ILLINOIS POLLUTION CONTROL BOARD

January 23,

1992

IN THE

MATTER

OF:

)

R91—19

POTENTIALLY INFECTIOUS NEDICAL

)

(Identical in Substance Rules)

WASTES:

ETIOLOGIC AGENTS

)

ADOPTED RULE.

FINAL ORDER.

OPINION AND

ORDER OF THE

BOARD

(by R.C. Flemal):

The Board reserved this docket on August

9,

1991 and issued

an Order on August 26,

1991 stating that we had opened this

docket for the purposes of a new legislative mandate contained in

H.B.

2491,

then awaiting the Governor’s signature.

The Governor

signed H.B.

2491

(now designated P.A.

87—752)

on September 26,

1991.

It became effective January

1, 199~.

Public Act 87—752 imposes four mandates on the Board,

each

of which includes a deadline for Board action:

1.

The repeal of existing Board regulations relating to

medical wastes

(new Section 56.2(d), due by January

1,

1992, the subject of docket R91—18);

2.

The adoption of rules identical in substance to the

etiologic agents

in Class

4 in.a 1974 federal Centers

for Disease Control, Office of Biosafety listing:

Classification of Etiologic Agents on the Basis of

Hazard (new Section 56.2(e), due January

1,

1992,

the

subject of this docket);

3.

The adoption of rules setting forth the standards for

facilities treating,

storing, and transferring poten-

tially infectious medical wastes

(new Section 56.2(a),

due January

1,

1993, the subject of docket R9l-20); and

4.

The adoption of rules setting forth standards

for

transportation, packaging,

segregation,

labelling,

and

marking of potentially infectious medical wastes (new

Section 56.2(c), due January

1,

1993, the subject of

docket R91-21).

The Board proposed rules for public comment in furtherance

of a portion of that mandate by its Opinion and Order of November

7,

1991.

A Notice of Proposed Rules appeared in the Illinois

Register on December 2,

1991, at 15 Ill. Reg.

17016.

The Board

today adopts those rules pursuant to that mandate.

PUBLIC COMMENTS

As of this date, the Board has received two public comments

in this matter.

The Board received PC #1 on September 18,

1991

129—49 1

---

2

from Van Allen Anderson, Ph.D., of the University of Illinois at

Urbana-Champaign, Division -of Environmental Health and Safety.

Further,

Dr. Anderson and others made pertinent comments regard-

ing this proceeding during the course of the September 18,

1991

public hearing in coinpanion-dockets, R91-20 and R91-21.

The

appropriate segment of the following discussion considers the

comments of Dr. Anderson and those made at the public hearing.

All references to the hearing transcript

(“Tr.

at

--“)

inquiry hearing held September 18,

Potentially Infectious Medical Waste:

Transfer Pacilities and R91-21:

Potentially Infectious Medical

Waste:

Treatment, Packaging, and Labeling.

Many portions of

that hearing testimony directly relate to the subject of this

docket.

The Board received PC #2 on December 9,

1991 from the

Administrative Code Division of the Office of the Secretary of

State.

This comment suggests a small number of Code format

correction.

These are mentioned in the end of the follc~wing

discussion.

DISCUSSION

The action taken today in this docket adopts a listing of

Class

4 Agents based on the U.S. Department of Health and Human

Services, Centers for Disease Control, Office o~Biosafety

publication entitled “Classification of Etiologic Agents on the

Basis

of Hazard,”

(4th edition, July 1974).

This action is

pursuant to new Section 56.2(e)

of the Environmental Protection

Act

(to be codified as Ill.

Rev. Stat.

1989 ch.

111½, par.

1056.2(e), effective January

1,

1992).

P.A. 87-752

(H.B.

2491), particularly new Section 56.1

(of

new Title XV:

Potentially Infectious Medical Waste),

includes

various prohibitions against the improper disposal, delivery,

transport,

storage,

treatment, transfer, and packaging of poten-

tially infectious medical wastes

(PIMWs).

This Section and

Sections 56.3 and 56.4 also include permitting, manifesting, and

reporting requirements for various activities related to PIMWs.

Section 56.2(e) mandates that the Board adopt a listing of

Class

4 etiologic agents by identical—in—substance procedures:

No later than January

1,

1992, the Board shall adopt

rules that are identical in substance to the list of

etiologic agents identified as Class

4 agents as set

forth in “Classification of Etiological Agents on the

Basis of Hazard,

1974”, published by Centers for Dis-

ease Control.

