13B_.1200_HearingOfficersReport

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HEARING OFFICER'S REPORT OF PROCEEDINGS OF
PUBLIC HEARING AND COMMENT PERIOD
Readoption and Amendments to
15A NCAC 13B .1201 - .1207 Medical Waste Management
Environmental Management Commission
August 28, 2019

FTIM
Basic Information
Commission: Environmental Management Commission
Groundwater and Waste Management Committee
Agency Department of Environmental Quality, Division of Waste Management,
Solid Waste Section
Title Medical Waste Management
Citations 15A NCAC 13B .1201 - .1207
Description of the It is the responsibility of the Division of Waste Management Solid Waste
Proposed Rules Section to regulate how solid waste is managed within the state under the
statutory authority of the Solid Waste Management Act, Article 9 of Chapter
130A of the General Statutes. State rules governing solid waste
management are found in Title 15A, Subchapter 13B of the North Carolina
Administrative Code. Rules adopted under the authority of 130A-309.26
which collectively establish standards for the transportation, storage,
treatment, and disposal of medical waste are found in Subchapter 1313,
Rules .1201 - .1207 Medical Waste Management.
Agency Contact Jessica Montie
Environmental Program Consultant
Jessica. [e-mail]
[phone]
Authority G.S. 130A-309.26; G.S. 15013-21.3A
Statement of Necessity Rules .1201 - .1204 are proposed for readoption in accordance with G.S.
15013-21.3A. Rules .1205 - .1207 are proposed for repeal, with the
requirements being consolidated into Rules .1202 - .1204.
Hearing Officer EMC Commissioner Steve Keen
Comment Period June 17, 2019 to August 16, 2019
Public Hearing July 9, 2019
Comment Summary One comment was received on the proposed rules at the public hearing in
general support of the rule changes. One comment letter was received via
e-mail on the proposed rules during the public comment period. One
comment letter was received prior to the comment period and the
comments were addressed in the amendments made prior to publication.
Appendices 1 — Agency Head Certification
2 — Hearing Officer Designation Memo
3 — Notice of Text Published in the NC Register
4 — Hearing Transcript and Attendance Sheet
5 — Comment Letters Received
6 — Rule Text for Adoption

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Rule Summary and Backaround
It is the responsibility of the Division of Waste Management (Division) Solid Waste Section
(Section) to regulate how solid waste is managed within the state under the statutory authority of
the Solid Waste Management Act, Article 9 of Chapter 130A of the General Statutes. State rules
governing solid waste management are found in Title 15A, Subchapter 13B of the North Carolina
Administrative Code. Rules adopted under the authority of 130A-309.26 which collectively
establish standards for the transportation, storage, treatment, and disposal of medical waste are
found in Subchapter 13B, Rules .1201 -.1207 Medical Waste Management.
Rules .1201 through .1207 are proposed for readoption pursuant to G.S. 150B-21.3A, and are
required to be readopted by the Environmental Management Commission (EMC) by the deadline
established by the Rules Review Commission (RRC) of April 30, 2021. General amendments to
the rules include consolidation of the rule requirements into Rules .1201 through .1204 and repeal
of Rules .1205 through .1207, technical corrections, updates to information such as Department
names, addresses, websites, and references, and removal of redundant or unnecessary
language. Amendments were made prior to the rule -making process to time limits and
refrigeration requirements in response to comments received from stakeholders in 2016.
Amendments also include clarification for the following:
• facility operations plan requirements;
• locations where medical waste is temporarily stored or transferred between vehicles
during shipping;
• process for alternative treatment method requests;
• disposal options for noninfectious medical waste, trace chemotherapy waste, and non-
hazardous pharmaceutical waste;
• packaging requirements to be consistent with CFR and allow some exceptions for
generator -loaded trailers; and
• requirements for using ozonation as another optional method for treatment.
The North Carolina Office of State Budget and Management approved the Regulatory and Fiscal
Impact Analysis for these rules on February 21, 2019, and the analysis indicated a minor impact
to state government, no impact to local government, and no substantial economic impact as a
result of the amendments, but a net benefit to the regulated community.
Public Comment and Hearing
The proposed rules and the Regulatory Impact Analysis were approved by the EMC to proceed
to public comment and hearing at the May 9, 2019 EMC meeting, and Commissioner Steve Keen
was designated as the hearing officer. The Agency Certification and Hearing Officer Designation
Memo are included in Appendix 1 and 2, respectively.
The proposed rules were published in the NC Register, and the proposed rules and Regulatory
Impact Analysis were published on the Department of Environmental Quality's (DEQ) website
throughout the public comment period from June 17, 2019 through August 16, 2019. The Notice
of Text as published in the NC Register (Volume 33 Issue 24, pages 2365 - 2373) is included in
Appendix 3.

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The Division also sent a link to the published notice and regulatory impact analysis for public
comment to interested parties including industry stakeholders, environmental groups, solid waste
management organizations, licensing boards, the League of Municipalities, the Association of
County Commissioners, and other state agencies such as the Department of Health and Human
Services via e-mail on June 14, 2019.
Public Hearin
The public hearing took place on July 9, 2019 at 6:00 p.m. at 217 West Jones Street, Raleigh.
Commissioner Steve Keen served as the hearing officer for the public hearing. The hearing
transcript and attendance sheet can be found in Appendix 6. Don Nuss with Stericycle, Inc.
attended the hearing. Mr. Nuss provided a comment in support of the rules as published and
thanked staff for their efforts in working with stakeholders to draft the rules.
Public Comments Received
The following comments were received either prior to beginning the rule -making process or during
the comment period. Comments received prior to the rule -making process were addressed in the
amendments to the rules prior to publication. Copies of the comment letters are included in
Appendix 5.
Comment #1: Submitted Prior to the Rule -making Process
Submitted By. Alan H. McConnell, Kilpatrick, Townsend, and Stockton, LLP, Counsel for
Stericycle, Inc.
Date: June 27, 2016
Comment: The comment letter expressed concerns regarding various requirements for storage
and refrigeration time limits throughout the existing rules.
Agency Response: The Division of Waste Management held eight stakeholder meetings between
June 19, 2017 and April 10, 2018, both in person and by conference call, with various
stakeholders that included staff representing Stericycle, Inc. A summary of the stakeholder
meetings can be found on the Section's website at https://deg.nc.gov/about/divisions/waste-
management/solid-waste-section/rules-review#medical-waste. The comments were discussed
and the rule amendments were drafted during these stakeholder meetings, and the amendments
were made to the rules prior to presentation of the proposed rules at the May 9, 2019 EMC
meeting and subsequent publication for comment.
Comment #2: Submitted During the Public Comment Period
Submitted By: Cara Simaga, Director of Government Affairs, Stericycle, Inc.
Date: August 16, 2019
Comment:
"We are extremely grateful to have had the opportunity to work with the Division and other
stakeholders to make the modifications and clarifications needed to improve the medical waste
regulations in the State. We appreciate the recommendations the Division has already
incorporated into the proposed regulations, however, have the following comments specifically
related to customer -loaded trailers under 15A NCAC 1313.1203(a)(9).

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This section currently states:
`The requirement in Part (E) of this Subparagraph does not apply to customer -loaded
trailers, except that all packages accessible from the cargo area door(s) shall be marked
with the date of shipment from the generator prior to transport from the generating facility.
The remaining medical waste packages shall be marked with the date of shipment from
the generator when they are removed from the customer loaded trailer unless the medical
waste packages are treated at that site within 24 hours.'
Part (E) in the above proposed text refers to the date of shipment from the generating facility.
During the stakeholder discussions we expressed to the Division that the regulations as related
to customer -loaded trailers were problematic for transporters and treatment facilities to comply
with because they do not fully offload all waste to observe it before transporting. This section tried
to take this request into consideration however it does not contemplate when waste may be
offloaded temporarily to be transferred to another treatment facility. For example, a customer -
loaded trailer may be loaded with medical waste that needs to be sent for incineration such as
pathological waste, but also be loaded with sharps waste that can be autoclaved. Such a trailer
may first arrive at an autoclave facility where the sharps waste is removed for treatment, but the
pathological waste would need to be transferred to an incineration facility. This takes additional
time during transport and treatment and the 24-hour requirement would be impractical to comply
with.
Part (E) of this subpart also requires that the date of shipment from the generator be physically
written on the container. Many transporters and treatment facilities now utilize technology (such
as barcoded containers or labels) to track containers through the shipment process. For example,
Stericycle utilizes a proprietary Biotrack system where the generator information, container
content, and the shipping document is fully imbedded in the barcode on the container. This
enables us to track the container through each of our systems to final treatment. This also allows
us to have the generator ship date electronically available at any point to an inspector.
Based on these two factors we would request the following be taken into consideration:
Allow for electronic tracking to be able to provide adequate compliance with the date
tracking requirement. This information is more impactful and reliable than if it were
handwritten as the date it was shipped.
For those facilities where an electronic option is not available, that the time be extended
to 72 hours to provide for adequate time to transfer and treat waste. After 72 hours the
waste would have to be marked properly with the date of shipment.
Please see the recommended modification to the language for the section below with changes in
bold:
`The requirement in Part (E) of this Subparagraph does not apply to customer -loaded
trailers, except that all packages accessible from the cargo area door(s) shall be marked
with the date of shipment from the generator prior to transport from the generating facility.
Where available the medical waste transfer or storage operation can provide
electronic records to document the date of shipment of undated containers. If
electronic records are not available, the remaining medical waste packages shall be
marked with the date of shipment from the generator when they are removed from the
customer loaded trailer unless the medical waste packages are treated at that site within
24 hours, or are transferred to be treated at another permitted treatment facility
within 72 hours."'

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Agency Response: The Division engaged in continued discussion with Stericycle, Inc. staff
following the submittal of the comment. Based on further discussion, the Division is addressing
this comment by revising Rule .1203(a)(9)(D) and (E) to allow exemptions to the requirement for
package labels on all packages to contain the treatment facility contact information and the date
of shipment, if the package label contains a tracking number that can be matched to a record that
contains this information, and the facility or transporter will provide that information during an
inspection and upon request. The Division is also revising Rule .1204(b)(4)(H) to require that a
contingency plan for a facility and transporter contain an emergency contact number that is
available 24 hours a day, 7 days per week to provide this information, if needed. The proposed
paragraph at the end of Rule .1203(a)(9) allowing the exemption only for generator -loaded trailers
is being removed because the revisions described above allow the exemptions for all packages
if they are tracked with a tracking number.
Summary
One comment letter was submitted in 2016 on behalf of Stericycle, Inc., and the comments were
addressed in the amendments as published. One comment was provided by Stericycle, Inc at the
public hearing in general support of the rule amendments, and one comment was submitted by
Stericycle, Inc. via e-mail during the public comment period with a requested change to Rule
.1203(a)(9), regarding the date labeling of packages on trailers loaded by the generator. Rule
.1203(a)(9) is being revised after the comment period to address the comment, and the Division
also chose to make some minor technical corrections and clarifications to the Rules after the
comment period. These changes are highlighted in the rule text for adoption provided in Appendix
6. These changes are not expected to affect the fiscal impact of the rule amendments, therefore
the regulatory impact analysis was not changed from what was published on the DEQ website
during the comment period.
Hearing Officer's Recommendation
The Hearing Officer's Recommendation is that the Environmental Management Commission
readopt 15A NCAC 13B Rules .1201 through .1204 and repeal Rules .1205 through .1207, as
provided in Appendix 6 with minor changes in response to a comment, and for clarification after
publication in the NC Register.

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APPENDIX 1
Agency Head Certification

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CERTIFICATION OF THE AGENCY HEAD
REGARDING COMPLETION OF A FISCAL NOTE AND RULE ANALYSIS
IN RE: 15A NCAC 13B .1201 - .1207 Medical Waste Management
FINDINGS
The Chair of the North Carolina Environmental Management Commission ("the
Commission") is appointed by the Governor to guide and coordinate the activities of the
Commission in fulfilling its duties. G.S. § 143B-284.
The Commission has the power and duty to promulgate rules to be followed in the
protection, preservation, and enhancement of the water and air resources of the State.
G.S. § 143B-.282(a).
The undersigned Chair of the North Carolina Environmental Management Commission
hereby certifies that the attached rules comply with the rulemaking principles set out in
Executive Order No. 70 as amended by Executive Order 48 (2014). The Chair specifically
certifies the following:
1. The attached rules are necessary because the rules are
required by federal law, citation:
x required by state law, citation: G.S. 150B-21.3A
x deemed necessary by the agency to serve the public interest
2. These rules were based on sound, reasonably available scientific, technical,
economic, and other relevant information that can be found in the rulemaking
record. The rulemaking record can be found in the minutes of the Commission and
in supporting documents. Those documents can be found on the Division of Waste
Resource's webpage at http://deq.nc.gov/about/divisions/water-resources/water-
resources-commissions/environmental-management-commission, or may be
requested from the Clerk of the North Carolina Environmental Management
Commission at [e-mail].
3. The fiscal impacts of the rules have been analyzed and appropriate action taken
as follows:
The Commission determined that no fiscal note was required under G.S. §
150B-21.4; or
x A fiscal note has been prepared and approved by the Office of State Budget
and Management in accordance with G.S. § 15013-21.4. A copy of the fiscal
note can be found in the rulemaking record at the locations described in (2)
above.
4. The rules meet all other requirements of Executive Order No. 70.

