packaging, segregating,

labeling, and marking potentially infectious medical waste”. The

38 Within the definition of “reusable container” at Section

1420.102, as well as at Sections 1421.121(d), 1421.121(e),

1421.141(i), 1422.111(a) (8), 1422.111(a) (11), and 1422.122(b) (5).

1

U~...L)

—26—

part is divided into five subparts, each addressing one of the

natural divisions of the topic. Part 1421 also has an Appendix A

that contains the International Biohazard Symbol.

The entire part is adopted today with only minor, generally

nonsubstantive modification from the Agency Proposal.

General Provisions (Subpart A)

This short subpart contains a single section specifying that

the date for compliance with Part 1421 is the effective date of

the part. That is, compliance is required immediately upon the

regulation becoming effective; that, in turn, will be upon the

acceptance by the Office of the Illinois Secretary of State of

the filing by the Board of today’s action.

Waste Segregation (Subpart B)

Subpart B consists of two sections that apply to all P1MW

generators, transporters, storage sites, transfer stations, and

treatment facilities (Section 1421.110).

A principal requirement, found in Section 1421.111(a), is

that generators segregate P1MW into sharps, oversized P1MW (a

single waste item that is too large to be placed into a 33-gallon

bag or container), and all other. These three categories are

derived from similar categories used in Section 56.1 of the Act,

including the interim P1MW regulations found there.

Subsections 1421.111(b) and (c) specify that properly

packaged and labeled sharps and mixed waste must be handled as

though the entire wastestream originated as P1MW. They do not,

however, preclude the applicability of other regulations. For

example, if a hazardous substance is also P1MW, both the

hazardous waste and P1MW rules are intended to apply.

This latter provision has raised the question of whether

rules that govern a waste as P1MW and rules that govern the same

waste under another categorization (e.g., hazardous waste) could

be incompatible. (Tr2. at 252-268.) The Board does not

immediately see that this presents a problem. As the Agency

indicates, a waste that is both P1MW and a hazardous waste may

occur, but is likely to be rare. (Tr2. at 271—276.) Where

overlap does occur, compliance with rules applicable to both P1MW

and hazardous wastes is required.

Packaging (Subpart C)

Subpart C consists of standards and criteria for packaging

that apply to any person who packages P1MW for off—site

transportation. (Section 1421.120.)

L~.3-O2B8

—27—

The standards and criteria, which are found in Section

1421.121, are designed to prevent discharge and protect handlers

from contact with P1MW (Tr2. at 27). They include packaging

requirements for all P1MW, with different standards for sharps

and oversized P1MW. Also included are standards for reusable

containers, standards for the management of the outside of

containers that are contaminated by P1MW, and standards for

residues from the cleaning of P1MW containers or discharges from

packages.

It is broadly believed that packaging is a critical element

in P1MW management, and that Subpart C correctly addresses that

matter. Subpart C is fashioned on the premise that performance

standards, rather than design standards, provide the most

effective method of assuring good P1MW management (Tn. at 100,

137; Exhs. 38—5, 38—13, 38—35, 38—64, 38—65, and 38—66).

Labeling and Marking (Subpart D)

This subpart applies to any person who packages P1MW for

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

The specific standards for labeling and marking are found in

Section 1421.131. Among these are requirements for marking the

exterior of the outer package by the generator and

transporter(s), and different standards for marking sharps

containers and oversized P1MW.

Transportation (Subpart E)

This subpart applies to transporters required to have a P1MW

hauling permit. It contains requirements regarding the

conditions under which P1MW can be transported, including the

condition of the vehicle, the management of the packages, the

information that must be displayed on the vehicle, the emergency

response plan that is required to be kept, and a 10 calendar—day

limitation for the transportation of P1MW.

Dedicated vehicles. At hearing the issue was raised as to

whether it was necessary to require “dedicated vehicles” for P1MW

transportation39. (Tr2. 776-814; Exh. 54.) In particular, it

was asked whether “long—haul” vehicles (i.e., those vehicles that

engage in interstate transport) should be allowed to backhaul

“hardgoods” (paint, water seal stains, plastic, etc.) after the

~ Subsection (i) reads: “Vehicles transporting P1MW cannot

be used for the hauling of non—waste materials, with the

exception of equipment and supplies intended for the use of waste

management, new P1MW containers or P1MW containers that have been

cleaned and disinfected in accordance with 35 Ill. Adm. Code

1420.107 of this Subtitle”.

U I ~3-0289

—28—

vehicle has been decontaminated in accordance with the procedures

given in Section 1420.107. (Tr2. at 796, 805.)

At first notice the Board proposed to follow the

recommendation of the Study Group and the Agency by requiring

“dedicated vehicles”. At second notice the Board again addressed

the issue, and observed that post—first notice public comments

uniformly contended that no exceptions to the prohibition against

hauling non—PIMW loads should be allowed beyond those already

specified within 1421.141(i). (See second notice opinion at p.

14.)

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 Agency40. This notwithstanding, the Board at

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

within the instant regulations, some additional presentation of

the use of manifests is needed. (First notice opinion at p. 32.)

None of the post—first notice public comments rose to this issue,

and accordingly no further consideration of manifests within the

bounds of today’s rules has been entertained by the Board.

PART-BY-PART ANALYSIS 

Part 1422

Part 1422 is addressed to the mandate of Section 56.2(a) of

the Act regarding the prescription of “design and operating

standards and criteria for all potentially infectious waste

treatment, storage, and transfer facilities”. Like Part 1421,

Part 1422 is a new part.

