Medical or Biological Waste, a.k.a., Regulated Medical Waste, is regulated by the Massachusetts Department of Public Health. DPH has adopted management requirements codified under 105 CMR 480 that affect those who generate such wastes. Individuals impacted by these rules would be employees who are responsible for the medical/bio waste management program and those who manage the waste onsite (e.g., internal transport, storage, onsite treatment, and other handling).

1. Managing Medical or Biological
Waste in Massachusetts:
Guidance for Generators
1

2. Doug Graham
Director of Client Training Services
Triumvirate Environmental
dgraham@triumvirate.com
2
Meet Your Presenter

3. Objective
•Learn the specific Mass.
DPH requirements for
managing medical or
biological waste (a.k.a.,
regulated medical waste (RMW))
3

4. Target Audience
• Employees who are
responsible for the
medical/bio waste
management program and
those who manage the
waste on-site (e.g.,
internal transport, storage,
onsite treatment, and
other handling)
4

5. Regulations
• The Massachusetts Department of
Public Health (DPH) sets the
minimum requirements for the
storage, treatment, disposal, and
transportation** of regulated
medical waste (RMW) in 105
CMR 480.00*
5
*105 CMR 480.00: State sanitary code
chapter VIII: Storage and disposal of
infectious or physically dangerous
medical or biological waste
** Note: RMW is considered a hazardous material and
is regulated by the U.S. Department of
Transportation when transported. Those signing
shipping papers, or otherwise involved in
preparation for transport must also be trained in
the DOT Hazardous Materials Regulations- 49
CFR 100-185

6. Module 1:
Definitions &
Applicability
6
Ref: 105 CMR 480.010

7. MA Definition of Medical or Biological
Waste
• Medical or Biological Waste: “Waste that because of its
characteristics may cause, or significantly contribute to, an
increase in mortality or an increase in serious irreversible or
incapacitating reversible illness; or pose a substantial present
potential hazard to human health or the environment when
improperly treated, stored, transported disposed of, or
otherwise managed”
7

8. Medical or Biological Waste,
includes…
1. Blood and Blood Products
• Discarded bulk human blood and
blood products in free draining,
liquid state; body fluids
contaminated with visible blood;
and materials saturated/dripping
with blood. Blood Products shall
not include feminine hygiene
products.
8

9. Medical or Biological waste,
includes…
2. Pathological Waste
• Human anatomical parts, organs, tissues, and
body fluids removed and discarded during surgery,
autopsy, or other medical or diagnostic
procedures;
• Specimens of body fluids and their containers;
• Discarded material saturated with body fluids other
than urine;
• Pathological waste does not include: teeth and
contiguous structures of bone without visible tissue, nasal
secretions, sweat, sputum, vomit, urine, or fecal
materials that do not contain visible blood or involve
confirmed diagnosis of infectious disease.
9

10. Medical or Biological Waste,
includes…
3. Cultures and Stocks of Infectious
Substances and Associated Biologicals
• All discarded cultures and stocks of infectious agents and
associated biologicals, including culture dishes, and
devices used to transfer, inoculate, and mix cultures, as
well as discarded live and attenuated vaccines intended
for human use, that are generated in:
- Laboratories involved in basic and
applied research;
- Laboratories intended for educational
instruction; or
- Clinical laboratories
10

11. Medical or Biological Waste, includes
4. Sharps
• Discarded medical articles that may
cause puncture or cuts, including,
but not limited to, all needles,
syringes, lancets, pen needles,
Pasteur pipettes, broken medical
glassware/plasticware, scalpel
blades, suture needles, dental
wires, and disposable razors used
in connection with a medical
procedure.
11

12. Medical or Biological Waste,
includes…
5. Biotechnology By-product
Effluents
• Any discarded preparations, liquids,
cultures, contaminated solutions made
from microorganisms and their
products including genetically altered
living microorganisms and their
products
12

