BEFORE THE ILLINOIS POLLUTION CONTROL BOARD CLERK'S

REICE

OFFICE

VED

DEC 3 1 2007

STATE OF ILLINOIS

AS 08-006

?

pollution Control Board

(Adjusted Standard – Land)

IN THE MATTER OF:

PETITION OF BIOMEDICAL TECHNOLOGY )

SOLUTIONS, INC.,

A Colorado Corporation,

)

FOR ADJUSTED STANDARD FROM

)

35 III.

Adm.

Code

Sec.

1422

)

NOTICE OF FILING

Dorothy M. Gunn, Clerk

Illinois Pollution Control Board

James R. Thompson Center

100 West Randolph Street

Suite 11-500

Chicago, IL 60601

GREENBERG TRAURIG, LIT

Attn: Neal H. Weinfield , Esq.

77 West Wacker Drive, Suite 2500

Chicago, Illinois 60601

PLEASE TAKE NOTICE

that I have today filed with the office of the Clerk of the

Pollution Control Board the

AMENDED RECOMMENDATION OF THE ILLINOIS EPA,

copies of which are herewith served upon you.

Respectfully submitted,

ILLINOIS ENVIRONMENTAL PROTECTION

AGENCY,

Respondent

William D. Ingersoll

Division of Legal Counsel

1021 North Grand Avenue, East

P.O. Box.19276

Springfield, Illinois 62794-9276

217/782-5544

217/782-9143 (TDD)

Dated: December 26, 2007

This filing submitted on recycled paper.

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

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LLINOIS

AS 08-006

Board

(Adjusted Standard – Land)

IN THE MATTER OF:

PETITION OF BIOMEDICAL TECHNOLOGY )

SOLUTIONS, INC., A Colorado Corporation, )

FOR ADJUSTED STANDARD FROM )

35 Ill. Adm. Code Sec. 1422

)

AMENDED ILLINOIS EPA RECOMMENDATION

The ILLINOIS ENVIRONMENTAL PROTECTION AGENCY ("Illinois EPA"), by its

attorney William Ingersoll, hereby submits its Amended Recommendation in the above captioned

matter. The only modification is to correct exhibit references in paragraph 14, and attach those

exhibits that were inadvertently omitted. This filing is submitted pursuant to Section 35 of the

Illinois Environmental Protection Act ("EPAct") [415 ILCS 5/35 (2006)] and 35 III. Adm. Code

104

et seq.

For the reasons outlined below, the Illinois EPA recommends that this petition be

GRANTED conditionally.

I.

INTRODUCTION

On June 28, 2007, Biomedical Technology Solutions, Inc. ("Petitioner"), filed a

petition for Variance ("Variance") requesting relief from the Initial Efficacy Test

("IET") within 35 Ill. Adm. Code 1422.124(a). (Variance at 3)

2.

According to the Variance, relief was sought "... to demonstrate the effectiveness of

its device by conducting the [Initial Efficacy Test] using the Brown Indicator...

(ATCC 9372) in place of ATCC 19659 as required by statute." (Variance at 3)

3.

A July 28, 2007, Board Order considering the petition noted that Petitioner

"...appears to be seeking more permanent relief more generally provided by an

adjusted standard under Section 28.1 of the [EPAct]" and further noted that for

Petitioner to seek temporary relief under a variance, it must provide a compliance

plan that indicated how it will comply with the rule of general applicability when the

variance expires. The Board found the petition failed to meet the necessary

requirements under 35 Ill. Adm. Code 104.204 and directed Petitioner to file an

amended petition by August 27, 2007, or the petition would be deemed dismissed.

(Exh. 1)

The Pollution Control Board ("Board") on July 26, 2007, found that the petition for

Variance did not meet the content requirements of the Board's regulations.

Petitioner was allowed the opportunity to file an amended petition by August 27,

2007. If not filed, the Board would dismiss the Variance petition and close the

docket.

4.

The Petitioner did not file an amended Variance petition. Thus, on September 20,

---

2007, the Board dismissed the petition for Variance and closed the docket. (Exh. 2)

5. On November 28, 2007, Petitioner filed a petition for Adjusted Standard ("petition

or pet.") with the Board. The Illinois EPA received a copy of this pleading on

November 30, 2007.

Within the Adjusted Standard, Petitioner notes that it manufactures a countertop

medical waste treatment device, the Demolizer ®, and seeks a technology-specific

adjusted standard from 35 Ill. Adm. Code Sec. 1422. (Pet. at

1)

II. INVESTIGATION

7.

Notice of the petition, pursuant to Section 28.1 of the EPAct and Section 104.408 of

the regulations, has been published in a newspaper of general circulation.

8.

To date, Respondent has not received a citizen inquiry.

9.

The Illinois EPA and Petitioner have engaged in discussions over this matter.

10.

The Illinois EPA notes that the copy of the Adjusted Standard served on it was miss

captioned as a pleading in the form of a Variance petition which identifies the

Illinois EPA as a Respondent. Such is not the case. Further, the Illinois EPA took

the liberty of captioning the pleading as a request for relief from 35 III. Adm. Code

Sec. 1422 as noted in the Adjusted Standard at page 1. However, as discussed

below, such relief is overly broad.

11.

The Illinois EPA further notes that the petition provides that "BMTS and the Illinois

[EPA] have agreed to waive a hearing for this petition." (Pet. at 1, footnote

1)

Though the Illinois EPA and Petitioner discussed the hearing requirement, the

Illinois EPA did not agree to waive a hearing since it is not within the Illinois EPA's

authority to waive a hearing. The Board regulations (35 Ill. Adm. Code 104.422)

discussed provides guidance relative to a public hearing and one may be held if

requested by the Petitioner, any person, or at the Board's discretion. In addition, one

must be held if the petition seeks relief from certain regulations. The Illinois EPA

does not request a hearing in this matter.

III. FACTS PRESENTED IN THE PETITION

12.

Petitioner starts off its petition requesting the Board "... for an Adjusted Standard

from a provision of 35 IAC 1422. Later in this paragraph, Petitioner clarifies that

relief is sought since Section 1422 requires the use of a particular microorganism,

Bacillus subtilis

(ATCC 19659), to determine the initial efficacy of the technology."

(Pet. at 1) Petitioner concludes its petition by providing that it seeks relief "... from

the provisions of 35 IAC 1422.Table B ."

(Pet. at 32) Generally speaking,

2

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Adjusted Standard petitions are filed from specific relief from rules of general

applicability. In this case, Petitioner does not request specific relief within its

discussion of the matter, choosing to request general relief from Section 1422. In

such a case, the Illinois EPA would recommend that, if the Board provides relief,

that relief by limited to the requirement that

Bacillus subtilis

(ATCC 19659) alone

may be used, which would be specific relief to 35 III. Adm. Code Section 1422,

Appendix A, Table B(1). Again, relief should not be granted, as plead, from Section

1422 in general.

13.

Within the Introduction, Petitioner provides that "... the waste [that is] sterilized

and rendered into a non-recognizable solid waste [ ] can then be disposed of as any

other refuse." (Pet. at 2) The Illinois EPA would suggest that treated PIMW would

still be an "industrial process waste" and a "special waste" under Illinois regulations

and not be like any other "solid waste" or "refuse."

14.

Petitioner states at various points within the petition that "[t]he technology is

formally approved or meets statutory requirements in 46 states." (Pet. at 2, See also

reference to 46 states at pages: 3, 5, 11, 15, and 27) Initially, some states do not

specify a particular strain of indicator and some states do not regulate such testing at

all. Some states, such as Texas, require that a commercially available species he

used that can achieve a "kill ratio" of 99.99%. States such as Alabama, West

Virginia, Virginia and Utah do recognize expressly ATC19659 as an appropriate

bacterial spore. (Exh. A) Moreover, it is possible, though more review would be

necessary to confirm that States such as Arizona and Delaware which have issued

approved the use of the KSU test reviewed more information regarding the

Demolizer ® than simply a recitation of whether ATCC 19659 and ATCC 9372 are

similar. Finally, this claim (that ... "[c]urrently, out of the 46 states that have

approved the Demolizer ® or for which the Demolizer ® meets statutory

requirements ...") is suspect, in general, since such a contention is that of the 46

states, the Demolizer ® "meets statutory requirements" which falls short of stating

that the unit is approved in 46 states. For example, according to Petitioner's web

site (www.bmtscorp.com) the Demolizer ® system is either formally approved or

meets the requirements for medical waste treatment and disposal in 46 U.S. states.

(www.bmtscorp.com/usmap.shtm) Yet, interestingly, the state of Illinois is listed as

one of the states "approved or meet[ing] state requirements" and not as a state

within which "approval [is] in process." (Exh. B)

15.

Likewise, Petitioner provides that ATCC 9372 "... is the scientifically-recognized

standard in 46 states ... ." (Pet. at 3) This contention is difficult to verify and

would seem suspect. If again Illinois is within the 46 number continually used by

Petitioner, the statement is not correct, to date. As noted within Attachment A to the

Petition, BMTS provides that the Demolizer ® is formally approved in only 22

states (20 states plus Arizona and Delaware) and that 23 states do not formally

review technologies for onsite treatment of low volumes of medical waste. Thus, it

is difficult to reconcile that 46 states scientifically-recognize ATCC 9372 when,

3

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according to Attachment A, 23 states do not formally review technologies.

However, more information could be provided to bolster this contention'.

Additionally, 1 state appears to be missing (22 states alleged to have formally

approved and 23 states alleged to meet or exceed regulatory requirements 45

states)

15.

Similarly, Petitioner offers that "[c]urrently, out of the 46 states that have approved

the Demolizer ® or for which the Demoizer meets statutory requirements, Illinois

is the only state that has required use of the Chemical Indicator in the lET for the

Demolizer ® technology rather than the Certified or Dry Heat Indicator for the

validation of the dry heat sterilization technology." (Pet. at 5) This statement is not

entirely correct in that, as noted within the petition, Arizona and Delaware have

regulations providing that ATCC 19659 be used. (Pet. at 11 -- "... three states

specifically identify [ATCC 19659] in their regulations for use in validation

procedures: Arizona, Illinois and Delawarel

16.

The Illinois EPA would also like to clarify several instances where Petitioner has

alleged Illinois EPA's position. For example, at page 6 of the petition, Petitioner

alleges "[b]ased on

all of this information, the Agency has agreed to

recommend to

the Board that it grant this Petition for an Adjusted Standard."

(Pet. at 15 – bold original, yet significance of such is unknown) The Illinois EPA's

agreement to these contentions is not present within the documents provided in the

petition and the Illinois EPA would like the opportunity to make its own

conclusions and recommendations known rather than having them thrust upon them.

No agreement was made regarding a recommendation prior to a pleading being

filed and reviewed.

Additionally, Petitioner provides that Bill Ingersoll of the Illinois EPA "...

recognized that the Yellow Indicator was not commercially available [footnote 9]."

(Pet. at 13) Such a statement is not contained within Mr. Ingersoll's e-mail of June

4, 2007. To the contrary, Mr. Ingersoll provides simply that "... I am told that while

this strain (ATCC 19659) may not be 'off the shelf at this time, it can still be

purchased." (Pet. Exh. E) The statement of Mr. Ingersoll is far from the statement

offered. Further adrift from anything Mr. Ingersoll stated in his e-mail is footnote

nine, which accompanies the above language attributed to Mr. Ingersoll, and

provides clarification of what Petitioner contends to be an obstacle to its use of

ATCC 19659. None of footnote 9 can fairly be placed into the brief discussion

contained in the June 4, 2007 e-mail.

This same paragraph, Petitioner offers that "[p]ursuant to the suggestion of Mr.

Ingersoll, BMTS filed a Variance Petition on or about June 24, 2007." (Pet. at 13)

Petitioner filed a Variance petition, this is true. However, the Illinois EPA

suggested, in writing, both on January 5, 2007 and April 4, 2007, that Petitioner had

1

Attachment A to the Petition includes a letter dated September 28, 2007, indicating that it was written in response to a

conversation with Kyle Davis of the Illinois Pollution Control Board. Mr. Kyle Davis is a counsel with the Illinois EPA and not

with the Board. The Illinois EPA is unaware of any discussions between the Board and Petitioner.

4

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options to use ATCC 19659 or to seek an Adjusted Standard. (Pet. Exh. B and D)

IV.

STATUTORY CRITERIA

STANDARD FROM WHICH ADJUSTED STANDARD IS SOUGHT

35 III. Adm. Code Section 104.406(a)

17. The Board promulgated the requirements of 35 III. Adm. Code Section 1422 Design

and Operation of Facilities for facilities treating potentially infectious medical

wastes in 1993. As of June 21, 1993, the regulations stated:

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. ...

b)

The Initial Efficacy Test must be conducted by the use of Options 1, 2 or

3 of Appendix A of this Part, ...

Appendix A provides:

... 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). ...

Appendix A, Table B, provides:

Section1422.TABLE B Indicator

Microorangisms

1. Bicillus subtilis (ATCC 19659) ...

Petitioner conducted testing of its medical waste treatment device using

Bacillus

subtilis

var.

niger,

ATCC 9372 in place of

Bicillus

?

ATCC 19659, as

required by Section 1422, Appendix A, Table B. Petitioner now seeks an

Adjusted Standard.

STATEMENT OF IMPLEMENTATIOIN OF FEDERAL REQUIREMENTS

35 III. Adm. Code 104.496(b)

18. This regulation of general applicability was not promulgated to implement, in whole

of in part, the requirements of the CWA (33 USC 1251 et seq.), CAA (42 USC 7401

et seq.), or the State programs concerning RCRA, UIC or NPDES [415 ILCS

5/28.1].

5

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LEVEL OF "USTI F1CATON

35 III. Adm. Code 104.406(c)

19.

The regulations do not specify a level of justification or other requirements.

DESCRIPTION OF PETITIONER'S ACTIVITY

35 Iii.

Adm. Code 104.406(d)

20.

Petitioner intends to sell its product throughout the State of Illinois.

DESCRIPTION OF COMPLIANCE EFFORTS AND ALTERNATIVES

35

111.

Adm. Code 104.406(e)

21.

Petitioner offers that "[u]nder the Agency's current interpretation of the Board's

regulations, it is impossible for BMTS to achieve immediate compliance, which

could take as long as two and a half years due to the time and resources required to

grow and certify a Chemical Indicator to the same standards already demonstrated in

the KSU Efficacy Test." (Pet. at 17) It is questionable what significance should be

attributed to the statement that it is impossible to achieve "immediate compliance."

Petitioner is not faced with an issue of immediate compliance other than one created

by its own conduct. In essence, Petitioner seeks review of it not complying with a

regulatory requirement that it never intends to comply with. Petitioner, simply put,

does not want to repeat the efficacy test it chose to perform with another indicator

spore with those required, since 1993, under Illinois law.

77

.

Petitioner also offers that "immediate compliance would impose an arbitrary and

unreasonable hardship." This standard is far more appropriate for seeking a

Variance. However, the Illinois EPA will address the basic argument presented.