Effective Date (Section 1422.101)

This section specifies that• the date for compliance with

Part 1422 is the effective date of the part. That is, compliance

is required immediately upon the regulation becoming effective41.

~° See, for example, the Act at Sections 56. 1(d) (2), 56.1(h),

and 56.4.

41 This provision notwithstanding, it should be noted that in

certain circumstances the requirements for an existing unit are

different than those for a unit that begins operation after the

effective date. An example is the Initial Efficacy Test

requirement for an autoclave, incinerator, or ethylene oxide unit

at Section 1422.123(c).

—29—

Permit Applications (Sections 1422.105 throu~h1422.107)

At first notice the Board raised an issue concerning the

need for greater 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 submitted

recommended provisions addressing application requirements. (PC

#39 at 5—12.)

The Board accordingly at second notice added three new

sections, Sections 1422.105, 1422.106, and 1422.107, that track

the Agency’s recommendation. The first section deals with

content of the application, the second with application

certifications, and the third with application filing

requirements. In each case, the provisions closely track similar

permit application provisions found in the Board’s landfill

regulations at 35 Ill. Adm. Code 812.

The addition of Sections 1422.105 through 1422.107 also

required collateral amendments at Section 1420.105(a) and (d).

Storage/Transfer Operations (Subpart B)

Subpart B consists of two sections that apply to the owner

or operator of any P1MW storage operation42. The subpart is

adopted today without substantive modification from the Agency

Proposal.

Design and operating requirements, which occur at Section

1422.111, constitute the principal standards and criteria of the

subpart. Standards and criteria applicable to any person who

stores P1MW prior to treatment or disposal on—site or transport

off—site are contained in subsection (a); these apply whether or

not a permit is required for the storage operation. Many of

these standards are repeated from Section 56.1(e) of the Act,

including requirements for maintaining the integrity of the

packages, limiting access to the storage operation, maintaining

the P1MW in a nonputrescent state, and protecting the P1MW from

animals and vectors. Other requirements in this subsection

include the management of reusable P1MW containers and residues,

retention of manifest copies, and closure of the storage

operation.

42 For the purpose of 1422.Subpart B a storage operation is

defined at Section 1422.110 to collectively include a “storage

site” or a “transfer station”. The latter two terms are defined

in the Act at Sections 3.47 and 3.83, respectively, and repeated

in the instant regulations in the definitions at Section

1420.102.

01 i~3-U29I

—30—

Subsection 1422.111(b) contains additional standards for

those storage operations that are required to have a permit.

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

(Tr2. at 30.) The standards include more detailed requirements

regarding to operating records, aisle space, the manner of

storage, signs, personnel training, contingency plan, storage

time limitations, and notification of closure. As the Agency

notes:

These requirements are necessary to meet the intent of

the Act to reduce the potential environmental and

public health risks associated with P1MW, since the

permitted storage operation is not normally the

generator of the waste. The owner or operator of the

storage operation does not possess the same knowledge

of the waste as the generator and does not maintain the

same control over what is placed in the packages as the

original generator. In addition, safeguards are

necessary because P1MW is stored for varying lengths of

time and under varying conditions. (Tr2. at 165-75.)

Treatment (Subpart C)

This subpart applies to all facilities that treat P1MW to

eliminate its infectious potential.

P1MW may not be disposed of in Illinois unless it has been

treated in accordance with the standards of this subpart; the

standards apply whether the treatment occurred at a facility

located in Illinois or elsewhere (Section 1422.120).

At Section 1422.121 it is required that there be

certification of the treatment:

No person shall cause or allow the disposal of any P1MW

where the infectious potential has been eliminated by

treatment unless the treatment facility certifies to

the transporter, if other than the generator, and

certifies to the landfill operator or receiving

facility operator that the P1MW has been treated in

accordance with this Part, and, if applicable, with all

terms and conditions specified in its operating permit.

Data to verify the efficacy of the treatment unit shall

be made available to the receiving facility. No person

shall falsely certify that P1MW has been treated in

accordance with this Part.

Design and operating requirements for P1MW treatment

facilities occur in Section 1422.122. Subsections (a) and (b)

apply to all treatment facilities, including those that do not

require a permit. Requirements include proper management of

residues, filing of an annual report, and the cleaning and

Oit~3-i292

—31—

disinfection of the facility upon closure. Mechanical treatment

of P1MW is allowed only if it is an integral step in the

treatment process; this is to minimize the dispersion of airborne

particles (Tr2. at 33).

The (a) (1) portion of Section 1422.122 has undergone

particular evolution during the course of this proceeding.

1422.122(a) (1) is intended to provide an operational definition

of the statutory term “eliminates the infectious potential of the

waste”, which is critical to the whole concept of treatment of

P1MW. Initially in the Agency proposal and in the first notice

proposal the definition was attempted by directing the interested

person to Sections 1422.124 and 1422.125. By the time of second

notice, however, it was apparent that this device did not provide

very much useful instruction and moreover was a source of

confusion to at least some of the affected persons (see PC #35,

#36, and Second Notice Opinion at p. 17). Accordingly, at second

notice and at the recommendation of the National Solid Waste

Management Association (PC #36 at 3), the Board modified the

language in a manner that it thought to be consistent with the

whole of Part 1422.

The Agency later objected to the amendment of its favored

language and sought to have JCAR reinstate that language (see

discussion above). Reinstatement was not acceptable either to

other participants or the Board.

Today’s final subsection (a) (1) language is language adopted

by the Board on June 3, 1993 in its resolution responding to the

JCAR objection (see discussion above). The language continues to

provide an “upfront” operational definition of “eliminates the

infectious potential”, in addition to providing direction to the

testing procedures of Sections 1422.124 and 1422.125.