If the Centers for Disease Control

amends the listing of etiologic agents identified as

Class

4 agents as set forth in “Classification of

129—492

---

3

Etiological Agents on the Basis of Hazard,

1974”, the

Board shall adopt rules that are identical in substance

to the amended list within 180 days after the Centers

for Disease Control amendment.

The provisions and

requirements of Title VII of this Act shall not apply

to rules adopted under this subsection

(e).

Section

5

of the Illinois Administrative Procedure Act relating

to the procedures for rulemaking shall not apply to

rules adopted under this subsection

(e).

P.A. 87—752,

§ 56.2(e)

(to be codified as Ill. Rev.

Stat. 1989 ch.

111½, par. 1056.2(e)).

The ultimate effect of fulfilling this mandate is to add

definition to one segment of the broader universe of

PIMW5.

Section 3.81(a)

of this legislation (to be codified as Ill. Rev.

Stat.

1989 ch. 111½,

par.

1003.81(a)) defines “potentially infec-

tious medical waste”.

Subsection 3.81(b) (6)

includes “isolation

waste” as part of the definition,

as follows:

Isolation waste.

This waste shall include but not be

limited to discarded waste materials contaminated with

blood, excretions,

exudates, and secretions from humans

that are isolated to protect others from highly com-

municable diseases.

“Highly communicable diseases”

means those diseases identified by the Board in rules

adopted under subsection

(e)

of Section 56.2 of this

Act.

P.A.

87—752,

S

3.81(b) (6)

(to be codified as Ill.

Rev.

Stat.

1989 ch.

111½,

par.

1003.81(b) (6)).

The 1974 document referred to by P.A.

87-752 defines five

classes of etiologic agents:

Class

1:

Pathogenic agents of no or minimal hazard under

ordinary conditions of handling.

Class

1 Agents

include all agents not classified as any of Clas-

ses

2 through 5 Agents.

Class

2:

Pathogenic agents of ordinary potential hazard.

Class

2 Agents include those which may produce

disease from accidental inoculation or injection

or other means of cutaneous penetration but which

are contained by ordinary laboratory techniques.

Class

3:

Pathogenic agents involving special hazard,

or

pathogenic agents derived outside the U.S. which

require a federal permit for importation, unless

the pathogenic agent is specified for higher clas-

sification.

Class

3 Agents include those for

129—493

---

4

which special conditions for their containment are

required.

Class

4:

Pathogenic agents that are extremely hazardous to

laboratory personnel or that may cause serious

epidemic disease.

Class

4 Agents include Class

3

Agents derived from outside the U.S. when they are

employed in entomological experiments or when

other entomological experiments are conducted in

the same laboratory area.

Class

3 Agents include

those that require the mc~ststringent conditions

for their containment.

Class

5:

Pathogenic agents that are excluded from the U.S.

by law or U.S. Department of Agriculture admin-

istrative policy.

“Classification of Etiological Agents on the Basis of

Hazard,” U.S. Department of Health,

Education,

and

Welfare, Centers for Disease Control (4th ed.

1974)

at

3—4.

Aside from the narrative description of what falls within each

class, the 1974 document includes listings of the Class

2,

Class

3, Class

4, and Class

5 agents.

The listings are divided into

separate sublistings of bacterial agents; fungal agents; parasit-

ic agents; and viral, rickettsial,

and chiamydial agents.

The

listing for Class

4 agents includes the following:

Bacterial agents:

no pathogenic agents specifically listed.

Fungal agents:

no pathogenic agents specifically listed.

Parasitic agents:

no pathogenic agents specifically listed.

Viral, Rickettsial, and Chlainydial agents:

Alastrim, Smallpox, Monkey pox, and Whitepox (when

used for transmission or animal inoculation ex-

periments)

Hemorrhagic fever agents (including Criniean~hemor—

rhagic fever

(Congo),

Junin,

and Machupo viruses,

and others not yet defined)

Herpesvirus simiae

(Monkey B virus)

Lassa virus

Marburg virus

129—494

---

5

Tick-borne encephalitis virus complex (including

Russian spring—summer encephalitis, Kyasanur for—

est 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 transmis-

sion or animal inoculation experiments)

“Classification of Etiological Agents on the Basis of

Hazard” at 9.

Thus,

the Class

4 listing of etiologic agents is limited to a

very small number of viral agents.