At the heart of Petitioner's claim for relief is the fact that Petitioner has already done

a test and does not wish to re-test. For such a contention to be weighed equitably

you need to review the circumstances surrounding the claim that it should not be

required to re-test. Illinois regulations relative to which strain of indicator spore to

used were enacted following a long regulatory process. The Board set the

compliance date of June 21, 1993 for its regulations. Thus, for over 14 years the

regulatory standards have been apparent for compliance with Illinois law. Petitioner

conducted its testing in 2006. This testing was 13 years following the enactment

and compliance deadline for Illinois law.

Additionally, if anything, the Illinois EPA's correspondence notes that the ATCC

19659 strain spore is commercially available. Petitioner's contention that it is not

commercially available is troubling since the spore is available. Petitioner's issue

with the spore is the fact that it will be require to purchase the strain, populate

certified cultures and then re-test. Yet, as noted above, and as provided for within

the petition, Illinois law required use of ATCC 19659 years long prior to Petitioner

contracting for a test to be preformed.

6

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There is no doubt that it will he more costly to do the IEF with the ATCC 19659.

However, you have to answer the question why? The reason it is more costly is

because Petitioner did not use the ATCC 19659 strain in the first place.

Moreover, this is not an issue relative to availability of the required spore, it is a

contention that such costs would have to be spread to consumers in the price of the

product. (Pet. at 21) This argument, is not unique to this matter, and as such should

not be persuasive in itself.

The Board and the Illinois EPA should not be responsible for Petitioner's choice to

use a spore which does not comply with long standing regulatory requirements. The

existence of this ATCC issue was apparent to Petitioner, and was considered by

Petitioner's consultant at Kansas State University. (Pet. at 8) Petitioner, though its

consultant, chose to use a spore that was similar to that required by a number of

states. Again, even arguendo if the spores are 99.8% similar in their genetic

material, the difference between them was the cost to culture them and certify the

population. (Pet. at 8) A choice to use the ATCC 9372 was purely elective and

considered. Thus, the cost spreading of the need to use ATCC 19659 (which is

overwhelmingly recognized as an appropriate spore for this type of testing) would

have been far easier, and spread over far more units, had Petitioner chosen to use the

spore identified in many states as an appropriate spore.

Is the time required to comply a factor? Petitioner posits that it could take a total

time from of up to two years to cultivate a population. (Pet. at 21) However, the

two year time frame surely must have been considered in Petitioner's initial decision

to use the ATCC 9372 strain in place of the ATCC 19659 strain. Thus, it is difficult

to assert that it will take Petitioner additional time to comply with Illinois law when

Petitioner itself determined long before the filing of this pleading to accept the

consequences of seeking approval for its use of a spore strain that did not comply

with the express language within several state statutes. Additionally, the cost of

time to sell these units in Illinois surely must have been considered prior to the filing

of this petition.

Petitioner is not economically situated in a unique position as compared to others

who would seek to comply with Illinois law. Other than the fact that Petitioner

chose to proceed using ATCC 9372 in place of ATCC 19659, Petitioner is situated

no differently than any other manufacturer of a medical waste treatment unit who

wanted to certify a unit's IET. The costs to be born by use of ATCC 19659 by

Petitioner, and indeed the time, would be the same for any manufacturer. The

regulations do not arbitrarily or adversely affect Petitioner in this manner. The

regulation does not impact this Petitioner more adversely or arbitrarily than any

other person subject to an IET.

PROPOSED ADJUSTED STANDARD

7

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35 III. Adm. Code 104.406(0

23.

The Illinois EPA notes the language proposed by Petitioner in at page 22 of the

Petition, but can not agree to such. In the Illinois EPA's opinion, this Adjusted

Standard petition would not be an appropriate mechanism to alter the rule of general

applicability as to others, and as such, the general amendment proposed to Section

1422, Appendix A, Table B is not correct. Additionally, the Illinois EPA is not sure

what the reference to it means within the last paragraph of Petitioner's Petitioner in

Section DC of page 22. The phrase "... the Agency has been acknowledged meets

..." is incomplete and adds nothing to the rationale presented.

Provided the Board agrees to grant Petitioner's Adjusted Standard in this matter, the

Illinois EPA would propose the following language for inclusion in the Board's

Order in this matter:

"The Board grants Petitioner an Adjusted Standard, as presented in In the Matter of:

Petition of Biomedical Technology Solutions, Inc., AS 08-006, from the

requirement that

Bicillus subtilis

(ATCC 19659) be used in an Initial Efficacy Test

under Section 1422, Appendix A, Table B(1) upon the condition that a appropriate

test is preformed using

Bacillus subtilis

var.

niger

(ATCC 9372) and the results of

such test comply with the requirements of this

Part."

IMPACT ON THE ENVIRONENT

35

Adm. Code

104.406(g)

24.

The

Illinois EPA does not take issue generally with the representations made by

Petitioner concerning environmental impact.

JUSTIFICATION FOR PROPOSED ADJUSTED STANDARD

35 III. Adm. Code

104.406(h)

25.

The Burden of Proof contained at Section 104.426 states those matters the Board

should consider in rendering a decision regarding a petition for Adjusted Standard.

(See also EPAct: 415 ILCS 5/27(a)) The Illinois EPA would agree with Petitioner

that the scholarly information provided establishes that the use of ATCC 9372 is

consistent with present practice in testing dry-heat resistance. As such, the Board

could find that factors relating to the Petitioner are substantially and significantly

different from the factors relied upon by the Board in adopting the general

regulations applicable to the Petitioner, and as such, grant an Adjusted Standard

based upon this rationale.

8

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CONSISTENCY WITH FEDERAL LAW

35I11. Adm. Code 104.406(i)

26.

No issues regarding compliance with Federal law were identified during the review

of this matter.

WAIVER OF HEARING

35 Ill. Adm. Code 104.406(j)

27.

As stated above, the Illinois EPA does not request a hearing in this matter. Should

the Board determine that a hearing is necessary, the Illinois EPA will participate.

V.

RECOMMENDATION

A thorough review of the petition for relief was made by Illinois EPA technical

staff. The Illinois EPA concludes that sufficient justification is presented to allow

Petitioner to be granted an Adjusted Standard regarding the use of ATCC 9372 in an

Initial Efficacy Test. The Illinois EPA recommends that the Board conditionally

grant Petitioner its Adjusted Standard as presented in In the Matter of: Petition of

Biomedical Technology Solutions, Inc., AS 08-006, from the requirement that

Bicillus subtilis

(ATCC 19659) be used in an Initial Efficacy Test under Section

1422, Appendix A, Table B(1), upon the condition that a appropriate test is

preformed using

Bacillus subtilis

var.

niger

(ATCC 9372) and the results of such

test comply with the requirements of this Part.

Based upon the forgoing, the Illinois EPA recommends that the Board conditionally

GRANT Petitioner's petition for Adjusted Standard.

Respectfully submitted,

ENVIRONMENTAL PROTECTION AGENCY

OF THE STATE OF ILLINOIS

William D. Ingersoll

Division of Legal Counsel

DATED: December 26, 2007

1021 North Grand Ave. East

P.O. Box 19276

Springfield, Illinois 62794-9276

217/782-5544

By:

9

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Groundwater System Monthl y

Operational Data Report

Groundwater System Monthly

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—

52

Registration Form for the

Rye istration Form for the

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103

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105

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Permit Application for Stationar y

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184

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278

Disposal Approval Request

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Notification for Underground

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283

Notification for Above Ground

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300

Solid Waste Profile Shed

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309

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310

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L? ii?

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313

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Rule 333-8-1-.11 Groundwater

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___

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317

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319

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320

ALG610000

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ALG490000

Authorization Termination

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ALG610000

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Departmental Forms

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AEU:10000

&

ALG490000 Inspection

Report and BMP Certification

This form is replaced by Form

#

500

C

322

ALG610000 & ALG490000

Noncompliance Notification

Report

This form is replaced by Form

#

501

ALG610000 &

ALG490000

Noncompliance Notification Report

This form is replaced by Form

#

501

C

323

Alternative Medical Waste

Alternative Medical Waste

_

Treatment Technoloip4 Equipment Treatment Technology Equipment

Approval Application

Approval Application

324

1

Annual Certification Form for

Discharges Associated with

Annual Certification Form tor

=-

11___

Discharges Associated with

Petroleum Storage and Handling

Areas

Petroleum Storage and I kindling

1—

Areas

325

Annual Compliance Statement

Annual CcAnpliance Statement Form

Form

326

Annual Statistical Inventory

Reconciliation?? ?

Reconciliation (SIRJ Report Form

>F l cation fgr a Permit fur tit

Construction of a Motel, I Iotei, or

Application for a Permit for the

Construction of a Motel Hotel, or

Other Multi-Unit Development on a

C

Other Multi-L`nit Development on

a Pttrty

-lntcisccteci

b}' the,

Property Intersected by the

Construction Cont of Line in the

Construction Control Line in the

Alabama Coastal Area

Alabama Coastal Area

Alication for a Permit for the

Application for a Permit for the

Constiuctio_n of Sii

?

le Family

Construction of Single Family

C

llwellii

ig

s,

Du

?

loxes, or Other

Dwellings, lluplexes, or Other

Similar Struct ues on Properties

Similar Structures on Properties

intersected by the Construction

Intersected by the Construction

Control Line in the Alabama

Control Line in the Alabama Coastal

Co

astal ?

Area

329

Application for Approval of a

Application for Approval of a Non-

Non-Regu lated Use in the

C

Alabama Coastal Area

Developments and Subdivisions of

Property Greater then 5 Acres in

Size

Regulated Use

_

in the Alabama

Coastal Area Developments and

Subdivisions of Property Greater

then 5 Acres in Size

ir

n In teln

n

---

Departmental Forms

?

Page 5 of 19

330

Application for Name

Change or

Transfer of Permit Solid Waste

Disposal Facility

Application for Name Change or

Transfer of Permit Solid Waste

Disposal Facility

331

Bulk (Gasoline)Plant Application

Bulk (Gasoline) Plant Application

332

Cathodic Protection Monitoring

Cathodic Protection Monitoring

—

Form for impressed Current

Systems

Form for Impressed Current Systems

333

CBM NPDES Stormwater

Dischar

ge

Monitoring Report

CBM NPDES Stormwater Discharge

Monitoring Report

C

334

CBM Toxicit

y Test Resort

Summary

CBM Toxicity Test Report Summary

C

335

Chemical Monitoring

?

Data

a Report

Chemical Monitoring Data Report

336

Chemical Monitoring_Waiver

Application

Chemical Monitoring_Waiver

Application

—

337

Chemical Sampling Chain of

Custod

y

Form

Chemical Sampling Chain of

Custody Form

338

Clean Water State Revolving Fund

Clean Water State Revolving Fund

(CWSRF) Construction Report Form

(This form is not available in a Word

or Excel Format)

_

(CWSRF) Construction Report

Form

339

Clean Water State Revolvin

g Fund

Clean Water State Revolving Fund

(CWSRF) Loan Application Form

(CWSRF) Loan Application Form

—

340

Clean

Water State Revolving Fund

Clean Water State Revolving Fu nd

(CWSRF) Preapplication Form

(CWSRF) Preapplication Form

_

341

Clean Water State Revolving Fund

Clean Water State RevolvingFund

(CWSRF) Supplemental General

(CWSRF) Supplemental General

Conditions

Conditions

342

Coal Permit Precipitation Event

Discharge Limitations Exemption

Coal Permit Precipitation Event

Discharge Limitations Exemption

C

Claim Report

Claim Report

—

343

Coalbed Methane Stormwater

Coalbed Methane Stormwater

Inspection Summary iepfilt

Inspection Summary Report

C

344

Coalbed Methane Temporary Pit

Coalbed Methane Temporary Pit

Wastewa teraandiApplica

t ion

Certification Report

WastewaterlandApplication

Certification Report

345

Community Public Nolificiaticm

Certification Form

Community Public Notification

r-

Certification

?

Form

_?

—

346

Community _S ystem

Susceptibility

Analysis Sheet

Community S_ystem Susc_ptibiliy

Analysis Sheet

i

ii

a?

ir--

---

Departmental Forms

?

Page 6 of 19

347

Consumer Confidence Report

Certification Form

Consumer Confidence Report

Certification Form

348

Discharge Monitoring Report for

CBM Coal - Tvw 60 Effluent

Discharge Monitoring Report for

CBM Coal - Type 60 Effluent

(This form is not available in a Word

or Excel Format)

C

Example

349

Discharge Monitoring;R(±Rorthor

ChM Coal -Type 60 Manual

Example

Discharge Monitoring Report for

CBM Coal - Type 60 Manual

(This form is not available in a Word

or Excel Format)

350

Discharge Monitorirni Report for

Discharge Monitoring Report for

CBM Coal - Type 60 Standard

(This form is not available in a Word

or Excel Format)

ChM Coal - Type 60 Standard

C

Example

351

Discharge Monitoring,Report or

Coal - Tvpe 1 & Type 3

Discharge Monitoring Report for

Coal - Type 1 & Type 3

(This form is not available in a Word

or Excel Format)

Example

352

Discharge Mo

nitoring Report for

Discharge Monitoring Report for

Coal - Type 11

(This form is not available in a Word

or Excel Format)

Coal -Type 11

Example

353

DischarMonitoring Report for

Discharge Monitoring Report for

Coal - Type 13

(This form is not available in a Word

or Excel Format)

Coal - Type 13

Example

354

Discharge Monitoring Report for

Discharge Monitoring Report for

Coal - Type 14 Sand & Gravel

(This form

is

not available in a Word

or_Excel Earmat)_

Coal - Type 14 Sand & Gravel

Example

355

Discharge MonitoringiReport for

Discharge Monitoring Report for

Coal - Type 14 Fire Clay

(This form is not available in a Word

or Excel Format)

IF

Coal - T

ype14

Eire Cla y

Example

II

lII

I?

At

---

Departmental Forms

?