Subsection (c) of Section 1422.122 contains additional

requirements that apply to those treatment facilities for which a

permit is required. These include personnel training, a written

contingency plan, and a written operating record to be kept at

the facility.

Section 1422.123 contains standards for treatment units.

The emphasis is on performance standards rather than on

authorization of particular techniques or technologies. Most

fundamentally, the treatment unit must be designed and operated

to eliminate the infectious potential of P1MW (subsection

(a)(1)). It must also be operated in modes determined by

manufacturer’s specifications and under the same conditions that

are used in the efficacy demonstrations (subsections (a) (2) to

(a)(5)). The same level of treatment is required whether Agency

permits are required or not.

t•~t ~

1

~ — u

—32—

Subsection (b) of 1422.123 allows treatment units to be used

by treatment facilities not required to have permits if the unit

meets certain requirements of the subsection or if the Board has

granted an adjusted standard.

A principle underlying the Section 1422.123(b) provisions

has been to allow for easy consideration of new technologies that

do not fit the definition of chemical, thermal, or irradiation

treatment. To achieve this end, participants and the Board have

addressed these provisions in some detail, with resolution not

achieved until second notice (see second notice opinion at pages

18—21)

The Initial Efficacy Test requirements are set out in

Section 1422.124, with supporting materials present in Section

1422.Appendix A. The Initial Efficacy Test is a one-time

demonstration made for each model of a particular treatment unit

that demonstrates that the unit will achieve a 6-log reduction of

all vegetative microorganisms. (Tr2. at 34.) If the Initial

Efficacy Test is undertaken by the unit’s manufacturer or some

person other than the treatment facility, the treatment facility

is responsible for obtaining and making available for inspection

at any time documentation of the test.

Section 1422.125, supported by Section l422.Appendix B, sets

out the requirements of the Periodic Verification Tests. These

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

to ensure that treatment efficacy continues.

Section 1422.126 sets out those conditions, in addition to

elimination of infectious potential, that are necessary.before a

sharp may be landfilled.

Section 1422.127 also allows the Agency to issue an

experimental treatment permit for a period of up to two years,

renewable once. Experimental permits are for processes or

techniques that do not otherwise satisfy the standards of Subpart

C. Residues from a treatment unit with an experimental permit

may or may not be considered P1MW, depending on the experimental

permit conditions.

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

‘11~

~

—33—

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 dentists43, and 3,906

funeral directors. (Report to the Governor, Exh. 5 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:

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.

***

~ Robert A. Rechner, Illinois Dental Association, estimates

that 7,000 dentists practice in Illinois. (Exh. 41).

L~.3-0295

—34—

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 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, NSWMA 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

(a.):

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

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.

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

I, •:~ 

—35—

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 today’s regulations 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 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 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.

I 4

~:)

* u

—36—

ORDER

The Clerk of the Board is directed to submit the text of the

following regulations to the Secretary of State for final notice

pursuant to Section 6 of the Administrative Procedure Act.

TITLE 35: ENVIRONMENTAL PROTECTION

SUBTITLE M: BIOLOGICAL MATERIALS

CHAPTER I: POLLUTION CONTROL BOARD

SUBCHAPTER b: POTENTIALLY INFECTIOUS MEDICAL WASTES

PART 1420

GENERAL PROVISIONS

Section

1420.101 Scope and Applicability

1420. 102 Definitions

1420.103 Incorporations by Reference

1420.104 Prohibitions

1420.105 Permit and Manifest Requirements and Exceptions

1420.106 Penalty Factor

1420.107 Cleaning and Disinfection

1420.120 Severability

AUTHORITY: Implementing and authorized by Section~56.2-fe)- and

~ of the Environmental Protection Act (Ill. Rev. Stat. 19&9~9~,

ch. 111 1/2, par~.1056.2(c), 

addcd by P.A. 87-752 cffcotivc

January 1, 1992. as amended by P.A. 87—1097. effective January 1,

1993, and 1027) 1415 ILCS 5/56.2 and 271.

SOURCE: Adopted in R91-19, at 16 Ill. Reg. 2594, effective

February 3, 1992; amended in R91-20, at 

_____

Ill. Reg.

effective ______________________

NOTE: Capitalization denotes statutory language.

1420.101 Scope and Applicability

a3-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.

z)

~nii~Lz1rt QCt3 

iortn 

act iflJ~iOflQ ~   ~

thio Cubti~’~cxcc’-4- 

-~r

-‘-coifically providcd

othcrwicic.

ropcal pro-exiBting rulca for handling modioalwaGtea

by January 1, 1992. Section 56.2(c) requires the Board

to adopt by January 1, 1992 a li3t of Claoa 4 otiologic

(1 1

I

•~-I

~ —

U~~J

r~2 Q~

—37—

agonto, which lendo operative mean

waste,” ao that term is used in the statutory

definition of potentially infectious medical wacte at

Section 3.81. Section 56.2(a) and (a) require the

Board to adopt standards for the tranoportation,

packaging, segregation, labelling, and marking of

potentially infectious medical waste by January 1,

1993. Section 56.2(f) authori~eoadditional rules to

promote the purposes of Title XV of the Environmental

Protection Act (Ill. Rev. Stat. 1989 oh. 111~,par.

1001 et sag., as amended by P.A. 87-752, affective

January 1, 1992).

(Source: Amended at 17 Ill. Reg. 

