13B_.1200_RegulatoryImpactAnalysis

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REGULATORY AND FISCAL IMPACT ANALYSIS FOR READOPTION AND
AMENDMENTS TO 15A NCAC 13B SECTION .1200 MEDICAL WASTE MANAGEMENT
February 21, 2019
General Information
Agency/Commission: Environmental Management Commission
Department: Department of Environmental Quality, Division of Waste
Management, Solid Waste Section
Contact: Jessica Montie
Environmental Program Consultant
Jessica. MontieCcDncdenr.gov
[phone]
John Patrone
Environmental Specialist II
John. Patrone(a�ncdenr.gov
[phone]
Title of Rule Set: Medical Waste Management
Citation: 15A NCAC 13B .1201 - .1207
Authority: G.S. 130A-309.26; G.S. 150B-21.3A
Impact Summary: State government: Yes
Local government: No
Private Sector: Yes
Substantial Impact: No
Federal Requirement or Impact: No
Proposed Rule -Making Schedule:
Date Action
3/13/2019 GWWMC Meeting: Approval of proposed text to go to EMC.
5/9/2019 EMC Meeting: Approval of rule text and impact analysis for public
comment.
6/17/2019 Rules published in NC Register and Agency website
Comment Period Begins.
7/2/2019 Earliest date for public hearing.
8/16/2019 Comment Period Ends.
9/12/2019 EMC Meeting: Approval of Hearing Officer's Report and Adoption
of Rules.
10/17/2019 RRC meeting: Approval of rule text
11/1/2019 Earliest effective date for rules.

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Necessity and Purpose of Rule Change
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. These rules are
proposed for readoption in accordance with G.S. 15013-21.3A, and are required to be
readopted by the deadline established by the Rules Review Commission of April 30,
2021.
Proposed amendments to the rules include consolidation of the requirements of the
rules into Rules .1201 - .1204 and repeal of Rules .1205 - .1207, technical corrections,
updates to information such as Department names, addresses, websites, and
references, clarification of vague or unclear language, and removal of redundant or
unnecessary language. Additional amendments are proposed in response to
stakeholder meetings and comments received and are discussed in more detail below.
Fiscal Summary
The proposed amendments to the Medical Waste Management Rules are expected to
result in a net economic benefit to the private sector regulated community and to state
government; but are not expected to have a substantial impact. No impacts to local
governments or private households are expected as a result of the amendments.
Fiscal Analysis
Private Sector Impact
Types of Businesses or Facilities Potentially Affected by Rule Changes:
- Medical Waste Treatment and Processing Facilities Permitted by the Division
(5 Processing Facilities, one of these is an Incineration Facility)
- Medical Waste Generators, Transfer or Storage Operations, and Transporters
(the number of these types of operations in NC is unknown as they are not
required to obtain a permit from the Division)
Benefits
The amendments in the proposed rule provide a benefit to the medical waste
management industry by extending time limits for storage of unrefrigerated medical
waste in proposed Rule .1202(o), (p), and (q). These changes were made in response
to a comment letter from private industry submitted in 2016 requesting that the Division
revise the rules during readoption to allow for extended storage times without
refrigeration to reduce costs, since no clear added value is realized from keeping

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shorter time limits. However, the amendments still require that the waste not become
putrescent or a nuisance, which are the main intentions of refrigeration and having
storage time limits on unrefrigerated waste; and therefore, the rules remain protective of
human health and the environment. A copy of the comment letter is included. The
benefits for this amendment are difficult to quantify since an estimation of cost would
depend on how the industry will choose to or be able to modify their current procedures
as a result of the extended limits while still ensuring that the waste will not be putrescent
or a nuisance, but this amendment is expected to reduce the burden on the regulated
community.
An amendment in proposed Rule .1203(a) provides a benefit by simplifying packaging
requirements by referring to and incorporating the federal requirements for packaging
based on waste type; which in practice should not change the behavior of the medical
waste industry, but provides clarification in rule that following the Federal CFR is
sufficient for State requirements. An additional proposed amendment to Rule .1203(a)
states that treatment facilities receiving shipments of customer loaded -trailers are not
required to label all packages with the shipping date. This amendment is proposed
because it is not practical or feasible for a receiving facility to completely unload a
customer -loaded trailer to label all boxes with a date, when they would not otherwise
need to be unloaded because the shipment is meant for further transportation. A
treatment facility estimated that a trailer may contain 600 packages, and approximately
21 trailers might arrive per week. Assuming 2 employees would be needed at 40 hours
per week to unload these 21 trailers at an hourly rate of $20.00, the benefit for clarifying
this exception in the proposed amendments can be estimated at $83,200 per year.
Additional benefits to the medical waste management industry in proposed Rule .1202(i)
include clarification on treatment and disposal options for additional waste types that are
not specifically addressed in existing rule such as trace chemotherapy waste and
pharmaceutical waste; adding ozonation as an option for a treatment method; and
clearly stating that noninfectious waste types may be disposed of via municipal solid
waste landfill or sanitary sewer and do not require treatment. These amendments
clarify in rule what is currently done in practice. Proposed Rule .1204 (g) also describes
the requirements for ozonation as a treatment method. While existing rules for
treatment methods allowed facilities to request alternate methods or procedures for
treatment, proposed Rule .1204(h) also clarifies the procedures to be used when
making that request, and what factors the Division will consider for approval.
While existing rules for permitting requirements in Subchapter 13B require that a facility
operations plan be included in a permit application for medical waste facilities permitted
by the Division, the amendments in proposed Rule .1204(b)(4) clarify the type of
information required to be submitted in the facility operations plan, and puts into rule
what is generally being done in practice as a permitting requirement.