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Based upon the foregoing Findings, and pursuant to the requirements of the North
Carolina Administrative Procedures Act and Executive Order No. 70, the undersigned
makes the following:
CERTIFICATION
The following proposed rules, 15A NCAC 13B .1201 - .1207, entitled "Medical
Waste Management", are in compliance with Executive Order No. 70.
This, the 9th day of May 2019 at Raleigh, North Carolina.
Chair
North Carolina Environmental Management Commission

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APPENDIX 2
Hearing Officer Designation Memo

ENVIRONMENTAL MANAGEMENT COMMISSION
NORTH CAROLINA
DEPARTMENT OF ENVIRONMENTAL QUALITY
Roy Cooper, Governor
Michael S. Regan, Secretary
May 21, 2019
MEMORANDUM
To: Steve P. Keen
David W. Anderson
Gerard P. Carroll
Charles Carter
Marion Deerhake
Charles B. Elam
Mitch Gillespie
Steve Keen
Member of the Environmental Management Commission
From: Dr. A. Stanley Meibur� � " "`
Chairman of Environmental Management Commission
Subject: Hearing Officer Appointment
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John D. Solomon
Chairman
Julie A. Wilsey
Vice Chairman
Dr. Suzanne Lazorick
Dr. Stan Meiburg
Manning Puette
Dr. Albert R. Rubin
Clyde E. Smith, Jr.
Richard Whisnant
A public hearing has been scheduled for July 9, 2019 at 6:00 p.m. in the Training Room
(Room 1210) of the Green Square building located at 217 West Jones Street, Raleigh to accept
comments on the proposed amendments and readoption of 15A NCAC 13B Section .1200
Medical Waste Management rules.
I am hereby appointing you to serve as hearing officer for this hearing. Please receive all
relevant public comment and report your findings and recommendations to the Environmental
Management Commission. Ms. Jessica Montie will provide staff support for you.
If you have any questions, please feel free to contact Jessica Montie at [phone].
ASM/lct
cc: Lois Thomas
Jessica Montie
Hearing Record

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APPENDIX 3
Notice of Text Published in the NC Register

TITLE 15A — DEPARTMENT OF ENVIRONMENTAL QUALITY A-13
Notice is hereby given in accordance with G.S. 150B-21.3A(c)(2)g. that the Environmental Management Commission intends to readopt
with substantive changes the rules cited as 15A NCAC 13B .1201-.1204 and repeal through readoption the rules cited as 15A NCAC
13B .1205-.1207.
Pursuant to G.S. 150B-21.17, the Codifier has determined it impractical to publish the text of rules proposed for repeal unless the
agency requests otherwise. The text of the rule(s) are available on the OAHwebsite at http:11reports.oah.state.nc.us/ncac.asp.
Link to agency website pursuant to G.S. 15011-19.1(c): https:lldeq.nc.gov/permits-regulations/rules-regulations/proposed-main
Proposed Effective Date: November 1, 2019
Public Hearing:
Date: July 9, 2019
Time: 6: 00 p.m.
Location: NCDEQ Green Square Building, 217 West Jones Street, Raleigh, NC 27603, Room 1210
Reason for Proposed Action: Rules 15A NCAC 13B. 1201-3207 Medical Waste Management are proposed for readoption to comply
with the Rule Review requirements pursuant to G.S. 150B-21.3A. Proposed amendments to the rules will provide clarification based on
stakeholder input to the requirements for packaging, temporary storage locations, the use of ozonation as a treatment method, and
disposal options for noninfectious medical waste, trace chemotherapy waste, and non -hazardous pharmaceutical waste. Proposed
amendments will also give clarification on facility operations plan requirements, the process for submitting alternative treatment method
requests, make technical corrections and provide updates to general information, give clarification of vague or unclear language, and
remove redundant or unnecessary language by consolidating the seven rules into four rules.
Comments may be submitted to: Jessica Montie, NC DEQ Division of Waste Management, Attn: Jessica Montie, 1646 Mail Service
Center, Raleigh, NC 27699-1646; phone [phone]; emailjessica. [e-mail]
Comment period ends: August 16, 2019
Procedure for Subjecting a Proposed Rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a
person may also submit written objections to the Rules Review Commission after the adoption of the Rule. If the Rules Review
Commission receives written and signed objections after the adoption of the Rule in accordance with G.S. 150B-21.3(b2) from 10 or
more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become
effective as provided in G.S. 150B-21.3(bl). The Commission will receive written objections until 5:00 p.m. on the day following the
day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or
facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a
Commission staff attorney at 919-431-3000.
Fiscal impact. Does any rule or combination of rules in this notice create an economic impact? Check all that apply.
® State funds affected
❑ Local funds affected
❑ Substantial economic impact (>= $1,000,000)
® Approved by OSBM
❑ No fiscal note required
CHAPTER 13 - SOLID WASTE MANAGEMENT
SUBCHAPTER 13B - SOLID WASTE MANAGEMENT
SECTION .1200 - MEDICAL WASTE MANAGEMENT
15A NCAC 13B .1201 DEFINITIONS
For the purpose of the this Section, the following definitions apply:
(1) 'Blood and body fluids" means liquid blood, serum, plasma, other blood products, emulsified human tissue, spinal
fluids, and pleural and peritoneal fluids. Blood and body fluids does not include dialysates, feces, or urine if not
removed during surgeries and autopsies. Duly"^`^" are not blood or body fl„:a^ under this definition.
(2) "Generator" and "Generating facility" means mean any business, integrated medical facility, and volunteer or non-
profit healthcare services where medical waste is produced, first beeames ^ waste, including bu4 not limited any
medical or dental facility, mortuary, funeral home, laboratory, veterinary hospital hospital, and blood bai4E. bank; but
does not include households.
(3) "Integrated medical facility" means one or more health service facilities as defined in G.S. 131E-176(9b) that are:
(a) located in a single county or two contiguous counties;

(b) affiliated with a university medical school or that are under common ownership and control; and
(c) serve a single service area. A-14
(4) "Medical waste" as means the term defined in G.S. 130A-290(17a). 128 A 1080 oT
(5) "Microbiological waste" means the term defined in Rule .0101(26) of this Subchapter. etti ifes and steeks e fin f etie
ifid'astfial laboratories.
(6) "Mier-owave tfea4mei-A" means treatment by mier-owa-ve energy faf sufAeient time to render- waste nan infeetious.
"09 " " "
-site �e�ns�s�te�*�i is-n�rs�te (9) "Off site" means the same or geographically contiguous property which may be divided by public or private
right of .
"Non -hazardous pharmaceutical waste" is a medical waste. It is a medical drug that is expired, unused, contaminated,
damaged, or no longer needed or used for its prescribed purpose and that is not a hazardous waste as defined in G.S.
130A-290(8).
"Nuisance" means odorous outside of the property boundary or transport vehicle; or attracting vermin or disease
vectors.
"Package" is the total contents of a box, drum, or vessel containing medical waste, including labeling and markings.
(9) "Pathological waste" means the term defined in Rule .0101(31) of this Subchapter.' *man tissues er-gans and body
humans.pa-14s; and the eafeasses and body pa-i4s of all animals tha4 were knewn to have been exposed to pathogens that afe
potentially dangerous to huma-as dufing r-eseafeh, wer-e used in the production of biolegieals or in vive testing of
phafmaeeu4ieals, or- thm died with a Ime3A% or- suspeeted disease transmissible to
"Record" means any data required to be kept on file by the operator or submitted to the Division in accordance with
the rules of this Section. A record may be in hard cope. (paper) or electronic format that is legible and in English.
tUl 40) "Regulated Medical Waste" means the term defined in Rule .0101(34) of this Subchapter. blood and body fluids : ,
individual containers in volumes greater than 20 ml, microbiological waste, and pathologieal waste that have not been
treated ptwsuant to Rule .1207 of this Section,
12 "Responsible party" means the entity that is in possession of and has accepted the regulated medical waste.
13 ""Sharps" means the term defined is G.S. 130A-309.26(a)(1). and ineludes needles syFinges with aftae oa needles,
eapillaFy nibes, slides and o
r- slips, and sealpel blades.
14 "Trace chemotherapy waste" means no more than three percent by weight of a medical drug used for chemotherapy.
Trace chemotherapy waste includes gowns, gloves, wipes, and other handling, preparation, administration, cleaning,
and decontamination items associated with chemotherapy.
"Transfer or storage operations" is the act of, and process by which, regulated medical waste is removed from a
transport vehicle and placed in another transport vehicle or in storage awaiting transport.
"Transport vehicle" means a vehicle or other conveyance type used to transport regulated medical waste to and from
transfer or storage operations or to and from a treatment facility,
tU7 42-) "Treatment" as means the term defined in G.S. 130A-309.26(a)(2).
"Treatment facility" means a regulated medical waste treatment facility_ permitted by the Division in accordance with
the rules of this Subchapter.
19 "Solid waste" means the term defined in G.S. 130A-290(a)(35).
History Note: Authority G.S. 130A-309.26;
Eff. October 1, 1990;
Amended Eff.' April 1, 1993. 1993:
Readopted Eff.' November 1, 2019.
15A NCAC 13B .1202 GENERAL REQUIREMENTS FOR MEDICAL WASTE
(a) Medical waste is subject to the requirements i all applicable rules in 15A NCAC 4-3$ 13B, "Solid Waste Management."
(b) Sharps and other sharp objects such as syringes with attached needles, capillary tubes, slides and cover slips, lancets, auto injectors,
connection needles and sets, exposed ends of dental wires, and objects that can penetrate the skin A4 the gene .a4ing f edit ..,>,alT. , shall
be placed in a rigid, leak -proof when in an upright position, and puncture -resistant container, and eant inn . „-hie, is -igid leak „roof
when in an upright position and ..,.tufe resistant. Contained s,.aps shall not be compacted prior to off -site tt
transportation unless placed in a sealed compactor unit that is hauled off for disposal by the transporter. After- . lea-ving the generating
faeility, the eantainer- and its eentents shall be handled in a manner- tha4 a -voids human eantaet with the •
(c) Blood and body fluids in individual containers in volumes of 20 milliliters frA or less whieh afe net stored in a seeufed area -est iet
to authorized personnel prior- to off site transportation shall be packaged —in ae-eener-d—manee-e-, ivith the regula4ed medical waste packaging
aments as described in Rule .1204(a)(1) of this Section or in a container suitable for sharps. Containers of blood and body fluids
which are packaged in accordance with Rule .1204(a)(1) of this Section or in a container siiitable for sharps as required by this Rule
shall be stored in a secured area and shall not be compacted prior to off -site transportation.
(d) Regulated medical waste shall not be compacted. compacted prior to treatment.
(e) Only the resnonsible nartv or their desienated renresentative shall have access to regulated medical waste
(f) Medical waste shall not become putrescent. Putrescent medical waste shall be disposed of or treated within three calendar days.
(a) Medical waste shall not become a nuisance.
(h) Medical waste accented at transfer or storage operations or a treatment facilitv shall not be subiect to the reauirements of Rule
.1203(a) and (b)(2) of this Section.
(i) Medical waste treatment and disposal methods:

Blood and body fluids in individual containers in volumes greater than 20 milliliters shall be disposed of by sanitary
sewer if the local sewage treatment authority has been notified; or treated by incineration or steam sterile - on.
Microbiological waste shall be treated by incineration, steam sterilization, ozonation, microwave, or chemical
treatment.
Non -hazardous pharmaceutical waste shall be treated by incineration, returned to the vendor, reused, or disposed of
at a municipal solid waste landfill.
Pathological waste shall be treated by incineration or ozonation.
Trace chemotherapy waste shall be treated by incineration or ozonation.
Noninfectious medical waste and blood and body fluids in individual containers in volumes of 20 ml or less may be
recycled, disposed of in a municipal solid waste landfill or sanitary sewer, or treated by the treatment methods as
described in this Paragraph.
(i) Medical waste treated at the generatingfacility acility is not subject to the requirements of Paragraphs (o) (P), and (q) of this Rule, and
Rule .1204(b)(1), (b)(3), and (b)(8) of this Section.
(k) Crematoriums are not subject to the requirements of this Section.
(1) Transport vehicles, transfer or storage operations, and treatment facilities shall:
be kept free of leaked, spilled, and unpackaged medical waste;
not contain porous floor coverings;
be ventilated;
not create a nuisance; and
have a method of leak control or spill cleanup, including decontamination.
(m) A responsible party shall be present when regulated medical waste is being transferred by means of transfer or storage operations.
(n) Regulated medical waste shall be transported and stored in a manner that prevents exposure to the environment and inclement
weather.
(o) Unrefrigerated regulated medical waste shall be treated within 21 calendar days of shipment from the generator.
(p) Refrigeration at an ambient temperature of a maximum of 45 degrees Fahrenheit (7.22 degrees Celsius) shall be maintained for
regulated medical waste not treated within 21 calendar days of shipment from the generator.
(a) All regulated medical waste shall be treated within 60 calendar days of shipment from the generator.
History Note: Authority G.S. 130A-309.26;
Eff. October 1, 1990;
Amended Eff. January 4, 1993; March 1, jggj. 1991;
Readopted ff. November 1, 2019.
15A NCAC 13B .1203 GENERAL REQUIREMENTS FOR REGULATED MEDICAL WASTE GENERATORS,
TRANSPORTERS, AND TRANSFER AND STORAGE OPERATIONS
(a) Regulated medical waste shall be treated prior to disposal. Acceptable methods of treatment are as follows:
blood and body fNids in individual con4ainers involumes greater than 20 ml incineration or sanitary sewage systems,
provided the sewage treaftnent authority is notified;
(2) ;
f3) pat-holegieal wastes— neinera4ien.
(e) Regula4ed medieal waste tfeated in weer-danee with Paragraph (a) of this Rule ma�l be managed in accordance �A� 15A NC;,A
i3B .0i0o .07 .
(d) Creniator-itims are not s*eet to the requiremen4s of Rule.1207(3) of this Section.
(e) A per -son who treats Regulated medical waste at the generating facility or within an integrated medical facility is not subject to f
storage and record keeping requirements of Rule .120''n�rthis Section.
not subjeet to the requirements of Rule . 1207(3)(a 1) of this Section unfil january (f) Generating facilities and integrated medieal f4eilities in operation on Oetober 1, 1990 that incinerate Regulated medical waste are-
1995,
(a) Regulated medical waste packaging requirements:
All Sections of the Code of Federal Regulations (CFR) cited in this Paragraph are hereby incorporated by reference,
includingsubsequent ubsequent amendments and editions and can be accessed at no cost at https://www.gpo.gov/.
Regulated medical waste may be packaged in accordance with 49 CFR 173.134, 49 CFR 173.196, 49 CFR 173.197,
or 49 CFR 173.199.
A plastic film bag shall be used as inner packaging, unless it is not required per the regulated medical waste type when
used in conjunction with one of the package designs pursuant to Subparag ax ph (2) of this Paragrgph.
The plastic film bag used as inner packaging shall be sealed to prevent leaks.
A rigid box, drum, or vessel constructed to prevent leakage shall be used as outer packaging.
Outer package labeling shall be written in En lg ish.
Outer packaging shall contain the universal biohazard symbol as described in 29 CFR 1910.1030(g).
Each package shall be handled to prevent leaks, damage, and changes to the package, labeling, and markings.
Labels and markings on the outside of each package shall contain the following information:
state that the content is an "infectious substance" or a "biohazard;"
(BB,) the generator name, physical address, and phone number;
the transporter name, physical address, and phone number;
(DD,) the treatment facility name, physical address, and phone number; and
the date of shipment from the generatingfacility_

The requirement in Part E of this Subparagraph does not apply to customer -loaded trailers exce t that all acka es
accessible from the cargo area door(s) shall be marked with the date of shipment from the generator pri to transport
from the generatingfacility. The remaining medical waste packages shall be marked with the date of shipment from
the generator when they are removed from the customer loaded trailer unless the medical waste packages are treated
at that site within 24 hours.
( Generator requirements:
The generatingfacility acility shall package medical waste by treatment method type in accordance with Rule .1202(i of this
Section.
The generatingfcility shall maintain a record of each shipment of regulated medical waste transported off -site for a
period of three years that includes the following information:
the number of packages;
the transporter name, physical address, and phone number;
LQ the treatment facility name, physical address, and phone number; and
the date of shipment from the generatingfacility.
acility.
The requirements of this Subparagraph do not apply to generating facilities that generate less than 50 pounds of
regulated medical waste per month.
(c) Transporter requirements:
The transporter shall not accept regulated medical waste that does not meet the requirements of Para rg aph (a) of this
Rule.
The universal biohazard symbol shall be displayed on the outside of a transport vehicle on both sides and rear of the
vehicle's cargo area, shall be legible, and shall not be obstructed from view.
0 Transport vehicles shall only transport medical waste for treatment, other solid wastes, and supplies related to the
handling of solid wastes. If a medical waste package leaks or spills, all of the contents, except for hazardous waste,
within the same storage area of the transport vehicle as the leaking or spilled package shall be treated at a medical
waste treatment facility. If the solid waste that leaked or spilled is a hazardous waste, all of the solid waste within the
same storage area of the transport vehicle as the leaking or spilled package shall be brought to a hazardous waste
treatment facility.
Transport vehicles shall be free of medical waste and disinfected with a mycobacteriocidal disinfectant before being
reused if any packages spilled or leaked while in the vehicle.
The vehicle operator shall keep a contingency plan as described in Rule .1204(b)(4)(H) of this Section in the transport
vehicle and shall be trained to implement the contingency plan prior to transporting medical waste.
The transporter shall be in compliance with Rule .1202(o), (p), and (q)) of this Section.
(d) Transfer or storage operations requirements:
W The responsible party for transfer or storage operations occurring at a treatment facility shall include a description of
the transfer or storage operations in the facility operations plan submitted to the Division in accordance with Rule
.1204(b)(4) of this Section.
Q The responsible party for transfer or storage operations occurring at a location other than a treatment facility shall
submit a record to the Division within 14 calendar days of commencing transfer or storage operations, and once every
two years thereafter, while the responsible party is managing the transfer or storage operations. The record shall
include the following information:
the name, mailing address, physical address, office and mobile phone numbers, and email address for the
responsible party(s) and operator(s);
0 county GIS property data for the location where transfer or storage operations occur;
LQ procedures for how the medical waste will be received, handled, stored, or transferred;
the frequency that transfer or storage operations occur;
the amount of medical waste that is expected to be on site at the transfer or storage operations; and
additional information that the Division may request pertaining to the transfer or storage operations if it is
necessary to determine compliance with the rules of this Subchapter.
The responsible party shall submit an updated record to the Division within 14 calendar days if any of the information
required to be submitted by this Subparagraph changes.
If the transfer or storage operations cease, the responsible party shall submit to the Division a record within 14 calendar
days. The record shall include the following information:
a signed statement by the responsible pgM(s) that transfer or storage operations have ceased and all medical
waste has been removed;
digital pictures of the area that was utilized for transfer or storage operations taken after operations have
ceased and all medical waste has been removed; and
LQ additional information that the Division may request pertaining to the transfer or storage operations if it is
necessary to determine compliance with the rules of this Subchapter.
Within 90 days of the readopted effective date of this Rule, existing transfer or storage operations shall comply with
Subparagraph (2) of this Para rg_Vh.
The transfer or storage operations shall comply with Rule .1202(o),p,), and (o) of this Section.
History Note: Authority G.S. 130A-309.26;
Eff. October 1, 1990;
Amended Eff. April 1, 1993-1993;

Readopted Eff.' November 1, 2019.
A-17
15A NCAC 13B .1204 REQUIREMENTS FOR THE TREATMENT OF REGULATED MEDICAL
WASTE
(a) A per -son w-ho ships fegulmed fnedieal waste ffam the gener-a4ing f4eility for- off site tfeatment shall meet the folio —ef4s:
(4)
Philadelphia,un-�—ef n-of-m—al coffditieffs of usage affd handling. Each bag shall be eonstructed of material of sufficiefft siffgle thiekness
strength to pass the 165 gram dropped dart impact resistance test as prescribed by Standard D 1709 91 of the Ameriean
Society for Testing and Materials, w-hieh is incorporated by referenee ineluding subsequent amendments and editions,
and eertified by the bag manufaeturer, A copy is available for inspection at the Department of Efwir-onment, Health,
and Natural Resources, Division of Solid Waste Management, 401 Oberhn Road, Raleigh, North Carolina. Copies
may be requested by mail at American Society for Testing and Materials, 1916 Raee Stfeet, P.A.
19103
or- by ealling [phone] fer a east of twelve dellafs ($12.00) plus one dellaf and fif4y eeffts ($1.50) fef shipping
and handling «less prepaid, then♦e.-, thee dollars is twelve dollrs ($1 7 00) (-3) Eaeh paekage ef fegulated fnedieal waste shall be labeled with a wa4er- fesistant univefsal biehazard •
(4) Eaeh paekage ef fegulated fnedieal waste shall be maf4Eed on the outer- suffaee with the following infor-mmiew
CAI >address, and ;
(B) the transporter's name, address, and telephone numbefl;
(G) storage faeility name, address, and telephone number-, when applicableq
lnJ treatment name, address and hone e
iEI date of shipment; and
(b) Reeofds of feg-ala4ed medieal waste shall be maintained for- eaeh shipmefft and shall inelude the information listed in this Paragraph,
This infeffna4ea shall be maintained a4 the gener-a4ing f4eility fer- ne less than three yeafs,
Crl ;
(71 da4e shipped eff site;
Cal ,l e;
7 C(21 e e f tr- ,free
=,
(4) name e f storage er tre.,tme«t F e;l;t..
The requirements of this Paragraph shall net apply to per -sons who generate less than 50 pounds of regulated medieal 'h-.
(c) A plan to enstwe proper- managemen4 of regulated medical waste shall be prepared and maintained at the generating faeility.
(a) General requirements for treated regulated medical waste:
Treated regulated medical waste shall be covered to prevent exposure to the environment and inclement weather.
Treated regulated medical waste may be placed uncovered in or under a weather resistant structure while dewatering
or while in the process of being covered.
Treated regulated medical waste shall be stored no longer than 14 calendar days after treatment unless the facility's
operations plan states that the storage unit is a necessarypart of the operation of the treatment process and is enclosed,
sealed, and watertight.
Treated regulated medical waste storage and transport containers, compactors, trailers, and cargo bays shall be
maintained in accordance with the manufacturer's specifications.
Treated regulated medical waste shall not be transported off site uncovered.
b The exterior of treated regulated medical waste storage and transport containers, compactors, trailers, and cargo bays
shall be free of solid waste and solid waste residue.
Treated regulated medical waste shall not become putrescent. Putrescent treated regulated medical waste shall be
disposed of within three calendar days.
Treated regulated medical waste shall not become a nuisance.
Treated regulated medical waste shall be noninfectious.
( General requirements for treatment facilities:
The treatment facility shall be compliant with Rule .1202(0), (p), and (9) of this Section.
The treatment facility shall issue a written record notifying the generatingfacility if it becomes aware of a package of
medical waste received that is not in compliance with Rule .1202(i) of this Section for the treatment method utilized.
A coon of the record shall be maintained at the treatment facility_.
The treatment facility shall maintain a record of each shipment of regulated medical waste received for treatment for
a period of three years to include the following information:
the number of packages;
the generator name, physical address, and phone number;
the transporter name, physical address, and phone number;
the date each package was picked up from the generator;
the date each package was received at the treatment facility;
the weight of each package in pounds; and
(GG) the date each package was treated.
The treatment facility shall submit a facility operations plan to the Division with the permit application required in
accordance with the rules of this Subchapter that shall include the following information:

W the name, mailing address, physical address, office and mobile phone numbers, and email address for the
responsible paAAs), owner(s), and operator(s); "'
the physical address and the county GIS property data for the facility location;
types and estimated amounts of medical waste to be accepted at and shipped out from the facility
a description of the treatment process or processes;
procedures for how the medical waste will be received, handled, stored, transferred, or treated at the facility;
procedures for sampling or testing required by the rules of this Section;
procedures that the facility shall use to prevent medical waste from becoming a nuisance or putrescent, and
procedures for abatement if medical waste becomes a nuisance or putrescent;
contingency plan identifying risks and describing how the facility will respond to incidents or emergencies,
and how regulated medical waste will be handled or redirected when facilities or transport vehicles are
unavailable due to maintenance, adverse weather, or other emergencies; and
additional information that the Division may request pertaining to the facility operations if it is necessary to
determine compliance with the rules of this Section.
A copy of the operations plan shall be kept at the facility and shall be available for review by the Division during
facility inspections or upon request by the Division. If the information required by this Paragraph changes, the facility
shall submit a revised facility operations plan to the Division and update the copies of the plan kept by the facility.
The treatment facility shall maintain a record of the disposal facility's contact information including the facility name,
permit number, physical location and mailing address, and contact name and phone number.
The treatment facility shall maintain a record of the dates and tonnages of treated regulated medical waste sent for
disposal.
The treatment facility shall maintain operating records and monitoring, testing, and maintenance records required in
accordance with the rules of this Section for a period of three years.
The facility shall submit an annual report to the Division in accordance with G.S. 130A-309.09D(b).
(c) Steam sterilization treatment requirements:
Steam under pressure shall be provided to maintain a temperature of not less than 250 degrees Fahrenheit for 45
minutes at 15 pounds per square inch of gauge pressure duringeach cycle.
The steam sterilization unit shall have a device that records the start and end time of each cycle.
The steam sterilization unit shall have a device that records the pressure and a device that records the temperature
throughout each cycle.
Testing of treatment under conditions of full loading to confirm compliance with Subparag ax ph (a)(9) of this Rule
shall be performed no less than once per week using a biological indicator of Geobacillus stearothermophilus spores
having a population of not less than 1.0 x 104 placed within the waste load.
A record of each test performed shall be maintained and shall include the type of indicator used, the test date, the start
and end times, and the test result.
(d) Incineration treatment requirements:
The Division shall not issue a solid waste management permit in accordance with the rules of this Subchapter to the
treatment facility unless the Division of Air Quality (DAQ) has issued a permit for operation of the incinerator.
The treatment facility shall maintain the DAQ permit for the operation of the incinerator.
Regulated medical waste shall be subjected to a burn temperature in the primary chamber of not less than 1200 degrees
Fahrenheit.
The incinerator shall have a monitoring device that records the primary chamber temperature. A record of the
continuous monitoringoprimary chamber temperature while in use shall be maintained.
Interlocks or other process control devices shall be provided to prevent the introduction of regulated medical waste
into the primary chamber until the secondary chamber achieves operating temperature as defined in the permit for
incinerator operation issued by DAQ
Procedures for obtaining uniform representative composite ash samples shall be submitted to the Division for approval
in the facility operations plan in accordance with Rule .1204(b)(4) of this Section. Ash sampling procedures shall be
approved if the procedures are compliant with the requirements of this Subchapter, are protective of human health and
the environment, and if the samples collected using the procedures are representative of the incinerator ash shipped
from the facility for disposal.
The ash samples shall be collected from the dewatered ash collection container or containers.
For the first three months of incinerator operation, the ash sampling procedures required by Subpara rgraph (6) of this
Paragraph shall include the collection of a representative ash sample of one kilogram (2.2 pounds):
W once for every eight hours of operation for an incinerator that is operated on a continuous schedule;
0 once for every 24 hours of operation for an incinerator that is operated on an intermittent schedule; or
LQ once for every batch for an incinerator that is batch -loaded.
The ash samples shall be composited in a closed container weekly and shall be mixed and reduced to a uniform ash
sample. The weekly ash samples shall be composited into a monthly ash sample, and the monthly ash sample shall be
analyzed.
For the remainder of the first year of incinerator operation, a representative ash sample shall be collected once per
month using the procedures described in the facility operations plan. The monthly ash samples shall be composited
and reduced to a uniform quarterly ash sample, and the quarterly ash samples shall be analyzed.

