13B_.1200_TrackedChanges

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. Dialy eAes are not bleed e
body fluids under- this definition.
(2) "Generator" and "Generating facility" heaps mean any business, integrated medical facili , , and
volunteer or non-profit healthcare services where medical waste is produced, first >,o,., mes a waste,
including but not rfnite any medical or dental facility, mortuary, fimer-al home, laboratory,
veterinary hospital hospital, and blood banes 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 2
(5) "Microbiological waste" means the term defined in Rule .0101(26) of this Subchapter. eultuFes an
,
"Mier-awave tr-eatmeat" means tfeatmei# by mier-ewave energy for stiffieient time to fender waste n f eti
(-7) "Off site" means any site .,1,ieh i of "on site".
Cal right of.
"Non -hazardous pharmaceutical waste" is a medical is a medical [ is�ta [waste. �t is] waste and means 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. f130A-290(8*.] 130A-290(a)(8).
Q "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 2 1

(9) 'Pathological waste" means the term defined in Rule .0101(31) of this Subchapter
2
3
4
5
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
['(paper-)] or electronic format that is legible and in En lg ish.
9
(3(40) 'Regulated Medical Waste" means the term defined in Rule .0101(34) of this Subchapter. bleed and
10
11
12
12
pathelegieal waste that have not been tfea4ed ptffsuaII4 to Rule . 1207 of this Seeti
'Responsible party" means the entity that is in possession of and has accepted the regulated medical
13
waste.
14
(L3)(� �) "Sharps" means mean the term as defined is G.S. 130A-309.26(a)(1). and ",^hides needles syringes
15
.
16
(14)
"Trace chemotherapy waste" means medical waste containing no more than three percent by weight
17
of a medical drug used for []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 [asses] 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
(16)
"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 { "Treatment" as means the term as 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.[ 4b
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
ReadoptedE,ff. November 1, 2019.
34
2
2 of 2

I 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 -equ ..ements in all appheable 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 shall be placed in a rigid, leak -proof when in an upright position, and puncture-
9 resistant container, and , leak proof when in an upr-ighl pesifien and pttnetidfe r-esista
10 Contained shafps shall not be compacted prior to off -site tfanspe4a4ion. transportation unless placed in a sealed
11 compactor unit that is hauled off for disposal by the transporter.
12 and its eentents shall be handled in a mamer- that avaids htunan eentaet with the shafps,
13 (c) Blood and body fluids in individual containers in volumes of 20 milliliters M1 or less ,.,, ieh afe not stored in
14 seour-ed area r-estrieted to authorized personnel prior- to off site transportation shall be paekaged in aeoeFdanee wi
15
16 stikable for- sharps. Containers of blood and body fittids whieh are paekaged in aeeor-danee with Rule .1204(a)(1)-4
17 this Seetio^ or on4ai ^r- suitable for shafps as re by this Rule shall be stored in -[a seettre ] an area accessible
18 only to the responsible party or their designated representative, and shall not be compacted prior to off -site
19 transportation.
20 (d) Regulated medical waste shall not be eempaeted. compacted prior to treatment.
21 (e) Onlv the responsible party or their designated representative shall have access to regulated medical waste.
22 (f) Medical waste shall not become putrescent. [Putreseent w,ea:^^'] Medical waste shall be disposed of or treated
23 within three calendar [dam] days of becoming putrescent.
24 (g) Medical waste shall not become a nuisance.
25 (h) Medical waste accepted at transfer or storage operations or a treatment facility shall not be subject to the
26 requirements of Rule .1203(a) and (b)(2) of this Section.
27 (i) Medical waste treatment and disposal methods:
28 (11,) Blood and body fluids in individual containers in volumes greater than 20 milliliters shall be
29 disposed of by sanitary sewer if the local sewage treatment authority has been notified; or treated
30 by incineration or steam sterilization.
31 Microbiological waste shall be treated by incineration, steam sterilization, ozonation, microwave,
32 or chemical treatment.
33 (33,) Non -hazardous pharmaceutical waste shall be treated by incineration [ire' eration, returned to the
34 ender, r^ ^a,] —or disposed of at a municipal solid waste landfill. The requirements of this
35 Subparagraph shall not prevent non -hazardous pharmaceuticals from being returned to the vendor.
36 (4) Pathological waste shall be treated by incineration or ozonation.
37 (5) Trace chemotherapy waste shall be treated by incineration or ozonation.
1 of 2 3