13. Medical or Biological Waste, does not
include
• . . . medical or biological waste that is contained in a mixture
which, due to the presence of other materials, such as amalgam
(mercury) and lead foil, is regulated by either hazardous or
radioactive waste laws or regulations.
13

14. Module 2:
Handling &
Storage
14
105 CMR 480.100

15. Primary Containers (Bags)
• All RMW, except sharps, must be contained in a
primary container which is a red, fluorescent
orange or orange-red plastic bag that is
impervious to moisture and has sufficient strength
to resist ripping, tearing, or bursting under normal
conditions of use and handling, and which meets
the American Society for Testing Materials (ASTM)
standard D192206a and ASTM D1709-04.
• Bags must be marked prominently with the
universal biohazard warning symbol and the word
“Biohazard” in a contrasting color; and be secured
so as to prevent leakage and to preclude loss of
contents during handling, storage, and/or
transport.
15
Ref: 105 CMR 480.100(A)

16. Leakproof Containers for Free Liquids
• Free draining blood and blood
products and biotechnology
by-product effluents shall be
stored at all times in leakproof
containers that are securely
sealed.
16

17. Sharps Containers
• Sharps must be collected in red,
fluorescent orange or orange-red
leakproof, rigid, puncture-resistant,
shatterproof containers that resist breaking
under normal conditions of use and
handling, meet ASTM standard F2132-01,
and that are marked prominently with the
universal biohazard warning symbol and
the word “Biohazard” in a contrasting color.
• Sharps must be segregated from other
wastes and aggregated immediately after
use (at the point of waste generation)
17
Ref: 105 CMR 480.100(D)

18. Secondary Containers for RMW to be
Shipped Off-Site
• Every container or bag of regulated medical waste
(other than sharps containers) which will be
transported off the premises must also be placed in
a secondary container which is:
• (1) Rigid;
• (2) Leak resistant;
• (3) Impervious to moisture;
• (4) Of sufficient strength to prevent tearing or bursting under normal
conditions of use and handling, and
• (5) Sealed to prevent leakage during transport.
18
Note: RMW must be packaged to comply with DOT
hazardous materials regulations 49 CFR Parts 100-
185- employees involved in offering waste for
shipment (e.g., signing shipping papers) must be
trained in those regulations also.
Ref: 105 CMR 480.300(B)

19. Storage Areas
19
Ref: 105 CMR 480.100(B)-(C)

20. Storage Areas
20
Ref: 105 CMR 480.100(B)-(C)
• Storage areas must. . . .
• Be uncarpeted rooms or areas with impervious, cleanable, non-
absorbent flooring,
• Be used only for waste storage;
• Have prominent signage indicating the space is used for the storage of
RMW;
• Be designed or equipped to prevent unauthorized access;
• Be designed or located to protect the waste from the elements and
prevent access by vermin;

21. Storage Areas
21
Ref: 105 CMR 480.100(B)-(C)
• Provide sufficient space to allow for clear separation
of RMW from any other waste;
• Be adequate to accommodate the volume of RMW
generated prior to removal
• Be maintained such that there is no putrescence or
off-site odors, using refrigeration when necessary.

22. Storage Time Limit
• All medical or biological waste, except from
home sharps users, must be treated on-site
or transported off-site for treatment at a
minimum once per calendar year.
22
Ref: 105 CMR 480.100(G)

23. Module 3: Disinfection &
Disposal
23

24. Disinfection
24
Ref: 105 CMR 480.150

25. Disinfection
• Other than pathological waste and
contaminated animal waste, the following
disinfection methods are approved (subject to any
additional conditions that may be specified by the DPH), to render
medical or biological waste noninfectious, :
• (1) Steam disinfection/autoclaving;
• (2) Chemical disinfection;
• (3) Incineration at an approved incineration facility;
or
• (4) Any other method approved in writing by the
DPH.
25
Note: Compactors or grinders
must not be used to process
medical or biological waste
until it has been rendered
noninfectious and safe for
disposal. 105 CMR 480.100(F)
Ref: 105 CMR 480.150