The intent of the CDC classification is to “define

minimal

safety conditions for their management without restricting or

hampering bona fide microbiological investigations.”

“Classific-

ation of Etiological Agents on the Basis of Hazard” at

1.

The

purpose is to foster safety for work using these agents in the

laboratory setting.

In 1986, the Department of Health and Human Services (succe-

ssor to the Department of Health, Education,

and Welfare), Na-

tional Institutes of Health published “Guidelines for Research

Involving Recombinant DNA Molecules” in the Federal Register.

51

Fed.

Reg.

16958

(May 7,

1986).

This set of guidelines applied to

all institutions engaged in recombinant DNA research that re-

ceived funding from the National Institutes of Health.

It used

the

Class

I

through

Class

5

system

established

by

the

CDC

in

the

1974

document

“Classification

of

Etiological

Agents

on

the

Basis

of

Hazard.”

The

NIH

revised

the

list

for

the

purposes

of

the

Guidelines.

51

Fed.

Reg.

16965

&

16967—68.

Class

4

no

longer

included

Alastrim,

Smallpox,

and

Whitepox.

These

are

all

prohib-

ited

from

study

in

the

United

States

except

at

specified

facili-

ties,

and

a

note

indicated

that

all

activities

relating

to

van-

ola

(smallpox)

and whitepox were restricted to a single facility.

51

Fed.

Reg.

16968

&

note

4;

see

also

Tr.

61-62

(testimony

re

the

deletion

of

agents

prohibited

from

use).

In 1988, the CDC and NIH conjunctively published “Biosafety

in

Microbiological

and

Biomedical

Laboratories,”

u.s.

Department

of Health and Human Services, Public Health Service, Centers for

Disease

control

and

National

Institutes

of

Health,

(HHS)

Publica-

tion No.

(NIH)

88—8395

(2d ed.

1988).

This document “described

combinations

of

standard

and

special

microbiological

practices,

safety

equipment,

and

facilities

that

constitute

biosafety

levels

1—4,

which

were

recommended

for

working

with

a

variety

of

infectious

agents

in

various

laboratory

settings.”

“Biosafety

in

12 9—495

---

6

Biomedical and Microbiological Laboratories” at vii.

“Classific-

ation of Etiological Agents .on the Basis of Hazard” “served as

the basic format” for this 1988 publication, and the 1988 publi-

cation included

a revised version of the 1974 document.

~

at

3.

The classification system under the 1988 biosafety recoimuen-

dation

is more elastic than the 1974 Classification.

Rather than

assign etiologic agents to classes, the 1988 publication assigns

them to biosafety levels

(Biosafety Level

(BL)

1 through BL 4),

which ‘can change for any specific agent, depending on the labora-

tory setting and nature of the experimentation.

For example,

Herpesvirus simiae,

in Class

4 in 1974,

is in BL

3 for materials

known to contain the virus and in BL 4 for the propagation of the

virus or for activities involving infected nonhuman primates.

~

at 74-75.

The pox viruses, other than smallpox; yellow fever

virus;

and one strain of venezuelan equine encephalitis virus,

in

Class

4 in the 1974 Classification, are in BL

2 for immunized

workers.

.~

at 78—79

& 82.

In the 1988 document, BL

4 includes

only Congo-Crimean hemorrhagic fever,

tick-borne encephalitis

complex (Kyasanur Forest disease, Omsk hemorrhagic fever,

and

Russian Spring-Summer encephalitis), Marburg,

Ebola, Junin,

Lassa, and Machupo viruses from the 1974 Class

4 list.

Added to

BL

4 and not appearing in Class

4 of the 1974 Classification are

four tick—borne encephalitis viruses:

Absettarov, Hanzalova,

Hypr,

and Kumlinge.

.~

at 92.

At the public hearing and in PC #1, Dr. Anderson stated that

he does not believe that the Board, should use any document other

than the 1974 “Classification of Etiological Agents on the Basis

of Hazard.”

He states that both the 1986 and 1988 documents are

updates of the 1974 Classification in two different formats.

He

asserts that the 1988 document abandoned a classification of

agents in favor of assigning biosafety levels based on potential

hazard in the laboratory setting.

He urges that the 1974 Clas-

sification or the 1986

(NIH)

Guidelines “more clearly delineate

strict classifications and are more complete in their representa-

tion of agents.”