1 C6) Noninfectious medical waste and blood and body fluids in individual containers in volumes of 20
2 milliliters[ml] or less may be []disposed of in a municipal solid waste landfill, [landfill e
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 (j.) Medical waste treated at the generating facility is not subject to the requirements of Para rag_phs (o), (p), and (q) of
8 this Rule, and Rule .1204(b)(l), (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 (3) 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, 1991. 1991;
28 Readopted Ee(f. November 1, 2019.
4
2 of 2

I 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 and body fluids in individual eontaineFs in voWmes greater- than 20 m! ineinefation o
8
the tfea4mefA
is
sanitafy sewage systems, pfevided
sewage
authority notified;
9
(2)
>
10 t -ea4f , ent;
r
11 (
.
13 Regulmed tfeated in
Pafagfa-ph
this Rule be
in
(e) medieal waste aeeofda-nee
with
(a) of may managed
aeeer-danee-
14 with 15A NCAC 13B.0100 —.0700.
15
.
16 A treats Regulated
the
f4eility integrated
faeili"
(e) pefson who fnedicalvvaste
at generating
ef within an
medical
17
.
18
19
.
20 (a) Regulated medical waste Dackaizina reauirements:
21
(1)
All Sections of the Code of Federal Regulations (CFR) cited in this Paragraph are hereby
22
incorporated by reference, includingsubsequent ubsequent amendments and editions and can be accessed at
23
no cost at htips://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 Mh.
29
(4)
The plastic film bag used as inner packaging shall be sealed to prevent leaks.
30
(55)
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
L8)
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;
$ 1 of 4

I (C)
the transporter name, physical address, and phone number,
2 (D)
the treatment facili , name, physical address, and phone [fmmber and]- umber, 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
requir-ement iff Pai4 (E) ef this Sttbpar-a�ffaph dees net apply to etistemer leaded tfailers, e*eep
10 tha4
ffem the door-(s) be the da4e
all
11
paekages aeeessible ear -go area shall mar-ked with of shipfnea4
12
be the date ffam the they ffe-m-
paekages
shall marked with E)f shipment genefa4ef when afe F-effieved
13 the
leaded tfailef, the tfe4ed thM 24
etistemef
unless medieal waste paekages afe a4 site within
14 hours.]
15 (b) Generator requirements:
16 The
generatingfacility acilishall package medical waste by treatment method type in accordance with
17 Rule
.
.1202(i) of this Section.
18 (2) The
generatingfacility 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 (C) 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) Transnorter reauirements:
27 (1) The transporter shall not accept regulated medical waste that does not meet the requirements of
28 Para rg aph (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 Mills, all of the
33 [eenteats,]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.
2 of 4 9

1
(4)
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 [vekiele. ]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
(6)
The transporter shall be in compliance with Rule .1202(o), (p), and (q) of this Section.
8
(d) Transfer or storage operations requirements:
9
(1)
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 facilityoperations 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
W the name, mailing address, physical address, office and mobile phone numbers, and email
17
address for the responsible parts and operator(s);
18
a 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, [or —]and
20
transferred;
21
(D) the frequency that transfer or storage operations occur;
22
(E) 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
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) a signed statement by the responsible party(s) that transfer or storage operations have
31
ceased and all medical waste has been removed;
32
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
LQ 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 Subparagraph (2) of this Paragraph.
10 3 of 4

1 (5) The transfer or storage operations shall comply with Rule .1202(o), (v), 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.
4 of 11