After the first year of incinerator operation, representative composite ash samples shall be collected usin2 the
procedures described in the facility operations plan twice per calendar year, with no less than four mo between
sample collection, and the samples shall be analyzed.
11 Ash samples required to be analyzed in accordance with Subpara rag phs (8) through (10) of this Paragraph shall be
analyzed in accordance with 40 CFR 261.24 for the eight metals listed in Table 1 (arsenic, barium, cadmium,
chromium, lead, mercury, selenium, and silver). 40 CFR 261 is incorporated by reference includingsubsequent
ubsequent
amendments and editions; and can be accessed at no cost at https://www.gpo.gov/.
12 A record of the testing and analysis results shall be submitted to the Division for the first year of incinerator operation,
and thereafter shall be maintained at the facility and available for inspection by the Division, and shall be submitted
upon request from the Division, and shall include:
the composite ash sample date and time;
the ash sample date and time;
LQ the ash sample identification number;
the ash sample analysis results; and
the testing laboratory name and contact information and certification number.
13 The Division may require the treatment facility to collect additional composite ash samples or analyze the samples for
the full contaminant list in accordance with 40 CFR 261.24 Table 1 if the results of the analysis required in
Subparagraphs (8,) through (11) of this Paragraph indicate an exceedance of the regulatory level provided in 40 CFR
261.24 Table 1; or during a permitting action, a facility inspection, or when a complaint is received if it is necessary
to determine compliance with the rules of this Subchapter. The requirements of this Paragraph shall not prevent a
municipal solid waste landfill that is accepting incinerator ash from a treatment facility from requiring that additional
ash samples be taken and analyzed to determine compliance with the rules of this Subchapter before the ash is accepted
for disposal.
(e) Chemical treatment requirements:
W Microbiological waste shall be treated with 10 percent chlorine solution for no less than one hour.
Testing of treatment under conditions of full loading to confirm compliance with Subparagraph (a)(9) of this Rule
shall be performed no less than once per week using a biological indicator of Bacillus atrophaeus spores having a
population of not less than 1.0 x 106.
A record of each test performed shall be maintained and shall include the type of indicator used, the test date, the start
and end times, and the test results.
(fl Microwave treatment requirements:
Microwave energy of appropriate output frequency shall be provided at a temperature of not less than 203 degrees
Fahrenheit (95 degrees Celsius) for no less than 30 minutes each cycle.
The microwave treatment system shall be provided with a monitoring device that records time and temperature of
each cycle. A record of the monitoring of the time and temperature of each cycle shall be maintained.
Testing of treatment under conditions of full loading to confirm compliance with Subparagraph (a)(9) of this Rule
shall be performed no less than once per week using a biological indicator of Bacillus atrophaeus spores having a
population of not less than 1.0 x 106 and in accordance with the equipment manufacturer's instructions.
A record of each test performed shall be maintained and shall include the type of indicator used, the test date, the start
and end times, and the test result.
(g) Ozonation treatment requirements:
Testing of treatment under conditions of full loading to confirm compliance with Subparagraph (a)(9) of this Rule
shall be performed no less than once per week using a biological indicator of Bacillus atrophaeus spores having a
population of not less than 1.0 x 106 and in accordance with the equipment manufacturer's instructions.
Once every six months samples collected under conditions of full loading shall be submitted to an independent
laboratory to confirm compliance with Subparagraph (a)(9) of this Rule.
A record of each test performed shall be maintained and shall include the type of indicator used, the test date, the
ozonation time, the incubation time, and the test result.
(h) Alternative treatment methods.
T (1) A treatment facility owner or operator may request to use a method of, or procedures for, regulated medical waste
treatment not listed or described in this Rule by submitting a request to the Division for approval. The request shall
include documentation that describes the alternative treatment method, explains the procedures and provides analysis
results to demonstrate that the treatment method will render the regulated medical waste noninfectious, and describes
how the treatment method meets the requirements of the rules of this Section.
A request for an alternate method of chemical treatment shall also describe the chemical used to treat the specific
microbiological agent(s) of concern for the regulated medical waste type, and shall consider factors such as
temperature, contact time, pH, concentration, and the presence and state of dispersion, penetrability, and reactivity of
organic material at the site of application.
The Division may approve the alternative treatment method by issuing the permit or an approval letter if the alternative
treatment method renders the regulated medical waste noninfectious, and the alternative treatment method is compliant
with the rules of this Section and protective of human health and the environment.
History Note: Authority G.S. 130A-309.26;
Eff. October 1, 1990;
Amended Eff. October 1, 1992; December 1, 1991; March 1, 1991. 1991;

Readopted Eff.' November 1, 2019.
A-20
15A NCAC 13B .1205 REQUIREMENTS FOR TRANSPORTERS OF REGULATED MEDICAL WASTE
15A NCAC 13B .1206 REQUIREMENTS FOR STORAGE OF REGULATED MEDICAL WASTE
15A NCAC 13B .1207 OPERATIONAL REQ/REGULATED MEDICAL WASTE TREATMENT FACILITIES
History Note: Authority G.S. 130A-309.26;
Eff. October 1, 1990;
Amended Eff.' April 1, 1993; January 4, 1993. 1993;
Repealed Eff.' November 1, 2019.

A-21
APPENDIX 4
Hearing Transcript and Attendance Sheet

A-22
PUBLIC HEARING TRANSCRIPT
Hearing Officer: EMC Commissioner Steve Keen
DEQ Staff: Jessica Montie and John Patrone, DWM
Attendees: Don Nuss, Stericycle
Hearing Officer Presentation:
I am calling this public hearing to order.
My name is Steve Keen and I am a member of the Environmental Management Commission. I
am the presiding officer for this evening's hearing.
This public hearing is being held by the Environmental Management Commission to solicit
written and oral comments on rules relating to Medical Waste Management. The Environmental
Management Commission is granted authority in the North Carolina General Statutes to adopt
certain rules following the procedures specified in General Statute 150B. Accordingly, a public
notice containing the proposed rules under consideration was published in the June 17, 2019
edition of the North Carolina Register and on the Department of Environmental Quality (DEQ)
website, and was sent by e-mail to interested parties including, but not limited to, advocacy
groups, local government contacts, and industry contacts. The audio of this hearing is being
recorded for the record.
The purpose of this hearing is to receive public comments on 15A NCAC 13B Rules .1201 -
.1207 for Medical Waste Management, which collectively establish standards for the packaging,
transportation, storage, treatment, and disposal of medical waste. Amendments to these rules
are being considered by the Environmental Management Commission as part of the readoption
process pursuant to G.S. 15013-21.3A, which requires that existing rules be reviewed every 10
years.
As the hearing officer, it is my responsibility to listen to your comments and assist in the
preparation of the hearing report, which summarizes the information presented tonight, all
comments received tonight and throughout the comment period, and provides recommendations
to the Commission on the proposed rule -making. The Commission will make the decision on
the final action, which may be to accept the hearing officer's recommendations, modify them, or
take a different course of action. As it now stands, the Commission should consider the adoption
of the proposed rules at their September 12, 2019 meeting in Raleigh. The Commission is
interested in your comments on these rules to help them decide what the final rule language
should be for their consideration. The Commission is not only seeking your comments on the
proposed rule language, but also on the Regulatory Impact Analysis document.
Information on these rules has been available on the DEQ website since June 17, 2019, and
copies of these documents can be found at the table in the entryway. The information includes
proposed wording of the rules, an explanation of the rules, information on the public comment
period and contact information for submitting written comments, and information on the possible
impacts from the rules as provided in the Regulatory Impact Analysis.

A-23
If anyone has written comments they would like to provide, including any speakers who have
written copies of their comments, please provide them to the staff before leaving today. Written
comments prepared after the hearing may be submitted by e-mail or US Mail to Jessica Montie
at the address provided in the information available at the back of the room today or on the DEQ
website. All comments received by August 16, 2019 will be included in the public comment
record. Equal weight is given to both written and oral comments.
I appreciate everyone's attendance and would like to take this time to recognize any public
officials in attendance tonight. (None present)
Now I would like to invite any additional public or elected officials to stand and introduce
themselves. (None present)
I would also like to recognize members of the DEQ staff that are here. Will you please raise your
hands? (Ms. Montie and Mr. Patrone are recognized)
At this time, I will provide an overview of how the meeting will be conducted:
1. 1 will call on speakers for each rule set in the order they signed up to speak. If you wish
to speak and have not yet signed up, you still have the opportunity to do so at the table
in the entryway.
2. When your name is called, please come to the microphone, and clearly state your name
and any group you may be representing or affiliated with.
3. Each speaker will be limited to 3 - 5 minutes so that everyone who wishes to speak has
an opportunity to do so. Staff will keep track of the time and raise a sign to indicate when
you have 1 minute remaining and when you have 30 seconds remaining to finish your
comments.
4. All public comments will be directed to me as the hearing officer.
5. 1 ask that everyone respect the right of others to speak without interruption.
6. Please keep your comments concise and limit them to the proposed rulemaking.
7. At the end of the meeting, if time remains, we will ask if anyone who did not sign up would
now like the chance to speak.
At this time, Jessica Montie with the Division of Waste Management will give a brief presentation
on the Medical Waste Management rules that are proposed for readoption, and after the
presentation we will ask for comments.
(slide presentation similar to presentation given at the May 2019 EMC meeting regarding
these rules was provided)

A-24
I will now call on speakers that signed up to give comments.
(no attendees signed up to provide comments)
Is there anyone else who did not sign up to speak but would now like to provide a comment on
the rules?
Mr. Don Nuss representing Stericycle provided comments in support of the rules as
published, and thanked staff for their efforts in working with the stakeholders to draft the
rule language.
I would like to thank everyone for attending tonight's hearing. Your input is greatly appreciated.
If there are no more comments, then this hearing is closed.
The public comment period will remain open until August 16, 2019. Written comments
may be submitted to Jessica Montie at the email address or mailing address provided in
the information available at the back of the room.