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Costs
Estimated costs to the medical waste management industry as a result of the proposed
amendments include costs resulting from the requirement in proposed Rule .1203(c)(3)
that any waste transported in the same storage area of the vehicle as a leaking or
spilled package be treated as medical waste, or be treated as hazardous waste if the
leaking or spilled package contains hazardous waste. While this requirement may have
been implied in existing rule, since any package that had been contaminated with
medical or hazardous waste would become medical or hazardous waste, this is now
clearly stated in the proposed amendments. However, since the rules for packaging
also require that the packages shall not leak, this circumstance is not expected to occur
or would occur only rarely.
A potential cost to transfer or storage operations for medical waste may result from the
requirement in proposed Rule .1203(d)(2) to submit notification documentation for
transfer or storage operations not located at a permitted medical waste treatment facility
when beginning the operation and every two years thereafter while in operation, when
there is a change to the operation, and when ending the operation. Based on past
information that was requested to be submitted voluntarily for these operations, the
Division estimates there may be between 5 and 10 operations of this type in NC. These
operations will be required to submit the initial notification documentation within 90 days
of the readopted effective date of the proposed rule, and submit a renewal notification
every two years thereafter. The document with the required information is expected to
be a one or two page letter and may take one or two hours of staff time to generate.
Assuming a transfer or storage operations staff hourly rate of $20.00 - $30.00, the cost
in 2020 and every two years thereafter to these operations can be estimated between
$100.00 and $600.00. The cost in subsequent years would also depend on whether the
operations are changed or ended, but these submittals would not be substantially
different from the initial notification documents.
Medical waste treatment facilities may incur a minimal cost to produce a document due
to the requirement in proposed Rule .1204(b)(2) that they notify the generating facility in
writing when medical waste packages are received that are not in compliance with
packaging requirements in these rules. Existing treatment facilities have indicated that
they currently notify the generating facility in practice, but may not send the notification
in writing and are not required to keep records of this notification. The notification
document is expected to be a one or two page letter and may take one or two hours of
staff time to generate. Assuming a transfer or storage operations staff hourly rate of
$20.00 - $30.00, and assuming that notifications may need to be sent out three to five
times per year depending on how often there are packaging issues with the generating
facility, the additional cost per year to these operations following the readopted effective
date of the proposed rules can be estimated between $60.00 and $300.00.

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State Government Impact
The proposed amendments to the rules will not require the distribution of state funds,
and will have a net benefit to state government. Assuming a staff salary of $30.00 per
hour, and assuming that staff may save two hours per month as a result of reduced staff
time spent on correspondence with permit applicants to produce a complete facility
operations plan, and providing technical assistance for disposal of noninfectious
medical waste and other specific wastes not mentioned in existing rule, packaging
requirements, or procedures for requesting alternate treatment methods, the benefit to
state government may be $720 per year. Staff may spend additional time reviewing the
submittal of records for transfer or storage operations, but the cost is not expected to
exceed $600.00 per year, assuming 10 operations in NC, and a staff hourly rate of
$30.00.

My
APPENDIX 1
Comment Letter

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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

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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

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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

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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

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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

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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

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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