__________________,

effective

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. 1989~j~,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 offootive January 1, 1992) 415

ILCS 5/1 et sep.1.

“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:

U I

L~3-O299

—38—

Alastrim, Smallpox, Monkey pox, and Whitepox (when

used for transmission or animal inoculation

experiments) 

j..

Hemorrhagic fever agents (including Crimean

hemorrhagic fever (Congo), Junin, and Machupo

viruses, and other~not yet defined)~

Herpesvirus simiae (Monkey B virus)~

Lassa virusl

Marburg virusj

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

3.81~4(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

seauestering agent.

“Detergent—sanitizer cleaner” means an a~entthat 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

r~i

‘

—39—

does not include the normal loading and unloading of

P1MW from a vehicle.

“Enclosed compartment” means a compartment that

provides protection from the elements. prevents

sDillage and Prevents containers from falling of f the

vehicle. The enclosed compartment cannot be used to

meet the packaging reguirements of 35 Ill. Mm. Code

1421.Subpart C.

“Equivalent ba 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 3.8~4(a)(6) of the Act)

“Indicator microorganisms” means those microorganisms

listed in 35 Ill. Adm. Code 1422.A~pendixA. Table B.

as classified bY ATCC.

“International biohazard symbol” means the symbol that

is shown in 35 Ill. Adm. Code 1421.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 aamma

(cobalt 60) and electron beam.

‘~XSOLATION WASTE”

MEANS DICCABDED WASTE MATERIALS

CONTAMINATED WITH BLOOD, EXCRETIONS, EXUDATEC,

AND

SECRETIONS FROM HUMANS THAT

ARE

ICOLATED TO PROTECT

OTHERS FROM HICHLY

COMMUNICABLE 

DICEASEC. 

(Ceotion

3.81(a) (6) of the Act)

“Log” means logarithm to the base ten (10).

“Loa 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

Larae to be placed into a thirty-three (33) gallon baa

or container.

“Package” means a receptacle that contains P1MW.

“PFU” means ~laaue forming unit.

01 ~43O3OI

—40—

“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)

“POTENTIALLY INFECTIOUS MEDICAL WASTE” or

“P1MW” 

MEANS

THE FOLLOWING TYPES OF WASTE GENERATED IN CONNECTION

WITH THE DIAGNOSIS, TREATMENT (I

•,

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:

Ar4irv~L WA~im;

CULTURES AND 

CTOCKC;

HUMAN ~vuu Ariu ~uuu PRODUCTC;

HUMAN 

PATHOLOCICAL WASTES;

i~uLariu1~1

~IACTE~*

ArlIJ

UHUCED SHARPS.

USED CHARrC;

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

GUM). BODY FLUIDS THAT ARE 

REMOVED DURING SURGERY.

AUTOPSY. OR OTHER MEDICAL PROCEDURES; OR SPECIMENS

OF BODY FLUIDS AND THEIR CONTAINERS.

HUMAN BLOOD AND BLOOD PRODUCTS. THIS WASTE SHALL

INCLUDE DISCARDED HUMAN BLOOD, BLOOD COMPONENTS

(e.g.

SERUM AND PLASMA)

•

OR SATURATED MATERIAL

CONTAINING FREE FLOWING BLOOD OR BLOOD COMPONENTS.

0 IL~-O3O2

—41—

USED SHARPS. THIS WASTE 

SHALL INCLUDE

BUT

NOT BE

LIMITED TO DISCARDED SHARPS USED IN

ANIMAL OR

HUMAN PATIENT CARE. MEDICAL RESEARCH, OR CLINICAL

OR PHARMACEUTICAL LABORATORIES; HYPODERMIC,

INTRAVENOUS. OR OTHER MEDICAL NEEDLES; HYPODERMIC

OR INTRAVENOUS SYRINGES; PASTEUR PIPETTES; SCALPEL

BLADES; OR BLOOD VIALS.

THIS WASTE SHALL ALSO

INCLUDE BUT NOT BE LIMITED TO OTHER TYPES OF

BROKEN OR UNBROKEN GLASS (INCLUDING SLIDES

AND

COVER SLIPS) IN CONTACT WITH INFECTIOUS AGENTS.

ANIMAL 

WASTE. ANIMAL WASTE MEANS DISCARDED

MATERIALS, INCLUDING CARCASSES, BODY PARTS. BODY

FLUIDS. BLOOD. OR BEDDING ORIGINATING FROM ANIMALS

INOCULATED DURING RESEARCH

•

PRODUCTION OF

BIOLOGICALS. OR PHARMACEUTICAL TESTING WITH AGENTS

INFECTIOUS TO HUMANS.

ISOLATION WASTE.

THIS WASTE SHALL INCLUDE

DISCARDED MATERIALS CONTAMINATED WITH BLOOD,

EXCRETIONS. EXUDATES, AND SECRETIONS FROM HUMANS

THAT ARE ISOLATED TO PROTECT OTHERS FROM HIGHLY

COMMUNICABLE DISEASES. “HIGHLY COMMUNICABLE

DISEASES” MEANS THOSE DISEASES IDENTIFIED BY THE

BOARD IN RULES ADOPTED UNDER SUBSECTION (e) OF

SECTION 56.2 of the ACT. (See Section 1420.102 of

this Part)

UNUSED 

SHARPS. THIS WASTE SHALL INCLUDE

BUT NOT

BE LIMITED TO THE FOLLOWING UNUSED. DISCARDED

SHARPS: HYPODERMIC, 

INTRAVENOUS. OR OTHER

NEEDLES: HYPODERMIC OR INTRAVENOUS SYRINGES: OR

SCALPEL BLADES.