Page 7 of 19

356

Discharge Monitoring Report for

Coal - T

ype 14 Shale - Common

Clay

Example

Discharge Monitoring Report for

Coal - Type 14 Shale - Common

Clay

(This form is not available in a Word

or Excel Format)

C

357

Discharge Monitoring Report for

Discharge Monitoring Report for

Coal - Type 15

(This form is not available in a Word

or Excel Format)

Coal - T±y-p 15

C

Example

358

Discharge Monitoring Report for

Coal - 'fype 38

Example

Discharge Monitoring Report for

Coal - Type 38

(This form is not available in a Word

or Excel Format)

C

—

359

Discharge Monitoring Report for

Discharge Monitoring Report for

Coal - Type 5

&

Type 7

(This form is not available in a Word

or Excel Format)

Coal - Type 5 & Type 7

C

Example

360

Dischaw Monitoring_t

Report for

Coal - Type 9

Example

Discharge Monitoring Report for

Coal - Type 9

(This form is not available in a Word

or Excel Format)

C

361

Discharge Monitoring Report for

Discharge Monitoring Report for

NonCoal - Type 30

(This form is not available in a Word

or Excel Format)

C

—

NonCoal - Type 30

Example

362

Discharge Monitoring Report for

Discharge Monitoring Report for

NonCoal - Type 32

(This form is not available in a Word

or Excel Format)

C

--

NonCoal - Type 32

Example

363

Discharge_Meport for

DischargaMonitoring Report for_

NonCoal - Type 34

(This form is not available in a Word

or Excel Format)

NonCoal - Type 34

C

Example

364

Discharge Monitoring Report for

Discharge Monitoring Report for

---

Departmental Forms

Page 8 of 19

NonCoal - T

y

pe 7,6 & Tya 48

&

The 50

Example

NonCoal - Type 36 & Type 48

&

Type 50

(This form

is not available in a Word

or Excel Format)

C

365

Discharge Mon nor] rigReport for

NonCoal - T

y

pe 41

Example

Discharge Monitoring Report for

NonCoal - Type 41

(This form is not available in a Word

or Excel Format)

C

366

Discharge Monitoring Report for

Discharge Monitoring Report for

NonCoal - Type 42

(This form is not available in a Word

or Excel Format)

NonCoal - Type 42

C

Example

367

Discharge Monitorina Report for

Discharge Monitoring Report for

NonCoal - Type 44 & Type 45

(This form is not available in a Word

or Excel Format)

Example

NonCoal - T

y

pe 44 & Type 45

C

Example

368

Discr Ye Monitoring Report for

Discharge Monitoring Report for

NonCoal - Type 46

(This form is not available in a Word

or Excel Format)

Example

NonCoal -

Type

46

C

Example

369

Drinking Water State Revolving,

Drinking Water State Revolving

Fund

(DWSR1l)

Loan Application

Fund (DWSRF) Loan Application

Form

Form

370

Drinking Water State Revolving

Drinking Water State Revolving

Fund LDWSRIMPreapplication

Form

Funci(DWSRF)Preapplication Form

371

Drhlilsin , Water State Revolving

Drinking Water State Revolving

.EimddliWSRE)Su pplementaL

General Conditions

(This form is not available in a Word

or Excel Format)

,

Eurut(DW_SRE) SuRlt_RibrrieaL

General Conditions

372

Emissions Statement

-R'portiner

Form

Emissions Statement Reporting

II

II

---Form

IF

---

Departmental Forms

?

Page 9 of 19

373

Excess I rnission Mor ti

?

ma

6

Excess Emission Monitoring Report

Report

374

Exemption Claim Form for Clofired

Combustors (Appendix li -

Division 3)

Exemption Claim Form for Cofired

Combustors (Appendix H - Division

33j

_

—

375

Exemption Claim Form I'or

Incinerators Burning Only

Pathological, Low-Level

Exemption Claim Form For

Incinerators Burning Only

Pathological, Low-Level Radioactive,

and Chemotherripeutic Waste

(Appendix H - Division 3)

Radioactive, and

Chemotherautic Waste

(Appendix 11 - Division 3)

376

Field Operation Division NPDES

Field Operation Division NPDES

Individual Permit Application

Addendum Form

Individual Permit Application

C

Addendum Form

377

Field Operation Division NPDES

Individual Permit Application

Minor Permit Modification

Field Operation Division NPDES

Individual Permit Application Minor

Permit Modification Addendum

Form

C

Addendum Form

378

Gasoline Dispensing Facility

Gasoline Dispensing Facility

Information Survey

Information Survey

=

379

General Permit Application Form

- NOI-61

& 49

This form is replaced by Form

#

498

General Permit Application Form

-

NOI-61 & 49

This form is replaced by Form

# 498

C

--

380

General Permit Application

General Permit Application Package

Package - N0111

- N01-11

381

General Permit Application

General Permit Application Packaae

Package - N01-12

- N01-12

382

General Permit Application

General Permit Application Package

Package - N01-14

- NOI-14

383

General Permit Application

General Permit Application Packaae

=

Package - N01-15

- NOI-15

384

General Permit Application

General Permit Application Package

Package - NOT-16

- N01-16

--

385

General Perrnit-A

pplication--

A

General Permit Application-Package-,

Package - N01-17

- N01-17

386

General Permit Application

Package - NOH18

General Permit Application Package

- NOI-18

387

General Permit Apication

Packa ge - NOI-2

General Permit Application Package

1—

- NOI-2

it

it

---

Departmental Forms

Page 10 of 19

388

Genf it

Permit Application

General Permit Npplication Package

Packaw - NO]-20

- NOI-20

389

General Perniit Application

General Permit Aplication Package

Package - NOI-23

- NOI-23

390

General Permit lipplication

General Permit Application Pack±Age

Package - NO1-24

- NOI-24

391

General Permit Application

General

_

Permit Application Package

Packa

?

NO1-25

- NOI-25

392

General Permit Application

General Permit Application Package

Package - NOI-28

- NOI-28

393

General PermitApplication

General Permit Application Package

Package- N01-3

- NOI-3

394

General l'ermit Application

General Permit Application Package

Package -

- NOI-34

395

General Permit Applica

General Permit Application Package

Package - NOI-36

- NOI-36

396

General Permit Application

General Permit Application Package

Package - NOI-6

- NOI-6

397

General Permit Application

General Permit Application Package

Package - NO1-67

- NOT-67

398

General Permit Renewal Form

General Permit Renewal Form

399

flydyegzp

r?

h

Control Release

Hydrograh Control ReleaselliCR)

(HCI:) Attachment

Attachment

400

Impressed Current Cathodic

Impressed Current Cathodic

Protection System 60-Day

Protection System 60-Da

y

Inspection

Inspection

Log

401

Individual NPDES Permit

Individual NPDES Permit

Noncompliance NotificationA5-

Noncompliance Notification (5-day

Report)

C

dav Report)

403

Interior Lining Inspection Form

Interior Lining Inspection Form

404

Interior Lining Report Form

Interior Lining Report Form

405

Lead and Copper Monitoring Data

Lead and Copper Monitoring Data

??

Report

Report

406

Manual Interstitial Monitoring

Manual Interstitial Monitoring

Monthl

y Log

Monthly

407

Material Safety Data Sheet

Material Safety Data Sheet Reporting

Reporting

408

Maximum Residual Disinfectant

Maximum Residual Disinfectant

---

?

k

cvel Input Ent miSaniples)

Maximum Residual Disinfectant

Level input Form (Sources)

Medical Waste Notification Form

Medical Waste Transporter Permit

Application

411

409

410

Level Input Form (Samples)

IL

Maximum Residual Disinfectant

Level Input Form (Sources)

412

414

415

416

417

418

420

421

422

423

424

Monthly Statistical Inventory

Reconciliation (SIR) Report

Municipal POTW SSO/MS4 Event

Fil2orting1Torm

Municipal Water Pollution

Prevention (MWPP) Annual

Report Package

Municipal Water Pollution

Prevention Resolution Form

MWPP Sewage Sludge Survey

Non-Community Public

Notification Certification Form.

Non-Compliance Report Form

Notice of Intent to Permanently

Close'Underground Storage Tanks

Departmental Forms

Page 11 of 19

Medical Waste Treatment Permit

Application

419

425

Municipal Water Pollution

Pre ven ti on_LIVIW FP) Annual

Report (Collection Systems)

Package

Notice of Proposed UST New

Installation or Upgrade

Medical Waste Notification Form

Medical Waste Transporter Permit

Application

Medical Waste Treatment Permit

Application

Monthly Statistical Inventory

Reconciliation (SIR) Report

Municipal POTW SSOf MS4 Event

Reporting Form

Municipal Water Pollution

Prevention LMWPP) Annual Report

(Collection Systems

.

) Package

Municipal Water Pollution

Prevention (MWPP) Annual Report

Packag

e

Municipal Water Pollution

Prevention Resolution Form

MWPP Sew_aze Sludge Survey

Non-Community Public Notification

Certification Form

Non-Compliance Report Form

Notice of Intent to Permanently

Close Unde

r

l Storage 'ranks

Notice of Proposed UST New

Installation or Upgrade

Notification - Above the Threshold

Planning Quantities (TPQ) of

Extremely Hazardous Substances

Notification of Election of Coverage

under The Alabama Drycleaning

Environmental Response Trust Fund

Act

Notification - Above the

'Threshold Planning Quantities

CITI Extremely Hazardous

Substances

Notification of Election of

CoverLige_under The Alabama

Drycl ea n lug Env ironmenta

Response Trust Fund Act

426

Nox Budget Permit Application

Nox Budget Permit Application

---

Departmental Forms

?

Page 12 of 19

IllForm

II

Form

427

Nox Budget Retired Unit

Exemption Claim Form

Nox Buduet Retired Unit Exemption

Claim Form

429

NPDES Annual Notice

or

NPDES Annual Notice of

Registration (NOR)

RAgistration (NOR)

This

form is for CAFO Registration

This form is for CAFO Registration

430

N PM'S Discharge Monitoring

Report Form (Monthl

y)

NPDES Discharge Monitoring

Report Form (Monthly)

433

NPDES Permitted Coalbed

Methane Operations Pollution

Abatement/ Trea t

MCilt

Measures

and Waste Treatment Facilities

Certification Report

t

434

Qper, Burnino_Incident Report

435

Operator Certification. Renewal

Operator Certification Renewal

Form

Form

(This form is not available in a

Word Format)

436

Perc Dry Cleaner Status Update

Perc Dry Cleaner Status Upthte

437

Permit Application

for Compliance

Permit Application for Compliance

Schedule

Schedule

438

Permit Application for Continuous

Permit Application for Continuous

Emission Monitoring Systems

Emission Monitoring Systems

(GEMS)

(CEMS)

439

Permit Application Solid Waste

Permit Application Solid Waste

Disposal Facility

Disposal Facility

440

Petroleum Solvent Dry Clearig

Petroleum Solvent Dry Cleaning

Questionnair

Ciestiontraireh

-

441

Plant and Collection System

Personnel Inventory

Plant and Collection System

Personnel Inventory

—

442

Potable Water Laboratory

Certification Application

Potable Water Laboratory

Certification Application

I

II

II

r

---

Departmental Forms

Page 13 of 19

443 Progress

Report form

Project Completion Form

Progress Report Form

444

Project Completion Form

445

PSD Project Information Form

PSD Projcct Information Form

446

Raw Sewage Bv_pass and Overflow

Event Ruportina Form

Raw Sewa/(0Bypass and Overflow

Event Reporting Form

447

Release Information Form

Release Information Form

—

C

448

Remediation Approval Form

Remediation Approval Form

449

Remediation Reporting Form

Remediation Reporting Form

450

ReRresentative Stormwater Outfall

Representative Stormwater Outfall

Certification

Certification

451

Request for Coal Permit Post-

Request for Coal Permit Post-Mining

Mining Discharae Limitations

Discharge Limitations

C

452

Request for Release from

Monitoring and Re porting

RiNu__Arements

Request for Release from Monitoring

anikeReporting; Requirements

C

453

Resuti_tst to Remove Subsurface

Request

_

to Remove Subsurface

Withdrawal From Dischar g e

Withdrawal From Discharge

C

Structure

Structure

454

Request to Remove Treatment

Request to Remove Treatment

Basin/Pond or Other Dischar ge

C

Structure

Basin/Pond or Other Discharge

Structure

455

Required Information for Mixing

Required Information for Mixing

Zone Modeling

Zone Modeling

456

Segmental Water System

Segmental Water System

Certification Application

Certification Application

457

SID Discharge Monitoring Report

SID Discharge Monitoring Report

Form (Monthl y)

Form (Monthly)

458

SID Discharge Monitorinort

SID Discharge Monitoring Report

Form (Qua

rte

rly

l

Form (Quarterly)

i._

459

SRF Payment Request Form

SRF Payment Request Form

(This form is not available in a Word

----

or–Excel-Format)

460

Statistical Inventor y

Reconciliation Statistical Inventory Reconciliation

SIR 7 Day Release investigation

SIR 7 Day Release Investigation

Notice Form

Notice Form

461

Surface Source Susceptibilit

y

Anal-y

sis Worksheet

Surface Source Susceptibility

ir-

IL____

Analysis Worksheet

n?Inn*,

-•

---

Departmental Forms

?

Page 14 of 19

462

lank Trust Fund Eligibility

/

Tank Trust Fund Eligibility'

/

I nel ioibility Determination harm

IneligNity Determination Form

464

Foxicity Discharge Monitoring

Report lorm

Toxicity Discharge Monitoring

Report Form

465

Toxicity Test Report Summary

Toxicity Test Report Summary

—C

466

'Transfer Agreement Form

Transfer Agreement Form

467

UIC Pemnt ,

Mplication

E

Existing

Discharge

UIC Permit .A_pication Existing

Discharge

468

UIC Permit Application New

Discharge

U1C Permit Application New

Discharge

469

Underground and Above Ground

_._

Underground and Above Ground

Storase Tank Transfer of

Storage Tank Transfer of Ownership

Ownership

471

UST ARBCA Tier 1 Report Forms

—

UST ARBCA Tier 1 Report Forms

(This form is available for purchase)

472

UST ARBCA Tier 2 Report Forms

UST ARBCA Tier 2 Report Forms

(This form is available for purchase)

—

473

UST ARBCA Tier 3 Report Forms

UST ARBCA Tier 3 Report Forms

(This form is available for purchase)

—

474

UST Closure Site Assessment

Report Form

UST_

Closure Site Assessment Report

Form

—

475

UST Free Product Recover

y Report

UST Free Product Recovery

Report

Form

Form

476

UST Groundwater Monitoring

USTI Groundwater Monitoring

Report Form

Report Form

477

UST Line Tightness test Report

UST Line Tightness Test Report

Form

Form

478

UST Natural Attenuation

UST Natural Attenuation

Monitoring Report Form

Monitoring Repprt Form

479

UST Release Pact Sheet

UST Release Fact_ Sheet

480

UST Release Report Form

UST Release Report Form

481

USTSitiTChassitica ti on-

?

s Liu

UST i

e eassificatiorrSystem

Checklist

Checklist

482

UST System Effectiveness

UST System Effectiveness

Monitoring Report Form

1—

Monitoring Report Form

483

'UST Tracer Tank?

iohtness Test

Report Fong

UST Tracer Tank Tightness Test

Report Form

11?

ir--

---

Departmental Forms

?