ATTENDANCE SHEET - JULY 9, 2019 RALEIGH PUBLIC HEARING FOR PROPOSED RULES A-25
15A NCAC 13B .1200 MEDICAL WASTE MANAGEMENT
If you do not wish to speak, you may submit written comments to Lsica.montie[dncdenr.gov by August 16, 2019.
PRINT NAME AFFILIATION E-MAIL PLEASE U
WOULD LIKE TO BE
(Resident, Elected Official, Other) if you wish to receive u dates CALLED UP TO SPEAK
1 Jss 5 �tt- < c. tx., CLASS :S 4-e.,pt c
2
3
4 .C%S — V�
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A-26
APPENDIX 5
Comment Letters Received

A-27
KILPATRICK
TOWNSEND
ATTORNEYS AT LAW
June 27, 2016
Via Electronic and First Class Mail
Michael E. Scott
NCDEQ, Director of Division of Waste Management
1601 Mail Service Center
Raleigh, NC 27699-1601
KILPATRICK TOWNSEND & STOCKTON LLP
www.ki I patricktownsend.com
Suite 1400 4208 Six Forks Rd.
Raleigh NC 27609
t 919 420 1700 f 919 420 1800
Alan H. McConnell
direct dial 919 420 1798
direct fax [phone]
[e-mail]
Re: Stericycle, Inc. —Information Related to Proposed Petition
for Rulemaking
Dear Michael:
Thank you for meeting with me on March 7, 2016 regarding Stericycle, Inc.'s ("Stericycle")
interest in amending certain elements of the North Carolina transport and storage
requirements for medical waste. As you are aware, Stericycle operates regulated medical
waste treatment and transfer facilities in Haw River and Concord, North Carolina pursuant to
Solid Waste Permit No. 01-02-I and Solid Waste Permit No. 1305TP-TP, respectively. As
we discussed on March 7, the purpose of this letter to provide you with additional
information regarding Stericycle's proposed rule changes. To support these proposed
changes, I have provided below: (i) the proposed amendments; (ii) information supporting
the proposed amendments; and (iii) a description of the potential effects of the proposed
amendments.
Proposed Amendments
Pursuant to N.C. Gen. Stat. § 130A-309.26, the Environmental Management Commission
has the authority to promulgate the proposed revised rules.
13505498V.5
ATLANTA AUGUSTA CHARLOTTE DALLAS DENVER LOS ANGELES NEW YORK RALEIGH SAN DIEGO SAN FRANCISCO
SEATTLE SHANGHAI SILICON VALLEY STOCKHOLM TOKYO WALNUT CREEK WASHINGTON WINSTON-SALEM

A-28
Michael E. Scott
June 27, 2016
Page 2
The proposed amendments to 15A NCAC 13B §§ .1205(7), (8) are as follow:
CHAPTER 13. SOLID WASTE MANAGEMENT
SUBCHAPTER 13B. SOLID WASTE MANAGEMENT
SECTION .1200. MEDICAL WASTE MANAGEMENT
.1205 REQUIREMENTS FOR TRANSPORTERS OF REGULATED MEDICAL
WASTE
A person who transports Regulated medical waste that has not been treated as the generating
facility shall meet the following requirements:
(7) Except as allowed by subsection (8) of this rule, Regulated medical waste shall be
delivered in a non -putrescent state to a permitted storage or treatment facility within seven
fourteen calendar days of the date of shipment from the generator.
(8) Refrigeration at an ambient temperature between 35 and 45 degrees Fahrenheit
shall be maintained for Regulated medical waste that will not be delivered for treatment
within sever fourteen calendar days.
The proposed amendment to 15A NCAC 13B § .1206(4) is as follows:
CHAPTER 13. SOLID WASTE MANAGEMENT
SUBCHAPTER 13B. SOLID WASTE MANAGEMENT
SECTION .1200. MEDICAL WASTE MANAGEMENT
.1206 REQUIREMENTS FOR STORAGE OF REGULATED MEDICAL WASTE
A person who stores Regulated medical waste that has not been treated at the generating
facility shall meet the following requirements:
13505498V.5

A-29
Michael E. Scott
June 27, 2016
Page 3
(4) Regulated medical waste shall be stored in a non -putrescent state net -lie -stored and
no longer than seven fourteen calendar days from the date of shipment from the generator
unless the Regulated Mmedical Wwaste is refrigerated at an ambient temperature between 35
and 45 degrees Fahrenheit. Provided that Regulated medical waste is refrigerated at an
ambient temperature between 35 and 45 degrees Fahrenheit in a non -putrescent state, such
waste shall be stored no longer than sixty calendar days from the date of shipment from the
generator.
The proposed amendment to 15A NCAC 13B § .1207(1) is as follows:
CHAPTER 13. SOLID WASTE MANAGEMENT
SUBCHAPTER 13B. SOLID WASTE MANAGEMENT
SECTION .1200. MEDICAL WASTE MANAGEMENT
.1207 OPERATIONAL REQ/REGULATED MEDICAL WASTE TREATMENT
FACILITIES
A person who treats Regulated medical waste shall meet the following requirements for each
type of treatment in addition to the requirements in Rule .1203 of this Section.
(1) General requirements:
(b) Regulated medical waste shall be store' prior- to treatment for treated or
placed into refrigerated storajZe consistent with 15A NCAC §13B .1206(4)
no more than seven calendar days after receipt.
Basis for Proposed Amendments
Currently, the North Carolina regulations addressing the storage of Regulated medical waste
provide that such waste: (i) shall be delivered to a permitted storage or treatment facility
I3505498V.5

A-30
Michael E. Scott
June 27, 2016
Page 4
within seven calendar days of the date of shipment from the generator unless the Regulated
medical waste is refrigerated at an ambient temperature between 35 and 45 degrees
Fahrenheit; (ii) shall not be stored longer than seven calendar days from the date of shipment
from the generator unless the Regulated medical waste is refrigerated at an ambient
temperature between 35 and 45 degrees Fahrenheit; and (iii) shall be stored prior to treatment
for no more than seven calendar days after receipt unless the Regulated medical waste is
refrigerated at an ambient temperature between 35 and 45 degrees Fahrenheit.
Limiting storage of Regulated medical waste to seven days without refrigeration provides no
health or environmental benefit and extending the storage time from seven to fourteen days
will not harm public health or the environment. In our meeting on March 7, the Division of
Waste Management specifically asked what happens to unrefrigerated Regulated medical
waste between seven and fourteen days. Based on Stericycle's experience in other states, the
most correct answer is "nothing." In almost every case, there is no difference in the
characteristics of Regulated medical waste that is not refrigerated during the period of seven
to fourteen days when compared to refrigerated. Importantly, unlike in other states, the
North Carolina regulations prohibit the transport or storage of Regulated medical waste in a
putrescent state. These protections ensure that Stericycle does not at any time transport or
store Regulated medical waste that is in a putrescent state.
Stericycle or its competitors operate regulated medical waste incinerators in the following
states: North Carolina, Florida, Maryland, Ohio, Illinois, Minnesota, Kansas, and Utah. The
storage requirements for each of these states and South Carolina are summarized below.
State
Storage Requirements
Cite
Florida
30-day limit for storage of biomedical waste at the
FLA. ADMIN.
generating facility and in a place other than the generating
CODE § 64E-
facilit .
16.004(a)
Maryland
Except under the supervision of the Department during an
CODE OF MD.
emergency, a special medical waste hauler may not store
REDS. §
special medical waste except in an approved facility.
26.13.13.01(E);
Storage in a special medical waste vehicle does not include
Permit
periods of stoppage. Stoppage is a period of time not to
conditions
exceed 72 hours during which a special medical waste
vehicle is at rest. The cumulative period of stoppage may
not exceed 5 days for a particular shipment of special
medical waste within the State. Any stoppage in excess of
12 hours shall be at an authorized facility or other suitable
site. Pursuant to a permit condition, there is a 10-day
13505448V.5

A-31
Michael E. Scott
June 27, 2016
Page 5
storage limit for non -refrigerated special medical waste
from the date of receipt at the treatment facility.
South
Infectious waste must be maintained in a non -putrescent
S.C. Code Ann.
Carolina
state, and storage of infectious waste shall not exceed
§ 61-105(K)(5)
twenty-eight (28) days without refrigeration or sixty (60)
days if maintained at or below 42 degrees Fahrenheit.
Ohio
14-day time limit to process regulated medical waste as
OHIO ADMIN.
long as it is not putrescent. If waste becomes putrescent,
CODE § 3745-
then the waste must be immediately refrigerated or frozen
27-35
and shall be treated and disposed of as soon as possible
regardless of any storage time frame.
Illinois
Unless otherwise permitted, 3-day time limit for storage at
35 IL. ADMIN.
storage or transfer operation with no refrigeration. 30-day
CODE §
time limit regardless of temperature.
1422.111
Minnesota
No time restrictions. Infectious waste must not be allowed
MINN. ADMIN.
to become putrescent during transportation. A person who
CODE §§
stores, incinerates, or decontaminates infectious or
7035.9120.2,
pathological waste, other than at the facility where the
7035.9120.4
waste was generated, or a person who incinerates
MINN. GEN.
infectious or pathological waste on site, must submit a
STAT. §
copy of a management plan to the commissioner of the
116.79(4)
Pollution Control Agency.
Kansas
No time restrictions. All medical services waste shall be
KAN. ADMIN.
stored in a manner and in a container that will prevent the
CODE 28-29-27
transmission of disease or the causing of injury. Medical
services wastes shall be collected at least daily from the
point of origin for transport to a storage or disposal area or
a processing facility. All medical services wastes
transported off -site shall be transported in a manner that
will prevent the spread of disease or the causing of injury
to persons.
Utah
7-day time limit without refrigeration and no longer than
UTAH ADMIN.
60 days.
CODE § 315-
316-3(9), (10
Other states in the Southeast generally provide for periods longer than seven (7) days for
storage of Regulated medical waste. See, e.g,, Fla. Admin. Code § 64E-16.004(a) (providing
30-day limit for storage of biomedical waste at the generating facility and in a place other
than the generating facility); Ga. Comp. R. & Regs. § 391-3-4-.15(4) (containment of
biomedical waste shall be in manner that minimizes exposure to the public); but see 9 Va.
13505498V.5

A-32
Michael E. Scott
June 27, 2016
Page 6
Admin. Code §§ 10-120-360, 20-120-430 (providing that Regulated medical waste stored
for more than seven days must be refrigerated, and no Regulated medical waste shall be
stored for more than fifteen days at the site of generation). Thus, other states in which
medical waste incinerators are located generally provide for periods longer than seven days
for storage of regulated medical waste.
With respect to the transporter requirements set forth in 15A NCAC § 13B .1205,
transporters often use consolidation facilities. However, the current regulation requires
shipment or refrigeration within seven days of shipment from the generator and does not
provide for additional time if consolidation facilities are used. Delivery or refrigeration of
Regulated medical waste within seven days of shipment from the generator without
consolidation is impracticable and unworkable. For example, Stericycle has determined that
in a typical year this requires an additional sixty-nine (69) refrigerated trailers resulting in
significant, unnecessary costs to Stericycle.
Limiting storage of Regulated medical waste to seven days without refrigeration has
significant economic impacts on the regulated community with no corresponding benefits to
public health or the environment. Stericycle estimates that such a restriction results in
economic losses of at least $675,000 per year to Stericycle. This amount is based upon the
costs associated with leasing additional refrigerated trailers and/or diverting waste to other
facilities to avoid the burdensome restrictions in North Carolina. Further, limiting the use of
diesel engines to provide power to refrigerated trailers will result in a decrease in criteria
pollutant emissions and benefit public health and the environment.
There have been no spills of regulated medical waste at Stericycle's Haw River facility in the
last five years. In addition, Stericycle has received no odor complaints related to the Haw
River facility in the last five years.
Effect of the Proposed Rule
The effect of these proposed amendments on existing rules would be to extend the time for
delivery of unrefrigerated Regulated medical waste by transporters to a permitted storage or
treatment facility from seven to fourteen calendar days provided that such waste is in a non -
putrescent state. The proposed amendments would allow Regulated medical waste to remain
unrefrigerated in a non -putrescent state for a maximum of 21 days after shipment from the
generator (14 days during shipment plus 7 days after receipt at the treatment facility). In
addition, the proposed amendments clarify that there is a 60-day time limit on the
refrigerated storage of Regulated medical waste at an ambient temperature between 35 and
45 degrees Fahrenheit provided that it remains in a non -putrescent state.
13505498 V.5

A-33
Michael E. Scott
June 27, 2016
Page 7
Effect of the Proposed Rule on Existing Practices
The proposed rule changes would have a significant beneficial effect on Regulated medical
waste transporters, storage facilities, and treatment facilities. First, the proposed rule
changes would allow Regulated medical waste transporters to continue the practice of using
consolidation facilities without incurring substantial and unnecessary costs of purchasing
additional refrigerated trailers. Second, the proposed rule changes would allow Regulated
medical waste transporters, storage facilities, and treatment facilities operational flexibility to
store such waste for an additional seven days without refrigeration. The proposed rule
changes would also harmonize North Carolina regulations with the majority of Southeastern
states. These proposed rule changes would provide operational flexibility while at the same
time protecting the public health and environment.
We look forward to hearing back from you regarding Stericycle's proposed petition for
rulemaking, and thank you for your assistance with this matter. If you need additional
information or would like to discuss, please do not hesitate to contact me.
Sincerely,
Alan H. McConnell
Counsel for Stericycle, Inc.
cc: Don Nuss
Ellen Lorscheider
13505498V.5