POTENTIALLY INFECTIOUS MEDICAL WASTE DOES NOT

INCLUDE THE FOLLOWINC:

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

fl I h

—

11

‘)

—42—

THE SHARPS ARE RENDERED UNRECOGNIZABLE

BY TREATMENT. (Section 3.8&j of the

Act)

“Putrescence” means the partial decomposition of

organic matter by microorganisms so as to cause

malodors. aases or other offensive conditions, or that

is capable of 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 sea.) 225 ILCS 325/1

et seg.1.

“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 aaent that is

intended for application to 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.

“Sharps” mean unused sharps and used sharps as stated

in the definition of potentially infectious medical

waste in this Section with or without residual fluids.

“Significant mechanical change” means the substitution

or addition of mechanical parts that result in

different operating conditions. A significant

mechanical chanae does not mean the replacement of a

part(s) that meets the same specifications p~ 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 THE ACT OR REGULATIONS THEREUNDER. (Section

3.43 of the Act) For the ~ur~ose of this Subtitle,

each campus of an educational institution is considered

to be

a single site.

q

—

—43—

“STORAGE”

MEANS 

THE CONTAINMENT OF WASTE, EITHER ON A

TEMPORARY 

BASIS OR FOR

A PERIOD OF YEARS. 

SUCH A

MANNER AS NOT TO CONSTITUTE DISPOSAL. (Section 

3.46 of

the Act)

“STORAGE SITE” means A SITE AT WHICH WASTE IS STORED.

“STORAGE SITE” INCLUDES TRANSFER STATIONS. (Section

3.47 of the Act)

“Test microoraanisms” means those microorganisms listed

in_Section 1422.Appendix A, Table A. as classified by

ATCC.

“Thermal treatment” means the treatment of P1MW in a

unit that uses elevated temperatures as the Primary

means to eliminate the infectious potential of the

waste. Examples of thermal treatment are incineration~.

steam sterilization. microwaving. radiowavina. infrared

heating, pyrolysis. plasma systems and baser

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

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 sharp may no lonaer

be used for its intended purpose.

0! L~3-O305

—44—

“Vector” means any living agent. other than human.

capable 

of transmitting, directly or

indirectly, an

infectious disease.

“Vehicbe” means any device used to transport special

waste in bulk or in packages. tanks or other

containers.

(Source:

Amended at 17 Ill. Reg.

)

effective

Section 1420.103

Incorporations by

Reference

The following materials are incorporated by reference. This

Section incorporates no later editions or amendments.

Standard Methods for the Examination of Water and

Wastewater. American Public Health Association et 

p1.

(1015 Fifteenth Street, N.W.. Washinaton, 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 Uødate 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.

(Source: Added at 17 Ill. Reg           

effective

Section 1420.104

Prohibitions

NO PERSON SHALL:

CAUSE OR ALLOW

THE DISPOSAL OF 

ANY P1MW. SHARPS MAY BE

DISPOSED OF IN ANY LANDFILL PERMITTED BY THE AGENCY

UNDER SECTION 21 OF the ACT TO ACCEPT MUNICIPAL WASTE

FOR DISPOSAL. IF BOTH:

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.

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.

gj. BEGINNING JULY 1. 1992,

CAUSE OR ALLOW THE DELIVERY OF

ANY P1MW 

TO A PERSON OR FACILITY FOR STORAGE.

ç~

i

I

;,

~~$\J~J

~

—45—

TREATMENT. OR TRANSFER THAT DOES NOT HAVE A PERMIT

IS SUED

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:

fl-

THE TRANSPORTER HAS A PERMIT ISSUED

BY THE AGENCY

TO

TRANSPORT P1MW.

OR THE TRANSPORTER IS EXEMPT

FROM THE PERMIT REQUIREMENT pursuant to subsection

1420.105(b) of this Part. Permit applications

must be submitted on forms provided by the Agency.

A P1MW MANIFEST IS COMPLETED FOR THE WASTE unless

no manifest is reauired pursuant to subsection

1420.105(e) of this Part.

~j CAUSE OR ALLOW THE ACCEPTANCE OF ANY P1MW FOR 

PURPOSES

OF TRANSPORT, STORAGE. TREATMENT.

OR

TRANSFER

EXCEPT IN

ACCORDANCE WITH Part 1421. Subpart C of this Subtitle

and Part 1422. Subpart B of this Subtitle.

~j BEGINNING JULY 1, 1992. CONDUCT ANY P1MW TRANSPORTATION

OPERATION:

WITHOUT A PERMIT ISSUED BY THE AGENCY TO TRANSPORT

P1MW. unless no permit is reauired pursuant to

subsection 1420.105(b) of this Part.

IN VIOLATION OF ANY CONDITION OF ANY PERMIT ISSUED

BY THE AGENCY UNDER the ACT.

IN VIOLATION OF ANY REGULATION ADOPTED BY THE

BOARD.

4j

IN VIOLATION OF ANY ORDER 

ADOPTED BY THE BOARD

UNDER the ACT.

gj BEGINNING JULY 1. 1992, CONDUCT ANY P1MW TREATMENT.

STORAGE,

OR TRANSFER OPERATION:

~j WITHOUT A PERMIT ISSUED BY THE AGENCY THAT

SPECIFICALLY AUTHORIZES THE TREATMENT, STORAGE. OR

TRANSFER OF P1MW pursuant with Section 39 of the

Act, unless no permit is reauired pursuant to

subsection 1420.105(c) of this Part. Permit

applications must be submitted on forms provided

by the Agency.