Page 15 of 19

484

US I' Ul lair 'lank lightness f est

Report

1 :

orm

UST Linage Tank Tightness Test

Report Form

485

US] Vacuum

:

1 ank Tiahtness 'fest UST Vacuum Tank Tightness Test

Report Form

Report Form

486

UST Volumetric Overfill lank

UST Volumetric Overfill Tank

Thrhtness

Test Report Form

Tightness Test Resort Form

487

US] Volumetric Underfill Tank

UST Volumetric Underfill Tank

Tightness Test Report Form

Tightness Test Report Form

488

Water Supply Construction Permit

Application

Water SupOyConstruction Permit

Application

489

Water Supply Permit Application

(Modificatiori)

Water Supply Permit Application

(Modification)

490

Water

Sup_pb*permit implication Water Suppl y Permit Application

(Renewall

(Renewal)

491

Water Sy stem Update

Water System Update

492

UST Closure Total Potential Voc

UST Closure Total Potential Voc

Emissions Calculations

Emissions Calculations

493

112

(D Part 1 Applicability

Notification

112 (j) Part 1 Applicability

—

Notification

494

Birminvham Fuel Suppli

e

r Report

Birmingham Fuel Supplier Report

495

Major Source Operating Permit

Major Source Operating Permit

Skeleton Form

Skeleton Form

496

Notice of Demolition and/or

Notice of Demolition and/or

c

..-

C

—

Asbestos Removal

Asbestos Removal

,

497

Asbestos Removal Contractor

Asbestos Removal Contractor

Certification

Certification

498

NPDES Construction

NPDES Construction,

Noncoal/Nonmetallic Mining and

Dry Procession less than Five

Noncoal/Nonmetallic Mining and

Dry Procession Less than Five Acres,

Acres,

Other Land Disturbance

Other Land Disturbance Activities

Activities Application Form

Application Form

499

N liDltS Construction, Noncoal

NPDES Construction, Noncoal

_

Mining Less than Five Acres

Mining Less than Five Acres

Stormwater

Regi

str

ation

Stormwater

Registration

Termination Request and

Termination Request and

Certification Form

Certification Form

500

N PDES Construction, and IN oncoal

Mining Less than Five Acres

Storm water Inspection Report and

NPDES Construction, and Noncoal

Mining_Less than Five Acres

C

Stormwater Inspection Report and

---

Departmental Forms

Page 16 of

19

11

BM P

Certification Form?

1BMP Certification Form

C

501

N I'D ES (onstruction, and Noncoal

Mining Less

than

Five Acres

Stormwater Noncompliance

Notification Report Form

NPDES Construction and Noncoal

Minim Less than Five Acres

Stormwater Noncompliance

Notification Report Form

502

Visible Emission Field 'Lest Sheet

Visible Emission Field Test Sheet

Only available in PDF

503

General Permit for Phase 11 Small

Municipal Separate Storm Sewer

General Permit for Phase II Small

Municipal Separate Storm Sewer

Systems (MS4) ALNOI

----

Sy stems LMS4) ALNOI

505

Water and Wastewater Operator

Water and Wastewater Operator

Exam Application

Only available in PDF

=

Exam

,

Application

C

506

Water and Wastewater Operator

Water and Wastewater Operator

Experience Verification

Only_ayailable in PDF

--

Experience Verification

C

507

Water and_ Wastewater Reciprocal

Application

Water and Wastewater Reciprocal

Application

Only_available in PDF

C

508

Water and Wastewater Operator

Water and Wastewater Operator for

Multiple Systems

Only available in PDF

for Multiple Systems

C

510

Cool Mg Water Supplemental

Information

Cooling Water Supplemental

Information

511

EDMR1 Permittee Registration

EDMR1 Permittee Registration Form

Form

512

ElDMR2 Electronic Signature

EDMR2 Electronic Signature

Application Ageement

Application Agreement

513

EDMR3 Deactivation Request

EDMR3 Deactivation Request Form

httn

.

//www

arum

Mato al ic/IThnntPnrme/Pnrmnrif htm

?

0/Q /0(1(17

---

Departmental Forms

?

Page 17 of 19

Form

514

Daily Discharac Monitor Report

Daily Discharge Monitor Report

Only_ available in PDF

515

Monthly Discharge

Monitoring

Monthly Discharge Monitoring

Report

Only available in PDF

.----

Report

516

Supplemental Petroleum

Application Information

Supplemental Petroleum

Application Information

530

1'

ec hn lc al Proposal for

Qualification as a Scrap Tire Fund

Remediation Center

Technical Proposal for Qualification

as a Scrap Tire Fund Rem

_

ediation

Center

531

Ei :tit° Tv

• Unit Evaluation

Hvdrogeolqgy Unit Evaluation

Report Form

Report Form

532

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httn

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ariom efatoa

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licillonfPnrrno/rnrrnnrif htrn

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0 1')1

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---

Departmental Forms

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---

Departmental Forms

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Last modified: 07/27/07

---

APPLICATION FOR APPROVAL OF

ALTERNATIVE TREATMENT TECHNOLOGIES

Please complete all items below. Mark N/A for any that are not applicable. Include any

support data that may be applicable. Use additional paper if necessary with a reference to

the appropriate section and number(s).

=== === === === === === === === === === === === === ===

A.

GENERAL

Al . Is the treatment technology best suited for on-site use at the point of generation,

or is it adaptable for use as a commercial or regional treatment process receiving

medical waste from several generators?

On-site

Commercial/Regional

Both

A2.

Is this treatment technology specified for use at small generator facilities (those

that treat less than 220 pounds per month)?

Yes No

A3.

Has this treatment technology been approved/disapproved in any other state? If

so, please indicate which states have issued a decision and submit copies of

approvals/disapprovals.

A4.

Has the use of this equipment ever resulted in any injuries of any kind, or the

transmission of any disease to any person? Describe all such instances.

A5.

Has the use of this equipment ever resulted in any environmental or occupational

safety violation (federal, state, or local)? Describe all such instances.

A6.

Have you reviewed all applicable state solid and medical waste regulations for

medical waste management and disposal?

Yes

No

A7.

Have you inquired as to whether any other permits are required? Please enclose

agency response and requirements with your application. List all required permits

and enclose copies of any permit approvals.

Yes

No NOTE:

Local governments or other agencies may

require permits and/or approvals.

ADEM Form 323 8-02

1

---

=== === === === === === === === === === =

== === === ===

B.

LEVEL OF TREATMENT

BL Does

the level of microbial inactivation achieved by the treatment process meet

the following definition?

"Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses,

parasites, and mycobacteria at a 6 LoglO Reduction or greater; and inactivation of

B. stearothermophilus spores or B. subtilis spores at a 4 Log10 reduction or

greater."

Yes No If

no, specify where the definition is unfulfilled. •

=== === === === === === === === == === === === === ===

C.

CHARACTERIZATION OF PROPOSED TREATMENT PROCESS

Cl. Please

check the appropriate categories that best describe the methods used by

this proposed technology. Proposed treatment technologies may incorporate

several of the categories listed below.

Chemical

Grinder

Encapsulation Heat

Microwave

Irradiation

Plasma Arc

Mechanical

Steam

Radiowave

=== =

Other

=

= ===

(specify)

===

===

=== === === === === === =

=

= === ===

D.

WASTE COMPATIBILITY WITH PROPOSED TREATMENT PROCESS

Type of Waste

DI. Animal

Waste

D2.

Blood & Body Fluids

D3.

Microbiological Waste

D4.

Pathological Waste

DI Renal

Dialysis Waste

Compatible Non-compatible

ADEM Form 323 8-02

2

---

D6.

Sharps

D7.

Surgical Waste

Please refer to the state medical waste regulations for further definition of the

medical waste categories and prescribed medical waste management

requirements.

D8.

What waste characteristics present the greatest challenge to the proposed

treatment process.

Organic materials

?

Liquids

Density/Compaction ?

D9.

Describe by composition (i.e.,

?

material

Other

and percentage)

characteristics

those

?

medical

Specify:

wastes

?

that

would pose the most challenge to the proposed technology. Why?

D10.

Describe the physical or chemical components of medical wastes that would

interfere, cause mechanical breakdown, or compromise the treatment process or

microbial inactivation efficacy.

=== === === === === === === === == === === === === ===

E.

MICROBIOLOGICAL TEST PROCEDURES

Any proposed treatment method shall be capable of inactivating vegetative

bacteria, fungi or yeast, parasites, lipophilic/hydrophilic viruses, and

mycobacteria at a 6 Log

i°

Reduction or greater. Bacterial spores shall be

inactivated at a 4 Log

i°

Reduction or greater. A representative from each of the

microbial groups, listed in "El" below, are required to be tested.

El .?

Listed below are several test organisms which have been used as microbiological

indicators to determine the effectiveness of a given treatment method. If there are

any data that supports or refutes the inactivation of any of the biological

indicators using the proposed treatment process under normal operating

conditions, please check the appropriate space next to the indicator.

NOTE:

If protocols utilized by the applicant

to generate

microbial inactivation data are

deemed unacceptable by the Department, the Department reserves the right to request that the

applicant resubmit data generated from Department-approved protocols. If data has not yet been

procured to support the inactivation of the listed biological indicators below, please contact the

Department before initiating efficacy testing to ensure research protocols are in accordance with

the Department's requirements

ADEM Form 323 8-02

3

---

Vegetative Bacteria:

Staphylococcus aureus (ATCC 6538)

Pseudomonas aeruginosa (ATCC 15442)

Fungi

Candida albicans (ATCC 18804)

Aspergillus

Penicillium

nigerchrysogenum

(ATCC 24791)

Viruses:

Polio 2 or Polio 3

MS-2 Bacteriophage (ATCC 15597-BI)

Parasites:

Cryptosporidium sap. Oocysts

Giardia

SPA.

Cysts

Mycobacteria:

Mycobacterium terrae

Mycobacterium phlei

Bacterial

Mycobacterium

Spores:

bovis (BCG) (ATCC 35743)

B. stearothemophilus (ATCC 7953)

B. subtilis (ATCC 19659)

E2.?

Were the results certified by an independent public health or certified testing

laboratory?

Yes*?

No

* If yes, indicate the name, address, and telephone number of the certifying

laboratory and attach the test protocol, results and an explanation of any

available data not supporting the reduction factors referenced above.

ADEM Form 323 8-02

4

---

=== ===

===

=== === === === =

==

== === === === ===

===

F.

BY-PRODUCTS AND DISCHARGES OF THE TREATMENT PROCESS

.?

Please indicate all by-products and discharges (to air, water, or land) which may

be generated as a result of this alternative treatment technology.

Aerosols

Leachate

Stack Emissions

Ash

Liquid

Steam

Chemical Residues Odor

Vapors or Fumes

Dust

Slag

Heat

Smoke

F2.

If any of the above by-products or discharges are indicated, how will they be controlled?

F3.

If there are no by-products or discharges indicated, how was this determined'?

F4.

Are any of these by-products or discharges ADEM-listed hazardous wastes (ADEM

Administrative Code 335-14)? If yes, explain necessary controls, personal protective equipment,

storage, disposal, etc.

Yes

No

=

== === === == =

=== === === ==

= === === === =

== === ===

G.

ENVIRONMENTAL EFFECTS OF THE TREATMENT PROCESS

G1.

Are any negative effects on the environment anticipated from the use of the treatment process

and/or disposal of the treated waste from the treatment process?

Yes

No

G2.

What environmental, occupational, and/or public health hazards would be associated with a

G3.

malfunction

If the treatment

of the

process

treatment

includes

process?

the use

Specify

of water,

steam,

or other liquids, how will this waste

G4.

discharge

What are the

be handled

physical

(i.e.,

characteristics

sewer, recycled,

of the waste

etc.)?

residues

Specify

generated

from

he treatment process

05. (i.e.,

How

wet,

will the

dry,

treated

shredded,

medical

powdered,

waste from

etc.)?

this

Specify

process

be

disposed of (i.e., landfill, incineration,

recycled, etc.)? Specify

ADEM Form 323 8-02

5

---

Are any by-products classified as hazardous waste according to Div

i sion 335-14 of the ADEM

Administrative Code? Yes

No

=== ==

=

=== === === === === === == === =

== === === ===

H.

OCCUPATIONAL HAZARDS

Hi. What

training will the operator(s) of the treatment process receive?

112.

===

===

What frequency

=== ===

will update

===

training

===

be

===

provided?

===

== === === === === ===

I.

?

CRITICAL FACTORS OF THE TREATMENT PROCESS

Ii. What

are the critical factors that influence the specific treatment technology? Specify

12.13.

What

What

are

type

the

of

consequences

ongoing maintenance

if these

is

factors

required

are

in

not

the

met?

operation

Specify

of

the

treatment system? Specify

14.

(may

What

attach

emergency

maintenance

measures

manual)

would be

required

in the event of a malfunction? Specify

15.

What is the maximum amount of waste to be treated by this process per cycle or per hour?

pounds

16.

How long is a cycle?

minutes

=== ==

= === === === = =

= === === == === === === === ==

=

J.

CHEMICAL INACTIVATION TREATMENT PROCESSES

Complete this section if the treatment process involves the use of chemical inactivation.

it.

J2.

What

What

concentrations

is the name of the

must

active

he used

ingredient?

and maintained?

J3.J4.

At

What

what

is the

pH

minimum

is the chemical

contact

agent

time?active?

minutes

ADEM Form 323 8-02

6

---

J5. Specify

any incompatibility with specific materials and surfaces.

J6.17. What

List any

is the

additional

pH of any

factors

end

that

products

may interfere

(i.e., liquid

with

effluents)?

the chemical's

inactivation

potential.

J8.

?

What is the active life of the chemical agent after it has been exposed to air or medical waste?

J9.

Have studies been conducted relative to the long-term effectiveness of the chemical agent while in

J10.

Is

use?

a

If

MSDS

yes, please

attached?

attach a copy

Yes__

of the

Nostudy

and test results.

11. Is

the chemical agent registered for this specific use with the USEPA Pesticide Registration

112. Division?

Is the spent

Yeschemical

agent

Noclassified

If

as

yes,

a hazardous

provide

waste

numberby

Division

335-14 of the ADEM

=== ===

Administrative

=== ===

Code?

===

Yes

=== ===

No

=== === === === === === ===

K.

QUALITY ASSURANCE AND VERIFIVATION OF MICROBIAL

INACTIVATION

K1. Specify

how quality assurance of the treatment process is addressed.

K2.

What is the recommended frequency that a microbiological indicator should be used to confirm

K3.

effectiveness

Other than the

of

biological

the system?

indicators

listed

in Section E, what other indicators, integrators, or

monitoring devices would be used to show that the treatment unit or process was functioning

properly?

ADEM Form 323 8-02

7

---

K4. How is it determined that the processed waste has received proper treatment?

Temperature indicator.

Visual only

Continuous

Both

Pressure indicator:

Visual only__

Continuous

Both

Time indicator:

Visual only

Continuous

Both_

Chemical concentration indicator:

Visual only

Continuous

Both

Other: Please specify

How have the treatment process monitors been correlated with biological indicators to ensure

K.6. effective

What is the

and

established

accurate monitoring

procedure and

of the

frequency

treatment

to

process?

calibrate

the

process monitors (gauges, clocks,

K7. computers,

How are the

etc.)?

process

monitors

interfaced with the system's operations to effect proper treatment

conditions?

KS. How

are the process monitor controls secured to prevent operator over-ride of the process before

K9. treatment

What failure

is adequately

mode and effect

affected?

analyses

have

been performed on the treatment system?

===

=== === ===

=== === === =

== === === ==

= === === ===

L.

OTHER RELEVANT INFORMATION AND COMMENTS

All approvals or denials received from other states, counties or agencies concerning any aspect of

equipment operation and efficacy; as well as all safety, competency or training requirements for

the users/operators, etc. must also be included.