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APPENDIX 2
Proposed Rules

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1 15A NCAC 13B .1201 is proposed for readoption with substantive changes as follows:
2
3 SECTION .1200 - MEDICAL WASTE MANAGEMENT
4
5 15A NCAC 13B .1201 DEFINITIONS
6 For the purpose of the -this Section, the following definitions apply:
7 (1) "Blood and body fluids" means liquid blood, serum, plasma, other blood products, emulsified human
8 tissue, spinal fluids, and pleural and peritoneal fluids. Blood and body fluids does not include
9 dialysates, feces, or urine if not removed during surgeries and autopsies. Dialysates are not blee
10 .
11
(2)
"Generator" and "Generating facility" fneans mean any business, integrated medical facili , , and
12
volunteer or non-profit healthcare services where medical waste i_pro daced,
13
including but not limiteany medical or dental facility, mortuary, fuffeF� laboratory,
14
veterinary hospital hospital, and blood bank. bank; but does not include households.
15
(3)
"Integrated medical facility" means one or more health service facilities as defined in G.S.
16
131E-176(9b) that are:
17
(a) located in a single county or two contiguous counties;
18
(b) affiliated with a university medical school or that are under common ownership and
19
control; and
20
(c) serve a single service area.
21
(4)
"Medical waste" as means the term defined in G.S. 130A-290(17a)..130 2
22
(5)
"Microbiological waste" means the term defined in Rule .0101(26) of this Subchapter. etiltures an
23
steeks of infeetietts agents, ineluding bet not lifnited to speeimens frem fnedieal, pathelegieal,
24
.
25
" tfeatment by for time to
means microwave eiier-gy sufficient render waste
26
non ififeetietts.
27
(7)
"Off site" means any site whiehisnot "on site".
28
"
29
or private Fight of .
30
(6)
"Non -hazardous pharmaceutical waste" is a medical waste. It is a medical drug that is expired,
31
unused, contaminated, damaged, or no longer needed or used for its prescribed purpose and that is
32
not a hazardous waste as defined in G.S. 130A-290(8).
33
(7)
"Nuisance" means odorous outside of the property boundary or transport vehicle; or attracting
34
vermin or disease vectors.
35
(8)
"Package" is the total contents of a box, drum, or vessel containing medical waste, including
36
labeling and markings.
1 of 20

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1 (9) "Pathological waste" means the term defined in Rule .0101(31) of this Subchapter. human fissues,
2 efgans and W4 pai4s;
3 &Epased to pathogens that afe petef4ially dangerous to h*maas dttriag r-eseareh, vver-e used in the
4 pr-eduetien ef bielegieals or- in vivo testing of phamaeeutieals, or- that died w-M a known of
6 (10) "Record" means any data required to be kept on file by the operator or submitted to the Division in
7 accordance with the rules of this Section. A record may be in hard copy (naner) or electronic format
8 that is legible and in English.
9 (11)(" "Regulated Medical Waste" means the term defined in Rule .0101(34) of this Subchapter. bleed
10
12 (12,) "Responsible party" means the entity that is in possession of and has accepted the regulated medical
13
waste.
14
(U3 (M "Sharps" means the term defined is G.S. 130A-309.26(a)(1). and ineludes needlessy-Finges i
15
attae ed needle pill ry tubes, slides and ee�vefslips and sealp"l blades.
16
(14)
"Trace chemotherapy waste" means no more than three percent by weight of a medical drug used
17
for chemotherapy. Trace chemotherapy waste includes gowns, gloves, wipes, and other handling,
18
preparation, administration, cleaning, and decontamination items associated with chemotherapy,
19
(15)
"Transfer or storage operations" is the act of, and process by which, regulated medical waste is
20
removed from a transport vehicle and placed in another transport vehicle or in storage awaiting
21
transport.
22
(16)
"Transport vehicle" means a vehicle or other conveyance type used to transport regulated medical
23
waste to and from transfer or storage operations or to and from a treatment facility.
24
(17)(12) "Treatment" as means the term defined in G.S. 130A-309.26(a)(2).
25
(18)
"Treatment facility" means a regulated medical waste treatment facility permitted by the Division
26
in accordance with the rules of this Subchapter.
27
(19)
"Solid waste" means the term defined in 130A-290(a)(35).
28
29
History Note:
Authority G.S. 130A-309.26;
30
Eff. October 1, 1990;
31
Amended Eff. April 1, 199-3 1993;
32
Readopted Eff. November 1, 2019.
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1 15A NCAC 13B .1202 is proposed for readoption with substantive changes as follows:
2
3 15A NCAC 13B .1202 GENERAL REQUIREMENTS FOR MEDICAL WASTE
4 (a) Medical waste is subject to the ^menu in all appheable rules in 15A NCAC 44B, 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 shall be placed in a rigid, leak -proof when in an upright position, and puncture-
9 resistant container, and , leak proof when in an epr-igh4 position a -ad piinetHfe resista
10 Contained shffips-shall not be compacted prior to off -site 4anspeA transportation unless placed in a sealed
11 compactor unit that is hauled off for disposal by the transporter. After- leaving the goner-afing f4eility, the eentaine
12 a -ad its eentents shall be hand4ed in a manner- thm a -voids human eentaet with the shafps,
13 (c) Blood and body fluids in individual containers in volumes of 20 milliliters f11 or less
14
15
16 suitable foF shams. Containers of blood and bodv fluids which are i3aekaeed in aeeor-dane
17 this Seetio^ ^ ^^+^i^er sruit ble f r shaf s as re by this R-ule 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 compacted prior to treatment.
20 (e) Only the responsible party or their designated representative shall have access to regulated medical waste.
21 (fl 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 Rules .1203(a) and (b)(2) of this Section.
26 (i) Medical waste treatment and disposal methods:
27 (1) 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 (2) 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, returned to the vendor, reused,
33 or disposed of at a municipal solid waste landfill.
34 (4) Pathological waste shall be treated by incineration or ozonation.
35 (5) Trace chemotherapy waste shall be treated by incineration or ozonation.
3 of 20