However, he states that the 1986 document “only

lists selected agents, not all agents currently identified as

requiring biosafety levels 2-4.”

PC #1 at

4.

Dr. Anderson believed that the Board should add as Class

4

to the 1974 Classification,

the newly-listed Absettarov virus,

Hanzalova virus, HYPR virus,

and Kumlinge virus because these

would qualify as Class

4.

PC #1 at 3—4; Tn. at 17—22,

51—56,

58—

62,

79-84

& 88-90.

Larry Von Behren, M.D.,

of the Southern

Illinois University School of Medicine, concurred in Dr. Ander-

son’s observations as to those agents the Board should include.

Tr. 48—49,

56—58,

63—68

& 84—88.

In ‘light of the character of the 1974,

1986, and 1988 publi-

cations; the public comment; and the testimony elicited at-the

129—496

---

7

R91-20/R9l-21 hearing, the Board agrees with Drs. Anderson and

Von Behren and concludes that it must base the list of Class

4

agents on the 1974 document with the addition of the four tick—

borne encephalitis viruses added in 1988.

Many reasons exist for not relying on the 1986 Recombinant

DNA Guidelines and the 1988 Biosafety in Laboratories as updates

of the 1974 CDC Classification.

First, as to the 1986 Recom-

binant DNA Guidelines, the NIH is independent of the CDC, and

Section 56.2(e) specifically refers to updates by the CDC.

This

document is not as complete a listing of Class

4 agents, due to

the omission of the three pox viruses,

for reasons unrelated to

their relative hazard.

Second, as to the 1988 Biosafety in

Laboratories, the classification is largely dependent on factors

immaterial to wastes generated in the clinical setting.

Third,

as to both documents,

neither expressly claims to be an update of

the 1974 classification (although the 1988 document claims to be

an updated system for managing etiologic agents in the labora-

tory).

Finally, the public comment and hearing testimony appears

to disfavor use of the more recent 1986 and 1988 listings.

In addition to the definitions of “class 4 etiologic agent,”

“highly infectious disease,” and”isolation waste,” the Board

will set forth the definition of “potentially infectious medical

waste.”

The language of each definition tracks the statutory

language to the maximum extent possible.

Capitalization of those

passages highlights this fact pursuant to

1 Iii.

Adm. Code

100. 380.

The Administrative Code Division suggests two Code format

corrections to the

text

of the proposed rules.

The Board adopts

the text of the proposed rules with the suggested corrections.

The Board uses the word “Section” in the section headings, and we

change the reference to the Environmental Protection Act to

“ch.

111½.”

ORDER

The Board hereby directs the Clerk of the Board cause a

Notice of Proposed Amendments reflecting these proposed rules be

published in the Illinois Register, and to submit the proposed

incorporations by reference to the Joint Committee on Administra-

tive Rules pursuant to Ill. Rev. Stat.

1989

ch.

127,

par.

1006. 02 (b)

The language of the proposed rules follows:

TITLE 35:

ENVIRONMENTAL

PROTECTION

SUBTITLE

M:

BIOLOGICAL

MATERIALS

CHAPTER

I:

POLLUTION CONTROL BOARD

SUBCHAPTER

b:

POTENTIALLY

INFECTIOUS

MEDICAL

WASTES

129—49 7

---

8

PART 1420

GENERAL PROVISIONS

Section

1420.101

Scope and Applicability

1420. 102

Definitions

AUTHORITY:

Implementing and authorized by Section 56.2(e)

of the

Environmental Protection Act

(Ill. Rev.

Stat.

1989,

ch.

111½,

par. 105&.2(e), as added by P.A.

87—752, effective January

1,

1992).

SOURCE:

Adopted in R91—19, at 16 Ill. Reg.

,

effective

Note:

Capitalization denotes statutory language.

Section 1420.101

Scope and Applicability

a)

This Subtitle applies to all persons who generate,

transport,

treat,

store,

or dispose of potentially

infectious medical waste.

It sets forth standards for

such activities occurring in whole or in part within

the State of Illinois.

b)

This Part sets forth definitions that apply throughou

this Subtitle except as specifically provided other-

wise.

BOARD NOTE:

Section 56.2(d) requires the

Board to repeal pre—existing rules for han-

dling medical wastes by January

1,

1992.