•

ADEM Form 323 8-02

8

---

CERTIFICATION STATEMENT

I certify that the information requested and contained in this document is accurate and complete and that all

existing documentation requested in this application for this system or similar systems is provided. The

Vendor, identified below, agrees to provide ADEM all results of all studies conducted by or for any state,

company, agency, country, or any other person as defined by Division 335-13 of the ADEM Administrative

Code, which the vendor conducts, or is in any way aware of, to determine the operational performance of

any aspect of the equipment for which authorization to operate in this state is requested on the filing of this

application. I am aware that regulated medical waste management systems to be operated in this state for

regulated medical waste treatment and/or destruction must be identical to the system described in this

application for authorization to operate in this state and for which operational data is presented in the

application for ADEM's review. Any and all changes in the system and related equipment after this

application submittal and ADEM's review and authorization to operate must be submitted in writing to

ADEM prior to use. The ADEM permitting conditions or other agency's authorizations granted to operate

this system to treat and/or destroy regulated medical waste will be reviewed by ADEM periodically to

ensure specifically authorized regulated medical waste technology systems meet currently accepted

standards for regulated medical waste management. ADEM may modify system operational or

performance requirements for systems that receive prior authorizations to operate, if warranted to protect

human health and the environment.

I am further aware that on reviewing the completed application and the required attachments, ADEM may

have additional questions and require submissions of data and other information deemed necessary

regarding this or related medical waste disposal systems. Failure to provide all existing requested

information will result in delays in processing the request for authorization to operate. Failure to provide

all required information as outlined in this application, or willfully withholding information, may be cause

for ADEM to deny or rescind authorization to operate if ADEM determines that the information not

submitted would have been in any way relevant to its review of this technology.

Name of system or equipment

Model Number

Name of certifying person (must be a owner, partner, etc.)

Title

Signature of certifying person

Date

Name of Vendor (company)

Telephone

Mailing Address

Fax Number

City, State & Zip Code

E-mail address

Vendor's contact person

Telephone

ADEM Form 323 8-02

9

---

IW-20

West Virginia Department of Health and Human Resources

Rev. 8/04

Office of Environmental Health Services

Infectious Medical Waste Program

Application for Alternative Treatment Technology Evaluation and Approval

Complete the following application and return it along with all supporting data which maybe applicable and the

evaluation fee of $500.00. Checks should be made payable to the WV Bureau for Public Health. Use

additional paper if necessary, reference with the related section and number(s).

A.

GENERAL

Al. Is the treatment technology best suited for on-site use at the point of generation, or is it adaptable for

use as a commercial or regional treatment process receiving waste from several generators?

A2.

On-siteIs

this treatment

Commercial/Regionaltechnology

specified for

use at

Bothsmall generator

facilities such as physician, dental, or

veterinary offices or clinics?

Yes No

A3.

Has this treatment technology been approved/disapproved in any other state? If so, please indicate

which states have issued a decision and submit copies of approvals/disapprovals.

Yes No

A4.

Has the use of this equipment ever resulted in any environmental or occupational safety violation

(federal, state, or local)?

Yes No

AS. Has the use of this equipment ever resulted in any injuries, of any kind, or transmissions of any disease

to any person? Describe all such instances.

Yes No

A6.

Have you reviewed all applicable state solid and medical waste regulations for medical waste

acceptance, treatment, and disposal?

Yes No

A7.

Have you inquired as to whether any other permits are required? Please enclose agency response and

requirements with your application. List all required permits and enclose copies of any permit

approvals.

Yes No

B. LEVEL OF TREATMENT

Bl. Does the level of microbial inactivation achieved by the treatment process meet the following

definition?

"Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria

at a 6 Log

i

o reduction or greater; and inactivation of Bacillus stearothermophilus spores or B. subtilis

spores at a 4 Log i

o reduction or greater."

Yes

No If

no, specify where the definition is unfulfilled.

---

C. CHARACTERIZATION OF PROPOSED TREATMENT PROCESS

Cl. Please check the appropriate categories that best describe the methods of this proposed technology.

Proposed treatment technologies may incorporate several of the categories listed below.

Hammer

ChemicalEncapsulationGrinderHeat mill

Mechanical

Plasma

Microwave

Radiowave

Shredder

Arc

D.

WASTE

Irradiation

COMPATIBILITY

WITH PROPOSED

Other

TREATMENT

(specify)

PROCESS

Please identify if the proposed system is compatible or non-compatible with the following types of waste.

Type of Waste

Compatible Non-compatible

Dl. Cultures and stocks of infectious

agents and associated biologicals

D2.

Liquid human and animal waste

including blood and blood

products and body fluids

D3.

Pathological waste

D4. Contaminated waste from animals

D5.

Sharps

D6. Other

Please refer to the state medical waste regulations for further definition of the medical waste categories and

prescribed medical waste management requirements.

D7.

What waste characteristics present the most challenge to the proposed treatment process:

Organic materials

Liquids

Density/compaction

08 Describe

Other characteristicsby

composition

(i.e.,

material

Specify:

and

percentage)

those

medical wastes that would pose the most

challenge to the proposed technology. Why?

D9. Describe the physical or chemical components of medical wastes that would interfere, cause

mechanical breakdown, or compromise the treatment process or microbial inactivation efficacy.

---

E.

MICROBIOLOGICAL TEST PROCEDURES

Any proposed treatment method shall be capable of inactivating vegetative bacteria, fungi or yeasts,

parasites, lipophiliehydrophilic viruses, and mycobacteria at a 6 Log reduction or greater. Bacterial spores

shall be inactivated at a 4 Log reduction or greater. A representative from each of the following microbial

groups is required for testing.

El. Listed below are several test organisms which have been used as microbiological indicators to

determine the effectiveness of a given treatment method. If there are any data either to support or

refute the inactivation of any of the biological indicators using the proposed treatment process under

normal operating conditions, please check the appropriate space next to the indicator.

NOTE:

If protocols utilized by the applicant to generate microbial inactivation data are deemed

unacceptable by the Department, the Department reserves the right to request that the

applicant resubmit data generated from Department-approved protocols. If data has not yet

been procured to support the inactivation of the listed biological indicators below, please

contact the Department before initiating efficacy testing to ensure research protocols are in

accordance with the Department's requirements.

Vegetative Bacteria

- Staphylococcus aureus (ATCC 6538)

- Pseudomonas aeruginosa (ATCC 15442)

Fungi

- Candida albicans (ATCC 18804)

- Penicillium chrysogenum (ATCC 24791)

- Aspergillus niger

Viruses

- Polio 2 or Polio 3

- MS-2 Bacteriophage (ATCC 15597-B1)

Parasites

- Cryptosporidium spp. oocysts

- Giardia spp. cysts

Mycobacteria

- Mycobacterium terrae

- Mycobacterium phlei

- Mycobacterium bovis (BCG) ATCC 35743)

Bacterial Spores

- B stearothermophilus (ATCC 7953)

- B. subtilis (ATCC 19659)

E2. Were the results certified by an independent public health or certified testing laboratory?

Yes?

No

If yes, indicate the name, address, and telephone number of the certifying laboratory and attach the test

protocol, results and an explanation of any available data not supporting the reduction factors

referenced above.

---

F. BY-PRODUCTS AND DISCHARGES OF THE TREATMENT PROCESS

F I. Please indicate all by-products and discharges (to air, water, or land) which may be generated as a

result of this alternative treatment technology.

F2.

AerosolsDustAshChemical

If

Heatany

?

?

?

of the

?

Residuesabove

by-products

?

?

?

?

?

or discharges

LiquidLeachateOdorOther,

Slag

?

?

?

?

specify

?

are indicated,

?

?

how

?

?

?

will

Vapors

Stack

SmokeSteamthey

Emissions

?

?

or

be

Fumescontrolled?

?

?

F3.

If there are no by-products or discharges indicated, how was this determined?

F4. Are any of these by-products or discharges USEPA-listed hazardous wastes (40 CFR Part 261),

biohazardous, etc.?

Yes

?

No

If yes, explain necessary controls, personal protective equipment, storage, disposal, etc.

G.

ENVIRONMENTAL EFFECTS OF THE TREATMENT PROCESS

GI . Are any negative effects on the environment anticipated from the use of the treatment process and/or

disposal of the treated waste from the treatment process?

G2.

What environmental, occupational, and/or public health hazards would be associated with a

malfunction of the treatment process? Specify.

G3.

If the treatment process includes the use of water, steam, or other liquids, how will this waste discharge

be handled (i.e., sewer, recycled, etc.)? Specify.

G4.

What are the physical characteristics of the waste residues generated from the treatment process (i.e.,

wet, dry, shredded, powdered, etc.)? Specify.

G5 How will the treated medical waste from this process be disposed of (i.e., landfill, incineration,

recycled, etc.)? Specify.

G6. Are any by-products classified as hazardous waste (40 CFR Part 261)?

Yes ?

No ?

Complete

?

Item A6.

---

H. OCCUPATIONAL HAZARDS

1-11. What are the potential hazards associated with the treatment process?

H2.

What hazard abatement/reduction strategies will be used during the operation of this treatment process

(include engineering controls, person protection equipment, etc.)?

H3.

What training will the operator(s) of the treatment process receive?

I.

CRITICAL FACTORS OF THE TREATMENT PROCESS

11.

What are the critical factors that influence the specific treatment technology? Specify.

12.

What are the consequences if these factors are not met? Specify.

13.

Explain the ease and/or difficulty of operation of the medical waste treatment system. Specify.

14.

What type of ongoing maintenance is required in the operation of the treatment system? Specify.

15.

Maintenance

What emergency

Manual

measures

Attached?

would

Yesbe

required

?

Noin

the

?

event of a malfunction? Specify.

16.

How are these measures addressed in an emergency plan or in the operations protocol?

17.

What is the maximum amount of waste to be treated by this process per cycle?

18.

How long is a cycle?

J.

CHEMICAL TREATMENT PROCESS

J1. If the treatment process involves the use of chemical inactivation:

a.

What is the name of the active ingredient?

b.

What concentrations must be used and maintained?

c.

At what pH is the chemical agent active?

d.

What is the necessary contact time?

e.

If there is any incompatibility with specific materials and surfaces, specify.

f What is the pH of any end products (i.e., liquid effluents)?

g. List any additional factors or circumstances that may interfere with the chemical's inactivation

potential.

J2. What is the active life of the chemical agent after it has been exposed to air or contaminated medical

waste?

---

J3.

Have studies been conducted relative to the long-term effectiveness of the chemical agent while in

use? If yes, please attach a copy of the study and test results.

J4.

What health and safety hazards may be associated with the chemical (present and long-term)? Specify.

MSDS Attached? Yes No

J5.

Is the chemical agent registered for this specific use with the Environmental Protection Agency

(USEPA) Pesticide Registration Division?

If

Yes

yes, provide

Nothe USEPA

registration number

and a copy of the EPA-

approved label instructions for use.

J6.

Is the spent chemical agent classified as a hazardous waste by USEPA (40 CFR Part 261) or by other

state criteria?

Yes

No

If yes, specify whether by USEPA or by which state(s).

J7.

Is an environmental impact study for the chemical agent available?

Yes

No

If yes, attach a copy of this information.

K. QUALITY

ASSURANCE AND VERIFICATION OF MICROBIAL INACTIVATION

K1.

How is the quality assurance of the treatment process addressed? Specify.

K2.

What is the recommended frequency that a microbiological indicator should be used to confirm

effectiveness of the system? Specify.

K3.

Other than the biological indicators listed in Section E, what other indicators, integrators, or

monitoring devices would be used to show that the treatment unit or process was functioning properly?

(Please describe and explain.)

K4.

How is it determined that the processed waste has received proper treatment? (Check the appropriate

item.)

K5 How

Temperature

Tune

Pressure

Other:

Chemical

have

indicator:Please

the

indicator:concentration

treatment

indicator:specify process

indicator:

monitors

visual

visual

visual

visual

been

onlyonlyonlyonlycorrelated

with

continuouscontinuouscontinuouscontinuousbiological

indicators

bothbothbothbothto ensure

effective

and accurate monitoring of the treatment process? Specify.

K6.

What is the established process monitor calibration schedule, and what is its frequency of calibration?

K7.

How are the process monitors interfaced to the system's operations to effect proper treatment

conditions? Explain.

K8.

How are the process monitor controls secured to prevent operator over-ride of the process before

treatment is adequately affected? Explain.

K9.

What failure mode and effect analyses have been performed on the treatment system? Specify and

provide.

---

L.

POST-TREATMENT RESIDUE DISPOSAL, RECLAMATION OR RECYCLING

Ll. How will the treated medical wastes from this process be disposed of:

Burial in an approved landfill ? Incineration??

Recycled

?

?

L2.

If the wastes are to be recycled, provide additional evidence regarding this strategy.

L3.

If the wastes arc to be recycled, what percentage of the treated waste will be recycled? How will the

remainder of the treated waste be disposed of ?

M. POTENTIAL ENVIRONMENTAL BENEFITS

Ml. Has an energy analysis been conducted on the proposed technology?

Yes ?

No

?

If yes, specify and provide results of that analysis.

M2.

Has an economic analysis been performed on the proposed technology?

Yes

?

No ?

If yes, specify and provide results of that analysis.

M3.

How does this treatment technology improve on existing medical waste treatment and disposal

methods? Specify.

M4.

What is the potential of this proposed technology for waste volume reduction? Specify.

N.

OTHER RELEVANT INFORMATION AND COMMENTS

All approvals or denials received from other states, counties or agencies concerning any aspect of equipment

operation and efficacy; as well as all safety, competency or training requirements for the users/operators, etc.

must also be included.

---

CERTIFICATION STATEMENT

I certify that the information requested and contained in this document is accurate and complete and that

all existing documentation requested in this application for this system or similar systems is provided. The

Vendor, identified below, agrees to provide the West Virginia Infectious Medical Waste Program with all

results of all studies conducted by or for any state, company, agency or country, or any other person, and all

results of all studies which the vendor conducts, or is in any way aware of, to determine the operational

performance of any aspect of the equipment for which authorization to operate in this state is requested on the

filing of this application. I am aware that infectious medical waste management systems to be operated in this

state for infectious medical waste treatment and/or destruction must be identical to the system described in this

application for authorization to operate in this state and for which operational data is presented in the

application for the West Virginia Infectious Medical Waste Program's review. Any and all changes in the

system and related equipment after this application submittal and West Virginia Infectious Medical Waste

Program review and authorization to operate must be submitted in writing prior to use.

The West Virginia Infectious Medical Waste Program's permitting conditions or other agency's

authorizations granted to operate this system to treat and/or destroy infectious medical waste will be reviewed

periodically to ensure specifically authorized infectious medical waste technology systems meet currently

accepted standards for infectious medical waste management. The West Virginia Infectious Medical Waste

Program may modify system operational or performance requirements for systems that received prior

authorizations to operate, if warranted to protect human health and the environment.