A-34
• Stericycle
August 16, 2019
NC DEQ Division of Waste Management
Attn: Jessica Montie
1646 Mail Service Center
Raleigh, NC 27699-1646
Richmond, VA 23218
Submitted via email: [e-mail]
Re: Rules 15A NCAC 13B .1201-.1207 Medical Waste Management as proposed for readoption
Stericycle, Inc. (Stericycle) is a publicly traded corporation (NASDAQ: SRCL) based in Lake Forest, Illinois.
In 2018, we had estimated revenues of approximately $3.513. We operate over 250 medical and hazardous
waste facilities providing services for customers throughout the U.S. primarily in the healthcare field. Our
services include compliant collection, transportation and treatment of medical waste, pharmaceutical waste and
hazardous waste, as well as secure document destruction. In the State of North Carolina, Stericycle operates a
medical waste incinerator in Haw River, a medical waste autoclave in Concord, medical waste transfer stations
in Selma, Moyock, and Asheville, secure document destruction facilities in Wilmington, Raleigh, Winston-
Salem, and Charlotte, as well 10-day hazardous waste transfer facilities in Raleigh and Charlotte. In all there
are approximately 360 employees in the state throughout our different divisions servicing North Carolina
businesses. Our corporate vision is "Protecting What Matters".
Stericycle has been operating these facilities under the current North Carolina Department of Environmental
Quality, Division of Waste Management (the Division) regulations and other applicable Federal regulations
(Department of Transportation (DOT), and Occupational Safety and Health Administration (OSHA) as
examples, since the commencement of these facilities. We are extremely grateful to have had the opportunity
to work with the Division and other stakeholders to make the modifications and clarifications needed to
improve the medical waste regulations in the State. We appreciate the recommendations the Division has
already incorporated into the proposed regulations, however, have the following comments specifically related
to customer -loaded trailers under 15A NCAC 1313.1203(a)(9).
This section currently states:
"The requirement in Part (E) of this Subparagraph does not apply to customer -loaded trailers, except
that all packages accessible from the cargo area door(s) shall be marked with the date of shipment
from the generator prior to transport from the generating facility. The remaining medical waste
packages shall be marked with the date of shipment from the generator when they are removed from
the customer loaded trailer unless the medical waste packages are treated at that site within 24 hours."
Part (E) in the above proposed text refers to the date of shipment from the generating facility. During the
stakeholder discussions we expressed to the Division that the regulations as related to customer -loaded trailers
were problematic for transporters and treatment facilities to comply with because they do not fully offload all
waste to observe it before transporting. This section tried to take this request into consideration however it
does not contemplate when waste may be offloaded temporarily to be transferred to another treatment facility.
For example, a customer -loaded trailer may be loaded with medical waste that needs to be sent for incineration
such as pathological waste, but also be loaded with sharps waste that can be autoclaved. Such a trailer may
first arrive at an autoclave facility where the sharps waste is removed for treatment, but the pathological waste
would need to be transferred to an incineration facility. This takes additional time during transport and
treatment and the 24-hour requirement would be impractical to comply with.

A-35
• Stericycle
Part (E) of this subpart also requires that the date of shipment from the generator be physically written on the
container. Many transporters and treatment facilities now utilize technology (such as barcoded containers or
labels) to track containers through the shipment process. For example, Stericycle utilizes a proprietary
Biotrack system where the generator information, container content, and the shipping document is fully
imbedded in the barcode on the container. This enables us to track the container through each of our systems
to final treatment. This also allows us to have the generator ship date electronically available at any point to an
inspector.
Based on these two factors we would request the following be taken into consideration:
• Allow for electronic tracking to be able to provide adequate compliance with the date tracking
requirement. This information is more impactful and reliable than if it were handwritten as the date
it was shipped.
For those facilities where an electronic option is not available, that the time be extended to 72 hours
to provide for adequate time to transfer and treat waste. After 72 hours the waste would have to be
marked properly with the date of shipment.
Please see the recommended modification to the language for the section below with changes in bold:
"The requirement in Part (E) of this Subparagraph does not apply to customer -loaded trailers, except that all
packages accessible from the cargo area door(s) shall be marked with the date of shipment from the generator
prior to transport from the generating facility. Where available the medical waste transfer or storage
operation can provide electronic records to document the date of shipment of undated containers. If
electronic records are not available, the remaining medical waste packages shall be marked with the date of
shipment from the generator when they are removed from the customer loaded trailer unless the medical waste
packages are treated at that site within 24 hours, or are transferred to be treated at another permitted
treatment facility within 72 hours."
We appreciate the opportunity to submit comments on this important regulation. If you have any further
questions or comments, please feel free to contact meat 312-720-6213 or via email [e-mail].
Sincerely,
Cara Simaga, Director of Government Affairs
Stericycle, Inc.
CC: Selin Hoboy, Vice President of Government Affairs, Stericycle, Inc.

A-36
From:
Simaaa, Cara
To:
Montie, Jessica
Cc:
Hoboy, Selin
Subject:
[External] Medical Waste Rule Comments from Stericycle
Date:
Friday, August 16, 2019 6:21:08 PM
Attachments:
imaoe003.Dna
Stericycle comments to NC DEQ on draft medical waste rules FINAL 8.16.pdf
I External email. Don c ic< links or open attachments unless you verify. Send all suspicious email as an
Uttar t0 rep V
Hello Jessica,
Attached are Stericycle's comments to the draft medical waste rules. Thank you for considering
them, please let me know if you have any questions or concerns. Have a great weekend!
Sincerely,
Cara Simaga, CHMM
Director, Regulatory Affairs
M: [phone] stericycle.com
For assistance with regulatory questions, please email ask -regulator stericycle.com
For questions on the pharmaceutical waste rule, please email
EPANewRules&stericycle.com
4 .• Stericycle
CONFIDENTIALITY NOTICE: The information in this Email is confidential and may be
privileged. This Email is intended solely for the named recipient or recipients. If you are not
the intended recipient, any use, disclosure, copying or distribution of this Email is prohibited.
If you are not the intended recipient, please inform us by replying with the subject line marked
"Wrong Address" and then deleting this Email and any attachments. Stericycle, Inc. uses
regularly updated anti -virus software in an attempt to reduce the possibility of transmitting
computer viruses. We do not guarantee, however, that any attachments to this Email are virus -
free. Nota de confidencialidad: La informacion que presenta este correo es confdencial, y
puede ser de use privilegiado. Este correo intenta ser enviado solo al destinatario, o a los
destinatarios. Si usted no es el destinatario, no podra usar, desglosar, copiar, o distribuir la
informacion de este correo ya que esta prohibido. Si usted no es el correcto destinatario, por
favor informenos reenviandonos el mismo con el asunto " Direccion Incorrecta', y luego borre
el correo y los adjuntos. Stericycle, Inc. usa regularmente actualizaciones de software anti-
virus para asi reducir posibles virus. De todas maneras, no garantizamos que los adjuntos esten
libres de virus.

A-37
APPENDIX 6
Rule Text for Adoption

A-38
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
15A NCAC 13B .1201 is readopted with changes as published in 33:24 NCR 2365 as follows:
SECTION .1200 - MEDICAL WASTE MANAGEMENT
15A NCAC 13B .1201 DEFINITIONS
For the purpose of the this Section, the following definitions apply:
(1) 'Blood and body fluids" means liquid blood, serum, plasma, other blood products, emulsified human
tissue, spinal fluids, and pleural and peritoneal fluids. Blood and body fluids does not include
dialysates, feces, or urine if not removed during surgeries and autopsies. Dialysates are not blood ^body fluids under this definition.
(2) "Generator" and "Generating facility" means mean any business, integrated medical facility, and
volunteer or non-profit healthcare services where medical waste is produced, F:rs.beeaf es ^ waste,
including bu� not lifnit^any medical or dental facility, mortuary, funeam laboratory,
veterinary hospital hospital, and blood baPAE. bank; but does not include households.
(3) "Integrated medical facility" means one or more health service facilities as defined in G.S.
131E-176(9b) that are:
(a) located in a single county or two contiguous counties;
(b) affiliated with a university medical school or that are under common ownership and
control; and
(c) serve a single service area.
(4) "Medical waste" as means the term defined in G.S. 130A-290(17a). 130A 290(1
(5) "Microbiological waste" means the term defined in Rule .0101(26) of this Subchapter. ^��'� an
stocks of infectious agen4s, including but not limited to specimens from medical, pathological,
pharmaceutical, research, commercial,and in „str;.,l laboratories
(6) "Mierewave treatment" means treatment by microwave energy for sufficient time to render waste
Boil „ f et
s
"OFF " �. h r ""
site" means-s�.�te�v-� is a�rs>-te .
(-8) "On site" Means the same or- geegr-aphieally eentiguatis preperty whieh may be divided by public
or- pr-ivae right of way.
"Non -hazardous pharmaceutical waste" is a medical waste. It is a medical drug that is expired,
unused, contaminated, damaged, or no longer needed or used for its prescribed purpose and that is
not a hazardous waste as defined in G.S. f l �" ^=moo==-'°�T130A-290(a)(81
C7) "Nuisance" means odorous outside of the property boundary or transport vehicle; or attracting
vermin or disease vectors.
"Package" is the total contents of a box, drum, or vessel containing medical waste, including labeling
and markings.
1 of 16

A-39
1
(9)
"Pathological waste" means the term defined in Rule .0101(31) of this Subchapter. human tissues,
2
organs and body parts; and the carcasses and body parts of all animals that were known to have
3
e"esed to pathogens tha4 afe potentially dangereus te hufna-as dufiag researeh, were used in the
4
, or- thm died with a kaoA% -of
5
suspeeted ,disease r.-.,.,smissible to 1...mans
6
10
"Record" means any data required to be kept on file by the operator or responsible party, or
7
submitted to the Division in accordance with the rules of this Section. A record may be a paper copy
8
[in hard copy (paper)] or electronic format that is legible and in En lg ish.
9
tUl "Regulated Medical Waste" means the term defined in Rule .0101(34) of this Subchapter. bloodan
10
body fluids in individual containers in voNmes greater than 20 wA, microbiological waste, an
11
.
12
12
"Responsible party" means the entity that is in possession of and has accepted the regulated medical
13
waste.
14
13 ""Sharps" means the term defined is G.S. 130A-309.26(a)(1). and ineludes needless�wiages with
15
attacked needles, capillary tubes, slides and cover slips and se 1pel blades
16
f U4
"Trace chemotherapy waste" means medical waste containing no more than three percent by weight
17
of a medical drug used for [chem�,�]chemotherapy, but is not a radioactive waste. Trace
18
chemotherapy waste includes gowns, gloves, wipes, and other handling, preparation, administration,
19
cleaning, and decontamination items [aid] used in association with chemotherapy.
20
15
"Transfer or storage operations" is the act of, and process by which, regulated medical waste is
21
removed from a transport vehicle and placed in another transport vehicle or in storage awaiting
22
transport.
23
(M)
"Transport vehicle" means a vehicle or other conveyance type used to transport regulated medical
24
waste to and from transfer or storage operations or to and from a treatment facility.
25
(17)(1-2) "Treatment" as means the term defined in G.S. 130A-309.26(a)(2).
26
18
"Treatment facility" means a regulated medical waste treatment facility permitted by the Division
27
in accordance with the rules of this Section. [84
28
19
"Solid waste" means the term defined in G.S. 130A-290(a)(35).
29
30
History Note:
Authority G.S. 130A-309.26;
31
Eff. October 1, 1990;
32
Amended Eff. April 1, 1993. 1993;
33
Readopted Eff. November 1, 2019.
2of16

A-40
1 15A NCAC 13B .1202 is readopted with changes as published in 33:24 NCR 2365 as follows:
2
3 15A NCAC 13B .1202 GENERAL REQUIREMENTS FOR MEDICAL WASTE
4 (a) Medical waste is subject to the i all applieable rules in 15A NCAC 4--313 13B, "Solid Waste
5 Management."
6 (b) Sharps and other sharp objects such as syringes with attached needles, capillary tubes, slides and cover slips,
7 lancets, auto injectors, connection needles and sets, exposed ends of dental wires, and objects that can penetrate the
8 skin At the generating facility, sharps shall be placed in a rigid, leak -proof when in an upright position, and puncture-
9 resistant container, andcontainer which is rigid, leak proof when in an upright position and punetwe resista
10 Con4ained sharps shall not be compacted prior to off -site transportation. transportation unless placed in a sealed
11 compactor unit that is hauled off for disposal by the transporter. Aer- leaving the ge er-a4 fig f4eility, the ^ i#ai o,.
12 .
13 (c) Blood and body fluids in individual containers in volumes of 20 milliliters Ml or less
14
seeur-ed area r-estfieted to au4her-ized personnel prior- to off site tfanspal4atieft shall be paE-
15 the regulated medical waste packaging requirements as described in Rule .1204 (a)(!) of th
16 suitable for shams. Containers of blood and bodv fluids which are i3ackaeed in aecor-dane
17 this Section ^ on4ai er suitable for sh -ps as red by this Rule shall be stored in a secured area and shall not
18 be compacted prior to off -site transportation.
19 (d) Regulated medical waste shall not be eompaeted. compacted prior to treatment.
20 (e) Only the responsible party or their designated representative shall have access to regulated medical waste.
21 (f) Medical waste shall not become putrescent. Putrescent medical waste shall be disposed of or treated within three
22 calendar days.
23 (g) Medical waste shall not become a nuisance.
24 (h) Medical waste accepted at transfer or storage operations or a treatment facility shall not be subject to the
25 requirements of Rule .1203(a) and (b)(2) of this Section.
26 (i) Medical waste treatment and disposal methods:
27 (11,) Blood and body fluids in individual containers in volumes greater than 20 milliliters shall be
28 disposed of by sanitary sewer if the local sewage treatment authority has been notified; or treated
29 by incineration or steam sterilization.
30 Microbiological waste shall be treated by incineration, steam sterilization, ozonation, microwave,
31 or chemical treatment.
32 (3) Non -hazardous pharmaceutical waste shall be treated by incineration [incineration, ..earn.d to the
33vendor-, r,]—or disposed of at a municipal solid waste landfill. The requirements of this
34 Subparagraph shall not prevent non -hazardous pharmaceuticals from being returned to the vendor.
35 (4) Pathological waste shall be treated by incineration or ozonation.
36 (5) Trace chemotherapy waste shall be treated by incineration or ozonation.
3of16