Section 56.2(e) requires the Board to adopt

by January

1,

1992

a. list of Class

4 etiolog-

ic agents, which lends operative meaning to

“isolation waste,” as that term is used in

the statutory definition of potentially in-

fectious medical waste at Section 3.81.

Section 56.2(a) and

(c) require the Board to

adopt standards for the transportation, pack-

aging, segregation,

labelling, and marking of

potentially infectious medical waste by Janu-

ary 1,

1993.

Section 56.2(f) authorizes

additional rules to promote the purposes of

Title XV of the Environmental Protection Act

(Ill. Rev. Stat.

1989 ch. 111½, par. 1001 et

seq., as amended by P.A. 87-752, effective

January

1, 1992).

Section 1420.102

Definitions

129—498

---

9

All definitions set forth in this Section shall have the follow-

ing meanings throughout this Subtitle, unless specifically pro-

vided otherwise:

“Act” means the Environmental Protection Act

(Ill. Rev.

Stat.

1989 ch.

111½, par.

1001 et

seq..,’ as amended by-

P.A. 87-752, effective January 1,

1992).

“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:

Alastnim, Smallpox, Monkey pox, and Whitepox (when

used for transmission or animal inoculation ex-

periments)

Hemorrhagic fever agents

(including Crimean hemor-

rhagic fever

(Congo),

Junin,

and Machupo viruses,

and

others

not

yet

defined)

Herpesvirus

simiae (Monkey B virus)

Lassa

virus

Marburg

virus

Tick-borne

encephalitis

virus complex (including

Absettarov, Hanzalova,

HYPR,

Kumlinge, Russian

spring—summer encephalitis, Kyasanur forest dis-

ease, 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 transmis-

sion or animal inoculation experiments)

BOARD

NOTE:

A Class

4 Agent helps define an “iso—

lation waste” for the purposes of Section 3.81(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.”

“HIGHLY COMMUNICABLE DISEASE” MEANS THOSE DISEASES

IDENTIFIED AS CLASS

4 ETIOLOGIC AGENTS.

(Section

3.81(a) (6)

of the Act)

“ISOLATION

WASTE”

MEANS

DISCARDED WASTE MATERIALS

CONTAMINATED

WITH

BLOOD,

EXCRETIONS,

EXUDATES,

AND

SECRETIONS

FROM

HUMANS

THAT

ARE

ISOLATED

TO

PROTECT

OTHERS

FROM

HIGHLY

COMMUNICABLE DISEASES.

(Section

3.81(a)

(6)

of

the

Act)

“POTENTIALLY

INFECTIOUS

MEDICAL

WASTE”

OR

“P1MW”

MEANS

THE FOLLOWING TYPES OF WASTE GENERATED IN CONNECTION

129—499

---

10

WITH THE DIAGNQSIS, TREATMENT

(I.E., PROVISION OF

MEDICAL SERVICES),

OR IMMUNIZATION OF

HUMAN

BEINGS OR

ANIMALS; RESEARCH PERTAINING TO THE PROVISION OF MEDI-

CAL

SERVICES; OR THE PROVISION OR TESTING OF BIOLOGI-

CALS:

CULTURES AND

STOCKS;

HUMAN PATHOLOGICAL WASTES;

HUMAN BLOOD AND

BLOOD PRODUCTS;

USED

SHARPS;

ANIMAL

WASTE;

ISOLATION WASTE; AND

UNUSED

SHARPS.

POTENTIALLY INFECTIOUS MEDICAL WASTE DOES NOT

INCLUDE

THE

FOLLOWING:

WASTE

GENERATED

AS

GENERAL

HOUSEHOLD

WASTE;

WASTE

(EXCEPT FOR SHARPS) FOR WHICH THE IN-

FECTIOUS POTENTIAL

HAS BEEN ELIMINATED BY

TREATMENT;

OR

SHARPS THAT MEET BOTH OF THE FOLLOWING CONDI-

TIONS:

THE INFECTIOUS POTENTIAL

HAS BEEN ELIMI-

NATED FROM THE SHARPS BY TREATMENT; AND

THE SHARPS ARE RENDERED UNRECOGNIZABLE

BY TREATMENT.

(Section 3.81 of the Act)

IT IS SO ORDERED.

I,

Dorothy H.

Gunn, Clerk of the Illinois Pollution Control

Board,

do hereby certify that

b~e~bove

Proposed—Qpinion

arid

Order was adopted on the

.

~

day of

1992, by a vote of

~—C

Board

129—500