B-18
1 (6) Noninfectious medical waste and blood and body fluids in individual containers in volumes of 20
2 ml or less may be recycled, disposed of in a municipal solid waste landfill or sanitary sewer, or
3 treated by the treatment methods as described in this Para rg anh.
4 (i) Medical waste treated at the generatingfacility is not subject to the requirements of Para rag phs (o), (p), and (o) of
5 this Rule, and Rule .1204(b)(1), (b)(3), and (b)(8) of this Section.
6 (k) Crematoriums are not subject to the requirements of this Section.
7 (1) Transport vehicles, transfer or storage operations, and treatment facilities shall:
8 (1) be kept free of leaked, spilled, and unpackaged medical waste;
9 (2) not contain porous floor coverings,
10 (3) be ventilated;
11 (4) not create a nuisance; and
12 (5) have a method of leak control or spill cleanup, including decontamination.
13 (m) A responsible party shall be present when regulated medical waste is being transferred by means of transfer or
14 storage operations.
15 (n) Regulated medical waste shall be transported and stored in a manner that prevents exposure to the environment
16 and inclement weather.
17 (o) Unrefrigerated regulated medical waste shall be treated within 21 calendar days of shipment from the generator.
18 (p) Refrigeration at an ambient temperature of a maximum of 45 degrees Fahrenheit (7.22 degrees Celsius,) shall be
19 maintained for regulated medical waste not treated within 21 calendar days of shipment from the ,generator.
20 (a) All regulated medical waste shall be treated within 60 calendar days of shipment from the generator.
21 History Note: Authority G.S. 130A-309.26;
22 Eff. October 1, 1990;
23 Amended Eff. January 4, 1993; March 1, 4994-. 1991;
24 Readopted Ejff. November 1, 2019.
4 of 20

B-19
1 15A NCAC 13B .1203 is proposed for readoption with substantive changes 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 (0 blood and body fluids in individual containers in vohimes greater- than 20 ml ineiner-ation e
8
,
9
, or- ehefflieal
10 tfo ff
11 (3) patkelegieal wastes ineineratien.
13 Regulmed tfemed in Paragraph
this Rule
be in
(e) medieal waste aeeer-da-neewith
(a) of may
managed aeear-da-ne-e
14 with 15ANCAC 13B .0 i 00—.0700.
15
.
16 A treats Regulated the
faeil4y integrated
faeility is
(e) per -son who medieal waste at generating
or- within an
medioal
17 not subjeet to the storage and -reser-kee. ' - e e�etits of
.
18
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, includingsbsequent amendments and editions and can be accessed at
23
no cost at https://www.gpo.gov/.
24
(2)
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 Paragraph.
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 packa ig ng.
31
(6)
Outer package labeling shall be written in English.
32
(7)
Outer packaging shall contain the universal biohazard symbol as described in 29 CFR 1910.1030(g).
33
(8)
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;
5 of 20

B-20
1 (C) the transporter name, physical address, and phone number;
2 (D) the treatment facili , name, physical address, and phone number; and
3 (E) the date of shipment from the generatingfacifity.
4 The requirement in Part (E) of this Subparagraph does not apply to customer -loaded trailers, except
5 that all packages accessible from the cargo area door(s) shall be marked with the date of shipment
6 from the generator prior to transport from the generatingfacility. The remaining medical waste
7 packages shall be marked with the date of shipment from the generator when they are removed from
8 the customer loaded trailer unless the medical waste packages are treated at that site within 24 hours.
9
(b) Generator requirements:
10
(1)
The generating facility shall package medical waste by treatment method type in accordance with
11
Rule .1202(i) of this Section.
12
(2)
The generatingfacility acility shall maintain a record of each shipment of regulated medical waste
13
transported off -site for a period of three years that includes the following information:
14
(A) the number of packages;
15
(B) the transporter name, physical address, and phone number;
16
(C) the treatment facility name, physical address, and phone number; and
17
(D) the date of shipment from the generatingfacility.
18
The requirements of this Subparagraph do not apply to generating facilities that ,generate less than
19
50 pounds of regulated medical waste per month.
20
(c) Transporter requirements:
21
(1)
The transporter shall not accept regulated medical waste that does not meet the requirements of
22
Para rg aph (a) of this Rule.
23
(2)
The universal biohazard symbol shall be displayed on the outside of a transport vehicle on both
24
sides and rear of the vehicle's cargo area, shall be legible, and shall not be obstructed from view.
25
(3)
Transport vehicles shall only transport medical waste for treatment, other solid wastes, and
26
supplies related to the handling of solid wastes. If a medical waste package leaks or spills, all of
27
the contents, except for hazardous waste, within the same storage area of the transport vehicle as
28
the leaking or spilled package shall be treated at a medical waste treatment facility. If the solid
29
waste that leaked or spilled is a hazardous waste, all of the solid waste within the same storage
30
area of the transport vehicle as the leaking or spilled package shall be brought to a hazardous waste
31 treatment facility.
32 (4) Transport vehicles shall be free of medical waste and disinfected with a mycobacteriocidal
33 disinfectant before being reused if any packages spilled or leaked while in the vehicle.
34 (5) The vehicle operator shall keep a contingency plan as described in Rule .1204(b)(4)(H) of this
35 Section in the transport vehicle and shall be trained to implement the contingency Plan prior to
36 transporting medical waste.
37 (6) The transporter shall be in compliance with Rule .1202(o), (p), and (q) of this Section.
6 of 20