26. Disinfection: Using Heat
• The methods which rely on heat shall be evaluated for
each load or cycle by using a recording thermometer,
thermocouple, parametric monitoring device, thermal
indicator strip, or by an equivalent method approved in
writing by the DPH.
26
Ref: 105 CMR 480.150(B)

27. Disinfection: Using Heat
• The two common steam-sterilizing
temperatures are 121°C (250°F) and
132°C (270°F). These temperatures (and
other high temperatures) must be
maintained for a minimal time to kill
microorganisms. Recognized minimum
exposure periods for sterilization of
wrapped healthcare supplies are 30
minutes at 121°C (250°F) in a gravity
displacement sterilizer or 4 minutes at
132°C (270°C) in a prevacuum sterilizer. -
CDC, Guideline for Disinfection and
Sterilization in Healthcare Facilities (2008)
27
Ref: 105 CMR 480.150(B)

28. • For any wastes that are rendered
noninfectious by chemical disinfection, the
chemical used shall be of demonstrated
efficacy, as determined by the DPH,
against the challenge testing target or
indicator organism and registered with:
• The U.S. Environmental Protection Agency,
Office of Pesticide Programs pursuant to the
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA); and
• The Massachusetts Department of
Agricultural Resources, Pesticide Bureau.
Disinfection: Using Chemical
Disinfectant
28
Ref: 105 CMR 480.150(C)

29. Disinfection: Quality Control
(Monitoring & Testing)
• All parametric monitoring equipment utilized in
conjunction with any approved disinfection
methods, including autoclaves, must be
calibrated at a minimum annually, by an
individual who has received training from
the manufacturer in the operations and
maintenance of the equipment.
• Quarterly qualitative (growth/no growth)
biological challenge testing must be
conducted during standard operations for all
approved disinfection methods including
autoclaves, but not incineration.
29
Ref: 105 CMR 480.150(D)-(E)

30. Disinfection: Growth Challenge
Testing Specifics
• (1) Testing shall consist of spore strips or a retrievable alternative medium approved by the Department, which
contain a 1.0 x 10 minimum challenge population of a bacterial indicator organism that is most resistant to any
aspect of the treatment technology as outlined in the most recent medical waste treatment technology
guidelines established by The State and Territorial Association on Alternative Treatment Technologies
(STAATT) or its successor, The International Society of Analytical Analysis of Treatment Technologies
(IStAATT); (2) Testing methodologies including the number, type and locations shall be in accordance with
manufacturers’ guidelines and procedures approved by the DPH; (3) Analytical testing results (growth/no
growth) should demonstrate a minimum bacterial spore reduction of 4 log 10 ; (4) When a 4 log10 bacterial
spore reduction has not been demonstrated (results indicate bacterial growth), an operations and mechanical
systems assessment shall be conducted by a qualified individual who has received training from the
manufacturer in the operations and maintenance of the equipment. Appropriate corrective actions shall be
implemented, when warranted, including but not limited to mechanical adjustments and when applicable,
recalibration of all parametric monitoring devices followed by re-treatment of the waste and additional
challenge testing to confirm the effectiveness of any implemented corrective action; (5) In accordance with
105 CMR 480.500(B)(1)(f), the analytical test results shall be documented on the required record-keeping log
form for medical or biological waste treated on site in conjunction with the date and all applicable
corresponding process parameter results. (6) When implemented, corrective actions pursuant to 105 CMR
480.150(E)(4) shall be documented in detail including the date, name of the individual implementing the
corrective actions and a description of the work performed, on the back of the applicable record-keeping log
form for medical or biological waste treated on-site.
• (7) All analytical test results shall be retained in the required record-keeping log for a period of three years.
30
Ref: 105 CMR 480.150(E)(1)-(2)

31. Disinfection: Shipping Disinfected
Waste for Disposal
• Prior to transport for off-site disposal, waste which has been
rendered noninfectious by a method other than incineration
shall be labeled or otherwise marked so as to clearly identify it
as noninfectious medical or biological waste and to identify the
waste generator responsible for the treatment. Such waste
need not be disposed of as RMW, except for sharps, which
shall be disposed of in accordance with the requirements of 105
CMR 480.200(E).
31
Ref: 105 CMR 480.300(C)