A-41
Noninfectious medical waste and blood and body fluids in individual containers in volumes of 20
2 milliliters[ml] or less may be Ireeyeled, ]disposed of in a municipal solid waste landfill, [landfill er
3 ]or treated by the treatment methods as described in this Paragraph. Blood and body
4 fluids in individual containers in volumes of 20 milliliters or less may also be disposed of in a
5 sanitary sewer. The requirements of this Subparagraph shall not prevent noninfectious medical
6 waste such as textiles, plastic, glass, or metal from being recycled.
7 (i) Medical waste treated at the generatingfacility acility is not subject to the requirements of Paragraphs phs (o), (p), and (q) of
8 this Rule, and Rule .1204(b)(1),b)(3), and (b)(8) of this Section.
9 (k) Crematoriums are not subject to the requirements of this Section.
10 (1) Transport vehicles, transfer or storage operations, and treatment facilities shall:
11 (1) be kept free of leaked, spilled, and unpackaged medical waste;
12 (2) not contain porous floor coverings;
13 (33,) be ventilated;
14 (4) not create a nuisance; and
15 (5) have a method of leak control or spill cleanup, including decontamination.
16 (m) A responsible party shall be present when regulated medical waste is being transferred by means of transfer or
17 storage operations.
18 (n) Regulated medical waste shall be transported and stored in a manner that prevents exposure to the environment
19 and inclement weather.
20 (o) Unrefrigerated regulated medical waste shall be treated within 21 calendar days of shipment from the generator.
21 (p) Refrigeration at an ambient temperature of a maximum of 45 degrees Fahrenheit (7.22 degrees Celsius,) shall be
22 maintained for regulated medical waste not treated within 21 calendar days of shipment from the generator.
23 (q) All regulated medical waste shall be treated within 60 calendar days of shipment from the generator.
24
25 History Note: Authority G.S. 130A-309.26;
26 Eff. October 1, 1990;
27 Amended Eff. January 4, 1993; March 1, 499j. 1991;
28 Readopted Eff. November 1, 2019.
4of16

A-42
1 15A NCAC 13B .1203 is readopted with changes as published in 33:24 NCR 2365 as follows:
2
3 15A NCAC 13B .1203 GENERAL REQUIREMENTS FOR REGULATED MEDICAL WASTE
4 GENERATORS, TRANSPORTERS, AND TRANSFER AND STORAGE
5 OPERATIONS
6 .
7 M blood affd body ftids in individual contaiffers involumes greater than 20 ml incineration o
8
the treatment
is
sanitary sewage systems,
provided sewage
authority notified;
9
ineiner-ation,
treatment,
(2) mier-obiological
waste steam sterilization,
mier-owave
or chemieal-
10 treatment*,
11 (-3) pmholegieal�vastesineiner-mien.
13 Regulmed trea4ed
in Pafagr-aph
this Rule
be
in
(e) medieal waste
aeeer-da-nee with
(a) of may
fnanaged
aeeor-danee
14 with 15A "T�3B .01�-9700
15
.
16 (e) A treats Regulated
the
f4eilivy integrated
faeilit�-�
per -son who
medical waste at generating
or- vMhin an
medieal
17
.
18 Generating f4eilities integrated
facilities in
October 1, 1990
that incinerate
Regulated
(f) and
medical operation
on
19
.
20 (a) Regulated medical waste packaging reauirements:
21
(1)
All Sections of the Code of Federal Regulations (CFR) cited in this Paragraph are hereby
22
incorporated by reference, includingsubsequent amendments and editions and can be accessed at
23
no cost at https://www.gpo.gov/.
24
Regulated medical waste may be packaged in accordance with 49 CFR 173.134, 49 CFR 173.196,
25
49 CFR 173.197, or 49 CFR 173.199.
26
(3)
A plastic film bag shall be used as inner packaging, unless it is not required per the regulated medical
27
waste type when used in conjunction with one of the package designs pursuant to Subparagraph (2)
28
of this Para rg aph.
29
(4)
The plastic film bag used as inner packaging shall be sealed to prevent leaks.
30
(5)
A rigid box, drum, or vessel constructed to prevent leakage shall be used as outer packaging.
31
C6)
Outer package labeling shall be legible and written in English.
32
C7)
Outer packaging shall contain the universal biohazard symbol as described in 29 CFR 1910.1030(g).
33
C8)
Each package shall be handled to prevent leaks, damage, and changes to the package, labeling and
34
markings.
35
(9)
Labels and markings on the outside of each package shall contain the following information:
36
(A) state that the content is an "infectious substance" or a "biohazard;"
37
(B) the generator name, physical address, and phone number;
5of16

A-43
1 (C) the transporter name, physical address, and phone number;
2 the treatment facility name, physical address, and phone [^�= d' number, unless the
3 label contains a tracking number that corresponds to a record that includes the treatment
4 facility name, physical address, and phone number, and the record is provided to the
5 Division at the time of inspection and upon request; and
6 (E) the date of shipment from the generating [f e facility, unless the label contains a
7 tracking number that corresponds to a record that includes the date of shipment, and the
8 record is provided to the Division at the time of inspection and upon request.
9 [The requirement in Part (E) of this S4paragraph does not apply to customer loaded trailers, except
10 that all pack -ages accessible from the car -go area deer(s) shall be marked with the da e of shipment
11
12
paekages shall be mafked with the date of shipment ffom the generater when they afe removed f+e-m-
13 the etistemer- loaded tFailer-, tialess the medieal waste paekages afe t-r-eated a4 that site within 24
14 l-ieufs.]
15 (b Generator requirements:
16 W The generatingfacility acility shall package medical waste by treatment method tyre in accordance with
17 Rule .12026) of this Section.
18 Q The generatingfacility acility shall maintain a record of each shipment of regulated medical waste
19 transported off -site for a period of three years that includes the following information:
20 (A) the number of packages;
21 (B) the transporter name, physical address, and phone number;
22 LQ the treatment facility name, physical address, and phone number; and
23 (M the date of shipment from the generatingfacility.
24 The requirements of this Subparagraph do not apply to generating facilities that ,generate less than
25 50 pounds of regulated medical waste per month.
26 (c) Transporter reauirements:
27
(1)
The transporter shall not accept regulated medical waste that does not meet the requirements of
28
Para rg anh (a) of this Rule.
29
(2)
The universal biohazard symbol shall be displayed on the outside of a transport vehicle on both sides
30
and rear of the vehicle's cargo area, shall be legible, and shall not be obstructed from view.
31
Transport vehicles shall only. transport medical waste for treatment, other solid wastes, and supplies
32
related to the handling of solid wastes. If a medical waste package leaks or spills, all of the
33
[eeits ]solid waste, except for hazardous waste, within the same storage area of the transport
34
vehicle as the leaking or spilled package shall be treated at a medical waste treatment facility. If the
35
solid waste that leaked or spilled is a hazardous waste, all of the solid waste within the same storage
36
area of the transport vehicle as the leaking or spilled package shall be brought to a hazardous waste
37
treatment facility.
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A-44
Transport vehicles shall be free of medical waste and disinfected with a mycobacteriocidal
2
disinfectant before being reused if any packages spilled or leaked while in the [vehiele. ]vehicle,
3
and prior to discontinuing use of the transport vehicles to haul medical waste.
4
(5)
The vehicle operator shall keep a contingency plan as described in Rule .1204(b)(4)(H) of this
5
Section in the transport vehicle and shall be trained to implement the contingency plan prior to
6
transporting medical waste.
7
L6)
The transporter shall be in compliance with Rule .1202(o), (p), and (g) of this Section.
8
(d) Transfer or storage operations requirements:
9
The responsible party for transfer or storage operations occurring at a treatment facility shall include
10
a description of the transfer or storage operations in the facility operations plan submitted to the
11
Division in accordance with Rule .1204(b)(4) of this Section.
12
(2)
The responsible party for transfer or storage operations occurring at a location other than a treatment
13
facility shall submit a record to the Division within 14 calendar days of commencing transfer or
14
storage operations, and once every two years thereafter, while the responsible party is managing the
15
transfer or storage operations. The record shall include the following information:
16
the name, mailing address, physical address, office and mobile phone numbers, and email
17
address for the responsible party(s) and operator(s);
18
county GIS property data for the location where transfer or storage operations occur;
19
(C) procedures for how the medical waste will be received, handled, stored, [e ]and
20
transferred;
21 (D) the frequency that transfer or storage operations occur;
22 the amount of medical waste that is expected to be on site at the transfer or storage
23 operations; and
24 additional information that the Division may request pertaining to the transfer or storage
25 operations if it is necessary to determine compliance with the rules of this Subchapter.
26 The responsible party shall submit an updated record to the Division within 14 calendar days if any
27 of the information required to be submitted by this Subparagraph changes.
28 (3) If the transfer or storage operations cease, the responsible party shall submit to the Division a record
29 within 14 calendar days. The record shall include the following information:
30 a signed statement by the responsible party(s) that transfer or storage operations have
31 ceased and all medical waste has been removed;
32 (B) digital pictures of the area that was utilized for transfer or storage operations taken after
33 operations have ceased and all medical waste has been removed; and
34 (C) additional information that the Division may request pertaining to the transfer or storage
35 operations if it is necessary to determine compliance with the rules of this Subchapter.
36 (4) Within 90 days of the readopted effective date of this Rule, existing transfer or storage operations
37 shall comply with Subpara rg aph (2) of this Para rg aph.
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A-45
1 (5) The transfer or storage operations shall comply with Rule .1202(o), (p), and (q) of this Section.
3 History Note: Authority G.S. 130A-309.26;
4 Eff. October 1, 1990;
5 Amended Eff. April 1, 1993-1993;
6 Readopted Eff. November 1, 2019.
8of16

A-46
1 15A NCAC 13B .1204 is readopted with changes as published in 33:24 NCR 2365 as follows:
2
3 15A NCAC 13B .1204 REQUIREMENTS FOR THE TREATMENT OF REGULATED
4 MEDICAL WASTE
5 (a) A perseR �"a ships fegulmed medieal waste ffem the gener-a4ing faeilit-y for- off site tfeatm&4 shall meet the
6 following requifementsi
7 Regulated medical waste shall be pack -aged in a minim -um of one plastic bag placed in a r-igiA
8 fiberboard box, rigid drum, or other rigid container constmeted in a manner that prevents leaka
9 of the contents. The plastie bag shall be impervious to moisture and have a strength sufficient to
10
preclude
ripping,
tearing or bursting
the
waste filled bag
under normal
eonditions of usage and
11
handling.
Eaeh
bag shall be eensti:ueted
of
fnmer-ial of suffieient
single
thiekness strength to pass
12
the 165
gain
dropped da-4 impaet
r-esistanee
test as pr-eser-ibed
by Standard
P 1709 91 of the
13
CD
14
subsequent
amendments
and editions,
and eei4ified
by the
bag fnafvafaetufer-.
A eopy is available
15
inspeetion
at
the Departmen4
of Efwironmen4,
Health, and
Natual Resources,
Division of Soli
16
, Raleigh,
North Carolina.
Copies
may be requested by m-
17
at American
Society fo-r- T "
—
I ' I iter-ials,
1916 Race
Street, Philadelphia,
P.A. 19103 or by
18
calling
(215)
299 5400 for a eost
of
twelve
dollars ($12.00)
plus one dollar
and fifty cents ($1.50)
19
f f shipping
and
handling , «less
prepaid,
then
the fee is twelve
dollars ie
l 2 nm
20
(2)
21
allT
22
(4)
Each package
of regulated medical
waste
shall
be labeled
with a water resistant
tmiver-sal biohazar-
23
symbol.
24
(4)
Each package
of regulated medieal
waste
shall be maFked
on the outer stiFface
with the following
25
in€ermatief
.
26
(A)
the s.e
of toffs name,
address
and
telephone number;
27
(44)
the t.-a
spei4er's name,
address,
and
telephone number;
28
stafage
f e:l;t.. name,
address
and
telephone number,
„ he„ applicable;
29
tFeetmepA
f eil;t.. name,
address
and
telephone number;
30
(E)
date
of shipment; and
31
(F)
"DWEC'l'IOUS
WASTE"
or
"MEDICAL
T WASTE"
32 (b)
Records
be
for
include
the information list
of
regulated
medical
waste shall
maintained
each shipment
and shall
33
.
34
()
amount
of waste
byf 4nbe.- of
p ekages
(p
eee a ..t\.
35
(2)
date shipped
off site.
36
(
e
eft
r
ei4e .
37
(4)
name
e f storage
or- t..e"tment facility,
9of16