B-21
1 (d) Transfer or storage operations reauirements:
2
(1)
The responsible party for transfer or storage operations occurring at a treatment facility shall include
3
a description of the transfer or storage operations in the facility operations plan submitted to the
4
Division in accordance with Rule .1204(b)(4) of this Section.
5
(2)
The responsible party for transfer or storage operations occurring at a location other than a treatment
6
facility shall submit a record to the Division within 14 calendar days of commencing transfer or
7
storage operations, and once every two years thereafter, while the responsible party is managing the
8
transfer or storage operations. The record shall include the following information:
9
(A) the name, mailing address, physical address, office and mobile phone numbers, and email
10
address for the responsible party(s) and operatorL,Z
11
(B) county GIS property data for the location where transfer or storage operations occur;
12
(C) procedures for how the medical waste will be received, handled, stored, or transferred;
13
(D) the frequency that transfer or storage operations occur;
14
(E) the amount of medical waste that is expected to be on site at the transfer or storage
15
operations; and
16
(F) additional information that the Division may request pertaining to the transfer or storage
17
operations if it is necessary to determine compliance with the rules of this Subchapter.
18
The responsible party shall submit an updated record to the Division within 14 calendar days if any
19
of the information required to be submitted by this Subparagraph changes.
20
(3)
If the transfer or storage operations cease, the responsible party shall submit to the Division a record
21
within 14 calendar days. The record shall include the following information:
22
(A) a signed statement by the responsible party(s) that transfer or storage operations have
23
ceased and all medical waste has been removed;
24
(B) digital pictures of the area that was utilized for transfer or storage operations taken after
25
operations have ceased and all medical waste has been removed; and
26
(C) additional information that the Division may request pertaining to the transfer or storage
27
operations if it is necessary to determine compliance with the rules of this Subchapter.
28
(4)
Within 90 days of the readopted effective date of this Rule, existing transfer or storage operations
29
shall comply with Subparagraph (2) of this Paragraph.
30
(5)
The transfer or storage operations shall comply with Rule .1202(o), (p), and (q) of this Section.
31
32 History Note: Authority G.S. 130A-309.26;
33 Eff. October 1, 1990;
34 Amended Eff. April 1, 1993. 1993:
35 Readopted Eff. November 1, 2019.
36
7 of 20

B-22
1 15A NCAC 13B .1204 is proposed for readoption with substantive changes as follows:
2
3 15A NCAC 13B .1204 REQUIREMENTS FOR GENERATO THE TREATMENT OF REGULATED
4 MEDICAL WASTE
5 (a) A person whe ships r-egulmed fnedieal waste ftem the genefa4ing f4eility for- eg site tfea4ment shall meet the
7 0) Regulated inedieal waste shall be paekaged in a minimm of one plastie bag plaeed in a rigid
8
9 of the contents. The plastie bag shall be impenvietts to fneistufe and hffie a strength suffieiefit to
10 pr-eeltide r4pping, teafing or- bufsting the waste filled bag tinder nofmal eanditiens of usage a -ad
11 handling. Eaeh bag shall be eenstpaeted of mater-ial of suffieient single thielffiess stfengtil to pass
12
13
14 subsequent amendments and editions, and eer-tified by the bag manufaetffer, A eopy is a-vaila
15 for inspeetion at the DepaAment of Environment, Health, and Natural ResetiFees, Division of Solid
lb , NeAh Carolina. Copies may be f-equested by —
17 ,
18
19 fef shipping and handling tmiess prepaid, then the fee is twelve dellafs ($12.00).
20 (2) Regulated medieal waste shall be stafed in a ma-mer- that maintains the integr-ity of the paekagiffg-a4
21 ..11 times.
22
(3) Eaeh Paekage of r-egulated medieal waste shall be labeled with a wateF resistant univer-sal biohazar-
23 steel.
24
25 deft
26 (A) the generator's name, address, and telephene nttfflber-;
27 (B) the tfanspai4er-'s name, address, and telephone number;
28 (c) star -age aEt" name, address, and tor ""e�iaib number-,e}-ippli
6& ;
29 (D) treatment faeil' y name, addressandtelephonenumber-;
30 ()d-at€ e shipment; and
31 (IF) "P�FEGTIOUS WASTE" or- "MEDICAL WASTE".
32 (b) ReeoFds Of Fegttlated medieal waste shall be maintained fer- eaeh shipmen4 and shall inelude the infofmation list
33 .
34 ;
35 (2) dote shipped off te;
36 (3) name Of t;afispeAer;
37 (4) name of storage or treatment f4eil'
8 of 20