21

IN VIOLATION OF ANY CONDITION OF ANY PERMIT ISSUED

BY THE AGENCY UNDER the ACT.

L43-03Q7

—46—

.~J..

IN VIOLATION OF ANY REGULATIONS ADOPTED

BY THE

BOARD.

~j..

IN VIOLATION OF

ANY

ORDER ADOPTED BY THE BOARI)

UNDER the ACT.

TRANSPORT

P1MW 

UNLESS THE TRANSPORTER CARRIES A

COMPLETED

P1MW MANIFEST, 

unless no

manifest is reauired

pursuant to subsection 1420.105(e)

of this Part.

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.

jj.  BEGINNING JANUARY 1, 1994. CONDUCT A P1MW TREATMENT

OPERATION AT AN INCINERATOR IN EXISTENCE ON THE

EFFECTIVE DATE OF THIS TITLE IN VIOLATION OF EMISSION

STANDARDS ESTABLISHED FOR THESE INCINERATORS UNDER

SECTION 129 OF THE CLEAN AIR ACT (42 USC 7429) 

•

AS

AMENDED. (Section 56.1 of the Act)

~çJ Cause or allow the discharge of P1MW from a vehicle.

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 resubtina 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, aarments and other cloth

materials, gauze, glass, pads, plastic, sharps.

shavinas. straw and syringes.

BOARD NOTE: Interested persons should note that

discharges to sewer systems can also be regulated by

units of local government.

(Source: Added at 17 Ill. Reg.          

effective

________________________________________________________________________________________)

1420.105  Permit and Manifest Reauirements and

Exceptions

~j The permit and permit appeal provisions of Sections 39

and 40 of the Act and Board regulations adopted

thereunder aPPly to this Subtitle.

UI i~3-O308

—47—

~  A person who conducts a P1MW transportation operation

is required to obtain a P1MW 

hauling permit from the

Aaency. except:

~

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

~  ThE U.S. POSTAL SERVICE. (Section 56.1(f) of the

Act)

~  A person who conducts a P1MW treatment, storaae, or

transfer operation is reauired to obtain a permit from

the Agency, except:

il 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 P1MW GENERATED BY ITS OWN ACTIVITIES OR BY

MEMBERS OF ITS MEDICAL STAFF. (Section 56.1(a) of

the Act) If the transportation of P1MW is

interrupted so as not to constitute storage, no

permit is required under Section 56.1(a) of the

Act. For example. transportation of P1MW

interrupted by vehicle repairs or inclement

weather does not constitute storaae.

~  A person applying for a permit for a P1MW treatment.

storage. or transfer operation shall file an

application with the Agency in accordance with the

requirements and procedures of 35 Ill Adm. Code

1422.105 through 1422.107.

~j Any Person who transports P1MW is required to carry a

completed P1MW manifest excePt for the transportation

of:

fl  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

01 L3-03O9

—48—

~j. P1MW BY THE U.S. POSTAL SERVICE. (Section 56.1(h)

of the Act)

(Source: Added at 17 Ill. Reg.           

effective

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)

(Source: Added at 17 Ill. Reg.          

effective

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 dearees

Centigrade (180 degrees Fahrenheit) for a

minimum of fifteen (15) seconds

~  Rinsing with. or immersion in, a chemical

disinfectant registered by the United States

Environmental Protection AgencY. as

identified on its label and used in

accordance with the manufacturer’s

instructions

~j Rinsing with, or immersion in. a hy~ochborite

solution at a concentration of 50 ppm. For

example. 1/8 cup of common household bleach

(5.25 sodium hvpochlorite) per aablon of ta~

water (31 milliliters bleach to 3.78 liters

of water); or

tfl4JUi

‘~

—49—

P1 Other 

disinfection

processes as approved by

the Agency in writing as an eauivalent

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.

(Source: Added at 17 Ill. Reg.           

effective

Section 1420.120 Severability

If anY Section. subsection. sentence or clause of this Subtitle

adludaed unconstitutional, invalid or otherwise not effective

for anY reason, such adludication does not affect the validity of

this Subtitle as a whole or of any Section. subsection, sentence

or clause thereof not adiudged unconstitutional, invalid or

otherwise not effective for any reason.

(Source: Added at 17 Ill. Req. 

_____

effective

0ii;3~O3JI

—50—

TITLE 35:

ENVIRONMENTAL PROTECTION

SUBTITLE M:

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

ILLUSTRATION A   

International Biohazard Symbol

AUTHORITY: Implementing and authorized by Sections 56.2 and 27

of the Environmental Protection Act (Ill. Rev. Stat. 1991, ch.

111 1/2, pars. 1056.2 and 1027) 415 ILCS 5/56.2 and 27.

SOURCE: Adopted in R91-20, at 

_____

Ill. Reg. 

_______,

effective

NOTE: Capitalization denotes statutory language.

SUBPART A: GENERAL PROVISIONS

Section 1421.101 Compliance Dates

0k3-0312

—51—

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:

RIGID;

2)  LEAK-RESISTANT;

3)  IMPERVIOUS TO MOISTURE;

L~~3-O313

—52—

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 unless treated and rendered unrecognizable

pursuant to 35 Ill. Adm. Code 1422.126, 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 combination

of containers must meet applicable requirements of

subsections (a) or (.b) of this Section.

e)  Once a reusable container has been cleaned and

disinfected in accordance with 35 Ill. Adm. Code

1420.107 of this Subtitle, it can be used for only

waste. If a reusable container is not or cannot be

cleaned and disinfected in accordance with Section

1420.107 of this Subtitle, it must be regulated as P1MW

pursuant to this Subtitle.

f)  Residues from cleaning a P1MW container, or discharges

from P1MW packages, are regulated under this Subtitle,

except when discharged directly into a sanitary or

combined sewer in accordance with 35 Ill. Adm. Code:

Subtitle C.