32. Disposal
32
Ref: 105 CMR 480.200

33. Disposal
Blood and Blood Products
• If the waste generator is connected to a municipal
sewerage system or septic system, free draining blood
and blood products, except blood saturated materials,
may be disposed of directly into these wastewater
systems unless such disposal is otherwise restricted by
the authorized approving agency;
• If not allowed to discharge, blood and blood products
must be rendered noninfectious prior to disposal in a
sanitary landfill approved by the Massachusetts
Department of Environmental Protection or in case of out-
of-state disposal, approved by the appropriate regulatory
agency responsible for landfill approval.
33
Ref: 105 CMR 480.200(A)

34. Disposal
Pathological Waste
• Pathological wastes must be disposed of at an
approved incineration facility or by interment
provided however that unprocessed liquid
pathological waste may also be disposed of in
the same way as blood and blood products.
34
Ref: 105 CMR 480.200(B)

35. Disposal
Contaminated Animal Waste
• (D) Contaminated Animal Waste.
Contaminated animal wastes shall be
disposed of at an approved incineration
facility, by proper burial, by interment or by an
alternative method approved in writing by the
Department. Unprocessed liquid pathological
waste may also be disposed of in accordance
with 105 CMR 480.200(A) and tissue may
also be disposed of in accordance with 105
CMR 480.200(C).
35
Ref: 105 CMR 480.200(D)

36. Disposal
Biotechnology By-Product Effluents
• Biotechnology by-product effluents that contain RG3 or RG4 agents
or are from BSL3 and BSL4 facilities shall not be removed from the
site of the waste generator unless all viable microorganisms,
whether containing recombinant DNA or not, have been rendered
non-infectious in accordance with 105 CMR 480.150.
• For specifics regarding all other biotechnology effluents and
effluents containing RG1 and RG2 agents, see 480.200(F)(1)-(2),
including institutional biocommitee (IBC) requirements if the
generator is to ship RG1 and RG2 agents off-site prior to
disinfection.
• Risk Group 3 (RG3) - Agents that are associated with serious or
lethal human disease for which preventive or therapeutic
interventions may be available (high individual risk but low
community risk) Risk Group 4 (RG4) - Agents that are likely to cause
serious or lethal human disease for which preventive or therapeutic
interventions are not usually available (high individual risk and high
community risk)
36
Ref: 105 CMR 480.200(F)

37. Disposal
Blood Saturated Materials, Cultures and Stocks of Infection Agents and
Associated Biologicals, Dialysis and Lab Waste
• . . . . .must either be:
• Rendered noninfectious onsite and disposed of in a sanitary
landfill approved by the Mass. DEP, or in the case of out-of-state
disposal, approved by the appropriate regulatory agency
overseeing landfills; or
• Placed in a secondary container and stored prior to transport to an
approved off-site facility to be rendered noninfectious (treatment to
landfill or incineration).
• Triumvirate Recycling Option
• May be eligible to be shipped out of state to TEI disinfection,
• recycling and plastic lumber production facility
37
Ref: 105 CMR 480.200(C)

38. Disposal
Sharps
• Sharps containers of sharps must either be:
• Disposed of by incineration at an approved incineration
facility; or
• Rendered noninfectious and processed by grinding or
other effective method to eliminate the physical hazard of the
sharps and disposed of in a sanitary landfill approved by the
Mass. DEP, or in the case of out-of-state disposal, approved
by the appropriate regulatory agency overseeing landfills.
• Triumvirate Recycling Option
▪ May be eligible to be shipped out of state to TEI
disinfection, recycling and plastic lumber production facility
38
Ref: 105 CMR 480.200(E)