B-23
1
The
this Paragraph to less than 50
r-e"ir-emefAs
ef shall net apply per -seas who generate potmds of regula4ed fnediea4
2
.
3
A to
be the
(e) plan easufe
proper fnaaagefnefA of r-egula4ed medieal waste shall pfepafed and maintained at gener-ating
4
€ac-ility. .
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
(2)
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
(3)
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 necessaa 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
(7)
Treated regulated medical waste shall not become putrescent. Putrescent treated regulated medical
19
waste shall be disposed of within three calendar dam
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 (1) The treatment facility shall be compliant with Rule .1202(o), (o), and (o) of this Section.
24 (2) The treatment facility shall issue a written record notifying the generatingfacility 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 (A) the number of packages;
31 (B) the generator name, physical address, and phone number;
32 (C) the transporter name, physical address, and phone number;
33 (D) 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.
9 of 20

B-24
4) The treatment facilitv shall submit a facilitv operations elan to the Division with the Dermit
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
(D) a description of the treatment process or processes;
10
(E) procedures for how the medical waste will be received, handled, stored, transferred, or
l l
treated at the facility;
12
(F) procedures for sampling or testing required by the rules of this Section;
13
(G) procedures that the facility shall use to prevent medical waste from becoming a nuisance
14
or putrescent, and procedures for abatement if medical waste becomes a nuisance or
15
putrescent;
16
(H) contingency plan identifying risks and describing how the facility will respond to incidents
17
or emergencies, and how regulated medical waste will be handled or redirected when
18
facilities or transport vehicles are unavailable due to maintenance, adverse weather, or
19
other emergencies; and
20
(1) additional information that the Division may request pertaining to the facility operations if
21
it is necessary to determine compliance with the Rules of this Section.
22
A copy of the operations plan shall be kept at the facility and shall be available for review by the
23
Division duringfy inspections or upon request by the Division. If the information required by
24
this Paragraph changes, the facility shall submit a revised facility operations plan to the Division
25
and update the copies of the plan kept by the facility.
26
(5)
The treatment facility shall maintain a record of the disposal facility's contact information including
27
the facility name, permit number, physical location and mailing address, and contact name and
28
phone number.
29
(6)
The treatment facility shall maintain a record of the dates and tonnages of treated regulated medical
30
waste sent for disposal.
31
(7)
The treatment facility shall maintain operating records and monitoring, tag, and maintenance
32
records required in accordance with the rules of this Section for a period of three years.
33
(8)
The facility shall submit an annual report to the Division in accordance with G.S. 130A-309.09D(b).
34
(c) Steam sterilization treatment requirements:
35
(1)
Steam under pressure shall be provided to maintain a temperature of not less than 250 degrees
36
Fahrenheit for 45 minutes at 15 pounds per square inch of gauge pressure during each cycle.
37
(2)
The steam sterilization unit shall have a device that records the start and end time of each cycle.
10 of 20