l 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 per -son who ships regulated fnedieal waste ftem the gener-ming f4eility for- off site tfea4fneat shall meet the
7 (4) Regulated mediea4 waste shall be paekaged in a minimum of one plastie bag plaeed in a rigi
8 fibeFbeaFd box, rigid di -am, or ether Figid eentainer- eens4ueted in a manner- that pr-eveffts leak -a
9
10
pr-eeltide
r-ipping,
teafing or-
bufsting
the
waste filled
bag tinder ftet:faal
eefidifiens of usage an
11
handling.
Eaeh
bag shall be
eanstftteted
of
material of
suffieient single
thiekness stfength to pass
12
13
14
subsequent
amendments
and
editions,
and eertified
by
the bag manufaetffer.
A eopy is available
15
inspeetion
at the
Department
of EnviFonment,
Health,
lb
Waste
Management,
401 Obeflin
Road,
Raleigh,
Thiefffi
Carolina. Copies
may be requested by fn
17
a4 mer;ea
Society
for Testing
and
Materials,
1916
R ee Street Philadelphia,
P.A. 19103 er by
18
ealling
(215) 299
5400 for- a
east of
twelve
dollars ($12.00)
phis ene dellaf
a -ad fifty eents ($1.50)
19
for shipping
and
handling «less
prepaid,
then
the fee
is twelve dollars ($12
00)
20
(2)
Regulmed
medieal
waste shall
be ster-ed
in
a manner- that
maintains the ii#egr-ity
of the paekaging at
21
albs.
22
(3)
Eaeh paekage
of
regulated medieal
waste
shall
be labeled
with a water- Fesistan4
universal biohazar-d
23
steel.
24
(4)
Eaeh
package of
Fegulated medieal
waste
shall be mar-ked
on the outer- suizfaee
with the foliewing
25
26
(A4
the geftera4ef's
fiame,
address,
and
telephefte
number-;
27
(B)
the t ansperter's
name,
address,
and
telephone
ff ri ber.
28
(C-)
ster",.e
f e l:ty name,
address
and
telephe,.e
mber ..,1.e " p
eab.le.
29
treatment
F e:lit., name,
address
and
telephone
n ibex.
30
(E-)
date of
shipmen4; and
31
()
"Pn EGPOUS
WASTE"
er
"NI
DICA WASTE"
32
Reeer-ds
be
fer-
ineltide
the infermation list
(b)
ef
regulated
medieal
waste shall
main4ained
eaeh shipmefA
and shall
33
.
34
()-)
,
35
(2)
date shipped
e ff
site.
36
(
e
of tr" ei4e
r .
37
(4)
name
ofat rage
r treatment
f eil;t.,
1 of 7 5

1
The
this Paragraph te less than 50
2
r-equir-emen4s
waste per meff&.
of shall net apply per-sefts who gener-a4e pounds of r-egttia4ed fnediea4
3
A to
be the
(e) plan ensuf
e proper managemen4 of r-egulated fnedieal waste shall prepared and maintained at gener-a4iffg
4
€ae-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
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 necessga 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
C6)
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
W
The treatment facility shall be compliant with Rule .1202(o), (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
facili .
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
(5) the generator name, physical address, and phone number;
32
CC) the transporter name, physical address, and phone number;
33
(D) the date each package was picked up from the generator;
34
M) 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.
6 2of7

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) tjypes 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 [pr-eeesses;]processes, and treatment unit
10
specifications;
l l
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 seven 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
(1) 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 during fg acili , inspections or upon request by the Division. If the information required by
26
this Paragr, apph changes, the facility shall submit a revised facilityoperations 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
(7)
The treatment facility shall maintain operating records and monitoring, testing, esting, and maintenance
34
records required in accordance with the rules of this Section for a period of three
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:
3 of 7 7

I
Cl)
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 duringecycle.
3
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 10' placed within
9
the waste load.
10
(5)
A record of each test performed shall be maintained and shall include the We of indicator used, the
11
test date, the start and end times, and the test result.
12
(d) 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 Quali . (t (DAQ) has issued a permit
15
for operation of the incinerator.
16
The treatment facility shall maintain the DAQ permit for the operation of the incinerator.
17
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
f
Procedures for obtaining uniform representative composite ash samples shall be submitted to the
26
Division for approval in the facilityoperations 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
Subpara rgraph (6) of this Paragrgph 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;
8 4of7