39. Module 4:
Documentation
39
105 CMR 480.400-500

40. Tracking Off-Site Shipments
• Waste generators must confirm, within 30 days of shipment,
the receipt at a treatment facility of all medical or biological
waste shipped off-site for treatment.
• Confirmation must be documented on a paper or electronic
medical waste tracking form, which includes all the shipping
paper information required in 105 CMR 480.400(B), as well as
documentation of-
• the treatment facility name and address; and
• telephone number with a contact person who has
knowledge about the waste material received or who has
immediate access to a person who possesses such
knowledge.
• A completed copy of the medical waste tracking form must be
retained with the corresponding shipping paper(s)* and the
record keeping log required by 105 CMR 480.500(B) for a
period of 375 days (*DOT requires the shipping paper be
retained for at least 2 years)
40
Ref: 105 CMR 480.425

41. Tracking Off-Site Shipments
• If the waste generator does not receive a hard copy or
can not access for download an approved electronic
copy of the completed medical waste tracking form
within 30 days after shipment, the waste generator,
must report this fact to the DPH.
• For recordkeeping requirements for small-scale
generators (<50 lbs./ month), see 105 CMR 480.425(C)
• For recordkeeping requirements for generators
receiving waste from small-scale generators and
Sharps Collection Centers, see 105 CMR 480.425(D).
• For recordkeeping requirements for generators
receiving waste from home sharps users, see 105
CMR 480.425(E).
41
Ref: 105 CMR 480.425

42. Written Procedures
• Waste generators must develop written procedures, as applicable, for
rendering waste noninfectious and to assure effectiveness and
compliance with the requirements set forth in 105 CMR 480.
• These must include:
• (1) Procedures for the identification of types, quantities and
disposition of regulated medical or biological waste including
identification of waste approved for disposal in accordance with 105
CMR 480.200(A)(1) (blood and blood products rendered
noninfectious and disposed of in a sanitary landfill).;
• (2) Procedures for safe handling and transportation within the
facility from the point of generation to the point of storage and/or
treatment;
• (3) Confirmation of OSHA Bloodborne Pathogens training for all
individuals who may potentially handle medical or biological waste;
42
Ref: 105 CMR 480.500(A)

43. Written Procedures
• These must include (cont’d):
• (4) The listing of a contact name and emergency
contact number for an individual(s) who either has
knowledge about the waste material, including
emergency response information, or who has
immediate access to a person who possesses
such knowledge and information; and
• (5) A description of on-site regulated medical or
biological waste storage areas, including those
used for short term storage, which detail the
ventilation and capacity of the storage areas,
and the duration waste will be retained in each
area.
43
Ref: 105 CMR 480.500

44. Recordkeeping Log
• Record-keeping Log is defined as a log book with secured,
consecutively numbered pages which is used solely for the
purpose of keeping and recording the information required by
105 CMR 480.500(B)-(I).
• Waste generators must maintain a current record-keeping log
for all medical or biological waste either treated on-site or
shipped off-site for treatment, excluding waste approved for
disposal pursuant to 105 CMR 480.200(A)(1) (blood and
blood products rendered noninfectious and
disposed of in a sanitary landfill).
• The record-keeping log must have secured, consecutively
numbered pages and have on its cover the name of the
facility, the name of the owner and operator, if applicable, and
in large print the words “Medical/Biological Waste Record-
keeping Log”. The record-keeping log forms must be
retained for three years.
44
Ref: 105 CMR 480.500(B), D)-(I)

45. Recordkeeping Log
• The recordkeeping log must include the following:
▪ Record of medical or biological waste treated on-site, specifying: the
exact date of each treatment; the quantity of waste treated; the type of
waste; the on-site treatment method with documentation of applicable
process parameters including, but not limited to, time, pressure,
temperature, and pH; the printed name and signature of the person
responsible for treatment; challenge testing/quality control (QC) analytical
(growth/no growth) results; and, in cases of those who receive waste
from off-site, the specifics of 480.500(B)(1)(g).
▪ Record of medical or biological waste shipped off-site for treatment,
specifying: the exact date of each treatment; the total number of
containers; the type of waste; the total combined weight or volume; the
name of the transporter and transporter ID # if applicable; or in the case
of small scale generators or sharps collection centers self-transporting,
the specifics of 480.500(B)(2)(e); or for those receiving waste, the term
”HS” in the ID column; the verification (via check box) of shipping papers
generated with receipt of corresponding medical waste tracking forms for
each shipment; and the printed name and signature of the person
responsible for shipping the waste.
45
Ref: 105 CMR 480.500(B)