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

B-26
1
The ash samples shall be composited in a closed container weekly and shall be mixed and reduced to
2
a uniform ash sample. The weekly ash samples shall be composited into a monthly ash sample, and
3
the monthly ash sample shall be analyzed.
4
(9)
For the remainder of the first year of incinerator operation, a representative ash sample shall be
5
collected once per month using the procedures described in the facility operations plan. The monthly
6
ash samples shall be composited and reduced to a uniform quarterly ash sample, and the quarterly
7
ash samples shall be anal.
8
(10)
After the first year of incinerator operation, representative composite ash samples shall be collected
9
using the procedures described in the facility operations plan twice per calendar year, with no less
10
than four months between sample collection, and the samples shall be analyzed.
11
(11)
Ash samples required to be analyzed in accordance with Subparagraphs (8) through (10) of this
12
Paragraph shall be analyzed in accordance with 40 CFR 261.24 for the eight metals listed in Table
13
1 (arsenic, barium, cadmium, chromium, lead, mercury, selenium, and silver). 40 CFR 261 is
14
incorporated by reference including sty ubsequent amendments and editions, and can be accessed at
15
no cost at htt2s://www.gl2o.gov/.
16
(12)
A record of the testing and analysis results shall be submitted to the Division for the first year of
17
incinerator operation, and thereafter shall be maintained at the facility and available for inspection
18
by the Division, and shall be submitted upon request from the Division, and shall include:
19
(A) the composite ash sample date and time;
20
(A) the ash sample date and time;
21
(B) the ash sample identification number;
22
(C) the ash sample analysis results; and
23
(D) the testing laboratory name and contact information and certification number.
24
(13)
The Division may require the treatment facility to collect additional composite ash samples or
25
analyze the samples for the full contaminant list in accordance with 40 CFR 261.24 Table 1 if the
26
results of the analysisquired in Subpara rags phs (8) through 01) of this Paragraph indicate an
27
c
exceedance of the regulatory level provided in 40 CFR 261.24 Table 1; or during a permittingaction,
28
a facility inspection, or when a complaint is received if it is necessary to determine compliance with
29
the rules of this Subchapter. The requirements of this Paragraph shall not prevent a municipal solid
30
waste landfill that is accepting incinerator ash from a treatment facility from requiring that additional
31
ash samples be taken and analyzed to determine compliance with the rules of this Subchapter before
32
the ash is accepted for disposal.
33 (e) Chemical treatment reauirements:
34 (1) Microbiological waste shall be treated with 10 percent chlorine solution for no less than one hour.
35 (2) Testing of treatment under conditions of full loading to confirm compliance with Paragraph (a)(9)
36 of this Rule shall be performed no less than once per week using a biological indicator of Bacillus
37 atrophaeus spores having_a population of not less than 1.0 x 106.
12 of 20

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

B-28
1 alternative treatment method is compliant with the rules of this Section and protective of human
2 health and the environment.
4 History Note: Authority G.S. 130A-309.26;
5 Eff. October 1, 1990;
6 Amended Eff. October 1, 1992; December 1, 1991; March 1, 499-1-.1991;
7 Readopted Eff. November 1, 2019.
14 of 20