I am further aware that on reviewing the completed application and the required attachments, the West

Virginia Infectious Medical Waste Program may have additional questions and require submissions of data and

other information deemed necessary regarding this or related medical waste disposal systems. Failure to

provide all existing requested information will result in delays in processing the request for authorization to

operate. Failure to provide all required information as outlined in the application, or willfully withholding

information, may be cause for the West Virginia Infectious Medical Waste Program to deny or rescind

authorization to operate if it is determined that the information not submitted would have been in any way

relevant to its review of this technology.

NAME OF SYSTEM/EQUIPMENT

?

MODEL NUMBER

NAME OF CERTIFYING PERSON (corporate officer)

?

TITLE

SIGNATURE OF CERTIFYING PERSON (corporate officer)

?

DATE

NAME OF PERSON COMPLETING APPLICATION ?

TITLE

NAME OF VENDER (COMPANY)

?

TELEPHONE

NAME OF DIVISION

FAX

ADDRESS

EMAIL

CITY, STATE & ZIP CODE

---

9VAC20-120-910. Criteria for microbial inactivation.

A.

Inactivation is required to be demonstrated of vegetative bacteria, fungi, all viruses, parasites, and mycobacteria at a

6 Log10 reduction or greater; a 6 Log10 reduction is defined as a 6 decade reduction or a one millionth (0.000001)

survival probability in a microbial population (i.e., a 99.9999% reduction).

B.

Inactivation is required to be demonstrated of B. stearothermophilus spores or B. subtilis spores at a 4 Log10

reduction or greater; a 4 Log10 reduction is defined as a 4 decade reduction or a 0.0001 survival probability in a microbial

population (i.e., a 99.99% reduction).

9VAC20-120-920. Representative of biological indicators.

A. One or more representative microorganisms from each microbial group shall be used in treatment efficacy

evaluation.

1.

Vegetative Bacteria.

- Staphylococcus aureus (ATCC 6538)

- Pseudomonas aeruginosa (ATCC 15442)

2. Fungi.

- Candida albicans (ATCC 18804)

- Penicillium chrysogenum (ATCC 24791)

- Aspergillus niger

3. Viruses.

- Polio 2 or Polio 3

- MS-2 Bacteriophage (ATCC 15597431)

4.

Parasites.

- Cryptosporidiumspp. oocysts

- Giardia spp. cysts

5.

Mycobacteria.

- Mycobacterium terrae

- Mycobacterium phlei

- Mycobacterium bovis (BCG) (ATCC 35743)

B. Spores from one of the following bacterial species shall be used for efficacy evaluation of chemical, thermal, and

irradiation treatment systems.

1. B. stearothermophilus (ATCC 7953)

2. B. subtilis (ATCC 19659)

9V?

-?

- 0. Quantification of microbial inactivation.

A.

Microbial inactivation ("kill") efficacy is equated to "Log10 Kill," which is defined as the difference between the

logarithms of number of viable test microorganisms before and after treatment. This definition is equated as:

Log10 Kill = Log101(cfu/g) %68 Log10 R(cfu/g) where:

Log10Kill is equivalent to the term Log10 reduction.

"1" is the number of viable test microorganisms introduced into the treatment unit.

"R" is the number of viable test microorganisms recovered after treatment.

"cfu/g" are colony forming units per gram of waste solids.

B.

For those treatment processes that can maintain the integrity of the biological indicator carrier (i.e., ampules, plastic

strips) of the desired microbiological test strain, biological indicators of the required strain and concentration can be used

to demonstrate treatment efficacy. Quantification is evaluated by growth or no growth of the cultured biological indicator.

C.

For those treatment mechanisms that cannot ensure or provide integrity of the biological indicator (i.e., chemical

inactivation/grinding), quantitative measurement of treatment efficacy requires a two step approach: Step 1, "Control';

Step 2, "Test." The purpose of Step 1 is to account for the reduction of test microorganisms due to loss by dilution or

physical entrapment.

1. Step 1.

Part XI, 9 VAC 20-120-910

Effective June 19, 2002

---

Department Use

Only

Date Application and Questionnaire

Received

Date Complete

PETITION FOR EVALUATION

AND APPROVAL OF

REGULATED MEDICAL WASTE TREATMENT TECHNOLOGY

PART

A:

GENERAL INFORMATION

Name of Company

Name of Petitioner (Must be an individual(s) Name)

Trade Name of Device

Model Number

Petitioner Address

City

State

ZIP

Code

Petitioner Telephone

Number

Note: The review and assessment process will not commence until all information required is

submitted by the petitioner and received by the Department.

Treatment Process Petition Page 1

---

EVALUATION OF MEDICAL WASTE TREATMENT TECHNOLOGY

INFORMATION REQUEST FORM

Complete the following questionnaire and return it along with the application. Please include

any additional support data that may be applicable. Use additional paper if necessary. Reference

with the related section and number(s).

A. GENERAL

Al. Is the alternative treatment technology best suited for onsite use at the point of

generation, or is it adaptable for use as a commercial or regional treatment process

receiving waste from several generators?

? Onsite

?

? Commercial/Regional? ? Both

A2.

Is this treatment technology specified for use at small generator facilities such as

physician, dental, or veterinary offices or clinics?

? No?? Yes

A3.

Has this alternative treatment technology been approved/disapproved in any other

state? If so, please indicate which states have issued a decision and submit copies of

approvals/disapprovals.

B. LEVEL OF TREATMENT

Bl. Does the level of microbial inactivation achieved by the treeatment process meet the

following definition:

"Inactivation of vegetative bacteria, fungi, all viruses, parasites, and mycobacteria at a 6

Logo reduction or greater, and B. stearothermophilus spores or B. subtilis spores at a 4

Log 10 reduction or greater."?

Yes I

No — If no, specify where the definition is unfulfilled.

Treatment Process Petition Page 2

---

C.

CHARACTERIZATION OF PROPOSED TREATMENT PROCESS

C:1 Please check the appropriate categories that best describe the methods of this

proposed technology. Proposed treatment technologies may incorporate several of the

categories listed below.

? Chemical

? Heat

?

Plasma Arc

? Encapsulation

? Irradiation

? Radiowave

? Grinder

? Mechanical

? Shredder

? Hammermill

? Microwave

? Other(specify)

D. WASTE COMPATIBILITY WITH PROPOSED TREATMENT PROCESS

Please identify whether the proposed system is compatible or non-compatible with the

following types of waste.

Types of Waste

Compatible Non-compatible

D I . Cultures and stocks of infectious

agents and associated biologicals

D2.

Liquid human and animal waste including ?

9

blood and blood products and body fluids

D3.

Human anatomical waste,

tissues and body fluids

D4.

Contaminated waste from animals

9

D5.

Sharps

Please refer to the State medical waste regulations for further definition of the medical waste

categories and prescribed medical waste management requirements.

Do. What

waste characteristics present the most challenge to the proposed treatment

process?

? Organic materials ? Liquids

? Density/compaction

D7.

?

Describe

Other characteristics

by composition

(Specify)(i.e.,

material

and

percentage) those medical wastes that

would provide the most challenge to the proposed technology. Why?

Treatment Process Pet

ition Page 3

---

E. BY-PRODUCTS OF THE TREATMENT PROCESS

El. Please

indicate all by-products which may be generated as a result of this alternative treatment

technology.

? Air Emissions '? Heat

? Slag

? Vapors or Fumes

? Ash ? Liquid

? Smoke

? Dust ? Odor

? Steam

E2.

If any of

?

the

Other

above

(Specify)by-products are

indicated, how will they be controlled?

E3.

If there are no by-products indicated, how was this determined?

E4.

Are any of these by-products toxic, biohazardous, etc.? ? No

? Yes

If yes, explain

necessary controls, personal protective equipment, storage, disposal, etc.

F. MICROBIALOGICAL TEST PROCEDURES

Any proposed treatment method shall be capable of inactivating vegetative bacteria, fungi or yeasts,

parasites, viruses, and mycobacteria at a 6 Log i

c, reduction or greater. A representative from each

microbial group is required for testing.

Fl. Lister

below are several test organisms which have been used as microbiological indicators to

determine the effectiveness of a given treatment method. If there are data to support the

inactivation of any of the biological indicators using the proposed treatment process under

normal operating conditions, please check the appropriate space next to the indicator.

Vegetative Bacteria

q

Staphylococcus aureus (ATCC 6538)

q

Pseudomonas aeruginosa(ATCC 15442)

Fungi

q

Candida albicans(ATCC 18804)

q

Penicillium chrysogenum(ATCC 24791)

q

Aspergillus niger

Viruses

q

Polio 2 or Polio 3

q

MS-2 Bacteriophage (ATCC 15597-B1)

Parasites

q

Cryptosporidium

spp. Oocysts

q

Giardia spp. Cysts

Mycobacteria

q

Mycobacterium terrae

q

Mycobacterium phlei

q

Mycobacterium

bovis(BCG)(ATCC 35743)

Bacterial Spores

q

B. stearothermophilus(ATCC 7953)

q

B. subtilis(ATCC 19659)

Treatment Process Petition Page 4

---

F.

MICROBIOLOGICAL TEST PROCEDURES (CONTINUED)

Fl. Were the results certified by an independent, public health or certified testing laboratory?

q

No

q

Yes — If so, indicate the name, address, telephone number of the

certifying laboratory and attach test protocol and results.

G.

CHEMICAL INACTIVATION TREATMENT PROCESSES

01. If

the treatment involves the use of chemical inactivation:

b)c)a)d)e)If

At

What

What

What

there

what

is

is

concentrations

is

the

the

Ph

any

is

necessary

name

the

incompatibility

chemical

of the

must

contact

active

be

agent

used

time?with

ingredients?active?and

specific

maintained? materials

and

surfaces, specify._

G2.

What is the active life of the chemical agent after it has been exposed to air or

contaminated medical waste?

G3.

Have studies been conducted relative to the long-term effectiveness of the chemical agent

while in use?

? No ? Yes - If yes, please attach a copy of the study and test results.

4.

What health and safety hazards may be associated with the chemical (present and long-

term)?

MSDS

SpecifyAttached?

? No ? Yes

5.

Is the chemical agent registered for this specific use with the Environmental Protection

Agency (EPA) Pesticide Registration Division?

G6.

?

Is

No

the

?

spent

Yes -

chemical

If yes, provide

agent classified

the EPA

as

registration

a hazardous

numberwaste by

U.S. EPA (40 CFR Part

261) or by other state criteria?

G7.

?

Is

No

an environmental

? Yes - If yes,

impact

specify

study

whether

for the

by

chemical

USEPA

agent

or which

available?state

? No ? Yes - If yes, attach a copy of this information.

Treatment Process Petition Page 5

---

H. ENVIRONMENTAL EFFECTS ON THE TREATMENT PROCESS

H1.

Can positive or negative effects on the environment be anticipated from the use and/or

disposal of the treated waste from the treatment process?

H2.

What

No

environmental,

? Yes - If yes, specifyoccupational, and/or

public hazards would be associated with a

H3.

malfunction

If the treatment

of the

process

treatment

includes

process?

the use

Specifyof

water,

steam,

or other liquids; how will this

waste discharge be handled (i.e., sewer, recycle, etc.)?

H4.

How

Specifywill the

treated waste from this process be disposed of (i.e., landfill, incineration,

H5.

recycle,

Are the by-products

etc.)? Specify

identified

as

a hazardous waste?

? No ? Yes - Complete item MI

I. CRITICAL FACTORS OF TREATMENT PROCESS

11.

What are the critical factors that influence the specific treatment technology?

12.

What

Specifyare the

consequences if these factors are not met?

13.

SpecifyExplain

the

ease and/or difficulty of operation of the medical waste treatment system?

14.

What

Specifytype of

ongoing maintenance is required in the operation of the treatment system?

Maintenance

Specify Manual

Attached?

? No ? Yes

IS. What emergency measures would be required in the event of a malfunction?

16.

SpecifyAre

these

measures

addressed in an emergency plan or in the operations protocol?

? No ? Yes - If yes, attach a copy

17.

What is the maximum amount of waste to be treated by this process per cycle?

18.

How long is a cycle?

Treatment Process Petition Page 5

---

J. QUALITY ASSURANCE AND VERIFICATION OF ADEQUATE TREATMENT

J I . How

is the quality assurance of the treatment process addressed?

J2. What

Specifyis

the

recommended frequency that a microbiological indicator should be used to

confirm effectiveness of the system?

J3.

Other

Specifythan

the

biological indicators listed in Section F, what other indicators, integrators,

or monitoring devices would be used to show that the treatment unit or process was

functioning properly? (Please describe and explain.)

J4.

How is it determined that the processed waste has received proper treatment?

(Check the appropriate item.)

Temperature indicator:

? Visual only ?

Continuous '? Both

Pressure indicator:

? Visual only ? Continuous ? Both

Time indicator:

? Visual

only

?

Continuous ? Both

Chemical concentration indicator: ?

Visual only

? Continuous

? Both

? Other - Please specify

J5.

Have the treatment process monitors been correlated with biological indicators to ensure

effective and accurate monitoring of the treatment process?

J6.

Is

Specifythere a

process monitor calibration schedule established, and at what frequency is

calibration performed?

J7.

Are the process monitors interfaced to the system's operations to effect proper treatment

conditions? Explain.

J8.

Are the process monitor controls secured to prevent operator over-ride of the process

before treatment is adequately effected? Explain.

Treatment Process Petition Page 6

---

K. POST TREATMENT RECYCLING

K I . Has

a strategy been developed for the recycling of any part of the treated waste?

q

No

q

Yes If yes, please include additional information regarding the strategy.

L. COMPLIANCE WITH MEDICAL WASTE REGULATIONS

LI. Does

your treatment technology meet the requirements of the State's medical waste

regulations for medical waste decontamination and disposal?

? No ? Yes

L2. Which of the following five categories of medical waste will be effectively treated by

your system? (Check all that apply.)

NO YES

a)

Cultures and Stocks

b)

Blood and Blood Products and Body Fluids

c)

Human Anatomical Waste,

Human Tissues and Body Fluids

d)

Sharps

e)

Contaminated Animal Wastes

M. INTERAGENCY COORDINATION

M1. Have you inquired from the States medical waste permit coordinator as to whether any

other permits are required? ? No ? Yes

If yes, please enclose the response and requirements with your application.

NOTE: Local governments may require permits.

Treatment Process Petition Page 8

---

N. POTENTIAL ENVIRONMENTAL BENEFITS

NI. Has an energy analysis been conducted on the proposed technology?

? No ? Yes - If yes, specify and provide results of that analysis.

N2.

Has an economic analysis been performed on the proposed technology?

? No ? Yes - If yes, specify and provide results of that analysis

N3.

How does this treatment technology improve on existing medical waste treatment and

disposal methods?

N4.

What

Specifyis the

potential of this proposed technology for:

0. OTHER

Waste

Recycling?

volume

RELEVANT

Specifyreduction? INFORMATION

Specify AND

COMMENTS

Treatment Process Petition Page 10

---

(Approvals received from other states, operator safety, competency or training requirements for the

users/operators, etc.)