A-47
1
The
this Paragraph to less than 50
2
requirements
waste per pA-,
of shall not apply per -sons who generate pounds of regulated medic
3
A te
be the
(e) plan ensufe
pr-eper- management of Feg-ala4ed medical waste shall prepared and maintained at genera4ing
4
€aeility.
5
(a) General requirements for treated regulated medical waste:
6
(1)
Treated regulated medical waste shall be covered to prevent exposure to the environment and
7
inclement weather.
8
Treated regulated medical waste may be placed uncovered in or under a weather resistant structure
9
while dewatering or while in the process of being covered.
10
Treated regulated medical waste shall be stored no longer than 14 calendar days after treatment
11
unless the facility's operations plan states that the storage unit is a necessM part of the operation of
12
the treatment process and is enclosed, sealed, and watertight.
13
(4)
Treated regulated medical waste storage and transport containers, compactors, trailers, and cargo
14
bays shall be maintained in accordance with the manufacturer's specifications.
15
(5)
Treated regulated medical waste shall not be transported off site uncovered.
16
(6)
The exterior of treated regulated medical waste storage and transport containers, compactors,
17
trailers, and cargo bays shall be free of solid waste and solid waste residue.
18
C7)
Treated regulated medical waste shall not become putrescent. Putrescent treated regulated medical
19
waste shall be disposed of within three calendar days.
20
(8)
Treated regulated medical waste shall not become a nuisance.
21
(9)
Treated regulated medical waste shall be noninfectious.
22
(b) General requirements for treatment facilities:
23
W
The treatment facility shall be compliant with Rule .1202(0), (p), and (q) of this Section.
24
Q
The treatment facility shall issue a written record notifying the generatingfacility acility if it becomes
25
aware of a package of medical waste received that is not in compliance with Rule .1202(i) of this
26
Section for the treatment method utilized. A copy of the record shall be maintained at the treatment
27
facility.
28
(3)
The treatment facility shall maintain a record of each shipment of regulated medical waste received
29
for treatment for a period of three years to include the following information:
30
W the number of packages;
31
(B) the generator name, physical address, and phone number;
32
LQ the transporter name, physical address, and phone number;
33
(M the date each package was picked up from the generator;
34
(E) the date each package was received at the treatment facility
35
(F) the weight of each package in pounds; and
36
(G) the date each package was treated.
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A-48
The treatment facility shall submit a facility operations plan to the Division with the permit
2
application required in accordance with the rules of this Subchapter that shall include the following
3
information:
4
(A) the name, mailing address, physical address, office and mobile phone numbers, and email
5
address for the responsible party(s), owner(s), and operator(s);
6
(B) the physical address and the county GIS property data for the facility location;
7
(C) types and estimated amounts of medical waste to be accepted at and shipped out from the
8
facility;
9
a description of the treatment process or [processes;; ]processes, and treatment unit
10
specifications;
11
(E) procedures for how the medical waste will be received, handled, stored, transferred, or
12
treated at the facility;
13
(F) procedures for sampling or testing required by the rules of this Section;
14
(G) procedures that the facility shall use to prevent medical waste from becoming a nuisance
15
or putrescent, and procedures for abatement if medical waste becomes a nuisance or
16
putrescent;
17
contingency plan identifying risks and describing how the facility or transporter will
18
respond to incidents or emergencies, including a phone number for a facility or transporter
19
representative that is available to respond 24 hours a day and 7 days a week, and how
20
regulated medical waste will be handled or redirected when facilities or transport vehicles
21
are unavailable due to maintenance, adverse weather, or other emergencies; and
22
Cl) additional information that the Division may request pertaining to the facility operations if
23
it is necessary to determine compliance with the rules of this Section.
24
A copy of the operations plan shall be kept at the facility and shall be available for review by the
25
Division duringfacility acili . inspections or upon request by the Division. If the information required by
26
this Paragraph changes, the facility shall submit a revised facility operations plan to the Division
27
and update the copies of the plan kept by the facility.
28
(5)
The treatment facility shall maintain a record of the disposal facility's contact information including
29
the facility name, permit number, physical location and mailing address, and contact name and
30
phone number.
31
C6)
The treatment facility shall maintain a record of the dates and tonnages of treated regulated medical
32
waste sent for disposal.
33
The treatment facility shall maintain operating records and monitoring, testing, and maintenance
34
records required in accordance with the rules of this Section for a period of three years.
35
(8)
The facility shall submit an annual report to the Division in accordance with G.S. 130A-309.09D(b).
36 (c) Steam sterilization treatment requirements:
11 of 16

A-49
W Steam under pressure shall be provided to maintain a temperature of not less than 250 degrees
2
Fahrenheit for 45 minutes at 15 pounds per square inch of gauge pressure duringeycle.
3
(2)
The steam sterilization unit shall have a device that records the start and end time of each cycle.
4
(3)
The steam sterilization unit shall have a device that records the pressure and a device that records
5
the temperature throughout each cycle.
6
(4)
Testing of treatment under conditions of full loading to confirm compliance with Subpara rg aph
7
(a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
8
Geobacillus stearothermophilus spores having a population of not less than 1.0 x 104 placed within
9
the waste load.
10
(5)
A record of each test performed shall be maintained and shall include the type of indicator used, the
11
test date, the start and end times, and the test result.
12
( Incineration treatment requirements:
13
(1)
The Division shall not issue a solid waste management permit in accordance with the rules of this
14
Subchapter to the treatment facility unless the Division of Air Qualit.. (DAQ) has issued a permit
15
for operation of the incinerator.
16
Q
The treatment facility shall maintain the DAQ permit for the operation of the incinerator.
17
0
Regulated medical waste shall be subjected to a burn temperature in the primary chamber of not less
18
than 1200 degrees Fahrenheit.
19
(4)
The incinerator shall have a monitoring device that records the primary chamber temperature. A
20
record of the continuous monitoring of the primary chamber temperature while in use shall be
21
maintained.
22
(5)
Interlocks or other process control devices shall be provided to prevent the introduction of regulated
23
medical waste into the primary chamber until the secondary chamber achieves operating
24
temperature as defined in the permit for incinerator operation issued by DAQ.
25
C6)
Procedures for obtaining uniform representative composite ash samples shall be submitted to the
26
Division for approval in the facility operations plan in accordance with Rule .1204(b)(4) of this
27
Section. Ash sampling procedures shall be approved if the procedures are compliant with the
28
requirements of this Subchapter, are protective of human health and the environment, and if the
29
samples collected using the procedures are representative of the incinerator ash shipped from the
30
facility for disposal.
31
C7)
The ash samples shall be collected from the dewatered ash collection container or containers.
32
C8)
For the first three months of incinerator operation, the ash sampling procedures required by
33
Subparagraph (6) of this Paragraph shall include the collection of a representative ash sample of one
34
kilogram (2.2 pounds
35
(A) once for every eight hours of operation for an incinerator that is operated on a continuous
36
schedule;
12 of 16

A-50
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
once for every 24 hours of operation for an incinerator that is operated on an intermittent
schedule; or
once for every batch for an incinerator that is batch -loaded.
The ash samples shall be composited in a closed container weekly and shall be mixed and reduced
to a uniform ash sample. The weekly ash samples shall be composited into a monthly ash sample,
and the monthly ash sample shall be analyzed.
For the remainder of the first year of incinerator operation, a representative ash sample shall be
collected once per month using the procedures described in the facility operations plan. The monthly
ash samples shall be composited and reduced to a uniform quarterly ash sample, and the quarterly
ash samples shall be analyzed.
10 After the first year of incinerator operation, representative composite ash samples shall be collected
using the procedures described in the facility operations plan twice per calendar year, with no less
than four months between sample collection, and the samples shall be analyzed.
11 Ash samples required to be analyzed in accordance with Subpara agr nhs (8) through (10) of this
Paragraph shall be analyzed in accordance with 40 CFR 261.24 for the eight metals listed in Table
1 (arsenic, barium, cadmium, chromium, lead, mercury, selenium, and silver). 40 CFR 261 is
incorporated by reference includingsubsequent ubsequent amendments and editions; and can be accessed at
no cost at https://www.gpo.gov/.
12 A record of the testing and analysis results shall be submitted to the Division for the first year of
incinerator operation, and thereafter shall be maintained at the facility and available for inspection
by the Division, and shall be submitted upon request from the Division, and shall include:
W the composite ash sample date and time;
the ash sample date and time;
LQ the ash sample identification number;
the ash sample analysis results; and
the testing laboratory name and contact information and certification number.
13 The Division may require the treatment facility to collect additional composite ash samples or
analyze the samples for the full contaminant list in accordance with 40 CFR 261.24 Table 1 if the
results of the analysis required in Subpara agr phs (8) through (,11) of this Paragraph indicate an
exceedance of the re ug lato . level in 40 CFR 261.24 Table 1; or during a permittingaction,
tion,
a facility inspection, or when a complaint is received if it is necessary to determine compliance with
the rules of this Subchapter. The requirements of this Paragraph shall not prevent a municipal solid
waste landfill that is accepting incinerator ash from a treatment facility from requiring that additional
ash samples be taken and analyzed to determine compliance with the rules of this Subchapter before
the ash is accepted for disposal.
(e) Chemical treatment requirements:
Microbiological waste shall be treated with 10 percent chlorine solution for no less than one hour.
13 of 16

A-51
Q Testing of treatment under conditions of full loading to confirm compliance with Subparagaph
2 (a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
3 Bacillus atrophaeus spores having a population of not less than 1.0 x 106.
4 (3) A record of each test performed shall be maintained and shall include the type of indicator used, the
5 test date, the start and end times, and the test results.
6
(fl Microwave treatment requirements:
7
W
Microwave energy of appropriate output frequency shall be provided at a temperature of not less
8
than 203 degrees Fahrenheit (95 degrees Celsius) for no less than 30 minutes each cycle.
9
Q
The microwave treatment system shall be provided with a monitoring device that records time and
10
temperature of each cycle. A record of the monitoring of the time and temperature of each cycle
11
shall be maintained.
12
(3)
Testing of treatment under conditions of full loading to confirm compliance with Subpara rg aph
13
(a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
14
Bacillus atrophaeus spores having a population of not less than 1.0 x 106 and in accordance with the
15
equipment manufacturer's instructions.
16
(4)
A record of each test performed shall be maintained and shall include the type of indicator used, the
17
test date, the start and end times, and the test result.
18
(g) Ozonation
treatment requirements:
19
(1)
Testing of treatment under conditions of full loading to confirm compliance with Subpara rg aph
20
(a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
21
Bacillus atrophaeus spores having a population of not less than 1.0 x 106 and in accordance with the
22
equipment manufacturer's instructions.
23
Q
Once every six months samples collected under conditions of full loading shall be submitted to an
24
independent laboratory to confirm compliance with Subparagraph (a)(9) of this Rule.
25
0
A record of each test performed shall be maintained and shall include the type of indicator used, the
26
test date, the start and end times, [the epa4ion time, the ine4ation time, ]and the test result.
27
(h) Alternative treatment methods.
28
(1)
A treatment facility owner or operator may request to use a method of, or procedures for, regulate
29
medical waste treatment not listed or described in this Rule by submitting a request to the Division
30
for approval. The request shall include documentation that describes the alternative treatment
31
method, explains the procedures and provides analysis results to demonstrate that the treatment
32
method will render the regulated medical waste noninfectious, and describes how the treatment
33
method meets the requirements of the rules of this Section.
34
(2)
A request for an alternate method of chemical treatment shall also describe the chemical used to
35
treat the specific microbiological agent(s) of concern for the regulated medical waste type, and shall
36
consider factors such as temperature, contact time, pH, concentration, and the presence and state of
37
dispersion, penetrability, and reactivity of organic material at the site of application.
14 of 16

A-52
1 0 The Division may approve the alternative treatment method by issuing the permit or an approval
2 letter if the alternative treatment method renders the regulated medical waste noninfectious, and the
3 alternative treatment method is compliant with the rules of this Section and protective of human
4 health and the environment.
6 History Note: Authority G.S. 130A-309.26;
7 Eff. October 1, 1990;
8 Amended Eff.' October 1, 1992; December 1, 1991; March 1, 1991. 199L
9 Readopted Eff.' November 1, 2019.
15 of 16

A-53
1
2
3
4
5
6
7
8
9
10
11
15A NCAC 13B .1205 - .1207 are repealed through readoption as published in 33:24 NCR 2365 as follows:
15A NCAC 13B .1205 REQUIREMENTS FOR TRANSPORTERS OF REGULATED MEDICAL WASTE
15A NCAC 13B .1206 REQUIREMENTS FOR STORAGE OF REGULATED MEDICAL WASTE
15A NCAC 13B .1207 OPERATIONAL REQ/REGULATED MEDICAL WASTE TREATMENT
FACILITIES
History Note: Authority G.S. 130A-309.26;
Eff. October 1, 1990;
Amended Eff. April 1, 1993; January 4, 1993. 1993;
Repealed ff. November 1, 2019.
16 of 16