46. Recordkeeping Log
• Develop, maintain and incorporate into the
record-keeping log a written contingency
plan for spills and accidents and have
available tools and materials sufficient to
implement the contingency plan in case of a
spill or accident.
• Retain results of annual calibration
procedures for parametric monitoring
equipment with the record-keeping log for
three years, if applicable.
• Retain results of all analytical Q.C. test
results with the required record-keeping log
for three years.
46
Ref: 105 CMR 480.500(C)-(E)

47. Recordkeeping Log
• (cont’d):
• Retain a copy of all applicable registrations and safety
data sheets for chemicals used in approved disinfection
methods pursuant to 105 CMR 480.150.
• Retain a list of all institutional biosafety committee (IBC)
members, past and present, with credentials, minutes of all
IBC meetings and recommendations of the IBC pursuant to
105 CMR 480.200(F)(3) and 105 CMR 480.200(F)(5).
• Retain copies of all shipping papers with corresponding
medical waste tracking forms, (or the signed original
shipping papers in the case of small-scale generators or
Sharps Collection Centers that transport their own waste
within the state) for a period of 375 days (DOT requires
shipping papers be retained for two years)
47
Ref: 105 CMR 480.500(F)-(H)

48. Recordkeeping Log
• (cont’d):
• Make all such procedures, records and
record-keeping log accessible and
available upon request to the
Mass. Department of Public Health
and the Board of Health at all
reasonable times.
48
Ref: 105 CMR 480.500(I)

49. Module 4: Shipping & Transportation
49

50. Offering for Transport
• Prior to transport for off-site disposal, waste which has
been rendered noninfectious must be labeled or otherwise
marked so as to clearly identify it as noninfectious medical
or biological waste and to identify the waste generator
responsible for the treatment.
• Waste generators, must not ship any container of medical
or biological waste which shows evidence of leaking or
which is otherwise torn or damaged.
• Small-scale generators and Sharps Collection Centers
may transport their own waste in accordance with the
requirements of 105 CMR 480.300(F).
50
Ref: 105 CMR 480.300(C), (E)-(F)

51. Shipping Papers
• Waste generators must prepare shipping papers before shipping
waste off-site that has not been rendered noninfectious prior to
transport. A designee must be appointed to prepare, sign and
maintain such shipping papers.
• The shipping papers must be signed and dated by the waste
generator’s, designee and must include the following information:
• The name, address, and phone number of the waste generator along with a
contact name and emergency contact number for an individual who either
has knowledge about the waste material, including emergency response
information, or who has immediate access to a person who possesses such
knowledge and information;
• A description of the waste to be shipped;
• The total quantity of waste to be shipped;
51
Ref: 105 CMR 480.400

52. Shipping Papers
• The type of container or containers in which waste is
to be transported;
• The destination of the delivery;
• All shipping papers must be retained, with the record-
keeping log, for a period of 375 days after the material
is accepted by the transporter (DOT requires shipping
papers be retained for two years)
• Shipping papers must be made available upon request
by the Mass. Department of Public Health or the local
Board of Health at all reasonable times.
52
Ref: 105 CMR 480.400

53. DOT Hazardous Materials Regulations
• Additional Requirements for those Preparing or
Authorizing Shipments of RMW
• Medical of Biological Waste is regulated as a hazardous
material by the USDOT and must be prepared for
shipment in accordance with the Hazardous Materials
Regulations- 49 CFR Parts 100-185
53
Ref: 105 CMR 480.300(D)
Supplemental Training for “Hazmat Employees”

54. Questions?