once for every 24 hours of operation for an incinerator that is operated on an intermittent
2
schedule; or
3
(C) once for every batch for an incinerator that is batch -loaded.
4
The ash samples shall be composited in a closed container weekly and shall be mixed and reduced
5
to a uniform ash sample. The weekly ash samples shall be composited into a monthly ash sample,
6
and the monthly ash sample shall be analyzed.
7
(9)
For the remainder of the first year of incinerator operation, a representative ash sample shall be
8
collected once per month usingprocedures described in the facility perations plan. The monthly
9
ash samples shall be composited and reduced to a uniform quarterly ash sample, and the quarterly
10
ash samples shall be anal,
l l
10
After the first year of incinerator operation, representative composite ash samples shall be collected
12
using the procedures described in the facility operations plan twice per calendar year, with no less
13
than four months between sample collection, and the samples shall be analyzed.
14
(11)
Ash samples required to be analyzed in accordance with Subpara ragbhs (8) through(10) of this
15
Paragraph shall be analyzed in accordance with 40 CFR 261.24 for the eight metals listed in Table
16
1 (arsenic, barium, cadmium, chromium, lead, mercury, selenium, and silver). 40 CFR 261 is
17
incorporated by reference includingsubsequent ubsequent amendments and editions; and can be accessed at
18
no cost at htt2s://www.gl2o• o��v/.
19
12
A record of the testing and analysis results shall be submitted to the Division for the first year of
20
incinerator operation, and upon request from the Division thereafter,lopefatior, and `hefe W The
21
record shall be maintained at the facility and available for inspection by the Division. f
22
shall be submitted upon Fe"est from the Division, and] The record shall include:
23 the composite ash sample date and time;
24 the ash sample date and time;
25 LQ the ash sample identification number;
26 (M the ash sample analysis results; and
27 (E) the testing laboratory name and contact information and certification number.
28 13 The Division may require the treatment facility to collect additional composite ash samples or
29 analyze the samples for the full contaminant list in accordance with 40 CFR 261.24 Table 1 if the
30 results of the analysis required in Subpara ra�phs (8) through (11) of this Paragraph indicate an
31 exceedance of the regulatory level provided in 40 CFR 261.24 Table 1; or during a permittin act
32 a facility inspection, or when a complaint is received if it is necessary to determine compliance with
33 the rules of this Subchapter. The requirements of this Paragraph shall not prevent a municipal solid
34 waste landfill that is accepting incinerator ash from a treatment facility from requiring that additional
35 ash samples be taken and analyzed to determine compliance with the rules of this Subchapter before
36 the ash is accepted for disposal.
37 (e) Chemical treatment requirements:
5 of 7 9

1
(1)
Microbiological waste shall be treated with 10 percent chlorine solution for no less than one hour.
2
Testing of treatment under conditions of full loading to confirm compliance with Subparagraph
3
(a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
4
Bacillus atrophaeus spores having_a population of not less than 1.0 x 10'.
5
(3)
A record of each test performed shall be maintained and shall include the type of indicator used, the
6
test date, the start and end times, and the test results.
7
Microwave treatment requirements:
8
Cl)
Microwave energy of appropriate output frequency shall be provided at a temperature of not less
9
than 203 degrees Fahrenheit (95 degrees Celsius) for no less than 30 minutes each cycle.
10
(22,)
The microwave treatment system shall be provided with a monitoring device that records time and
11
temperature of each cycle. A record of the monitoring of the time and temperature of each cygle
12
shall be maintained.
13
(3)
Testing of treatment under conditions of full loading to confirm compliance with Subparagraph
14
(a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
15
Bacillus atrophaeus spores having a population of not less than 1.0 x 101 and in accordance with the
16
equipment manufacturer's instructions.
17
(4)
A record of each test performed shall be maintained and shall include the type of indicator used, the
18
test date, the start and end times, and the test result.
19
(a) Ozonation treatment requirements:
20
(1)
Testing of treatment under conditions of full loading to confirm compliance with Subparagraph
21
(a)(9) of this Rule shall be performed no less than once per week using a biological indicator of
22
Bacillus atrophaeus spores having a population of not less than 1.0 x 101 and in accordance with the
23
equipment manufacturer's instructions.
24
Once every six months samples collected under conditions of full loading shall be submitted to an
25
independent laboratory to confirm compliance with Subparagraph (a)(9) of this Rule.
26
(33,)
A record of each test performed shall be maintained and shall include the We of indicator used, the
27
test date, the start and end times, [the ezenation time, the .,.mien time, ]and the test result.
28
(h) Alternative treatment methods.
29
(1)
A treatment facility owner or operator may request to use a method of, or procedures for, regulate
30
medical waste treatment not listed or described in this Rule by submitting a request to the Division
31
for approval. The request shall include documentation that describes the alternative treatment
32
method, explains the procedures and provides analysis results to demonstrate that the treatment
33
method will render the regulated medical waste noninfectious, and describes how the treatment
34
method meets the requirements of the rules of this Section.
35
(2)
A request for an alternate method of chemical treatment shall also describe the chemical used to
36
treat the specific microbiological agent(s) of concern for the regulated medical waste type, and shall
10 6of7

1
2
3
4
5
6
7
8
9
10
12
consider factors such as temperature, contact time, pH, concentration, and the presence and state of
dispersion, penetrability, and reactivi , of organic material at the site of application.
The Division [] shall 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 E, ff. November 1, 2019.
7of7
11

1
2
3
4
5
6
7
8
9
10
12
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 E,ff. November 1, 2019.
20
lofl