BOARD NOTE: Interested persons 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

G1~3-031E~

—53—

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 bettering that is readable at a

minimum distance of five (5) feet:

i)  The International Biohazard Symbol as

shown in 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) (1) of this Section.

—54—

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

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 Symbob as shown in 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,

C)  The transporter’s address,

tii4u u~J

—55—

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.

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.

e)  During transport, a P1MW package must not be compacted

or subjected to stress that compromises the integrity

of the container.

L~.3-Q3

—56—

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.

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

PRESCRIBED

AND

PROVIDED BY THE AGENCY.

(Section 56.3

of the Act)

01143-0318

—57—

Section 1421.IllustratiOfl

01 t~i.3-0319

—58—

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

1422.105

1422.106

1422.107

Section

1422.110

1422.111

Section

1422. 120

1422. 121

1422. 122

1422.123

1422.124

1422.125

1422.126

1422.127

Section

1422 .APPENDIX

TABLE A

TABLE B

TABLE C

1422 .APPENDIX

Compliance Date

P1MW Permit Application Contents

P1MW Permit Application Certifications

P1MW Permit Application Filing Requirements

SUBPART B:

STORAGE OR TRANSFER OPERATIONS

Scope and Applicability

Design and Operating Standards and

Criteria

SUBPART C:

TREATMENT FACILITIES

Scope and Applicability

Treatment Facility Certification

Design and Operating Standards

Treatment Units

Initial Efficacy Test

Periodic Verification Test(s)

Sharps

Experimental Permits

A Initial Efficacy Test Procedures

Test Microorganisms

Indicator Microorganisms

Challenge Loads

B Correlating Periodic Verification Test

Procedures

AUTHORITY:

Implementing and authorized

by Sections 56.2 and 27

of the Environmental Protection Act (Ill. Rev. Stat. 1991, ch.

111 1/2, pars. 1056.2 and 1027) 415 ILCS 5/56.2 and 27.

SOURCE: Adopted in R91-20, at   

Ill. Reg.

_______,

effective

NOTE: Capitalization denotes statutory language.

b,3-0320

—59—

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;

01 ~~3-.Q32I

—60—

The operations for initial

facility

startup, daily

startup and scheduled and unscheduled shutdowns;

The days and hours of operation;

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

—61—

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

p~It

ç’~F)1)t)

I 4

~‘

—62—

approval issued by that unit of local government. If

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 filed with the Agency

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 of filing 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.

LIMIT ACCESS TO ON-SITE STORAGE AREAS TO

AUTHORIZED EMPLOYEES.

STORE THE

P1MW IN A MANNER 

THAT AFFORDS PROTECTION

FROM

ANIMALS 

AND DOES NOT PROVIDE

A BREEDING PLACE

OR FOOD SOURCE FOR vectors. (Section

56.1(e) (2) (D) (i)—(v) of the Act)

i

—63—

6)  P1MW packages must not be compacted or subjected

to stress that compromises the integrity of the

container.

7)  Multiple generators in the same building may store

their P1MW packages in a common storage area.

8)  Reusable P1MW containers or facility equipment

(e.g., carts, squeegees or shovels) which are

visually contaminated with P114W 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 for

inspection and photocopying by the Agency. The

retention period for P1MW manifests is extended

automatically during the course of any unresolved

enforcement action regarding the storage operation

or as requested in writing by the Agency.

11) Upon closure of a storage operation, the owner or

operator shall clean the area, equipment and

structures in accordance with 35 Ill. Adm. Code

1420.107 of this Subtitle.

b)  In addition to the requirements listed in subsection

(a) of this Section, storage operations required to

have a permit pursuant to 35 Ill. Adin. 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.

01 L~.3-0325

—64—

Stat. 1991, ch. 147, pars. 101 et seq.)

225 ILCS

470.

2)  P1MW packages must be stored in designated areas

so as not to contaminate other waste or materials.

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.

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:

When loading or unloading a vehicle; or

When a fully—loaded vehicle is on a site.

Either exemption, or both exemptions, must not

exceed five (5) calendar days.

Material handling equipment must be designed so as

to maintain the integrity

of the package.

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.

Adni. 

Code 1421.Illustration

A and

the word “biohazard”.

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.

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

‘~

r”~’~

Ut ~

—65—

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

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:

Quantities and disposition of

P1MW stored 

transferred;

B) Date and time

the P1MW arrived at the

permitted storage operation

site;

C) Date and

time the P1MW left the storage

operation;

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

01 I~3-0327

—66—

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

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. Within

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

U~4JUJ

—67—

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

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. A treatment process eliminates the

infectious potential of P1MW if the owner or

operator of a treatment unit demonstrates

that an Initial Efficacy Test and Periodic

Verification Test have been completed

suc-

cessfully.

A)  Successful completion of an Initial Efficacy

Test must be demonstrated by a 6-log kill of

test

microorganisms. For a thermal unit that

maintains the

integrity of the container, a

6—log kill of indicator microorganism spores

may be used as an alternative test. These

demonstrations must be conducted in

accordance with Section 1422.124.