PETITION FOR EVALUATION AND APPROVAL OF

REGULATED MEDICAL WASTE TREATMENT TECHNOLOGY

PART B: ATTACHMENTS

The general information contained in Part A and this check sheet are a required part of

the petition package. These assist the petitioner in submitting the petition and the

Department in its review, and they are supplemental to the required documents listed

below. The complete petition package consists of a completed Part A form, this Part B

check sheet, all the documents listed below, and any other supportive data or information

the petitioner wishes to be considered.

? Petitioner's submittal certification

? Quality Assurance and Quality Control Report

Microbiological testing report

? Material Safety Data Sheets

7 Environmental Protection Agency pesticide registration documents

Treatment Process Petition Page 10

---

? Maintenance manual

? Emergency operations manual

? Operations manual

? Design plans and specification

Treatment Process Petition Page 10

---

. DAR File No. 29215 (Rule R315-316) UT Bull 2006-23 (12/1/2006)

?

Page 1 of 6

OV?

line

Services Agency List Business

DAR File No. 29215

This filing was published in the 12/01/2006, issue, Vol. 2006, No. 23, of the Utah State Bulletin.

[ 12/01/2006 Bulletin Table of Contents I Bulletin Page I Rules Home ]

Environmental Quality, Solid and Hazardous Waste

R315-316

Infectious Waste Requirements

NOTICE OF PROPOSED RULE

DAR File No.: 29215

Filed: 11/09/2006, 03:28

Received by: NL

RULE ANALYSTS

Purpose of the rule or reason for the change:

The rule is changed to make it easer to find requirements for approval of an alternative treatment method and to clarify

storage.

Summary of the rule or change:

Rule language outlining the requirements for an alternative treatment approval is moved from the applicability section to

the treatment and disposal section. Storage wording is clarified.

State statutory or constitutional authorization for this rule:

Section 19-6-105

Anticipated cost or savings to:

the state budget:

The rule change does not affect state agencies and the enforcement and oversight of the rule will not change.

Therefore, no cost or saving impact is anticipated for the state budget.

local governments:

Since the requirements of the rule are clarified and not changed, there is no cost or savings impact anticipated for local

governments.

other persons:

Since the requirements of the rule are clarified and not changed, there is no cost or savings impact anticipated for other

persons.

Compliance costs for affected persons:

httn://www.rules Utah noviniihlirat/hi

illintin/71111R/7/111R17(1117Q71C htm

?

PP-2/0/1/17

---

DAR File No. 29215 (Rule R315-316) UT Bull 2006-23 (12/1/2006)

?

Page 2 of 6

Since the requirements of the rule are clarified and not changed, no compliance cost or savings impact for affected

persons is expected beyond that required by current statute or rule as a result of the proposed rule change.

Comments by the department head on the fiscal impact the rule may have on businesses:

Since the requirements of the rule are clarified and not changed, no compliance

cost

or savings impact for businesses is

expected beyond that required by current statute or rule as a result of the proposed rule change. Dianne R. Nielson,

Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative

Rules, or at:

Environmental Quality

Solid and Hazardous Waste

288 N 1460 W

SALT LAKE

CITY

UT 84116-3231

Direct questions regarding this rule to:

Ralph Bohn at the above address, by phone at 801-538-6794, by FAX at 801-538-6715, or by Internet E-mail at

Rbohn@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no

later than 5:00 p.m. on:

01/02/2007

This rule may become effective on:

01/31/2007

Authorized by:

Dennis Downs, Director

RULE TEXT

R315. Environmental Quality, Solid and Hazardous Waste.

R315-316. Infectious Waste Requirements.

R315-316-1. Applicability.

(1)

The standards of Rule R315-316 apply to:

(a)

any health facility as defined by Subsection 19-6-102(10) that generates more than

2 00 pounds, per month,

of infectious waste as defined by Subsection 19-6-1o2(12);

(b)

any transporter that collects and transports more than

200 pounds of infectious waste in any one load; and

(c)

a storage, treatment, or disposal facility.

•

(2)

The standards of Rule R315-316 do not apply to a

health

facility that generates

200

pounds, or less, of

infectious waste per month.

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---

DAR File No. 29215 (Rule R315-316) UT Bull 2006-23 (12/1/2006)

?

Page 3 of 6

(A)1 ,, ,„„iictd

lai,(

tf S„f11,,tt

(B)

ii„,,e, ihst„,,,,, ed ini,..t,t,..Itcel„,:q„c„,

(C) ,fils.1

lc

a ti.tit

ha be

tl., test orga s,rL;,,tc,1 tc, the ,,,o r ,, „1 Le,

(A) s t.,„toTet5, In—Leh) Etaplgyl„ h„et

9,„„hs (ATCC h538) ar Pscude,(NTCC 15442) at ,.

„,r oft:ohs 9,(„95q996 ;,,h,5...ofthe hi b“,:wra

(B) fac

g

Ibi, uas (ATCC 18804),

(ATCC

E420), r Asp,,,;11..3 Rigel.

use,

,

.„, 1/4,t‘t(

(D) p„zat.,3 C

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F . 6

nAlua.C.

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(E) If

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M r

Ivry

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th,

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(BCC) (ATCC 35743)

at.,

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.

,

(B) Bathe/L;(11

apts

:ce

tb,ria ap„rcl

(ATCC 7933)

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of

ti,, t-4,u1o;,11).

1

R315-316-3. Storage and Containment Requirements.

(i) Containment shall be in a manner and location which affords protection from animal intrusion, does not

provide a breeding place or a food source for insects [tmtHor rodents, and minimizes exposure to the public.

(2)

Unless all waste is considered infectious and labeled as such, infectious waste shall be segregated by

separate containment from other waste [bit

poiot of

9,

;,..eldur-a re.

(3)

Except for sharps, infectious waste shall be contained in plastic bags or inside rigid containers. The bags

shall be securely tied and the containers shall be securely sealed to prevent leakage or expulsion of solid or liquid

wastes during storage, handling, or transport.

(4)

Sharps shall be contained for storage, transportation, treatment, and disposal in leak-proof, rigid, puncture

resistant containers which are taped closed or tightly lidded to preclude loss of contents.

(5)

All containers used for containment of any infectious waste shall he red or orange, or if containers are not

red or orange, shall be clearly identified with the international biohazard sign and one of the following labels:

"INFECTIOUS WASTE", "BIOMEDICAL WASTE", or "BIOHAZARD".

(6) If other waste is placed in the same container as [

,,„lothdd infectious waste, then the generator must

package, label, and mark the container and its entire contents as infectious waste,

HA rigid infectious waste container may be reused for infectious or non-infectious waste if it is thoroughly

washed and decontaminated each time it is emptied or if the surfaces of the container have been completely

protected from contamination by disposable, unpunctured, or undamaged liners, bags, or other devices that are

removed with the infectious waste, and the surface of the liner has not been damaged or punctured.

(8)

Storage and containment areas it „,enthshall: protect infectious waste from the elements[;]; be ventilated to

the outside[;]; be only accessible to authorized persons[;]; and be marked with prominent warning signs on, or

adjacent to, the exterior doors or gates. The warning signs shall contain the international biohazard sign and shall

state: "CAUTION -- INFECTIOUS WASTE STORAGE AREA -- UNAUTHORIZED PERSONS KEEP OLIr and must

be easily read during daylight from a distance of 25 feet.

(9)

If infectious waste is stored longer than seven days, it shall be stored at 40 degrees Fahrenheit (5 degrees

Celsius), or below[ 8.1..;e

he t—ted di:iv/net' within 3 th.r].

htto://www

rules titah

onv/rn 'Hie:at/hi Olefin/70(16/701)61201 /2921 htm

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RK1/71g17

---

OAR File No. 29215 (Rule R315-316) UT Bull 2006-23 (12/1/2006)

?

Page 4 of 6

(io) Under no conditions ma

y

_

infectious waste be stored fur longer than 30 days.

[4(.+H

wi Compactors, grinders, or similar devices shall not he used to reduce the volume of infectious waste

before the waste has been rendered non-infectious unless the device is contained sufficiently to prevent

contamination of the surrounding area.

R315-316-5. Infectious Waste Treatment and Disposal Requirements.

(t) Infectious waste shall be treated or disposed as soon as possible but not to exceed 30 days after generation,

and shall be treated or disposed at a facility with a permit or other form of approval allowing the facility to treat or

dispose infectious waste.

(21(gl All material that has been rendered non infectious through an approved treatment method ma

y

be

handled as non-infectious waste, provided it is not otherwise a hazardous waste or radioactive waste excluded from

disposal in a solid waste facility b y

Rule Rots-116.

tbi Except for incineration and steam sterilization,. no treatment method

,

ma y

be used to render materials non-

in tections without receiving prior approval from the Executive Secretary

[(3ff3) Infectious waste may be incinerated in an incinerator.

(a)

The incinerator shall comply with the requirements of Rule R315-306 and provide complete combustion of

the waste to carbonized or mineralized ash.

(b)

A composite sample of the ash and residues from the incinerator shall be taken at least once each year. The

sample shall be analyzed by the U.S. EPA Test Method 1311 as provided in go CPR Part 261, Appendix II, 1991 ed.,

Toxic Characteristics Leaching Procedure (TCLP) on parameters determined by the Executive Secretary to

determine if it is a hazardous waste. If hazardous, it shall be managed by applicable state regulations.

[(3)][41 Infectious waste may be sterilized by heating in a steam sterilizer to render the waste non-infectious.

(a)

The operator shall have available and shall certify in writing that he understands written operating

procedures for each steam sterilizer, including time, temperature, pressure, type of waste, type of container, closure

on container, pattern of loading, water content, and maximum load quantity.

(b)

Infectious waste shall be subjected to sufficient temperature, pressure and time to inactivate Bacillus

stearothermophilus spores in the center of the waste load at a 6 Log

in reduction or greater.

(c)

Unless a steam sterilizer is equipped to continuously monitor and record temperature and pressure during

the entire length of each sterilization cycle, each package of infectious waste to be sterilized shall have a temperature

sensitive tape or equivalent test material, such as chemical indicators, attached that will indicate if the sterilization

temperature and pressure have been reached. Waste shall not be considered sterilized if the tape or equivalent

indicator fails to indicate that a temperature of at least 25o degrees Fahrenheit (121 degrees Celsius) was reached

during the process.

(d)

Each sterilization unit shall be evaluated for effectiveness with spores of B. stearothermophilus at least once

each 40 hours of operation or each week, whichever is less.

(e) A written log for each load shall be maintained for each sterilization unit which shall contain at a minimum:

(i)

the time of day, date, and operator's name;

(ii)

the amount and type of infectious waste placed in the sterilizer; and

(iii) the temperature and duration of treatment.

s)(a) Alternative treatment methods may be approved on a site-specific basis when the Executive Secrety

finds the proposed alternative treatment method renders the material non-infectious.

(MThe determination shall be based on the results of laboratory tests submitted b y the person proposing the

ose of the treatment ntethod. meeting the follow ingfeonirements:

(i) the laboratory tests shall be conducted:

(A) by qualified laboratory personnel;

http

://www.rules.utah.ciov/oublicat/bulletin/2006/20061201/29215.htm ?

8/3/2007

---

OAR File No. 29215 (Rule R315-316) UT Bull 2006-23 (12/1/2006)

?

Page 5 of 6

0111'01

a

FM/

gilized microbial techniques:

(C) on samples

,

that have been inoculated with the test organ

isms.

then subjected to the_promed treatment

method and processed the same warms

Will

be used in file treatmer*process if ap_proved; and

1) the results of the tests must document that themwmosed treatment method inactivates:

LALveget a ti ve bacteria -

Sta

.

'ivlococc us au mils (ATCC 652B) or PseudoltIonas acrugi nosa

ICC ;54‘in

at_ a n

„reduction otigreateda cry,y929% redu

ction?

eater of the organism popitlation),

(1)Thingi - Candida albican

iATCC

188gMenicillium chrysogentim

LATCC 24790, oi &Tel:gibs niger at a

Lua

u,

reduction or greate

K} viruses - Polio

2,

:

POI 0 '2,, or IS-11

Bacteriophage 15017- t

a tlgio.

reduct ion or greater;

(ILLmrasites - Cryptosporidium sp_p. oocrysts

or Giardia spp. cysts at a 6 Lo

n

to

reduction or greater;

(E4 nwcobacteri a - Mycobacterium terrae, Mycobacterium

phlei. or Mimobacteri

tun

limas (BCC) (MCC 3574a)

at a 6 Log ic

reduction or greater;tand

(B) Bacterial spores - Bacillus stearothermophilus sPoresIATCC: 7053/ or Bacillus subtilis spores (ATCC 105g)

at a

4

Log

ic;

reduction orgreater (a 62_,go% reduction oLgreater of the p_gr

anima population'

(iii) The Executive Secretarishall review the submitted materials and repl

y

in waiting within 4o days of the

reed1Lpi

the submittal.

f(-et-)]

(±t21

infectious waste may be discharged to a sewage treatment system that provides secondary treatment of

waste but only if the waste is liquid or semi-solid and if approved by the operator of the sewage treatment system.

[f5)](7) Infectious waste may be disposed in a permitted Class

I, II,

or V Landfill. Upon entering the landfill, the

transporter of infectious waste shall notify the landfill operator that the load contains infectious waste. The landfill

operator shall abide by the following procedures in the disposition and covering of infectious waste:

(a)

place the infectious waste containers at the bottom of the working face with sufficient care to avoid breaking

them;

(b)

completely cover the infectious waste immediately with a minimum of

12

inches of earth or waste material

containing no infectious waste; and

(c)

not compact the infectious waste until completely covered with

12

inches of earth

or

waste material

containing no infectious waste.

KEY: solid waste management, waste disposal

Date

of Enactment or Last Substantive Amendment: [Octet—.

13, 2003]2007

Notice of Continuation: March

14., 2003

Authorizing, and Implemented or Interpreted Law: 19-6-103

ADDITIONAL INFORMATION

Text to be deleted is struck through and surrounded by brackets (e.g., [cxomploJ). Text to be added is

underlined (e.g.,

example). Older browsers may not depict some or any of these attributes on the screen or when the document is

printed.

For questions regarding the

content

or

application

of this rule, please contact Ralph Bohn at the above address, by

phone at 801-538-6794, by FAX at 801-538-6715, or by Internet E-mail at Rbohn@utah.gov

htto://www.rules.utah.aov/nuhlicat/hullptin/20nRonn617n1 owl

F him

R/2/911117

---

DAR File No. 29215 (Rule R315-316) UT Bull 2006-23 (12/1/2006)

?

Page 6 of 6

For questions about the

rulemaking process,

please contact the Division of Administrative Rules (801-53B-3764).

Please Note:

The Division of Administrative Rules is

NOT

able to answer questions about the content or application of

these administrative rules.

[ 12/01/2006 Bulletin Table of Contents I Bulletin Page I Rules Home ]

Last modified: 11/29/2006 11:05 AM

Utah.gov Home I Utah.gov Terms of Use I Utah.gov Privacy Policy I Utah.gov Accessibility Policy

Copyright © 2007 State of Utah - All rights reserved.

http://www.rules.utah.gov/oublicatibulletin/2006/20061201/29215 htm

?