B-29
1 15A NCAC 13B .1205 is proposed for readoption as a repeal as follows:
2
3 15A NCAC 13B .1205 REQUIREMENTS FOR TRANSPORTERS OF REGULATED MEDICAL WASTE
4 A per -son who tfanspefts Regulmed fnedieal waste tha4 has not been tfeated M the genera4ing f4eility shall fneet
5 following r-e e ents:
6 0) Transporters shall not aeeept waste whieh is improperly paekag
7 (2) Regulated fnedieal waste shall be tFansperted in a manneF that prevents leakage of the eentents a
8 the ^e�-
9 .
10 .
11 .
12
13 Dep, .them efTfanspeftat;e.. Standards and 49 G v 172 Subp ft F.
14 (7) Regulated fnedioal waste shall be delivered to a permitted storage or treatment f4eility within
15 ealendar- days of the date of shipment from the genefateT,
lb (9) Reffiger-ation at an am ient temperature between 35 and 45 degrees Fabfenheit shall be mainta
17 .
18 (9) A een4ingeney plan shall be pfepafed and maintained in eaeh vehiele used in the 4anspoi4ing-af
19 .
20 (10) Vehieles used for- the tfanspeftation of Regulmed medieal waste shall be thefoughly eleaned a -a
21 disinfeeted with a ffiyeebaetefieeidal disinfeetan4 before being used for- any other- puTese a -ad in
22 event of leakage from paek-ages.
23
24 .
25
26 History Note: Authority G.S. 130A-309.26;
27 Eff. October 1, 499.0.1 990;
28 Repealed E(f. November 1, 2019.
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15A NCAC 13B .1206 is proposed for readoption as a repeal as follows:
15A NCAC 13B .1206 REQUIREMENTS FOR STORAGE OF REGULATED MEDICAL WASTE
A pefsen whe stefes Regulated fnedieal waste that has nat been tfeated at the genefating faeility shall meet the
following f„tom•
0) Regulated medical waste shall be ster-ed in a manner- that pfevents leakage of the contents of th
„"
(2) Regulated mediealwaste shall be stor-ed in a manneF that maintains the integfity Of the paekagi"
all times.
..t all tim
(4) Regula4ed fnedieal waste shall not be stafed langef than seven efflendaf days ffam the date 0
shipment ffafn the genefatef tailess the Regulated Medieal Waste is feffigefated at an ambient
(5) Only authofized personnel shall have aeeess to afeas used to stofe Regulated medieal waste.
(6) All afeas used to stotv Regulated medieal waste shall be kept elean. Ver-min and inseets shall bee
eont-rolled,
management(8) A plan shall be pfepafed, maintained and updated as neeessafy to enstife eentinued pfope
of Regulated .nedieal waste ..t the f edit..
History Note: Authority G.S. 130A-309.26,-
Eff. October], 19 .1 990;
RepealedE-- November1,2019.
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B-31
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15A NCAC 13B .1207 is proposed for readoption as a repeal as follows:
15A NCAC 13B .1207 OPERATIONAL REQ/REGULATED MEDICAL WASTE TREATMENT
FACILITIES
A pefsen who treats Regulated fnedieal waste shall meet the following fequifements faf eaeh type of treatment i
addition to the Few}UirementsiiizCpulie.1203 of this Seetion..
0 ) General equir-etnents:
(a) Reffigetution at an ambient temperature between 35 and 45 degfees Fahfenheit shall
maintained for- Regulated medieal waste not treated within seven calendar days afteF
days after-eeeipt-.
(e) Regulated mediealwaste shall be stafed no longef than seven ealendaf days aftef tfeatment,
(d) Only authoFized pefsonnel shall have aeeess to areas used to store Regulated tnediea
(e) All areas used to store Regulated medieal waste shall be kept elean. NeitheF earpets not:
floor- eovefings with seams shall be ttsed in stoFage areas. Vermin and inseets shall bee
eontrelled.
(g) All fqeaf drains shall disehafge dir-eetly to an appFeved sanitafy sewage system. Ventilation
shall be pr-evided and shall disehafge so as not to efeate nttisanee odor-s.
(h) A plan shall be prepared, maintained and updated as neeessar-y to ensure eentinued proper -
management of Regulated medieal waste at the f4eility.
(i) Reeords of Regulated medical waste shall be maintained for- eaeh shipment and shall
inelude the infot:ma4iofi listed in this Pafagr-aph. This infbi:Hi4ion shall be faaintained-a4
the t,-o4Hient f e l;t. f no loss than three .
(i) name and address of genefineF;
(ii) date 00
(iii) amount of wasteFeceived by number of paelcages (pieee eon nt`c) fom each
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;
2 a ba4eh leaded
ifieifiefa4ef.
The be
ffem
the disehafge
samples shall
eelleeted
either E)
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4
5 r-epr-esentativesaffiple.
These
be
ifite
Fer-thefifstthr-
shall eemp E) sited
menthly
samples.
6 months of epe,-atio
e.,..h
ly
be le.l
,
ment sample shall
an.,.�
7
8
9 (i) After the first
yeaf, r e
t tiye samples shall
be analyzed
at least ♦wiee .
10
11 s1ibfnitEed to theN.C.
12 (k) A leg shall be
Solid
kept deettmenting
aste Seetien.
ineltide the da4e time
ash sampling,
whieh shall
and eft
13
,
14 and the , „1ts
of the
ineluding labefate.-y
i entifie
lion
analyses,
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16 facility.
17 (m) Existing genefating
faeilities
shall eendtiet one
weekly fepfesentative
ash sampling and
18 testing in aeeerdanee
Sub items
this Rule during the
with
(3)(f), (g)
and 0) of
a-finually
19 seeend quai4ef
yeaf.
of eaeh ealendar
20(4) Chefnieal-tfeatmeetr-equifements:
21
,
22
i,
, and
23 B. cer-etts er-
flor-a in
indivi&al
tubes
5 20 be-
normal
pleAes
er- eefftaining
ml media shall
24
,
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.
27
.
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,
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.
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34 enstife eensisteftt
e,l
e to tfeat the
waste.
p re
tised
35 (5) Miefowave tfeatment feguir-emexts:
36
37
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History Note: Authority G.S. 130A-309.26;
Eff October 1, 1990;
Amended Eff. April], 1993; January 4, 4993: 1993:
Repealed E, ff. November 1, 2019.
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B-35
From: Hollis, Carrie
To: Montie. Jessica; Patrone, John; Everett, Jennifer
Cc: Masich, Mollv; McGhee, Dana; Grozav, Anca
Subject: Approval - Medical Waste Management, 15A NCAC 13B .1201 - .1207
Date: Thursday, February 21, 2019 3:20:34 PM
Attachments: DEO 2019-02-21.pdf
OSBM has reviewed the Division of Waste Management's proposed amendments to rules 15A NCAC
13B .1201 - .1207 in accordance with G.S. 15013-21.4 and with E.O. 70 from 10/21/2010 as amended
by E.O. 48 from 4/9/2014. The fiscal note is approved for publication. Please ensure that the state
government impact is included in the Notice of Text.
The .pdf file of the rule impact analysis (attached) will be posted on our website at the following URL
(please allow for some time):
https://files.nc.gov/ncosbm/documents/files/DEQ_2019-02-21.pdf
Please post this link on your agency's website to ensure compliance with G.S. 150B-19.1(c)(5).
Please let me know if you have any questions.
-Carrie
Carrie Hollis
Economic Analyst
NC Office of State Budget and Management
919 807 4757 office
carrie.hollis&osbm.nc.gov
E-mail correspondence to and from this address may be subject to the North Carolina Public Records
Law (GS 132) and may be disclosed to third parties by an authorized state official.
Email correspondence to and from this address may be subject to the North Carolina Public Records Law and may be disclosed to third
parties by an authorized state official.