B)  Successful completion of a Periodic

Verification Test must be demonstrated, in

accordance with Section 1422.125, by:

i)  a 6-log kill of test microorganisms or

indicator microorganism spores as

provided in subsection (a) (1) (A) above;

or

ii)

a minimum 3-log kill of indicator

microorganism spores that has been

correlated with a 6-log kill of test

microorganisms; or

iii) an alternate method submitted to and

approved in writing by the Agency.

2)  PREVENTS THE COMPACTION AND RUPTURE OF CONTAINERS

DURING HANDLING OPERATIONS, except when compaction

—68—

or rupture is an integral part of the treatment

process and the treatment process is conducted

without discharge of P1MW

to the environment;

DISPOSES OF TREATMENT RESIDUALS

IN ACCORDANCE WITH

THIS ACT AND REGULATIONS ADOPTED THEREUNDER;

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;

Identifies the person(s)

who shall evaluate

any discrepancies

or problems;

Identifies the person(s) who

shall propose

actions to correct any problems identified;

and

I)  Identifies the person(s) who shall assess

actions taken and document improvement;

PROVIDES FOR PERIODIC TESTING USING BIOLOGICAL

TESTING, WHERE APPROPRIATE, THAT DEMONSTRATE

PROPER TREATMENT OF THE WASTE;

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:

Oti~3-033O

—69—

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. Adin. 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. Adm.

Code

1420.105 of this Subtitle must be retained by

and kept at the

treatment facility for three (3)

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. Adni. 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 

POUNDS PER MONTH OF POTENTIALLY INFECTIOUS MEDICAL

WASTE 

SHALL

FILE A REPORT WITH THE AGENCY

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. Adin. Code 1420.105 of this Subtitle shall

also comply with the following requirements that the

Agency shall review during the permitting process:

01 ~3-0331

—70—

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.

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. Adin. Code

l421.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

qualified to act as emergency coordinator,

procedures for cleanup, protection of personnel,

disposal of spill residue and 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;

01 li,3-0332

—71—

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

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

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.

(‘~ñ

U14~U~)

—72—

Section 1422.123

Treatment Units

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

a treatment facility not required to have a permit

pursuant to 35 Ill. Adin. Code 1420.105 of this

Subtitle, if the requirements of subsection (b) (1) or

(2) below are met.

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 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

0

3- 0 33 

—73—

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 Iii. 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

P114W

treatment units or pilot

projects.

e) The treated

P1MW is managed in accordance with this

Subtitle and 35 Ill. 

Adin. Code: Subtitle G.

Section 1422.124

Initial Efficacy Test

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.

—74—

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

indicator ‘microorganism spores after treatment

must be greater than or equal to six (6).

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

—75—

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 sharps container

that 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 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.

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

01

~3-0337

—76—

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 name(s), date, 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.

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

01 ~~3-0338

—77—

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 

visually inspecting the ash from

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:

L~3-lj339

—78—

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;

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 microorganism spores must be placed in a

representative

load in accordance with Section

1422.124(e) (1) of this Part;

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;

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.

Athu. 

Code 1420.103.; and

The Periodic Verification

Test and the Initial

Efficacy Test may be run concurrently to verify

the correlation.

If a load of

P1MW 

fails a Periodic Verification

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

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

—79—

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.

Periodic Verification Test(s) must be conducted

monthly, or more frequently if required by the permit

or recommended by the manufacturer.

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:

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,

with description of data handling, and a

presentation and interpretation

of final test

results;

A detailed description of the operating parameters

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

chemical concentrations,

irradiation dose and feed

rates);

01~3-O3L~I

—80—

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;

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;

The name(s), date, signature(s)

and title(s)

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:

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);

3)  Test protocols;

4)  Evaluation of test results; and

The name(s), dates, signature(s)

and title(s)

person(s) conducting the Periodic Verification

Test(s).

01

~~3-Q3~~2

—81-

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

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;

and

3)  Accompanied by a P174W 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

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.

Original experimental permits and renewals granted to

any one person cannot exceed a total of four (4) years.

0

~.3-Q3L~.3

—82—

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

applicable manufacturer’s recommendations, and Standard

Methods for the Examination of Water and Wastewater,

incorporated by reference at 35 Ill. Adm. Code

1420.103.

01 ~3-O3~L~

—83—

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

must be increased and steps (a) through (f) in Phase 1

must be repeated until Log N1A is ? 6. N0A is the

inoculum size for challenge load Type A in Phase 2

below.

01

~3-U3L~.5

—84—

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 (NoA) 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=LogNoA-SA-L0gN2A?

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 (CFU/gram 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).

This Option 2 is for a treatment unit that maintains the

integrity of the container of test microorganisms (e.g.,

autoclaves).

01

i~j-uj4

—85—

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.

b)  The container of indicator microorganisms must be

placed within a Type A challenge load as identified in

Table C of this Appendix.

01 L~3-03L~.7

—86—

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 inoculuin.

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)

Trichophyton mentagrophytes

(ATCC 9533)

5.  MS—2 Bacteriophage (ATCC 15597—Bi)

6.  Mycobacterium smegmatis (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 pumulus (ATCC 27142)

Section 1422.APPENDIX A: Initial Efficacy Test Procedures

Table C: Challenge Loads

U! 4U’L~)4

—87—

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)

—

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.

H

I

4’)

“~

U.J

—88—

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 14. Gunn, Clerk of the Illinois Pollution

Control Board, hereby ce tify that the ove pinion and order

was adopted on the 

day of ___________________________

1993, by a vote of  7—~O 

~‘

Dorothy N. G)ztj~t, Clerk’

Illinois Po1~XitionControl Board

01 L~.3-Q350