R/1/911(17

---

R315. Environmental Quality, Solid and Hazardous Waste.

R315-316. Infectious Waste Requirements.

R315-316-1. Applicability.

(1) The standards of Rule R315-316 apply to:

(a) any health facility as defined by Subsection 19-6-

102(10) that generates more than 200 pounds, per month, of

infectious waste as defined by Subsection 19-6-102(12);

(b)

any transporter that collects and transports more than

200 pounds of infectious waste in any one load; and

(c)

a storage, treatment, or disposal facility.

(2) The standards of Rule R315-316 do not apply to a health

facility that generates 200 pounds, or less, of infectious waste

per month.

R315-316-2. General Operational Requirements.

(1) Every facility that generates, transports, stores,

treats, or disposes of infectious waste must prepare and maintain

on file a management plan for the waste that identifies the:

(a)

type and estimated quantity of waste generated or

handled;

(b) segregation, packaging, and labeling procedures;

(c)

collection, storage, and transportation procedures,

including the name of the transporter, to be implemented;

(d)

treatment or disposal methods that will be used, and

disposal facility that will be used; and

(e)

person responsible for the management of the infectious

waste.

(2) All infectious waste generators and handlers shall

report any delivery of unauthorized waste to the local health

department immediately upon recognition.

(3) Infectious waste consisting of recognizable human

anatomical remains including human fetal remains shall be disposed

by incineration or interment.

R315-316-3. Storage and Containment Requirements.

(1)

Containment shall be in a manner and location which

affords protection from animal intrusion, does not provide a

breeding place or a food source for insects or rodents, and

minimizes exposure to the public.

(2)

Unless all waste is considered infectious and labeled as

such, infectious waste shall be segregated by separate containment

from other waste during storage.

(3)

Except for sharps, infectious waste shall be contained

in plastic bags or inside rigid containers. The bags shall be

securely tied and the containers shall be securely sealed to

prevent leakage or expulsion of solid or liquid wastes during

storage, handling, or transport.

(4)

Sharps shall be contained for storage, transportation,

treatment, and disposal in leak-proof, rigid, puncture-resistant

containers which are taped closed or tightly lidded to preclude

loss of contents.

(5)

All containers used for containment of any infectious

waste shall be red or orange, or if containers are not red or

orange, shall be clearly identified with the international

---

biohazard sign and one of the following labels:

?

"INFECTIOUS

WASTE", "BIOMEDICAL WASTE", or "BIOHAZARD".

(6)

If other waste is placed in the same container as

infectious waste, then the generator must package, label, and mark

the container and its entire contents as infectious waste.

(7)

A rigid infectious waste container may be reused for

infectious or non-infectious waste if it is thoroughly washed and

decontaminated each time it is emptied or if the surfaces of the

container have been completely protected from contamination by

disposable, unpunctured, or undamaged liners, bags, or other

devices that are removed with the infectious waste, and the

surface of the liner has not been damaged or punctured.

(8)

Storage and containment areas shall: protect infectious

waste from the elements; be ventilated to the outside; be only

accessible to authorized persons; and be marked with prominent

warning signs on, or adjacent to, the exterior doors or gates.

The warning signs shall contain the international biohazard sign

and shall state: "CAUTION -- INFECTIOUS WASTE STORAGE AREA --

UNAUTHORIZED PERSONS KEEP OUT" and must be easily read during

daylight from a distance of 25 feet.

(9)

If infectious waste is stored longer than seven days, it

shall be stored at 40 degrees Fahrenheit (5 degrees Celsius), or

below.

(10)

Under no conditions may infectious waste be stored for

longer than 30 days.

(11)

Compactors, grinders, or similar devices shall not be

used to reduce the volume of infectious waste before the waste has

been rendered non-infectious unless the device is contained

sufficiently to prevent contamination of the surrounding area.

R315-316-4. Infectious Waste Transportation Requirements.

(1) Infectious waste shall not be transported in the same

vehicle with other waste unless the infectious waste is contained

in a separate, fully enclosed leak-proof container within the

vehicle compartment or unless all of the waste is to be treated as

infectious waste in accordance with this section.

(2)

?

Persons manually loading or unloading containers of

Infectious waste onto or from transport vehicles shall:

(a)

be trained in the proper use of protective equipment;

(b)

have available and easily accessible at all times

puncture resistant gloves and shoes, shatterproof glasses, and

coveralls; and

(c)

have face shields and respirators available as deemed

necessary by the transporter.

(d)

Protective gear that becomes soiled shall be

decontaminated or disposed as infectious waste.

(3) Surfaces of transport vehicles that have contacted

spilled or leaked infectious waste shall be decontaminated by

procedures approved by the Executive Secretary.

(4)?

Transport vehicles transporting infectious waste shall

meet all warning requirements of the Department of Transportation.

(5) Each truck, trailer, or semitrailer, or container used

for transporting infectious waste shall be so designed and

constructed, and its contents limited so that under conditions

---

normally incident to transportation, there shall be no releases of

infectious waste to the environment.

(6)

Any truck, trailer, semitrailer, or container used for

transporting infectious waste shall be free from leaks, and all

discharge openings shall be securely closed during transportation.

(7)

No person shall transport infectious waste into the

state for treatment, storage,

or

disposal unless the waste is

packaged, contained, labeled and transported in the manner

required by this section.

(8)

All transporter vehicles shall carry a spill containment

and cleanup kit and the transport workers shall be trained in

spill containment and cleanup procedures.

R315-316-5. Infectious Waste Treatment and Disposal Requirements.

(1) Infectious waste shall be treated or disposed as soon as

possible but not to exceed 30 days after generation, and shall be

treated or disposed at a facility with a permit or other form of

approval allowing the facility to treat or dispose infectious

waste.

(2)(a) All material that has been rendered non-infectious

through an approved treatment method may be handled as non-

infectious waste, provided it is not otherwise a hazardous waste

or radioactive waste excluded from disposal in a solid waste

facility by Rule R315-316.

(b) Except for incineration and steam sterilization, no

treatment method may be used to render materials non-infectious

without receiving prior approval from the Executive Secretary.

(3) Infectious waste may be incinerated in an incinerator.

(a)

The incinerator shall comply with the requirements of

Rule R315-306 and provide complete combustion of the waste to

carbonized or mineralized ash.

(b) A composite sample of the ash and residues from the

incinerator shall be taken at least once each year. The sample

shall be analyzed by the U.S. EPA Test Method 1311 as provided in

40 CFR Part 261, Appendix II, 1991 ed., Toxic Characteristics

Leaching Procedure (TCLP) on parameters determined by the

Executive Secretary to determine if it is a hazardous waste. If

hazardous, it shall be managed by applicable state regulations.

(4) Infectious waste may be sterilized by heating in a steam

sterilizer to render the waste non-infectious.

(a)

The operator shall have available and shall certify in

writing that he understands written operating procedures for each

steam sterilizer, including time, temperature, pressure, type of

waste, type of container, closure on container, pattern of

loading, water content, and maximum load quantity.

(b)

Infectious waste shall be subjected to sufficient

temperature, pressure and time to inactivate Bacillus

stearothermophilus spores in the center of the waste load at a 6

Log, reduction or greater.

(c) Unless a steam sterilizer is equipped to continuously

monitor and record temperature and pressure during the entire

length of each sterilization cycle, each package of infectious

waste to be sterilized shall have a temperature sensitive tape or

equivalent test material, such as chemical indicators, attached

---

that will indicate if the sterilization temperature and pressure

have been reached. Waste shall not be considered sterilized if

the tape or equivalent indicator fails to indicate that a

temperature of at least 250 degrees Fahrenheit (121 degrees

Celsius) was reached during the process.

(d)

Each sterilization unit shall be evaluated for

effectiveness with spores of B. stearothermophilus at least once

each 40 hours of operation or each week, whichever is less.

(e)

A written log for each load shall be maintained for each

sterilization unit which shall contain at a minimum:

(i)

the time of day, date, and operator's name;

(ii)

the amount and type of infectious waste placed in the

sterilizer; and

(iii)

the temperature and duration of treatment.

(5)(a) Alternative treatment methods may be approved on a

site-specific basis when the Executive Secretary finds the

proposed alternative treatment method renders the material non-

infectious.

(b) The determination shall be based on the results of

laboratory tests, submitted by the person proposing the use of the

treatment method, meeting the following requirements:

(i) the laboratory tests shall be conducted:

(A) by qualified laboratory personnel;

(B)

using recognized microbial techniques;

(C) on samples that have been inoculated with the test

organisms, then subjected to the proposed treatment method and

processed the same way as will be used in the treatment process if

approved; and

(ii)?

the results of the tests must document that the

proposed treatment method inactivates:

(A) vegetative bacteria - Staphylococcus aureus (ATCC 6538)

or Pseudomonas aeruginosa (ATCC 15442) at a 6

Log10 reduction or

greater (a 99.9999% reduction or greater of the organism

population);

(B)

fungi - Candida albicans (ATCC 18804), Penicillium

chrysogenum (ATCC 24791), or Aspergillus niger at a 6 Log10

reduction or greater;

(C) viruses - Polio 2, Polio 3, or MS-2 Bacteriophage

(ATCC15597-B1) at a 6

Log10 reduction or greater;

(D) parasites - Cryptosporidium spp. oocysts or Giardia spp.

cysts at a 6 Log10

reduction or greater;

(E) mycobacteria - Mycobacterium terrae, Mycobacterium

phlei, or Mycobacterium bovis (BCG) (ATCC 35743) at a 6 Log10

reduction or greater; and

(B) Bacterial spores - Bacillus stearothermophilus spores

(ATCC 7953) or Bacillus subtilis spores (ATCC 19659) at a 4 Log10

reduction or greater (a 99.99% reduction or greater of the

organism population).

(iii) The Executive Secretary shall review the submitted

materials and reply in writing within 30 days of the receipt of

the submittal.

(6) Infectious waste may be discharged to a sewage treatment

system that provides secondary treatment of waste but only if the

waste is liquid or semi-solid and if approved by the operator of

---

the sewage treatment system.

(7) Infectious waste may be disposed in a permitted Class I,

II, or V Landfill. Upon entering the landfill, the transporter of

infectious waste shall notify the landfill operator that the load

contains infectious waste. The landfill operator shall abide by

the following procedures in the disposition and covering of

infectious waste:

(a)

place the infectious waste containers at the bottom of

the working face with sufficient care to avoid breaking them;

(b) completely cover the infectious waste immediately with a

minimum of

12

inches of earth or waste material containing no

infectious waste; and

(c) not compact the infectious waste until completely

covered with 12 inches of earth or waste material containing no

infectious waste.

KEY: solid waste management, waste disposal

Date of Enactment or Last Substantive Amendment: February 1, 2007

Notice of Continuation: March 14, 2003

Authorizing, and Implemented or Interpreted Law: 19-6-105

---

PUMIC REAM..

T.

VETERINARY MEDICIPRL

MILITARY

MEDICINE

DEVELOPING WORLD ITFAITH

BMTS

?

Page 1 of 1

WHAT WE Do

...maselgraorescsi-e

BioMedical

El?

Technology Solutions, Inc.

W

innovative solutions to biomedical waste management

BioMedical Technology Solutions, Inc.

9800 Mt. Pyramid Court, Suite 350

Englewood, CO 80112

Toll Free: 866.525.BMTS1i

,

1ione. 803-653-01001 Fax: 303-653-0120

Who We Are 1 What We Do I Clinical Solutions i Long Term Care I Home Health

Public Health 1 Veterinary Medicine 1 Military Medicine 1 Developing World Health 1 Environmental Responsibility I Cont

@BioMedical Technology Solutions, Inc

2007. All Rights Reserved.

all1■111111111aaalliallal

EXHIBIT B

http://www.bmtscorp.com/index.htm

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8/2/2007

---

BMTS - Federal Compliance

Page 1 of 1

BIOMEDICAL TECHNOLOGY SO

Innovative solutions to biomedical waste ma

▪

Home

w Who We Are

0 What We Do

Clinical Solutions

▪ Long-Term Care

0" Home Health

O Public Health

•

Veterinary Medicine

Pr

Military Medicine

w

Developing World Healthcare

•

Environmental Responsibility

Regulatory Compliance

The Demolizer® II system is designed to meet or exceed the standards or

guidelines for biomedical waste treatment by the EPA, CDC and OSHA.

Laws and regulations for medical waste treatment and disposal are

managed at the state or local level. The Demolizer® technology has been

reviewed by over 76 governmental agencies and is either formallly approved

or meets regualatory requriements for treatment in 46 U.S. Mates.

U S State Regulatory Compliance

Safety

Simplicity

Savings

Operation

Applications

Specification:

Performance

Technical Su

Perpetual Lia

Regulatory

Compliance

State Approv

Collector Tec

Patents

View Demoli;

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Public Health 1 Veterinary Medicine I Military Medicine 1 Developing World Health 1 Environmental Responsibility 1 Contai

BioMedical Technology Solutions, Inc..

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111 Approved or meet Blab requirement's

q

Approval in prowl;

BMTS - State Approvals

Page 1 of 2

E3NAMS

„

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4'

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BIOMEDICAL TECHNOLOGY SO

Innovative solutions to biomedical waste ma

•

Home

•

Who We Are

• What We Do

• Clinical Solutions

• Long-Term Care

• Home Health

•

Public Health

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Veterinary Medicine

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Military Medicine

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Developing World Healthcare

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Environmental Responsibility

State Approvals

The Demolizer® system is approved or meets the regulatory requirements

for treatment as an alternative medical waste treatment device in the

following states

1 The Demolizer® system is either formally approved or meets the

requirements for medical waste treatment and disposal in 46 U.S. states.

The information above is not intended to be an endorsement of the

Demolizer® technology by any state or local agency.

For more information on the use of the Demolizer® II System in your

location, please complete the form below or contact BMTS at 1-866-525-

BMTS.

Safety

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Corngiance

State Approv

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= Required Item

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Address

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Zip Code

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SNITS - State Approvals

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Page 2 of 2

Telephone

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Preferred Means of Delivery (email, fax, post):

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(;)BioMedical Technology Solutions, Inc.,

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8/2/2007

---

William D. Ingersoll

CERTIFICATE OF SERVICE

I, the undersigned attorney at law, hereby certify that on December 26, 2007 I

served A true and correct copy of the

AMENDED RECOMMENDATION OF THE

ILLINOIS EPA,

by placing true and correct copies in properly sealed and addressed

envelope and by depositing said sealed envelope in a U.S. mail drop box located within

Springfield, Illinois, with sufficient

following named persons:

Dorothy M. Gunn, Clerk

Illinois Pollution Control Board

James R. Thompson Center

100 West Randolph Street

Suite 11-500

Chicago, IL 60601

Certified Mail postage affixed thereto, upon the

GREENBERG TRAURIG, LLP

Attn: Neal H. Weinfield , Esq.

77 West Wacker Drive, Suite 2500

Chicago, Illinois 60601

This filing submitted on recycled paper.